Friday Factoids

COVID-19

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    • “Today, the FDA issued a draft guidance “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle”.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 On Oct. 15, 2024, the FDA will host a webinar for industry and other parties interested in learning more about the draft guidance.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.”

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.”

Monday Roundup

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Per a Congressional press release,
    • “Today, House Budget Committee Chairman Jodey Arrington (R-TX) and Senate Budget Committee Ranking Member Chuck Grassley (R-IA) spearheaded a letter to Congressional Budget Office (CBO) Director Phillip Swagel asking the CBO to analyze a new Medicare Part D Premium Stabilization Demonstration program that invites an unchecked taxpayer-funded bailout to paper over the flaws in the Inflation Reduction Act (IRA). 
    • Chairman Arrington and Ranking Member Grassley were joined by Senate Finance Committee Ranking Member Mike Crapo (R-ID), House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), and House Ways and Means Committee Chairman Jason Smith (R-MO).
  • Kevin Moss, now writing in Federal News Network, provides advice on whether to pay an IRMAA tax to obtain Medicare Part B coverage when you are retired with FEHB coverage. He notes that “The only question is whether you expect to be at this high IRMAA level throughout retirement.” The IRMAA tax, which for 2024 is based on your 2022 adjusted gross income, can disappear following retirement. In contrast, the hefty Medicare Part B late enrollment penalty is forever. Planning is important.
  • STAT News reports,
    • Covid caught the world flat-footed. No antiviral drugs were immediately available, and nearly two years would pass and over 800,000 Americans would die before the first pill, Paxlovid, was authorized. The Biden administration was determined not to be caught off guard again. In June 2021, it announced the Antiviral Program for Pandemics, or APP, for which $3.2 billion was to be spread across several government divisions and dozens of academic labs.  * * *
    • “That structure, STAT has learned, was never built. Just five months after the APP was announced, Omicron broke out, sending a seemingly waning pandemic into overdrive. When Congress refused to appropriate more funds to purchase variant-specific vaccines, the White House diverted money from the APP.”
    • The article goes onto to explain in depth why the APP is fizzling out.
  • Per an HHS press release,
    • “The Biden-Harris Administration today continued its historic investment in health care coverage and the Affordable Care Act (ACA) by awarding a new round of $100 million to organizations vital to helping underserved communities, consumers, and small businesses find and enroll in quality, affordable health coverage through HealthCare.gov, the Health Insurance Marketplace®. The Centers for Medicare & Medicaid Services (CMS) is awarding the grants, in advance of this year’s Marketplace Open Enrollment (which begins November 1, 2024) to 44 Navigator grantees in states using HealthCare.gov. The grants are part of a commitment of up to $500 million over five years – the longest grant period and financial commitment to date, and a critical boost for recruiting trusted local organizations to better connect with those who often face barriers to obtaining health care coverage.”
    • That’s a lot of boxes of ziti as they would say on the Sopranos.
  • Per MedTech Dive,
    • “Insulet received Food and Drug Administration clearance on Monday for its newest insulin pump to be used by people with Type 2 diabetes.
    • “The regulatory decision will bring to market the first automated insulin delivery (AID) system, also known as an “artificial pancreas,” for both Type 1 and Type 2 patients. By pairing Insulet’s Omnipod 5 pump with a continuous glucose monitor, the device will automatically adjust insulin delivery based on a person’s blood glucose levels. 
    • “Insulet’s new indication comes as other diabetes device makers target the Type 2 market. Tandem Diabetes Care is running a randomized controlled trial of its Control IQ AID system in people with Type 2 diabetes, which could lead to an expanded indication for its t:slim X2 and Mobi pumps. Meanwhile, Medtronic struck a partnership with Abbott to make a sensor that would pair with Medtronic’s insulin pumps, with the goal of expanding access to its AID algorithms.” 

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Among Covid’s superlatives is the blow it dealt to people’s career plans en masse. 
    • “Never before have so many Americans redrawn their relationships with work as a result of one public-health crisis. More than four years after the pandemic began, some are still reckoning with how to balance their livelihoods and life with long Covid, the chronic condition doctors are still trying to understand. People at the height of careers in finance, technology and healthcare are operating without clarity on when, or if, they can resume the paths they once laid out.
    • “Covid just kicked me off the train while it was still moving,” said Amie Pascal, 47, who spent years climbing the ladder at a digital-marketing agency in Oregon before getting long Covid.
    • “Long Covid has pushed around one million Americans out of the labor force, economists estimate. More than 5% of adults in the U.S. have long Covid, and it is most prevalent among Americans in their prime working years. About 3.6 million people reported significantly modifying their activities because of the illness in a recent survey by the Centers for Disease Control and Prevention.”
  • KFF offers expert observations on the newly approved Covid booster, while MedPage Today tells us that COVID Vaccine Myocarditis stays mild with a good prognosis over a year later as the evolution of postvaccine myocarditis was tracked for 18 months in a cohort study.
  • The Washington Post alerts us,
    • “A rare but deadly disease spread by mosquitoes has nearly a dozen Massachusetts communities on alert, prompting some towns to close parks after dusk, restrict outdoor activities and reschedule public events.
    • “Massachusetts health officials this month confirmed the state’s first human case of the eastern equine encephalitis virus this year — a man in his 80s exposed in Worcester County, west of Boston. Ten communities are now designated at high or critical risk for the virus, health officials said Saturday. Plymouth, about 40 miles south of Boston, closed all public parks and fields from dusk until dawn, when mosquitoes are most active. Nearby, Oxford banned all outdoor activities on town property after 6 p.m.
    • “We have not seen an outbreak of EEE for four years in Massachusetts,” Robbie Goldstein, the state’s department of public health commissioner, said in a statement. “We need to use all our available tools to reduce risk and protect our communities. We are asking everyone to do their part.” * * *
    • “Residents are urged to use mosquito repellents, drain standing water around their homes, wear clothing that covers skin, and reschedule outdoor activities to avoid the hours between dusk and dawn.”
  • STAT News points out,
    • “The U.N. health agency on Monday launched a six-month plan to help stanch outbreaks of mpox transmission, including ramping up staffing in affected countries and boosting surveillance, prevention and response strategies.
    • “The World Health Organization said it expects the plan from September through February next year will require $135 million in funding and aims to improve fair access to vaccines, notably in African countries hardest hit by the outbreak.
  • MedTech Dive adds,
    • “Roche said it is working with partners to increase laboratory capacity for mpox testing worldwide.
    • “The push to support diagnosis of mpox comes days after the World Health Organization declared an outbreak of the viral disease a public health emergency of international concern. 
    • “A new strain of mpox is spreading rapidly in parts of the Democratic Republic of the Congo (DRC), the WHO said in a statement, and a coordinated international response is needed to stop outbreaks.”
  • The Washington Post notes,
    • “For years, Amanda Smith and her husband were jolted awake at night by a buzz-buzz-beep — an alarm warning that her blood sugar was too high or too low. She would reach for juice boxes stored in her nightstand or fiddle with her pump to release a bolus of insulin.
    • “Smith, a 35-year-old nurse from London, Ontario, has Type 1 diabetes, which wipes out critical islet cells within the pancreas that produce insulin. Without them, Smith relied on vials of insulin from a pharmacy and constant vigilance to stay alive. “You have to pay attention to your diabetes, or you die.”
    • “On Valentine’s Day 2023, doctors transplanted replacement islet cells, grown in a lab from embryonic stem cells, into a blood vessel that feeds Smith’s liver. By August, she no longer needed insulin. Her new cells were churning it out.
    • “I just feel normal again,” Smith said. “You didn’t realize how much of your life it took up — until it’s taking up none, now.”
    • “Smith is at the forefront of a medical experiment that seeks to treat the root cause of diabetes by replacing the cells the disease destroys. It’s a key step forward in the long quest to develop a cure for diabetes and a front-runner to finally deliver the sci-fi promise that has enveloped the stem cell field for more than two decades.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “McKesson plans to grow its oncology platform by investing nearly $2.5 billion into a community oncology clinic operator’s business and administrative services arm.
    • “Announced Monday, the deal sees Irving, Texas-based McKesson picking up a 70% stake in Community Oncology Revitalization Enterprise Ventures (Core Ventures), which was launched earlier this year by Florida Cancer Specialists & Research Institute (FCS).
    • “The Fort Myers, Florida-based institute is a group practice of over 250 physicians, 280 advanced practice providers and almost 100 Florida locations that will remain independent following the deal’s close. Its physician owners will retain their minority interest in Core Ventures.
    • “Pending closing conditions and regulatory clearances, Core Ventures would become part of McKesson’s oncology platform.”
  • Per FiercePharma,
    • “When CVS Caremark removed AbbVie’s Humira from its national commercial formularies back in April, biosimilar prescriptions picked up at a whirlwind pace. Now, Cigna’s Express Scripts is following suit in a move that could further chip away at Humira’s market share.
    • “Express Scripts, which is Cigna’s pharmacy benefit unit, is removing branded Humira from its largest commercial formularies come 2025 in favor of biosimilar options from Teva, Sandoz and Boehringer Ingelheim.
    • “We’ve been thoughtful in developing a comprehensive approach that considers not just the formulary placement of biosimilars, but also each product’s clinical efficacy, interchangeability, available supply, dose, and concentration that will provide a seamless patient experience with these more affordable products,” Express Scripts president Adam Kautzner said in a release, adding that the company is “prepared to embrace the savings biosimilars offer.”
  • STAT News discusses the impending launch of the over-the-counter glucose monitors.
    • “By the end of the summer, both Dexcom and Abbott will begin selling CGMs over the counter, without a prescription. Dexcom will start selling its CGM, called Stelo, on Monday. Abbott previously said it planned to release its version, called Lingo, before the end of the summer. The company told STAT it plans to launch and provide pricing details “soon.”
    • “The devices are being targeted at a huge swath of potential users: The nearly 100 million Americans with prediabetes (including the majority who don’t know it), people with type 2 diabetes who don’t use insulin, and even healthy people who want to keep an eye on their blood sugar levels. It’s a giant market for Abbott and Dexcom to tackle, and one especially welcomed by Dexcom, as it recently lowered sales guidance for its prescription CGMs. The companies are also betting that the frenzy over new weight loss drugs, GLP-1s, might generate more consumer interest in tracking glucose. 
    • “But the overall impact of the devices will depend a lot on how both clinicians and consumers decide to use them. “You’re looking at questions like affordability, how often patients are going to use this, whether they’re actually going to change their behavior and keep using it,” said Marie Thibault, a medical technology and digital health analyst at finance firm BTIG.” 
  • The Society for Human Resource Management relates,
    • “Despite the importance of open enrollment, employees aren’t exactly thrilled about reviewing forms for health insurance and other benefits every fall.
    • “Nearly 7 in 10 benefits-eligible employees (67%) spend just 30 minutes or less reviewing their options during open enrollment, while 42% spend 20 minutes or less, according to a 2023 Voya Financial survey. And the overwhelming majority of employees (roughly 90%) choose the same options as they did the previous year, a report by insurance firm Aflac found.
    • “Choosing benefits is “extremely overwhelming for people,” said Christin Kuretich, vice president of supplemental products at Voya, a New York City-based financial and insurance firm. “It’s not something that people generally want to think about or take the time to focus on.” * * *
    • “It’s not that employees don’t care about benefits—they mostly feel overwhelmed, confused, and now cost-conscious, industry experts said. That’s where employers come in, as many have been falling short with their important task of communication.
    • “Educating employees on the importance of open enrollment is always a challenge,” said Jess Gillespie, head of product and underwriting at Prudential Group Insurance. “HR departments can be stretched thin and will sometimes lack the time and resources to communicate about all workplace benefits available, let alone noncore products such as supplemental health.”
    • “In short, Gillespie said, employers “need to ensure employees see the value” of benefits.”

Weekend Update

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Mental health care, Patient safety, U.S. Healthcare–

From Washington, DC

  • The House of Representatives and the Senate remain on their District / State work breaks until September 9.
  • ABC News reports,
    • “The federal government will restart its free at-home COVID tests program in September as officials prepare the country for the upcoming respiratory virus season.
    • “Dawn O’Connell, assistant secretary for preparedness and response at the Department of Health and Human Services, said Friday that this is the seventh time the Biden-Harris administration has allowed Americans to order over-the-counter tests at no charge.
    • “It’s not clear when the website, COVID.gov/tests, will come back online. The website stopped accepting orders in early March.”
  • Cardiovascular Business lets us know,
    • “The U.S. Food and Drug Administration (FDA) has announced that Inari Medical is recalling its ClotTriever XL catheter for large blood vessels. 
    • “The news comes after the FDA received several reports of “serious adverse events” due to the device becoming entrapped or blocking arteries in the patient’s lungs. Six deaths and four other patient injuries have been associated with the issue so far. 
    • “The ClotTriever XL catheter, like Inari Medical’s other ClotTriever devices, was designed to treat deep vein thrombosis. Marketed as “a large device for the largest vein,” it was built specifically to target issues found in the vena cava.” 

From the public health and medical research front,

  • MedPage Today offers a series of interviews with public health experts on the measles, bird flu, and Covid.
  • McKinsey and Company share a string of insightful articles on closing the women’s health gap.
    • “In the quest for women’s equality, the health gap is a major player. Women live longer than men, but they spend 25 percent more of that time in poor health. This gap boils down to disparities in efficacy, data, and care delivery, say McKinsey’s Anouk Petersen, Lucy Pérez, and coauthors. 
    • “Closing this gap could add up to seven more healthy days of life per year, per woman. The key? Recognizing that women’s health is not just a scaled-down version of men’s health but is biologically distinct. Change can begin by tackling specific diseases and conditions at a country or regional level.
    • “Ahead of Women’s Equality Day [tomorrow] August 26, explore these insights to understand the widespread benefits of closing the chasm.”
  • Per Medscape,
    • “Patients with dementia may instead have hepatic encephalopathy (HE) and should be screened with the Fibrosis-4 (FIB-4) index for cirrhosis, one of the main causes of the condition, new research suggests.
    • “The study of more than 68,000 individuals in the general population diagnosed with dementia between 2009 and 2019 found that almost 13% had FIB-4 scores indicative of cirrhosis and potential HE.
    • “The findings, recently published online in The American Journal of Medicine, corroborate and extend the researchers’ previous work, which showed that about 10% of US veterans with a dementia diagnosis may in fact have HE.
    • “We need to increase awareness that cirrhosis and related brain complications are common, silent, but treatable when found,” corresponding author Jasmohan Bajaj, MD, of Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, told Medscape Medical News. “Moreover, these are being increasingly diagnosed in older individuals.”
    • “Cirrhosis can also predispose patients to liver cancer and other complications, so diagnosing it in all patients is important, regardless of the HE-dementia connection,” he said.”
  • and
    • “When doctors and patients consider the appendix, it’s often with urgency. In cases of appendicitis, the clock could be ticking down to a life-threatening burst. Thus, despite recent research suggesting antibiotics could be an alternative therapy, appendectomy remains standard for uncomplicated appendicitis.
    • “But what if removing the appendix could raise the risk for gastrointestinal (GI) diseases like irritable bowel syndrome and colorectal cancer? That’s what some emerging science suggests. And though the research is early and mixed, it’s enough to give some health professionals pause .
    • “If there’s no reason to remove the appendix, then it’s better to have one,” said Heather Smith, PhD, a comparative anatomist at Midwestern University, Glendale, Arizona. Preemptive removal is not supported by the evidence, she said.”

Friday Factoids

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

From Washington, DC

  • Fedweek posted an August update on implementation of the Postal Service Health Benefits Program (“PSHBP”).
    • “At least one major insurance carrier, FEP Blue Cross Blue Shield, has already sent letters to current participants letting them know that a plan similar to their current plan has been conditionally approved and stating that they’ll share more details on the PSHB benefits and premiums “later this year, in time for Open Season”
    • “The USPS reports new plan details will be available as of September 15, and will be sent out via hard mail in the weeks that follow.
    • “The USPS says that participants will receive a “crosswalk letter” in late October showing the new plan into which the USPS intends to enroll them. If you agree, there’s nothing to do: you’ll be enrolled in that plan.”
  • The FEHB enrollees who may be in for a surprise are those who currently participate in an FEHB plan that is not participating in the PSHBP. In October, OPM will enroll those folks in the lowest cost nationwide plan option that is not a high deductible plan or charge associate member dues. Those folks will have an opportunity to change plans during the regular federal benefits open season. The FEHBlog expects that the PSHBP navigators will be lending a helping hand to those folks, particularly those eligible for Medicare.
  • The Postal Times reminds us,
    • “If you were an annuitant entitled to Medicare Part A (typically at age 65) as of Jan. 1, 2024, and did not enroll in Medicare Part B, you and your covered eligible family members may be able to participate in a one-time PSHB Special Enrollment Period (SEP) for Medicare Part B from April 1 through Sept. 30, 2024. Those who choose to enroll during the SEP will have the late enrollment penalty paid for by the Postal Service. Eligibility letters were sent to annuitants and eligible family members in March 2024. If you have misplaced the notification letter mailed to you or believe that you are eligible to participate in the PSHB SEP and did not receive a notification letter, call the PSHB Navigator toll-free help line at 833-712-PSHB (7742) or email retirementbenefits@usps.gov.”
  • Speaking of the Postal Service, Federal News Network lets us know,
    • “The Postal Service is planning to roll out several changes next year to drive down its operating costs and ensure more reliable service to most of its customers.
    • “USPS says the next step of its network modernization plan, which will happen next year, is to get mail and packages to their destination in fewer trips between mail processing plants and post offices.
    • “The agency expects these adjustments will not only help it squeeze $3 billion of annual overhead costs out of its operations, but enable faster delivery of mail and packages to customers within 50 miles of the agency’s largest regional mail processing plants.
    • “For customers outside that 50-mile radius, however, USPS, anticipates ”some mail and packages will experience a longer service standard,”  according to a filing submitted to its regulator on Thursday. 
    • “In those cases, mail and packages in those more rural areas will remain in transit for about a day longer before reaching their final destination.
    • “USPS, however, told the Postal Regulatory Commission that these changes will have a “net positive impact” on service for first-class mail, packages and marketing mail, and will be delivered “at the same level of service or faster,” for most customers.”
  • The American Hospital News expresses distress because
    • Johnson & Johnson announced Aug. 23 that it would be fundamentally changing the way it makes 340B pricing available for two of its most popular products, Stelara and Xarelto. Starting Oct. 15, J&J will require all disproportionate share hospitals participating in the 340B Drug Pricing Program to purchase these drugs at full price and submit data to J&J. Upon verification of the drug’s 340B status, DSHs would receive a rebate for the discounted 340B price.
    • Last week, the AHA contacted the Health Resources and Services Administration for more information as soon as it was made aware that J&J was considering these actions. HRSA notified the AHA today that it has informed J&J that its rebate model is inconsistent with the 340B statute and that this model has not been approved by the Secretary of the Department of Health and Human Services. HRSA further informed the AHA that it has told J&J that HRSA will take appropriate action as warranted.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention (“CDC”) announced today,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in many areas. * * * “Nationally, the wastewater viral activity level for COVID-19 is currently very high.“
    • “COVID-19
      • Many areas of the country are continuing to experience increases in COVID-19 activity, though other areas are experiencing declines in COVID-19 activity following increases this summer. 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
  • The University of Minnesota’s CIDRAP adds,
    • “High-dose (HD) and adjuvanted influenza vaccines offered the best protection for people aged 65 years and older against symptoms and hospitalization during the 2022-23 flu season, concludes a real-world study published this week in Clinical Infectious Diseases.
    • “High-dose flu vaccines contain four times the standard dose (SD), while adjuvanted vaccines contain an extra immune-boosting ingredient. In 2022, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended high-dose, adjuvanted, or recombinant (cell-based) vaccines over SD vaccines for older adults, who are at elevated risk for severe disease and flu-related hospitalization and death.”
  • The New York Times reports,
    • “After a years long lull thanks to Covid-19 precautions like isolation and distancing, whooping cough cases are now climbing back to levels seen before the pandemic, according to data from the Centers for Disease Control and Prevention.
    • “So far this year, there have been 10,865 cases of whooping cough, or pertussis, nationwide. That’s more than triple the number of cases documented by this time last year, and is also higher than what was seen at this time in 2019. Doctors say these estimates are most likely an undercount, as many people may not realize they have whooping cough and therefore are never tested.
    • “The pandemic delayed routine childhood vaccinations, including those that protect against whooping cough, and led to fewer pregnant women getting vaccinated. Those factors have likely contributed to the current uptick in cases, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center. Pertussis cases tend to peak in the summer and fall, he said, and so it’s particularly critical to be aware of the disease now, as children head back to school and respiratory illnesses pick up.”
  • Bloomberg tells us,
    • “US teenagers aren’t getting vaccinated against HPV at the same pace as before the Covid pandemic, a trend that could imperil efforts to control a common cause of cervical and other cancers.
    • “Immunization rates have stagnated for kids aged 13 to 17 for the past two years, according to data that the Centers for Disease Control and Prevention published Thursday. Meanwhile, routine shots for diseases like tetanus and meningitis have returned to pre-pandemic levels, according to the CDC survey, which analyzed results from nearly 17,000 teenagers.
    • “The trend could cause alarm among public health officials. Each year, human papillomavirus causes more than 21,000 cases of cancer in women and about 16,000 in men. * * *
    • “This is the only vaccine I know of that prevents cancer,” said Sunil Sood, a pediatrician who specializes in infectious disease at Northwell Health in New York. “Putting it like that has been known to make a difference” to parents who might be resistant to having their children vaccinated, he said.”
  • Per MedCity News, “Side Effects are Limiting GLP-1 Drug Efficacy: How Can Personalization Offer a Solution? By integrating digitization and machine learning, there is an opportunity to deliver personalized care to all patients and scale precision dosing with minimal physician involvement, maximizing the effectiveness and accessibility of these drugs.”
    • “There is a clear and unique opportunity to apply dose optimization to GLP-1s to improve real-world persistence and adherence, supporting patients to continue treatment long enough to experience the full benefits, such as positive cardiovascular outcomes. We know clinicians are seeing the need for this and are already making necessary interventions but struggling still to find a scalable solution. Pairing drugs with proven digital solutions, within a single label, can facilitate personalization across the GLP-1 market, improving the effectiveness of these drugs and diminishing side effects. Not only can pharma leverage this approach to deliver best-in-class clinical and commercial outcomes, but it also promises to revolutionize disease management, enhancing patient safety and outcomes by tailoring treatment to individual needs, truly bringing precision care to all.”
  • Pulmonary Advisor notes, “About two-thirds of adults who smoked wanted to quit in 2022, although fewer than 10% were successful, according to study findings published in the Morbidity and Mortality Weekly Report.

From the U.S. healthcare business front,

  • EBRI offers an Issues Brief concerning “Trends in Self Insured Health Coverage; ERISA at 50.”
  • Per MedTech Dive,
    • “Stryker said Thursday it has agreed to acquire Vertos Medical, an Aliso Viejo, California-based company whose minimally invasive technology treats chronic lower back pain, for an undisclosed sum.
    • “The Vertos procedure, which can be performed in an outpatient setting, is designed to provide pain relief for patients with lumbar spinal stenosis by restoring space in the spinal canal and reducing nerve compression.
    • “This acquisition strengthens our minimally invasive pain management portfolio with differentiated treatments and expands our reach across ambulatory surgery centers,” Andy Pierce, head of Stryker’s medical and surgical equipment and neurotechnology business, said in a statement.”

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, FDA, Medical / Rx research, OPM, Patient safety, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Govexec reports,
    • “Republican leaders on the House Homeland Security Committee want to know what the Biden administration is doing about Havana syndrome, mysterious brain injuries that became public in 2016 after State Department officials in Cuba’s capital city were affected. 
    • “We are deeply alarmed that these incidents continue to take place here and abroad, and that there has been little to no explanation from the administration as to who or what has caused these phenomena,” wrote full committee Chairman Mark E. Green, R-Tenn., and Counterterrorism, Law Enforcement and Intelligence Subcommittee Chairman August Pfluger, R-Texas, in a letter to National Security Advisor Jake Sullivan Tuesday. 
    • “The brain injuries, referred to as anomalous health incidents, include symptoms of headaches, pain, nausea, disequilibrium and hearing loss. Additional reports of similar symptoms later emerged from federal employees in other countries such as China, Russia, Vietnam, Colombia and various parts of Europe.
    • “Green and Pfluger, who have held numerous hearings and briefings on this matter, requested a committee briefing from the National Security Council. They also urged the administration to prioritize expending unused funds allocated to provide care for AHI victims and to fully implement the HAVANA Act, a 2021 law that authorizes payments to impacted intelligence, diplomatic and other governmental personnel.”  
  • Reuters informs us,
    • “The U.S. Navy has received more than 546,500 claims for compensation from people impacted by decades of contaminated water at Marine Corps Base Camp Lejeune in North Carolina, a new court filing shows, putting it squarely among the largest injury cases of all time.
    • “That number may fluctuate up or down by a few thousand, the government said in the filing, opens new tab. The U.S. Navy is reviewing additional claims received up to the Aug. 10 deadline and removing claims that are found to be duplicates.
    • “The number of administrative claims filed with the U.S. Navy – a step claimants must have taken by the Aug. 10 deadline to receive compensation for injuries they attribute to the water – surpasses the nearly 400,000 lawsuits filed over 3M Co’s military-issue earplugs, which is regarded as the largest multidistrict litigation in history.”
  • The Chair and Ranking Member of the House Education and Labor Committee sent a letter to the Assistant Secretary of Labor who handles ERISA matters. The letter asks the Assistant Secretary about the Department’s efforts to “address troubling practices of certain group health plan service providers.”
  • Federal News Network interviews Colleen Heller-Stein, the first career fed to lead the CHCO Council.

From the public health and medical research front,

  • Per a Food and Drug Administration press release,
    • “Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.”
  • Beckers Hospital Review offers three notes on the FDA action.
  • The Wall Street Journal adds,
    • “The two shots [Pfizer and Moderna] will be available to anyone over 6 months of age, a move that comes as Covid hospitalizations continue to climb and remain higher than they were at this time last year, according to data from the Centers for Disease Control and Prevention. 
    • “Doctors say everyone who is eligible should get a shot. But older people who have skipped other recent vaccine updates should especially consider it. 
    • “I saw a lot of people in the hospital who got a lot of shots in the beginning of the pandemic and then didn’t get any shots for a year or two years,” said Dr. Peter Chin-Hong, a professor of medicine at University of California-San Francisco and an infectious-disease specialist. * * *
    • “Unless you’re very concerned about acquiring Covid right now, my recommendation would be to get it in September or October,” said Dr. William Schaffner, a professor of preventive medicine at the Vanderbilt University School of Medicine. “That will provide the best protection throughout the winter season.” 
    • “The CDC recommends people get one of the new vaccines by the end of October. Both will be available at local clinics and pharmacies.” 
  • The American Hospital Association News lets us know,
    • “The Food and Drug Administration Aug. 22 granted emergency use authorization for two new combined COVID-19 and influenza tests. The Nano-Check Influenza-COVID-19 Dual Test is authorized for use by laboratories to detect and differentiate influenza A and B and SARS-CoV-2 in nasal swab specimens. The Flowflex Plus COVID-19 and Flu A/B Home Test is authorized for home use for people aged two and older.” 
  • The American Medical Association lets us know what doctors wish their patients knew about pre-eclampsia.
  • MedPage Today suggests that “Europe Offers Clues for Solving America’s Maternal Mortality Crisis.”
  • The Brown and Brown consulting group makes an urgent call for employers worldwide to become more aware of the risk of suicide among their employees and engage in suicide prevention efforts.
  • Beckers Hospital Review shares patient safety goals at top rated U.S. hospitals.
  • Per HealthDay, “The overdose-reversing drug naloxone can help save the lives of people whose hearts have stopped due to an opioid OD, a new study shows.”
  • The Institute for Clinical and Economic Review’s “independent appraisal committee voted that current evidence is not adequate to demonstrate net health benefits for imetelstat added to best supportive care when compared to best supportive care alone; treatment [for the treatment of anemia in patients with low-to-intermediate risk myelodysplastic syndrome] would meet common thresholds of cost effectiveness if priced between $94,800 to $113,000 per year, therapy currently priced at approximately $365,000 per year.”

From the U.S. healthcare business front,

  • Modern Healthcare tells us,
    • A federal judge’s ruling this week that blocked the Federal Trade Commission’s near-total ban on noncompete clauses in employment contracts is creating more uncertainty for healthcare employers as they await the agency’s next move.
    • Federal regulators have cracked down on what they view as anticompetitive behavior in recent years, particularly in healthcare. The FTC’s nationwide noncompete ban will no longer take effect Sept. 4, but that doesn’t mean the issue is resolved.
    • Noncompete agreements are common in the healthcare industry. Many organizations, including hospitals, health systems, physician groups, insurance companies and pharmacy benefit managers, use the agreements in employment contracts to protect business interests and ensure competitors don’t obtain proprietary information.” * * *
    • “The FTC has said Tuesday’s ruling does not remove its authority to challenge noncompete bans on a case-by-case basis.”
    • “There’s not going to be any certainty on this for a while,” said Jason Weber, an employment attorney at law firm Polsinelli.” * * *
    • “Polsinelli’s Weber said companies should try to reduce confusion by educating employees on the ruling and emphasizing that noncompete obligations remain in effect.
    • Weber said employers also have a good opportunity to assess their existing agreements and reevaluate whether noncompete clauses are essential to protecting their businesses. For example, employers could use less-restrictive options such as non-solicitation covenants, he said.” 
  • Beckers Payer Issues lists,
    • “Several insurers [that] landed on Forbes’ annual ranking of the “Best Employers by State.” 
    • “The 2024 ranking, published Aug. 20, sorts 1,294 top employers in the U.S. by state. Forbes surveyed more than 160,000 employees at companies with more than 500 people. Respondents evaluated their current employers, employers they’d worked with in the past two years and organizations they knew through their industry. 
    • “Insurers appeared among the top employers in most states, except for Alaska, Delaware, Washington, D.C., Idaho, Maine, Mississippi, Montana, Oklahoma, Rhode Island, Vermont and Wyoming.” 
  • Medscape relates,
    • “Most physicians oppose the way standardized relative value units (RVUs) are used to determine performance and compensation, according to Medscape’s 2024 Physicians and RVUs Report. About 6 in 10 survey respondents were unhappy with how RVUs affected them financially, while 7 in “10 said RVUs were poor measures of productivity.
    • The report analyzed 2024 survey data from 1005 practicing physicians who earn RVUs.” * * *
    • “[O]ver half of clinicians said alternatives to the RVU system would be more effective, and 77% suggested including qualitative data.” 
  • Per Fierce Healthcare,
    • “A Thursday afternoon [bankruptcy] sale hearing scheduled for several Steward Health Care hospitals was shelved in favor of an amended bankruptcy court itinerary hashing out multiple disputes related to the company’s pending deals for hospitals in Florida and Pennsylvania.”  ***
    • “Though not the focus on Thursday’s hearing, Steward’s counsel also opened the hearing with quick updates on developments in Massachusetts and Ohio.
    • “For the former, Candace Arthur, who represents Steward, said that the company’s estate is “very close to the finish line and still fully engaged in mediation” regarding the deal announced last week.
    • “As for Ohio, where closure notices were issued yesterday for two Steward hospitals, Arthur described those filings as “a deadline thing.”

Midweek Update

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

From Washington, DC,

  • Beckers Payer Issues explains how members of Congress receive their health benefit coverage. Of course, since 2014, the answer has been and remains the DC Affordable Care Act exchange. However, retired members of Congress often are eligible for federal pension which includes FEHB coverage with the full government contribution.
  • Federal News Network lets us know,
    • “The Office of Personnel Management is starting to see the light at the end of the tunnel on its never-ending journey to modernize its retirement systems.
    • “A pilot to test out a new online retirement application platform is showing promise with several federal payroll providers.
    • “Guy Cavallo, OPM’s chief information officer, said the pilot includes the Agriculture Department’s National Finance Center and several others to reduce both the amount of paper needed and the error rate in processing retirement applications.
      Guy Cavallo is the CIO at the Office of Personnel Management.
    • “We believe doing the online checking will help really reduce that back and forth that often is needed. We’re also rebuilding the way calculations are done, and we’re implementing a digital file system so that we can stop dealing with millions and millions of pages of paper to be part of retirement,” Cavallo said in an interview with Federal News Network. “It’s going to take many years for us to do this, but by taking the heart of that, we’re improving the way somebody starts to retirement. We’re making sure the calculation service is correct, and then we’re working to get rid of paper versions and move to digital. Those are our first three building blocks.
    • “Cavallo said the goal of the test is to test out the technology and the process changes and continually improve them. He said there is no specific time frame for how long the pilot will last.”
  • Per Beckers Hospital Review,
    • “The FDA is building a post-market surveillance program for medical devices.
    • “The agency will look for medical device-related safety issues reported in EHRs, billing claims and pharmacy data, according to a U.S. Government Accountability Office report released Aug. 15.
    • “The program will begin surveillance of two medical devices by December, with plans to increase the number of devices under investigation each year over the next five years. 
    • “There were more than 1.7 million injuries, and 83,000 deaths linked to medical device safety issues over a 10-year period, according to FDA data from 2018, the report said.”

From the public health and medical research front,

  • The Wall Street Journal reports
    • “The average age of hip- and knee-replacement patients is getting younger.” * * *
    • “For patients ages 45 to 64, there was a 211% increase in inpatient hip replacements and a 240% increase in inpatient knee replacements between 2000 and 2017, according to data from the U.S. Department of Health and Human Services’ Agency for Healthcare Research and Quality. (Records after 2017 are less accurate due to changes in Medicare coding.)
    • “There was also an increase in joint replacements for patients ages 65 to 84, but the rise wasn’t as steep.
    • “This tracking doesn’t include the growing share of replacements that are outpatient surgeries, which allow patients to go home the same day as their procedure. More than a million hip and knee replacement surgeries are performed in the U.S. every year.”
  • The New York Time warns us,
    • “Without a sharp pivot in state and federal policies, the bird flu virus that has bedeviled American farms is likely to find a firm foothold among dairy cattle, scientists are warning.
    • “And that means bird flu may soon pose a permanent threat to other animals and to people.
    • “So far, this virus, H5N1, does not easily infect humans, and the risk to the public remains low. But the longer the virus circulates in cattle, the more chances it gains to acquire the mutations necessary to set off an influenza pandemic.
    • “I think the window is closing on our ability to contain the outbreak,” said Dr. Krutika Kuppalli, an infectious-disease physician who worked at the World Health Organization until April.”
  • Here’s a link to the CDC’s website on the disease.
  • STAT News tells us,
    • “Lack of research into miscarriage in the U.S. — its prevalence, its causes, and how best to treat people who’ve experienced pregnancy loss — has helped to reinforce what has long been a culture of silence and shame around miscarriage. That knowledge gap means that people who miscarry, and miscarry repeatedly, like Hanson, aren’t given the emotional support they need at a time when they are most vulnerable. Equally important, they aren’t given the medical treatment, screening, and support from the health care system that might help them avert future miscarriages. And research into the possible reasons for recurrent pregnancy loss has been limited and siloed, several experts told STAT.”  * * *
    • “When Carol Gilbert, an assistant professor at the University of Nebraska Medical Center College of Public Health, examined CDC data for her 2021 Ph.D. dissertation on perinatal periods of risk, she realized that she needed more complete data for losses before 20 weeks. For public health researchers like Gilbert, incomplete data prevents them from making accurate comparisons between states.When she examined the data, she understood why the CDC doesn’t publish statistics on fetal losses before 20 weeks of gestation. 
    • The individual case data on pregnancy losses are collected by hospitals, assembled by states, and then forwarded to the CDC. But a trifecta of quality problems may explain why the CDC does not publish what data it does receive on losses before 20 weeks of gestation. First, laws regarding the gestational age at which fetal losses need to be reported vary across states. The second problem Gilbert found was that states were inconsistent in their reporting, failing to follow their own laws. This was especially true for fetal deaths between 20 and 24 weeks. 
    • “The third problem was that not all states fill forms completely, leaving out data elements like birthweight and basic maternal characteristics. Some of this is inevitable because it is difficult to weigh fetal tissue in the early stage of pregnancy loss. A CDC spokesperson told STAT that “information regarding early pregnancy losses before 20 weeks’ gestation, including ectopic pregnancies and miscarriages, is challenging to obtain as these outcomes are not routinely reported to CDC.”
  • and
    • “Rachel Gross wants to clear up misconceptions about children and Covid-19. A pediatrician and population health researcher, she recalls a time four years ago when people didn’t think children could even contract the disease. Then, after accepting kids’ vulnerability to the virus, it was thought only adults could suffer from the myriad symptoms that persist or crop up post-infection, collectively known as long Covid.
    • “Now that it’s clear kids can also develop long Covid, Gross wants to correct assumptions that the condition looks the same in adults as in children, no matter their age. In new research published Wednesday in JAMA, Gross and the RECOVER-Pediatrics Consortium report that school-age children and adolescents experience similar long Covid symptoms across multiple organ systems, but those symptoms cluster in ways that vary depending on their age while diverging to some degree from the pattern seen in adults.” * * *
    • “Gross told STAT the study’s purpose was to learn how to identify children experiencing long Covid and how these symptoms change over time. “Then we will be able to better understand the question we really want to know: Why is this happening?”
  • Medscape adds, “Severe COVID-19 was associated with elevated risks for depression and serious mental illness months after infection, especially among unvaccinated people, a cohort study involving more than 18 million individuals in the U.K. found.”

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “Renton, Wash.-based Providence posted an operating loss of $123 million in the second quarter of 2024, a $79 million improvement from the $202 million loss the 51-hospital system posted during the same period last year.
    • “Operating revenues increased by 6% compared to the same period last year, according to an Aug. 21 Providence news release shared with Becker’s. Operating expenses increased 5% for the three months ended June 30. 
    • “Providence saw higher volumes in the second quarter of 2024, according to the release. Inpatient admissions and case mix adjusted admissions were both up 5% compared to the same period last year. 
    • “Despite ongoing headwinds, our strategies for renewal and recovery are driving positive results, and we remain focused on continued improvement in 2024,” Providence CFO Greg Hoffman said in the release.” 
  • and
    • “Dallas-based Steward Health Care plans to close Trumbull Regional Medical Center and Hillside Rehabilitation Hospital, both in Warren, Ohio, on or around Sept. 20 after the facilities failed to attract qualified buyers, the health system said in an Aug. 21 statement shared with Becker’s.
    • “Steward, which sought Chapter 11 protection May 6, shared that the “regrettable but unavoidable situation” has occurred due to its “significant cash constraints.”
    • “We remain hopeful we can find an alternative solution that would keep the hospitals open and preserve the jobs of our dedicated team members,” the statement said. “We want to help save this hospital and will continue to work with qualified bidders during this process.”

Monday Roundup

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

From Washington, DC,

  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS) launched a new national campaign today to inform the public about common respiratory viruses and available vaccines. The campaign, Risk Less. Do More., aims to increase awareness of vaccines that reduce serious illness from influenza (flu), COVID-19, and respiratory syncytial virus (RSV) in high-risk populations and to limit the spread of these viruses among all Americans.” * * *
    • “For more information on the Risk Less. Do More. campaign, please visit RiskLessDoMore.hhs.gov.”
    • “For more information about respiratory illnesses, please visit cdc.gov/RiskLessDoMore.”
  • The American Hospital Association News lets us know,
    • “The Organ Donation and Transplantation Alliance has created new resources for health care providers to encourage more organ donation and transplants. It has launched an educational guide to enhance collaboration between organ procurement organizations, transplant centers and hospitals. The Alliance last week hosted a workshop complementing the guide launch. An on-demand learning pathway video and other supporting materials will be available in September.”
  • Federal News Network tells us,
    • “The Biden administration says federal agencies are getting rid of office space they no longer need, and will shed millions of square feet in the coming years, now that many federal employees are on a hybrid schedule of in-office and work-from-home days.
    • “The Office of Management and Budget, in a sweeping report released earlier this month, said telework-eligible federal employees are working in their offices about 60% of the time.
    • “That hybrid schedule allows agencies to reevaluate their office space needs, and shed excess leased and government-owned real estate.
    • “While agencies reach more durable, long-term decisions about their telework and work environment posture, they are also considering the impacts of these changes on their real property portfolios,” OMB wrote. “Agencies have undertaken considerable work to dispose of unneeded property, reduce costs, and improve overall utilization of real estate.”

From the public health and medical research front,

  • The New York Times reports,
    • “In the study, which was published Monday in the journal Nature Medicine, researchers transformed deep brain stimulation — an established treatment for Parkinson’s — into a personalized therapy that tailored the amount of electrical stimulation to each patient’s individual symptoms.
    • “The researchers found that for Mr. Connolly and the three other participants [with Parkinson’s Disease], the individualized approach, called adaptive deep brain stimulation, cut in half the time they experienced their most bothersome symptom.
    • “Mr. Connolly, now 48 and still skateboarding as much as his symptoms allow, said he noticed the difference “instantly.” He said the personalization gave him longer stretches of “feeling good and having that get-up-and-go.”
    • “The study also found that in most cases, patients’ perceived quality of life improved. “That’s very important,” said Dr. Sameer Sheth, a professor of neurosurgery at Baylor College of Medicine who was not involved in the research.
    • “Although the study was small, it represents the strides being made in using brain implants and artificial intelligence to personalize treatment for neurological and psychiatric disorders — essentially developing pacemakers for the brain.”
  • STAT News points out,
    • “The distress from receiving a cancer diagnosis is something that clinicians widely anticipate in patients, but suffering often doesn’t just afflict the patient. It can blanket an entire household, burdening spouses and other family members with stress and anxiety and the exhausting routine of treating a life-threatening disease.
    • “But while standards exist for assessing and managing distress in patients, it’s often “hidden” in family members, sometimes with devastating consequences, said Weiva Sieh, an epidemiologist at MD Anderson Cancer Center. In a study published in JAMA Oncology on Thursday, spouses of cancer patients were found to be at significantly higher risk of suicide attempt and death compared to those married to people without cancer.  
    • “Psychosocial distress in cancer patients themselves are better anticipated, widely known, and accepted,” said Sieh, who did not work on the study but wrote an accompanying editorial in JAMA Oncology. “This problem is not extremely well recognized. Fortunately, mental health is often treatable. It’s just a question of recognizing it.”
  • MedPage Today notes,
    • “Primary care practitioners (PCPs) provided the majority of prescriptions for HIV preexposure prophylaxis (PrEP) in the U.S., but the odds of patients filling a PrEP prescription were better when it came from an infectious disease (ID) specialist, according to a cross-sectional study.”
  • Fierce Healthcare asserts that “Insurers push ‘food is medicine’ interventions but rarely weigh in on ultra-processed food.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Rochester, Minn.-based Mayo Clinic reported an operating income of $449 million (8.9% margin) in the second quarter, a substantial improvement on the $300 million operating gain (5.9% margin) it posted in the same period last year.
    • “Second-quarter revenue increased 12.1% year over year to $5 billion while expenses grew by 9.4% to $4.6 billion, according to financial documents published Aug. 19. Solid patient volumes and increased donor contributions drove revenue growth during the second quarter. 
    • “Labor costs increased 7% year over year to $2.6 billion while supplies and services expenses rose 13.3% to $1.6 billion. The 7% increase in labor costs — which accounted for 56.9% of total second-quarter expenses — is attributed to staff growth to accommodate higher volumes and a 4% annual salary increase for all allied health staff.
    • “After factoring in nonoperating items, including philanthropy and returns from investments, Mayo reported a net income of $613 million in the second quarter, compared to $547 million in the second quarter of 2023.” 
  • Healthcare Dive adds,
    • “Bankruptcy filings in the healthcare sector have slowed so far in 2024 after spiking last year, according to a report by healthcare restructuring advisory firm Gibbins Advisors.
    • “This year is on track to see 58 filings by healthcare companies with at least $10 million in liabilities, compared with 79 cases in 2023.
    • “But the decline doesn’t necessarily mean the financial headwinds driving bankruptcies have lessened, according to the advisory firm. Restructuring could be taking place outside of courts, and case volumes might increase later this year, Clare Moylan, principal at Gibbins Advisors, said in a statement.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb’s highly anticipated schizophrenia drug KarXT is fast approaching a September deadline for the Food and Drug Administration to decide on approval. Yet competition already looms for a market that’s estimated to soon be worth billions of dollars.
    • “KarXT, a so-called muscarinic agonist, may become the first new kind of schizophrenia drug in decades. Close behind it is AbbVie’s emraclidine, which works in a similar fashion.
    • “People with schizophrenia experience a broad range of symptoms, from hallucinations and delusions to cognitive impairments and social withdrawal. Clinical testing has shown that, like KarXT, emraclidine, which AbbVie acquired from Cerevel Therapeutics in a multibillion-dollar deal, is effective at controlling symptoms without the debilitating side effects or drawbacks of traditional antipsychotics, which cause almost three-quarters of patients to abandon treatment.
    • “But experts say once-daily dosing versus twice-daily treatment, and a potentially more gut-friendly formulation, may give emraclidine an edge over KarXT, which Bristol Myers Squibb acquired in a $14 billion acquisition of Karuna Therapeutics.”
  • MedCity News considers “Why Primary Care Physicians Are Reluctant to Join Value-Based Care.”

Weekend Update

David Ermer–CMS, Congress, COVID-19, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The House of Representatives and the Senate remain on their August recess until September 9.
  • Roll Call reported on August 14,
    • “New Jersey Democratic Gov. Phil Murphy intends to appoint his former chief of staff, George Helmy, to fill the Senate seat that Sen. Bob Menendez will vacate next week, multiple New Jersey media outlets reported Wednesday evening, citing sources.
    • “Helmy, who has most recently worked as executive vice president and head of external affairs for RWJBarnabas Health, will serve until the end of the 118th Congress. The seat for the full term starting in January will be filled by the winner of the November election between Rep. Andy Kim, the Democratic nominee, and Republican Curtis Bashaw.”
  • On August 16, the Congressional Budget Office released to the House Oversight and Accountability Committee a report on H.R. 7868, the FEHB Protection Act.
    • The problematic aspect of the bill is that it focuses on tightening up oversight of family member eligibility when OPM does not give FEHB plans the information to confirm that plan enrollees are paying the proper premium or any premium for their coverage, which creates a yawning gap in internal controls. OPM can cure this problem by implementing the HIPAA 820 enrollment roster transaction.

From the public health and medical research front,

  • Fortune Well identifies where COVID has been spiking in the U.S. this summer.
    • “In the four-week period ended Aug. 10, the national test positivity rate was 15.6%. During that time, five states in the South-Central U.S. saw the highest test positivity, 21%. These states collectively make up the CDC’s Region 6:
      • Arkansas
      • Louisiana
      • New Mexico
      • Oklahoma
      • Texas
    • “States in Region 9—Arizona, California, Hawaii, and Nevada—had the next-highest four-week positivity rate, 18.8%. Ten other states across two Midwestern regions were also above the national average. No state—as well as the District of Columbia, Puerto Rico, and the Virgin Islands—had a positivity rate below 10%.”
  • The Washington Post lets us know,
    • “The Centers for Disease Control and Prevention is warning clinicians to be on the lookout for a viral disease that is spread by small flies and some types of mosquitoes and that causes sudden fever, severe headaches and chills.
    • “Cases of Oropouche virus disease have been climbing in South America and the Caribbean in the past two years and turned deadly for the first time this year.
    • “The CDC advisory issued Friday recommends that pregnant people reconsider nonessential travel to Cuba, which reported its first confirmed case in June.”
  • and
    • “Though appendectomies have been the gold standard of care since before the turn of the 20th century, doctors have been treating appendicitis with antibiotics since the 1950s, as soon as they became available — a “dark secret” in the surgery world, says David R. Flum, professor of surgery and director of the Surgical Outcomes Research Center at the University of Washington. A 1959 paper detailed the use of antibiotics to treat nearly 500 people (a mix of adults and children) with appendicitis. They were — and still are — often used in people whose appendicitis is so advanced that surgery risks spreading the infection further. The military relied on antibiotics for service members who got appendicitis while in inaccessible locations, like submarines.
    • “But the treatment didn’t get wider attention until the late 1990s and early 2000s, Flum says, when researchers began to collect data on how often antibiotics don’t work and found that failure was not as common as they thought.
    • “Then came two large, randomized trials in adults. In the first, published in 2015, 257 adults received an antibiotic treatment. Seventy of those patients, or 27 percent, had to have an appendectomy within one year. But the rest were fine.
    • “A second, larger study of 1,552 adults had similar results: Twenty-nine percent of the 776 people who received antibiotics underwent surgery within 90 days; 4 percent of people in the antibiotics group had serious adverse events, compared with 3 percent in the appendectomy group. The New England Journal of Medicine published the results in 2020. The same year, the American College of Surgeons added nonoperative management as an option in its guidelines for treating appendicitis.
    • “It wasn’t a slam dunk, but the studies showed that antibiotics could be a good choice.”
  • The New York Times discusses “The Painkiller Used for Just About Anything. In huge numbers, older people are taking gabapentin for a variety of conditions, including itching, alcohol dependence and sciatica.”
    • “It’s crazy how many [off label] indications it’s used for,” said Dr. Michael Steinman, a geriatrician at the University of California, San Francisco, and a co-director of the U.S. Deprescribing Research Network. “It’s become a we-don’t-know-what-else-to-do drug.”
    • “What has fueled this multipurpose popularity? “The history of gabapentin is really a history of uses getting ahead of the evidence,” said Dr. Joseph Ross, an internist and health policy researcher at Yale School of Medicine.” * * *
    • Dr. Steinman called it a “sticky” drug. He was an author of a 2022 study on older adults who were prescribed gabapentin after surgery, most commonly hip and knee replacements. One in five refilled the prescription more than three months later, when “presumably their surgical pain has long since resolved,” he said.
    • As older patients seek to find relief from chronic pain, “we don’t have a lot of great options,” Dr. Steinman said of health care providers. Prescribers try to avoid opioids, and nonsteroidal anti-inflammatories like ibuprofen are recommended only for short-term use.
    • Some find relief from medical cannabis, topical medications like creams and patches, and non-pharmacological approaches such as acupuncture, therapeutic massage and exercise.
    • “Often the single best thing I can do for patients with pain is to get them to physical therapy,” Dr. Steinman added.

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Orlando Health has offered to buy Steward Health Care’s three “Space Coast” Florida properties, including three hospitals and a medical practice, for $439 million, according to a court document filed Wednesday.
    • “Bankrupt Steward Health Care and Orlando Health have entered into a binding asset purchase agreement to sell Rockledge Regional Medical Center, Melbourne Regional Medical Center, Sebastian River Medical Center. The proposed deal also includes Steward Medical Group Practices in East Central Florida.
    • “According to the court document, filed in U.S. bankruptcy court in the southern district of Texas, Steward designated Orlando Health a “stalking horse bidder,” which is the first to negotiate a purchase agreement with a debtor in bankruptcy. The bidder sets a minimum price and protects the debtor from low bids.
    • “The purchase agreement for Steward’s northern Florida assets is for $439.42 million in cash, according to the court document.
    • “Orlando Health’s bid will be subject to higher or better-qualified bids received by August 26, at which time a bankruptcy court-approved auction may occur, according to a press release from Steward Health Care.”
  • The Wall Street Journal adds
    • “Steward Health Care System was in such dire straits before its bankruptcy that its hospital administrators scrounged each week to find cash and supplies to keep their facilities running. 
    • “While it was losing hundreds of millions of dollars a year, Steward paid at least $250 million to its chief executive officer, Dr. Ralph de la Torre, and to his other companies during the four years he was the hospital chain’s majority owner.
    • “Steward filed for bankruptcy in May, becoming one of the biggest hospital failures in decades.” * * *
    • “The Senate Committee on Health, Education, Labor and Pensions in a bipartisan vote authorized an investigation and subpoenaed de la Torre to testify at a Sept. 12 hearing.”