Today's News and Commentary

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

About health insurance/insurers

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

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

About hospitals and healthcare systems

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

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

About healthcare IT

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

Today's News and Commentary

About Covid-19

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

About health insurance/insurers

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

About hospitals and healthcare systems

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

15 most common reasons for hospital citations in 2023 FYI

About pharma

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

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

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

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

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

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

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

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

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

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

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

About the public’s health

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

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

About healthcare IT

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

Today's News and Commentary

About Covid-19

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

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

About health insurance/insurers

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

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

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

About hospitals and healthcare systems

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

About pharma

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

About healthcare personnel

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

About health technology

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

About healthcare finance

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

Today's News and Commentary

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

About Covid-19

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

About health insurance/insurers

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

About pharma

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

About the public’s health

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

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

About healthcare IT

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

About health technology

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

About healthcare finance

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

Today's News and Commentary

About Covid-19

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

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

About health insurance/insurers

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

About hospitals and healthcare systems

 Medicare reimbursement hits new low Four things to know:

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

About pharma

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

About the public’s health

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

About healthcare IT

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

About healthcare personnel

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

Today's News and Commentary

About Covid-19

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

About health insurance/insurers

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

About hospitals and healthcare systems

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

About the public’s health

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

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

About healthcare IT

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

Today's News and Commentary

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

About Covid-19

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

About health insurance/insurers

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

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

About hospitals and healthcare systems

DECEMBER 2023 National Hospital Flash Report “Key Takeaways

1. Hospital performance in November signals continued stabilization and growth. Operating margins improved compared to the previous month and last year, and other data points indicate movement towards recovery, though the gap between high and low performers remains quite wide.
2. Revenue per adjusted discharge has increased while total expense per adjusted discharge has
decreased month-over-month and year-over-year—a sign of financial recovery. This reflects the
efforts organizations have taken to deliver care in the most effective settings and reduce reliance on
contract labor where possible.
3. Average length of stay declined indicating a shift towards more normal patient acuity.
Organizations that have adopted value-based and bundled payment models will benefit further as
they transition and provide care at the appropriate clinical setting.

About pharma

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

About the public’s health

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

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

About healthcare IT

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

About healthcare personnel

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

About health technology

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

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

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

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

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

About healthcare finance

Payer M&A deals to watch in 2024 FYI

 

Today's News and Commentary

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

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

 About healthcare quality and patient safety

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

About pharma

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

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

About the public’s health

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

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

About healthcare IT

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

 About healthcare finance

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

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

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

Today's News and Commentary

State healthcare laws debuting in 2024 FYI

About Covid-19

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

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

About health insurance/insurers

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

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

About hospitals and healthcare systems

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

About healthcare IT

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

About healthcare finance

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

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

Today's News and Commentary

About Covid-19

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

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

About health insurance/insurers

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

About hospitals and healthcare systems

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

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

About pharma

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

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

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

About healthcare finance

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

Today's News and Commentary

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

About Covid-19

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

About health insurance/insurers

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

About pharma

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

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

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

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

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

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

About healthcare personnel

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

About health technology

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

About healthcare finance

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

Today's News and Commentary

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

About health insurance/insurers

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

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

About hospitals and healthcare systems

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

About pharma

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

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

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

About the public’s health

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

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

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

About healthcare IT

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

About healthcare finance

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

Today's News and Commentary

HAPPY NEW YEAR!

About Covid-19

 Guidance Extends FDA COVID-19 Monoclonal Antibody EUA Policy Beyond Pandemic “The 14-page guidance, “Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization,” focuses on the data and information that may be used to support a request for emergency use authorization of a drug product to prevent or treat the virus. The guidance, set to be effective immediately, is intended to remain in effect only for the duration of circumstances that exist to justify the authorization of emergency use of COVID-19 drugs.”

About health insurance/insurers

 Healthcare billing fraud: 11 recent cases Once again, most are related to federal program.

Georgia offered Medicaid with a work requirement. Few have signed up. “A GOP experiment forcing low-income people to work to qualify for public health insurance benefits is stumbling in Georgia.
The state’s Republican governor, Brian Kemp, expected 31,000 Georgians to sign up in the first year of the program, which started in July. Through four months, only 1,800 people enrolled — and critics blame the paltry expansion on an overly complex program with too many hurdles for people to clear.”

About hospitals and healthcare systems

Changes in Hospital Adverse Events and Patient Outcomes Associated With Private Equity Acquisition “…private equity acquisition was associated with a 25.4% increase in hospital-acquired conditions, which was driven by falls and central line–associated bloodstream infections. Medicare beneficiaries at private equity hospitals were modestly younger, less likely to have dual eligibility for Medicare and Medicaid, and transferred more to other acute care hospitals relative to control, likely reflecting a lower-risk population of admitted beneficiaries. This potentially explained a small relative reduction for in-hospital mortality that dissipated by 30 days after hospital discharge.”

Financial updates from 29 health systems: HCA, Mayo & more FYI

 About pharma

McKinsey and Co. agrees to $78 million settlement over claims it helped fuel opioid crisis “Consulting firm McKinsey and Co. has agreed to pay $78 million to settle claims from insurers and health care funds that its work with drug companies helped fuel an opioid addiction crisis.
The agreement was revealed late Friday in documents filed in federal court in San Francisco. The settlement must still be approved by a judge.”

Exclusive: Drugmakers set to raise US prices on at least 500 drugs in January “Excluding different doses and formulations, more than 140 brands of drugs will have their prices raised next month, the data showed.
The expected price hikes come as the pharmaceutical industry gears up for the Biden Administration to publish significantly discounted prices for 10 high-cost drugs in September, and continues to contend with higher inflation and manufacturing costs.”

Biosimilar Uptake in Medicare Advantage vs Traditional Medicare “After accounting for some differences due to indication, biosimilar market share was consistently greater in MA than TM, aligned with other studies supporting more lower cost prescribing substitution in MA.
A study of lower cost uptake in Medicaid of an insulin biosimilar and complex generic found uptake was more than 10 times higher in managed care vs fee-for-service Medicaid. One suggested explanation was differential statutory state inflation rebates in managed care vs fee-for-service payers. Implementing the Medicare inflationary rebate may also affect MA and TM biosimilar uptake.”

About healthcare personnel

 Medical group expenses per physician top $1M “Medical group revenue per physician jumped 16.7% in 2023 but expenses are also on the rise, according to the AMGA Medical Group Operations and Finance Survey.
The median revenue per physician hit $719,901, which is up even 9.1% from pre-pandemic levels, while the median expense per physician soared 14.7%, hitting $1.03 million for the year.
System-affiliated medical groups reported an annual loss of $249,000 on average, according to the survey of more than 15,000 providers. Labor costs and changes to the CMS fee schedule in addition to other policy updates have driven financial trends for the last 12 months.”
Comment: The actual “loss” for system-affiliated groups is debatable, since allocated costs may be higher than with free-standing groups.

This Week's News and Commentary

Americans less satisfied with almost every part of the health system “Americans are happiest with the care they received from nurses, with 82% rating the care as excellent or good — down 6 percentage points from 2010.
69% said the same about physicians this year, down from 84% percent in 2010.
Americans were least satisfied with nursing home care. Just 25% rated nursing homes as excellent or good, while 37% rated them as poor.”

FTC merger enforcement hits highest level in 20 years “The Federal Trade Commission and the Justice Department filed 50 merger enforcement actions in fiscal year 2022 — the highest level of enforcement activity in more than 20 years. 

The commission brought 24 merger enforcement challenges in FY 2022, including:

  • Eleven in which it issued final consent orders after a public comment period

  • Seven in which the transaction was abandoned or restructured due to antitrust concerns 

  • Six in which the FTC initiated administrative or federal court litigation”


About Covid-19

 Paxlovid halved deaths, hospitalizations with optimal timing: Study “Pfizer's COVID-19 antiviral Paxlovid cut the prevalence of hospitalizations and deaths in half when it was used within the first day of diagnosis, according to a study published Dec. 16 in Nature
The risk grew as more days passed since symptoms appeared, the researchers found. The incidence of 28-day all-cause deaths and hospitalizations was 5.1% for early initiators and 6.6% for delayed users.”

COVID-19 vaccinations shift to regular immunization as COVAX draws to a close “COVAX, the multilateral mechanism for equitable global access to COVID-19 vaccines launched in 2020, will draw to a close on 31 December. Jointly led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance (Gavi), UNICEF and the World Health Organization (WHO), COVAX has so far supplied nearly 2 billion COVID-19 vaccine doses and safe injection devices to 146 economies. Its efforts are estimated to have helped avert the deaths of at least 2.7 million people in the COVAX Advance Market Commitment (AMC) low- and lower middle-income participating economies (lower-income economies) that received free doses through the mechanism, alongside nearly US$ 2 billion in critical support to turn vaccines into vaccinations.”

About health insurance/insurers

White House touts record-breaking ObamaCare enrollment “More than 15 million people to date have signed up for health insurance, a 33 percent increase over the same point last year. The administration said it estimates more than 19 million people will have selected plans by the Jan. 16 deadline, an increase of 7 million compared to when President Biden took office. 
On Dec. 15, the deadline for coverage starting Jan. 1, more than 745,000 people selected a plan through HealthCare.gov — the most in a day in history, according to the Department of Health and Human Services.”

Feds Finalizes $115 Participation, Other Fees for IDR Process “The Departments said in a final rule…r that each party will have to pay $115 for disputes initiated on or after Jan. 20th, or 30 days after the publication of the final rule in the Federal Register. The Federal Register has scheduled publication for Dec. 21st.
The final rule also solidified future certified IDR entity fees, finalizing a fee between $200 and $840 for single determinations and a fee between $268 and $1,173 for batched determinations. However, the Departments will charge between $75 and $250 if batched determinations exceed 25 dispute line items. The fees will apply to each increment of 25 dispute line items included in the batch dispute.”

Medicaid Enrollment and Unwinding Tracker “At least 13,379,000 Medicaid enrollees have been disenrolled as of December 20, 2023, based on the most current data from all 50 states and the District of Columbia. Overall, 34% of people with a completed renewal were disenrolled in reporting states while 66%, or 23.9 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.”

 The $2.5B Elevance Health, BCBSLA merger is back from the dead “Two months ago, Elevance Health and Blue Cross and Blue Shield of Louisiana hit the pause button on a potential $2.5 billion merger in the midst of regulatory scrutiny.
The insurers brought the deal back to life… with BCBSLA filing an updated application on Thursday seeking to reorganize as a for-profit, which would allow it to be purchased by Elevance Health.”

About hospitals and healthcare systems

Jefferson Health, Lehigh Valley Health Network targeting $14B, 30-hospital merger “Philadelphia-based Jefferson Health and Allentown, Pennsylvania-based Lehigh Valley Health Network (LVHN) have taken the initial steps toward a $14 billion merger, the systems announced Tuesday.
The organizations said they have signed a non-binding letter of intent…
Pending further negotiations, regulatory approvals and closing conditions, the combined 62,000-employee system would span 30 hospitals and over 700 care sites in Pennsylvania and New Jersey. The systems are targeting a 2024 close.”

Froedtert, ThedaCare to launch combined system Jan. 1 “Milwaukee-based Froedtert and Neenah, Wis.-based ThedaCare have finalized their merger agreement and will launch as a combined 18-hospital system Jan. 1.”

386 hospitals now owned by private equity firms: 6 things to know FYI

Community Health Network pays $345M to settle illegal referral scheme allegations “Indianapolis-based Community Health Network has agreed to a $345 million settlement with the Department of Justice to settle allegations of illegal physician referrals and related False Claims Act violations.
Announced Tuesday, the deal stems from a whistleblower complaint filed in 2014 by the nonprofit’s former chief financial officer and chief operating officer, Thomas Fischer, which was investigated by the Department of Health and Human Services’ Office of Inspector General (HHS OIG) and Federal Bureau of Investigations (FBI).
The government alleged that Community Health Network had knowingly submitted false claims to Medicare from 2008 to 2017 as part of senior management’s “illegal scheme to recruit physicians for employment for the purpose of capturing their lucrative ‘downstream referrals,’” the Justice Department said.”

Nearly 20% of hospitals have been warned over price transparency violations “Government regulators evaluated 1,750 hospitals as of early December, and about 1,300 have received warnings of rule violations, according to the report. Most corrected errors after receiving warnings. To date, only 446 hospitals that CMS has reviewed were free of violations.”

About pharma

Mark Cuban Cost Plus Drugs teams up with 4th PBM companyMark Cuban Cost Plus Drug Co. has announced a partnership with pharmacy benefit management company PCA Rx to bring members even more clarity about drug pricing, according to a Dec. 18 news release. The company is now the fourth PBM to team up with Cost Plus.”

48% of biotechs leaning on Big Pharma as current funding method: ICON survey “Against a backdrop of a tough funding environment, nearly half (48%) of biotechs are using partnerships with Big Pharmas as a financing method, according to a survey commissioned by CRO Icon.
Venture capital firms are the second most sought-after financiers, at 32%, followed by government grants/public funding at 28%, according to a Citeline report commissioned by Icon. The survey was completed this summer by 133 senior-level decision-makers in biotech, about half (46%) of whom are based in North America, with a similar proportion based in Europe and 8% in the Asia-Pacific region.”

Reduced Coinsurance for Certain Part B Rebatable Drugs under the Medicare Prescription Drug Inflation Rebate Program A list of the drugs and rebate amounts.

FirstWord’s most-read stories of 2023 and what they say about biopharma state of play FYI

German court quashes CureVac patent after challenge by BioNTech “A German court on Tuesday invalidated a patent that was the basis of a patent violation lawsuit brought by CureVac against its domestic rival BioNTech, in a blow to CureVac's claims for a share in billions of euros in COVID-19 vaccine revenues.”

BMS inks $14-billion buyout for Karuna “Bristol Myers Squibb is raising its bet on selling psychiatric and neurological drugs with a cash deal to buy Karuna Therapeutics for about $14 billion. The FDA is expected to make a decision by September 26 next year on whether to approve Karuna's lead asset, KarXT – an experimental treatment Bristol Myers Squibb sees as eventually making ‘a significant revenue contribution.’”

About the public’s health

 Flu Activity 'Elevated,' CDC Warns of Low Vaccination Rates “CDC estimates there have been at least 3.7 million illnesses, 38,000 hospitalizations and 2,300 deaths so far this season, and reported that 1 in 10 clinical lab tests for influenza were positive during the week ending Dec. 9, up from about 7% a week earlier.”

 Fewer young adults smoke today than in 2011. That’s not true of seniors. “Just 5 percent of young adults in the United States smoked in 2022, down from 19 percent in 2011, according to research published in JAMA Health Forum.
Based on data on 353,555 adults, the study found that the prevalence of smoking in those years declined in nearly all age groups, and did so at a faster pace among younger adults — averaging an 11 percent annual decrease for young adults (ages 18 to 24) compared with a 3 percent annual decline for those 40 to 64.
By comparison, smoking prevalence among the oldest adults (those 65 and older) increased slightly, although less than 1 percent, to about 9 percent.
The increase, however, was greatest among those with lower incomes. The researchers found that in all age groups, smoking prevalence was highest among those with the lowest incomes.”

Few Providers Use Z-Codes to Document Social Determinants of Health “The first study, completed by researchers from the NYU School of Global Public Health, showed that despite the utility of Z-codes, they aren’t being used for very diverse social determinants of health. More than half of the hospitals tested used the Z-code for housing insecurity, but other than that, the use of Z-codes was scant, the researchers found.
In the second study from experts at the Colorado School of Public Health and Johns Hopkins, researchers found that Z-code use was 50 percent more common in the Medicaid population than for commercially insured patients, and it was most commonly used in mental health or psychiatric settings.”

Healthcare quality

30 moves from The Joint Commission in 2023 FYI

About healthcare IT

Google unveils MedLM generative AI models for healthcare with HCA, Augmedix and BenchSci as early testers “This week, the tech giant unveiled MedLM, a family of foundation models designed for healthcare industry use cases and available through Google Cloud.”

Health data breaches hit an all-time high in 2023 “As many as 116 million individuals have been impacted by large health data breaches reported to the Department of Health and Human Services this year, according to records from its Office for Civil Rights as of December 21. That number has more than doubled over recent counts, driven primarily by a surge in hacking and ransomware attacks on health care organizations regulated by the privacy rule HIPAA.”
Comment: These numbers are why Americans don’t trust IT and prevents the much-needed single patient identifier.

About healthcare personnel

 Kroger eyes opportunities in senior-focused primary care, rolls out service in Atlanta clinics “The grocery chain has teamed up with Better Health Group, a provider network, to shift some of its in-store clinics, called The Little Clinic, into primary care centers for seniors, in addition to offering regular services.
Better Health Group is rolling out the value-based model at eight of Kroger's Altanta-area stores.”

Well-Being Parameters and Intention to Leave Current Institution Among Academic Physicians “In this cross-sectional study of 18 719 academic physicians, approximately one-third reported moderate or greater intention to leave. Burnout, lack of professional fulfillment, and other personal and organizational factors were associated with intention to leave.”

Medical schools in 2023: Fewer applicants, mixed results in diversity “This year, there were 52,577 applicants, a 4.7% decline compared to 2022-23, and it’s the second consecutive year medical schools saw a drop in applicants. It’s worth noting that medical schools saw a record number of applicants in the 2021-22 year, possibly driven by people inspired to pursue careers in medicine due to the COVID-19 pandemic.
Even with the drop in applicants, the number of matriculants, or first-year enrollees, rose 1.2% compared to 2023, according to AAMC data.”

Medical Groups Faced High Expenses, Staffing Challenges in 2023 “From 2020 to 2023, medical groups’ revenue grew by 9.1 percent, while expenses increased by 26.5 percent…
System-affiliated groups faced financial challenges, with the median loss per physician at more than $249,000. While median total revenue per physician increased from $608,639 to $719,901, median total expenses per physician grew from $905,283 to $1,036,238.”

About health technology

 Illumina sets a date to divest Grail following antitrust appeal ruling “The DNA sequencing giant announced it will aim to finalize the details of the divestiture within the first six months of the new year—whether it be through a sale to an interested suitor or by having Grail take itself public…
While the Fifth Circuit did indeed vacate the FTC’s order—with its opinion saying the agency had applied an erroneous legal standard during its analysis—the panel of judges determined the commission still ‘had substantial evidence to support its conclusion’ that its antitrust concerns were valid…”

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.”