Census projects U.S. population bust by 2080 A great review of demographic projections.
Americans’ Trust in Scientists, Positive Views of Science Continue to Decline “Overall, 57% of Americans say science has had a mostly positive effect on society. This share is down 8 percentage points since November 2021 and down 16 points since before the start of the coronavirus outbreak.
About a third (34%) now say the impact of science on society has been equally positive as negative. A small share (8%) think science has had a mostly negative impact on society.”
About Covid-19
FDA clears its first OTC home antigen test for COVID-19. No, really “This week, the FDA granted its first full, bona fide clearance to an over-the-counter home antigen test for COVID-19, and its first to carry an official 510(k) for use in children under age 18…
The Flowflex COVID-19 antigen home test, developed by ACON Laboratories, initially received an EUA in 2021. It now marks the second home COVID-19 test to successfully complete the FDA’s traditional premarket review pathway—following the de novo clearance claimed this past June by Cue Health for its at-home molecular-based test.”
Supreme Court Delivers Blow to Vaccine Skeptics “The U.S. Supreme Court rejected to hear an appeal relating to COVID-19 vaccine requirements in the workplace, dealing a blow to vaccine skeptics across the nation.
On Tuesday morning, the Supreme Court orders list showed that it was denying to hear any further arguments in the case Katie Sczesny, et al. v. Murphy, Gov. of New Jersey, et al. The case focused on four New Jersey nurses who filed a lawsuit against New Jersey's COVID-19 vaccine requirements in the workplace, citing religious freedom and health concerns.”
About health insurance/insurers
Health Care Digest A great source of managed care data and trends since 1987.
The Cost of Not Getting Care: Income Disparities in the Affordability of Health Services Across High-Income Countries “Highlights:
Adults in the United States face wider income-related disparities in health care affordability compared to adults in other high-income countries.
Germany and the Netherlands experienced among the lowest rates of affordability problems and the fewest income-related disparities.
Adults in the U.S. with lower or average incomes are more likely to skip needed medical care and have problems paying medical bills than all other countries in this analysis.
In the U.S., adults with higher incomes are more likely to have health care affordability problems, including cost-related access issues and medical bill problems, than their counterparts in most other countries.”
Anthem, Cigna settle contract claims, clearing way for appeal in $14.8 bln suit “Anthem and Cigna Group's CI.N Express Scripts unit on Monday settled the last pending claim in a long-running contract dispute, clearing the way for Anthem to appeal the dismissal of its $14.8 billion lawsuit accusing Express Scripts of overcharging it for prescription drugs.
Anthem had sued Express Scripts, a pharmacy benefit manager, in Manhattan federal court in 2016, accusing it of failing to negotiate over drug prices in good faith under a 10-year contract that began in 2009. Anthem said it was entitled to $14.8 billion in damages as a result of the breach.”
Officials project sharp drop in Medicaid enrollment next year as unwinding continues “The [KFF] survey projected national Medicaid enrollment will decline by 8.6 percent in fiscal 2024, as states keep removing ineligible people from their Medicaid rolls.
According to KFF, more than 10 million low-income people have lost coverage as of Nov. 8, based on the most current data from 50 states and the District of Columbia. More than 70 percent of those who lost coverage were removed because of “procedural” reasons such as missing paperwork or errors by state officials, raising concerns that many people who remain eligible for Medicaid may be losing coverage.”
Biden expands veterans’ health care coverage “Starting this month, all living World War II veterans can access health care services from the Department of Veterans Affairs (VA) at no cost, including nursing home care, the White House said in a press release.
The VA will also accelerate eligibility under the PACT Act, a major law that passed last year and expanded benefits for veterans exposed to toxins and chemicals. Veterans who have yet to enroll will be able to do so next year.
Biden also announced a new campaign and task force called Veteran Scam and Fraud Evasion (VSAFE), aimed at protecting veterans and their families from scams, which the administration said cost the military and veterans more than $414 million last year.”
UnitedHealth faces class action lawsuit over algorithmic care denials in Medicare Advantage plans “Aclass action lawsuit was filed Tuesday against UnitedHealth Group and a subsidiary alleging that they are illegally using an algorithm to deny rehabilitation care to seriously ill patients, even though the companies know the algorithm has a high error rate.
The class action suit, filed on behalf of deceased patients who had a UnitedHealthcare Medicare Advantage plan and their families by the California-based Clarkson Law Firm, follows the publication of a STAT investigation Tuesday. The investigation, cited by the lawsuit, found UnitedHealth pressured medical employees to follow an algorithm, which predicts a patient’s length of stay, to issue payment denials to people with Medicare Advantage plans. Internal documents revealed that managers within the company set a goal for clinical employees to keep patients rehab stays within 1% of the days projected by the algorithm.”
CMS tightening network adequacy standards for exchange plans “Beginning in 2025, health plans sold in state-run insurance exchanges would be required to meet time and distance standards that are at least as adequate as mandated on federal marketplaces, according to a rule released by the Centers for Medicare and Medicaid Services on Wednesday.
Time and distance standards would be calculated at the county level and then applied to lists of provider specialties.”
Health Insurers Have Been Breaking State Laws for Years Great piece of investigative journalism from ProPublica.
Over the last four decades, states have enacted hundreds of laws dictating precisely what insurers must cover so that consumers aren’t driven into debt or forced to go without medicines or procedures. But health plans have violated these mandates at least dozens of times in the last five years, ProPublica found.”
About hospitals and healthcare systems
CMS finalizes rule requiring greater transparency for nursing home ownership “The Centers for Medicare & Medicaid Services (CMS) has finalized a rule that will require more transparency into nursing home ownership.
Under the rule, nursing facilities that are enrolled in Medicare and Medicaid, which encompasses most, must disclose additional details about their owners, operators and management. CMS said in a press release that the final rule aims to more clearly define private equity and real estate investment trusts to make these disclosures simpler.”
Under Amazon, One Medical builds out health system, employer partnerships for primary care services “Amazon's One Medical inked a major partnership with Health Transformation Alliance, expanding access to its primary care services to 67 employers and nearly 5 million employees.
HTA is a collective of large U.S. employers, and its member companies include Coca-Cola, American Express, Marriott, Boeing and Intel…
The company already works with more than 8,500 companies to offer its primary care services as an employee health benefit. The company, which opened for business in 2007, operates more than 200 primary care clinics in nearly 20 major metropolitan areas, combining in-person and virtual care services.”
CommonSpirit opens its fiscal 2024 with $441M operating loss, $738M net loss “CommonSpirit Health marked the first quarter of its 2024 fiscal year with a $441 million operating loss (-5.1% operating margin) and a $738 million net loss due to inflation-boosted expenses and struggling investments, according to a Wednesday financial filing.
The nonprofit’s performance for the period ended Sept. 30 is a setback from the $23 million operating gain (0.3% operating margin) and $397 million net loss of the year prior, but a sequential continuation of the trends that left the organization with a $1.4 billion operating loss (-3.8% operating margin) for the full 2023 fiscal year, which closed over the summer.”
Joint Commission says acute, critical access hospitals must join safety network “As part of its accreditation process, acute care and critical access hospitals will be required to join The Joint Commission National Healthcare Safety Network, the organization noted in a Nov. 1 news release.
The revisions are for The Joint Commission's ORYX initiative, which measures hospital performance data as part of the accreditation process…
These hospitals will required to share de-identified data across five measurement areas beginning Jan. 1, 2024:
Catheter-associated urinary tract infection outcomes
Facilitywide inpatient hospital-onset clostridium difficile infection outcomes
Central line-associated bloodstream infection outcomes
Colon and abdominal hysterectomy surgical site infection outcomes
Facilitywide inpatient hospital-onset methicillin-resistant staphylococcus aureus bacteremia outcomes”
About pharma
Trends in Proportion of Medicare Part D Claims Subject to 340B Discounts, 2013-2020 “This cohort study demonstrated that from 2013 to 2020, the share of Medicare Part D claims prescribed by a 340B-affiliated clinician increased; however, the rate at which 340B-eligible prescriptions were filled at 340B pharmacies increased at a faster rate, driving the overall increase in 340B claims. Despite these trends, only half of 340B-eligible prescriptions were subject to the 340B discount in 2020.”
Express Scripts embraces cost-plus pricing with new ClearNetwork model “Express Scripts on Tuesday announced the launch of its new pharmacy network option, ClearNetwork, which operates under a cost-plus model. In this approach, clients pay a "straightforward" acquisition cost for individual drugs as well as a small markup that covers dispensing and service costs.
ClearNetwork will be available to a range of clients including employers, government organizations and private payers.”
Wegovy cuts risk of heart attacks in milestone cardiovascular trial “Wegovy specifically cut the rate of heart attacks by 28% among patients who were already taking statins and other medications to prevent heart problems, according to the results, simultaneously published in the New England Journal of Medicine. The drug also reduced the rate of cardiovascular-related deaths by 15% and strokes by 7%.”
Mayo Clinic moves to limit weight loss drug coverage for employees “Mayo Clinic will limit coverage for weight loss drugs through its employee health plan starting in 2024... The Mayo Medical Plan, administered by Medica, will impose a new lifetime limit of $20,000 for weight loss medication coverage. The coverage limit does not apply to GLP-1s prescribed to employees for diabetes, such as Ozempic….
Mayo joins other health systems moving away from weight loss drug coverage for employees this year.”
Intermountain's health plan aims to end PBM 'games' through Cuban partnership “Intermountain Health's insurance arm, Select Health, has rolled out a new partnership with Mark Cuban's Cost Plus Drug Co. to its more than 1 million members — a move its chief pharmacy benefits officer said is aimed at eliminating "all the games" in the PBM marketplace.”
Novo Nordisk to Pull Long Lasting Insulin Levemir From the Market “After committing in March to cut 65 percent off the price of its long-lasting insulin Levemir (insulin detemir), Novo Nordisk has announced that it will discontinue its marketing of the product in the U.S. with supply disruptions beginning as early as January.
The company stated in its announcement that it made the decision because of ‘global manufacturing issues, decreasing patient coverage, and because we are confident that patients in the U.S. will be able to find alternative treatments.’”
Comment: Pharma companies are required by law to notify the FDA of shortages. If you read this announcement even not-so-carefully, you will know that reduced insulin prices made this drug much less profitable.
Three Men Sentenced for $54M Fraudulent Prescriptions Scheme “Three men were sentenced today in connection to a $54 million bribery and kickback scheme involving TRICARE, a federal program that provides health insurance benefits to active duty and retired service members and their families…
Moss, Copeland, and Gordon, along with their accomplices, engaged in a practice known as “test billing” to develop the most expensive combination of compounded drugs to maximize reimbursement from TRICARE.”
In Shocking Reversal, CMS Wants to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars “On November 6, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn's disease and cancer. The policy change represents a stark departure from the perspectives of the U.S. medical community and patient advocacy organizations, a decade of state-level policymaking, and CMS' recent assurances, warns the Alliance for Safe Biologic Medicines.”
About the public’s health
Effect of Dietary Sodium on Blood Pressure “Dietary sodium reduction significantly lowered BP in the majority of middle-aged to elderly adults. The decline in BP from a high- to low-sodium diet was independent of hypertension status and antihypertensive medication use, was generally consistent across subgroups, and did not result in excess adverse events.”
The 2023 report of the Lancet Countdown on health and climate change: the imperative for a health-centred response in a world facing irreversible harms Part of a series of articles in The Lancet about climate change a brief summary:
“In 2023, the world saw the highest global temperatures in over 100 000 years, and heat records were broken in all continents through 2022. Adults older than 65 years and infants younger than 1 year, for whom extreme heat can be particularly life-threatening, are now exposed to twice as many heatwave days as they would have experienced in 1986–2005... Harnessing the rapidly advancing science of detection and attribution, new analysis shows that over 60% of the days that reached health-threatening high temperatures in 2020 were made more than twice as likely to occur due to anthropogenic climate change…; and heat-related deaths of people older than 65 years increased by 85% compared with 1990–2000, substantially higher than the 38% increase that would have been expected had temperatures not changed....”
2023 March of Dimes Report Card: The state of maternal and infant health for American families “In 2022, over 380,000 babies were born preterm—10.4% of all births—earning the U.S. a D+ for the second year in a row. Despite a 1% overall improvement nationally compared to 2021, 14 states saw an increase in preterm birth. Concurrently, maternal mortality rates have nearly doubled since 2018, increasing from 17.4 deaths per 100,000 births to 32.9 in 2021. While the infant mortality rate held steady at 5.4 infant deaths per 10,000 births, nearly 20,000 babies born in 2021 did not survive to see their first birthday.
Racial and ethnic disparities persist across measures of maternal and infant health. The data shows that the preterm birth and infant mortality rates among babies born to Black and American Indian/Alaska Native moms are 1.4x higher than the rates among all others. What this truly demonstrates is the failure of our policies, systems, and environments to protect the well-being of pregnant people and their babies.”
Widening Gender Gap in Life Expectancy in the US, 2010-2021 “As life expectancy at birth in the US decreased for the second consecutive year, from 78.8 years (2019) to 77.0 years (2020) and 76.1 years (2021), the gap between women and men widened to 5.8 years, its largest since 1996 and an increase from a low of 4.8 years in 2010. For more than a century, US women have outlived US men, attributable to lower cardiovascular and lung cancer death rates related largely to differences in smoking behavior. This study systematically examines the contributions of COVID-19 and other underlying causes of death to the widened gender life expectancy gap from 2010 to 2021….
This analysis finds that COVID-19 and the drug-overdose epidemic were major contributors to the widening gender gap in life expectancy in recent years.”
About healthcare IT
Social media giants must face child safety lawsuits, judge rules “Meta, ByteDance, Alphabet, and Snap must proceed with a lawsuit alleging their social platforms have adverse mental health effects on children, a federal court ruled on Tuesday. US District Judge Yvonne Gonzalez Rogers rejected the social media giants’ motion to dismiss the dozens of lawsuits accusing the companies of running platforms ‘addictive’ to kids.”
Completion of Recommended Tests and Referrals in Telehealth vs In-Person Visits “Findings In this cohort study of 4133 diagnostic tests and referrals (colonoscopies, cardiac stress tests, and dermatology referrals) ordered between March 1, 2020, and December 31, 2021, at 2 affiliated clinical primary care sites, 58% of those ordered during in-person visits were completed within the designated time frame compared with 43% of those ordered during telehealth visits. The rate of completion was between 40% and 65% for all test types, regardless of visit modality.
Meaning The findings of this study suggest that rates of completion for diagnostic tests and referrals were low for all visit types but worse when ordered during telehealth visits.”
About healthcare personnel
After 50 Years, Health Professional Shortage Areas Had No Significant Impact On Mortality Or Physician Density “Since 1965, the US federal government has incentivized physicians to practice in high-need areas of the country through the designation of Health Professional Shortage Areas (HPSAs). Despite its being in place for more than half a century and directing more than a billion dollars annually, there is limited evidence of the HPSA program’s effectiveness at reducing geographic disparities in access to care and health outcomes. Using a generalized difference-in-differences design with matching, we found no statistically significant changes in mortality or physician density from 1970 to 2018 after a county-level HPSA designation. As a result, we found that 73 percent of counties designated as HPSAs remained physician shortage areas for at least ten years after their inclusion in the program. Fundamental improvements to the program’s design and incentive structure may be necessary for it to achieve its intended results.”
ANNUAL REGULATORY BURDEN REPORT From the MGMA. Lots of good data in the figures. Bottom line is that 90% of respondents say their overall regulatory burden has increased in the past year. Specific tasks are listed.
Active Residents by Specialty and Gender FYI
About health technology
FDA grants approval for first time to a home test for chlamydia and gonorrhea “The marketing approval was granted to LetsGetChecked’s Simple 2 Test, which allows individuals to collect a sample at home that is then submitted to a laboratory for processing. Prior to this, the only approved tests for these two STIs required samples to be collected at medical facilities such as doctors’ offices.”
More drug and device patents were invalidated for bad info than those filed by other industries, analysis finds “Between 2004 and 2021, a U.S. appeals court that handles patent litigation found 36 cases in which companies committed what is called inequitable conduct — failing to provide accurate or complete information to the U.S. Patent & Trademark Office. As a result, 75 patents filed by companies in various industry sectors were subsequently invalidated, according to the analysis in JAMA.”
Primary care player Forward unveils AI-based, self-serve CarePods backed by $100M series E round A fascinating look into the possible future of medicine.
Vertex, CRISPR gain 'historic' nod in UK for exa-cel. But will cost watchdogs embrace the gene-editing therapy? “Vertex and CRISPR Therapeutics have scored authorization in the U.K. for their exa-cel gene therapy to treat patients with severe forms of sickle cell and transfusion-dependent beta thalassemia, two genetic disorders of the blood.
It is the first ever endorsement for a CRISPR-based gene-editing treatment.”