About Covid-19
Pfizer, BioNTech delay FDA request to expand COVID-19 jab in young children: “Pfizer and BioNTech said Friday they are delaying their request for the FDA to authorise their COVID-19 vaccine Comirnaty for children under 5, as they await more data on the effectiveness of a third dose. An FDA advisory panel set to discuss the filing on February 15 has also been postponed. ‘The extension allows the FDA time to receive updated data on the two- and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion,’ the companies said.”
Booster effectiveness wanes after 4 months, but showed sturdy protection against hospitalization, CDC study shows: “Booster shots of the Pfizer-BioNTech and Moderna vaccines lose substantial effectiveness after about four months — but still provided significant protection in keeping people out of the hospital during the omicron surge, according to a study published Friday by the Centers for Disease Control and Prevention.
Researchers found the booster shots remained highly effective against moderate and severe covid-19 for about two months after a third dose. But their effectiveness declined substantially after four months, suggesting the need for additional boosters, the study said.”
Association of Primary Care Physicians Per Capita With COVID-19 Vaccination Rates Among US Counties: “In this cross-sectional study, we found that the number of PCPs per 100 000 population was independently associated with higher COVID-19 vaccination rates in the US. Our findings suggest that PCPs play a critical role in ensuring vaccine acceptance, especially in resource-limited and vaccine-hesitant regions, potentially through counseling and building local community trust and partnerships before they had access to vaccines.”
What are taxpayers spending for those ‘free’ COVID tests? The government won’t say: “How much is the government paying for each test? And what were the terms of the agreements? The government won’t yet say, even though, by law, this information should be available.”
Placental Tissue Destruction and Insufficiency from COVID-19 Causes Stillbirth and Neonatal Death from Hypoxic-Ischemic Injury: A Study of 68 Cases with SARS-CoV-2 Placentitis from 12 Countries: “The pathology abnormalities composing SARS-CoV-2 placentitis cause widespread and severe placental destruction resulting in placental malperfusion and insufficiency. In these cases, intrauterine and perinatal death likely results directly from placental insufficiency and fetal hypoxic-ischemic injury. There was no evidence that SARS-CoV-2 involvement of the fetus had a role in causing these deaths.”
In a related article: Association of BNT162b2 COVID-19 Vaccination [Pfizer-BioNTech]During Pregnancy With Neonatal and Early Infant Outcomes: “Maternal BNT162b2 vaccination in pregnancy was not associated with detrimental outcomes to the offspring.”
NYC set to fire nearly 3,000 unvaccinated employees: “The city requires its workforce of 370,000 — teachers, police, firefighters, office staff and others — to get at least one dose of the coronavirus vaccine by Friday. Nearly 95 percent have received at least one dose…”
New Report Finds 82% of Patients Still Experience Medication Delays, Despite Healthcare Industry Advancements: “New data…[from] CoverMyMeds found 82% of patients experienced medication delays in the last year due to COVID-19 restrictions, insurance processes, communication challenges and prescription cost. Of patients who experienced medication delays, 85% had to make financial sacrifices to afford their prescriptions…
In addition to medication delays, many patients also postponed medical visits in the past year. According to the 2022 Medication Access Report, 84% of patients delayed or skipped in-person healthcare visits, mostly due to COVID-19 fears or a scarcity of appointments, contributing to an estimated 500 million missed diagnostic visits and more than 15 million fewer new prescriptions.”
How much 7 drugmakers are earning from COVID-19 treatments: FYI
And in a related article: Lilly back in COVID-19 antibody game with $720 million deal with U.S. for omicron-busting hopeful: “The U.S. has agreed to a $720 million deal for bebtelovimab, the company announced on Thursday. Lilly has submitted its request for an emergency use authorization, and contingent upon an FDA nod, the company will supply 600,000 courses of the treatment for high-risk patients with mild-to-moderate COVID-19.”
About health insurance
2021 AMA prior authorization (PA) physician survey: Among other findings, this AMA member survey found the following:
—”24% of physicians report that PA has led to a patient’s hospitalization.
—18% of physicians report that PA has led to a life-threatening event or required intervention to prevent permanent impairment or damage.
—8% of physicians report that PA has led to a patient’s disability/permanent bodily damage, congenital anomaly/birth defect or death.”
Undoubtedly, insurers will push back on the necessity of PA for cost and quality reasons.
Even insured Americans lack funds for out-of-pocket medical costs, new Aflac Care Index shows Nationwide survey reveals the financial implications of medical bills not covered by insurance and identifies the 11 most at-risk states: “According to the Aflac Care Index, 24% of respondents report having no money in their savings accounts and 48% say they have $1,000 or less. Further exacerbating the situation is that 33% of insured Americans cannot go more than one week without a paycheck, while 71% cannot endure a month without pay, leading many (25%) to have to borrow money in the event of a medical emergency, almost a quarter (22%) saying they would need to find an additional job, and 6% would have to file bankruptcy. At the same time, approximately three-quarters of insured respondents underestimate their financial exposure to common medical challenges, such as heart disease (79%) and breast cancer (73%).”
Association Between Hospice Enrollment and Total Health Care Costs for Insurers and Families, 2002-2018: “In this cohort study, hospice use by community-dwelling Medicare beneficiaries was associated with significantly lower total health care costs across all payers in the last 3 days to last 3 months of life. We found no evidence of cost shifting from Medicare to families and families had significantly lower out-of-pocket health care costs in the last 3 days to last month of life when patients enrolled with hospice.”
Signify Health Buying Caravan Health for $250 Million: “The transaction also includes contingent additional payments of up to $50 million based on the future performance of Caravan, which will join Signify Health in supporting a wide spectrum of advanced payment models.
With the acquisition, Signify adds Caravan's more than 200 health systems and 100 Federally Qualified Health Centers with more than 10,000 primary care providers that collectively manage over 500,000 patients.
The combination supports Signify Health's diversification strategy to offer a comprehensive platform and solution set supporting and integrating episodes and total cost of care risk arrangements across Medicare programs.”
Molina Healthcare revenue up 43% to $27.8B: 6 things to know: “The payer reported $659 million in net income, down 2 percent over 2020's year-end income. The medical care ratio for 2021 was 88.3 percent, up 1.7 percentage points from 2020's. Molina Healthcare set a $29.5 billion revenue outlook for 2022, representing an increase of 6 percent.”
South Florida Medical Clinic Owner Sentenced to 10 Years in Prison for Orchestrating $42 Million Health Care Fraud Conspiracy: “Yesterday, a federal district judge in Miami sentenced Bradley Jason Kantor, 49, of Key Largo, Florida, to 10 years in federal prison for submitting approximately $42 million in fraudulent health care claims to United Healthcare.
From April 2013 to March 2017, Kantor owned and operated Mobile Diagnostic Imaging, Inc. (“MDI”), a medical clinic in Davie, Florida that purported to provide antigen therapy and other allergen immunotherapy services, such as allergy testing and allergy shots, to commercial insurance beneficiaries. Kantor offered and paid kickbacks to co-conspirators to induce them to refer beneficiaries to MDI, so that MDI could bill commercial insurers for services that it never provided.”
Ten Indicted for Healthcare Kickbacks: “Ten people, including two medical doctors, have been indicted in a $300 million healthcare fraud, announced U.S. Attorney for the Northern District of Texas Chad E. Meacham…
According to the indictment, the founders of several lab companies, including Unified Laboratory Services, Spectrum Diagnostic Laboratory, and Reliable Labs LLC, allegedly paid kickbacks to induce medical professionals to order medically unnecessary lab tests, which they then billed to Medicare and other federal healthcare programs.
The medical professionals -- including internal medicine specialist Eduardo Canova, family medicine practitioner Jose Maldonado, and nurse practitioner Keith Wichinski – allegedly accepted the bribes and ordered millions of dollars’ worth of tests.
Meanwhile, Unified, Spectrum, and Reliable disguised the kickbacks as legitimate business transactions, including as medical advisor agreement payments, salary offsets, lease payments, and marketing commissions.”
About hospitals and healthcare systems
Prospect to sell Crozer to ChristianaCare: “Newark, Del.-based ChristianaCare plans to acquire Springfield, Pa.-based Crozer Health from Los Angeles-based Prospect Medical Holdings after signing a letter of intent.
Through the deal, ChristianaCare would also take over Crozer's related businesses, real estate assets, Crozer Health Medical Group, associated assets, ambulatory centers, medical office buildings, physician clinics and ancillary outpatient services, according to a Feb. 11 news release…
Crozer, which has about 4,000 employees, will return to a nonprofit organization once the deal is finalized.”
About pharma
Pharma R&D Pipeline and New Product Launches Reach Record Levels in 2021 According to New IQVIA Institute for Human Data Science Report: Highlights of the study:
“Clinical trial activity saw sustained growth through the pandemic with 5,500 new planned clinical trial starts in 2021, a 14% increase over 2020
The total number of products in active development exceeded 6,000, up 68% from 2016
A record 84 novel active substances were initially launched globally in 2021, double the number of five years ago
The composite R&D success rate across all therapy areas declined to 5% in 2021, due to the more challenging clinical development programs being deployed
Emerging biopharma companies are responsible for a record 65% of the molecules in the R&D pipeline — up from less than 50% in 2016”
FDA panel gives thumbs down to Lilly, Innovent's China-developed cancer drug: A “follow-on” to yesterday’s article about FDA’s caution approach to Chinese studies:
”An FDA advisory panel voted 14 to 1 on Thursday that Eli Lilly and Innovent Biologics should conduct more trials of their anti-PD-1 antibody sintilimab in order to win US approval. The vote comes days after FDA staff scientists concluded that a Chinese study used to support the drug's administration in first-line non-small-cell lung cancer (NSCLC) had several shortcomings and its results were not applicable to US patients.”
Researchers restore function in a gene that can suppress liver cancer and enhance immunotherapy: “A team of researchers from Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital (BWH) has reprogrammed the tumor microenvironment of liver cancer by using mRNA nanoparticles. This technology, similar to the one used in COVID-19 vaccines, restored the function of the p53 master regulator gene, a tumor suppressor mutated in not just liver but also other types of cancer. When used in combination with immune checkpoint blockade (ICB), the p53 mRNA nanoparticle approach not only induced suppression of tumor growth but also significantly increased antitumor immune responses in hepatocellular carcinoma (HCC) laboratory models.”
About the public’s health
CMS expanding coverage for low-dose CT lung cancer screening: “CMS’ final decision will expand eligibility for Medicare beneficiaries to receive such lifesaving screenings by dropping the starting age from 55 down to 50 years old. The agency will also reduce the tobacco smoking history threshold from at least 30 packs per year down to at least 20, according to an announcement.”
The 10 States With the Longest Life Expectancy: At the top is Hawaii. “Nine of the 10 states with the lowest life expectancy in 2019 were located in the South.” For a full report, see this CDC website.
CDC proposes softer guidance on opioid prescriptions: The current, 6 year old, recommendations have fixed dose limits. The proposed changes call for more individualized doses- the minimum needed to control pain.
And in a related article: Fight over opioid prescribing — and when it turns criminal — heads to Supreme Court: “Doctors have wide latitude to prescribe drugs, including potentially dangerous ones, but even they face limits. The question is, what threshold do physicians have to cross — and what sort of intent do they need to have — for their prescribing to be considered a crime?
It’s an issue headed to the Supreme Court next month, in a case concerning two physicians who were convicted of unlawfully dispensing opioid painkillers.”
Evaluation of Statewide Restrictions on Flavored e-Cigarette Sales in the US From 2014 to 2020: “Were statewide restrictions on flavored e-cigarette sales in Massachusetts, New York, Rhode Island, and Washington associated with a reduction in total e-cigarette unit sales from 2014 to 2020?
Findings In this cross-sectional study, a difference-in-differences analysis of e-cigarette retail data showed that statewide restrictions on non–tobacco-flavored e-cigarette sales were associated with reductions of 25.01% to 31.26% in total e-cigarette unit sales compared with total sales in states without restrictions. The reductions were attributable mostly to decreases in non–tobacco-flavored e-cigarette sales.”
Uterine Cancer Mortality Now Neck and Neck With Ovarian Cancer: “Uterine cancer has pulled even with ovarian cancer as a leading cause of gynecologic cancer mortality, accompanied by an ‘alarming’ racial disparity, a large epidemiologic study showed.
Annual uterine cancer mortality declined from 4.3 to 4.0 per 100,000 women from 1990 to 1997, then increased to 5.1/100,000 in 2019, representing a 1.7% annual increase. In contrast, ovarian cancer mortality decreased from 9.3/100,000 in 1990 to 6.0/100,000 in 2019 (-2.7%/year from 2010-2019).”
About healthcare IT
UnitedHealth rolls out new virtual options for dental care: “UnitedHealthcare Dental is launching multiple digital resources aimed at making it more convenient for members to manage their oral health, the insurer announced this week.
UHC will enhance its 24/7 virtual dental benefit to provide two free virtual visits with a dentist per year, an upgrade that will be made available to fully insured employer plans. During these visits, members can seek advice telephonically or via video about acute oral health needs, as well as find guidance on where to access care in-person if needed.”
Outpatient telehealth use soared early in the COVID-19 pandemic but has since receded: “Prior to the onset of the pandemic in the United States, telehealth use was a negligible share (rounding to 0%) of outpatient visits. Many enrollees have had increased access to telehealth services over the last two years. During this period, telehealth use soared from less than 1% of outpatient visits before the pandemic to 13% of outpatient visits in the first 6 months of the COVID-19 pandemic. This rate declined to 11% during the next 6-month period, and then to 8% a year into the pandemic (March-August, 2021).”
About healthcare personnel
Medicine’s Worst-Paying Specialty Is Luring Billions From Wall Street : “U.S. companies focused on primary care raised about $16 billion from investors in 2021, according to unpublished research by Harvard scholars. That’s more than four times the amount invested in 2020 and up from just $15 million reported in 2010, they said.”
The entire article is well-worth reading for an explanation of how primary care is essential for delivery of risk-based, value-driven care models.
If 1 in 5 healthcare workers have quit, where have they gone?: “When looking at the national numbers, based on Bureau of Labor Statistics data, the overall healthcare workforce is only down 2.7 percent from February 2020…
That number is mostly in nursing homes, she added. When looking at just hospitals, the workforce is down 1.8 percent from February 2020.
This means many people who quit their jobs are being hired in other healthcare jobs. Or as some leave, others are being hired…”