This Week's News and Commentary

Below are a two studies that cover a broad range of topics on our healthcare system:

National Health Care Spending In 2022: Growth Similar To Prepandemic Rates An annual MUST-READ from Health Affairs: “Health care spending in the US grew 4.1 percent to reach $4.5 trillion in 2022, which was still a faster rate of growth than the increase of 3.2 percent in 2021 but was much slower than the rate of 10.6 percent seen in 2020. In 2022, strong Medicaid and private health insurance spending growth, including a turnaround in the net cost of insurance, was somewhat offset by continued declines in federal spending associated with the COVID-19 pandemic. The insured share of the population reached a historic high of 92.0 percent in 2022 as enrollment in private health insurance increased at a faster rate relative to 2021 and Medicaid enrollment continued to experience strong growth. The share of the economy accounted for by the health sector was 17.3 percent in 2022, which was down from a peak of 19.5 percent in 2020 but was more consistent with the average share of 17.5 percent during 2016–19.”
2023 Year in Review: Healthcare Economics Edition “From Q1 to the end of Q3, we saw an increase of 2.0% across all 500 shoppable services. This is in line with the 1.9% overall US inflation measured by the Personal Consumption Expenditures Price Index (PCE) and below the overall US inflation measured by the Consumer Price Index (CPI-U)…
While inflation across these 500 services has been moderate overall, we see a lot of variation when we investigate service by service. We see the largest price increases in areas like Chickenpox and Measles vaccines. On the deflationary side, off-hours medical services, allergy tests, and vaginal delivery of placentas have seen the largest price drops.”

About Covid-19

 Covid and flu rising ahead of holidays, increasing ER visits “Respiratory viruses are rebounding in the United States on the precipice of the end-of-year holidays, with emergency room visits for covid-19, influenza and respiratory syncytial virus collectively reaching their highest levels since February.
Among the three viruses, covid continues to be the biggest driver of hospitalizations, settling into a familiar rhythm of causing periodic waves without wreaking havoc on the health-care system as it once did. Hospitals reported more than 22,000 new covid admissions the week ending Dec. 2, the highest since the peak of the summer wave in September.”

About healthcare quality/safety

Thousands of Patients May Be Undergoing Vascular Procedures Too Soon or Unnecessarily Read this expose from ProPublica. It names physicians doing these procedures and their Medicare payments.

Summary of Revisions: Standards of Care in Diabetes—2024 From the American Diabetes association

Quality First: Consumer Product Recalls Have Risen 115% Since 2018We recently dove deep into publicly available data about recalls in the U.S. from the U.S. Food and Drug Association (FDA) and the Consumer Product Safety Commission (CPSC). Our goal was to better understand the regulatory environment and get a clearer sense of how often companies had to recall products.
We were shocked to discover that recalls across the FDA and CPSC are up 115% since 2018.”
The article goes into more detail by product type. For example: “Allergens are the most common driver of recalls by the FDA, driving 34% of instances.”

Medicare Advantage Provides Higher Quality of Care And Better Rates of Preventive Service Use WHEN COMPARED TO ORIGINAL MEDICARE “To assess differences in quality of care and utilization of services and medication, we compared performance results for certain Healthcare Effectiveness Data and Information (HEDIS) measures focused on preventive and chronic disease care in original Medicare and Medicare Advantage in 2019. Across 11 HEDIS measures, Medicare Advantage outperformed original Medicare in all but one all but one…”
See the summary and Table 1.

About health insurance/insurers

 Cigna Calls Off Humana Pursuit, Plans Big Stock Buyback “The companies couldn’t come to agreement on price and other financial terms, according to people familiar with the matter. In the near term, Cigna is turning its focus toward smaller, so-called bolt-on, acquisitions…
nstead, Bloomfield, Conn.-based Cigna said Sunday that it plans an additional $10 billion of stock buybacks, bringing its total planned repurchases to $11.3 billion. It made no comment on the Humana talks.”

Estimated Savings From the Medicare Shared Savings Program Results  The MSSP was associated with net losses to traditional Medicare of between $584 million and $1.423 billion over the study period. Savings from MSSP-related reductions to MA benchmarks totaled between $4.480 billion and $4.923 billion. Across traditional Medicare and MA, the MSSP was associated with savings of between $3.057 billion and $4.339 billion. This represents approximately 0.075% of combined spending for traditional Medicare and MA over the study period.
Conclusions and Relevance  This economic evaluation found that the MSSP was associated with net losses to traditional Medicare, net savings to MA, and overall net savings to CMS. The total budget impact of the MSSP to CMS was small and continues to be uncertain due to challenges in estimating the effects of the MSSP on gross spending, particularly in recent years.”

The Comprehensive Primary Care Plus [CPC+] Model and Health Care Spending, Service Use, and Quality “CPC+ was not associated with a reduction in total expenditures over 5 years. Positive interaction between CPC+ and the Shared Savings Program suggests transformation models might be more successful when provider cost-reduction incentives are aligned across specialties.”
Comment: The second “conclusion” is so longstanding that to say “might” is unnecessary.

A New Government Forum for Surprise Medical Bills Is Getting More Disputes Than It Can Handle So Far From the GAO: “As of June 2023, over 490,000 disputes have been submitted, a much larger number than anticipated by the agencies.
And 61% of the disputes are unresolved as of June 2023…
To address concerns from insurers and providers, CMS and Labor look into complaints; however, stakeholder groups expressed concern with what they describe as a lack of response to submitted complaints. The departments reported limited ability to increase enforcement efforts due to budget constraints.:

Payers' increasing claims denials, delays 'wreaking havoc' on provider revenue cycles “Kodiak RCA (formerly Crowe healthcare consulting), pulls average revenue cycle performance benchmarks from platform incorporating more than 1,800 hospitals’ and 200,000 physicians’ data.
The analysis found, among other trends, an increase in overall initial denial rates from 10.15% in 2020 to 11.2% in 2022, and then up again to 11.99% in the first three quarters of 2023…
The other report, released late last month by Syntellis and the American Hospital Association (AHA), reviewed the financial data of more than 1,300 hospitals and health systems.
Its highlights included 55.7% and 20.2% increases in denials from Medicare Advantage and commercial payers, respectively, from the top of 2022 to the midway point of 2023.”

The cities with the most competitive commercial insurance markets | 2023 FYI
For the full analysis, see: COMPETITION in HEALTH INSURANCE A comprehensive study of U.S. market See Table A-1 (starting on page 160 in the appendix for information on all SMSAs.

About hospitals and healthcare systems

100 largest hospitals and health systems in the US | 2023 FYI

7 hospitals, health systems recently hit with rating downgrades FYI
In a related article: CHS suffers credit rating downgrade

68 health systems with strong finances FYI

The 340B repayments 100 hospitals are set to receive “CMS bookmarked $9 billion for the 2,600 340B hospitals to repay unlawful payment cuts, and nearly half, $4.3 billion, is planned for 100 of those hospitals, according to data from the Community Oncology Alliance.”
A list of hospitals is in the article.

About pharma

Biden administration to impose inflation penalties on dozens of drugmakers “Prices of 48 drugs that fall under Medicare Part B, which covers drugs administered at a health facility, surged faster than inflation in the last quarter of 2023, according to the White House.
These drugs may be subject to inflation rebates in the first quarter of 2024 as a result of the IRA, which Biden, a Democrat, signed last year.
The Centers for Medicare and Medicaid Services and the White House did not immediately respond to requests for more details on the 48 drugs.”

An analysis of the $6 billion in grants distributed by PhRMA and its member companies A must-read to see how large and pervasive these payments are.

Pfizer finds room for ADC snack after swallowing Seagen, inking deal for mesothelin candidate “Pfizer just swallowed a $43 billion antibody-drug conjugate (ADC) company and still isn’t full. Hours after Pfizer closed the Seagen buyout, Nona Biosciences put out news that the Big Pharma has committed $53 million in upfront and near-term payments for rights to its mesothelin-targeted ADC.”

Justices will review lower-court ruling on access to abortion pill The Supreme Court on Wednesday morning agreed to review a ruling by a federal appeals court that would significantly restrict (but not eliminate altogether) access to a drug [mifepristone] used in medication abortions, which account for over half of all abortions performed in the United States. Wednesday’s announcement means that the justices will weigh in on the issue of abortion for the first time since overruling the constitutional right to an abortion last year in Dobbs v. Jackson Women’s Health Organization. Their decisions in the new cases, Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine, are likely to come sometime next summer, in the middle of the 2024 presidential campaign.”

Spending on Dual Over-the-Counter and Prescription Drugs in the Medicare Part D Program “Medicare Part D frequently paid more for dual OTC and prescription drugs than the OTC cash prices. Patients’ cost-sharing was sometimes higher than what they would pay for the same drug without insurance or a prescription.”
Comment: These findings are not new, but it is a good reminder of the issue.

Unsupported Price Increases Occurring in 2022 [Institute for Clinical and Economic Review, 2023] “The price of many existing drugs, both brand and generic, can increase substantially over time, and questions are frequently raised regarding whether these price increases are justified. State policymakers have been particularly active in seeking measures to address this issue. Despite these initiatives, there had been no systematic approach at a state or national level to determine whether certain price increases are justified by new clinical evidence or other factors.”
For a quick look atbthe results of this year’s analysis, see Table ES1.

Pharmacies sharing medical data without police warrant: Congressional investigation “A congressional investigation has discovered that law enforcement agencies have been accessing patient prescription records through pharmacies without warrants, with most people unaware that their private data is being handed over to authorities.”

 Moody's cuts Walgreens to junk on health care strategy push “Walgreens Boots Alliance Inc. had its senior unsecured credit rating cut to junk by Moody’s Investors Service, with the credit grader citing the drugstore chain’s high debt relative to earnings and risks associated with its push to offer more healthcare services. 
The downgrade to Ba2 — two steps into high-yield — reflects ‘Walgreens’ stubbornly high financial leverage, weak interest coverage and pressured free cash flow that Moody’s believes will be sustained over the next 12-18 months,’ senior credit officer Chedly Louis wrote in a note Monday.”

AstraZeneca buys US vaccine company in $1.1bn deal “AstraZeneca is buying its first vaccine company in a $1.1bn deal that will expand the vaccine and immune therapy business it set up during the Covid pandemic.
Britain’s biggest drugmaker has agreed to take over the Seattle-based company Icosavax, which is developing a potential vaccine for two common respiratory diseases.
The US firm’s lead product targets two diseases – respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) – that cause severe illness and hospitalisation in adults over 60 and people with chronic conditions such as cardiovascular, kidney and respiratory disease. RSV and hMPV can also be serious in young children.”

Sigma Healthcare Agrees to $5.79 Billion Merger With Pharmacy Chain “Australian drug supplier Sigma Healthcare agreed to merge with privately owned pharmacy operator CW Group, creating a listed company worth more than 8.8 billion Australian dollars (US$5.79 billion)…
The merger will create a combined healthcare wholesaler, distributor and retail pharmacy franchiser, Sigma said.”

Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity “Findings  After 36 weeks of open-label maximum tolerated dose of tirzepatide (10 or 15 mg), adults (n = 670) with obesity or overweight (without diabetes) experienced a mean weight reduction of 20.9%. From randomization (at week 36), those switched to placebo experienced a 14% weight regain and those continuing tirzepatide experienced an additional 5.5% weight reduction during the 52-week double-blind period.
Meaning  In participants with obesity/overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction.”
Comment: The non-clinical implication is that medications in this class of drugs will need to be prescribed for a chronic illness, with attendant costs.

2023's Most Influential Drug and Vaccine Approvals — As Selected by GoodRx Pharmacists FYI. At the top of the list is Paxlovid.

Half of Diabetes Patients Taking Class of Meds That Includes Ozempic, Mounjaro Stop Using Them “Many Americans battling diabetes are turning to a new class of injected drugs that includes blockbusters like Ozempic (semaglutide) and Mounjaro (tirzepatide).
But a new study finds half of patients who use these "second line" therapies -- a class called GLP-1 RAs -- quit them within a year.
One potential reason why: Gastrointestinal issues like nausea, vomiting and diarrhea, according to the researchers.”

Pfizer set to close $43-billion Seagen purchase after gaining US nod “Pfizer announced on Tuesday that it agreed to address concerns from the US Federal Trade Commission (FTC) related to its $43-billion acquisition of Seagen. The company noted that it now expects to close the deal for the antibody-drug conjugate (ADC) developer on December 14 having secured clearance from the European Commission in October.”

First postpartum depression pill now available in the US, drugmakers say “The US Food and Drug Administration approved the therapy, called Zurzuvae, in August. The product, which is now at specialty pharmacies, can be shipped directly to patients, Biogen and Sage Therapeutics Inc. said in an announcement Thursday.
However, the medication will cost $15,900 per course before insurance, raising some concerns about how many people will be able to access it.”

About the public’s health

US CDC says there's urgent need to increase respiratory vaccine coverage “The U.S. Centers for Disease Control and Prevention (CDC) on Thursday issued an alert urging healthcare providers to increase immunization coverage for influenza, COVID-19 and respiratory syncytial virus (RSV).
The health regulator said that low vaccination rates, coupled with ongoing increases in respiratory disease activity, could lead to more severe disease and increased healthcare capacity strain in the coming weeks.”

Texas top court rules against woman who sought abortion for medical emergency “The Texas Supreme Court on Monday overturned a lower court's ruling that would have allowed a pregnant woman to get an emergency abortion under the medical exception for the state's near-total abortion ban, granting a petition by Republican Attorney General Ken Paxton.”
Read the entire article. the Court’s double-talk is astounding!

 America’s Health Rankings 2023 Annual Report: Chronic Conditions on the Rise “Eight chronic conditions reached their highest levels since America’s Health Rankings began tracking them. Notably:

  • Diabetes prevalence increased to 11.5% of the adult population, impacting nearly 31.9 million adults.

  • Depression prevalence increased to 21.7% of the adult population, affecting nearly 54.2 million adults.

Stark disparities across nearly all demographic groups include:

  • Chronic Obstructive Pulmonary Disease was 7.1 times higher among American Indian/Alaska Native adults than Asian adults.

  • Cancer was 3.9 times higher among white adults than Asian adults.

  • Depression was 2.4 times higher among adults who identified as LGBQ+ than straight adults.

  • When compared to white adults with diabetes, Hispanic and Black adults were 2.1 times and 1.8 times more likely to have uncontrolled blood sugar levels, as indicated by the A1c test.”

About healthcare IT

Survey Reveals Only 36% of Healthcare Organizations are Prepared to Meet the Requirements of the 21st Century Cures Act “…while more than half of surveyed organizations (61%) have invested effort and resources into meeting the requirements of the Cures Act, only 36% report having the necessary comprehensive data quality programs in place to do so.
 The 21st Century Cures Act set standards for the secure and frictionless exchange of data among payers, providers and consumers, including the establishment of an information-blocking rule that was finalized earlier this year.”

Patterns of Telemedicine Use and Glycemic Outcomes of Endocrinology Care for Patients With Type 2 Diabetes Not everything is better with telemedicine:
Findings 
In this cohort study including 3778 adults, there was no significant change in estimated hemoglobin A1c (HbA1c) over 12 months (−0.06%) among patients using telemedicine alone, while patients who used in-person (−0.37%) and mixed care (−0.22%) had significant HbA1c improvements.
Meaning  These findings suggest that patients with type 2 diabetes who rely on telemedicine alone to access endocrinology care may require additional support to achieve glycemic goals.”

HHS finalizes rule to move the needle on interoperability, algorithm transparency “The rule, called Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency and Information Sharing, or the HTI-1, implements key provisions of the 21st Century Cures Act, with a specific emphasis on health IT certification and information blocking.”

Artificial Intelligence:Agencies Have Begun Implementation but Need to Complete Key Requirements “GAO's analysis of agencies' inventories of use cases identified instances of incomplete and inaccurate data. Specifically, five agencies provided comprehensive information for each of their reported use cases while the other 15 had instances of incomplete and inaccurate data. For example, some inventories did not include required data elements, such as the AI life cycle stage or an indication of whether an AI use case was releasable or not. In addition, two inventories included AI uses that were later determined by the agencies to not be AI. Without accurate inventories, the government's management of its use of AI will be hindered by incomplete and inaccurate data.”

Healthcare providers to join US plan to manage AI risks - White House “Twenty-eight healthcare companies, including CVS Health, are signing U.S. President Joe Biden's voluntary commitments aimed at ensuring the safe development of artificial intelligence (AI), a White House official said on Thursday.
The commitments by healthcare providers and payers follow those of 15 leading AI companies, including Google, OpenAI and OpenAI partner Microsoft to develop AI models responsibly.”

About healthcare personnel

Top 25 physician groups by size and Medicare charges FYI

Most healthcare provider leaders are eying the door—and many have already heard offers, survey finds “The poll of 666 executives, directors and managers from provider organizations from staffing firm AMN Healthcare found that 66% of respondents intend to seek out a new position. Twelve percent plan to do so immediately, 62% within the next year and 38% within the next three to five years, according to the survey.
The responses also suggest there’s no shortage of open doors for job seekers. Nearly four in five survey participants said they had been approached about a new job opportunity within the past half month, with 17% of the full sample indicating that they had pursued the offer.”

About health technology

Bluebird’s sickle cell gene therapy comes with safety warning and higher price. Can Lyfgenia overcome CRISPR’s halo? “Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared bluebird bio’s rival gene replacement therapy, Lyfgenia, also for sickle cell disease (SCD).
But a higher price tag, a black box warning and the absence of a much-needed cash infusion could usher in a tough time for bluebird, several analysts figured.”

Floreo nabs FDA breakthrough label for its VR software “Floreo, maker of virtual reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation…
Launched in 2016, Floreo develops clinically designed VR lessons that help teach life skills aimed at children with autism and other neurodevelopmental disorders. It works with healthcare providers and the education sector, with its products already on the market for use alongside educators and clinicians. It also has Medicaid waivers in several states.” 

This Week's News and Commentary

In historic decision, FDA approves a CRISPR-based medicine for treatment of sickle cell disease “The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology, a groundbreaking treatment for sickle cell disease that delivers a potential cure for people born with the chronic and life-shortening blood disorder.
The new medicine, called Casgevy, is made by Vertex Pharmaceuticals and CRISPR Therapeutics. Its authorization is a scientific triumph for the technology that can efficiently and precisely repair DNA mutations — ushering in a new era of genetic medicines for inherited diseases.”

Biden-⁠Harris Administration Announces New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition “[The]Biden-Harris Administration is announcing new actions to promote competition in health care and support lowering prescription drug costs for American families, including the release of a proposed framework for agencies on the exercise of march-in rights on taxpayer-funded drugs and other inventions, which specifies that price can be a factor in considering whether a drug is accessible to the public. The Administration believes taxpayer-funded medications should be reasonably available and affordable.”
Read the entire release.

About health insurance/insurers

 CVS To Rebrand Growing Health Services As ‘CVS Healthspire’ “To help ‘demonstrate the connection and convenience CVS Health uniquely delivers,’ [CEO Karen] Lynch said Monday…that the company has created the CVS Healthspire name for the company’s health services segment that includes: Oak Street; Signify; more than 1,100 MinuteClinics; Caremark pharmacy benefit manager (PBM); and the newly created Cordavis, a new company that is working directly with drug makers to produce and commercialize “biosimilar” drugs, the less expensive versions of expensive brand prescriptions derived from biotechnology.”

Over 7 million people have signed up for 2024 Obamacare plansNearly 7.3 million Americans so far have signed up for health insurance for next year through the Affordable Care Act's (ACA) marketplace, according to data released by the U.S. Department of Health and Human Services on Wednesday.The enrolment for 2024 includes 1.6 million new additions to the marketplace, the data showed.”

10 payers audited for Medicare Advantage overpayments in 2023 “OIG audits found over $213 million in estimated Medicare Advantage overpayments in 2023. 
According to the agency's fall semiannual report, the agency issued 65 audits with an expected $82.7 million in recoveries between April and September 2023.”
See the accompanying list of individual companies.

Man sentenced to prison for $30M scheme that defrauded major payers “A Tulsa, Okla., man was sentenced to 54 months in prison for a scheme that involved submitting more than $30 million in claims to major payers for COVID-19 testing services that were never performed. 
William Gray, 50, admitted that he and his co-conspirators accessed private patient information from electronic medical records, according to a Nov. 30 Justice Department news release. They then used the information to submit claims to insurance providers for COVID-19 testing services that were never performed. 
The insurance companies that were billed fraudulent claims were Blue Cross Blue Shield, Cigna, UnitedHealthcare, Aetna, Humana and Molina Healthcare. The companies collectively reimbursed $7 million of the fraudulent claims. Mr. Gray was ordered to pay that amount in restitution.”
Comment: Fraud of this magnitude does not usually occur for private insurance companies.

About hospitals and healthcare systems

 Trinity vs. CommonSpirit vs. Providence: How 3 nonprofit systems' finances compare “Three of the largest nonprofit health systems, Providence, CommonSpirit and Trinity Health, reported operating losses and margins in the red for the three months ending Sept. 30, with higher labor and supply costs across the board. However, the systems all experienced increases in revenue as patient volumes continue to rebound.”

A busy week of mergers and acquisitions FYI

The Joint Commission announces Responsible Use of Health Data Certification for U.S. hospitals “The Joint Commission… announced a voluntary Responsible Use of Health Data™ (RUHD™) Certification program for U.S. hospitals and critical access hospitals, effective Jan. 1, 2024. Protecting patient privacy is a foundational element of a strong data use policy. The new certification will provide guidance and recognize healthcare organizations navigating the appropriate sensitivities needed to safely use data for purposes beyond clinical care, known as secondary use of data.”

 Tough year ahead for healthcare credit ratings, more defaults expectedMoody's Investor Services expects healthcare company defaults to increase next year as credit ratings deteriorate.
In a Nov. 30 report, Moody's noted nearly 21% of the 192 North America-based healthcare companies on its credit ratings list were at B3 Negative ratings or lower, up from nearly 18% on Dec. 31, 2022. In 2023, 10 healthcare companies defaulted and nine on the B3 negative list were further downgraded, according to the report.”

 About pharma

AbbVie to acquire Cerevel for $8.7 billion “In its second major buyout in the last week, AbbVie said Wednesday that it reached a deal to acquire Pfizer spinout Cerevel Therapeutics for $45 per share in cash, or roughly $8.7 billion, in a move aimed at bolstering its portfolio of neuroscience treatments. The announcement comes days after AbbVie struck a deal to take over ImmunoGen for $10.1 billion as it looks to expand its pipeline in the face of biosimilar competition for its top seller Humira (adalimumab)…
The acquisition will give it access to multiple clinical-stage and preclinical assets across diseases including schizophrenia, Parkinson's disease and mood disorders. AbbVie's neuroscience portfolio, which brought in a total $2 billion in sales in the third quarter, is centred on the migraine drugs Ubrelvy (ubrogepant) and Qulipta (atogepant), the atypical antipsychotic Vraylar (cariprazine), and Botox (onabotulinumtoxinA) for therapeutic use.”

CVS to revamp drug pricing model “CVS Pharmacy is taking a cue from Mark Cuban Cost Plus Drugs and will launch a pharmacy reimbursement model built around a drug's cost, a pharmacy services fee and a set markup.
The new approach, CVS CostVantage, will define a drug's cost and related reimbursement for contracted pharmacy benefit managers and payers, according to a Dec. 5 news release from CVS. 
The new ‘cost plus’ model will be available to consumers in 2024 and will incorporate PBM contracts with commercial payers in 2025…”

Roche (RHHBY) to Acquire Obesity Drug Maker Carmot for $2.7B “Swiss pharma giant, announced that it will acquire the privately owned U.S.-based company, Carmot Therapeutics, Inc. for $2.7 billion. It did so in a bid to foray into the lucrative obesity market.
Per the terms of the agreement, Roche will pay Carmot’s equity holders $2.7 billion in cash upon closing. Carmot’s equity holders are also entitled to receive up to $400 million as milestone payments.
The acquisition provides Roche access to Carmot’s differentiated portfolio of incretins, including lead assets CT-388, CT-996 and CT-868.
CT-388, a dual GLP-1/GIP receptor agonist, is being evaluated for the treatment of obesity in patients with and without type 2 diabetes, injected subcutaneously once a week. This candidate is phase II-ready and has the potential to work as a standalone as well as combination therapy to improve weight loss.
CT-996, a once-daily oral, small molecule GLP-1 receptor agonist currently in phase I, is intended to treat obesity in patients with and without type 2 diabetes.
CT-868, a phase-II, once-daily subcutaneous injectable, is a dual GLP-1/GIP receptor agonist intended for the treatment of type 1 diabetes patients who are obese.
Per the company, the incretin-based portfolio could also be expanded to other indications where incretins play a role, including cardiovascular, retinal and neurodegenerative diseases.”

AbbVie’s domination of top drug ad spenders continues, with overall spending holding high See the list for top advertised drugs.

'No one was spared': 2023 biopharma funds projected to fall $13B YOY, Pitchbook finds “By the end of the year, biopharmas are projected to have raised about $24 billion across about 840 transactions—the lowest tally in four years, according to a new PitchBook analysis.
This is compared to annual values of $38.1 billion in 2020, $53.9 billion in 2021 and $36.9 billion for 2022, representing a $12.9 billion drop.”

US sets policy to seize patents of government-funded drugs if price deemed too high “The Biden Administration on Thursday announced it is setting new policy that will allow it to seize patents for medicines developed with government funding if it believes their prices are too high.
The policy creates a roadmap for the government's so-called march-in rights, which have never been used before. They would allow the government to grant additional licenses to third parties for products developed using federal funds if the original patent holder does not make them available to the public on reasonable terms.”


About the public’s health

 A Texas judge grants a pregnant woman permission to get an abortion despite the state’s ban “A Texas judge on Thursday gave a pregnant woman whose fetus has a fatal diagnosis permission to get an abortion in an unprecedented challenge over bans that more than a dozen states have enacted since Roe v. Wade was overturned.
The lawsuit by Kate Cox, a 31-year-old mother of two from the Dallas area, is believed to be the first time since the landmark U.S. Supreme Court decision last year that a woman has asked a court to approve an abortion. The order only applies to Cox and her attorneys afterward spoke cautiously about any wider impacts, calling it unfeasible that scores of other women seeking abortions would also now to turn to courts.”
 

About healthcare IT

 Genetic testing firm 23andMe admits hackers accessed DNA data of 7m users “The genetic testing company 23andMe has said that nearly 7 million people have been affected by a security breach that put DNA ancestry information into the hands of hackers who broke into the site in early October.”   

 About health technology

US FDA clears Becton's less-invasive blood collection device  Becton Dickinson said on Thursday the U.S. Food and Drug Administration (FDA) cleared its finger-prick blood collection device that could provide a less-invasive option for some commonly ordered lab tests.
The device, BD MiniDraw Collection System, can help collect blood samples from a patient's finger through a trained healthcare professional without the need to do it from a vein, the company said.”

This Week's News and Commentary

Rising Health Care Costs, Surging Prescription Drug Pricing, Acute Focus on Chronic Conditions Among 9 Trends to Watch in 2024, Says Business Group on Health FYI, Well worth reading this short piece.

About Covid-19

 New COVID-19 Hospitalizations Increase “New coronavirus hospital admissions topped 18,100 the week ending in Nov. 18 – a nearly 10% increase over the week prior.”

About health insurance/insurers

Cigna, Humana in Talks for Blockbuster Merger “Cigna, which had revenue of about $181 billion last year, would be able to marry its huge pharmacy-benefit unit, which manages drug plans, and its strength in commercial insurance with Humana’s big position in the fast-growing Medicare segment, something Cigna has long sought.”
Comment: Let’s see what the DOJ has to say.

A Look at Navigating the Health Care System: Medicaid Consumer Perspectives “Key take-aways include the following:

  • Medicaid enrollees report worse health status compared to those with other coverage, which could lead to greater need for health care and more opportunities to encounter problems with the system. Still, the large majority (83%) of Medicaid enrollees rate the overall performance of Medicaid positively. However, over half of Medicaid enrollees report having experienced a problem in the past year, and relative to Medicare and employer-sponsored insurance (ESI), Medicaid enrollees are more likely to report certain negative outcomes from insurance problems.

  • Medicaid enrollees report fewer cost-related problems relative to those with Marketplace coverage and ESI; however, Medicaid enrollees report more problems with prior authorization and provider availability compared to people with other insurance types.

  • Across racial and ethnic groups, most enrollees rate their Medicaid coverage positively, with White Medicaid enrollees the most likely to describe their insurance as ‘excellent.’ Similar shares of enrollees among all racial and ethnic groups report experiencing problems with their coverage. Similar to the experiences of people with other coverage, Medicaid enrollees who utilize more health care services experience more problems with their insurance.”

Optum faces antitrust lawsuit from California health system “According to court documents, several physicians employed at an Optum-owned clinic in Covina left to join Emanate Health in and after December. Optum then transferred patients to other Optum-affiliated physicians without informing them of their physicians' departure, Emanate Health alleged in its complaint. 
The health system alleged Optum instructed its employees not to inform patients their physicians had moved practices, telling patients their physicians had retired or were on vacation…
Emanate Health also alleged that Optum pressured the system to stay out of the primary care business. Optum did not renew its hospital service agreement contracts with Emanate's three hospitals for its commercial and Medicare Advantage HMO members after the system did not agree to limit its primary care business, the system said in court documents.”

Cost of Exempting Sole Orphan Drugs From Medicare Negotiation Findings  This cross-sectional study identified 25 “sole orphan” drugs qualifying for exemption from Medicare price negotiation. Medicare spending on these drugs increased from $3.4 billion in 2012 to $10.0 billion in 2021; the sole orphan exemption would have prevented Medicare from negotiating prices on drugs with $1.1 to $3.0 billion in Medicare spending in each year.
Meaning  The results of this study suggest that exempting sole orphan drugs from Medicare price negotiation will cost taxpayers billions of dollars per year; such savings could be used to control Medicare premium increases or provide other benefits for patients.”

Consistency and Adequacy of Public and Commercial Health Insurance for US Children, 2016 to 2021 “This cross-sectional study of 203 691 children found that publicly insured children experienced higher rates of inconsistent coverage, whereas commercially insured children faced higher rates of inadequate coverage. Public insurance consistency and commercial insurance adequacy improved substantially during the COVID-19 public health emergency.”

CMS cut Medicaid improper payments in 2023 “CMS reported …The improper payment rate in the program was 8.58%, or $50.3 billion, in fiscal year 2023, down from 15.62% in 2022, according to a fact sheet from the agency.”

No Improvement In Mental Health Treatment Or Patient-Reported Outcomes At Medicare ACOs For Depression And Anxiety Disorders “Among patients not enrolled in ACOs at baseline, those who newly enrolled in ACOs in the following year were 24 percent less likely to have their depression or anxiety treated during the year than patients who remained unenrolled in ACOs, and they saw no relative improvements at twelve months in their depression and anxiety symptoms. Better-designed incentives are needed to motivate Medicare ACOs to improve mental health treatment.”

About hospitals and healthcare systems

 BJC, Saint Luke's move forward with 28-hospital merger St. Louis-based BJC Healthcare and Kansas City, Mo.-based Saint Luke's Health System — which signed a letter of intent to combine in May — have satisfied all regulatory reviews and reached a definitive agreement to merge. 
The transaction is expected to close Jan. 1, 2024, according to a Nov. 29 news release shared with Becker's. An integrated academic health system will be formed, though the systems will maintain their distinct brands and operate from dual headquarters: BJC in St. Louis, and Saint Luke's in Kansas City. 
Together, the two entities will pool $10 billion in revenue, 28 hospitals and hundreds of clinics and service centers, reaching more than 6 million patients across Missouri, Illinois and Kansas. Richard Liekweg, the CEO of BJC, will helm the new system, while Melinda Estes, MD, the CEO of Saint Luke's, will retire.”

Health system antitrust cases pick up steam FYI

NOVEMBER 2023 National Hospital Flash Report “Key Takeaways

1. Hospital performance in October reflects continued stabilization. Operating margins are elevated over pandemic levels and revenue continue to show improvement compared to the previous month.
2. Emergency department visits declined compared to the previous month. This likely reflects the shift in patient behavior to outpatient care. Organizations need to continue to build strong
provider and outpatient networks.
3. This month there was a decrease in observation patient days. This could be attributed to patient type but also likely reflects increased vigilance of these patients, including the deployment of case managers and use of observation units.”

Lawmakers seek to ban fees that cost hospitals millions “A bipartisan group of U.S. representatives introduced a bill Nov. 28 that would ban fees on electronic healthcare payments that cost hospitals millions of dollars.
The No Fees for EFTs Act would outlaw payers from tacking on fees for providers to be reimbursed electronically. The ACA required payers to offer electronic payments to providers, but payers and middlemen charge as much as 5% for the transactions, a practice exposed in August by ProPublica.”

About pharma

Mounjaro is more effective than Ozempic for weight loss in overweight and obese adults, real-world study saysThe blockbuster diabetes drug Mounjaro is more effective for weight loss than another highly popular diabetes treatment, Ozempic, in overweight or obese adults, according to a large analysis of real-world data published Monday.
Patients taking Eli Lilly’s Mounjaro were significantly more likely to lose 5%, 10% and 15% of their body weight overall and saw larger reductions in body weight after three months, six months and a year compared with those on Novo Nordisk’s Ozempic in the study by Truveta Research. The firm compiles and analyzes patient data from a collective of health-care systems.”

The Impact of Biosimilar Use on Total Cost of Care [TCOC] and Provider Financial Performance in the Medicare Oncology Care Model: A Population-Based Simulation Study “Among the total of 8281 6-month oncology care episodes identified in the study period (initiating January 2020 to July 2020) in Medicare claims, 1586 (19.2%) episodes met OCM [Medicare’s Oncology Care Model] and study criteria and were included. Applying the simulation methods to these observed episodes, biosimilar substitution reduced mean TCOC per episode by $1193 (95% CI $583–1840). The cost reduction from biosimilars represented 2.4% of the average TCOC benchmark and led to a 15% reduction in the risk of providers needing to pay recoupments to Medicare for exceeding TCOC benchmarks.”

Pharma's Q3 growth rankings: GLP-1 drugs from Eli Lilly, Novo Nordisk were once again the big story FYI

 FDA publishes Real-Time Oncology Review (RTOR) Guidance for Industry  “To be considered for RTOR, submissions should demonstrate the following:
—Clinical evidence from adequate and well-controlled investigation(s) indicates that the drug may demonstrate substantial improvement on a clinically relevant endpoint(s) over available therapies.
—Easily interpreted clinical trial endpoints (e.g., overall survival, response rates), as determined by the review division and OCE [Oncology Center of Excellence].
—No aspect of the submission is likely to require a longer review time (e.g., requirement for new REMS [Risk Evaluation and Mitigation Strategy]  advisory committee, etc.).”

Insulin users beware: your Medicare drug plan may drop your insulin. What it means for you In an informal survey of 22 Medicare plans, 10 plans are dropping at least one insulin from their formulary, according to Diane Omdahl, founder of 65 Inc., which provides Medicare enrollment guidance through fee-for-service, one-on-one consultations. Four plans are dropping four or more different insulins, she said. 
If you’re banking on the $35 out-of-pocket insulin cap to continue saving money next year, you must check your plan to see if your insulin is still covered. Only if your drug plan covers your insulin will you receive the $35 cap, according to the Centers for Medicare & Medicaid Services.”

About the public’s health

U.S. life expectancy rose in 2022, but not enough to erase the pandemic's toll “Life expectancy in the U.S. ticked upward in 2022, following two years of significant declines driven primarily by the Covid pandemic, according to a Centers for Disease Control and Prevention report published Wednesday. 
The CDC data showed that life expectancy at birth — how long a baby born in a particular year is expected to live — was 77.5 years in 2022, a 1.1-year increase from 2021. 
The number, however, still lags behind what U.S. life expectancy was in 2019: 78.8 years.”

Flu hospitalizations climb for 3rd week in a row “For the third straight week, flu hospitalizations have climbed in the U.S., according to new CDC data.
For the week ending Nov. 18, 3,296 patients with laboratory-confirmed flu cases were admitted to a hospital — up from 2,721 the week prior. Influenza A continues to be the dominant strain, still making up 79.4% of cases. Influenza B currently accounts for 20.6% of cases.”

Ultra-processed foods, adiposity and risk of head and neck cancer and oesophageal adenocarcinoma in the European Prospective Investigation into Cancer and Nutrition study: a mediation analysis Purpose: To investigate the role of adiposity in the associations between ultra-processed food (UPF) consumption and head and neck cancer (HNC) and oesophageal adenocarcinoma (OAC) in the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort…
Conclusions: We reaffirmed that higher UPF consumption is associated with greater risk of HNC and OAC in EPIC. The proportion mediated via adiposity was small. Further research is required to investigate other mechanisms that may be at play (if there is indeed any causal effect of UPF consumption on these cancers).”

Mortality risk from United States coal electricity generation “Exposure to coal PM2.5 was associated with 2.1 times greater mortality risk than exposure to PM2.5 from all sources. A total of 460,000 deaths were attributable to coal PM2.5, representing 25% of all PM2.5-related Medicare deaths before 2009 and 7% after 2012.”

Health experts decry New Zealand's scrapping of world-first tobacco ban “Health and tobacco campaigners said on Monday that New Zealand's plan to repeal laws that would ban tobacco sales for future generations threatened lives and put international efforts to curb smoking at risk.
The country's new centre-right coalition will scrap the laws introduced by the previous Labour-led government, according to coalition agreements published on Friday.
The package of measures would have seen bans on selling tobacco to anyone born after Jan. 1, 2009, reduced the amount of nicotine allowed in smoked tobacco products and cut the number of retailers able to sell tobacco by over 90%.”
Comment: The law was the first of its kind in the world and real progress for public health. The “problem” for countries passing tobacco bans is loss of tax revenue.

Minister for Health announces Ireland is on target to eliminate cervical cancer by 2040 “Goal will be achieved by:
—Increasing HPV vaccination rates for girls by age 15 from 80% to WHO target of 90% by 2030
—Continuing to exceed WHO targets by maintaining cervical screening coverage at or above 73%
—Continuing to exceed WHO targets by maintaining the number of women receiving treatment within the first year of diagnosis at or above 97%”

Long-Term Aspirin Use and Cancer Risk: a 20-Year Cohort Study “Among 1,909,531 individuals, 422,778 were diagnosed with cancer during mean follow-up of 18.2 years. Low-dose aspirin use did not reduce the HR [Hazard Ratio] for cancer overall irrespective of continuity and duration of use (continuous use: 1.04, 95% CI, 1.03-1.06). However, long-term (≥5 or ≥ 10 years) use was associated with ≥10% reductions in HRs for several cancer sites: colon, rectum, esophagus, stomach, liver, pancreas, small intestine, head and neck, brain tumors, meningioma, melanoma, thyroid, non-Hodgkin lymphoma, and leukemia. Substantially elevated HRs were found for lung and bladder cancer. In secondary analyses, consistent high-dose aspirin use was associated with reduced HRs for cancer overall (0.89, CI, 0.85-0.93) and for several cancer sites.”

Sports despite masks: no negative effects of FFP2 face masks on cardiopulmonary exercise capacity in children “In this study, no significant differences in the cardiorespiratory function at peak exercise could be discerned when wearing an FFP2/N95 face mask.” 

About healthcare personnel

 Optum now has 90,000 physicians “Optum added nearly 20,000 physicians in 2023, Optum Health CEO Amar Desai, MD, said. 
During a presentation at UnitedHealth Group's 2023 investor conference on Nov. 29, Dr. Desai said Optum has nearly 90,000 employed or affiliated physicians and another 40,000 advanced practice clinicians serving tens of millions of people.”

About health technology

Avoid syringes made in China, FDA says “As the FDA investigates reports of China-made syringes breaking and leaking, the agency is recommending healthcare workers prioritize syringes manufactured in other countries. 
Glass syringes, pre-filled syringes, and syringes used for oral or topical purposes are not part of the quality control concern, the FDA said Nov. 30. Incident reports have included several syringe manufacturers based in China, so the agency is analyzing the issue that might be attributed to changes in the products' dimension.”

 Britain’s genetic databank to unveil largest-ever sequencing release “The pioneering UK Biobank is to publish the largest-ever release of genetic sequencing data to boost the research and development of drugs to treat diseases ranging from heart conditions to cancers. The latest £200mn project was a collaboration funded by the government, Wellcome Trust, Britain’s biggest biomedical charity, and four pharmaceutical companies. Biobank’s store of data from some 500,000 individuals collected over more than 15 years makes it a world-leading resource to study the impact on health of genetics, lifestyle and ageing.”

Biden Administration Announces Actions to Strengthen the Drug Supply Chain “‘I'm proud to announce that I'll be invoking what's known as the Defense Production Act to boost production of essential medicines in America by American workers,’ Biden said. ‘You notice that people have to get certain kinds of shots overseas’ because they're not available in the U.S. ‘Well, that supply chain is going to start here in America.’
President Biden also will issue a Presidential Determination giving HHS the authority to invest in domestic manufacturing of essential medicines and medical countermeasures. ‘HHS has identified $35 million for investments in domestic production of key starting materials for sterile injectable medicines,’ according to a White House fact sheet.”

About healthcare finance

 AbbVie pays $10B to acquire ImmunoGen, doubling down on red-hot ADC cancer field “…AbbVie is shelling out $10.1 billion in cash to acquire ImmunoGen, maker of the ovarian cancer treatment Elahere, which won accelerated approval from the FDA about a year ago.
The acquisition accelerates AbbVie’s entry into the solid tumor space and strengthens the company’s oncology pipeline…”

This Week's News and Commentary

About Covid-19

 CDC: New COVID-19 Hospitalizations Increase “Over 16,200 new COVID-19 hospital admissions were reported last week – an increase of more than 8% over the week prior. Experts will surely be monitoring the jump as it could potentially signal the start of a widely expected fall and winter coronavirus wave.”

Moderna loses a COVID vaccine patent in Europe amid heated clash with BioNTech, Pfizer “Pfizer’s Comirnaty partner BioNTech chalked up a win as the European Patent Office (EPO) snatched back one of Moderna’s patents, ruling it invalid.
The patent in question protects “respiratory virus vaccines,” according to its listing in the European Patent Register. Opposers to the patent include BioNTech and Pfizer, as well as Sanofi, the listing notes.”

About health insurance/insurers

CMS releases standards and payment parameters for plans on the ACA marketplace A really good summary of these standards and parameters for the next year.

Medicare Snapshot: AEP Costs & Trends Highlights:

• Zero-premium Medicare Advantage plans remain popular, but demand has hit a plateau: 66% of all Medicare Advantage plans come with no monthly premium*, but they’re popular with enrollees. eHealth found that 83% of beneficiaries choosing Medicare Advantage plans selected zero- premium plans. Nevertheless, demand for zero-premium plans is lower than in prior years: 84% of beneficiaries chose zero-premium plans for the 2023 coverage year; for 2022, that figure was 88%.

• The average premium for Medicare Advantage plans is higher for the second year in a row: $9 is the average monthly premium among Medicare Advantage plans selected by beneficiaries shopping for 2024 coverage at eHealth, compared to $7 in the same period last AEP and $4 the year before.

• Average premiums for Medicare Part D prescription drug plans remains historically high: $29 is the average monthly premium for Part D plans selected by Medicare beneficiaries at eHealth, down slightly from $31 in the same period last AEP, but still significantly higher than eHealth tracked for the 2019 through 2022 coverage years.”

HHS' call to action for payers on health equity “CMS issued its first-ever playbook to address social determinants of health…
Here are HHS' calls for payers: 

  • Medicare Advantage plans can partner with community organizations to address unmet health-related social needs for chronically ill beneficiaries. 

  • States can contract with Medicaid managed care plans to address social needs, such as providing healthy meals to those living in food deserts, and design ways to address social determinants of health through the program using federal waivers. 

  • Payers can work in partnership with community organizations to provide navigation and care pathways for members. 

  • Payers can consider reimbursing the community-based workforce for helping patients with navigation, access and improving the cultural competency of services delivered to members.”


Fiscal Year 2023 Improper Payments Fact Sheet This CMS document covers federally sponsored programs. For example, “The Medicare Fee-for-Service (FFS) estimated improper payment rate was 7.38%, or $31.2 billion, marking the seventh consecutive year this figure has been below the 10% 
threshold for compliance established by improper payment statutory requirements.”
Comment: When proponents of “Medicare for all” cite lower administrative costs vis-a-vis private payers, they did not take into account this higher rate of improper payments.

Medicare HI Trust Fund Solvency Assuming MA Utilization “Findings

  • MA vs. FFS Utilization Differences: For all Part A services analyzed, MA utilization, as measured by patient days, was lower than FFS. Between 2018 and 2019, the differences between MA and the alternative, utilization-based scenario were 36% for inpatient, 14% for SNF, and 28% for HH.

  • HI Trust Fund Solvency Projection: The HI Trust Fund would remain solvent for an additional 17 years—until 2048—if FFS utilization levels were similar to MA utilization levels.”

Quality Outcomes Are Better When Medicaid MCOs Administer Pharmacy Benefits  “Pharmacy-related quality outcomes were better in states where Medicaid managed care organizations administered health plans’ pharmacy benefits, according to a report from Elevance Health…
Carve-in managed care organizations had more favorable HEDIS scores in 65 percent of the quality performance comparisons made between managed care organizations operating in pharmacy carve-in and carve-out states. Similarly, after excluding age-related measures, HEDIS scores were better in the carve-in setting for 65 percent of comparisons.”

About hospitals and healthcare systems 

Hospital Vitals: Financial and Operational Trends, Q1-Q2 2023 Among the findings: “The median health system1 saw cash reserves — measured as days cash on hand — drop 28% from 173 in January 2022 to 124 in June 2023. Rapidly rising expenses across the board exacerbated the declines in cash reserves…
A recent American Hospital Association (AHA) member survey found that 50% of hospitals and health systems reported having more than $100 million in unpaid claims that were more than six months old.”
A related problem is the rising rate of insurer payment denials.

NCQA Picks 18 Organizations to Pilot Virtual Care AccreditationThe National Committee for Quality Assurance (NCQA) has launched a Virtual Care Accreditation Pilot program, which it says is a key step in NCQA’s development of a quality improvement framework for organizations that provide care via telehealth or other digital platforms.
The nonprofit NCQA selected as pilot organizations a set of 18 organized and engaged entities from the more than 100 that applied. Based in 12 states and Puerto Rico, pilot organizations include health plans, health systems, Federally Qualified Health Centers, patient-centered medical homes and virtual first/virtual only organizations.”

About pharma

FDA finalizes DTC ad rule 13 years after posting proposal, creating new standards for TV and radio “The FDA is finally finalizing its rule on the need for direct-to-consumer ads to present side effects and contraindications ‘in a clear, conspicuous and neutral manner’ more than 10 years after closing the third and final comment period…
The final rule, which is set to take effect May 20, establishes a set of standards for determining if an ad complies with the need to be clear, conspicuous and neutral.”
The article explains the background for this much-needed rule.
See, also: Drug ads must be more upfront about side effects, FDA says

Outcomes of the 340B Drug Pricing Program “In this scoping review of the 340B program, we found that the 340B program was associated with financial benefits for hospitals, clinics, and pharmacies; improved access to health care services for patients; and substantial costs to manufacturers. Increased transparency regarding the use of 340B program revenue and strengthened rulemaking and enforcement authority for the Health Resources and Services Administration would support compliance and help ensure the 340B program achieves its intended purposes.”

25% of current drug shortages are more than 5 years old “In early 2023, the number of drug shortages hit a 10-year high. A fourth of these shortages are more than five years old, and 58% are older than two years, according to a new report
Shortages are more common in the cheapest drugs.”

Boom in weight-loss drugs to drive up US employers' medical costs in 2024 - Mercer “GLP-1 medications approved by the U.S. Food and Drug Administration could contribute between 50 and 100 basis points to the trend, Mercer's Chief Health Actuary, Sunit Patel, told Reuters in an interview.”

Therapeutic Benefit From New Drugs From Pharmaceutical Companies The article concludes that more beneficial drugs come from public sector research than private industry. “Over a quarter of new drugs originate in the public sector, and those drugs have more therapeutic value than the ones coming from industry. However, since industry is still ultimately responsible for up to 75% of new drugs, the question is how to structure public policy to better align pharmaceutical companies research and development activities with public health needs.”

About the public’s health

WHO asks China for data on ‘undiagnosed pneumonia’ cases “The World Health Organization has asked China for information on a rise in respiratory illness among children, in a sign of the heightened vigilance over outbreaks of infectious disease since the Covid-19 pandemic. The global health body made the request after reports of ‘undiagnosed pneumonia’ in northern China from ProMed, the outbreak surveillance network that first alerted the world to Covid.”
In 2 related articles:
China says no unusual pathogens found after WHO queries respiratory outbreaks and
Pandemic-related immunity gap in kids explains surge of respiratory infections in children in China, says WHO

 Economic Evaluation of Blood Pressure Monitoring Techniques in Patients With Hypertension Findings  In this systematic literature review of 16 studies, at-home self-monitoring was the most cost-effective strategy long-term compared with traditional blood pressure monitoring in clinics, with 24-hour ambulatory blood pressure monitoring and at-home blood pressure monitoring combined with additional support or team-based care being more cost-effective compared with at-home blood pressure monitoring alone.
Meaning  These findings suggest that clinicians, hospitals, health care systems, third-party payers, and other stakeholders should prioritize at-home self-monitoring of blood pressure as the main strategy for blood pressure measurement among patients with hypertension.”

About health technology

Masimo W1 watch gets FDA clearance for OTC, prescription use “The FDA has cleared Masimo’s W1 medical watch for both prescription and over-the-counter use.
The watch provides continuous real-time oxygen saturation and pulse rate monitoring and is approved for use by adults in hospitals, clinics, long-term care facilities and at home.”

This Week's News and Commentary

Census projects U.S. population bust by 2080 A great review of demographic projections.

Americans’ Trust in Scientists, Positive Views of Science Continue to Decline “Overall, 57% of Americans say science has had a mostly positive effect on society. This share is down 8 percentage points since November 2021 and down 16 points since before the start of the coronavirus outbreak.
About a third (34%) now say the impact of science on society has been equally positive as negative. A small share (8%) think science has had a mostly negative impact on society.”

About Covid-19

 FDA clears its first OTC home antigen test for COVID-19. No, really “This week, the FDA granted its first full, bona fide clearance to an over-the-counter home antigen test for COVID-19, and its first to carry an official 510(k) for use in children under age 18…
The Flowflex COVID-19 antigen home test, developed by ACON Laboratories, initially received an EUA in 2021. It now marks the second home COVID-19 test to successfully complete the FDA’s traditional premarket review pathway—following the de novo clearance claimed this past June by Cue Health for its at-home molecular-based test.”

Supreme Court Delivers Blow to Vaccine Skeptics “The U.S. Supreme Court rejected to hear an appeal relating to COVID-19 vaccine requirements in the workplace, dealing a blow to vaccine skeptics across the nation.
On Tuesday morning, the Supreme Court orders list showed that it was denying to hear any further arguments in the case Katie Sczesny, et al. v. Murphy, Gov. of New Jersey, et al. The case focused on four New Jersey nurses who filed a lawsuit against New Jersey's COVID-19 vaccine requirements in the workplace, citing religious freedom and health concerns.

About health insurance/insurers

Health Care Digest A great source of managed care data and trends since 1987.

The Cost of Not Getting Care: Income Disparities in the Affordability of Health Services Across High-Income CountriesHighlights:

  • Adults in the United States face wider income-related disparities in health care affordability compared to adults in other high-income countries.

  • Germany and the Netherlands experienced among the lowest rates of affordability problems and the fewest income-related disparities.

  • Adults in the U.S. with lower or average incomes are more likely to skip needed medical care and have problems paying medical bills than all other countries in this analysis.

  • In the U.S., adults with higher incomes are more likely to have health care affordability problems, including cost-related access issues and medical bill problems, than their counterparts in most other countries.”

 Anthem, Cigna settle contract claims, clearing way for appeal in $14.8 bln suit “Anthem and Cigna Group's CI.N Express Scripts unit on Monday settled the last pending claim in a long-running contract dispute, clearing the way for Anthem to appeal the dismissal of its $14.8 billion lawsuit accusing Express Scripts of overcharging it for prescription drugs.
Anthem had sued Express Scripts, a pharmacy benefit manager, in Manhattan federal court in 2016, accusing it of failing to negotiate over drug prices in good faith under a 10-year contract that began in 2009. Anthem said it was entitled to $14.8 billion in damages as a result of the breach.”

Officials project sharp drop in Medicaid enrollment next year as unwinding continuesThe [KFF] survey projected national Medicaid enrollment will decline by 8.6 percent in fiscal 2024, as states keep removing ineligible people from their Medicaid rolls. 
According to KFF, more than 10 million low-income people have lost coverage as of Nov. 8, based on the most current data from 50 states and the District of Columbia. More than 70 percent of those who lost coverage were removed because of “procedural” reasons such as missing paperwork or errors by state officials, raising concerns that many people who remain eligible for Medicaid may be losing coverage.”

Biden expands veterans’ health care coverage “Starting this month, all living World War II veterans can access health care services from the Department of Veterans Affairs (VA) at no cost, including nursing home care, the White House said in a press release.
The VA will also accelerate eligibility under the PACT Act, a major law that passed last year and expanded benefits for veterans exposed to toxins and chemicals. Veterans who have yet to enroll will be able to do so next year.
Biden also announced a new campaign and task force called Veteran Scam and Fraud Evasion (VSAFE), aimed at protecting veterans and their families from scams, which the administration said cost the military and veterans more than $414 million last year.”

UnitedHealth faces class action lawsuit over algorithmic care denials in Medicare Advantage plans “Aclass action lawsuit was filed Tuesday against UnitedHealth Group and a subsidiary alleging that they are illegally using an algorithm to deny rehabilitation care to seriously ill patients, even though the companies know the algorithm has a high error rate.
The class action suit, filed on behalf of deceased patients who had a UnitedHealthcare Medicare Advantage plan and their families by the California-based Clarkson Law Firm, follows the publication of a STAT investigation Tuesday. The investigation, cited by the lawsuit, found UnitedHealth pressured medical employees to follow an algorithm, which predicts a patient’s length of stay, to issue payment denials to people with Medicare Advantage plans. Internal documents revealed that managers within the company set a goal for clinical employees to keep patients rehab stays within 1% of the days projected by the algorithm.”

CMS tightening network adequacy standards for exchange plans “Beginning in 2025, health plans sold in state-run insurance exchanges would be required to meet time and distance standards that are at least as adequate as mandated on federal marketplaces, according to a rule released by the Centers for Medicare and Medicaid Services on Wednesday.
Time and distance standards would be calculated at the county level and then applied to lists of provider specialties.”

Health Insurers Have Been Breaking State Laws for Years Great piece of investigative journalism from ProPublica.
Over the last four decades, states have enacted hundreds of laws dictating precisely what insurers must cover so that consumers aren’t driven into debt or forced to go without medicines or procedures. But health plans have violated these mandates at least dozens of times in the last five years, ProPublica found.”

About hospitals and healthcare systems

CMS finalizes rule requiring greater transparency for nursing home ownership “The Centers for Medicare & Medicaid Services (CMS) has finalized a rule that will require more transparency into nursing home ownership.
Under the rule, nursing facilities that are enrolled in Medicare and Medicaid, which encompasses most, must disclose additional details about their owners, operators and management. CMS said in a press release that the final rule aims to more clearly define private equity and real estate investment trusts to make these disclosures simpler.”

 Under Amazon, One Medical builds out health system, employer partnerships for primary care services “Amazon's One Medical inked a major partnership with Health Transformation Alliance, expanding access to its primary care services to 67 employers and nearly 5 million employees.
HTA is a collective of large U.S. employers, and its member companies include Coca-Cola, American Express, Marriott, Boeing and Intel…
The company already works with more than 8,500 companies to offer its primary care services as an employee health benefit. The company, which opened for business in 2007, operates ​more than 200​ ​primary care clinics in ​nearly ​2​0 major ​metropolitan areas, combining in-person ​and​​ virtual care services.”

CommonSpirit opens its fiscal 2024 with $441M operating loss, $738M net loss “CommonSpirit Health marked the first quarter of its 2024 fiscal year with a $441 million operating loss (-5.1% operating margin) and a $738 million net loss due to inflation-boosted expenses and struggling investments, according to a Wednesday financial filing.
The nonprofit’s performance for the period ended Sept. 30 is a setback from the $23 million operating gain (0.3% operating margin) and $397 million net loss of the year prior, but a sequential continuation of the trends that left the organization with a $1.4 billion operating loss (-3.8% operating margin) for the full 2023 fiscal year, which closed over the summer.”

Joint Commission says acute, critical access hospitals must join safety network “As part of its accreditation process, acute care and critical access hospitals will be required to join The Joint Commission National Healthcare Safety Network, the organization noted in a Nov. 1 news release. 
The revisions are for The Joint Commission's ORYX initiative, which measures hospital performance data as part of the accreditation process…
These hospitals will required to share de-identified data across five measurement areas beginning Jan. 1, 2024:

  1. Catheter-associated urinary tract infection outcomes

  2. Facilitywide inpatient hospital-onset clostridium difficile infection outcomes

  3. Central line-associated bloodstream infection outcomes

  4. Colon and abdominal hysterectomy surgical site infection outcomes

  5. Facilitywide inpatient hospital-onset methicillin-resistant staphylococcus aureus bacteremia outcomes”

About pharma

Trends in Proportion of Medicare Part D Claims Subject to 340B Discounts, 2013-2020 “This cohort study demonstrated that from 2013 to 2020, the share of Medicare Part D claims prescribed by a 340B-affiliated clinician increased; however, the rate at which 340B-eligible prescriptions were filled at 340B pharmacies increased at a faster rate, driving the overall increase in 340B claims. Despite these trends, only half of 340B-eligible prescriptions were subject to the 340B discount in 2020.”

Express Scripts embraces cost-plus pricing with new ClearNetwork model “Express Scripts on Tuesday announced the launch of its new pharmacy network option, ClearNetwork, which operates under a cost-plus model. In this approach, clients pay a "straightforward" acquisition cost for individual drugs as well as a small markup that covers dispensing and service costs.
ClearNetwork will be available to a range of clients including employers, government organizations and private payers.”

Wegovy cuts risk of heart attacks in milestone cardiovascular trial “Wegovy specifically cut the rate of heart attacks by 28% among patients who were already taking statins and other medications to prevent heart problems, according to the results, simultaneously published in the New England Journal of Medicine. The drug also reduced the rate of cardiovascular-related deaths by 15% and strokes by 7%.”

Mayo Clinic moves to limit weight loss drug coverage for employees “Mayo Clinic will limit coverage for weight loss drugs through its employee health plan starting in 2024... The Mayo Medical Plan, administered by Medica, will impose a new lifetime limit of $20,000 for weight loss medication coverage. The coverage limit does not apply to GLP-1s prescribed to employees for diabetes, such as Ozempic….
Mayo joins other health systems moving away from weight loss drug coverage for employees this year.”

Intermountain's health plan aims to end PBM 'games' through Cuban partnership “Intermountain Health's insurance arm, Select Health, has rolled out a new partnership with Mark Cuban's Cost Plus Drug Co. to its more than 1 million members — a move its chief pharmacy benefits officer said is aimed at eliminating "all the games" in the PBM marketplace.”

Novo Nordisk to Pull Long Lasting Insulin Levemir From the MarketAfter committing in March to cut 65 percent off the price of its long-lasting insulin Levemir (insulin detemir), Novo Nordisk has announced that it will discontinue its marketing of the product in the U.S. with supply disruptions beginning as early as January.
The company stated in its announcement that it made the decision because of ‘global manufacturing issues, decreasing patient coverage, and because we are confident that patients in the U.S. will be able to find alternative treatments.’”
Comment: Pharma companies are required by law to notify the FDA of shortages. If you read this announcement even not-so-carefully, you will know that reduced insulin prices made this drug much less profitable.

Three Men Sentenced for $54M Fraudulent Prescriptions Scheme “Three men were sentenced today in connection to a $54 million bribery and kickback scheme involving TRICARE, a federal program that provides health insurance benefits to active duty and retired service members and their families…
Moss, Copeland, and Gordon, along with their accomplices, engaged in a practice known as “test billing” to develop the most expensive combination of compounded drugs to maximize reimbursement from TRICARE.”

In Shocking Reversal, CMS Wants to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars “On November 6, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn's disease and cancer. The policy change represents a stark departure from the perspectives of the U.S. medical community and patient advocacy organizations, a decade of state-level policymaking, and CMS' recent assurances, warns the Alliance for Safe Biologic Medicines.”

About the public’s health

 Effect of Dietary Sodium on Blood Pressure “Dietary sodium reduction significantly lowered BP in the majority of middle-aged to elderly adults. The decline in BP from a high- to low-sodium diet was independent of hypertension status and antihypertensive medication use, was generally consistent across subgroups, and did not result in excess adverse events.”

The 2023 report of the Lancet Countdown on health and climate change: the imperative for a health-centred response in a world facing irreversible harms Part of a series of articles in The Lancet about climate change a brief summary:
“In 2023, the world saw the highest global temperatures in over 100 000 years, and heat records were broken in all continents through 2022. Adults older than 65 years and infants younger than 1 year, for whom extreme heat can be particularly life-threatening, are now exposed to twice as many heatwave days as they would have experienced in 1986–2005... Harnessing the rapidly advancing science of detection and attribution, new analysis shows that over 60% of the days that reached health-threatening high temperatures in 2020 were made more than twice as likely to occur due to anthropogenic climate change…; and heat-related deaths of people older than 65 years increased by 85% compared with 1990–2000, substantially higher than the 38% increase that would have been expected had temperatures not changed....”

2023 March of Dimes Report Card: The state of maternal and infant health for American families “In 2022, over 380,000 babies were born preterm—10.4% of all births—earning the U.S. a D+ for the second year in a row. Despite a 1% overall improvement nationally compared to 2021, 14 states saw an increase in preterm birth. Concurrently, maternal mortality rates have nearly doubled since 2018, increasing from 17.4 deaths per 100,000 births to 32.9 in 2021. While the infant mortality rate held steady at 5.4 infant deaths per 10,000 births, nearly 20,000 babies born in 2021 did not survive to see their first birthday.
Racial and ethnic disparities persist across measures of maternal and infant health. The data shows that the preterm birth and infant mortality rates among babies born to Black and American Indian/Alaska Native moms are 1.4x higher than the rates among all others. What this truly demonstrates is the failure of our policies, systems, and environments to protect the well-being of pregnant people and their babies.”

Widening Gender Gap in Life Expectancy in the US, 2010-2021 “As life expectancy at birth in the US decreased for the second consecutive year, from 78.8 years (2019) to 77.0 years (2020) and 76.1 years (2021), the gap between women and men widened to 5.8 years, its largest since 1996 and an increase from a low of 4.8 years in 2010. For more than a century, US women have outlived US men, attributable to lower cardiovascular and lung cancer death rates related largely to differences in smoking behavior. This study systematically examines the contributions of COVID-19 and other underlying causes of death to the widened gender life expectancy gap from 2010 to 2021….
This analysis finds that COVID-19 and the drug-overdose epidemic were major contributors to the widening gender gap in life expectancy in recent years.”

About healthcare IT

 Social media giants must face child safety lawsuits, judge rules “Meta, ByteDance, Alphabet, and Snap must proceed with a lawsuit alleging their social platforms have adverse mental health effects on children, a federal court ruled on Tuesday. US District Judge Yvonne Gonzalez Rogers rejected the social media giants’ motion to dismiss the dozens of lawsuits accusing the companies of running platforms ‘addictive’ to kids.”

Completion of Recommended Tests and Referrals in Telehealth vs In-Person Visits Findings  In this cohort study of 4133 diagnostic tests and referrals (colonoscopies, cardiac stress tests, and dermatology referrals) ordered between March 1, 2020, and December 31, 2021, at 2 affiliated clinical primary care sites, 58% of those ordered during in-person visits were completed within the designated time frame compared with 43% of those ordered during telehealth visits. The rate of completion was between 40% and 65% for all test types, regardless of visit modality.
Meaning  The findings of this study suggest that rates of completion for diagnostic tests and referrals were low for all visit types but worse when ordered during telehealth visits.”

About healthcare personnel

After 50 Years, Health Professional Shortage Areas Had No Significant Impact On Mortality Or Physician Density “Since 1965, the US federal government has incentivized physicians to practice in high-need areas of the country through the designation of Health Professional Shortage Areas (HPSAs). Despite its being in place for more than half a century and directing more than a billion dollars annually, there is limited evidence of the HPSA program’s effectiveness at reducing geographic disparities in access to care and health outcomes. Using a generalized difference-in-differences design with matching, we found no statistically significant changes in mortality or physician density from 1970 to 2018 after a county-level HPSA designation. As a result, we found that 73 percent of counties designated as HPSAs remained physician shortage areas for at least ten years after their inclusion in the program. Fundamental improvements to the program’s design and incentive structure may be necessary for it to achieve its intended results.”

ANNUAL REGULATORY BURDEN REPORT From the MGMA. Lots of good data in the figures. Bottom line is that 90% of respondents say their overall regulatory burden has increased in the past year. Specific tasks are listed.

Active Residents by Specialty and Gender FYI

About health technology

FDA grants approval for first time to a home test for chlamydia and gonorrhea “The marketing approval was granted to LetsGetChecked’s Simple 2 Test, which allows individuals to collect a sample at home that is then submitted to a laboratory for processing. Prior to this, the only approved tests for these two STIs required samples to be collected at medical facilities such as doctors’ offices.”

More drug and device patents were invalidated for bad info than those filed by other industries, analysis finds “Between 2004 and 2021, a U.S. appeals court that handles patent litigation found 36 cases in which companies committed what is called inequitable conduct — failing to provide accurate or complete information to the U.S. Patent & Trademark Office. As a result, 75 patents filed by companies in various industry sectors were subsequently invalidated, according to the analysis in JAMA.”

Primary care player Forward unveils AI-based, self-serve CarePods backed by $100M series E round A fascinating look into the possible future of medicine.

Vertex, CRISPR gain 'historic' nod in UK for exa-cel. But will cost watchdogs embrace the gene-editing therapy? “Vertex and CRISPR Therapeutics have scored authorization in the U.K. for their exa-cel gene therapy to treat patients with severe forms of sickle cell and transfusion-dependent beta thalassemia, two genetic disorders of the blood.
It is the first ever endorsement for a CRISPR-based gene-editing treatment.”

This Week's News and Commentary

Health at a Glance 2023 OECD INDICATORS This biennial report has a wealth of information about international healthcare systems and is the standard, reliable source for these data.

US Senate confirms Monica Bertagnolli as NIH director “The U.S. Senate on Tuesday voted to confirm President Joe Biden's pick to run the National Institutes of Health (NIH), Dr. Monica Bertagnolli, filling the director spot at the country's top medical research agency after a vacancy of almost two years.
Bertagnolli, a cancer surgeon, was approved by a bipartisan 62 to 26 vote. The NIH had been without a director since December 2021, when former director Francis Collins retired, ending a 12-year reign.”

About Covid-19

Trends in United States COVID-19 Hospitalizations, Deaths, Emergency Department (ED) Visits, and Test Positivity by Geographic Area From the CDC. You can look up data from your location.

About health insurance/insurers

Payers ranked by total enrollment in Q3 FYI

Payers ranked by medical loss ratios in Q3 FYI

14 insurers exiting Medicare Advantage in 2024 FYI

Biden administration seeks to crack down on private Medicare health plans “Under a draft rule issued Monday by the federal Centers for Medicare and Medicaid Services, Medicare Advantage plans would be required to work harder to encourage customers to make use of extra benefits available to them, rather than the companies merely invoking them as a selling point.
The proposal also would help Americans with Medicare drug benefits gain access to biosimilars, less expensive versions of biologic drugs made from living cells or other organisms.”
In a related article: What Non-Medical Supplemental Benefits Will MA Plans Offer in 2024? “Food and produce services are the most common non-medical supplemental benefit in Medicare Advantage for 2024, offered by 1,475 plans, a report from ATI Advisory found.”

ACA RISK ADJUSTMENT — A SUCCESS STORY WITH ROOM TO IMPROVE “Oliver Wyman Actuarial recently authored a report for the Blue Cross Blue Shield Association, a federation of 35 separate US health insurance organizations and companies, providing health insurance to more than 106 million Americans. The report analyzed publicly available data to determine whether the risk adjustment system of the Affordable Care Act (ACA) is functioning as intended…
In this report we use publicly available data to show the following:

  • The current risk adjustment system does move funds from issuers with low-cost claimants to issuers with high-cost claimants, as intended

  • The risk adjustment system does not appear to disadvantage small issuers or issuers that are new to the market

  • The current risk adjustment system does not disadvantage issuers that are new to a state

  • The risk adjustment system underpays for high-cost claimants

  • It is likely that some issuers’ financial difficulties were the result of underpricing, and not risk adjustment

  • Making changes to the risk adjustment system to favor new or small issuers would be unworkable and would cause existing issuers to reconsider their participation in the market”

Allstate looking to sell health benefits division “Allstate is looking to sell its health benefits division in 2024, CEO Tom Wilson told investors on a Nov. 2 quarterly earnings call.
The health benefits division is composed of group, individual and voluntary benefits offerings. It generated $2.3 billion in revenue and $240 million in adjusted net income over the last 12 months. The division has about 48,000 customers ranging from Fortune 50 companies to small businesses.”

Amazon launches One Medical for Prime “Amazon Prime members can now get healthcare for an extra $9 a month.
The tech giant launched One Medical for Prime on Nov. 8, hoping to capitalize on its nearly $4 billion acquisition of the membership-based primary care company earlier this year.
The new service offers One Medical subscriptions to Prime members at a discounted rate, giving them unlimited 24/7 virtual visits and online scheduling for same- or next-day appointments at One Medical's more than 200 brick-and-mortar clinics.”

Health Benefits In 2023: Premiums Increase With Inflation And Employer Coverage In The Wake Of Dobbs “In 2023 the average annual premium for employer-sponsored family health insurance coverage was $23,968—an increase of $1,505 (7 percent) from 2022. Both single and family premiums increased faster in 2023 than in 2022, in a period of generally high inflation throughout the US economy. On average, covered workers contributed 17 percent ($1,401) of the cost of single coverage and 29 percent ($6,575) of the cost of family coverage. When compared to employers’ perceptions of the number of primary care providers in their networks, a smaller share of employers believed that their provider networks had a sufficient number of mental health and substance abuse providers to provide timely access to services. One-quarter of employers indicated that their employees had a “high” level of concern with the level of cost sharing required by their plans. When asked about abortion coverage in the wake of the Supreme Court Dobbs decision, almost a third of large employers reported that their largest plan covered abortion in most or all circumstances.”

Cigna explores selling Medicare Advantage business: report “Discussions to sell the business are preliminary, and Cigna could decide to hold onto its MA plans, sources told Reuters. Cigna expects changes to the reimbursement model and star rating system could impact its MA performance next year.”

About hospitals and healthcare systems

New Fall 2023 Hospital Safety Grades from The Leapfrog Group Find Improved Infection Rates Following Major Spike During COVID-19 Pandemic  “The latest grades show hospitals reducing health care-acquired infections (HAIs) post-pandemic, after significant increases in infection rates during the COVID-19 pandemic. This cycle, nearly 30% of hospitals earned an ‘A,’ 24% earned a ‘B,’ 39% earned a ‘C,’ 7% earned a ‘D,’ and less than 1% earned an ‘F.’”
You can check individual hospitals on the site.

Hospital cash flow, margins to surge in 2024: Moody's “Operating cash flow hit nearly -40% last year, but is projected to have double-digit growth this year. The operating cash flow growth will mean hospitals can invest in facilities and programs for the future.”

Average hospital payer mix in every state FYI

Initial Findings From an Acute Hospital Care at Home [AHCAH] Waiver Initiative “Patients who received care under AHCAH had a low mortality rate consistent with the hospital-at-home literature and minimal complications related to escalations back to the brick-and-mortar hospital.”

'Stunning' court ruling broadens hospitals' 340B use, calls HRSA's enforcement authority into question “A recent federal district court ruling against the office overseeing the 340B Drug Pricing Program has opened the doors for hospitals to more broadly claim discounts, healthcare legal experts say.
The decision in Genesis Healthcare, Inc. v. Becerra, handed down Friday by the U.S. District Court of South Carolina, establishes that ‘at least some of [the] interpretative policies surrounding the 340B definition of patient are inconsistent with the 340B statute,’ Anil Shankar, a partner at Foley & Lardner, told Fierce Healthcare.”

CMS bumps up pay increase to 3.1% in final FY24 OPPS rule “The Centers for Medicare & Medicaid Services (CMS) initially proposed a 2.8% payment increase for 2024 as part of its annual Outpatient Prospective Payment System rule, which providers slammed as subpar. In the final rule, the increase is instead set at 3.1%.
The agency said the rate is based on a projected market basket percentage increase of 3.3%, according to a fact sheet…”

2023 State of the Healthcare Consumer Report From Kaufman Hall:
“KEY FINDING #1
Among hospital system leaders, use of consumer-focused measurement is limited, and organizations over-rely on traditional transaction-focused metrics.

KEY FINDING #2
Leading healthcare systems— and more frequently companies outside of healthcare—are using consumer-focused measurement to understand key business drivers and measure ROI on consumer-focused investments.

KEY FINDING #3
There are barriers to health systems adopting consumer- focused measurement, but
the path forward is clear if organizations are committed to becoming consumer centric.”

About pharma

FDA approves new obesity drug from Eli Lilly named Zepbound If you can access this Washington Post article, it has a great review of the current weight loss drugs- including how they work.

"I've never seen anything like this": High demand fuels drug shortages Good, short article about drug shortages.

 FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book Tuesday, “the Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the ‘Orange Book.’
The Commission has also notified FDA that it disputes the accuracy or relevance of the listed information for these patents, which may require that the manufacturers remove the listing or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.  
The FTC sent notice letters to 10 companies, which include: AbbVie, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Impax Laboratories, Kaleo, Mylan Specialty, and subsidiaries of Glaxo-Smith Kline and Teva.”

About the public’s health

Marijuana use increases risk of heart attacks, new studies suggest “Two new studies suggest that regular use of marijuana could be linked to a higher risk of heart failure or heart attack, especially among older people. 
The preliminary findings of the studies, which have yet to be published, will be presented next week at the American Heart Association’s (AHA) Scientific Sessions 2023 in Philadelphia.”

 Syphilis cases in US newborns skyrocketed in 2022. Health officials suggest more testing “More than 3,700 babies were born with congenital syphilis in 2022 — 10 times more than a decade ago and a 32% increase from 2021, the Centers for Disease Control and Prevention said Tuesday. Syphilis caused 282 stillbirth and infant deaths, nearly 16 times more than the 2012 deaths.
The 2022 count was the most in more than 30 years, CDC officials said, and in more than half of the congenital syphilis cases, the mothers tested positive during pregnancy but did not get properly treated.”

Reduction of Financial Health Incentives and Changes in Physical Activity Findings  In this case-control study using a large natural experiment design with 584 760 participants, financial health incentive withdrawal after more than a year of incentive intervention led to statistically significant, but modest and not clinically meaningful, physical activity declines.
Meaning  These results suggest that physical activity, once established, may be maintained with less frequent and less costly financial health incentive reinforcement.”

The Global Wellness Economy Reaches a Record $5.6 Trillion—And It’s Forecast to Hit $8.5 Trillion by 2027If the market was worth a record $4.9 trillion in 2019, and then shrank 11% to $4.4 trillion in the pandemic year of 2020, the research indicates that the wellness economy has seen recent, economy-defying momentum. It grew 27% since 2020 to reach $5.6 trillion, with 7 of the 11 wellness sectors now surpassing their 2019, pre-pandemic values. With consumers, the medical world, and governments now placing a much bigger value on prevention and wellness, the GWI forecasts that the wellness economy will grow at an impressive 8.6% annual pace through 2027, when the market will reach $8.5 trillion—nearly double its 2020 size.”
The article also breaks down data by sector.

Coverage with Selected Vaccines and Exemption from School Vaccine Requirements Among Children in Kindergarten — United States, 2022–23 School Year “During the 2022–23 school year, coverage remained near 93% for all reported vaccines, ranging from 92.7% for DTaP to 93.1% for measles, mumps, and rubella and polio. The exemption rate increased 0.4 percentage points to 3.0%. Exemptions increased in 41 states, exceeding 5% in 10 states.
What are the implications for public health practice?
Exemptions >5% limit the level of achievable vaccination coverage, which increases the risk for outbreaks of vaccine-preventable diseases. Vaccination before school entry or during provisional enrollment periods could reduce exemptions resulting from barriers to vaccination during the COVID-19 pandemic.”

About healthcare IT
CMS EXTENDS MEDICARE TELEHEALTH REIMBURSEMENT WAIVER THROUGH 2024“The Centers for Medicare & Medicaid Services has included in its final CY 2024 Medicare Physician Fee Schedule (PFS) Medicare reimbursement for providers who use virtual care at home to treat patients. In addition, the provision states that providers will not be required to list their home address as a practice location.”

Studies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity “We conducted the first retrospective cross-sectional analysis of clinical studies of twenty prescription digital therapeutics authorized by the FDA and available on the market as of November 2022. Our analysis found that just two prescription digital therapeutics had been evaluated in at least one study that was randomized and blinded and that used other rigorous standards of evidence. Two-thirds of clinical studies of prescription digital therapeutics were conducted on a postmarket basis, with less rigorous standards of evidence than the standards used in premarket studies. More than half of studies did not report data on participants’ race, and more than 80 percent did not report their ethnicity. More than one-third required English proficiency, and nearly half of nonpediatric studies had an upper age limit. These results suggest the need for a more rigorous and inclusive approach to clinical research supporting FDA-authorized prescription digital therapeutics.”

About healthcare personnel

After 50 Years, Health Professional Shortage Areas Had No Significant Impact On Mortality Or Physician Density “Since 1965, the US federal government has incentivized physicians to practice in high-need areas of the country through the designation of Health Professional Shortage Areas (HPSAs). Despite its being in place for more than half a century and directing more than a billion dollars annually, there is limited evidence of the HPSA program’s effectiveness at reducing geographic disparities in access to care and health outcomes. Using a generalized difference-in-differences design with matching, we found no statistically significant changes in mortality or physician density from 1970 to 2018 after a county-level HPSA designation. As a result, we found that 73 percent of counties designated as HPSAs remained physician shortage areas for at least ten years after their inclusion in the program. Fundamental improvements to the program’s design and incentive structure may be necessary for it to achieve its intended results.”

Nineteen Surgical Organizations Strongly Oppose CMS’ Plan to Implement the G2211 Code From The American College of Surgeons:
“The American College of Surgeons (ACS), with 18 other surgical organizations, has expressed strong opposition to the implementation of Centers for Medicare & Medicaid Services (CMS) code G2211, which would harm surgeons and, in turn, surgical patients.
In a letter today to CMS, the 19 groups expressed continued opposition to the code, which was first introduced in 2020 but has been delayed for three years. During this time, nothing has been done to fix flaws in the G2211 code or the larger problems with the Medicare physician payment system.
The G2211 add-on code is an effort by CMS to pay more for certain office visits. These additional payments would predominately help primary care physicians despite the fact that the majority of the office visit codes for this type of care were increased in 2021.”


About health technology

Surgeons in New York announce world's first eye transplant “Surgeons in New York have performed the first-ever whole-eye transplant in a human, they announced on Thursday, an accomplishment being hailed as a breakthrough even though the patient has not regained sight in the eye.
In the six months since the surgery, performed during a partial face transplant, the grafted eye has shown important signs of health, including well-functioning blood vessels and a promising-looking retina, according to the surgical team at NYU Langone Health.”

About healthcare finance

BMS snags another ADC with modest $100M Orum deal “Another day, another antibody-drug conjugate deal. This time it’s Bristol Myers Squibb snapping up Orum Therapeutics’ phase 1 blood cancer med for $100 million upfront.
Orum will also be eligible for milestone payments of $80 million if the ORM-6151 program is successful, according to a Monday press release. Further financial details of the acquisition were not disclosed.” 

This Week's News and Commentary

About Covid-19

 US, global COVID-19 markers show declines “Of the two main severity indicators, hospitalizations last week declined by 0.2%, with some counties in the moderate range—especially in Montana—and a few counties listed as high, mainly in the central part of the country, the Centers for Disease Control and Prevention (CDC) said in its weekly data updates.
Deaths rose 12.5% compared to the week before, with the percentage of deaths from COVID highest in North Carolina, at 4%, compared to 2.7% for the nation as a whole.”

About health insurance/insurers

CMS drops 4 final payment rules for 2024: 19 takeaways A really good summary of these rules.

New Research Examining ACA Impact on Employers Offering Health Insurance Finds a 5 Percent Increase in Worker Eligibility for Employment-Based Health Coverage Since 2014 A couple key points from the research:
• In 2017, the overall percentage of private-sector employers offering health benefits increased for the first time in nearly a decade. In 2008, 56.4 % of private-sector employers offered health benefits. By 2016, it was down to 45.3%. By 2020, it was up to 51.1%, but it fell to 48.3% in 2022.
• In 2022, nearly 81% of workers employed by private-sector employers were eligible for health benefits.”

CMS: Insurers to lose $1.1B in risk adjustment payments from Bright Health, Friday exits Bright Health and Friday Health Plans are unable to meet their risk-adjustment payment obligations, leaving other insurers $1.1 billion short, CMS disclosed Oct. 27. 
Bright Health exited the ACA exchange market at the end of 2022, and Friday Health Plans went out of business in June 2023. 
In the ACA market, insurers must pay in risk-adjustment payments to CMS, designed to even out financial risk between payers with higher- and lower-risk enrollees in each market.”
Comment: Since these insurers cannot make their payments, other companies will not receive their risk adjustments.

Feds float No Surprises Act changes “Federal officials issued proposed changes to the No Surprises Act's independent dispute resolution process…”
This article is a good summary of the lengthy CMS press release.

Medicare expands options for mental health care “For decades, Medicare has covered only mental health services provided by psychiatrists, psychologists, licensed clinical social workers and psychiatric nurses. But with rising demand and many people willing to pay privately for care, 45 percent of psychiatrists and 54 percent of psychologists don’t participate in Medicare, the federal insurance system for some 65 million older or disabled Americans.
Citing low payments and bureaucratic hassles, more than 124,000 behavioral health practitioners have opted out of Medicare — the most of any medical specialty…
Beginning in January, Medicare for the first time will allow marriage and family therapists and mental health counselors to provide services. This cadre of more than 400,000 professionals makes up more than 40 percent of the licensed mental health workforce and is especially critical in rural areas.”

Errors in Patient Access Such as Eligibility or Missing Prior Authorization Cited as Top Reason for Initial Payer Denials by Financial Leaders “Rounding out the top five reasons for initial payer denials, healthcare leaders cited lack of documentation to support medical necessity, missing or incorrect patient information, physician documentation issues, and utilization management. These were closely followed by coding, duplicate claims, and untimely filing.”

CVS Health posts $2.3B profit in Q3 “CVS Health posted $2.3 billion in net income in the third quarter and revenue growth across its core lines of business in insurance, care delivery, pharmacy and retail, according to the company's earnings report published Nov. 1.”
Read the article for a breakdown by service line.

Harvard-Inovalon Medicare Study: Quality Outcomes Under Medicare Advantage vs. Medicare Fee-for-ServiceWe find that MA delivers superior quality and health outcomes relative to FFS, especially after rigorously adjusting for enrollment differences across the two programs and for the pre-existing disadvantages faced by MA members in terms of baseline demographic, clinical, and social risk factors. These differences were outlined in detail in the first white paper in this series ‘Who Enrolls in Medicare Advantage vs. Traditional Medicare Fee-for-Service.’
Specifically, MA enrollees have over 70% fewer hospital readmissions and 25% fewer preventable inpatient admissions. At the same time, we find that MA exhibits lower rates of inappropriate medication use, and comparable rates of medication adherence.”

Medicaid Enrollment and Unwinding Tracker Some highlights from this KFF study:
At least 10,046,000 Medicaid enrollees have been disenrolled as of November 1, 2023, based on the most current data from 50 states and the District of Columbia.
Overall, 35% of people with a completed renewal were disenrolled in reporting states while 65%, or 18.2 million enrollees, had their coverage renewed (one reporting state does not include data on renewed enrollees). Due to varying lags for when states report data, the data reported here undercount the actual number of disenrollments to date.
There is wide variation in disenrollment rates across reporting states, ranging from 65% in Texas to 10% in Illinois…
Across all states with available data, 71% of all people disenrolled had their coverage terminated for procedural reasons.”
[Emphases in the original]

Medical Debt Was Erased from Credit Records for Most Consumers, Potentially Improving Many Americans' Lives “Since the changes went into effect, consumers who had medical debt collections in August 2022—about 27 million adults—experienced a significant improvement in their Vantage scores. From August 2022 to August 2023, their average score increased from 585 to 615 points, moving these consumers from a subprime level (below 600) to near prime level (between 601 and 660). In contrast, consumers without medical debt in the records in August 2022 experienced almost no change in their credit scores by August 2023 (from 712 to 711).”

About hospitals and healthcare systems

Avoiding Overuse: Coronary Stents “KEY TAKEAWAYS

  • U.S. hospitals performed over 229,000 unnecessary coronary stents from 2019-2021. That’s a rate of one every seven minutes.

  • Of the approximately 1 million stents placed by hospitals, 22 percent met criteria for overuse.

  • Medicare wasted as much as $2.44 billion on unnecessary stents from 2019-2021.

  • Rates of overuse varied widely: at some hospitals, more than 50 percent of all stents met criteria for overuse, while at others, fewer than 5 percent were unnecessary.” 

 How CHS, Tenet, HCA and UHS fared in Q3 FYI

Hospital Operating Margins Increase for Second Month but Remain Narrow, According to New Syntellis Performance Solutions Data “Hospitals nationwide had a median operating margin — measured as actual year-to-date operating margin — of 1.6% for the month, up slightly from 1.4% in August. The increase marked a seventh consecutive month of positive operating margins, and a second consecutive month of increases after margins slid downward from 2% in June to 1.1% in July.”
And in a related study:
National Hospital Flash Report “Key Takeaways

1. Hospital performance in September declined slightly when compared to the previous month. Volume decreased across all categories; however, the data show that September 2023 levels are still an improvement over 2022. YTD margins increased slightly, paradoxically, due to the historical variation in performance of hospitals across 2023.
2. Bad debt and charity care remained elevated on a year-over-year basis. This is partly attributed to the ongoing Medicaid redetermination process, which has resulted in at least 9.5 million people disenrolled.
3. Labor expenses increased, though overall expenses softened as volume decreased. Labor expenses and workforce issues continue to challenge hospitals and health systems.”

CMS has finalized its remedy for 340B payments, and hospitals are not happy “As part of its final rule, CMS is maintaining budget neutrality. The agency estimates that hospitals were paid $7.8 billion more for non-drug items and services during that time period than they otherwise would have been without the 340B payment policy. To carry out the nearly $8 billion budget neutrality adjustment, CMS will reduce future non-drug item and service payments by adjusting the conversion factor for payments for outpatient services.”

Hospitals file lawsuit to bar HHS' ban on 3rd-party web trackers “In a new federal lawsuit—filed Thursday in the Northern District of Texas by the American Hospital Association (AHA), the Texas Hospital Association and two health systems, Texas Health Resources and United Regional Health Care System—the hospital lobby called on the judicial branch to bar enforcement of a December 2022 bulletin released by HHS’ Office for Civil Rights (OCR).
That bulletin addressed tools like the Meta Pixel and Google Analytics that media and researcher investigations have found across nearly all hospital websites and that have since become a focus of class-action lawsuits.”

CMS finalizes $140M increase to home health payments “Centers for Medicare & Medicaid Services (CMS) released a rule Wednesday that increases the 2024 home health payments by 0.8%, or $140 million.”

About pharma

 Drugmakers Are Set to Pay 23andMe Millions to Access Consumer DNA “GSK Plc will pay 23andMe Holding Co. $20 million for access to the genetic-testing company’s vast trove of consumer DNA data, extending a five-year collaboration that’s allowed the drugmaker to mine genetic data as it researches new medications.

An estimated 4,500 participating in CVS, Walgreens walkouts: 5 updates A quick read updating this story.

Cost-Effectiveness of Pharmacist Prescribing for Managing Hypertension in the United States “In this simulated cost-effectiveness analysis of a 5-state Markov model, 50% uptake of a pharmacist-prescribing intervention to improve blood pressure control was associated with a $1.137 trillion in cost savings and could save an estimated 30.2 million life years over 30 years.”

About the public’s health

Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes Question  Is time-restricted eating (TRE) without calorie counting more effective for weight loss and lowering of hemoglobin A1c (HbA1c) levels compared with daily calorie restriction (CR) in adults with type 2 diabetes (T2D)?Findings  In a 6-month randomized clinical trial involving 75 adults with T2D, TRE was more effective for weight loss (−3.6%) than CR (−1.8%) compared with controls. However, changes in HbA1c levels did not differ between the TRE (−0.91%) and CR (−0.94%) groups compared with controls.”

Food insecurity increased as pandemic-era meal waivers ended “Food insecurity in U.S. households with children increased to 17.3% in 2022, up from 12.5% the year before and 14.8% in 2020, according to federal research released Wednesday on household food security by the U.S. Department of Agriculture’s Economic Research Service.
Food insecurity among children, specifically, rose from 6.2% in 2021 to 8.8% in 2022. An increased percentage of children also experienced more severe food insecurity, up to 1% in 2022 from 0.7% in 2021.”

Infant mortality rose in 2022 for the first time in two decades “The U.S. infant mortality rate rose last year for the first time in two decades. The rate refers to the number of infants who died before their first birthdays out of every 1,000 live births.
The U.S. recorded 5.6 infant deaths per 1,000 live births in 2022, a 3% increase over the previous year, according to a report Wednesday from the Centers for Disease Control and Prevention.”

Survey: 10% of US students report current tobacco use “Survey responses analyzed by the CDC and FDA showed that 10% of middle and high school students in the United States reported currently using a tobacco product, although use fell among high schoolers over the past year.
The data were from this year’s edition of the National Youth Tobacco Survey, in which U.S. middle school students in grades 6 to 8 and high school students in grades 9 to 12 answered questions about tobacco products.”


About healthcare IT

Biden plans to step up government oversight of AI with new 'pressure tests' “Tech companies currently do their own ‘red-teaming’ of products – subjecting them to tests to find potential problems, like disinformation or racism. The White House has already worked with the major developers on a series of voluntary commitments to red-team their systems by third parties before releasing them.
But Biden's executive order requires the government to set new standards, tools and tests for red-teaming – and requires companies to notify the government and share the red-teaming results for the products that could pose major risks before releasing systems. The power to require companies to do so comes from the Defense Production Act, a Korean-War era law that expands presidential authorities, especially when it comes to national security issues.”

Use of Telemedicine and Quality of Care Among Medicare Enrollees With Serious Mental Illness “In this cohort study of 120 050 Medicare beneficiaries with schizophrenia or bipolar I disorder, patients receiving mental health care at practices that almost exclusively switched to telemental health service had 13.0% more mental health visits than those receiving care at practices that largely used in-person visits. There were no changes in medication adherence, hospital and emergency department use, or mortality based on the extent of telemental health use.”

About healthcare personnel

 Clinician of the Future 2023 Education Edition Some highlights:
—“25% of medical students in the USA and 21% in the UK are considering quitting their studies
—58% see their current studies as a stepping-stone towards a broader career in healthcare
While a minority of students plan to quit their studies, the majority report that they plan to move into roles in which they do not intend to treat patients directly.
—60% are worried about their current mental health”

Smaller Employers Weigh a Big-Company Fix for Scarce Primary Care: Their Own Clinics KFF’s annual survey of workplace benefits this year found that about 20% of employers who offer health insurance and have 200 to 999 workers provide on-site or near-site clinics. That compares with 30% or better for employers with 1,000 or more workers.
Those figures have been relatively steady in recent years, surveys show.”

Nearly 60% of doctors work in a practice that’s part of an ACO “More than one-third (34.4%) of physicians were in a practice that was an accredited or recognized medical home in 2022, compared with 32.3% in 2020 and 23.7% in 2014.
Participation in ACOs has seen similar growth, with 57.8% of physicians surveyed saying that their practice belonged to at least one type of ACO in 2022, compared with 44% in 2016.
Among the three types of ACOs, participation in commercial ACOs was the most prevalent, 45.1% in 2022, up from 42.7% in 2020; followed by Medicare ACOs, 38.1% in 2022, 36.7% in 2020; and Medicaid ACOs, 30% in 2022, 29.5% in 2020.”

Changes in Employment in the US Health Care Workforce, 2016-2022 “Health care employment growth declined after the onset of the COVID-19 pandemic and recovery patterns varied by health care subsectors… Staffing in SNFs had already declined before the pandemic and further declines after the pandemic are concerning. The differential employment trends across health care subsectors may be driven by worker concerns of infectious disease threats, modest wage levels, and high turnover rates among many long-term care occupations.”
Please see the article for specific sector data.

About healthcare finance

 Healthpeak Properties, Physicians Realty Trust to Merge in $21B Deal “The merger is expected to generate run-rate synergies of at least $40 million by the end of year one and up to $60 million by the end of year two.”

This Week's News and Commentary

About Covid-19

 Kids with COVID shed virus for median of 3 days, supporting school-isolation policies “Children who tested positive for COVID-19 in 2022 were contagious for a median of 3 days, regardless of vaccination status, suggesting that 5-day school isolation policies are sufficient amid Omicron variant predominance, University of Southern California (USC) and Stanford University researchers report… in JAMA Pediatrics.”

About health insurance/insurers/costs

Three quarters of ACOs in direct contracting model earned savings “The Global and Professional Direct Contracting Model for Performance Year 2022 saved the Centers for Medicare and Medicaid Services $371.5 million and saved direct contracting entities $484.1 million, according to the agency's first evaluation report of the model.
This represents an increase from $70.4 million in savings to CMS and $46.5 million in net savings to direct contracting entities (DCEs) in 2021. 
Ninety-nine DCEs, compared to 53 in 2021, participated in the program in 2022, the second year of the model. CMS has posted quality and financial results for each model participant.”

Centene boosts guidance on the back of $469M in Q3 profit “Centene Corporation posted $469 million in profit for the third quarter, according to its earnings report released Tuesday morning.
That's down from the $738 million reported in the third quarter of 2022, but it did surpass Wall Street's expectations, according to analysts at Zacks Investment Research. Centene also beat the Street on revenue with $38 billion.”
In a related article: Centene still expects to lose more than 2M members as Medicaid redeterminations reach midway point

11th Circuit upholds $2.7 billion Blue Cross antitrust settlement “An 11th Circuit panel on Wednesday upheld a federal judge's approval of a nearly $2.7 billion subscriber class action settlement in an antitrust action against the Blue Cross Blue Shield association.
The 11th Circuit ruling allows for the settlement to move forward and for benefits to be distributed, over a decade after subscribers who bought health insurance sued Blue Cross. They argued the health insurance giant violated the Sherman Antitrust Act by restricting competition between its 36 insurer companies, creating a hike in prices for customers.”

Obamacare premiums rise for 2024, but subsidies will protect most enrollees “The average monthly premium for the benchmark silver plan in 2024 will rise by 4% in the 32 states participating in the federal exchange, healthcare.gov, according to a Centers for Medicare and Medicaid Services report released Wednesday. That matches the increase for this year, which was preceded by four straight years of premium declines...
Open enrollment launches November 1 and runs through January 15, though folks must sign up by December 15 if they want coverage to begin at the start of the year.”

GNC launches virtual healthcare services Hard to figure out how to categorize this story, but here goes: “Nutrition and wellness company GNC is expanding into healthcare through new membership plans that offer virtual urgent and primary care.
GNC Health is offering three tiers of membership plans to individuals and families. The GNC Health Basic plan is a $34.99 per year offering that provides members with virtual urgent care, virtual lifestyle care and access to more than 100 prescriptions with no copay…
The Health Plus plan costs $9.99 per month for individuals and members gain access to virtual primary care and more than 400 prescriptions with no copay. The company's Health Premier plan costs $39.99 per month for individuals and allows members to access virtual mental healthcare and virtual physical therapy.”

Paying for It: How Health Care Costs and Medical Debt Are Making Americans Sicker and Poorer “Survey Highlights

  • Large shares of insured working-age adults surveyed said it was very or somewhat difficult to afford their health care: 43 percent of those with employer coverage, 57 percent with marketplace or individual-market plans, 45 percent with Medicaid, and 51 and percent with Medicare.

  • Many insured adults said they or a family member had delayed or skipped needed health care or prescription drugs because they couldn’t afford it in the past 12 months: 29 percent of those with employer coverage, 37 percent covered by marketplace or individual-market plans, 39 percent enrolled in Medicaid, and 42 percent with Medicare.

  • Cost-driven delays in getting care or in missed care made people sicker. Fifty-four percent of people with employer coverage who reported delaying or forgoing care because of costs said a health problem of theirs or a family member got worse because of it, as did 61 percent in marketplace or individual-market plans, 60 percent with Medicaid, and 63 percent with Medicare.

  • Insurance coverage didn’t prevent people from incurring medical debt. Thirty percent of adults with employer coverage were paying off debt from medical or dental care, as were 33 percent of those in marketplace or individual-market plans, 21 percent with Medicaid, and 33 percent with Medicare.

  • Medical debt is leading many people to delay or avoid getting care or filling prescriptions: more than one-third (34%) of people with medical debt in employer plans, 39 percent in marketplace or individual-market plans, 31 percent in Medicaid, and 32 percent in Medicare.”

About hospitals and healthcare systems

Lawmakers mull lifting ban on physician-owned hospitals as doc lobbying groups claim major cost savings “A new analysis backed by doctor lobbying groups suggests that physician-owned hospitals could have fueled about $1.1 billion in savings across 20 of Medicare’s most expensive conditions in 2019— though the hospital industry is sticking firm to its stance that the broadly restricted facilities are a detriment to the U.S. healthcare system.
The technical report , commissioned by the Physicians Advocacy Institute and The Physicians Foundation but conducted by researchers from UConn Health and Loyola University Chicago, concluded that the Medicare program and its beneficiaries’ total payments at traditional hospitals would have been 8.6% and 15.2% (depending on the condition) lower if reimbursed at the same rate as a POH.
It also found that patient demographics and comorbidity levels were very often statistically similar among POHs and traditional hospitals in the same hospital referral region—a counter to the hospital industry’s assertions that POHs often selectively treat patients that are healthier and less costly.”

 HCA says 2 IT issues could affect future earnings “After reporting $16 billion in third-quarter revenue, Nashville, Tenn.-based HCA Healthcare said that the July data breach and the health system's ability to use its EHR could affect future earnings. 
The July data breach affected 11 million patients and 171 hospitals. The health system is now facing at least five lawsuits relating to the incident where a hacker stole data from an external storage location and posted it online. 
HCA also said that "our ongoing ability to demonstrate meaningful use of certified electronic health record technology and the impact of interoperability requirements" could determine future financial results.”

HCA joint venture to lose $50M a quarter “Nashville, Tenn.-based HCA Healthcare reported $1.63 billion in third-quarter operating income on revenues of $16.21 billion, but the company's results were ‘unfavorably impacted’ by its Valesco physician staffing joint venture, which ‘performed below expectations,’ CEO Sam Hazen said during an Oct. 24 earnings call. 
In April, HCA went from a 50 percent owner to 90 percent owner of Valesco, a joint venture with  EmCare, a physician practice management firm affiliated with Envision Healthcare, which filed for Chapter 11 bankruptcy in May. HCA is consolidating operations at Valesco, but the move reduced the health system's consolidated margins by about 30 basis points in the second quarter, according to CFO Bill Rutherford.”

CHS reports $91M net loss in Q3 “Franklin, Tenn.-based Community Health Systems reported a $91 million net loss in the third quarter of 2023, down from a net loss of $42 million over the same period last year, according to the health system's earnings report released Oct. 25. 
The 76-hospital system attributed the increase in net loss to unfavorable changes in payer mix, a reduction in pandemic relief funds recognized, higher costs for supplemental reimbursement programs and an increased rates for outsourced medical specialists. These were partially offset by strong inpatient volumes and reduced expense for contract labor.”

UHS reports $167M net income in Q3 “King of Prussia, Pa.-based Universal Health Services, one of the largest for-profit health systems in the country, has reported third-quarter net income of $167 million on revenue of $3.6 billion.
Those figures compared with $182.8 million net income in the same period in 2022 on revenue of $3.3 billion.”

About pharma

 5 years in, Civica Rx makes 80 drugs for 1/3 of US hospitals “Since launching in 2018, hospital-owned Civica Rx works with about a third of the nation's hospitals and manufactures 80 drugs facing shortages…”

EU Commission fines pharma companies for price fixingThe European Commission on Thursday said it had fined five pharmaceutical companies for a total of 13.4 million euros ($14.1 million) in a settlement of an antitrust investigation.
The commission fined Alkaloids of Australia, Alkaloids Corporation, Boehringer, Linnea and Transo-Pharm for participating in a cartel aimed at fixing the minimum price of an ingredient to produce the abdominal antispasmodic drug Buscopan and its generic versions.”

Roche agrees $7.1bn deal for Telavant to boost drug pipeline “Roche plans to buy immunology company Telavant from Roivant Sciences and Pfizer for more than $7bn, as the drugmaker’s new chief executive seeks to replenish its drug pipeline. The Swiss company will acquire the rights to develop and manufacture Telavant’s potential drug for inflammatory bowel disease, which affects almost 8mn people worldwide. It will acquire the rights to sell it in the US, where there is a $15bn market for IBD, and in Japan.”

Sanofi’s shares fall 19% as dropped 2025 target overshadows planned consumer unit split “Sanofi will split off its consumer healthcare division into a separate unit as part of plans to increase R&D investment in its biopharma business. The move – announced Friday - will see the company prioritise its drug-development spending and modernise its approach to commercial delivery.
CEO Paul Hudson said “in this new chapter of our strategy, we are deepening our investment in R&D, taking steps toward becoming a pure play biopharma company and further optimising our cost structure.” Sanofi is targeting savings of up to €2 billion ($2.1 billion) from 2024 to the end of 2025, with the majority to be reinvested in innovation and growth drivers.”

HRSA Policy Change Could Mean Some Outpatient Clinics Lose 340B Discounts “Some hospital outpatient clinics are likely to lose 340B drug discount program eligibility under a policy the Health Resources and Services Administration issued Thursday. Hospitals participating in the drug pricing program now must register offsite clinics with HRSA and list them on Medicare cost reports to qualify for 340B, the agency announced in a Federal Register notice. This reverses a 2020 HRSA policy that aimed to streamline 340B certifications during the height of the COVID-19 pandemic.”

About the public’s health

 RSV shots for infants in short supply: CDC “The monoclonal antibody for preventing the respiratory syncytial virus, known as RSV, in infants is in short supply, and federal officials are advising doses be prioritized for those at the highest risk for severe illness, with the drug’s manufacturer saying demand has outpaced expectations.”

EPA proposes banning cancer-causing chemical TCE used in automotive care and other products “The U.S. Environmental Protection Agency on Monday proposed banning the cancer-causing chemical trichloroethylene, which can be found in consumer products including automobile brake cleaners, furniture care and arts and crafts spray coating.
The move would end a nearly four decade battle to ban the chemical known as TCE, which can cause sudden death or kidney cancer if a person is exposed to high levels of it, and other neurological harm even at lower exposure over a long period.
EPA’s recent risk-evaluation studies found that as much as 250 million pounds of TCE are still produced in the United States annually.”

Firearm Homicide Rates, by Race and Ethnicity — United States, 2019–2022 “Although the overall national rate of firearm homicide decreased from 2021 to 2022, the rate remained higher than in 2019. The onset of higher rates has been attributed to a range of factors, including economic and social stressors and disruptions in health and emergency services related to longstanding systemic inequities (such as employment or housing), which were worsened by the COVID-19 pandemic…”

National medication, medical equipment shortages harming patients, ECRI survey finds “Most respondents reported that shortages have compromised patient care. Half said shortages have delayed patient treatments, while a third said they were unable to provide patients with optimally recommended drugs or treatments. A quarter said they were aware of at least one error related to a drug, supply or device shortage…
Six in 10 respondents reported shortages of more than 20 drugs, single-use supplies or other medical devices during the six months prior to the survey. Various specialties have had care quality affected as a result, including in surgery and aesthetics (74%), emergency care (64%), pain management (52%), cardiology (45%), hematology and oncology (44%), infectious disease (39%) and obstetrics and gynecology (37%).”

'Extremely rare' case of mosquito-borne dengue found in California The case was in a patient without a travel history to endemic areas. This case is important, along with those Americans who have malaria , because it is a harbinger of changing infectious disease patterns due to global warming.

The official definition of infertility now includes LGBTQ+ and single people “Last week, the American Society for Reproductive Medicine (ASRM) issued an expanded description of the condition, stating that infertility involves ‘the need for medical intervention, including, but not limited to, the use of donor gametes or donor embryos in order to achieve a successful pregnancy either as an individual or with a partner.’
Before this update, the ASRM officially described infertility as a condition in which heterosexual couples weren’t able to conceive after a year of unprotected intercourse.”

The opioid crisis has gotten much, much worse despite Congress’ efforts to stop it “Even though 105,000 Americans died last year, Congress is showing little urgency about reupping the law since it expired on Sept. 30. That’s not because of partisan division, but a realization that there are no quick fixes a new law could bring to bear.”

About healthcare IT

Clinician EHR Efficiency: Software and Services 2023 FYI from KLAS. School down to check the two charts.

Teladoc Health Reports Third Quarter 2023 Results Summary:
“Third quarter 2023 revenue grows 8% year-over-year to $660.2 million
Third quarter 2023 operating cash flow of $105.6 million ; free cash flow of $68.0 million
Third quarter 2023 net loss of $57.1 million , or $0.35 per share
Third quarter 2023 adjusted EBITDA of $88.8 million , up 73% year-over-year”

NCC Group Monthly Threat Pulse - September 2023 “In September, Industrials continued to experience the highest volume of attacks 40% (19), followed by Consumer Cyclicals with 21% (10) and Healthcare 15% (7). The continued targeting of Industrials is unsurprising given that the theft of Personally Identifiable Information (PII) and Intellectual Property (IP) remain attractive motivators for threat actors.
The Healthcare sector experienced a significant increase in ransomware attacks. It witnessed 18 attacks, marking an 86% month-on-month increase from August. However, the increase is in line with trends in earlier months this year, suggesting that the dip in August was an anomaly to the overall trend. Healthcare continues to be an attractive target for threat actors because of the financial impact that a ransomware attack on companies in the pharmaceutical industry can have.”
And in a related article: Since 2016, ransomware attacks on healthcare organizations have cost the US economy $77.5bn in downtime alone “Since 2016, 539 ransomware attacks on healthcare organizations in the US have been confirmed. These attacks impacted more than 52 million patient records and have had an often devastating impact on 10,000 separate facilities.
In total, we estimate the cost of these attacks to be around US$77.5 billion in downtime alone.”

Patient Comfort with Social Needs Data Sharing “For the first time in 2022, the Health Information National Trends Survey (HINTS 6) asked about individuals’ comfort with social needs data sharing for three social needs data types: food, housing, and transportation. Here, we show results that reflect individuals’ comfort with each type of social needs data sharing. Overall, about 6 in 10 Americans reported being comfortable with their health care provider sharing information about their social needs with other providers for treatment purposes in 2022.”

About healthcare personnel

 Burnout, harassment driving mental health crisis in health care workers “Overall, about 46 percent of health care workers reported feeling burnout often or very often in 2022, compared with 32 percent in 2018. Nearly half of those in the field also reported they were likely or very likely to apply for a new job — in contrast to other worker groups who reported a decrease in job turnover intention.
Harassment also spiked during the pandemic, CDC found. More than double the number of health workers reported harassment at work in 2022 than in 2018 — 13.4 percent in 2022, up from 6.4 percent in 2018.”

About health technology

US trade tribunal issues potential Apple Watch import ban in Masimo patent fight “The U.S. International Trade Commission (ITC) on Thursday issued an order that could bar Apple from importing its Apple Watches after finding the devices violate medical technology company Masimo's patent rights.
The full commission upheld a judge's ruling from January that Apple violated Masimo's rights in light-based technology for reading blood-oxygen levels.
The decision will not have an immediate effect since it now faces presidential review and possible appeals.”

 Medtronic claims FDA approval for defibrillator implant routed outside the heart and veins “Medtronic has secured an FDA green light for a new type of implantable cardioverter-defibrillator that the medtech giant describes as the first of its kind.
Unlike other ICDs that are wired into beating hearts through the body’s veins, the Aurora’s electrical leads can be placed outside of the cardiac muscle and blood vessels to help reduce the risks of long-term complications.”

The Way You Speak Can Reveal Whether You Have Type 2 Diabetes “The team asked 267 participants – some with type 2 diabetes, and some without – to record a fixed phrase six times a day into a phone app, for a period of two weeks. A total of 18,465 recordings were then processed to extract 14 different characteristics from the vocals, including pitch and intensity.
The researchers used a set of these recordings to train the AI on what a person's voice sounds like, based on factors like their sex, age, BMI, and whether they had type 2 diabetes or not. They used the remaining samples to test what the AI had 'learnt'.
Factoring in considerations like age and sex, the model was able to spot type 2 diabetes to an accuracy level of 89 percent for women and 86 percent for men.”

About healthcare finance

 Healthcare investor raises $4.3B “Healthcare-focused investment firm OrbiMed has raised over $4.3 billion in its three latest funds, The Wall Street Journal reported Oct. 24.
The firm raised more than $1.86 billion for its ninth venture capital vehicle. OrbiMed partner Carl Gordon said that the firm plans to use the venture fund to invest in 40 to 45 companies. Halfway through 2023, healthcare venture capital funds had raised $13.7 billion, according to Silicon Valley Bank.”

This Week's News and Commentary

Every year, the Kaiser Family Foundation (KFF) issues a report on employer-based health insurance. This year’s report was issued on Wednesday. It is truly a treasure trove of information on all aspects of the commercial insurance market and is a must-read. You can read the executive summary, but far more impactful is to look at the excellent Figures.
I also recommend the following article to get a big-picture overview of this study:
Health Benefits In 2023: Premiums Increase With Inflation And Employer Coverage In The Wake Of Dobbs

About Covid-19

 Serotonin reduction in post-acute sequelae of viral infection Highlights

  • Long COVID is associated with reduced circulating serotonin levels

  • Serotonin depletion is driven by viral RNA-induced type I interferons (IFNs)

  • IFNs reduce serotonin through diminished tryptophan uptake and hypercoagulability

  • Peripheral serotonin deficiency impairs cognition via reduced vagal signaling”

HHS pledges to keep Paxlovid available as it transitions to commercial market “HHS announced …an agreement with Pfizer to ensure continued access to the antiviral Paxlovid for the next few years as it prepares to transition the drug into the commercial market.”
And in a related story: Pfizer to price COVID treatment Paxlovid at $1,390 per course “Pfizer on Wednesday said it will set the U.S. price for its COVID-19 antiviral treatment Paxlovid at nearly $1,400 per five-day course when it moves to commercial sales after government stocks run out, more than double what the government currently pays for it.
The new list price, which does not include rebates and other discounts to insurers and pharmacy benefit managers, is $1,390 per course, Pfizer said in an emailed statement. The U.S. government paid around $530 per course for Paxlovid it has made available to Americans at no cost.”

U.S. halts collection on some past-due covid loans, sparking federal probes “The U.S. government has halted some efforts to collect an estimated $62 billion in past-due pandemic loans made to small businesses, concluding that aggressive attempts to recover the money — a portion of which may have been lost to fraud — could cost more than simply writing off the debt.”

About health insurance/insurers

Reducing Hospital Costs Without Hurting Patients “Policymakers have multiple options for reducing Medicare and Medicaid expenses without harming patients. Implementing site-neutral payment for ambulatory care services, equalizing the tax treatment of hospital investments, reforming GME payments, and addressing Medicaid provider taxes over time all would produce significant savings. Policymakers will likely deploy some of these savings to improve the Medicare program; they should prioritize improving the physician office fee schedule through a routinized inflation update and supporting GNE. Policymakers should ask the advisors to Congress—the CBO, the Joint Committee on Taxation, and (as necessary) the CMS Office of Actuary—to estimate the impacts of these changes on taxpayers, beneficiaries, and to the Medicare Trust Fund(s).”
And in a related article from the Urban Institute: Post-Acute Care and Medicare Solvency: Reducing Excessive PAC Payments Can Promote Financial Stability One of the largest Medicare expenses is Post Acute Care services. This analysis offers ways to reduce those costs.

Annual window to shop for Medicare Advantage plans returns on Sunday “During the enrollment period, which ends Dec. 7, people will have the opportunity to choose between traditional Medicare and privately run Medicare Advantage plans in their area, as well as prescription drug plans.
But research shows that most people don’t bother shopping.”

Elevance Health braces for $500M hit to bonus revenue amid MA star ratings drop “CEO Gail Boudreaux said on the insurer's third-quarter earnings call on Wednesday that Elevance Health is bracing for a $500 million loss to its quality bonus revenue following offsets from contract provisions thanks to the star ratings decline. The company's performance on consumer surveys was subpar, and it also felt the sting in the way the Centers for Medicare & Medicaid Services is applying new statistical methodology, she said.”
In a related article: Elevance Health boosts guidance as it posts $1.3B in Q3 profit “The insurer reported $1.6 billion in profit for the third quarter of 2022, making for a nearly 20% decline year over year.”

 Fewer Medicare Advantage plans snag 5-star ratings for 2024 “CMS' overall average star ratings declined slightly for Medicare Advantage plans for plan year 2024. 
CMS published its star ratings for Medicare Advantage and part D standalone plans Oct. 13. The average Medicare Advantage star rating for 2024 is 4.04, down from 4.14 in 2023. Around 74 percent of Medicare Advantage enrollees will be in a plan rated four stars or higher in 2024, up from 72 percent in 2023.”

Humana has highest customer satisfaction among health insurers “Health insurance satisfaction surges 4% to a record-high score of 76 (out of 100), with customer engagement points like call centers and websites improving 5% year over year, according to the American Customer Satisfaction Index (ACSI®) Insurance and Health Care Study 2022-2023. Meanwhile, hospitals improve 4%, reaching their highest score (74) since 2018.”

Many payers expect IRA to have negative impact on Part D plans “Changes to the Medicare Part D program—including capping insulin copays and out-of-pocket spending and eliminating the 5% coinsurance requirement for the catastrophic phase—from the Inflation Reduction Act (IRA) could negatively impact payers, according to a survey of health plans.”

About hospitals and healthcare systems

 Downgrades outpace upgrades in Q3 and trend will continue, Fitch says “Nonprofit health system and hospital downgrades outnumbered upgrades by a ratio of 3-to-1 in the third quarter, Fitch said in an Oct. 18 public finance report.
And such a trend is likely to continue for the foreseeable future as staffing costs remain elevated amid tighter operating margins, according to the report.”

Henry Ford Health, Ascension Michigan unveil plans to form $10.5B joint venture “Henry Ford Health is coming together with several of Ascension Michigan’s hospitals and other facilities to form a joint venture with over $10.5 billion in annual operating revenue, the organizations announced Wednesday.
The deal, which is expected to close in summer 2024 pending federal and state regulatory reviews, includes all of Henry Ford’s acute care hospitals, related facilities and assets, including its Health Alliance Plan.”

About pharma

Rite Aid files for bankruptcy, names new CEO “Rite Aid is filing for Chapter 11 bankruptcy protection and has a new CEO to lead it through the turnaround, the U.S. drugstore chain announced Oct. 15. 
The Philadelphia-based company, which has 2,100 stores across the U.S., named Jeffrey Stein as its CEO, chief restructuring officer and a member of its board of directors, effective immediately. He replaces Elizabeth Burr, who has served as interim CEO since January 2023 after Heyward Donigan abruptly resigned. Ms. Burr will remain director of the Rite Aid board. 
Rite Aid is reporting that it has secured $3.45 billion from lenders to fund operations throughout the bankruptcy process. The largest creditor is McKesson Corp. with trade-payable claims of approximately $667.6 million, according to Bloomberg.” 

CVS, Walgreens and Rite Aid are closing thousands of stores. Here’s why Among the reasons: “Researchers find pharmacy closures lead to health risks such as older adults failing to take medication
[Also] pharmacies at greatest risk for closures are those with a large customer base on public insurance, which have lower reimbursement rates than private plans, as well as independent pharmacies.”

EU and UK regulators warn fake diabetes drug found at wholesalers “EU and UK regulators have warned fake versions of the diabetes drug Ozempic — often used for weight loss — have been discovered at wholesalers… The pre-filled injection pens are falsely labelled as the drug sold by the Denmark-based Novo Nordisk and were discovered as fakes because of inactive serial numbers. The pens came from suppliers in Austria and Germany and appear to be 1mg doses with authentic German packaging, although it is a different shape and shade of blue to the originals.”

Mayo, Lifepoint sue Bristol Myers Squibb over cancer drug cost “Mayo Clinic and Lifepoint Health are suing Bristol Myers Squibb and its subsidiary, Celgene, alleging the companies inflated the price of the cancer drug Revlimid by paying other drugmakers to keep their generic versions off the market…
The practice, known as ‘pay-for-delay’ or ‘reverse payments,’ has faced scrutiny from the Federal Trade Commission and insurance plans, which claim they cause consumers to overpay for medications.”

Alignment Healthcare, Walgreens launch co-branded Medicare Advantage plans “The plans will be offered in 10 counties across Arizona, California, Florida and Texas beginning Jan. 1 and include $0 premiums. The partners expect that the new plans will reach 1.6 million potential MA enrollees, according to an announcement.
Members who select the co-branded plans can use over-the-counter benefits at Walgreens' stores or online through a mail-order provider. They will also have access to a $0 copayment on more than 10,000 prescriptions at Walgreens or other in-network pharmacies.”

Johnson & Johnson, riding high after Kenvue spinoff, touts new launches as Stelara cliff nears “The company's top drug by sales, the immunology giant Stelara, generated $2.86 billion during the quarter, a 17% increase from the same period last year. The drug is expected to face its first biosimilar competition in 2025, so J&J is busy getting ready for the looming patent cliff.
To that end, the company is making progress on the launches of CAR-T drug Carvykti, novel antidepressant Spravato and cancer launch Tecvayli…”

Merck & Co. shells out $4 billion upfront in mega ADC pact with Daiichi Sankyo “Merck & Co. has agreed to pay Daiichi Sankyo $4 billion upfront, in a deal potentially worth as much as $22 billion, to advance three of the Japanese drugmaker's antibody-drug conjugate (ADCs) candidates across multiple cancer types. As part of the deal, the companies will jointly develop and commercialise patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan globally, except for Japan where Daiichi Sankyo has exclusive rights.”

BioNTech expects €900-million charge after Pfizer’s COVID vaccine write-offs “BioNTech said Monday it will likely record a charge of €900 million ($949 million) in the third quarter related to the COVID-19 vaccine Comirnaty after partner Pfizer announced that inventory write-offs will cost it $5.5 billion. Pfizer's charges primarily relate to the oral antiviral treatment Paxlovid (nirmatrelvir/ritonavir), but also include $900 million of inventory write-offs for Comirnaty.”
And in a related article with the same message: Pfizer targets $3.5 billion in cost cuts amid weakening COVID product sales
Comment: This charge was predictable as COVID has become more endemic. Manufacturers of the vaccines will still make money, just not as much as during the pandemic. The key to increased profitability is using the mRNA technology for other vaccines/treatments.
 
Walgreens inks new clinical trial dealAs part of its new clinical trials business, Walgreens Boots Alliance has teamed up with the Cardiovascular Research Foundation to find patients for a clinical trial that aims to study the prevalence of valvular heart disease in older Americans, the organizations announced Wednesday.
Deerfield-based Walgreens, which has about 9,000 stores in the U.S., says it will leverage its national presence to help identify and reach potential participants. The study has already begun, with top-line results expected to be released in 2025, Walgreens said in a statement.”

Walgreens to settle Rite Aid investors' merger claims for $192 million “Walgreens Boots Alliance has agreed to pay $192.5 million to settle a class action lawsuit by investors in Rite Aid who accused Walgreens of misleading them in 2017 about scrutiny of the two drugstore chain operators' then-pending merger.”

Walgreens, CVS workers plan nationwide strike “Pharmacy employees at Walgreens and CVS are in talks to organize nationwide walkouts and protests in late October, people familiar with the matter told CNBC.
CVS pharmacy employees in Kansas City called out of work in late September to protest heavy workloads and understaffing. Executives at the pharmacy chain met with the workers, who returned to work after CVS agreed to pay overtime, increase staffing and curb the amount of vaccination appointments.”

Israeli drugmaker Teva loses appeal against EU fine -EU court ruling “The General Court of the European Union ruled on Wednesday that Israeli drugmaker Teva and Cephalon must pay a 60.5 million euro fine by the European Commission for delaying the market entry of a cheaper generic version of Cephalon’s drug for sleep disorders that Teva sought to challenge in court.”

GoodRx, Sanofi to offer insulin for $35, regardless of insurance, at select pharmacies “All Americans with a valid prescription, regardless of their insurance status, can use GoodRx at more than 70,000 retail pharmacies to access a 30-day supply of Lantus for $35. Patients can visit GoodRx.com/lantus to access the coupon, redeemable at any pharmacy that accepts GoodRx including CVS, Walgreens and Walmart.”

State Drug Pricing Boards Tee Up New Front in Pharma Legal Fight “A wave of state boards aiming to set limits on what health plans pay for prescription drugs is likely to trigger lawsuits from drugmakers, policy analysts and lobbying groups say, as the industry also fights government price-setting policy at the federal level.
The Michigan Senate voted Oct. 4 to pass a package of bills… that would create an independent board to evaluate the impact of prescription drug costs on patients in the state, and to establish upper payment limits on some of the most expensive products. The legislation, if enacted, would make Michigan the ninth state to establish a prescription drug affordability board (PDAB), and the sixth with the ability to set payment limits.”

About the public’s health

Influenza Vaccine for 2023-2024 Each year, The Medical Letter covers recommendations for flu shots. This issue has always been my go-to source of information and is open to all for access.

Living alone and cancer mortality by race/ethnicity and socioeconomic status among US working-age adults “Compared to adults living with others, adults living alone were at a higher risk of cancer death in the age-adjusted model (HR, 1.32; 95% CI, 1.25–1.39) and after additional adjustments for multiple sociodemographic characteristics and cancer risk factors (HR, 1.10; 95% CI, 1.04–1.16). Age-adjusted models stratified by sex, poverty level, and educational attainment showed similar associations between living alone and cancer mortality, but the association was stronger among non-Hispanic White adults (HR, 1.33; 95% CI, 1.25–1.42) than non-Hispanic Black adults (HR, 1.18; 95% CI, 1.05–1.32; p value for difference < .05) and did not exist in other racial/ethnic groups.”
Having a college degrees somewhat attenuated the findings.

Red meat intake and risk of type 2 diabetes in a prospective cohort study of United States females and males “Intakes of total, processed, and unprocessed red meat were positively and approximately linearly associated with higher risks of T2D. Comparing the highest to the lowest quintiles, hazard ratios (HR) were 1.62 (95% confidence interval [CI]: 1.53, 1.71) for total red meat, 1.51 (95% CI: 1.44, 1.58) for processed red meat, and 1.40 (95% CI: 1.33, 1.47) for unprocessed red meat. The percentage lower risk of T2D associated with substituting 1 serving/d of nuts and legumes for total red meat was 30% (HR = 0.70, 95% CI: 0.66, 0.74), for processed red meat was 41% (HR = 0.59, 95% CI: 0.55, 0.64), and for unprocessed red meat was 29% (HR = 0.71, 95% CI: 0.67, 0.75); Substituting 1 serving/d of dairy for total, processed, or unprocessed red meat was also associated with significantly lower risk of T2D. The observed associations became stronger after we calibrated dietary intakes to intakes assessed by weighed diet records.”

Race and Ethnicity and Prehospital Use of Opioid or Ketamine Analgesia in Acute Traumatic Injury “In this cohort study of over 4.7 million patient encounters across the US during a 3-year period (2019-2021), among patients with acute traumatic injuries, patients from minoritized racial and ethnic groups were less likely to have a pain score recorded. Among patients with a high pain score, Black patients were significantly less likely to receive analgesia when compared with White patients.”

 FDA takes ‘momentous’ step toward banning menthol cigarettes and flavored cigars “The US Food and Drug Administration took a ‘momentous’ step Monday toward banning menthol in cigarettes and banning flavored cigars, proposing a rule that public health experts say could save hundreds of thousands of lives…
The agency has sent the rule to the White House Office of Management and Budget for final review, the last regulatory step before the rule becomes final.”

Expanding PrEP Coverage in the United States to Achieve EHE Goals “Overall in 2022, 36% of the 1.2 million people who could benefit from PrEP were prescribed it, compared to 23% in 2019, the year that EHE [Ending the HIV Epidemic] was announced. Today’s data also show progress in increasing PrEP uptake in virtually all EHE jurisdictions, despite the unprecedented public health challenges funding recipients faced during this period with the COVID-19 pandemic and outbreaks of mpox, which consumed considerable resources as EHE efforts were just getting underway.”

Kids' Use of Cannabis and Tobacco Rose From 2021 to 2022 “In 2021, 11% of respondents reported exclusive use of tobacco, 10.8% reported simultaneous use of tobacco and cannabis, 3.4% reported exclusive use of cannabis, and 74% reported no cannabis or tobacco use, while in 2022, there was an increase in use in all three smoker groups:
13.6% reported use of both tobacco and cannabis
11.7% reported use of tobacco alone
4.1% reported use of cannabis alone
Respondents who reported using neither cannabis or tobacco declined to 70.6%”

About healthcare IT

Telemedicine Versus In-Person Primary Care: Treatment and Follow-up Visits “In-person return visits were somewhat higher after telemedicine compared with in-person primary care visits but varied by specific clinical condition.”

Private Health Data Still Being Exposed to Big Tech, Report Says “Despite recent efforts to address the issue, medical-related websites continue to be mined for data including personal medical information, in an apparent violation of patients’ privacy rights, according to a new study.
Some of the most common tracking pixels were from Alphabet Inc.’s Google, Microsoft Corp., Meta Platforms Inc. and ByteDance, the parent company of TikTok, according to a report by the cybersecurity company Feroot Security.”

Hacked to Pieces? The Effects of Ransomware Attacks on Hospitals and Patients “In this paper, we provide the first empirical evidence on the effect of ransomware attacks on hospital operations and health outcomes. We find that ransomware attacks immediately affect hospital operations - causing large reductions in ER, inpatient, and outpatient hospital volume and even larger reductions in Medicare revenue for care provided…
We find a marginally statistically significant (P=0.07) differential increase in in-hospital mortality of 0.77 percentage points for patients of ransomware-attacked hospitals who are hospitalized at the time of the attack. Compared to the in-hospital mortality rate of patients discharged in the five weeks prior to attack, this represents a 20.7% relative increase in in-hospital mortality. We find no similar increase for 30-day mortality, nor for 30-day readmissions.”

Supreme Court takes up fight over Biden administration’s online misinformation fight “The Biden administration can continue its efforts to fight misinformation on social media, the Supreme Court said on Friday in an order agreeing to pause a lower court order and hear the case later this term. 
Justices Samuel Alito, Clarence Thomas, and Neil Gorsuch publicly dissented from the ruling, calling the government’s misinformation efforts a coordinated federal campaign against disfavored views on important published issues.”
Comment: One of the main reasons the Biden administration wants clearance to fight online misinformation is because of the non-scientific and harmful comments about public health measures, e.g., Covid-19 immunizations and harmful medications.

Carta Healthcare survey results indicate that education around AI may improve consumer trust “The survey finds that on average, three out of four Americans do not trust AI in a healthcare setting. Nearly four out of five patients in the U.S. report not knowing if their provider is using AI; in reality, 100% of healthcare providers are using AI, and have been for a long time. This discrepancy illustrates the public’s misperception of the use of this technology, which is made evident by the 43% of respondents who admit there are limitations in their understanding of AI.”

About healthcare personnel

 Doctors Unionize at Big Health Care System “The doctors, roughly 400 primary and urgent-care providers across more than 50 clinics operated by the Allina Health System, appear to be the largest group of unionized private-sector physicians in the United States. More than 150 nurse practitioners and physician assistants at the clinics were also eligible to vote and will be members of the union, which will be represented by a local of the Service Employees International Union.”
Comment: In addition to nurses and pharmacists, physicians are now going on strike. Those who want more of a British healthcare system are starting to get their wish.

Kaiser pharmacy workers continue 3-week strike, approve to double it “As hundreds of pharmacy workers for Kaiser Permanente continue striking for up to three weeks in Oregon and Southwest Washington, their union approved another strike that could last almost four more weeks.”

Addressing the healthcare staffing shortage Lots of valuable information in this survey. For example, from 2021-2022, more than 71,000 left the workforce—about 20,000 of whom were primary care physicians.

About health technology

 CMS is removing PET scan restrictions for Alzheimer's patients  “The Centers for Medicare & Medicaid Services (CMS) has decided to remove the national coverage determination (NCD) that limits patients’ ability to qualify for new drugs, giving people with Alzheimer’s disease symptoms a better path to treating the condition.
The policy means amyloid PET scans will no longer be limited and will give patients a better chance of being prescribed a drug like Eisai's Leqembi, which clears beta amyloid proteins from the brain to slow the advances of Alzheimer’s.”

GE HealthCare and Novo Nordisk to Collaborate to Advance Novel Non-invasive Treatment for Type 2 Diabetes and Obesity with Ultrasound “GE HealthCare … announced a collaboration with Novo Nordisk to further advance the clinical and product development of peripheral focused ultrasound (PFUS). This is a novel technology that has potential to specifically regulate metabolic function in the body using ultrasound that may support the treatment of chronic diseases such as type 2 diabetes and obesity.
PFUS is a non-invasive type of bioelectronic medicine that uses ultrasound to activate the nervous system to stimulate a response that may be able to treat disease. Pre-clinical proof of concept and initial early-stage clinical research suggests that it may impact glucose metabolism in people with diabetes via personalized ultrasound stimulation of nerve pathways.”

About healthcare finance

For-profit hospital M&As: 9 deals involving HCA, CHS and Tenet FYI

17 latest healthcare bankruptcies FYI

 Thermo Fisher to absorb proteomics player Olink in $3.1B deal “Thermo Fisher Scientific is putting down a premium to extend its reach in protein research. It has moved to acquire Olink, a Swedish provider of proteomics analysis equipment and services for tracking down and developing biomarkers.
Through a deal pegged at $3.1 billion, Thermo Fisher has signed on to pay $26 for each of Olink’s Nasdaq shares—for a price that comes to about 74% above the company’s previous closing value. The transaction includes the absorption of $143 million in Olink’s net cash, alongside the company’s international operations in Boston, Tokyo and Shanghai.”

Pfizer secures unconditional EU antitrust nod for Seagen buyThe EU announced that it has unconditionally approved Pfizer's pending $43-billion acquisition of antibody-drug conjugate (ADC) developer Seagen. In a statement on Thursday, the European Commission said it concluded that the transaction would not raise competition concerns, nor is it like to have a negative impact on prices.”

This Week's News and Commentary

About Covid-19

 Can Rapid COVID Tests Reveal More Than a Positive/Negative Result? “…people can interpret their test results in two simple ways: time to test line appearance and test line darkness after 15 minutes, he explained.
The basics of these variations come down to showing how much viral load a person has at one point in time. A darker test line or a faster test line mean a higher viral load. Mina noted that a person with a dark line that appears quickly has a very high viral load, and he or she is likely near the peak of their infectiousness. Conversely, a lighter line that appears closer to the 10- to 15-minute mark means viral load is low.”

About health insurance/insurers

 Employer plans are unsuitable for many Americans, survey finds “Four in 10 people insured by employer-provided health plans find their out-of-pocket costs are so expensive they need to dip into savings and take on debt, according to a nationwide survey of 2,500 Americans enrolled in employer-sponsored coverage.
Nearly half of the respondents said they would struggle to afford healthcare expenses should a medical emergency occur, or they were diagnosed with a chronic illness.”

Medicare Part B premiums to rise by 6 percent in 2024 “The Centers for Medicare and Medicaid Services (CMS) announced the monthly Medicare Part A and B premiums for 2024 on Thursday, with the costs set to go up by 6 percent next year.
The premiums would increase by $9.80 from $164.90 to $174.70 in 2024 and the annual deductible for Medicare Part B beneficiaries will go up from $226 to $240 as well. This price increase comes after Medicare Part B premiums went down for the first time in more than 10 years in 2023.”

UnitedHealth Group posts $5.8B profit in Q3 The articles has data for both the parent and its two divisions.

Medicaid Enrollment and Unwinding Tracker “At least 8,696,000 Medicaid enrollees have been disenrolled as of October 11, 2023, based on the most current data from 50 states and the District of Columbia…
There is wide variation in disenrollment rates across reporting states, ranging from 66% in Texas to 11% in Illinois.”

About hospitals and healthcare systems

Kaiser Permanente reaches $200M settlement over behavioral health access “Kaiser Permanente has reached a $200 million settlement with the California Department of Managed Health Care to resolve deficiencies in its delivery and management of behavioral healthcare. 
The $200 million settlement agreement includes a $50 million fine and requires Kaiser Permanente to take corrective action to repair Kaiser Foundation Health Plan's access and oversight of enrollees' behavioral healthcare. Kaiser Permanente also agrees to a $150 million investment, over five years, toward behavioral healthcare programs…”

Kaiser Permanente reaches tentative agreement with workers “After a historic strike, healthcare giant Kaiser Permanente and the Coalition of Kaiser Permanente Unions announced Friday that they reached a tentative 4-year union contract agreement in the early hours of this morning.
The deal gives frontline healthcare workers the resources to do the job they love and keep patients safe, said Yvonne Esquivel, a pediatric medical assistant at Kaiser Permanente in Gilroy, California, in a statement issued by the coalition.”

 Health Systems Invest in Capital Rx Pharmacy Benefit Manager “More than 10 health systems are participating in a $50 million investment round for pharmacy benefit manager and pharmacy benefit administrator Capital Rx.
Atlantic Health System, Banner Health, Hawai'i Pacific Health, Inova Health System, Lehigh Valley Health Network, Memorial Hermann Health System, Nebraska Medicine, Novant Health, Ochsner Health, and WellSpan Health, among others, as well as Transformation Capital, are involved in the funding round.”
 
The debate over adequacy of non-profit hospitals’ charitable services has resurfaced at the national level:
Sanders: Nonprofit hospitals 'should lose their tax-exempt status' if they 'refuse' to increase charity care “The Senate Health, Education, Labor and Pensions (HELP) Committee chairman released a report Tuesday calling on Congress and the IRS to strengthen oversight on the community benefit and charity care spending necessary for nonprofit hospitals to retain their status.
The report also outlines the HELP Committee majority staff’s review of 16 major nonprofit health systems’ fiscal year 2021 financial statements, among which 12 dedicated less than 2% of their total revenue to charity care.”
The AHA responded: Results from 2020 Tax-Exempt Hospitals’ Schedule H Community Benefit Reports “Tax-exempt hospitals provided nearly $130 billion in total benefits to their communities in 2020 alone — the most recent year for which comprehensive data is available.”
The report does not say how much these hospitals received in tax benefits.

About pharma

Surescripts analysis finds e-prescribing by pharmacists on the rise “A new analysis finds that more pharmacists are electronically prescribing medications as they assist in managing chronic disease, which offers a peek at the next evolution in primary care.
The study, backed by health information network Surescripts, found that the number of prescribers in its network that were not traditional primary care providers grew by 12.1% on average each year between 2018 and 2022, while the number of clinicians who often provide primary care grew by less than 1%.
At the same time, providers of all kinds are concerned about the significant dearth in primary care. A recent survey shows that 73% of prescribers and half of pharmacists expressed worry about the number of primary care providers in their area, and, in rural regions, that jumps to 81% and 62%, respectively.”

Walgreens was in the news several times this week, notably for a strike and the appointment of a new CEO. See:
Walgreens taps former Express Scripts chief Wentworth as CEO
Walgreens walkout enters last day: 5 notes
Walgreens to cut $1B in costs, close 60 VillageMD sites

 Pfizer inks another EpiPen antitrust settlement, this one worth $50M “Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief medicine.”

DEA, HHS issue 2nd extension of controlled substances via telehealth “The U.S. Drug Enforcement Agency is, for a second time, extending clinicians' ability to prescribe controlled substances using telehealth services, according to a revised rule the agency published. 
Under the guidelines developed during the pandemic, a patient can be prescribed a controlled substance, ‘even if the patient isn’t at a hospital or clinic registered with the DEA,’ according to the HHS. This was initially extended through Nov. 11, 2023, but the Oct. 10 revision has pushed that date to now expire on Dec. 31, 2024.”

About the public’s health

Influenza Vaccine for 2023-2024 You should read this article to find out which vaccine is appropriate for you.

Cannabis Commercialization Linked to More Hospitalizations “In a repeated cross-sectional analysis that included some 26.9 million individuals, researchers found that the rate of hospitalizations due to cannabis increased 1.62 times between 2015 and 2021.
The rate of hospitalizations increased most precipitously after commercialization, including a 40% increase in hospitalizations for cannabis-induced psychosis.”

About healthcare IT

Analysis of Devices Authorized by the FDA for Clinical Decision Support [CDS] in Critical Care “While many prediction models might offer CDS for patients with critical illness, our review of the database revealed that only 10 AI/ML [Artificial Intelligence/Machine Learning] CDS devices have received FDA authorization. The clinical evidence for these devices ranged from completely absent to peer-reviewed assessment of model performance, and most of the devices authorized through the 510(k) pathway relied on equivalence to non-AI/ML predicates. Furthermore, at least 1 high-profile and widely implemented model did not appear to have received FDA authorization. While this study was limited to critical care, these findings highlight the need to update regulatory requirements to align with current knowledge about using AI/ML systems across many clinical practice settings.”
And in a related article: FDA Establishes New Advisory Committee on Digital Health Technologies
“ …the U.S. Food and Drug Administration announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.
The Digital Health Advisory Committee will advise the FDA on issues related to DHTs, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. The committee should be fully operational in 2024.”

Kaiser Permanente, UPMC among 13 major health systems to sign interoperability pact with VA “Kaiser Permanente, UPMC, Intermountain Health, Mass General Brigham and several others have agreed to the pact, which the VA encourages other systems to join as well.” 

DEA extends pandemic rules for telehealth prescribing through 2024 as agency irons out new policies “The Drug Enforcement Administration (DEA) said Friday it will extend telehealth flexibilities that enable clinicians to virtually prescribe controlled medications to their patients through 2024 as it mulls permanent policy changes.”

 AHA asks CMS to stop telehealth rule “During the pandemic's public health emergency, CMS removed a rule that clinicians delivering telemedicine from their homes list their addresses on enrollment and claims forms. But that flexibility is scheduled to end Dec. 31.”

Beyond Hype: Getting the Most Out of Generative AI in Healthcare Today “Generative AI can increase productivity and cost efficiency, but only 6% of health systems currently have a strategy.”

About healthcare personnel

Healthcare job  cuts up 121% year over year “Healthcare/products companies and manufacturers, including hospitals, announced 52,611 job cuts from January through September this year, a 121 percent increase from the 23,850 cuts announced in the same period last year.”

Survey: The Majority of New Physicians Receive Over 100 Job Solicitations but Many Would Not Choose Medicine Again “Despite a plethora of jobs to choose from, close to one-third of medical residents (30%) said they would not choose medicine if they had their careers to do over again, the highest number recorded by the survey since its inception. Like many more seasoned physicians, the majority of residents surveyed have experienced feelings of burnout. Eighty-one percent of residents surveyed said they sometimes, often or always experienced feelings of burnout during their training. Close to one-half (45%) said they often or always experienced feelings of burnout.”

Striking Healthcare Workers Return to Work—Without New ContractsStriking Kaiser Permanente workers returned to work Saturday but without new contracts, ending the largest healthcare strike on record as their unions and employer continued to bargain. 
Negotiations are scheduled to pick up again Thursday.”

About health technology

 Illumina ordered by EU antitrust regulators to sell Grail “U.S. genetic testing company Illumina has been ordered by EU antitrust regulators to sell cancer test maker Grail after it completed the deal before securing their approval.”

FDA Gives De Novo Authorization for DNA Test for Hundreds of Cancer Variants “The Common Hereditary Cancers Panel can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer. The first of its kind to be granted FDA marketing authorization, the test evaluates DNA to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer.”

New ‘brain atlas’ maps the highly complex organ in dazzling detail “Scientists on Thursday unveiled the most detailed and complex portrait yet of the human brain in a dazzling catalogue of more than 3,000 types of brain cells that collectively give rise to emotion, thought, memory and disease.
The painstaking work is part of the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) initiative, a $3 billion government-funded effort to develop tools and technology to understand and map the human brain. The results, published in 21 papers across multiple journals, are starting to open up the black box of the brain by providing an initial parts list for the most complex organ scientists have ever studied.”

About healthcare finance

GSK signs £2.5bn shingles vaccine deal with China’s Zhifei “GSK has signed a deal with Zhifei, China’s largest vaccine company by revenue, as the British drugmaker aims to double global sales of its shingles vaccine by 2026. The UK-based pharmaceutical company said Zhifei had agreed to buy £2.5bn worth of GSK’s bestselling shot, Shingrix, which is targeted at older adults, over three years.”

This Week's News and Commentary

About Covid-19

Say goodbye to the COVID-19 vaccination card. The CDC has stopped printing themNow that COVID-19 vaccines are not being distributed by the federal government, the U.S. Centers for Disease Control and Prevention has stopped printing new cards.
The federal government shipped more than 980 million cards between late 2020, when the first vaccines came out, through May 10, according to the latest available data from the CDC.”

FDA authorises Novavax's updated COVID vaccine “Novavax announced Tuesday that the FDA granted an emergency-use authorisation (EUA) for an updated formula of its adjuvanted COVID-19 vaccine targeting the Omicron subvariant XBB.1.5 in people ages 12 and over. According to the company, it expects a recommendation from the US Centers for Disease Control and Prevention ‘imminently,’ adding that doses of the shot, dubbed NVX-CoV2601, will likely be available within the next few days.”

Moderna reports trial success for dual Covid and flu vaccine “Moderna’s combined Covid-19 and influenza vaccine was as effective as separate shots in an early stage trial, giving the US biotech company hope that the more convenient way of protecting against the diseases could be approved by 2025.”

Nirmatrelvir-Ritonavir [Paxlovid] and COVID-19 Mortality and Hospitalization Among Patients With Vulnerability to COVID-19 Complications “In this cohort study of 6866 individuals with COVID-19, treatment with nirmatrelvir and ritonavir was associated with lower risk of death or hospitalization in the most clinically extremely vulnerable individuals but not in less vulnerable individuals.”

About healthcare quality and safety

Most common sentinel events in first half of 2023: Joint Commission “The six most frequently reported sentinel events for the first half of 2023:
Falls — 47 percent
Unintended retention of foreign object — 9 percent
Assault, rape, sexual assault or homicide — 8 percent
Wrong-site surgery, such as wrong procedure, patient or implant — 8 percent
Suicide — 5 percent
Delay in treatment — 5 percent
Most sentinel events, or 88 percent, happened in a hospital in the first six months of 2023. Eighteen percent were associated with a patient's death, 63 percent with severe temporary harm and 7 percent with permanent harm.”

About health insurance/insurers

Federal Budgetary Effects of the Activities of the Center for Medicare & Medicaid Innovation From the CBO: “CBO currently estimates that CMMI’s activities increased direct spending by $5.4 billion, or 0.1 percent of net spending on Medicare, between 2011 and 2020… Specifically, CMMI spent $7.9 billion to operate models, and those models reduced spending on health care benefits by $2.6 billion…
Looking ahead, CBO currently projects that CMMI’s activities will increase net federal spending by $1.3 bil-lion, or 0.01 percent of net spending on Medicare, over the center’s second decade, which extends from 2021 to 2030.”
The report also explains performance of some specific programs, such as ACOs.
Comment: If the purpose of CMMIs experiments was to find models that reduced healthcare costs, one can accept the losses as an investment. However, narrowing of programs to include “successes” or modifications of existing programs do not seem to be part of the “grand plan.” Some programs have been extended, but the savings are very small compared to overall Medicare spending.

Court strikes down Trump-era rule that allowed insurers to not count copay assistance “Patient advocacy groups are declaring victory after a federal judge struck down a Trump-era policy that allowed health insurers not to count drug manufacturer copay assistance toward a beneficiary’s out-of-pocket costs.
That policy allowed health plans to increase out-of-pocket prescription drug costs for consumers, advocacy groups claimed.
The case—brought forward by three patients, the HIV+Hepatitis Policy Institute, the Diabetes Leadership Council and the Diabetes Patient Advocacy Coalition against the Department of Health and Human Services—will now only permit insurers to use copay accumulators for branded drugs that have a generic equivalent, if allowed by state law. Copay accumulators are features within insurance plans where manufacturers' payments do not count toward a patient’s deductible or out-of-pocket maximum, according to the American Society of Clinical Oncology.”
Comment: The purpose of the policy was to prevent pharma companies from charging very high prices and then offering individuals rebates. The patients benefitted, but the insurance companies were stuck with large costs.We will need to wait and see if this decision results in higher premiums.

Feds Rein In Use of Predictive Software That Limits Care for Medicare Advantage PatientsThe federal government will try to even the playing field next year, when the Centers for Medicare & Medicaid Services begins restricting how Medicare Advantage plans use predictive technology tools to make some coverage decisions.”

 Federal judge denies request to block Medicare negotiation “A federal judge on Friday declined to block the Medicare Drug Price Negotiation program, meaning companies will have to play ball with the government for the time being.
U.S. District Judge Michael J. Newman ruled against a request for a preliminary injunction on the program that was requested by the Chamber of Commerce in its lawsuit to stop negotiations.”

Drugmakers sign on to negotiate Medicare prices under protest “All the drugmakers that make the 10 prescription medicines subject to the first-ever price negotiations for the U.S. Medicare health program, including Amgen and Novartis , said they signed on to participate in the talks by the Oct. 1 deadline.
The penalties for not doing so would have been steep: drugmakers would have to pay 65% to 95% taxes on their drug's Medicare sales or withdraw all of their products from the Medicare and Medicaid programs, which together provide health benefits to 158 million Americans.”

The next two articles remind me of the Jimmy Durante quotation:
“Everybody wants to get into the act!”

Meijer jumps into health insurance market with new Blue Cross partnership “Blue Cross Blue Shield of Michigan’s newest Medicare Advantage plan for senior citizens comes with an allowance that enrollees can spend at Meijer Inc. stores across the state. 
Under the Medicare Plus Blue PPO + Meijer plan that begins enrollment this month, subscribers will get a $660 allowance to buy health-related items such as vitamins, bandages, medications and equipment. They can also use it to purchase healthy foods if they have a chronic medical condition.”

Instacart, Alignment to launch co-branded Medicare Advantage plan “Grocery delivery company Instacart is launching a co-branded Medicare Advantage plan next year with Alignment Healthcare in 13 counties across California and Nevada.
Pending regulatory approvals, 3.9 million Medicare-eligible individuals will have access to the new plans, which will feature $50 to $100 quarterly grocery allowances through Instacart, a complimentary Instacart+ membership with free delivery on qualifying orders, technical support for setting up an account and placing orders, and Alignment Health's new "virtual storefront" on Instacart where members can shop for recommended products.

Cigna to pay $172 million in Medicare Advantage fraud settlement “Health insurer Cigna is paying more than $172 million to settle allegations that it committed fraud by knowingly submitting inaccurate diagnoses of its Medicare Advantage members, the company and Department of Justice announced Saturday.
The settlement stems from a wide-ranging government investigation into the coding practices of Medicare Advantage insurers, as well as a specific whistleblower lawsuit against Cigna that the DOJ joined last year.”

Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Aetna, Inc. (Contract H5521) Submitted to CMS “With respect to the seven high-risk groups covered by our audit, most of the selected diagnosis codes that Aetna submitted to CMS for use in CMS's risk adjustment program did not comply with Federal requirements. For 155 of the 210 sampled enrollee-years, the medical records that Aetna provided did not support the diagnosis codes and resulted in $632,070 in overpayments. On the basis of our sample results, we estimated that Aetna received at least $25.5 million in overpayments for 2015 and 2016. As demonstrated by the errors found in our sample, Aetna's policies and procedures to prevent, detect, and correct noncompliance with CMS's program requirements, as mandated by Federal regulations, could be improved.”

About hospitals and healthcare systems

 National Hospital Flash Report  Key Takeaways
1. Hospital performance in August improved compared to July as margins continue to stabilize.
While margins are still below historical levels, there is less variance and an overall trend of positive margins in 2023.
2. Lengths of stay in 2023 continue to decline.
Patients continue to resume more normal patterns of accessing care.
3. Expenses increased but were offset by increased revenue.
Labor expenses also declined alongside less contract labor utilization, reflecting overall financial stability.

 About pharma

AstraZeneca pays $425M to settle heartburn drug lawsuits “Biopharmaceutical company AstraZeneca has agreed to pay $425 million to settle product liability suits over two heartburn drugs, Prilosec and Nexium, according to an Oct. 3 news release…
Many of the claims alleged that the two drugs led to kidney injuries that over time could evolve into end-stage renal disease.”

Novartis completes Sandoz spin-off “Novartis on Wednesday completed the spin-off of its generics and biosimilars business Sandoz, finalising its transition to an innovative medicines business focused on four core therapeutic areas of cardiovascular, renal and metabolic (CRM), immunology, neuroscience and oncology.”

Court tosses $223.8 million verdict against J&J in talc cancer case A New Jersey appeals court on Tuesday threw out a $223.8 million verdict against Johnson & Johnson that a jury had awarded to four plaintiffs who claimed they developed cancer from being exposed to asbestos in the company's talc powder products.
The Superior Court of New Jersey, Appellate Division found that a lower court judge should not have allowed some of the scientific expert testimony the plaintiffs presented to jurors at trial.”

Boehringer launches 81% discounted biosimilar of AbbVie's Humira “Germany's Boehringer Ingelheim on Monday launched an unbranded version of its biosimilar of AbbVie's Humira with a list price 81% cheaper than the blockbuster rheumatoid arthritis drug.
The company in July launched a branded biosimilar, Cyltezo, priced at a 5% discount to Humira's current list price of $6,922 per month. Boehringer's close-copies of Humira are the only ones that can be substituted for the original without consulting the prescriber after being designated as interchangeable by the U.S. Food and Drug Administration.” However: Save Billions or Stick With Humira? Drug Brokers Steer Americans to the Costly Choice “The biggest hitch seems to be the PBMs. Express Scripts and Optum Rx, two of the three giant PBMs, have put biosimilars on their formularies, but at the same price as Humira. That gives doctors and patients little incentive to switch. So Humira remains dominant for now.”

Discounted drug purchases under 340B grew 22% to $54B across 2022, HRSA reports “Discounted prescription drugs purchased wholesale under the 340B program grew 22.3% to $53.7 billion from 2021 to 2022, according to data published by the Health Resources and Services Administration (HRSA).”

15 biggest pharmacies by prescription revenue FYI

Regulatory tracker: Pfizer's Humira biosimilar wins interchangeability tag from FDA “Pfizer's Abrilada, the company's biosimilar version of AbbVie's Humira, has won an interchangeability designation from the FDA. 
The tag means that the drug can be substituted at the pharmacy counter by a pharmacist. Abrilada is only the second Humira biosim to gain the designation, following Boehringer Ingelheim's Cytelzo.”

AbbVie continues winning streak as leading TV drug ad spender while budgets start to swell again A current list of top spenders FYI.

After short FTC fight, Amgen wraps up $27.8B Horizon buyout “Amgen has completed its $27.8 billion acquisition of Horizon Therapeutics after fending off a legal challenge by the U.S. antitrust watchdog.
The California-based drugmaker made the announcement Friday following a signoff from the High Court of Ireland the prior day.”

Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss “This study found that use of GLP-1 agonists for weight loss compared with use of bupropion-naltrexone was associated with increased risk of pancreatitis, gastroparesis, and bowel obstruction but not biliary disease.”

About the public’s health

What is the current state of health and healthcare in the US? Well worth reading (lots of graphs make it easy). The bottom line(s): Government spending on healthcare is at an all-time high (dollars and percent of spending), yet life expectancy has declined and the percent uninsured has not changed.

Artificial sweeteners: the health controversy that will not go away From the Financial Times: The crux of the problem is that artificial sweeteners alter glucose metabolism through their effects on the gut microbiome.
So having a diet drink with fries may be worse that having the fries alone.

AN EPIDEMIC OF CHRONIC ILLNESS IS KILLING US TOO SOON An excellent article from The Washington Post that is well-worth reading.

 CDC to recommend some people take an antibiotic after sex to prevent sexually transmitted infections “Certain people should consider taking an antibiotic treatment after having unprotected sex to prevent sexually transmitted infections (STIs), the Centers for Disease Control and Prevention (CDC) will soon recommend.
The agency just released a draft of its recommendations for who should use the drug regimen, known as doxy-PEP, and how, and the agency will be accepting public feedback on that draft until Nov. 16. In its drafted guidelines, the CDC says that doxy-PEP should be given to those most heavily impacted by the recent surge in bacterial STIs in the U.S.: men who have sex with men (MSM), as well as transgender women.”

Discrimination exposure impacts unhealthy processing of food cues: crosstalk between the brain and gut “We show that discrimination is associated with increased food-cue reactivity in frontal-striatal regions involved in reward, motivation and executive control; altered glutamate-pathway metabolites involved in oxidative stress and inflammation as well as preference for unhealthy foods. Associations between discrimination-related brain and gut signatures were skewed towards unhealthy sweet foods after adjusting for age, diet, body mass index, race and socioeconomic status. Discrimination, as a stressor, may contribute to enhanced food-cue reactivity and brain–gut–microbiome disruptions that can promote unhealthy eating behaviors, leading to increased risk for obesity. Treatments that normalize these alterations may benefit individuals who experience discrimination-related stress.

Britain proposes ban on cigarettes for younger generationsBritain's government on Wednesday proposed banning younger generations from ever buying cigarettes, a move that would give the country some of the world's toughest smoking rules and hurt the sales of major tobacco firms.
If passed into law, the smoking age would rise by one year every year, potentially phasing out smoking among young people almost completely as soon as 2040, a briefing paper said.
‘A 14-year-old today will never legally be sold a cigarette,’ Prime Minister Rishi Sunak told the Conservative Party conference, where he announced the plan.”
Comment: New Zealand has already enacted such a program.

CDC finds 22 states had an adult obesity prevalence of 35% or higher in 2022 “According to CDC data, 22 states had an adult obesity prevalence of 35% or higher in 2022, up from 19 in 2021 and none in 2012.”

About healthcare IT

 There's a generational gap in satisfaction with telehealth, J.D. Power finds “Telehealth continues to enjoy elevated popularity thanks to the COVID-19 pandemic, but significant generational gaps persist in satisfaction, according to a new analysis from J.D. Power.
The report found that patient satisfaction with telehealth lands at a 698 score on a 1,000-point scale. Millennials and Generation Zers reported the highest satisfaction scores, while baby boomers and members of the Silent Generation had the lowest satisfaction.
Overall trust is a concern to watch, according to the report, as that produced the lowest scores. However, telehealth received higher marks for satisfaction with the clinicians patients interact with and for patients feeling their needs are met during a visit.”

About healthcare personnel

 More than 75,000 Kaiser Permanente workers begin multistate strike “More than 75,000 Kaiser Permanente workers walked off the job Wednesday in what is set to be the largest health-care strike in U.S. history, seizing on momentum in the labor movement across multiple industries.
Workers in California, Oregon, Colorado and Washington state launched the three-day strike, with direct implications for thousands of patients. A smaller number — about 400 pharmacists and optometrists — in Virginia and D.C. plan to stop work for one day.”

Overworked and Understaffed, More Than 1 in 4 US Nurses Say They Plan to Leave the Profession A really good discussion of the problem.

About health technology

Nobel Prize in medicine awarded to scientists who laid foundation for messenger RNA vaccines “The Nobel Prize in medicine was awarded Monday to two scientists whose research laid the groundwork for messenger RNA vaccines that transformed the threat of the coronavirus pandemic.
Early in her career, Katalin Kariko, 68, a Hungarian-born scientist, saw mRNA’s medical potential and pursued it with ferocious and single-minded tenacity that exiled her to the outskirts of science. After a chance meeting over the photocopier at the University of Pennsylvania 25 years ago, she worked closely with Drew Weissman, 64, an immunologist who saw the potential for the technology to create a new kind of vaccine.”

FDA moves to tighten oversight of laboratory-developed tests to make them safer and more accurate “The US Food and Drug Administration is proposing to step up its oversight of a growing category of medical tests called laboratory-developed tests.
The FDA approves and clears many types of lab tests for blood, saliva or tissue if they are used by many different hospitals or labs. But for almost 50 years, the agency has given individual labs leeway to develop and use their own tests in-house, as long as the labs met certain standards.” 

About healthcare finance

Healthcare Dealmakers A great summary of recent deals.

Lilly to surf radiopharmaceutical wave with $1.4B acquisition of Point Biopharma “Eli Lilly is snapping up Point Biopharma Global for $1.4 billion, marking an official entrance into the radiopharmaceutical cancer therapeutic space. 
Lilly will acquire all of Point’s outstanding shares at $12.50 apiece for a total of $1.4 billion. The transaction has already received the stamp of approval from the boards of both companies and is expected to close near the end of this year, subject to customary closing conditions.
The price is an 87% premium to Point's closing stock value on Oct. 2—$6.68 per share—and a 68% premium to the 30-day volume-weighted average price.”

This Week's News and Commentary

Ave Atque Vale: Victor R. Fuchs, ‘Dean’ of American Health Care Economists, Dies at 99 Read the entirety of the article or, if not accessible, find a medium that is. Professor Fuchs was one of the most influential health economists of the past 50 years.

About Covid-19

Did the government get a bad deal on the Covid-19 boosters? “[HHS Secretary] Becerra said then that the price that the federal government will pay for some vaccines “will be similar to what we paid in the past for the vaccines.”
However, the Centers for Disease Control and Prevention is paying $81.61 for the Moderna booster this year, and $85.10 for the Pfizer shot — which is around triple the amount the federal government paid for each shot last year. Moderna charged the government $26.36 per booster dose last year, and Pfizer charged $30.48.
The change is partly because the federal government ran out of money to continue to buy the vaccines in bulk to distribute across the country, so the vast majority of vaccine purchases are instead flowing through normal channels and will be paid for by a variety of different insurance plans this year, including Medicare and Medicaid.”

Effectiveness of Maternal mRNA COVID-19 Vaccination During Pregnancy Against COVID-19–Associated Hospitalizations in Infants Aged <6 Months During SARS-CoV-2 Omicron Predominance — 20 States, March 9, 2022–May 31, 2023 “During the period of recent SARS-CoV-2 Omicron predominance, maternal receipt of an mRNA COVID-19 vaccine during pregnancy reduced the likelihood of COVID-19-related hospitalizations and serious complications among infants aged <6 months.”

The Top COVID-19 Hot Spots in the U.S. “After increasing for nine consecutive weeks, COVID-19 hospitalizations in the U.S. have declined week over week, based on data from the Centers for Disease Control and Prevention.
The U.S. tallied about 19,700 new hospitalizations of people with COVID-19 over the seven days ending Sept. 16, marking a 4% decline from the week ending Sept. 9 and disrupting an upward trend that started at the end of June after hospitalizations had dipped to approximately 6,300.”

Multiorgan MRI findings after hospitalisation with COVID-19 in the UK (C-MORE): a prospective, multicentre, observational cohort study “After hospitalisation for COVID-19, people are at risk of multiorgan abnormalities in the medium term. Our findings emphasise the need for proactive multidisciplinary care pathways, with the potential for imaging to guide surveillance frequency and therapeutic stratification.”

Merck & Co.'s molnupiravir tied to transmissible COVID virus mutations: study “New findings published in the journal Nature suggest Merck & Co.'s oral antiviral treatment molnupiravir can cause mutations in the COVID-19 virus that occasionally spread to other people, potentially fuelling the evolution of new variants. However, there has been no evidence that the drug, which is also known under the brand name Lagevrio, has produced more transmissible or severe strains of COVID, according to the study.”

Biden administration draws commitment from health insurers to cover COVID-19 shots “The Department of Health and Human Services (HHS) met with representatives from the health insurance industry on Wednesday, receiving commitments that the updated COVID-19 vaccines will be covered after reports arose of some people having to pay out-of-pocket for their immunizations.”

About health insurance/insurers

 Deloitte Analysis: Employed Women Have as Much as $15.4 Billion More in Out-of-Pocket Medical Expenses a Year Than Men “Deloitte health actuaries found that women not only generally have more out-of-pocket medical expenditures than men but get less coverage for every health insurance premium dollar spent. Key takeaways:

·       Employed women have as much as $15.4 billion more a year than men in out-of-pocket health care expenses.

·       At all ages between 19 and 64, women have more in average out-of-pocket health care expenses than men, excluding maternity claims.

·       For people with commercial insurance, the value of benefits for women is more than $1.3 billion less than men.

·       The cost to employers to cover this actuarial value gap is less than $12 per employee or less than $1 a month.”

Federal Subsidies for Health Insurance: 2023 to 2033 From the CBO. The entire report is worth at least a skim. Overall: “Net federal subsidies for health insurance (that is, subsidies minus certain payments, such as Medicare premiums, amounts paid to providers and later recovered, and penalty payments) are projected to total $1.8 trillion in 2023 and $3.3 trillion in 2033. Measured as a share of gross domestic product (GDP), those subsidies are estimated to amount to 7.0 percent and 8.3 percent, respectively.”

 Florida nurse convicted for fraudulent orders billing Medicare for $200M “A Florida nurse practitioner was convicted this week by a federal jury for her participation in a $200 million healthcare fraud scheme.
Elizabeth Hernandez, 45, ‘signed thousands of orders’ for orthotic braces and genetic tests that were medically unnecessary and billed to Medicare, the Department of Justice (DOJ) said in a release announcing the conviction.”

Physician and Two Pharmacists Charged for $170M Fraud Scheme “According to court documents, Shalondria Simpson, 45, of Houston, is a pharmacist who owned and operated two pharmacies in Houston: Advance Pharmacy (Advance) and TruCare Pharmacy (TruCare). Simpson’s twin sister, physician Lashondria Simpson-Camp, 45, of Allen, Texas, allegedly referred prescriptions to Advance and TruCare in exchange for illegal kickbacks and bribes. Shayla Bryant, 38, of Houston, was a pharmacist and Advance and TruCare’s business manager.”

CMS: Most Medicare Advantage beneficiares won't see premiums rise in 2024 “The average monthly plan premium for MA plans, which is projected to increase nearly 4%, will go up from $17.86 to $18.50, but, if enrollees choose to stay in their plan, they will likely not see any price increase, according to a press release. Ahead of Medicare’s open enrollment period beginning Oct. 15, CMS expects 73% of beneficiaries will not see a premium increase, while the number of plans and supplemental benefits will both increase.”

Biden administration to ban medical debt from Americans' credit scores “The Biden administration announced a major initiative to protect Americans from medical debt on Thursday, outlining plans to develop federal rules barring unpaid medical bills from affecting patients’ credit scores.
The regulations, if enacted, would potentially help tens of millions of people who have medical debt on their credit reports, eliminating information that can depress consumers’ scores and make it harder for many to get a job, rent an apartment, or secure a car loan.”

Federal government to propose setting IDR fee under No Surprises Act at $150 “The federal government released preliminary documents Thursday, indicating that it plans to set the administrative, per-party fee for resolving out-of-network payment disputes at $150 in 2024.
Back in August, a district court sided with physicians in one of several lawsuits related to the No Surprises Act, which is aimed at protecting patients from unexpected IOUs. The Texas Medical Association and others had challenged the feds for hiking this fee by 600%, up to $350 from the original $50.”

Ensuring Continuous Eligibility for Medicaid and CHIP: Coverage and Cost Impacts for Adults “If all states adopted 12-month continuous eligibility for adults, 451,000 more adults would be enrolled in Medicaid in an average month in 2024, a 1.3 percent increase. There would be 267,000 fewer uninsured people in an average month, and the reduction in the number of people uninsured at any time would be greater. Federal and state spending in 2024 would increase by $479 million and $158 million, respectively. Both are increases of only 0.1 percent in spending on acute care for the nonelderly. Households and employers would each save about $1 billion a year in health care spending, and total health care spending would decline by $1.8 billion in 2024. Continuous eligibility for 24 months would further expand coverage and reduce costs.”

About hospitals and healthcare systems

Hospital Concentration Decreases Care for Medicaid Beneficiaries
Concentration and Medicaid Admissions:
—A 1% increase in a hospital-specific measure of concentration was associated with a 0.59% decrease in admissions for Medicaid patients at the average hospital level.
—The impact of concentration was more pronounced for birth admissions and was associated with a 1.3% decrease in birth admissions compared to a 0.51% decrease for other Medicaid patients' admissions.
—Hospital mergers, a strong driver of hospital concentration, were linked to decreases in birth admissions for Medicaid patients at the hospital level.
—There were very small overall market-level decreases in admissions to any hospital following concentration, suggesting reduced access to inpatient care.

Impacts for Non-Profit and Public Hospitals:
Among non-profit hospitals, a 1% increase in a hospital-specific measure of concentration was associated with an average 1.42% decrease in Medicaid birth admissions, while public hospitals experienced an increase of 1.38%.

Physicians:
Concentration was associated with physicians serving high shares
of Medicaid patients attending fewer deliveries in non-profit hospitals, indicating that physician admitting privileges could be a key mechanismdriving the shift in patient flows from non-profit to public hospitals.”

CommonSpirit’s answer to losing money: get bigger “CommonSpirit Health keeps adding more hospitals — and billions in new debt — even as it bleeds money.
Formed through a 2019 merger and headquartered in Chicago, CommonSpirit is one of the country’s largest not-for-profit health systems, with north of 140 hospitals. Even though it has scale, the system has lost money almost every year since its inception, including $2.7 billion on operations in the past two years. CommonSpirit’s latest financial statement also shows its total debt grew $2.9 billion in the year that ended June 30.”

Ascension outlook revised to negative “While affirming its default rating and $6.6 billion of bonds at "AA+," Fitch Ratings on Sept. 26 lowered the outlook for St. Louis-based Ascension to negative from stable.
The move followed Ascension reporting a $3 billion operating loss Sept. 14, an amount described by Fitch as "noteworthy." Operating margins will be pressured for the near term even as improvements are expected in the long term, Fitch said, with a 3 percent figure expected in the next several years.”

How 23 health systems' labor costs are trending FYI

Hospital Finances Stabilize with Six Months of Positive Margins  “Key trends for the month include:

  • Median hospital operating margins increased in August after dropping nearly one percentage point the month before, signaling that hospital finances are stabilizing with six months of positive results

  • Outpatient revenue had sizable increases for the month due to the ongoing shift in care to less expensive and more convenient ambulatory settings

  • Hospitals saw fewer high-acuity patients, as evidenced by a decline in the lengths of inpatient stays and minimal movement in the share of patients held for inpatient observation

  • Hospital supply and drug expenses continued to climb both on an overall and per-patient basis, driving up total non-labor costs”

How One Health System Got Rid of Bureaucratic Busywork Well-worth a quick read. The article summarizes elimination of needless work that was adding thousands of hours of work.

 Costco expands healthcare footprint, teams up with Sesame to offer members $29 virtual care visits Several years ago, who would have thought that Costco would have been mentionedd in the same sentence as “healthcare?”
“Costco is joining retail competitors Walgreens, Walmart and CVS Health by expanding its healthcare footprint.
The big-box retailer teamed up with startup Sesame to offer special discount pricing to Costco members on a broad range of outpatient medical care services, including telehealth visits. Costco members nationally can book appointments directly through their Costco memberships for Sesame's "best pricing" including virtual primary care visits for $29 and online mental health therapy visits for $79.”

About pharma

 Rite Aid Plans to Shut Down Hundreds of Stores in Bankruptcy “Rite Aid is negotiating with creditors over the terms of a bankruptcy plan that would include liquidating a substantial portion of its more than 2,100 drugstores, according to people familiar with the talks.
Rite Aid has proposed to close roughly 400 to 500 stores in bankruptcy, and either sell or let creditors take over its remaining operations, one of the people said.”

EXCLUSIVE: The 340B Program Reached $54 Billion in 2022—Up 22% vs. 2021 “For 2022, discounted purchases under the 340B program reached a record $53.7 billion—an astonishing $9.8 billion (+22.3%) higher than its 2021 counterpart. The difference between list prices and discounted 340B purchases also grew, to $52.3 billion (+$2.6 billion). 
Hospitals accounted for 87% of 340B purchases for 2022. Every 340B covered entity type experienced double-digit growth, despite drug prices that grew more slowly than overall inflation.
Another surprise: HRSA estimated that manufacturers' contract pharmacy restrictions reduced 340B purchases by only $470 million—or less than 1% of 2022's total purchases. That's far below the figure quoted by 340B lobbyists.”

Wegovy, other weight-loss drugs scrutinized over reports of suicidal thoughts “The U.S. Food and Drug Administration has received 265 reports of suicidal thoughts or behavior in patients taking these or similar medicines since 2010, Reuters found in an examination of the agency's adverse-event database. Thirty-six of these reports describe a death by suicide or suspected suicide.”

THE BURDEN OF PATENT THICKETS “Extending patent protection nets drugmakers $158 billion on just four drugs.” Wel-worth reading the entire article.

Cough syrup deaths overseas prompt US crackdown on toxic testing “The U.S. FDA is cracking down on lax testing practices by dozens of makers of healthcare products following hundreds of deaths overseas from contaminated cough syrups, a Reuters review of regulatory alerts found.
The Food and Drug Administration has reprimanded at least 28 companies this year, saying they failed to prove sufficient testing of ingredients used in over-the-counter drugs and consumer products for the toxins ethylene glycol (EG) and diethylene glycol (DEG), according to a Reuters analysis of agency import alerts and warning letters to manufacturers.”

About the public’s health

Sedentary Behavior and Incident Dementia Among Older Adults “In this retrospective study of prospectively collected data of 49 841 adults participating in the UK Biobank, more time spent in sedentary behaviors (determined through a machine learning–based analysis of wrist-worn accelerometer data) was significantly associated with higher risk of incident dementia.”
Sedentary behavior counteracts the beneficial effects of exercise.

Biden plans $100 million drive to combat drug-resistant 'superbugs' The headline is the story.
In a related article that is worth reading in its entirety: The World Needs New Antibiotics. The Problem Is, No One Can Make Them Profitably. “Six startups have won Food and Drug Administration approval for new antibiotics since 2017. All have filed for bankruptcy, been acquired or are shutting down. About 80% of the 300 scientists who worked at the companies have abandoned antibiotic development, according to Kevin Outterson, executive director of CARB-X, a government-funded group promoting research in the field…
The reason, the companies say: They couldn’t sell their lifesaving productsbecause the system that produces drugs for cancer and Alzheimer’s disease—which counts on companies selling enough of a new treatment or charging a high enough price to reward investors and make a profit—isn’t working for antibiotics.”

CDC data shows obesity prevalence more common in a growing number of states According to data from the Centers for Disease Control (CDC), the prevalence of obesity is rising all across the nation.
The CDC data found that 22 states had a prevalence, or “proportion of adults with a body mass index (BMI) equal to or greater than 30,” of obesity over 35 percent in 2022. In comparison, 17 states had a prevalence of obesity over 35 percent in 2021.”

LDL-C Reduction With Lipid-Lowering Therapy for Primary Prevention of Major Vascular Events Among Older Individuals “Our study supports a relative clinical benefit of lowering LDL cholesterol for primary prevention of major vascular events in individuals aged ≥70 years similarly as in individuals aged <70 years.”

Surrogate Adiposity Markers and Mortality Question  Among body mass index, fat mass index, and waist-to-hip (WHR) ratio, what is the optimal adiposity measure with the strongest association with mortality outcomes in adults?
Findings  In this cohort study consisting of 387 672 UK adult participants from the UK Biobank, WHR was found to have the strongest and most consistent association with all-cause and cause-specific mortality.
Meaning  In this study, WHR had the most robust association with mortality risk and may serve as a more appropriate target for health care intervention.”

In new effort to reset flu shot expectations, CDC to avoid messages that "could be seen as a scare tactic" “ ‘People are more likely to perceive messages as credible and trustworthy if they set realistic expectations about what vaccines can and cannot do,’ the CDC's Sara Dodge Ramey told a panel of federal vaccine advisers at a meeting Friday.
Ramey said the agency's new ‘Wild to Mild campaign had been created as the result of a dozen focus groups in June and July earlier this year. 
That led to them rolling out a campaign this year carefully crafted to ‘avoid messages that could be seen as a scare tactic,’ she said, acknowledging some voiced ‘fatigue’ around talking about important steps to avoid dying from respiratory diseases this fall and winter.”

Biden signs bill introducing more competition to US' organ transplant network “President Joe Biden signed into law Friday a bipartisan bill that overhauls the country’s organ transplant system by increasing competition among contractors and paving the way for additional funding…
Alongside the open bidding, the new law eliminates a funding cap to make way for several network reforms floated by the Department of Health and Human Services’ Health Resources and Services Administration (HRSA) back in March.
That so-called OPTN Modernization Initiative already began with a data dashboard sharing de-identified information on donors, procurement, transplant waitlists and recipients, and with the funds would continue with other IT updates and increased independence of OPTN’s board of directors through the contracting process, per plans shared by HRSA.”

About healthcare IT

Private insurer payments for telehealth and in-person claims during the pandemic “In 2021, as was the case in 2020, private insurers continued to pay providers similarly for telehealth and in-person professional claims, on average. This is true for both evaluation and management and mental health therapy services. Among providers who offered both telehealth and in-person care, the vast majority of providers received similar payments regardless of whether the service was provided in-person or over telehealth.”

 Amazon moves into healthcare generative AI with $4B investment “Amazon is making a big bet on generative artificial intelligence — and its use in healthcare — with a $4 billion investment in AI company Anthropic.
The tech giant will take a minority ownership in the startup and incorporate Anthropic's AI assistant, Claude, into Amazon Bedrock, Amazon Web Services' new generative AI service.”

Telehealth: The Innovation That’s Not Yet a Habit “The Top Takeaways: A few services lead telehealthuse, but the picture is mixed. Providers use telehealth for follow-up more than any other reason, with behavioral health second. All other services rank well below these two.
—Highest Use: Follow-up visits comprise 37% of practice telehealth services and 27% of hospital services.
—Lowest Use: Providers use telehealth the least for initial visits (11%) and triage (5%).
— Increases: For practices, the biggest year-over-year usage gain was for behavioral health (13% to 20%); for hospitals, it was for chronic care management (8% to 19%).
—Decreases: Telehealth year-over-year use declined the most for hospital initial visits (21% to 11%).
—2025 Projections: Practices expect telehealth use to increase the most for behavioral health and primary care (4% each). Hospitals project that behavioral health services will grow from 20% to 31%.”

About healthcare personnel

 75,000 Kaiser workers plan to strike: 6 things to know FYI

The less than 1%: 49 hospitals with 5+ Magnet certifications “Of the 6,000-some hospitals in the United States, less than 1 percent have achieved five Magnet certifications. 
Forty-nine hospitals have at least five Magnet certifications, and 14 — or 0.23 percent — have more than five, according to the American Nurses Credentialing Center's website.”

CMS' staffing proposal will cost nursing homes $6.8B for 102K nurse hires, industry-backed report finds “Meeting the Biden administration’s minimum staffing proposals for nursing homes would require facilities nationwide to hire more than 102,000 additional nurses at a cost of $6.8 billion, well above the government’s $4 billion estimate, according to a report released Tuesday by an industry group.”

About health technology

Sources of Low-Value Care Received by Medicare Beneficiaries and Associated Spending Within US Health Systems In this national analysis, specialists accounted for a higher share of spending relative to volume across 40 low-value services, building on evidence that specialists have greater aggregate low-value spending to suggest they may both offer higher-cost services (eg, procedures) and use higher cost options within given low-value service definitions. PCPs ordered most examined drugs and laboratory tests, which have lower direct costs but potential for direct harms and care cascades. To encourage employed and affiliated clinicians to reduce these services, health systems could use evidence-based interventions including clinical decision support (eg, point-of-care alerts) and clinician feedback (eg, peer comparisons).”

About healthcare finance

 Virgin Pulse, HealthComp to merge in $3B deal aimed at improving employer health “Virgin Pulse and benefits administrator HealthComp are set to merge in a $3 billion deal that aims to drive lower costs and improve outcomes for employers.
The deal was first reported in The Wall Street Journal. Virgin Pulse is backed by Marlin Equity Partners and HealthComp is backed by New Mountain Capital, according to the report. New Mountain will hold a majority ownership of the new, combined company.”

Intercept, once a biotech trailblazer, sells itself for less than $1 billion “Intercept Pharmaceuticals, a firm whose treatment for a prevalent liver disease once made it the hottest stock in biotech, said Tuesday it would sell the company for less than $1 billion.
Alfasigma, an Italian pharmaceutical firm, will pay $19 a share for Intercept, in a roughly $800 million cash deal that represents an 80% premium to the company’s recent trading price. Intercept expects the deal to close by the end of the year.”

Pfizer hooks up with Ginkgo for $331M biobucks deal on unspecified targets “Ginkgo Bioworks has snared one of its biggest partners to date. The biology biotech will work with none other than Pfizer in a drug discovery deal for RNA medicines worth $331 million in biobucks for three programs. 
The companies did not break down the deal details, but the $331 million encompasses an upfront payment, research fees and development and commercial milestone payments plus royalties later on.”

This Week's News and Commentary

About Covid-19

Biden administration announces $600M to produce COVID tests and will reopen website to order them “The Biden administration announced Wednesday that it is providing $600 million in funding to produce new at-home COVID-19 tests and is restarting a website allowing Americans to again order up to four free tests per household — aiming to prevent possible shortages during a rise in coronavirus casesthat has typically come during colder months.
The Department of Health and Human Services says orders can be placed at COVIDTests.gov starting Sept. 25, and that no-cost tests will be delivered for free by the United States Postal Service.
And in a related article: New COVID vaccine campaign off to a bumpy start New billing codes, insurance company funding glitches, and shortages have caused the “bumpy start” of the headline.

COVID-19 admissions up for 9th straight week “More than 20,500 patients with COVID-19 were admitted to U.S. hospitals for the week ending Sept. 9, according to the latest CDC update. 
This marks a nearly 8 percent jump from the week prior and the ninth straight week of increase. COVID-19 hospitalizations are rising from record lows, though healthcare officials are watching moving trends as fall begins and activity forother respiratory viruses also ramps up.”

Does the risk of getting long Covid increase each time you get reinfected? “We compared people who have a reinfection to people who have no reinfection — not comparing the severity of infection versus the first. What we found is really undeniable: It’s very clear in our data that reinfection contributes additional risk of long Covid.”

Outpatient Treatment of Confirmed COVID-19: Living, Rapid Practice Points From the American College of Physicians (Version 2) FYI. [nirmatrelvir–ritonavir is Paxlovid].

 The Top COVID-19 Hot Spots in the U.S. FYI

Covid Infections Rise as OSHA Health-Care Inspections, Rule LagOSHA inspections of health-care facilities dropped by about 84% so far this year, returning to pre-pandemic levels as Covid-19 hospitalizations tripled over the summer and infections quadrupled among nursing-home workers.
From January through August 2023, the Occupational Safety and Health Administration inspected 159 nursing homes and 99 hospitals, according to agency data analyzed by Bloomberg Law. In the same period last year, the agency probed 915 nursing homes and 664 hospitals.”

About health insurance/insurers/Cost

US employers to see biggest healthcare cost jump in a decade in 2024 “Benefit consultants from Mercer, Aon and Willis Towers Watson see employer healthcare costs jumping 5.4% to 8.5% in 2024 due to medical inflation, soaring demand for costly weight-loss drugs and wider availability of high-priced gene therapies.”

CMS: Out-of-network billing arbitration may continue for cases submitted Aug. 3 or earlier “The Centers for Medicare and Medicaid Services (CMS) has instructed certified independent dispute resolution (IDR) entities to resume processing single and bundled disputes submitted on Aug. 3 or earlier, though those after the cutoff will have to wait for future guidance from the agency.
The IDR process has been on hold for a month and a half due to two court decisions handed down on Aug. 3 and Aug. 24 that vacated certain portions of out-of-network billing regulations…”

Tenet, HCA, CHS and UHS ranked by Q2 margins FYI

AMA posts CPT 2024 code set FYI: The American Medical Association released updates Sept. 8 to its Current Procedural Terminology code set for 2024.

The best-rated health plans of 2023, per NCQA “The National Committee for Quality Assurance has named the best-rated health plans of 2023 based on factors that include care quality, patient satisfaction and efforts to keep improving.” And in a related article: The best-rated Medicaid plans of 2023, per NCQA

Traditional Medicare lags behind MA, commercial plans in utilization, efficacy: research “A white paper by Harvard Medical School and Inovalon Harvard Medical School and Inovalon, which provides cloud-based healthcare data aggregation services, looks at enrollment data from 2015 through 2019. Researchers found that MA enrollees have more than 50% fewer inpatient hospital stays than fee-for-service Medicare enrollees.
In addition, MA members visited emergency departments 22% fewer times than those enrolled in traditional Medicare.
While people who enrolled in MA plans saw stable utilization in the first two years, those who enrolled in fee-for-service Medicare instead saw utilization increase by 35%, according to the report.”

Half a million children, others being reinstated after removal from Medicaid “Nearly a half-million children and other individuals in 30 states have been improperly dropped from Medicaid rolls, prompting federal health officials to shut down parts of a massive campaign to figure out who qualifies for the safety-net health insurance in more than half the country.
Leaders of the Centers for Medicare and Medicaid Services (CMS) on Thursday revealed the scope of the trouble, caused by computer systems failing to determine whether individual family members qualify for Medicaid. CMS discovered the problem late last month and ordered every state to report whether it was doing things wrong.
The officials said Thursday that states are in the process of reinstating everyone who should not have been cut off from Medicaid.”

About hospitals and healthcare systems

 100 hospital financial benchmarks | 2023 FYI

55 health systems with strong finances FYI

CommonSpirit posts $1.4B operating loss Aside from the specific organization, the general principles behind this loss indicates widespread industry conditions.

What Share of Nursing Facilities Might Meet Proposed New Requirements for Nursing Staff Hours? “On September 1, 2023, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would create new requirements for nurse staffing levels in nursing facilities, settings that provide medical and personal care services for nearly 1.2 million Americans. The adequacy of staffing in nursing homes has been a longstanding issue…
Key takeaways include:

  • Among all nursing facilities, fewer than 1 in 5 could currently meet the required number of hours for registered nurses and nurse aides, which means over 80% of facilities would need to hire nursing staff.

  • 90% of for-profit facilities would need to hire additional nursing staff compared with 60% of non-profit and government facilities.

  • The percentage of nursing facilities that would meet the requirements in the proposed rule varies from all in Alaska (100%) to nearly none in Louisiana (1%).

  • CMS is seeking comment on several alternatives to the proposed rule, one of which would require facilities to comply with requirements that were adjusted to reflect the health and frailty of nursing facility residents. Assuming this alternative was implemented using CMS’ existing approach for adjusting staff hours for resident health and frailty, virtually all facilities would need to hire new staff to meet the requirements.”

Comparison of Hospital Online Price and Telephone Price for Shoppable Services Findings  In this cross-sectional study of 60 US hospitals, online and phone cash prices were poorly correlated within a given hospital for vaginal childbirth (Pearson correlation coefficient [r] = 0.118) and brain magnetic resonance imaging (Pearson r = −0.169).
Meaning  These findings suggest that at US hospitals, price estimates for shoppable services posted online correlate poorly with prices obtained via phone; these findings suggest that patients will continue to face barriers to comparison shopping.”
And in a related article: Hospital price transparency fines in 10 numbers Specifics about the hospitals that have been fined since July.

About pharma

 After FDA experts smack down ineffective decongestant, class-action lawsuits fly After the FDA’s determination that phenylephrine was not effective, it was only a matter of time before law suits were filed against the companies marketing the preparations.

MedImpact, GoodRx team on new prescription savings program “Pharmacy benefit manager MedImpact is teaming up with GoodRx on a new program that offers drug discounts "seamlessly" at the pharmacy counter.
Under the initiative, when a MedImpact member gets a prescription filled, the cost under the benefit will automatically be compared to GoodRx's price, with the lower option automatically applied, according to an announcement. What the member pays will apply to their deductible, the companies said.”

Ranitidine Use and Incident Cancer in a Multinational Cohort Question  Is use of ranitidine associated with higher risk for incident cancer compared with other histamine-2 (H2) receptor antagonists (H2RAs)?
Findings  In this cohort study including 1 183 999 individuals from 11 large databases across Europe, North America, and Asia, risk of cancer among ranitidine users did not differ from users of other H2RAs. Ranitidine use was not associated with an increased risk of esophageal, stomach, or colorectal cancer, or 13 other subtypes of cancer.
Meaning  These findings suggest that a history of ranitidine use is not associated with an increased risk of cancer compared with use of other H2 receptor antagonists, but further research is needed on the long-term effects of ranitidine on cancer development.”

 Medicare’s Historic Prescription Drug Price Negotiations A really good review of the legal dimensions of this program.

About the public’s health

Estimated Lifetime Gained With Cancer Screening TestsA Meta-Analysis of Randomized Clinical Trials “In this systematic review and meta-analysis of 18 long-term randomized clinical trials involving 2.1 million individuals, colorectal cancer screening with sigmoidoscopy prolonged lifetime by 110 days, while fecal testing and mammography screening did not prolong life. An extension of 37 days was noted for prostate cancer screening with prostate-specific antigen testing and 107 days with lung cancer screening using computed tomography, but estimates are uncertain.”

 Associations of Dietary Sugar Types with Coronary Heart Disease Risk: A Prospective Cohort Study “Sugar and carbohydrate intake, including total fructose equivalents (TFE, from fructose monosaccharides and sucrose), total glucose equivalents (TGE, from glucose monosaccharides, disaccharides, and starch), and other sugar types, was measured every 2-4 years by semiquantitative food frequency questionnaire…
Intakes of TGE, total sugar, added sugar, and fructose from added sugar and juice were associated with higher CHD risk, but TFE and fructose from fruits and vegetables were not.”

Global report on hypertension: the race against a silent killer An extensive report from the WHO. In addition to the prevalence data, the following statement is also disturbing: “Currently, among adults aged 30–79 years with hypertension, only 54% have been diagnosed with the condition, 42% are being treated for their hypertension, and 21% are considered to have their hypertension controlled.”

US Supply Shortages Create Adverse Health Impacts for Millions Three years after the worst of Covid-era supply-chain disruptions, about one in six Americans adults are experiencing shortages of medications or other critical medical equipment, based on a Census Bureau survey.
That’s equivalent to more than 45 million people who couldn’t get hold of prescribed drugs, over-the-counter medication, home medical equipment or other critical goods in the previous 30 days. About half of them faced mental distress or had negative health impacts as a result, according the survey, conducted Aug. 23 to Sept. 4.”

CDC Awards to Establish National Infectious Disease Forecasting Network “The CDC’s Center for Forecasting and Outbreak Analytics has awarded over $260 million to 13 infectious disease forecasting and analytics centers.”

About healthcare IT

Commercial Payer Coverage for Digital Medicine Codes A great summary of the topic from the AMA. Worth reading the entire monograph. In summary: “This research surfaced the following findings, related to commercial coverage of digital medicine CPT codes:

  1. There is a lack of alignment across commercial, Medicare and Medicaid plans regarding coverage of digital medicine CPT codes. This lack of alignment makes it difficult for physicians to reliably provide digital services and for the consumer to know what services are accessible to them.

  2. Within the commercial market, there is inconsistent adoption of new digital medicine CPT codes.

  3. The level of transparency regarding coverage of digital medicine services is highly variable across

    commercial health plans.

  4. There are varying processes and timelines for adopting new CPT codes across health plans.

  5. There is limited widespread utilization of most new digital health CPT codes, and health plans are eager for research on the impact and quality of digital medicine services.

  6. Health plans often partner with health tech companies directly to provide digital health services to members, but these directly-contracted services are often disconnected from a patient’s medical home.”

 Oracle Cerner adds generative AI to its EHR platforms “The multimodal voice and screen-based tool ‘participates in the appointment,’ according to Oracle, to automate note taking and propose ‘context-aware next actions,’ such as ordering medications or scheduling labs and follow-ups.
Providers can use the tool – which will be available in the next 12 months, the company says – to verbally access elements of a patient's EHR record during an appointment, avoiding the need for ‘multi-menu, multi-step’ interactions with the software.”

About healthcare personnel

The cost of physician turnover The Association for Advancing Physician and Provider Recruitment's report on physician and provider retention and turnover in 2022 showed around 76 percent of physician exits in organizations with the most and least providers were due to retirement. Physicians finding a new role elsewhere was also a top response…
[For example]:Losing a physician means hospitals won't receive the revenue associated with those cases until the physician is replaced. Physicians also typically have a ramp-up period for to build a patient base. On average, physicians generate $2.4 million for affiliated hospitals each year, according to Merritt Hawkins. The highest revenue generating physicians being interventional cardiologists who generate $3.48 million per year and then orthopedic surgeons who generate $3.29 million per year.”

Provision of evaluation and management visits by nurse practitioners and physician assistants in the USA from 2013 to 2019: cross-sectional time series study “The proportion of visits delivered by nurse practitioners and physician assistants in the USA is increasing rapidly and now accounts for a quarter of all healthcare visits.”

FTC sues private-equity backed anesthesia staffing firm, saying it tried to corner the market and drive up prices “The Federal Trade Commission sued U.S. Anesthesia Partners Inc., one of the country’s top anesthesia staffing companies, and its private-equity backer, Welsh, Carson, Anderson & Stowe, on Thursday, accusing both entities of scheming over a decade to acquire anesthesia practices in Texas, monopolize the market, drive up prices for patients and generate profits.”

About healthcare finance

Novo Holdings closes $462 mln acquisition of Paratek Pharmaceuticals “Novo Holdings, the controlling shareholder in drugmaker Novo Nordisk, on Thursday said it had closed its acquisition of biopharmaceutical company Paratek Pharmaceuticals in a deal valued at $462 million.
The acquisition of Paratek Pharmaceuticals, which was announced in early June, is Novo Holdings' largest individual investment in antimicrobial resistance therapies to date, it said in a statement.”

This Week's News and Commentary

About Covid-19

CDC Data: New Weekly COVID Hospitalizations Climb 9% “Coronavirus hospital admissions increased nearly 9% during the week ending in Sept. 2, according to the data. With over 18,800 new hospitalizations recorded that week, the latest COVID-19 wave is no doubt still rising.
But it’s a notably smaller percentage increase from the week prior, when hospitalizations jumped nearly 16%. It could be a sign that the latest increase is starting to plateau.”

FDA signs off on updated COVID vaccines “Pfizer/BioNTech and Moderna on Monday obtained an FDA nod for their updated COVID-19 vaccines, which target the Omicron XBB.1.5 variant, amid an uptick in hospitalisations and concern about the spread of several new strains. The US Centers for Disease Control and Prevention (CDC) is expected to follow up on Tuesday with an advisory meeting to discuss who should get the new shots, and once a final decision is made by the CDC's director, millions of doses will be shipped to pharmacies, clinics and health systems nationwide within days.”
C.D.C. Recommends New Covid Vaccines for All Americans “The Centers for Disease Control and Prevention recommended on Tuesday that all Americans 6 months and older receive at least one dose of the latest Covid shots, the last of a trifecta of vaccines intended to prevent another surge in respiratory infections this fall and winter.”
US pharmacy chains gear up to administer updated COVID shots “U.S. drugstore chains CVS Health and Walgreens Boots Alliance said on Wednesday that updated COVID-19 vaccines would be available at their stores as soon as this week.”
US CDC says existing antibodies can work against new COVID variant The headline is the story.

Fraudsters may have stolen $1 of every $7 in covid jobless aid, watchdog finds “Fraudsters may have stolen as much as $135 billion in federal unemployment aid during the coronavirus pandemic, according to a report released Tuesday by the Government Accountability Office, which found the theft encompassed roughly one out of every seven dollars set aside for jobless Americans during the public health crisis.”

About health insurance/insurers

This Obamacare disaster had a surprising turnaround “Obamacare’s co-ops were once arguably the landmark health care law’s biggest failure.
The federal government pumped $2.4 billion into 24 nonprofit insurers in an effort to stoke competition in the nascent health care markets. Within four years, almost all had collapsed, hemorrhaging red ink and leaving tens of thousands of patients in the lurch.
But a decade after the tumultuous launch of the Obamacare markets, there are three unlikely survivors with robust enrollment growth, providing much-needed competition in sparsely populated parts of the country with older demographics that aren’t particularly attractive to commercial insurers.”
Comment: The article is worth reading in its entirety.

 National gym chain to limit hours for Medicare members “In a statement shared with Becker's, a Life Time spokesperson said the changes were implemented after reimbursement rate negotiations with Medicare fitness benefit administrators. 
Beginning in January 2024, Life Time members who receive their memberships through Medicare benefits will be able to use the clubs from 9:30 a.m. to 3 p.m. on weekdays, after 2 p.m. on Saturdays, and all day on Sundays.”
Comment: Many Medicare eligibles also work. How does this change benefit their health?

About hospitals and healthcare systems

 World's Best Specialized Hospitals 2024 FYI (From US News)

Ascension reports $3B annual operating loss St.Louis-based Ascension, one of the largest health systems in the country, has reported a full-year operating loss of $3 billion on revenue of $28.35 billion, compared with an $879.2 million loss on $27.98 billion in revenue last year, according to recently released financial documents.
The $3 billion figure includes $1.5 billion of nonrecurring losses and impairment in the fiscal year ending June 30. That $1.5 billion figure compares with a gain of $26 million in 2022.
Expenses rose 4.1 percent over the previous year to total $29.9 billion. Salaries and wages decreased 2.5 percent to total $11.8 billion.”

 Fitch: Healthcare's runaway labor costs slow down, allowing hospitals to ease off contract labor “Citing Bureau of Labor Statistics data and conversations with its rated nonprofit systems, the report highlights three and four consecutive months of decelerating year-over-year hourly earnings growth for the hospital and ambulatory sub-sectors.
For hospitals specifically, the measure has dropped from a pandemic high of 8.4% and a 2023 high of 5.15% to July’s 3.75%—all of which are still above the 2.3% average of the past decade…”

2023 Perspectives on Value-Based Care Interesting report from the Terry Group. One of the many findings is: “Healthcare system participants worry that significant obstacles are holding back VBC. Sixty-one percent of respondents say that reluctance to assume downside risk is a very significant factor in slowing VBC’s growth, 51 percent say that the requirement to prove near-term ROI is, and 47 percent say that ongoing administrative costs are.”

About pharma

Another round of Medicare Part B drugs capped by inflation rebates “A third set of Medicare Part B prescription drugs will cost up to $618 less per average dose beginning Oct. 1, announced the Centers for Medicare & Medicaid Services (CMS).
The policy, which applies to 34 drugs until Dec. 31, is possible through the Medicare Prescription Drug Inflation Rebate Program in the Inflation Reduction Act (IRA). It works through reducing coinsurance for beneficiaries with Part B coverage and discouraging drug companies from increasing prices faster than inflation, according to a release.”

New York Attorney General Signs Deal With Novo Nordisk to Cap Insulin Prices for Uninsured “New York Attorney General Letitia James has secured a five-year agreement with Novo Nordisk to cap the price of insulin at $35 per month for uninsured New Yorkers, as reported in Morningstar.
The agreement comes four months after James' office secured the same deal with Eli Lilly and Sanofi.
In March, Novo Nordisk said it would cut the US list prices for several insulin drugs by up to 75% amid pressure to curb diabetes-treatment costs.
A provision from earlier this year under the Inflation Reduction Act capped Medicare patients' copays or other out-of-pocket spending on insulin at $35 a month.”

Venous thromboembolism with use of hormonal contraception and non-steroidal anti-inflammatory drugs [NSAIDs]: nationwide cohort study “NSAID use was positively associated with the development of venous thromboembolism in women of reproductive age. The number of extra venous thromboembolic events with NSAID use compared with non-use was significantly larger with concomitant use of high/medium risk hormonal contraception compared with concomitant use of low/no risk hormonal contraception. Women needing both hormonal contraception and regular use of NSAIDs should be advised accordingly.”

Walgreens inks deal with startup Pearl Health on value-based care for doctors Walgreens and Pearl will help doctors manage value-based care in traditional Medicare’s accountable care organization program, called ACO REACH, starting in 2024. The two plan to eventually expand to Medicare Advantage and potentially commercial payers and Medicaid down the line.”
Comment: My guess is that this deal was in the works before Roz Brewer stepped down. It does continue the direction of Walgreens getting into direct patient care, which the company should be re-evaluating.
This one makes more sense:
GoodRx, Walgreens team to lower prices for 200 drugsThe new program will reduce prices on these products by 40% on average, and there are greater savings possible on select medications, according to an announcement.”

After initial stumbles, Moderna finally gains clean phase 3 win for mRNA flu shot “An updated version of mRNA-1010 has met all primary endpoints in a phase 3 trial, Moderna said in an announcement Wednesday as part of its annual R&D day. Compared to GSK's Fluarix, Moderna's vaccine showed higher antibody levels for all four influenza strains (two each for influenza A and B) recommended by the World Health Organization (WHO) as well as higher seroconversion rates. Seroconversion is the development of specific antibodies against a virus.”

25th drugmaker imposes restriction on 340B participants “Jazz Pharmaceuticals is the latest drugmaker to impose pricing restrictions for 340B participants, according to a Sept. 11 news release from the 340B Health organization. Its decision makes it the 25th drugmaker to impose the restrictions since 2020. 
The drugmaker will no longer facilitate orders from 340B hospitals or pharmacies for the childhood epilepsy drug Epidiolex, according to the release.”

Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them “Across a selection of 20 generic drugs carried by the Cuban pharmacy, Cigna’s prices were 27.4 times higher than Cuban’s on average for the 19 drugs for which data was available.
CVS’s prices were 24.2 times higher on average for 17 drugs for which data was available. UnitedHealth’s prices were 3.5 times higher than Cuban’s on average for the 19 drugs with available data.”
Comment: If you can access this Wall Street Journal article, it is worth reading in its entirety.

US FTC warns drugmakers that improper patent listings may be illegal “The US Federal Trade Commission (FTC) warned brand-name drugmakers that they could face legal action if they improperly list patents in the FDA’s ‘Orange Book.’ Lina Khan, chair of the FTC, said the regulator is ‘making clear that improper…listings may be an unfair method of competition,’ and could constitute illegal monopolisation.”

About the public’s health

US CDC expects 'tripledemic' hospitalizations to remain high this year vs pre-pandemic levels “The U.S. Centers for Disease Control and Prevention (CDC) said on Thursday it expects the total number of hospitalizations from COVID-19, respiratory syncytial virus infections and flu this year to be similar to last year, higher than pre-pandemic levels.
The government health agency also said it expects flu and RSV infections to increase over the fall and winter seasons.
Vaccines for all three major respiratory viruses – COVID-19, flu, and RSV – will be available this fall, the CDC said.”

US Supreme Court freezes order curbing Biden administration social media contacts “The U.S. Supreme Court on Thursday temporarily put on hold an order restricting the ability of President Joe Biden's administration to encourage social media companies to remove content it considers misleading, including about the COVID-19 pandemic.
Conservative Justice Samuel Alito, acting for the court, issued an order freezing a lower court's decision finding that federal officials had likely violated the free speech protections of the U.S. Constitution's First Amendment by coercing social media platforms into censoring certain posts.”

Poverty Rate Soared in 2022 as Aid Ended and Prices Rose “The poverty rate rose to 12.4 percent in 2022 from 7.8 percent in 2021, the largest one-year jump on record, the Census Bureau said Tuesday. Poverty among children more than doubled, to 12.4 percent, from a record low of 5.2 percent the year before. Those figures are according to the Supplemental Poverty Measure, which factors in the impact of government assistance and geographical differences in the cost of living.
The increases followed two years of historically large declines in poverty, driven primarily by safety net programs that were created or expanded during the pandemic.”

Imagine a World: Where innovations could save the lives of 2 million more mothers and babies An excellent article from the Gates foundation is worth reading in its entirety. The four measures that are the focus of interventions are: Postpartum hemorrhage identification and management, anemia identification and management, use of azithromycin to reduce sepsis, and AI-enabled ultrasound.

White House announces $240 million investment to fight cancer The White House announced a $240 million investment Wednesday to fight cancer, along with a slew of new health resources to further the administration's "Cancer Moonshot" initiative.
The money — awarded through the Advanced Research Projects Agency for Health, which was created last year based on a proposal by President Joe Biden — will go to researchers working on cancer prevention, detection, treatment and survival projects, including initiatives to detect cancers earlier, better visualize cancer cells during surgery and ‘design devices that could deliver treatments directly to cancer cells to treat tumors more effectively, the White House said.”
And in a related article:
AACR CANCER PROGRESS REPORT Brief summary:
”In the United States, the overall cancer death rate has been steadily declining since the 1990s, with the reductions between 1991 and 2020 translating into more than 3.8 million cancer deaths avoided.
The decline in overall U.S. cancer death rates is driven by steady declines in mortality from cancers of the breast, colon and rectum, lung, and prostate.
More than 18 million cancer survivors were living in the United States as of January 1, 2022.
Progress has not been uniform against all cancer types or all subtypes and stages of a given cancer type.
There are stark inequities in the cancer burden among many sociodemographic groups within the United States; these inequities occur across the cancer continuum and are driven largely by social factors.
The economic burden of cancer both on individuals and the U.S. health care system is expected to rise in the coming decades, highlighting the urgent need for more research to accelerate the pace of progress against cancer.”

Cleveland Clinic Survey Examines the Current State of Men’s Health in America “In the survey, 81% of American men said they believe they are leading a healthy lifestyle. However, the survey results show the habits and behaviors of many men tell a different story.

  • Almost half of men (44%) do not get a yearly physical

  • 44% do not take care of their mental health

  • Only half of men said they keep a healthy diet (51%)

  • 83% have experienced stress in the last six months

  • About a quarter of U.S. men (27%) watch TV for more than five hours per day on average”

 Red Cross: Weather, travel contributing to blood shortage “The American Red Cross has declared a national blood supply emergency, citing weather and travel as reasons for the shortfall.
The organization said that national blood supply levels have fallen by nearly 25 percent since early August, which potentially threatens those who need emergency blood and those who rely on blood transfusions for conditions like cancer and sickle cell disease.”

Vaping e-cigarettes can be as harmful to gum and oral health as smoking traditional cigarettes “The EFP (European Federation of Periodontology) warns that vaping electronic cigarettes can be as harmful to gum and oral health as smoking traditional tobacco cigarettes. Despite the fact that the vaping phenomenon is relatively new compared to smoking, meaning research details are still incomplete, evidence does show a clear link between e-cigarettes and poor gum and oral health…
One of the reasons behind vaping's unhealthy impact is nicotine, whether smoked or vaped, which restricts the blood flow to the gums. Other chemicals contained in the e-cig vapor (including formaldehyde, propylene glycol, and benzene) may aggressively increase the damage to the mouth, starting with a progressive destruction of the periodontium, the tissues supporting the teeth.”

About healthcare IT

Meta facing lawsuit over violation of medical privacy “Five anonymous plaintiffs have alleged that at least 664 medical providers have used pixel tracking technology on their websites and patient portals, which has allowed Meta to obtain patients' protected health information, Bloomberg Law reported Sept. 8. 
In a consolidated lawsuit, the plaintiffs allege that Meta collected health information of people with Facebook accounts by installing pixels on the patient portals of their healthcare providers. 
The plaintiffs also say the tech giant was able to profit from the information by using it to deliver targeted ads, according to the publication.”
Comment: Many suits have been initiated agains different companies because of the pixel installation on patient portals; this consolidation was inevitable.

Geisinger doubles down on collaboration with Best Buy Health, Geek Squad to support tech-driven care in the home “By working with Best Buy and its Geek Squad, Geisinger was able to cut in half the time from admission into the chronic care at-home program to when device setup is completed for the patient. That process used to take 96 hours, and the program reduced that time to 48 hours, according to the health system. This makes it faster for Geisinger care teams to begin monitoring the patient remotely.
Results from the pilot program found a 19% improvement in how well patients follow their care plans by wearing and using their remote technology equipment more consistently. Patients in the program also reported fewer technical issues, down 18% compared to before the pilot with Best Buy.”

About healthcare personnel

 The Shrinking Number of Primary Care Physicians Is Reaching a Tipping Point “The percentage of U.S. doctors in adult primary care has been declining for years and is now about 25% — a tipping point beyond which many Americans won’t be able to find a family doctor at all.
Already, more than 100 million Americans don’t have usual access to primary care, a number that has nearly doubled since 2014. One reason our coronavirus vaccination rates were low compared with those in countries such as China, France, and Japan could be because so many of us no longer regularly see a familiar doctor we trust.”
Comment: Well worth reading the entire article.

Companies Can’t Ask You to Shut up to Receive Severance, NLRB Rules “The National Labor Relations Board ruled Tuesday that employers can no longer demand laid-off employees avoid publicly disparaging the company as part of their severance agreements, nor can they stop affected employees from disclosing the terms of their exit packages. Doing so, the federal agency determined, would be a violation of the laid-off employees’ rights under the National Labor Relations Act.”
Comment: Along with recent restrictions on restrictive covenants, this measure opens up many problems for employers.

About health technology

Backed by space-age tech, MRI-compatible biopsy robot earns FDA clearance The dangers of introducing any extra objects to a strong, fluctuating magnetic field are obvious, and when combined with a cramped working space, the entire prospect poses significant obstacles.
But Insight Medbotics appears to have found a solution. It has secured an FDA clearance for what the company describes as the world’s first surgical robot to operate within the bore of an MRI machine.
The IGAR, or image-guided automated robot, is designed to assist in performing breast biopsies to investigate suspicious lesions for traces of cancer. 
In order to not be tossed around the MRI suite, the system is constructed mostly of plastic and non-ferrous metals—with ceramic materials forming the piezoelectric motors that help align and insert the biopsy tools. At the same time, the device’s copper wiring is routed to prevent any loops that could interact with a magnetic field, while mechanical connections are fashioned out of brass or stainless steel.”

About healthcare finance

 Moderna commits up to $1.8 billion in cancer therapeutics deal with Immatics “Moderna agreed to pay $120 million upfront as part of a collaboration that will pair its expertise in mRNA technology alongside Immatics' T-cell receptor (TCR) platform to develop cancer therapeutics, the companies announced Monday. The agreement, potentially worth over $1.8 billion, will tackle various therapeutic modalities including bispecifics, cell therapy and cancer vaccines.”

This Week's News and Commentary

About health insurance/insurers/cost

States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model Read this announcement from CMS. Too many moving parts to summarize. Some news media say it is an all-payer system, but hospitals would be on global budgets. No mention is made of patients being assigned to providers/systems; which creates a financial incentive to hand off more intense cases to others. One of the program’s goals is to enhance primary care; but the details of how that will happen when choices in medical school will not be affected.

Health Benefit Cost Expected to Rise 5.4% in 2024, Mercer Survey Finds “According to the survey, even after taking into account changes US-based employers made to healthcare plans that are designed to slow cost growth, employers expect total health benefit cost per employee to rise 5.4% on average in 2024.
The estimate suggests that last year’s high inflation and labor shortages in the healthcare industry have pushed healthcare costs higher, contributing to higher health benefit costs. The projected increase comes after more than a decade of annual cost increases typically averaging 3 to 4%. Over 1,700 employers responded to the survey when the preliminary results were analyzed in August.”

 Humana sues feds over Medicare Advantage risk adjustment changes “Humana has filed suit against the feds, saying the Biden administration's bid to claw back overpayments in Medicare Advantage (MA) is built on "shifting justifications and erroneous legal reasoning."
Earlier this year, the Centers for Medicare & Medicaid Services (CMS) finalized a hotly anticipated rule that would overhaul risk adjustment data validation (RADV) audits, which determine whether MA plans were overpaid. In a win for insurers, the agency elected not to backdate these audits beyond 2018.”

States ranked by percentage of employers offering health insurance “Hawaii has the highest rate of private employers that offer health insurance to their employees, while Montana has the lowest, according to 2022 data published by KFF and sourced from the Agency for Healthcare Research and Quality.”
The national average is 48.3 percent.

Medicare Switching: Patterns Of Enrollment Growth In Medicare Advantage, 2006–22 “We found that switching from fee-for-service Medicare to MA more than tripled between 2006 and 2022, whereas switching from MA to fee-for-service Medicare decreased, with the change rates accelerating since 2019. The share of switchers among all new MA enrollees rose from 61 percent in 2011 to 80 percent in 2022. Black, dual-eligible, and disabled beneficiaries had higher odds of switching in both directions, whereas younger and healthier beneficiaries had higher odds of switching from fee-for-service Medicare to MA but lower odds of switching from MA to fee-for-service Medicare. Two-thirds of annual switching between MA and fee-for-service Medicare in 2022 occurred in January, likely reflecting the open enrollment period.”

Health Care Service Price Comparison Suggests That Employers Lack Leverage To Negotiate Lower Prices “We compared prices for common services in self-insured plans with those in fully insured plans. Using the Health Care Cost Institute’s data set of claims for one-third of the US population with employer-sponsored insurance, we found that unadjusted prices were higher in self-insured plans for most of the services we studied, with the largest differences found for endoscopies (approximately 8 percent higher in self-insured plans), colonoscopies (approximately 7 percent), laboratory tests (approximately 5 percent), and moderate-severity emergency department visits (4 percent). When patient characteristics, plan type, and geography were adjusted for, differences were generally smaller but were consistent with these findings. Higher prices in self-insured plans suggest that there may be opportunities for employers to lower prices and for policy makers to act where employers have limited leverage to negotiate with providers.”

MA Beneficiaries With Cancer Spend Less on Healthcare Than Traditional Medicare Beneficiaries “Medicare Advantage beneficiaries with a cancer diagnosis spend $3,996 on out-of-pocket costs and premiums annually, versus $6,091 for traditional Medicare beneficiaries with cancer, a new report found.”

Wide Variation In Differences In Resource Use Seen Across Conditions Between Medicare Advantage, Traditional Medicare “Total resource use in MA was generally lower than in traditional Medicare but by varying amounts across conditions, and it was not significantly different from traditional Medicare for some conditions. This variation was explained by resource use for hospital inpatient services in MA relative to traditional Medicare. Resource use for treatments was considerably lower in MA than in traditional Medicare across all conditions, whereas resource use for imaging and testing was consistently higher in MA for all conditions.”

About hospitals and healthcare systems

 Utilization, Steering, and Spending in Vertical Relationships Between Physicians and Health Systems Findings  In this case-control study involving 4 030 224 observations, PCP–health system vertical relationships were associated with increased total specialist visits and total spending per patient-year as well as specialist visits, emergency visits, and hospitalizations within the health system. There was no change in readmission rates or use of hospitals with low readmission rates.
Meaning  Findings of this study suggest that the vertical relationships between PCPs and large health systems were associated with steering patients into health systems and increased spending on patient care.”
Comment: Yet another finding about increase costs of health system consolidation.

About pharma

 The 10 highest value R&D projects in biopharma “The top 10 most valuable projects have a net present value of $79.1 billion, with a combined potential product revenue of $19.4 billion worldwide by 2028. The estimated cost of developing a drug—even if it never makes it to market—is on the rise, according to a report by Deloitte covering 2022. Drugmakers spent an estimated $2.2 billion last year, a $298 million rise over 2021. Meanwhile, forecast peak sales per pipeline asset declined from $500 million in 2021 to $389 million in 2022.”
The article also provides a list of the top ten.

California pharmacists make 5 million mistakes every year: Report “Pharmacists are overworked and understaffed, according to the California Board of Pharmacy, and it may be what is leading them to make up to 5 million errors each year, the Los Angeles Times reported Sept. 5.
Ninety-one percent of pharmacists surveyed in California working in chain settings like Walgreens, Rite Aid or CVS stores told the state's Board of Pharmacy in a 2021 survey that staffing at their place of employment is not adequate for providing patients proper care.”

Cross-Sectional Analysis of Out-of-Pocket Payments forCommonly Prescribed Generic Medications Versus DiscountCard Pricing “Out-of-pocket payments made by patients exceededAmazon and GoodRx prices for about 20% and 43% of the prescrip-tions included in this analysis, respectively. Out-of-pocket payments exceeded Amazon and GoodRx prices for 40% and 79% of the pre-scriptions assumed to be in the deductible phase, respectively. Theestimated cumulative OOP cost savings, assuming patients obtainedtheir medications using Amazon and GoodRx discount cards,amount to approximately $969 million and $1.83 billion (Table 2),respectively. Most of the cumulative OOP savings were generatedfrom 90-day prescriptions (Table 2)…
Of note, most prescriptions where OOP payments exceededdiscount card pricing were during the deductible phase.”
Comment: This situation can be a “Catch-22.” The discount site purchases can be cheaper in the deductible phase of pharma benefits, but insurers may not recognize these payments as counting toward the deductible. This situation leads to the conclusion that for frequently used, expensive drugs, it may be cheapest in the long run to use the drug benefit.

Walgreens to pay $44M to Theranos blood test customers “Walgreens Boots Alliance has agreed to a $44 million settlement to resolve class-action claims related to its partnership with Theranos, according to Bloomberg
The proposed settlement is still in need of court approval.”

FDA Reviewers Say OTC Decongestant Doesn't Work “When weighed by that standard, ‘we have now come to the initial conclusion that orally administered PE [phenylephrine] is not effective as a nasal decongestant at the monographed dosage (10 mg of PE hydrochloride every 4 hours) as well as at doses up to 40 mg (dosed every 4 hours),’ the FDA documents noted.
The agency is weighing whether to scuttle the indications for phenylephrine hydrochloride and phenylephrine bitartrate due to lack of efficacy.
‘However, we are concerned about avoiding potential unintended consequences,’ the reviewers added. ‘We anticipate that any action taken by the Agency in this regard will have significant downstream effects, including effects on both industry and consumers, because the only other oral decongestant listed in the CCABA [Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC Human Use] Monograph is pseudoephedrine, which is now regulated as a 'behind-the-counter' product under the Combat Methamphetamine Epidemic Act of 2005.’”

Kroger shares rise on 2Q earnings beat as investors brush of $1.4B opioid charge “The company said the settlement, with payments scheduled over the next 11 years, won’t affect its ability to complete its proposed merger with US grocery rival Albertsons Companies Inc and it still expects to meet debt targets that were set out as part of the merger agreement.
Kroger said it agreed to pay up to $1.2 billion to states and subdivisions and $36 million to Native American tribes in funding for abatement efforts, and approximately $177 million to cover attorneys' fees and costs.”

About the public’s health

Defining Usual Oral Temperature Ranges in Outpatients Using an Unsupervised Learning Algorithm
“ In this cross-sectional study, machine learning was applied to 618 306 adult outpatient encounters to define the usual or mean “normal” temperature as 36.64 °C. Using individual and temporal characteristics, the range of mean temperatures for the coolest to the warmest individuals was 36.24 °C to 36.89 °C.
These findings suggest that age, sex, height, weight, and time of day are factors that contribute to variations in individualized normal temperature ranges.”
Note: 37°C is 98.6°F. 

Global trends in incidence, death, burden and risk factors of early-onset cancer from 1990 to 2019 Results Global incidence of early-onset cancer increased by 79.1% and the number of early-onset cancer deaths increased by 27.7% between 1990 and 2019. Early-onset breast, tracheal, bronchus and lung, stomach and colorectal cancers showed the highest mortality and DALYs in 2019. Globally, the incidence rates of early-onset nasopharyngeal and prostate cancer showed the fastest increasing trend, whereas early-onset liver cancer showed the sharpest decrease. Early-onset colorectal cancers had high DALYs within the top five ranking for both men and women. High-middle and middle Sociodemographic Index (SDI) regions had the highest burden of early-onset cancer. The morbidity of early-onset cancer increased with the SDI, and the mortality rate decreased considerably when SDI increased from 0.7 to 1. The projections indicated that the global number of incidence and deaths of early-onset cancer would increase by 31% and 21% in 2030, respectively. Dietary risk factors (diet high in red meat, low in fruits, high in sodium and low in milk, etc), alcohol consumption and tobacco use are the main risk factors underlying early-onset cancers.
Conclusion Early-onset cancer morbidity continues to increase worldwide with notable variances in mortality and DALYs between areas, countries, sex and cancer types. Encouraging a healthy lifestyle could reduce early-onset cancer disease burden.”

Racial Disparities in Obesity‐Related Cardiovascular Mortality in the United States: Temporal Trends From 1999 to 2020 “Absolute, crude, and age‐adjusted mortality rates (AAMRs) were calculated by racial group, considering temporal trends and variation by sex, age, and residence (urban versus rural). Analysis of 281 135 obesity‐related cardiovascular deaths demonstrated a 3‐fold increase in AAMRs from 1999 to 2020 (2.2‐6.6 per 100 000 population). Black individuals had the highest AAMRs. American Indian or Alaska Native individuals had the greatest temporal increase in AAMRs (+415%). Ischemic heart disease was the most common primary cause of death. The second most common cause of death was hypertensive disease, which was most common in the Black racial group (31%). Among Black individuals, women had higher AAMRs than men; across all other racial groups, men had a greater proportion of obesity‐related cardiovascular mortality cases and higher AAMRs. Black individuals had greater AAMRs in urban compared with rural settings; the reverse was observed for all other races.”

Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety “The 9vHPV vaccine demonstrated sustained immunogenicity and effectiveness through ∼10 years post 3 doses of 9vHPV vaccination of boys and girls aged 9 to 15 years.”

U.S.-funded hunt for rare viruses halted amid risk concerns “The Biden administration has halted funding for a research program that sought to discover and catalogue thousands of exotic pathogens from around the world, officials confirmed Thursday, effectively ending a controversial virus-hunting endeavor that opponents say raised the risk of an accidental outbreak.
The U.S. Agency for International Development quietly notified the program’s main contractor in July that the $125 million project was being terminated less than two years after its inception, amid opposition from lawmakers as well as a number of prominent scientists and public health experts.
A USAID spokesman said the funding was halted following a reevaluation of the ‘relative risks and impact’ of various government-backed efforts to prevent future pandemics.”

About healthcare personnel

 Biden administration proposes minimum staffing standards for nursing homes “The Centers for Medicare & Medicaid Services (CMS) has made good on President Joe Biden’s word during the 2022 State of the Union with new proposed staffing requirements for nursing homes.The proposed rule, issued Friday, includes for the first time national minimum nurse staffing standards that have been broadly opposed by the long-term care industry.
It would require nursing homes participating in Medicare and Medicaid to provide a minimum of 0.55 hours of care from a registered nurse per resident per day, as well as 2.45 hours of care from a nurse aid per resident per day—a bottom floor that CMS estimates three quarters of nursing homes would need to increase hiring to achieve. Facilities would also be required to have at least one registered nurse onsite at all times.”

The shrinking number of primary-care physicians is reaching a tipping point “The percentage of U.S. doctors in adult primary care has been declining for years and is now about 25 percent — a tipping point beyond which many Americans won’t be able to find a family doctor at all.
Already, more than 100 million Americans don’t have usual access to primary care, a number that has nearly doubled since 2014. The fact that so many of us no longer regularly see a familiar doctor we trust is likely one reason our coronavirus vaccination rates were low compared with those in other countries.
Another telling statistic: In 1980, 62 percent of doctor’s visits for adults over 65 were for primary care and 38 percent were for specialists, according to Michael L. Barnett, a health systems researcher and primary-care doctor in the Harvard Medical School system. By 2013, that ratio had exactly flipped and has likely ‘only gotten worse,’ he said…”

About healthcare finance

 Healthcare Dealmakers—Oregon's $6.6B hospital merger; Syntellis' $1.3B sale and more FYI

Today's News and Commentary

About health insurance/insurers

CMS suspends all dispute resolution processes after latest No Surprises Act court loss “CMS said all federal independent dispute resolution processes are temporarily suspended in response to a Texas judge's latest ruling in a series of lawsuits challenging provisions of the No Surprises Act. 
The agency said the suspension is taking place while necessary changes are being made to comply with the court's decision, according to an Aug. 25 notice on CMS' website. Disputing parties should continue to engage in open negotiation. “

Humana sues Biden administration over Medicare Advantage audit rule “Humana sued the federal government Friday, arguing that this year’s new rule to claw back overpayments from it and other Medicare Advantage insurers violates federal law due to its “shifting justifications and erroneous legal reasoning.”
‘The [Centers for Medicare and Medicaid Services] did not even try to offer an empirical or actuarial justification for its new audit methodology, relying instead on purely legal rationales — none of which withstand scrutiny,’ Humana said in the lawsuit.”

 CMS suspects auto-renewal process at fault for wrongful Medicaid disenrollmentsIn a letter sent to all states, the Centers for Medicare & Medicaid Services (CMS) said it is requiring states to determine whether an eligibility systems issue is to blame for disenrolling adults and children from Medicaid or the Children’s Health Insurance Program (CHIP) despite many terminated individuals still being eligible for coverage.
CMS said in the letter that it believes eligibility systems, which utilize auto-renewals (otherwise known as ex parte renewals), have been programmed incorrectly and are conducting renewals at the family level but not at the individual level.”

Trends in Self-Insured Health Plans: Overall Trends Mask Differences by Firm Size “Key findings:

  • The percentage of private-sector establishments offering a self-insured health plan increased through 2016 but has since ebbed and flowed with no discernible long-term trend.

  • Recent trends have been more clearly defined when examined by firm size.

  • Since 2018, the percentages of small and medium-sized establishments offering at least one self-insured plan both increased. In contrast, the percentage of large establishments offering a self-insured plan has declined. The decline among large establishments occurred in most years since 2013.

  • Overall, the percentage of workers in self-insured plans has been bouncing around between 58 percent and 60 percent since 2010 but fell to 55 percent in 2022. This occurred despite the increase in self-insurance among small and medium-sized companies because of the drop in self-insurance among large firms.

  • Self-insurance varied substantially by state. Overall, the percentage of private-sector enrollees in self-insured plans varied from 33 percent in Hawaii to 70 percent in Ohio.

UnitedHealthcare's prior authorization cuts begin “The first wave of UnitedHealthcare's prior authorization cuts began Sept. 1.
In August, the payer released details of its plan to eliminate 20 percent of its current prior authorization. The cuts are coming across two waves. The second phase will begin Nov. 1. “

About hospitals and healthcare systems

 Hospital Distress Worsens Amid Labor Scarcity and Inflation “More than 600, or about 30%, of all rural hospitals in the country are at risk of closing, according to the Center for Healthcare Quality and Payment Reform, a national policy center. As of August, 13 rural hospitals had shut their doors, exceeding seven and three in 2022 and 2021, respectively, according to the Cecil G. Sheps Center for Health Services Research, a unit of the University of North Carolina at Chapel Hill. 
Rural hospitals number about 1,800 out of roughly 6,100 total in the U.S., according to the American Hospital Association.”

About pharma

 Walgreens CEO steps down “Rosalind "Roz" Brewer — a former Starbucks and Sam's Club executive — has stepped down as CEO of Walgreens Boot Alliance after taking on the position in March 2021, the retail chain said Sept. 1. 
In a statement, Walgreens said Ms. Brewer and the board of directors "mutually agreed" she would step down from the helm and as a board member, effective Aug. 31. Ms. Brewer became CEO at the start of the nation's COVID-19 vaccine rollout and led a team that put technology in place for the vaccine scheduling system.”  

Wegovy costs $1.1m to prevent one heart attack, stroke, or cardiovascular death “Airfinity analysis on data from the Wegovy trial on cardiovascular outcomes reveals that even after a 65% rebate on the list price, it will cost $1.1m to prevent one heart attack, stroke or cardiovascular death.
The SELECT trial found that the drug semaglutide, sold under brand names Wegovy and Ozempic, resulted in a 20% reduction in major adverse cardiovascular events (MACE) in the enrolled population.”

About the public’s health

 Overdose deaths from counterfeit drugs at historically high levels, and rising: CDC “The CDC report, conducted between July 2019 and December 2021, found that evidence of fake pill use and overdose deaths more than doubled during this period and tripled in the western United States.
In total, there were more than 54,000 overdose deaths, including 2,437 with evidence of counterfeit pill use. The study found that overdose deaths in connection with the use of counterfeit pills were often associated with people 35 and younger, those who are Hispanic or Latino and those with a history of prescription drug misuse.
The study found that more than half of the deaths with evidence of fake pill use were related to counterfeit oxycodone or with counterfeit alprazolam, which is more commonly sold under the brand name Xanax. The study notes that the counterfeit pills are made to look like the legitimate pharmaceutical pills.”

FDA says it will finalize ban on menthol tobacco products ‘in coming months’ “In April 2022, when the FDA initially announced that it was going to ban the popular flavor, it set a deadline of August 2023 to work out the details. That deadline is still listed online, but a spokesperson said it will instead complete work on the rule ‘in the coming months.’”

About healthcare personnel

The most dangerous places to work in healthcare FYI

About healthcare finance

 Amgen settles with FTC on Horizon merger “Amgen announced Friday that it has reached a consent order agreement with the US Federal Trade Commission (FTC) that resolves an administrative lawsuit by the antitrust regulator and clears a path forward to closing its planned $27.8-billion takeout of Horizon Therapeutics. The companies anticipate being able to close the acquisition early in the fourth quarter.
Amgen first moved to buy Horizon last December in an effort to gain access to the latter's rare disease assets, including its thyroid eye disease therapy Tepezza (teprotumumab) and the chronic refractory gout treatment Krystexxa (pegloticase). However, the FTC sought to block the merger on grounds that it would stifle competition.”

Today's News and Commentary

About Covid-19

 EU body endorses Pfizer, BioNTech's updated COVID booster “The European Medicines Agency's (EMA) drug advisory panel has recommended Pfizer and BioNTech's updated COVID-19 vaccine, which is tailored to the new Omicron XBB.1.5 variant. The endorsement by the EMA's Committee for Medicinal Products for Human Use (CHMP) puts the Comirnaty jab on track to become the third adapted shot by the two companies to be approved in the EU bloc.
The recommendation is for the updated vaccine to be given as a single dose to those who are at least five years old, regardless of COVID vaccination history. In addition, children from six months to four years of age may have one or three doses depending on whether they have completed a primary vaccination course or have had COVID-19.”

About health insurance/insurers

Medicaid Enrollment and Unwinding Tracker Update from KFF. Highlights:
— “At least 5,504,000 Medicaid enrollees have been disenrolled as of August 29, 2023, based on the most current data from 47 states and the District of Columbia. Overall, 38% of people with a completed renewal were disenrolled in reporting states while 62%, or 9.0 million enrollees, had their coverage renewed (three of the reporting states do not provide data on renewed enrollees). Because not all states have publicly available data on total disenrollments, the data reported here undercount the actual number of disenrollments.
—There is wide variation in disenrollment rates across reporting states, ranging from 72% in Texas to 8% in Wyoming
—Across all states with available data, 74% of all people disenrolled had their coverage terminated for procedural reasons”

Healthcare billing fraud: 10 recent cases FYI. All involve federal payers.

About pharma

 Providers can now see patients' insurance coverage in GoodRx's cost comparison tool “GoodRx has launched a new feature to allow healthcare professionals to see the cost of a patient’s prescription with their insurance.
The real-time benefit check (RTBC) feature was developed in collaboration with AssistRx, a specialty therapy initiation and patient solutions provider. The RTBC surfaces a patient’s coverage and benefits at the point of care with the goal of increasing price transparency and access to drugs. It also includes whether a prior authorization is required.”

About the public’s health

Opioid overdose antidote Narcan will be available over the counter in coming days “The opioid overdose antidote Narcan will be available to purchase over the counter in a few days, making it the first treatment of its kind available to the public without a prescription. 
In a statement Wednesday, Narcan manufacturer Emergent BioSolutions announced the first batch of the nasal spray has ‘officially’ shipped to leading drug stores, pharmacies, groceries and online retailers. 
The original version of the prescription-strength naloxone 4-milligram nasal spray, whose brand name is Narcan, will be available beginning in September. The suggested retail price for the two-dose package of Narcan is $44.99.”

Emerging group of synthetic opioids may be more potent than fentanyl, study warns “A group of novel synthetic opioids emerging in illicit drugs in the United States may be more powerful than fentanyl, 1,000 times more potent than morphine, and may even require more doses of the medication naloxone to reverse an overdose, a new study suggests.
Nitazenes are a synthetic opioid, like fentanyl, although the two drugs are not structurally related. In the small study published Tuesday in the journal JAMA Network Open most of the patients who overdosed on nitazenes received two or more doses of the opioid overdose reversal drug naloxone, whereas most patients who overdosed on fentanyl received only a single dose of naloxone.”

US health officials look to move marijuana to lower-risk drug category “The U.S. Department of Health and Human Services (HHS) has recommended easing restrictions on marijuana, a department spokesperson said on Wednesday, following a review request from the Biden Administration last year.
Nearly 40 U.S. states have legalized marijuana use in some form, but it remains completely illegal in some states and at the federal level. Reclassifying marijuana as less harmful than drugs like heroin would be a first step toward wider legalization, a move backed by a majority of Americans.”

Blood and Urinary Metal Levels among Exclusive Marijuana Users in NHANES (2005–2018) “Our results suggest marijuana is a source of cadmium and lead exposure. Research regarding cannabis use and cannabis contaminants, particularly metals, should be conducted to address public health concerns related to the growing number of cannabis users.”

Today's News and Commentary

About Covid-19

 Pfizer, BioNTech challenge Moderna COVID-19 vaccine patents at US Patent Office 

  • “Pfizer and BioNTech have asked a US government tribunal to cancel patents on COVID-19 vaccine technology that rival Moderna has accused the companies of infringing, reported NASDAQ.

  • Pfizer and BioNTech told the US Patent Office's Patent Trial and Appeal Board that the two Moderna patents are "unimaginably broad" and cover a "basic idea that was known long before" their invention date of 2015.

  • Pfizer stated that its vaccine was "based on BioNTech's proprietary mRNA technology and developed by both BioNTech and Pfizer," and that they remain confident in their intellectual property.

  • Pfizer and its German partner have separately challenged the two patents and a third related Moderna patent in court in an ongoing Massachusetts federal lawsuit that Moderna filed against them last year.

  • In a lawsuit, Moderna accused Pfizer and BioNTech of violating its patent rights in mRNA vaccine technology. The case is one of several that have been brought by biotech companies seeking patent royalties from Moderna, Pfizer and BioNTech's COVID-19 jabs.”

 About healthcare IT

 75% of cyberattacks disrupt patient care “A survey of 1,100 cybersecurity, engineering, IT and networking professionals from healthcare organizations reported that 60 percent of cyberattacks have had a moderate or substantial impact on care delivery. 
An additional 15 percent of respondents said cyberattacks led to a severe impact on care delivery and compromised patients' health or safety…”

HHS will begin enforcing health IT information blocking penalties Sept. 1. “Under the 21st Century Cures Act final rule published in June, certified health IT developers and entities and health information exchanges and networks can be penalized up to $1 million for interfering with the access, exchange and use of electronic health information.”

Today's News and Commentary

About Covid-19

 Not Over Yet: Late-Summer Covid Wave Brings Warning of More to Come “Hospitalizations have increased 24 percent in a two-week period ending Aug. 12, according to the most recent data from the Centers for Disease Control and Prevention. Wastewater monitoring suggests a recent rise in Covid infections in the West and Northeast. In communities across the United States, outbreaks have occurred in recent weeks at preschools, summer camps and office buildings.
Public health officials said that the latest increase in Covid hospitalizations is still relatively small and that the vast majority of the sick are experiencing mild symptoms comparable to a cold or the flu.”

About pharma

Biden administration names 10 prescription drugs for price negotiations “Half of the drugs chosen first for price negotiations are medications to prevent blood clots and treat diabetes and were taken by millions of people on Medicare in the past year, according to a list released by federal health officials who oversee Medicare, the vast public health insurance system. Others are used to treat heart trouble, autoimmune disease and cancer. Consumers will not see benefits swiftly; the lower, negotiated prices are due to become available in early 2026.
The three highest-cost drugs on the widely anticipated list of 10 are Eliquis, a blood thinner; Jardiance, which treats diabetes and heart failure; and Xarelto, another blood thinner. They cost Medicare $16 billion, $7 billion and $6 billion, respectively in the past year.”
Other drugs are Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara and Fiasp.

Rite Aid reportedly plans bankruptcy filing to restructure debt, halt pending opioid lawsuits “Rite Aid is reportedly preparing to file for bankruptcy within a few weeks to help restructure its debt and potentially halt ongoing lawsuits.
The move is said to be an attempt to address mass federal and state lawsuits Rite Aid faces over its alleged role in the opioid crisis, The Wall Street Journal first reported Friday. The Chapter 11 filing would cover its $3.3 billion in debt and pending legal allegations, the outlet reported. The plans are subject to change.”

About the public’s health

 Some Older Adults Are Being Charged Over $300 for the New R.S.V. Vaccine “Several common vaccines, including those for the flu and Covid-19, are included under Medicare Part B, which provides medical coverage. However, the R.S.V. vaccines, as well as a few others, including the vaccine for shingles, are covered under Medicare Part D, which pays for prescription drugs. As a result, Medicare enrollees without a Part D plan — roughly 16 million people — may have to pay for the R.S.V. vaccine out of pocket depending on their non-Medicare prescription drug coverage…
For people with private insurance, like Mr. Dhooge, the situation is less clear. According to the Affordable Care Act, private health insurers must cover the cost of preventive care, including vaccines recommended by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. However, the A.C.I.P. recommendations for the R.S.V. vaccine put the final decision in the hands of individuals in consultation with their doctors…”

Neuropathologic and Clinical Findings in Young Contact Sport Athletes Exposed to Repetitive Head Impacts Findings  In this case series of 152 contact sport athletes younger than 30 years at the time of death, chronic traumatic encephalopathy (CTE) was found in 63 (41.4%), with nearly all having mild CTE (stages I and II). Neuropathologic abnormalities associated with CTE included ventricular enlargement, cavum septum pellucidum, thalamic notching, and perivascular pigment–laden macrophage deposition in the frontal white matter.
Meaning  These findings confirm that CTE and other brain pathologies can be found in young, symptomatic contact sport athletes, but the clinical correlates of these pathologic conditions are uncertain.”

Estimated Lifetime Gained With Cancer Screening TestsA Meta-Analysis of Randomized Clinical Trials Findings  In this systematic review and meta-analysis of 18 long-term randomized clinical trials involving 2.1 million individuals, colorectal cancer screening with sigmoidoscopy prolonged lifetime by 110 days, while fecal testing and mammography screening did not prolong life. An extension of 37 days was noted for prostate cancer screening with prostate-specific antigen testing and 107 days with lung cancer screening using computed tomography, but estimates are uncertain.
Meaning  The findings of this meta-analysis suggest that colorectal cancer screening with sigmoidoscopy may extend life by approximately 3 months; lifetime gain for other screening tests appears to be unlikely or uncertain.”

About healthcare IT

 Virtually Enabled New Entrants Are Disintermediating the Traditional Healthcare Journey “Between Q2 2021 and Q3 2022, 11.1% of telehealth visits nationally resulted in an in-person follow-up visit for the same clinical reason within one week, with behavioral health diagnoses and select chronic conditions accounting for most duplicate visits.”

Telehealth and In-Person Mental Health Service Utilization and Spending, 2019 to 2022 “In this cohort study, utilization and spending rates for mental health care services among commercially insured adults increased by 38.8% and 53.7%, respectively, between 2019 and 2022. This disproportionate increase in spending will likely evolve now that the PHE has ended, with insurers either continuing or stopping coverage for telehealth visits for mental health services.”

HCA, Google roll out generative AI project “Nashville, Tenn.-based HCA Healthcare has started using generative artificial intelligence technology from Google to document emergency room visits and speed up nurse handoffs.
The 182-hospital system has rolled out the clinical documentation at four hospitals, where it's being used by 75 emergency physicians, while the patient handoff tool is in testing at UCF Lake Nona Hospital in Orlando, Fla.”
 
About healthcare finance

Danaher To Buy Life Sciences Co. Abcam In $5.7B Deal “Global health care tech conglomerate Danaher Corp. said Monday it has agreed to acquire Abcam PLC, a global supplier of protein research tools to life scientists, in a deal worth a total enterprise value of about $5.7 billion, including debt.

Today's News and Commentary

About Covid-19

CDC expects new Covid vaccines from Pfizer, Moderna and Novavax to be available in mid-September

  • “The Centers for Disease Control and Prevention expects updated Covid vaccines from Pfizer, Moderna and Novavax to be available to the public in mid-September, an agency official said.

  • That amounts to the most specific timeline to date for the new shots, which are designed to target omicron subvariant XBB.1.5.

  • Those vaccines still need approvals from the Food and Drug Administration and the CDC, which will form eligibility guidelines. “

 Pandemic ushered 'unprecedented' declines in hospital patient experience scores, study finds The analysis of Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) responses found a steady decrease in summary HCAHPS scores across nearly 3,400 participating hospitals.
Compared to expected trends based on survey data from 2018 and 2019, U.S. hospitals logged a 1.2 percentage point decline in the second quarter of 2020, the start of the pandemic, that deteriorated to a 3.6 percentage point reduction by the end of 2021, per the study.”

Clinical Antiviral Efficacy of Remdesivir in Coronavirus Disease 2019 “Under the linear model, compared with the contemporaneous control arm (no study drug), remdesivir accelerated mean estimated viral clearance by 42% (95% credible interval, 18%–73%).”

About health insurance/insurers

 HHS loses 4th No Surprises Act lawsuit “A federal judge for the fourth time sided with the Texas Medical Association in legal challenges over the No Surprises Act. 
The Texas Medical Association filed a lawsuit in November arguing that portions of the No Surprise Act artificially deflate the qualifying payment amount. The group alleged the provisions of the rule ‘skew negotiations in favor of health insurers so strongly that health insurers will force physicians out of insurance networks and physicians will face significant practice viability challenges, struggling to keep their doors open in the wake of the pandemic.’”

Trends in Cumulative Disenrollment in the Medicare Advantage Program, 2011-2020 “After 1 year, 13.2% of nondually enrolled and 15.9% of dually enrolled beneficiaries had left their contract; after 3 years, 35.0% and 40.3%, respectively, had left their contract; and after 5 years, 48.3% and 53.4%, respectively, had left their contract. In analyses of disenrollment to TM [Traditional Medicare] over time, after 1 year, 2.3% of nondually enrolled and 5.8% of dually enrolled beneficiaries had switched to TM, and after 5 years, 8.9% and 13.6%, respectively, had switched to TM.”
Comment: The message must be interpreted carefully. The media may twist the findings and say there is a high rate of disenrollement from MA plans. Actually, most Medicare eligibles are switching amomhg MA advantage plans at stated not unlike people change their commercial plans.

About hospitals and healthcare systems

 National Hospital Flash Report: August 2023  “Key Takeaways

  1. Hospital performance declined on a month-over-month basis in July.

    All volume indicators registered declines this month. However, when compared to 2022, there is some slight improvement in operating margins.

  2. Outpatient volumes decreased slightly more than inpatient.

    Some of this decline may be attributed to less patients seeking elective procedures in summer.

  3. Expenses declined, but not enough to offset revenue losses.

    Labor continues to be the biggest share of hospital expenses, and expenses will likely continue to fluctuate due to inflation.

  4. Bad debt and charity care rose month-over-month.

    Medicaid eligibility redetermination continues to affect hospitals and patients, with more than 30 states disenrolling people in June and July.”

Trilliant Health Announces Open Access to Its National Provider Directory “Trilliant Health, the healthcare industry’s leading analytics and market research firm, today announced that it will open access to its dynamic, national provider directory, making information about America's 2.7 million healthcare facilities, physicians and allied health professionals publicly available for the first time.”

About the public’s health

 Salt-free diet ‘can reduce risk of heart problems by almost 20% “Researchers found those who never add salt to meals were 18% less likely to develop atrial fibrillation (AF), a heart condition, compared with those who always do.”

About healthcare personnel

Overworked and Undervalued: Unmasking Primary Care Physicians’ Dissatisfaction in 10 High-Income Countries An interesting international comparison.