Weekend Update

Federal employment benefits

Weekend Update

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Rx coverage, U.S. Healthcare–

Happy first day of Fall 2024!

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republican leaders on Sunday unveiled a bipartisan spending deal that would keep the government open for three more months and give the Secret Service an extra $231 million to help the agency to protect presidential candidates during the final hectic weeks of election season. 
    • “Secret Service officials have faced questions on whether a lack of resources contributed to the security lapses that enabled a gunman to shoot Republican presidential nominee Donald Trump in the ear during a campaign rally in Butler, Pa., in July. Secret Service agents stopped a second apparent assassination attempt on Trump at his Florida golf course last weekend.
    • “The additional money wouldn’t be available until the agency transmits a report on the first assassination attempt to a bipartisan task force investigating the incident. It would also give Secret Service officials the flexibility to move around money within the agency to accommodate demand through the end of the year. Leaders of both parties and President Biden have said that they are open to sending additional money to the agency.” 
  • Federal News Network informs us,
    • “Legislation to repeal the Windfall Elimination Provision and the Government Pension Offset is nearing the finish line in the House.
    • “Just over a week after it was filed, a discharge petition for the Social Security Fairness Act has reached the 218-signature threshold needed to force the bill to a floor vote.”
  • FedWeek adds,
    • “Repealing the government pension offset and windfall elimination provisions would benefit those affected by those two Social Security reductions—including current and future federal retirees under the CSRS system—by a total of $196 billion over 10 years, says a cost estimate for Congress.
    • “But that also means passage would increase costs by that much to that already financially troubled system, the Congressional Budget Office said in an estimate whose price tag may complicate the current push to enact that long-standing proposal this year.”
  • The new mental health parity rule has been published in a complete and more compact form in the Federal Register.

From the public health and medical research front,

  • STAT News lets us know,
    • “A second health worker who cared for a person hospitalized in Missouri with H5N1 bird flu developed mild respiratory symptoms but was not tested for influenza, the Centers for Disease Control and Prevention reported on Friday.
    • “The CDC said Missouri health officials didn’t learn that the health worker had symptoms until after the individual had recovered, too late to run a diagnostic test.
    • “CDC is in close communication with the state of Missouri in its ongoing investigation into the positive H5N1 case there, including regarding the identification of an additional symptomatic close contact,” a spokesperson for the agency told STAT via email. “The finding does not change CDC’s assessment that the risk to the public remains low.” * * *
    • “The CDC said that the newly identified health worker will also be asked to submit a blood sample for testing. Asked if the health care workers have agreed to provide blood samples for antibody testing, Cox said: “We should know more next week.”
    • “Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy, said there could be another explanation for this health care worker’s illness. At the time the confirmed case was in hospital, there was a lot of respiratory illness, including high levels of Covid-19 activity.
    • “We’ll have to see what the serology shows,” Osterholm said. 
    • “This news emerged as California announced it had found seven more infected dairy herds, bringing the number of affected farms in the state to 17, and the cumulative number of infected herds in the country to 215 in 14 states. The outbreak in cattle was first confirmed in late March.”
  • The Washington Post points out,
    • “Immigration status, structural racism and other social factors may contribute to disparities in cardiovascular health among Asian Americans, according to a statement prepared by a group of clinicians and researchers and published in the American Heart Association journal, Circulation.
    • “Asian Americans are less likely than White adults to have or die of heart disease, according to the Department of Health and Human Services Office of Minority Health. But researchers in the Circulation article note that cardiovascular health can vary widely between subgroups of Asian Americans and warn that combining different subgroups of people into a single “Asian” category could mask important differences.
    • “A 2021 Pew Research Center analysis of federal census data found that the number of Asian Americans grew 81 percent between 2000 and 2019, making it the nation’s fastest-growing racial group. Yet the term includes people from different subgroups, including Chinese, Indian, Filipino, Vietnamese, Korean and Japanese Americans.”
  • Per BioPharma Dive,
    • “Roche’s antiviral drug Xofluza reduced influenza transmission among household contacts in a large Phase 3 study, the company said Wednesday.
    • “Treatment with a single dose of Xofluza within 48 hours of symptom onset lowered the likelihood an infected person passed on the virus to other individuals within the same household. Roche didn’t disclose detailed results in its press release.
    • “Xofluza is currently approved to treat flu symptoms and prevent infections after exposure to the virus. The new data bolster its benefits and, according to Roche, represent the first time an antiviral drug has reduced transmission of a respiratory virus in a global Phase 3 study.”
  • MedPage Today discusses how GLP-1 drugs have the potential to reduce healthcare costs in unexpected ways.

From the U.S. healthcare business front,

  • Modern Health tells us,
    • “Cardinal Health plans to acquire Integrated Oncology Network for $1.12 billion in cash.
    • “The transaction is subject to regulatory approval and expected to close later this year, a Cardinal spokesperson said.
    • “As part of the deal, Nashville, Tennessee-based Integrated Oncology would join Cardinal’s oncology practice alliance, Navista, and share resources for practice management services, analytics capabilities and artificial intelligence tools, according to a Friday news release.
    • “Integrated Oncology has more than 50 practice sites in 10 states and represents more than 100 providers, offering medical oncology, radiation, diagnostic testing and other services.
    • “Dublin, Ohio-headquartered Cardinal, a pharmaceutical distributor and medical product manufacturer, has about 48,000 employees operating facilities in more than 30 countries. In March, the company acquired multispecialty group purchasing organization Specialty Networks for $1.2 billion in cash.”
  • Per Healthcare Dive,
    • “Cigna is the latest health insurer to roll back its Medicare Advantage offerings next year, as the privately run Medicare plans look for ways to preserve profits amid higher costs from more seniors utilizing medical care.
    • “Cigna’s planned reductions will affect 36 plans in eight states, and include the insurer exiting at least three counties entirely, according to a notice to marketing agents published by Pinnacle Financial Services on Wednesday.
    • “However, the majority of those plans have low membership, and patients in most markets will have access to another Cigna MA plan, according to the notice.”
  • Per Fierce Pharma,
    • “Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. That changed Friday.
    • “The FDA has approved Sarclisa to be used in combination with bortezomib, lenalidomide and dexamethasone (VRd) to treat patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplant.
    • “With the expansion, Sarclisa stands to give Johnson & Johnson’s Darzalex some company in the indication. Since 2018, the J&J med has been the lone CD38 antibody approved for first-line myeloma. For that Darzalex approval, the FDA cleared the med to be paired with bortezomib, melphalan and prednisone, also for transplant-ineligible patients. That Darzalex regimen is considered outdated and not used very often these days.
    • “Before the latest FDA approval, Sarclisa-VRd was recently added to the National Comprehensive Cancer Network (NCCN) myeloma treatment guidelines as a preferred regimen for transplant-ineligible patients, along with VRd alone and a Darzalex-Rd combo. All three regimens bear the highest category 1 recommendation.
    • “We’re getting access to the biggest segment of this market, and we are leveling the playing field in a major class of drug,” Olivier Nataf, Sanofi’s global head of oncology, said in a recent interview with Fierce Pharma.”

Midweek update

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • NBC News informs us,
    • “House Republicans on Wednesday defeated their own plan to avert a government shutdown at the end of the month, with the party divided over the length of a short-term funding bill and what, if anything, should be attached to it.
    • “It was an embarrassing blow to Speaker Mike Johnson, R-La., who had yanked the same funding package off the floor last week amid growing GOP defections, only to watch it collapse on Wednesday in a vote that seemed doomed from the start.
    • “The vote was 202-220 with two members voting present. In all, fourteen Republicans voted against the package and three Democrats voted for it.
    • “Thirteen days before money runs out for the federal government, there is still no bipartisan plan to stave off a shutdown. While the GOP-led House could try again, the focus now likely shifts to the Senate, where leaders in both parties agree a shutdown would be disastrous weeks before the election.”
  • Govexec adds,
    • “Legislation to cover a $3 billion shortfall in veterans’ benefits through the end of the month passed the House Tuesday, three days before benefits could be disrupted.  
    • “Lawmakers passed the Veterans Benefits Continuity and Accountability Supplemental Appropriations Act by voice vote Tuesday evening, sending it to the Senate ahead of a Friday deadline to ensure the Veterans Affairs Department can process benefit payments for 7 million veterans. * * *
    • “Senate Veterans’ Affairs Committee Chairman Jon Tester, D-Mont., said in a statement Tuesday that it was critical that the Senate move with haste to pass the legislation.”
  • STAT News reports,
    • “A House committee on Wednesday advanced legislation that would extend Medicare telehealth flexibilities, and a home hospital program adopted during the pandemic, the final step before the bills face a vote by the full House of Representatives.
    • “Congress in 2022 extended pandemic-era flexibilities about where and what kinds of care Medicare enrollees could receive over telehealth. The two-year telehealth extension unanimously passed on Wednesday by the House Energy & Commerce Committee is very similar to bills advanced in May by Commerce’s health subcommittee and the House Ways & Means Committee. 
    • “The two bills set up the House position heading into negotiations with the Senate on extending the telehealth policies, which expire at the end of December.” 
  • Per Federal News Network,
    • “House Democrats are pushing harder to try to help federal employees more easily access IVF treatments. A new bill, called the Right to IVF Act, rolls together four previous bills all aiming to broaden fertility coverage nationwide. Part of the legislation would require carriers in the Federal Employees Health Benefits Program to increase their coverage of IVF for FEHB enrollees. The Democrats who introduced the bill are calling for a House floor vote, but so far, the legislation has no Republican co-sponsors.(Right to IVF Act – Reps. Gerry Connolly (D-Va.), Susan Wild (D-Pa.), Rick Larsen (D-Wash.) and Rosa DeLauro (D-Conn.))”
  • and
    • “Federal benefits for health and retirement are a major recruitment and retention influence for employees, especially for early-career talent.
    • “Women as well as individuals in younger generations ranked the importance of federal benefits more highly than older or male employees, according to the results of the 2023 Federal Employee Benefits Survey (FEBS) from the Office of Personnel Management, obtained exclusively by Federal News Network.
    • “The benefits stemming from the Federal Employees Health Benefits (FEHB) program and the paid parental leave program are particularly important to younger generations of employees, OPM’s survey showed. Specifically, 94% of millennial and Gen Z respondents said the FEHB was either “important” or “extremely important” to them, compared with 84% of baby boomers and older generations who gave the same response.
    • “It is clear that these major benefit programs have an impact on both recruiting and retaining talent in the federal government, making it critical to continuously improve these benefits to meet employee needs,” OPM wrote in the survey results.”
  • A commentator writing in Real Clear Health commends the FEHB Program for being a catalyst for change in women’s health care and suggests three improvements:
    • Provide solutions for perimenopause and menopause
    • Provide a safety net for caregivers, and
    • Provide enhanced family planning and maternal care.
  • Mercer Consulting offers FAQs on the Supreme Court’s recent Loper Bright decision.
    • “The US Supreme Court overturned a 40-year-old principle of administrative law known as the Chevron deference doctrine (Loper Bright Enterprises et al. v. Raimondo, Secretary of Commerce, et al.). That doctrine required courts to defer to administrative agencies’ reasonable interpretation of a federal law that is silent or ambiguous. Now, federal courts must exercise independent judgment when determining the best interpretation of a statute and cannot simply defer to agency interpretations, even when they are reasonable. This will likely increase courts’ scrutiny of federal agency regulations that are subject to legal challenges. These FAQs provide high-level information about the case and its potential impact on employee benefit plans and their sponsors. Also, this Mercer US Health News 15-minute video highlights the practical implications of this opinion on employer-sponsored health plans.”

From the public health and medical research front,

  • MedPage Today lets us know,
    • “The new COVID-19 variant XEC may overtake others in circulation to become dominant in the coming months, experts said but will not prompt a meaningful change in symptoms or vaccine response.” * * *
    • “XEC represents a fairly minor evolution relative to the SARS-CoV-2 diversity currently in circulation, and is not a highly derived novel variant such as those that were granted Greek letters,” like Alpha, Delta, and Omicron, Francois Balloux, PhD, a computational biologist at University College London and director of the UCL Genetics Institute, said in a Science Media Centre statement.
    • “Experts noted that while XEC may have a small advantage in transmission, available vaccines are still likely to provide protection from serious illness.
    • “XEC is a “recombinant variant of some of the other Omicron lineages that have been around for a while, and it does appear to be more immune evasive, giving it a transmissibility advantage in the population with the immunity that it has,” Amesh Adalja, MD, of the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today. “But it doesn’t really change anything, just like the last variant didn’t change anything, or the one before that, one before that, or the one before that.”
  • NBC New points out,
    • “Black women are more likely than white women to die from even the most treatable types of breast cancer, a study published Tuesday in the Journal of Clinical Oncology found.
    • “The findings, experts say, underscore that it’s racial disparities, not biology, driving the biggest differences in death rates between Black and white women. While Black women and white women are diagnosed with breast cancer at similar rates, Black women are 40% more likely to die from the disease.” * * *
    • “If you look at breast cancer data from 40 years ago, there really weren’t differences in mortality for breast cancer between Black and white women. We weren’t very good at treating and diagnosing it. But as we’ve gotten better, the gap between white and Black women has grown,” [lead author Dr. Erica] Warner said. “That is problematic, but that also tells us we have our foot on the pedal for these differences. If we can create them, we can eliminate them.” 
  • STAT News reports,
    • “A long-running race to develop a gene therapy for the most common cause of age-related blindness is heating up.
    • “On Wednesday, 4D Molecular Therapeutics announced new data from its program for the disease, known as wet age-related macular degeneration, or wet-AMD. In one 30-person Phase 2 study, patients’ need for standard-of-care injections fell by 89% after receiving gene therapy, and 73% did not need another standard-of-care shot for at least 32 weeks. 
    • “Notably, only two of 71 patients who received a high dose of therapy have shown signs of ocular inflammation, 4D said. In 2021, another leading contender, Adverum, was set back after a patient with a related disease went blind in one eye. 
    • “I think it’s very positive and there’s a good chance they’ll be able to move toward approval,” said Ron Crystal, chair of genetic medicine at Weill Cornell Medical Hospital, who has served as a scientific adviser to and has stock in Adverum.”
  • The New York Times notes,
    • “Adults under age 50 have been developing breast cancer and colorectal cancer at increasingly higher rates over the last few decades, and alcohol use may be one factor driving the trend, according to a scientific report published on Wednesday.
    • “The report, by the American Association for Cancer Research, highlights scientific breakthroughs that have led to new anticancer drugs and improved overall survival.
    • “But the authors also described a troubling pattern: Even as cancer death rates have declined, the overall incidence of several cancers has been rising inexplicably, with an especially alarming increase among younger adults in cancers of the gastrointestinal system, like colorectal cancer.
    • “The report estimates that 40 percent of all cancer cases are associated with modifiable risk factors. It recommends reducing alcohol consumption, along with making lifestyle changes such as avoiding tobacco, maintaining a healthy diet and weight, exercising, avoiding ultraviolet radiation and minimizing exposure to pollutants.”
  • Per NIH press releases,
    • “Results from a large study supported by the National Institutes of Health show that protein analyses taken during the first trimester of pregnancy did not improve predictions for identifying people at risk for experiencing conditions related to having high blood pressure during pregnancy. Since there is an urgent need to better predict people at risk for developing conditions related to having high blood pressure during pregnancy, also called hypertensive disorders of pregnancy, researchers have been studying if proteins taken from blood or urine samples could provide this insight. This study provides the largest data to date based on using protein analyses from blood samples during early pregnancy.”
  • and
    • “Researchers at the National Institutes of Health (NIH) and their collaborators have identified a protein, known as RNF114, that reverses cataracts, a clouding of the eye’s lens that occurs commonly in people as they age. The study, which was conducted in the 13-lined ground squirrel and rats, may represent a possible surgery-free strategy for managing cataracts, a common cause of vision loss.  The study published in the Journal of Clinical Investigation.
    • “Scientists have long searched for an alternative to cataract surgery, which is effective, but not without risk. Lack of access to cataract surgery is a barrier to care in some parts of the world, causing untreated cataracts to be a leading cause of blindness worldwide,” said Xingchao Shentu, M.D., a cataract surgeon and the co-lead investigator from Zhejiang University, China.” * * *
    • “According to the scientific team, these findings are proof-of-principle that it is possible to induce cataract clearance in animals. In future studies, the process will need to be fine-tuned so scientists can stimulate specific protein degradation to see how to precisely regulate protein stability and turnover. This mechanism is also an important factor in many neurodegenerative diseases, they said.”
  • and
    • “A clinical trial supported by the National Institutes of Health (NIH) was stopped early after researchers found sufficient evidence that a drug used to treat bone marrow cancer and Kaposi sarcoma is safe and effective in treating hereditary hemorrhagic telangiectasia (HHT), a rare bleeding disorder that affects 1 in 5,000 people worldwide. The trial results, which are published in the New England Journal of Medicine, detail how patients with HHT given the drug, called pomalidomide, experienced a significant reduction in the severity of nosebleeds, needed fewer of the blood transfusions and iron infusions that HHT often demands, and showed improved quality of life.
    • “Finding a therapeutic agent that works in a rare disorder is highly uncommon, so this is a real success story,” said Andrei Kindzelski, M.D., Ph.D., of NIH’s National Heart, Lung, and Blood Institute. “Before our trial, there was no reliable therapeutic to treat people with HHT. This discovery will give people who suffer with this disease a positive outlook and better quality of life.”

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “St.-Louis-based Ascension reported a $79 million operating loss (-0.3% margin) for the 10 months ending April 30, a substantial improvement on the $1.2 billion operating loss in the previous 10-month period. 
    • “The results include $402 million in one-time, non-cash write-downs and non-recurring losses.
    • “In May and June 2024, operations were hampered by the May ransomware attack, resulting in reduced revenues from the associated business interruption along with costs incurred to address the issues and other business-related expenses.
    • “Despite this incident, Ascension drove a $1.2 billion operational improvement year over year for the 10 months ending April 30. The 136-hospital system’s economic improvement plans focused on volume growth, rates and pricing, and cost levers. 
    • “The results are a notable improvement on the $3 billion operating loss (-5.5% margin) reported in fiscal year 2023. Including the cyberattack, Ascension reported a $1.8 billion (-4.9% margin) loss in FY 2024. 
    • “Ascension is also reorganizing its portfolio with several transactions in multiple markets.”
  • Healthcare Dive tells us,
    • “Community Health Systems’ Northwest Urgent Care has signed a definitive agreement to purchase 10 Arizona urgent care centers from Carbon Health for an undisclosed price, according to a press release this week.
    • “The acquisition, which is expected to close in the fourth quarter, will grow CHS’ integrated health network to more than 80 care sites in the Tucson, Arizona region, according to CHS.
    • “The acquisition is a reversal from CHS’ recent string of hospital divestitures, which have been integral to helping the operator deleverage its portfolio.”
  • Per BioPharma Dive,
    • “Organon has agreed to buy Roivant’s dermatology subsidiary Dermavant for $175 million upfront plus more than $1 billion in potential additional payments if certain milestones are hit.
    • “With the acquisition, Organon will gain Dermavant’s cream called Vtama, which was approved in 2022 to treat plaque psoriasis. The medicine is also awaiting action from the Food and Drug Administration that could expand its use to include atopic dermatitis, commonly known as eczema.
    • “Approval in eczema, expected in the fourth quarter, would trigger a $75 million payment, Organon said Wednesday. The deal also includes $950 million in potential commercial milestone payments as well as tiered royalties on net sales to Dermavant shareholders. Roivant owns the majority of Dermavant.”
  • Fierce Healthcare points out,
    • “If a patient receives a continuous glucose monitor device through their medical benefit, they may be more adherent and may have lower costs, according to a new analysis.
    • “Researchers at CCS, which offers clinical services and home delivery for medical supplies for people with chronic conditions, published the peer-reviewed study this week in the Journal of Medical Internet Research Diabetes (JMIR) and found that patients who secured the monitors through their medical coverage had 23% higher rates of adherence.
    • “The study included data on 2,356 people, with 1,178 in the pharmacy benefit group and 1,178 in the durable medical equipment cohort. In addition to greater adherence, the study found that people who received the devices through their medical benefit had 35% lower average annual total costs of care.
    • “And, for patients who were not adherent to their devices, there was a higher rate of reinitiation (22%) for those in the medical benefit compared to those who received the glucose monitors through their pharmacy benefit (11%).”
  • Per MedTech Dive,
    • “Zimmer Biomet will phase out sales of its CPT Hip System by December due to concerns about the risk of thigh bone fractures, the Food and Drug Administration said in a Tuesday notice. 
    • “Despite plans to pull the device, the FDA said it is still concerned about the hip system being implanted in new patients, and it is “working with the manufacturer to address these concerns.” 
    • “Earlier this month, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) flagged a higher risk of thigh bone fracture after surgery with the CPT Hip System, compared with similar hip replacement devices. While the analysis is currently unpublished, the British Hip Society and the British Orthopaedic Association advised against using the implant for elective surgery unless in exceptional circumstances.”

Monday Roundup

David Ermer–Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NCQA, OPM, U.S. Healthcare–

This morning, while driving from Plano, TX, to our home in Dripping Springs, TX, the FEHBlog listened to this week’s Econtalk episode in which the host Russ Roberts interviewed Dr. Marty Makary about his new book “Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health.” I encourage folks to listen to the podcast or read the transcript, either of which is eye opening.  

From Washington, DC,

  • OPM has shared its supplemental Postal Service Health Benefits Program final rule with the Office of Management and Budget’s Office of Information and Regulatory Affairs for its review before publication in the Federal Register.
  • This is the rulemaking in which OPM laid out its plan to deprive Medicare Part D eligible members of their PSHB plan’s prescription drug benefits if they opt out of the Plan’s Part D EGWP. OPM does not reduce the premium in the event of an opt out.
  • OPM settled on this approach based on its finding that the statute is ambiguous, thereby triggering the since then discredited Chevron doctrine. In any case, the statute is not ambiguous. PSHB plans must offer a Part D EGWP, and members can choose whether or not to join the Part D EGWP.
  • As the FEHBlog has explained, the new and improved Part D program, with a $2000 out of pocket maximum, coupled with the Medicare Prescription Payment Plan, should sell itself to FEHB Part D eligible members.
  • NCQA “announced its 2024 Health Plan Ratings, an annual list that evaluates commercial, Medicare and Medicaid health plans based on assessments of patient experience and clinical quality. The 2024 Health Plan Ratings are based on data from calendar year 2023, when approximately 227 million people were enrolled in health plans that reported Healthcare Effectiveness Data and Information Set (HEDIS®) results to NCQA.”
  • Beckers Payer Issues identifies the plans with the top NCQA ratings.
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services has issued a request for information that seeks information on artificial intelligence use from health care providers, companies and others that can improve health care outcomes and care delivery. CMS plans to select organizations on a rolling basis to give 15-minute demonstrations of their AI products and services to the agency during quarterly CMS AI Demo Days which begin in October. The presentations will inform future CMS actions on AI. The deadline for questions is Sept. 27 and responses are due by Oct. 7.”

From the public health and medical research front,

  • Healio makes one of Dr. Makary’s points when it informs us that “Hormone therapy use among menopausal women has fallen to just 1.8% as of 2023, data show, despite evidence and clinical guidance suggesting HT is safe and effective for most women for bothersome menopausal symptoms.”
  • The New York Times reports,
    • “Research is revealing intriguing clues about how pregnancy changes the brain. 
    • “Studies scanning women’s brains before and after pregnancy have found that certain brain networks, especially those involved in social and emotional processing, shrink during pregnancy, possibly undergoing a fine-tuning process in preparation for parenting. Such changes correspond with surges in pregnancy hormones, especially estrogen, and some last at least two years after childbirth, researchers have found.
    • “A new study, published Monday in the journal Nature Neuroscience, adds to the picture by documenting with M.R.I.s brain changes throughout one woman’s pregnancy. It confirms previous results and adds detail, including that white matter fibers showed greater ability to efficiently transmit signals between brain cells, a change that evaporated once the baby was born.
    • “What’s very interesting about this current study is that it provides such a detailed mapping,” said Elseline Hoekzema, a neuroscientist who heads the Pregnancy and the Brain Lab at Amsterdam University Medical Center and has helped lead studies analyzing brain scans of more than 100 women before and after pregnancy.
    • “Dr. Hoekzema, who was not involved in the new study, said it showed that along with previously documented “longer-lasting changes in brain structure and function, more subtle, transient changes also occur.”
  • Consumer Reports, writing in the Washington Post, explains how to track your health at home.

From the U.S. healthcare business front,

  • Per MedCity News,
    • “A new Mercer report predicts there will be a national surplus of about 30,000 nurses by 2028. Though an overall surplus is projected nationally, there will still be significant shortages of nursing labor in a handful of states, as well as most of the country’s rural areas. To solve this issue, providers need to recruit from wider labor pools, minimize nurses’ nonclinical tasks and prioritize creating a more supportive work environment.”
  • Beckers Hospital Review discusses the threats looming over hospital revenue cycles.
  • Per MedTech Dive,
    • “Smiths Medical recalled tracheostomy kits because of a manufacturing defect that could cause the balloon to separate from the inflation line. 
    • “The recall, which includes the Portex Bluselect, Blugriggs and Bluperc kits, comprises more than 850,000 units, according to Food and Drug Administration database entries posted Wednesday. In a June letter to customers, Smiths said it received more than 10 reports of serious injuries related to the problem. 
    • “So far this year, Smiths has had seven Class I recalls, a designation the FDA uses for recalls with a risk of potential serious injury or death.”

Friday Factoids

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association (AHA) News tells us,
    • “Sens. Chuck Schumer, D-N.Y., Susan Collins, R-Maine, and Bob Casey, D-Pa., Sept. 11 introduced the SEPSIS Act, legislation which would task the Centers for Disease Control and Prevention with building on its current efforts addressing sepsis care. New efforts would include an education campaign about addressing sepsis in hospitals, improving pediatric sepsis data collection, sharing information with the Department of Health and Human Services on data collection, including the Centers for Medicare & Medicaid Services on sepsis quality measures, and the development and implementation of a sepsis outcome measure. The bill also includes a voluntary recognition program for hospitals which maintain effective sepsis programs or improve their programs over time.”  
  • The University of Minnesota’s CIDRAP lets us know,
    • “A National Academies of Sciences, Engineering and Medicine report recommends five actions to transition the National Wastewater Surveillance System (NWSS)—developed as a response to the COVID-19 pandemic—to a forward-looking version for both endemic and emerging pathogens.
    • “The paper, released yesterday, is the second and final report by the Academies’ Committee on Community Wastewater-Based Infectious Disease Surveillance done at the behest of the Centers for Disease Control and Prevention (CDC).
    • “The CDC launched the NWSS with the US Department of Health and Human Services to centralize the detection and quantification of pathogen biomarkers that people shed into the sewer system.
    • “Whereas clinical laboratory testing tracks individual cases of infection, sampling and analysis at the wastewater treatment plant level (termed community-level wastewater surveillance) provide aggregate data from the homes, businesses, and other institutions that share a common sewer system,” the committee wrote.”
  • CMS has launched a public facing website and posted a consumer fact sheet about the Medicare Prescription Payment Plan which will take effect January 1, 2025.
  • Healthline offers a projection of 2025 IRMAA brackets applicable to Medicare Parts B and D coverage for higher income beneficiaries.
  • Tammy Flanagan, writing in Govexec, offers thirteen things to know about long-term care planning.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention posted their weekly summary concerning respiratory illnesses in the U.S. today.
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
    • “COVID-19
      • “COVID-19 activity remains elevated nationally, but there are continued signs of decline in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • RSV
      • “Nationally, RSV activity remains low.
    • Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines was low for children and adults for the 2023-24 respiratory illness season. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
  • Ruh roh. The New York Times reports,
    • “Someone who lived with a Missouri resident infected with bird flu also became ill on the same day, the Centers for Disease Control and Prevention reported on Friday.
    • “The disclosure raises the possibility that the virus, H5N1, spread from one person to another, experts said, in what would be the first known instance in the United States.
    • “On Friday night, C.D.C. officials said that there was “no epidemiological evidence at this time to support person-to-person transmission of H5N1,” but that additional research was needed.
    • “The coincidental timing of the illnesses, especially outside flu season, concerned independent experts. H5N1 has been known to spread between close contacts, including those living in the same household.
    • “And neither the initial patient nor the household contact had any known exposure to the virus via animals or raw milk.
    • “Neither patient has been identified, and details are scant. The household contact was not tested, so officials cannot be sure that the individual actually was infected with the bird flu virus.”
  • More ruh roh. Health Day points out,
    • “U.S. obesity rates keep rising, with 1 in every 5 people in every state reported to be obese in 2023
    • “In 23 states, 35% or more of the population is now obese
    • “Tackling unhealthy weight gain as early as childhood may be key to turning these numbers around.”
  • The NIH Director cheers us up by writing in her blog,
    • In Parkinson’s disease, neurons in parts of the brain gradually weaken and die, leading people to experience worsening problems with movement and other symptoms. While the causes of this disease aren’t fully known, studies have suggested the Parkinson’s brain lacks fuel to power dopamine-producing neurons that are essential for movement. When too many of those neurons are lost, Parkinson’s disease symptoms appear. But what if there was a way to boost energy levels in the brain and stop the neurodegenerative process in its tracks?
    • While the findings are preliminary, an NIH-supported study reported in Science Advances takes an encouraging step toward this goal. The key element, according to the new work, is an energy-producing enzyme known as phosphoglycerate kinase (PGK1). In fact, these latest preclinical findings in models of the disease suggest that boosting this enzyme in the brain even slightly may be enough to restore energy and afford some protection against Parkinson’s disease.
    • The team, led by Timothy Ryan and Alexandros Kokotos , Weill Cornell Medicine, New York City, was inspired by recent discoveries suggesting an unexpectedly important role for PGK1 in protecting the normal function of neurons. They knew PGK1 plays an essential role in the pathway through which cells use glucose to generate and store energy in the form of adenosine 5′-triphosphate (ATP) molecules. The surprise came when studies showed the drug terazosin, which is used to treat high blood pressure and enlarged prostate, has an unexpected side effect: it enhances PGK1 activity, although perhaps weakly. * * *
    • “For the approximately one million Americans with Parkinson’s disease today, current treatments help to relieve symptoms but don’t stop the disease from progressing. These new findings raise the possibility that terazosin or drugs that enhance PGK1 activity even more may fuel the brain, helping to protect essential dopamine-producing neurons to treat or even prevent Parkinson’s disease, as well as other neurodegenerative conditions where PGK1 may play a role.”
  • Per an NIH press release,
    • “The National Institutes of Health (NIH) has established a pandemic preparedness research network to conduct research on high-priority pathogens most likely to threaten human health with the goal of developing effective vaccines and monoclonal antibodies. Currently, many of the diseases caused by these pathogens have no available vaccines or therapeutics, and investing in this research is key to preparing for potential public health crises—both in the United States and around the world. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) expects to commit approximately $100 million per year to fund the program, pending the availability of funds.
    • “The Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness network—called ReVAMPP—will focus its research efforts on “prototype pathogens,” representative pathogens from virus families known to infect humans, and high-priority pathogens that have the potential to cause deadly diseases. By studying specific prototype pathogens, scientists will build a knowledge base that could be applied to other related viruses. For example, NIAID’s earlier work on the Middle East respiratory syndrome coronavirus (MERS-CoV) played a crucial role in understanding and developing safe and effective treatments and vaccines for SARS-CoV-2, the virus that caused the COVID-19 pandemic. The ReVAMPP network will study viruses from virus families that have caused human disease for millennia—many of which have the potential to become pandemic threats in the future.
    • “In the wake of the COVID-19 pandemic and ongoing outbreaks of emerging infectious diseases, the need for robust pandemic preparedness is evident,” said NIAID Director Jeanne M. Marrazzo, M.D., M.P.H. “The ReVAMPP network will enable researchers to fill key knowledge gaps and identify strategies to develop safe and effective medical countermeasures for targeted virus families before the need becomes critical.”
  • STAT News reports,
    • “A new drug — approved by regulators last month — has shown it can delay tumor progression, meaning patients could get more years to work and travel and be with their families before subjecting themselves to the rigors of the more pernicious treatments, which can lead to a range of health and cognitive problems. It is one of the first major brain tumor breakthroughs in decades.
    • “It gives you more time to do the things you love to do and lets you live a more normal life,” said [a patient], who enrolled in the trial that led to the approval of the drug, called Voranigo and developed by the privately held French firm Servier.
    • “Taken as a daily pill, Voranigo, or vorasidenib, is a signal to researchers and other pharmaceutical companies that success in this field is possible. It’s also the first targeted therapy designed specifically for this brain cancer, homing in on a genetic mutation that drives tumor formation and bringing the type of the success seen in lung and breast cancers to among the most difficult-to-treat tumors. 
    • “The drug, which has a list price of nearly $480,000 a year, is approved for patients with specific types of brain tumors — gliomas and astrocytomas — that are categorized as grade 2, a few thousand of which are diagnosed every year in the U.S. (Brain tumors are graded on a scale of 1 to 4, with higher grades indicating tumors that are more aggressive.) It’s also only meant for people who have particular mutations in one of two related genes, known as IDH1 or IDH2, who account for the large majority of low-grade glioma patients. Now, researchers are starting to test it in combination with other treatments in more advanced brain cancers. 
    • “I was in the field for 38 years, and when you can count the number of approved drugs on one hand, you know you’ve got a difficult disease to treat,” said Mark Gilbert, who recently retired as chief of the National Cancer Institute’s neuro-oncology branch.” 

From the U.S. healthcare business front,

  • The New York Times reports,
    • Boar’s Head announced on Friday that it would indefinitely shut down the troubled Virginia deli meat plant that it acknowledged had caused a deadly listeria outbreak, killing nine people and sickening dozens more in 18 states.
    • The company also said it had identified liverwurst processing as the source of contamination and would permanently discontinue the product.
    • “Given the seriousness of the outbreak, and the fact that it originated at Jarratt, we have made the difficult decision to indefinitely close this location,” the company said in a statement posted on its website Friday. The shutdown affects about 500 workers in Jarratt, Va., a small rural town whose economic livelihood largely depended on the plant’s business.
  • Per Fierce Healthcare,
    • “Employers are bracing for a third straight year with health benefit costs increasing more than 5%, according to a new report from Mercer.
    • “The organization released preliminary findings from its annual National Survey of Employer-Sponsored Health Plans and found that the total health benefit cost for individual employees is expected to increase by 5.8% in 2025. This accounts for any cost-reduction initiatives that employers may take on.
    • “The survey, based on responses from 1,800 employers across the country, estimates that with no cost-reduction efforts, expenses would increase by 7% per worker.”
  • and
    • “Elevance Health has entered into a deal to acquire Indiana University Health Plans, the company’s Anthem Blue Cross unit announced this week.
    • “Should the deal close, IU Health Plans will operate as part of Anthem in the Hoosier State, according to the press release. Financial terms of the sale were not disclosed.
    • “IU Health Plans provides Medicare Advantage plans to 19,000 people across 36 counties and has a 4.5-star rating from the Centers for Medicare & Medicaid Services. It also has 12,000 fully insured commercial plan members, according to the release.” * * *
    • “The parties expect the deal to close at the end of 2024.”
  • Per Beckers Hospital Review,
    • “Oakland, Calif.-based Kaiser Permanente received approval from the San Jose (Calif.) planning commission during a Sept. 11 meeting to move forward with plans to demolish its existing San Jose Medical Center and build a new hospital.
    • “Kaiser Permanente San Jose is excited about this new facility, which will provide greater access to high-quality care and medical services to our members and patients in the greater San Jose community,” a spokesperson for Kaiser shared with Becker’s in a Sept. 12 statement. 
    • “The project, which the health system shared initial plans for in February, would demolish the current 250,000-square-foot hospital and develop a new 685,000-square-foot hospital, central utility plant and a five-level parking garage, resulting in the addition of around 800 new employees.
    • “It would also increase bed count from 247 to 303, according to project highlights during the meeting.” 
  • Per Healthcare Dive,
    • “Steward Health Care exited a federal bankruptcy court hearing on Wednesday absolved of billions of dollars in outstanding lease agreements and with a plan to keep the majority of its remaining hospitals open.
    • “Under the deal, Steward’s landlord, Medical Properties Trust, will forgive approximately $7.5 billion in outstanding obligations and allow Steward to receive $395 million in proceeds from a recent hospital sale in Florida in order to pay its lenders and unsecured creditors, according to testimony from the health system’s chief restructuring advisor, John Castellano.
    • “In exchange, Steward will waive its rights to pursue lawsuits against the real estate investment trust.”
  • Per Fierce Pharma,
    • “When Roche’s Genentech gained approval for Ocrevus in 2017, the first-in-class infused drug quickly became the best-selling treatment in a crowded multiple sclerosis (MS) market. Three years later, Novartis’ next-in-class Kesimpta stole some of Ocrevus’ thunder, offering a convenience edge with its once-monthly, at-home prefilled injection. 
    • “Now, Genentech has responded with a new formulation as the FDA has endorsed a subcutaneous version of Ocrevus. While it can’t match the at-home convenience of Kesimpta, subcutaneous Ocrevus Zunovo, with its twice-a-year, under-the-skin dosing regimen, provides an attractive option.
    • “This is something than can be provided in clinics and doesn’t require people to go to an infusion center,” David Jones, Genentech’s medical director for MS, said in an interview. “This will expand access to individuals who may not be able to access Ocrevus now, especially for reasons like geography or rural setting, individuals that might have challenges with their healthcare provider.”
    • “Ocrevus Zunovo can be injected in 10 minutes, compared to the two-plus hours needed for an infusion of the drug. For patients who experience side effects, the intravenous infusion can take up to four hours.” 
  • and
    • “It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company’s initial launch plans last year.
    • “The agency was originally slated to issue its verdict on Tecentriq in its under-the-skin formulation last September but the drug’s manufacturing processes needed updating, Roche’s delivery technology partner Halozyme Therapeutics said in a filing at the time. The tweaks, which a Roche spokesperson said were made in response to the FDA’s evolving requirements, were expected to wrap up in 2023 to support a 2024 launch. The world-first approval for the formulation came in the U.K. last year. 
    • “Now, the therapy has been cleared for use in the U.S. in all of the Tecentriq adult formulation’s indications, including types of lung, liver, skin and soft tissue cancers. The new version uses Halozyme’s Enhanze drug delivery tech to subcutaneously inject the product over seven minutes, compared to the 30 to 60 minutes needed for an IV infusion.
    • “By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” Roche’s chief medical officer and head of global product development Levi Garraway, M.D., Ph.D., said in a press release.”

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, Patient safety, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Two U.S. senators are aiming to crack down on deceptive or misleading online promotion of weight-loss and other prescription drugs by telehealth firms and social-media influencers who profit from their posts.
    • “New bipartisan legislation proposed by Sens. Dick Durbin (D., Ill.) and Mike Braun (R., Ind.) would authorize the Food and Drug Administration to warn and potentially impose costly fines on those who post false information online about medicines or omit important information about a drug’s safety risks.
    • “One impetus for the bill, according to a Senate aide, is the 2024 reporting by The Wall Street Journal about how social media has fueled demand for Ozempic and Wegovy from Novo Nordisk as well as other drugs used for weight loss. The Journal found that posts on platforms such as TikTok, YouTube and Instagram often omit information about difficult side effects, and that some influencers and companies profit from the posts.”
  • Healthcare Dive informs us,
    • “Top executives at major pharmacy benefit managers are standing behind recent testimony on the Hill that put them in hot water with the chair of the powerful House Oversight Committee.
    • “Chair James Comer, R-Ky., accused Patrick Conway, the CEO of UnitedHealth’s Optum Rx; Adam Kautzner, the president of Cigna’s Express Scripts; and David Joyner, the president of CVS’ Caremark, of lying during a July hearing, and gave them until Wednesday to correct their statements or face potential fines or jail time.
    • “Optum Rx, Caremark and Express Scripts have responded to Comer and declined to change any testimony, the companies confirmed. The House Oversight Committee is “reviewing the PBMs’ written responses as well as the additional documents and information they provided,” according to a spokesperson.”
  • Per Fierce Healthcare,
    • “Steward Health Care CEO Ralph de la Torre, M.D., defied a subpoena to testify before Congress Thursday morning, leading heads of the investigating committee to promise civil enforcement and criminal charges for the executive.
    • “During the summer, the Senate Committee on Health, Education, Labor and Pensions (HELP) had voted to issue its first subpoena in over 40 years. Chairman Bernie Sanders, D-Vermont, said at the time that de la Torre needed to “explain to Congress the financial chicanery that made him extremely wealthy while the hospitals he managed went bankrupt.”
    • “Sanders and Committee Ranking Member Bill Cassidy, M.D., R-Louisiana, said Thursday that de la Torre’s legal team suggested he would be in attendance until they received a letter eight days ago. The letter informed the committee that he would not be attending out of concern that his testimony could harm the company’s ongoing bankruptcy proceedings. His legal counsel also suggested that the senators planned to turn their hearing into a “pseudo-criminal proceeding.”
    • “The committee overruled the letter a day later and told de la Torre to show up anyway. He did not.”
  • American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention Sept. 12 released a rural health strategic plan which includes the agency’s key priorities, objectives and outcomes in rural health for the next five years. The CDC’s priorities include advancing results-based engagement with partners and communities to address rural health challenges, strengthening rural health infrastructure and the workforce, advancing rural health science and improving rural health preparedness and response capacity. As part of the fiscal year 2023 Congressional appropriations, CDC created an Office of Rural Health to coordinate its growing rural health portfolio across the agency.”
  • Per HHS press releases,
    • “Today, the Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Health (OASH) and the Health Resources and Services Administration (HRSA), announce a Notice of Proposed Rulemaking (NPRM) to amend the regulations implementing the National Organ Transplant Act of 1984. * * *
    • “The proposed rule change, if finalized, would remove clinical research and institutional review board (IRB) requirements for transplantation of kidney and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. The proposed rule, Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act, is based on rigorous analysis of clinical data.
    • “If the proposed rule is finalized, HHS expects this rule will allow a larger number of transplant centers to conduct HOPE Act kidney and liver transplants and will help reduce the stigma and health disparities associated with HIV. 
    • “Public comments on the NPRM are due 30 days after publication of the NPRM in the Federal Register on October 15, 2024, at 11:59 PM ET. The NPRM may be viewed or downloaded at: Federal Register: Public Inspection: Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act.”
  • and
    • “Today, the U.S. Department of Health and Human Services, through the Office of Research Integrity (ORI), finalized the 2024 Public Health Service (PHS) Policies on Research Misconduct. This rule updates the 2005 regulation and clarifies requirements for addressing research misconduct in PHS-funded research.” * * *
    • “The research landscape has changed over the past 20 years with new technology, scientific advances, and globalization, which increases the need for ORI to remain nimble and collaborative. ORI is committed to keeping up with the needs of the research community,” said ORI Director Sheila Garrity. “The Final Rule aims to adapt to our current time, support our colleagues in the research community, and fortify ORI’s role in fostering research integrity and preserving public trust in science for future generations.”
    • “The Final Rule takes effect January 1, 2025, and becomes applicable on January 1, 2026. In the coming months, ORI plans to release sample policies and guidance to help prepare PHS-funded entities. The Final Rule can be found here https://www.federalregister.gov/public-inspection/2024-20814/public-health-service-policies-on-research-misconduct.”
  • FedWeek discusses the all-important Five-Year Rule which generally is a prerequisite for continuing FEHB and FEGLI coverage into federal retirement.

From the public health and medical research front,

  • STAT News reports,
    • “Disease investigators have not been able to determine how a person in Missouri with no known exposures to animals or poultry became infected with an H5 bird flu virus, the principal deputy director of the Centers for Disease Control and Prevention said Thursday.
    • “But Nirav Shah said the ongoing investigation has turned up no evidence of onward spread of the virus, suggesting this case may turn out to be a one-off infection that defies explanation.
    • “Here’s the bottom line: Our influenza surveillance system is designed to find needles in haystacks,” Shah said at a news briefing. “Here in this case, we found such a needle, but we don’t know how it got there. Our investigation continues, and we will keep everyone updated as we learn more.”
  • and
    • “Gilead said Thursday that its twice-yearly antiviral reduced the risk of HIV infections by 96% compared to an expected rate of infection in a second pivotal trial, paving the way for the likely approval of the drug for pre-exposure prophylaxis, or PrEP.
    • “The study, which enrolled cisgender men, transgender women, transgender men, and gender nonbinary individuals who have sex with partners assigned male at birth, also showed that the antiviral, called lenacapavir, was 89% more effective than a daily pill called Truvada.
    • “Specifically, two out of the 2,180 participants taking lenacapavir contracted HIV, while nine out of the 1,087 individuals in the Truvada group did.
  • The New York Times reports,
    • One dozen of 36 cinnamon products tested by a consumer group contained elevated levels of lead, according to a study released on Thursday that reinforced concerns about metals in foods after tainted cinnamon applesauce poisoned dozens of children last year.
    • The study, by Consumer Reports, documented levels that were far lower than the amounts discovered last year.
    • The Consumer Reports team tested the spice and found high levels in lead in 12 items sold at discount stores and ethnic markets, with lead levels reaching 3.5 parts per million. New York, the only state with tough lead standards in spices, recalls spices — among them curry powder, chili powder, cumin and five-spice powder — with more than one part per million of lead. Consumer Reports advised that people throw out items with that amount.
  • The American Hospital Association News lets us know,
    • “The AHA Sept. 12 released a new report that found hospital and health system performance on key patient safety and quality measures was better in the first quarter of 2024 than it was prior to the COVID-19 pandemic, and that hospitals made these improvements while caring for patients with more significant health care needs.  
    • “Hospitals and health systems are continuously working to advance patient safety and quality — which is always the hospital field’s top priority,” said AHA President and CEO Rick Pollack. “This report shows hospitals have made significant improvements on pre-pandemic performance in key patient safety outcomes. Hospitals’ commitment to improving patient outcomes and enhancing the patient experience continues to drive these efforts forward.”  
       
  • Beckers Hospital Review points out,
    • “Among 95 patients who are overweight or obese, an experimental daily pill from Novo Nordisk reduced their mean body weight by 13.1%, NBC News reported Sept. 10. 
    • “Novo Nordisk, the manufacturer of Ozempic, Wegovy, and other popular GLP-1 drugs, shared the phase 1 trial results at the European Association for the Study of Diabetes annual meeting. 
    • “The Denmark-based company recruited 124 patients and randomly assigned them either a placebo or its daily pill candidate, amycretin, to take for 12 weeks. Amycretin is a GLP-1 and protein-based unimolecular amylin, according to an abstract on the association’s website. 
    • “The trial’s primary endpoint was the number of treatment-emergent adverse events — which were found to be mild to moderate — and body weight changes were a key exploratory endpoint. The weight reduction results are “remarkable,” according to the abstract.
  • Per MedPage Today,
    • “The FDA warned that fezolinetant (Veozah), a hormone-free pill for moderate to severe hot flashes caused by menopause, could cause rare but serious liver injury.
    • “If women experience any signs or symptoms suggesting liver injury, they should stop fezolinetant, the agency said. Symptoms include new-onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or right upper quadrant pain.
    • “Treatment discontinuation may prevent worsening liver injury and may potentially return liver function to normal, the FDA explained.”
  • Per an NIH press release,
    • “National Institutes of Health (NIH) researchers and collaborators have found that being a carrier for sickle cell disease, known as having sickle cell trait, increases the risk of blood clots, a risk that is the same among diverse human populations that may not traditionally be associated with sickle cell disease. The study provides estimated clinical risks for people with sickle cell trait, which can inform clinical practice guidelines. Researchers examined the largest and most diverse set of people with sickle cell trait to date, which includes data from over 19,000 people of various ancestral backgrounds with sickle cell trait.  
    • The study, published in Blood Advances was led by researchers at National Human Genome Research Institute (NHGRI), part of NIH, The Johns Hopkins University School of Medicine, Baltimore, and the company 23andMe, South San Francisco, California.  * * *
    • “This study, therefore, provides important insights about patterns of venous blood clots and suggests a unique mechanism of blood clotting in people with sickle cell trait,” said Rakhi Naik, M.D., clinical director for the Division of Hematology at Johns Hopkins University, Baltimore, who co-led the study. “Knowing the risks of blood clots in people with sickle cell trait is important for situations such as surgeries or hospitalizations, which add to the risk of developing serious blood clots.” 
    • Over 2 million people in the United States have sickle cell trait. People with sickle cell trait have one copy of the genomic variant that causes sickle cell disease, a genetic condition that causes red blood cells to become rigid and sticky, which blocks blood flow. While people with sickle cell trait typically do not have any associated health complications, they are carriers for sickle cell disease. In rare cases, sickle cell trait has been found to be a risk factor for health complications such as muscle breakdown, presence of blood in the urine and kidney disease.  
  • Per Healio,
    • “Nearly one in 20 adults in the U.S. are estimated to have atrial fibrillation, many more than previous studies had indicated, according to new data out of the University of California, San Francisco.
    • “Atrial fibrillation doubles the risk of mortality, is one of the most common causes of stroke, increases risks of heart failure, myocardial infarction, chronic kidney disease and dementia, and results in lower quality of life,” Jean Jacques Noubiap, MD, PhD, postdoctoral scholar at University of California, San Francisco, said in a press release. “Fortunately, atrial fibrillation is preventable, and early detection and appropriate treatment can substantially reduce its adverse outcomes.”
  • The Institute for Clinical and Economic Review announced the release of a Draft Evidence Report on Treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease. The Public comment period now open until October 8, 2024; Requests to make oral comment during public meeting also being accepted.

From the U.S. healthcare business front,

  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones.
    • Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.” 
  • McKinsey and Company explain why the U.S. physician shortage isn’t going anywhere.
  • STAT News reports,
    • “A new [medical debt relief model] pioneered in North Carolina shows how hospitals could make money off of a larger national program.
    • “In North Carolina, hospitals are set to collect billions in federal money to cancel patients’ medical debt and implement new policies to help prevent debt from accumulating in the first place. The funding comes as part of the state’s Medicaid expansion.
    • “Hospitals have significant political power to work federal programs to their advantage, and the template opens the door to other creative ways to use taxpayer funds to pay providers for medical debt. Read the full case study here.”
  • Beckers Payer Issues notes,
    • “Anthem Blue Cross Blue Shield is requesting payments from some providers it alleges falsified patients’ medical records when prescribing Ozempic, Bloomberg reported Sept. 12. 
    • “A spokesperson for Elevance Health, which owns Anthem BCBS, told Bloomberg it contacted a small number of providers about repayments for Ozempic prescribed to their patients. In some cases, the amount of repayment requested was more than $1 million. 
    • “Representatives for Elevance told Bloomberg that Anthem BCBS only covers Ozempic for patients with Type 2 diabetes. The drug is not approved by the FDA for weight loss, but is often prescribed off-label for that purpose.” 
  • Per Becker’s Hospital Review,
    • “A Wilmington, Del.-based physician has agreed to pay more than $1 million to settle allegations he violated the False Claims Act by ordering medically unnecessary durable medical equipment for Medicare and Federal Employees Health Benefits Program patients. 
    • “Vishal Patel, MD, referred patients for more than 1,750 orthotic devices between February 2018 and April 2019, according to a Sept. 11 Justice Department news release. The department alleged that Dr. Patel had no medical relationship with these patients and the referrals were based on brief reviews of their medical charts. 
    • “Medicare and the Federal Employees Health Benefits Program paid more than $400 on average for each device, according to the release. The patient files were provided to Dr. Patel by RediDoc, a telemedicine company whose owners pleaded guilty in 2022 to their roles in a $64 million fraud scheme. 
    • “The claims resolved by Dr. Patel’s settlement are only allegations and there has been no determination of liability, according to the release.”  

Tuesday’s Tidbits

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

From Washington, DC

  • BioPharma Dive reports
    • The U.S. House of Representatives voted Monday to approve legislation that would restrict U.S. companies from working with five China-based biotechnology firms on clinical development, research and manufacturing, in an attempt to secure the pharmaceutical supply chain.
    • The Biosecure Act passed 306-81 under a procedure used to pass relatively noncontroversial legislation. It was left out of a large Department of Defense bill that cleared the House in June, but may yet need to be included in a Senate version of that defense bill for it win support in that chamber.
    • The legislation would prohibit the federal government from contracting with the five “companies of concern” or any biotech that has a contract with those companies. Drugmakers with current contracts would have until 2032 to allow those deals to expire before being subject to the law.
  • Roll Call and Govexec bring us up to date on FY 2025 appropriations measures under consideration on Capitol Hill.
  • Govexec tells us,
    • “A bipartisan pair of lawmakers on Tuesday filed a discharge petition seeking to force a vote on the House floor on a measure that would eliminate a pair of controversial tax rules that reduce the retirement benefits of some ex-government workers.
    • “Reps. Abigail Spanberger, D-Va., and Garret Graves, R-La., are the lead sponsors of the Social Security Fairness Act (H.R. 82), a measure introduced last year that would eliminate Social Security’s windfall elimination provision and government pension offset.” * * *
    • “Though the bill has widespread support in Congress among both parties—with more than 300 cosponsors in the House alone—the chamber’s leadership has balked at allowing the bill to receive a floor vote. If Spanberger and Graves can secure at least 218 signatures among House lawmakers, they can then force such a vote to take place.”
  • FedWeek reminds us,
    • “September 30 is the end of the “special enrollment period” in which Postal Service retirees eligible for Medicare Part B but not currently enrolled in it may elect that coverage without the standard penalty for enrolling more than three months beyond first eligibility, which typically is on turning age 65.” * * *
    • “Further information on the special enrollment period is here.
    • “Meanwhile, the announcement of plans, coverage terms and premium rates in both the FEHB and the PSHB for 2025 is just ahead. That announcement commonly comes in late September or early October, with fuller information provided just ahead of the open season for enrolling or changing current enrollments, which this year will run November 11-December 9.”
  • Newfront poses a Q&A,
    • “Question: What steps do employers need to take to ensure their coverage meets the ACA affordability standard in 2025?
    • “Short Answer: The 2025 ACA affordability threshold increases to 9.02%. The easiest way to ensure affordability in 2025 is to meet the federal poverty line affordability safe harbor by offering at least one medical plan option (that provides minimum value) for which the monthly employee-share of the premium for employee-only coverage does not exceed $113.20. Otherwise, employers will need to calculate the applicable affordability threshold under one of the other safe harbor approaches, which are based on employee compensation levels.”
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), recently awarded $68 million in grants for suicide prevention and mental health care programs. Addressing the U.S. mental health crisis and preventing suicide are top priorities of the Biden-Harris Administration and part of President Biden’s Unity Agenda.
    • “Every September we recognize Suicide Prevention Month as a time to raise awareness—to remind those struggling that they are not alone and that there is hope. Many people who have experienced suicidal thoughts are alive today because they got help,” said HHS Secretary Xavier Becerra, “The Biden-Harris Administration is deeply committed to expanding and improving suicide prevention in order to save lives. That is why we launched the 988 Suicide & Crisis Lifeline two years ago and why we continue to invest in suicide prevention programs that help save lives across this country.”
  • The Census Bureau posted its report with 2023 statistics on health insurance coverage in the United States based on information collected in the Current Population Survey Annual Social and Economic Supplement (CPS ASEC).
    • “Of the subtypes of health insurance coverage, employment-based insurance was the most common, covering 53.7 percent of the population for some or all of the calendar year, followed by Medicaid (18.9 percent), Medicare (18.9 percent), direct-purchase coverage (10.2 percent), TRICARE (2.6 percent), and VA and CHAMPVA coverage (1.0 percent).
    • “While the private coverage rate was statistically unchanged between 2022 and 2023, the employment-based coverage rate declined by 0.7 percentage points to 53.7 percent in 2023. At the same time, the rate of direct-purchase coverage increased by 0.3 percentage points to 10.2 percent in 2023.”

From the public health and medical research front,

  • Modern Healthcare reports,
    • “Cost, wait times, transportation problems and negative interactions with healthcare professionals are driving U.S. women to delay medical care or skip it altogether, according to a recent Deloitte survey.
    • “Half of the approximately 1,000 women who responded to the consultancy’s 2024 Health Care Consumer Survey said they had forgone care in the past year, compared with 37% of men, Deloitte said in a report Tuesday.
    • “Deloitte paired the results of its survey — which asked a representative sample of roughly 2,000 people in February 2024 about how everyone in the country could have quality medical care — with an analysis of claims data. It found that although women require on average almost 10% more health services than men, they’re about 35% more likely to say they’ve skipped or delayed care.”
  • JD Supra offers “5 Tips for Employers to Prepare for Cold, Flu, and COVID Season.”
  • The Centers for Disease Control and Prevention suggest five actions that communities can take to reduce suicides.
  • Per National Institutes of Health press releases,
    • “A scientific team supported by the National Institutes of Health (NIH) has created a preclinical blood test to identify adults most likely to develop severe respiratory conditions, including chronic obstructive pulmonary disease (COPD). The blood test analyzes 32 proteins that scientists determined accurately predicted an adult with an increased likelihood for requiring medical care for or dying from severe respiratory illness. The risk score was based on lung health data collected from nearly 2,500 U.S. adults over a 30-year period. The findings were published in the American Journal of Respiratory and Critical Care Medicine(link is external).
    • “We are still not ready for this test to be used in practice, but it’s a promising advance,” said James P. Kiley, Ph.D., director of the Division of Lung Diseases at NIH’s National Heart, Lung, and Blood Institute (NHLBI), which funded the study. “It consolidates insights from decades of breathing tests and medical evaluations into a single tool that has the potential to identify patients at risk for severe disease and complications.”
  • and
    • “Providing optional syphilis tests to most people seeking care at a large emergency department led to a dramatic increase in syphilis screening and diagnosis, according to a National Institutes of Health (NIH)-supported study of nearly 300,000 emergency department encounters in Chicago. Most people diagnosed had no symptoms, which suggests that symptom-based testing strategies alone could miss opportunities to diagnose and treat people with syphilis. The results were published today in the journal Open Forum Infectious Diseases.
    • “The Centers for Disease Control and Prevention (CDC) estimates that adult and congenital syphilis cases increased by 80% and 183% respectively between 2018 and 2022. Improved syphilis diagnosis strategies will be essential for reaching populations such as pregnant women and people with limited access to health care. The optimal model for syphilis screening has not been identified, particularly for preventing congenital syphilis. Previous literature supports targeted emergency department syphilis screenings based on clinical factors such as active symptoms or pregnancy. However, the screening criteria used in those models would not capture most people whose syphilis is asymptomatic.”
  • Here is a link to NIH’s Research Matters report covering “Deep brain stimulation for Parkinson’s | Brain-computer interface for speech | Glucose metabolism and Alzheimer’s disease.”
  • Per STAT News,
    • “The first late-stage trial of a GLP-1 drug in young children with obesity showed the treatment helped lower body mass index. But the findings also raise questions about whether obesity medications, some of which are currently approved for teenagers, should also be given to children at such a young age.”
  • Per Medscape
    • “Sustained participation in a community-based structured exercise program is linked to a reduced risk for all-cause hospitalization among older adults, but the benefits varied by gender {favoring women], according to a new study.”
  • Ruh roh. Bloomberg Prognosis lets us know,
    • “I [the reporter] was exposed to Covid at a family get-together in upstate New York last month. Two days later, I woke up feeling awful — sniffles, fatigue and fever. So I swabbed both nostrils with the last Covid test in our cabinet. 
    • “To my great surprise, it was negative, and I went back to sleep. When I tested again two days later, it turned positive in seconds. I started to wonder: Are home Covid tests bad at detecting the latest variants?
    • “The short answer is no, the doctors I spoke with told me. But that answer comes with a big caveat. It turns out the way the immune system interacts with the virus these days means home tests may not turn positive until several days after you get sick.”
  • More ruh roh. The New York Times reports,
    • “Two years before a deadly listeria outbreak [earlier this year], U.S. inspectors warned that conditions at a Boar’s Head plant posed an “imminent threat” to public health, citing extensive rust, deli meats exposed to wet ceilings, green mold and holes in the walls.
    • ‘But the U.S. Agriculture Department did not impose strict measures on the plant, in Jarratt, Va., which could have ranged from a warning letter to a suspension of operations.
    • “Since then, other inspections found that many of the problems persisted, but again, the plant continued to process tons of beef and pork products, including liverwurst.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “More providers are opting out of contracts with Medicare Advantage plans as national insurers reconfigure their networks, leaving patients in limbo.
    • “Medicare Advantage enrollment and profitability surged in recent years as a growing number of seniors sought plans with minimal copays and extra benefits not offered in traditional Medicare. However, Medicare Advantage enrollment growth has slowed and insurance companies’ earnings per member have declined over the past year as insurers grapple with stiffer competition, higher medical costs and utilization, lower reimbursement rates and stricter regulatory oversight.” * * *
    • “This is just the start of insurers’ squeeze on Medicare Advantage markets and provider contracts, the effects of which will grow as Medicare Advantage enrollment is expected to account for about 60% of all Medicare membership by 2030, consultants, analysts and policy experts said.
    • “This is the first year that MA plans have really hammered hospitals, and I think it will get uglier,” industry consultant Paul Keckley said.
    • “Health systems have walked away from in-network agreements or looked to scale up as a buffer and negotiating tool.”
  • and
    • “The American Medical Association released its updated list of Current Procedural Terminology codes for 2025, adding 270 new universal codes used for billing healthcare services and reimbursing providers.
    • “The organization announced 420 updates to its list Tuesday, with several revisions and additions for genetic testing, digital health services like remote patient monitoring and care involving artificial intelligence.”
  • Even more ruh roh. The American Hospital Association News complains,
    • “Hospitals and health systems are seeing significant increases in administrative costs, including due to burdensome practices by commercial insurers that often delay and deny care for patients, according to a new report released Sept. 10 by the AHA. 
    • “Many hospitals and health systems are forced to dedicate staff and clinical resources to appeal and overturn inappropriate denials, which alone can cost billions of dollars every year,” the report notes. 
    • “Among other findings, the report highlights recent data from Strata Decision Technology showing that administrative costs alone account for more than 40% of total expenses hospitals incur in delivering care to patients. In addition, between 2022 and 2023, care denials increased an average of 20.2% and 55.7% for commercial and Medicare Advantage claims, respectively.” 
  • Per Fierce Healthcare,
    • “UnitedHealth Group’s Optum Rx will join its peers in the big three pharmacy benefit managers by pulling Humira from some of its preferred formularies, according to a report from Reuters.
    • “Instead, it will recommend a cheaper biosimilar as the preferred option beginning Jan. 1, 2025, according to the article. Amgen’s Amjevita biosimilar will be among the options.
    • “CVS Health’s Caremark announced similar steps in April, and Cigna’s Express Scripts unit followed suit in August. Prescriptions for Sandoz’s Hyrimoz biosimilar spiked after CVS removed Humira from its major commercial formularies, according to a report in Stat.
    • “Reuters reported that UnitedHealth will continue to offer Humira coverage until the biosimilars are awarded an interchangeable designation from the Food and Drug Administration, which is expected in 2025.”

Friday Factoids

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC,

  • Federal News Network tells us,
    • “House Republicans are leading a supplemental funding bill to address a multi-billion-dollar budget crunch at the Department of Veterans Affairs.
    • “Leaders of the House Appropriations and House VA committees introduced a bill Friday that would give the VA $3 billion to ensure the department can keep paying benefits to veterans for the rest of the fiscal year.
    • “The Veterans Benefits Continuity and Accountability Supplemental Appropriations Act would ensure the VA has enough funding to keep paying veterans’ compensation, pension and readjustment benefits for the rest of fiscal 2024.
    • “The emergency funding bill, however, does not address a $12 billion shortfall the VA anticipates for fiscal 2025.” * * *
    • “The supplemental spending bill would require the VA to give Congress regular updates on the status of funds needed to pay veterans’ benefits until the end of fiscal 2026.
    • “The bill would also require the VA’s inspector general office to issue a report on the root causes of the VA’s budget shortfall.”
  • Per an FDA press release,
    • “Today, the FDA issued a draft guidance “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle”. This guidance, when finalized, is intended to provide recommendations on how patient preference information might be collected and shared with the FDA and potentially be considered in FDA decision-making processes. It also provides recommendations on designing patient preference studies that may provide reliable scientific evidence. On Oct. 15, 2024, the FDA will host a webinar for industry and other parties interested in learning more about the draft guidance. Please submit comments under docket number FDA-2015-D-1580 at www.regulations.gov by Dec. 5, 2024, to ensure the FDA considers comments before it begins work on the final version of the guidance.”
  • Healthcare Dive lets us know,
    • “The Federal Trade Commission is urging Indiana to block a hospital merger that antitrust regulators say will raise costs and lead to worse outcomes for patients.
    • “On Thursday, the FTC submitted a comment with the Indiana Department of Health asking it to oppose the combination of Union Hospital and Terre Haute Regional Hospital on the state’s western border — two hospitals that proposed their merger under a controversial certificate that opponents say allows problematic mergers to pass regulatory review.
    • “Union’s proposed acquisition of Terre Haute Regional — a facility owned by mammoth for-profit hospital operator HCA Healthcare — will likely increase hospital costs while negatively impacting healthcare services in Indiana, the FTC argued in its letter. It could also depress wages for registered nurses in the state.”
  • The American Journal of Managed Care informs us,
    • “The trend of food insecurity persists in the United States, with food insecurity, food expenditures, and need of assistance all reported in the country throughout 2023, according to a a new report from the US Department of Agriculture (USDA).
    • “The USDA defines food insecurity as either have a reduced quality, variety, or desirability of diet or having multiple indications of disrupted eating patterns and reduced food intake. Food insecurity is different than hunger according to the USDA, as hunger is a physiological condition that comes as a result of food insecurity whereas food insecurity itself is an economic and social condition that indicates uncertain or limited access to food.
    • “The new report found that 13.5% of households in the US were food insecure, totaling approximately 18 million households. Food insecurity in this context was defined as households who had difficulty providing enough food for their residents at some point during the year. The percentage increased from 2022 when it was 12.8%, from 2021 when it was 10.2%, and 2020 when it was 10.5%.1Low food security was reported in 5.1% of households in the country, which wasn’t different from the 2022 number but an increase from 3.8% reported in 2021. This food insecurity led to disrupted eating patterns through the year.
    • “A total of 8.9% of households with children were food insecure, which is similar to the 8.8% reported in 2022 but higher than the 6.2% reported in 2021. A total of 1.0% of households reported children experiencing very low food security, which is similar to the 1.0% reported in 2022 and 0.7% reported in 2021. Skipping a meal, not eating for a whole day due to lack of resources, and children being hungry was common in these households.”
  • Tammy Flanagan, writing in Govexec, discusses how to prepare for retirement as a federal employee.

From the public health and medical research front,

  • STAT News reports,
    • “A person in Missouri who didn’t report any contact with animals has tested positive for H5 bird flu, the state’s Department of Health and Senior Services and the Centers for Disease Control and Prevention said Friday. It’s not yet clear if the person was infected with the same virus strain that’s causing the ongoing outbreak among dairy cattle.
    • “The individual, who had been hospitalized on Aug. 22, had a number of underlying health issues. The person has since recovered and has been released, the state said in its statement.
    • “The CDC said this is the first case of H5 bird flu detected through the country’s national flu surveillance system, and the first H5 case in an individual without occupational exposure to infected cows or poultry.
    • “While news of an H5 infection in a person without known exposures to infected animals is unsettling, experts who spoke with STAT cautioned that it is too early to jump to any conclusions.”
  • The Centers for Disease Control and Prevention issued its weekly summary on respiratory illnesses in the U.S.
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
    • “COVID-19
      • “COVID-19 activity remains elevated nationally, but there are continued signs of decline in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • ‘Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines was low for children and adults for the 2023-24 respiratory illness season. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.
    • “Season Outlook
      • “CDC expects the upcoming fall and winter virus season will likely have a similar or lower peak number of combined hospitalizations from COVID-19, influenza, and RSV compared to last year. However, peak hospitalizations from all respiratory viruses remain likely to be substantially higher than they were before the emergence of COVID-19. COVID-19 activity this fall and winter will be dependent on the progression of the ongoing summer COVID-19 wave. Influenza and RSV seasons generally begin in October, although they can vary in timing and burden. Read the entire 2024-2025 Respiratory Season Outlook here.
      • “CDC will update this outlook every two months during the fall and winter virus season and if there are big changes in how COVID-19, flu, or RSV are spreading.”
  • The University of Minnesota’s CIDRAP adds,
    • “New research from a randomized controlled trial presented at the European Respiratory Society (ERS) Congress in Vienna, Austria, this week suggests that simple saline nasal drops can reduce the length of the common cold in children by 2 days, according to an ERS news release.
    • “The authors also said using saline nasal drops can reduce forward transmission often virus to household members.”
  • The Wall Street Journal reports
    • “The Food and Drug Administration starting Sept. 10 will require that women nationwide be notified whether their mammograms reveal dense breast tissue. Mammography reports will also encourage women to speak with doctors about their breast density and personal risk.
    • “Nearly 40 states already require that women be notified about dense breast tissue. But there isn’t consensus on what to do with such results. Many doctors encourage women with dense tissue to consider additional tests including an ultrasound or MRI. Others say further tests could lead to unnecessary procedures. Some aren’t caught up on the trade-offs.
    • “The U.S. Preventive Services Task Force, a government-backed group that sets guidance on screening and preventive care, says there isn’t enough evidence to recommend more testing. And insurance coverage for ultrasounds or MRIs varies by state and insurer. 
    • “It’s a very challenging, patchwork landscape,” said Dr. Wendie Berg, a radiologist and breast-imaging researcher at the University of Pittsburgh. “And it’s hard to see women who could have had a better outcome and just didn’t know.” 
  • Healio adds,
    • “Less than three in 10 women are aware that a healthy diet can help reduce the risk for breast cancer, according to a recent survey.
    • “Public education programs on breast cancer have focused on mammograms, which play a vital role, but are not enough,” Neal Barnard, MD, president of the Physicians Committee for Responsible Medicine (PCRM), said in a press release. “It is essential to empower people with steps they can take to protect themselves, and a healthy diet is at the top of the list.”
  • Per BioPharma Dive,
    • “GSK on Friday said its Nucala medicine succeeded in a Phase 3 study of patients with chronic obstructive pulmonary disease, offering the British drugmaker another shot at an expanded approval for the drug
    • “The trial, known as MATINEE, included COPD patients suffering from chronic bronchitis and/or emphysema who were already taking inhaled therapies and showed evidence of a certain type of inflammation. Adding Nucala to the patients’ treatment regimens significantly reduced disease exacerbations compared with placebo, GSK said.
    • “Researchers followed the progress of patients in the study for as long as two years, GSK said. The company didn’t release detailed data on safety or efficacy but said the preliminary results on side effects were consistent with previous research on Nucala.”

From the U.S. healthcare business front,

  • The Peterson-KFF Health System Tracker projects that “In the private insurance market, 57.4 million adults under 65 could be potentially eligible for GLP-1 drugs.”
    • “These broad estimates indicate the potential number of non-elderly adults who meet the clinical criteria for GLP-1 drugs, although employers and insurers may have more restrictive eligibility standards for coverage. Additionally, because many people with diabetes or who are overweight may control their condition with diet, other medications and therapies, or choose to not seek treatment, not all people who meet these clinical criteria would use GLP-1 drugs. This analysis of survey data finds that over 40% of adults under 65 with private insurance could be indicated for a GLP-1 drug though relatively few have a claim, suggesting that a much smaller share seeks treatment through healthcare providers. Therefore, the potential market size for GLP-1 drugs suggests the broadest possible impacts on private insurance premiums and health system spending.”
  • Not surprisingly, Beckers Hospital Review points out,
    • Pharmaceutical company Eli Lilly may become the first healthcare company to hit a market value of $1 trillion, according to a Sept. 5 CNBC report. 
    • This growth is fueled by the company’s popular weight loss and diabetes drugs, Zepbound and Mounjaro. When discussing its second-quarter results in August, company officials said the two drugs accounted for almost 40% of Eli Lilly’s total sales.
    • Eli Lilly’s current market value is close to $900 million, as of this writing.
  • STAT News reports,
    • “Private equity firms are leading the buyout of R1 RCM, a major provider of billing and administrative services for hospitals and physician groups. But R1’s hospital customers — some of the biggest systems in the country — were influential in steering the company to that outcome.
    • “Ascension, a nonprofit Catholic health system, is R1’s largest client and biggest shareholder through an investment fund with private equity firm TowerBrook Capital Partners. Throughout the process of taking R1 private, Ascension and TowerBrook had no intention of giving up their ownership of R1, according to new financial disclosures from R1. TowerBrook ultimately partnered with private equity firm Clayton, Dubilier & Rice on the $8.9 billion deal.
    • “The company’s other largest customers — the nonprofits Intermountain Health, Providence, and Sutter Health and the for-profit Lifepoint Health — also supported Ascension and TowerBrook preparing a takeover offer to rival New Mountain Capital. New Mountain is a private equity firm and R1’s second-largest shareholder. It started the R1 sweepstakes in February by offering to buy the company at $13.75 per share.”
  • Speaking of New Mountain Capitol, Healthcare Dive notes,
    • “New Mountain Capital is combining three of its portfolio companies to create a new payment accuracy firm for health plans, the private equity firm said Thursday.
    • “The deal will merge The Rawlings Group, an analytics firm that finds third parties responsible for paying medical claims, the payment integrity platform of health tech provider Apixio and overpayment identification firm Varis. 
    • “David Pierre, previously the chief operating officer of home healthcare company Signify Health, will head up the newly combined company.”

Friday Factoids

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • Govexec tells us,
    • “President Biden formalized his plan to provide civilian federal workers with an average pay increase of 2% next year, in a letter to congressional leaders Friday.
    • “Last March, Biden first announced the pay raise plan as part of his fiscal 2025 budget proposal, marking a significant decrease from previous pay raises of 5.2% in 2024 and 4.7% in 2023. Friday’s announcement confirms that, if implemented, federal employees will see an across-the-board boost of 1.7% to basic pay and an average 0.3% increase to locality pay, a slight departure from the traditional 0.5% of the overall raise figure being set aside for locality adjustments.”
  • and
    • “In accordance with a 2021 Biden administration executive order promoting voting access, OPM in 2022 began requiring agencies to provide federal employees up to four hours of administrative leave to vote in federal, state, local, tribal and territorial elections, which can be used both on Election Day and during early voting. Additionally, agencies must provide an additional four hours of paid leave to employees who serve as election judges or observers.
    • “In a memo to agency heads Thursday, acting OPM Director Rob Shriver reminded agencies of the new voting leave rules.”
  • The Washington Post reports,
    • “Tens of thousands of D.C. residents on Friday will begin receiving letters with good news. That medical debt weighing them down? Poof, it’s gone.
    • “D.C. has deals in place to cancel $42 million in medical debt for 62,000 residents, through a partnership with a nonprofit that has helped cities and states across the country purchase the debt for pennies on the dollar, city officials said.
    • “The program is one way, they say, to ease a financial burden that can have ramifications for jobs, housing and physical and mental health, and disproportionately impacts people of color.
    • “In the District, about 60 percent of the total debt relief will benefit 36,000 residents making $25,000 or less, and 80 percent of residents receiving the relief live in D.C. Zip codes that are majority Black or Latino, city officials said.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention lets us know,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.”
    • “COVID-19
      • “COVID-19 activity is elevated nationally, with continued increases in many areas and early signs of decline in others. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines was low for children and adults for the 2023-24 respiratory illness season. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
  • The University of Minnesota’s CIDRAP adds,
    • “Wastewater SARS-CoV-2 detections are still at the very high level and are highest in the South. Though levels are dropping in the West, they are rising in the South, Midwest, and Northeast, the CDC said.
    • “Meanwhile, wastewater tracking from WastewaterSCAN shows that detections nationally are still at the high level, with no clear trend up or down over the past 3 weeks. The group, however, noted an upward trend in the Midwest.”
  • and
    • “The US Food and Drug Administration (FDA) today announced that it has granted emergency use authorization for Novavax’s updated COVID-19 vaccine. 
    • “Approval of the protein-based vaccine comes about a week after the FDA green-lighted the two updated mRNA vaccines—made by Moderna and Pfizer-BioNTech—which target the KP.2 variant. The Novavax vaccine targets JN.1, the parent of KP.2.
    • “Novavax’s updated vaccine is authorized for people ages 12 and older.” 
  • The New York Times reports,
    • “Wegovy, the popular obesity drug, may have yet another surprising benefit. In a large clinical trial, people taking the drug during the pandemic were less likely to die of Covid-19, researchers reported on Friday.
    • “People on Wegovy still got Covid, and at the same rate as people randomly assigned to take a placebo. But their chances of dying from the infection plunged by 33 percent, the study found. And the protective effect occurred immediately — before participants had lost significant amounts of weight.
    • “In addition, the death rate from all causes was lower among subjects taking Wegovy, a very rare finding in clinical trials of new treatments. The result suggests that lower life expectancy among people with obesity is actually caused by the disease itself, and that it can be improved by treating obesity.
    • “Stunning,” Dr. Jeremy Faust, an emergency room physician at Brigham and Women’s Hospital who wrote an editorial accompanying the study, said of the data. The study was published in The Journal of the American College of Cardiology.”
  • What’s more, STAT News informs us,
    • “Novo Nordisk’s obesity drug Wegovy cut the risk of severe complications in patients with a common form of heart failure, according to a new analysis that could boost the company’s efforts to expand the label for the blockbuster treatment.
    • “Researchers combined data on nearly 4,000 patients across four trials who had heart failure with reduced ejection fraction (or HFpEF) and found that 5.4% of those treated with Wegovy experienced cardiovascular-related death or heart failure events, compared with 7.5% of those who received placebo. This translated to a 31% risk reduction.
    • “On heart failure events, defined as hospitalizations or urgent care visits, Wegovy cut the risk by 41%. On cardiovascular-related deaths, it reduced the rate by 18%, but this result was not statistically significant, according to the data, presented Friday at the annual meeting of the European Society of Cardiology and published in the Lancet.”
  • and
    • “An experimental drug from Alnylam Pharmaceuticals substantially cut the risk of death and serious cardiovascular complications among patients with an increasingly diagnosed heart disease, likely teeing up the medicine to be a new option for patients, but one that will face competition from another treatment [from Bridge Bio] also nearing potential approval. 
    • “The full results from the Phase 3 HELIOS-B study, presented here Friday at the European Society of Cardiology’s annual meeting, bolstered the case that the drug, vutrisiran, can offer added benefits for patients with the progressive disease, known as ATTR-CM. Top-line data were released in June.
  • Per FiercePharma,
    • “As a new deadly strain of mpox continues its global spread, Emergent BioSoultion’s smallpox vaccine ACAM2000 has officially joined the ranks of FDA-approved defense measures against the virus.
    • ‘The FDA signed off on the vaccine’s use as an mpox disease preventive in those deemed to be at a high risk for infection.” * * *
    • “Emergent last week linked up with the U.S. government and the World Health Organization (WHO) to donate 50,000 doses of ACAM2000 to the impacted countries the Democratic Republic of Congo, Burundi, Kenya, Rwanda and Uganda through relief organization Direct Relief.” 
  • Here’s food for weekend thought. NBC News reports,
    • “For adults who struggle to get the recommended amount of quality sleep, new research suggests “catching up” those lost hours on the weekends may significantly decrease the risk of heart disease. 
    • “Many people build up “sleep debt” during the week, hoping to make up for it by getting extra hours over the weekend. Sleep debt is the difference between how much quality sleep we need — at least seven hours each night — and how much we actually get, according to the Cleveland Clinic.
    • “In a new analysis being presented Sunday at the European Society of Cardiology Congress in London, cardiovascular researchers based in China found that people who got the most sleep on the weekend were 19% less likely to develop heart disease, compared with a group who slept the fewest extra hours those two days.  
    • “Previous research has shown that not getting enough sleep is associated with poor health. However, there has been little research into how getting extra sleep on the weekend affects the heart.

From the U.S. healthcare business front,

  • Healthcare Dive points out,
    • “U.S. hospitals reported strong operating margins on growing patient volumes in July, according to new data from analytic solutions firm Strata.
    • “Hospitals’ median year-to-date operating margin climbed from 4.9% in June to 6.5% in July amid increasing demand for both inpatient and outpatient services, according to the report.
    • “Still, expense increases were “sizable” in July, Strata said. Non-labor expenses, including for drugs and supplies, grew at a quicker clip than labor costs year over year.”
  • and
    • “Steward Health Care has signed definitive agreements to sell four Massachusetts hospitals and is close to finalizing agreements to transition two other facilities to new operators, according to documents filed in U.S. federal bankruptcy court Thursday.
    • “Rhode Island-based Lifespan Health System will pay $175 million for the operating licenses, buildings and land associated with St. Anne’s Hospital in Fall River and Morton Hospital in Taunton, according to the purchase agreement. Massachusetts-based Lawrence General Hospital plans to take over both Holy Family Hospital campuses in Methuen and Haverhill for approximately $28 million.
    • “Steward is “continuing to work to finalize” deals to sell St. Elizabeth’s Medical Center and Good Samaritan Medical Center to Boston Medical Center, according to a press release Thursday.”
  • Beckers Hospital Review identifies five major health system mergers yet to close.
  • Per Fierce Healthcare,
    • “Pennsylvania-based insurer and care delivery network Highmark Health recorded $7.4 billion in revenue and $223 million in net income during the second quarter.
    • “Combined with first-quarter results, Highmark’s revenue is 8% higher year over year compared to the first half of 2023.
    • “Executives credited Highmark Health Plans, United Concordia Dental and HM Insurance Group for the robust results.
    • “Highmark Health continues to be financially strong and stable, positioning our organization to adapt and succeed as the healthcare landscape continues to evolve,” said Carl Daley, chief financial officer and treasurer of Highmark Health, in a news release.
    • “After entering southeastern Pennsylvania, with plans to launch Medicare Advantage products in 2025, the health plan’s segment said membership was stronger than anticipated. 
    • “Still, high pharmaceutical costs, utilization trends and Medicaid redeterminations are headwinds to the business.”

Midweek Update

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Per an HHS press release,
    • “Today, United States Surgeon General Dr. Vivek Murthy released a Surgeon General’s Advisory on the Mental Health and Well-Being of Parents, highlighting the urgent need to better support parents, caregivers, and families to help our communities thrive.
    • “Over the last decade, parents have been consistently more likely to report experiencing high levels of stress compared to other adults. 33% of parents reporting high levels of stress in the past month compared to 20% of other adults. When stress is severe or prolonged, it can have a harmful effect on the mental health of parents and caregivers, which in turn also affects the well- being of the children they raise. Children of parents with mental health conditions may face heightened risks for symptoms of depression and anxiety and for earlier onset, recurrence, and prolonged functional impairment from mental health conditions.” * * *
    • “The work of parenting is essential not only for the health of children but also for the health and future of society. Better supporting parents will require policy changes and expanded community programs that will help ensure parents and caregivers can get paid time off to be with a sick child, secure affordable childcare, access reliable mental health care, and benefit from places and initiatives that support social connection and community.” * * *
    • “You can read the full Advisory here.”
  • Fedweek recounts OPM sub regulatory guidance to carriers who are adding a Postal Service Health Benefits plan to their offerings for 2025.
    • “For the purposes of this [guidance], FEHB plan HRAs, Personal Care Accounts or similar medical funds for qualified medical expenses provided as part of the medical plan, will be referred collectively as OPM HRAs.
    • “OPM is instructing Carriers offering FEHB HDHPs and CDHPs to carry over any OPM HRA credits remaining as of December 31, 2024, for eligible Postal Service enrollees from FEHB plans to PSHB plans as detailed below. This policy is only applicable when an eligible Postal Service enrollee is enrolled in or is automatically enrolled in a PSHB HDHP or CDHP with an OPM HRA offered by the same Carrier as their 2024 FEHB plan. Those FEHB Carriers not offering a PSHB HDHP or CDHP with an OPM HRA will need to inform their Postal Service enrollees that their HRA credits will be forfeited.”

From the public health and medical research front,

  • The CDC’s Advisory Committee on Immunization Practices released recommendations for 2024-25 flu season vaccines today. Here is a link to a summary of those recommendations.
  • Beckers Hospital Review tells us,
    • “GLP-1s reduced mortality and complications from cardiovascular events, according to a study published Aug. 22 in Diabetes, Obesity and Metabolism: A Journal of Pharmacology and Therapeutics.” * * * 
    • “Jeffrey Wessler, MD, a cardiologist with New Hyde Park, N.Y.-based Northwell Health, shared his perspective on GLP-1s and patient adherence with Becker’s earlier in August. 
    • “There are certainly some downstream issues with GLP-1s,” he said. “But for adherence, which is a prime issue for many cardiac medications that work really well in a clinical trial setting, that is not really an issue. People want to take it. It is really transforming how I think about managing an early stage cardiometabolic patient.”
  • BioPharma Dive lets us know, “After an FDA rejection, here’s what’s next in the psychedelics pipeline. By rejecting the first MDMA therapy this month, the FDA signaled to the psychedelic drug field that the road to approval isn’t easy.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Kaiser Permanente’s Risant Health plans to pour well over $1 billion in capital into Cone Health after its acquisition.
    • “The nonprofit pledged a minimum of $1 billion in capital funds to Cone for five years once the deal has closed to support investments in facilities, health equity initiatives and other capital projects, according to financial documents published Tuesday.” * * *
    • “The Cone transaction is expected to close in early 2025, subject to regulatory approval. Cone would operate independently but draw resources and support from Risant. 
    • “Cone reported $164 million in net income in the first nine months of its fiscal 2024, which ends Sept. 30, compared with $104 million in the year-ago period.”
  • STAT News shares the downside of Lilly’s GLP-1 drug announcement yesterday.
    •  “[A] deeper look at the announcement suggests the new offering may not expand access as much as the company indicates. 
    • “Doctors noted that the price of the vials [of Zepbound] will still be out of reach for many patients, and only the starter doses will be offered in the vials, not the higher doses that many patients need to achieve significant weight loss. Additionally, not all patients will be able to pick up vials; they will only be available to patients who are paying for their own medication without insurance and who exclusively order through Lilly’s online portal.
    • “On the same day Lilly launched the vials, it also quietly increased costs for other patients. Before, people who have commercial insurance but don’t have coverage for Zepbound could apply for a savings coupon to get the pens, at whichever dose, for $550 a month, but on Tuesday Lilly raised that price to $650 a month — a move that wasn’t mentioned in the press release.”
  • Per MedTech Dive,
    • “Illumina said Tuesday the Food and Drug Administration has approved its TruSight Oncology (TSO) Comprehensive test.
    • ‘The test uses Illumina’s Nextseq 550Dx sequencing instrument to detect variants in 517 genes using nucleic acids extracted from solid tumor tissue samples.
    • “Illumina also received two companion diagnostic indications for the test, positioning physicians to use TSO Comprehensive to identify people eligible for treatment with Bayer’s Vitrakvi and Eli Lilly’s Retevmo cancer drugs.”
  • Financial Advisor IQ informs us,
    • “The expected cost of future health care and medical expenses for a 65-year-old retiring this year has reached an average of $165,000, which is 5% more than in 2023 and more than double what it was in 2002, Fidelity Investments says in a new report.
    • “Fidelity estimates that about 10% of the total outlay will go toward out-of-pocket prescription drug costs, 43% toward Medicare Plan B and Part D premiums, and the remaining 47% to “other medical expenses,” such as co-payments and deductibles. 
    • “The study suggests that many Americans may be unprepared to manage their health in retirement: The average American estimates the total health care costs in retirement to be much less — about $75,000 — Fidelity said it found in a separate report published last year.”

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Fedweek lets us know,
    • “Another report to Congress has estimated an annual $1 billion cost to the FEHB program from ineligible persons being covered as family members, a cost that is passed on to both enrollees and the government in the form of higher premiums.
    • “The Congressional Budget Office estimate—agreeing with one last year from the GAO—was done in an analysis of S-4035, which is pending a vote in the full Senate after Congress reconvenes September 9. A counterpart bill, HR-7868, has cleared the House committee level, as well.
    • “The bills would require agencies to verify the eligibility of dependents enrolled in the FEHB when the employee or annuitant starts or changes a dependent’s enrollment; require OPM to audit dependents’ enrollment in the program; and expand fraud risk assessments of the program to include information on ineligible enrollees. * * *
    • “CBO expects that implementing the bill would cause enrollment to decline by about 100,000 people, on average, in each year over the 2025-2034 period. Verifications of eligibility during open season would cause a decline of about 10,000 people, on average, in each year over the same period,” it says.
    • However, that estimate “is subject to significant uncertainty because no similar verification audit of the FEHB program has been undertaken,” it added.
  • FEHBlog sermonette — About ten years ago, OPM added a provision to the FEHB standards contracts providing that the carriers would foot the bill for any family member eligibility audits. OPM never has performed a verification audit due to the FEHB program’s size. However, audits are based on sampling, and surely a sample-based audit of various geographic regions where federal and postal employees live (e.g., Washington, DC and nearby counties, Texas, Florida, etc.) would have told OPM whether or not it has a family member eligibility problem.
  • OPM does have a more glaring enrollment problem because OPM separately reports enrollment and premiums to carriers. Consequently, carriers, which carry the insurance risk, do not have the opportunity to confirm that enrollees in their records (based on OPM’s data) are paying the proper premiums for selected self only or other than self only coverage. What is the sense of nailing down family member coverage when no one knows whether the enrollee is paying the proper or any premium?
  • For close to twenty years, CMS, which implements HIPAA’s electronic standards, has made available an electronic enrollment roster transaction known as the HIPAA 820, which would allow FEHB carriers to reconcile enrollment and premiums at the individual level using computer systems. That’s a massive gap in internal controls that needs to be corrected without further delay, in the FEHBlog’s humble opinion. All that OPM has to do is tell the payroll offices to use the HIPAA 820. End of sermonette.
  • Per a company press release,
    • Maximus has been awarded a $20 million contract from the Office of Personnel Management (OPM) to serve as the Contact Center Services Provider for the agency’s new Postal Service Health Benefits Program. This program will provide health insurance to eligible Postal Service employees, annuitants, and their eligible family members starting in 2025.
    • Maximus will be leading the customer support effort to answer calls and emails for OPM’s new, enhanced customer service platform dedicated to assisting eligible individuals access health insurance benefits. Maximus will leverage offerings from its Total Experience Management (TXM) solution, including state-of-the-art telephony, customer relationship management, and call quality reporting tools to provide best-in-class customer service.
    • “The Postal Service Health Benefits Program is an invaluable benefit for the U.S. Postal Service workforce, and Maximus is uniquely positioned to develop this new contact center and Customer Experience (CX) approach based on more than 30 years of experience working with OPM,” said Larry Reagan, Senior Managing Director, Federal Civilian Market, Maximus. “Our senior team has vast experience standing up new customer service programs at scale for federal agencies to deliver a range of services, including disaster recovery, education, and health benefit services.”
  • Healthcare Dive tells us,
    • “An expensive drug for weight loss could become one of Medicare’s costliest medications, even if the majority of patients are ineligible for coverage, according to a study published on Monday in the Annals of Internal Medicine.
    • “The analysis found 3.6 million people are highly likely to be eligible for semaglutide like Wegovy, a GLP-1 that’s effective at treating obesity. More liberal definitions of eligibility could increase that number to 15.2 million patients.
    • “If all newly eligible patients received semaglutide, spending in Medicare’s Part D prescription drug benefit could increase by $34 billion to $145 billion each year, according to the study. Even if the government narrowly defined eligibility, federal spending on the medicine could still exceed $10 billion annually.”
  • Medscape adds,
    • “Now that the U.S. government has negotiated prices for some Medicare program drugs effective in 2026, Wall Street analysts are betting on a 2027 list that will include Novo Nordisk’s blockbuster Ozempic for diabetes and have a limited impact on Big Pharma. [FEHBlog note — Wegovy is the weight loss version of Ozempic. Medicare by statute does not cover weight loss drugs.]
    • “Other possible 2027 candidates include Pfizer’s cancer drugs Ibrance and Xtandi, GSK’s asthma and chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta, Teva’s Huntington’s disease treatment Austedo and Abbvie’s irritable bowel syndrome drug Linzess, according to five analysts as well as researchers and company executives.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced more than $558 million in funding to improve maternal health, building on the Biden-Harris Administration’s commitment to reducing the nation’s high maternal mortality rate through the White House Blueprint for Addressing the Maternal Health Crisis. The Health Resources and Services Administration (HRSA), an agency of HHS, is awarding more than $440 million in funding to expand voluntary, evidence-based maternal, infant, and early childhood home visiting services for eligible families across the country. In addition, the Centers for Disease Control and Prevention (CDC) announced a new investment of $118.5 million, over five years, to 46 states, six territories, and freely associated states to continue building the public health infrastructure to better identify and prevent pregnancy-related deaths.” * * *
    • “For a complete list of Maternal, Infant, and Early Childhood Home Visiting Program awardees, visit https://mchb.hrsa.gov/programs-impact/programs/home-visiting/maternal-infant-early-childhood-home-visiting-miechv-program/fy24-awards.”
  • A Federal News Network Data Dive tells us, “USPS improves on-time delivery in delay ‘hotspots’, but faces year-end challenges. Postal experts say USPS improvements to on-time delivery are needed, and must continue, for Congress to allow these plans to keep moving forward.”

From the public health and medical research front,

  • Beckers Hospital Review reports on an August 23, 2024, press conference that leaders of the CDC, HHS and FDA held to discuss the upcoming respiratory virus season.
  • The American Medical Association informs us about what doctors wish their patients knew about lung cancer screening.
    • “Lung cancer causes about 160,000 U.S. deaths a year, which is greater than the toll of the next three most common cancers—colon, breast and prostate—combined. Yet only about 30% of lung cancer cases are diagnosed early. Most patients are diagnosed at a far less treatable, later stage of the disease. And with about 20% of lung cancer deaths preventable, evidence-based screening recommendations for high-risk patients offers the best hope to catch the disease early and provide the best chance for effective treatment.”
  • Medscape looks into how old is too old to undergo a screening colonoscopy.
  • The National Institutes of Health (NIH) issued a medical research report this afternoon.
  • Per an NIH press release,
    • “So-called low-intensity blood stem cell transplants, which use milder conditioning agents than standard stem cell transplants, do not appear to damage the lungs and may help improve lung function in some patients with sickle cell disease (SCD), according to a three-year study of adults who underwent the procedure at the National Institutes of Health (NIH).
    • “Damage to lung tissue and worsened lung function is a major complication and leading cause of death in people with sickle cell disease, a debilitating blood disorder. The new study, published today in the Annals of the American Thoracic Society, helps answer whether less intensive types of transplants, which tend to be better tolerated by many adults, by themselves either cause or promote further harm to the lungs.
    • “By using a low-intensity blood stem cell transplant for sickle cell disease, we may be able to stop the cycle of lung injury and prevent continued damage,” said study lead Parker Ruhl, M.D., an associate research physician and pulmonologist at NIH. “Without the ongoing injury, it’s possible that healing of lung tissue might occur, and this finding should help reassure adults living with sickle cell disease who are considering whether to have a low-intensity stem cell transplant procedure that their lung health will not be compromised by the transplant.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group’s philanthropic arm has released a new deep dive into maternal and infant health, underscoring socioeconomic disparities in women’s health.
    • “The study found that American Indian/Alaska Native, Black and Hawaiian/Pacific Islander women had maternal mortality rates that were between 2.5 and 4.5 times higher than other ethnic groups. Severe maternal morbidity was, in 2020, two times higher among Black mothers than white mothers, and 1.5 times higher among Black mothers compared to Hispanic mothers.
    • “There were also racial disparities identified in low-birth weight, according to the study. Low birth weight rates were 2.1 times higher among babies born to Black mothers compared to infants born to white mothers.
    • “There were some bright spots in the data, however. Between 2008 and 2011 and 2018 to 2021, there were improvements to infant mortality rates among some racial groups. The study found improvements of 15% among infants born to white mothers, 12% among babies born to Black mothers and 9% for babies born to Hispanic mothers.
    • “Lisa Saul, M.D., national medical director of maternal child health at UnitedHealthcare, said in a press release that analyses like this are critical to developing targeted solutions to key challenges.”
  • Beckers Hospital Review informs us,
    • “After about 18 months since the FDA greenlit preventive COVID-19 medication Pemgarda for emergency use, the agency has tweaked its decision. 
    • “The agency has narrowed the medicine’s emergency use authorization. It is now OK to use when “the combined national frequencies of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%,” the FDA said in an Aug. 26 letter to the drug’s maker, Invivyd. 
    • “Pemgarda (pemivibart) is authorized for the pre-exposure prophylaxis of COVID-19 in some adults and children older than 12. Eligible patients are those who have a moderate-to-severe immune compromise and are unlikely to have an adequate response to a COVID-19 vaccine.
    • “Early data indicate that COVID-19 variant KP.3.1.1 may have substantially reduced susceptibility to Pemgarda. As of Aug. 17, the variant accounted for 36.8% of COVID-19 infections, according to CDC data. If this percentage surpasses 90%, Pemgarda’s emergency use authorization could be revoked.”
  • Per MedTech Dive,
    • “Insulet received U.S. clearance Monday for its Omnipod 5 system for Type 2 diabetes management — a first for the industry — making automated insulin delivery to control blood sugar available to millions of additional people living with diabetes.
    • “The system’s tubeless pump automatically adjusts insulin levels based on data from a continuous glucose monitor (CGM), replacing manual dosing. Since its approval for Type 1 patients in 2022, Omnipod 5 has become the most prescribed insulin pump in the U.S. and has more than 250,000 users globally, Insulet Chief Medical Officer Trang Ly said in an interview with MedTech Dive.
    • “Ly discussed the product’s launch for Type 2 diabetes patients, partnerships with other device makers and how the company is working to win over doctors reluctant to prescribe insulin pump therapy.”
    • Check out the interview.

From the U.S. healthcare business front,

  • BioPharma Dive tells us,
    • Eli Lilly is now distributing a single-dose vial form of its popular weight loss medicine Zepbound that it says people with a valid prescription can obtain for a cash price that’s 50% less than the current cost of other GLP-1 drugs for obesity.
    • The single-dose vials are available through Lilly’s online service LillyDirect as a self-pay option, which could appeal to people without employer insurance coverage or those who don’t qualify for the company’s savings card program, Lilly said.
    • A four-week supply of Zepbound single-dose vials at a 2.5 milligram dose will cost $399, while the 5 milligram dose will cost $549. While those prices are well below the $1,060 monthly list price of Zepbound’s injector pen formulation, they’re not far from the drug’s estimated net price after accounting for rebates and discounts to insurers, according to a client note from Evercore ISI analyst Umer Raffat.
  • Per Healthcare Dive,
    • “Pfizer on Tuesday launched a direct-to-consumer service it claims will help people schedule telehealth appointments, fill prescriptions and access savings programs for the company’s migraine, COVID-19 or influenza medicines.
    • “Dubbed PfizerForAll, the online service will provide resources for people looking to obtain treatment for migraine, COVID or the flu, or to schedule vaccinations for diseases like pneumococcal pneumonia and respiratory syncytial virus.
    • “The platform aims to “streamline the path for those seeking better health,” Aamir Malik, Pfizer’s chief U.S. commercial officer, said in a statement. The company said it is working with partners UpScriptHealth, Alto Pharmacy and Instacart.”
  • MedCity News notes,
    • “Waltz Health, a digital health company focused on prescription drugs, launched Waltz Connect on Monday. The new solution aims to reduce the cost of specialty medications.
    • “Chicago-based Waltz Health was founded in 2021 and serves payers and pharmacies. It has a product called Marketplace Search, which allows users to search for any prescription and see the range of prices available at their pharmacy. It also works with health plans to bring its marketplace solutions into their pharmacy benefit.
    • “The company’s Waltz Connect product supports payers and focuses on specialty medications. When a specialty prescription is submitted for a member, Waltz Connect redirects it to the most suitable pharmacy, regardless of the pharmacy’s network status with the payer. This routing is based on the member’s benefit design and several factors, including price, turnaround time, fulfillment accuracy, member experience and adherence rates. These factors can be customized by drug class or specific drugs. Health plans also receive information on the member’s condition, prescription onboarding, the selected pharmacy’s contact information, expected fulfillment turnaround time and the number of refills.”
  • and discusses the pros and cons of artificial intelligence for health insurers. “With so much hinging on technology that is the subject of so much hype, it is important to understand where AI actually helps at present — and where it most definitely does not.”
  • Beckers Hospital Review points out,
    • “Boston-based Mass General Brigham’s Home Hospital program has expanded to 70 beds, making it the largest home hospital in the country, according to a news release shared with Becker’s.
    • “The capacity increase was accompanied by expanded clinical care teams and the creation of dedicated roles within Home Hospital created. The system has also incorporated medical assistants into the care model and expanded the ambulance services to meet growing demand.
    • “Since its launch in January 2022, the program has had more than 4,000 patient admissions and saved more than 20,000 acute care hospital-based bed days. The average patient stays in a Home Hospital bed is 5 days.”
  • and
    • Where Steward’s 31 hospitals stand
      • From seeking Chapter 11 protection on May 6 to sharing plans to close four of its hospitals across Massachusetts and Ohio that would result in a combined 2,187 layoffs, Dallas-based Steward Health Care has experienced a great deal of turbulence over the last year.
      • As the for-profit health system continues to push back bid deadlines and sale hearings for many of its hospitals, the status of each facility remains in question, leaving community members, healthcare workers and state and local lawmakers concerned.
      • Below, Becker’s has provided a list of Steward’s 31 hospitals by state, per the health system’s website, and the most recent information regarding each facility. [FEHBlog note — Beckers plans to keep this list updated.]
  • Per Fierce Healthcare,
    • “Aetna will cover intrauterine insemination as a medical benefit for eligible plans, a move the insurer called a “landmark policy change.” 
    • “Intrauterine insemination, or IUI, is usually only covered if employers offer a separate fertility benefit plan, according to an Aug. 26 news release from Aetna. 
    • “The change will apply to fully insured Aetna commercial plans. * * *
    • “Expanding IUI coverage is yet another demonstration of Aetna’s commitment to women’s health across all communities, including LGBTQ+ and unpartnered people,” Cathy Moffitt, MD, Aetna’s chief medical officer, said in the news release. “This industry-leading policy change is a stake in the ground, reflecting Aetna’s support of all who need to use this benefit as a preliminary step in building their family.”
  • Medscape adds,
    • “In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
    • “The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
    • :A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee-based firm that provides navigation and coordination services to oncology practices and insurers.”