Today's News and Commentary

About Covid-19

 Cases of BQ.1, BQ.1.1 COVID variants double in U.S. as Europe warns of rise “U.S. health regulators on Friday estimated that BQ.1 and closely related BQ.1.1 accounted for 16.6% of coronavirus variants in the country, nearly doubling from last week, while Europe expects them to become the dominant variants in a month.
The European Centre for Disease Prevention and Control said the variants are likely to drive up cases in the coming weeks to months in the European region.
The two variants are descendants of Omicron's BA.5 subvariant, which is the dominant form of the coronavirus in the United States. Regulators in Europe and the U.S. have recently authorized vaccine boosters that target it.”

Among Seniors, a Declining Interest in Boosters “Although Americans over 65 remain the demographic most likely to have received the original series of vaccinations, at 92 percent, their interest in keeping their vaccinations up-to-date is steadily declining, data from the C.D.C. shows. To date, about 71 percent have received the first recommended booster, but only about 44 percent have received the second.”

About health insurance/insurers

 Elevance Health CEO says company is now the nation's largest commercial insurer “Elevance Health, formerly Anthem, is now the largest commercial health insurer in the nation by total membership, according to the company's CEO, Gail Boudreaux.
’Over the past year, we've grown to serve 2.2 million more consumers, with both our commercial and government businesses delivering robust growth that solidifies our position as the largest carrier by U.S.-based medical membership,’ she said during a call with investors Oct. 19.
As of Sept. 30, total membership at Elevance was 47.3 million, an increase of 4.9 percent year over year. Total commercial and specialty membership was 31.4 million, and government was nearly 15.9 million. Elevance has 11.3 million Medicaid members and 1.97 million Medicare Advantage beneficiaries.”

About healthcare IT

 Highmark steps up coverage of prescription digital therapies as companies see momentum in the payer market “Pittsburgh-based Highmark plans to expand insurance coverage for some prescription digital therapeutics cleared by the Food and Drug Administration, marking a major step forward for app makers in the market.” 

About health technology

 Medtronic to spin out respiratory, patient monitoring divisions amid flagging ventilator sales “Medtronic laid out plans to spin out its patient monitoring and respirator businesses into a separate company, pitching it as a global player with devices across the hospital and the home spanning $2.2 billion in annual sales.
The new enterprise will shepherd the medtech giant’s Puritan Bennett brand of ventilators—which had once seen wide demand during the early phases of the COVID-19 pandemic, though sales have since dramatically declined—as well as Medtronic’s connected bedside monitors, pulse oximetry sensors and anesthesia hardware.”

Oxford Nanopore debuts portable version of its high-throughput DNA sequencer “The company’s PromethION 2 Solo is described as a portable device, about the size of a large book, that can deliver high-yield sequencing at an affordable rate. It uses the same sequencing hardware as its larger PromethION predecessors, which run 24 or 48 flow cells.
With its hardware starting at $10,455, Oxford Nanopore said in its announcement that the Solo can deliver comprehensive human genomes for less than $1,000 apiece—or for between $300 and $600 each when operating in bulk and connected to the company’s larger flow cell equipment.”

Today's News and Commentary

About Covid-19

ACIP Immunization Schedule Vote “CDC’s Advisory Committee on Immunization Practices (ACIP) recommended updates to the 2023 childhood and adult immunization schedules, which includes incorporating additional information for approved or authorized COVID-19 vaccines. CDC only makes recommendations for use of vaccines, while school-entry vaccination requirements are determined by state or local jurisdictions.”

 Pfizer expects to raise COVID vaccine price to $110-$130 per dose “Pfizer executive Angela Lukin said the company expects to roughly quadruple the price of its COVID-19 vaccine to about $110 to $130 per dose after the US government's current purchase program expires, reported Investing.com.
She indicated that the vaccine, which is currently provided for free to all by the government, will likely be made available at no cost to people who have private insurance or government paid insurance.
The US government currently pays around $30 per dose to Pfizer and partner BioNTech, although the market is expected to move to private insurance next year after the US public health emergency expires.”

About health insurance/insurers

 Characteristics of Terminated Medicare Advantage Contracts, 2011 to 2020 “This study included 935 unique MA contracts that were offered for at least 1 year between 2011 and 2020. Of these contracts, 170 (18.2%) were terminated, affecting 2.4% of MA beneficiaries. Terminated contracts tended to have lower quality (mean star rating 3.1 vs 3.6, P < .001), tended to have $0 premiums (20.0% vs 13.2%, P = .001), and enrolled a greater proportion of Black (21.9% vs 14.3%, P < .001) beneficiaries. In all years but 2020, terminated contracts disproportionately enrolled Black beneficiaries compared with nonterminated contracts.

About hospitals and healthcare systems

 HCA revenues, net income slip in Q3 “Nashville, Tenn.-based HCA Healthcare saw revenues of $14.97 billion in the third quarter of 2022, down from $15.28 billion over the same period last year, according to its financial report released Oct. 21. 
The 182-hospital, for-profit system saw a net income of $1.13 billion in the quarter ended Sept. 30, down from $2.27 billion over the same period last year
The third-quarter results include Hurricane Ian's impact, primarily at the system's Florida facilities, causing additional expenses and lost revenues estimated at $35 million, according to the report. That amount is before any potential insurance recoveries.”

About pharma

 CMS to pay all eligible 340B drug claims for CY 2022 at ASP plus 6% due to AHA’s legal victory  “Medicare Administrative Contractors will pay 340B hospitals Average Sales Price plus 6%, rather than ASP minus 22.5%, for all CY 2022 drug claims with modifier “JG,” the Center for Medicare and Medicaid Services confirmed for AHA yesterday. Judge Rudolph Contreras of the U.S. District Court for the District of Columbia on Sept. 18 ordered CMS to immediately halt its unlawful outpatient payment reimbursement for certain 340B hospitals. 
Affected 340B hospitals should reach out to their MAC if the contractor has not notified them about the adjustment to ensure eligible 2022 claims for drugs provided before Sept. 28 are adjusted.” 

About healthcare personnel

 AMN Healthcare Survey: 85% of Healthcare Facilities Face Shortages of Allied Healthcare Professionals “Eighty-five percent of hospitals, medical groups, home health providers and other healthcare facilities are experiencing a shortage of allied healthcare professionals, according to a new survey conducted by AMN Healthcare… Eighty-two percent hired newly graduated allied healthcare professionals over the last 12 months to help address staffing shortages.
The survey of 1,005 healthcare facilities indicates that the majority of facilities are seeking newly graduated allied healthcare professionals in order to address a widespread shortage of therapists, imaging technologists, laboratory technologists, and other allied healthcare providers. Eighty-five percent of facilities surveyed said they are experiencing shortages of allied healthcare professionals ‘great deal, ‘a lot’ or ‘a moderate amount.’ Only 15% responded ‘a little’ or ‘not at all.’”

Definitive Healthcare Analysis: Billed Claims Show Worsening of Staffing Shortages “Leaders at the Framingham, Mass.-based Definitive Healthcare on Oct. 20 released the results of a study that they’ve produced, based on medical claims data, that provides a different lens through which to look at clinician staff shortages in hospitals, medical groups, and health systems.
The report, ‘Addressing the Healthcare Staffing Shortage,’ involved an analysis of data from Definitive Healthcare’s ClaimsMx and PhysicianView products, with the analysis focusing on the numbers of providers billing each year, by primary specialty on medical claims, based on August 2022 data….
Key findings include:

> 333,942 healthcare providers dropped out of the workforce in 2021
> 33 percent of all physicians are over 59 years old. The average age of a nurse is 57, psychiatrist is 55, surgeon is 56, and family practice physician is 52
> Internal medicine was the specialty that lost the most providers in the last year, followed by family practice and emergency medicine
> The largest healthcare systems added 10,000 beds, 35 hospitals, and 163 physician groups in the past three years
Based on their analysis, the Definitive Healthcare leaders believe found that 117,000 physicians left the workforce in the fourth quarter of 2021, while 53,295 nurses did so…
he analysis also found that the average increase in contract labor expense rose dramatically as a percentage of total organizational expense by bed size, with a 4.1-percent increase for contracted labor being far more devastating to hospitals with 25 or fewer beds, than a 10.6-percent increase for hospitals with more than 250 beds.”

Today's News and Commentary

About general trends

 2022 Secular Trends Shaping the Health Economy A thoughtful monograph from Trilliant Health. Whether or not you agree with the assessments, it is thought-provoking piece that is a good basis for debate or discussion.

Demand

TREND 1 | The Total Available Market (TAM) Of Commercially Insured Patients Is Shrinking
TREND 2 | Care Forgone During the Pandemic Is Permanently Lost, and the Observed Rebound Is Illusory TREND 3 | Higher Patient Acuity Is Likely to Materialize Eventually
TREND 4 | Projected Growth in Demand for Healthcare Services Is Tepid
TREND 5 | How Individuals Access the Healthcare System Varies
TREND 6 | Individuals Are Increasingly Making Healthcare Decisions Like Consumers
TREND 7 | Increasing Unaffordability Is Suppressing Healthcare Demand

Supply
TREND 8 |
Migration of Care Delivery to Lower-Acuity Ambulatory Settings Is Accelerating
TREND 9 | Low-Acuity Healthcare Services Are Increasingly Being Commoditized
TREND 10 | The Impacts of Commoditization Are Predictable
TREND 11 | Provider Burnout Is Exacerbating the Long-Standing Physician Supply Shortage
TREND 12 | Only in Healthcare Can a Monopoly Lose Money, and Regulators Want to Prevent More of Them TREND 13 | More Providers Are Competing for Fewer Patients”

About health insurance/insurers

 Millions at risk of losing health insurance if U.S. ends Covid public health emergency in January “KEY POINTS

  • When the public health emergency does end, HHS estimates up to 15 million people will be disenrolled from Medicaid and the Children’s Health Insurance Program.

  • HHS will give the public 60 days notice before lifting the public health emergency, Health Secretary Xavier Becerra said.

  • The end of the public health emergency will also result in reduced food benefits for the poor and could impact vaccine access at pharmacies among many other consequences.”

About hospitals and healthcare systems

 Hospital price transparency ‘moving in the right direction’ “Almost two years after the Hospital Price Transparency Final Rule laid the foundation for public access to standard charges for medical services, most large U.S. health systems and payers are publishing negotiated prices for all items and services, a new report from Turquoise Health has found.
Nearly 4,200 hospitals and 80 insurers have published negotiated rates, representing a majority of covered lives in the United States, according to the San Diego-based startup, which has developed a scorecard for rating compliance.”

About healthcare IT

 Advocate Aurora Health says 'pixel' data breach may affect 3 million patients “The health system, dually headquartered in Downers Grove, Ill., and Milwaukee, said it implemented the tracking tools to better understand patient behaviors but that the data may have been sent to Google or Facebook parent company Meta.
‘We have disabled and/or removed the pixels from our platforms and launched an internal investigation to better understand what patient information was transmitted to our vendors,’ Advocate Aurora Health said in a statement.”

About health technology

 Philips' CPAP and BiPAP mask recall stretches to 22M devices, lands Class I FDA label “Just a few weeks after racking up its fifth Class I recall from the FDA this year, Philips has hit the half-dozen mark.
Its sixth of the classifications—which denote the agency’s most serious rating for a medical device safety issue—was given to a recall that began in August and centers around the magnetic clips and straps found in some masks used with its CPAP and BiPAP machines.
The FDA handed down its rating in a safety alert published Wednesday. In addition to adding the Class I tag, the regulator’s release also updated the number of devices included in the recall: An initial report Philips issued in early September said it affected “more than 17 million masks,” but the FDA now counts a total of 18,670,643 devices recalled in the U.S. alone, while entries in its recall database bring the global tally to more than 22 million masks.”

Today's News and Commentary

About health insurance/insurers

 Traditional Medicare or Medicare Advantage: How Older Americans Choose and Why Good summary from the Commonwealth Fund. No surprises, however: those who choose traditional Medicare value freedom to choose providers; Medicare Advantage enrollees value the extra benefits and “out of pocket cost limits.”

Elevance Health beats the Street with $1.6B in profit for Q3 “The company released its quarterly earnings report Wednesday morning. Profits were up 7.2% from the prior-year quarter, where Elevance Health posted $1.5 billion. The insurer, formerly Anthem, also surpassed Wall Street's expectations on revenue, according to Zacks Investment Research, with $39.9 billion.
Revenues were up 11.5% from the third quarter of 2021, when the company reported $35.8 billion in revenue.”

As ACA Marketplace Enrollment Reaches Record High, Fewer Are Buying Individual Market Coverage Elsewhere Now, with enhanced subsidies in place, the vast majority of people buying coverage on the individual market are subsidized. The recently passed Inflation Reduction Act continues the ARPA subsidies without interruption for another three years through 2025. That means premiums are capped for people with incomes over 400% of the poverty level ($111,000 for a family of 4) who were ineligible for subsidies previously, and those who were already eligible for subsidies are paying even less than they were before. Overall, about three in four individual market enrollees are now subsidized – by far the highest share since the ACA was implemented – and some of those who aren’t receiving a subsidy might find they are eligible if they moved onto the Marketplace.”

About hospitals and healthcare systems

 2022 State of Healthcare Performance Improvement: Mounting Pressures Pose New Challenges  Select “Survey Highlights

100% of respondents have adopted some type of recruitment and retention strategy 98% have raised starting salaries or minimum wage
69% reported an increase in inpatient length of stay over the past year
67% have seen wage increases of more than 10% for clinical staff

67% reported an increased rate of claim denials

66% have run their facilities at less than full capacity because of staffing shortages

63% have pursued at least one outsourcing solution; the most common areas were revenue cycle, environmental services, and IT

56% have at least a 1-to-1 ratio of advanced practice providers to physicians in their physician enterprise; 40% have a ratio of 2-to-1 or higher”

Request a view: Having window in hospital room increases odds of survival after surgery “Researchers from the University of Michigan report that certain hospital room qualities — such as having a window view, staying in a single room, or closer proximity to a nursing station — may influence outcomes following high-risk operations.”

About pharma

 Mark Cuban's online pharmacy, Vivio partner on specialty drugs for health plans, employers “Mark Cuban's online pharmacy, Cost Plus Drug Co., has picked up another partner to help it enter the specialty drug market.
Cost Plus said Oct. 18 it's now collaborating with Vivio, a San Leandro, Calif.-based specialty drug management platform that markets itself as a PBM alternative.
Vivio's clinicians and researchers match evidence from drug trials with individual patient data to improve outcomes and lower costs for their customers, which include health plans and self-insured employers.”

'Stickier than most have assumed': Abbott upends COVID forecasts yet again with $1.7B in test sales “After kicking off 2022 with its highest COVID test sales haul for a single quarter since the start of the pandemic—helped along by a new $1 billion contract with the U.S. government—Abbott predicted that marked the last hurrah for COVID-related sales. Though it roped in more than $3.3 billion in test sales during that three-month period alone, it forecasted full-year sales of just $4.5 billion, spreading out one last billion-dollar haul across the entire remaining nine months of the year.
One quarter later, Abbott had already far surpassed those expectations, reeling in another $2.3 billion in COVID test sales. Even so, it took a conservative view toward the end of the year, penciling in only another $500 million in test sales for the entire second half.
Fortunately for Abbott, once again, those predictions haven’t panned out. In its third-quarter earnings report, released Wednesday, the medtech giant tallied another $1.7 billion in the category, bringing its year-to-date total to more than $7 billion.”

Lilly to Acquire Akouos to Discover and Develop Treatments for Hearing Loss “Lilly will commence a tender offer to acquire all outstanding shares of Akouos for a purchase price of $12.50 per share in cash (an aggregate of approximately $487 million) payable at closing plus one non-tradeable contingent value right per share ("CVR") that entitles the holder to receive up to an additional $3.00 in cash, for a total consideration of up to $15.50 per share in cash without interest (an aggregate of up to approximately $610 million).”
”Akouos has integrated expertise across otology, inner ear drug delivery, and gene therapy with the goal of addressing the needs of people living with disabling hearing loss worldwide. Akouos's lead product candidate, AK-OTOF, is a gene therapy for the treatment of hearing loss due to mutations in the otoferlin gene (OTOF). Additional pipeline programs span across multiple inner ear conditions, and include AK-CLRN1 for Usher Type 3A, an autosomal recessive disorder characterized by progressive loss of both hearing and vision; GJB2 (which encodes connexin 26) for a common form of monogenic deafness and hearing loss; and AK-antiVEGF for the treatment of vestibular schwannoma.”

About the public’s health

 FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers “U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers. These cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
Each of these defendants failed to submit premarket applications for their e-cigarettes and have continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA that they were in violation of the law. The injunctions would require the companies and named individuals to stop manufacturing, selling, and distributing their e-cigarettes. The injunctions would also require the defendants to obtain marketing authorization from the FDA before marketing such products, as required by law.”

NATIONAL BIODEFENSE STRATEGY AND IMPLEMENTATION PLAN From the White House:
”The Strategy has five goals with associated objectives for strengthening the biodefense enterprise, establishing a layered risk management approach to countering biological threats and incidents.”

'Medically tailored' meals can avert hospital stays, save billions, study says Question  What potential changes in health care utilization and expenditures would be associated with national implementation of medically tailored meal (MTM) access for patients with diet-related diseases and limited instrumental activities of daily living who have Medicaid, Medicare, or private insurance?
Findings  This economic evaluation among 6 309 998 eligible US adults found that national implementation of MTMs for patients with diet-sensitive conditions and activity limitations could potentially be associated with 1.6 million averted hospitalizations and net cost savings of $13.6 billion annually from an insurer perspective.”

About healthcare IT

 Hospital Capabilities to Enable Patient Electronic Access to Health Information, 2021 Just-published monograph from the ONC.
HIGHLIGHTS

  • Seven in ten hospitals enabled patients to access their health information using mobile or other software applications in 2021.

  • Over half of hospitals enabled patient access through FHIR-based APIs in 2021.

  • Over four in five hospitals enabled their patients to view their clinical notes in their patient

    portal in 2021.

  • Small, Critical Access, rural, and independent hospitals enabled patient access to health information at lower rates compared to their counterparts.

  • Nearly three quarters of hospitals using 2015 Edition Certified Health IT reported they provide patients access through apps using APIs.” 

Fueling the AI transformation: Four key actions powering widespread value from AI, right now. From Deloitte. Below is a summary of the action recommendations, but the entire report is worth a look.
Invest in culture and leadership:
Leaders should embark on reinventing work to capitalize on the growing optimism and opportunity that their human workforce sees in AI. People are still at the core of a business’ success, and AI can help unleash the power of a combined human and machine workforce.

Transform operations:
To ensure ethical and quality application of AI,
the entire operating model may need to change
to accommodate the unique capabilities of intelligent machines. Workflows and roles should be reevaluated to manage risk and achieve new value.

Orchestrate tech and talent:
On the flip side of the culture and leadership coin, companies must develop their AI strategies in a tight talent market, with growing off-the-shelf platforms, tools and accelerators that can jump-start a company’s transformation.

Select high-value use cases:
AI is fueling transformations across all industries, and many leaders have begun to unlock which use cases are driving the most value within their given context. The important takeaway is to orchestrate a strategy of both near- and long-term differentiating applications of AI.” 

Today's News and Commentary

About health insurance/insurers

 Feds sue Cigna over alleged Medicare Advantage overpayments linked to home assessments ”The federal government has filed suit against Cigna, alleging that the insurer submitted false and inaccurate Medicare Advantage diagnostic codes in a bid to boost its reimbursement.
The Department of Justice (DOJ) will intervene in a suit initially filed by a whistleblower, the agency said Monday. The suit claims that the diagnostic codes in question were based on forms submitted by contracted vendors who conducted in-home assessments of Cigna members.”

Apple Will Launch Health Insurance In 2024, Says Analyst “Apple will start to offer health insurance in 2024 as it looks to build on the health data it has acquired from the Apple Watch, an analyst has predicted.
CCS Insight believes that Apple will take its tentative first steps into the U.S. health insurance market in partnership with a major insurer, using the health data it’s already collecting to give it a competitive edge over rivals.
Apple already collects data such as blood pressure, blood oxygen levels, ECG readings and body temperature from the Watch, as well as helping people regulate their medication. With accompanying devices, the Watch and iPhone can also be used to monitor conditions such as diabetes.”

About pharma

 J&J sets sights on $60B in pharma sales by 2025, targets 8 brands to deliver growth “During an investor call Tuesday, J&J execs said the company aims to generate $60 billion in pharmaceutical sales by 2025. The unit pulled down $13.2 billion in the third quarter, which would annualize at nearly $53 billion.
J&J is targeting the $60 billion goal for 2025 despite next's year's loss of exclusivity for Stelara, currently the company's top drug by sales. The immunology blockbuster generated $7.33 billion in the first 9 months of 2022, a 12% increase from the same period last year operationally.”

HRSA: AbbVie, Amgen violating 340B program “The HRSA, an HHS subagency, said the companies are surpassing the ceiling prices for drugs dictated by the 340B statute, a federal program that aims to cut certain outpatient drug costs for some hospitals and specialized clinics.”

Pfizer Appeals Anti-Kickback Decision to the Supreme Court “Pfizer is appealing a decision by the Second U.S. Circuit Court of Appeals in August that its proposed copay assistance program for its $225,000-a-year heart treatment, tafamidis, would violate the federal anti-kickback statute (AKS).
In its appeal to the Supreme Court, Pfizer stated that it manufactures the only FDA-approved drug for a rare, and fatal cardiac condition, transthyretin amyloid cardiomyopathy, and that it “seeks to provide financial assistance to needy Medicare patients to help them access this breakthrough treatment.”
Pfizer’s plan was to grant patients $13,000 a year to cover all Medicare copays for the drug, while Medicare would have to pay the rest of the cost. Before launching the program, the company asked the HHS Office of the Inspector General (OIG) for a regulatory opinion on whether its assistance program would be legal.”

Post Dobbs fallout tracker—HHS investigating Walgreens, CVS over reports of withheld prescriptions “The Department of Health and Human Services (HHS)' Office for Civil Rights (OCR) has opened an investigation into chain pharmacies including Walgreens and CVS over complaints that some pharmacists are refusing to fill prescriptions for medications that could threaten a patient's pregnancy.”

Roche’s sales of Covid drugs fall by $1bn “Roche chief executive Severin Schwan said health authorities are holding back from ordering more coronavirus tests and treatments despite a rise in cases, after sales of the company’s Covid-19 drugs fell SFr1.12bn ($1bn) in the first nine months of the year. The Swiss pharmaceutical company sells the antibody treatment ronapreve and the anti-inflammatory actemra, originally developed for arthritis, for Covid.”

About the public’s health

 1.3 million Americans with diabetes rationed insulin in the past year, study finds “ According to research published Monday in the journal Annals of Internal Medicine, over a million people with diabetes in the US rationed their insulin in the past year.
’The main takeaway is that 1.3 million people rationed insulin the United States, one of the richest countries in the world,’ Dr. Adam Gaffney, the lead author of the study and a pulmonologist and critical care doctor at Harvard Medical School and Cambridge Health Alliance, told CNN. ‘This is a lifesaving drug. Rationing insulin can have life-threatening consequences.’”

Today's News and Commentary

About pharma

Competition in Commercial PBM Markets and Vertical Integration of Health Insurers with PBMs A good review of the sector and its major players. The overall message is how concentrated the market is.

 The top 10 vaccine companies worldwide FYI. Pfizer is #1.

2022 Biosimilar Trends Report A good review from Amgen. Look at Figure 3 for projected drug launches.

About the public’s health

 Scientists say ‘forever chemicals’ may be contaminating 57,000 US sites “The researchers said that in the absence of information proving otherwise, contamination from per- and polyfluoroalkyl substances (PFAS) should be presumed at 57,412 locations spread across all 50 states and the District of Columbia.
The areas in question include sites that discharge jet fuel firefighting foam, certain industrial facilities and places where waste contains these cancer-linked chemicals, according to the study, published in Environmental Science & Technology Letters.”

About healthcare IT

 VA warns 41,500 patients that Oracle Cerner EHR issues may have affected care “The Department of Veterans Affairs is notifying 41,500 patients that their care may have been affected due to the delays in the rollout of its Oracle Cerner EHR system…” 

About healthcare personnel

 The cost of nurse turnover in 23 numbers FYI

About health technology

 Listen up: You can now buy hearing aids without a prescription “The government on Monday will begin allowing pharmacies and big-box stores to sell hearing aids without prescriptions, a move that is expected to shake up an industry that has long been dominated by a handful of manufacturers under a model of care that critics said raised costs and stifled innovation.
Backers of the change say the move to over-the-counter hearing aid sales will usher in a revolution of lower prices and new technologies, and expand access for millions of people with untreated hearing loss.”

Today's News and Commentary

About Covid-19

Pfizer, BioNTech find updated COVID booster protects against Omicron in trial “In a joint statement on Thursday, the companies said data from roughly 80 adult patients showed the booster dose led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after one week.”

Biden administration extends COVID public health emergency “The Biden administration said Thursday that the COVID-19 public health emergency will continue through Jan. 11…”

 11.5M Americans have received updated COVID booster: CDC “About 11.5 million Americans have received the updated bivalent COVID-19 booster, according to data from the Centers for Disease Control and Prevention.”

About health insurance/insurers

 UnitedHealth Group reports $5.3B in Q3 profit, revenues up 12% year over year “UnitedHealth Group said the boost in revenue reflects significant growth at both UnitedHealthcare and Optum. At UnitedHealthcare, revenues grew 11% year over year to $62 billion. The number of people served by UnitedHealthcare has grown by 850,000 over the first three quarters, including 185,000 new lives added in the third quarter.” 

Medicare open enrollment starts Oct. 15. Here’s what’s new for 2023. “Lower premiums, insulin price caps, free shingles vaccines: There are some noteworthy changes to Medicare for 2023, and the annual open enrollment period is a good time to check them out.”

Lawsuit by KHN Prompts Government to Release Medicare Advantage Audits Federal health officials have agreed to make public 90 audits of private Medicare Advantage health plans for seniors that are expected to reveal hundreds of millions of dollars in overcharges to the government.
The Centers for Medicare & Medicaid Services agreed to release the records to settle a lawsuit filed by Kaiser Health News against the agency in September 2019 under the Freedom of Information Act'.”

About pharma

 Walgreens aims to rapidly scale US healthcare business next year “Despite the rosy outlook, WBA's financial results lagged behind last year. The company's fourth quarter sales were down 5.3 percent to $32.4 billion, and net loss from continuing operations was $415 million, compared to $358 million net income for the same period last year. Sales from continuing operations were slightly up to $132.7 billion for the full year.
In the fourth quarter, U.S. digital sales were up 14 percent, and the company's myWalgreens membership topped 102 million members. It's continuing to roll out VillageMD with 342 total clinics — 82 opened in the last year — and 152 co-located clinics open. By the end of the calendar year, the company is on track to have 200 co-located clinics.”

2022 Biosimilar Trends Report An excellent review of the current state of the industry. 

About healthcare IT

 Samsung partners with HealthTap to bring virtual primary care to smart TVs “Through a new partnership with virtual primary care company HealthTap, Samsung Smart TV users can connect to the company's healthcare platform and visit with a doctor of their choice using the built-in camera on their television, according to the companies in a press release.
Consumers can review doctor bios, credentials and video interviews to select a doctor and easily schedule an appointment, often within the same week. 
HealthTap developed its platform to provide members access to a long-term primary care doctor to address ongoing health conditions as well as preventive care and referrals. At a cost of $15 per month, consumers get access to free texting with their doctor, $39 video appointments and $59 visits for 24/7 urgent care with the first available clinic doctor. The platform also includes a network of 90,000 volunteer U.S. doctors across 147 specialties providing free informational answers to health questions from HealthTap members.
The company says it serves tens of millions of consumers online and provides many thousands of doctor visits each year. The company has raised $88 million to date, according to Crunchbase.”

Today's News and Commentary

About hospitals and healthcare systems

 Fitch: Children's hospitals showing stronger liquidity, profitability than adult providers “Standalone nonprofit children’s hospitals have largely rebuffed the pandemic’s financial disruptions and are in a better position to "weather expected and unexpected challenges” including high labor costs, according to a new Fitch Ratings report.
Among a sample of 23 organizations, children’s hospitals increased their median days cash on hand from 396.1 days in fiscal 2020 to 416 days in fiscal 2021, the agency’s analysts wrote. Median cash to debt rose from 249.1% to 323.5%, they wrote.”

About pharma

 Medicare Drug Negotiation and Rebate Group Formally Organized “The Biden administration has formally established the Medicare Drug Rebate and Negotiations Group to implement Medicare drug price negotiations and the inflation rebate program authorized under the Inflation Reduction Act of 2022.
Operating within the Center for Medicare, the new group, and the reorganization it required, was approved by HHS Secretary Xavier Becerra and took effect Oct. 8, according to a summary document released Wednesday that will be published in the Federal Register Oct. 14.”

About the public’s health

USDA awards $110M toward improving rural healthcare “The U.S. Department of Agriculture has invested $110 million toward healthcare facilities in rural areas. 
The grant will affect 208 rural facilities and help provide services to 5 million people across 43 states. Funds will go toward renovating, building and equipping facilities and be distributed through the American Rescue Plan Act, according to an Oct. 12 news release.”

HHS Announces Initiatives to Address Language Barriers in Care Access “The US Department of Health and Human Services (HHS) has announcedseveral commitments to ease language barriers preventing care access…
As a first step, HHS announced it will relaunch its Language Access Steering Committee (Steering Committee) to enhance communication with LEP [limited English proficiency] patients. Alongside the Steering Committee, HHS will require all agencies to update their language access plans. 
In concert with the committee relaunch, the HHS Office of Minority Health (OMH) announced it will distribute more than $4 million in grants to 11 organizations for an initiative called Promoting Equitable Access to Language Services in Health and Human Services.
Through the three-year initiative, organizations will develop and test methods for informing patients with LEP about accessibility to language services in healthcare-related settings.”

GSK says RSV vaccine offers "exceptional" protection in older adults “GSK announced Thursday that its experimental vaccine RSVPreF3 OA demonstrated overall efficacy of 82.6% against respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD) in adults aged 60 years and above. The company said earlier this year that the primary endpoint of the Phase III AReSVi 006 study was "exceeded," without providing further details at the time.”

About health technology

 Skip the doctor's office? Quest Diagnostics pitches consumer testing in new ad campaign “Quest Diagnostics’ line-up of 50+ tests, from sexually transmitted disease screenings to allergy and metabolic panels, lets people skip the line at doctors’ offices and get results at home. And now it’s launching its largest inaugural consumer marketing campaign in support…
The 30-second commercial directs viewers to the Quest Health website where they can browse and purchase its more than 50 tests — from $39 for gout or cholesterol information to $349 suites of men’s or women’s assessments. Interested shoppers’ tests are ordered by a physician digitally, scheduled at their nearby Quest Diagnostic labs, and results are then delivered to their private MyQuest portal, said Ryan Anderson, Quest’s executive director of consumer marketing. Its biggest selling category to date? STD tests. While people can’t use traditional insurance for the Quest Health tests, they can use funds from health flexible spending accounts (FSAs).”

Today's News and Commentary

About Covid-19

 FDA authorizes adolescent use of Omicron-specific boosters “The FDA has authorized Pfizer and BioNTech’s booster in children ages 5 through 11, the companies announced on Wednesday, as well as Moderna’s formulation in kids 6 through 17 years old. Both shots are specific to the Omicron BA.4/BA.5 subvariants, which account for more than 80% of cases in the US, according to Pfizer.”

About health insurance/insurers

 Biden administration's 'family glitch' fix kicks in soon “Individuals who do not have access to affordable health insurance through their employers can qualify for subsidies to purchase plans through the ACA marketplace. These affordability definitions only applied to individuals, not families, meaning many people were not eligible for subsidies. 
The IRS and Treasury Department are implementing the final rule designed to fix the glitch, according to a White House press release issued Oct. 11. 
Starting next month, people can sign up for subsidies for families if they cannot receive affordable insurance from their employer, according to the release.”
 

About hospitals and healthcare systems

 Expansion of the Veterans Health Administration Network and Surgical Outcomes “In this nonrandomized regression discontinuity study of 615 473 unique surgical procedures among 498 427 patients, expanded access to care was associated with a greater proportion of surgical procedures in a community setting, and this proportion varied by procedure type. However, no difference in postoperative emergency department visits, inpatient readmissions, or mortality was found between VHA-provided and VHA-paid procedures in the community setting.
Meaning  Expanding access to health care outside of the VHA was associated with a shift in the location of surgical procedures among veterans but had no association with postoperative outcomes; these findings may assuage concerns of worsened patient outcomes resulting from care coordination issues when care is expanded outside of a single health care system.” 

About the public’s health

 NOWHERE TO GO: MATERNITY CARE DESERTS ACROSS THE U.S. (2022 REPORT) Report from The March of Dimes: “THE NEW FINDINGS:

  • Areas where there is low or no access affect up to 6.9 million women and almost 500,000 births across the U.S.

  • This includes a five percent increase in counties that have less maternity access since 2020.

  • In maternity care deserts alone, approximately 2.2 million women of childbearing age and almost 150,000 babies are affected.

  • There’s a two percent increase in counties that are maternity care deserts since our 2020 report. That’s 1,119 counties and an additional 15,933 women with no maternity care.

  • Florida had the most women impacted by improvements to maternity care access (more than 92,000).

  • Ohio had the most women impacted by overall reductions in access to care (over 97,000).”

About healthcare IT

 Survey Finds Majority of Healthcare Consumers Conditioned to Not Shop Around for the Best Price “6 in 10 Americans have never tried to research pricing for services; 58% of Americans would shop around for optimal pricing in healthcare if pricing data is provided prior to service needed.”

 25% of ransomware attacks cause healthcare organizations to halt operations, study says “A new study from cybersecurity company Trend Micro Incorporated found that 25 percent of healthcare organizations hit by ransomware attacks were forced to halt operations completely.
The study also revealed that 86 percent of global healthcare organizations affected by ransomware attacks suffered operational outages, according to the Oct. 11 Trend Micro news release.”

Today's News and Commentary

About Covid-19

 Nasal version of Oxford/AstraZeneca Covid vaccine fails in trial “A nasal version of the Oxford/AstraZeneca Covid-19 vaccine has failed in an early-stage trial, dealing a blow to hopes for a more effective way to prevent transmission of the virus. Oxford university said on Tuesday a nasal formulation of the vaccine elicited mucosal antibody responses in a ‘minority of participants’ and systemic immune responses were weaker compared with intramuscular vaccination.”

About health insurance/insurers

 Centene barred from growing some Medicare Advantage plans “Centene will not be allowed to expand its Medicare Advantage footprint in certain geographies next year after its plans consistently received poor scores in the federal quality ratings program. 
The insurer will be unable to expand nine of its 108 contracts in 2024, according to an analysis by HealthMine, a consultancy for health insurance companies. About 84,000, or 5%, of Centene’s 1.5 million Medicare Advantage members with Part D prescription drug coverage are enrolled in the nine plans, which cover counties in Ohio, North Carolina, Arizona, Connecticut and Nevada.”

Health plans say texting could help reach underserved patients. But a federal rule is getting in their way “Health plans trying to reach low-income and underserved customers say they’re being stymied by a decades-old federal rule limiting texting — and they’re framing it as a health equity issue in their bid to change it. 
Low-income and underserved patients, they say, are more likely to see and respond to texts about their health than they are to answer calls from unknown numbers or to receive mailed notices, especially if they’re at work or move frequently. But a 1991 law designed to protect consumers from unwanted telemarketing blocks health plans contracting with Medicaid from texting patients without their prior consent, meaning that they can’t send reminders about services like mammograms or well-child visits unless they’ve reached the patient by phone or mail first.”

Healthcare billing fraud: 10 recent cases Nine of ten are explicitly Medicare and/or Medicaid.

About pharma

 For $392M, Walgreens to fully acquire CareCentrix “About a month after acquiring a majority stake in CareCentrix, Walgreens Boots Alliance said Oct. 11 it plans to fully own the home healthcare company for $392 million. 
Walgreens said the acquisition of CareCentrix, which reported sales of $1.5 billion in 2021, will be completed by March 2023.”

Rite Aid, Google Cloud partner to create the 'modern pharmacy' “Rite Aid will partner with Google Cloud to introduce Google's Anthos platform to its more than 2,350 pharmacies, the companies said Oct. 11. 
The yearslong partnership is "defining the modern pharmacy," Carrie Tharp, vice president of retail and consumer solutions of Google Cloud, said in a statement. 
With Google Cloud, the retail pharmacy plans to transition its "vaccine scheduling tool, customer messaging infrastructure and digital engagement platform" into an app.”

About the public’s health

 Walmart's Healthcare Research Institute Launches With Mission To Improve Care for Underserved Communities Through Research “Today, Walmart is announcing the launch of the Walmart Healthcare Research Institute SM (WHRI) to increase community access to healthcare research that may help lead to safer, higher quality and more equitable healthcare.
WHRI will be focused on innovative interventions and medications that can make a difference in underrepresented communities including older adults, rural residents, women and minority populations. WHRI initially is focused on inclusion in studies on treatments for chronic conditions and innovative treatments that should include members from these communities.”

Screening for Depression and Suicide Risk in Children and Adolescents “The USPSTF concludes with moderate certainty that screening for MDD [major depressive disorders] in adolescents aged 12 to 18 years has a moderate net benefit. The USPSTF concludes that the evidence is insufficient on screening for MDD in children 11 years or younger. The USPSTF concludes that the evidence is insufficient on the benefit and harms of screening for suicide risk in children and adolescents owing to a lack of evidence.”

About healthcare IT

 Risks are low for sharing patient data, study finds “Between September 2016 and September 2021, there were no instances of deidentified data being reidentified, according to the review of more than 10,000 U.S. media publications. During the same period, more than 100 million health records were stolen in data breaches from supposedly secure systems.” 

Today's News and Commentary

About Covid-19

 Few Americans get new covid booster shot ahead of projected winter surge “Only about 105 million U.S. adults — roughly 40 percent — have received the third shot of vaccine initially offered a year ago, according to federal data, a far lower rate than countries like the United Kingdom, where more than 70 percent of adults have gotten a third dose. That figure is also well behind the 200 million U.S. adults who completed their primary series of shots.”  

About health insurance/insurers

The Role Of Administrative Waste In Excess US Health Spending  “Per the research summarized…, administrative spending accounts for between 15 and 30 percent of medical spending. Some of these estimates encompass only billing- and insurance-related expenses and, as a result, are lower than those that include both billing- and insurance-related and non–billing- and insurance-related costs. Even at the lower end of estimates, US spending on administrative costs annually accounts for twice the spending on care for cardiovascular disease and three times the spending for cancer care…
if administrative spending is about 15–30 percent of national health spending, then wasteful administrative spending comprises half of that, or 7.5–15 percent of national health spending (or $285–$570 billion in 2019).” 

About pharma

 EU says Teva likely breached antitrust rules to delay Copaxone competition “The European Commission on Monday said that Teva likely breached antitrust rules in an effort to delay competition to its multiple sclerosis (MS) drug Copaxone (glatiramer acetate). The Commission noted that Teva ‘artificially’ extended patent protection for Copaxone and spread "misleading" information about a competing product.” 

About the public’s health

 FDA authorizes Abbott’s monkeypox PCR test for emergency use “The FDA has issued an emergency use authorization to Abbott Molecular for its real-time PCR test for monkeypox using lesion swab specimens from those with suspected virus infection.
The PCR test (Alinity m MPXV) is the first commercial test to be authorized for detection of monkeypox and is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, according to an FDA press release.”

FDA Approves Boostrix for Whooping Cough Prevention “The FDA has approved GlaxoSmithKline’s Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) vaccine for immunization during the third trimester of pregnancy to prevent pertussis, or whooping cough, in infants younger than two months of age.”

Today's News and Commentary

About Covid-19

Evusheld Likely Not Effective Against Omicron, FDA Says “The FDA has updated its fact sheet for healthcare providers for the use of AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) which is authorized for emergency use for treatment of COVID-19 infections.
The agency warned that the injectable treatment might not be able to neutralize certain SARS-CoV-2 viral variants and that Evusheld might not be effective at preventing COVID-19 caused by the variants.”

Merck Covid antiviral pill did not cut hospitalisation risk, study finds “Results from a UK pivotal trial showed that Merck & Co.'s COVID-19 antiviral pill Lagevrio (molnupiravir) failed to lower the risk of hospitalisation and death among adults at higher risk from the disease, reported Financial Times.”

APIC urges members to disregard new CDC masking guidelines “The recent relaxation of masking guidelines for healthcare professionals by the Centers for Disease Control and Prevention (CDC) seems a bit premature to one professional organization.
In fact, infection preventionists should disregard the CDC’s updated recommendation and maintain mandatory masking requirements for healthcare workers who come into contact with patients, states the Association for Professionals in Infection Control and Epidemiology (APIC) in a press release.”

Newsom signs bill to police California doctors on COVID-19 misinformation “California doctors will be subject to discipline and possible suspension of their licenses to practice for spreading misinformation about the COVID-19 pandemic to patients, following Gov. Gavin Newsom’s signature of one of the most controversial pieces of pandemic legislation lawmakers sent to his desk.
AB 2098 by Assemblyman Evan Low, D-Campbell, was co-sponsored by the California Medical Association to tamp down COVID-19 misinformation, often spread through social media, promoting untested or ineffective treatments and cures and questioning the effectiveness of face masks and vaccines.”

 CDC ends daily reporting of COVID case and death data, in shift to weekly updates “After more than two years of publishing data on COVID-19 cases and deaths on a daily basis, the Centers for Disease Control and Prevention announced Thursday it would shift to weekly updates to its nationwide tracking of the virus.”

About health insurance/insurers

Readmission Reduction as a Hospital Quality MeasureTime to Move on to More Pressing Concerns? A good, thoughtful review of the topic.

Elevance Health faces Medicare Advantage fraud suit “Elevance Health is facing a federal lawsuit alleging the insurer received more than $100 million in overpayments from CMS after a judge declined to dismiss the suit, the Indianapolis Business Journal reported Oct. 5.”

 Comparison of Health Care Utilization by Medicare Advantage and Traditional Medicare Beneficiaries With Complex Care NeedsQuestion  Do rates of health care utilization for beneficiaries with complex care needs differ between traditional Medicare and Medicare Advantage (MA)?
Findings  In this cross-sectional study of 1 844 326 Medicare beneficiaries, those enrolled in MA had lower rates of hospital stays, emergency department visits, and 30-day readmissions. The largest relative differences were observed for hospital stays, which ranged from −9.3% to −11.9% across different cohorts of beneficiaries with complex care needs.”

About hospitals and healthcare systems

 CommonSpirit Health seeks to raise $1.5B from bond issues “CommonSpirit Health has issued a pair of bonds as it aims to raise $1.5 billion to cover past and future expenses.
Chicago-based CommonSpirit will use the proceeds to refinance prior debt, reimburse prior capital expenditures and fund general corporate purposes…”

About pharma

FDA Awards $1.3 Million Grant to Biologics & Biosimilars Collective Intelligence Consortium “The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) announced… that it has received a major grant from the Food & Drug Administration (FDA) in support of biosimilars research. The award provides $1.3 million over two years for a new BBCIC study focused on increasing the efficiency of biosimilar drug development and review.
The study—entitled "Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data to Produce Real-World Evidence"—reflects BBCIC's longstanding commitment to evaluating the safety and effectiveness of biologics, including biosimilars, through the generation of reliable, real- world data (RWD) and evidence (RWE).”

 Mark Cuban Cost Plus Drug Company announces first health plan partner, Capital Blue Cross “Beginning this month, the Pennsylvania-based plan and Mark Cuban's drug company (MCCPDC) will begin to let members and community organizations know about their collaboration and how they can access low-cost drugs, according to a press release. In 2023, Capital Blue Cross members will be able to use their insurance cards at the company's online pharmacy.”

Novo Nordisk ready to submit once-weekly insulin to FDA after scoring final phase 3 win “Icodec demonstrated non-inferiority in reducing hemoglobin A1c, a measure of blood sugar, in patients with type 2 diabetes at week 52 when compared with once-daily basal insulin analogs. Specifically, participants who received Icodec saw an HbA1c reduction of 1.68% points, compared with 1.31% for patients who received once-daily basal insulins.”

HHS: Specialty drug costs up more than $300 billion since 2016 “Key takeaways:

--HHS released two reports that showed the U.S. health care system spent about $603 billion on prescription drugs in 2021.

--The cost of specialty drugs has continued to grow, increasing 43% since 2016 and representing 50% of total drug spending in 2021.

--HHS said the reports highlight the potential benefits of the Inflation Reduction Act. If the legislation had been in place from July 2021 to July 2022, at least 1,200 drugs may have been subjected to a provision that now requires manufacturers to pay Medicare rebates if they implement a price increase that is higher than drug inflation.”

US considers first over-the-counter birth control pill “Two US Food and Drug Administration advisory committees will in November consider an application by HRA Pharma, a subsidiary of Perrigo Company, to sell a previously prescription-only oral contraceptive pill over the counter. It is the first such application to be considered by the agency, which is also in talks with another company, Cadence Health, over its plan to sell contraceptive pills in the same manner.”

About the public’s health

Smoking Costs U.S. Economy Almost $900 Billion a Year  “Smoking isn't only costly in terms of health risks, it also cost the U.S. economy $891 billion in 2020.
That was almost 10 times the cigarette industry's $92 billion revenue, according to the authors of a new American Cancer Society study.”

2022 National Survey: Attitudes about Influenza and Pneumococcal Disease, and the Impacts of COVID-19 “The National Foundation for Infectious Diseases (NFID) commissioned an annual survey to better understand beliefs about influenza (flu) and pneumococcal disease, as well as attitudes and practices around vaccination, including the impacts of the COVID-19 pandemic…”
Some highlights:
--"69% agree that annual flu vaccination is the best preventive measure against flu-related deaths and hospitalizations but only 49% plan to get a flu vaccine during the 2022-2023 flu season
--Of concern, about 1 in 5 (22%) who are at higher risk2 for flu-related complications said they were not planning to get vaccinated this season”

Guide to Evidence for Health-Related Social Needs Interventions: 2022 Update “This updated evidence guide is intended for users of the Return on Investment (ROI) Calculator for Partnerships to Address the Social Determinants of Health, sponsored by the Commonwealth Fund. It summarizes our most recent assessment of the evidence available for the calculator to establish a business case for sustainable financial arrangements between health care and community-based organizations serving adults with complex health and social needs.”
This monograph is an excellent resource evidence-based SDOH interventions.

About healthcare IT

Google Cloud introduces digital suite for medical imaging “Google Cloud is rolling out a set of tools specifically for digital imaging, designed to make diagnostic data more accessible and interoperable.
The company’s Medical Imaging Suite will also serve as a gateway for the development and implementation of artificial intelligence programs for quickly parsing patient scans and potentially finding hidden details.”

Call it data liberation day: Patients can now access all their health records digitally “Under federal rules taking effect Thursday, health care organizations must give patients unfettered access to their full health records in digital format. No more long delays. No more fax machines. No more exorbitant charges for printed pages.”

About health technology

 Natera’s Blood Test for Ovarian Cancer Relapse Shows Promise in Study “Natera’s Signatera circulating tumor DNA (ctDNA) test outperformed the cancer antigen CA 125 test by one month and radiological imaging by 10 months in identifying patients with the highest risk of recurrence of epithelial ovarian cancer (EOC), researchers reported in the journal Gynecologic Oncology.

Today's News and Commentary

About Covid-19

 CDC revises 'up to date' term on COVID-19 vaccination “The CDC revised its "up to date" COVID-19 vaccination term Sept. 30 to include the primary series and the recently authorized omicron-targeting booster.”

Supreme Court declines 10 states' challenge to CMS' vaccine mandate “The U.S. Supreme Court on Oct. 3 declined a case brought by 10 states challenging the Biden administration's rule that requires employees to be vaccinated against COVID-19 if they work in healthcare facilities that receive federal funding.”

U.S. CDC ends country-specific COVID travel health notices “The Centers for Disease Control and Prevention (CDC) said on Monday it had ended its COVID-19 country travel health notices as fewer countries reported enough data for accurate assessments.”

About health insurance/insurers

 A boost for biosimilars payments unveiled by CMS “CMS announced Monday that it had started to implement a temporary reimbursement boost for biosimilars that is mandated in the Inflation Reduction Act.
Under the law, the add-on payment for biosimilars administered in physician offices, hospital outpatient departments, and ambulatory surgical centers will be 8% of the average sales price (ASP) or the reference drug. Prior to enactment of the IRA, the add-on payment for biosimilars was 6% of the reference product’s ASP.”
Comment: Physicians will still be incentivized to use the most expensive products.

Federal employee health-care premiums to rise 8.7 percent on average “Premiums in the health-care program for federal employees and retirees will increase by 8.7 percent on average for 2023 — the largest increase in more than a decade, the government announced Friday.
That change in Federal Employees Health Benefits Program premiums is significantly larger than the 3.8 percent average increase for 2022, although closer to the 5-7 percent range of most other recent years.
The cost increase is a reflection of rising prices for some drugs and higher uses of professional services and outpatient treatments, said the Office of Personnel Management.”

About hospitals and healthcare systems

 7-hospital system files for bankruptcy “Pipeline Health System, which includes seven hospitals in three states, filed for Chapter 11 bankruptcy Oct. 2. 
El Segundo, Calif.-based Pipeline said the decision to enter bankruptcy was prompted by several factors, including financial challenges tied to skyrocketing costs and delayed payments from insurance plans.”

Trinity Health reports $1.4B annual loss “Higher labor costs put pressure on Trinity Health's margins in fiscal year 2022, according to financial documents released Sept. 30. 
Livonia, Mich.-based Trinity Health posted revenue of $19.93 billion in the 12 months ended June 30, down from $20.16 billion a year earlier. The health system said net patient service revenue was up 1.8 percent year over year, primarily because of increased outpatient volume and payment rates.”

About pharma

 OIG raises concerns about accelerated approval pathway “More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years past their confirmatory trial deadlines, according to a recent report released by the US Department of Health and Human Services Office of Inspector General (OIG)…
OIG’s report examined 278 drugs approved by the FDA Center for Drug Evaluation and Research (CDER) between 1992 and December 2021 to estimate the number of drug applications that completed confirmatory trials. The authors of the report also evaluated Medicare and Medicaid claims data between 2018 and 2021 for drug applications that received accelerated approval but had not yet completed confirmatory trials.
The authors of the report found 104 drug applications (37.8%) have not completed confirmatory trials, 35 drug applications (33.6%) had one or more trials that missed a completion date, and 4 drug applications had significantly passed the originally-planned clinical trial completion date by between 5–12 years. For the 139 drug applications (50.0%) where confirmatory trials were completed, the average time to completion was 48 months.”

Today's News and Commentary

About health insurance/insurers

 18 payers to join CMS value-based Medicare Advantage model for 2023 “CMS' Value-Based Insurance Design program for Medicare Advantage plans is growing for 2023, expanding to 52 participating organizations, the agency said Sept. 29. 
CMS estimates the number of enrollees covered by the program will increase by 24 percent this year with the new participating organizations, according to a news release. 
The model, started in 2017, is designed to test improvements in care quality for Medicare Advantage plan enrollees, including people with low income and those dually eligible for Medicare and Medicaid. 
Medicare Advantage plans participating in the test can offer supplemental benefits like nutrition and transportation assistance, reduced cost sharing, or other incentives designed to promote healthy behavior and health equity.”

Optum, Change Healthcare complete $7.8B merger “Optum has completed its $7.8 billion merger with Change Healthcare. 
Optum's parent company, UnitedHealth Group, completed the acquisition Oct. 3, which merges Optum with healthcare data and analytics giant Change Healthcare, according to an Oct. 3 press release. The acquisition allows Optum to gain access to data from millions of healthcare transactions covering a broad swath of the U.S. population.”

Health care costs in retirement: They could exceed $300K for women, $264K for men “A healthy 65-year-old man can expect to incur up to $264,000 in health care expenses during retirement, while a woman retiring at age 65 may spend up to $300,000, according to a projection by consulting and actuarial firm Milliman Inc.
The 2022 Retiree Health Cost Index projects total premiums and out-of-pocket expenses for medical and prescription drug costs in retirement and looks at cost variations across sex, geography and the two most common coverage options for Medicare-eligible retirees.
According to Milliman, a healthy 65-year-old man with a Medicare Advantage plus Part D (MAPD) plan will spend $137,000 in health care expenses, while the same retiree with Original Medicare with Medigap (Plan G) and Part D is projected to spend $264,000. A corresponding woman on MAPD will spend $158,000 and on Original Medicare will spend $300,000. That equates to savings needed of between $92,000 and $177,000 for a man and $103,000 and $194,000 for a woman. Higher health care costs for women are largely the result of longer life expectancy when compared to men.”

About hospitals and healthcare systems

 September 2022 National Hospital Flash Report Highlights:
1.Volumes were higher in August than in July, boosting revenue. However, costs still climbed slightly month-over-month as hospitals and health systems continue to shoulder heightened expense loads.

2. Expenses rose, but not as much as revenue. Supplies and expensive drugs contributed to this uptick more than labor costs, which remain elevated.

3. Outpatient revenue slightly drove up margin. This metric is substantially higher than it was in August of 2021. It demonstrated the most growth month-over-month as patients scheduled more elective procedures.

4. Hospitals are still facing extreme difficulty. Nine months into a challenging year, margins have fluctuated wildly. Although most metrics improved from July to August, organizations are still operating with negative margins and well below pre-pandemic levels.

5. New market entrants present strategic challenges. As disruptors chip away at outpatient volume, hospitals should reimagine how to deliver care in non- hospital settings as part of their long-term planning.

About pharma

Amylyx's ALS drug will cost $158K for annual supply “A recently approved amyotrophic lateral sclerosis treatment will be $158,000 for a year's supply, the product's manufacturer said in a Sept. 30 investor conference call, according to The New York Times.”

Rite Aid lost $331M in Q2 “Rite Aid reported a loss of nearly $331.3 million in its second fiscal quarter, which is three times more than its loss in its 2021's second quarter…
the Philadelphia-based retail pharmacy chain attributed the most recent financial results to inflationary pressures.”

HHS: Price of more than 1,200 drugs outpaced inflation “Between July 2021 and July 2022, the prices for 1,216 drugs rose more than the 8.6 percent rate of inflation, with these products having an average price increase of 31.6 percent. The price increases observed in 2022 were affected by the high rate of general inflation this year. The HHS report noted that most drug price increases occur in either January or July.
The prices for some drugs rose by more than 500 percent in 2022. The antifungal fluconazole, a common medicine, saw increases of 1101 percent, with the price of one 150 mg tablet rising from $2 to $28.
Some of the drugs that saw the highest dollar amount increases in 2022 include lymphoma medications like Tecartus, Yescarta and Zevalin as well as diabetes medications like Korylm, though the overall percentage increases were small due to the already enormous cost of these drugs.”

About healthcare IT

 Prevalence and Sources of Duplicate Information in the Electronic Medical Record “In this cross-sectional analysis of 104 456 653 routinely generated clinical notes, 16 523 851 210 words (50.1% of the total count of 32 991 489 889 words) were duplicated from prior documentation. Duplicate content was prevalent in notes written by physicians at all levels of training, nurses, and therapists and was evenly divided between intra-author and inter-author duplication.” 

Today's News and Commentary

About health insurance/insurers

 Biden-Harris Administration Announces Lower Premiums for Medicare Advantage and Prescription Drug Plans in 2023 “he projected average premium for 2023 Medicare Advantage plans is $18 per month, a decline of nearly 8% from the 2022 average premium of $19.52. Medicare Advantage plans will continue to offer a wide range of supplemental benefits in 2023, including eyewear, hearing aids, preventive and comprehensive dental benefits, access to meals (for a limited duration), over-the-counter items, and fitness benefits.
In addition, more than 1,200 Medicare Advantage plans will participate in the CMS Innovation Center’s Medicare Advantage Value-Based Insurance Design (VBID) Model in 2023, which tests the effect of customized benefits that are designed to better manage diseases and meet a wide range of health-related social needs, from food insecurity to social isolation. The benefits under this model are projected to be offered to 6 million people.”

Understanding Medicare Advantage Payment A really good summary of the issues around Medicare Advantage plans, along with recommendations for correction of problems.

Association of Oncologist Participation in Medicare’s Oncology Care Model With Patient Receipt of Novel Cancer Therapies Question  Was implementation of Medicare’s Oncology Care Model in 2016 associated with a decrease in patient receipt of novel cancer therapies?
Findings  This cohort study included 2839 patients with cancer who were eligible to receive a novel cancer therapy. The start of the Oncology Care Model did not correspond with a decreased likelihood of receiving a novel therapy.”

The State of U.S. Health Insurance in 2022: Findings from the Commonwealth Fund Biennial Health Insurance SurveySurvey Highlights

  • Forty-three percent of working-age adults were inadequately insured in 2022. These individuals were uninsured (9%), had a gap in coverage over the past year (11%), or were insured all year but were underinsured, meaning that their coverage didn’t provide them with affordable access to health care (23%).

  • Twenty-nine percent of people with employer coverage and 44 percent of those with coverage purchased through the individual market and marketplaces were underinsured.

  • Forty-six percent of respondents said they had skipped or delayed care because of the cost, and 42 percent said they had problems paying medical bills or were paying off medical debt.

  • Half (49%) said they would be unable to pay for an unexpected $1,000 medical bill within 30 days, including 68 percent of adults with low income, 69 percent of Black adults, and 63 percent of Latinx/Hispanic adults.

  • Sixty-eight percent of Democrats, 55 percent of Independents, and 46 percent of Republicans said President Biden and Congress should make health care costs a top priority in the coming year.”

About pharma

 FDA hits Lupin with another warning notice for troubled API plant “Lupin is having continued difficulty solving problems at its factory in Tarapur, India, and has received another warning letter from the FDA, the generics producer revealed in a regulatory filing.
This comes on top of the FDA slapping Lupin with a Form 483 letter in April after the regulator inspected the active pharmaceutical ingredient (API) plant from March 22 to April 4.”
See yesterday’s API comment.

About health technology

 Illumina pitches $200 genomes with new line of DNA sequencers “Now, for only the cost of a few dozen cheeseburgers, you could have a fully sequenced human genome. Illumina is rolling out a new line of DNA analyzers that it says can read a person’s genetic code for a cost of about $200.
The company unveiled a new line of sequencers this week, dubbed the NovaSeq X Series, designed to parse DNA strings 2.5 times faster than previous models. Fully supplied, a single machine could generate data on more than 20,000 whole genomes per year.”

Today's News and Commentary

About pharma

FDA approves first ALS drug in 5 years after pleas from patients “The newly approved therapy, which will be sold under the brand name Relyvrio, is designed to slow the disease by protecting nerve cells in the brain and spinal cord destroyed by ALS — amyotrophic lateral sclerosis.” 

 FDA blasts Chinese drug ingredients outfit for subpar impurity testing and poor equipment hygiene The FDA has scolded Zhejiang Tianyu Pharmaceutical in the wake of an inspection at the company’s plant in the Chinese province of Zhejiang between Feb. 28 and March 4, 2022. In FDA’s warning letter, dated Aug. 17, the regulator laid out a laundry list of complaints tied to lapses in Tianyu’s active pharmaceutical ingredient (API) production, which the company failed to amply address in its response to an earlier Form 483.
Making matters worse, the FDA raised similar concerns more than three years back. Now, it’s urging Tianyu to summon outside help to get its manufacturing operations in order.  
Up top, the FDA critiqued Tianyu’s investigation into impurities found in an unnamed drug ingredient.”
Recall most APIs come from China and India.

SK Capital buys generics producer Apotex, troubled since the murder of founder Barry Sherman “Private investment firm SK Capital has bought the Toronto-based, family-owned company. Terms of the sale for Canada’s largest producer of generic drugs were not disclosed. In 2019, when the company hired a financial advisor to review its options, Apotex was said to be worth up to $3 billion.”

The 340B Drama Continues “The American Hospital Association and others brought suit against HHS for its 2018 outpatient drugs reimbursement policy for 340B hospitals. Prior to 2018, CMS paid all hospitals (i.e., 340B hospitals and non-340B hospitals) Average Sale Price (ASP) + 6% for outpatient drugs. In 2018, the Trump administration reduced the reimbursement rate to 340B hospitals to ASP – 22.5% to account for the average minimum 340B discount these hospitals receive from manufacturers. The Supreme Court found these cuts to be illegal because, under the statute’s plain language, CMS must conduct a survey of acquisition costs prior to establishing varying payment amounts among hospitals. There is, however, still an open question as to remedy, which the Supreme Court did not address.”

About the public’s health

 White House reveals $8B in private sector spending to fight hunger with focus on nutrition and chronic illness “The White House announced today more than $8 billion in commitments to the "food is medicine" movement linking nutrition and chronic illness.
The announcement coincided with the White House Conference on Hunger, Nutrition, and Health, held for the first time in more than 50 years. After a call to action this summer, over 100 private and public sector contributors offered funds and services to catalyze healthcare delivery in addressing health equity.
Of the committed funds, $2.5 billion will be invested in startup companies addressing food and nutrition insecurity, and $4 billion will be directed toward initiatives improving access to nutritious food and philanthropy promoting healthy choices and increasing physical activity.”

The FDA announces a new definition of what’s ‘healthy’ “The Food and Drug Administration announced new rules Wednesday for nutrition labels that can go on the front of food packages to indicate that they are ‘healthy.’
Under the proposal, manufacturers can label their products ‘healthy’ if they contain a meaningful amount of food from at least one of the food groups or subgroups (such as fruit, vegetable or dairy) recommended by the dietary guidelines. They must also adhere to specific limits for certain nutrients, such as saturated fat, sodium and added sugars. For example, a cereal would need to contain three-quarters of an ounce of whole grains and no more than 1 gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars per serving for a food manufacturer to use the word ‘healthy’ on the label.
The labels are aimed at helping consumers more easily navigate nutrition labels and make better choices at the grocery store. The proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans, the FDA said.”

 USPSTF Advises to Keep Screening for Syphilis as Cases Soar “Nonpregnant teens and adults who have ever been sexually active and are at increased risk for syphilis should still be screened for the sexually transmitted infection, the U.S. Preventive Services Task Force (USPSTF) said on Tuesday.
The final recommendations garnered an "A" grade, and are firmly in line with the draft guidance posted earlier this year and the Task Force's 2016 recommendation on the matter, according to Carol Mangione, MD, MSPH, of the University of California Los Angeles, and other members of the USPSTF. (Pregnant women should continue to follow separate recommendations for syphilis screening most recently released in 2018.)

About healthcare IT

 CHIME Leads Request for HHS to Delay Information Blocking Deadline “The College of Healthcare Information Management Executives (CHIME) and nine other healthcare industry groups have called on HHS to postpone the approaching information blocking compliance deadline, which is set to go into effect on October 6, 2022.
The Cures Act Final Rule, commonly known as the Information Blocking Final Rule, published by ONC in May of 2020, was passed to prevent information blocking practices by providers, health IT developers, health information exchanges (HIEs), and health information networks.
When the Cures Act Final Rule was published, the scope of electronic health information (EHI) was limited to the United States Core Data for Interoperability (USCDI) version 1, which includes information such as clinical notes. 
Anticipating an October 6, 2022, start date, the definition of EHI will expand well beyond the current USCDI version 1, and stakeholders will be expected to share all EHI. Notably, EHI will now include unstructured data.”

Your Clinical Decision Support Software: Is It a Medical Device? If you are currently or, in the future, may be involved in IT healthcare applications this FDA document is a must-read. 

About health technology

 Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes “In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level.”

Today's News and Commentary

About Covid-19

CDC no longer recommends universal masking in health facilities “The Centers for Disease Control and Prevention no longer recommends universal masking in health care settings, unless the facilities are in areas of high COVID-19 transmission.
The agency quietly issued the updates as part of an overhaul to its infection control guidance for health workers published late Friday afternoon. It marks a major departure from the agency’s previous recommendation for universal masking.”

We wear 'black robes, not white coats': Court overturns ruling compelling UPMC to give ivermectin “A Pennsylvania appeals court on Sept. 22 overturned an injunction that required a Pittsburgh-based UPMC hospital to administer ivermectin to a COVID-19 patient, court documents show. 
In January, a county court issued a preliminary injunction, directing UPMC Harrisburg (Pa.) to allow two physicians — who were not credentialed at the hospital — to give a critically ill COVID-19 patient ivermectin at the request of his power of attorney. UPMC appealed the ruling, and the patient, who was in intensive care, died in February before the issue was resolved. 
In its ruling, the appeals court rebuked the lower court for the injunction, saying courts do not have the legal authority to compel a healthcare organization to administer a treatment contrary to physicians' professional judgment and outside the standard of care.”

HHS to pay for 60K doses of Eli Lilly's COVID-19 drug following its commercialization “The federal government said Sept. 23 that it will cover the cost for 60,000 doses of bebtelovimab, Eli Lilly's COVID-19 antibody drug. The news comes about a month after the drugmaker started selling the treatment commercially for $2,000 per dose.
The initiative is intended to help uninsured and underinsured patients, as health systems and hospitals that bought bebtelovimab can now have HHS replace the dose for free for eligible patients, according to the department.”

Coronavirus (COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types “The updated policy describes the FDA’s intent to review only a small subset of new emergency use authorization (EUA) requests for diagnostic tests and encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways.”

About health insurance/insurers

Strengthen States’ Oversight of Medicaid Managed Care Plans’ Reporting of Medical Loss Ratios From the HHS OIG: “States reported that most Medicaid managed care plans submitted MLR reports as required. However, we found that 49 percent of the 495 MLR reports reviewed were incomplete. These incomplete MLR reports were missing at least one of seven numeric data elements that are essential to the MLR calculation. This missing data occurred across four of the seven MLR report data elements—non-claims costs; taxes and fees; member months; and quality-improvement activity expenses. Two-thirds of the incomplete MLR reports did not contain fields for plans to even enter amounts for at least one of these data elements.
The data element for non-claims costs, generally defined as plans’ expenses for administrative services, accounted for the majority of incomplete MLR reports.”
Read the report for proposed solutions.

 Medicare Part B premiums to decrease for the first time in over a decade “The Centers for Medicare & Medicaid Services (CMS) announced that Medicare Part B premiums would be lowered by three percent, or $5.20, going from $170.10 a month to $164.90. The program’s annual deductible will also fall by $7, from $233 to $226…”
However, it is not a true decrease because:
”In 2022, Medicare Part B premiums rose by 14.5 percent, one of the largest annual increases ever seen in the program’s history. A major factor in this increase was the inclusion of Aduhelm, the first Alzheimer’s medication approved by the Food and Drug Administration in 20 years.
The drug was highly scrutinized due to questions regarding its efficacy in treating Alzheimer’s disease as well as its sky-high price. Aduhelm initially cost $56,000 before its manufacturer Biogen announced it was halving the price to $28,200.”

 OIG finds fewer Medicare improper payments to acute care hospitals in latest audit “Acute care hospitals generated $39.3 million in Medicare Part B improper payments over four years but faced a steep drop after the federal government implemented new tools to root out such errors.”

Review Identifies “Noteworthy” Differences in Effects on Patients of Traditional Medicare vs Medicare Advantage Well-worth reading to understand the quality and cost differences between the plans.

About hospitals and healthcare systems

THE ECONOMIC AND SOCIAL BENEFITS OF PHYSICIAN-LED HOSPITALS A good in-depth monograph on the topic.

CommonSpirit Health weathers $1.85B net loss in fiscal 2022, eyes dual challenges of staffing and inflation “The Catholic healthcare giant said Friday it saw a nearly $1.3 billion operating loss (-3.8% operating margin) and a $1.85 billion net loss across the full year. During the previous fiscal year, it had brought in almost $1 billion in operating income (3% operating margin) and experienced a $5.45 billion net gain….
Similar to other systems, CommonSpirit’s $551 million nonoperating loss was fueled by dicey investment markets. The organization reported a $971 million net loss attributed to its investments, a contrast to the $3.4 billion it enjoyed during last year’s swelling markets.”
Additionally, CommonSpirit has received $1.6 billion in CARES Act grants as of June 30, most of which were awarded in 2020 and 2021.

About pharma

Mark Cuban's pharmacy on track to make profit in 2023 Mark Cuban's pharmacy, Cost Plus Drugs, is expected to be profitable in 2023, Forbes reported Sept. 26.
Mr. Cuban says the company has more than a million customers with roughly a 10 percent growth rate each week. Although no official revenue reports have been released, Forbes estimates Cost Plus has made at least $25 million in sales during the first nine months.”

 Experimental Alzheimer’s drug slows cognitive decline in trial, firms say “An experimental Alzheimer’s drug slowed cognitive and functional decline by 27 percent in a closely watched clinical trial, the sponsors of the medication said Tuesday, increasing the therapy’s chance for approval as soon as early next year.
Japanese drugmaker Eisai and its American partner, Biogen, in a news release said the slowing of deterioration, compared with a placebo, was “highly statistically significant.” They said the drug, called lecanemab, had met the primary and secondary goals of the 18-month late-stage study. The trial results have not undergone peer review.

Biogen finalizes $900M deal to settle whistleblower’s long-running MS kickback suit “Biogen has finalized an agreement to pay $900 million to resolve a lawsuit in which a former employee alleged that the Massachusetts biotech paid kickbacks to doctors over a five-year span starting in 2009 to boost sales of its multiple sclerosis drugs, the Department of Justice said Monday. Biogen in July said it had reached the $900 million deal in principle.”

 Association of Research and Development Investments With Treatment Costs for New Drugs Approved From 2009 to 2018 “In this cross-sectional study of 60 new therapeutic agents approved by the US Food and Drug Administration from 2009 to 2018, there was no association between estimated research and development investments and treatment costs based on list prices at the launch of the product or based on net prices a year after launch.”

About the public’s health

Opioid-Reversal Drug Access to Ease Under Relaxed FDA Rules Harm reduction programs distributing the opioid-reversal drug naloxone are exempt from certain federal product tracing requirements in an effort to better expand supply, the FDA said Thursday. 
The Food and Drug Administration said in guidance that it won’t enforce certain Drug Supply Chain Security Act requirements on programs distributing FDA-approved naloxone to underserved communities while an opioid public health emergency declaration is in place.

About healthcare IT

 Comparison of Quality Performance Measures for Patients Receiving In-Person vs Telemedicine Primary Care in a Large Integrated Health System “In this cohort study of 526 874 patients, telemedicine exposure was associated with significantly better performance or no difference in 13 of 16 comparisons, mostly in testing-based and counseling-based quality measures. Patients with office-only visits had modestly better performance in 3 of 5 medication-based quality measures.” 

Public Health Emergencies: Data Management Challenges Impact National Response From the GAO: “Longstanding challenges in the federal government’s management of public health data undermine the nation’s ability to quickly respond to public health emergencies like COVID-19 and monkeypox. These challenges include the lack of:

  • common data standards—requirements for public health entitles to collect certain data elements, such as patient characteristics (e.g., name, sex, and race) and clinical information (e.g., diagnosis and test results) in a specific way;

  • interoperability—the ability of data collection systems to exchange information with and process information from other systems; and

  • public health IT infrastructure—the computer software, hardware, networks, and policies that enable public health entities to report and retrieve data and information.”

    See the report for recommendations.

Today's News and Commentary

About Covid-19

 U.S. CDC expects Omicron COVID boosters for kids by mid-October “The U.S. Centers for Disease Control and Prevention expects COVID-19 vaccine boosters targeting circulating variants of the virus to be available for children aged 5-11 years by mid-October.
The CDC said in a document released on Tuesday that it expects to make a recommendation in early- to mid-October on the use of the new bivalent vaccines in the group, if they are authorized by the U.S. Food and Drug Administration (FDA).”

Pfizer to Supply Global Fund Up to 6 Million PAXLOVID™ Treatment Courses for Low-and-Middle-Income Countries “Treatment courses will be available for procurement by 132 Global Fund-eligible low-and-middle-income countries in all regions of the world beginning in 2022, subject to local regulatory approval or authorization.”

FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing From the HHS OIG: “FDA's decision to accept all EUA requests resulted in a record number of submissions-often low-quality and from developers lacking experience with FDA's processes. In response, FDA took steps to support developers and ease its workload, which included issuing EUA guidance, updating templates (submission guides for developers requesting EUA), and adjusting its EUA review process, among others. Some developers still reported being frustrated and confused.”
See the report for recommendations to correct the problems.

About health insurance/insurers

 Impending changes to the methodology used to calculate Medicare Advantage Star ratings could make it difficult for highly rated plans to retain those ratings in 2023 and 2024 A good review of the changes Medicare is making to its Star system.

About hospitals and healthcare systems

 Biden vows to crack down on poorest-performing nursing homes “The White House on Monday announced plans to boost nursing home staffing and oversight, blaming some of the 200,000-plus covid deaths of nursing home residents and staff during the pandemic on inadequate conditions.
Officials said the plan would set minimum staffing levels, reduce the use of shared rooms and crack down on the poorest-performing nursing homes to reduce the risk of residents contracting infectious diseases. The White House also said it planned to scrutinize the role of private equity firms, citing data that their ownership was linked with worse outcomes and higher costs.”

About pharma

 Aetna: Aduhelm is medically necessary “The payer will require pre-authorization for all providers and members covered under plans where the new policy applies.
Under the new policy, the drug must also be prescribed by or in consultation with a gerontologist, neurologist, psychiatrist or neuropsychiatrist.
The move follows CMS' decision in April to only cover Aduhelm for Medicare members participating in clinical trials. In May, UnitedHealthcare deemed it "unproven and not medically necessary" and said it would only cover the drug for members in clinical trials who have received prior authorization.”

About the public’s health

 AACR CANCER PROGRESS REPORT 2022 An excellent update of the progress in cancer research and treatment.

Most Global Deaths Are From Preventable Noncommunicable Diseases “A new global report by the World Health Organization finds noncommunicable diseases now outnumber infectious diseases as the top killers globally. Each year, it says 17 million people under age 70 die prematurely from noncommunicable diseases or NCD. The biggest killers are cardiovascular diseases, followed by cancers, chronic respiratory diseases, and diabetes.”

About healthcare IT

 Receipt of Out-of-State Telemedicine Visits Among Medicare Beneficiaries During the COVID-19 Pandemic “ In this cross-sectional study of telemedicine visits in the first half of 2021 among patients with Medicare, 422 547 patients had an out-of-state telemedicine visit; these visits were most common among those who lived near a state border and were largely for primary care and mental health treatment. In 62.6% of all out-of-state visits, a prior in-person visit occurred between the same patient and clinician.
Meaning  Limitations on out-of-state telemedicine care may disrupt many existing patient-clinician relationships in primary care and mental health treatment.”

Exploring EHR Satisfaction by Provider Specialty “Physicians and advanced practice providers who are very satisfied with the EHR are almost five times more likely to report plans to stay at their organization, compared to peers who are very dissatisfied…” See the chart for data by specialty.

Today's News and Commentary

About Covid-19

U.S. delivers over 25 mln COVID boosters; Moderna's shot in limited supply “The United States government has sent out over 25 million of the updated COVID-19 booster shots, mostly from Pfizer/BioNTech, as production of the Moderna shot continues to ramp up, a federal health agency said on Tuesday.
Some U.S. pharmacies like CVS Health and Walgreens Boots Alliance also reported on Tuesday that government supply of Moderna’s updated shot remains limited, causing appointments for the product to vary across the country.
Both CVS and Walgreens said they are working with the government to acquire more Moderna doses and have not seen any supply issues for the Pfizer/BioNTech booster.”

Safety of COVID-19 vaccine challenge in patients with immediate adverse reactions to prior doses: A multi-centre cohort study “Severe immediate adverse events following immunization (AEFI) with COVID-19 vaccines have been reported in up to 2.5 per 10,000 vaccinations…
In this cohort study of patients reporting immediate AEFI post-COVID vaccination, 61.2% of the 116 had negative vaccine challenge with a further 34.4% developing mild, subjective symptoms post-vaccination. Thus, 95.6% of the cohort were able to be re-vaccinated safely with 4.3% developing objective signs of a possible immune AEFI, consistent with international experience.”

2 omicron offshoots to keep an eye on “While BA.5 is still the nation's dominant strain, its prevalence has fallen over the past two weeks, according to the CDC's latest estimates
The subvariant now accounts for 84.8 percent of all U.S. COVID-19 cases — down slightly from 86 percent a week prior, according to estimates for the week ending Sept. 17. 
At the same time, the proportion of other omicron offshoots is rising…”

About health insurance/insurers

 OIG: Medicare Part B overpaid critical access hospitals and docs for same services “Medicare paid critical access hospitals and providers more than $1 million for duplicate claims in 2019, according to a federal watchdog that called for reforms to detect such errors.
The Department of Health and Human Services’ Office of Inspector General’s (OIG's) report, released Tuesday, called for the Centers for Medicare & Medicaid Services (CMS) to create post-payment reviews of claims.”

Doctor, hospital lobbies move to dismiss lawsuit over surprise billing ban “The American Medical Association and the American Hospital Association are seeking to dismiss their own lawsuit against the federal government over its implementation of The No Surprises Act.
The two lobbying groups filed a motion on Tuesday in federal court seeking to dismiss their claims, along with co-plaintiffs Renown Health, UMass Memorial Health Care and physicians Stuart Squires and Victor Kubit. The motion comes before a status hearing Wednesday.
The groups filed suit over the interim file rule, which was released last year.”

About pharma

 Walgreens to acquire remaining stake in Shields Health for $1.37B, announces exec moves “Walgreens Boots Alliance on Tuesday said it will buy the remaining stake in specialty pharmacy company Shields Health Solutions for approximately $1.37 billion.
Walgreens last year spent $970 million to increase its stake in the company to 71%, according to Reuters, with the possibility of taking full ownership over the pharmacy company.
The transaction is expected to be completed by the end of the year.”

In Zantac litigation at state level, drugmakers face claims for cancer types not covered in federal action “Multidistrict litigation is looming for several pharma companies—including GSK, Sanofi, Pfizer, Boehringer Ingelheim and Thermo Fisher—that manufactured and marketed Zantac. The federal litigation targets five types of cancers allegedly caused by consumption of the heartburn medicine.
But now, in state-level litigation, plaintiffs who used Zantac are filing lawsuits that cover other types of cancers, ramping up the concern for the companies already faced with the daunting task of defending themselves in federal court.
In the multidistrict litigation, plaintiffs originally identified 10 cancer types. But that list was pared to five types—bladder, esophageal, gastrointestinal, liver and pancreatic. Many of those who were pared from the multidistrict litigation—including plaintiffs with breast, kidney, colorectal, prostate and lung cancers—are now pursuing their cases in state courts…
 Two years ago, Zantac was pulled from the market when it was linked to unacceptable levels of N-nitrosodimethylamine, a potential cancer-causing agent, sparking a wave of litigation.”

The Inflation Reduction Act aims to lower drug costs — but here’s how Big Pharma could get around it “The Inflation Reduction Act is set to lower drug prices for millions of people in the U.S. — but experts fear pharmaceutical companies could exploit loopholes in the bill, ultimately keeping prescription costs high for many.

The law takes aim at insulin costs, caps out-of-pocket spending for Medicare beneficiaries, and allows the federal government to negotiate prices on the costliest prescription drugs. It also will require drugmakers to pay a rebate to Medicare if they raise prices too sharply.
These provisions won’t be implemented all at once.  Instead, they’ll go into effect gradually over the next several years, beginning with insulin price caps and rebates in 2023, out-of-pocket caps in 2025, and finally drug negotiations in 2026.
Because of the four-year gap before the law is fully implemented, policy and legal experts fear that pharmaceutical companies may have ample time to go on the offense and — if they don’t try to get the law thrown out in court — figure out ways to sidestep provisions that affect their ability to maintain their high profits.”

Current and Resolved Drug Shortages and Discontinuations Reported to FDA Some examples: Cefazolin Injection, Dextrose injections (several concentrations), Diltiazem injection, Furosemide injection, and 119 more.

Today's News and Commentary

About health insurance/insurers

 The US Medicaid ProgramCoverage, Financing, Reforms, and Implications for Health Equity A really good summary of the Medicaid system. Highlights: In 2022, Medicaid insured approximately 80.6 million individuals (56.4% from racial and ethnic minority groups in 2019). In 2020, estimated Medicaid spending was $671.2 billion (16.3% of total US health spending). The proportion of beneficiaries enrolled in Medicaid managed care was 69.5% in 2019, 45 states have pursued 139 Medicaid delivery system reforms from 2003 to 2019, and 38 states and Washington, DC, have expanded Medicaid under the Affordable Care Act. Racial and ethnic health disparities are common within Medicaid, and evidence on the association of Medicaid policies and reforms with achieving racial health equity remains limited.”
The Medicare Financing Conundrum An excellent analysis of the Medicare funding problem from the Urban Institute. Some conclusions:
”Although creating a new dedicated financing source could close a given Medicare financing shortfall, it is hard to match future growth in Medicare spending needs exactly with growth in a particular financing source.

It is easier to enact reforms consistent with the goals of tax or budget policy through general revenue financing than through dedicated financing.

Dedicated financing via a trust fund can work when it covers all costs and imposes budgetary rigor on matching spending and receipts, but the HI trust fund is not set up to work that way.

Broadening the base of an existing dedicated tax, such as subjecting employer-sponsored health insurance to the HI payroll tax, would follow the tax policy principle of horizontal equity without necessarily adding to the complex array of Medicare financing sources.

Addressing HI and SMI financing issues together would help confront longer-term Medicare financial challenges and allow fairer and more efficient financing and spending trade-offs to be made within HI, SMI, and the broader tax system.”

Centene to Pay $166 Million to Texas in Medicaid Drug Pricing Settlement “Health insurance giant Centene Corp. has agreed to pay $165.6 million to Texas to resolve claims that it overcharged the state’s Medicaid program for pharmacy services.
It’s the biggest known payout by the nation’s largest Medicaid insurer over its drug pricing practices. The deal was signed July 11 but hadn’t been publicly announced until Monday after KHN obtained a copy of the settlement through a Texas public records request and began asking questions.
The agreement makes Texas at least the 12th state to settle pharmacy billing claims with St. Louis-based Centene.”

About hospitals and healthcare systems

 Ascension Health closes 2022 with $1.8B loss, -3.1% operating margin “Ascension Health closed its 2022 fiscal year with an $879.1 million operating loss and net loss of more than $1.8 billion, according to investor disclosures for the period ended June 30.
A nearly $2.1 billion rise in operating expenses and $1.2 billion in net losses from investments drove the 144-hospital system’s poor performance, according to the financial documents.
The losses are a turnaround from the previous year’s $676 million operating income and almost $5.7 billion net gain.”

About pharma

 A $3M gene therapy: Bluebird bio breaks its own pricing record with FDA approval of Skysona “On the heels of an FDA go-ahead for gene therapy Zynteglo, bluebird bio has won an FDA accelerated approval for Skysona, or eli-cel, for the rare neurological disorder cerebral adrenoleukodystrophy (CALD), the company said Friday. The company is charging $3 million per treatment with Skysona, higher than Zynteglo’s $2.8 million, making it the priciest therapy in the world.”

About the public’s health

 Association of improved air quality with lower dementia risk in older women “In this study on a geographically diverse cohort of US community-dwelling older women, we found that long-term improvement in ambient air quality in late life was associated with reduced dementia risk. The associations did not significantly differ by age, education, geographic region, Apolipoprotein E e4 genotypes, or cardiovascular risk factors. These findings strengthen the causal association between late-life exposure to air pollution and dementia risk.”

In a first, health panel calls for routine anxiety screening in adults “In a nod to the nation’s pressing mental health crisis, an influential group of medical experts for the first time is recommending that adults under age 65 get screened for anxiety.
The draft recommendations, from the U.S. Preventive Services Task Force, are designed to help primary care clinicians identify early signs of anxiety during routine care, using questionnaires and other screening tools.”