Senate votes unanimously to make daylight saving time permanent: “Clock-switching would end in 2023 under measure that still must pass the House and get Biden’s signature before it can become law.”
About Covid-19
Pfizer and BioNTech seek authorization of second coronavirus booster shot for people 65 and older: As anticipated yesterday, the filing was submitted.
Senate votes to overturn mask mandate on airplanes, transit: “The Senate on Tuesday voted 57-40 to overturn a federal requirement that passengers on U.S. airplanes and other modes of public transportation wear masks.
The Congressional Review Act measure, introduced by Sen. Rand Paul, R-Ky., is the latest salvo in a fight between congressional Republicans and the Biden administration over public health requirements related to the pandemic, which has killed more than 963,000 Americans to date, according to Centers for Disease Control and Prevention statistics.”
If passed by the house (unlikely), the President vowed to veto the law.
Omicron sub-variant makes up 23.1% of COVID variants in U.S. - CDC: “The BA.2 sub-variant of Omicron was estimated to be 23.1% of the coronavirus variants circulating in the United States as of March 12, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.”
U.S. will run out of key COVID treatments without more funds, White House says: “The White House said on Tuesday that the US government will run out of supplies of monoclonal antibodies as soon as late May and will have to scale back plans to get more unless Congress provides more funding…
The government would also not have enough money to provide additional COVID-19 booster vaccine doses or variant-specific vaccines without a new injection of cash.
The White House has requested $22.5 billion in immediate emergency funding to address the pandemic, but the money was removed from the latest government funding bill recently passed by lawmakers.”
Lab Advisory: HHS Updates COVID-19 Laboratory Reporting Guidance: From the CDC:
Beginning April 4, 2022, COVID-19 testing facilities are no longer required to report NEGATIVE results for tests authorized for use under a CLIA certificate of waiver. This includes rapid and antigen testing performed for screening testing at schools, correctional facilities, employee testing programs, long-term care facilities, and rapid testing performed in pharmacies, medical provider offices, and drive-through and pop-up testing sites. In addition, testing facilities are no longer required to report POSITIVE or NEGATIVE antibody test results.
The updated guidance still requires laboratories to report both POSITIVE AND NEGATIVE results for laboratory-based nucleic acid amplification tests (NAATs) that are performed in a facility that is certified under CLIA to perform moderate- or high-complexity tests.” [Emphases in the original.]
About health insurance
No Medicare Payment Hike Needed for Docs in 2023, MedPAC Says: [Sign up for this free site to read the article]. A really good summary of the recommendations for all Medicare programs and some feedback from the AMA and MGMA. In the case of physicians and other healthcare professionals, the recommendation was: “For calendar year 2023, the Congress should update the 2022 Medicare base payment rate for physician and other health professional services by the amount determined under current law.” The current law specifies no change.
For the complete document go to this site. The summary recommendations start on page 551.
About pharma
FDA approves transdermal patch to treat Alzheimer’s-related dementia: “Biopharmaceutical company Corium announced that the FDA has approved Adlarity to treat patients with mild, moderate or severe dementia associated with Alzheimer’s disease…
The FDA approved once-weekly use of Adlarity (donepezil, Corium) in 5 mg/day or 10 mg/day formulations. The transdermal patch, which can be placed by a patient or caregiver on a patient's back, thigh or buttocks, delivers a consistent dose of donepezil through the skin, resulting in a low likelihood of adverse gastrointestinal side effects associated with oral donepezil.”
Eli Lilly to halt exports of non-essential medicines to Russia: “Eli Lilly will stop exporting non-essential medicines to Russia including Cialis, a treatment for erectile dysfunction, following Vladimir Putin’s invasion of Ukraine. Highlight text The US drugmaker said on Tuesday it would continue to supply treatments for life-threatening diseases such as cancer and diabetes but that it would suspend all investments, promotional activities and new clinical trials in Russia.”
First Generic OK'd for Popular Asthma, COPD Inhaler: “The first generic version of Symbicort -- a metered-dose inhaler that combines the corticosteroid budesonide with the long-acting bronchodilator formoterol -- has been approved for asthma and chronic obstructive pulmonary disease (COPD), the FDA announced on Tuesday…
’Today's approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,"‘Sally Choe, PhD, who heads the Office of Generic Drugs at FDA, said in a statement. ‘This reflects the FDA's continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.’”
And in a related article: First Generic to Treat Dry Eye: “The FDA recently approved the first generic formulation of cyclosporine ophthalmic emulsion (Restasis) to increase tear production for patients with a condition commonly known as dry eye.”
Gilead to limit 340B discounts for hepatitis C drugs: “Gilead will stop offering 340B discounts to safety-net hospitals effective May 2 if providers do not submit certain patient claims data, the drugmaker said March 15. ‘We are making this change across our branded hepatitis C products because of the acute impact of duplicate discounts and diversion," Gilead said in its announcement. "The claims level data being requested is similar to the data Gilead receives from other purchasers and payers and is tailored to minimize burdens on covered entities while mitigating duplicate discount and diversion concerns.’”
Drug manufacturers are fighting their holy war on three fronts: A great perspective about how “big pharma” is protecting its turf. Among the facts that should be considered:
”For drug manufacturers, it’s a holy war to defend its US business which generates $363 billion (9% of total 2020 US spending), employs 811,000 and generates per capita spending for prescription drugs that’s 104% higher than the 38-country OECD median. Understandably, they spend big to fend-off unwelcome intrusion in their pricing strategies:
From 1998 to 2021, the Pharmaceuticals/Health Products industry spent $5,066,805,717 on its lobbying activity—more than any other industry and 56% more than #2 insurers, 145% more than hospitals and nursing homes (#8) spending) and 191% more than health professionals (#12).
In 2021, the pharmaceutical industry spent $353,940, 506 on its lobbying activity for 546 companies employing 1746 lobbyists—58% of who previously worked for the government—to garner favor from lawmakers.”
Cancer Drug Approvals That Displaced Existing Standard-of-Care Therapies, 2016-2021: “Between May 1, 2016, and May 31, 2021, there were 207 FDA cancer drug approvals in oncology and malignant hematology. Of these 207 approvals, 28 drugs (14%) were first-line displacing therapies. A total of 32 drugs (15%) were first-line drug alternatives/new drugs. A total of 61 drugs (29%) were add-on therapies. Finally, 86 drugs (42%) were approved as later-line therapies.”
About the public’s health
2022 Alzheimer’s Disease Facts and Figures: “An estimated 6.5 million Americans age 65 and older are living with Alzheimer’s dementia in 2022.A2,224 Seventy-three percent are age 75 or older…
Of the total U.S. population: About 1 in 9 people (10.7%) age 65 and older has Alzheimer’s dementia.”
While the rate of new cases has declined, the expansion of the older population has increased total number of cases. This monograph is an excellent review.
The Association of Consumption Time for Food With Cardiovascular Disease and All-Cause Mortality Among Diabetic Patients: “Higher intake of potato or starchy vegetable in forenoon, whole grain in the afternoon, and dark vegetable and milk in the evening and lower intake of processed meat in the evening was associated with better long-term survival in people with diabetes.”
Autism Screening Test for Toddlers Wins on Accuracy— Younger diagnosis age means earlier support for kids with autism, researcher says: “n autism diagnosis tool for toddlers proved highly accurate, creating the potential for autism to be diagnosed at a younger age, results from a community-based study suggest.
The Social Attention and Communication Surveillance-Revised (SACS-R) tool had an 83% positive predictive value (95% CI 0.77-0.87) and an estimated 99% negative predictive value (95% CI 0.01-0.02) in over 13,500 toddlers ages 12 to 24 months…”
About healthcare IT
Global Achievement: Intermountain Healthcare Named World’s First Triple Stage 7 Organization under new HIMSS model: “The Healthcare Information and Management Systems Society (HIMSS) has announced that Intermountain Healthcare has become the first organization in the world to earn Triple Stage 7 designation under new requirements, the highest level of achievement on how health systems are improving care using digital tools…
HIMSS measured Intermountain in three areas to see how they utilized their EMR. To reach a level 7 an organization is scored by how they’re improving patient safety and satisfaction, supporting clinicians and securing data.
Electronic Medical Record Adoption Model (EMRAM) – measures clinical outcomes, patient engagement and clinical use of EMR technology to strengthen organizational performance and health outcomes across patient populations.
Outpatient Electronic Medical Record Adoption Model (O-EMRAM) – assesses maturity of EMR technology in outpatient facilities and its impact on patients served, overall population health and health system operational efficiency with a focus on quality of care, patient safety, and cost reduction.
Adoption Model for Analytics Maturity (AMAM) – measures the analytics capabilities that healthcare organizations have gained from having a strong analytics strategy and competency and advances an organization’s healthcare analytics regardless of the technologies installed.”
Morgan Health invests $5M in physician-led analytics company: “Morgan Health, the healthcare arm of JPMorgan Chase, invested $5 million in a physician-led analytics company.
Morgan Health participated in Embold Health's $23 million series B funding round. The platform measures provider performance through real-time data, connecting patients to top-performing providers and specialists, according to a March 16 press release.
This is the second investment the company has made in the healthcare field.
On Aug. 5, Morgan Health also made a $50 million investment into Vera Whole Health, a holistic primary care startup based in Seattle.”
About healthcare personnel
Clinician of the Future-2022: I picked some interesting (to me) highlights from this Elsevier physician survey”
—”More informed patients: in the survey, 86% of clinicians agreed the rise of patients informed about their health conditions is driving healthcare change
—51% of clinicians agreed telehealth will negatively impact their ability to demonstrate empathy with patients
—64% of clinicians agreed the impact of health inequalities will be exacerbated by the greater use of digital health
— 43% expect every individual will have their genome sequenced to support illness prevention
—Noncommunicable diseases: 71% of clinicians agreed there will be an increase in comorbidities among younger patients in 10 years
—73% of clinicians globally identified that in 10 years’ time managing public health will be a key priority in their role
—41% of clinicians expect to be seen as less valuable to patients”
About health technology
Illumina Unveils Groundbreaking Comprehensive Genomic Profiling Test for Cancer in Europe: “Illumina, Inc…. announced the launch of TruSight™ Oncology (TSO) Comprehensive (EU), a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer.
TSO Comprehensive (EU) assesses biomarkers in 517 cancer-relevant genes across nearly 30 solid tumor types by evaluating both DNA and RNA, and complex genomic signatures, such as microsatellite instability (MSI) and tumor mutational burden (TMB). This comprehensive assessment eliminates the need for running separate, sequential gene tests from multiple biopsy procedures. The fast turnaround time of four to five days for sample-to-clinical report generation, versus weeks in some cases, enables clinicians to make decisions regarding personalized medicine or clinical trial enrollment for their cancer patients.”
The announcement came after the test received a CE-mark.
About healthcare quality and safety
How CMS is Improving ACO Data Aggregation, Quality Care Reporting: “…CMS has been transitioning from web-based reporting to more digital methods like electronic clinical quality measures (eCQMs), merit-based incentive payment system quality measures (MIPS CQMs) and digital quality measures (dQMs)…
CMS new six-prong strategy to implement quality measure changes include:
Incentive for eCQMs/MIPS CQM reporting
Extension of web interface collection for an additional three years to give more time to ACOs to transition to eCQMs/MIPS CQM reporting
ACI listening session to provide plans and address concerns with reporting
ACO engagement with Office of Burden Reduction and Health Informatics to address transition questions
Written guidance documentation with stakeholder input for reporting”