Today's News and Commentary

About Covid-19

 Biden says ‘pandemic is over’ “President Biden declared the coronavirus pandemic ‘over,’ in apparently off-the-cuff remarks that reflect the growing sentiment that the threat of the virus has receded, even as hundreds of Americans continue to die of covid each day.
’We still have a problem with covid,’ Biden said on ‘60 Minutes,’ which aired Sunday night. ‘We’re still doing a lot of work on it … but the pandemic is over.’”

About health insurance/insurers

UnitedHealth Beats Class Suit Over Office Surgery Facility Fees “UnitedHealth Group. Inc. defeated a class action by more than 200 doctors who say they weren’t paid facility fees for office-based surgeries, when a New York federal judge ruled that the insurer used reasonable payment systems and followed ERISA plan terms.
“[Judge] Oetken’s ruling, issued after a five-day nonjury trial, also blessed UnitedHealth’s ‘C Flag process,’ which internally flags physician offices submitting claims for facility fees and sends these offices a letter inviting them to submit proof of facility licensure. This was a ‘reasonable way to ensure that benefits are administered consistent with plan terms,’ he said.”

Humana raises profit outlook as it looks to regain footing in Medicare Advantage market “Humana is bullish on future growth in Medicare Advantage (MA), its main line of business, in 2023 to bounce back from lackluster performance this year.
The insurer also raised its profit outlook for 2022, sending its shares up some 8% since the news Thursday.
The company projected it will grow its adjusted profits at a 14% annual rate over the next three years, executives told investors.”

Humana looks to buy clinics from PE partner for up to $550M “Humana expects to pay between $450 million and $550 million to acquire the first group of senior-focused primary care centers that it developed through a joint venture with Welsh, Carson, Anderson & Stowe, Chief Financial Officer Susan Diamond said Friday during the insurer’s investor day.

  • The agreement inked with Welsh Carson in 2020 included options for Humana to acquire the private equity firm’s interest in the joint venture in stages over the next five to 10 years. The venture was expected to open 67 clinics by early 2023. “We are planning for the full acquisition of centers built in partnership with Welsh Carson through our put and call options beginning in 2025,” Diamond said.

  • In mid-May, Humana and Welsh Carson announced a second joint venture that will spend up to $1.2 billion to open about 100 new value-based primary care clinics for Medicare patients between 2023 and 2025 under the CenterWell Senior Primary Care brand.”

 Beneficiary Experience, Affordability, Utilization, and Quality in Medicare Advantage and Traditional Medicare: A Review of the Literature “We found few differences between Medicare Advantage and traditional Medicare that are supported by strong evidence or have been replicated across multiple studies. Both Medicare Advantage and traditional Medicare beneficiaries reported similar rates of satisfaction with their care and overall measures of care coordination. Medicare Advantage outperformed traditional Medicare on some measures, such as use of preventive services, having a usual source of care, and lower hospital readmission rates. However, traditional Medicare outperformed Medicare Advantage on other measures, such as receiving care in the highest-rated hospitals for cancer care or in the highest-quality skilled nursing facilities and home health agencies. Additionally, a somewhat smaller share of traditional Medicare beneficiaries than Medicare Advantage enrollees experienced a cost-related problem, mainly due to lower rates of cost-related problems among traditional Medicare beneficiaries with supplemental coverage. Several studies found lower use of post-acute care among Medicare Advantage enrollees but were inconclusive as to whether that was associated with better or worse outcomes. Findings related to the use of other health care services, including hospital care and prescription drugs, and condition-specific quality of care measures varied – likely due to differences in data and methodology across studies.”

Medicare is using one of its biggest hammers to try to fix the dialysis system: how providers are paid “The new End-Stage Renal Disease Treatment Choices (ETC) model is the largest such experiment in the history of American health care, signaling to some a more aggressive federal approach to improving dialysis. This program, unlike previous voluntary ones, mandates about 30% of dialysis providers in the country participate, and the other 70% are used as a control group…
The ETC model is a two-part incentive system on top of the existing payment system. The first incentives, which rolled out in 2021, were focused on increasing home dialysis use exclusively — centers got a boost in payments for home dialysis use relative to in-center dialysis. The second part of the incentive is payment increases or decreases depending on how dialysis facilities perform in home dialysis, waitlisting patients for organ transplant, and living donor kidney transplantation rates, relative to control facilities…
The ETC model is slated to run through the middle of 2026. After that, it’s up to Medicare to decide whether the program continues or not.”

UnitedHealth beats Justice Dept on $13 billion merger “UnitedHealth Group's $13 billion acquisition of Change Healthcare will proceed, after a federal judge on Monday denied the Justice Department's efforts to block the deal on antitrust grounds.”

About hospitals and healthcare systems

 The Current State of Hospital Finances: Fall 2022 Update Highlights:

  1. “Margins remain depressed relative to pre-pandemic levels. After a difficult first half of 2022, optimistic projections for the rest of the year indicate margins will be down 37% relative to pre-pandemic levels.

  2. More than half of hospitals are projected to have negative margins through 2022. Projections for the remainder of the year demonstrate an increase in hospitals with negative margins relative to pre-pandemic levels, to 53%.

  3. Expenses are significantly elevated from pre-pandemic levels. Expenses are projected to increase throughout the rest of 2022, leading to an increase of nearly $135 billion over 2021 levels. Labor expenses are projected to increase by $86 billion, while non-labor expenses are projected to increase by $49 billion.

  4. Hospitals have faced a profound financial toll. Hospitals have incurred serious losses in 2022 relative to pre-pandemic levels and future federal support is uncertain.”

NCQA Unveils 2022 Health Plan Ratings FYI: “The 2022 Health Plan Ratings are based on data from calendar year 2021, when 203 million people were enrolled in health plans that reported Healthcare Effectiveness Data and Information Set (HEDIS®) results to NCQA. Plans are rated on a 0–5 stars scale. Six out of 1,048 health plans that earned a numerical rating achieved 5 stars—the highest possible rating.”

Social Risk Adjustment In The Hospital Readmissions Reduction Program: A Systematic Review And Implications For Policy “These findings support the use of social risk adjustment to improve provider payment equity and highlight opportunities to enhance social risk adjustment in value-based payment programs.”

About pharma

Curbing patent abuse: Tackling the root of the drug pricing crisis Highlights:
■ “On average, there are 74 granted patents on each of America’s ten top selling drugs, providing major drugmakers substantial advantage to keep generic and biosimilar competitors off the market.
■ Drugmakers filed more than 140 patent applications on average per drug; on average 66% of patent applications were filed after the FDA approved the drug to be on the market.
■ Nearly one-third of Revlimid’s cumulative sales in the U.S. have occurred after its primary patents expired, and over two-thirds of Humira’s U.S. sales have come after the expiration of its primary patents.
■ On average, four times as many patents are granted on the top ten drugs in the U.S. compared to Europe.
■ Lower-cost generic and biosimilar versions of three top selling drugs - Humira, Eliquis, and Enbrel - launched in Europe an average of 7.7 years earlier than their expected U.S. entry. During this time, without generic or biosimilar competition Americans will spend an estimated $167 Billion on branded versions of just these three drugs. To date, these drugs still do not have generic or biosimilar competition in the U.S.”

 McKesson to acquire private pharmacy tech company “Pharmaceutical and medical supply company McKesson signed an agreement Sept. 19 to acquire Rx Savings Solutions, a tech insights business that aims to lower drug costs, for up to $875 million.”

About health technology

FDA slaps Class I tag on Baxter recall of Clearlink chemotherapy delivery sets “After uncovering a handful of patient safety and cybersecurity risks in many of its infusion pumps over the last year, Baxter has now begun a recall of yet another product that works alongside those pumps.
The medtech giant’s latest recall concerns some of its solution sets, also known as IV sets, which connect patients to their prescribed IV bags and bottles of medications. It’s specifically focused on the Clearlink Basic Solution Sets with Duovent, a drug that’s used to open the airways.
According to Baxter, which first issued the recall notice (PDF) in early August, the company has received an increased number of reports of leaks in the Clearlink IV sets. As of this week, the FDA has categorized the recall as Class I, indicating a high risk of patient injury or death.”

About healthcare finance

AmerisourceBergen (ABC) to Buy Germany's PharmaLex for $1.3B “AmerisourceBergen Corporation announced that it has signed a definitive agreement to acquire Germany-based PharmaLex Holding GmbH for €1.28 billion (approximately $1.3 billion) in cash.
PharmaLex is a leading provider of specialized services for the life sciences industry that is owned by funds advised by AUCTUS Capital Partners AG. The company consists of a global team of scientific, regulatory, and safety and compliance experts who provide strategic guidance and regulatory support to biopharma companies throughout a product’s lifecycle.”

Today's News and Commentary

About Covid-19

End of COVID pandemic is 'in sight' -WHO chief “The world has never been in a better position to end the COVID-19 pandemic, the head of the World Health Organization said on Wednesday, his most optimistic outlook yet on the years-long health crisis which has killed over six million people.
‘We are not there yet. But the end is in sight,’ WHO Director-General Tedros Adhanom Ghebreyesus told reporters at a virtual press conference.”

About health insurance/insurers

 Lowell Nurse Pleads Guilty in $100 Million Home Health Care Fraud and Kickback Scheme “According to the indictment, from January 2013 to January 2017, Newton was part owner and operator of Arbor Homecare Services LLC. Waruru was a Licensed Practical Nurse employed as a home health nurse at Arbor. Waruru and, allegedly, Newton engaged in a conspiracy to use Arbor to defraud MassHealth and Medicare of at least $100 million by committing health care fraud and paying kickbacks to induce referrals. Newton then allegedly laundered the ill-gotten gains.
Specifically, it is alleged that Arbor, through Newton and others, including Waruru, failed to train staff, billed for home health services that were never provided or were not medically necessary and billed for home health services that were not authorized. Arbor, through Newton and others, developed employment relationships as way to pay kickbacks for patient referrals, regardless of medical necessity requirements. They also allegedly entered sham employment relationships with patients’ family members to provide home health aide services that were not medically necessary and routinely billed for fictitious visits that did not occur. As alleged in the civil complaint, Newton either directly or through Arbor, targeted particularly vulnerable patients who were low-income, on disability and/or suffering from depression and/or addiction.”

About hospitals and healthcare systems

 World's Best Smart Hospitals 2023 and World's Best Specialized Hospitals 2023 Both from Newsweek, FYI.

 About healthcare quality

Joint Commission Official Statement on Standards Review Tuesday “we announced the beginning of a review of all Joint Commission ‘above-and-beyond’ requirements, those that go beyond the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (CoPs) and are not on crosswalks to the CoPs.
During the COVID-19 public health emergency (PHE), CMS put many requirements on hold. As the PHE nears its end, CMS has been reviewing the waived requirements to determine whether some should be permanently retired. The Joint Commission will similarly address the necessity of our own unique requirements. 
Specifically, we will review each requirement to answer:

  • Does the requirement still address an important quality and safety issue?

  • Is the requirement redundant?

  • Are the time and resources needed to comply with the requirement commensurate with the estimated benefit to patient care and health outcomes?

In addition to a direct review of each requirement, we will conduct quantitative analyses of scoring patterns and tests for redundancy. Where necessary, we also will conduct literature and field reviews and engage experts within the field.”

About pharma

 Novartis headquarters raided in Swiss competition authority's patent probe “The Swiss Competition Commission (COMCO) said it has opened an investigation into an unnamed pharma company about possible unlawful use of a patent to stymie competition. As part of the probe, the agency conducted an early morning raid of the company’s offices on Tuesday, the agency said Thursday.
Novartis then identified itself as the target in its own statement Thursday…
The exact drug under question remains unknown. Among Novartis’ offerings, the one skin drug that might come close to a dominant status is psoriasis treatment Cosentyx.”

About the public’s health

 Biden admin officials worried about potential polio spread “The high-level meetings and the involvement of national security officials speak to the concern Biden officials have about the possible spread of a potentially deadly virus that until recently had not been recorded in the United States for decades.
New York has recorded one polio case but has found additional poliovirus samples in the state’s wastewater, prompting Gov. Kathy Hochul last week to declare a public health emergency.”

Today's News and Commentary

About Covid-19

HHS expected to renew COVID-19 PHE for 11th time “HHS is set to extend the COVID-19 public health emergency by its standing deadline of Oct. 13.
HHS last renewed the PHE July 15 for another increment of 90 days with a pledge to provide states with 60 days' notice if it decided to terminate the declaration or allow it to expire. Aug. 14, the date in which states would have 60 days' notice, came and went without updates or notifications from the agency, suggesting the declaration will extend.
If renewed on the deadline of Oct. 13, the next deadline would be Jan. 11, 2023…
For an overview of the flexibilities tied to the PHE and what occurs when the declaration ends, check out a comprehensive brief from Kaiser Family Foundation here.”

 Americans are moving on from COVID-19 despite acknowledged risks Some highlights of the survey:

  • The share of Americans who report being concerned about COVID-19 (57%) is among the lowest captured throughout the pandemic. Of those who are concerned, a plurality is more concerned about spreading the virus to people who are at higher risk of serious illness (28%) than for themselves, whether it’s developing long COVID (18%), being hospitalized (12%), or dying (11%).

  • Nearly two in three (65%) say there is a small risk or no risk in returning to their normal, pre-COVID life.

  • More Americans now say they already have returned to their normal, pre-COVID life (46%) than at any point during the pandemic.

  • Still, just 11% say there is no risk of them contracting COVID. 

  • The share of Americans that report occasionally or never wearing a mask outside their home has remained consistent since June (around 63%) but is significantly higher than during height of Omicron in mid-January 2022 (27%).

  • Nearly two in three (65%) support federal, state, and local governments lifting all COVID-19 restrictions.

  • Despite the program ending earlier this month, 83% support the federal government mailing free at-home COVID-19 tests to anyone who wants one.

  • Similarly, 87% support the federal government providing COVID-19 vaccines and treatments for free, regardless of health insurance status.”

About health insurance/insurers

Health Insurance Coverage in the United States: 2021-Current Population Reports From the US Census Bureau: Highlights:
--”More people were insured in 2021 than 2020. In 2021, 8.3 percent of people, or 27.2 million, did not have health insurance at any point during the year, representing a decrease in the uninsured rate and number of uninsured from 2020 (8.6 percent or 28.3 million).
--In 2021, private health insurance coverage continued to be more prevalent than public coverage, at 66.0 percent and 35.7 percent, respectively.
--Of the subtypes of health insurance coverage, employer- based insurance was the most common, covering 54.3 percent of the population for some or all of the calendar year, followed by Medicaid (18.9 percent), Medicare (18.4 percent), direct-purchase coverage (10.2 percent), TRICARE (2.5 percent), and VA and CHAMPVA coverage (1.0 per- cent).
--Overall, public coverage increased between 2020 and 2021. In 2021, 35.7 percent of people held public coverage for some or all of the year, marking a 1.2 percentage- point increase from 2020.
--Between 2020 and 2021, the rate of Medicaid coverage increased by 0.9 percentage points to cover 18.9 percent of people.
--The uninsured rate among children under the age of 19 decreased 0.6 percentage points to 5.0 percent between 2020 and 2021, driven in part by an increase in public coverage.
--In 2021, 7.9 percent of full- time, year-round workers had public health insurance, up 1.8 percentage points from 2020. Among less than full- time, year-round workers, the percentage with public coverage increased 1.6 percentage points to 22.6 percent during this period.”
This annual document is a great resource for health insurance information.

How State Surprise Billing Protections Increased ED Visits, 2007-2018: Potential Implications for the No Surprises Act Results: By analyzing 15 state-level bans, we find that the bans reduced spending per visit by 14% but spurred a demand response, an increase of 3 percentage points in ED visits, which wiped away the cost savings. Based on an ED severity index, these extra ED visits were 9% less urgent than prior to the bans.
Conclusions: We predict that the federal ban will result in $5.1 billion in savings but 3.5 million more ED visits at $4.2 billion in extra spending per year, largely negating expected savings. Health plans must be prepared to manage this spike in ED visits as the No Surprises Act takes effect.”

 Top 10 Accountable Care Organizations by Medicare Shared Savings  FYI

AMA, 2 state medical societies join class-action suit against Cigna “The American Medical Association (AMA) has joined a class-action lawsuit against Cigna, alleging the insurer underpaid for claims filed by providers in the contracted MultiPlan network.
MultiPlan is the country's largest third-party network, and Cigna contracts with it to access providers. According to the lawsuit, which was initially filed in June, Cigna reimbursed for claims from providers in MultiPlan's network at its non-participating providers rate rather than at the rate expected for a MultiPlan contract.
As such, the insurer ‘significantly underpaid claims, and put patients at risk of balance billing,’ the plaintiffs claim.”

The number of Americans with past-due medical bills is unchanged since 2015 “The report explores the relationship between past-due medical bills and demographics. Among the key findings:

  • Since 2015, the percentage of Americans who reported past-due medical bills has remained in the low 20% range, down from 26% in 2012.

  • Compared with other sources of debt, Americans were less likely to report that they had past-due medical bills.

  • Women were slightly more likely than men to report that they had past-due medical bills.

  • The likelihood of having past-due medical bills increased with age for younger adults but decreased with age for older adults.

  • Black adults were more likely than other race and ethnicity groups to report that they had past-due medical bills.

  • Adults with a high school degree or less were more likely than those with a college or graduate degree to report that they had past-due medical bills.

  • As income increased, the odds of having past-due medical bills decreased.

  • Health insurance and living in a Medicaid expansion state reduced the percentage of individuals reporting that they had past-due medical bills.

  • Past-due medical bills were highly correlated with a lower level of use of health care services.

  • Individuals with past-due medical bills were more likely than those without them to report several other financial challenges.”

About hospitals and healthcare systems

 Illinois delays Atrium, Advocate Aurora merger “The Illinois Health Facilities and Services Review Board voted Sept. 13 to postpone a vote on the change of ownership for 10 Advocate Aurora facilities in the state covered by the system's plan to merge with Charlotte, N.C.-based Atrium Health. 
Atrium and Advocate Aurora, dually headquartered in Milwaukee and Downers Grove, Ill., announced plans to merge into a 67-hospital system with upward of $27 billion in revenue in May.” 

About pharma

 Rebate walls may thwart biosimilar savings: Biosimilars of AbbVie's Humira are expected to reduce annual pharmaceutical expenditures by $5 billion, but they may be delayed by rebate strategies. “Several biosimilars for the world’s top-selling drug are slated to hit the market next year, but the potential billions of dollars in savings may not materialize until at least 2024. 
Humira, the rheumatoid arthritis and anti-inflammatory biologic that has netted AbbVie nearly $200 billion in sales, has benefited from nearly two decades of exclusivity, allowing the manufacturer to hike the price 470% since the drug was introduced. The monopoly will end with the introduction of several Food and Drug Administration-approved copycat versions slated to hit the market in 2023, and more are on the way. 
Humira’s biosimilars will save the healthcare system an estimated $5 billion or so a year, cutting costs for providers and patients. Biosimilars will likely be about half the price of Humira, which is $84,000 for a year of treatment. 
But AbbVie may manipulate the rebates associated with Humira to limit competition and the potential savings from lower-cost biosimilars.”

About healthcare IT

 Increased Mortality Rates Linked to Cyber-Attacks Against Healthcare Organizations “Cyber–attacks against healthcare organizations cause more than 20% to experience increased mortality rates, suggests new research by Proofpoint’s Ponemon Institute.
The report, which surveyed 641 healthcare IT and security practitioners, also found that 89% of them experienced an average of 43 attacks in the past 12 months, with more than 20% suffering one of the following types of attacks: cloud compromise, ransomware, supply chain, and phishing….
he most common consequences of these attacks were delayed procedures that resulted in poor patient outcomes for 57% of the healthcare providers and increased complications from medical procedures for roughly half of them.
The attack type most likely to negatively impact patient care was ransomware, leading to procedure or test delays in 64% of cases and longer patient stays (59%).”

Doximity expands access to telehealth service free of charge to thousands of clinics “Doximity, a digital platform for medical professionals, is expanding access to its telehealth service, Dialer Pro, to free medical clinics across the U.S. at no cost.
The telehealth platform is accessible to the purported 1,007 free clinics that offer medical care at zero cost to the patient. Such patients are estimated to total 1.8 million nationwide. The platform’s pilot program was utilized by 48 clinics and roughly 1,000 clinicians in various communities throughout the country.”
The question now is: Do these clinics’ patients have access to the hardware and software to access telemedicine?

About healthcare personnel

 2022 Survey of Physician Appointment Wait Times and Medicare and Medicaid Acceptance Rates “Average physician appointment wait times have increased significantly since the survey was last conducted in 2017 and first conducted in 2004. The average wait time for a physician appointment for the 15 large metro markets surveyed in 2022 is 26.0 days, up from is 24.1 days in 2017, an 8% increase, and up from 20.9 days in 2004, a 24% increase….
The average rate of physician Medicare acceptance is 82.4% for all 15 metropolitan areas, down from 84.5% in 2017, a decrease of 4%.
The average rate of physician Medicaid acceptance is 54.1% in all 15 metropolitan areas, up from 53% in 2017, an increase of 2%.”
See the study for specialty and location-specific data.

About health technology

Estimated Cost of Developing a Therapeutic Complex Medical Device in the US “In this economic evaluation study using data from public and proprietary sources, an analytical cost model found that the estimated mean expected capitalized development cost per therapeutic complex medical device was $522 million. The nonclinical development stage accounted for 85% of this cost, whereas the US Food and Drug Administration submission, review, and approval stage comprised 0.5%.”

 Baxter reportedly considering shedding dialysis businesses: Bloomberg “Following its blockbuster buy of medtech manufacturer Hillrom late last year, Baxter may now be preparing to trim some of the fat from its newly expanded product portfolio.
The devicemaker is said to be considering a sale of two units within its kidney care division, Bloomberg reports. Unnamed sources familiar with the considerations told the outlet that Baxter is working with advisers to explore the potential sale of its renal care services and hemodialysis divisions.”

Sony dives into nascent over-the-counter hearing aid market with WS Audiology partnership “The consumer electronics giant said it plans to provide a device that users can buy, fit and program themselves, without requiring a visit to a hearing specialist. Sony will work with the Denmark-based WS Audiology, and the development of their first product under the Sony brand is already underway, the companies disclosed in their announcement.
The FDA finalized its long-awaited regulatory rule in August to allow adults with mild to moderate hearing loss to purchase certain types of hearing aids online and in retail stores without a prescription—specifically air-conduction amplifiers that don’t require a surgical implant and can be worn in or behind the ear. The rule takes full effect in mid-October.”

“Human vs Machine” Validation of a Deep Learning Algorithm for Pediatric Middle Ear Infection Diagnosis “We compared the diagnostic performance of human clinicians with that of a neural network algorithm developed using a library of tympanic membrane images derived from children taken to the operating room with the intent of performing myringotomy and possible tube placement for recurrent acute otitis media (AOM) or otitis media with effusion (OME)…
Our model achieved a mean prediction accuracy of 80.8% (95% CI, 77.0%-84.6%). The Google model achieved a prediction accuracy of 85.4%. In a validation survey of 39 clinicians analyzing a sample of 22 endoscopic ear images, the average diagnostic accuracy was 65.0%. On the same data set, our model achieved an accuracy of 95.5%.
Conclusion
Our model outperformed certain groups of human clinicians in assessing images of tympanic membranes for effusions in children. Reduced diagnostic error rates using machine learning models may have implications in reducing rates of misdiagnosis, potentially leading to fewer missed diagnoses, unnecessary antibiotic prescriptions, and surgical procedures.”
Think about the implications for home diagnostics.

Today's News and Commentary

About Covid-19

 COVID-19 Economic Injury Disaster Loan Applications Submitted from Foreign IP Addresses “We evaluated the U.S. Small Business Administration’s (SBA) controls to flag or prevent potentially fraudulent Coronavirus Disease 2019 (COVID-19) Economic Injury Disaster Loan (EIDL) applications submitted from foreign Internet Protocol (IP) addresses.
Although the agency implemented several layers of controls to prevent or reduce fraud from foreign countries, individuals at foreign IP addresses were able to access the COVID-19 EIDL application system. SBA received millions of attempts to submit COVID-19 EIDL applications from foreign IP addresses and stopped most of them; however, the agency processed more than 233,000 of these applications from March 20, 2020 to November 12, 2021, our review period. Of this amount, SBA approved and disbursed 41,638 COVID-19 EIDLs, advances, and grants for $1.3 billion.”

About health insurance/insurers

AMA Releases 2023 CPT Code Set, Aims to Reduce E/M Coding Burden The article provides a good summary of the changes.

 Support for greater government role in health care for older adults “Expanding Medicare coverage of certain services is… popular across age groups, racial and ethnic groups, and party identification. More than 8 in 10 adults think Medicare coverage should be expanded to cover dental care (87%), eye examinations for prescription glasses (87%), hearing aids (86%), and long-term care (81%). 
Public satisfaction with the current state of health care—overall and for older adults—is quite low. Just 12% of adults think health care in general is handled very or extremely well in the United States, and few think health care for older adults, community support and resources for older adults, and the quality of care at nursing homes are handled well.
Overall, 66% of adults think it is the federal government’s responsibility to make sure all Americans have health insurance coverage. Those age 18-49 are more likely to say so than those age 50 and older (73% vs. 58%). While those age 50 and older are more supportive of government policies to address the costs of care for older adults, younger adults are more supportive of a single-payer health care system for all Americans (47% vs. 38%).”
See the poll for more results.

About hospitals and healthcare systems

 Purchaser Business Group on Health Announces Five-Year Plan, Goals to Reduce and Reallocate Health Care Spending in Push for Higher Value Care for its Members The Purchaser Business Group on Health (PBGH), a nonprofit coalition of nearly 40 large, private employers and public health care purchasers committed to transforming health care nationwide, today announced a series of strategic goals that will guide the organization over the next five years. Additionally, the organization is launching a new public purchaser advisory committee to help better illuminate and address the unique needs of public purchasers, while enhancing its long-standing work aligning public and private efforts to reform health care payment. ..
Specifically, PBGH’s newly announced goals are to address:

  • Affordability by redirecting existing health care spend to high-quality, equitable and evidence-based care while holding total cost flat

  • Health by redirecting purchasing to support whole-person health (the full spectrum of medical, behavioral, socioeconomic and needs) and
    create accountability for health and well-being outcomes

  • Equity by eliminating disparities in care delivery and in health outcomes.

In a related article:EmsanaRx and Cleveland Clinic Collaborate to Bring Transparency to Pharmacy Benefits “EmsanaRx, a public benefit corporation, and Cleveland Clinic have announced a first-of-its-kind strategic affiliation today. This collaboration will align EmsanaRx with Cleveland Clinic to further both organizations’ mission of providing cost-effective, high-quality care.
Cleveland Clinic will advise clinicians and multidisciplinary teams at EmsanaRx to support the company’s formulary development and utilization management programs and inform some of its benefit offerings…
EmsanaRx is the first company launched by Emsana Health, an innovation studio created by the Purchaser Business Group on Health (PBGH) to tackle the largest problems facing employers today.”

About pharma

 Examining 340B Hospital Price Transparency, Drug Profits, and Incentives Highlights:

  • “340B hospitals’ own self-reported pricing data reveals that they price the top oncology drugs at 4.9 times their 340B acquisition costs, assuming a 34.7 percent discount, which is a conservative estimate…

  • Hospitals remain slow to adopt biosimilars. For certain products, up to 26 percent of hospitals were found to only list prices for an innovator product but not its biosimilar and only 10 hospitals carry all of the biosimilars studied.

  • Cash paying patients, of whom many may be uninsured, receiving care at 340B hospitals do not seem to receive discounts on their drugs.”

About the public’s health

 First US death due to monkeypox confirmed in Los Angeles County “A Los Angeles County resident's death has been attributed to monkeypox, the county Department of Public Health said Monday, the first known death from the virus in the US.
The department and the US Centers for Disease Control and Prevention confirmed the link and said the person had a severely weakened immune system and had been hospitalized.”

Food Insecurity for Families With Children Reached Two-Decade Low in 2021 “Food insecurity for households with children declined to its lowest rate in two decades last year, the Agriculture Department said on Wednesday, as government assistance programs continued to blunt the effect of the coronavirus on the economy.
The department’s findings were in line with data last year showing that vast expansions of government aid helped reduce hunger. But experts warned that picture was almost certain to change as pandemic-era programs expire and inflation remains high.”

Biden touts cancer ‘moonshot’ at JFK Library, despite setbacks “Leaning into the symbolism of President John F. Kennedy’s aspirational effort to send a man to the moon, President Biden on Monday sought to give a renewed boost to his own “cancer moonshot” initiative, aimed at cutting the U.S. death toll from the disease in half over the next 25 years…
Biden on Monday also signed an executive order for a biotechnology initiative that the White House hopes will make the U.S. less dependent on foreign countries for the tools and raw materials needed for medical progress.”

Screening for Prediabetes and Type 2 Diabetes in Children and Adolescents “The USPSTF concludes that the evidence is insufficient to assess the balance of benefits and harms of screening for type 2 diabetes in children and adolescents. There is a lack of evidence on the effect of screening for, and early detection and treatment of, type 2 diabetes on health outcomes in youth, and the balance of benefits and harms cannot be determined.”

FROM 2016 TO 2020, MENTAL HEALTH INEQUITIES COST NEARLY 117K LIVES, REPORT FINDS “KEY TAKEAWAYS

From 2016 to 2020, the costs associated with premature mental and behavioral health-related deaths among indigenous populations and racial and ethnic groups linked to mental illness, substance abuse, and suicide were $278 billion.
Solutions for mental health inequities include development of socio-culturally crafted approaches to mental and behavioral health services as well as tackling the social and political determinants of health inequities.”

About healthcare personnel

 Physician Salaries Ranked by Hourly Rate Compare these hourlies to partners at a law firm.

 Nurse practitioner will be fastest-growing job over next decadeThe occupation with the highest projected percent change of employment in the U.S. between 2021 and 2031 is nurse practitioner, according to the latest data from the Bureau of Labor Statistics.  
The bureau estimates that employment of nurse practitioners will grow by 46 percent during that period, from 246,700 to 359,400.
Other healthcare occupations among the 20 with the highest projected percent change of employment in the U.S. between 2021 and 2031 are:       

  • Medical and health services managers (28 percent)

  • Physician assistants (28 percent)

  • Physical therapist assistants (26 percent)”

Doctor Wait Times Average Almost Four Weeks In Big Cities “Patients are waiting an average of 26 days for a scheduled appointment with a doctor, according to a study of commonly used specialty physicians in 15 major U.S. cities.
The survey by Merritt Hawkins, a unit of healthcare staffing firm AMN Healthcare, polled more than 1,000 physician offices looking at average wait times among family medicine, dermatology, obstetrics/gynecology, orthopedic surgery and cardiology.
The average wait time is up 8% from 24.1 days in 2017, ‘the last year the survey was conducted, and up from 21 days in 2004, when the survey first was conducted,’ according to Merritt Hawkins and AMN Healthcare…
Though the analysis looked at major U.S. cities, the wait times are likely worse elsewhere in the country given large markets tend to have more physicians because they are home to academic medical centers and high concentrations of healthcare facilities generally.”

Today's News and Commentary

About Covid-19

COVID DATA TRACKER WEEKLY REVIEW “As of September 7, 2022, the current 7-day moving average of daily new cases (70,488) decreased 18.8% compared with the previous 7-day moving average (86,853). A total of 94,888,931 COVID-19 cases have been reported in the United States as of September 7, 2022.”

 Antiviral agents found to be effective against Omicron BA.2.75 “Researchers say multiple COVID-19 drugs that have been approved in Japan show efficacy against the Omicron BA.2.75 subvariant.
They say the antiviral agents remdesivir, molnupiravir and nirmatrelvir may be effective against BA.2.75 [however],…The virus-neutralizing antibodies casirivimab-imdevimab and sotrovimab were found to be significantly less effective against the variant.
But the researchers do say that tixagevimab-cilgavimab, approved last month, did show neutralizing activity.”

A single-administration therapeutic interfering particle reduces SARS-CoV-2 viral shedding and pathogenesis in hamsters “Recently, we reported the discovery of a single-administration antiviral therapeutic interfering particle (TIP) against SARS-CoV-2 that prevents severe disease in hamsters and exhibits a high genetic barrier to the evolution of resistance. Here, we report that TIP intervention also reduces SARS-CoV-2 transmission between hamsters.”

About health insurance/insurers

 Blue Cross $2.7B antitrust settlement appealed by Home Depot, others  “Three employers have appealed a $2.67 billion antitrust settlement with the Blue Cross and Blue Shield Association, potentially altering the terms of the landmark federal agreement and extending the timeline of the 10-year case. 
Retailer Home Depot filed its appeal Thursday while design consultancy Topographic and benefits providers Employee Services Inc. appealed the settlement the day before, according to filings submitted to the U.S. District Court for the Northern District of Alabama. 
None of the companies’ legal briefs explain why they are appealing Judge David Proctor’s decision to approve the deal last month. Home Depot, Topographic, Employee Services and the Blue Cross and Blue Shield Association didn't immediately responded to interview requests.”

HCSC teams with Teladoc to roll out virtual primary care next year “HCSC, the country's largest customer-owned health insurer, will begin offering the virtual care service to some midsize and large employer groups in Illinois and Texas starting Jan. 1, 2023.
The virtual primary care model is designed to help employers with employees scattered across diverse geographies get timely and convenient access to a trusted online care team—all while managing healthcare outcomes and costs, executives said.”

About pharma

 Providers spent $44B on 340B drugs in 2021 “The 30-year-old program that allows hospitals to buy drugs directly from manufacturers to avoid inflated prices, 340B, cost providers $43.9 billion in 2021, according to HHS' Health Resources and Services Administration. 
Most of that spending — more than $34 billion — was from disproportionate share hospitals. Health center programs bought more than $2 billion worth of 340B drugs, children's hospitals about $1.3 billion and critical access hospitals nearly $621 million.”

Effects of Real-time Prescription Benefit Recommendations on Patient Out-of-Pocket Costs Question  Do real-time prescription benefit (RTPB) recommendations for clinically appropriate, lower-cost alternatives at the point of prescribing reduce patient medication out-of-pocket costs?
Findings  This cluster randomized clinical trial found that RTPB recommendations led to a 11% reduction in patient out-of-pocket costs for ordered medications. Among high-cost drug classes, the intervention led to a 40% reduction in out-of-pocket costs; however, RTPB recommendations were made for only a small proportion of orders.”

About health technology

 President Biden Announces Intent to Appoint Dr. Renee Wegrzyn as Inaugural Director of Advanced Research Projects Agency for Health (ARPA-H) The headline is the story.

GE Healthcare to spin off in January “GE Healthcare is set to spin off as a standalone public company in the first week of January.”

Today's News and Commentary

About Covid-19

 New Covid boosters look a lot like the old ones. Doctors worry that could lead to errors. “As updated Covid booster shots roll out across the nation, many experts are raising an eyebrow — and perhaps squinting at the label. That's because the new doses come in capped vials that look strikingly similar to the old ones.
It's a design decision, experts say, that could result in some people mistakenly receiving the wrong dose.”

COVID-19-Associated Hospitalizations Among Vaccinated and Unvaccinated Adults 18 Years or Older in 13 US States, January 2021 to April 2022 “In this cross-sectional study of US adults hospitalized with COVID-19 during January 2022 to April 2022 (during Omicron variant predominance), COVID-19-associated hospitalization rates were 10.5 times higher in unvaccinated persons and 2.5 times higher in vaccinated persons with no booster dose, respectively, compared with those who had received a booster dose. Compared with unvaccinated hospitalized persons, vaccinated hospitalized persons were more likely to be older and have more underlying medical conditions.”

Covid Rebound Symptoms, Positive Tests After Paxlovid Are Common, Study Says “Resurgence of Covid-19 symptoms in patients treated with Pfizer Inc.’s Paxlovid appeared far more common than has been reported, and rebounding patients still risked spreading the disease, doctors said in a report on a series of cases in a top medical journal.
The article published Wednesday in the New England Journal of Medicine documented 13 fully vaccinated patients whose rapid Covid tests turned strongly positive and symptoms reappeared several days after finishing five-day courses of Paxlovid.”

RADx reloaded: NIH puts out the call for more effective, easier-to-use COVID tests “In the two-and-a-half years of the COVID-19 pandemic, diagnostic test makers have fine-tuned their development and manufacturing processes to quickly roll out countless tests for the virus, many of them helped along by infusions of federal funding specifically set aside for innovative new testing approaches.
And the government isn’t done yet. With its sights set on the endemic stage of the coronavirus, the National Institutes of Health has re-upped its call for new and improved COVID diagnostics, it announced Thursday.
The summons arrives via the Rapid Acceleration of Diagnostics Tech program, or RADx, which launched in the early days of the pandemic with an initial commitment of $1.5 billion and a ‘Shark Tank’-style competition to quickly develop both at-home and point-of-care tests for the virus.”

About health insurance/insurers

 Comparison of Low-Value Services Among Medicare Advantage and Traditional Medicare Beneficiaries Question  Do rates of low-value care differ between traditional Medicare (TM) and Medicare Advantage (MA), and, if so, what elements of insurance design are associated with the differences?
Findings  In this cross-sectional study of 2 470 199 Medicare beneficiaries, those enrolled in MA received 9.2% fewer low-value services than those in TM (23.1 vs 25.4 total low-value services per 100 beneficiaries). The MA beneficiaries in health maintenance organizations and those in primary care organizations reimbursed within advanced value-based payment models had the lowest rates of low-value care.”

UnitedHealth Deal Is 'Not A Merger To Monopoly,' Judge SaysThe D. C. federal judge who will decide the fate of UnitedHealth's $13. 8 billion bid for Change Healthcare challenged the U. S. Department of Justice during closing arguments Thursday on its assertions that the deal will create a monopoly for health insurance claims processing technology, repeatedly noting plans to divest the sole overlapping business unit.”

About hospitals and healthcare systems

 Hospitals Divert Primary Care Patients to Health Center ‘Look-Alikes’ to Boost Finances “A growing number of hospitals are outsourcing often-unprofitable outpatient services for their poorest patients by setting up independent, nonprofit organizations to provide primary care.
 Medicare and Medicaid pay these clinics, known as federally qualified health center look-alikes, significantly more than they would if the sites were owned by hospitals.
Like the nearly 1,400 federally qualified health centers — which get those additional dollars as well — a clinic designated by the government as a ‘look-alike’ is also eligible for federal programs that could help reduce costs and recruit providers. They allow the clinics to obtain prescription drugs at deep discounts and attract doctors by making them eligible for a government program that helps them pay off their student debt if they work in an area with a shortage of medical providers.
But unlike the community health centers, the look-alikes do not get an annual federal grant to cover operational costs. Nor do the look-alikes get the financial benefit in which the federal government covers their malpractice risks.”

National Alliance Helps Employers Get to Fair Price for Hospital Services “ To support employers and other healthcare purchasers in efforts to stop paying indefensible hospital prices, the National Alliance of Healthcare Purchaser Coalitions (National Alliance) released a new resource for plan sponsors to map out strategies to identify and negotiate fair market prices for hospitals.
Recent data indicates that for most hospitals a “fair price” for patients privately insured by employers is 140%-200% of what Medicare pays for the exact same products, procedures and services at the exact same facilities. Some hospitals charge 250% more for those services, with others even higher at 500% or more over Medicare. A fair price should allow for a reasonable markup from costs and a price that is competitive with peer hospitals…
The playbook, “Beyond Hospital Transparency: Getting to Fair Price,” helps purchasers navigate and understand how to best leverage newly available hospital price and quality transparency data and tools from Sage Transparency which incorporates content from RAND Corporation, the National Academy for State Health Policy(NASHP), and other sources. It also offers guidance on rights and responsibilities as plan sponsor fiduciaries to determine fair prices for hospital services, market- and policy-based strategies, and ways to work individually and through coalitions to achieve fair pricing for hospital services.
While there isn’t a one-size-fits-all approach as available data and market conditions vary among regions and states, the methodology and action steps in the playbook to help plan sponsors determine and achieve a fair price include:

  • Identify breakeven costs – Uncover what hospitals need to charge commercial customers to break even considering all other incomes and expenses plus a reasonable margin.

  • Compare costs among peer hospital systems – Determine how hospital charges compare to other hospitals with similar services and quality.

  • Determine a fair market price – Use data from Sage Transparency to negotiate fees based on a reasonable markup of hospital costs.”

Nursing facilities and debt collectors “The Consumer Financial Protection Bureau (CFPB) and the Centers for Medicare & Medicaid Services (CMS) remind you of your responsibilities under the Nursing Home Reform Act (NHRA), Fair Debt Collections Practices Act (FDCPA), and Fair Credit Reporting Act (FCRA).
The NHRA prohibits nursing facilities from requesting or requiring that a third party personally guarantee payment to the facility as a condition of a resident’s admission or continued stay in the facility. Contract terms that conflict with the NHRA are unlawful, and alleged debts resulting from such unlawful contract terms are invalid and unenforceable. Some nursing facilities have attempted to evade this prohibition by creating admission contracts that attempt to hold third parties liable for a resident’s debt. When a nursing facility claims that a non-resident is personally financially responsible for a resident’s bill and engages a third-party debt collector to collect the debt, the debt collector may violate the FDCPA by attempting to collect debts that are invalid under the NHRA. They may also violate the FCRA by furnishing information regarding such invalid debts to consumer reporting agencies.”

About pharma

 US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018 “In this cohort study, the FDA granted accelerated approval of 48 drugs for 57 nononcology indications from 1992 to 2018 with a median time to regular approval of 53.1 (95% CI, 38.7-70.2) months. Nine postapproval confirmatory trials failed to verify clinical efficacy, but only 1 indication was withdrawn due to a failed confirmatory trial 136 months after approval.” 

About the public’s health

 DHS unwinds Trump-era 'public charge' rule for immigrants “The Department of Homeland Security on Thursday finalized a regulation rolling back a policy instituted under former President Donald Trump that sought to limit immigration benefits for those likely to rely on government aid.
The new law unravels the Trump-era public-charge rule, under which immigrants could be denied permanent resident status if they had received or were expected to receive food assistance, Medicaid, housing assistance, or other public benefits.”

Artificial sweeteners and risk of cardiovascular diseases: results from the prospective NutriNet-Santé cohortThe findings from this large scale prospective cohort study suggest a potential direct association between higher artificial sweetener consumption (especially aspartame, acesulfame potassium, and sucralose) and increased cardiovascular disease risk. Artificial sweeteners are present in thousands of food and beverage brands worldwide, however they remain a controversial topic and are currently being re-evaluated by the European Food Safety Authority, the World Health Organization, and other health agencies.”

About healthcare IT

Medical breaches accounted for 342 million leaked records from 2009 to 2022 The entire report is worth reading.
”Key findings:

  • 4,746 medical breaches recorded from 2009 to June 2022

  • 342,017,215 individual records were affected as a result of these breaches

  • 2020 was the biggest year for medical breaches with 803 reported (the second-highest was 2021 with 711)

  • 2015 saw the highest number of records affected with over 112 million in total

  • In 2021 and 2022 (so far), specialist clinics (clinics that specialize in a certain field of medicine–e.g. cardiology or radiology, etc.) account for the most data breaches (15 percent) with 130 breached entities in total, but hospital networks account for the most breached records with 8.8 million affected in total (16 percent of the overall records affected)

  • In 2021 and 2022 (so far), hacking was the most common type of breach, accounting for 40 percent of breaches (353 out of 862)”

 Cyber Insecurity in Healthcare “According to the research, 89 percent of organizations in this research experienced cyberattacks in the past 12 months. For organizations in that group, the average number of attacks was 43. We asked respondents to estimate the single most expensive cyberattack in the past 12 months from a range of less than $10,000 to more than $25 million. Based on the responses, the average total cost for the most expensive cyberattack experienced was $4.4 million. This included all direct cash outlays, direct labor expenditures, indirect labor costs, overhead costs and lost business opportunities.
At an average cost of $1.1 million, lost productivity was the most significant financial consequence from the cyberattack. However, despite the connection between cyberattacks and patient safety, the least amount of cost following a cyberattack was the time required to ensure the impact on patient care was corrected ($664,350).”
This study is also worth reading in its entirety.

About healthcare personnel

 More DOs Join Physician Ranks as Osteopathic Pipeline Heats Up “The number of doctors of osteopathic medicine (DOs) is enjoying a significant growth pattern. This year alone, 7300 osteopathic physicians are entering the workforce, and they make up more than 25% of the medical student population. The pipeline of future DOs is at an all-time high of 36,500 students, according to the American Osteopathic Association (AOA).”

About healthcare finance

Alphabet's Verily Raises $1 Billion and Shakes Up Leadership Team “Verily, the Alphabet Inc. life sciences unit that experimented with diabetes-detecting contact lenses and launched Covid-19 testing programs, said it raised $1 billion in new investments led by its parent company, padding its war chest as the health-tech market heats up.”

Today's News and Commentary

About the public’s health

Oxford malaria vaccine maintains bite after booster; Researchers hope for shot approval in 2023 “New phase 2b findings show an investigational malaria vaccine booster from the University of Oxford maintained high efficacy levels a year after the initial three-shot regimen—a feat in a disease area that scientists have long struggled to develop effective vaccines and therapies.
The vaccine, dubbed R21/Matrix-M, was developed by the University of Oxford and includes Novavax's proprietary saponin-based Matrix-M adjuvant. R21 is also being studied in a phase 3 trial aimed at licensing the shot for widespread use by 2023, with topline results anticipated later this year.”

Distance to supermarkets is a risk factor for CKD, hypertension, diabetes development The headline is the message.

About healthcare IT

 Remote vs In-home Physician Visits for Hospital-Level Care at Home “In this 2-site randomized clinical trial of 172 patients, the mean adverse event count was 6.8 per 100 patients for patients receiving remote care vs 3.9 per 100 patients for control patients, for a difference of 2.8, supporting noninferiority, although 19% of patients receiving remote care required in-home physician visits. Patient experience was noninferior.”

Electronic Connectivity Among US Hospitals Treating Shared Patients “In total, hospitals in our sample participated in 127 HIE networks. Thirty-two of these were vendor/national HIE networks and 95 were community HIE networks. Seventy-nine percent of hospitals participated in at least one HIE network, with 61% participating in a vendor/national network and 58% participating in a community network. On average, each hospital participated in 1.6 networks: 1.0 vendor/national networks and 0.6 community networks.”

Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks From the HHS OIG: “We identified 1,714 providers whose billing for telehealth services during the first year of the pandemic poses a high risk to Medicare. These providers billed for telehealth services for about half a million beneficiaries. They received a total of $127.7 million in Medicare fee-for-service payments.
Each of these 1,714 providers had concerning billing on at least 1 of 7 measures we developed that may indicate fraud, waste, or abuse of telehealth services. All of these providers warrant further scrutiny. For example, they may be billing for telehealth services that are not medically necessary or were never provided.
In addition, more than half of the high-risk providers we identified are a part of a medical practice with at least one other provider whose billing poses a high risk to Medicare. This may indicate that certain practices are encouraging such billing among their associated providers. Further, 41 providers whose billing poses a high risk appear to be associated with telehealth companies; however, there is currently no systematic way to identify these companies in the Medicare data.”
See the report for recommendations.

About healthcare finance

 R1 RCM gets $2.3B in financing “Capital One Commercial Bank said Sept. 7 that it was the joint lead arranger for an amended and restated credit facility for R1 RCM.  
The facility increased R1 RCM's borrowing capacity from $1.2 billion to $2.3 billion, according to a Capital One news release emailed to Becker's…”

Today's News and Commentary

About health insurance/insurers

Judge invalidates parts of the ACA that mandate health coverage of many preventive services and drugs He’s at it again: “Judge Reed O’Connor also said the ACA’s requirement that health plans cover HIV pre-exposure prophylaxis, or PrEP, at no cost violates religious freedom law.
The decision, released Wednesday, is a temporary win for the plaintiffs, which include Steven Hotze, a physician and conservative activist who has campaigned against the ACA and previously called same-sex marriage a ‘wicked, evil movement.’ The Department of Health and Human Services did not immediately say if it would appeal the decision, although an appeal is considered likely.”

Where Does Your Health Care Dollar Go A nice summary with graphics from AHIP.

MedPAC explores standardized plan options in Medicare Advantage “The Medicare Payment Advisory Commission (MedPAC), which advises Congress on Medicare issues, is researching how standardized benefit options would work for MA. The goal is to include the findings in an annual report to Congress next year and explore how standardization could help simplify choice for seniors.”
Comment: This idea is a good one. It would make plan selection easier and would mimic the Medicare Supplement market.

Walmart And UnitedHealth Group Launch Medicare Advantage Partnership “Walmart and UnitedHealth Group are rolling out a major partnership to provide healthcare services and “improve the patient experience” for Medicare Advantage enrollees in certain markets across the country.
The 10-year collaboration announced Wednesday between the retail giant’s fast-growing Walmart Health business and UnitedHealth’s Optum health services will begin in 2023 in Florida and Georgia where Walmart Health has a combined 15 locations. Eventually, the collaboration will be expanded across the U.S., serving Medicare Advantage health plan enrollees no matter which health plan seniors choose.”

 New Survey Highlights What Americans Are Willing to Pay More for in Healthcare “Respondents were asked: "When you seek out healthcare, are you willing to pay more or less for any of the following factors?" The survey of more than 2000 Americans ranked factors that impact their healthcare provider choice with regards to costs, with quality of care being the top influencing factor:

  • Quality of care (57%)

  • Ability to work with care team of choice (47%)

  • Ability to work with hospitals of choice (41%)

  • Location proximity or convenience (41%)

  • Ability to get an appointment quickly (40%)”

    NOTE: The referenced websites are proprietary. The article does not say how much people are willing to pay for those features.

About hospitals and healthcare systems

 FTC Investigating Amazon Deal to Buy One Medical Network of Health Clinics “The Federal Trade Commission is investigating Amazon.com Inc.’s $3.9 billion deal to buy 1Life Healthcare Inc., which operates One Medical primary care clinics in 25 U.S. markets.
1Life, which went public in 2020, disclosed the investigation in a securities filing. The disclosure says One Medical and Amazon each received a request on Friday for additional information about the deal from the FTC.”

About pharma

 Bayer to pay $40m to resolve claims over alleged kickbacks and false statements “The Justice Department said Laurie Simpson, a former Bayer employee who worked in its marketing department, filed two lawsuits against the company.

  • In one, Simpson alleged Bayer paid kickbacks to hospitals and physicians to induce them to prescribe the drugs Trasylol and Avelox, marketed these drugs for off-label uses that were not "reasonable and necessary" and downplayed the safety risks of Trasylol.

  • The lawsuit alleged Bayer's actions caused the submission of false Medicare and Medicaid claims and violated the laws of 20 states and the District of Columbia.

  • The second lawsuit filed by Simpson alleged the company knowingly downplayed the drug Baycol’s risks of causing rhabdomyolysis and misrepresented its efficacy compared to other drugs of its kind.

  • Bayer subsequently withdrew Trasylol and Baycol from the market for safety reasons.”

About the public’s health

 US states with the highest smoking rates in 2022 “Researchers found that, at 23.8%, West Virginia had the highest smoking rate and the highest number of smoking-related deaths, at 241 per 100,000 people.
On the other end of the spectrum, Utah had the lowest smoking rates of any U.S. state, with 7.9% of the population maintaining the habit. It also had the fewest smoking-related deaths, at 39 per 100,000 people.”

Trends in Parents’ Confidence in Childhood Vaccines During the COVID-19 Pandemic “From April 2020 to March 2022, the percentage of parents who agreed with the ‘important benefits’ and ‘useful and effective’ statements remained stable and high, ranging from 89.5 to 92.5% and from 89.3 to 93.2%, respectively... By contrast, the percentage of parents who agreed with the illness or death and harmful side effects statements increased significantly by 13.2% (95% confidence interval [CI]: 9.4% to 16.9%) and 6.1% (95% CI: 2.2% to 9.9%), respectively…. Statistically significant increases were observed for most parent subgroups (with overlapping CIs noted, suggesting no statistically significant differences between subgroups).”

Racial Differences in Detection of Fever Using Temporal vs Oral Temperature Measurements in Hospitalized Patients “In this multicenter study, temporal compared with oral temperature measurement was associated with a lower odds of identifying fever in Black patients, while there was no significant difference in White patients.”
This data joins problems with accuracy of pulse oximetry in black patients. The implications of those findings could significantly affect the “wearable technology” sector.

The Forgotten Middle: Housing & Care Options for Middle-Income Seniors in 2033 “Summary of Findings [emphases in the original]:
Over the next decade, the number of middle-income seniors will almost double—reaching 16M adults ages 75+ by 2033.

• This group will be more racially and ethnically diverse, including 22% who are people of color.
Many seniors will have health needs, like mobility limitations and cognitive impairments, that make it hard to live independently.

• Middle-income seniors may be more reliant on paid caregiving since a majority of them will be unmarried in 2033, and many do not have children living nearby.

Without selling their homes, three-quarters of middle-income seniors (11.5M) have insufficient resources to pay for private assisted living.

  • Many seniors are reluctant to sell their homes either because their spouse still lives there or because it is a “nest egg” to protect against unforeseen expenses or pass to their children.

  • Even with home equity, 6M (39%) middle-income seniors cannot pay for assisted living.

The research does not offer solutions to these problems.

About healthcare IT

 eClinicalWorks moves EHR to Microsoft cloud in $100M deal “eClinicalWorks is moving its EHR to Microsoft Azure and plans to invest $100 million in the tech giant.
The EHR vendor was looking for a cloud solution that was ‘scalable, secure and HIPAA-compliant’ to help reach its goals of digitizing its EHR, more quickly deploying new applications and improving customer satisfaction, said Bharat Satyanarayan, vice president of technology and quality assurance for eClinicalWorks…”

About healthcare personnel

 Travel nurses' gold rush is over. Now, some are joining other nurses in leaving the profession altogether “During the Covid pandemic, nurses tripled their pay by moving from job to job. But the short-lived boom was a temporary fix for a long-term decline in the nursing profession.”
A really good piece about the recent history of this travel nurses. 

About health technology

 EU blocks merger of US firms in cancer screening sector  “The European Union’s anti-trust watchdog announced on Tuesday that it is blocking the buyout of cancer-screening company GRAIL by biotech giant Illumina in a rare move by European regulators against two U.S. companies.
Illumina is a major supplier of next-generation sequencing (NGS) systems for genetic and genomic analysis, while GRAIL is a health company developing blood tests to try to catch cancer early. Illumina announced an $8 billion acquisition of GRAIL in 2020.”
The US recently cleared the deal.

Today's News and Commentary

About Covid-19

CDC recommends reformulated coronavirus booster shot for fall The Centers for Disease Control and Prevention recommended Thursday that millions of eligible Americans, including those as young as 12, get an updated omicron-targeting booster shot to bolster defenses against serious illness and death during a potential fall or winter rise in covid-19 cases.
CDC Director Rochelle Walensky endorsed a recommendation by an advisory panel, paving the way for some clinicians, pharmacies and other providers to begin administering the shots as early as this weekend. The Advisory Committee on Immunization Practices voted 13-1 to recommend updated shots from Moderna, for those 18 and older, and from Pfizer-BioNTech, for people 12 and older.”

 White House signals most people will only need annual Covid booster “‘It is becoming increasingly clear, that looking forward with the Covid-19 pandemic, in the absence of a dramatically different variant, we likely are moving towards a path with a vaccination cadence similar to that of the annual influenza vaccine, with annual updated Covid-19 shots matched to the currently circulating strains for most of the population,’ Anthony Fauci, the country’s top infectious disease official, said at the briefing.”

About health insurance/insurers

 CVS Health to Acquire Signify Health From the press announcement: “ CVS Health and Signify Health ("Signify") have entered into a definitive agreement under which CVS Health will acquire Signify Health for $30.50 per share in cash, representing a total transaction value of approximately $8 billion.
Signify Health is a leader in Health Risk Assessments, value-based care and provider enablement. With a network of more than 10,000 clinicians across all 50 states and a nationwide value-based provider network, combined with its proprietary analytics and technology platforms, Signify Health is improving patient engagement, patient outcomes and care coordination for stakeholders across the health care system. Signify Health's clinicians and providers can have an even greater impact by engaging with CVS Health's unique collection of assets and connecting patients to care how and when they need it.”

Patient groups sue feds to crack down on insurer, PBM copay adjustment programs “A 2019 rule issued by the Trump administration blocks insurers from applying the drugmaker coupons to out-of-pocket limits like deductibles if there is a generic drug version on the market. However, the Trump administration decided to not enforce the rule in 2020 after complaints of confusion from stakeholders.
The 2021 Notice of Benefit and Payment Parameters rule—which outlines insurance regulations for Affordable Care Act exchange plans—enabled insurers to decide how to interpret cost-sharing. An insurer could “either include or exclude copay assistance from cost-sharing calculations,” according to a release on the lawsuit. 
The groups also charged that the Department of Health and Human Services (HHS) abandoned the 2019 copay accumulator policy that enabled assistance to count toward a deductible or out-of-pocket cost responsibility except for a brand-name drug that has a generic version.
The complaint asserts that the HHS rule violates federal law and directly contradicts the government’s own definition of cost-sharing.”
Comment: These actions were necessary because pharma companies raised prices and then gave coupons for discounts. Patients paid at the same rate as generics but insurers paid significantly more. Inevitably premiums will need to be raised if these consumer demand are met.
Maximus Awarded Centers for Medicare & Medicaid Services Contract for Contact Center Operations Maximus… announced that it has been awarded a contract for a base period for transition plus nine (one year) option periods with a total value of $6.6 billion by the Centers for Medicare & Medicaid Services (CMS) for Contact Center Operations (CCO). Under the contract, Maximus will continue supporting CMS’ contact center operations that help 75 million Americans seeking vital information about their Medicare benefits as well as navigating insurance programs available through the Federal Marketplace established by the Affordable Care Act (ACA).”

Social Risk Adjustment In The Hospital Readmissions Reduction Program: A Systematic Review And Implications For Policy “We reviewed fourteen studies of social risk adjustment in Medicare’s Hospital Readmissions Reduction Program (HRRP), a value-based payment model that initially did not adjust for social risk factors but subsequently began to do so…
These findings support the use of social risk adjustment to improve provider payment equity and highlight opportunities to enhance social risk adjustment in value-based payment programs.”

13 Novus Healthcare Fraud Defendants Sentenced to Combined 84 Years in Prison “According to plea papers and evidence presented to a jury, Novus Health Services, a Dallas-based hospice agency, defrauded Medicare by submitting materially false claims for hospice services, providing kickbacks for referrals, and violating HIPAA to recruit beneficiaries.  Novus employees also dispensed Schedule II controlled substances to patients without the guidance of medical professionals and moved patients to a new hospice company in order to avoid a Medicare suspension.”

About hospitals and healthcare systems

Cybersecurity investments could go by the wayside at cash-strapped hospitals, Fitch warns “More not-for-profit hospitals will likely become susceptible to cyberattacks as slimming margins keep hard-hit organizations from making the necessary investments and preparations…
Although a handful of recent industry trends are increasing the costs of protecting hospitals from attack, the agency warned that a successful breach would only add to a hospitals’ financial woes and potentially affect their credit ratings.”

About pharma

In blow to public health, judge tosses FDA lawsuit targeting a clinic offering unproven stem cell treatments A federal judge in Riverside declared a California stem cell treatment firm to be exempt from Food and Drug Administration regulations, opening the door to the further proliferation of clinics offering therapies the FDA says are scientifically unproven and potentially dangerous…
[Judge] Bernal accepted the center’s position that its treatments qualified for an exception from FDA regulations, in part because they were tantamount to surgical procedures.”
Read the entire article. This decision is not only scientifically and legally wrong [see the FDA definition of a drug] but will be harmful to the public. I hope it will be appealed soon.

Walgreens Boots Alliance Completes Majority Share Acquisition of CareCentrix “Walgreens Boots Alliance, Inc… announced it has completed its previously announced majority share acquisition of CareCentrix, Inc.—the leading independent home-centered platform that coordinates care to the home for health plans, patients and providers. The majority investment in CareCentrix accelerates Walgreens Health’s capabilities in delivering quality healthcare across a spectrum of settings including primary care, specialty pharmacy care, post-acute care and home care.”

About the public’s health

 Juul to pay $439 million in settlement over marketing to teens “E-cigarette company Juul, which at the height of its success dominated the market with its sweet flavors, has agreed to pay $438.5 million in a settlement with 33 states and one territory over marketing its product to teens.
Connecticut Attorney General William Tong (D), who led the plaintiff effort, said in a statement that the settlement will send millions of dollars to programs aimed at reducing tobacco use.”

About healthcare IT

Assessment of Clinician Diagnostic Concordance With Video Telemedicine in the Integrated Multispecialty Practice at Mayo Clinic During the Beginning of COVID-19 Pandemic From March to June 2020 Findings  In this diagnostic study of 2393 patients who underwent a video telemedicine consultation followed by an in-person outpatient visit for the same clinical problem in the same specialty within a 90-day window, the provisional diagnosis established over video telemedicine visit matched the in-person reference standard diagnosis in 86.9% of cases.
Meaning  These findings suggest that video telemedicine visits yield a high degree of diagnostic concordance to in-person visits for most new clinical concerns.”

Amazon Care is dead, but the tech giant’s health-care ambitions live on An excellent summary of Amazon’s recent healthcare activities.

Medical Record Closure Practices of Physicians Before and After the Use of Medical Scribes This [study] suggests that the use of scribes may not be a solution to clinical documentation burdens.”

Medicare Boosts Incentives for Hospitals to Provide Data to Public Health Agencies A final rule announced Aug. 1 by the Centers for Medicare & Medicaid Services (CMS) makes changes for hospitals participating in the Medicare Promoting Interoperability Program that should result in better data to help improve responses to public health threats. The rule, which takes effect Oct. 1, gives hospitals greater financial incentives to report information electronically about patient illnesses, injuries, and treatments to state and local health departments.” 

About healthcare personnel

Association of Private Equity Acquisition of Physician Practices With Changes in Health Care Spending and Utilization “Question What are the implications of private equity acquisition of physician practices for health care spending and utilization?
Findings  This difference-in-differences event study of 578 private equity−acquired dermatology, gastroenterology, and ophthalmology physician practices and 2874 similar independent practices found that spending, new and unique patient volume, and total encounters increased differentially compared with controls. The share of outpatient visits longer than 30 minutes increased, and there were modest differences along key outcomes within specialties.
Meaning The findings of this economic evaluation suggest that among a large commercially insured population, private equity acquisitions of physician practices were associated with increased health care spending and several measures of utilization.”

 Private Equity Acquisitions Of Ambulatory Surgical Centers Were Not Associated With Quality, Cost, Or Volume Changes “There was no statistically significant observed change in the probability of an unplanned hospital visit, total costs, or total encounters after acquisition by private equity relative to acquisition by non–private equity entities. When we compared private equity–acquired ASCs with matched ASCs that were never acquired, we also found no statistically significant relative change in the probability of an unplanned hospital visit, total costs, or total encounters. Regulators should ensure that data on private equity acquisitions are transparent and that data are available to track the long-term quality and financial implications of these acquisitions.” 

About health technology

Illumina wins case against FTC in bid to hold onto early cancer detection company Grail “Sequencing behemoth Illumina on Thursday won its case against the Federal Trade Commission in its bid to hold onto Grail, a Bay Area early cancer detection company that the genomics giant acquired for $8 billion last year.
An administrative law judge rejected the FTC’s argument that the San Diego company’s acquisition of Grail would quash competition in the nascent market for multi-cancer early detection…”

Today's News and Commentary

About Covid-19

 F.D.A. Authorizes Updated Covid Booster Shots, Targeting Omicron Subvariants “The Food and Drug Administration on Wednesday authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week.
The agency cleared two options aimed at the BA.5 variant of Omicron that is now dominant: one made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older. The doses can be given at least two months since people last received a booster dose or completed their initial series of vaccinations.”

FDA takes N95 respirators off medical device shortage list “The Food and Drug Administration has taken N95 respirators off of the medical device shortage list as increased manufacturing has helped build a sufficient supply of the devices.”

About health insurance/insurers

 CMS: ACOs saved Medicare $1.6B overall in 2021 as big changes on the horizon “Accountable care organizations saved Medicare $1.66 billion last year as value-based care providers brace for potential major changes to the program like new health equity measures…
CMS reported that 99% of all ACOs in the Medicare Shared Savings Program (MSSP) met quality standards, and approximately 58% earned shared savings for abiding by spending targets. An ACO agrees to take on a certain degree of financial risk and to meet spending and quality benchmarks.”

About pharma

 Novartis' Entresto infringes on university patents, lawsuit claims “Novartis was served with a federal lawsuit earlier this week in the Northern District of California, alleging that its heart failure treatment Entresto infringes a patent jointly held by the University of Michigan and the University of South Florida related to ‘engineering crystals for the design of new drug compounds.’
According to the 10-page complaint, the universities allege that the US patent and trademark office issued a patent on April 28, 2020 to three inventors: Michael Zaworotko, Brian Moulton and Nair Rodríguez-Hornedo. Zaworotko and Moulton assigned their rights as inventors to the University of South Florida Board of Trustees, as did Rodríguez-Hornedo to the Regents of the University of Michigan.”

About the public’s health

 Marijuana use is outpacing cigarette use for the first time on record “More people in the U.S. are now smoking marijuana than cigarettes, according to a Gallup poll.
Cigarette use has been trending downward during the past decades, with only 11% of Americans saying they smoke them in a poll conducted July 5 to 26, compared to 45% in the mid-1950s.
Sixteen percent of Americans say they smoke marijuana, with 48% saying they have tried it at some point in their lives. In 1969, only 4% of Americans said they smoked marijuana.”

Nearly 30% of US Cancer Deaths Linked to Smoking “Nearly 123,000 cancer deaths – or almost 30% of all cancer deaths – in the United States in 2019 were linked to cigarette smoking, a new analysis suggests.
That corresponds to more than 2 million person-years of lost life and nearly $21 billion in annual lost earnings.”

Association of an Automated Blood Pressure Measurement Quality Improvement Program With Terminal Digit Preference and Recorded Mean Blood Pressure in 11 Clinics “In this quality improvement study of 1 541 227 BP measurements from 225 504 patients, when aneroid sphygmomanometers were replaced with automated monitors, terminal digit preference decreased, mean systolic BP immediately increased, and during the subsequent 3 years, the proportion of patients with the diagnosis of hypertension increased from 19.1% to 23.4%…
Conclusions and Relevance In this quality improvement study, automated BP measurement was associated with decreased terminal digit preference and significantly higher mean BP levels. The method of BP measurement was also associated with the rate at which hypertension was diagnosed. These findings may have implications for pay-for-performance programs, which may create an incentive to record BP levels that meet a particular goal and a disincentive to adopt automated measurement of BP.”

Today's News and Commentary

About Covid-19

Administration of Anti–SARS-CoV-2 Monoclonal Antibodies After US Food and Drug Administration Deauthorization “According to the results of this serial cross-sectional study, hospitals and health systems administered more than 158 000 anti–SARS-CoV-2 mAb doses in early 2022, despite FDA deauthorization because of a lack of efficacy against the Omicron variant. Medicare payments for mAb administration range from $450 to $750 per dose, indicating that spending on these deauthorized treatments likely exceeds $71 million.”

California Approves Bill to Punish Doctors Who Spread False Information ”The legislation, if signed by Gov. Gavin Newsom, would make the state the first to try to legislate a remedy to a problem that the American Medical Association, among other medical groups and experts, says has worsened the impact of the pandemic, resulting in thousands of unnecessary hospitalizations and deaths.
The law would designate spreading false or misleading medical information to patients as “unprofessional conduct,” subject to punishment by the agency that licenses doctors, the Medical Board of California. That could include suspending or revoking a doctor’s license to practice medicine in the state.”

About health insurance/insurers

'Not so optimistic:' Surprise billing arbitrations cause frustration  “Mediators have decided just 1200 out of 46000 claims.”

Blue Cross Blue Shield of Michigan Files More Deeply Reduced Premiums for ACA Individual Plans Thanks to Extension of Federal Subsidy Program File this article under “spin.” Recall that last week MIchigan’s governor required planss to lower their premiums because of the subsidies. This announcement basically says “We have complied.”

About hospitals and healthcare systems

National Hospital Flash Report: August 2022 “U.S. hospitals and health systems are experiencing some of the worst margins since the beginning of the pandemic, and 2022 continues to be on pace to be the worst year of the pandemic in terms of financial performance. The gains hospitals saw in recent months reversed themselves in July, as lagging outpatient volumes shrunk revenues and expenses jumped up from June. Hospitals can no longer count on supplemental federal funding to buffer these mounting losses, as they did in previous pandemic years. The situation is so dire that on August 16 Fitch Ratings revised its sector outlook for U.S. not-for-profit hospitals and health systems to ‘deteriorating.’”
Read the entire summary on page 4.

 Cleveland Clinic reports $1B loss in first half of this year “Cleveland Clinic's revenue was down year over year in the second quarter of this year, and the health system ended the period with a loss, according to financial documents released Aug. 29. 
The health system's revenue totaled $3.1 billion in the three-month period ended June 30, down from $3.2 billion in the same quarter last year. 
Cleveland Clinic reported expenses of $3.1 billion in the second quarter of this year, up from $2.7 billion in the same period last year. The system saw expenses rise across all categories, including supplies and salaries, wages and benefits.”

 About healthcare quality

PATIENT ACCESS AND VALUE-BASED OUTCOMES AMID THE GREAT ATTRITION “Data from the survey found that revenue from value-based contracts accounted for varying amounts of total medical revenue in 2021 among reporting practices:

• 6.74% in primary care specialties • 5.54% in surgical specialties
• 14.74% in nonsurgical specialties.

Across all practices, the median revenue amount from value-based contracts was $30,922 per FTE provider.

About the public’s health

White House to make all federally funded research immediately accessible “The White House… issued a new policy that will require all federally funded research to be immediately — and freely — available to the public upon publication starting no later than 2026.
Why it matters: The memorandum, issued by the Office of Science and Technology Policy (OSTP), will end journals' abilities to put the results from federally funded research behind paywalls for up to one year and will increase the public's immediate access to such research.”

US Signs $11 Million Deal to Fund Monkeypox Vaccines Grand River Aseptic Manufacturing, Inc. in Michigan will produce the vaccine.

About healthcare IT

 Privacy bill triggers lobbying surge by data brokers “Congress has never been closer to passing a federal data privacy law — and the brokers that profit from information on billions of people are spending big to nudge the legislation in their favor.
Five prominent data brokers boosted their collective spending on lobbying by roughly 11 percent in the second quarter of this year compared with the same period a year ago, according to lobbying disclosure records reviewed by POLITICO. The $180,000 lobbying bump came as House Democrats and Republicans reached a compromise on a bipartisan bill aimed at giving consumers new powers to limit the collection and sharing of their data.”

Feds sue firm for selling data that could track people at abortion clinics “The Federal Trade Commission sued an app analytics company on Monday for selling cell phone location data that the agency said could be used to track people to sensitive locations like abortion clinics, domestic violence facilities and places of worship. 
Kochava, an Idaho-based firm, has been ordered to delete the data and stop collecting it in the future, according to the antitrust and consumer protection regulator.”

About healthcare finance

 InterWell Health finalizes $2.4B kidney care merger to combine tech, value-based care capabilities “InterWell Health completed a three-way merger with Fresenius Health Partners and Cricket Health to create a kidney care powerhouse on track to have $11 billion in costs under management by 2025. 
The three big players in kidney care announced in March plans to form a new value-based care company focused on services for the earlier stages of kidney disease.
The deal creates a company valued at $2.4 billion, according to the companies.”

Today's News and Commentary

About Covid-19

 COVID DATA TRACKER WEEKLY REVIEW From the CDC: “As of August 24, 2022, the current 7-day moving average of daily new cases (90,676) decreased 6.7% compared with the previous 7-day moving average (97,184). A total of 93,777,133 COVID-19 cases have been reported in the United States as of August 24, 2022.” 

Secret Service recovers $286 million in stolen Covid relief funds “The Secret Service said Friday that it has recovered $286 million in Covid relief funds that were meant for small businesses but were siphoned off by fraudsters using thousands of stolen or fake identities.
The conspirators used fake identities to apply for Covid relief funds known as Economic Injury Disaster Loans (EIDL), and created 15,000 accounts at Green Dot Bank, an online institution in Texas, to try to access the money using debit cards. Green Dot notified the Secret Service when it discovered suspicious accounts, and the EIDL money was returned to the Small Business Administration, which had administered the relief funds.”

About health insurance/insurers

 CMS indefinitely delays controversial radiation oncology model The Biden administration has finalized a rule that indefinitely delays the controversial radiation oncology payment model, which generated significant pushback from providers.
The Centers for Medicare & Medicaid Services (CMS) issued a final rule… surrounding the payment model that intended to reimburse oncology practices and outpatient sites for a total episode of care. It would also develop site-neutral payments for certain radiation therapies.”

Today's News and Commentary

About Covid-19

 Twitter labeled factual information about covid-19 as misinformation “Over the past week, Twitter has flagged dozens of tweets with factual information about covid-19 as misinformation and in some cases has suspended the accounts of doctors, scientists, and patient advocates in response to their posts warning people about the illness’s dangers.
Many of the tweets have since had the misinformation labels removed, and the suspended accounts have been restored. But the episode has shaken many scientific and medical professionals, who say Twitter is a key way they try to publicize the continuing risk of covid to a population that has grown weary of more than two years of shifting claims about the illness.”

Laboratory-Confirmed COVID-19–Associated Hospitalizations Among Adults During SARS-CoV-2 Omicron BA.2 Variant Predominance — COVID-19–Associated Hospitalization Surveillance Network, 14 States, June 20, 2021–May 31, 2022 From the CDC: “Increased hospitalization rates among adults aged ≥65 years compared with rates among younger adults were most pronounced during the Omicron BA.2–predominant period. Among hospitalized nonpregnant patients, 44.1% had received primary vaccination and ≥1 booster or additional dose. Hospitalization rates among unvaccinated adults were approximately triple those of vaccinated adults.”

About health insurance/insurers

 Association of Medicare Advantage Premiums With Measures of Quality and Patient Experience 
Findings  This retrospective cross-sectional study found statistically significant but small-to-medium sized (1-3 points of 100) improvements for most clinical and patient experience quality measures with higher premiums. There was a negative association for 1 measure; in contrast, at each premium level, there was substantial variation (≥5 points) in the quality of care among Medicare Advantage plans.
Meaning  These findings suggest that although there were modest improvements in the mean quality of care offered by high-premium Medicare Advantage plans, plans with high quality of care are available at every premium level.”
Read, also, the accompanying editorial: Getting the Most From Payments to Medicare Advantage Health Plans—Thoughts on the Controversy

Overall inflation has not yet flowed through to the health sectorWhile medical care prices increased by 4.8% between July 2021 and July 2022, the prices of many other consumer goods increased by significantly more.” Read this excellent summary by KFF with its usually well-done graphics.

About hospitals and healthcare systems

 CHS faces class-action fraud suit “The lawsuit alleges CHS misstated its financial position in documents provided to investors. In refusing to dismiss the action on Aug. 17, Judge Eli J. Richardson said the complaint adequately pleaded fraud, according to the report. 
The for-profit hospital operator allegedly used unreasonable accounting practices to produce financial documents that were unlikely to trigger defaults. The question of whether the practices were actually unreasonable is a question for the jury, the judge said.”

About pharma

 Moderna sues Pfizer and BioNTech for infringing on mRNA vaccine patents used in blockbuster Covid shots “Moderna alleges that Pfizer and BioNTech’s Covid-19 vaccine copied parts of its vaccine technology that it had patented between 2010 and 2016, when it was developing an mRNA vaccine for MERS. Moderna filed its lawsuit in a US district court in Massachusetts and the Regional Court of Düsseldorf in Germany, it said in a press release.
The lawsuit centers around two components of the mRNA vaccines and their three related patents. First, Moderna says that Pfizer and BioNTech made the same chemical modification to the mRNA to help it evade the immune system. And second, it says that Pfizer and BioNTech also used the full-length spike protein in its vaccine, which is a design Moderna says it patented.”

Drug manufacturers must submit reports on quality problems to FDA. Almost half of sites still don't, new report finds “The reports, known as Field Alert Reports (FARs), are crucial for the agency to root out manufacturing issues that can cause recalls or lead to harm.
But a new report from the agency found that of the 1,143 manufacturing sites that were eligible to submit a FAR  from 2018 to 2021, almost half (49%) of the sites did not submit a report.
Sites that did not submit FARs tend to be foreign, producing non-sterile products, and have fewer approved applications, the agency said.” 

Today's News and Commentary

About Covid-19

 Nirmatrelvir [Paxlovid] Use and Severe Covid-19 Outcomes during the Omicron Surge “Among patients 65 years of age or older, the rates of hospitalization and death due to Covid-19 were significantly lower among those who received nirmatrelvir than among those who did not. No evidence of benefit was found in younger adults.” 

About health insurance/insurers

Amazon plans to shut Amazon Care service amid One Medical overlap “Amazon.com Inc. is closing its primary care and telehealth service, a sudden move that follows the company’s deal to buy the One Medical chain of clinics.
Amazon Care, which was launched in 2019, will close by the end of the year, Senior Vice President Neil Lindsay said in an email to the company’s health care team…
’Although our enrolled members have loved many aspects of Amazon Care, it is not a complete enough offering for the large enterprise customers we have been targeting, and wasn’t going to work long-term.’

Medicare Advantage in 2022: Enrollment Update and Key Trends An excellent update from the KFF. Two statistics stand out: 48% of Medicare eligibles now belong to a MA plan; that number is expected to grow to 61% by 2032.

Evaluation of Spending Differences Between Beneficiaries in Medicare Advantage and the Medicare Shared Savings Program “In this economic evaluation of 15 763 MA and MSSP beneficiaries between 2014 and 2018, spending was 22% to 26% higher for MSSP beneficiaries than for MA beneficiaries even after controlling for detailed clinical risk factors. This was accounted for by higher outpatient hospital spending for MSSP beneficiaries.”

 NO SURPRISES ACT QPA CALCULATION QUESTIONED FOR VIOLATION IN NEW STUDY “In possible violation of the No Surprises Act, health insurance company calculations of qualified payment amounts (QPA) for anesthesiology, emergency medicine, and radiology services likely include rates from primary care provider (PCP) contracts, a new study says
This method may violate the No Surprises Act law and produce insurer-calculated QPAs that do not represent typical payments for these services, the study said.”

About pharma

Novartis to spin off generics business Sandoz next year “Novartis plans to spin off its underperforming generics unit Sandoz to sharpen its focus on its patented prescription medicines, the Swiss group said on Thursday, acknowledging it had not received any formal offers for the business to date.”
And in the Financial Times: Founded by the Sandoz family, the business merged with Ciba-Geigy to create Novartis in 1996. Drugs manufactured by Sandoz, which employs about 20,000 people and generates almost $10bn in annual sales, are a staple of medicine cabinets in Germany, Austria and Switzerland.”

 Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder: A Randomized Clinical Trial “In this double-blind randomized clinical trial with 93 participants, the percentage of heavy drinking days during 32 weeks of follow-up was significantly lower in the psilocybin group than in the diphenhydramine group.
Meaning  The results in this trial showed that psilocybin administered in combination with psychotherapy produced robust decreases in the percentage of heavy drinking days compared with those produced by active placebo and psychotherapy.” 

About the public’s health

Pfizer Announces Positive Top-Line Data from Phase 3 Trial of Older Adults for its Bivalent Respiratory Syncytial Virus (RSV) Vaccine CandidateVaccine efficacy of 85.7% was observed in participants with more severe disease primary endpoint of lower respiratory tract illness (LRTI-RSV) defined by analysis of three or more RSV-associated symptoms
—Investigational vaccine was well-tolerated with no safety concerns
—Based on the findings of this pre-planned, interim efficacy analysis, Pfizer intends to submitfor regulatory approval in fall 2022”

Mental Health Care: Last Week Tonight with John Oliver Excellent review of problems addressing mental health delivery in the US.

Judge blocks part of Idaho’s abortion law from taking effect “The Biden administration on Wednesday scored its first legal victory since the Supreme Court overturned Roe v. Wade, convincing a judge to block the portion of an Idaho law that criminalizes performing an abortion on a woman to protect her health.
The law, which was set to take effect on Thursday, bans abortions except in cases involving rape, incest or when a woman’s life is in danger — and does not contain an exception for when a pregnant person’s health is at risk…
In a ruling late Wednesday, U.S. District Judge B. Lynn Winmill said the statute violates a federal act that requires hospitals participating in the federally funded Medicare program to provide medical care when a person’s life or health is at stake.”

About healthcare IT

 2022 Healthcare Data Breach Report Here are the major takeaways from data collected over the first six months of 2022:

  • The total number of breaches is down 6% when comparing the first half of 2022 with the first half of 2021. Total breaches have declined for three consecutive six-month periods, and 2022 may see the first decline in annual breaches since Critical Insight began tracking the data. But, the yearly total is still expected to be above pre- pandemic levels.

  • Attackers seem to be shifting their focus away from large healthcare facilities, big targets that might yield the most data but also tend to have the strongest defenses, to smaller hospital systems and specialty clinics that might not have the same level of security preparedness, staff size, or budget. Hackers are also targeting physician groups. The number of attacks on physician groups has increased from 2% of total breaches in the first half of 2021 to 12% in the first half of 2022. 

  • 􏰀 Consolidation within the industry (multiple healthcare systems using the same electronic medical record (EMR) vendors, for example), has led to millions of exposed records as a result of attacks against third-party service providers. Electronic medical records (EMR) systems have emerged as a serious target for hackers, and increasingly breaches are occurring on third- party business associates, rather than on providers themselves.”

Surescripts Joins Civitas Networks for Health Surescripts has joined Civitas Networks for Health as a strategic business and technology partner to continue leveraging healthcare interoperability nationwide, providing better informed patient care and lower healthcare costs.
Civitas is the largest national network of its kind that includes member organizations working to use health information exchange, health data and multi-stakeholder, cross-sector approaches to improve health.

About healthcare finance

 Fresenius completes $2.4B merger with digital health startup “Fresenius Health Partners, InterWell Health and Cricket Health have completed a three-way merger to create an independent $2.4 billion company…
The new company will bring together the provider and payer relationships of InterWell Health, the technology and digital platform of Cricket Health and Fresenius's value-based care arm to deliver kidney disease care, according to the press release.”

Today's News and Commentary

About Covid-19

Moderna seeks FDA nod for booster shot aimed at Omicron BA.4, BA.5 “Moderna In on Tuesday sought U.S. authorization for its COVID-19 booster shot tailored against the BA.4 and BA.5 subvariants of Omicron and said if cleared it would be ready to deliver the doses in September.
Its application with the U.S. Food and Drug Administration (FDA) is based on pre-clinical data for the so-called bivalent dose that contains the dominant BA.4/BA.5 variants along with the original coronavirus strain. 

Pfizer COVID shots appear 73% effective in children under 5 The headline is the story

House investigates Trump’s ‘inappropriate’ pressure on FDA during the pandemic “The 69-page report found that the Trump White House “exerted extreme and inappropriate pressure” on FDA and former FDA commissioner Stephen Hahn to not only reauthorize hydroxychloroquine’s EUA, but deliver misleadingly positive news about convalescent plasma on the eve of the 2020 Republican National Convention, and to block the issuance of Covid-19 vaccine guidance, which the agency had to unilaterally release to require additional safety data.”

About health insurance

Michigan governor orders all payers to lower 2023 rates “Michigan Gov. Gretchen Whitmer sent a letter Aug. 18 to the Michigan Department of Insurance and Financial Services that requires all payers in the state to lower their already filed 2023 health insurance rates.
Ms. Whitmer said the order comes after the Inflation Reduction Act extended ACA premium subsidies through 2025.
’The new law extended insurance premium subsidies, which are currently saving hundreds of thousands of Michiganders nearly $800 a year,’ she wrote in the letter. ‘Today, I am instructing DIFS to require all insurers that offer coverage on HealthCare.gov to submit revised rates that reflect the cost savings as a result of enhanced subsidies.’”
Fascinating! Could this action be the harbinger of other state-based rate reductions?

 Cancer Now Top Driver of Employer Health Care Costs From the Business Group on Health: “Cancer has overtaken musculoskeletal conditions as the top driver of large companies’ health care costs, according to the Business Group on Health’s 2023 Large Employers’ Health Care Strategy and Plan Design Survey.
While the top three conditions fueling health care costs remained the same from last year – they include cardiovascular disease, in addition to cancer and musculoskeletal conditions – 13% of employers said they have seen more late-stage cancers and another 44% anticipate seeing such an increase in the future, likely due to pandemic-related delays in care.”

Common mistakes and helpful tips for parties initiating an IDR dispute More information from CMS on the Independent Dispute Resolution process for surprise bills.

About hospitals and healthcare systems

Mercy Mourns the Passing of Sister Mary Roch RocklageSister Mary Roch Rocklage, the modern day foundress of the Mercy health care system who served the ministry for 65 years, passed away on Tuesday, August 23, 2022 following a long illness she endured with grace and tenacity. She was 87.”
You should read the entire obituary- she was such an important force in the healthcare field.

 UPMC's 6-month operating income drops 86% alongside $866M investment loss “The Pennsylvania-based organization reported Tuesday nearly $12.5 billion in total operating revenues and over $12.4 billion in total operating expenses during the first half of 2022, yielding a net operating income of $82 million (0.7% operating margin).
Year over year, those numbers reflect a 2.5% increase in revenues, a 6.7% increase in expenses and an 86.4% plummet in operating income following the prior year’s 5% operating margin.
The negative pressure on operations came from the provider side of UPMC’s business. Its six-month operating margin fell $577 million compared to the year prior for a $101 million loss.”

Merger with SCL Health spurs Intermountain to $2.7B in net income “Dive Brief:

  • Intermountain Healthcare reported net income of $2.7 billion in the first six months of the year, despite a heavy loss on investments and flagging operating income.

  • The 46% year-over-year jump in net income for the Utah-based nonprofit was spurred by more than $4 billion in contribution from its merger with SCL Health that closed in April, according to recent financial documents.

  • By comparison, Intermountain brought in annual net income of $1.2 billion in 2020, $1.1 billion in 2019 and $599 million in 2018.”

About the public’s health

Life expectancy drops by almost 2 years “Overall life expectancy in the United States dropped by 1.8 years from 2019 to 2020, new data shows. The decline affected all 50 states and Washington, D.C., according to a new National Vital Statistics report [see Figure 4 for state-by-state statistics on these decreases], and ranged from as little as 0.2 years in some states to as many as 3 years in others…
The drop is the largest year-to-year change in more than 75 years…”
The study is full of statistics and mathematical models, but does not offer an explanation for the findings.

Judge in Texas blocks Biden administration emergency abortion guidance “A federal judge in Texas blocked the Biden administration late on Tuesday from enforcing new guidance in the Republican-led state requiring hospitals to provide emergency abortions to women regardless of state bans on the procedure…
 The judge declined to enjoin the guidance nationwide and instead only barred HHS from enforcing it and its interpretation of the Emergency Medical Treatment and Active Labor Act in Texas and against two anti-abortion groups of doctors.”
The federal government claims EMTALA mandates treatment in emergencies- including providing abortion services.  

Today's News and Commentary

About Covid-19

 COVID DATA TRACKER WEEKLY REVIEW “As of August 17, 2022, the current 7-day moving average of daily new cases (95,652) decreased 9.9% compared with the previous 7-day moving average (106,116). A total of 93,124,238 COVID-19 cases have been reported in the United States as of August 17, 2022.” 

About health insurance

 CMS approves first measures to track social determinants at federal level “The measure set, proposed by the Physicians Foundation, was adopted for use earlier this month in the Hospital Inpatient Prospective Payment System rule, effective 2023…
These measures are based on the foundation’s framework for addressing SDOH, published last year. An optional set is also being considered for physicians separately by CMS, the nonprofit organization told Fierce Healthcare.”
See, also, Meaningful Measures 2.0: Moving from Measure Reduction to Modernization

Judge rules CMS unfairly overturned Georgia's Medicaid work requirements program “A federal judge has sided with Georgia that the Biden administration unfairly struck down the state’s Medicaid work requirements program.
The ruling, issued late Friday, overturns the Centers for Medicare & Medicaid Services’ (CMS') decision to a controversial program first approved by the Trump administration.”
If upheld, this ruling could have major implications in other states that implemented such requirements.

About hospitals and healthcare systems

 Advocate Aurora reports $600.8M loss in first half of year “Advocate Aurora Health… reported revenue of $7.1 billion in the first two quarters of this year, up from $6.7 billion in the same period a year earlier. 
The health system's expenses were also up. Expenses climbed 9 percent year over year to $7 billion in the first six months of this year. Expenses increased across all categories, including salaries, wages and benefits…
After factoring in nonoperating items, the health system reported a net loss of $600.8 million in the first half of this year, compared to net income of $1.1 billion in the same period a year earlier.”

About pharma

 Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021 “ In this cohort study, among new drug indications approved through the accelerated approval or conditional marketing authorization pathways in the US and Europe from 2007 to 2021, 38.9% and 37.5%, respectively, demonstrated high therapeutic value. A substantially lower proportion of cancer indications than noncancer indications were rated as having high therapeutic value. Policy makers and regulators should increase enforcement of timely postapproval study completion for drugs qualifying for these pathways.”

About the public’s health

 1 in 3 American women have already lost abortion access. More restrictive laws are coming. “Two months after the Supreme Court overturned Roe v. Wade, about 20.9 million women have lost access to nearly all elective abortions in their home states, and a slate of strict new trigger laws expected to take effect in the coming days will shut out even more.
Texas, Tennessee and Idaho all have existing restrictions on abortion, but the laws slated to begin Thursday will either outlaw the procedure entirely or heighten penalties for doctors who perform an abortion, contributing to a seismic shift in who can access abortion in their home states.”

Wyoming confirms 1st monkeypox case; outbreak reaches all 50 statesWith its confirmation, Wyoming becomes the 50th state to diagnose at least one monkeypox infection in the current outbreak, according to the U.S. Centers for Disease Control and Prevention. Puerto Rico and Washington, D.C., have also reported infections, it said.”

Statin Use for the Primary Prevention of Cardiovascular Disease in Adults “The USPSTF recommends that clinicians prescribe a statin for the primary prevention of CVD for adults aged 40 to 75 years who have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD risk of 10% or greater. (B recommendation) The USPSTF recommends that clinicians selectively offer a statin for the primary prevention of CVD for adults aged 40 to 75 years who have 1 or more of these CVD risk factors and an estimated 10-year CVD risk of 7.5% to less than 10%. The likelihood of benefit is smaller in this group than in persons with a 10-year risk of 10% or greater. (C recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating a statin for the primary prevention of CVD events and mortality in adults 76 years or older. (I statement).”
Read one of the accompanying editorials: Statin Usage in Primary Prevention—Comparing the USPSTF Recommendations With the AHA/ACC/Multisociety Guidelines

 

Today's News and Commentary

Fauci plans to step down in December after half a century in government “Anthony S. Fauci, the nation’s preeminent infectious-disease expert who achieved unprecedented fame while enduring withering political attacks as the face of the coronavirus pandemic response under two presidents, plans to step down in December after more than a half-century of public service, he announced Monday.
Fauci, 81, has led the National Institute of Allergy and Infectious Diseases since 1984. He joined the parent agency, the National Institutes of Health, in 1968 as a 27-year-old doctor who had just finished medical residency and was quickly identified as a rising star…
Fauci emphasized that he is not exiting the public square. He said he hopes to teach, lecture, write — perhaps a book, along with essays and other types of writing — and use his experience to inspire and teach a younger generation of scientists.”

About Covid-19

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine “Pfizer Inc. and BioNTech SE today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine to address the continued evolution of SARS-CoV-2. Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.”

Creating a Roadmap for the End of the COVID-19 Public Health Emergency “CMS has developed a roadmap for the eventual end of the Medicare PHE waivers and flexibilities, and is sharing information on what health care facilities and providers can do to prepare for future events. Similar to the guidance CMS has made available to states, CMS is releasing fact sheets that will help the health care sector transition to operations once the PHE ends, whenever that may occur….
The fact sheets we are releasing… summarize the current status of Medicare Blanket waivers and flexibilities by provider type as well as flexibilities applicable to the Medicaid community.”

 Everyone over 12 expected to be eligible for new boosters, White House official says The headline is the story.

 FDA authorizes Novavax Covid-19 vaccine for emergency use in ages 12-17 The headline is the story.

About health insurance/Costs

REQUIREMENTS RELATED TO SURPRISE BILLING: FINAL RULES Fact Sheet from the Department of Labor

An early look at what is driving health costs in 2023 ACA markets “We find that insurers in this market are proposing to raise premiums by more than in recent years. The median proposed premium increase is 10% across these 72 insurers. The main contributor to premium growth is health cost trend, which reflects rising prices paid to providers and pharmaceutical companies as well as a rebound in utilization. While our analysis focuses on the ACA markets, the main premium drivers we identified (prices and utilization) are systemic and not specific to the ACA markets.”

 Aon: U.S. Employer Health Care Costs Projected to Increase 6.5 Percent Next Year “Average costs for U.S. employers that pay for their employees' health care will increase 6.5 percent to more than $13,800 per employee in 2023, according to Aon…
This projection is more than double the 3 percent increase to health care budgets which employers experienced from 2021 to 2022; but is significantly below the 9.1 inflation figure reported through the Consumer Price Index…
Medical claims were suppressed for most employers during the first year of the COVID-19 pandemic, during which time much care was postponed or skipped during quarantines. Employers have seen the medical claims experience return to more typical levels of growth and anticipate inflationary cost pressures in the coming year.”

CMS Releases Proposed Rule to Improve Medicaid & CHIP Quality Reporting Across States “This rule proposes requirements for mandatory annual state reporting of three different quality measure sets:

  • the Core Set of Children’s Health Care Quality Measures for Medicaid and CHIP;

  • the behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid; and

  • the Core Sets of Health Home Quality Measures for Medicaid.

These Core Sets are designed to measure the overall national quality of care for beneficiaries, monitor performance at the state level, and improve the quality of health care.”

About hospitals and healthcare systems

 Failed Medicaid expansion negotiations reveal N.C. hospitals' might  The expansion had bipartisan support, but the state hospital association successfully quashed the effort because in contained a provision pulling back on the certificate of need (CON)law; in other words, it could have increased competition for hospitals.
For an update of CON laws, see: Certificate of Need (CON) State Laws

About pharma

 Pharma ad spending up just 1% this year as the slow move away from TV into digital continues For “the first six months of 2022, the pharma industry spent $5.5 billion on all ads for its products, most of which was on its drug products.  
While that’s a huge figure, it actually represents a slow drop in growth from previous years, with only a slight 1% lift during January to June 2022 versus the same time last year.
Ad spend for prescription drugs, which accounts for 88% of pharma category dollars ($4.8 billion), in fact fell 2% year on year. On the other hand, ad expenses for over-the-counter medicines and remedies jumped 23% during the same period.“  

FDA accepts Astellas menopause drug NDA “Tokyo-based Astellas Pharma announced this week that the U.S. FDA has accepted its New Drug Application for fezolinetant, an investigational new drug for the treatment of menopause-associated symptoms such as hot flashes or night sweats.
The indicated PDUFA date is February 22, 2023, as Astellas is also employing a priority review voucher. The NDA acceptance hinged on three phase 3 trials which enrolled 2,800 women from across the U.S., Canada and Europe. The trials evaluated the efficacy and safety of the drug for the treatment of moderate to severe vasomotor symptoms (VMS) caused by menopause or sex-related hormone disorders.”
However, this March: Astellas' menopause drug suffers rare setback as failed Asian trial blots previously pristine record “Astellas’ $550 million bet on menopause drug fezolinetant has hit unexpected turbulence. After acing a pair of phase 3 clinical trials and racing to regulators, Astellas has reported the failure of fezolinetant to beat placebo in a late-stage study of patients in Asia.”
This case highlights the vagaries of the FDA approval process.

About the public’s health

 The global burden of cancer attributable to risk factors, 2010–19: a systematic analysis for the Global Burden of Disease Study 2019 “The leading risk factors at the most detailed level globally for risk-attributable cancer deaths and DALYs in 2019 for both sexes combined were smoking, followed by alcohol use and high BMI. Risk-attributable cancer burden varied by world region and Socio-demographic Index (SDI), with smoking, unsafe sex, and alcohol use being the three leading risk factors for risk-attributable cancer DALYs in low SDI locations in 2019, whereas DALYs in high SDI locations mirrored the top three global risk factor rankings.” 

Low-temperature mineralization of perfluorocarboxylic acids “Per- and polyfluoroalkyl substances (PFAS) are persistent, bioaccumulative pollutants found in water resources at concentrations harmful to human health. Whereas current PFAS destruction strategies use nonselective destruction mechanisms, we found that perfluoroalkyl carboxylic acids (PFCAs) could be mineralized through a sodium hydroxide–mediated defluorination pathway. PFCA decarboxylation in polar aprotic solvents produced reactive perfluoroalkyl ion intermediates that degraded to fluoride ions (78 to ~100%) within 24 hours.”
A potentially low-cost, effective means to address this important solution problem.

WHO says monkeypox vaccine ‘not a silver bullet’ as breakthrough cases reported “There is limited data on the efficacy of the vaccine, and what is available has been drawn from animal studies. The main study used to indicate efficacy dates back to the 1980s and looked at a different type of smallpox vaccine — potentially more powerful than the safer vaccines that have since been developed. That study showed 85 percent protection against monkeypox.”

High-Contact Object and Surface Contamination in a Household of Persons with Monkeypox VirusInfection — Utah, June 2022Monkeypox virus DNA was detected from many objects and surfaces sampled indicating that some level of contamination occurred in the household environment. However, the inability to detect viable virus suggests that virus viability might have decayed over time or through chemical or environmental inactivation. Although both patients were symptomatic and isolated in their home for >3 weeks, their cleaning and disinfection practices during this period might have limited the level of contamination within the household. These data are limited, and additional studies are needed to assess the presence and degree of surface contamination and investigate the potential for indirect transmission of Monkeypox virus in household environments.”

About healthcare IT

 NIH ANNOUNCES 4 TELEHEALTH RESEARCH CENTERS OF EXCELLENCE FOR CANCER CARE “The National Institutes of Health's National Cancer Institute (NCI) has designated four health systems as national centers for excellence for their work in using telehealth to improve cancer treatment and care management. The four programs will split $23 million over the next five years to establish the NCI's Telehealth Research Centers of Excellence (TRACE) initiative, which is being supported by the Cancer Moonshot, launched in 2016 and restarted earlier this year by President Joe Biden.”

Electronic Public Health Reporting & Recording of Social & Behavioral Determinants of Health Among Office-Based Physicians, 2019 HIGHLIGHTS:

  • In 2019, less than one in five primary care physicians electronically exchanged (i.e., sent or received) health information with PHAs.

  • Nearly half of primary care physicians reported electronically searching or querying for vaccination or immunization history from sources outside their health care organization.

  • Most physicians electronically recorded social and behavioral determinants of health data.

  • Physicians who engaged in interoperability were more likely to electronically: exchange information with PHAs; search for vaccination information; and record social and behavioral determinants of health data.

  • Certified health IT use is associated with higher rates of electronic public health reporting and electronic recording of social and behavioral determinants of health data.

  • Public health reporting and recording capabilities varied by EHR developer market share…

  • In 2019, about one in ten (12%) office-based physicians nationally electronically exchanged patient health information with PHAs, including the Centers for Disease Control and Prevention (CDC), state or local public health authorities..

  • Electronic exchange capabilities were higher among primary care physicians (18%) compared to physicians nationally, ranging from 12% of general/family practice primary care physicians to 24% of internal medicine and 26% of pediatric primary care physicians.

  • Overall, about a quarter of physicians nationally did not know whether their practice electronically exchanged patient health information with PHAs.”

More than 80 health systems hit by cybersecurity breaches in August FYI

About healthcare personnel

 CommonSpirit readies launch of nation’s largest nursing residency program According to CEO Wright Lassiter: “ We’re creating this inner nationwide staffing company to create a platform whereby nurses can work in 21 states with out having to depart the employer, with out having to lose seniority, with out being outdoors the profit and mission halo of the group.”

About health technology

 Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy Read the FDA notice about this Class 1 recall.
And in a related article: Medical Device Recalls Hit Two-Year Record in Q2 “Medical device recalls reached their highest level in two years during the second quarter of 2022 with 268 events, a 34 percent increase from the 200 recalls in the first quarter…” 

Today's News and Commentary

About health insurance

 Customers Perceive Shortfall in Medicare Advantage Plan Coverage of Mental Health and Substance Abuse Services, J.D. Power Finds “Following are some of the key findings of the 2022 study:

  • Overall member satisfaction with Medicare Advantage plans rises: Overall customer satisfaction with Medicare Advantage plans is 809 (on a 1,000-point scale), which is up 3 points from 2021 and up 15 points during the past five years.

  • Missing the mark on mental health and substance abuse disorder services: Just 38% of Medicare Advantage plan members say they have enough coverage for mental health treatment, down from 39% a year ago. Just 27% of members say they have enough coverage for substance use disorder services. These numbers compare with 91% of members who say they have enough coverage for routine diagnostics and 89% who say they have enough coverage for preventive and wellness services.

  • Telemedicine usage declines, despite largely positive experiences: Just 24% of Medicare Advantage plan members used telemedicine during the past year, down from 35% in 2021. Among those who have used the technology, however, 48% say they are very likely to use it again, an increase of five percentage points from last year.

  • Health plan portals still show promise, but breaking inertia is hard: A strong majority (82%) of Medicare Advantage members are registered for their health plan’s member portal—up four percentage points from a year ago. However, 14% have registered for the portal but never logged in. Overall customer satisfaction scores are 72 points higher (823) when customers register and log-in to the portal than when they do neither (751).” 

About hospitals and healthcare systems

 Fitch: Nonprofit hospitals' outlook 'deteriorating' for remainder of 2022 “Fitch Ratings adjusted its outlook for nonprofit hospitals from ‘neutral’ to ‘deteriorating’ halfway through what has proven to be a rough year for the industry…
’While severe volume disruption to operations appears to be waning, elevated expense pressure remains pronounced,’ Kevin Holloran, senior director at Fitch Ratings, said in a release accompanying the outlook report. ‘Even if macro inflation cools, labor expenses may be reset at a permanently higher level for the rest of 2022 and likely well beyond.’
Fitch anticipates nonprofit hospitals’ operating margins will reflect those pressures through the back half of the year, although many organizations will be able to somewhat weather the storm with the record levels of cash they accumulated last year. Still, asset price corrections in the market are substantially trimming the investment portfolios built up during 2021’s strong markets, the agency noted.”
And in a related story: Inflation Reduction Act may help ease payers' Medicaid losses if public health emergency ends, Fitch says “Payers with large Medicaid operations are expected to face negative pressure on revenues if the federal public health emergency ends in October, but the total impact on profits is likely to be small because of coverage alternatives offered by the Inflation Reduction Act, according to an Aug. 11 analysis Fitch Ratings shared with Becker's.
If the public health emergency is allowed to end October 13, a redetermination process will begin a major disenrollment of Medicaid beneficiaries, likely over the course of a year.
All payers operating Medicaid plans will be affected, but those with higher enrollments are expected to be more impacted. The loss of beneficiaries will be mitigated through the Inflation Reduction Act's extensionof ACA premium tax credits through the end of 2025, which will allow some to regain coverage in the individual market.”

Hospital collection rates for self-pay patient accounts ”As out-of-pocket payment responsibilities continue to rise for patients, hospitals employ more and different efforts to collect these self-pay amounts. But Crowe analytics are showing that after the patient portion reaches into the thousands of dollars, collectability drops off starkly. And that “vanishing point” threshold is now $7,500…
Self-pay after insurance accounts for almost 58% of bad debt.” 

About pharma

 Walmart, CVS and Walgreens ordered to pay $650 million to Ohio counties for opioid crisis “U.S. District Court Judge Dan Aaron Polster ordered Walmart, CVS Pharmacy and Walgreens to pay a total of $650.5 million to Lake County and Trumbull County over the next 15 years. In the lawsuit, the companies were accused of oversupplying opioids through their pharmacies, contributing to the opioid crisis.”

FDA Approves Citrate-Free, High Concentration of Biosimilar Hadlima “The Food and Drug Administration (FDA) has approved a citrate-free, high concentration formulation of 100mg/mL of Hadlima™(adalimumab-bwwd), a biosimilar to Humira®(adalimumab).” No information is yet available about the price.

About the public’s health

 Monkeypox cases jump 20% in 1 week, WHO finds: 5 updates  FYI. Among the most worrisome statistic is t “The U.S. accounts for more than 38 percent of global cases.”
And in a related article: Monkeypox Vaccine Maker Seeks Partners in Race to Meet Demand “Bavarian Nordic A/S, the only company with an approved vaccine for monkeypox, said it’s no longer certain it can meet demand and is talking to multiple production partners as cases rise across the world. 
The Danish company is exploring the possibility of outsourcing some of its production, including a technology transfer to a US contract manufacturer, to meet accelerating demand.”
Breaking news: Deal struck to expedite production of monkeypox vaccines in U.S. “Under the arrangement, Denmark-based Bavarian Nordic will work with Michigan-based Grand River Aseptic Manufacturing to package 2.5 million doses of vaccine that the United States had ordered in July.”

About healthcare IT

 Satisfaction with modes of telemedicine delivery during COVID-19: A randomized, single-blind, parallel group, noninferiority trial “Among a group of diverse, established older or underserved patients the satisfaction rate for phone-only was noninferior to video visits. These findings could impact practice and policies governing telemedicine.” 

NY Billing Company Suffers Ransomware Attack, 942K Impacted “New York-based medical billing and practice management company Practice Resources, LLC (PRL) began notifying 942,138 individuals of a ransomware attack that impacted 26 of its healthcare organization clients.
According to a notice posted on the California Attorney General’s Office website, PRL suffered a ransomware attack on April 12, 2022. PRL immediately took steps to secure its systems and gained assistance from third-party experts.
The information involved in the attack potentially included names, addresses, health plan numbers, dates of treatment, and medical record numbers.”
This case highlights the importance of “Business Associate” agreements.

About health technology

 Raymond Damadian, Creator of the First M.R.I. Scanner, Dies at 86 

New Method Improves Speed and Cost of Birth Defect Testing “After 10 years of effort, medical researchers at Columbia University have developed a very fast and cheap way to detect the extra or missing chromosomes that most often cause miscarriages or severe birth defects.
The method, described Wednesday in the New England Journal of Medicine, takes less than two hours using a palm-size device and costs $200 per use. With current testing procedures, women can end up paying $1,000 to $2,000, often out of pocket.
The technique, developed by Dr. Zev Williams, director of the Columbia University Fertility Center, and his colleagues, uses cells and tissues obtained from existing prenatal screening procedures of embryos and fetuses, or tissue obtained after miscarriages. Its key advantage is that the cells or tissue do not have to be sent to a testing lab — the analysis can be done in the same office that obtained the material, and results are ready in hours rather than days or weeks.”

Guardant Health’s Liquid Biopsy Test Reveal Gets Expanded Clearance “Guardant Health’s Reveal liquid biopsy test received an expanded clearance from the FDA to include patients with breast and lung cancers.
The test works by detecting circulating tumor DNA in the blood after surgery to identify patients with minimal residual disease who have a higher risk for recurrence and may benefit from additional therapy.”

Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application “Is self-monitoring of blood pressure using an enhanced device that pairs with a connected smartphone application more effective in reducing systolic blood pressure than self-monitoring using a standard device?” The short answer is “No.”
”In this randomized clinical trial of 2101 patients with uncontrolled blood pressure, patients were randomly assigned to standard or enhanced self-monitoring of their blood pressure and mailed a self-monitoring device, after which usual care and in-person clinic blood pressure measurements from ambulatory visits during 6 months of follow-up were used to compare changes from baseline. The mean (SD) change in systolic blood pressure was −10.8 (18) mm Hg vs −10.6 (18) mm Hg in enhanced vs standard groups.”

Today's News and Commentary

About Covid-19

 Biden administration will stop buying Covid-19 vaccines, treatments and tests as early as this fall, Jha says “‘My hope is that in 2023, you're going to see the commercialization of almost all of these products. Some of that is actually going to begin this fall, in the days and weeks ahead. You're going to see commercialization of some of these things,’ he said.”

About health insurance

 CMS discontinues medical device forms to ease physician administrative burdens “The Centers for Medicare and Medicaid Services announced Wednesday it will discontinue the certificates of medical necessity (CMN) and durable medical equipment information forms (DIF) starting in 2023. 
Both forms are currently needed to get reimbursement for medical equipment to ensure they are medically necessary. However, CMS rethought the need for the forms recently…
Earlier this month, CMS suspended prior authorization requirements under certain circumstances for orthopedic medical equipment like prosthetics. Congress is also considering legislation that would mandate electronic prior authorization processes for Medicare Advantage plans and streamline a process that physicians say consumes too much of their time.”

About hospitals and healthcare systems

 NRC Health Consumer Loyalty Award 2022 Award Winners  FYI

About pharma

FDA approves one of the priciest new treatments of all time — bluebird's gene therapy for beta thalassemia “And while bluebird said it will charge up to $2.8 million for the therapy, drug pricing watchdog ICER previously said the therapy would be cost-effective up to $3 million per dose, Thomas Klima, chief commercial officer at bluebird told Endpoints News in an interview earlier this week. He said the price makes sense considering it can cost $6.4 million for a lifetime of transfusions…
 Bluebird is also saying it will provide up to an 80% rebate if the patient doesn’t hit or maintain transfusion independence.” 

Endo files for Chapter 11 as it looks to finish off its opioid litigation ”The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.”

Since Biden took over, Big Pharma has spent $205 million to protect drug price status quo, analysis finds “Since 2020, the year Biden moved into the White House, the industry has spent more than $205 million battling to preserve the status quo, an analysis from Accountable.US finds. The figure includes $149 million in lobbying efforts aimed specifically at drug pricing and more than $57 million in television, cable, radio and social media ads opposing Medicare price negotiations.”

J&J Unit Tells Appeals Court Only Bankruptcy Can Settle Talc Claims “The subsidiary, LTL Management LLC, said in court papers filed on Monday that chapter 11 is the only option for compensating all claimants relatively quickly.
LTL, which J&J created last year to move mass talc litigation to bankruptcy, laid-out a defense of its strategy in its filing in the Third U.S. Circuit Court of Appeals, which is considering a request by injury claimants to have the subsidiary’s chapter 11 bankruptcy thrown out of court.”

About the public’s health

 CDC, under fire, lays out plan to become more nimble and accountable “A background briefing document shared with The Washington Post spells out some of CDC’s most pressing problems and proposed solutions.
Some measures, such as new authority to mandate state data reporting, hire people faster and offer competitive salaries to recruit and retain top people, will require action from Congress. Others are internal changes that Walensky can make, such as having science and laboratory sciences offices, two key divisions that would be out front on a public health crisis, report directly to her. And some will require negotiations with unions.”
Read the article for more details.

About healthcare personnel

 Primary Care Matters Medi-Cal Study Key Findings

  • The level of investment in primary care — defined as the percentage of a health plan’s overall spending dedicated to primary care services — varied widely among the 13 Medi-Cal managed care plans that participated in the study, with a low of 5% to a high of 19%. The average was roughly 11%.

  • A significant statistical relationship was observed between plans with higher primary care spending percentages and those that scored higher on the Aggregated Quality Factor Score, a composite measure of overall care quality, which includes the percentage of plan members who complete well-child visits, receive immunizations, have control of their diabetes, and receive recommended cancer screenings, among other measures.

  • When individual measures of quality were studied, a relationship was found between plans with a higher percentage of spending on primary care and better performance on 9 of 11 measures. Three of these measures met criteria for statistical significance.

  • Plans that spend a higher percentage on primary care were more likely to get a better plan rating from the National Committee for Quality Assurance. NCQA evaluates health plans on the quality of care patients receive, measures of patient experience, and health plans’ efforts to keep improving.”

Today's News and Commentary

Biden Signs Expansive Health, Climate and Tax Law “President Biden on Tuesday signed a long-awaited bill meant to reduce health costs, reduce greenhouse gas emissions and raise taxes on corporations and wealthy investors, capping more than a year of on-again, off-again negotiations and cementing his early economic legacy…
The bill, which Democrats named the Inflation Reduction Act, invests $370 billion in spending and tax credits in low-emission forms of energy to fight climate change. It extends federal health-insurance subsidies, allows the government to negotiate prescription drug prices for seniors on Medicare and is expected to reduce the federal budget deficit by about $300 billion over 10 years.”

About Covid-19

Profiling post-COVID syndrome across different variants of SARS-CoV-2 This preprint paper posits several different types of post-Covid syndrome:
”We identified distinct profiles of symptoms for post-COVID syndrome within and across variants: four endotypes were identified for infections due to the wild-type variant; seven for the alpha variant; and five for delta. Across all variants, a cardiorespiratory cluster of symptoms was identified. A second cluster related to central neurological, and a third to cases with the most severe and debilitating multi-organ symptoms. Gastrointestinal symptoms clustered in no more than two specific phenotypes per viral variant. The three main clusters were confirmed in an independent testing sample, and their functional impact was assessed.”

 Multiple Shots of the Bacillus Calmette-Guerin (BCG) Vaccine Protect Patients with Type 1 Diabetes from COVID-19 “Researchers at Massachusetts General Hospital (MGH), published a new paper in Cell Reports Medicine demonstrating the protective potential of multiple doses of the Bacillus Calmette-Guerin (BCG) vaccine against COVID-19 and other infectious diseases.
In a double-blind, placebo-controlled study of patients with type 1 diabetes conducted at the start of the pandemic (before COVID-specific vaccines were available), the researchers found that 12.5% of placebo-treated individuals and 1% of BCG-treated individuals met criteria for confirmed COVID-19, yielding a vaccine effectiveness of 92%.
The BCG-vaccinated group also displayed protective effects against other infectious diseases, including fewer symptoms, lesser severity and fewer infectious disease events per patient. No BCG-related systemic adverse events occurred.” 

About health insurance

 Healthcare billing fraud: 10 recent cases FYI

About hospitals and healthcare systems

 The 10 Largest Health Systems in the US FYI

FTC warns states against laws permitting hospital mergers under special conditions “The Federal Trade Commission (FTC) is warning states away from certificates of public advantage (COPAs) legislation, cautioning that hospital mergers permitted under these laws still bring many of the detrimental effects of consolidation they purport to prevent.
State-level COPA laws allow hospitals to avoid federal antitrust enforcement should they demonstrate that a merger’s benefits outweigh the negative impacts of reduced market competition, such as higher prices and reduced quality of care.
The laws often come with specific terms such as price controls or mechanisms to pass along cost savings and efficiencies and are supervised by state departments of health and attorneys' general offices.
In a policy paper released Monday by the FTC, the agency said it has seen a ‘resurgence’ of the laws in recent years, including those passed by state legislatures ‘with the intent of exempting specific proposed hospital mergers from anticipated antitrust challenges.’”

About pharma

Newly launched U.S. drugs head toward record-high prices in 2022 “The median annual price of 13 novel drugs approved for chronic conditions by the U.S. Food and Drug Administration so far this year is $257,000, Reuters found.
They were in good company: seven other newly-launched drugs were priced above $200,000. Three other drugs launched in 2022 are used only intermittently and were not included in the calculation.”

Analysts rule out major industry impact from drug pricing negotiations “While it is hard to predict which drugs Medicare will target, BofA estimates that negotiations will lead to a 25% price reduction for the 25 drugs the program spends the most in 2026 and beyond. The firm does not expect the bill to cause a significant impact on industry growth.
Meanwhile, noting the limited scope of the provisions, UBS argues that Medicare negotiations under the bill are unlikely to be the worst-case scenario for the industry.”
The law’s initial impact will obviously not be immediate: however we will need to see how much else is implemented in the future, especially, purchasing Part B drugs and expansion of government limits to the private sector.

 Merck bets big on circular RNA, paying $150M and dangling $3.5B in biobucks to work with Orna “The Big Pharma is making the upfront payment and committing to up to $3.5 billion in milestones to work with Orna to advance programs including engineered circular RNA (oRNA) vaccines and therapeutics against infectious diseases and cancers. Orna will retain rights to its oRNA-LNP platform and continue to advance other wholly owned programs internally.”

About the public’s health

FDA moves to make over-the-counter hearing aids available to millions “The Food and Drug Administration on Tuesday moved to make hearing aids available to consumers to buy over the counter without a prescription or medical exam…
‘As early as mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country,’ President Biden said…”

U.S. to provide states with up to 442,000 Jynneos doses to combat monkeypox “The U.S. government said on Monday it will provide states with up to 442,000 doses of Bavarian Nordic's Jynneos vaccine to combat the outbreak of monkeypox disease.
The allocation, as part of the Phase 3 of the national vaccine strategy, is double the number of doses originally anticipated, the Department of Health and Human Services said.
The government was initially planning to dispatch the doses in two segment but combined it together after the Food and Drug Administration last week allowed administering the shot intradermally…” 

About healthcare IT

 Facebook tracker compromised PHI of 1.3M Novant Health patients “Novant Health notified patients Aug. 12 that their protected health information may have been improperly disclosed because of a Facebook tracking tool used in a May 2020 marketing campaign. 
In May, Novant Health launched a promotional campaign involving Facebook advertisements and a Meta tracking pixel which was placed on the health system's website, according to a press release from Novant. 
The tracking tool was intended to help Novant Health track the campaign's success, but ended up allowing certain private information to be transmitted to Facebook's parent company Meta from the Novant Health website and MyChart patient portal. Novant discovered the possible disclosures June 17.”

About healthcare personnel

 Revisiting the Time Needed to Provide Adult Primary Care “PCPs were estimated to require 26.7 h/day, comprising of 14.1 h/day for preventive care, 7.2 h/day for chronic disease care, 2.2 h/day for acute care, and 3.2 h/day for documentation and inbox management. With team-based care, PCPs were estimated to require 9.3 h per day (2.0 h/day for preventive care and 3.6 h/day for chronic disease care, 1.1 h/day for acute care, and 2.6 h/day for documentation and inbox management).”
Are there organizational and/or technical changes that would enhance efficiencies? Are all  requirements equally productive?