Thursday Miscellany

OPM

Thursday Miscellany

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Aug. 15 announced it negotiated lower prices with drug makers for 10 high-cost, sole-source drugs, with the new prices becoming effective in 2026 for individuals with Medicare Part D coverage. The drugs treat conditions such as heart disease, diabetes and cancer, and about nine million Medicare beneficiaries use at least one of the 10 drugs selected for negotiation. The new prices are estimated to save $1.5 billion in out-of-pocket costs for individuals with coverage. A CMS fact sheet includes more information about the newly negotiated prices. The agency last year announced the first list of 10 Medicare Part D drugs subject to price negotiations.”
  • STAT News cautions,
    • “The White House is touting just how much its new Medicare negotiation process cut drug prices. The problem is the numbers it’s using don’t actually mean much.”
    • “In a striking side-by-side comparison, President Biden tweeted out a graphic showing newly negotiated prices that Medicare will pay for 10 drugs including blood thinners, cancer treatments, and diabetes medications, among others. The table compares the new prices to the list price of the medicines last year, showing discounts ranging from hundreds to thousands of dollars. 
    • “However, Medicare generally doesn’t pay list prices for medications. Currently, prescription drug plans negotiate discounts off of the list prices at a smaller scale than the new program — but those prices are secret, even in a public program.
    • “The White House did release more meaningful overall numbers tied to the amount Medicare actually pays for drugs that show discounts of roughly 22% on the 10 drugs collectively, compared to what the program paid last year. That’s more modest than the exaggerated discounts based on list prices that show price reductions of up to 79%.”
  • In any case, why didn’t Congress align the effective dates for the enormous consumer improvements in Part D, discussed yesterday, with the “negotiated prices”?
  • Govexec tells us,
    • “The Biden administration on Wednesday announced a new initiative aimed at improving the hiring process for federal job applicants, hiring managers and other agency HR officials alike, as the White House continues to search for ways to speed up the process and better compete for top talent.
    • “Strategic human capital management has been on the Government Accountability Office’s famed High-Risk List, a biennial report highlighting issues that present potential liabilities of at least $1 billion for the federal government, for more than two decades. In 2021, GAO found that the government had actually regressed in its effort to address difficulties in hiring new federal workers during the final two years of the Trump administration.
    • “The Office of Personnel Management and Office of Management and Budget worked jointly on the effort, announced Wednesday in a memo to agency heads entitled “Improving the Federal Hiring Experience.” The document encompasses plans to improve strategic workforce planning, making it easier for potential job applicants to find jobs they are interested in and making the hiring process both faster and more transparent for jobseekers, as well as making hiring less agonizing for the hiring managers and other human resources personnel.”
  • The Food and Drug Administration announced,
    • “Today, the U.S. Food and Drug Administration marked a milestone building on Phase I of its voluntary sodium reduction targets and issued draft guidance for Phase II in a data-driven, stepwise approach to help sodium reduction across the food supply. Prior to 2021, consumer intake was approximately 3,400 milligrams per day on average, far higher than the limit recommended by the Dietary Guidelines for Americans of 2,300 milligrams per day for those 14 years and older. If finalized, the new set of voluntary targets would support reducing average individual sodium intake to about 2,750 milligrams per day. This reduction is approximately 20% lower than consumer intake levels prior to 2021. 
    • “The Phase II voluntary sodium reduction targets follow an initial set of targets issued in October 2021. The initial set of targets encouraged the food industry to reduce sodium levels in a wide variety of processed, packaged, and prepared foods. Preliminary data from 2022 show about 40% of the initial Phase I targets are very close to or have already been reached indicating early success of this effort.”
  • FedWeek explains the uncommon exceptions to the FEHB Program’s five-year rule which governs whether a federal employee can continue FEHB coverage into a civil service retirement with the full government contribution.

From the public health and medical research front,

  • CNN reports,
    • “Americans, and especially those under age 35, are changing their tune on alcohol use, with a growing share endorsing the view that moderate drinking is bad for health — and a new study backs them up.
    • “According to a Gallup poll released Tuesday, almost half of Americans, 45%, say that having one or two alcoholic drinks a day is bad for a person’s health. That’s the highest percentage yet recorded by the survey, which has been conducted 10 times since 2001.”
  • The National Institutes of Health (NIH) Director, writing in her blog, discusses “Mapping Psilocybin’s Brain Effects to Explore Potential for Treating Mental Health Disorders.”
    • “Psilocybin is a natural ingredient found in “magic mushrooms.” A single dose of this psychedelic can distort a person’s perception of time and space, as well as their sense of self, for hours. It can also trigger strong emotions, ranging from euphoria to fear. While psilocybin comes with health risks and isn’t recommended for recreational use, there’s growing evidence that—under the right conditions—its effects on the brain might be harnessed in the future to help treat substance use disorders or mental illnesses.
    • “To explore this potential, it will be important to understand how psilocybin exerts its effects on the human brain. Now, a study in Nature supported in part by NIH has taken a step in this direction, using functional brain mapping in healthy adults before, during, and after taking psilocybin to visualize its impact. While earlier studies in animals suggested that psilocybin makes key brain areas more adaptable or “plastic,” this new research aims to clarify changes in the function of larger brain networks and their connection to the experiences people have with this psychedelic drug.”
    • The blog explains the latest research.
  • Per an NIH press release,
    • “The National Institutes of Health (NIH) has launched a program that will support Native American communities to lead public health research to address overdose, substance use, and pain, including related factors such as mental health and wellness. Despite the inherent strengths in Tribal communities, and driven in part by social determinants of health, Native American communities face unique health disparities related to the opioid crisis. For instance, in recent years, overdose death rates have been highest among American Indian and Alaska Native people. Research prioritized by Native communities is essential for enhancing effective, culturally grounded public health interventions and promoting positive health outcomes.”
  • The New York Times reports that “In an experiment that surpassed expectations, implants in an ALS patient’s brain were able to recognize words he tried to speak, and A.I. helped produce sounds that came close to matching his true voice.” Truly amazing.
  • Per Healio,
    • “Women with vs. without cognitive impairment had more intense menopause symptoms.
    • ‘Lower BMI, sexual activity, exercise, hormone therapy use, and higher education were tied to lower cognitive impairment odds.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Employer-sponsored health plan costs are expected to rise 9% in 2025, totaling more than $16,000 per employee before cost-saving measures, according to professional services and consulting company Aon.
    • “Aon predicts that demand for prescription drugs such as glucagon-like peptide-1 agonists and growth in medical claims for high-cost treatments such as gene and cell therapies are among the main drivers of rising costs for employers.
    • Janet Faircloth, senior vice president of innovation and integrated solutions for Aon, said employers are expected to apply cost-saving strategies used in previous years, including raising out-of-pocket costs for employees and bidding between insurers for the best price.
    • For 2024, Aon predicted health plan costs would increase by 8.5%, but the firm projects employer cost-saving efforts are likely to hold the increase to 6.4% overall.
    • “We generally see a 1% to 2% reduction from the initial trend expectation after employers make their changes,” Faircloth said.
    • The International Foundation of Employee Benefit Plans released a similar report Thursday, estimating employer-sponsored health plan costs would rise 8% in 2025 due to the same factors Aon cited.
  • Per Healthcare Dive,
    • “Health insurers have invested heavily in building out their Medicare and Medicaid businesses in recent years, tempted by the prospect of healthy margins and growing membership in the government-run insurance programs.
    • “But privately run Medicare Advantage and safety-net Medicaid plans are seeing their profitability shrink amid ongoing operational pressures, creating a sharp reversal in expected fortunes — much to health insurance executives’ chagrin.
    • “For much of the past year, insurers bemoaned the headwinds in MA as seniors using more medical care caused spending to snowball. But in the second quarter, many payers suggested Medicaid has become a bigger problem, as states remove ineligible beneficiaries from the safety-net coverage, sickening insurers’ risk pools and saddling them with higher costs.”
  • Beckers Payer Issues illustrates the fact that “The CEOs of the six largest for-profit insurers have different perspectives on Medicare Advantage.” 
  • Per a Health Care Cost Institute announcement,
    • “Technological medical advancements have shifted an array of procedures previously rendered in inpatient hospitals to ambulatory surgical centers (ASCs). For example, same-day procedures (e.g., cataracts surgery) that do not require an overnight hospital stay and musculoskeletal procedures, such as arthroscopy, are commonly performed at ASCs. 
    • “Because they operate independently of brick-and-mortar hospital facilities, ASCs are considered “off site.” Compared to procedures rendered in hospital outpatient departments, ASC’s receive lower reimbursement. For low-risk procedures, ASCs may be a cost-efficient site of care. Recent market analysis found that procedures at ASCs have grown over time and now account for half of all outpatient surgeries. 
    • “In this brief, we compare employer-sponsored insurance (ESI) ASC reimbursement amounts for a subset of procedures to Medicare fee-for-service (FFS) payment for the same procedures. We find that, on average, ESI pays two times more than Medicare FFS for procedures provided at ASCs. If ESI reimbursed at Medicare average rates, spending would have been nearly $9 billion lower in 2021.”
  • Per Beckers Hospital Review,
    • “Cleveland Clinic saw an operating income of $45.3 million at a 1.2% margin in the second quarter of 2024 for the three months ended June 30, a 312% increase from a $21.4 million operating loss (-0.6% margin) during the second quarter of 2023, according to its Aug. 16 financial report.
    • “Total revenue for the system was $3.9 billion in the second quarter of 2024, up from $3.6 billion during the same period last year. 
    • “Net income for the health system was $187.8 million for the three months ended June 30, 2024, up from $145.2 million during the second quarter of 2023.
    • “Expenses increased 8% to $3.7 billion, with salaries, wages and benefits also increasing 8% to $2.3 billion. Cleveland Clinics outstanding and long term debt was $5.4 billion, the report said.” 
  • Per MedTech Dive,
    • “Neuronetics said Monday it has agreed to merge with Greenbrook TMS to acquire treatment centers that use its mental health devices.
    • “Greenbrook provides transcranial magnetic stimulation (TMS) and other mood treatments from 130 sites. Neuronetics sells a TMS device to treat major depressive disorder (MDD).
    • “William Blair analysts said in a note to investors that the merger changes Neuronetics’ profile “from device-centric to a device-service business operating brick-and-mortar facilities.”
  • Per Reuters,
    • “Eli Lilly (LLY.N) has sent cease-and-desist letters to U.S. healthcare providers in recent days to stop the promotion of the compounded versions of its drugs for weight loss and diabetes, as their supply increases, the company said on Wednesday.
    • “The letters were sent to telehealth companies, wellness centers and medical spas selling compounded versions of the drugmaker’s popular treatments Zepbound and Mounjaro, a spokesperson told Reuters.”

Midweek Update

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

From Washington, DC,

  • Kevin Moss, writing in Govexec, explains the pros and cons of Medicare Part D coverage for FEHB annuitants over age 65. The key point is that for 2025 the Medicare Part D out of pocket maximum is $2000. Also, Part D members with higher Part D cost sharing can spread out the Part D cost sharing over the plan / calendar year using Medicare Part D’s new Medicare Prescription Payment Plan (MPPP). The MPPP savings coupled with the $2000 out of pocket max could make Part D valuable for folks who otherwise would use manufacturer coupons.  
  • Although not discussed in the Govexec article, Postal Service Health Benefit (PSHB) annuitants over age 65 generally will be required to use the PSHB plan’s Part D EGWP. Those who opt out are ineligible for the PSHB plan’s regular Rx benefits, and there’s no concomitant premium reduction. We are waiting for OPM’s final supplemental PSHB rule which will include the Part D opt out penalty details.
  • Politico discusses a Biden Harris administration initiative to subsidize standalone Part D plans with a a $15 per Part D member payment to stabilize Part D premiums in consideration of these significant Part D improvements. The article observes,
    • “The Part D market has two types of plans. One is a standalone plan that only offers drug coverage, and the other is coverage included in a privately run Medicare Advantage plan that covers other health services.
    • “Medicare Advantage plans can absorb higher costs better than a standalone option, according to a 2023 analysis from the consulting firm Avalere Health.
    • “Since a Medicare Advantage plan offers a wide array of both medical and drug benefits, it can spread out the cost impact. Standalone plans do not have such flexibility, and the law is causing some to exit the market.”
  • It’s worth noting that Part D EGWPs absorb the basic Part D premium typically charged to the Medicare beneficiary. Part D EGWPs do not absorb the extra IRMAA tax on high income Medicare beneficiaries.
  • Last week, the Centers for Medicare and Medicaid Services released 2025 enrollment and disenrollment guidance for Medicare Advantage and Part D plans.
  • KFF adds,
    • “Among the 167 million people with employer-sponsored insurance in 2022, 3.4 million used at least one of the first 10 drugs identified for Medicare price negotiations, according to a new KFF analysis. Medicare is expected to release the negotiated drug prices, which will go into effect in 2026, by no later than September 1, 2024.
    • “The most used drug for people with employer-sponsored health insurance was Jardiance, a drug used to treat diabetes and heart failure, which was taken by more than 911,000 enrollees.
    • In the future, the Medicare program will negotiate prices for additional drugs, which millions more people with employer coverage could also be taking. As the policy currently stands, lowering drug prices in Medicare has no direct effect on private insurance plans, and the indirect effects are still unclear. Some argue lower negotiated prices in Medicare will result in higher prices in private insurance plans, while others suggest Medicare prices could serve as a benchmark and lead to savings.
    • “The full analysis and other data on health costs are available on the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.”
  • Per HHS press releases,
    • “This week, the Africa Centres for Disease Control and Prevention (Africa CDC) declared the mpox clade I outbreak a Public Health Emergency of Continental Security, and the World Health Organization (WHO) declared this outbreak a Public Health Emergency of International Concern. The United States government supports those declarations. The United States will continue to work closely with African governments, Africa CDC and WHO to ensure an effective response to the current outbreak and to protect the health and lives of people of the region.” * * *
    • “The risk to the general public in the United States from clade I mpox circulating in the DRC is very low, and there are no known cases in the United States at this time. Due to efforts over the last nine months, the United States is well prepared to rapidly detect, contain, and manage clade I cases should they be identified domestically. The United States has a robust surveillance system in place, including through clinical testing and wastewater analysis. We continue to encourage those at high risk to get vaccinated with the JYNNEOS mpox vaccine, which has been demonstrated to be safe and highly effective at preventing severe disease from mpox. Those who have already had clade II mpox or are fully vaccinated against mpox are expected to be protected against severe illness from clade I mpox.
    • “CDC has issued an updated Health Alert Network advisory urging clinicians to consider clade I mpox in people who have been in DRC or neighboring countries in the previous 21 days; clinicians are also asked to submit specimens for clade-specific testing for these patients if they have symptoms consistent with mpox. Given the geographic spread of clade I mpox, the U.S. CDC issued an updated Travel Health Notice on Aug. 7, 2024, recommending travelers to DRC and neighboring countries practice enhanced precautions.”
  • and
    • “The federal interagency National Integrated Heat Health Information System (NIHHIS) today released a National Heat Strategy for 2024-2030. The strategy aims to promote proactive coordination related to heat planning, response, and resilience. * * *
    • “For more information on the National Heat Strategy, please click here – PDF. To learn more about HHS’ climate change-related efforts, please visit HHS’ Office of Climate Change and Health Equity. To find more information about the federal government’s heat-related initiatives and resources, please visit heat.gov.”
  • STAT News informs us,
    • “The Food and Drug Administration on Wednesday approved a new treatment for primary biliary cholangitis, an autoimmune liver disease mainly affecting women that causes decreased liver function, debilitating itching, and fatigue.
    • “The drug, called Livdelzi, will be sold by Gilead Sciences, following the $4.3 billion acquisition of CymaBay Therapeutics, its developer, earlier this year.
    • “Regulators cleared Livdelzi for patients with primary biliary cholangitis, or PBC, that doesn’t respond adequately to initial treatment with a commonly used medicine. Gilead estimates there are approximately 130,000 people in the U.S. who are impacted by PBC, of which about 30,000 to 40,000 don’t respond to first-line therapy.
    • “Competition will come primarily from two drugs: Ipsen’s Iqirvo, which won FDA approval in June; and an older medicine called Ocaliva, developed by Intercept Pharma and recently acquired by Alfasigma, an Italian pharmaceutical firm.
    • “There’s still a real need out there for patients with PBC today, despite all the new arrivals. We believe Livdelzi can make a real difference for these people,” said Gilead Chief Commercial Officer Johanna Mercier.”

From the public health and medical research front,

  • The American Hospital Association News lets us know,
    • “The Centers for Disease Control and Prevention Aug. 13 issued an advisory alerting of an uptick of cases of parvovirus B19 across the U.S. Parvovirus B19 is a seasonal respiratory virus spread by respiratory droplets through symptomatic or asymptomatic individuals. Many people are asymptomatic, but immunocompetent children and adults with symptomatic disease typically develop a biphasic illness, CDC said. The first phase lasts approximately five days and includes symptoms of fever, myalgia and malaise, which develop about a week after infection. During the second phase, children often develop a facial rash which may be followed by reticulated body rash or joint pain one to four days later. For immunocompetent adults, the most common symptoms of parvovirus B19 disease typically occur during the second phase and include a reticular rash on the trunk and joint pain. Parvovirus B19 infection could also lead to adverse health outcomes among people without pre-existing immunity who are pregnant, immunocompromised or have chronic hemolytic disorders.”
  • Here is a link to the National Cancer Institute’s latest cancer information highlights.
  • Per National Institutes of Health press releases,
    • “Two National Institutes of Health (NIH)-supported trials of an experimental malaria vaccine in healthy Malian adults found that all three tested regimens were safe. One of the trials enrolled 300 healthy women ages 18 to 38 years who anticipated becoming pregnant soon after immunization. That trial began with drug treatment to remove malaria parasites, followed by three injections spaced over a month of either saline placebo or the investigational vaccine at one of two dosages. Both dosages of the vaccine candidate conferred a significant degree of protection from parasite infection and clinical malaria that was sustained over a span of two years without the need for a booster dose—a first for any malaria vaccine. In an exploratory analysis of women who conceived during the study, the vaccine significantly protected them from malaria in pregnancy. If confirmed through additional clinical trials, the approach modeled in this study could open improved ways to prevent malaria in pregnancy.
    • “Spread by Anopheles mosquitoes, malaria parasites, including those of the species Plasmodium falciparum (Pf), can cause illness in people of any age. However, pregnant women, infants and very young children are especially vulnerable to life-threatening disease. Malarial parasitemia in pregnancy is estimated to cause up to 50,000 maternal deaths and 200,000 stillbirths in Africa each year.  
  • and
    • “National Institutes of Health (NIH) researchers discover that while artificial intelligence (AI) tools can make accurate diagnoses from textbook-like descriptions of genetic diseases, the tools are significantly less accurate when analyzing summaries written by patients about their own health. These findings, reported in the American Journal of Human Genetics, demonstrate the need to improve these AI tools before they can be applied in health care settings to help make diagnoses and answer patient question.” * * *
    • “For these models to be clinically useful in the future, we need more data, and those data need to reflect the diversity of patients,” said Dr. Ben Solomon [,the study’s senior author]. “Not only do we need to represent all known medical conditions, but also variation in age, race, gender, cultural background and so on, so that the data capture the diversity of patient experiences. Then these models can learn how different people may talk about their conditions.”
    • “Beyond demonstrating areas of improvement, this study highlights the current limitations of large language models and the continued need for human oversight when AI is applied in health care.
    • “These technologies are already rolling out in clinical settings,” Dr. Solomon added. “The biggest questions are no longer about whether clinicians will use AI, but where and how clinicians should use AI, and where should we not use AI to take the best possible care of our patients.”
  • The Washington Post reports,
    • For many, middle age is associated with midlife crises and internal tumult. According to new research, it is also when the human body undergoes two dramatic bouts of rapid physical transformation on a molecular level.
    • In a new study, scientists at Stanford University tracked age-related changes in over 135,000 types of molecules and microbes, sampled from over 100 adults. They discovered that shifts in their abundance — either increasing or decreasing in number — did not occur gradually over time, but clustered around two ages.
    • “Obviously you change throughout your entire life. But there are two major periods when there are lots of changes: One is when people hit their mid-40s, and one is they hit their 60s,” said Michael Snyder, a geneticist at Stanford University who co-wrote the study, in a phone interview. On average, the changes clustered around the ages of 44 and 60.” * * *
    • “The exact reason these molecular changes cluster at the mid-40s and 60s is unclear. But the study’s authors say their findings show that from your 40s, people stand to gain particular benefits from taking care of their health. This includes getting regular medical check ups — at least twice a year once you hit your 40s, Shen suggested — as well as making lifestyle adjustments.”
  • Reuters tells us,
    • “The U.S. Department of Agriculture said on Tuesday it will expand bird-flu testing of beef entering the food supply as part of its response to the ongoing outbreak among dairy cattle, adding that U.S. beef and dairy products remain safe to consume.
    • ‘USDA officials, in a call with reporters along with staff from other U.S. health agencies, said the tests will begin in mid-September and urged livestock workers to remain vigilant.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Elevance and its private equity partner have officially introduced their care delivery platform, called Mosaic Health, after teasing the joint venture earlier this spring.
    • “Mosaic is comprised of two of Clayton, Dubilier and Rice’s primary care portfolio companies — Apree Health and Millennium Physician Group — along with the care delivery and enablement assets of Elevance’s health services division Carelon.
    • “However, Mosaic is launching without Carelon’s advanced primary care platform, according to the announcement on Wednesday. Carelon’s assets will join Mosaic subject to ongoing regulatory approvals. An Elevance spokesperson did not respond to a request for comment on the timeline of approvals.”
  • Per MedTech Dive,
    • “Otsuka’s digital health subsidiary has launched its first product, an app-based treatment for major depressive disorder. 
    • “The app, called Rejoyn, is available only by prescription and is intended to be used in addition to medications. It consists of a six-week program with cognitive behavioral therapy-based video lessons and exercises for identifying emotions. Otsuka announced the launch on Tuesday.
    • “Sanket Shah, president of the Japanese pharmaceutical company’s new Otsuka Precision Health subsidiary, said the treatment was priced at $50 on a cash-pay basis, with the goal of making it accessible. “This is, to be honest, not going to make money,” Shah said in an interview. “We have to put the investment into this to build this out because we do believe in the [digital therapeutics] model and digital solutions and using technology to really help patients.” 
  • Per Fierce Healthcare,
    • “Startup Abridge has notched its largest partnership to date as Kaiser Permanente is making the company’s AI-powered medical note-taking app available to more than 24,000 doctors across its system.
    • “The integrated nonprofit is rolling out Abridge’s technology at 40 hospitals and more than 600 medical offices in eight states and Washington, D.C., the organization announced Wednesday. The health system’s clinical staff includes 24,600 physicians and 73,600 nurses.
    • “Kaiser Permanente’s venture arm also is one of Abridge’s investors. The company, founded in 2018, has raised $212.5 million to date, including a $150 million series C funding round in February.
    • “The health system has worked with Abridge over the past year to implement the AI-based medical documentation technology. Desiree Gandrup-Dupre, senior vice president of care delivery technology services at Kaiser Permanente, said it was the largest implementation to date of ambient listening technology.
    • “At Kaiser Permanente, we have a long history of successfully deploying proven technologies on a broad scale, as we continue to provide health care and services when, how, and where our patients need it,” Gandrup-Dupre said in a statement.
    • “The goal is to help doctors reduce time spent on administrative tasks, allowing them to be more present with patients during medical visits, Kaiser Permanente executives said.”
  • Morningstar points out,
    • “The Social Security cost-of-living adjustment for 2025 could shrink in 2025 from this year’s 3.2% increase as inflation cools. 
    • “COLA could be 2.6% in 2025, according to Mary Johnson, an independent Social Security and Medicare analyst and former analyst with the Senior Citizens League. The new forecast compares to her forecast in July that called for a 2.7% increase. 
    • “The 2.6% increase would be the lowest COLA since 2021, but average for the past 20 years, Johnson said.”

Tuesday Tidbits

David Ermer–Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Per a Senate press release,
    • “U.S. Senator Sherrod Brown (D-OH) announced [on August 12, 2024] the introduction of legislation to make it easier for workers without 4-year college degrees, including veterans, to get federal jobs, and to promote hiring based on workers’ skills rather than the degree they attain.
    • “The Federal Jobs for STARs Act would make federal jobs more accessible for non-degree-holders by taking steps to reduce or remove unnecessary educational requirements and making it easier for Ohioans to search on USAJOBS.com for jobs that match their experience and skills.
  • Federal News Network lets us know,
    • “New instances of fraud in the government’s Flexible Spending Account program, FSAFEDS, are dwindling. But the investigation into the issue remains ongoing. In total, fraudulent activity in the Office of Personnel Management benefits program has now cost more than $1 million. OPM has been working with FSAFEDS vendor HealthEquity to secure impacted federal employee accounts and add security measures to the program. OPM’s inspector general office is also working with the FBI to look into the issue further. But OPM said there’s so far no evidence of the FSAFEDS systems being compromised.”
  • Per a CMS press release,
    • “CMS is encouraging pharmacies and other affected parties to prepare now for the expected transition of coverage from Medicare Part D to Medicare Part B for Preexposure Prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. We expect to release the final National Coverage Determination (NCD) in late September 2024. Coverage under Part B will begin once we release the final NCD.
    • “Do you have questions about pharmacy enrollment?  We’re going to answer your questions so you can prepare your pharmacy for Part B coverage of PrEP for HIV during Pharmacy Enrollment Office Hours on Thursday August 22 from 3:30-4:30 pm ET. 
    • “Register for this webinar. After you register, you’ll receive a confirmation email with information about joining the webinar.”
  • The American Hospital Association News informs us,
    • “The AHA Aug. 13 commented to the Medicare Payment Advisory Commission in anticipation of the commission’s 2024-2025 cycle. The AHA urged MedPAC to carefully consider the negative consequences for beneficiaries, providers and communities if Medicare payments to 340B hospitals are cut; reconsider its pursuit of inpatient rehabilitation facility-skilled nursing facility site-neutral payment policy; support updates to physician reimbursement that more adequately account for inflation; and recommend repealing in-person visit requirements for tele-behavioral health services.

From the public health and medical research front,

  • MedCity News tells us,
    • “There are more than 123 million people in the U.S. living with obesity, and this prevalence is largely due to a lack of access to care, environmental factors, stigma and inadequate coverage, according to a new report. Tackling these issues will take a “multifaceted approach,” the report states.
    • “The publication was released last week in the American Journal of Managed Care and was funded by the Diabetes Leadership Council, a nonprofit patient advocacy organization. The researchers conducted an internet search of relevant studies and government reports.
    • “Our goal is to ensure that people are getting the right treatment at the right time for them. And we understand that this looks differently for everybody … and not everyone fits the same mold,” said Erin Callahan, chief operating officer of Diabetes Leadership Council and Diabetes Patient Advocacy Coalition, in an interview. “So our goal is to ensure that people are well cared for and have equitable access to the things they need along any part of their medical journey.”
  • Cardiovascular Business notes,
    • “Over the past few decades, research has clearly shown that there are distinct characteristics of ischemic heart disease in women that are not seen in men. While women often need tailored diagnostic approaches for diagnosis and treatment, the one-size-fits-all approach using the male heart disease presentations as the standard of care has likely impacted female mortality in terms of cardiac deaths, which is the No. 1 killer in the world for both men and women.
    • “Emily Lau, MD, director of the Cardiometabolic Health and Hormones Clinic at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, shed light on the critical issue of gender differences in chest pain imaging evaluations in sessions at the American College of Cardiology (ACC) 2024 meeting earlier this year. She spoke with Cardiovascular Business about her presentation.
    • “Women are more likely to present with non-obstructive coronary disease,” Lau explained. “This means they may not have significant blockages in their arteries, but they still experience symptoms of heart disease.”
  • Beckers Hospital Review points out,
    • “Adverse drug reactions [affecting the skin] are a known risk of antibiotic use, but it has been unclear which drug classes carry the highest risk — until now. 
    • “To crack at this mystery, researchers in Toronto analyzed two decades worth of data on hospitalizations and emergency department visits for serious skin reactions in older adults, according to a study published Aug. 8 in JAMA. They compared the results for each drug class to macrolides. 
    • “Among the 21,758 older adults, the antibiotics most strongly associated with serious skin conditions were sulfonamides, cephalosporins, nitrofurantoin, penicillins and fluoroquinolones. 
    • For the 2,852 hospitalized patients, the average length of stay was six days, 9.6% required transfer to a critical care unit and 5.3% died in the hospital. 
    • “When clinically appropriate, the researchers recommended prescribers use lower-risk antibiotics.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Kaiser Permanente reported a $2.1 billion net gain in the second quarter, representing a solid end to the nonprofit hospital and health plan’s financial performance in the first half of its fiscal year, according to an analyst.
    • “Kaiser’s operating margin rose to 3.1%, up from 2.9% the same time last year. The Oakland, California-based health system reported an operating income of $908 million as revenues grew at a faster clip than expenses.
    • “The second quarter marked the first time Geisinger Health’s financial performance was fully integrated into Kaiser’s earnings. While Kaiser did not break out Geisinger’s results, one analyst estimated the system contributed up to $2 billion in revenue during the quarter.”
  • and
    • “Orthopedics device company Stryker said Monday it has reached an agreement to acquire Care.ai, a company that offers artificial intelligence-based tools for hospitals. The Orlando, Florida-based startup makes patient monitoring, virtual rounding and AI-assisted decision support tools based on a network of sensors. 
    • “Stryker did not immediately respond to questions about the price or timing of the acquisition.
    • “The acquisition comes about two weeks after Stryker CEO Kevin Lobo forecast a “very active deal pipeline” for the second half of the year.”
  • Per Fierce Healthcare,
    • “Steward Health Care has agreed to sell its physicians network, Stewardship Health, to Rural Healthcare Group, which is owned by a private equity group.
    • “The embattled health system signed a definitive agreement to sell Stewardship, one of the largest primary care provider organizations in the country, for a proposed purchase price of $245 million, according to court documents filed in federal bankruptcy court Aug. 12. The court documents (document 1953 and 1954) can be found on an online portal set up for court filings and other restructuring information about Steward Health Care.
    • “RHG, an affiliate of PE firm Kinderhook Industries, will buy Stewardship through Brady Health Buyer, a company set up by Kinderhook to complete the transaction, according to court documents.
    • “Kinderhook offered $245 million in cash for Stewardship, according to court documents.
    • “The sale is subject to bankruptcy court and regulatory approval.”
  • Per BioPharma Dive,
    • “Galderma on Tuesday said the Food and Drug Administration has approved its antibody drug Nemluvio for adults with prurigo nodularis, a chronic skin condition characterized by intense itch.
    • “A subcutaneous injection, Nemluvio works by blocking cellular signaling via a cytokine called IL-31. Results from two Phase 3 clinical trials showed treatment helped to reduce itch intensity, clear skin and improve sleep, compared to a placebo.
    • “In an email, Galderma declined to disclose the price it plans to charge for Nemluvio. The company said the drug will be available in the coming weeks.” 
  • Per MedTech Dive,
    • “Medtronic said Monday it received Food and Drug Administration approval for deep brain stimulation (DBS) technology that is implanted while the patient is under general anesthetic.
    • “Surgeons traditionally perform DBS procedures, a treatment for medical conditions like epilepsy and Parkinson’s disease, while the patient is awake. However, a series of studies have shown there may be benefits to putting the patient to sleep for the procedure.
    • “Medtronic said it is the first company to receive FDA approval to offer DBS surgery while a patient is asleep or awake. U.S. surgeons have used DBS devices off-label in asleep patients for years.”
  • and
    • “Baxter has agreed to sell its Vantive kidney care business to private equity firm Carlyle Group for $3.8 billion, the companies said Tuesday. Carlyle is partnering with Atmas Health in the investment. 
    • “Carlyle formed Atmas Health in 2022 with healthcare executives Kieran Gallahue, Jim Hinrichs and Jim Prutow to focus on acquiring assets in the medical technology, life science tools and diagnostics sectors. Gallahue will become chairman of Vantive, working with Vantive CEO Chris Toth.
    • “Baxter will target annual operational sales growth of 4% to 5% after the Vantive transaction is complete.”
  • Per Stat News,
    • “The unwinding of Illumina’s ill-fated acquisition of Grail earlier this year left investors and the genomics community with a pressing question: What kind of company is Illumina going to be going forward?
    • “CEO Jacob Thaysen on Tuesday made clear that the sequencing firm, which controls about 80% of the current DNA-sequencer market, is essentially returning to its traditional role of creating instruments for researchers in academia, the biopharma industry, and health care settings.”
  • The Wall Street Journal examines the state of the hospital at home business. “Institutions say it is safe and opens hospital beds, but policymakers fear it’s too pricey and lacks strict standards.”
  • Risk & Insurance alerts us that “Employers are expanding comprehensive wellbeing programs to meet employee needs, while adopting varied cost management strategies amid rising health and drug costs, a Gallagher benchmarking report finds. * * * View the complete benchmark report, including breakouts by region and employer size, on Gallagher’s website.” 

Monday Roundup

David Ermer–CDC, Congress, COVID-19, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec reports,
    • “A new initiative from the Biden administration aims to quell a varied series of consumer “headaches” by reducing their extraneous time and processes, including for federal employees trying to file health insurance claims.
    • “Detailed in a memo Monday, the “Time Is Money” initiative would touch upon processes across multiple industries that the White House deemed deliberate, time-consuming and burdensome for consumers, such as procuring refunds, canceling subscriptions and filing insurance claims.”  * * *
    • “The memo also outlined plans by the Office of Personnel Management to make it easier for employees on the Federal Employees Health Benefits and Postal Service Health Benefits plans to submit out-of-network claims online, would provide them with better information about which providers are in-network and how to appeal claim denials. 
    • “The proposed OPM requirements are part of a larger proposal within the initiative that would focus on streamlining the insurance claims process, with the Labor and Health and Human Services secretaries calling on insurance carriers to simplify their claims process and move it online, while also improving information access and call center times.” * * *
    • OPM officials were unable to respond by press time to questions about how and when the requirements will be rolled out. 
  • The FEHBlog doubts that many people submit health insurance claims. Dental claims may be a different story.
  • Here’s a link to an HHS and Labor Secretary message to health insurer CEOs about the new initiative.
  • Federal News Network points out six federal workforce bills pending in Congress that are worth tracking.

From the public health and medical research front,

  • STAT News lets us know,
    • “The Centers for Disease Control and Prevention issued a new risk assessment of the H5N1 bird flu virus circulating in dairy cows on Friday, increasing slightly its estimate of the chance it poses of triggering a pandemic.
    • “The new assessment, developed using the CDC’s influenza risk assessment tool or IRAT, gauged the risk the virus might someday cause a pandemic at 5.79, up from a previous score of 5.12 from an assessment of a related virus conducted in April 2023. Both numbers are within what the CDC tool terms a “moderate” risk of 4.0 to 7.9. Some swine influenza viruses and the H7N9 bird flu virus have scored higher than this version of H5N1 using the IRAT process.” * * *
    • “Vivien Dugan, director of the CDC’s influenza division, cautioned that the IRAT is a tool for government planning purposes, and isn’t meant to gauge the risk for the public. The agency still characterizes the risk H5N1 poses to the general public as low.”
  • Per an NIH press release,
    • “A National Institutes of Health (NIH)-supported study has found that routine lab tests may not be useful in making a long COVID diagnosis for people who have symptoms of the condition. The study, part of NIH’s Researching COVID to Enhance Recovery (NIH RECOVER) Initiative and published in the Annals of Internal Medicine, highlights how challenging it can be to identify and diagnose a novel illness such as long COVID.” * * *
    • “Future work will use RECOVER’s biobank of cohort samples such as blood and spinal fluid, to develop more novel laboratory-based tests that help us better understand the pathophysiology of long COVID,” said Kristine Erlandson, M.D., professor of medicine-infectious disease at the University of Colorado Anschutz Medical Campus, Aurora.”
  • BioPharma Dive tells us,
    • “Pfizer on Monday said its RSV vaccine Abrysvo led to strong immune responses in immunocompromised adults given the shot in a late-stage study.
    • “The results came from a sub-study of a Pfizer-run Phase 3 trial testing two doses of Abrysvo in adults at risk of severe lower respiratory tract disease associated with respiratory syncytial virus, or RSV. Vaccination was well-tolerated, Pfizer said, and led to a “strong neutralizing response” against RSV subtypes A and B.
    • “The data add to evidence of the effectiveness of Abrysvo, which faces competition from GSK’s rival vaccine Arexvy and Moderna’s mResvia, which gained Food and Drug Administration approval in May.”
  • Beckers Hospital Review informs us,
    • “Labels for GLP-1 medications, like Ozempic and Mounjaro, might see more approved uses as researchers study the drugs’ effects on sleep apnea, dementia and other health issues. Meanwhile, oncologists are looking at a GLP-1 role in cancer care.
    • “Several studies have shown the therapies — currently approved for Type 2 diabetes and weight loss — can diminish the risk of multiple cancers:
      • “Compared with Type 2 diabetes patients taking insulin, those who took the medications were less likely to develop 10 of 13 obesity-related cancers, one study found. 
      • “In another study of Type 2 diabetes patients, GLP-1 users saw a decreased risk of colorectal cancer than those who took insulin, metformin, SGLT2 inhibitors, sulfonylureas and thiazolidinediones. 
      • “Both bariatric surgery and GLP-1 use reduced the risk of obesity-related cancers in a retrospective analysis, according to data presented at the American Society of Clinical Oncologists meeting in June. Post-surgery, the risk declined 22%; with GLP-1s, the risk fell 39%. 
    • “The results are promising, but oncologists will need to see more research before they change their practices.”
  • Per Health Day,
    • “Folks can overcome their genetic risk for type 2 diabetes through healthy diet and regular exercise, a new study says.
    • “A healthy lifestyle reduced the risk of type 2 diabetes by 70% among a group of people with a high genetic likelihood of developing the metabolic disorder, researchers found.
    • “In fact, healthy behaviors had a greater impact on their risk than it did for people with a low genetic propensity for type 2 diabetes, results showed. A healthy diet and exercise had a statistically insignificant impact on the diabetes risk of those with low-risk genetics, researchers found.
    • “Nevertheless, “these findings encourage everyone to make lifestyle changes that promote health,” said lead researcher Maria Lankinen, a lecturer in nutrition with the University of Eastern Finland.
    • “That’s because all participants tended to achieve better blood sugar control and lost weight if they engaged in a healthy lifestyle, researchers said.”
  • The Wall Street Journal notes,
    • “Multiple servings of milk, cheese or yogurt have long been a staple of American nutrition advice. Now a growing number of researchers and doctors say you need less dairy than you think, and maybe even none at all.
    • “The U.S. government, which recommends that adults eat three servings of dairy a day, is taking a fresh look at its guidance. A committee of scientific advisers is analyzing diets with lower amounts of dairy to study what happens to people’s nutrient levels. That is the first step toward possibly changing the recommendation in the next update of the country’s dietary guidelines. Other countries already recommend less dairy than the U.S. does.
    • “The problem? Dairy-rich diets have been linked to increased risks of cardiovascular diseaseand certain cancers in some studies. Foods like ice cream, full-fat cheese and pizza are high in calories and saturated fat. 
    • “However, the research isn’t clear-cut. Some studies link dairy foods to a lower risk of heart disease, some cancers and Type 2 diabetes. When it comes to milk, scientists can’t agree on whether full fat or skim is better. 
    • “Long story short: Go ahead and enjoy your Greek yogurt and that mozzarella in your caprese salad. Just don’t have too much; some experts say one serving a day—one cup of yogurt or 1.5 ounces of the cheese—is good.” 
  • The New York Times warns us,
    • “Even light drinking was associated with an increase in cancer deaths among older adults in Britain, researchers reported on Monday in a large study. But the risk was accentuated primarily in those who had existing health problems or who lived in low-income areas.
    • “The study, which tracked 135,103 adults aged 60 and older for 12 years, also punctures the long-held belief that light or moderate alcohol consumption is good for the heart.
    • “The researchers found no reduction in heart disease deaths among light or moderate drinkers, regardless of this health or socioeconomic status, when compared with occasional drinkers.
    • “The study defined light drinking as a mean alcohol intake of up to 20 grams a day for men and up to 10 grams daily for women. (In the United States, a standard drink is 14 grams of alcohol.)
    • “We did not find evidence of a beneficial association between low drinking and mortality,” said Dr. Rosario Ortolá, an assistant professor of preventive medicine and public health at Universidad Autónoma de Madrid and the lead author of the paper, which was published in JAMA Network Open.
    • “On the other hand, she added, alcohol probably raises the risk of cancer “from the first drop.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “U.S. nonprofit hospitals and health systems’ median days of cash on hand hit a 10-year low in 2023, falling below 200 days for the first time in a decade, according to a report from S&P Global Ratings.
    • “Cash flow did not meaningfully improve from 2022 to 2023, the report said. However, operating expenses grew only modestly at 5%, following a steep 17% growth rate in 2022.
    • “While the sector is making incremental progress toward financial recovery, performance metrics are still below providers’ financial targets. The authors also noted a growing gap between the sector’s top performers and weaker providers.”
  • The American Journal of Managed Care examines “Hospitals’ Strategies to Reduce Costs and Improve Quality: Survey of Hospital Leaders.”
    • “Takeaway Points
    • “A decade after the implementation of value-based payment models, little is known about the strategies hospitals currently use to improve outcomes and reduce costs.
    • “On average, across 20 strategies in 4 domains—inpatient, post-acute, outpatient, and community resources for vulnerable patients—hospitals reported having implemented between 65% and 89% of the strategies queried.
    • “A higher proportion of hospitals participating in bundled payments implemented interventions aimed at reducing post-acute care compared with other hospitals (78.3% vs 37.6%; P < .0001), but patterns were otherwise similar.
  • Beckers Hospital Review looks into why Kaiser Permanente is having success with its retail clinics located inside Target stores in southern California.
  • Beckers Payer Issues explores UnitedHealthcare’s approach to consumerism in 2024.
  • Fierce Healthcare reports,
    • While customer satisfaction with mail order pharmacies is continuing to grow, brick-and-mortar pharmacies are falling behind, according to a new survey from J.D. Power.
    • The firm’s annual Pharmacy Survey found that retail pharmacies saw overall satisfaction scores decrease by more than 10 points, while scores for mail order pharmacies grew by six. The survey found that consumers visiting brick-and-mortal facilities are facing long-wait times and issues in ordering prescriptions, which is worsening the experience.
    • What brick-and-mortar pharmacies do best is communicate clearly with consumers, according to the survey, with 89% of customers indicating that messages from the pharmacist were offered clearly and understood.
    • However, there’s a trust gap. Only 51% said they view their pharmacist as trustworthy, and the same percentage said prescriptions were filled quickly.
    • Building that trust is critical to improving the consumer experience, Christopher Lis, managing director of global healthcare intelligence at J.D. Power, told Fierce Healthcare in an email interview.
    • [T]here is room for improvement for mail order pharmacies as well, the study found. While the key factor consumers enjoy is the convenience of ordering prescriptions, just 18% of consumers said that their pharmacy has a well-designed digital experience.
  • Per Fierce Pharma,
    • “Ascendis Pharma should be well prepared for the U.S. launch of its hormone replacement therapy for hypoparathyroidism, which was approved on Friday by the FDA.
    • “After all, the company was initially set to bring the drug to the market 15 months ago before the FDA rejected it with a surprise complete response letter (CRL). Then three months ago, Ascendis again was ready to roll before the U.S. regulator said it needed an additional three months to make its decision.
    • “Finally, Copenhagen-based Ascendis is now good to go with once-daily Yorvipath (palopegteriparatide), also known as TransCon PTH, which is the first FDA-approved product for hypoparathyroidism in adults.
    • Ascendis expects the initial supply to be available in the first quarter of next year with the potential to move the launch up to the fourth quarter this year, as the company has requested FDA approval to commercialize doses it has already made.
  • and
    • “With Gilead Sciences’ stated focus to grow in oncology, the company’s recent quarterly updates have placed a heavy emphasis on its developments in the cancer space. But, with a unique pre-exposure prophylaxis (PrEP) offering for HIV that could “redefine” the market, the drugmaker is touting lofty ambitions there, too.
    • “After scoring an FDA approval for Sunlenca (lenacapavir) to treat multidrug-resistant HIV, Gilead launched the drug at end of 2022. The drug’s every-six-month dosing schedule has yet to show its full potential given that it must still be paired with other daily drugs to form a complete regimen. The indication isn’t exactly a major sales driver, as Sunlenca’s approved patient population represents just 2% of adults with HIV.
    • “That approval was just “the beginning of the rest of this journey,” Gilead’s vice president of clinical development Jared Baeten, M.D., Ph.D., said in an interview at the time. Now, the company is looking to another milestone late next year with the planned commercial launch of Sunlenca as a long-acting PrEP med, CEO Daniel O’Day said on Gilead’s second-quarter earnings call.” 

Weekend Update

David Ermer–CDC, Congress, COVID-19, Medical / Rx research, OPM–

From Washington, DC,

  • The House of Representatives and the Senate are on District / State work breaks until September 9.
  • Federal News Network reports,
    • “After more than a year of pressure building in Congress, lawmakers now have more answers on federal telework levels, return-to-office policies and office space plans from the White House.
    • “In a report the Office of Management and Budget sent to Congress Friday afternoon, shared with Federal News Network, the Biden administration released details on agencies’ varying policies and approaches to where and how federal employees work, as well as federal real estate holdings and plans to improve office space utilization.
    • “While noting that more than half of the federal workforce is not able to telework at all, OMB reported that agencies are on average exceeding the administration’s 50% in-the-office goal for telework-eligible feds. Governmentwide, roughly 61% of the work hours that telework-eligible federal employees performed have been in person, according to time and attendance data OMB collected from the 24 CFO Act agencies during two pay periods in May.
    • “Also based on agencies’ time and attendance data, OMB reported that out of about 2.2 million federal employees:
    • “About 54% of federal employees worked fully in person due to the nature of their work
    • “About 46% of federal employees were eligible for telework
    • “About 10% of federal employees worked fully remotely.

From the public health and medical research front,

  • Per NPR Shots,
    • “Four years after SARS-CoV2 sparked a devastating global pandemic, U.S. health officials now consider COVID-19 an endemic disease.
    • “At this point, COVID-19 can be described as endemic throughout the world,” Aron Hall, the deputy director for science at the CDC’s coronavirus and other respiratory viruses division, told NPR in an interview.
    • “That means, essentially, that COVID is here to stay in predictable ways. 
    • “The classification doesn’t change any official recommendations or guidelines for how people should respond to the virus. But the categorization does acknowledge that the SARS-CoV2 virus that causes COVID will continue to circulate and cause illness indefinitely, underscoring the importance of people getting vaccinated and taking other steps to reduce their risk for the foreseeable future.” * * *
    • “We’re going to have to continue to live with COVID,” says Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. “It’s one more thing people have to deal with. It’s another reason your kids might miss school, or you might miss work or another thing to think about when planning gatherings. We’re stuck with it.”
  • The Washington Post lets us know,
    • “Mammogram callbacks are common — about 10 out of every 100 womenare told they need more imaging after an initial screening, according to the American College of Radiology — but can be scary, especially if you have to wait for an appointment. The vast majority of the callbacks, however, turn out to be false alarms, according to the American Cancer Society. Fewer than 1 in 10 women who return for more imaging have cancer.
    • “Women should never ignore a callback, which usually involves more extensive pictures, known as a diagnostic mammogram, and sometimes will require a sonogram and biopsy, experts say. Early detection of breast cancer usually means less-invasive treatment and high survival, more than 90 percent five years out, experts say.
    • “Callbacks happen frequently and with good reason, because we want to be sure,” says Karen E. Knudsen, chief executive officer of the American Cancer Society. “Most of the time, nothing is wrong. But if you get a callback, make the appointment.”
  • and
    • “Women who have not been very physically active over the years were 40 percent more likely to experience a fall when they reached their 70s, according to new research published in the British Journal of Sports Medicine.
    • “The study involved over 11,700 participants (with an average age of 54) in the Australian Longitudinal Study on Women’s Health, which has been following the health of over 57,000 Australian women in four different age cohorts.
    • “For this study, which lasted 18 years, women born from 1946 to 1951 reported every three years how much exercise they had been getting. That level of weekly physical activity participation was based on the total of three types of exercise: walking briskly and moderate and vigorous leisure activity. When participants were age 68 to 73, they were also asked about falls and related injuries they had experienced.”
  • Fortune Well offers tips on how to improve your chances of becoming a SuperAger.
    • “Some people have won the longevity lottery—they are among the lucky few known as SuperAgers. 
    • “In a relatively new field, researchers are examining what contributes to people in their 80s and 90s having stronger brain power than their peers. Many are wondering if those findings can be distilled into a longevity routine or pill to help everyone become a SuperAger. Is it possible to increase your odds of becoming a SuperAger? 
    • “It’s not inevitable that we will become disabled and sick as we get older. What we’re learning from these unique individuals is that it is biologically plausible for us to live long and healthy,” says Dr. Sofiya Milman, the director of the Human Longevity Studies at Einstein’s Institute for Aging Research and the lead investigator of the SuperAgers Family Study, which has enrolled 550 SuperAgers since 2022. “Once we know what causes longevity, that it’s not a disease, we can then create therapies that will promote that biological longevity, and ultimately, that’s the goal of what we’re doing.” 

From the U.S. healthcare business front,

  • Per HR Dive,
    • “Employers may continue to use the most recent Form I-9 until May 31, 2027, U.S. Citizenship and Immigration Services said last week, extending the document’s expiration date.
    • “HR professionals must ensure they’re using the form with an Aug. 1, 2023, edition date, according to the agency. Newly downloaded forms will bear the new expiration date but employers may — for now — continue using any previously downloaded or printed forms bearing the previous July 31, 2026, expiration date. 
    • “Either form may be used until its respective expiration date,” USCIS said in a statement. However, “[e]mployers are encouraged to update their electronic Forms I-9 systems to use the [2027] expiration date as soon as possible and must do so no later than July 31, 2026,” it said.
  • Per Legal Dive,
    • “States and local governments should prohibit employers from using non-disclosure and non-disparagement agreements to keep employees from speaking out about sexual and other types of harassment, the American Bar Association says.
    • “NDAs … have effectively resulted in silencing people who experience sexual assault, sexual harassment, and other forms of harassment and discrimination in the workplace, preventing accountability for those who commit these harms and allowing the behavior to persist,” the ABA says.” * * *
    • “The resolution comes at a time when employers could be turning to NDAs even more if a nationwide ban on noncompete agreements takes effect this fall. The Federal Trade Commission passed the ban, but it faces court challenges, one of which has resulted in a partial stay. 
    • “Should the ban take effect, employers are likely to lean more heavily on other types of agreements, like non-disparagement agreements and other types of NDAs, to protect their interests from employees who leave to work for a competitor or to start a competing business.”

Midweek Update

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Govexec reports,
    • “Federal agencies have not implemented roughly half of the 428 recommendations that the Government Accountability Office has made to improve preparedness following the COVID-19 pandemic, which has killed 1.2 million Americans. 
    • “In a report published on Aug. 1, the watchdog reviewed its oversight work concerning COVID-19 and the approximately $4.65 trillion Congress provided in response. GAO found that agencies haven’t addressed 220 of its recommendations. 
    • “Reflecting on federal agencies’ emergency response actions and our recommendations can reveal lessons from the COVID-19 pandemic for federal agencies. These lessons can help federal agencies identify actions that successfully facilitated the implementation of the federal response and should be incorporated into future emergency response plans. Other lessons can help federal agencies identify weaknesses in their response to the pandemic and identify areas for improvement,” GAO investigators wrote.”
  • Per an HHS press release,
    • “Today, to mark National Health Center Week, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded nearly $9 million to 18 HRSA-funded health centers to improve access to life-saving cancer screenings in underserved communities. Health centers will partner directly with National Cancer Institute-Designated Cancer Centers to expedite patient access to cancer care and treatment. These awards advance the Biden Cancer Moonshot mission to prevent 4 million cancer deaths by 2047 and end cancer as we know it. This effort builds on work supported by the 21st Century Cures Act to expand use of proven cancer prevention and early detection strategies to reduce cancer risk in all populations.”
  • Federal News Network tells us about OPM telework guidance issued today.
    • “In the federal government’s case, remote work is distinct from telework. Federal employees with remote work agreements perform their job duties at a location away from their normal work site without the expectation of regularly returning to that site. In contrast, federal employees with telework agreements, by OPM’s definition, can perform their work away from the office — but are still expected to come to the worksite “on a regular and recurring basis.”
    • “OPM’s new guidance doesn’t change the definitions for federal remote work or telework, which are set in law, but rather provides additional clarifying guidance on how agencies should approach their workplace arrangements moving forward. In the document, OPM details what factors agencies should consider as they hammer out their remote work posture — both as it currently exists, as well as what it will look like in the future.
    • “The guidance builds on the Office of Management and Budget’s April 2023 memo that called on agencies to strike a balance between in-person work and telework, as well as 2021 OPM guidance that told agencies to weave telework and remote work into their workforce culture. Following those documents, OPM said human capital leaders and other senior executives asked for additional guidance on how to ensure agencies are relatively consistent as they consider changes to their remote work arrangements.
    • “OPM said it’s still up to each agency to determine the right balance for workplace flexibilities, such as remote work, for their employees. Agencies can decide if they want to offer remote work in the first place. They also have the authority to determine how they’d like to use the flexibility, and what positions are potentially good candidates for the alternative workplace arrangements.”

From the public health and medical research front,

  • American Hospital Association lets us know,
    • “The Centers for Disease Control and Prevention has updated respiratory syncytial virus vaccination recommendations for adults 60 and older. Adults aged 60-74 at increased risk for RSV and all aged 75 and older are recommended a single dose of the GSK, Pfizer or Moderna vaccine. Individuals who previously received a dosage should not seek another.” 
  • The New York Times reports,
    • “When exposed to a virus, the human body marshals the immune system to fend off the intruder. Sometimes, the defense goes awry, and the body mistakenly turns against itself instead of the attacker.
    • “This sort of friendly fire drives multi-inflammatory syndrome in children, or MIS-C, a mysterious condition that in rare cases strikes children who have had a severe bout of Covid-19, according to a new study.
    • “In a subset of children with the syndrome, immune cells become confused by the similarity between a protein carried by the coronavirus, and one found throughout the human body, said Joseph DeRisi, an infectious disease expert and the president of the Chan Zuckerberg Biohub in San Francisco, who led the study. This phenomenon is called molecular mimicry, Dr. DeRisi said.
    • The study was published on Wednesday in the journal Nature. The results offer the first direct proof that Covid-19 sets off an autoimmune reaction that leads to MIS-C.”
  • The Wall Street Journal alerts us,
    • “Antidepressants are one of several classes of medications that can make people more vulnerable to heat by tampering with the body’s internal thermostat or interfering with its cooling strategies. Others include antipsychotics, diuretics, stimulants and heart medications such as beta blockers and ACE inhibitors. 
    • “The risk is growing during longer, more frequent heat waves: Last summer was the hottest on record, and this one is setting records, too. The rate of emergency-room visits for heat-related illnesses was higher last summer than in the previous five.” * * *
    • “Many of these drugs are associated with an increased risk of heat-related hospitalizations, a study published in 2020 in the journal PLOS One found. But the extent to which these drugs pose risks isn’t well studied, said Dr. Soko Setoguchi, an epidemiologist at Rutgers University who co-wrote the study. Setoguchi said people should avoid heat, not their medication.”
  • Beckers Hospital Review informs us,
    • “Neuralink, a company co-founded by Elon Musk, has successfully implanted a second brain-computer interface device into a human subject, Nature reported Aug. 6.
    • “During a podcast released Aug. 2, Mr. Musk said the new implant is functioning well, with around 400 of its 1,042 electrodes actively transmitting signals from the person’s brain.
    • “Although details regarding the recipient or the specifics of the surgery were not disclosed, Mr. Musk said the individual, similar to the first recipient, suffers from a spinal cord injury. 
    • “The procedure comes after Neuralink’s first patient had a number of threads on the implant retracted from his brain shortly after the surgery.”
  • and
    • “New York City-based Hospital for Special Surgery has the lowest hospital wide readmission rate, according to CMS’s Unplanned Hospital Visits database.
    • “The data, released July 31, is based on provider data for hospital return days, including unplanned readmission measures in 2022.”
    • The article lists “the 10 hospitals with the highest and lowest hospital wide readmission rates, along with their respective scores.”
  • STAT News notes,
    • “Novo Nordisk is pulling its regulatory submissions to expand the use of its obesity drug Wegovy for a common type of heart failure, saying that waiting for more data on cardiovascular outcomes could bolster its case.
    • “Trials of Wegovy in the condition, heart failure with preserved ejection fraction (or HFpEF), have primarily looked at the drug’s effects on symptoms and physical function. The company plans to reapply to expand Wegovy’s label early next year when it has more data on complications such as hospitalizations and cardiovascular-related deaths, Martin Lange, Novo’s head of development, said Wednesday on an earnings call.” 
  • Per a National Institutes of Health press release,
    • “A National Institutes of Health (NIH)- supported study has found race- and sex-based differences in the increased chances of survival from people who received bystander cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest. Average survival benefits for cardiac arrest, when the heart suddenly stops beating, could be three times as high for white adults compared to Black adults and twice as high for men compared to women. The findings published in Circulation.
    • “CPR saves lives — that, we know,” said Paula Einhorn, M.D., a program officer at NIH’s National, Heart, Lung, and Blood Institute (NHLBI). “Yet the disparities revealed in this research show we need to do more to understand how to ensure equitable outcomes for all patients needing CPR. We’re hoping new insights will lead to better survival * * *.” * * *
    • “Prior research already found inequities in the frequency with which bystander CPR was being performed in Black and Hispanic individuals compared to white individuals, and with women compared to men in public places. In response, CPR training awareness and programs have expanded nationally, as have online courses. Mannequins resembling a woman’s body have also been designed.
    • “Evaluating access to and the effectiveness of different types of CPR trainings could be one way to identify differences in survival outcomes and inform solutions, according to researchers. For example, future studies could inquire about whether a bystander received online or in-person training; if they practiced on women mannequins or models with black or brown skin; if multiple bystanders were around, which may indicate a person had additional support; and what kind of support from emergency dispatchers they had — and for how long — which may reveal whether a person was receiving CPR instructions for the first time. Since the arrival times of emergency medical responders were fairly similar among groups, the researchers don’t believe this factored into outcomes observed in the study. Future studies could also explore the role that underlying health conditions may have in the survival outcomes of those who needed CPR.”

From the U.S. healthcare business front,

  • MedCity News reports,
    • “Hospital finances seem to be stabilizing overall — but a closer look shows that there is a widening gap between the highest- and lowest-performing organizations, according to a report released by Kaufman Hall this week.
    • “For the report, Kaufman Hall examined data from more than 1,300 hospitals. It showed that hospitals’ year-to-date operating margin index held steady at 4.1% in June for the second month in a row.” * * *
    • “Kaufman Hall also released another report on healthcare finances this week, with this one showing that rising labor costs are here to stay.: * * *
    • “This aligns with recent research from Strata Decision Technology, which showed that healthcare providers’ labor expenses grew by 5.2% while their non-labor costs rose by 3.3% from June 2023 to June 2024. This resulted in a 4.8% increase in overall expenses during the 12-month period, according to the report.” 
  • Healthcare Dive adds
    • “Tenet Healthcare will sell its majority ownership in Birmingham, Alabama-based Brookwood Baptist Health for about $910 million to Orlando Health, the health system said Monday.
    • “The sale, which is expected to close in the fall of this year, includes 70% of Tenet’s interest in the five-hospital system, as well as affiliated physician practices and other related operations. 
    • “The deal continues Tenet’s streak of divestitures as it looks to deleverage its portfolio. This year, the system has sold nine hospitals to Novant Health, UCI Health and Adventist Health for a combined after-tax profit of $3 billion.”
  • Beckers Payer Issues discusses payer efforts to defend affiliated prescription benefit managers.
  • The Wall Street Journal reports
    • “CVS Health’s Medicare business continued to struggle in the second quarter, fueling yet another cut to its full-year earnings outlook, a new $2 billion cost-cutting plan and the departure of a top executive. 
    • “CVS bet big on attracting seniors to its Aetna Medicare Advantage health plans last year, adding one million new people to its insurance rolls in 2024. But the gamble began backfiring in the first quarter of the year as seniors used more healthcare services than in the past and the government has become stingier in how much it pays private insurers. 
    • “On Wednesday, CVS said the pressures continued into the second quarter. The company reported total revenue of $91.2 billion in the quarter, up 2.6% from a year ago, and driven in large part by growth in its Medicare and commercial insurance businesses. 
    • But much of the sales increase was eaten up by higher medical costs, and adjusted earnings per share of $1.83 in the quarter were down 17.2% from last year. 
  • Beckers Payer Issues adds,
    • “Medicare Advantage costs could rise in the second half of 2024, CVS Health CEO Tom Cowhey told investors. 
    • “On an Aug. 7 call, Mr. Cowhey said costs in inpatient care, dental and pharmacy all rose toward the end of the second quarter. The company’s guidance for the rest of the year reflects that costs in the second half of the year could be higher than the first, the CFO said.” * * *
    • “Revenues in the company’s health benefits segment are down 40% year over year. The company ousted Aetna President Brian Kane over the financial results. Ms. Lynch and Mr. Cowhey will oversee Aetna’s day-to-day operations until a successor is named.” 
  • Per BioPharma Dive,
    • “Novo Nordisk shares tumbled 7% in early trading Wednesday after the company reported lower-than-expected revenue from its blockbuster obesity franchise.
    • “Even as revenue from Wegovy and Ozempic continued to soar, the second-quarter numbers failed to reach the high expectations set by Wall Street, analysts said. Sales of the so-called GLP-1 obesity drugs were about 9% below consensus estimates, according to analysts with the investment bank Jefferies.
    • “Overall revenue for the second quarter was “borderline in line with expectations,” Stifel analyst Eric Le Berrigaud wrote in a note to clients. But the fact that older products in Novo Nordisk’s portfolio helped offset the disappointing results for obesity drugs “is not so reassuring in the long term,” he wrote. The company’s “sales composition is not good.”
  • and
    • “The first medicine approved for a liver disease known as MASH is off to a faster launch than Wall Street analysts expected, according to quarterly results disclosed Wednesday by developer Madrigal Pharmaceuticals.
    • “Madrigal said its drug Rezdiffra, which was approved by the Food and Drug Administration in March and became available the following month, generated $14.6 million in U.S. sales in the second quarter. As of June 30, more than 2,000 patients were on treatment and coverage policies were in place for more than 50% of people with commercial health insurance, the company said.
    • “While only an early snapshot, the results surpassed consensus analysts estimates of about $4 million and have encouraged Madrigal to commercialize Rezdiffra in Europe on its own. An approval decision there is expected next year. “We’re still in the early stages, but we are confident that we’re building the foundation needed to create a blockbuster medicine,” CEO Bill Sibold told analysts.”

Tuesday Tidbits

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

From Washington, DC,

  • Per a Senate press release,
    • “Lawmakers are calling on the Government Accountability Office (GAO) to review the Medicare Part D Premium Stabilization Demonstration recently announced by the Centers for Medicare & Medicaid Services (CMS), noting its dubious legality and the danger it poses to health care affordability for seniors.  The effort comes as part of a letter to GAO from U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho), U.S. House Ways and Means Committee Chair Jason Smith (R-Missouri) and U.S. House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Washington).
    • “Through new taxpayer-financed policy adjustments, the demonstration seemingly intends to deflate seniors’ premiums that are otherwise slated to increase dramatically following the counterintuitive, haphazardly-written Inflation Reduction Act’s drug price provisions.  However, the agency has not produced any budgetary analysis and appears to lack a clear statutory basis or credible research goals for the proposal.  Crapo, Smith and McMorris Rodgers request GAO review the demonstration’s legality under section 402 of the Social Security Amendments of 1967; what budgetary analysis CMS undertook in developing the demonstration; and the estimated budgetary impact of the demonstration.”
  • FedWeek discusses similarities and differences between the House and Senate appropriations bills concerning federal workforce issues. For example,
    • “Both of the appropriations bills meanwhile would continue several long-running workplace policies that must be renewed annually. These include a general requirement that FEHB plans cover prescription contraceptives but not abortion; a ban on training not directly related to an employee’s official duties; and a ban on studying commercial type federal jobs for possible contracting-out.”
  • Reg Jones, writing in FedWeek, explains the nuts and bolts of FEHB coverage of young adult children.
  • Govexec informs us,
    • “The federal government’s dedicated HR agency reported a slight uptick in its backlog of pending federal employee retirement claims for the second straight month in July.
    • “Last month, the Office of Personnel Management reported that it received 6,451 new retirement requests, a decrease of roughly 450 cases from June. But despite increasing its output by more than 300 cases, processing 5,994 claims was not enough to stop the backlog from climbing from 15,340 in June to 15,797 last month.
    • “OPM’s goal is a “steady state” backlog of 13,000 pending claims in any given month. Since the backlog hit an eight-year low of 14,035 in May, the backlog has increased by nearly 1,800 cases.
    • “As a result, the monthly average processing time for a federal worker’s retirement request has increased from 61 days in May to 65 at the end of last month. Measured since the beginning of fiscal 2024 last October, the average wait time has remained static at 61 days since March.”

From the public health and medical research front,

  • The New York Times reports,
    • “In 2021, a survey by the Centers for Disease Control and Prevention on teen mental health focused on a stark crisis: Nearly three in five teenage girls reported feeling persistent sadness, the highest rate in a decade.
    • “But the newest iteration of the survey, distributed in 2023 to more than 20,000 high school students across the country, suggests that some of the despair seen at the height of the pandemic may be lessening.
    • “Fifty-three percent of girls reported extreme depressive symptoms in 2023, down from 57 percent in 2021. For comparison, just 28 percent of teenage boys felt persistent sadness, about the same as in 2021.
    • “Suicide risk among girls stayed roughly the same as the last survey. But Black students, who reported troubling increases in suicide attempts in 2021, reported significantly fewer attempts in 2023.” * * *
    • “For young people, there is still a crisis in mental health,” said Kathleen Ethier, head of the C.D.C.’s adolescent and school health program. “But we’re also seeing some really important glimmers of hope.”
  • WorldatWork informs us
    • “Current events and uncertainty about what the future holds is causing anxiety to increase at an alarming rate among U.S adults, according to the American Psychiatric Association’s 2024 mental health poll. This year’s version of the annual APA poll showed 43% of surveyed adults feel more anxious than they did last year, up from 37% in 2023 and 32% in 2022.
    • “According to the poll, which surveyed more than 2,200 adults, people are particularly anxious about current events, with 77% citing the economy as their greatest worry, while 73% of adults are anxious about the 2024 presidential election and 69% are anxious about gun violence.
    • “Other anxiety-inducing topics cited in the survey include safety related to family, self and identity; issues related to health; the ability to pay bills; climate change; the opioid epidemic; and advances in technology impacting day-to-day life. Americans also cited issues such as stress, sleep and social connections as contributing factors to their mental health.”
    • The article explains steps employers can take to help their employees with such problems.
  • The Wall Street Journal reports on an encouraging new approach to rotator cuff surgery that is based on the tooth structure of python snakes.
    • “When it comes to rotator cuff tendon tears, surgeons are trying to repair soft tissue back to bone, which is really stiff,” said Iden Kurtaliaj, lead author of the paper and a former biomedical engineering graduate student at Columbia. “So, if python snakes are capable of grasping soft tissue without tearing through it, [we thought] ‘Can we apply this concept to rotator cuff repairs?’”
    • “The device attaches to the shoulder bone and the tendon like a python grabs its prey, according to Kurtaliaj. In early experiments, the implant doubled the strength of repairs compared with commonly used suture restoration.”
    • The approach needs more refinement and government approval before it’s ready for prime time.
  • The New York Times lets us know,
    • “The United States spent $43 billion annually on screening to prevent five cancers, according to one of the most comprehensive estimates of medically recommended cancer testing ever produced.
    • “The analysis, published on Monday in The Annals of Internal Medicine and based on data for the year 2021, shows that cancer screening makes up a substantial proportion of what is spent every year on cancer in the United States, which most likely exceeds $250 billion. The researchers focused their estimate on breast, cervical, colorectal, lung and prostate cancers, and found that more than 88 percent of screening was paid for by private insurance and the rest mostly by government programs.
    • “Dr. Michael Halpern, the lead author of the estimate and a medical officer in the federally funded National Cancer Institute’s health care delivery research program, said his team was surprised by the high cost, and noted that it was likely to be an underestimate because of the limits of the analysis.
    • “For Karen E. Knudsen, the chief executive of the American Cancer Society, the value of screening for the cancers is clear. “We are talking about people’s lives,” she said. “Early detection allows a better chance of survival. Full stop. It’s the right thing to do for individuals.”
  • The Wall Street Journal warns us,
    • “Drinking water is crucial for preventing dehydration and keeping the body functioning, particularly in the heat of the summer. But consuming too much over a short period can lead to health problems including disorientation, nausea, vomiting and, in severe cases, seizures or death.
    • “Overhydration could be a growing issue, some researchers say, as more people train for endurance competitions like marathons, heat waves become more frequent and reusable water bottles become a staple of everyday life. The message of staying hydrated is so ubiquitous that 40-ounce, stainless-steel tumblers have become status symbols. 
    • “People have this fear that they’re always dehydrated or underhydrated and they need to fix that regularly,” said Colleen Muñoz, director and co-founder of the Hydration Health Center at the University of Hartford. “That’s probably not usually the case.”
    • “Water intoxication isn’t as well-known as dehydration. That can make it difficult to pinpoint the cause of symptoms, which can be similar to those associated with heat exhaustion or heat stroke, said Rayven Nairn, senior dietitian for student health and well-being at Johns Hopkins University.” 
  • Per a National Institutes of Health press release,
    • “A new study from the NIH National Institute of Neurological Disorders and Stroke on the occurrence of active epilepsy in sexual and gender minorities (SGM) highlights the importance of health disparities research. It found that SGM individuals—those who identify as gay, lesbian, bisexual, queer, transgender, non-binary, or gender-diverse—are twice as likely to report active epilepsy compared to their non-SGM counterparts. “Active epilepsy” means a person has been diagnosed with epilepsy and has had more than one seizure in the past year or is currently taking anti-seizure medication.” 

From the U.S. healthcare business front,

  • Per Beckers Payer Issues,
    • “Premiums for plans on the ACA marketplace will rise 7% on average in 2025, according to an analysis from Peterson-KFF Health System Tracker published Aug. 5. 
    • “Most insurers participating in the marketplace requested premium increases between 5% and 10%. Around 15% of plans requested rate decreases, and less than 10% requested rate increases higher than 15%. 
    • “The report analyzed public reports insurers made requesting premium increases. Several insurers said GLP-1 drugs, including Ozempic and Wegovy, are one of the things driving premium increases. 
    • “The pharmacy trend, especially cost, is heavily influenced by the impact of GLP-1 drugs and their use in diabetes treatment as well as the expectation for continued use with the approval for expanded indications,” Priority Health, a Michigan insurer, wrote.”
    • “Read the full report here.“
  • Per Beckers Hospital Review,
    • “Becker’s has compiled a list of the hospitals patients are most likely to recommend in every state using [recent] Hospital Consumer Assessment of Healthcare Providers and Systems data from CMS.
    • “CMS shares 10 HCAHPS star ratings based on publicly reported HCAHPS measures. The recommended hospital star rating is based on patients’ responses to the question, “Would you recommend this hospital to your friends and family?” Hospitals must have at least 100 completed HCAHPS surveys in a four-quarter period to be eligible for a star rating. Learn more about the methodology here.”
  • and
    • “More than 700 rural U.S. hospitals are at risk of closure due to financial problems, with more than half of those hospitals at immediate risk of closure.  
    • “The latest analysis from the Center for Healthcare Quality and Payment Reform, based on CMS’s July 2024 hospital financial information, reveals the financial vulnerability of rural hospitals in two categories: risk of closure and immediate risk of closure.
    • “In the first category, nearly every state has hospitals at risk of closure, measured by financial reserves that can cover losses on patient services for only six to seven years. In over half the states, 25% or more of rural hospitals face this risk, with nine states having a majority of their rural hospitals in jeopardy.
    • “The report also analyzes hospitals facing immediate threat of closure meaning financial reserves could offset losses on patient services for two to three years at most. Currently, 360 rural hospitals are at immediate risk of shutting down due to severe financial difficulties.”
    • The article breaks down by U.S. state and DC the number of hospitals in each category.
  • Per BioPharma Dive, “Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.”
  • MedTech Dive reports,
    • “Labcorp has received de novo authorization for a kitted, pan-solid tumor liquid biopsy test, the company said Friday.
    • “The product, PGDx elio plasma focus Dx, is a targeted blood test that profiles 33 cancer genes.
    • “Securing Food and Drug Administration authorization expands the cancer portfolio that Labcorp has built since buying Personal Genome Diagnostics (PGDx) for $450 million in 2022.”
  • MedCity News lets us know,
    • “Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure.
    • “In preliminary results reported Monday, Bayer said Kerendia reduced cardiovascular death and hospitalizations in heart failure patients, meeting the main goal of the Phase 3 clinical trial. The company did not release specific figures detailing the reductions, but said it will present the clinical data next month during the European Society of Cardiology Congress, which will be held in London. Bayer added that it plans to meet with the FDA to discuss a submission seeking regulatory approval for the drug in heart failure.”

Monday Roundup

David Ermer–CDC, Medicare, Mental health care, Obesity, OPM, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Kiplinger Private Finance reminds us,
    • “Beginning in 2025, people with Part D plans won’t have to pay more than $2,000 in out-of-pocket costs, thanks to a provision in the Inflation Reduction Act of 2022. The $2,000 cap will be indexed to the growth in per capita Part D costs, so it may rise each year after 2025. Part D enrollees will also have the option of spreading out their out-of-pocket costs over the year rather than face high out-of-pocket costs in any given month.”
  • The Part D EGWP benefit package is so generous for 2025 that it should sell itself. Given this juicy carrot, there is no reason why OPM chose to resort to the stick – prohibiting Part D EGBP opt outs from receiving the regular PSHBP prescription drug benefits. Hopefully, OPM will switch back to the carrot in the final PSHBP supplemental rule.
  • Govexec points out,
    • “Only 7% of the full-time civil service was under the age of 30 at the end of fiscal 2022 compared with 20% of the overall U.S. labor force, according to the Partnership. This shaky pipeline of young workers could exacerbate staffing shortages, as a 2022 White House document concluded that 30% of the federal workforce would be eligible to retire over the next five years.
    • “The underrepresentation also means that federal agencies could miss out on younger perspectives and talent, particularly from Generation Z (individuals born in the late ‘90s and early ‘00s). Gaurav Gupta — managing director of the consulting firm Kotter, which researches workforce transformation — argues that workplaces could greatly benefit from younger workers who have a “much higher propensity for change.” 
    • The article discusses approaches for attracting more Gen Zers to federal government service.
  • MedTech Dive reports,
    • “The Food and Drug Administration has approved Guardant Health’s Shield blood test as a primary screening option for colorectal cancer in average-risk adults age 45 and older, the company said Monday.
    • “Guardant is positioning the test, which can be completed during a routine doctor visit, as a more pleasant and convenient alternative to colonoscopy or stool-based tests that will encourage more people to undergo colorectal cancer screening.
    • “Shield can address a number of unscreened individuals (with a blood draw) for those not willing or unable to perform a colonoscopy or take a stool test,” Leerink Partners analyst Puneet Souda wrote in a report to clients. Still, Souda expects colonoscopy to remain the first-line screening choice of physicians based on clinical evidence, followed by Exact Sciences’ Cologuard stool test.”
  • Supreme Court journalist Amy L. Howe shares the Supreme Court’s October and November 2023 oral argument calendars. None of the scheduled cases directly impacts health plans as such.

From the public health and medical research front,

  • NBC News reports,
    • “The number of measles cases recorded this year is more than triple the total from all of last year — with five months still to go.
    • “According to data released Friday by the Centers for Disease Control and Prevention, 188 cases have been reported in 26 states and Washington, D.C. No deaths have been reported, but 93 people have been hospitalized — mostly children under 5 years old.
    • “The U.S. has seen 13 measles outbreaks this year, the largest of which took off at a migrant shelter in Chicago in March and was linked to more than 60 cases.
    • “This month, measles cases have been reported in Massachusetts, Michigan, Minnesota, New Hampshire, New York, Oregon and Vermont. Massachusetts’ case was the first in the state since early 2020.” * * *
    • “Experts attribute this year’s uptick to two main factors: declining vaccination rates in the U.S. and a rise in measles cases worldwide.
    • “Around 85% of the people who got measles this year were either unvaccinated or had an unknown vaccination status, according to the CDC. Many of the cases have been linked to international travel, meaning the disease was brought into the U.S. by travelers who were infected in other countries.”
  • STAT News tells us,
    • “With the number of U.S. dairy herds infected with H5N1 bird flu rising almost daily, fears are growing that the dangerous virus cannot be driven out of this species. That belief is amplifying calls for the development of flu shots for cows.
    • “Multiple animal vaccine manufacturers are reportedly at work trying to develop such products. And the U.S. Department of Agriculture is eagerly encouraging the effort, detailing in a notice last week what kinds of evidence would be needed to win licensing approval for cow vaccines.
    • “But a number of scientists question whether investing too heavily in this strategy is a wise approach at this point, given that there remain many outstanding questions about whether vaccinating cows would be an effective way of stopping spread of the virus in cattle in the first place. Some wonder whether farmers will be willing to absorb the costs of vaccines to prevent an infection they don’t currently view as a serious threat to their operations, or whether they would agree to the stringent post-vaccination surveillance that must go hand-in-glove with any attempt to use vaccines to solve this vexing problem.” * * *
    • “David Swayne, an avian influenza expert who worked for the USDA for nearly 30 years and is now a private consultant, agreed that vaccination of cows would have to be done as part of a more multifaceted response. “It’s not just about injecting a vaccine,” he said. “You need to then follow up to look serologically, and then you also need to follow up to make sure there’s no virus by testing, let’s say, bulk milk or something like that. Surveillance is really a critical part of any kind of vaccination program for a severe disease like [highly pathogenic avian influenza.]”
    • “Swayne acknowledged the concerns about the unanswered questions about how H5N1 is spreading in cows, but he said vaccine manufacturers should be working on vaccines while researchers are seeking those answers. Vaccines may be a necessary tool for controlling this disease in the future. “Instead of waiting until you answer all the questions on pathogenesis, it’s good to go ahead and start working on those vaccines now, so that when you get to the end, and you have all your answers, you’ve got the vaccines ready for that final step,” he said.”
  • Beckers Hospital Review lets us know,
    • “The FDA is warning healthcare providers of dosing errors associated with compounded versions of semaglutide, the active ingredient in Ozempic, Rybelsus and Wegovy.
    • “The agency has received reports of hospitalizations and adverse events tied to the issue, including gastrointestinal issues, fainting, headache, dehydration and acute pancreatitis, according to a July 26 update. 
    • “Most adverse events occurred when patients self-administered incorrect doses of weight loss drugs from multiple-dose vials, sometimes taking five to 20 times the intended amount. Several reports also involved clinicians miscalculating doses, resulting in patients receiving five to 10 times more than the intended dose. 
    • “The agency said patients’ inexperience with self-injections and confusion over different measurement units may have contributed to the errors. 
    • “FDA encourages health care providers and compounders to provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe,” the agency said in the update. “Additionally, health care providers should be vigilant when prescribing and administering compounded semaglutide, as there may be different concentrations available.”
    • “Learn more here.”
  • At this link, “KFF Examines the Latest Data on Calls, Texts, and Chats to the 988 National Suicide and Crisis Hotline, Two Years After Its Launch.” 

From the U.S. healthcare business front,

  • Per its website,
    • “”Community Health Systems (CHS) operates 71 acute-care hospitals and more than 1,000 other sites of care, including physician practices, urgent care centers, freestanding emergency departments, occupational medicine clinics, imaging centers, cancer centers and ambulatory surgery centers.”
  • Healthcare Dive adds,
    • “Community Health Systems grew same-store surgical volumes and outpatient volumes in the second quarter, helping the Franklin, Tennessee-based system trim losses for the second consecutive quarter. However, the system still posted a net loss of $13 million for the quarter.
    • “CHS attributed its improved financial position to an early “extinguishment” of debt, reduced expenses for contract labor and increased reimbursement rates.
    • “On an earnings call Thursday, CEO Tim Hingtgen said the results speak to CHS’ solid fundamentals, and said he believes the company can continue to improve in subsequent quarters. CHS raised the midpoint of its full-year EBITDA guidance by $10 million in light of the results.”
  • Per BioPharma Dive,
    • “An experimental heart drug from biotechnology company NewAmsterdam Pharma met its main goal in the first of several Phase 3 trials, but the results fell short of investor and analyst expectations.
    • “In the trial, people with an inherited condition called heterozygous familial hypercholesterolemia who received the drug alongside other medicines saw their levels of LDL, or “bad,” cholesterol fall by 36% after three months, when adjusted for placebo, and by 41% after one year. The drug, obicetrapib, reduced other markers of heart disease while its safety was “comparable to placebo,” the company said.
    • “On a conference call, NewAmsterdam CEO Michael Davidson said the results raise the company’s confidence in other ongoing studies. But shares fell by as much as one-third in premarket trading before opening down 4% Monday morning, as investors had anticipated more powerful cholesterol-lowering effects.”
  • American Hospital Association News points out,
    • “A fact sheet released July 29 by the Coalition to Strengthen America’s Healthcare features analysis from KNG Health Consulting that shows nearly half of all hospital emergency department visits occur after-hours (between 5 p.m. and 8 a.m.), when patient care options are limited. The analysis found that children are particularly more likely to receive care at an ED outside of normal business hours. It also found that of the 136 million ED visits in 2021, 18.1 million were in rural areas, and that 34.3 million visits that year were trauma related. The AHA is a founding member of the Coalition.”
  • That means over 100 million of the ED visits were not trauma related. What’s up with that?
  • Per Fierce Pharma,
    • “A month after a CDC panel narrowed its recommendations for who should receive vaccines to protect against respiratory syncytial virus (RSV), Airfinity has put numbers to the impact, reducing the projected market value in the United States by 64% by the end of the decade.
    • “The London-based healthcare analytics company has sliced the RSV market value for seniors in the US from $4.7 billion to $1.7 billion in 2030.” * * *
    • “Much still has to be decided related to RSV vaccines. Airfinity pointed out that “future dosing recommendations could change as long-term efficacy and safety data emerge.” With recommendations for a booster every two to three years, the U.S. market could increase in annual value to between $5.2 billion and $6.6 billion, Airfinity projects.”
  • The Washington Post reports,
    • “Almost half the counties in the United States lack a single cardiologist, according to a new study that puts the decades-long rural health-care crisis into sharp relief.
    • “Researchers at Brigham and Women’s Hospital in Boston looked at all 3,143 U.S. counties and found that just over 46 percent had no cardiologist, a finding senior author Haider J. Warraich called “truly shocking.”
    • “Compounding the problem, researchers discovered that risk factors for cardiovascular disease such as smoking, diabetes, obesity and high blood pressure “were actually more prevalent in the counties that did not have a cardiologist,” said Warraich, who spent several months in 2019 moonlighting as the only cardiologist in rural Randolph County, N.C.” * * *
    • “Alexander Razavi, a cardiology fellow at Emory University School of Medicine in Atlanta, said cardiologists may need to look beyond telemedicine to additional measures to reach rural communities. Cardiology practices that serve these areas, he said, might consider extending their hours or creating mobile examination units.
    • “We need to invest and provide resources to these communities,” Razavi said.”
  • Consumer Reports, writing in the Washington Post, lets us know how to know if claims made by health products are real or just hype. Check it out.


Midweek update

David Ermer–CDC, CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • At long last, the federal employee press is publicizing the Part D opt out penalty found in the proposed supplemental Postal Service Health Benefits (PSHB) Program rule.
  • Federal News Network reports, “There’s a catch in USPS insurance program for Medicare-eligible retirees. USPS annuitants who opt out of Medicare Part D will lose underlying prescription drug coverage, according to OPM’s [proposed] regulations.” Those opt out annuitants will continue to pay the full premium.
  • OPM reads the PSHB law as only offering Part D EGWP benefits to Part D eligible annuitants in the PSHBP. There is no underlying Rx coverage according to the agency’s FAQs. That statutory interpretation puts federal employees who live overseas in quite a pickle because Part D coverage is not available outside the United States.
  • In any case, it’s the FEHBlog’s legal opinion that the opt out penalty may not survive judicial review in our post-Chevron era, and because the penalty is roughly 20% of the premium, annuitants may be incented to bring a lawsuit challenging the penalty. Time will tell.
  • Govexec tells us,
    • “The Office of Personnel Management is opening a channel to provide federal employees affected by Hurricane Beryl to obtain emergency paid leave.  FEHBlog note: Beryl hit Houston TX hard.
    • “Acting OPM director Robert Shriver said in a July 19 memo that the agency had established an emergency leave transfer program, by which other federal employees may donate unused annual leave to impacted employees through the creation of agency leave banks. 
    • “Through the agency leave banks, impacted employees “who are adversely affected by a major disaster or emergency, either directly or through adversely affected family members, and who need additional time off from work” can utilize donated leave without having to use their own.” 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) has released new data on risk adjustment payments for 2023.
    • “The agency said (PDF) insurers participating on the Affordable Care Act’s exchanges will pay $10.3 billion as part of the risk adjustment program. Risk adjustment state transfers as a percent of premiums declined from 2022, according to the report.
    • “This trend is likely driven by shifts in the risk pools, according to CMS, which are likely impacted by ongoing insurer expansion into new regions.”
  • The American Hospital Association News informs us,
    • “The Substance Abuse and Mental Health Services Administration July 24 announced it is awarding $45.1 million in grants toward various behavioral health initiatives. The funding includes $15.3 million specifically planned to support children through mental health services in schools, services for those who have experienced traumatic events, and services specific to those at risk for or with serious mental health conditions.” 
  • Roll Call reports,
    • “House leaders canceled votes scheduled for next week as the GOP majority struggles to pass its fiscal 2025 appropriations bills.
    • “The decision to scrap next week’s session came a day after Republican leaders had to yank the Energy-Water spending bill from the floor amid growing doubts they could muster enough votes to pass it with their razor-thin majority. * * *
    • “GOP leaders all week had been mulling the possibility of sending members home early rather than remain in session next week as previously scheduled. Speaker Mike Johnson, R-La., said Wednesday that the decision to cancel votes next week wasn’t a direct result of problems with the appropriations bills.
    • “It’s not related to that. We’ve had a tumultuous couple of weeks in American politics and everybody’s, to be honest, still tired from our convention, and it’s just a good time to give everybody time to go home to their districts and campaign a little bit. We’ll come back and regroup and continue to work on this.”
    • “Johnson also said funeral arrangements for Rep. Sheila Jackson Lee, D-Texas, who died last weekend after a battle with pancreatic cancer, would pose logistical challenges next week. Johnson said a lot of members would want to attend the events, to be held in Houston, which could keep members away from Washington for three days.”
  • Per a Senate press release,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and five senators today introduced a bill to apply criminal penalties to rogue insurance brokers who are changing Americans’ Affordable Care Act (ACA) marketplace plans without their knowledge or consent, and take other steps to strengthen consumer health insurance protections. * * *
    • “The one-pager is available here. A summary of the bill is available here. The bill text is available here.”

From the public health and medical research front

  • ABC News relates,
    • “So far, only 25 cases of West Nile virus have been reported in 14 states, according to data from the Centers for Disease Control and Prevention. This is lower than the 117 cases reported at the same time last year. * * *
    • “Mosquitoes typically become infected with the virus after feeding on infected birds and then spread it to humans and other animals, the federal health agency said. Cases typically begin rising in July and are highest in August and September, CDC data shows.
    • “The majority of people with the virus do not have symptoms, but about one in five will experience fever along with headaches, body aches, joint pain, diarrhea, vomiting or a rash. Most symptoms disappear but weakness and fatigue may last for weeks or months.
    • “About one in 150 will develop severe disease leading to encephalitis, which is inflammation of the brain, or meningitis, which is inflammation of the membranes that surround the brain and spinal cord — both of which can lead to death. So far this year, 11 of the 25 cases have resulted in neuroinvasive disease, according to the CDC.
    • “There are currently no vaccines or specific treatments available for West Nile virus. The CDC recommends rest, fluids and over-the-counter medications. For those with severe illness, patients often need to be hospitalized and receive support treatments such as intravenous fluids.
    • “To best protect yourself, the CDC suggests using insect repellant, wearing long-sleeved shirts and pants, treating clothing and gear and taking steps to control mosquitoes. This last step includes putting screens on windows and doors, using air conditioning and emptying out containers with still water.”
  • The New York Times adds,
    • “As the bird flu outbreak in dairy cows has ballooned, officials have provided repeated reassurances: The virus typically causes mild illness in cows, they have said, and because it spreads primarily through milk, it can be curbed by taking extra precautions when moving cows and equipment.
    • “A new study, published in Nature on Tuesday, presents a more complex picture.
    • “Some farms have reported a significant spike in cow deaths, according to the paper, which investigated outbreaks on nine farms in four states. The virus, known as H5N1, was also present in more than 20 percent of nasal swabs collected from cows. And it spread widely to other species, infecting cats, raccoons and wild birds, which may have transported the virus to new locations.
    • “There’s probably multiple pathways of spread and dissemination of this virus,” said Diego Diel, a virologist at Cornell University and an author of the study. “I think it will be really difficult to control it at this point.” * * *
    • Although many infected cows did recover on their own, the researchers found, two farms reported a spike in cow deaths. On the Ohio farm, 99 cows died over the course of a three-week outbreak, a mortality rate roughly twice as high as normal.
    • “I think the potential for this virus to cause very serious disease has been downplayed a bit,” said Richard Webby, an influenza expert at St. Jude Children’s Research Hospital, who was not involved in the new study. “That has probably hurt the response.”
    • “Still, Dr. Diel noted, the cause of these deaths remains unknown. “Whether the mortality observed in those cases was due directly to influenza or whether the influenza infection led to a secondary bacterial infection, I think that’s a question that remains to be answered,” he said.”
  • Per BioPharma Dive,
    • “An experimental gene therapy from Pfizer succeeded in a Phase 3 study of people with hemophilia A, overcoming safety concerns that had put the trial on hold for almost a year.
    • “The treatment, giroctocogene fitelparvovec, is a one-time infusion designed to help patients produce a protein called Factor VIII that’s needed for normal blood clotting. Currently, people with hemophilia A use infusions of Factor VIII to prevent bleeding episodes.
    • “In the AFFINE study, researchers followed 75 patients for at least 15 months after they received Pfizer’s therapy. Study participants had fewer bleeding episodes and higher levels of Factor VIII, compared with standard prophylactic treatment before the infusion, Pfizer said Wednesday. Only one treated patient returned to prophylactic infusions.”
  • Healio notes that “In a single-center cohort of patients with heart failure and obesity, weight-loss surgery led to improved clinical outcomes including reduced BMI and HbA1c and less reliance on diuretics, researchers reported.”
  • mHealth Intelligence reports,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Humana’s CenterWell is planning to open 23 clinics at Walmart locations in four states, the company announced Wednesday.
    • “The health clinics will operate in space that previously held Walmart’s own clinics, according to the announcement. CenterWell intends to have the locations across Florida, Georgia, Missouri and Texas fully equipped, staffed and opened by the first half of 2025.
    • “The locations will operate under both the CenterWell and Conviva brands, providing senior-focused primary care. CenterWell is the fastest-growing senior-focused primary care provider in the nation, Humana said.”
  • Per Healthcare Dive,
    • “S&P Global Ratings analysts have downgraded Walgreens Boot Alliance by two notches, to ‘BB’ from ‘BBB-’, which puts the drugstore company into speculative-grade territory.
    • ‘Analysts Diya Iyer and Hanna Zhang cited guidance for the year “notably below” their expectations, and said “material strategic changes, limited cash flow generation, and large maturities in coming years are key risks to the business.”
    • “The company is struggling in its retail business as well as its pharmacy operations, they said in a Friday client note. In the U.S., margins are taking a hit on the pharmacy side from reimbursement pressure and on the retail side from declining sales volume and higher shrink. They expect Walgreens’ S&P Global Ratings-adjusted EBITDA margin to decline more than 100 basis points this fiscal year, dipping below 5%, from 6% last year, though the company’s cost cuts will counter that somewhat.”
  • MedTech Dive points out the top five medtech deals in the first half of 2024.
  • Per HR Dive,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

    Tuesday Tidbits

    David Ermer–Congress, Electronic health records, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–
    Photo by Patrick Fore on Unsplash

    From Washington, DC

    • Modern Healthcare reports,
      • “Lawmakers and executives from three major pharmacy benefit managers presented diametrically opposing views at a heated Capitol Hill hearing Tuesday, as major bills aimed at reining in the organizations remain stalled in Congress. 
      • “Members of the House Committee on Oversight and Accountability blamed the highly concentrated PBM industry for raising drug prices and running independent pharmacies out of business, while leaders from CVS Caremark, Express Scripts and Optum Rx all countered that the sector in fact lowers prices and supports local pharmacies.
      • “The hearing accompanied the committee’s release of a report detailing what its investigators characterized as abuses by the three large companies.”
    • Govexec lets us know,
      • “A federal employee group within the Justice Department last week made its final pitch to the federal government’s dedicated HR agency to boost the federal government’s coverage of in vitro fertilization and other assisted reproductive technology through the Federal Employees Health Benefits Program.
      • “The Department of Justice Gender Equality Network, an employee association representing nearly 2,000 workers at the Justice Department, sent acting Office of Personnel Management Director Rob Shriver three dozen testimonials from members describing the hardships they endured while trying to conceive. The move comes amid OPM’s final round of negotiations with insurance carriers over what FEHBP plans will cover next year.”
    • Federal News Network tells us,
      • “More than 15 years in the making, plans to update the federal pay system for blue-collar government employees are finally gaining some traction.
      • “A proposal to reform the Federal Wage System (FWS) has moved into the early stages of the government’s rulemaking process, the Federal Prevailing Rate Advisory Committee (FPRAC) announced during a public meeting Thursday morning.
      • “The proposal, if finalized, would amend the federal pay system for blue-collar government workers, more closely aligning it with the locality pay areas for the General Schedule (GS). An estimated 15,000 blue-collar feds would see their pay rates increase.”
    • Fierce Healthcare informs us,
      • “Walgreens has received $25 million in grant funding to conduct a decentralized clinical trial assessing how well a person vaccinated against COVID-19 is protected from future infections. 
      • “The award funding comes from a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), embedded in the U.S. Department of Health and Human Services. The partnership is BARDA’s first with a major retail pharmacy. Walgreens will conduct a phase IV observational clinical study, using COVID vaccine data, to assess correlates of protection, known as responses to a vaccine that predict how well a vaccinated person will be protected from future infections, using COVID-19 vaccine data.
      • “The initiative’s goal is to increase access to clinical trials. Currently, participants in a vaccine clinical trial often travel to hospitals, universities or other central locations that are far from their homes. Taking a decentralized approach through a geographically diverse retailer like Walgreens can help reach patients where they are and enable the collection of real-world data, the organizations said. The partners also hope that learning what aspects of decentralized clinical trials work for vaccine correlates of protection studies can help drive future studies at scale.”
    • The Office of National Coordinator for Health Information Technology issued a standards bulletin that is “a companion to the USCDI v5 standard document published in July 2024. This issue provides background of USCDI v5 and the new data classes and elements that support improved patient care and advance the Administration’s goals of equity, diversity, and access to health care.”
    • The Food and Drug Administration announced,
      • On Monday, [July 22,] the FDA approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
      • “Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”
      • The most common adverse reactions to Femlyv are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. See full prescribing information for additional information on the safety and effectiveness of Femlyv.

    From the public health and medical research front,

    • The American Hospital Association News relates,
      • “The Department of Health and Human Services July 23 released an amendment to a 2013 emergency declaration under the Food, Drug and Cosmetic Act that broadens the scope in which the agency can help facilitate certain medical countermeasures in response to a public health emergency such as a pandemic. The amendment now applies to pandemic influenza A viruses and others with pandemic potential, such as the current H5N1 strain of bird flu that has infected cattle and subsequently humans in some states. Previously, the declaration specifically covered just the H7N9 strain of bird flu. The declaration would allow the Food and Drug Administration to extend the expiration date of certain medical products and allow HHS to issue an emergency use authorization for unapproved drugs, devices or products, among other actions.”
    • Per BioPharma Dive,
      • “An experimental Merck & Co. drug designed to protect infants from illness caused by respiratory syncytial virus succeeded in a late-stage trial, the company said Tuesday.
      • “In a statement, Merck said the therapy, an antibody called clesrovimab, met its main safety and efficacy objectives in a placebo-controlled trial involving more than 3,600 healthy or preterm infants. Those goals included the incidence of RSV-associated lower respiratory infections requiring medical attention over the course of five months, compared to placebo, as well as the percentage of patients experiencing certain types of adverse events.
      • “A spokesperson told BioPharma Dive in an email that clesrovimab met a key secondary measure by reducing the risk of hospitalization from RSV in the trial. But the company didn’t provide specifics on that result or the rest of the study findings, which will be presented at a future medical meeting. In the meantime, Merck plans to share the data with global health authorities.”
    • Per National Institutes of Health press releases,
      • “Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in the follow-up phase of a global study among cisgender women. The analysis of outcomes from more than 300 pregnancies and infants will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
      • “Cisgender women experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during pregnancy and the postnatal period, and we need to offer them evidence-based options when they may need them most,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “These data provide reassurance about long-acting injectable cabotegravir for HIV prevention during pregnancy.”
    • and
      • “A single laboratory-based HIV viral load test used by U.S. clinicians who provide people with long-acting, injectable cabotegravir (CAB-LA) HIV pre-exposure prophylaxis (PrEP) did not reliably detect HIV in a multi-country study. In the study, a single positive viral load test was frequently found to be a false positive result. However, a second viral load test with a new blood sample was able to distinguish true positive results from false positive results for all participants whose initial viral load test was positive. The findings were presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
      • “We are still learning how to optimize the package of services that accompany long-acting PrEP, including HIV testing,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “The viral load testing findings observed in this study illuminate performance gaps in the current U.S. HIV testing algorithm for injectable cabotegravir PrEP.”
    • and
      • “Researchers at the National Institutes of Health (NIH) found that an artificial intelligence (AI) model solved medical quiz questions—designed to test health professionals’ ability to diagnose patients based on clinical images and a brief text summary—with high accuracy. However, physician-graders found the AI model made mistakes when describing images and explaining how its decision-making led to the correct answer. The findings, which shed light on AI’s potential in the clinical setting, were published in npj Digital Medicine.  The study was led by researchers from NIH’s National Library of Medicine (NLM) and Weill Cornell Medicine, New York City.
      • “Integration of AI into health care holds great promise as a tool to help medical professionals diagnose patients faster, allowing them to start treatment sooner,” said NLM Acting Director, Stephen Sherry, Ph.D. “However, as this study shows, AI is not advanced enough yet to replace human experience, which is crucial for accurate diagnosis.”
    • Per MedPage Today,
      • “Patients with dementia may instead have hepatic encephalopathy (HE) and should be screened with the Fibrosis-4 (FIB-4) index for cirrhosis, one of the main causes of the condition, new research suggests.
      • “The study of more than 68,000 individuals in the general population diagnosed with dementia between 2009 and 2019 found that almost 13% had FIB-4 scores indicative of cirrhosis and potential HE.
      • “The findings, recently published online in The American Journal of Medicine, corroborate and extend the researchers’ previous work, which showed that about 10% of US veterans with a dementia diagnosis may in fact have HE.”

    From the U.S. healthcare business front,

    • Healthcare Dive reports,
      • “HCA Healthcare reported second-quarter earnings that handily beat Wall Street expectations.
      • “The Nashville, Tennessee-based operator posted $17.5 billion in revenue, a net income of $1.5 billion and a 5.8% increase in same facility admissions. During a call Tuesday, HCA’s executive team attributed the company’s success to broad demand for services and an ability to manage expenses.
      • “HCA updated its full-year revenue guidance following the results. It now expects to draw between $69.8 billion and $71.8 billion, up from the originally forecast $67.8 billion to $70.3 billion.”
    • Modern Health points out,
      • “Molina Healthcare said Tuesday it is expanding into Connecticut through an agreement to acquire EmblemHealth subsidiary ConnectiCare Holding Co., for $350 million.
      • “The Farmington, Connecticut-based health insurer has approximately 140,000 members in marketplace, Medicare and other health insurance plans across the state, according to a news release. Molina said the purchase price represents a quarter of ConnectiCare’s $1.4 billion in expected 2024 revenue. The company said it will fund the deal with cash on hand and plans to close it in the first half of 2025.
      • “The ConnectiCare purchase is part of Long Beach, California-based Molina’s strategy to develop stable revenue streams and deploy capital more efficiently, President and CEO Joe Zubretsky said in the news release.
      • “The deal is Molina’s second acquisition this year. In January it completed the purchase of Bright Health Group’s California Medicare Advantage business for $425 million.”
    • Beckers Hospital Review identifies fifteen health systems that are dropping certain Medicare Advantage plans and notes,
      • Medicare Advantage accounted for around 1 in 4 inpatient hospitals days in 2022, according to a report from KFF published July 23.  * * *
      • In rural and micropolitan counties, the share of inpatient days from Medicare Advantage enrollees doubled between 2015 and 2022. 
      • Read more here. 
    • Behavioral Health Business discusses virtual applied behavioral therapy.
      • “It’s no secret that there is a steep supply-and-demand issue for applied behavior analysis (ABA) services nationwide. 
      • “The industry is relatively new, which means the pool of qualified professionals is still small compared to the need. There are less than70,000 board-certified behavior analysts in the U.S. Still, autism impacts 1 in 36 children, according to the CDC. 
      • “Many of those qualified clinicians are prioritizing flexibility in the workplace and turning to telehealth.”