Midweek Update

Obesity

Midweek Update

David Ermer–CMS, Congress, COVID-19, Cybersecurity, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson, R-La., and his top lieutenants on Wednesday morning moved to quell reservations among their conference about the emerging $1.2 trillion-plus final spending package headed for a vote likely on Friday, while their Democratic counterparts did likewise in a separate meeting.
    • “Appropriators were scrambling under a tight timeline to finish drafting the measure, which is taking longer than expected due to a last-minute decision to write a full-year Homeland Security bill. But Johnson told reporters after a GOP conference meeting that text is expected as soon as Wednesday afternoon.
    • “Other sources expected the bill drop to slip to Thursday, with the standard “reading out” of the DHS title, to catch any errors before posting, not even expected to begin until later Wednesday. But no matter: Lawmakers said they expect the chamber to vote as soon as Friday, regardless of a 72-hour review rule. * * *
    • “Final passage wouldn’t come until this weekend at the earliest, and senators are working to accommodate Sen. Susan Collins, R-Maine, who has never missed a vote but will be attending her mother’s funeral on Saturday. That could push votes off until Sunday or Monday, though few are worried at this point about the effects of such a brief funding lapse. 
    • “I don’t think we’ll do a [continuing resolution],” Johnson said.”
  • The American Hospital Association (AHA) News informs us,
    • “The House Energy and Commerce Committee March 20 unanimously passed AHA-supported legislation to reauthorize through 2029 the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 7153), which provides grants to help health care organizations offer behavioral health services for front-line health care workers. The bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. Without congressional action, the law will expire at the end of this year.”
  • and
    • “Congress should address any statutory constraints that prevent the Centers for Medicare & Medicaid Services and Department of Health and Human Services from adequately helping hospitals and other health care providers impacted by the Change Healthcare cyberattack, AHA said a letter submitted to the House Ways and Means Committee for a hearing March 20 with HHS Secretary Xavier Becerra on fiscal year 2025 funding for HHS.”
  • Govexec tells us,
    • “The top senator with direct oversight of the U.S. Postal Service is calling on its leadership to pause its overhaul of the agency’s mailing network due to potential impacts they are having on delivery, rejecting USPS assertions that is has provided transparency. 
    • “USPS should not continue its nationwide operational reforms until it can prove the changes will not negatively impact mail service, Sen. Gary Peters, D-Mich., who chairs the Senate Homeland Security and Governmental Affairs Committee, said in a letter to Postmaster General Louis DeJoy. Agency leadership said in response to the letter it has offered volumes of documents and many staff-level briefings to Congress, though Peters said USPS ignored many of his requests for additional information on its efforts and left Congress uncertain about the fallout that could befall postal customers.”
  • On March 18, 2024, the Office of Management and Budget’s Office of Information and Regulatory Affairs received for final regulatory review an OPM proposed rule with additional requirements and clarifications for the Postal Service Health Benefits Program (RIN 3206-AO59).
  • The AHA News tells us,
    • “U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., and should only use other plastic syringes made in China until they can transition to alternatives, the Food and Drug Administration announced March 19, citing potential quality and performance issues. The recommendations do not apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, FDA said. The agency advises health care providers to confirm the manufacturing location by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization.”
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa M. Gomez, posted on her blog about “Health and Money Smarts for Women.”
  • Fierce Healthcare lets us know,
    • “The Employee Retirement Income Security Act, or ERISA, is turning 50 this year and lawmakers are curious to hear about how the law could be updated to increase coverage affordability and care access.
    • “Payers and providers, it turns out, have very different ideas on where Congress should focus its efforts.
    • “In response to the House Committee on Education and the Workforce’s January request for information, lobbying groups representing both sides of the industry weighed in on the act that outlines federal guidelines for employee benefit plans, including employer-sponsored group health plans.”
    • The article delves into these comments.
  • Newfront offers insights about 2024 RxDC reporting considerations. The reports are due June 1, 2025.
  • The Congressional Budget Office released a presentation about “The Federal Perspective on Coverage of medications to treat obesity. Assuming Congress allows Medicare to cover anti-obesity medications (AOM),
  • “The future price trajectory of AOMs is highly uncertain.
    • “CBO expects semaglutide to be selected for price negotiation by the Secretary of Health and Human Services within the next few years, which would lower its price (and potentially the prices of other drugs in the AOM class).
    • “CBO expects generic competition for semaglutide and tirzepatide to start in earnest in the second decade of a policy allowing Medicare Part D to cover AOMs.
    • “New AOMs are expected to become available. The new drugs might be more effective, have fewer side effects, or be taken less frequently or more easily than current medications. Those improvements could translate to higher prices, on average, even if prices decline for drugs that exist today.”
  • See also the Beckers Hospital Review article below on the next generation of AMOs.
  • Healthcare Dive tells us,
    • “The Medicare Advisory Payment Commission, which advises Congress on Medicare policy, is recommending boosting hospital payment rates by 1.5% in 2025 and base physician payment rates by 1.3% above current law, according to its annual report released Friday. 
    • “MedPAC suggested tying the rate of physician payment increasesmoving forward to the Medicare Economic Index, an annual measure of practice cost inflation. MedPAC suggested payments increase “by the amount specified in current law plus 50% of the projected increase in the MEI.”
    • “Provider groups, including the Medical Group Management Association and American Medical Association, have said the proposed payment increases are inadequate.”

From the public health and medical research front,

  • The Washington Post reports,
    • “More than two-thirds of young children in Chicago could be exposed to lead-contaminated water, according to an estimate by the Johns Hopkins Bloomberg School of Public Health and the Stanford University School of Medicine.
    • “The research, published Monday in the journal JAMA Pediatrics, estimated that 68 percent of children under the age of 6 in Chicago are exposed to lead-contaminated drinking water. Of that group, 19 percent primarily use unfiltered tap water, which was associated with a greater increase in blood lead levels.
    • “The extent of lead contamination of tap water in Chicago is disheartening — it’s not something we should be seeing in 2024,” lead author Benjamin Huynh, assistant professor of environmental health and engineering at the Johns Hopkins Bloomberg School of Public Health, said in a news release.”
  • The Wall Street Journal relates,
    • “Debi Lucas had a tremor in her arm. Her feet froze when she tried to walk and she fell into her coffee table, busting her lip. 
    • “She went to a neurologist who thought she had Parkinson’s disease. Doctors normally diagnose the neurodegenerative condition by symptoms. Lucas, 59, had them. 
    • “But the neurologist, Dr. Jason Crowell, couldn’t be sure. The symptoms might be related to a traumatic brain injury Lucas suffered in a car accident decades earlier, he thought. Or they might be from her medications. 
    • “To find an answer, Crowell turned to a new test: a skin biopsy that can detect an abnormal protein people with Parkinson’s have inside their nerves. He took samples of skin near her ankle, knee and shoulder and sent them to a lab. 
    • “The results confirmed that Lucas has Parkinson’s. The diagnosis was scary, but Lucas finally knew what was causing her symptoms. “I was glad to have a name on it,” she said. 
    • “The test sped her diagnosis, said Crowell, a movement-disorders neurologist at the Norton Neuroscience Institute in Louisville, Ky. “It just gives me more confidence,” he said. 
    • “The skin test is an important part of progress researchers are making against Parkinson’s, the second-most common age-related neurodegenerative condition, which is on the rise and a major driver of disability, dementia and death. The test Lucas received, made by CND Life Sciences, a medical technology company in Scottsdale, Ariz., is one of a few in use or development to allow doctors to diagnose Parkinson’s based on biology rather than symptoms that can take years to appear“.
  • Medscape explains “why a new lung cancer treatment is so promising.”
  • MedPage Today notes,
    • “The FDA has approved aprocitentan (Tryvio), making it the first endothelin receptor antagonist for the treatment of high blood pressure (BP), Idorsia Pharmaceuticals announced on Wednesday.
    • “The once-daily oral medication is indicated in combination with other antihypertensive drugs to lower BP in adult patients who do not have their BP controlled with other therapies.
    • “It is believed that some people may respond better to the drug’s novel mechanism, as aprocitentan is a dual endothelin receptor antagonist that works differently than conventional diuretics, renin-angiotensin-aldosterone system antagonists, calcium channel blockers, and beta-blockers used to lower BP.”
  • Beckers Hospital Review considers the three generations of weight loss drugs.
    • “Anita Courcoulas, MD, defines GLP-1s as “generation one;” dual GLP-1 and GIPs as the second; and a triple threat of GLP-1, GIP and GCGRs as the third generation of weight loss drugs. 
    • “Dr. Courcoulas is chief of Pittsburgh-based UPMC’s minimally invasive bariatric and general surgery program. She told Becker’s the next class of anti-obesity medications are finally reaching weight loss outcomes seen from gastric sleeve and bypass procedures, the two most common surgeries for trimming pounds. * * *
    • “Dr. Courcoulas said the biggest unknown is long-term durability of these medications, a concern other bariatric experts have raised. 
    • “She expects GLP-GIP-GCGR medications to gain approval and enter the U.S. market next year. 
    • “I think it’s very exciting to realize there are medications that are under investigation now that could come to market that could have even better weight loss results than the two drug [classes] we’re seeing now,” Dr. Courcoulas said.”
  • The National Institutes of Health announced,
    • “SARS-CoV-2, the virus that causes COVID-19, can damage the heart even without directly infecting the heart tissue, a National Institutes of Health-supported study has found. The research, published in the journal Circulation, specifically looked at damage to the hearts of people with SARS-CoV2-associated acute respiratory distress syndrome (ARDS), a serious lung condition that can be fatal. But researchers said the findings could have relevance to organs beyond the heart and also to viruses other than SARS-CoV-2.
    • “Scientists have long known that COVID-19 increases the risk of heart attack, stroke, and Long COVID, and prior imaging research has shown that over 50% of people who get COVID-19 experience some inflammation or damage to the heart. What scientists did not know is whether the damage occurs because the virus infects the heart tissue itself, or because of systemic inflammation triggered by the body’s well-known immune response to the virus.
    • “This was a critical question and finding the answer opens up a whole new understanding of the link between this serious lung injury and the kind of inflammation that can lead to cardiovascular complications,” said Michelle Olive, Ph.D., associate director of the Basic and Early Translational Research Program at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH. “The research also suggests that suppressing the inflammation through treatments might help minimize these complications.”
  • and
    • “An investigational gene therapy for a rare neurodegenerative disease that begins in early childhood, known as giant axonal neuropathy (GAN), was well tolerated and showed signs of therapeutic benefit in a clinical trial led by the National Institutes of Health (NIH). Currently, there is no treatment for GAN and the disease is usually fatal by 30 years of age. Fourteen children with GAN, ages 6 to 14 years, were treated with gene transfer therapy at the NIH Clinical Center and then followed for about six years to assess safety. Results of the early-stage clinical trial appear in the New England Journal of Medicine. 
    • “The gene therapy uses a modified virus to deliver functional copies of the defective GAN gene to nerve cells in the body. It is the first time a gene therapy has been administered directly into the spinal fluid, allowing it to target the motor and sensory neurons affected in GAN. At some dose levels, the treatment appeared to slow the rate of motor function decline. The findings also suggest regeneration of sensory nerves may be possible in some patients. The trial results are an early indication that the therapy may have favorable safety and tolerability and could help people with the rapidly progressive disease.
    • “One striking finding in the study was that the sensory nerves, which are affected earliest in GAN, started ‘waking up’ again in some of the patients,” said Carsten G. Bonnemann, M.D., senior author and chief of the Neuromuscular and Neurogenetic Disorders of Childhood Section at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH. “I think it marks the first time it has been shown that a sensory nerve affected in a genetic degenerative disease can actually be rescued with a gene therapy such as this.”
  • Lifesciences Intelligence reports,
    • “Recently, JAMA Network Open published a study analyzing the association between a healthy diet, sleep duration, and type 2 diabetes (T2D) risk. The study data revealed that habitual short sleep duration was linked to an increased probability of T2D by as much as 41%.
    • “Using data on 247,867 individuals from the UK biobank, researchers divided patients into groups based on their sleeping habits. The stratified groups included normal (7–8 hours per night), mildly short (6 hours per night), moderately short (5 hours per night), and extremely short (3–4 hours per night).
    • “Across all study participants, only 3.2% were diagnosed with T2D; however, the adjusted hazard ratios revealed that the prevalence of T2D was higher among shorter sleep groups. More specifically, the increased probability of T2D was identified in those who slept 5 hours or less per night. Those in the moderate short sleep group were 16% more likely to have a T2D diagnosis. Additionally, those in the extremely short sleep group had a 41% greater likelihood of being diagnosed with T2D.”

From the U.S. healthcare business front,

  • BioPharma Dive relates,
    • “Orchard Therapeutics said Wednesday it will offer a new gene therapy to children with a rare, devastating disease at a record-setting wholesale price of $4.25 million. 
    • “The therapy, Lenmeldy, won Food and Drug Administration approval on Monday to treat patients with early-onset metachromatic leukodystrophy, or MLD. The disease, which most often attacks infants between six months and two years of age, robs patients of the ability to walk, talk and function in the world, killing most of its earliest victims within five years of onset.
    • “Lenmeldy’s price tag will leapfrog those of the two most expensive gene therapies available in the U.S. Sarepta Therapeutics sells its Elevidys treatment for Duchenne muscular dystrophy for $3.2 million, while CSL and UniQure’s hemophilia treatment Hemgenix costs $3.5 million.”
  • MedPage Today lets us know,
    • “Despite being a growing percentage of the physician workforce, women physicians continued to be paid less than their male colleagues, a strong body of evidence shows.
    • “While the gender pay gap decreased by 2% from 2021 to 2022 — from 28% to 26% — the gap was still significant, according to online networking service Doximity’s 2023 physician compensation reportopens in a new tab or window.
    • “Women doctors in 2022 earned nearly $110,000 less per year than men physicians, on average, after adjusting for specialty, location, and years of experience. Data from individual states have backed up this figure, too. For instance, in 2022, the Maryland State Medical Society conducted a survey and found that women doctors in Maryland are paid about $100,000 less annually than men.”
  • Beckers Hospital Review lists ten common issues in pharmacies.
  • United Healthcare updated its Change Healthcare cyberattack response website today.
  • HR Daily Advisor explains how companies are exploring the limitations of employee assistance plans amid the country’s mental health crisis.
  • Forbes reports,
    • “Medical diagnosis and procedure codes are so numerous and varied that Debbie Beall, manager of coding at Houston Methodist in Texas, needs a 49-person team to translate the medical notes written by the system’s 1,600 clinicians into the codes needed to bill insurers.
    • “There is a medical code for every imaginable scenario – from “burn due to water-skis on fire” to “spacecraft collision injuring occupant” — and their specificity determines how much the insurance companies pay. Each team member processes anywhere from 70 to 250 claims per day, depending on the complexity, she said. That’s why Beall is so excited about the possibility of using artificial intelligence to speed up the job.
    • “There’s no way I’m ever going to replace coders completely with an AI system,” Beall told Forbes. But for run-of-the-mill procedures performed multiple times a day in a hospital, like X-rays and EKGs? “Yes, an AI engine can do that.”
    • “Beall was one of the first dozen or so people to test a prototype of an AI-powered medical coding tool from electronic health records giant Epic Systems, which had $4.6 billion in revenue in 2022. Based on GPT-4, the large language model that powers the viral chatbot ChatGPT, Epic’s coding assistant prototype ingests and summarizes clinician notes and then tees up the “most likely” diagnosis codes and procedures codes, along with suggestions of “other potential codes,” according to mock ups viewed by Forbes that did not include real patient information. * * *
    • “While Epic has so far focused on using generative AI in back office functions, it has also been working on a patient-facing application that wouldn’t require human review. Krause told Forbes a tool that would help explain the patient’s bill, including their deductible and outstanding balance, could be rolled out by November. “We feel like that’s a fairly benign place to start. It’s not about healthcare at that point, but it’s really about their billing,” he said. “That’s not going to harm a patient in any way.”

   

Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Beware the Ides of March. Wm. Shakespeare

From Washington, DC,

  • STAT News reports
    • “A panel of expert advisers to the Food and Drug Administration on Friday voted in favor of expanding the use of CAR-T therapy in blood cancer, despite concerns about the powerful treatment’s side effects.
    • “The group voted 11-0 that the benefits of Carvykti, a CAR-T medicine from Johnson & Johnson and Legend Biotech, outweighed its risk for patients with multiple myeloma whose disease has persisted despite initial treatment. The same panel voted 8-3 in favor of Abecma, from Bristol Myers Squibb and 2seventy Bio, for multiple myeloma patients who’ve received at least two lines of therapy. Currently both medicines are approved only for patients who have been treated for myeloma with four or more medications.”
    • “In clinical trials, each drug proved to significantly delay disease progression compared to standard therapy. But zooming in on the data, the FDA observed an alarming imbalance of deaths in the early months of both studies, finding that more patients in the CAR-T group died of myeloma or side effects than those receiving the standard of care.
    • “That’s a legitimate concern, panelists said, but one that is outweighed by the potential for a single dose of CAR-T to help patients live without the need for regular, taxing cancer treatment.”
  • MedTech Dive notes,
    • “Intuitive Surgical said Thursday it received 510(k) clearance from the Food and Drug Administration for a fifth-generation robotic surgery system intended to help the company keep its dominant market share in the face of looming competition.
    • “The da Vinci 5 system incorporates features that surgeons have long sought, such as feedback that simulates the feel of the patient’s body tissue, a smaller physical footprint in the operating room, and better console ergonomics.
    • “The improvements “can help drive incremental demand for the system and raise the bar for competition in the future,” William Blair analyst Brandon Vazquez said Friday in a note to clients.”
  • One Digital offers its thoughts about “How will the Inflation Reduction Act of 2022 Impact Employer-Sponsored Group Health Plans in 2025?”
    • It’s not good news, and the FEHBlog doesn’t understand why CMS is making life so difficult for plan sponsors, e.g.,
      • “[T]he Centers for Medicare and Medicaid Services (CMS) released Draft CY 2025 Part D Redesign Program Instructions on January 31, 2024. These instructions, which are still in draft form, noted that one of the methods previously used by a majority of plan sponsors to determine the creditable nature of their plans, the creditable coverage simplified determination methodology, would no longer be a “valid method to determine whether an entity’s prescription drug coverage is creditable or not.”

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 16 jurisdictions experienced high or very high activity compared to 22 jurisdictions previous week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Influenza test positivity increased slightly nationally. COVID-19 and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, has decreased to low.
    • “Reported on Friday, March 15th, 2024.“
  • STAT News gives us good news,
    • “A series of new studies are raising hopes that CAR-T, a process in which treatments are made by genetically editing a patient’s own white blood cells, can eventually be used to treat an incurable and deadly type of brain cancer, called glioblastoma multiforme, or GBM.
    • “In the most dramatic result, from a three-person study conducted by researchers at Massachusetts General Hospital, a 72-year-old man saw his tumor shrink 18.5% in just two days and then decrease further over the next two months until it was 60% smaller than when treatment began. That’s notable because glioblastoma is a cancer where drugs can normally only prevent a tumor from growing. Researchers say the results, published in the New England Journal of Medicine on Wednesday, do not mean the treatment is ready to be used widely but give reason to think they are on the right track.”
  • Healio calls our attention to a study on the benefits of bariatric surgery.
    • Bariatric surgery was associated with reductions in body weight, blood pressure, total cholesterol, triglycerides, glucose and HbA1c.
    • Adults who underwent surgery reduced their 10-year Atherosclerotic cardiovascular disease ASCVD risk by 34.4%.
  • The National Institutes of Health’s Director, in her blog, discusses a study suggesting that during sleep, a neural process helps clear the brain of damaging waste.
    • “We’ve long known that sleep is a restorative process necessary for good health. Research has also shown that the accumulation of waste products in the brain is a leading cause of numerous neurological disorders, including Alzheimer’s and Parkinson’s diseases. What hasn’t been clear is how the healthy brain “self-cleans,” or flushes out that detrimental waste.
    • “But a new study by a research team supported in part by NIH suggests that a neural process that happens while we sleep helps cleanse the brain, leading us to wake up feeling rested and restored. Better understanding this process could one day lead to methods that help people function well on less sleep. It could also help researchers find potential ways to delay or prevent neurological diseases related to accumulated waste products in the brain.
    • “The findings, reported in Nature, show that, during sleep, neural networks in the brain act like an array of miniature pumps, producing large and rhythmic waves through synchronous bursts of activity that propel fluids through brain tissue. Much like the process of washing dishes, where you use a rhythmic motion of varying speeds and intensity to clear off debris, this process that takes place during sleep clears accumulated metabolic waste products out.”

From the U.S. healthcare business front,

  • MedTech Dive lets us know,
    • “Most U.S. hospital executives expect low- to mid-single-digit increases in procedure volumes this year, according to a survey conducted by BTIG analysts.
    • “The forecast, which reflects the resolution of staff shortages at most surveyed sites and a small overall rise in capital equipment budgets, could benefit Boston Scientific, Medtronic and Stryker, the analysts wrote Wednesday in a note to investors.
    • “Robotic surgery jumped up the list of spending priorities, climbing from sixth to third place year over year. The change is a “good sign” for Intuitive Surgical, the analysts said, although the forecast of a continued slump in bariatric procedures has negative implications for the company.”
  • Per Fierce Healthcare,
    • “Medicare households are spending far more on healthcare than other households, according to a new KFF analysis.
    • “Researchers analyzed data from the 2022 Consumer Expenditure Survey, tracking spending trends between 2013 and 2022. At the end of that window, health-related expenses in Medicare households averaged $7,000, or 13.6% of total household spending.
    • “By comparison, non-Medicare households spent on average 6.5% of their total on health-related expenditures, or $4,900.
    • “Healthcare expenses included insurance premiums, medical services, prescription drugs and medical supplies like crutches, hearing aids and eyeglasses.”
  • From Healthcare IT News, a Gartner expert points to AI and hospital-at-home as the biggest emerging technologies at HIMSS24. Veronica Walk, senior director analyst, healthcare and life sciences, at the consulting giant offers an end-of-the-week look at the emerging technologies at the conference that provider organization C-suite executives must grasp. Check it out.
  • Fierce Healthcare discusses why payers and providers continue to tussle over Change Healthcare cyberattack response. Hint: The reason is money.

Midweek Update

David Ermer–CMS, Cybersecurity, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Federal News Network builds on OPM’s March 12 press release about the Postal Service Health Benefits Program launch in January 2025.
  • STAT News calls attention to healthcare points that you might have missed in the President’s FY 2025 budget. For example,
    • “The budget proposes for the first time a change to the law that would let pharmacists fill prescriptions for brand-name biologics with biosimilars without doctor permission. The measure is part of the administration’s plan to lower drug costs. * * *
    • “Besides budget boosts for behavioral health services, research, and the 988 crisis hotline, the administration is asking Congress for legislative changes to make mental health care more accessible. Those include eliminating Medicare’s 190-day lifetime limit on psychiatric services in hospitals, which it estimates would cost the program $2.9 billion over 10 years. * * *
    • “Medicare would also have to cover three behavioral health visits without cost-sharing, a move that could cost $1.5 billion over a decade. Biden wants to extend this requirement to private insurers as well, at an estimated cost of $428 million over that time.”
  • HealthDay informs us,
    • The White House on Wednesday launched a nationwide call for more training and better access to the lifesaving opioid overdose drug naloxone.
    • Called the Challenge to Save Lives from Overdose, the initiative urges organizations and businesses to commit to train employees on how to use opioid overdose medications, to keep naloxone in emergency kits and to distribute the drug to employees and customers so they might save a life at home, work or in their communities.
    • “Today, we’re calling on organizations and businesses — big and small, public and private — across the country to help ensure all communities are ready to use this lifesaving tool to reduce opioid deaths,” the White House said in a fact sheet announcing the new initiative. “As the drug supply has gotten more dangerous and lethal, we’re asking allies to join us because we all must do our part to keep communities safe.”
  • The CDC is offering free webinars on the RxDC process on March 27 and April 3.

From the Change Healthcare situation front,

  • United Healthcare updated its Change Healthcare situation response website this afternoon.
  • The HHS Office for Civil Rights, which enforces the HIPAA Privacy and Security Rule, issued a Dear Colleague letter about the Change Healthcare situation and announced opening an investigation of UHC about cyberattack and its fallout.
  • The Congressional Research Service posted an insight report titled “The Change Healthcare Cyberattack and Response Considerations for Policymakers.’
  • The American Medical Association explained how providers can navigate the Change Healthcare situation.

From the public health and medical research front,

  • The New York Times reports,
    • “Early detection of colon cancer can prevent a majority of deaths from this disease, possibly as much as 73 percent of them. But just 50 to 75 percent of middle-aged and older adults who should be screened regularly are being tested.
    • “One reason, doctors say, is that the screening methods put many people off.
    • “There are two options for people of average risk: a colonoscopy every 10 years or a fecal test every one to three years, depending on the type of test.
    • “Or, as Dr. Folasade P. May, a gastroenterologist at UCLA Health puts it, “either you take this horrible laxative and then a doctor puts an instrument up your behind, or you have to manipulate your own poop.”
    • “But something much simpler is on the horizon: a blood test. Gastroenterologists say such tests could become part of the routine blood work that doctors order when, for example, a person comes in for an annual physical exam. * * *
    • “A study published on Wednesday in The New England Journal of Medicine found that a blood test searching for such [colon cancer] DNA called Shield and made by the company Guardant Health detected 87 percent of cancers that were at an early and curable stage. The false positive rate was 10 percent.
    • “But there is a caveat to the blood test: While it detects cancers, it misses most large polyps, finding just 13 percent of them. In contrast, the fecal test detects 43 percent and a colonoscopy finds 94 percent, Dr. Carethers said.
    • “While polyps are usually harmless, a few can turn into cancers, so doctors want to find all of them and remove them to prevent cancers from forming.”
  • The Department of Health and Human Services posted a fact sheet on in vitro fertilization across our country.
  • BioPharma Dive tells us,
    • “Merck on Wednesday announced plans to start clinical trials testing a newer version of its vaccine for human papillomavirus, or HPV, as well as a different regimen of the shot it currently sells.
    • “The trials are bids to improve upon vaccines Merck currently markets as Gardasil and Gardasil 9. One will test a shot meant to provide protection against more strains of HPV. The other will evaluate a single-dose regimen of Gardasil 9. Both studies should begin in the fourth quarter of this year. 
    • “Gardasil is approved for use against genital warts and to prevent several cancers caused by stains of HPV. The vaccine is one of Merck’s top-selling products and still growing. It generated $8.9 billion in sales in 2023, up 29% from the previous year.” 
  • STAT News informs us,
    • “For four decades, researchers and companies searched for ways to replace the broken blood-clotting genes that cause hemophilia, a multibillion dollar effort designed to turn a chronic, sometimes debilitating disease into a curable one. 
    • “But the first two gene therapies have so far been met with crickets. Only a handful of patients with hemophilia B, the rarer form of the disease, appear to have been treated worldwide since Hemgenix was approved in November 2022. After Roctavian was approved for hemophilia A last June, only three patients were treated through the rest of the year.
    • “The issue doesn’t appear to be access. Hemgenix and Roctavian, marketed by the Australian biotech CSL Behring and the San Francisco biotech BioMarin, are Malibu-mini-mansion expensive: $3.5 million and $2.9 million, respectively. But current hemophilia treatments can run over $1 million per year. So most insurers have been happy to pay the lump sum.
    • “​​You can’t blame the payers this time,” said Michael Sherman, former chief medical officer of the nonprofit insurer Harvard Pilgrim.” 
  • The National Cancer Institute posted research highlights.
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health (NIH) have discovered that symptoms of attention-deficit/hyperactivity disorder (ADHD) are tied to atypical interactions between the brain’s frontal cortex and information processing centers deep in the brain. The researchers examined more than 10,000 functional brain images of youth with ADHD and published their results in the American Journal of Psychiatry. The study was led by researchers at NIH’s National Institute of Mental Health and National Human Genome Research Institute. * * *
    • “The findings from this study help further our understanding of the brain processes contributing to ADHD symptoms—information that can help inform clinically relevant research and advancements.”
  • The Institute for Clinical and Economic Review published a “Final Evidence Report on Treatments for Paroxysmal Nocturnal Hemoglobinuria. — Independent appraisal committee voted that current evidence is not adequate to demonstrate a net health benefit for iptacopan over C5 inhibitor; committee voted that the evidence is adequate to demonstrate a net health benefit for add-on danicopan compared to C5 inhibitor alone.”
  • Medscape relates,
    • “Chronic smoking remains a major cause of premature mortality on a global scale. Despite intensified efforts to combat this scourge, a quarter of deaths among middle-aged adults in Europe and North America are attributed to it. However, over the past decades, antismoking campaigns have borne fruit, and many smokers have quit before the age of 40 years, enabling some case-control studies.
    • “Among those abstainers who made the right choice, the excess mortality attributable to smoking over a lifetime would be reduced by 90% compared with controls who continued smoking. The estimated benefit is clear, but the analysis lacks nuance. Is smoking cessation beneficial even at older ages? If so, is the effect measurable in terms of magnitude and speed of the effect? An article published online on February 8, 2024, in The New England Journal of Medicine Evidenceprovided some answers to these questions.”

From the HIMSS conference front,

  • Healthcare IT News reports “Samsung focuses on intuitive mobile tech and wearables at HIMSS24. These technologies can help cure healthcare worker burnout, patient confusion and inefficient communications between care teams, says a top exec and nurse.”
  • Forbes explains why AI is taking center stage at the conference.
    • “At the HIMSS conference in Orlando, healthcare leaders, including CIOs, CMIOs, CNIOs, and other C-suite members, were focused on AI as the central theme. They explored how healthcare organizations can better utilize their clinical data. They identified security, AI platforms, and workforce optimization as the three main areas for healthcare AI development.”
  • In related news, Health IT Analytics lets us know,
    • “Researchers from Mount Sinai have been awarded a four-year, $3 million grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) to develop artificial intelligence (AI)-driven prediction models to flag risk of cardiovascular disease events in patients with obstructive sleep apnea.
    • “The American Heart Association (AHA) indicates that obstructive sleep apnea increases patients’ risk of cardiovascular disease, including coronary artery disease, hypertension and stroke. The use of continuous positive airway pressure (CPAP) machines is often prescribed to treat sleep apnea, but evidence to suggest the benefits of CPAP use in relation to cardiovascular event rates is limited.
    • “To bridge this gap, the research team will build machine learning (ML) tools to identify obstructive sleep apnea patients at high risk for atherosclerosis progression and cardiovascular events like stroke and heart attack.”

In other U.S. healthcare business news,

  • The Wall Stree Journal reports,
    • “People seeking a popular new weight-loss drug will have a new home-delivery option from a familiar name: Amazon.com.
    • “Amazon Pharmacy, which has sold prescription medicines online since 2020, will now handle some of the home delivery of anti-obesity therapy Zepbound and other Eli Lilly drugs that are ordered through the drugmaker’s new direct-to-consumer service, the companies said Wednesday.
    • “The service, called LillyDirect, connects patients with telehealth services specializing in obesity that can write prescriptions for Zepbound or another weight-loss drug. The service also arranges for a prescription to be processed and mailed directly to customers.” 
  • The Society for Human Resource Management notes,
    • “According to the latest Employer Costs for Employee Compensation report, released March 13 by the U.S. Bureau of Labor Statistics (BLS), employers spent 3.8 percent more on wages and benefits in December 2023 compared to September 2023.
    • “Total employer compensation costs for private-industry workers averaged $43.11 per hour worked in December 2023. Wages and salaries averaged $30.33 per hour worked and accounted for 70.4 percent of employer costs, while benefit costs averaged $12.77 per hour worked and accounted for the remaining 29.6 percent, according to the BLS report.
    • :That’s a significant jump from the total employer compensation costs for those same workers last fall, and one indicating that despite slowing compensation growth over the past year, bigger hikes are not yet over.”

Tuesday Tidbits

David Ermer–COVID-19, Cybersecurity, Electronic health records, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, OPM, Patient safety, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Because this is the FEHBlog, the lede tonight necessarily is OPM’s announcement naming the carriers who are currently prepared Postal Service Health Benefit Program benefit and rate proposals. Good luck to them all.
  • FedWeek notes,
    • “President Biden has issued an open letter to federal employees thanking them for their “tireless service on behalf of our country.”
  • and
    • “While seeking a January 2025 raise of 2 percent (see related story), the White House’s fiscal 2025 budget proposal cites several initiatives related to federal pay.
    • “In addition to year-to-year pay increases, the Administration is pursuing structural reforms to enhance the competitiveness of the Federal pay system,” it says.
  • Reg Jones, writing in Fedweek, fills us in on benefits available upon the death of a federal employee or annuitant.
  • The Department of Health and Human Services provided a readout from “Biden-Harris Administration Convening with Health Care Community Concerning Cyberattack on Change Healthcare. Leaders from HHS, White House, DOL, and the health care community convened to discuss ways to mitigate harms to patient and providers caused by the cyberattack.”
  • The Food and Drug Administration “advised consumers in Some Medicines and Driving Don’t Mix to make sure they know if their prescription or over-the-counter medication can cause side effects that may make it unsafe to drive. Most medications won’t affect consumers’ ability to drive safely or operate other heavy machinery, but some do.”
  • The Buck consulting firm points out why “maintaining creditable coverage may prove difficult for some employer sponsored plans in 2025.”
  • STAT News discusses the treatment impact of new federal methadone rules.
    • “The federal government is reforming methadone care for the first time in over two decades. But how far do the changes actually go?
    • “To many methadone clinics, the Biden administration’s recent refresh of the rules governing opioid treatment programs represents an unprecedented opportunity to offer care that is more compassionate and responsive to patients’ needs. To many patient advocates, however, it simply nibbles around the edges. 
    • “The reality is likely somewhere in between: It will depend, in large part, on whether state-level regulators embrace the changes, and whether individual clinics actually implement them. In reform-oriented states, and at patient-centered clinics, the new rules could make a world of difference for people seeking addiction treatment.” 
  • The Office of National Coordinator for Healthcare Information Technology, Micky Tripathi, in his blog, looks forward to “HTI-2 & ONC’s Commitment to Furthering the Vision of Better Health Enabled by Data.”

From the public health and medical research front,

  • BioPharma Dive reports,
    • “Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of amyloid protein from the brains of patients enrolled in a small clinical trial, the company said Monday.
    • “A majority of patients receiving the highest dose of the drug, which is specially designed to penetrate brain tissue, saw their amyloid levels drop below detectable levels after 12 weeks, Roche executives said in an investor presentation on the pharmaceutical giant’s neurology pipeline.”
  • Reuters tells us, “Pfizer  said on Tuesday its drug, Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen [in 2023].
  • MedPage Today lets us know,
    • “Pragmatic implementation of an automated online behavioral obesity treatment program that included 9 months of active maintenance helped people with overweight or obesity lose a clinically significant amount of weight by 12 and 24 months, a randomized trial showed. * * *
    • “This pattern persisted at 24 months, reported J. Graham Thomas, PhD, of the Weight Control and Diabetes Research Center in Providence, Rhode Island, and colleagues in JAMA Internal Medicine.
    • “This study shows that a fully automated online obesity treatment program can produce beneficial results for many patients in real-world primary care settings,” Thomas told MedPage Today. “We were encouraged to find that the online weight-loss program performed just as well in real-world primary care practices as it does in our previous highly controlled clinical trials.”
    • “These patients lost weight “at rates comparable” to those seen in studiesopens in a new tab or window in which the researchers were completely hands-on in every aspect of the program, he added.
    • “Because the treatment program is online and fully automated, Thomas said it is quite practical for widespread implementation across primary care practices. “The data show that the primary care clinicians were able to implement the program independently, and patients were able to use it successfully.”
  • Beckers Hospital Review adds,
    • “Hospital transplant departments have strict cutoffs for patients with higher body mass indexes because of the increased risk of complications, but GLP-1s such as Ozempic and Wegovy are helping more patients be eligible for surgery. 
    • “Potential transplant donors and diabetic patients who otherwise would not be able to undergo surgery because of their BMI are now quickly dropping weight. Popular GLP-1s, including Ozempic, and GLP-1s and glucose-dependent insulinotropic polypeptides, such as Mounjaro and Zepbound, are dramatically helping these weight loss efforts.” 
  • Medscape cautions,
    • “Novo Nordisk’s CEO on Friday said the company was working with authorities in several countries to tackle counterfeit versions of its popular diabetes drug Ozempic, as new reports emerge of patient harm across the world.
    • “This is something we take very seriously,” Lars Fruergaard Jorgensen, CEO of the Danish drugmaker, told Reuters. * * *
    • “Jorgensen, echoing comments from the FDA’s Califf, also said compounded semaglutide in the United States was a serious health issue, and that the raw materials, or active pharmaceutical ingredients (API), for these products were coming from unregulated facilities in Asia and elsewhere. 
    • “We don’t know them, and we have really no insights or ability to understand what the API is in a certain compounded product,” he said.
    • “While fake drugs often do not contain any of the medication advertised, compounded drugs are custom-made medicines that are based on the same ingredients as branded drugs. Because Wegovy and Ozempic are in short supply, they can be legally produced by licensed pharmacies in the U.S.
    • “Further reports obtained by Reuters through FOIA requests show that one person died last year from abnormal blood clotting after taking a drug that was advertised as compounded semaglutide. Three others suffered severe vomiting and nausea, sensory loss in their legs, and a drop in blood platelet levels.”
  • The U.S. Census Bureau announced,
    • “An additional 573,000 people died in the United States during the first year of the COVID-19 pandemic but “excess mortality” at the national level masks substantial variations by state, age, sex, and race and ethnicity, according to new U.S. Census Bureau research recently published in Demography.
    • “Excess mortality” refers to deaths from any cause above what is expected from recent mortality trends.
    • “This research shows the pandemic widened the mortality gap between the nation’s Black and White populations and completely erased the mortality advantage of the Hispanic population in relation to the non-Hispanic White population.”
  • The National Institutes of Health announced‘,
    • “Two phase 2 clinical trials to test the safety and effectiveness of three treatments for adults with autonomic nervous system dysfunction from long COVID have begun. The autonomic nervous system acts largely unconsciously and regulates bodily functions, such as heart rate, digestion and respiratory rate. Symptoms associated with autonomic nervous system dysfunction have been among those that patients with long COVID say are most burdensome. The trials are part of the National Institutes of Health’s Researching COVID to Enhance Recovery (RECOVER) Initiative, a nationwide research program to fully understand, diagnose and treat long COVID. Other RECOVER phase 2 clinical trials testing treatments to address viral persistence and neurological symptoms, including cognitive dysfunction (like brain fog), launched in July 2023. * * *
    • “People 18 years of age and older who are interested in learning more about these trials can visit https://trials.RECOVERCovid.org/autonomic or ClinicalTrials.gov and search identifier NCT06305793, NCT06305806 and NCT06305780. Please do not contact the NIH media phone number or email to enroll in these trials.”
  • The Wall Street Journal warns,
    • “Ultra-processed foods may not only affect our bodies, but our brains too.
    • “New research suggests links between ultra-processed foods—such as chips, many cereals and most packaged snacks at the grocery store—and changes in the way we learn, remember and feel. These foods can act like addictive substances, researchers say, and some scientists are proposing a new mental-health condition called “ultra-processed food use disorder.” Diets filled with such foods may raise the risk of mental health and sleep problems. 
    • “The science is still early and researchers say there is a lot they don’t know. Not all ultra-processed foods are equal, some scientists say, adding that some might be good for you. A diet high in ultra-processed foods has been linked with obesity, Type 2 diabetes, cancer and cardiovascular disease, but researchers are still figuring out exactly why, beyond calorie counts and nutrient composition. 
    • “Makers of foods such as processed meats and muffins defend their products, and note that there isn’t a consistent, universally accepted definition of ultra-processed food.”

From the HIMSS Conference in Orlando,

  • HIMSS offers an article about “Google Cloud’s debut of new genAI advancements for healthcare at HIMSS24. In total, the company is offering its cloud clients updates to Vertex AI Search, Healthcare Data Engine and MedLM, designed to improve patient care.”

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Nearly half of U.S. workers don’t have the benefits they need at work, according to the results of a survey by Perceptyx, an employee experience company. Of the 1,500 full-time employees surveyed, 59% said they had “benefits envy” of friends’ and family members’ healthcare coverage.
    • “When it comes to benefits equity, the survey found that medical, maternity and mental health are the “magic trifecta,” Emily Killham, senior director of people analytics, research and insights at Perceptyx, said. “When employees have access to all three, women and men feel equally that their needs are met.”
    • “Yet 53% of those surveyed said they don’t have mental health coverage, 51% don’t have maternity leave, and 25% don’t have any medical benefits, per the results.”
  • Beckers Hospital Review informs us,
    • “Healthgrades recognized 832 hospitals with its 2024 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 79 of those hospitals received both awards. 
    • “The dual recipients spanned 27 states. Texas had the most dual recipients with 13 honorees — including four Baylor Scott and White Health and four Houston Methodist hospitals.”
    • The article lists the dual recipients.
  • Beckers Payer Issues relates,
    • “Selective contracting with primary care physicians may be one factor behind lower per-patient expenses in Medicare Advantage, a study published in the March edition of Health Affairs found. 
    • “The study examined 4,456,037 traditional Medicare patients who visited 151,679 primary care physicians. The physicians who participated in Medicare Advantage networks had $433 lower costs per patient than the regional average of physicians. 
    • “The quality measures for physicians participating in Medicare Advantage were similar to the regional average, the study found. 
    • “Physicians who did not participate in any MA networks cost $1,617 more per patient per year than those participating in MA networks, and they had lower quality measures. 
    • “The findings suggest that “managed care tools, particularly selective contracting with primary care physicians” contribute to lower costs in Medicare Advantage, the authors concluded. Though the differences in cost are most likely attributable to differences in practice style, that could also serve as a mechanism for plans to select healthier patients, the authors wrote.” 
  • Health Payer Intelligence adds,
    • “The average Medicare Advantage premium has remained low and stable, with many beneficiaries choosing plans with a zero-dollar monthly premium, according to data from eHealth, Inc.
    • “eHealth’s seventh annual Medicare Index Report includes data from over 190,000 applications for Medicare insurance products submitted to eHealth during the annual enrollment period for 2024 coverage.
    • “The average monthly premium for Medicare Advantage plans chosen by eHealth customers for 2024 is $9, the same as last year and up slightly from $6 in 2022. The popularity of plans with zero-dollar premiums contributed to the low average.”
  • HealthDay informs us,
    • “The cost to American families of caring for a child with a mental health condition jumped by almost a third between 2017 and 2021.
    • “It now costs an average $4,361 more per year for a U.S. family to care for a child with a mental health condition, compared to families without such children, a new study has found.” 

Monday Roundup

David Ermer–AHRQ, COVID-19, Electronic health records, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “President Biden proposed Monday a $7.3 trillion budget for the next fiscal year that would raise taxes on wealthy people and large corporations, trim the deficit and lower the costs of prescription drugs, child care and housing.
    • “The proposal isn’t expected to gain momentum in Congress, but will be a cornerstone of Biden’s re-election campaign as he looks to contrast his economic policies with those of presumed Republican presidential nominee Donald Trump. The administration has yet to reach an agreement with Congress on the budget for the current fiscal year, which began Oct. 1, and House Republicans have blasted Biden’s new proposal as reckless.
    • “The fiscal 2025 budget would cut the deficit by $3 trillion over the next decade, and it would raise taxes by a net total of $4.9 trillion, or more than 7% above what the U.S. would collect without any policy changes.” 
  • Here’s a link to the OMB page for the FY 2025 budget.
  • The Department of Health and Human Services offers a fact sheet on the budget measures impacting health insurance.
  • Govexec delves into the significant program reforms found in the budget details.
  • Federal News Network adds,
    • “For 2025, the White House is pushing for a more modest 2% federal pay raise for the roughly 1.5 million federal employees on the General Schedule.
    • “If enacted, most civilian federal employees would see the boost to their paychecks starting in the first full pay period of January 2025. Military members would receive a 4.5% raise next year, according to the budget request.
    • “The percentage adjustment would be the smallest pay raise since President Joe Biden took office. Federal employees received raises of 5.2%, 4.6% and 2.7%, in 2024, 2023 and 2022, respectively. In all three years, Biden’s federal pay raise proposals were finalized without intervention from Congress.
    • “The Biden administration said it opted for the smaller raise proposal for 2025 due to financial constraints agencies are expected to face over the next fiscal year.”
  • The U.S. Office of Personnel Management posted its FY 2025 Congressional Budget Justification and Annual Performance Plan. Here are OPM’s legislative proposals for FEDVIP and FEHBP/PSHBP:
    • “Expand Family Member Eligibility Under FEDVIP;
    • “Expand FEDVIP to Certain Tribal Employers;
    • “Expand FEHB to Tribal Colleges and Universities;
    • “Preempt State/Local Taxation of FEDVIP Carriers to Align with FEHB Carriers;
    • “Shorten FEDVIP Contract Terms to Allow Flexibility for New Carriers;
    • “Require Coverage of Three Primary Care Visits and Three Behavioral Health Visits Without Cost-Sharing;
    • “Limit Cost-Sharing for Insulin at $35 per Month.”
  • These proposals generally are retreads from earlier performance plans. If at first you don’t succeed, etc.

From the patient safety front,

  • HHS’s Agency for Healthcare Research and Quality reminds us that this is Patient Safety Awareness Week.
  • Fierce Healthcare tells us,
    • “Through no fault of their own, clinicians who started practicing medicine in the last several years didn’t have the same early experience as those who came before them–before the pandemic laid bare critical weaknesses in our healthcare system,” Marcus Schabacker, M.D., president and CEO of ECRI, said in a release. “ECRI’s top patient safety concern is a call to action to set new clinicians up for success through a ‘total systems safety’ approach and assess and redesign the environments in which clinicians are trained, onboarded, mentored and supported.”
    • “Among the recommendations proposed by ECRI and its affiliate, the Institute for Same Medication Practices (ISMP), in the patient safety report are new collaborative partnerships between healthcare and academic to support hands-on and simulation-based learning, as were wellness programs and adopting “a culture of safety that empowers newly trained clinicians to report safety events.”
    • “Just behind new hire challenges in ECRI’s 2024 ranking was concern that healthcare staff’s workarounds for barcode medication administration systems could lead to an increase in medication safety events.
    • “These workarounds occur when drug’s barcode can’t be scanned due to damage on a label, or when a medication hasn’t yet been added to an organization’s system, ECRI explained. This can lead to back-charting, proxy scanning, unlogged medication administration and ignored system alerts, and has historically been to blame for a majority of technology-related medication safety issues, according to the report.”
  • USAA Today reports,
    • “Beginning this year, the Centers for Medicare & Medicaid Services announced it would cover navigation services for older Americans on Medicare. The agency also established billing codes for hospitals and doctors to bill health insurance companies for navigator services.
    • “The Biden administration announced that seven large private health insurance companies have agreed to cover navigator services: Aetna, Blue Cross Blue Shield of Minnesota, Elevance Health, Health Alliance Plan, Humana, Priority Health and Select Health.
    • “In addition, 40 cancer care centers and clinics will extend navigator services to patients. The list includes high-profile cancer care centers such as Dana-Farber Cancer Institute in Boston, the Duke Cancer Institute, Northwell Health and the Mayo Clinic.
    • “This is about making sure that a growing number of Americans can get access as they need it,” Arati Prabhakar, director of the White House Office of Science and Technology Policy, told USA TODAY. “The companies that have signed up to provide insurance coverage for these services … reach 150 million Americans.”

From the Food and Drug Administration front,

  • BioPharma Dive informs us,
    • “The Food and Drug Administration has expanded the label for Novo Nordisk’s fast-selling weight loss drug Wegovy following study results that proved the medicine can protect heart health. 
    • “The agency on Friday approved use of Wegovy to reduce the risk of heart attacks, strokes or death in people with cardiovascular disease and who are either obese or overweight. The drug should be used alongside exercise and a reduced-calorie diet, the agency said. 
    • “Wegovy, part of a popular class of medicines that control blood sugar and appetite, is already approved for use in treating obesity. The drug generated about $4.5 billion in sales in 2023 despite manufacturing issues that made it difficult for the company to meet surging demand.” * * *
    • “The FDA clearance issued Friday is one step in that direction. It was based on the results of a large study, the results of which were published in The New England Journal of Medicine last year, showing that treatment with Wegovy reduced the risk of heart attack, stroke or cardiovascular death by 20% compared to a placebo.” 
  • MedTech Dive lets us know,
    • “A Food and Drug Administration advisory committee has voted that the benefits of a new agent used in Lumicell’s breast cancer imaging tool outweigh the risks.
    • “The committee, which convened last week, assessed evidence that the tool can detect residual cancer in real-time during breast conserving surgery. Detecting residual cancer during surgery could reduce the need for additional procedures.
    • “While the committee supported the risk-benefit profile of the agent, pegulicianine, by a 16-2 vote, many of the experts noted its limitations, with one panelist who voted yes saying that the “incremental benefits outweigh the small risks of anaphylaxis.”

From the public health and medical research front,

  • David Leonhardt writing in the New York Times reflects on the fourth anniversary of the beginning go of the Covid shutdown in the U.S.
  • The American Medical Association tells us what doctors wish their patient knew about sickle cell disease.
  • The Institute for Clinical and Economic Review posted a “Final Evidence Report on Treatment for Schizophrenia — An independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits for KarXT compared to generically available aripiprazole; if long-term data confirm KarXT’s benefits and lack of weight gain, it would achieve common thresholds for cost-effectiveness if priced between $16,000 to $20,000 per year.
  • Beckers Hospital Review relates,
    • “Pfizer’s shortage of penicillin G benzathine injection, an antibiotic for syphilis and other bacterial infections, is now predicted to last until the end of 2024. 
    • “Pfizer previously said the medication’s supply would rebound by the end of June, but in a March 8 update on the FDA’s drug shortage website, the drugmaker said the estimated recovery date is the fourth quarter of 2024. 
    • “Two solutions are in limited availability and another, the 600,000 [iU]/1 mL solution, is unavailable until its next shipment in April. 
    • “The FDA first reported the supply issue in April 2023, and Pfizer then said it would end within five months. A year later, clinicians are rationing penicillin, and the U.S. is importing solutions from a France-based drugmaker as syphilis rates dramatically increase.”

From the HIMSS global conference front,

  • This week, HIMSS is holding its popular global conference in Orlando, Florida.

From the U.S. healthcare business front,

  • Fierce Healthcare discusses lobbying efforts to obtain a Congressional extension of Medicare’s hospital at home program.
  • Healthcare Dive notes,
    • “Elevance Health said on Monday it closed its deal to acquire infusion and drug therapy company Paragon Health.
    • “Under the deal, the insurer will expand Plano, Texas-based Paragon’s real estate footprint and scale up operations, according to the announcement. Paragon will operate under CarelonRx, Elevance’s pharmacy services segment.
    • “An Elevance spokesperson declined to share financial terms of the deal. However, Axios, citing sources familiar, reported the purchase would run Elevance over $1 billion.”
  • Beckers Hospital Review ranks 34 health systems by operating margin.
  • Medscape informs us,
    • “A Maryland firm that oversees the nation’s largest independent network of primary care medical practices is facing a whistleblower lawsuit alleging it cheated Medicare out of millions of dollars using billing software “rigged” to make patients appear sicker than they were.
    • “The civil suit alleges that Aledade, Inc.’s, billing apps and other software and guidance provided to doctors improperly boosted revenues by adding overstated medical diagnoses to patients’ electronic medical records.
    • “Aledade did whatever it took to make patients appear sicker than they were,” according to the suit.”
  • HR Dive reminds us,
    • “The U.S. Department of Labor’s independent contractor final rule went into effect Monday, after businesses scrambled last week to have it enjoined or halted through a preliminary injunction. 
    • “DOL announced the final rule in January, more than a year after it proposed changes to its evaluation of workers’ independent contractor status in October 2022. 
    • “The new “totality-of-the-circumstances” framework uses six nonexhaustive factors to determine workers’ independent contractor status, including the nature and degree of control over the work, extent to which the work performed is an integral part of the employer’s business and permanence of the arrangement. 

Happy Leap Day!

David Ermer–CDC, Congress, Cybersecurity, Government Contracting, Medicare, Mental health care, Obesity, SDOH, U.S. Healthcare–
Photo by Joe Caione on Unsplash

From Washington, DC,

  • Politico reports,
    • “The Senate approved a stopgap funding bill Thursday night for President Joe Biden’s signature, thwarting a partial government shutdown on Saturday and buying more time to finalize half a dozen spending bills that congressional leaders aim to pass next week.
    • “Congress now officially has until March 8 to clear that initial six-bill bundle, which leaders struck a deal on earlier this week. But they’re still working on an agreement to fund the rest of the government, including the military and some of the biggest domestic programs, before a second deadline on March 22. The upper chamber cleared the measure in a 77-13 vote, following votes on four Republican amendments that were defeated on the floor.”
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan concerning Primary Care Interventions for Tobacco and Nicotine Use Prevention and Cessation in Children and Adolescents. The comment period ends on March 27, 2024.
  • The Labor Department’s Office of Federal Contract Compliance Programs created an updated website for the “The Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA) [which] is a law that prohibits federal contractors and subcontractors from discriminating in employment against protected veterans and requires employers take affirmative action to recruit, hire, promote, and retain these individuals.”
  • Yesterday, the Politico Pulse posted a story on a December 2022 Government Accountability Office report, released January 9, 2023, criticizing OPM’s internal controls over FEHB family member eligibility. Here is a link to the GAO’s website for the report which offers August 2023 updates on OPM’s efforts to implement GAO’s recommendations. Here’s are FEHBlog recommendations for GAO and OPM:
    • Family member eligibility hinges on the enrollee’s eligibility. OPM needs to have the payroll offices implement the HIPAA 820 enrollment roster electronic transaction which allows carriers to reconcile premiums to actual headcount. Use of the HIPAA 820 will be a huge step toward confirming the accuracy of family member eligibility and the 50% of FEHB enrollees who have self only coverage.
    • The Politico article suggests that the high cost of a family member eligibility audit discourages OPM from implementing one for the FEHBP. Auditors do their work based on samples. Arrange for a family member eligibility audit using statistically appropriate samples which will disclose, at the very least, the scope of the problem.

From the U.S. public health and medical research front,

  • The New York Times reports,
    • “Long Covid may lead to measurable cognitive decline, especially in the ability to remember, reason and plan, a large new studysuggests.
    • “Cognitive testing of nearly 113,000 people in England found that those with persistent post-Covid symptoms scored the equivalent of 6 I.Q. points lower than people who had never been infected with the coronavirus, according to the study, published Wednesday in The New England Journal of Medicine.
    • “People who had been infected and no longer had symptoms also scored slightly lower than people who had never been infected, by the equivalent of 3 I.Q. points, even if they were ill for only a short time.
    • “The differences in cognitive scores were relatively small, and neurological experts cautioned that the results did not imply that being infected with the coronavirus or developing long Covid caused profound deficits in thinking and function. But the experts said the findings are important because they provide numerical evidence for the brain fog, focus and memory problems that afflict many people with long Covid.”
  • and
    • “Alcohol-related deaths surged in the United States by nearly 30 percent in recent years, with roughly 500 Americans dying each day in 2021, according to a new study published by the Centers for Disease Control and Prevention.
    • “The study chronicled a sustained spike in drinking during the Covid pandemic that continued to rise after the shock of the lockdowns of 2020. The incidence of alcohol-related deaths was higher in men, but among women the death rate shot up at a quicker pace.
    • “I think the results of this research are really alarming,” said Dr. Michael Siegel, who is a professor of public health at Tufts University School of Medicine and was not involved in the study. “It shows that there’s been a truly substantial increase in alcohol-related deaths over the last six years.”
  • and
    • “The 2022 outbreak of mpox, previously known as monkeypox, was curbed in large part by drastic changes in behavior among gay and bisexual men, and not by vaccination, according to a new analysis published on Thursday in the journal Cell.
    • “Public health response to outbreaks often relies heavily on vaccines and treatments, but that underestimates the importance of other measures, said Miguel Paredes, lead author of the new study and an epidemiologist at the Fred Hutchinson Cancer Center in Seattle.
    • “Although the Food and Drug Administration approved a vaccinefor mpox in 2019, getting enough doses produced and into arms proved challenging for many months after the outbreak began. Vaccines for new pathogens are likely to take even longer.
    • “The new analysis suggests an alternative. Alerting high-risk communities allowed individuals to alter their behavior, such as reducing the number of partners, and led to a sharp decrease in transmission, Mr. Paredes said. In North America, the outbreak began petering out in August 2022, when less than 8 percent of high-risk individuals had been vaccinated.
    • “Public health messaging can “be really powerful to control epidemics, even as we’re waiting for things like vaccines to come,” he said.”
  • Roll Call adds,
    • “Cases of measles are rising across the country and seem to be striking counties at random, but experts say there is one thing the public health system can do to turn the tide, and that’s to stem the post-pandemic vaccine lag and get parents to vaccinate their kids.
    • “General vaccination rates, including measles vaccination, declined during the COVID-19 pandemic, as people had less access to health care and kids were unable to access in-school vaccine clinics.
    • “That, combined with a new wave of vaccine skepticism and anti-vaccine sentiment has contributed to a wave of unvaccinated kids falling sick with the once-eradicated virus.”
  • MedPage Today tells us,
    • “The benefits of vaccination against respiratory syncytial virus (RSV) for adults ages 60 and older probably outweigh the small risk of vaccine-related Guillain-Barré syndrome (GBS), the CDC’s Advisory Committee on Immunization Practices (ACIP) reaffirmed.
    • “In a presentation on the second day of the ACIP’s 2-day meeting, Amadea Britton, MD, of the CDC’s RSV adult vaccination work group in Atlanta, noted that a small number of cases of Guillain-Barre syndrome had been observed in the clinical trials for both FDA-approved RSV prefusion F protein vaccines, but that it remained unclear whether those cases were actually caused by RSV vaccination or just chance occurrences.”
  • and
    • The CDC has issued new guidance —  its first since 1988 — on identifying and responding to clusters of suicide, as tens of thousands of lives are lost to suicide each year in the U.S.
    • Though suicide clusters are rare, they “can have unique characteristics and challenges,” and “are often highly publicized and can have considerable negative effects on the community, including prolonged grief and elevated fear and anxiety about further deaths,” Michael Ballesteros, PhD, of CDC’s National Center for Injury Prevention and Control (NCIPC), and colleagues wrote in Morbidity and Mortality Weekly Report (MMWR).
  • Beckers Hospital Review informs us,
    • “The CDC is anticipating a shortage of Td vaccines — which protect against tetanus and diphtheria — as the maker of one shot has discontinued production. 
    • “As a result, the CDC has updated guidance for providers and is recommending that they switch to administering Tdap vaccines, which protect against pertussis in addition to tetanus and diphtheria, whenever possible.  
    • “MassBiologics discontinued production of its TdVax shot, and while Sanofi also manufactures a Td vaccine and is working to boost supplies, the CDC anticipates the U.S. could see a shortage of the vaccines later this year. 
    • “Because not everyone can receive the Tdap vaccine, “the limited supply of Td vaccine needs to be preserved for those with a contraindication to receiving pertussis-containing vaccines,” the CDC said in its guidance.” 
  • Medscape notes,
    • “Injectable weight loss drugs like Wegovy, Saxenda, and Zepbound have been getting all the glory lately, but they’re not for everyone. If the inconvenience or cost of weight loss drugs isn’t for you, another approach may be boosting your gut microbiome.
    • “So how does one do that, and how does it work?
    • “In theory, all you have to do is boost your gut microbiome.
    • “There are a lot of different factors naturally in weight gain and weight loss, so the gut microbiome is certainly not the only thing,” said Chris Damman, MD, a gastroenterologist at the University of Washington. He studies how food and the microbiome affect your health. “With that caveat, it probably is playing an important role.”
  • STAT News adds,
    • “New obesity drugs like Wegovy and Zepbound are currently taken once a week, indefinitely. But what if they could be taken once a year instead, like a vaccine?
    • “That’s a question that Novo Nordisk, the pharma company behind Wegovy, is exploring as it faces increased competition from other drugmakers aiming to develop similar GLP-1-based treatments for obesity.
    • “We have a very early think tank on: what would it take us, from a technology point of view and from an ecosystem point of view, to make long-lasting GLP-1 molecules?” Marcus Schindler, Novo’s chief scientific officer, said in an interview with STAT Wednesday. “Could we think about vaccine-like properties, where imagine you had, once a year, an injection with an equivalent of a GLP-1 that really helps you to maintain weight loss and have cardiovascular benefits?”

From the U.S. healthcare business and cybersecurity issues front,

  • Beckers Hospital Review informs us,
    • “Optum’s Change Healthcare confirmed Feb. 29 that it was hacked by a ransomware gang after the group claimed to have stolen massive amounts of data.
    • “Change Healthcare can confirm we are experiencing a cybersecurity issue perpetrated by a cybercrime threat actor who has represented itself to us as ALPHV/Blackcat,” an Optum spokesperson emailed Becker’s on Feb. 29. “We are actively working to understand the impact to members, patients and customers.” * * *
    • “ALPHV/Blackcat, aka BlackCat, claimed responsibility for the hack, posting on its dark web leak site that it stole 6 terabytes worth of Change Healthcare data involving “thousands of healthcare providers, insurance providers, pharmacies, etc,” Bleeping Computer reported Feb. 28. The allegedly stolen data includes medical records, patient Social Security numbers, and information on active military personnel (Change serves some military healthcare facilities).
    • “But as Politico noted Feb. 28: “Ransomware groups, which demand extortion payments in exchange for restoring or not publishing stolen data, often exaggerate their exploits as a negotiating tactic.”
    • “ALPHV/Blackcat, which has been linked to Russia, has been targeting the U.S. healthcare industry since December after the FBI disrupted its operations.”
  • STAT News adds,
    • “The outage caused by the Change Healthcare cyberattack could last weeks, a top UnitedHealth executive suggested in a Tuesday conference call with hospital cybersecurity officers, according to a recording obtained by STAT.
    • “UnitedHealth Group Chief Operating Officer Dirk McMahon said the company is setting up a loan program to help providers who can’t submit insurance claims while Change is offline. He said that program will last “for the next couple of weeks as this continues to go on.”
    • “McMahon’s remarks about the loan program highlight the scope of UnitedHealth’s damage control. UnitedHealth maintained it has “not determined the [cyberattack] incident is reasonably likely to materially impact our financial condition or results of operations,” according to its annual report to investors this week. But doctors and pharmacists are scrambling to find ways to get patients what they need, and to get paid. As of 2022, Change facilitated $1.5 trillion in health care transactions.”
  • HR Brew lets us know,
    • “The cost of healthcare went up last year, according to a new report from Marsh McLennan Agency (MMA), a US-based subsidiary of global brokerage Marsh. The amount that employers spent on health benefits per employee grew by 5.2%, while the estimated cost of employer contributions to premiums increased by more than $1,400, to $11,762.
    • “Healthcare inflation can affect employees, as well, the report noted, with 38% of Americans reporting they put off medical treatment in the last year due to cost concerns. MMA noted that “delayed care is associated with worse health outcomes and higher costs for patients and benefit providers.”
    • “Younger workers appear to be feeling the pinch of high health costs the most, with 74% of millennial and 56% of Gen Z patients canceling doctors’ visits because of high costs, compared to 13% of Baby Boomer patients. Putting off behavioral healthcare, in particular, can be costly for younger age groups, said Monte Masten, chief medical officer with MMA. Given these trends, employer investment in incentives may be warranted, he told HR Brew.”
  • Drug Store News alerts us,
    • “Walgreens’ VillageMD is closing six Chicago clinic locations—five standalone and one co-located with a Walgreens store, per a Telehealth & Telecare Aware report.
    • “The closures in Walgreens’ home state are set to take place April 19. These closures follow on the heels of news last week that VillageMD exited the Florida market.” 
  • Per Fierce Healthcare,
    • “Telemedicine clinic Virta Health believes its members can achieve significant and sustained improvement in weight loss, even if a patient has stopped taking a GLP-1 drug, a newly released paper in Diabetes Therapy shows.
    • “According to the company, it is a first-of-its-kind study offering an opposing viewpoint against clinical trials showing GLP-1 deprescription leading to weight regain. The results have potentially major implications for employers and plans looking to help its members improve health outcomes and fight obesity but that are concerned about rising costs amid increasing demand.
    • “This is unheard of,” said Sami Inkinen, Virta Health CEO and co-founder. “To my knowledge, nobody has published or shown this kind of data to date.”
  • Beckers Health Payer Issues points out five health insurers that “are making commitments to advance a White House initiative to end hunger and reduce diet-related disease by 2030.” 
  • Per BioPharma Dive,
    • “Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders.
    • “Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round announced Thursday, alongside Alaska Permanent Fund Corporation and The Column Group. The investment is the first announced by Cure since it debuted last year with a $350 million fund. Euclidean Capital and Saisei Ventures also participated in the round.
    • “Previously known as Ryne Bio, Kenai’s research aim is to create so-called off-the-shelf cell therapies that replace neurons. The company’s most advanced medicine is made from genetically reprogrammed stem cells and designed to treat Parkinson’s disease by restoring dopamine production.
    • “The medicine has “displayed robust survival, innervation, and behavioral rescue in preclinical models of Parkinson’s disease,” according to Kenai, which claims it could work in inherited forms of the disease as well as in cases where the exact cause isn’t understood.
    • “The company said the funding proceeds will be enough to push the medicine, named RNDP-001, into human testing and through early-stage clinical trials, which should start within the year.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Congressional leaders emerged from the White House on Tuesday optimistic about avoiding a partial shutdown of several departments and agencies — after a meeting with President Joe Biden that also focused on the importance of aid to Ukraine.
    • “The speaker said unequivocally he wants to avoid a government shutdown,” Senate Majority Leader Charles E. Schumer, D-N.Y., told reporters outside the West Wing, adding he did not believe differences on domestic spending were insurmountable.
    • “When he got back to the Capitol, Schumer told reporters that he made clear to Speaker Mike Johnson, R-La., that avoiding a shutdown would require another continuing resolution. Senate Minority Leader Mitch McConnell, R-Ky., also told reporters at the Capitol that leaders seemed to agree at the White House on the need to avert a shutdown.”
  • The Wall Street Journal relates,
    • “The Justice Department has launched an antitrust investigation into UnitedHealth, owner of the biggest U.S. health insurer, a leading manager of drug benefits and a sprawling network of doctor groups.
    • “The investigators have in recent weeks been interviewing healthcare-industry representatives in sectors where UnitedHealth competes, including doctor groups, according to people with knowledge of the meetings.
    • “During their interviews, investigators have asked about issues including certain relationships between the company’s UnitedHealthcare insurance unit and its Optum health-services arm, which owns physician groups, among other assets. 
    • “Investigators have asked about the possible effects of the company’s doctor-group acquisitions on rivals and consumers, the people said.
    • “Spokespeople for UnitedHealth and the Justice Department declined to comment. UnitedHealth executives have said Optum and UnitedHealthcare don’t favor one another, and routinely work with competitors.” 
  • According to Healthcare Dive,
    • “Proposed Medicare Advantage rates for 2025 could have a steeper impact on health plans’ payment than the government expects, according to a new study funded by a payer lobbying group.
    • “The analysis — backed by the Better Medicare Alliance, which represents payers in the private Medicare program — found MA payment per month per beneficiary could drop by 1% next year if the CMS finalizes the changes. In comparison, the CMS expects payments to MA plans to drop 0.16% under its proposal.
    • “Study authors warned that when government reimbursement drops, MA benefits for seniors like supplemental benefits and lower premiums and cost-sharing also tend to be reduced. Health insurers have made similar arguments in recent earnings calls lobbying against the rate changes, which could reduce profitability of their MA businesses.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Community Living (ACL), announced several new initiatives and resources from ACL’s Direct Care Workforce (DCW) Strategies Center to address the dire shortage of professionals who provide the services many older adults and people with disabilities need to live in the community. These include two technical assistance opportunities to help states strengthen their systems for recruiting, retaining, and developing direct care workers; a national hub to connect states, stakeholders and communities to best practices and other resources related to the direct care workforce; and a webinar series for states and stakeholders focused on a range of direct care workforce topics. These initiatives will help sustain the impact of the $37 billion in American Rescue Plan funding invested to date by states in home and community-based services, and support the comprehensive set of actions and investments included in the President’s executive order to improve care.”
  • Per an OPM press release,
    • “The U.S. Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) released the first-ever government-wide Military-Connected Strategic Plan for FY 2024-2028 to support agencies in their efforts to recruit, hire, and retain military-connected spouses, caregivers, and survivors within the federal government. 
    • “Advancing economic opportunity for military-connected spouses, caregivers, and survivors strengthens our federal workforce and the nation,” said OPM Director Kiran Ahuja. “A good-paying, flexible, and dependable federal job strengthens the economic security of our military families and helps spouses succeed in their own careers, while also supporting their loved ones in uniform. Tackling barriers to recruiting, hiring, and retaining talent also improves our workforce and expands our talent pool to mission-driven public servants who want to give back to their country.” 
  • Federal News Network informs us,
    • “As agencies ramp up recruitment of federal AI professionals, the Office of Personnel Management is highlighting existing workplace flexibilities that can ease the process.
    • “Incentives such as pay bonuses, faster leave accrual, student loan repayments, and telework and remote work can all help agencies more effectively hire AI specialists, OPM said in new federal AI hiring guidance, published Tuesday.
    • “Agencies can extend most — but not all — of the workplace flexibilities to incoming federal AI experts without first needing to get approval from OPM.
    • “For the few flexibilities that require OPM approval — special rates, critical pay and waivers of the recruitment, relocation and retention incentive payment limits — we stand ready to assist agencies and respond to their requests for enhanced compensation tools,” OPM Director Kiran Ahuja said in the guidance.”
  • Beckers Hospital Review adds,
    • “On Feb. 23, Colorado secured a national first by agreeing to establish a price ceiling on a medication, The Denver Post reported. 
    • “The state’s Prescription Drug Affordability Board voted in favor of capping the cost of arthritis drug Enbrel, which has a list price of $1,850.46 for a weekly dose. Colorado legislators createdthe five-member board in 2021 to sniff out medications deemed “unaffordable” and establish a payment limit for state-regulated commercial payers.
    • “By late August, the board will either narrow down an appropriate cost for Enbrel or vote against setting a price ceiling, according to The Denver Post. If established, the price cap would limit how much pharmacies could pay for the drug, and patients and payers would then pay that amount and a fee to cover the pharmacy’s handling costs.” 

From the public health and medical research front,

  • The Food and Drug Administration announced yesterday,
    • “[O]n May 16, 2024, the FDA’s Vaccines and Related Biological Products Advisory Committee will meet to publicly discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.  
    • “The FDA anticipates that changes to the vaccine composition may need to be made based on the currently circulating strains of the virus that causes COVID-19. As the agency has previously stated, barring any new major changes to circulating virus, the FDA expects that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.
    • “Following any potential recommendations to update the 2024-2025 formula, the FDA anticipates that, subject to appropriate regulatory actions, manufacturers will be able to make updated COVID-19 vaccines available in advance of the fall/winter respiratory virus season.”
  • The National Institutes of Health announced today,
    • “People with type 2 diabetes who underwent bariatric surgery achieved better long-term blood glucose control compared to people who received medical management plus lifestyle interventions, according to a new study supported by the National Institutes of Health. The participants who underwent bariatric surgery, also called metabolic or weight-loss surgery, were also more likely to stop needing diabetes medications and had higher rates of diabetes remission up to 12 years post-surgery. Results of the study were published in JAMA(link is external) and funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of NIH.
    • “While there are many factors involved, and not all of them are completely understood, bariatric surgery typically results in greater weight loss that affects a person’s metabolic hormones, which improves the body’s response to insulin and ability to maintain healthy blood glucose levels,” said Dr. Jean Lawrence, NIDDK project scientist. “These results show that people with overweight or obesity and type 2 diabetes can make long-term improvements in their health and change the trajectory of their diabetes through surgery.”
    • “The current study is a follow-up that combined data from four independent single-center randomized trials conducted at clinical sites in the United States. The original trials, which were conducted between May 2007 and August 2013, evaluated the effectiveness of bariatric surgery compared to intensive lifestyle and medication therapy involving oral and injectable diabetes medications including insulin, for adults with type 2 diabetes and overweight or obesity. While some participants in the study were prescribed GLP-1 agonists as part of their medical management of diabetes, these drugs were not specifically examined in the study. The investigators from the four individual studies pooled their data to provide a larger and more geographically diverse data set to evaluate efficacy, durability, and safety of bariatric surgery to treat type 2 diabetes. Follow-up data were collected through July 2022.”
  • The U.S. Preventive Services Task Force preliminarily recommended an inconclusive grade for Screening and Supplementation of Iron Deficiency and Iron Deficiency Anemia During Pregnancy. The public comment period is open until March 25, 2024.
  • The Centers for Disease Control offers important guidance on diabetes and feet.
    • “About half of all people with diabetes have some kind of nerve damage. You can have nerve damage in any part of your body, but nerves in your feet and legs are most often affected. Nerve damage can cause you to lose feeling in your feet.”
  • BioPharma Dive lets us know,
    • “An experimental weight loss drug developed by Viking Therapeutics helped overweight and obese people lose up to 15% of their body weight after 13 weeks of treatment in a mid-stage trial, the company said Tuesday.
    • “The drug, a potential rival to Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, led to greater weight loss over that time period than both of those medicines did in clinical testing. However, Wall Street analysts cautioned the effects of Viking’s therapy need to be confirmed in a larger Phase 3 trial.”

From the U.S. public health front,

  • Beckers Hospital Review points out,
    • “UnitedHealth Group estimates 90% of the 70,000-plus pharmacies in the U.S. using Change Healthcare’s platform have modified electronic claims processing to mitigate effects of the cybersecurity incident that hit the company last week.
    • “The remaining 10% have offline processing workarounds, according to a Feb. 26 statement from UnitedHealth Group, which owns Change Healthcare. The cybersecurity issue, believed to be the work of a foreign nation-state-associated cybersecurity threat actor, caused enterprisewide connectivity issues.
    • “UnitedHealth Group reported Optum Rx and UnitedHealthcare have seen few reports of issues, and fewer than 100 out of the 65 million pharmacy benefit manager members have not been able to get their prescriptions. The company has immediately escalated patients that haven’t been able to access prescriptions to preserve continuity of care.
    • “Since identifying the issue on Feb. 21, Change has worked closely with customers and clients to secure access to medications during the network disruption. The company is also working with law enforcement, Mandiant, Palo Alto Networks, and other third parties to investigate and resolve the issues.
    • “We appreciate the partnership and hard work of all of our relevant stakeholders to ensure providers and pharmacists have effective workarounds to serve their patients as systems are restored to normal,” said the statement. “As we remediate, the most impacted partners are those who have disconnected from our systems and/or have not chosen to execute workarounds.”
    • “The company also noted hospitals and health systems have connections with multiple clearinghouses and manual workarounds to continue providing care.”
  • Per Fierce Healthcare,
    • “Signify Health is expanding its in-home diagnostics offering to include a test for heart arrhythmias.
    • “The CVS Health subsidiary said Tuesday that the prevalence of irregular heartbeats is set to grow alongside an aging population. Atrial fibrillation, the most common type of arrhythmia, can be asymptomatic, and there are likely between 1.26 million and 1.52 million undiagnosed cases.
    • “Patients with a heart arrhythmia who are undiagnosed may face symptoms like shortness of breath, chest pain and rapid or irregular heartbeat, and face potential stroke or diabetes.
    • “Through the program, Signify members who are at risk for an arrhythmia are identified, and then its clinical teams will test for contraindications. Members will asked to wear a continuous ECG patch, which tracks continuous cardiac activity, and, after 14 days, the team will review the results for signs of irregular heartbeat.”
  • and
    • “Highmark is teaming up with Epic and Google Cloud to improve the flow of data between payers and providers to enhance care coordination and drive better outcomes.
    • “The goal, the insurer said, is to arm providers with the most valuable data at the point of care, enabling them to improve patient outcomes and close critical care gaps.
    • “We really need better ways to get the right information in front of the clinicians at the right time,” Richard Clarke, Ph.D., senior vice president and chief analytics officer for Highmark Health, told Fierce Healthcare. 
    • “Epic’s Payer Platform allows for “bidirectional” data sharing between the payer and the provider, he said, and Google Cloud’s technology makes it flexible enough to connect with Highmark’s existing systems readily.”
  • Fortune Well writes about a woman whose recently deceased mother’s estate is saddled with an $81,000 air ambulance bill because her mother declined Medicare Part B coverage.
    • “People who are eligible for Medicare are encouraged to sign up for Part B, unless they have private health insurance through an employer or spouse.
    • “If someone with Medicare finds that they are having difficulty paying the Medicare Part B premiums, there are resources available to help compare Medicare coverage choices and learn about options to help pay for Medicare costs,” Meena Seshamani, director of the federal Center for Medicare, said in an email to KFF Health News.
    • “She noted that every state offers free counseling to help people navigate Medicare.”

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Cybersecurity, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Biden is calling congressional leaders to the White House as the clock ticks toward a partial government shutdown Friday night and a Ukraine aid package remains stuck.
    • “The president has called the meeting for Tuesday, seeking to break a logjam. House and Senate leaders have been working to negotiate the details of 12 funding bills totaling $1.6 trillion for federal agencies, which have been operating on temporary extensions since Sept. 30. Funding for the Transportation Department and several other agencies expires after March 1, which would affect some housing, food and veterans’ programs; the rest expires after March 8.” 
  • STAT News reports,
    • “Congress has abandoned its attempt to reform how pharmacy middlemen operate in an upcoming package to fund the federal government, 11 lobbyists and sources following the talks told STAT.”
  • and
    • “Congress will not move forward with a controversial policy to equalize certain Medicare payments to hospitals and physicians’ offices in an upcoming government funding package, five lobbyists and sources following the talks told STAT.”
  • From an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $36.9 million in notices of funding opportunities for grant programs supporting behavioral health services across the country. Additionally, HHS, through the Centers for Medicare & Medicaid Services (CMS), issued guidance that allows states to expand the pool of behavioral health care providers eligible for enhanced federal Medicaid funding, which will better support this critical workforce as well as improve access to care. The guidance also allows states to claim federal dollars for nurse advice lines.”
  • BioPharma Dive tells us,
    • “The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals’ Simlandi, a biosimilar of the most popular version of AbbVie’s rheumatoid arthritis drug Humira. The drug, which can be directly substituted by a pharmacist, was rejected by the FDA twice before due to manufacturing issues at a plant in Iceland.
    • “The partners didn’t announce a launch date or a price for Simlandi, which will be the 10th Humira biosimilar reach market since Amgen’s Amjevita arrived on Jan. 31, 2023. Some biosimilars have launched at a steep upfront discount while others have a list price only slightly below Humira’s to allow for negotiation over rebates.
    • “Alvotech also announced a stock sale Monday, raising around $166 million at $16.41 a share. The company had $68 million in cash and equivalents on Sept. 30, after recording losses of $275 million on $30 million in revenue through the first nine months of 2023.”
  • HR Dive informs us,
    • “A federal district court has delayed a National Labor Relations joint employer rule effective date to March 11. Friday marks the second time the start date has been delayed; NLRB previously extended a Dec. 26, 2023, start date to Feb. 26.
    • “This new rule establishes a standard for determining if two organizations are joint employers of particular employees; two entities are joint employers when they co-determine the essential terms of an individual’s employment.”
  • The Census Bureau issued a tip sheet on grandparents and co-resident grandchildren 2021.
    • “According to the 2017-2021 ACS, 5-year estimates, 8.0% of children under age 18 lived in their grandparents’ home.
    • “The proportion of children living with only their grandparents or with their grandparents and one or both parents varied across race and ethnicity. For grandchildren who lived with grandparents, it was more common to also live with both parents or their mother in the household than to live with their father or no parent in the household.
    • “Overall, about 38.6% of children under age 18 who lived with grandparents also lived with two parents. Of all race and Hispanic origin groups, Asian grandchildren had the highest percentage (70.9%) in this living arrangement.
    • “About 16.2% of grandchildren under age 18 living with grandparents were in poverty. The percentage was higher for those in grandparent-maintained households (18.6%) compared to parent-maintained households (12.1%).
    • “About 76.1% of all grandchildren under age 18 living with grandparents lived in households that received public assistance, most commonly through the school lunch program.”
  • The tip sheet drew the FEHBlog’s attention due to FEHB coverage of foster children.
  • Health Reform Beyond the Basics offers an an explanation of the ACA Summary of Benefits and Coverage

From the public health and medical research front,

  • The New York Times offers a 2024 guide to COVID symptoms and treatments.
  • CNN points out,
    • “Cases of norovirus are on the rise in the US, on par with seasonal trends, according to the most recent data from the US Centers for Disease Control and Prevention.
    • “In the week ending February 17, more than 12% of tests for norovirus – a common and very contagious virus that causes gastrointestinal symptoms – came back positive, CDC data showed. That’s up from 11.5% the week before. Cases are particularly high in the Northeast, where more than 13% of tests came back positive. Positivity rates in the region have been over 13% since late January.
    • “However, these levels are below what they were at this point last season, when about 15% of tests were positive, both nationally and in the Northeast.
    • “Outbreaks of norovirus are most common in the late fall, winter and early spring, according to the CDC.”
  • HR Daily Advisor identifies eight tips to help employees improve mental health in the face of the winter blues.
  • Medscape lets us know that “Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.”
  • The National Institutes of Health announced,
    • “Results from a large clinical trial funded by the National Institutes of Health show that an intervention for anxiety provided to pregnant women living in Pakistan significantly reduced the likelihood of the women developing moderate-to-severe anxiety, depression, or both six weeks after birth. The unique intervention was administered by non-specialized providers who had the equivalent of a bachelor’s degree in psychology—but no clinical experience. The results suggest this intervention could be an effective way to prevent the development of postpartum mental health challenges in women living in low-resource settings.
    • “In low resource settings, it can be challenging for women to access mental health care due to a global shortage of trained mental health specialists,” said Joshua A. Gordon, M.D., Ph.D., Director of the National Institute of Mental Health, part of NIH. “This study shows that non-specialists could help to fill this gap, providing care to more women during this critical period.”
    • “Led by Pamela J. Surkan, Ph.D., Sc.D.(link is external), of Johns Hopkins Bloomberg School of Public Health, Baltimore, the study was conducted in the Punjab Province of Pakistan between April 2019 and January 2022. Pregnant women with symptoms of at least mild anxiety were randomly assigned to receive either routine pregnancy care or a cognitive behavioral therapy (CBT)-based intervention called Happy Mother-Healthy Baby. The researchers assessed the participants (380 women in the CBT group and 375 women in the routine care group) for anxiety and depression six weeks after the birth of their child.
    • “The researchers found that 9% of women in the intervention group developed moderate-to-severe anxiety compared with 27% of women in the routine care group. Additionally, 12% percent of women in the intervention group developed depression compared with 41% of women in the routine care group.”
  • According to BioPharma Dive,
    • “An experimental obesity drug from Boehringer Ingelheim and Zealand Pharma succeeded in a mid-stage liver disease study, the latest evidence new weight loss medicines could also help people with metabolic dysfunction-associated steatohepatitis, or MASH.
    • “Summary results disclosed Monday show that up to 83% of trial participants treated with the companies’ drug, survodutide, experienced a significant improvement in their disease without worsening liver scarring, compared to about 18% of those given placebo. The drug met its secondary study goals, notably demonstrating a benefit on liver scarring, the companies said.
    • “Boehringer and Zealand didn’t provide many other details, leaving unanswered questions about the magnitude of survodutide’s effect. The companies also didn’t describe safety findings in depth, although they noted treatment “did not show unexpected safety or tolerability issues” at any of the three doses tested. Data will be presented at an upcoming medical meeting.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Elevance Health’s CarelonRx will begin offering a weight management program, providing its members access to digital-first coaching and wellness tools.
    • “Behavioral health and social drivers of health screenings will be included in the offerings, according to a news release. The program will help members that take, as well as those that don’t take, GLP-1 medications. It will be available to ASO-integrated clients.
    • “At CarelonRx, we want to ease the complexities of weight loss and weight management, and support healthier lifestyles for our members,” said Paul Marchetti, president of CarelonRx, in a statement. “Our weight management program is unique because it considers a member’s whole health needs, including pharmacy, medical and social drivers of health data, and creates opportunities for care coordination between nutrition and exercise experts, pharmacists, physicians and health plans.”
  • and
    • “Humana tapped data automation company Veda to improve the accuracy of its provider information and ensure seniors have real-time details about in-network providers. The partnership was announced at the ViVE 2024 conference Monday morning. * * *
    • “Founded in 2015, Veda developed an AI platform that enables payers to transform and ingest provider rosters rapidly, reducing turnaround times from weeks to hours, according to the company.
    • “Veda will use its patented automation technology to analyze, verify and standardize Humana’s data to ensure the information is accurate and comprehensive, along with real-time scoring of data quality.
    • “Accurate provider data is a key component of efficient health plan operations, care delivery, interoperability, and ultimately patient satisfaction,” Meghan Gaffney, Veda co-founder and CEO, said. “By addressing the challenges that members may face with finding in-network care providers, Humana is ensuring their members have access to the timely, high-quality care they deserve.”  
    • “Veda says its platform achieves high data accuracy, ensuring quality across networks as measured by the Centers for Medicare & Medicaid Services (CMS).”
  • and
    • “The cybersecurity incident at Change Healthcare will stretch on for at least another day, according to the latest update from Optum.
    • “The company posted early Monday morning that it is taking multiple angles to get Change’s systems back online, and stressed that it has a “high level of confidence” that other systems within Optum, UnitedHealthcare and UnitedHealth Group are unaffected. * * *
    • “In a statement to CNBC, CVS Health said that while it is continuing to fill prescriptions for customers, it’s not able to process all of its insurance claims. The pharmacy giant added that there is “no indication” that its own systems have been breached.”
  • Reuters notes,
    • “Pharmaceutical companies last year launched new U.S. drugs at prices 35% higher than in 2022, reflecting in part the industry’s embrace of expensive therapies for rare diseases like muscular dystrophy, a Reuters analysis found.
    • “The median annual list price for a new drug was $300,000 in 2023, according to the Reuters analysis of 47 medicines, up from $222,000 a year earlier. In 2021, the median annual price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published in JAMA.”
  • The Society for Human Resource Management relates,
    • “Millions more employees than expected are leaving the workplace in favor of retirement—a phenomenon that stands to have an outsized impact on employers.
    • “The U.S. currently has roughly 2.7 million more retirees than predicted, Bloomberg reports, according to a model designed by an economist at the Federal Reserve Bank of St. Louis. That’s up 80 percent from six months ago, when there were roughly 1.5 million more retirees than anticipated. By contrast, prior to the pandemic, there often were fewer retirees than expected.”

Thursday Miscellany

David Ermer–Congress, FDA, HSA, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • American Hospital Association (AHA) News reports,
    • “AHA Feb. 22 voiced support for the Child Suicide Prevention and Lethal Means Safety Act (H.R. 7265), legislation that would provide funding for training programs to help health care workers identify patients at high risk for suicide or self-harm. The bill would also provide grants to facilitate suicide prevention training at health professions schools.”  
  • and
    • “Senate Health, Education, Labor & Pensions Committee Ranking Member Bill Cassidy, R-La., Feb. 21 released a report proposing ways to modernize the existing HIPAA framework and protect health and other data not covered by HIPAA. Responding to Cassidy’s request for information on the issue last year, AHA asked Congress to urge the Department of Health and Human Services’ Office for Civil Rights to immediately withdraw a rule that would violate HIPAA and its implementing regulations; explore how to better require entities not covered by HIPAA to protect patient privacy; and strengthen HIPAA preemption.”
  • Roll Call tells us,
    • “The House Democratic Women’s Caucus has asked the biggest insurance association to urge insurers to comply with contraceptive coverage requirements and Biden administration guidance issued in January, according to a letter shared first with CQ Roll Call. * * *
    • “The Democratic Women’s Caucus wrote to AHIP President and CEO Mike Tuffin on Thursday urging the group to have its members follow the suggestions HHS outlined. 
    • “Despite repeated clarification of these requirements from the Departments, multiple investigations — including by the House Oversight Committee — have revealed that plans routinely violate the [2010 health care law] by refusing to cover certain products, imposing administrative hurdles like prior authorizations and step therapy (fail first protocols), and requiring patient cost-sharing,” wrote the 143 House members as well as 13 senators.
    • “The members asked Tuffin to respond if insurance plans will be adopting the standard and when; how plans that will not adopt the standard intend to comply with the coverage requirement and if any member plans have been using techniques to deny coverage as described in the HHS guidance. 
    • “The letter also seeks clarity on which plans have an exceptions process publicly available on their websites for when a therapeutically equivalent product does not work for a patient.
    • “The letter requests a response by March 1.”
  • MedTech Dive notes,
    • Better Therapeutics has received breakthrough device status for a digital therapeutic designed to treat adults with advanced liver disease, the company said Tuesday.
    • The Food and Drug Administration awarded the designation after seeing the results of a clinical trial that linked the digital cognitive behavioral therapy (CBT) to reductions in liver fat.
    • Better Therapeutics won FDA authorization in Type 2 diabetes in July but, like the wider digital therapeutics sector, has struggled to allay concerns about commercialization. The company has discussed substantial doubts about its ability to continue as a going concern. 
  • Mercer Consulting projects “the 2025 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted-benefit health reimbursement arrangements (HRAs) will all rise from 2024 levels. These unofficial 2025 amounts are determined using the Internal Revenue Code (IRC)’s cost-of-living adjustment methods, the US Bureau of Labor Statistics (BLS) published Chained Consumer Price Index for All Urban Consumers (C-CPI-U) values through January 2024, and Mercer’s projected C-CPI-U values for February and March.”
  • “The U.S. Preventive Services Task Force posted today a final research plan on screening for HIV. The draft research plan for this topic was posted for public comment from November 30, 2023, to January 3, 2024. The Task Force reviewed all of the comments that were submitted and took them into consideration as it finalized the research plan. To view the final research plan, please go here.”

From the public health and medical research front,

  • MedPage Today calls our attention to the following
    • “More than 134,000 cancers might have gone undiagnosed during the first 10 months of the COVID-19 pandemic, according to a study of national trends in cancer incidence.
    • “Annual cancer incidence fell almost 30% short of the expected rate from March through December 2020. The difference represented potentially 134,395 undiagnosed cancers during that period. Diagnosis of early- and late-stage cancers declined. Prostate, breast, and lung cancers accounted for the most potential missed cases. Overall, rates of “screenable” cancers decreased by 13.9% versus expected rates. * * *
    • “It is important that we continue to evaluate the trends identified in this study as U.S. cancer incidence data for years after 2020 become available,” the authors wrote. “Pandemic-associated disruptions will continue to affect rates of cancer incidence, and how long it will be until we fully recover is still unknown.”
    • “Beyond incidence, it is important that we measure the pandemic’s contribution to future trends in cancer mortality and survival,” they added. “With a near 10% reduction from expected rates in overall late-stage incidence from March to December 2020, there will undoubtedly — and unfortunately — be a subsequent rise in cancer mortality. How substantial a rise and for how long will provide a more complete picture of the consequences of COVID-19 disruptions on the burden of cancer in the U.S.”

The Wall Street Journal reports that “There’s No Easy Way to Stop Taking Ozempic. Those who go off weight-loss drugs risk regaining weight, but staying on them forever isn’t always a realistic option.” Quite a conundrum. The article discusses approaches to stopping the medicine and alternatives, such as bariatric surgery.

  • The National Institutes of Health announced,
    • “A research project supported by the National Institutes of Health has developed a tool to rapidly and inexpensively diagnose sarcoidosis, a chronic inflammatory disease marked by the growth of tiny lumps called granulomas in the lungs and other organs in the body. The tool, which uses a simple blood test, could allow for selective use of more invasive diagnostic tests often used to identify the disease. The findings published in the American Journal of Respiratory and Critical Care Medicine.
    • “Currently, diagnosing sarcoidosis isn’t a straightforward process, and requires tissue removal and testing with additional screenings to rule out other diseases, such as tuberculosis or lung cancer,” said James Kiley, Ph.D., Director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute, part of NIH. “Using a blood test will help diagnose faster, particularly in those organs that are more challenging to biopsy and with less harm to the patient.”
  • The NIH Director, in her blog discusses “A Potential New Way to Prevent Noise-Induced Hearing Loss: Trapping Excess Zinc.”
    • “Hearing loss is a pervasive problem, affecting one in eight people aged 12 and up in the U.S.1 While hearing loss has multiple causes, an important one for millions of people is exposure to loud noises, which can lead to gradual hearing loss, or people can lose their hearing all at once. The only methods used to prevent noise-induced hearing loss today are avoiding loud noises altogether or wearing earplugs or other protective devices during loud activities. But findings from an intriguing new NIH-supported study  exploring the underlying causes of this form of hearing loss suggest it may be possible to protect hearing in a different way: with treatments targeting excess and damaging levels of zinc in the inner ear.”
  • STAT News points out “Embryo loss is integral to [in vitro fertilization] IVF. [The] Alabama ]Supreme Court]’s ruling equating embryos with children jeopardizes its practice.” For more information, listen to this Advisory Opinions podcast from the Dispatch.

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Fourteen organizations representing providers, payers, consumer technology companies and employers are teaming up to cut through the noise and raise higher standards for finding digital health solutions that work and are worth the investment.
    • “The new Digital Health Collaborative, supported by the Peterson Health Technology Institute, brings together provider groups, purchasers and end users and initial work will focus on pulling together a national purchaser survey, grantmaking and convenings, the organization said.
    • “The Peterson Health Technology Institute formed in July 2023, armed with $50 million in funding, to evaluate digital health technologies and help cut through the hype to identify innovations that actually benefit patients. PHTI focused on providing independent, evidence-based assessments of emerging products, something that is currently lacking in the market.”
  • BioPharma Dive tells us,
    • “Moderna shares rose by as much as 10% Thursday morning after the COVID-19 vaccine developer reported fourth quarter profit that beat Wall Street expectations of a net loss during the final three months of 2023.
    • “Full-year sales of $6.7 billion matched estimated numbers Moderna disclosed in January, but were down by about two-thirds versus 2022 as COVID vaccination rates declined substantially last year. The company has restructured its manufacturing operations in response to match the lower demand.
    • “Moderna forecasts $4 billion in sales this year, with some expected to come from an experimental vaccine for respiratory syncytial virus that’s under regulatory review in the U.S. and several other countries.”
  • McKnight’s Long Term Care News lets us know,
    • “A shortage of registered nurses in the first two years of the pandemic was probably temporary, according to a new report. That’s because the workforce rebounded in 2022 and 2023, the authors said. Even still, a lot of RNs aren’t going back to hospitals and are moving into other settings including nursing homes and long-term care communities, authors of the report said.
    • “The study, published on Feb. 16 in JAMA Health Forum, noted that the workforce of RNs fell by about 100,000 employees in 2021. That decrease was the largest drop in a single year in the past 40 years. In 2022, hiring started to go back up, according to data from the US Bureau of the Census Current Population Survey. 
    • “The data included RNs between the ages of 23 and 69 who were employed between 1982 and 2023. The researchers also used another cohort of data on employment trends by birth year and age to project the age distribution and employment of RNs through the year 2035. There were 455,085 RNs included in the study. In 2022 and 2023, there were 3.35 million full-time RNs, which is 6% higher than in 2019 when there were 3.16 million nurses.”
  • Per Healthcare Dive,
    • “Walgreens is planning to close its remaining VillageMD clinics in Florida as the beleaguered retail giant continues to cut costs.
    • “VillageMD operated 52 clinics in Florida, but 14 have closed to date. The remainder will shutter by March 15, according to multiple news reports citing Walgreens. The closures fully exit VillageMD from Florida, one of its largest markets and a key target for value-based primary care chains given the state’s large population of elderly patients with chronic health needs.
    • “Walgreens did not share details of what’s driving the closures. But analysts say Walgreens may have struggled getting enough doctors and patients into the smaller clinics, which are co-located within Walgreens stores.”
  • Beckers Hospital News notes,
    • “Grubhub has teamed up with CVS Pharmacy to deliver health and wellness products to consumers in 48 states. 
    • “Grubhub users can now access thousands of products on the mobile ordering and delivery platform from more than 6,000 CVS locations nationwide. * * *
    • “CVS is the second national drugstore chain to partner with Grubhub, behind Rite Aid. Walgreens has also teamed up with Doordash and Uber to deliver medications and other health products.”
  • Per HR Dive,
    • “Business advocates and the U.S. Department of Labor can resume their fight over independent contractor regulations, the 5th U.S. Circuit Court of Appeals decided Monday (Coalition v. Su).
    • “The litigation began after the Biden administration in 2021 nixed a Trump-era rule on the issue. Business groups challenged that withdrawal, arguing DOL overstepped its authority. A federal district court judge agreed, and the Biden administration appealed that ruling to the 5th Circuit. The appeals court issued a stay pending DOL’s publication of a new rule.
    • “Biden’s DOL finalized its own version of the regulations in January, with a March 11 effective date, leading the 5th Circuit to lift its stay Monday at the request of the business groups. The court also vacated the lower court’s opinion at DOL’s request, sending it back for the court to revisit.
    • “Considering this and other litigation related to the new regulations, a court could very well put the upcoming rules on hold, an employment law attorney told HR Dive last month; but with the effective date just weeks away, employers should monitor developments closely, he said.”

Happy Presidents’ Day

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC

From the public health and medical research front,

  • ABC News reports,
    • “Half of all states are seeing high levels of respiratory virus activity, new federal data updated Friday shows.
    • “Currently, 25 states plus New York City and Washington, D.C., are experiencing “high” or “very high” levels of respiratory illness activity, according to the Centers for Disease Control and Prevention (CDC).
    • “While this is higher than the 23 states experiencing “high” or “very high” activity levels last week, it is fewer than the peak of 38 states reporting “high’ or ‘very high’ levels the week ending Dec. 30. * * *
    • “Adults over age 65 continue to have the highest rates of both COVID and flu hospitalizations.”
  • Fortune Well informs us,
    • “Vaccines that protect against severe illness, death and lingering long Covid symptoms from a coronavirus infection were linked to small increases in neurological, blood, and heart-related conditions in the largest global vaccine safety study to date.
    • “The rare events — identified early in the pandemic — included a higher risk of heart-related inflammation from mRNA shots made by Pfizer Inc., BioNTechSE, and Moderna Inc., and an increased risk of a type of blood clot in the brain after immunization with viral-vector vaccines such as the one developed by the University of Oxford and made by AstraZeneca Plc. 
    • “The viral-vector jabs were also tied to an increased risk of Guillain-Barre syndrome, a neurological disorder in which the immune system mistakenly attacks the peripheral nervous system.”
  • and
    • “They say anything men can do, women can do better—which may include reaping the health benefits of regular exercise. That’s according to a new study published today in the Journal of the American College of Cardiology.
    • “An international team of researchers from the U.S. and China showed that women who exercise regularly have a significantly lower risk of an early death or a fatal cardiovascular event than men who do the same. On top of that, the advantage holds true even when women put in less effort.
    • “The observational study, which analyzed the exercise habits of more than 400,000 U.S. adults, found that compared to being inactive, engaging in regular physical activity lowered women’s mortality risk by 24%. Men saw a 15% reduction in risk.
    • “Women who worked out also had a 36% reduced risk of a fatal cardiovascular event, such as a stroke or heart attack, than their inactive peers. Among men, those who were physically active showed a 14% reduced risk.”
  • The Washington Post reports,
    • “About 1 in 4 U.S. adults 65 and older — more than 14 million people — suffer a fall each year, according to the Centers for Disease Control and Prevention.
    • “Falls are the leading cause of injury among those 65 and older, even though not all falls result in an injury, the CDC says. About 37 percent of older people who have fallen have sustained an injury that required medical treatment or activity restrictions. For instance, the CDC reports that 95 percent of hip fractures result from a fall, and falls also are the most common cause of traumatic brain injuries.
    • “The National Institute on Aging notes that the odds of falling increase with age, but falls often can be prevented. Standard suggestions include fall-proofing your home space (making sure all stairs have hand rails and are well-lit, eliminating most throw rugs and keeping walk spaces clutter-free), careful management of medications (especially those that can cause dizziness or confusion), having regular vision checks and staying as active as possible (including doing exercises to maintain strength and balance).”
  • STAT News tells us,
    • “Niacin, or vitamin B3, has long been a U.S. public health darling to the point that it is added, by law, to cereal products. But a new study published Monday in Nature Medicine points to a potentially concerning effect of an excess of the vitamin: It may increase the risk of cardiovascular disease.
    • “The study looked into two cohorts of patients without active heart disease, 60% of whom were treated with statins, and found a strong association between a metabolic product of excess niacin and an increased risk of major adverse cardiovascular events such as a heart attack or stroke. One in four of the people in the study had excess niacin, which doubled their risk of major cardiovascular events to levels comparable with diabetes or a previous heart attack.
    • “It’s a fairly sizable risk. It’s on par with what we consider other large risks,” said Stanley Hazen, the section head of preventive cardiology and cardiac rehabilitation at the Cleveland Clinic and senior author of the study. “This opens up the door; it lays the foundation for new studies and new interventions from both a diagnostic and therapeutic perspective to try to reduce inflammation and cardiovascular disease.”
  • Per Medscape,
    • “A plant-based diet, low in dairy and meat but rich in fruits, vegetables, grains, and nuts, can improve sexual and urinary health in patients treated for local prostate cancer, new research showed.
    • “The findings, published on February 13, 2024, in the journal Cancer, bolster previous research showing plant-based diets can reduce the risk for recurrence and improve survivorship in men with prostate cancer.
    • “The current study shows for the first time an association between eating more plant-based food with better scores for quality of life among patients diagnosed with prostate cancer,” Stacy Loeb, MD, a urologist in the Departments of Urology and Population Health at NYU Langone Health, in New York City, who led the research.”
  • and
    • Cefepime-taniborbactam was 22% more effective than meropenem, which is a current treatment for complicated urinary tract infections (UTIs) and acute pyelonephritis, according to a study published in The New England Journal of Medicine.

From the healthcare business front,

  • The Wall Street Journal reports,
    • “China has more obese people than anywhere else in the world, and they are increasingly turning to weight-loss drugs to solve the problem.
    • “That is fueling a gray market of drug sellers and buyers, who have little trouble getting around China’s rules on the use of Ozempic. 
    • “Ozempic isn’t available for weight loss in the country, instead being reserved for the treatment of Type 2 diabetes. But users on e-commerce platforms are able to buy the shots, colloquially known as “miracle drugs,” simply by declaring they have been diagnosed with diabetes—without providing proof. 
    • “They aren’t getting a bad deal: On JD.com, a dosage of Ozempic retails for around $139. That is higher than its cost on the country’s national-insurance plan but much cheaper than the $970 some users pay in the U.S. each month. JD.com didn’t respond to requests for comment.”
  • NPR Shots notes,
    • “Bayer is the latest name-brand drugmaker to dip its toe into the world of Mark Cuban’s online pharmacy, Cost Plus Drugs. 
    • “The website offers drugs at steep discounts bypassing middlemen called pharmacy benefit managers. It mostly sells generics, but has been slowly adding brand name products as well. 
    • “Yaz birth control pills and Climara, a hormone patch for menopause, will both now be available for a fraction of their list prices, including Cost Plus’s standard 15% markup and shipping.
    • “As I look at our partnership with Cost Plus, I really look at this as a test and learn,” says Sebastian Guth, president of U.S. Pharmaceuticals at Bayer. “It’s a first initial step. We will learn and see what the results of this partnership are and may then decide to expand it further.”
  • Beckers Payer Issues points out,
    • “Some health systems are getting out of the insurance business. 
    • “In the first weeks of 2024, two health systems announced plans to sell their health insurance subsidiaries. In February, Springfield, Mass.-based Baystate Health reached a deal to sell Health New England to Point32Health. 
    • “In January, Toledo, Ohio-based ProMedica said it planned to sell its insurance subsidiary, Paramount Health, to Medical Mutual of Ohio. 
    • “Baystate Health has around 180,000 members in Medicare, Medicaid and commercial, and Paramount Health has more than 77,000 members in Medicare Advantage, commercial, individual and short-term plans. Both are set to be acquired by larger nonprofit insurers. Point32Health and Medical Mutual of Ohio each have over 1 million members.”