Today's News and Commentary

About health insurance/insurers

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

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

About pharma

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

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

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

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

About the public’s health

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

About healthcare IT

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

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

 

Today's News sand Commentary

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

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

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

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

About health insurance/insurers

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

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

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

About hospitals and healthcare systems

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

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

About pharma

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

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

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

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

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

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

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

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

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

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

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

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

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

About the public’s health

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

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

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

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

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

About healthcare IT

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

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

About healthcare personnel

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

Today's News and Commentary

About Covid-19

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

 About healthcare safety

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

  1. Timely, effective and appropriate care;

  2. Safe health care processes and practices;

  3. Qualified and competent health workers;

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

  5. Safe and secure health care facilities;

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

  7. Information, education and supported decision making

  8. Access medical records;

  9. To be heard and fair resolution;

  10. Patient and family engagement.”

About health insurance/insurers

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

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

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

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

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

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

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

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

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

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

About pharma

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

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

About the public’s health

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

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

Today's News and Commentary

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

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

About health insurance/insurers

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

About pharma

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

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

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

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

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

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

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

About the public’s health

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

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

About healthcare IT

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

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

About healthcare finance

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

Today's News and Commentary

About health insurance/insurers

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

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

About hospitals and healthcare systems

 20 large health systems ranked by reputation score FYI

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

About the public’s health

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

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

About healthcare IT

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

About healthcare finance

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

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About health insurance/insurers

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

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

About pharma

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

Top 15 specialty pharmacies by 2023 revenue FYI

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

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

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

About the public’s health

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

About healthcare personnel

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

About healthcare finance

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

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About health insurance/insurers

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

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

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

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

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

About pharma

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

About the public’s health

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

Today's News and Commentary

About Covid-19

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

About healthcare quality

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

  1. Patient attribution

  2. Benchmarking 

  3. Risk adjustment

  4. Quality performance impact on payment 

  5. Levels of financial risk 

  6. Payment timing and accuracy 

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

About health insurance/insurers

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

 Healthcare billing fraud: 12 recent cases FYI

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

About pharma

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

 About healthcare personnel

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

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

About health technology

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

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

Today's News and Commentary

About health insurance/insurers

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

About hospitals and healthcare systems

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

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

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

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

About the public’s health

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

Today's News and Commentary

About health insurance/insurers

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

About hospitals and healthcare systems

 472 hospitals honored for patient safety, price transparency FYI

 About pharma

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

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

Drug Shortages Statistics Summary

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

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

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

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

 

About the public’s health

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

About healthcare personnel

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

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

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

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

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

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

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

About healthcare finance

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

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About pharma

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

About the public’s health

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

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

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

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

About healthcare IT

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

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About health insurance/insurers

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

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

About hospitals and healthcare systems

How labor costs are tracking at 30 health systems FYI

About pharma

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

About healthcare IT

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

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

Surescripts exploring a sale: report Dive Brief:

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

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

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

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

Today's News and Commentary

About quality and safety

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

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

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

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

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

About health insurance/insurers

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

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

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

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

About hospitals and healthcare systems

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

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

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

About pharma

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

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

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

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

About healthcare finance

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

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

Today's News and Commentary

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

About Covid-19

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

About health insurance/insurers

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

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

About hospitals and healthcare systems

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

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

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

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

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

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

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

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

About pharma

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

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

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

About the public’s health

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

Today's News and Commentary

About health insurance/insurers

Change Healthcare to begin processing $14B in claims “Change Healthcare said March 22 it plans to restore its biggest clearinghouse platforms over the weekend and start processing $14 billion in claims.
The UnitedHealth Group subsidiary said it brought the Assurance claims preparation system back online March 18 and intends to reinstate Relay Exchange, its largest clearinghouse, the weekend of March 23.”

Taxpayers Were Overcharged for Patient Meds. Then Came the Lawyers. Suits against PBM overcharges, “which now total nearly $1 billion, [appear to have been ] driven by state governments cracking down on a company that had ripped off taxpayers.
But a New York Times investigation, drawing on thousands of pages of court documents, emails and other public records in multiple states, reveals that the case against Centene was conceived and executed by a group of powerful private lawyers who used their political connections to go after millions of dollars in contingency fees….
So far, the lawyers have been awarded at least $108 million in fees.”

About hospitals and healthcare systems

 Hospitals Are Adding Billions in ‘Facility’ Fees for Routine Care  A great article in The Wall Street Journal that highlights the increased costs of facility fees that hospitals (but not independent physician offices) can and do charge.

About the public’s health

Requiring ugly images of smoking’s harm on cigarettes won’t breach First Amendment, court says “A federal requirement that cigarette packs and advertising include graphic images demonstrating the effects of smoking — including pictures of smoke-damaged lungs and feet blackened by diminished blood flow — does not violate the First Amendment, an appeals court ruled Thursday.
The ruling from a three-judge panel of the 5th U.S. Circuit Court of Appeals was a partial victory for federal regulators seeking to toughen warning labels. But the court kept alive a tobacco industry challenge of the rule, saying a lower court should review whether it was adopted in accordance with the federal Administrative Procedure Act, which governs the development of regulations.
The 5th Circuit panel rejected industry arguments that the rule violates free speech rights or that it requires images and lettering that take up so much space that they overcome branding and messaging on packages and advertisements.”

US exceptionalism? International trends in midlife mortality Background Rising midlife mortality in the USA has raised concerns, particularly the increase in ‘deaths of despair’ (due to drugs, alcohol and suicide). Life expectancy is also stalling in other countries such as the UK, but how trends in midlife mortality are evolving outside the USA is less understood. We provide a synthesis of cause-specific mortality trends in midlife (25–64 years of age) for the USA and the UK as well as other high-income and Central and Eastern European (CEE) countries.
Results US midlife mortality rates have worsened since 1990 for several causes of death including drug-related, alcohol-related, suicide, metabolic diseases, nervous system diseases, respiratory diseases and infectious/parasitic diseases. Deaths due to homicide, transport accidents and cardiovascular diseases have declined since 1990 but saw recent increases or stalling of improvements. Midlife mortality also increased in the UK for people aged 45–54 year and in Canada, Poland and Sweden among for those aged 25–44 years.”

Healthcare Quality and Safety

J&J's Abiomed sees serious Impella recall linked to heart perforations, 49 deaths “Johnson & Johnson MedTech’s Abiomed division has another serious recall on its hands stemming from its line of miniaturized Impella heart pumps, following reports that the devices could pierce and cut through the wall of the left ventricle during operation.
The FDA reported this week that it was aware of 49 patient deaths related to the issue, among 129 records of severe injuries.”

BD boosts U.S. production as FDA warns against using plastic syringes from China “The FDA last week re-upped its recommendations that healthcare providers avoid using plastic syringes made in China wherever possible, while it continues to investigate growing quality concerns. In response, BD said it would be increasing U.S. production of the ubiquitous drug delivery hardware to help cover the gap.
The agency first made its worries public late last November, after it collected reports of leaks, breakages and other problems.”

FDA elevates recall of 6.6M Vyaire Medical emergency bag valve masks “The FDA is getting the word out on an ongoing recall of millions of hand-powered bag valve masks, which may not deliver enough oxygen to a patient in need of resuscitation.
The disposable emergency devices, stocked in ambulances and kept at hospital bedsides, are used to force air into the lungs to help counter insufficient breathing or respiratory arrest.
The recall covers different sizes and accessories of Vyaire Medical’s AirLife adult manual resuscitators, spanning some 6.6 million devices. The FDA said that a manufacturing defect—present only in equipment produced in 2017 or before—could result in patients not receiving enough ventilation, or any at all.”

Medicaid Health Plan Will Reimburse Health Equity Certification “Meridian Health Plan of Illinois, Inc.—a wholly-owned subsidiary of Centene Corporation that offers Medicaid coverage—announced that it will cover part of the fee hospitals must pay to undergo health equity certification through the Joint Commission.”

About healthcare IT

Digital Diabetes Management Solutions “Digital diabetes management solutions in the remote patient monitoring and behavior and lifestyle modification categories do not deliver meaningful clinical benefits, and they increase healthcare spending relative to usual care. The evidence showed that improvements in glycemic control for patients using digital diabetes management solutions were minimal and short-term.”

About healthcare finance

 Novo Nordisk inks $1B Cardior buyout to pump up heart failure plans Novo Nordisk is pumping up its heart failure plans. The drugmaker, swelled by its GLP-1 windfall, has decided to buy Cardior Pharmaceuticals and its midphase prospect in a deal that could top out above 1 billion euros ($1.1 billion).
Cardior is developing an antisense oligonucleotide to inhibit a piece of non-coding RNA, miR-132, that is implicated in heart failure. Upregulation of the RNA when certain cells are stressed can lead to changes in the size and shape of the heart. Blocking elevated miR-132 could therefore prevent or reverse changes that are associated with poor prognosis in patients who have heart attacks.”

Today's News and Commentary

Tomorrow (March 23) is the 14th anniversary of passage of the first part of the Patient Protection and Affordable Care Act (AKA Obamacare). [The law was amended by the Health Care and Education Reconciliation Act on March 30, 2010.]

Congress unveils $1.2 trillion plan to avert federal shutdown and bring budget fight to a close First read this overview from the AP. Then look at the Democratic summary and the Republican summary.
The former has good details about the healthcare and human services provisions while the latter focuses more on items like the defense budget.
In related news: House-passed bill instructs Congressional Budget Office to take longer view when grading preventive health laws “Tuesday, the House of Representatives passed a bill that would allow lawmakers to request the Congressional Budget Office (CBO) to generate budgetary savings estimates of prospective preventive healthcare legislation over a 30-year window as opposed to the current 10-year scoring window.”

About health insurance/insurers

 Republican majorities block efforts to expand Medicaid in Georgia and Kansas “ Plans to expand Medicaid coverage to over half a million more people in Georgia and Kansas were defeated by Republican-led committees in the states’ legislatures Thursday.
There are currently only 10 states that don’t cover people with incomes up to 138% of the federal poverty line, after North Carolina began offering Medicaid to uninsured adults last December.”

Providers 'wasted' $10.6B in 2022 overturning claims denials, survey finds “Providers spent nearly $20 billion in 2022 pursuing delays and denials across all payer types, yet those efforts are substantially more costly on average when dealing with private plans, Premier, a group purchasing organization, wrote in a recent blog post on the new data.
Just over half of the total comes from denied claims that are eventually paid out, meaning that about $10.6 billion is ‘wasted arguing over claims that should have been paid at the time of submission,’ Premier wrote.”

About pharma

 GSK to cap out-of-pocket inhaler costs in US  “British pharmaceutical giant GSK said on Wednesday it would cap out-of-pocket costs for all its inhaled asthma and chronic lung disease medicines at $35 per month for eligible patients in the United States, following similar moves by two of its rivals.
GSK said the decision will take effect by Jan. 1, 2025.
The cost cap would apply to all of its asthma and chronic obstructive pulmonary disease (COPD) medicines, including Advair Diskus, Advair HFA, and Trelegy Ellipta, and would apply to patients whose monthly costs currently exceed $35.”

Arches Medical Partners buys 11 primary care clinics from VillageMD “Walgreens-owned VillageMD sold 11 primary care clinics in Rhode Island to Boston-based Arches Medical Partners.
The deal establishes the medical group management company's presence in the Providence metro area while continuing to provide access to high-quality care with experienced providers to approximately 75,000 patients, according to the company in a press release…
VillageMD continues to shed clinics across the country as part of Walgreens' aggressive $1 billion cost-saving strategy as it looks to boost profitability in its healthcare business. That effort also includes slashing capital expenditures by about $600 million.
The companies did not disclose the financial details.”

About the public’s health

 Drug overdoses reach another record with almost 108,000 Americans in 2022, CDC says “Nearly 108,000 Americans died of drug overdoses in 2022, according to final federal figures released Thursday.
Over the last two decades, the number of U.S. overdose deaths has risen almost every year and continued to break annual records — making it the worst overdose epidemici n American history.
The official number for 2022 was 107,941, the U.S. Centers for Disease Control and Prevention said, which is about 1% higher than the nearly 107,000 overdose deaths in 2021.”

House committee launches investigation into organ transplant network “The House Committee on Energy and Commerce has launched a bipartisan investigation into the U.S. organ transplant system – the latest scrutiny of the system following reports from the Senate and whistleblowers alleging its failures and mismanagement.
The move by the committee aims to "ensure successful implementation" of a bipartisan bill that was signed into law by President Joe Biden last September. The law was aimed at breaking up the monopoly system that allowed a private nonprofit --- the United Network for Organ Sharing -- to be the sole contractor managing the country's Organ Procurement and Transplantation Network (OPTN) for over 40 years.”

About health technology

 US surgeons transplant a gene-edited pig kidney into a patient for the first time “Doctors in Boston have transplanted a pig kidney into a 62-year-old patient, the latest experiment in the quest to use animal organs in humans.
Massachusetts General Hospital said Thursday that it’s the first time a genetically modified pig kidney has been transplanted into a living person. Previously, pig kidneys have been temporarily transplanted into brain-dead donors. Also, two men received heart transplants from pigs, although both died within months.”

Today's News and Commentary

About health insurance/insurers

 Medicare creates coverage path for anti-obesity meds “The US Centers for Medicare and Medicaid Services (CMS) confirmed to FirstWord Thursday that Medicare Part D plans can cover the cost of obesity drugs if – like Novo Nordisk's Wegovy (semaglutide) – they have received FDA approval for an additional ‘medically accepted indication’ such as preventing heart attacks and strokes.”

About pharma

Orchard settles on $4.25M US price tag for leukodystrophy gene therapy “Orchard Therapeutics disclosed Wednesday that its metachromatic leukodystrophy (MLD) gene therapy Lenmeldy (atidarsagene autotemcel) will carry a wholesale acquisition cost of $4.25 million in the US. The company said that the price of the one-time treatment – which makes it the most expensive drug ever – reflects its ‘clinical, economic and societal value.’”

Novel Oral Antihypertensive Gets FDA's Blessing “The FDA has approved aprocitentan (Tryvio), making it the first endothelin receptor antagonist for the treatment of high blood pressure (BP), Idorsia Pharmaceuticals announced on Wednesday.
The once-daily oral medication is indicated in combination with other antihypertensive drugs to lower BP in adult patients who do not have their BP controlled with other therapies.”

About the public’s health

A distinct Fusobacterium nucleatum clade dominates the colorectal cancer niche Fusobacterium nucleatum (Fn), a bacterium present in the human oral cavity and rarely found in the lower gastrointestinal tract of healthy individuals, is enriched in human colorectal cancer (CRC) tumours. High intratumoural Fn loads are associated with recurrence, metastases and poorer patient prognosis.”

Global fertility rates to plunge in decades ahead, new report says “A new study projects that global fertility rates, which have been declining in all countries since 1950, will continue to plummet through the end of the century, resulting in a profound demographic shift.
The fertility rate is the average number of children born to a woman in her lifetime. Globally, that number has gone from 4.84 in 1950 to 2.23 in 2021 and will continue to drop to 1.59 by 2100, according to the new analysis, which was based on the Global Burden of Diseases, Injuries, and Risk Factors Study 2021, a research effort led by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. The study was published Wednesday in the journal the Lancet.”

Mortality in the United States, 2022 Data from the National Vital Statistics System

  • Life expectancy for the U.S. population in 2022 was 77.5 years, an increase of 1.1 years from 2021.

  • The age-adjusted death rate decreased by 9.2% from 879.7 deaths per 100,000 standard population in 2021 to 798.8 in 2022.

  • Age-specific death rates increased from 2021 to 2022 for age groups 1–4 and 5–14 years and decreased for all age groups 15 years and older.

  • The 10 leading causes of death in 2022 remained the same as in 2021, although some causes changed ranks. Heart disease and cancer remained the top 2 leading causes in 2022.

  • The infant mortality rate was 560.4 infant deaths per 100,000 live births in 2022, an increase of 3.1% from the rate in 2021 (543.6).”

 

About healthcare IT

 Providers file class action lawsuits over fallout from Change Healthcare cyberattack “On the heels of proposed class action lawsuits from patients, providers are also filing legal challenges against UnitedHealth Group in the wake of the cyberattack on Change Healthcare.”
The article has several example of groups filing suits.

Key Issues as Wearable Digital Health Technologies Enter Clinical Care This NEJM article requires subscription but it is well-worth reading if you can access it. The authors summarize their findings: “…we identify six interlocking and vexing issues at the foundation of delivering DHT-informed care: data ownership; patient trust, literacy, and access; standards and interoperability; integration of DHTs into clinical care; patient empowerment and agency; and reimbursement and a return on investment for health care systems.” 

Today's News and Commentary

About health insurance/insurers

 The 10 best health insurance companies of 2024 FYI

About the public’s health

 Biden Administration Announces Rules Aimed at Phasing Out Gas Cars “The Biden administration on Wednesday issued one of the most significant climate regulations in the nation’s history, a rule designed to ensure that the majority of new passenger cars and light trucks sold in the United States are all-electric or hybrids by 2032…
The rule increasingly limits the amount of pollution allowed from tailpipes over time so that, by 2032, more than half the new cars sold in the United States would most likely be zero-emissions vehicles in order for carmakers to meet the standards.”

About healthcare IT

 Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates This OCR update is worth reading. In summary: “Regulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of PHI to tracking technology vendors or any other violations of the HIPAA Rules. For example, disclosures of PHI to tracking technology vendors for marketing purposes, without individuals’ HIPAA-compliant authorizations, would constitute impermissible disclosures.”

Today's News and Commentary

About health insurance/insurers

 Highmark Health hits $27B in revenue and net income exceeds half-billion following layoffs “Highmark Health recorded $27.1 billion in revenue and a net income of $533 million for 2023, the company announced during its fourth-quarter results Monday.
The company reported an operating margin of $338 million, though there was an operating loss of of $117 million during 2023 for the Allegheny Health Network as the system recovers from the pandemic. That was offset by gains seen in health insurance and other investments.”

 About pharma

 Kroger to sell specialty pharmacy business to Elevance Health's CarelonRx  “Grocer Kroger said on Monday it had entered a definitive agreement for the sale of its specialty pharmacy business to CarelonRx, a unit of U.S. health insurer Elevance Health .
The financial terms of the deal were not disclosed…
Kroger Specialty Pharmacy is separate from other Kroger Family of Pharmacies, including in-store retail pharmacies and The Little Clinics, which are not included in the deal.”

AstraZeneca to pay $2B to buy radiopharmaceuticals partner “AstraZeneca is making its first major purchase in the radiopharmaceuticals space, forking out around $2 billion to buy Fusion Pharmaceuticals and its pipeline of assets based on actinium-225. The companies first joined forces in 2020 to develop next-generation alpha-emitting radiopharmaceuticals and combination therapies for the treatment of cancer.”

AstraZeneca to cap out-of-pocket inhaler costs in US, following rival Boehringer's move “Drugmaker AstraZeneca (AZN.L), opens new tab said on Monday it would cap out-of-pocket costs for its inhaled respiratory products at $35 per month in the United States from June, following a similar move by rival Boehringer Ingelheim earlier in the month.”

Online sales begin for first over-the-counter birth control pill in US “Online sales began Monday for the first over-the-counter birth control pill approved in the U.S. 
The product, Opill, can be bought online at Amazon and directly from Opill.com, said Sara Young, senior vice president and chief consumer officer at Perrigo, the pill’s manufacturer. Once the drugs are in stock, Walgreens and Walmart will sell them online, as well. Orders will be fulfilled within 24 to 48 hours, according to Young, and will usually arrive in three to five business days.”

About the public’s health

After calling on Congress to fund women's health, Biden directs agencies to boost R&D “Ten days after asking Congress to fund women’s health research with $12 billion, President Joe Biden is doing what he can to boost investment via an executive order to expand and improve research on women’s health.
The orders come with 20 new actions across federal agencies such as the Department of Health and Human Services, under which the FDA sits. Within the actions is a $200 million National Institutes of Health initiative for fiscal year 2025 to fund new women’s health research. This would be the first step in the call to action issued by Biden at the State of the Union on March 8.”

8-hour time-restricted eating linked to a 91% higher risk of cardiovascular death Research Highlights:

  • A study of over 20,000 adults found that those who followed an 8-hour time-restricted eating schedule, a type of intermittent fasting, had a 91% higher risk of death from cardiovascular disease.

  • People with heart disease or cancer also had an increased risk of cardiovascular death.

  • Compared with a standard schedule of eating across 12-16 hours per day, limiting food intake to less than 8 hours per day was not associated with living longer.”

CDC urges vaccination amid rise in measles cases in the US and globally “US health officials are warning doctors about the dramatic rise in measles cases around the world, and advising families traveling to a measles-affected country to get babies as young as 6 months vaccinated before they go.”

About healthcare IT

STATE OF CPS SECURITY REPORT Healthcare 2023 “The Cybersecurity and Infrastructure Security Agency (CISA) maintains a growing catalog of Known Exploited Vulnerabilities (KEVs). KEVs that exist on hospital networks are particularly alarming, because
these exposures have exploits written to compromise them, and are therefore easily compromisable. 63% of KEVs tracked by CISA can be found on healthcare networks, while 23% of medical devices—including imaging devices, clinical IoT devices, and surgery devices—have at least one known exploited vulnerability. Complicating matters is that users must contend with 360 medical device manufacturer (MDM) patch certification programs to ensure compliance requirements and verify that products provide reasonable protection against risk…
[For example:] From our research, 4% of devices used in surgeries can be accessible via a hospital’s guest network.”

The new era of consumer engagement: Insights from Rock Health’s ninth annual Consumer Adoption Survey A great summary of consumer preferences for IT use.

Today's News and Commentary

About health insurance/insurers

 From today’s STAT newsletter re: UnitedHealth’s loan program due to the Change hack: “Eleven providers and provider lobbying groups told [STAT that] UnitedHealth was handing out minuscule amounts in its initial loan program. Many loans were in the three-figure range. Mike Gebhart, CFO of Highlands Oncology Group in Arkansas, told [STAT] his practice was offered $59,000 — less than 1% of the $7 million per week in claims the group normally gets. But UnitedHealth has since rolled out another program, where providers tell the company what their shortfall is. Gebhart got a loan offer that he described as ‘exactly what we needed.’”
In a related post: UnitedHealth has paid out $2B in advanced payments following cyberattack “In its latest update on the response to the cyberattack on Change Healthcare, UnitedHealth Group said that it will begin today to release medical claims preparation software, a move it says is a critical step in restoring services.
The software will be rolled out to thousands of customers in the next several days, according to the announcement. UHG said that it intends to have third-party attestations available before services are fully online.”

Medicare Payment Policy [March, 2024 MedPAC report] An excellent summary of current status and recommendations for the Medicare program. For example: “We estimate that Medicare spends 22 percent more for [Medicare Advantage] enrollees than it would spend if those beneficiaries were enrolled in [traditional] Medicare, a difference that translates into a projected $83 billion in 2024 … the many iterations of full-risk contracting with private plans have never yielded aggregate savings for the Medicare program.”
Absolutely worth a least a skim.

About pharma

 The top 10 pharma R&D budgets for 2023  FYI Merck earned the top spot with $30.53 billion.

About the public’s health

Toxic asbestos is now fully banned, a move that EPA calls ‘historic’ “ The Environmental Protection Agency on Monday finalized a ban on chrysotile asbestos, part of a family of toxic minerals linked to lung cancer and other illnesses that the agency estimates is responsible for about 40,000 U.S. deaths each year.
The federal ban comes more than 30 years after EPA first tried to rid the nation of asbestos, but was blocked by a federal judge. While the use of asbestos in manufacturing and construction has declined since, it remains a significant health threat.”

National HIV self-testing program finds high demand, many testing for first time “…from March 2023 to December 2023…181,558 orders were placed — most (86%) for two tests — and a total of 337,812 tests were shipped.
Sixty percent of orders included enough information to describe people ordering the tests in terms of priority populations: 61% were men who reporting having sex with male partners in the previous 12 months — 18% Black and 33% Hispanic — 10.7% were gender diverse people and 10% were Black women.
Most participants (62%) ordered tests through messages and in-app buttons in the Grindr app — seven out of 10 orders were placed through a social media or dating app — and most people who ordered tests either had never had an HIV test (26%) or did not have a test in more than 12 months (27%).”

About healthcare personnel

Nurses report wage, staffing dissatisfaction but most say they'll stick around until retirement, report finds  “…nearly a quarter of nurses say they are very likely to leave their role this year. Though nurses are slightly less dissatisfied with current staffing levels compared to 2023, 88% believe that patient care is being negatively impacted by staffing shortages. More than half of nurses (63%) are assigned to care for too many patients at a time. Nearly a quarter reported they were required to perform tasks outside of their job description due to staffing shortages.”

NRMP® Celebrates Match Day for the 2024 Main Residency Match®, Releases Results for Over 44,000 Applicants and Almost 6,400 Residency Programs FYI. Concerns remain about primary care numbers.