Tuesday Tidbits

Mental health care

Tuesday Tidbits

David Ermer–Congress, Medical / Rx research, Mental health care, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Federal News Network informs us
    • “Agencies don’t have to worry about a 1% sequestration on discretionary funds kicking in for a few more months.
    • “The Office of Management and Budget says the requirement to reduce discretionary spending under the Fiscal Responsibility Act (FRA), signed into law in June, wouldn’t take effect until “after full year appropriations are enacted, or April 30, whichever comes first.”
    • “OMB will take no action on Jan. 1, 2024, and no additional action should be taken by agencies to reduce impacted discretionary funding, even though a short-term continuing resolution will be in effect at that time,” OMB wrote in frequently asked questions on 2024 discretionary spending sent to agencies on Dec. 22. “If any discretionary appropriation account remains on a short-term CR past April 30, OMB is required to issue a final sequestration report that compares the annualized appropriation levels provided by all discretionary appropriations bills under current law as of April 30 against the [FRA’s] section 102 interim spending limits. A breach of the section 102 spending limits would require OMB to order a sequestration to bring the current law discretionary appropriations in line with those interim spending limits.”
  • Govexec identifies the federal agencies with the greatest increases and decreases in employee morale in 2023 according to OPM’s 2023 Federal Employee Viewpoint Survey.
  • Fedweek offers a summary of OPM’s current regulatory activities.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Immune-boosting drugs have revolutionized cancer care. Now doctors are experimenting with cutting them off.  
    • “Immunotherapies unleash the immune system on tumors. They have extended the lives of people with melanoma, lung and bladder cancers. They have also been a boon for drugmakers, generating global sales of $44 billion in 2022, according to Leerink Partners analysts. 
    • “But some patients are getting more of the drugs than they need, exposing them to side effects and costs they could avoid without risking their cancer recurring. Preliminary research suggests taking the drugs at a lower dose or for a shorter period could be sufficient, but drugmakers haven’t funded the studies needed to confirm the findings. 
    • “We don’t know when to stop,” said Dr. Jedd Wolchok, an oncologist focused on melanoma at Weill Cornell Medicine in New York. * * *
    • “Recalibrating care toward less treatment is a fraught undertaking. Drug companies won’t fund studies exploring whether patients can do as well with less of their products, doctors said. Some doctors and patients worry about pulling back before exhausting their best chance to beat the disease.
    • “There was this dogma that more is better,” said Dr. Mark Ratain, an oncologist at the University of Chicago. 
    • “He is trying to recruit cancer patients to study whether they could do as well with less of Merck’s Keytruda or Bristol-Myers Squibb’s Opdivo, so-called immune checkpoint inhibitors. After three years, he has found just 60 of the 260 patients he wants, and most medical centers have declined to join the trial. “It was going to be difficult to convince people,” he said.”
  • Beckers Payer Issues interviews Kofi Essel, MD, Elevance Health’s first food as medicine program director. Dr Essel “sat down with Becker’s to discuss how Elevance is building a food as medicine strategy intended to eventually touch and improve the lives of its more than 47 million members nationwide.” Check it out.
  • MedPage Today tells us,
    • “The 988 lifeline routes callers to a network of more than 200 state and local call centers that are financially supported by the Substance Abuse and Mental Health Services Administration (SAMHSA), as well as state and local governments. In its first year, according to a July press release from SAMHSA, the lifeline answered nearly 5 million calls, texts, and chats from people looking for help with suicide, mental health, and substance use-related crises; that’s 2 million more contacts than the lifeline received in the previous 12 months, when it was a 10-digit phone number. (That 10-digit number — 800-273-8255 — is still in operation.)
    • “So far, 1.5 years in, things seem to be going well overall, said Michele Gilbert, MPH, senior policy analyst at the Bipartisan Policy Center in Washington, D.C. “Luckily, the implementation of 988 has seen some real success,” Gilbert said in a phone interview. “A lot of the operations have gone relatively smoothly.”
    • “Debbie Plotnick, MSS, executive vice president for state and federal advocacy for Mental Health America, agreed. “We have seen tremendous increases in the number of people who call, and even more importantly, what has improved dramatically is the wait time to speak to an actual human being,” she told MedPage Today. “Going back a couple of years, it could have been up to, like, 2 minutes, and now it’s within 30 or 40 seconds that you are actually connected to a live human being.”
    • “That decrease in wait time may not sound like a lot, but it’s actually “huge,” Plotnick said. “If you’re at the point where you’re going to hurt yourself and you don’t know if anybody in the world cares, 2 minutes can really feel like an eternity. But now calls are being answered very quickly.” She also praised the lifeline’s addition of text and chat options, as well as special lines for veterans, for Spanish speakers, and for LGBTQ+ callers.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • “The median hospital operating margin rose to 2% in November after holding steady at 1.6% in September and October, but escalating expenses — including rising drug costs — remain a concern as 2023 draws to a close, according to a Dec. 21 report from Syntellis Performance Solutions, which includes data from more than 1,300 hospitals.
    • “U.S. hospitals began the year with a median operating margin of -0.9%, but that figure has steadily increased and looks set to end the year at a healthier level around the 2% mark in December. November was the ninth consecutive month of positive operating margins. 
    • “While the median hospital margin remains far below pre-pandemic levels, it has shown significant progress in recent months as hospitals continue their recovery after more than a year of negative results. 
  • The Wall Street Journal reports,
    • “Drug company Bristol-Myers Squibb struck a $4.1 billion deal to buy  RayzeBio in a bet on a re-emerging cancer drug technology.
    • “RayzeBio develops radiopharmaceutical drugs, which use targeted forms of radiation that are delivered directly to cancer cells. Earlier products using the technology struggled commercially, but further research led to another wave of promising therapies that can attack tumors while limiting damage to surrounding healthy cells.  * * *
    • “Bristol said the RayzeBio deal is slated to close in the first half of 2024.”
  • and
    • AstraZeneca has agreed to buy Gracell Biotechnologies for a transaction value of $1.2 billion, as part of the former’s efforts to grow its cell therapies business.
    • The acquisition will help grow AstraZeneca’s pipeline of cell therapies for potential treatment of cancer and autoimmune diseases.
    • The transaction is expected to close in the first quarter of next year, AstraZeneca said. 

Weekend update

David Ermer–Congress, COVID-19, Medical / Rx research, Mental health care–

From Washington, DC,

  • The Wall Street Journal adds,
    • “Senate negotiators failed Sunday to reach a deal on a framework for border-security measures that Republicans have demanded as a condition of passing new funding for Ukraine, further slimming the chances of any vote before Christmas.”Senate negotiators failed Sunday to reach a deal on a framework for border-security measures that Republicans have demanded as a condition of passing new funding for Ukraine, further slimming the chances of any vote before Christmas.
    • “The lack of a breakthrough by the self-imposed weekend deadline underscored the difficulties facing the Senate talks, even after the Biden administration signaled it was prepared to make significant concessions on immigration policy. Many Republicans not involved in the discussions have expressed skepticism in recent days about any deal, while progressive Democrats have raised concerns that the White House was bowing to conservative demands.
    • “We’ve got lots of issues to work through, in which there are many different ways to try and address and solve problems,” Sen. Kyrsten Sinema (I., Ariz.) told reporters Sunday evening. “We have to choose the one that works the best and that allows us to earn the votes of both houses [of Congress] and both parties,” she said.”
  • Govexec tells us,
    • “Federal employees must proactively take steps to make their work travel more sustainable under new guidance from the Biden administration, which the White House said would save taxpayer money and help take on the climate change crisis. 
    • “Workers on official business will have to prioritize taking public transit, renting electric vehicles or even riding bikes under a new memorandum from the Office of Management and Budget and a General Services Administration bulletin that updated the Federal Travel Regulation. Agencies should also consider not sending employees on business trips at all, with GSA noting, “In every case, the trip not taken is the least expensive and most sustainable.” 

From the public health front,

  • The University of Minnesota’s CIDRAP tells us,
    • Levels of three main respiratory viruses—SARS-CoV-2, flu, and respiratory syncytial virus (RSV)—remain elevated or are rising, but so far hospital occupancy remains stable, the US Centers for Disease Control and Prevention (CDC) said today [December 15] in its latest data updates.
    • Though levels this year are tracking behind last year at the same time, the CDC—expecting further impact from the viruses—yesterday sent an alert to health providers that underscored an urgent need to vaccinate more people against the three diseases to reduce severity and the potential impact on healthcare systems.
    • In a respiratory virus snapshot today, the CDC said COVID-19 indicators remain elevated and are increasing in some regions, such as the Midwest. The CDC said it expects the proportion of JN.1 viruses, part of the BA.2.86 family, to continue to increase. Scientists and CDC officials are closely watching JN.1, because of mounting evidence of its immune-evasive potential.
    • Meanwhile, flu activity is increasing in most parts of the country. And though RSV activity declined a bit in southeastern states, levels remain high nationally, with trends still rising in other parts of the country as hospitalizations continue to increase in older adults and young children.
  • NPR Shots discusses the use of CPR.
    • “After studying CPR for sixty years, physicians have a sense of which factors tend to be associated with survival. The first is age. I wrote before that older patients do worse with CPR, on average. But that relationship cuts both ways; younger patients sometimes do much better. In 2017, researchers studying a group of about 2,000 patients in Austria found that survival after cardiac arrest at thirty days was around 25% for patients under age 65, but only 4% for patients over 65. A study conducted in Toronto of patients aged 2 to 45 with cardiac arrest found a survival rate of 21%, while average survival for all age groups from cardiac arrest tends to be about 10%.
    • “Another factor is chronic illness. In 2014, researchers examined the effects of diseases like heart failure, cancer, cirrhosis, and kidney failure on the odds of survival in patients that received CPR. Patients with chronic illnesses were significantly less likely to survive to hospital discharge than those without them. The more severe the illness, the less likely was survival. And among the survivors, patients with a chronic illness tended to live just a few more months, while healthier patients often lived for several years. * * *
    • “When you’re young, it might make sense to choose everything, CPR and all. As you age, if you value life above all else, then perhaps you may still opt for CPR, defibrillation, intubation, and everything else a hospital can do when your heart stops, regardless of the odds of futility, or even harm. 
    • “The harm can be considerable. As I wrote in May, CPR can cause bleeding in the lungs, lacerations to the liver, and fractured ribs or sternum. Many survivors of CPR sustain damage to their brains, and may never be quite the same again. All of these outcomes become more likely with age, frailty, or chronic illness – and the likely harm of CPR may begin to outweigh its potential benefit. 
    • “If instead you hope for a gentler, quieter death at the end of your life, with minimal medical interventions, then CPR might not be for you.”
  • The article includes a picture of a person who has no noCPR tattooed on their chest.
  • In the wake of the autopsy results on actor Matthew Perry, Fortune Well discusses ketamine.
    • “What is ketamine?
      • “Ketamine is an anesthetic used by medical providers and veterinarians with some hallucinogenic effects, according to the U.S. Drug Enforcement Administration. A dissociative drug similar to psychedelics like nitrous oxide, it makes users feel detached from their pain, as well as their environment, distorting perception of sight and sound.
    • “What is ketamine approved to treat?
      • “It’s been approved by the U.S. Food and Drug Administration, in low doses, for use as a short-acting anesthetic in humans and animals, and as a nasal spray (esketamine) for treatment-resistant depression in conjunction with another oral antidepressant, according to the DEA. It’s a fast-acting antidepressant, used to bridge the gap while waiting for SSRIs to kick in, which can take weeks.
    • “Can ketamine be used for depression?
      • “Ketamine is only FDA approved for use as a nasal spray in treatment-resistant depression. But it’s increasingly used “off label” for treating depression, suicidal ideation, and chronic pain, according to the U.S. National Institutes of Health’s National Library of Medicine. An increasing number of clinics offer infusions for the treatment of depressions. Patients are monitored during and after the infusion.
    • “Is it possible to abuse ketamine?
      • “It can be used illegally to get high—via an injectable, liquid mixed with other liquids, or a powder to be snorted, mixed in drinks, or smoked. On the street it’s sometimes known by the names Cat Tranquilizer, Cat Valium, Jet K, Kit Kat, Purple, Special K, Special La Coke, Super Acid, Super K, Horse Trank, and Vitamin K. An overdose can lead to loss of consciousness and dangerously slowed breathing, according to the DEA. * * *
    • “What are signs of a ketamine overdose?

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “The House [of Representatives] voted Thursday to clear the fiscal 2024 National Defense Authorization Act and send it to President Joe Biden for his signature.
    • “The conference report was considered under suspension of the rules, which requires a two-thirds majority. The bipartisan package easily cleared that threshold on a 310-118 vote. * * *
    • “The conference report is notable for authorizing a 5.2 percent pay raise for all military personnel, the biggest in two decades, as well as an increase in troops’ basic allowance for housing payments.”
  • Govexec adds that “Under a provision of the fiscal 2024 National Defense Authorization Act, federal agencies would be required to incorporate veterans’ military service when determining eligibility for paid leave.”
  • Back to Roll Call,
    • “The Senate planned to delay its holiday recess and stay in session next week as lawmakers signaled they could be close to a bipartisan border security deal that would clear a path for aid to Ukraine and Israel.
    • “The change in schedule came after several days of intense negotiations among senators of both parties and White House staff who were struggling to reach a deal on immigration policies designed to curb the flow of migrants at the southern border. Republicans have insisted on tougher border security as their price for additional Ukraine aid, part of a broader $110.5 billion supplemental funding package.
    • “We can get this done before we leave,” said Connecticut Sen. Christopher S. Murphy, the lead negotiator for Senate Democrats, after a Thursday morning negotiating session. “I just think if . . . the border is an emergency, if Ukraine is an emergency, then let’s act like it.” ***
    • “Even if the Senate can agree to a package combining border security with military aid to Ukraine and Israel, the measure is unlikely to become law this month. The House recessed for the year Thursday and Speaker Mike Johnson, R-La., appeared unlikely to call the chamber back into session before January.”
  • MedPage Today reviews several drug pricing developments that the Biden Administration announced this morning.
  • What’s more,
    • “HHS released a new data strategy to enhance data capabilities and accelerate progress on cancer moonshot goals,”
  • and
    • “The Biden-Harris Administration announced voluntary commitments from leading healthcare companies to harness the potential and manage the risks posed by AI.”
  • Govexec tells us,
    • “The Office of Personnel Management on Wednesday urged supervisors at federal agencies to take a more active role in managing the performance of new federal employees, including removing those who perform poorly and improving engagement to ensure they have the tools to succeed.”

From the public health and medical research front,

  • The Centers for Disease Control issued a health alert.
    • “to alert healthcare providers to low vaccination rates against influenza, COVID-19, and RSV (respiratory syncytial virus). Low vaccination rates, coupled with ongoing increases in national and international respiratory disease activity caused by multiple pathogens, including influenza viruses, SARS-CoV-2 (the virus that causes COVID-19), and RSV, could lead to more severe disease and increased healthcare capacity strain in the coming weeks. In addition, a recent increase in cases of multisystem inflammatory syndrome in children (MIS-C) following SARS-CoV-2 infection in the United States has been reported
    • “Healthcare providers should administer influenza, COVID-19, and RSV immunizations now to patients, if recommended. Healthcare providers should recommend antiviral medications for influenza and COVID-19 for all eligible patients, especially patients at high-risk of progression to severe disease such as older adults and people with certain underlying medical conditions.
    • “Healthcare providers should also counsel patients about testing and other preventive measures, including covering coughs/sneezes, staying at home when sick, improving ventilation at home or work, and washing hands to protect themselves and others against respiratory diseases.”
  • Mercer Consulting notes,
    • “With the release in August of the first orally administered medication for postpartum depression, now is a good time to review plan coverage and overall employer support for maternal health. While there are risk factors, postpartum mental health issues can happen to anyone within a year of birth and are often made worse by a lack of social support, including from the workplace. Sadly, the Centers for Disease Control and Prevention reported that mental-health conditions have become the leading cause of maternal death, contributing to nearly one in four pregnancy-related deaths.” 
  • The Robert Wood Johnson Foundation shares its five best health equity stories of 2023.
  • EHR Intelligence adds, “The Regenstrief Foundation has awarded LOINC and Health Data Standards at Regenstrief Institute a $4.4 million grant to support a global initiative to standardize social determinants of health (SDOH) data into EHR systems.”
  • The CDC reports about “Teenagers in the United States: Sexual Activity, Contraceptive Use, and Childbearing, 2015–2019.”
    • “In 2015–2019, 40.5% of never-married female teenagers (3.8 million), and 38.7% of never-married male teenagers (3.8 million) had ever had vaginal intercourse with an opposite-sex partner. For females this percentage was stable across the four time points, but for males this percentage decreased from the 2002 (45.7%) and 2011–2015 (44.2%) time points.
    • “For teen males, use of any contraception at first sex increased across the four time points, from 82.0% in 2002 to 92.1% in 2015–2019, while no consistent trend was seen for teen females.
    • “Nearly four out of five female teenagers (77.3%) in 2015–2019 used a method of contraception at first sex. Among female teenagers, ever-use of long-acting reversible contraception, which includes intrauterine devices and contraceptive implants, increased from 5.8% to 19.2% from 2011–2015 to 2015–2019.”
  • Beckers Hospital Review lets us know,
    • “Results from a phase 2 trial found a drug-vaccine combination developed by Merck and Moderna cut the risk of recurrence or death in patients with severe melanomas by 49%.
    • “The experimental therapy involves an mRNA vaccine from Moderna in combination with Merck’s cancer drug Keytruda. Patients with resected stage 3 or 4 melanoma who received the combination therapy were 49% less likely to die or have their cancer return within three years, compared to those who received only Keytruda.
    • “The findings build on results from an earlier phase study that followed patients for two years, the drugmakers said in a Dec. 14 news release.” 
  • Bloomberg Prognosis informs us,
    • “Obesity researchers are only beginning to explore what happens after people lose weight with GLP-1 drugs such as Wegovy or Zepbound. Most trials of the drugs have only lasted a year or so. While some type of long-term drug therapy is likely to be needed — just as it is with other diseases like high blood pressure — exactly what form it will take is a big unknown, says Robert Kushner, an obesity doctor at Northwestern University Feinberg School of Medicine.
    • “This whole idea of maintenance is a huge black hole,” Kushner told my colleague Madison Muller in a recent interview. “We’re going into this area but we don’t have the long-term game figured out.”
  • Per Medscape,
    • “For researchers involved with sleep disorders, developing a pharmacologic treatment for obstructive sleep apnea (OSA) is a bit like searching for the holy grail. P K Schweitzer and colleagues have published the results of the randomized MARIPOSA study assessing a combination of two medicinal products known as AD109, one of the products having an antimuscarinic effect (aroxybutynin), and the other a noradrenergic effect (atomoxetine), in treating this condition. These molecules increase the activity of the dilator muscles in the upper airways by activating the genioglossus muscle with a synergic effect on the upper respiratory tract during sleep. * * *
    • [T]hese results herald important scientific benefits if we consider that Colin Sullivan’s original 1981 research paper, which ushered in the CPAP era, presented the results of just five participants. 
  • The Wall Street Journal reports,
    • “A year and a half of treatment with the new Alzheimer’s drugs has been shown to reduce the chance of progression to mild stage dementia by about 10%. This benefit comes with notable risks, including small patches of brain bleeding and swelling, which can cause falls and confusion and may require stopping the drug. And there are other barriers. The new Alzheimer’s therapies are very expensive—one year of lecanemab therapy is priced at $26,500. They are difficult to deliver, require an extensive work-up to determine eligibility and involve intensive monitoring for side effects. As many as 8 million Americans are estimated to be living with mild cognitive impairment, but only about 8% to 17.4% will meet all the criteria to take one of these drugs, according to a study published last month in the journal Neurology.”

From the U.S. healthcare business front,

  • Merck Consulting looks back at top benefit trends from 2023 that it expects to carry over into 2024.
  • Beckers Hospital Review explains
    • “Healthcare leaders have been talking about the transition to value-based care for years, but without significant movement away from fee for service. That could all change in the next three years.
    • “The current economic climate, with tightening margins and increased costs, is pushing health systems to finally make a move.
    • “We will continue to see margin pressure resulting from reimbursement rates not keeping pace with inflationary trends that are escalating staffing and supply chain costs,” said Cliff Megerian, MD, CEO of University Hospitals in Cleveland. “As a result, you will see health systems optimizing their operations, which may include footprint re-evaluation, increasing focus on value-based care and greater utilization of digital technology, such as remote monitoring and telehealth services.”
    • “Dr. Megerian also sees more partnerships and expanded services as the growth mechanism for health systems instead of the traditional brick-and-mortar projects and acquisitions.”
  • Per Fierce Healthcare,
    • “Most insurer markets are highly concentrated, including many regions where a single payer dominates at least half of the market share, according to a new analysis from the American Medical Association.
    • “The AMA [hardly a neutral observer] released an updated look at concentration in payer markets and found that across product lines, 73% of metropolitan statistical areas were highly concentrated in 2022. In most (90%) regions, a single payer owns a 30% market share, and in 48% of markets, one payer controls at least 50% of the share.
    • “In 11% of markets, a single insurer has a 70% or higher market share, according to the report.”
  • Per Healthcare Dive,
    • “Private equity firm KKR is in talks to buy a 50% stake in healthcare data analytics firm Cotiviti from Veritas Capital, according to The Wall Street Journal. 
    • “The deal, which sources familiar said could be finalized in the coming weeks, would value the health technology company at about $11 billion. Veritas acquired Cotiviti in a take-private deal valued at $4.9 billion in 2018. 
    • “If the purchase is finalized, it would also rate among the largest U.S. private equity deals announced this year, according to the WSJ.” 

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Electronic health records, Employee Wellness Programs, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • STAT News informs us,
    • “The Senate health care committee will consider a sweeping bill next week meant to combat the opioid epidemic, according to four lobbyists and a congressional aide familiar with the legislation. 
    • “The proposal would reauthorize a number of programs first created by the SUPPORT Act, an addiction-focused bill that Congress first passed in 2018. Many of those programs’ authorizations expired earlier this year, however, leading addiction treatment advocates to fret that lawmakers — and specifically the committee’s chairman, Sen. Bernie Sanders (I-Vt.) — no longer view the issue as a priority.    
    • “If passed, the legislation would mark Capitol Hill’s first major action this year on the addiction crisis. Current data shows that roughly 110,000 Americans are dying of drug overdoses each year. Roughly 85,000 of those overdoses involve opioids.” 
  • The Department of Health and Human Services announced,
    • “Today, United States Surgeon General Dr. Vivek Murthy is launching the 5-for-5 Connection Challenge, calling on Americans to take five actions over five days to build more connection in their lives. Dr. Murthy recently issued this challenge to students across the country on his “We Are Made to Connect” College Tour, which concluded just last week. Now, as we enter the holiday season, the 5-for-5 Connection Challenge aims to inspire people of all ages to build, strengthen, and prioritize their relationships.
    • “For the next two weeks, from December 4th – December 15th, the Surgeon General will encourage people to take five actions over five days that express gratitude, offer support to, or ask for help from people in their lives. These types of actions are outlined in the Surgeon General’s Advisory on Our Epidemic of Loneliness – PDF as some of the ways that people can catalyze social connection. As outlined in the Advisory, social connection can advance physical, mental, and cognitive health, and it is even associated with a decreased risk of mortality.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration is evaluating the potential for plastic syringes made in China to suffer problems such as leaks and breakages.
    • “Officials began the investigation after receiving information about quality issues associated with “several Chinese manufacturers of syringes” that made them concerned that some devices “may not provide consistent and adequate quality or performance.”
    • “The FDA is advising consumers and healthcare providers to check where syringes are made and “consider using syringes not manufactured in China, if possible.” The advice applies to plastic syringes used for injecting fluids into, or withdrawing fluids from, the body.”

In FEHB Open Season news, Govexec offers helpful, last-minute advice from Kevin Moss.

From the public health and medicare research front,

  • U.S. News and World Report points out,
    • “After a period of limited change, COVID-19 activity is increasing again especially in the Midwest and Mid-Atlantic regions,” the CDC said in a report published Friday.
    • “Federal health officials are likely watching the increase given that they expect a “moderate” winter wave of coronavirus and this could be the start of it. Holiday gatherings and travel are also typically followed by an increase in coronavirus cases and hospitalizations.
    • “COVID-19 vaccination rates, meanwhile, have been disappointing for many.
    • “CDC Director Mandy Cohen told Congress this week that about 16% of Americans have gotten the updated COVID-19 vaccine.
    • “That’s not enough,” Cohen said.”
  • Beckers Hospital Review notes,
    • “So far this year, the CDC estimates there have been at least 1.8 million illnesses, 17,000 hospitalizations, and 1,100 deaths from flu in the U.S. 
    • “Influenza A continues to be the dominant strain in circulation, making up around 82% of cases, while influenza B is only accounting for around 18%. 
    • “Louisiana and South Carolina are still reporting the highest levels of flu activity in the country. 
    • “Nine states are experiencing high activity levels, but less than the two states above, including: California, New Mexico, Texas, Mississippi, Alabama, Georgia, Colorado, Florida and Tennessee. 
    • “Cases are also high in New York City and Puerto Rico.”
  • The Journal of the American Medical Association presented the following study results:
    • “Question  Is smoking still decreasing among US adults and do the trends vary by age, income, and race and ethnicity?
    • “Findings  In this cross-sectional study of 353 555 adults responding to the 2011 to 2022 National Health Interview Surveys, adults younger than 40 years had dramatic declines in smoking prevalence during the last decade, especially among those with higher incomes. In contrast, relatively slow declines were observed among adults aged 40 to 64 years, with no decrease in smoking among those 65 years or older.
    • “Meaning  These findings suggest that the precipitous decline in smoking among younger adults should be maintained, but that additional efforts are required to further reduce smoking in older adults.”
  • The American Medical Association explains “What doctors wish patients knew to improve their mental health.”
  • Per Endocrinology Advisor, “Decreased mortality risk is associated with concomitant reductions in glycated hemoglobin (HbA1c) and body weight among patients with type 2 diabetes, according to study results published in Diabetes Obesity and Metabolism.”

From the U.S. healthcare business front,

  • Fierce Healthcare profiles ten women of influence in U.S. healthcare. Check it out.
  • BioPharma Dive reports
    • “Roche on Monday agreed to acquire biotechnology company Carmot Therapeutics in a deal that bulks up the Swiss pharmaceutical giant’s pipeline with a group of weight loss drugs in early clinical testing.
    • “Roche will pay $2.7 billion upfront for the Berkeley, California-based Carmot. Roche could owe as much as $400 million more in future payments to Carmot shareholders, among them The Column Group and RA Capital, if certain milestones are met. The companies expect the acquisition to close next year.
    • “The deal hands Roche a trio of drugs in human testing for obesity, an area of pharmaceutical research that has been catalyzed by the success of weight loss medicines like Wegovy and Zepbound. Their progress has fueled a gold rush among large drugmakers, a number of which are either advancing in-house medicines or inking deals to acquire new prospects.”
  • and
    • “The Food and Drug Administration granted conditional approval to Eli Lilly’s oral cancer drug Jaypirca in two types of blood cancer, expanding its use from a rare type of lymphoma to people with leukemia and lymphoma patients who have previously received two other treatments, the company said Friday.
    • “Jaypirca is the fourth of a group of drugs called BTK inhibitors, a class that includes AbbVie and Johnson & Johnson’s Imbruvica and AstraZeneca’s Calquence. It gained approval earlier this year and posted $42 million in sales through Sept. 30.
    • “With this approval, Jaypirca can now be used in chronic lymphocytic leukemia or small lymphocytic lymphoma after patients have been treated with AbbVie and Roche’s Venclexta and another BTK inhibitor. Lilly said a Phase 3 trial meant to confirm Jaypirca’s accelerated approval has already met its primary goal.”
  • HR Dive discusses “Why EAPs go unused despite growing mental health awareness; Many factors contribute to the historic underutilization of employee assistance programs, despite their value as an access point to quality care.”
  • Medscape offers an infographic on how doctors grade their EHR systems while MedCity News explains how improved coding quality by healthcare providers can prevent denials and improve cash flow.
  • Health Payer Intelligence adds,
    • “Payers are investing in healthcare IT resources to support cost optimization and improve member experience, according to a study from EY-Parthenon and KLAS Research.
    • “As payers face operational and financial pressures, they are turning to healthcare IT solutions for help. Researchers sought to understand what strategies payers prioritize, how much they spend on healthcare IT resources, and what future investments look like.
    • “The study findings reflect responses from over 100 executives across payer entities serving commercial, Medicare, and Medicaid populations. Around 70 percent of respondents were traditional payers; the remaining were provider-sponsored, third-party administrators, and management services organizations.”
  • According to Healthcare Dive,
    • “A merger between major health insurers Cigna and Humana would go through the wringer of an intense antitrust review, but could come out finalized, experts say.
    • “Though, to receive the regulatory green light, a combined company would probably have to emerge looking different from the Cigna and Humana of today. * * *
    • “Gaining regulatory approval — especially if a challenge further ties up the process in the courts — could set a deal’s finalization back by a year or more. But, due to a lack of direct competition between the two, Cigna and Humana could be allowed to combine, creating a healthcare powerhouse with roughly $300 billion in annual revenue.”
  • and
    • “For-profit hospital chain HCA Healthcare’s Houston affiliate announced last week it completed its acquisition of 11 free-standing emergency departments from SignatureCare Emergency Centers. 
    • “HCA Houston Healthcare, which operates a network of 13 hospitals and nine outpatient surgery centers, now has 26 free-standing emergency departments in the area in addition to hospital-based emergency rooms, according to a Friday press release.
    • “The SignatureCare centers will be re-branded to HCA Houston ER 24/7. Financial terms of the deal were not disclosed.
  • and
    • “Rural hospital chain Lifepoint Health and Ascension Saint Thomas announced a joint venture last week to co-own Highpoint Health, a four-hospital system in Tennessee currently operated by Brentwood, Tennessee-based Lifepoint.
    • “The hospitals and care sites will be co-branded with Ascension Saint Thomas, but will be majority-owned and operated by Lifepoint, according to the release. The companies declined to comment on the cost of the buy-in.
    • “The health systems have partnered before. Ascension Saint Thomas partnered with Kindred Rehabilitation Services, a Lifepoint business unit, in 2022 to jointly own Ascension Saint Thomas Rehabilitation Hospital in Nashville.” 

Midweek Update

David Ermer–CDC, Congress, COVID-19, FDA, Medicare, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Senate Finance Committee announced,
    • Senate Finance Committee Chairman Ron Wyden, D-Ore., will convene a committee hearing on Tuesday, December 5, 2023 titled “Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective.” The hearing will take place at 10:00 a.m. in Room 215 of the Dirksen Senate Office Building.
  • The American Hospital Association News notes,
    • “The House Energy and Commerce Subcommittee on Health Nov. 29 held a hearing  to explore how medical devices and hospitals are using artificial intelligence and what Congress should consider as AI in health care evolves.”
  • BioPharma Dive reports,
    • “The Food and Drug Administration’s top scientist Namandjé Bumpus will assume the role of principal deputy commissioner when longtime agency leader Janet Woodcock retires from that role in early 2024, according to an announcement Thursday.
    • “Among Bumpus’ priorities when she assumes the role will be “creating a new model” for the FDA’s Office of Regulatory Affairs, the branch that conducts inspections, monitors drug imports, and issues recalls, market withdrawals and safety alerts, Commissioner Robert Califf said in a memo to agency staff.”
  • Sequoia reminds us,
    • “Beginning in 2024, group health plans and carriers will be required to include all covered items and services in their self-service internet-based price comparison tool, as required under the Transparency in Coverage (TIC) Final Rules.
    • “As background, plans must provide participants and beneficiaries with out-of-pocket cost estimates via a user-friendly online self-service tool (and by paper upon request). The intent of this requirement is to provide individuals with real-time cost-sharing information to support making informed health care decisions. Implemented in two phases, the first phase of the price comparison tool required the first 500 items and services (as defined by the DOL) to be published in the tool effective for plan years beginning on or after January 1, 2023, and the second phase will require all other services covered by the plan to be included in the tool effective for plan years beginning on or after January 1, 2024.”

From the public health and medical research front,

  • The Centers for Disease Control announced,
    • “CDC’s National Center for Health Statistics released two reports today examining provisional mortality data from 2022. While analysis shows the number and rate of suicides increased for the second year in a row from, overall life expectancy at birth increased by just over a year. This increase regains some of the 2.4 years of life expectancy lost between 2019 and 2021.
    • “The findings are featured in two new reports, “Provisional Life Expectancy Estimates for 2022” and “Provisional Estimates of Suicide by Demographic Characteristics: United States, 2022. * * *
    • “The increase of 1.1 years in life expectancy from 2021 to 2022 primarily resulted from decreases in mortality due to COVID-19, heart disease, unintentional injuries, cancer, and homicide. Declines in COVID-19 mortality accounted for approximately 84% of the increase in life expectancy. * * *
    • “The percentage increase in the number of suicides was greater for females (4%) than males (2%), but the provisional 2022 suicide number for males (39,255) was nearly four times that of females (10,194).”
  • Health Day points out,
    • “The prevalence of a highly mutated COVID variant has tripled in the past two weeks, new government data shows.
    • “Now, nearly 1 in 10 new COVID cases are fueled by the BA.2.86 variant, the U.S. Centers for Disease Control and Prevention reported Monday.
    • “The variant is spreading the fastest in the Northeast: Just over 13% of cases in the New York and New Jersey region are blamed on BA.2.86. * * *
    • “So far, preliminary data on the variant suggests it does not trigger more severe illness than previous variants, the WHO said in a recent risk evaluation, but the international agency still noted a recent and “substantial rise” in BA.2.86 cases.
    • “The CDC also noted that BA.2.86 variant poses a “low” public health risk.”
  • and
    • “Personal trainers can help people increase their strength and their fitness.
    • “Could a “brain coach” be just as useful in preventing Alzheimer’s’ disease?
    • “A new study suggests that personalized health and lifestyle changes can delay or even prevent memory loss for older adults at high risk of Alzheimer’s or dementia.
    • “People who received personal coaching experienced a 74% boost in their thinking and memory tests compared with those who didn’t receive such attention.
    • “This is the first personalized intervention, focusing on multiple areas of cognition, in which risk factor targets are based on a participant’s risk profile, preferences and priorities, which we think may be more effective than a one-size-fits-all approach,” said co-lead researcher Dr. Kristine Yaffe, vice chair of research in psychiatry at the University of California, San Francisco (UCSF).”
  • Healio informs us,
    • “One in four adults relied solely on medications to manage chronic pain, highlighting an opportunity to increase use of nonpharmacologic therapies, particularly in men, older adults and those with public insurance, according to researchers.
    • “Findings from this study contribute important information about use of over-the-counter pain relievers, prescriptions nonopioids and exercise, which were found to be some of the most common pain management therapies used by adults with chronic pain,” Stephanie Michaela Rikard, PhD, a health scientist at the CDC, told Healio.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Cigna and Humana are in talks for a combination that would create a new powerhouse in the health insurance industry.
    • “The companies are discussing a stock and cash deal that could be finalized by the end of the year, assuming the talks don’t fall apart, according to people familiar with the matter.”
  • and
    • “A law designed to protect patients from surprise medical bills is contributing to the financial distress of some medical-service providers, which say lengthy billing disputes and payment delays with insurers are hurting their ability to stay afloat. 
    • “The No Surprises Act, which took effect last year, aims to protect patients from surprise medical bills from out-of-network healthcare providers when there are disagreements over reimbursements between insurers and providers. Previously, providers often billed patients to make up for the amounts insurers were unwilling to pay. 
    • “Numerous healthcare businesses, some owned by private equity, said the legislation is contributing to delays and reductions in payments by insurance companies, hurting their cash flows and earnings. A handful of major healthcare-service providers already have filed for chapter 11 protection this year, specifically naming the law as a major reason for their bankruptcies. These include physician-staffing companies Envision Healthcare and American Physician Partners as well as helicopter-ambulance operator Air Methods.”
  • and
    • “There are five tech companies valued at over $1 trillion. In healthcare, the closest contender is  Eli Lilly. 
    • .”This year it became the first big pharmaceutical to surpass a market capitalization of $500 billion thanks to the popularity of its obesity and diabetes medications and, to a lesser extent, its experimental Alzheimer’s drug. But hanging over Lilly and rival  Novo Nordisk is a reality that puts the brakes on big pharma’s ascent: the patent cliff.
    • “There are several reasons why there isn’t a big pharma company in the trillion-dollar club, but the boom-and-bust nature of drug development is high on the list. Unlike Apple, which hypothetically can make huge margins off the iPhone for perpetuity, U.S. drug companies have a limited period from which to profit from their innovation. As their patents expire and generic competitors enter the market, sales plunge. Pharma executives, overly focused on short-term growth, don’t often prepare their companies for that.”
  • FEHBlog notes on the Journal articles,
    • Cigna and Humana are undoubtedly aware of the firebreathing nature of anti-trust enforcers in the federal government. Cigna is focused on the commercial market while Humana currently is pulling out of that market to focus on government business. Time will tell.
    • Out-of-network doctors and air ambulance companies flying the pirate flag can avoid No Surprises Act problems by joining health plan networks.
    • Lilly’s recent growth has been impressive.
  • Reuters tells us,
    • “UnitedHealth Group on Tuesday forecast 2024 profit broadly in line with Wall Street expectations, indicating that medical costs are likely to remain elevated for the health insurance giant.
    • “The healthcare sector has this year seen a recovery in demand, especially among older patients who started returning to doctors’ clinics and hospitals for procedures they had delayed during the COVID-19 pandemic.”
  • Healthcare Dive adds,
    • “Healthcare insurers could get a slight respite from rising medical costs next year. Global costs are expected to rise 9.9% year over year in 2024, down from a 10.7% increase in 2023, according to a new survey from consultancy WTW released on Tuesday.
    • “However, that decline might not last long. Nearly three-fifths of insurers surveyed anticipate higher medical cost growth over the next three years as new medical technologies, overuse of care and members’ poor health habits drive increased spend.
    • “Many insurers told WTW they are leaning on deductibles, contracted provider networks and telehealth options to manage costs. Others are excluding coverage for healthcare such as fertility treatments or gender re-affirming care.”
  • Beckers Hospital CFO Report identifies the states with the most rural hospital closures.
    • “Since 2005, 104 rural hospitals have closed and more than 600 additional rural hospitals — 30% of all rural hospitals in the U.S. — are at risk of closing in the near future, according to the Center for Healthcare Quality and Payment Reform.”
  • Beckers Hospital Review calls attention to this development,
    • “Mayo Clinic’s board of trustees has given the green light to an initiative dubbed “Bold. Forward. Unbound.,” which involves a $5 billion redesign of Mayo Clinic’s downtown Rochester, Minn., campus. 
    • “The redesign will introduce new facilities that incorporate innovative care approaches and digital technologies, according to a Nov. 28 news release from Mayo, with a pivotal element of these being specialized “neighborhoods.” According to the health system, the neighborhood concept will offer patients a centralized location for all required services related to their specific condition, eliminating the need for navigating between different departments.”
  • Per Fierce Healthcare,
    • “Accountable care organizations do not positively influence treatment and outcomes for chronic mental health conditions for Medicare patients, according to a study in Health Affairs.
    • “For patients newly enrolled in ACOs, they saw no improvements in their depression and anxiety symptoms after one year. These patients were also 24% less likely to have their depression or anxiety treated than patients unenrolled in ACOs, and 9.8% less likely to have an evaluation and management visit for depression or anxiety with a primary care clinician.
    • “Since mental health conditions in Medicare patients are often underdiagnosed and undertreated, some have suspected that mental health illnesses are ideal conditions for ACOs to handle, but the study found that there were no significant differences in any other measures of mental health treatment.”
  • Beckers Hospital Review also names the winners of Forbes 30 under 30 in healthcare for 2024.


 

Tuesday Tidbits

David Ermer–CDC, Congress, FDA, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The New York Times reports,
    • “The House passed legislation on Tuesday to keep federal funding flowing into early 2024, after Democrats stepped in to rescue a plan opposed by many Republicans to avert a government shutdown at the end of the week.
    • “A coalition of Democrats and mainstream Republicans overcame the opposition of G.O.P. conservatives to approve the bill under special expedited procedures that required a supermajority. That approach, hatched by Speaker Mike Johnson, amounted to a gamble that a substantial number of Democrats would rally to help pass a package that Mr. Johnson’s own party was unwilling to back.
    • “The vote was 336 to 95, clearing the two-thirds threshold required for passage. In the end, 209 Democrats and 127 Republicans joined to pass the bill. Ninety-three Republicans opposed it, as did two Democrats.
    • “Senator Chuck Schumer of New York, the majority leader, told reporters that he wanted the Senate to vote on the bill “as soon as possible.”
  • The American Academy of Pediatrics News announced,
    • “The advisory was issued after the Food and Drug Administration (FDA) received 22 reports of high blood lead levels (BLLs) in children who consumed recalled fruit pouches that contain high levels of lead. The recall includes WanaBana brand apple cinnamon fruit puree pouches, Schnucks brand cinnamon applesauce pouches and Weis brand cinnamon applesauce pouches.”
  • ICD Monitor points out that “the new Healthcare Common Procedural Coding System (HCPCS) codes were released on Nov. 6. These codes include supplies, medications, implants, surgeries, etc. The latest release contained 553 changes and updates to the coding system . . . .
  • The Acting NIH Director Lawrence Tabak released his farewell issue of the NIH Directors blog.
    • “I congratulate Dr. Monica Bertagnolli as she takes the helm as the next permanent NIH director. Dr. Bertagnolli—an outstanding physician scientist—is a strong leader who will bring fresh, bold new ideas to NIH and the biomedical research enterprise. I know she’ll be in good hands thanks to the outstanding staff across NIH and the leadership in the Department of Health and Human Services. I look forward to supporting her efforts and continuing to ensure that NIH research optimizes health for all people.”

From the public health and medical research front,

  • MedPage Today informs us that early detection is the key to longer survival rates for people afflicted with pancreatic cancer.
  • NPR tells us,
    • “If your hearing begins to decline, your risk of falling may rise.
    • “Research shows older adults with mild hearing loss are at a greater risk — more than double — of falling. Though it’s not exactly clear how hearing loss increases the risk, it’s known that falls are the top cause of death from injury among people 65 and older.
    • “Now, new evidence shows that restoring hearing through the use of hearing aids may be protective, especially when people wear them consistently. That’s according to a study published this summer in the Journal of the American Geriatrics Society.”
  • The Wall Street Journal reports,
    • “Millions of adults struggle for years with chronic low-back pain—a disabling ailment that has no easy fix.
    • “Common causes include injury, arthritis and degenerative changes in the spine. It tends to start at midlife with the natural wear and tear of aging. But often there is no clearly identifiable physical cause, leaving patients to veer from one ineffective treatment to another—including highly addictive prescription opioids.
    • “Now, researchers are working on personalized treatment plans that can address physical, emotional and psychological traits in individual patients that influence the pain they are experiencing. Physical therapy, exercise, diet and lifestyle choices often play a role. Some research is also looking at ways to retrain the brain to think differently about pain.
    • “To be sure, low-back pain can be a sign of something life-threatening, such as cancer, or a severe spine condition that requires surgery. As a result, chronic low-back pain needs to be fully evaluated. But once “red flags” are eliminated, doctors need a more precise way to determine what will work for individual patients, says Dr. Matt Mauck, a researcher and pain-medicine physician at the University of North Carolina Chapel Hill’s UNC Pain Management Center.”
  • The Institute for Clinical and Economic Review “posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension (PAH).”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC (Midwest CEPAC) on December 1, 2023. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans announced,
    • “A new survey report from the International Foundation of Employee Benefit Plans reveals U.S. employer coverage and considerations surrounding glucagon-like peptide-1 (GLP-1) drugs, which have historically been used to treat diabetes. These drugs were also found to cause weight loss and have been subsequently used to treat obesity.
    • “Among survey respondents, 76% provide GLP-1 drug coverage for diabetes, 27% provide coverage for weight loss, and 13% are considering covering for weight loss.
    • “In 2023, the average representation of GLP-1 drugs used for weight loss in employers’ total annual claims was 6.9%, according to survey respondents. Those who are covering GLP-1 drugs are relying heavily on utilization management (79%) to control costs. A less common approach (32%) is step therapy. Fourteen percent of employers have no cost control mechanism in place.
    • “Though GLP-1 drugs have a high price tag, they currently represent only 6.9% of annual claims, according to survey respondents,” said Julie Stich, CEBS, Vice President of Content at the International Foundation. “Employers can take this information into account when designing long-and short-term benefit strategies.”
  • Bloomberg reports,
    • “Cigna Group is taking a page from billionaire Mark Cuban’s playbook to sell medicines for a set markup, the latest sign that companies that manage drug benefits are responding to pressure from upstart competitors.
    • “Next year Cigna’s Express Scripts subsidiary will offer employers and health plans the option to pay pharmacies up to 15% above their wholesale costs, plus an extra fee for dispensing the medicines. Employers now typically pay pharmacies based on an average discount, which can result in them paying more for drugs than a pharmacy charges.”
  • Reuters notes,
    • “Elevance Health (ELV.N) and Cigna Group’s (CI.N) Express Scripts unit on Monday settled the last pending claim in a long-running contract dispute, clearing the way for Elevance to appeal the dismissal of its $14.8 billion lawsuit accusing Express Scripts of overcharging it for prescription drugs.”
  • The Albany Times-Union reports that Empire Blue Cross is changing its name to Anthem Blue Cross.
    • “The company retains the Blue Cross Blue Shield name and remains part of the Blue Cross Blue Shield Association, which serves one in three insured Americans. * * *
    • “Empire joined Anthem in 2006, and the new name represents the next stage in the company’s journey to merge with the national brand, benefiting from combined resources and capabilities of its parent company and affiliates, company executives said.”
  • Per Fierce Healthcare,
    • “BeMe, a digital behavioral health app aimed at teenagers, has inked several partnerships with major payers, including $1.5 million in investment from Blue Cross and Blue Shield of Kansas (BCBSKS).
    • “Through the investment, BeMe’s platform will be made available to 20,000 teenagers across the Sunflower State. Executives said in an announcement that tools like BeMe will become increasingly critical as youth mental health issues continue to worsen.”

Happy Veterans’ Day

David Ermer–CDC, Congress, Mental health care, Rx coverage, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Veterans Day is being observed today because November 11 is a Saturday. Thanks for your service, vets.

From Washington, DC,

  • Reuters reports,
    • “U.S. Senate Majority Leader Chuck Schumer on Thursday took a procedural step to allow the Democratic-majority chamber to pass a stopgap government funding bill before a Nov. 17 deadline to avert a partial government shutdown.”
  • and
    • “U.S. House of Representatives Republicans aim to release a stopgap measure to avert a partial government shutdown [next] Saturday”
  • and
    • “Moody’s on Friday lowered its outlook on the U.S. credit rating to “negative” from “stable” citing large fiscal deficits and a decline in debt affordability, a move that drew immediate criticism from President Joe Biden’s administration.
    • “The move follows a rating downgrade of the sovereign by another ratings agency, Fitch, this year, which came after months of political brinkmanship around the U.S. debt ceiling.”
  • Forbes offers an overview of the situation.
    • “[T]here are 12 appropriations subcommittees that comprise the U.S. budget. The Senate has made progress on three of them, passing a bipartisan combined bill on November 1 for Agriculture; Veterans Affairs and Transportation; Housing and Urban Development.
    • “The House has so far passed bills for seven of the 12 budgetary areas, although further progress this week has stalled so far. House bills have been passed along partisan lines, and so they are unlikely to attract the necessary support within the Democratic-controlled Senate. In contrast, the Senate measures have been bipartisan.
    • “In addition, the text of the bill raising the debt limit includes automatic 1% cuts to the government’s entire budget if a full one is not passed by January 1, 2024. The intent of that measure was to incentivize relatively quick progress on the budget, rather than for the cuts to actually be implemented. Still it’s another deadline consideration in the budgetary process.”
  • MedTech Dive tells us,
    • “The Federal Trade Commission is challenging patents for 17 drugs marketed by Abbvie, AstraZeneca, GSK and other pharmaceutical companies, claiming Tuesday that the intellectual property was “improperly or inaccurately listed” in a regulatory database.
    • “The notice letters are largely about products with specialized injectors or inhalers, such as Viatris’ anaphylaxis shot EpiPen and GSK’s asthma drug Advair, which rely on those devices to deliver a precise dose. The FTC said it has filed a dispute with the Food and Drug Administration seeking to have the patents removed from the database, called the Orange Book.
    • “The FTC’s action comes two months after it approved a policy statement saying the agency would “use its full legal authority” to invalidate improperly listed patents. Drugmakers are increasingly under scrutiny for creating so-called “patent thickets” that make it difficult for generic challengers to enter the market.”

From the public health and research front,

  • NBC News reports,
    • “The number of kids whose caregivers are opting them out of routine childhood vaccines has reached an all-time high, the Centers for Disease Control and Prevention reported Thursday, potentially leaving hundreds of thousands of children unprotected against preventable diseases like measles and whooping cough. 
    • “The report did not dive into the reasons for the increase, but experts said the findings clearly reflect Americans’ growing unease about medicine in general.
    • “There is a rising distrust in the health care system,” said Dr. Amna Husain, a pediatrician in private practice in North Carolina, as well as a spokesperson for the American Academy of Pediatrics. Vaccine exemptions “have unfortunately trended upward with it.”
    • “The CDC report found that 3% of children entering kindergarten during the 2022-2023 school year were granted a vaccine exemption from their state. This is the highest exemption rate ever reported in the U.S.”
  • The Wall Street Journal points out,
    • “If you think canceling plans is always good self-care, you might want to think again. People who keep an active social calendar not only enjoy a better quality of life—they could also stave off an early trip to the grave.
    • “Loneliness and social isolation were linked to an increased risk of death from any cause, according to new research. That includes missing out on seeing loved ones, not having weekly group activities like a book club, or just often feeling lonely.
    • “Just like we need to make time in our busy lives to be physically active, we need to make time in our busy lives to be socially active,” said Julianne Holt-Lunstad, director of the Social Connection & Health Lab at Brigham Young University, who wasn’t involved in the report.
    • “A combination of several loneliness factors could be even more harmful, the data suggested. For example, having few family and friend visits was riskier when the person also lived alone.” 
  • Per Fierce Healthcare,
    • “Nearly two-thirds of specialty centers that conduct autism evaluations have wait times longer than four months, according to a new report.
    • “The report, focused on the state of pediatric autism diagnosis in the U.S., is based on a survey designed and conducted by Scott Badesch, former president of the Autism Society of America. Cognoa, maker of an FDA-approved, AI-powered diagnostic tool for autism, sponsored the study. The survey reached 111 specialty centers across the U.S., including hospitals, private practices, public health clinics, government agencies and academic entities. 
    • “Its findings underscore “how dysfunctional the current state of affairs is,” Cognoa’s CEO Sharief Taraman, M.D., told Fierce Healthcare.”
  • Medscape notes,
    • “The US Food and Drug Administration has approved fruquintinib (Fruzaqla, Takeda) for the treatment of certain adults with metastatic colorectal cancer who experience disease progression during or after prior treatment.
    • “More specifically, the approval extends to adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, in some cases, an anti-EGFR therapy.
    • “In a company press release, Takeda Pharmaceuticals said the drug “is the first targeted therapy approved for metastatic colorectal cancer regardless of biomarker status or prior types of therapies in more than a decade.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Novo Nordisk plans to invest $6 billion to expand its drug manufacturing capacity as it tries to meet skyrocketing demand for its popular obesity and diabetes medicines Wegovy and Ozempic.
    • “The investment, announced by the Danish drugmaker Friday, will be spread over the next six years and builds on the company’s existing capital spending plans. Most of the money will go toward building a new plant for making active pharmaceutical ingredients, like the semaglutide protein that’s contained in both Wegovy and Ozempic.
    • “Construction, which will also add a new packaging facility, is expected to be completed in phases from the end of 2025 through 2029, Novo said. Once finished, the company expects the production site will employ 700 staff, with another 100 working at the packaging plant.”
  • Per Fierce Healthcare,
    • “As cold and flu season truly sets in, major home delivery platforms are now allowing customers to purchase products using their health benefits.
    • “Both DoorDash and Instacart announced this week that they would accept payments from health savings accounts and flexible spending accounts to cover the cost of health and wellness items. In particular, according to Instacart, this rollout will make it easier for people to take full advantage of their FSAs, as funds expire at the end of each year.
    • “In addition, some may find it difficult to use their HSA or FSA cards when making purchases at retail stores. Instacart said its new integration will allow for HSA and FSA payments from all retailers on its app that offer eligible items.”
  • According to the Society for Human Resource Management,
    • “According to a recent Gusto survey of over 300,000 small and midsize businesses, 30 percent of all employees in the professional services industries who get paid time off (PTO) have taken sick leave so far this year, an increase of 42 percent from 2019. 
    • “The average amount of sick time these workers have taken has increased by 15 percent since 2019 and is now 15.5 hours per year. The largest increase is among workers ages 25-34: Nearly a third (32 percent) of them have taken sick leave in 2023, compared to 28 percent of workers ages 35-54.”
  • AHIP announced,
    • AHIP joined with four other leading healthcare organizations to announce the Common Health Coalition: Together for Public Health.
    • The Common Health Coalition is focused on translating the hard-won lessons and successes of the COVID-19 pandemic response into actionable strategies that will strengthen the partnership between our healthcare and public health systems. The Coalition is the product of a joint commitment to public health made in March 2023 by founding members AHIP, the Alliance of Community Health Plans, the American Hospital Association, the American Medical Association, and Kaiser Permanente. 
    • In early 2024, the Coalition will publish recommendations informed by technical advisory groups of subject matter experts and an advisory council of public health leaders. The recommendations will focus on 4 initial priority areas:
      • spearheading greater coordination between the public health and healthcare systems;
      • building shared, well-maintained emergency preparedness plans;
      • establishing national standards for health care data that help identify health disparities; and
      • and modernizing infectious disease detection.
    • The development of these recommendations is being facilitated by ChangeLab Solutions, a national nonprofit that uses the tools of law and policy to advance health equity.

Midweek Update

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today lauded committee passage of the Better Mental Health Care, Lower Drug Cost, and Extenders Act, which was reported out of committee 26-0.” 
  • “The legislation expands mental health care and substance use disorder services under Medicaid and Medicare, reduces prescription drug costs for seniors at the pharmacy counter, extends essential Medicaid and Medicare provisions that will expire this year, and increases Medicare payments to support physicians and other providers. * * *
  • “Click here for more information on the legislation, including a description of the Chairman’s Mark and a section-by-section summary.”
  • Fierce Healthcare adds,
    • “Under the Senate Finance proposal, the $8 billion in cuts to hospitals through the Medicaid disproportionate share hospital (DSH) payments will be eliminated, saving providers $16 billion over the next two years, according to the mark released earlier this week.
    • “Hopefully in further discussion Senators will decide not to pursue so-called ‘site neutral’ policies,” said Federation of American Hospitals President and CEO Chip Kahn in a statement. “This is no time for hospital cuts – particularly for struggling hospitals serving rural America. This ‘one-size-fits-all’ policy will ultimately threaten service resulting in limits on access to care for seniors and others who are better served receiving necessary treatment in the hospital. “
    • “The draft also includes decreasing physician reimbursements by 1.25%, a reduction from larger cuts that could better appease physician interest groups.”
  • STAT News reports
    • “Eli Lilly’s blockbuster drug tirzepatide, sold as Mounjaro for type 2 diabetes [and nicknamed the Godzilla of GLP-1 drugs], has been cleared to treat obesity, making it the second in a highly effective class of weight loss medications to enter the market.
    • “The Food and Drug Administration’s long-awaited approval of the injectable drug, which will be marketed under the name Zepbound for obesity, is a milestone for Lilly. It also introduces stiff competition for Novo Nordisk, which has had to limit starter doses of its obesity treatment Wegovy due to ongoing shortages. * * *
    • “Lilly will sell Zepbound at a list price of $1,059.87 per month, about the same price as Mounjaro and about 20% lower than the price of Novo’s Wegovy. Lilly is also introducing a savings card program for people with commercial insurance.
    • “Lilly expects the drug to be available in American pharmacies after Thanksgiving. In an effort to prevent future shortages, the company plans to have roughly doubled its manufacturing capacity by the end of the year, CEO David Ricks said on a conference call with reporters. Only about 5 million people in the U.S. receive any form of GLP-1 treatment, Ricks said, but there are roughly 50 million Americans who would be eligible for Zepbound and who have commercial insurance that covers obesity treatments.
    • “We know with such an effective medication there’ll be a lot of demand,” Ricks said. “We’re stepping up to that challenge and hope to fulfill it in the coming years.”
  • Ka-ching!!
  • Per an EEOC news release,
    • “The U.S. Equal Employment Opportunity Commission (EEOC) today released three reports focusing on different groups of women in the federal government: American Indian and Alaska Native (AIAN) women, African American women, and Hispanic women and Latinas.
    • “The reports examined fiscal year (FY) 2020 data to compare the participation, retention, advancement, and pay of each group of women to three different groups: the total federal workforce, all women, and men of the same ethnicity or race. Results show that employment outcomes for these three groups of women were not equal to the comparison groups. Understanding the challenges these groups of women face in the federal workplace can help agencies better address these inequalities.”

From the public health and research front,

  • The Wall Street Journal reports that children in mental health crises have been surging into hospital emergency rooms.
    • “Broadly, children’s demand for emergency mental-health services has eased from the pandemic’s extreme highs, according to an analysis of records across more than 1,100 hospitals by the research arm of Epic Systems, a medical record software company. Still, the rates remain elevated. 
    • “For adults, the data on trips to emergency departments for psychiatric reasons during the pandemic is limited, but doctors say they are more used to seeing such cases. E.R.s aren’t accustomed to seeing large numbers of children in psychiatric crisis—and many are ill-equipped to handle them.”
  • STAT News reports,
    • “The radiopharmaceutical world is now approaching critical mass. There are currently around 75 such startups in the U.S., several of which have raised sizable financing rounds this year. In September, RayzeBio managed to complete an IPO — rare amid an industry slump — raising $358 million. Bayer has made a few acquisitions in the field. And last month, pharmaceutical giant Eli Lilly jumped in, acquiring Point Biopharma and its Phase 3 radiopharmaceutical treatment for prostate cancer for $1.4 billion.
    • “Investors and executives are optimistic these investments will pay off not just for venture capitalists, but for cancer patients. But just how much they can benefit the field remains to be seen. To achieve anything, radiopharmaceutical companies must hurriedly address supply and production challenges — issues that have handicapped other promising areas of oncology drug development.”
  • and
    • Vaccines work well to prevent cancers caused by the human papillomavirus (HPV). So well, in fact, that it may be time to review HPV screening protocols, according to the somewhat provocative conclusion of a new study examining the occurrence of genital HPV types eight years after immunization, published Wednesday in Cell Host & Microbe.
  • and
    • “In American health care, overtreatment is common. Recently though, there has been a subtle shift in the opposite direction. It’s possible that “less is more” is catching on.
    • “Now, some providers are asking what the line between necessary and unnecessary really is. The results are encouraging, suggesting that, in some cases, it may be possible to achieve the same health outcomes with less treatment — and fewer side effects, too.
    • “This shift is particularly noticeable in cancer care.”
  • Here is a link to the National Cancer Institute’s latest research update.
  • Gallup announced
    • “U.S. workers are optimistic that employer-sponsored wellness initiatives could enhance their wellbeing, according to data from the Bentley-Gallup Business in Society Report. When asked to rate the potential impact of six wellness initiatives on wellbeing, the top three most positively rated (based on combined extremely and somewhat positive ratings) are employers offering a four-day workweek option (77%), providing mental health days (74%) and limiting the amount of work employees are expected to perform outside of work hours (73%).”
  • Becker’s Payer Issues tells us,
    • “Increasing Medicare Advantage enrollment in rural areas did not increase rural hospitals’ financial distress or risk of closing, a study published Nov. 3 in the American Journal of Managed Care found. 
    • “Researchers studied rural hospitals in 14 states from 2008 to 2019. Medicare Advantage enrollment in rural hospital counties increased from 14.3% of Medicare beneficiaries in 2008 to 28.4% in 2019. The percentage of Medicare inpatient stays paid for by MA plans increased from 6.5% in 2008 to 20.6% in 2019. 
    • “The researchers found that when Medicare Advantage penetration increased by 1% in a county, hospitals’ financial stability increased slightly, and they experienced a 5% reduction in risk of closing. 
    • “One in 5 of the hospitals studied treated no Medicare Advantage patients during the study period.” 

From the U.S. healthcare business front,

  • The Segal Company highlights fraud, waste, and abuse trends in this fourth quarter of 2023.
  • Healthcare Dive provides the biggest takeaways from health insurers’ third-quarter earnings.
  • KFF offers
    • “One new analysis shows that the typical beneficiary has a choice of 43 Medicare Advantage plans as an alternative to traditional Medicare for 2024. That is the same number available as in 2023, but more than double the number of plans offered in 2018, which shows how this market is attractive to both enrollees and insurers.
    • “In addition, the typical person covered under traditional Medicare can choose among 21 Medicare stand-alone prescription drug plans (PDPs), the second analysis shows. The number of PDP options for 2024 is lower and the number of Medicare Advantage prescription drug plan (MA-PD) options is higher than in any other year since Part D started, reflecting the broader trend toward Medicare Advantage.”
  • Fierce Healthcare informs us,
    • “A recent federal district court ruling against the office overseeing the 340B Drug Pricing Program has opened the doors for hospitals to more broadly claim discounts, healthcare legal experts say.
    • “The decision in Genesis Healthcare, Inc. v. Becerra, handed down Friday by the U.S. District Court of South Carolina, establishes that “at least some of [the] interpretative policies surrounding the 340B definition of the patient are inconsistent with the 340B statute,” Anil Shankar, a partner at Foley & Lardner, told Fierce Healthcare.
    • “This is a stunning decision that will have the attention of every 340B stakeholder,” he said. “… This creates new opportunities for 340B-covered entities to purchase 340B for their patients and suggests that [the Health Resources and Services Administration’s (HRSA’s)] audit processes will need to change.”
  • and
    • “Building on its One Medical deal, Amazon is now offering a One Medical for Prime membership, including 24/7 virtual care, for $9 per month, or $99 a year. That’s $100 less than the standard One Medical membership fee, according to the company.
    • “Prime members can add up to five additional memberships, each for just $6 a month, or $66 annually.
    • “The One Medical for Prime membership fee covers unlimited access to 24/7 virtual care nationwide, including video chats with licensed providers and access to an in-app “Treat Me Now” feature that lets users get fast care for common concerns like cold and flu, skin issues, allergies, urinary tract infections.”

Friday Factoids

David Ermer–CDC, CMS, Congress, Electronic health records, Federal employment benefits, Medicare, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Department of Health and Human Services discusses its efforts to support rural healthcare.
  • Today, the proposed No Surprises Act regulation that would change current Independent Dispute Resolution processes was published in the Federal Register. OPM’s proposed FEHB rules changes are described on page 75,808 and may be found on page 75,851.
  • The Centers for Medicare and Medicaid Service issued FAQs on its new final rule imposing civil monetary penalties on Section 111 reporting violations. The rule, which impacts FEHB carriers, becomes enforceable on October 11, 2024.
  • Congressman Gerry Connolly (D VA) released a “statement in support of the Office of Personnel Management’s (OPM) expansion of infertility coverage benefits for Federal Employee Health Benefits (FEHB) program enrollees.” The FEHBlog is pleased to read about Congressman Connolly’s support.
  • The Office of the National Coordinator of Health Information Technology created a blog post titled “Coming in Hot! TEFCA Will Soon Be Live and Add Support for FHIR-Based Exchange.” The post indicates that this critically important electronic health record key to data sharing will be going live soon.
    • “Our TEFCA timelines will remain aggressive and ambitious as ONC and the RCE help support the industry to usher in a new era of data exchange for the United States.
    • “For more information on TEFCA in general, please check out the RCE resources and sign up for the RCE newsletter and monthly public calls.”
  • Govexec reports, “The Office of Personnel Management on Friday announced new plans aimed at helping the federal government’s HR agency better weather the annual surge of retirement applications from departing federal employees that occurs each winter.” Good luck.
  • HR Dive reports,
    • “The U.S. Equal Employment Opportunity Commission opened its 2022 EEO-1 Component 1 data collection Oct. 31. Reports must be submitted by Dec. 5, the agency said in a news release. 
    • “The EEO-1 Component 1 report is a mandatory demographic data report the EEOC requires from all private-sector employers with 100 or more employees, and from certain federal contractors.
    • “EEOC’s Office of Enterprise Data and Analytics released a booklet to help filers complete the process. It has also provided a Filer Support Team Message Center and other resources, the agency said.”

From the public health front,

  • The Centers for Disease Control posted its inaugural issue of FluSight for the current flu season. Here’s the kickoff forecast.
  • Health Payer Intelligence explains how public and private payers cover healthcare for the LGBTQ+ community.
  • The Institute for Clinical and Economic Research published
    • “its third annual “Barriers to Fair Access” assessment of prescription drug coverage policies (Report |Supplemental Materials) within US commercial insurance and the Veterans Health Administration. The analysis found that major payer coverage policies for 18 drugs often met fair access criteria for cost sharing, clinical eligibility, step therapy, and provider restrictions. However, the report’s findings suggest that major improvements are needed in the transparency of coverage policy information for consumers and in detailing out-of-pocket costs for patients.” 
  • Beckers Hospital Review shares CMS statistics on emergency department wait times across our country.
  • The Wall Street Journal gives advice on how to avoid the gloom associated with turning the clock to standard time this weekend.
    • “Daylight hours affect our brain chemistry. As days grow shorter, light receptors in the eyes receive less light and send a signal to the brain about what chemicals to produce, says Lina Begdache, associate professor of health and wellness studies at Binghamton University. 
    • “Our brains begin producing more melatonin—the sleep-related hormone—and less serotonin, which enhances mood and controls appetite. When the brain starts making more melatonin at 4 p.m. due to the earlier dusk, people can feel prematurely sluggish, which can affect mood, diet, exercise and sleep patterns.  
    • “Focusing on improving one area that is affected by the time change, such as exercise, can help the others and might be more doable than trying to improve everything at once, says Begdache, the associate health and wellness studies professor.  * * *
    • “If you improve your diet, you’re more likely to exercise more. And if you exercise more, you’re more likely to sleep better,” says Begdache, who led a 2021 study on mental well-being and seasonal changes. “
  • The FEHBlog personally likes having more sunlight in the morning.

From the U.S. healthcare business front,

  • Here’s a link to the American Medical Association’s reaction to the 2024 Medicare Part B pay cut announced this week. The pay cut is a wash for FEHB carriers because the cut applicable to Medicare prime annuitants will be offset by price increases for younger members. The big problem is that the cut will drive more doctors out of Medicare Part B. When the FEHBlog, who is on traditional Medicare, lived inside the Beltway, his primary care doctor joined the crowd of local PCPs who had dropped out of Medicare. When the FEHBlog moved to Texas last year, he had no problem finding a PCP who takes Medicare, and what’s more, his PCP participates in an accountable care organization. Access to affordable healthcare and dental care is better in central Texas than inside the Beltway, at least for now. The FEHBlog agrees with the AMA that Congress needs to step up.
  • BioPharma Dive informs us,
    • “Moderna on Thursday shifted its revenue forecast for the year to “at least” $6 billion from a previous range of between $6 billion to $8 billion, a change it said reflected COVID-19 vaccination trends in the U.S.
    • “The biotechnology company also disclosed third-quarter earnings showing a net loss of $3.6 billion, driven mainly by non-cash charges of $3.1 billion related to a “manufacturing resizing” and a tax charge. Shares slumped 6% Thursday on the news but traded up Friday morning.
    • “Moderna said it plans to break even in 2026 through “disciplined investment” and launches for new products like its mRNA flu and respiratory syncytial virus vaccines as well as a combination flu and COVID shot.”
  • MedTech Dive shares medtech executives’ views on the new GLP-1 obesity drugs.
    • “Strong patient interest in GLP-1 drugs to treat obesity has prompted medtech companies to take a hard look at the potential impact on demand for procedures like bariatric surgery and products such as glucose monitors and sleep apnea devices.
    • “The potential threat to medical device sales has spooked investors, who have sold shares in companies across the sector.
    • “Fears that medications such as Ozempic, Mounjaro and Wegovy, which are used for diabetes and weight loss, will eventually reshape treatment for a variety of diseases have driven the most severe correction in the medtech sector since the onset of COVID-19, wiping out about $370 billion in market capitalization, according to Mizuho analyst Anthony Petrone.”

Weekend update

David Ermer–CDC, Congress, COVID-19, Mental health care, U.S. Healthcare, Uncategorized–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC,

  • The federal marketplace open enrollment period for Affordable Care Act coverage will open on November 1. This enrollment opportunity closes on December 15.
  • The Wall Street Journal reports, “Insurers spar With Biden Administration over coverage for mental-health care; New requirements aim to reduce out-of-pocket costs for treatment; insurers cite a shortage of mental-health providers.” Per the Journal,
    • “A landmark law, the Mental Health Parity and Addiction Equity Act of 2008, helped curtail arbitrary annual limits imposed by insurers on mental-health coverage. Insurers aren’t supposed to put such limits on mental-health visits if they don’t also have similar limits on doctor visits for a chronic condition like asthma. They also aren’t supposed to impose higher copayments and deductibles or more restrictive prior authorization requirements for mental health care.
    • “But the promise of out-of-pocket parity remains far more elusive. The reasons are complex: There is a shortage of mental health clinicians, with an estimated 350 individuals for every one mental-health provider, according to Mental Health America.”
  • The legal issue is that the law requires parity in quantitative treatment limits (QTL), which health plan compliance with the law has created. The regulators, however, created a separate nonquantitative treatment limitation category, which includes network adequacy, prior authorization, and many, many other factors. The regulators in the proposed rule demand that the QTL parity factors be applied to all NQTLs. That is an infeasible, pointless task, in the FEHBlog’s opinion. The regulators need to try again.
  • On a related note, the Washington Post informs us,
    • “Beginning in January, Medicare [Part B], for the first time, will allow marriage and family therapists and mental health counselors to provide services. This cadre of more than 400,000 professionals makes up more than 40 percent of the licensed mental health workforce and is especially critical in rural areas.
    • “Medicare is also adding up to 19 hours a week of intensive outpatient care as a benefit, improving navigation and peer-support services for those with severe mental illness, and expanding mobile crisis services that can treat people in their homes or on the streets.”

From the public health front,

  • NBC News notes,
    • “A new Covid variant has become dominant in the U.S., but relatively few people have thus far gotten the new shots that could offer some protection against it.
    • “The variant, called HV.1, replaced EG.5 as the country’s most prevalent this week, according to data released Friday by the Centers for Disease Control and Prevention.
    • “The two variants are genetically similar versions of omicron.
    • “HV.1 makes up around 25% of Covid cases now, up from around 1% at the beginning of August. EG.5, meanwhile, represents nearly 22% of cases, down from 24% at the start of the month.
    • “Both are descendants of the XBB variant. The updated Covid vaccines from Pfizer and Moderna, which became available last month, target a different XBB descendant, called XBB.1.5.
    • “But disease experts say the new shots should offer cross-protection against the currently dominant strains. Dr. Scott Roberts, an infectious disease specialist at Yale Medicine, said that although the vaccine is not a “perfect match” for HV.1, “it’s still a good match because it’s still within the same family of variants.”
  • WTOP, a news radio station in Washington DC, reports,
    • “We’ve already been receiving warnings from the CDC that there are RSV cases in the Southeast, which is kind of an indication to us that it’s going to be moving our way soon,” said Dr. Christine Ashburn, a pediatrician with Kaiser Permanente’s Mid Atlantic Group.
    • “While an increase in RSV cases could be coming soon,  Ashburn says she doesn’t think it’ll be as bad as last year, which saw hospital systems across the region — and the country — overrun with cases in infants. * * *
    • “Ashburn says looking for early signs of this illness in infants and small children is key.
    • “Watch for fast, rapid breathing,” she said. “Sometimes in babies, you’ll even see the area around their chest sinking in as they’re breathing.”
    • “She also said flared nostrils, prolonged fever, and even rhythmic grunting — or any signs of respiratory distress — are signs your baby is struggling to get air.
    • “If you think your child could be suffering from RSV, it’s imperative you make an appointment with your health care provider,” she said.
    • “Dr. Ashburn said she’s also optimistic about a new antibody treatment for RSV, AstraZeneca’s Beyfortus™ (or nirsevimab, generically), which is designed to help prevent and mitigate the illness’s effects.”
  • Vox adds
    • Demand for Beyfortus currently exceeds supply. But as the need for the drug becomes more predictable, and as other monoclonal RSV antibodies in development make it onto the market, we can expect supply to better meet that demand. 
    • It’s more complicated to fix the fragmented US health care system that creates big barriers to Beyfortus access for some kids, [Dr. Sean] O’Leary [a pediatric infectious disease specialist at the University of Colorado’s medical school] said. That system is structured such that many pediatricians have to take huge financial risks to keep Beyfortus in stock. For patients who get care at those practices, access will likely be a little touch-and-go until demand also stabilizes and pediatricians can better forecast how much to stock. * * *
    • One dose costs a doctor’s office nearly $500 — and as a totally novel immunization, its popularity was hard to forecast. “For a medium-sized practice, they might have to spend $250,000 to cover their [privately insured”] patient population,” O’Leary said. “And that is not money they have lying around.”
    • “It’s not that pediatricians and family docs don’t want to do the right thing,” he added — but the financial risk of just keeping Beyfortus on the shelves is a barrier.
  • However, according to a 2018 survey about vaccine financing billing practices at medical practices serving adults
    • Of 242 practices approached, 43% (n=104) completed the survey. Reported payment levels and perceived profit varied by payer type. Only for preferred provider organizations did a plurality of respondents report profiting on adult vaccination services. Over half of respondents reported losing money vaccinating adult Medicaid beneficiaries. One-quarter to one-third of respondents reported not knowing about Medicare Part D payment levels for vaccine purchase and vaccine administration, respectively. Few respondents reported negotiating with manufacturers or insurance plans on vaccine purchase prices or payments for vaccination.
  • FEHBlog note: It’s no wonder that chain pharmacies are the principal distributors of vaccines.

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “AbbVie Inc. raised its profit outlook for this year and next as demand for newer biologic drugs helped fill the gap left by falling Humira sales, but investors were disappointed as Botox sales missed estimates.
    • “Adjusted earnings will be $11.19 to $11.23 a share this year, up from the earlier range of $10.86 to $11.06, AbbVie said Friday in a statement. Profit for 2024 will be at least $11 a share, up from the earlier view of at least $10.70, the drugmaker said.
    • “However, sales of Botox, Juvaderm and other aesthetics products were $1.24 billion, missing the average sales estimate by about $100 million. Shares of the North Chicago, Illinois-based drugmaker dropped as much as 5.6% at the New York market open, their biggest intraday loss since April.”
  • Reuters points out,
    • “Healthcare companies who profit from treating obese and overweight patients are trying to convince investors that powerful new weight-loss drugs won’t shrink their businesses.
    • “The global market for obesity drugs could reach as much as $100 billion within a decade due to the effectiveness of Novo Nordisk’s (NOVOb.CO) Wegovy and similar medicines.
    • “Such forecasts have prompted a sell-off in a wide range of companies from makers of bariatric surgery devices to companies whose products address the health issues created by excess weight, from diabetes to sleep apnea.”