Tuesday Tidbits

Medical / Rx research

Tuesday Tidbits

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Govexec lets us know,
    • “The U.S. Postal Service is pausing some of the most controversial reforms to its mailing network as its leadership has agreed to the demands of a growing, bipartisan chorus in Congress. 
    • “The mailing agency has halted its plans to consolidate dozens of processing facilities until at least Jan. 1, 2025, ensuring the network overhaul is paused until after the upcoming presidential election in which millions of Americans will be voting by mail. A large swath of lawmakers across the ideological spectrum have called on Postmaster General Louis DeJoy to delay or cease the changes, some of which would shift the bulk of mail processing across state lines. 
    • “The decision marks a reversal for DeJoy, who just last week remained resolute in defending his vision as the only viable path forward for his agency. He called the issue an existential one, saying his reforms were “what we must continue to do to survive.” 
  • HHS’s Agency for Healthcare Research and Quality posted its March 2024 “NATIONAL HEALTHCARE QUALITY AND DISPARITIES REPORT CHARTBOOK ON PATIENT SAFETY.”
  • Per an FDA press release, “[o]n Monday [May 13], the FDA issued a safety communication to warn patients, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to an increased risk of false results. The FDA had also issued a Warning Letter to Cue Health after an inspection revealed that the company made changes to these tests and that the changes reduced the reliability of the test to detect SARS-CoV-2 virus.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “The coronavirus has once again evolved, in a familiar echo of past years. Unlike earlier iterations of the virus, this new variant is not sparking widespread havoc.
    • “The Centers for Disease Control and Prevention said it is monitoring a variant called KP.2 and does not see evidence it causes more severe illness than other strains. Laboratory tests have shown that KP.2 is not causing a surge in infections or transmission, the agency said.
    • “The CDC has identified a second emergent variant, KP.1.1. But it is KP.2 that is leading the pack. Both new variants belong to a group of coronavirus variants dubbed “FLiRT” by scientists. The acronym was coined to describe a combination of mutations found in the spike protein of the SARS-CoV-2 virus. * * *
    • “KP.2 has symptoms similar to earlier versions of the virus, including fever, chills, cough and muscle or body aches.”
    • The current vaccines are effective against KP.2. [“H]ealth experts predict that the new formulation of the coronavirus expected for the fall could offer even stronger protection because it will probably be tailored to thwart the new variant.”
  • Beckers Hospital News informs us,
    • “On average, people taking Novo Nordisk’s weight loss drug Wegovy see a 10% reduction in weight, which is sustained for four years, according to findings from a major trial published May 13.  * * *
    • “Wegovy is tied to a 20% reduced risk of heart attacks and other cardiovascular events — a benefit that was seen across the board, irrespective of how much weight people lost.” 
  • STAT News adds,
    • “Novo Nordisk will test whether its GLP-1 drugs can help people with alcohol-associated liver disease, and, as part of that, will study if the treatments will change the amount of alcohol people drink.
    • “This appears to be the first time the company is getting involved in research to see if the booming class of GLP-1 diabetes and obesity drugs can affect substance consumption, a question that academic researchers have been probing but the pharmaceutical industry has so far avoided.
    • “The nine-month study will try three drugs alone and in combinations against placebo. The primary outcome being tested is change in liver scarring, or fibrosis, and one of the secondary outcomes is changes in alcohol consumption. The news of the study was first reported by Bloomberg.
    • “The medications that will be tested include the blockbuster semaglutide, sold as the diabetes drug Ozempic and obesity drug Wegovy, as well as CagriSema, a drug Novo is developing that combines semaglutide with the dual amylin and calcitonin receptor agonist cagrilintide. A third drug, NNC0194-0499, targets FGF-21, a hormone produced by the liver that plays a role in inflammation.”
  • NIH’s All of Us Program posted its latest newsletter.
  • Per an Institute for Clinical and Economic Research press release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of 3,4-Methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD). * * *
    • “Key Clinical Findings
    • “Although ICER attempted to explore the concerns raised about MDMA-AP and the MAPP trials, ICER was not able to assess the extent that bias influenced reporting of benefits or the frequency with which there may have been misreporting of harms. As such, ICER concluded that the current publicly available evidence is insufficient (“I”) to assess the overall net benefit of MDMA-AP. 
    • “Key Cost-Effectiveness Findings
    • “Given the “I” rating, the economic analyses of MDMA-AP in this Evidence Report are only exploratory analyses that provide insights into costs and benefits if it is assumed that the results of the MAPP trials are accurate. ICER did not calculate a health-benefit price benchmark for MDMA-AP.”
  • Benefitfocus released an “Employee Benefits Strategy Playbook for Mental Healthcare.

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “The majority of the nation’s leading for-profit hospital systems by revenue reported net gains during the first quarter led by stronger than expected inpatient volumes.
    • “The boost in inpatient volumes and associated revenue comes just a quarter after providers said they would be betting more heavily on outpatient services to drive growth. 
    • “Increases in inpatient revenues is an area to watch as providers weigh whether and how to adjust their portfolios. Community Health Systems, for example, has been on a selling spree recently in an attempt to deleverage its balance sheets, while HCA Healthcare, Tenet Healthcare and Universal Health Services are expanding services in key markets. 
    • “Should inpatient care utilization continue to rise over multiple quarters, it could influence hospitals’ capital spending, according to research notes from analysts.”
  • BioPharma Dive tells us,
    • “Biosimilars are gaining ground. The IRA could push them further next year.
    • “As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.”
  • Modern Healthcare reports,
    • Behavioral health provider Talkspace rolled out services Tuesday to 13 million Medicare members across 11 states and will expand to 33 million members nationwide by the end of the year.
    • Talkspace services are available to those with traditional Medicare in California, Florida, New York, Ohio, New Jersey, Virginia, Missouri, Maryland, South Carolina, New Mexico and Idaho. The company plans to offer services to Medicare Advantage members later on, as well.

Monday Roundup

David Ermer–CDC, Congress, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Fierce Healthcare tells us
    • “A slew of bills targeting enhanced access to care within rural communities have, to the applause of the hospital industry, passed through committee to the full House of Representatives.
    • “The rural care bills that made it through the Ways and Means Committee’s Wednesday markup broadly support the financial stability of designated Critical Access Hospitals (CAHs) and Rural Emergency Hospitals (REH) along with other smaller hospitals serving rural communities [, among other objectives discussed in the article].
    • “These included The Preserving Emergency Access in Key Sites Act of 2024 (PEAKS Act), which expands increased emergency ambulance services coverage for patients served by CAHs; The Rural Hospital Stabilization Act, which authorizes new grants funding for investments into CAHs, REHs and small rural hospitals staving off potential closure; and The Second Chances for Rural Hospitals Acts, which expands the eligibility requirements for low-volume hospitals that wish to become REHs.”
  • Per an HHS press release,
    • “Today, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced the winners of the FentAlert Challenge, which sought innovative ideas from U.S. youth, aged 14-18, to develop a community strategy to educate their peers about fentanyl and fake pills ― and prevent drug overdose deaths. The Challenge supports primary prevention efforts prioritized in the Department of Health and Human Services (HHS) Overdose Prevention Strategy, a key element of the Biden-Harris Administration’s Unity Agenda’s focus on beating the opioid crisis. The Challenge received almost 200 entries from across the country.
    • “The announcement launched National Prevention Week (NPW) (May 12-18), which celebrates the possibilities of prevention science and offers a platform to showcase substance use prevention activities across the country.”
  • Federal News Network lets us know,
    • “The nation’s top doctor is prescribing more attention to federal employees’ mental health and well-being.
    • But now in a hybrid work environment, that task has become remarkably more challenging, U.S. Surgeon General Vivek Murthy said.
    • “I do think that there are a lot of positives to having flexibility to be able to work from home — reduced commute times, time with family, being able to pick your kids up from school, be home for family dinner, while also not sacrificing your work,” Murthy said Thursday during a mental health and wellness event at the Office of Personnel Management. “But I think one of the things we also have to realize is that all of these choices come with trade-offs.”
    • “One of those trade-offs, he said, is that it can become harder to build social connections among coworkers — something that’s crucial for an agency’s operations overall.
    • “When people feel connected to other people in the workplace, that actually positively impacts their creativity, their productivity, and ultimately contributes to their engagement and retention,” Murthy said. “Creating opportunities for people to come back in person periodically, creating more intentional opportunities for people to be able to connect and learn about one another virtually, those become increasingly important when you’re in a hybrid work environment.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Do you know how old your heart is? And does it even matter? 
    • “More online calculators, wearable devices and medical tests are attempting to estimate your heart’s age. The companies and organizations behind the tools say that having insight into your heart health can prompt you to make lifestyle changes to help stave off cardiovascular disease down the road.
    • “It’s an extension of our newfound obsession with “biological age,” the concept that your body, or parts of it, can be physically aging faster or slower than your actual age. And that by knowing those ages, you can take control to live longer and healthier. 
    • “As for the heart, scientists say the tools can be a helpful jumping-off point for conversations with doctors about habit changes or medications before heart disease sets in. 
    • But you should take the results with a grain of salt, doctors and researchers say. The age calculations tend to be imprecise and don’t capture all of your possible risk factors, such as family history, air pollution, pregnancy complications or genetic variations. 
    • “It’s pretending to quantify something for you specifically that is just directionally true,” says Dr. Gregory Katz, a cardiologist at NYU Langone Heart. “It’s based on a true story, but it’s not actually a true story.”
  • Bloomberg Prognosis discusses “advances in treating brain cancer using different forms of immunotherapy — CAR-T, which uses engineered T-cells, and a messenger RNA-based therapeutic vaccine.”
  • Bloomberg also notes,
    • “Patients could wean themselves off blockbuster drugs such as Ozempic or Wegovy without piling the pounds back on, according to a scientific study.
    • “Data [from a small study] presented at the European Congress on Obesity in Venice, Italy on Sunday provides some of the first evidence that it could be possible to stop taking Novo Nordisk’s Ozempic or Wegovy and not regain any weight that has been lost — as long as a healthy lifestyle is maintained. * * *
    • “The Danish study of patients using semaglutide, which is the active ingredient in Ozempic and Wegovy, alongside a weight management program run through the Embla app, suggests that tapering the drug — instead of a hard stop — could potentially prevent weight regain. 
    • “However, just 353 patients were in the sample of patients who stopped semaglutide, which is a small study size. These patients had reached their target weight and reduced their semaglutide dose over nine weeks. Patients continued to lose weight as they tapered, losing an average of 2.1% over the nine weeks. * * *
    • “The combination of support in making lifestyle changes and tapering seems to allow patients to avoid regaining weight after coming off semaglutide,” said Henrik Gudbergsen, lead researcher and Embla’s chief medical officer, in a statement.”
  • STAT News informs us,
    • “Reluctance among dairy farmers to report H5N1 bird flu outbreaks within their herds or allow testing of their workers has made it difficult to keep up with the virus’s rapid spread, prompting federal public health officials to look to wastewater to help fill in the gaps.
    • “On Tuesday, the Centers for Disease Control and Prevention is expected to unveil a public dashboard tracking influenza A viruses in sewage that the agency has been collecting from 600 wastewater treatment sites around the country since last fall.
    • “The testing is not H5N1-specific; H5N1 belongs to the large influenza A family of viruses, as do two of the viruses that regularly sicken people during flu season. But flu viruses that cause human disease circulate at very low levels during the summer months. So the presence of high levels of influenza A in wastewater from now through the end of the summer could be a reliable indicator that something unusual is going on in a particular area.
    • “Wastewater monitoring, at least at this stage, cannot discern the sources — be they from dairy cattle, run-off from dairy processors, or human infections — of any viral genetic fragments found in sewage, although the agency is working on having more capability to do so in the future.”
  • The Washington Post offers Consumer Reports guidance on how to reduce your exposure to plastics in food (and elsewhere).

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Kaiser Permanente kicked off 2024 with $935 million of operating income (3.4% operating margin) and over $2.7 billion of net income when excluding a one-time, $4.6 billion net asset gain from its Geisinger Health acquisition, according to topline first-quarter numbers shared late Friday.
    • “The performance handily outpaces the $233 million operating income (0.9% operating margin) and $1.2 billion bottom line of last year’s opening quarter.
    • “Still, the integrated nonprofit noted that its operating income was still “below historical first-quarter trends leading up to the pandemic” due to industry-wide cost pressures around high utilization, care acuity and elevated goods and services expenses. The top of the year is typically bolstered by the timing of the open enrollment cycle, and then followed by steady revenue but rising expenses, the organization explained.”
  • RAND reports
    • “Prices paid to hospitals during 2022 by employers and private insurers for both inpatient and outpatient services averaged 254 percent of what Medicare would have paid, with wide variation in prices among states, according to a new RAND report.
    • “Some states (Arkansas, Iowa, Massachusetts, Michigan, Mississippi) had relative prices under 200 percent of Medicare, while other states (California, Florida, Georgia, New York, South Carolina, West Virginia, Wisconsin) had relative prices that were above 300 percent of Medicare.
    • “Even as the number of hospitals and insurance claims analyzed has grown across multiple rounds of the RAND Hospital Price Transparency Study the state-level average price has remained above 200 percent of Medicare—from 247 percent of Medicare prices in 2018 to 224 percent in 2020 and to 254 percent in 2022.”
  • Fierce Healthcare also points out
    • “Foley & Lardner released a new state survey of telehealth insurance laws that tracks the changes in the legal landscape from 2019, before the COVID-19 public health emergency, until April 2024.
    • “The survey includes key figures on each state’s telehealth commercial insurance coverage and payment/reimbursement laws.
    • “Nearly all states have adopted a telehealth statute as of April 2024. Of particular note is the number of states that expanded audio-only coverage, states that implemented coverage and payment parity for mental and behavioral health provided via telehealth, and states that passed reimbursement and parity laws.” 
  • Following up on Cybersecurity Saturday, Fierce Healthcare noted earlier today,
    • “Ascension said it is communicating with several government organizations and for the first time referred to its cybersecurity event as a “ransomware incident” in an update posted this weekend. 
    • “The 140-hospital health system said that it is still working to investigate and restore its systems—a process that is “making progress” but “will take time to complete” across each of its care sites. 
    • “In the meantime, the system said it has notified law enforcement and other government bodies including the FBI, the Cybersecurity and Infrastructure Security Agency (CISA) and the Department of Health and Human Services, among others.” 

Weekend update

David Ermer–CMS, Congress, Medical / Rx research, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

Happy Mothers’ Day!!

From Washington, DC,

  • Roll Call informs us,
    • “Six months after the launch of the Biden administration’s “birthing friendly” designation for hospitals, advocates are questioning the next steps for the tool aimed at incentivizing better care for patients. 
    • “Beginning last fall, hospitals that achieved the designation received an icon on Care Compare, a federal website aimed at helping consumers pick health care providers. 
    • “But it’s not difficult for hospitals to receive the designation, with 2,225 — that is, most eligible hospitals — having received it as of April. 
    • “Of the nearly 1,000 acute care hospitals that didn’t get the designation, more than 800 said they didn’t provide delivery or labor care. 
    • “And only 135 didn’t get the designation because they didn’t meet the requirements of participating in a statewide or national perinatal quality improvement collaborative program.”  

From the public health and medical research front,

  • STAT News reports,
    • “Rick Slayman, the first man to receive a kidney transplant from a genetically engineered pig, has died, according to a statement from his family and Massachusetts General Hospital, where he underwent the historic operation in March.
    • “Our family is deeply saddened about the sudden passing of our beloved Rick but take great comfort knowing he inspired so many,” his family said in the statement released Saturday evening.
    • “The hospital did not say how or when Slayman died. A spokesperson declined to provide further information, citing “privacy issues.”
    • “We have no indication that [Slayman’s death] was the result of his recent transplant,” Mass. General said in the statement. * * *
    • “Slayman’s family also thanked his team of doctors, “who truly did everything they could to help give Rick a second chance.”
    • “Their enormous efforts leading the xenotransplant gave our family seven more weeks with Rick, and our memories made during that time will remain in our minds and hearts,” they said.”
    • RIP and thanks for your courage, Mr. Slayman.
  • The Washington Post lets us know,
    • “A recent analysis found poor survival rates after bone fractures in older adults, with fewer than a third of men and half of women surviving five years after a fracture.
    • “Published in JBMR Plus, the study looked at a cohort of 98,474 Ontario residents age 66 and older who suffered fractures to parts of the body associated with osteoporosis between January 2011 and March 2015. The patients were grouped into sets based on the fracture site and matched to patients with a similar demographic profile but no bone breaks during the study period.
    • “The fracture cohort was mostly female (73 percent), and the median age at fracture was 80. In the year before the fracture, up to 45 percent of the women and 14 percent of the men had been treated for osteoporosis.
    • “The analysis revealed that those within a year of a hip, vertebral or proximal non-hip, non-vertebral fracture were at the highest risk of death. The survival probability was lower for the oldest patients.”
  • STAT News tells us,
    • “An ambitious effort to cure HIV with CRISPR genome editing fell short in an early clinical trial, investigators announced Friday morning.
    • “In the study, run by Excision BioTherapeutics, researchers tried to use the gene editing tool to address a chief reason HIV has been so hard to cure. While antiviral drugs can clear patients of replicating virus, HIV is able to worm its way into a patients’ own DNA in certain cells. If the patient ever stops taking medicines, those cells start pumping out HIV particles and the infection roars back.
    • “Researchers hoped they could send CRISPR to those cells and, by cutting the HIV DNA lurking there at two spots, slice out the virus. In the Phase 1 trial, investigators administered the treatment to five patients. They then took three of them off conventional antiviral treatment.
    • “In all three patients, the virus soon rebounded and they needed to resume antiviral therapy.
    • “Their approach did not work,” said Fyodor Urnov, director of technology and translation at the Innovative Genomics Institute.”
  • Fortune Well explains,
    • Parenting brings many joys, but sleep deprivation is not one of them. So, it’s no wonder that moms and dads are willing to take some drastic measures—in the form of sleep medications—when it comes to getting their kids down for the night.
    • New survey results from Sleep Doctor reveal that 79% of parents have given their child a substance to get them to sleep—with 66% using melatonin, 35% using Benadryl, and 20% turning to prescription sleep aids. Others reported using everything from herbal and over-the-counter aids to CBD, THC, and even alcohol. * * *
    • “Parents are desperate, they’re tired, they’re juggling so many things … and a child having difficulty sleeping just piles onto that,” says Dr. Nilong Vyas, pediatrician, public health specialist, and board-certified sleep expert working closely with Sleep Doctor, which conducted the survey of 1,201 parents in April. * * *
    • “Still, Vyas tells Fortune, “Ideally it’s better to change [bedtime] behaviors and modify them so a child can learn to fall asleep independently, without the need of supplements.”
  • The Wall Street Journal considers how helpful are mental health chatbots.
    • “Interest in mental-health chatbots is rising, fueled by advances in AI’s ability to conduct sophisticated conversations. But how much therapy can they really provide?
    • “Chatbots are still no substitute for a human therapist, researchers say. Not only do some of these tools have trouble helping patients in crisis, they don’t always offer a sufficient level of personalization or provide advice that is guaranteed to be accurate.
    • “Yet researchers are homing in on some of the supporting roles that chatbots and artificial intelligence could play in mental-health care. For instance, chatbots are showing promise in helping people determine whether they need care and connecting them to the proper resources, in lifting people’s moods and in practicing skills taught in cognitive-behavioral therapy. 
    • “There’s an enormous need for innovation in mental-health care,” says Olga Troyanskaya, a computer-science professor and AI expert at Princeton University, who leads Princeton Precision Health, an interdisciplinary initiative that aims to use technology to improve healthcare. At the same time, she says, it’s also important to balance enthusiasm with caution, especially when it comes to using artificial intelligence in mental health.”
  • The Journal also offers general advice on how to talk with a chatbot.

Friday Factoids

David Ermer–CDC, Congress, COVID-19 vaccine, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Govexec reports,
    • “In the face of mounting pressure from lawmakers of all political stripes, watchdogs, stakeholders and even members of its own governing board, as well as another financial quarter in the red, leadership of the U.S. Postal Service is doubling down on its controversial plan to overhaul the agency. 
    • “USPS posted a net loss of $1.5 billion in the second quarter of fiscal 2024, though management noted that was trimmed to a $300 million loss after dispensing with costs outside of its control. USPS leaders boasted they have turned a $200 million profit in the first half of the fiscal year using that same metric, which marked a $600 million turnaround compared to the first six months of fiscal 2023.
    • “While First-Class mail volume has continued its longstanding decline, revenue grew in the quarter by nearly $500 million due in large part to the dramatic price increases USPS has instituted. The Postal Service has cut $100 million in costs, driven largely by a reduction in transportation expenses and slashing 9 million work hours. 
    • “On-time delivery of mail, however, has plummeted as USPS has instituted significant reforms to its network as laid out in Postmaster General Louis DeJoy’s 10-year Delivering for America plan.” 
  • HHS posted a fact sheet on new government efforts to reduce the impact of spread of avian flu H5N1
  • Senators John Fetterman (D PA) and Tina Smith (D MN) announced a bill, “the United States Senate Commission on Mental Health Act of 2024. The bill would establish a U.S. Senate Commission on Mental Health tasked with providing Congress and the president independent, expert policy recommendations to improve access to and affordability of mental health care services. * * * Full text of the bill can be found here.“

From the public health and medical research front,

  • The Centers for Disease Control tells us today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, no jurisdictions experienced moderate, high, or very high activity.
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.
    • “Nationally, influenza and RSV test positivity decreased compared to the previous week. COVID-19 test positivity remained stable at low levels.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, is minimal.”
  • STAT News reports “Harvard scientists unveil the most detailed map of the brain ever: ‘It’s an alien world inside your own head’”.
    • “On Thursday, [Dr. Jeffrey’ Lichtman and his partners unveiled the results of their [decade long] efforts in the prestigious journal Science, and also posted to the internet renderings of the human brain unlike any ever seen. They came complete with a program that allows viewers to move through a microscopic alien landscape so detailed Lichtman can’t resist waxing poetic when he talks about it.
    • “It’s an alien world inside your own head,” he said. “Neurons themselves are truly awe inspiringly beautiful. There’s no two ways about it.”
    • “True, the insights gleaned from the tiny sample have not yet unraveled the mysteries of autism, schizophrenia, or depression. They can’t yet explain the mechanics of human learning, memory, and personality on the cellular level. But they represent an important first step in that direction, and provide a tantalizing preview of the kind of insights we might see in the decades ahead.”
  • The Wall Street Journal reports,
    • “Bristol Myers Squibb said on Friday that its trial evaluating a combination of cancer treatments failed to meet its primary endpoint.
    • “The company’s trial was evaluating the cancer-drug Opdivo and concurrent chemoradiotherapy, followed by Opdivo plus Yervoy, the brand name for a monoclonal antibody, in treating unresectable, locally advanced non-small cell lung cancer. The trial’s primary endpoint was progression-free survival.
    • “Bristol Myers Squibb said it would fully evaluate the data and work with investigators to share results with the scientific community.
    • “Opdivo and certain combinations with Opdivo are approved treatments for eligible patients with non-small cell lung cancer.”
  • Per Fierce Healthcare,
    • “Cancer diagnoses are on the rise among younger adults, and a new guidebook seeks to arm employers with the tools necessary to tackle this issue.
    • “The Northeast Business Group on Health’s new toolkit highlights actions employers can take to proactively address growing rates for five types of cancer in their workforce: breast cancer, colorectal cancer, head and neck cancer, cancer of the reproductive organs and skin cancer.
    • “There’s a clear business case for putting a focus on cancer, as the cost of therapies continues to increase and patients often require treatment for the long haul, NEBGH Medical Director Mark Cunningham-Hill, M.D., told Fierce Healthcare.
    • “He said that many employers, especially larger firms, have established sophisticated and comprehensive wellness and health programs for their workers. But they can do more to “connect the dots” between those offerings and critical preventive care around cancer and conditions that increase risk factors, like obesity.”
  • USA Data relates,
    • One out of every 42 babies born in the United States in 2021 was conceived using IVF or other assisted reproductive technologies.  
    • Parents who started treatments in 2021 gave birth to 97,128 babies, a 49% increase from 2012. In 2021, 238,126 patients initiated 413,776 IVF or similar treatment cycles, up 135% from 2012. 
    • IVF was most common in Washington, DC, with 5.8% of babies conceived via IVF, Massachusetts (5.4%), and New Jersey (5.0%). Less than one percent of infants born in Puerto Rico were conceived via IVF (0.4%). Alabama (0.6%) and Arkansas (0.7%) also had low rates.  

From the U.S. healthcare business front,

  • The Kaiser Family Foundation released a “KFF Health Tracking Poll May 2024: The Public’s Use and Views of GLP-1 Drugs.” Here are the key finding from the poll:
    • “The latest KFF Health Tracking Poll finds that about one in eight adults (12%) say they have ever taken a GLP-1 agonist – an increasingly popular class of prescription drugs used for weight loss and to treat diabetes or prevent heart attacks or strokes for adults with heart disease – including 6% who say they are currently taking such a drug. The share who report ever taking these drugs rises to four in ten (43%) among adults who have been told by a doctor that they have diabetes, a quarter who have been told they have heart disease, and one in five (22%) who have been told by a doctor that they are overweight or obese in the past five years1. Public awareness of GLP-1 drugs has increased in the past year, with about one-third (32%) of adults now saying they have heard “a lot” about these drugs, up from 19% in July 2023.
    • “Most adults who have taken GLP-1 drugs say they took them to treat a chronic condition including diabetes or heart disease (62%), while about four in ten say they took them primarily to lose weight.
    • “About half (54%) of all adults who have taken GLP-1 drugs say it was difficult to afford the cost, including one in five (22%) who say it was “very difficult.” While most insured adults who have taken these drugs say their insurance covered at least part of the cost, even among insured adults about half (53%) say the cost was difficult to afford2.
    • “While 8% of adults ages 65 and older say they have taken a GLP-1 medication for a chronic condition, just 1% say they have ever taken a GLP-1 drug to lose weight, which may reflect Medicare’s lack of coverage for prescription drugs used for weight loss. Nearly four in ten (37%) adults ages 65 and older report being told by a doctor they are overweight or obese in the past five years.
    • “With Medicare currently prohibited by law from covering prescription drugs used for weight loss, six in ten adults say they think Medicare should cover the cost of these drugs when prescribed for weight loss for people who are overweight, including more than half of Democrats, independents and Republicans. Similar shares of the public continue to support Medicare coverage of these drugs for weight loss even after hearing arguments for and against this proposal.”
  • Per BioPharma Dive,
    • “Sanofi will pay vaccine maker Novavax $500 million and take a small equity stake in the Maryland-based company as part of a broad COVID-19 shot alliance, the companies announced Friday.
    • “Through the deal, Sanofi will gain rights to co-market Novavax’s protein-based COVID vaccine globally, excepting certain countries, and a license to combine it with Sanofi’s existing influenza shots. Sanofi will also hold a non-exclusive right to use Novavax’s soap bark tree-derived adjuvant in other products it develops.
    • “Starting next year, Sanofi will book sales of Novavax’s COVID shot and pay Novavax double-digit percentage royalties. The French pharmaceutical company will also support certain R&D, regulatory and commercial expenses.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.”Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.
    • “After updating the app in February, Tandem received 224 injury reports in about two months. The reports related to an issue that caused the app to crash and relaunch, resulting in excessive use of Bluetooth and potentially draining the battery of the connected insulin pump.
    • “The FDA categorized the event as a Class I recall because of the life-threatening potential for pumps to deliver too little insulin. Tandem corrected the fault in an app update in March.”
  • The Wall Street Journal explains why “Getting Alzheimer’s treatment to those who need it poses particular challenges.” For example
    • “The problem isn’t this drug. Sure. It has risks, et cetera,” said Jason Karlawish, co-director, of the Penn Memory Center at the University of Pennsylvania. “But the problem was the drug and the system — namely with a system of care for its delivery.”
    • “Karlawish said his memory center infused its first patient with Leqembi on November 16. He said that in the six months since, the number of patients who have received the drug there has climbed into the double-digits, reaching roughly 50 people. That, he said, required setting up an infrastructure that “either didn’t exist or existed in bits that had to be put together.”
  • MedCity new points out,
    • “Navigation challenges are the top reason consumers stop seeing healthcare providers, while experience issues are the main reason consumers leave their health insurer, a new survey found.
    • “The Accenture report, released last week, surveyed more than 9,700 insured consumers and 8,000 consumers who sought or received care in the prior year. The survey is a follow-up to a 2021 report, which examined why people are loyal or not loyal to their payer or provider.
    • “We wanted to leverage our patient and member experience surveys to continue to track the state of consumerism in health care, assessing how providers and health insurers perform across a number of key touchpoints that drive selection, loyalty, value and ease of use,” said Sarah Sinha, a managing director in Accenture’s health business, in an email.”
  • Insurance Business tells us,
    • “Offering support across a variety of functions including customer service, claims processing, underwriting, and fraud detection, the capability of AI to analyze large datasets and process information will continue to revolutionize insurance.
    • “Nirmal Ranganathan, vice president of engineering, AI, at Rackspace Technology, spoke with Insurance Business on how insurance companies can take advantage of AI to generate cost savings across their businesses.”
    • Check it out.

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, Federal employment benefits, HSA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “The House overwhelmingly voted to table Rep. Marjorie Taylor Greene’s attempt to oust Speaker Mike Johnson on Wednesday night, with nearly all Republicans and most Democrats coming to Johnson’s rescue.
    • “The final tally was 359-43, with 11 Republicans and 32 Democrats voting against the motion to table Greene’s resolution. Seven Democrats voted “present.”
  • The Society for Human Resource Management tells us,
    • “The annual limit on HSA contributions for self-only coverage in 2025 will be $4,300, a 3.6 percent increase from the $4,150 limit in 2024, the IRS announced May 9. For family coverage, the HSA contribution limit will jump to $8,550, up 3 percent from $8,300 in 2024.
    • “The jump in the contribution limits is significantly less than the roughly 7 percent increase seen from 2023 to 2024.
    • “The IRS did not yet release the 2025 catch-up contribution for savers age 55 and older. It currently stands at $1,000 for 2024, unchanged from 2023.
    • “Meanwhile, for 2025, a high-deductible health plan (HDHP) must have a deductible of at least $1,650 for self-only coverage, up from $1,600 in 2024, or $3,300 for family coverage, up from $3,200, the IRS noted. Annual out-of-pocket expense maximums (deductibles, co-payments and other amounts, but not premiums) cannot exceed $8,300 for self-only coverage in 2025, up from $8,050 in 2024, or $16,600 for family coverage, up from $16,100.
    • “The IRS also announced that the excepted-benefit HRA limit will be $2,150 in 2025, up from $2,100.”
  • Here’s a link to the IRS announcement.
  • Fierce Healthcare points out,
    • “The U.S. Department of Justice announced Thursday it has established a new task force to take on healthcare monopolies and collusion.
    • “The task force, called HCMC for short, will guide the division’s enforcement strategy and policy approach in healthcare, including by facilitating policy advocacy, investigations and, where warranted, civil and criminal enforcement in healthcare markets, the agency said in a press release.”
  • Govexec lets us know,
    • “The Office of Personnel Management continued to make gains in its backlog of federal employees’ pending retirement applications, though progress has begun to slow.
    • “The federal government’s dedicated HR agency processed 7,647 claims in April. That marks a sharp decrease from the 10,711 claims handled in March but remains above the 6,901 new claims OPM received last month.
    • “Overall, the backlog of pending claims ticked down to 16,077 by the end of April, a decrease of roughly 750 from March’s backlog of 16,823. The federal government’s retirement backlog has fallen 23% since January, but remains short of OPM’s “steady state” goal of 13,000 pending claims.”
  • Fedweek explains the circumstances under which an FEHB enrollee can make coverage changes outside of Open Season. Meanwhile, Reg Jones wraps up his series on FEGLI coverage.

From the public health and medical research front,

  • “U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a white paper detailing proposals to improve the National Institutes of Health (NIH). Last year, Cassidy requested feedback from stakeholders on policies Congress could consider to modernize NIH.  * * * Read the full white paper here.  
  • The NIH Director in her blog lets us know,
    • “Precision oncology, in which doctors choose cancer treatment options based on the underlying molecular or genetic signature of individual tumors, has come a long way. The Food and Drug Administration has approved a growing number of tests that look for specific genetic changes that drive cancer growth to match patients to targeted treatments. The NCI-MATCH trial, supported by the National Cancer Institute, in which participants with advanced or rare cancer had their tumors sequenced in search of genetic changes that matched them to a treatment, has also suggested benefits for guiding treatment through genetic sequencing. But there remains a need to better predict treatment responses for people with cancer.
    • “A promising approach is to analyze a tumor’s RNA in addition to its DNA. The idea is to not only better understand underlying genetic changes, but also learn how those changes impact gene activity as measured by RNA sequencing data. A recent study introduces an artificial intelligence (AI)-driven tool, dubbed PERCEPTION (PERsonalized single-Cell Expression-based Planning for Treatments In ONcology), developed by an NIH-led team to do just this.1 This proof-of-concept study, published in Nature Cancer, shows that it’s possible to fine-tune predictions of a patient’s treatment responses from bulk RNA data by zeroing in on what’s happening inside single cells.”
  • NIH announced,
    • “Starting people with opioid use disorder on extended-release, injectable naltrexone (XR-naltrexone) within five to seven days of seeking treatment is more effective than the standard treatment method of starting within 10-15 days, but requires closer medical supervision, according to results from a clinical trial(link is external) supported by the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA). Published in JAMA Network Open, the findings suggest that this rapid treatment protocol could make XR-naltrexone more viable as a treatment option for opioid use disorder, which continues to take lives at an alarming rate.
    • “When someone is ready to seek treatment for opioid use disorder, it is crucial that they receive it as quickly as possible,” said Nora Volkow, M.D., NIDA director. “This study paves the way for more timely care with one of the three medications for opioid use disorder we have available, better supporting people in their ability to choose the treatment option that will work best for them.”
  • The U.S. Preventive Health Task Force made available for public comment a draft research plan about the “Early Introduction of Allergens to Prevent Food Allergies in Infants: Counseling.” The comment period ends on June 5, 2024.
  • The Institutes for Clinical and Economic Review
    • “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of imetelstat (Geron Corporation) for the treatment of anemia in myelodysplastic syndrome (MDS).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.”
    • The comment deadline is June 10, 2024.
  • The Wall Street Journal explores the quest for treatments to keep weight off after taking blockbuster drugs such as Ozempic and Wegovy. Reading the article makes the FEHBlog think that that the drug manufacturers put the cart before the horse.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Some 23% of what patients owe is collected by hospitals before treatment, according to an analysis of first-quarter data this year from 1,850 hospitals by Kodiak Solutions, a healthcare consulting and software company. For the same period in 2022, the figure was 20%.
    • “They are seeking advance payment for nonemergencies, they say, because chasing unpaid bills is challenging and costly. Roughly half the debt hospitals wrote off last year was owed by patients with insurance, the Kodiak analysis found.
    • “We need those patients who are able to pay to do so,” said Leslie Taylor, a spokeswoman for University of Arkansas for Medical Sciences, which owns one general hospital in Arkansas and will—after discussing with doctors—reschedule some procedures until patients can pay.
    • “For patients, the hospitals say, knowing the cost ahead of service gives them the opportunity to comparison-shop and avoid getting walloped with a huge bill unexpectedly. * * *
    • “Still, finding money for treatment is a challenge for many American households. Half of adults say they can’t afford to spend more than $500 on medical care should they be suddenly sick or injured, a survey by health policy nonprofit KFF found. They would need to borrow. 
    • “In addition, determining how much a patient will owe can be tricky. How much each patient pays depends on their health plan, its deductible or other out-of-pocket costs and the prices the plan negotiated with a hospital to pay.” 
  • Fierce Healthcare relates that doctors are trying to add a CPT code for prior authorization which would give them health plan reimbursement for this administrative services.
  • MedTech Dive alerts us that “Surgical robots are ‘gift that will keep on giving,’ ortho firms say. Stryker, Zimmer and Globus reported double-digit sales growth in their robot segments and outlined plans for new products.”
    • “Orthopedics companies posted record robot sales in the first quarter, even as they plan new product launches in the second half of 2024.
    • “Stryker reported record installations of its Mako surgical robot in the first quarter, although it didn’t share an exact number. Jason Beach, Stryker’s vice president of finance and investor relations, said the company has seen “really good results” from direct-to-consumer ads promoting the surgical robot to people who might consider a hip or knee replacement.” 
  • Per BioPharma Dive,
    • “AstraZeneca will no longer manufacture or supply its COVID-19 vaccine Vaxzevria, announcing Tuesday it is voluntarily withdrawing the shot due to a “decline in demand,” a spokesperson wrote in an email to BioPharma Dive. 
    • “Prior to the announcement, the company had already taken steps to pull Vaxzevria from the market in Europe. It submitted a withdrawal request there in March which took effect on May 7. 
    • “The decision to withdraw the vaccine comes just after the company reported plummeting yearly sales for Vaxzevria, and reportedly admitted in court documents that the shot can cause a rare side effect that leads to a combination of blood clots and low platelet levels. AstraZeneca didn’t mention safety concerns as a reason for the vaccine’s withdrawal, however.”  

Midweek Update

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare, Wellness–

From Washington, DC

  • Modern Healthcare tells us,
    • “Congress took the first step Wednesday to extend expiring telehealth rules, hospital at home services and other programs aimed at rural hospitals.
    • “The House Ways and Means Committee passed the Preserving Telehealth, Hospital, and Ambulance Access Act of 2024 by a vote of 31-0, setting it up for passage by the full House later this year. * * *
    • “One potentially controversial provision in the bill requires pharmacy benefit managers that work with Medicare Part D plans to de-link the compensationthey pay themselves from the rebates they secure based on drugs’ high list prices. Rep. Brad Schneider (D-Ill.) said the provision will save the government about $500 million, although official estimates were not yet available. The provision does not apply to the broader commercial market, though Schneider and Rep. Nicole Malliotakis (R-N.Y.) both called for expansion of the provision to the commercial market. Large PBMs oppose such provisions.”
  • Govexec lets us know,
    • “A new report from the Congressional Budget Office found that a gap between the combined pay and benefits of federal workers and their private sector counterparts has nearly disappeared between 2015 and 2022, raising new questions about President Biden’s proposed 2% average pay raise for the federal workforce in 2025.
    • “Federal policymakers generally rely on one of two reports comparing the compensation of federal and private sector workers. First is an annual analysis compiled by the Bureau of Labor Statistics for review by the Federal Salary Council, which compares only the wages of similar jobs, is the preferred citation of Democrats and federal employee unions. * * *
    • “CBO’s analysis, which is typically conducted every five years and is preferred by conservatives, compares “total compensation”—wages plus the cost of benefits like health care, paid leave and retirement—of federal and private sector employees with similar educational backgrounds. This model has traditionally concluded that the cost of federal employees’ pay and benefits is moderately higher than their counterparts in the private sector, although federal workers with master’s or professional degrees still tend to earn less.
    • “The latest version of CBO’s report, which was released last month, covers only 2022, rather than the traditional 2015-2020 period, due to the economic upheaval caused by the COVID-19 pandemic. It found that the total compensation gap between federal and private sector jobs cratered between 2015 and 2022, falling from 17% in its last analysis to just 5%.”
  • Per May 8 HHS press releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is announcing the Increasing Organ Transplant Access (IOTA) Model. The proposed model, which would be implemented by the CMS Innovation Center, aims to increase access to kidney transplants for all people living with end-stage renal disease (ESRD), improve the quality of care for people seeking kidney transplants, reduce disparities among individuals undergoing the process to receive a kidney transplant, and increase the efficiency and capability of transplant hospitals selected to participate. This proposed model would build on the Biden-Harris Administration’s priority of improving the kidney transplant system and the collaborative efforts between CMS and the Health Resources and Services Administration (HRSA) to increase organ donation and improve clinical outcomes, system improvement, quality measurement, transparency, and regulatory oversight.” * * *
    • “The proposed rule on the Increasing Organ Transplant Access Model can be accessed from the Federal Register at https://www.federalregister.gov/public-inspection/current. Standard provisions are included in the proposed rule that would be applicable to all Innovation Center model participants that begin participation in a model on or after January 1, 2025.
    • “View – PDF a fact sheet on the Increasing Organ Transplant Access Model.
    • “More information on the Increasing Organ Transplant Access Model is available on the model webpage.”
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $46.8 million in notices of funding opportunities to promote youth mental health, grow the behavioral health workforce, improve access to culturally competent behavioral care across the country, and strengthen peer recovery and recovery support. President Biden made tackling the mental health crisis and beating the opioid epidemic key pillars in his Unity Agenda for the nation. Today’s announcement will help communities transform how they address behavioral health.”
  • Beckers Clinical Leadership notes,
    • “Starting this summer, rural health clinics seeking Medicare reimbursement can apply through a new accreditation program from The Joint Commission. 
    • “On May 7, The Joint Commission said it has received deeming authority from CMS for a new rural health clinic accreditation program, which is meant to support patient safety improvements by reducing variation and risks in the delivery of primary care and personal health services.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Geneoscopy received Food and Drug Administration approval for its Colosense noninvasive colorectal cancer screening test, the company said Monday.
    • “The stool-based test, which Labcorp will offer, is approved for screening people aged 45 years or older who are at average risk of developing colorectal cancer. The indication puts Geneoscopy in competition with Exact Sciences’ Cologuard test.
    • “Geneoscopy focused on the opportunity in people aged under 50 years in its statement about the approval. Around 2% of people in that cohort used a stool-based test in 2021, but Evercore ISI and TD Cowen analysts expect Colosense to have a limited impact on Exact.”
  • STAT News points out,
    • “The Apple Watch has secured a new qualification from the Food and Drug Administration that could make the smartwatch an appealing tool for medical device companies hoping to illustrate the benefits of a common heart procedure.
    • “Last week, the Apple Watch’s Atrial Fibrillation History feature became the first digital tool qualified under the Medical Device Development Tools (MDDT) program. Released in 2022, the feature estimates a user’s A-fib burden, or how much time they spend in atrial fibrillation, which is an irregular heart rhythm that can cause shortness of breath and fatigue, and is also linked to an increased risk of stroke.
    • “The qualification means that FDA has determined in advance that sponsors can use the feature as a secondary endpoint in clinical trials without having to do additional work. Specifically, the Apple Watch is qualified for use as a secondary endpoint in clinical trials for cardiac ablation devices, which reduce the electrical signals that cause A-fib by scarring the heart with extreme heat or cold energy. Pulsed field ablation is the latest version of the technology, using a controlled electric field to scar tissue rather than the riskier thermal energy.”
  • Regulatory Focus notes,
    • “The US Food and Drug Administration (FDA) is piloting a program to enhance communication between drugmakers, investigators, and its drug shortage team during inspections to prevent facilities from unnecessarily shutting down and potentially contributing to shortages of essential drugs, said Patrizia Cavazzoni, MD, director of the agency’s Center for Drug Evaluation and Research (CDER).
    • “Cavazzoni made these remarks during a webinar hosted by the Alliance for a Stronger FDA on Monday, during which, she said “we strongly encourage manufacturers not to stop manufacturing as the result of an inspection.” She added that manufacturers sometimes shut down production lines based on what they are hearing during the inspection, which she said could worsen shortages.”

From the public health and medical research front

  •  The Washington Post reports that “Olive oil use [is] associated with lower risk of dying from dementia. An observational study has found that regular olive oil consumption may have cognitive health benefits.”
    • “Vasilis Vasiliou, a professor and the chair of the department of environmental health sciences at Yale School of Public Health, said the Harvard study “has been done very carefully,” and there is a broader effort to try to “find a mechanism” as to why olive oil, or other parts of the plant, could be beneficial to cardiovascular or cognitive health.”Vasilis Vasiliou, a professor and the chair of the department of environmental health sciences at Yale School of Public Health, said the Harvard study “has been done very carefully,” and there is a broader effort to try to “find a mechanism” as to why olive oil, or other parts of the plant, could be beneficial to cardiovascular or cognitive health.
    • “We don’t believe it’s one compound or two. The olive oil has the phenolic antioxidants, which are very important for protecting against oxidative stress,” Vasiliou said. “But there is a lot of other stuff that’s going on there.”
  • Per MedPage Today,
    • “Use of cannabis and nicotine together during pregnancy was associated with higher risks for infant death and maternal and neonatal morbidity compared with no exposure to either substance, with dual-use risk estimates higher than with either substance alone, a retrospective population-based cohort study.
    • “Compared with use of neither substance, the risk of infant death was more than twice as high with combined use in pregnancy after controlling for possible confounders (adjusted risk ratio [aRR] 2.18, 95% CI 1.82-2.62), reported Jamie O. Lo, MD, MCR, of Oregon Health & Science University in Portland, and colleagues.
    • “By comparison, risks were 65% higher with cannabis use only (aRR 1.65, 95% CI 1.41-1.93) and 62% higher with nicotine use only (aRR 1.62, 95% CI 1.45-1.80) versus no exposure, the researchers detailed in JAMA Network Open.
    • “Lo told MedPage Today in an email that she and her colleagues were surprised to see the increased infant death rate in the combined cannabis and nicotine users compared with those using each substance alone.
    • “We also did not expect so many maternal and neonatal/infant outcomes to be worse with combined cannabis/nicotine use,” she added.”
  • The National Cancer Institute posted its periodic cancer information highlights.
  • The National Institutes of Health announced,
    • The National Institutes of Health (NIH) will launch clinical trials to investigate potential treatments for long-term symptoms after COVID-19 infection, including sleep disturbances, exercise intolerance and the worsening of symptoms following physical or mental exertion known as post-exertional malaise (PEM). The mid-stage trials, part of NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative, will join six other RECOVER studies currently enrolling participants across the United States testing treatments to address viral persistence, neurological symptoms, including cognitive dysfunction (like brain fog) and autonomic nervous system dysfunction. The new trials will enroll approximately 1,660 people across 50 study sites to investigate potential treatments for some of the most frequent and burdensome symptoms reported by people suffering from long COVID.
    • “People 18 years of age and older who are interested in learning more about these trials can visit trials.RECOVERCovid.org(link is external) or ClinicalTrials.gov and search identifiers NCT06404047, NCT06404060, NCT06404073, NCT06404086, NCT06404099, NCT06404112.” 
  • BioPharma Dive reports,
    • “A profoundly deaf baby who received Regeneron’s experimental gene therapy was able to hear normally within six months, the company announced Wednesday.
    • “The data, presented at a medical conference, build on initially promising research released in October. The baby was dosed at 11 months of age, one of the youngest children in the world to receive gene therapy for genetic deafness, Regeneron said. A second patient, treated at age 4, also showed hearing improvements at a six-week assessment, the company said.
    • “Both children suffer from a type of deafness caused by mutations in a gene known as otoferlin. The initial research on Regeneron’s DB-OTO therapy is part of an ongoing Phase 1/2 trial known as CHORD enrolling infants and children in the U.S., U.K. and Spain.

From the U.S. healthcare business front,

  • MedCity News informs us,
    • “About a third of employers are integrating value-based care into their employer-sponsored insurance, according to a new survey. Another third of employers are determining the “best-fit strategies for their organization” when it comes to accountable care.
    • “The report was published Sunday by the Milken Institute with support from Morgan Health, a JPMorgan Chase healthcare unit for employer-sponsored insurance. The Milken Institute is a nonprofit think tank focused on financial, physical, mental and environmental health. The survey received responses from 72 employers of varying sizes and industry types.
    • “The researchers found that when making health benefit decisions, expanding preventive care, improving access to primary care and focusing on whole-person health are the top three tenets of accountable care. The lowest-ranked tenets are reducing health outcome disparities and increasing access to digital care.”
  • Fierce Healthcare adds,
    • “Employers are in a strong position to lead the charge in changing the conversation around obesity care, according to a new report from the Milken Institute.
    • “The group released a how-to guide employers of all sizes can use to push for obesity to be recognized as a chronic condition, driving a more multifaceted model for care and addressing the stigma that exists around weight.
    • “The guidebook notes that obesity and conditions related to it are having a major impact on healthcare costs, accounting for $425.5 billion in costs for the civilian workforce, according to a recent study. This includes higher medical costs for both employers and employees as well as costs related to absenteeism.
    • “Sarah Wells Kocsis, director of the Center for Public Health at the Milken Institute and one of the paper’s authors, told Fierce Healthcare that employers are starting to take notice of this issue and lead a conversation that’s “decades in the making.”
    • “We’re really at an inflection point,” she said. “Our goal here is to put this in writing and explain what a strong case there is to think about obesity as a chronic disease.”
  • HealthDay explains,
    • “Worries over health-related costs are plaguing the minds of older Americans of all backgrounds, a new poll suggests.
    • “Five of the six health-related issues that most people found very concerning had to do with health care costs, according to results from the University of Michigan National Poll on Healthy Aging. 
    • “And the sixth issue – financial scams and fraud – also had to do with money, results show.
    • “In this election year, these findings offer a striking reminder of how much health care costs matter to older adults,” Dr. John Ayanian, director of the University of Michigan Institute for Healthcare Policy and Innovation, where the poll is based, said in a news release. The poll is supported by AARP and Michigan Medicine, U-M’s academic medical center.
    • “Overall, 56% of people over 50 said they’re concerned about the cost of medical care for older adults, poll results show.”
  • Per mHealth Intelligence,
    • New research reveals that a text message and telephone-based virtual care approach can improve rates of screening, identification, and treatment of maternal mental health conditions.
    • Published in Health Affairs, the study assessed an intervention that addresses various barriers to adopting maternal mental health screening and referral to treatment. Medical University of South Carolina researchers noted that perinatal mental health disorders, perinatal substance use disorders (SUDs), and intimate partner violence are common during pregnancy and the postpartum year. According to data from the Mental Health Leadership Alliance, maternal mental health conditions affect 800,000 families each year in the United States.
  • BioPharma Dive offers a helpful database of patent expiration dates for thirty top-selling medicines.

Tuesday Tidbits

David Ermer–CMS, Congress, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington DC,

  • STAT News tells us
    • “A new bill set to be considered on Wednesday by the House Ways & Means Committee would extend for two years telehealth flexibilities for Medicare enrollees that were adopted during the Covid-19 pandemic, and look to reform drug industry middlemen to pay for it. [FEHBlog note — The bill focuses on PBMs serving Medicare Prescription Drug Plans.]
    • “At the end of the official public health emergency, Congress extended flexibilities that changed where and what kinds of care people could receive over telehealth, but those rules are set to expire at the end of the year.  * * *
    • “Lawmakers discussed reforming PBMs in spending talks earlier this year, but ultimately failed to come to an agreement. The December deadline will be another chance for Congress to take action. * * *
    • “The new bill language will be marked up by lawmakers and may be subject to changes before it receives a vote. A likely path to passage is inclusion in a year-end spending package.”
  • AP reports,
    • “The go-broke dates for Medicare and Social Security have been pushed back as an improving economy has contributed to changed projected depletion dates, according to the annual Social Security and Medicare trustees report Monday.
    • “Still, officials warn that policy changes are needed lest the programs become unable to pay full benefits to retiring Americans. 
    • “Medicare’s go-broke date for its hospital insurance trust fund was pushed back five years to 2036 in the latest report, thanks in part to higher payroll tax income and lower-than-projected expenses from last year. * * *
    • “Meanwhile, Social Security’s trust funds — which cover old age and disability recipients — will be unable to pay full benefits beginning in 2035, instead of last year’s estimate of 2034. Social Security would only be able to pay 83% of benefits.”
  • The New York Times relates,
    • “The White House has unveiled tighter rules for research on potentially dangerous microbes and toxins, in an effort to stave off laboratory accidents that could unleash a pandemic.
    • “The new policy, published Monday evening, arrives after years of deliberations by an expert panel and a charged public debate over whether Covid arose from an animal market or a laboratory in China. * * *
    • “The new policy, which applies to research funded by the federal government, strengthens the government’s oversight by replacing a short list of dangerous pathogens with broad categories into which more pathogens might fall. The policy pays attention not only to human pathogens, but also those that could threaten crops and livestock. And it provides more details about the kinds of experiments that would draw the attention of government regulators.
    • “The rules will take effect in a year, giving government agencies and departments time to update their guidance to meet the new requirements.”

From the public health and medical research front,

  • EHS Today adds,
    • “With the FDA’s approval of naloxone as an OTC drug, workplaces now have access to a lifesaving tool. and therefore, it should be included in workplace first aid kits, says the International Safety Equipment Association (ISEA). ISEA publishes the ANSI/ISEA Z308.1-2021 standard.
    • “According to the U.S. Bureau of Labor Statistics, 525 people died from overdoses at work in 2022
    • “In a March 2024 statement, the White House challenged leaders to increase training and access to opioid overdose reversal medications, keeping the medications in first aid kits, and distributing the medications to employees and customers so they might save a life at home, work, or in their communities.”  
  • Medscape informs us,
    • “All obesity interventions eventually lead to a plateau in weight, where further loss ceases despite ongoing efforts. But the duration of continuous weight loss before hitting a plateau is longer with both glucagon-like peptide 1 (GLP-1) receptor agonist drugs and gastric bypass surgery than with dietary restriction, primarily because they alter how weight loss affects appetite, not energy expenditure.
    • “That’s the conclusion from a new mathematical modeling study based on published data. The study showed that both GLP-1 agonists and Roux-en-Y gastric bypass (RYGB) surgery act to weaken the increase in appetite that normally occurs with time after weight loss attained through dietary restriction alone.
    • “The average time to weight loss plateau occurred within 12 months with dietary restriction vs 24 months in studies of tirzepatide (a dual glucose-dependent insulinotropic polypeptide/GLP-1 agonist), semaglutide, and RYGB, according to Kevin D. Hall, PhD, chief of the integrative physiology section at the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.
    • “The findings were published in Obesity.
    • “Both RYGB and tirzepatide resulted in greater weight loss than semaglutide, but plateau timing of the three was roughly the same at 24 months. “The timing of the plateau is a different question than how much weight they lost,” Hall told Medscape Medical News.”

From the U.S. healthcare business front,

  • Beckers Hospital Review lets us know,
    • “Dallas-based Steward Health Care has placed its 31 U.S. hospitals up for purchase to help offload its $9 billion debt after the health system filed for Chapter 11 bankruptcy, Reuters first reported May 7.
    • “During a court hearing May 7 in Houston, Steward attorney Ray Schrock told U.S. Bankruptcy Judge Chris Lopez that the for-profit health system is aiming to keep all of its hospitals open and to finalize the sale of the facilities by the end of this summer, the news agency reported.
    • “Our goal remains that there are zero hospitals closed on our watch,” Mr. Schrock said, according to Reuters. “There’s going to be a change in ownership in many hospitals, we recognize that. But we don’t want to see any of these communities fail to be served.”
  • Healthcare Dive offers more details on this bankruptcy proceeding.
  • Per Fierce Healthcare,
    • “Telehealth company Amwell continues to struggle in the stock market, and both its bottom- and top-line results in the first quarter missed Wall Street analysts’ estimates.
    • “The company, formerly American Well, brought in revenue of $59.5 million in the first quarter, down 7% from $64 million a year ago, and it reported a quarterly loss of $73.4 million, according to its first-quarter financial results (PDF). That compares to a loss of $398 million during the same quarter last year when it took a hefty impairment charge as a result of its stock market performance. * * *
    • “But, the virtual care giant is plotting accelerated revenue growth and a path to EBITDA profitability in 2026, boosted by a major contract with the Defense Health Agency (DHA).” 

Monday Roundup

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec reports
    • “Weeks following the news that Office of Personnel Management Director Kiran Ahuja would step down, agency Deputy Director Rob Shriver has been appointed acting director of the federal government’s dedicated HR agency.
    • “Shriver announced the news in a post on LinkedIn. * * *
    • “According to the Vacancies Act, Shriver may serve as acting OPM director for 210 days, or until Dec. 2. If he is ultimately nominated to succeed Ahuja on a permanent basis, he likely will be able to remain in the acting director role during the Senate confirmation process, thanks to his service as her “first assistant” in a Senate-confirmed position.”
  • Federal News Network tells us,
    • “Highlighting the work federal employees and other civil servants perform, and especially noting their efforts in administrating pandemic recovery programs, President Joe Biden expressed his appreciation for public servants across the country. In keeping with tradition, the White House issued a proclamation that May 5 will mark the beginning of Public Service Recognition Week.
    • “PSRW is traditionally celebrated the first full week of May. Many federally-focused organizations, including the National Active and Retired Federal Employees Association, show appreciation for public servants during the month of May.”
  • Govexec adds,
    • “Sammie Tafoya, a foreign service officer assigned to Haiti, said she didn’t know what the State Department was when her African history professor encouraged her to apply to work there. 
    • “Whenever I wrote for his class, he said…‘I think what you are looking for — the idea of being able to push change and to be able to write to inform the people that have power to make policies — there’s actually an agency for that. It’s the State Department. It’s the Foreign Service,’” she said. 
    • “Tafoya is one of 25 finalists announced Monday for the Partnership for Public Service’s 2024 Service to America Medals. Nicknamed the Sammies after the award’s namesake, Samuel J. Heyman, who founded the nonpartisan organization, the program has been around since 2002 and honors excellence and innovation in the career federal service. 
    • “The finalists will be recognized at a reception on Thursday, and winners will be announced ahead of an awards ceremony on Sept. 11 at the Kennedy Center.  * * *
    • “A full list can be found here.” 
  • The Society for Human Resource Management informs us,
    • “On May 3, President Joe Biden vetoed a resolution to overturn the National Labor Relations Board’s (NLRB’s) joint employer rule. However, the rule has been blocked by a federal district court in Texas, and litigation might continue.
    • “Overcoming the veto by a two-thirds majority vote in the Senate and House of Representatives is unlikely. The resolution passed the House by a 206-177 vote on Jan. 12 and cleared the Senate by a 50-48 vote on April 10. SHRM had urged Biden not to veto the measure.”

From the public health and medical research front,

  • The New York Time reports,
    • “Scientists are proposing a new way of understanding the genetics of Alzheimer’s that would mean that up to a fifth of patients would be considered to have a genetically caused form of the disease.
    • “Currently, the vast majority of Alzheimer’s cases do not have a clearly identified cause. The new designation, proposed in a studypublished Monday, could broaden the scope of efforts to develop treatments, including gene therapy, and affect the design of clinical trials.
    • “It could also mean that hundreds of thousands of people in the United States alone could, if they chose, receive a diagnosis of Alzheimer’s before developing any symptoms of cognitive decline, although there currently are no treatments for people at that stage.
    • “The new classification would make this type of Alzheimer’s one of the most common genetic disorders in the world, medical experts said.”
  • and
    • “A new study, published Saturday in The Journal of the American Medical Association, revealed growing disparities in child death rates across racial and ethnic groups. Black and Native American youths ages 1 to 19 died at significantly higher rates than white youths — predominantly from injuries such as car accidents, homicides and suicides.
    • “Dr. Coleen Cunningham, chair of pediatrics at the University of California, Irvine, and the pediatrician in chief at Children’s Hospital of Orange County, who was not involved in the study, said the detailed analysis of the disparities documented “a sad and growing American tragedy.”
    • “Almost all are preventable,” she said, “if we make it a priority.”
  • The Wall Street Journal discusses efforts in the U.S. to eliminate cervical cancer using the HPV vaccine.
    • “Doctors are rallying around an audacious goal: eliminating a cancer for the first time. 
    • “Cervical cancer rates in the U.S. have dropped by more than half since the 1970s. Pap tests enable doctors to purge precancerous cells, and a vaccine approved in 2006 has protected a generation of women against human papillomavirus, a sexually transmitted infection that causes more than 90% of cervical cancers. 
    • “With this evidence that the disease is preventable, groups that have worked for decades to end polio and malaria are turning to cervical cancer, plotting to take cases down to null. The World Health Organization is urging countries to boost vaccination, screening and treatment. Doctors in the U.S. are working on a national plan.” 
  • Beckers Hospital Review lets us know,
    • “A 12-year-old boy is the first commercial patient in the world to receive an FDA-approved gene therapy for sickle cell disease, The New York Times reported May 6.
    • “Kendric Cromer is a 12-year-old boy from the suburbs of Washington, D.C., and the first to receive Lyfgenia, a gene therapy treatment created by Somerville, Mass.-based Bluebird Bio. Kendric’s treatment, which costs about $3.1 million, is covered by his family’s insurance. He underwent the first part of treatment at Washington, D.C.-based Children’s National Hospital, in which physicians removed his bone marrow stem cells, which Bluebird will genetically modify for his treatment. The modified cells will be returned in three months.
    • “The FDA gave two companies authorization to sell gene therapy to people with sickle cell disease, a genetic disorder that affects roughly 100,000 people, most of them Black. 
    • “Bluebird estimates it can only treat 85 to 105 patients each year with sickle cell or beta thalassemia, who can receive a similar gene therapy. Children’s National, meanwhile, said it can accept only 10 gene therapy patients a year.”
  • The American Medical Association points out “What doctors wish patients knew about osteoporosis.”
  • The National Institute for Mental Health updated its website about coping with traumatic events.
  • The Washington Post notes, Ultrasound technology is used in many ways. Addiction is the next frontier. The use of the high-frequency sound waves is also being adapted to treat Alzheimer’s disease, tumors and psychiatric disorders.

From the U.S. healthcare business front,

  • Fierce Healthcare offers a look at how “major payers fared in a Q1 dragged by a cyberattack, MA challenges,” and Beckers Payer Issues ranks major payers by first quarter 2023 and 2024 medical loss ratios.
  • Beckers Payer Issues discusses major Medicare Advantage insurer plans for 2025.
  • Healthcare Dive reports,
    • “Dallas-based Steward Health Care, the largest physician-led hospital operator in the country, filed for Chapter 11 bankruptcy this morning in the U.S. Bankruptcy Court for the Southern District of Texas, following months of financial struggles including missed payments to its landlord and vendors.
    • “Steward operates more than 30 hospitals across eight states, according to a spokesperson for the company. The filing marks the largest provider bankruptcy in decades, according to Laura Coordes, professor of law at the Sandra Day O’Connor College of Law at Arizona State University.” 

Friday Factoids

David Ermer–CDC, CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • A Senate Finance Committee tells us,
    • “U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Chair Ron Wyden (D-Oregon) released a legislative proposal to address persistent economic problems leading to shortages of generic medicines plaguing America’s health care system, including chemotherapy drugs and ADHD medications. * * *
    • “The proposal, released as a discussion draft, would establish a new program in Medicare for hospitals and physicians to incentivize transparent, reliable, and resilient purchasing practices across supply-chain participants, including by driving health care providers, intermediaries (such as group purchasing organizations, or GPOs) and drug manufacturers to meet ambitious, proactive standards in securing a sustainable, high-quality supply of essential medicines for patients from all walks of life. * * *
    • “A one-page summary of the discussion draft can be found here.
    • “A section-by-section summary can be found here.
    • “The legislative text can be found here.”
  • STAT News reports,
    • “Members of Congress appear poised to advance another short-term [two year] extension of pandemic-era telehealth flexibilities instead of permanently addressing the issue, seven sources familiar with the talks said.
    • “During the Covid-19 pandemic, lawmakers allowed Medicare patients to access telehealth services in more places and with a greater variety of providers than before, but some of those flexibilities are set to expire at the end of the year. The expiration is expected to be an impetus for a broader health care package in December, when other public health programs also run out. * * *
    • “The House Ways & Means Committee is planning to mark up a two-year telehealth policy extension next week, per five sources familiar with the planning. Politico first reported the markup. According to two sources, the markup will contain entirely new language than is in the dozen or so bills that have been circulated so far.”
  • The U.S. Office of Personnel Management’s final Postal Service Health Benefits Program (PSHBP) implementation rule appeared in the Federal Register’s Public Inspection list today. The final rule will be published in the Federal Register on Monday May 6.
    • “OPM is making several changes between the interim final rule and this final rule:
      • “In § 890.1604, OPM is clarifying the requirements to enroll in Medicare Part B by expressly providing that the exceptions referring to events occurring “as ofJanuary 1, 2025” includes events that occur on January 1, 2025.”
      • In § 890.1604, OPM is clarifying the requirements to enroll in Medicare Part B by expressly providing that the exceptions referring to events occurring “as of January 1, 2025” includes events that occur on January 1, 2025.
      • “Section 890.1604(c) is reserved in anticipation of future rulemaking. [FEHBlog note — This provision creates exceptions from the Medicare Part B enrollment mandate for certain PSHBP enrollees and family members.]
      • “In § 890.1604(e), OPM is clarifying that a Postal Service annuitant or their family member who is required to be enrolled in Medicare Part B must promptly notify OPM or the Postal Service, in writing, if they choose not to enroll in or to disenroll from Medicare Part B.
      • “In § 890.1604, OPM is removing reference to the Postal Service as the entity to receive documentation of overseas residency to qualify for an exception to the Part B enrollment requirement.
      • “In § 890.1606(e), OPM is correcting a typographical error by removing the word “the” before “January 1 of the next year.”
  • A proposed follow-up PSHBP rule is pending review at OMB’s Office of Information and Regulatory Affairs. OPM further explains in the preamble.
    • “Topics OPM plans to address in more detail in the proposed rule include: reconsideration of initial decisions concerning PSHB eligibility; application of the Medicare Part B requirement and associated exceptions in specific scenarios; allocation of Reserves credits; calendar year alignment of government contribution requirements; financial reporting and actuarial calculations; premium payment prioritization from the Postal Service Retiree Health Benefits Fund; and Medicare Part D integration.” 
  • CMS also released a No Surprises Act user guide for resubmission of certain IDR cases.
    • “This user guide provides an overview of the “Notice of IDR Initiation – Resubmission” web form and the steps for successfully completing and submitting the web form. This user guide is intended to assist parties who have submitted a dispute through the Federal Independent Dispute Resolution (IDR) process and received an email from Auto-Reply-FederalIDRQuestions@cms.hhs.gov with a link to the “Notice of IDR Initiation – Resubmission” web form.
    • “The “Notice of IDR Initiation – Resubmission” web form will be sent to the initiating party if the certified IDR entity’s eligibility review of a dispute determines that one or more of the dispute line items must be resubmitted because it was improperly batched or bundled. The initiating party must complete the “Notice of IDR Initiation – Resubmission” web form by the deadline specified in the email. The non-initiating party will not need to take any action.”

From the public health and medical research front,

  • The Centers for Disease Control informs us on May 3:
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, no jurisdictions experienced moderate, high, or very high activity. Last week one jurisdiction experienced moderate activity. No jurisdictions experienced high or very high activity.
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.”
  • NBC News reports,
    • “New research suggests patients with an average risk of colon cancer may only need to undergo a colonoscopy screening every 15 years instead of the recommended 10. 
    • “Swedish researchers found that waiting an extra five years after a first negative colonoscopy carried about the same risk of later having a colorectal diagnosis or dying from the disease as getting screened every 10 years. Extending screening time could reduce “unnecessary invasive examinations,” according to the study published Thursday in JAMA Oncology.  * * *
    • “In an editorial accompanying the new study, gastroenterologists suggested that future screening guidelines may safely be prolonged for some people, noting that “15 has the potential to be the new 10.” * * *
    • “We do not have enough gastroenterology doctors to do a colonoscopy every 10 years in everyone over 50,” said Dr. Otis Brawley, the Bloomberg distinguished professor of oncology and epidemiology at Johns Hopkins University, who was not associated with the new research. * * *. 
    • “Employing cheaper, less invasive screening methods 10 to 15 years after a negative colonoscopy could greatly reduce the number of missed screenings, said the study’s lead author, Dr. Mahdi Fallah, head of the Risk Adapted Cancer Prevention Group at the German Cancer Research Center in Heidelberg. 
    • “The best screening test is the one that is actually done. So, if a test like colonoscopy is unaffordable for a person, an alternative cheaper valid test is much better than no test at all,” said Fallah, who is also a visiting professor in the department of clinical sciences at Lund University in Sweden.”
  • The Institute for Clinical and Economic Review announced on May 2,
    • “[We] will assess the comparative clinical effectiveness and value of tabelecleucel (“tab-cel”, Pierre Fabre) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in November 2024, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“

From the U.S. healthcare business front,

  • Kaufmann Hall announced on May 2,
    • “[Hospital m]argins and volumes declined slightly in March, which may signal more challenges ahead. Hospital outpatient revenue also fell 5%, reflecting the competitive challenges of providing outpatient care.
    • “The median Kaufman Hall Calendar Year-To-Date Operating Margin Index reflecting actual margins for the month of March was 3.9%.
    • “The April issue of the National Hospital Flash Report covers these and other key performance metrics.
  • and
    • “Overall labor expenses and revenue continue to rise, and Q1 2024 data show that labor represented 84% of total expenses. The median investment/subsidy per provider increased 2% compared to Q1 2023.
    • “The [Q1] Physician Flash Report features the most up-to-date industry trends drawn from the same data physician groups use to track their finances and operations.”
  • Beckers Hospital Review compares Spring 2024 Leapfrog Hospital Safety Grades against CMS Star ratings for hospitals receiving high and low Leapfrog grades.
  • BioPharma Dive notes,
    • “Amgen shares soared by double digits Friday following its announcement an obesity drug it’s developing has shown enough promise to warrant advancing into late-stage testing.
    • “On an earnings call with analysts Thursday, CEO Robert Bradway said the company is “confident” in the drug’s “differentiated profile” following an internal review of interim Phase 2 study results. Full data are expected by the end of the year and should support a subsequent move into Phase 3 trials, executives said.
    • “Yet Amgen’s drug is likely at least two years away from regulators’ desks, by which time Eli Lilly and Novo Nordisk may already have successors to their weight loss medicines Wegovy and Zepbound. It will take even more time to accumulate data to prove the drug can protect heart health, a key claim for convincing commercial and federal insurers to reimburse for treatment.”
  • Healthcare Dive lets us know,
    • “Walgreens has inked a clinical trial deal with major German drugmaker Boehringer Ingelheim.
    • “Under the deal, Walgreens will find candidates who are overweight or have obesity or diabetes and connect them with a Phase III clinical trial for Boehringer’s GLP-1 drug survodutide, according to a release.
    • “Walgreens launched its clinical trials business in 2022 as part of the company’s broader pivot to health services. Since then, Walgreens has notched more than 35 clinical trials deals with life sciences companies, according to a spokesperson.”

Thursday Miscellany

David Ermer–CMS, Congress, Medical / Rx research, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Washington Post reports,
    • “Congressional leaders unveiled Thursday a $275 million bill to boost federal research, physician training and public awareness about menopause, a campaign led by prominent female lawmakers and boosted by the star power of actor Halle Berry.
    • “The bipartisan Senate bill, the Advancing Menopause Care and Mid-Life Women’s Health Act, is led by Sen. Patty Murray (D-Wash.), chair of the Senate Appropriations Committee, and has support from Sens. Lisa Murkowski (R-Alaska), Tammy Baldwin (D-Wis.), Susan Collins (R-Maine) and other lawmakers. The legislation has been championed by Berry, who has discussed her experience with menopause-related misdiagnoses and joined female senators at a news conference Thursday at the U.S. Capitol.”
  • The Wall Street Journal lets us know,
    • “Drunken-driving deaths in the U.S. have risen to levels not seen in nearly two decades, federal data show, a major setback to long-running road-safety efforts.
    • “At the same time, arrests for driving under the influence have plummeted, as police grapple with challenges like hiring woes and heightened concern around traffic stops. 
    • “We are really stuck in some quicksand,” said James Fell, who has been studying impaired driving since 1967 and is a principal research scientist at NORC at the University of Chicago, a nonpartisan research organization.
    • “About 13,500 people died in alcohol impairment-related crashes in 2022, according to data released in April by the National Highway Traffic Safety Administration. That is 33% above 2019’s toll and on par with 2021’s. The last time so many people died as a result of accidents involving intoxicated drivers was in 2006.”
  • The Society for Human Resource Management notes,
    • “Compensation growth kicked up more than expected in the first quarter of the year in another sign of persistent inflation.
    • “Workers were paid 1.2 percent more in the first three months of 2024 than in the fourth quarter of 2023, according to the Employment Cost Index (ECI), released April 30 by the U.S. Bureau of Labor Statistics (BLS). That’s up from the 0.9 percent climb in the fourth quarter of 2023. Wages and salaries increased 1.1 percent, as did benefits costs, from December 2023. Many economists forecasted that the ECI would rise 1 percent.
    • “Year over year, compensation costs—including pay and benefits— in the U.S. for civilian workers rose 4.2 percent, an uptick from the 4.1 percent year-over-year rise in the final quarter of 2023. Meanwhile, compensation for state and local government workers is up 4.8 percent.
    • “Wages and salaries grew 4.4 percent for the 12-month period ending in March 2024 and rose 5 percent for the 12-month period ending in March 2023, according to the BLS. Benefits costs grew 3.7 percent over the year and rose 4.5 percent for the 12-month period ending in March 2023.”

From the public health and medical research front,

  • NBC News reports,
    • “The number of women dying while pregnant is returning to pre-pandemic levels following a worrisome 2021 spike, a new report from the Centers for Disease Control and Prevention shows.
    • “In 2022, 817 U.S. women died either while pregnant or soon after giving birth, down from 1,205 the previous year.
    • “If you look at 2021, we had such a sharp increase as we were really still in the pandemic and still dealing with disruptions of care, the fear of coming into the healthcare space and the inability to access care during that time,” said Dr. Veronica Gillispie-Bell, an OB-GYN at Ochsner Medical Center in Kenner, Louisiana. She was not involved in the new report, which was published Thursday by the CDC’s National Center for Health Statistics.”
  • mHealth Intelligence tells us,
    • “Telehealth-based interventions can help lower the risk of readmissions and emergency department (ED) visits after abdominal surgery, according to new research published in JAMA Network Open.
    • “The study notes that amid the digital healthcare boom of the COVID-19 pandemic, telehealth technologies were applied in areas where they were previously not used, including surgery. Though the use of telehealth in surgery is growing, the study authors noted that there is little research on how telehealth utilization affects patient safety in abdominal surgery.
    • “Thus, the researchers conducted a systematic review and meta-analysis to evaluate whether telehealth-based interventions reduce complications, readmissions, and postoperative ED visits among abdominal surgery patients. They searched PubMed, Cochrane Library, and Web of Science databases from inception through February 2023 to identify randomized clinical trials (RCTs) and nonrandomized studies that compared perioperative telehealth interventions with usual care and reported at least one patient safety outcome.”

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “Cigna has written off more than half of its multibillion-dollar investment in VillageMD amid the declining value of the primary care chain.
    • “Cigna invested $2.5 billion into VillageMD in late 2022, with the goal of accelerating value-based care arrangements for employer clients by tying VillageMD’s physician network with Cigna’s health services business, Evernorth — hopefully reaping profits from shared savings as a result.
    • “But on Thursday, Cigna wrote off $1.8 billion of that investment, citing VillageMD’s lackluster growth after its majority owner Walgreens elected to close underperforming clinics. The writedown drove Cigna’s shareholder earnings down to a net loss of almost $300 million, compared to profit of $1.3 billion in the same time last year.”
  • Per BioPharma Dive,
    • “Sales of Novo Nordisk’s obesity drug Wegovy slowed over the first three months of 2024, compared to the fourth quarter last year, as lower realized prices and continued supply constraints curbed growth from the in-demand medicine.”Sales of Novo Nordisk’s obesity drug Wegovy slowed over the first three months of 2024, compared to the fourth quarter last year, as lower realized prices and continued supply constraints curbed growth from the in-demand medicine.
    • “Still, the $1.3 billion in first quarter sales Novo reported for Wegovy was twice the total in the first quarter of 2023. The company has been working to boost supply and, in January, gradually started increasing the number of Wegovy “starter” doses.
    • “Wegovy gained competition last November with the U.S. approval of Eli Lilly’s Zepbound, which brought in $517 million in sales in its first quarter on the market. Citing data from analytics company Iqvia, Novo said that, while new prescriptions of Zepbound are tracking slightly ahead of Wegovy, its drug has larger market share.”
  • and
    • “Pfizer’s rare disease drug Vyndaqel may be its least well known blockbuster medicine. The pharmaceutical company’s COVID-19 vaccine became a household name during the pandemic, while its other top-sellers for blood clots, breast cancer and pneumococcal infections are routinely and widely advertised on TV.
    • “Yet during the first quarter, it was Vyndaqel that outperformed expectations, delivering sales that substantially exceeded Wall Street forecasts. The drug, which treats the cardiac form of a rare disease called transthyretin amyloidosis, brought in $1.1 billion between January and March, 25% higher than the consensus estimate of just over $900 million.”
  • MedCity News considers whether “Walmart’s decision to shutter its healthcare division reflects just how difficult it is to achieve profitability in the primary care and telehealth markets. Experts think retailers simply aren’t prepared to handle the bevy of challenges that come along with delivering healthcare — but could this news also be a sign of the system being broken?”
  • Bloomberg tells us,
    • “Amid the GLP-1 craze, companies including Quest Diagnostics and Labcorp are offering a suite of blood tests intended to help doctors decide if drugs like Wegovy and Zepbound are the right choice for their patients. So far, business is booming.”