About Covid-19
Updated Pediatric COVID-19 Vaccination Operational Planning Guide — Information for the COVID-19 Vaccine for Children 6 Months–4 Years Old: From the CDC: “This operational planning guide includes details about the anticipated Pfizer-BioNTech product and may be updated as other manufacturers submit applications for FDA review…
There are approximately 18 million children ages 6 months through 4 years in the United States. The U.S. government has procured enough vaccine to support vaccination of this population, pending FDA EUA and CDC recommendation. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on February 15, 2022. ACIP is anticipated to meet within several days of VRBPAC; the meeting will be posted here once scheduled: https://www.cdc.gov/vaccines/acip/index.html.”
U.S. CDC stands by K-12 school masking guidance as states relax rules –Walensky: “With COVID-19 cases still high nationwide, "now is not the moment" to drop mask mandates in schools and other public places, U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky told Reuters on Tuesday.”
J.&J. Pauses Production of Its Covid Vaccine Despite Persistent Need: “A crucial Johnson & Johnson plant has stopped making its Covid vaccine, though the company says it has millions of doses in inventory…
[T]he American company… late last year quietly shut down the only plant making usable batches of the vaccine, according to people familiar with the decision.
The facility, in the Dutch city of Leiden, has instead been making an experimental but potentially more profitable vaccine to protect against an unrelated virus.
The halt is temporary — the Leiden plant is expected to start churning out the Covid vaccine again after a pause of a few months — and it is not clear whether it has had an impact on vaccine supplies yet, thanks to stockpiles.”
The CDC’s do-not-travel list now encompasses more than half the world’s destinations: “The Centers for Disease Control and Prevention has moved seven more countries to its highest-risk category for travel — a list that has grown to include 134 destinations, with many added since the World Health Organization declared omicron a “variant of concern” on Nov. 26.
The CDC on Monday gave the Democratic Republic of Congo, Oman, Libya, Japan, Israel, Cuba and Armenia a “Level 4″ warning, which means it is recommending that Americans avoid traveling there, even if vaccinated.”
HHS is running out of money to pay doctors to treat uninsured COVID-19 patients: “Federal program which reimburses healthcare workers who care for uninsured COVID-19 patients, is expected to run out of money by spring or summer.
The Provider Assistance Fund has paid more than $17 billion to treatment, testing and vaccination providers for the uninsured throughout the pandemic. The Department of Health and Human Services program has become a lifeline for health care providers, especially in states like Texas and Florida, where the percentage of people without health insurance is high.”
Relief funds are not just paying doctors. In a related story: Travel Nurses Make Twice as Much as They Did Pre-Covid-19: “Hospitals and lawmakers are pressing the Biden administration to review federal pandemic-relief programs that they say have distorted pay rates for travel nurses.”
About health insurance
Anthem rolling out virtual primary care to plans in 11 states: “The expansion will roll out the offering to fully insured plans and select large group administrative services clients in Colorado, Connecticut, Georgia, Indiana, Kentucky, Missouri, Nevada, New York, Ohio, Virginia and Wisconsin, the company said. Eligible members can access a virtual care team that will conduct an initial health check-in and then craft a personalized care plan.
The insurer is expecting a significant number of its administrative services clients to adopt the platform over the course of this year.”
Obamacare Insurers Use Tech, Tenacity to Keep Customers on Board: “Every year, roughly 10% of marketplace plan members have their coverage terminated for nonpayment or other reasons. To maintain the new bumper crop of enrollees, some insurers will use artificial intelligence, advanced analytics, and machine learning to identify members most likely to let their policies lapse. Eventually, all carriers will target their at-risk enrollees with phone calls, emails, texts, and letters.”
Highmark Makes a $245M Impact in the Fight Against Healthcare Fraud, Waste and Abuse in 2021: “Highmark's Financial Investigations and Provider Review (FIPR) department generated more than $245 million in savings related to fraud, waste and abuse in 2021, and has made a cumulative financial impact of nearly $1 billion in such activity since 2017…
FIPR's 2021 savings included approximately $184 million in activity related to billing/coding errors, fraud, waste and abuse in Pennsylvania, $25 million in West Virginia, and $23 million in Delaware.”
Bay City Vascular Surgeon Pleads Guilty in Connection with Defrauding Medicare, Medicaid, And Blue Cross Blue Shield Of $19.5 Million: “According to the plea agreement, [Dr. Vasso] Godiali began knowingly defrauding the three medical insurers in approximately 2009 and did so by causing the submission of false billing to all three insurers. As evidenced in the plea agreement, Godiali’s false and fraudulent billing includes admissions related to claims for the placement of stents in dialysis patients and for the treatment of arterial blood clots. Godiali admitted that he billed for the placement of multiple stents in the same vessel, and prepared medical records purporting to document the medical necessity justifying that billing. In fact, Godiali did not place those stents, and he admitted to billing the insurers for services never rendered while preparing materially inaccurate medical records to justify the fraudulent billing.”
Health Connector offering health insurance sign up on Mass income tax form: Interesting idea: “The Massachusetts Health Connector’s new Simple Sign-up program will let uninsured residents check a box on their state tax forms and start the process of getting health insurance. This will allow the Department of Revenue (DOR) to forward the tax filer’s information to the Health Connector, which will then create and send information to the tax filer to help them obtain the best health plan.”
About hospitals and healthcare systems
Health Care Paradox: Medicare Penalizes Dozens of Hospitals It Also Gives Five Stars: “The federal government has penalized 764 hospitals — including more than three dozen it simultaneously rates as among the best in the country — for having the highest numbers of patient infections and potentially avoidable complications….
This year’s list of penalized hospitals includes Cedars-Sinai Medical Center in Los Angeles; Northwestern Memorial Hospital in Chicago; a Cleveland Clinic hospital in Avon, Ohio; a Mayo Clinic hospital in Red Wing, Minnesota; and a Mayo hospital in Phoenix. Paradoxically, all those hospitals have five stars, the best rating, on Medicare’s Care Compare website.”
100 top critical access hospitals, by state: FYI: “The Chartis Center for Rural Health recently released its annual list of the top 100 critical access hospitals in the U.S.”
About pharma
Amgen reports revenue bump in Q4, but Enbrel slides: “The company said revenues in the last three months of 2021 were driven by an increased contribution from the collaboration it has to help make Eli Lilly's COVID-19 antibody treatment. It did not say how much it received from the arrangement in the period, but Amgen recorded $575 million listed under ‘other revenue’ in its quarterly report.
Meanwhile, product sales were down 1% during the period because while unit volumes grew, Amgen said this gain was ‘more than offset by lower net selling price and lower inventory levels,’ which notably affected Enbrel. Still, the company did see double-digit volume growth on some key products such as Prolia, Mvasi, Repatha and Evenity.”
GSK's Q4 results boosted by sales of COVID-19 treatment: “GlaxoSmithKline noted that fourth-quarter sales of prescription drugs were mainly driven by new and specialty products. Sales of Xevudy, a monoclonal antibody for the treatment of COVID-19, reached £828 million ($1.1 billion), topping estimates of £774 million ($1 billion), contributing approximately 20 percentage points to pharmaceuticals growth.”
FDA wary of drugs developed in China: “The FDA is concerned about the quality of studies evaluating cancer drugs and other new medicines developed in China, The Wall Street Journal reported Feb. 9…
Drug industry analysts said the FDA's reservations may mean Chinese biotech companies and their Western partners will need to lead additional U.S.-based tests for their proposed drugs.”
Regular Acetaminophen Use and Blood Pressure in People With Hypertension: The PATH-BP Trial: “Regular daily intake of 4 g acetaminophen increases systolic BP in individuals with hypertension by ≈5 mm Hg when compared with placebo; this increases cardiovascular risk and calls into question the safety of regular acetaminophen use in this situation.”
If confirmed, this finding could indicate a major problem in treating these patients, since NSAID drugs have the same effect.
About the public’s health
Appeals court rules in Biden’s favor on abortion referrals: “Federally funded family planning clinics can continue to make abortion referrals for now, a federal court ruled Tuesday, in a setback for a dozen Republican attorneys general who have sued to restore a Trump-era ban on the practice.
The 6th U.S. Circuit Court of Appeals in Cincinnati denied a request by the 12 states to pause rules for the federal government’s family planning program while their case is heard. The states were eager to stop implementation before the next round of federal grants starts rolling out in March.”
Prevalence and Income-Related Disparities in Thirdhand Smoke Exposure to Children: “Nicotine was detected on the hands of 189 of 193 children (97.9%) reportedly exposed…and on the hands of 296 of 311 children (95.2%) reportedly protected from exposure to tobacco products…. In multivariable linear regression models, child age, family income, parent tobacco use, home smoking rules, and the number of tobacco users with whom a child had contact were significantly associated with hand nicotine…. Children aged 2 to 4 years, from low-income homes, whose parents used any tobacco products, with multiple contacts with tobacco users, and without complete smoking bans had the highest hand nicotine levels…. Children from lower-income families benefited significantly more from tobacco protections compared with children from higher-income homes…”
What is surprising is the unexpectedly high rate of nicotine detection in houses reported as non-smoking.
About healthcare IT
Guidelines for US Hospitals and Clinicians on Assessment of Electronic Health Record Safety Using SAFER Guides: “On August 13, 2021, the Centers for Medicare & Medicaid Services (CMS) released a final rule requiring eligible hospitals to attest annually that they performed a safety assessment of their electronic health record (EHR) system using SAFER (Safety Assurance Factors for EHR Resilience) Guides.1 This milestone affects virtually all US hospitals, but there is no specific guidance on how hospitals should perform a self-assessment of these recommended practices. To address this gap, pragmatic guidelines were developed to provide a streamlined, stepwise approach for conducting a systematic EHR safety assessment that optimizes organizational resources, minimizes process inefficiencies, and maximizes EHR vendor involvement.”
The essence of the recommendations is in the online supplement to the article:
”1 Identify the SAFER assessment team…
2 Determine which recommendations require EHR vendor action or attestation…
3 Meet synchronously and asynchronously…
4 Document and communicate implementation status…
5 Prioritize and address unmet SAFER recommendations…”
Health insurers may be using biased machine learning models. Here’s how to fix them: “In an analysis published in Health Affairs, researchers from Independence Blue Cross, the Massachusetts Institute of Technology and the University of California Berkeley identified several areas where bias can arise in machine learning tools used by health insurers and outlined recommendations for tackling those issues.”
Indicators of Compromise Associated with LockBit 2.0 Ransomware and Additional Mitigations: “A warning from HHS’s cybersecurity program: “LockBit 2.0 operates as an affiliate-based Ransomware-as-a-Service (RaaS) and employs a wide variety of tactics, techniques, and procedures, creating significant challenges for defense and mitigation. The indicators of compromise (IOCs) and malware characteristics outlined in this Report were derived from field analysis and are current as of February 2022.”
Amazon expanding healthcare service to 20 more cities, lands Silicon Labs, Whole Foods Market as customers: “The online retailer has inked deals to provide healthcare services to Silicon Labs, TrueBlue and Whole Foods Market, the company announced Tuesday. These companies join Precor, a Washington-based fitness equipment company that was acquired by Peloton, and Hilton as clients Amazon has publicly disclosed.”