Monday Roundup

Congress

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.”

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.”

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.”

Thursday Miscellany

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Tidbits

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Roundup

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Miscellany

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

From Washington, DC

  • Fierce Healthcare lets us know,
    • “The Department of Health and Human Services’ technology office dropped a new proposed rule on Thursday that would require healthcare entities that contract with HHS to use government-certified health information technology. 
    • “One group said the proposed rule could expand ASTP/ONC’s scope beyond setting standards for electronic health records (EHRs) to include data systems used by public health entities and insurers’ information systems. The proposed rule could potentially impact the regulation of artificial intelligence and cybersecurity in healthcare, a source said.
    • “The  Office of the Assistant Secretary of Technology Policy’s proposed rule, “Acquisition Regulation: Information Technology; Standards for Health Information Technology” proposes that health IT meet ONC standards requirements when: solicitations and contracts issued by or on behalf of HHS entities involve implementing, acquiring or upgrading health IT where individually identifiable health information (IIHI) is exchanged; and, health IT is used by healthcare providers, health plans, or health insurance issuers under HHS contracts.
    • “The proposed rule would also include healthcare providers who have been eligible to participate in CMS’s health IT-focused incentive programs.”
  • MedTech Dive tells us,
    • “The Centers for Medicare and Medicaid Services shared a final notice on Wednesday for a new pathway to cover breakthrough medical devices. 
    • “The pathway, called Transitional Coverage for Emerging Technologies (TCET), is intended to expedite Medicare coverage of new medical devices. On average, it takes about five years after a device is authorized by the Food and Drug Administration to gain national Medicare and commercial insurance coverage, according to a survey by the Stanford Byers Center for Biodesign. 
    • “The CMS plans to accept up to five candidates per year for the TCET pathway, with the goal of finalizing a national coverage determination within six months of FDA market authorization for technologies that are accepted. The devices must have the FDA’s breakthrough designation, meaning they provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.
    • “Medtech lobbying firm Advamed pushed back on the five devices per year cap. CEO Scott Whitaker said in a Thursday statement that the limit “demonstrates clearly to Congress the need for greater resources at CMS” and the exclusion of diagnostics from the pathway is “disappointing.” 
  • The Congressional Research Service posted a legal sidebar titled “Private Equity Investments in Healthcare: Selected Enforcement Issues.”
  • STAT News reports,
    • “A federal judge [who sits on the bench of the U.S. District Court for the Southern District of Ohio] on Thursday tossed out a U.S. Chamber of Commerce lawsuit challenging Democrats’ drug pricing law.”
    • “The decision is yet another loss for the pharmaceutical industry and its allies, which have filed lawsuits across the country arguing that the Inflation Reduction Act, which created a drug price negotiation program in Medicare, is unconstitutional. So far, they have lost every one.” * * *
    • “Because the case wasn’t filed in the correct court, Judge Newman didn’t address substantive issues about whether the law is constitutional or not.
    • “Medicare officials are expected to release the outcome of the price negotiations for the first 10 drugs in the program by Sept. 1.”
  • Per Federal Network News,
    • “The Postal Service is seeing steady growth in revenue, but not enough to outpace its substantial operating costs.
    • “USPS saw a $2.5 billion net loss for the third quarter of fiscal 2024 — higher than the $1.7 billion net loss it saw for the same period last year.
    • “USPS reported $18.8 billion in revenue this quarter — 1% higher than revenue for the same quarter last year. It’s also the agency’s fourth consecutive quarter of revenue growth.
    • “However, the agency also saw a more than 4% increase in its operating costs, which grew to more than $21 billion for the quarter.
    • “Postmaster General Louis DeJoy said Thursday that USPS plans to accelerate efforts to cut costs and boost revenue.”

From the public health and medical research front,

  • The Hill reports,
    • “Fewer U.S. adults today say it is important to get children vaccinated than in recent years, according to a Gallup poll published Wednesday.
    • “In the July survey, only 40 percent of U.S. adults said it is “extremely important” for parents to vaccinate their children, a marked decline from the 58 percent who said the same in 2019 and the 64 percent who said the same in 2001.
    • “The drop over the last two decades is similarly stark when tracking the combined percentage who said vaccinating children is either “extremely” or “very” important. Taken together, 69 percent of U.S. adults hold this view now, down from 84 percent in 2019 and from 94 percent in 2001.” * * *
    • “The poll included phone interviews conducted July 1-21, with 1,010 adults. The margin of error is 4 percentage points.”
  • The New York Times points out,
    • “Scientists have developed a new weapon against H.I.V.: a molecular mimic that invades a cell and steals essential proteins from the virus.
    • “A study published in Science on Thursday reported that this viral thief prevented H.I.V. from multiplying inside of monkeys.
    • “The new therapeutic approach will soon be tested in people, the scientists said. Four or five volunteers with H.I.V. will receive a single injection of the engineered virus. “This is imminent,” said Leor Weinberger, a virologist at the University of California, San Francisco, who led the new study.” * * *
    • “Asher Leeks, a virologist at Yale University who was not involved in the research, said that it represented a big step forward in the study of so-called cheating viruses. Researchers have been investigating them for decades, but only in recent years have scientists like Dr. Weinberger tried turning them into medical treatments.”
  • Per a Cleveland Clinic press release,
    • New Cleveland Clinic research shows that consuming foods with erythritol, a popular artificial sweetener, increases risk of cardiovascular events such as heart attack and stroke. The findings, from a new intervention study in healthy volunteers, show erythritol made platelets (a type of blood cell) more active, which can raise the risk of blood clots. Sugar (glucose) did not have this effect.
    • Published in Arteriosclerosis, Thrombosis and Vascular Biology, the research adds to increasing evidence that erythritol may not be as safe as currently classified by food regulatory agencies and should be reevaluated as an ingredient. The study was conducted by a team of Cleveland Clinic researchers as part of a series of investigations on the physiological effects of common sugar substitutes. * * *
    • “I feel that choosing sugar-sweetened treats occasionally and in small amounts would be preferable to consuming drinks and foods sweetened with these sugar alcohols, especially for people at elevated risk of thrombosis such as those with heart disease, diabetes or metabolic syndrome,” Dr. Stanley Hazen advises. “Cardiovascular disease builds over time, and heart disease is the leading cause of death globally. We need to make sure the foods we eat aren’t hidden contributors.”
  • The Wall Street Journal reports,
    • “Millions of people are flocking to drugs like Ozempic and Wegovy to lose weight and treat health problems. Doctors say one group that could benefit from the drugs is missing out: seniors.
    • “For older people, these medications can help in ways that go beyond losing weight, physicians say. Fewer pounds can lead to more mobility and better balance, allowing older people to become more active. That can boost mood, overall health, and sometimes makes the difference between walking freely or using a wheelchair or cane. 
    • “Doctors say they’re hearing more from older people who are interested in taking the drugs. However, seniors face [Medicare] insurance hurdles to get the drugs covered. And doctors note that older people need to be careful about losing muscle mass when on the drugs, as well as possible interactions with other medications.    
    • “Nine percent of people 65 and older reported taking GLP-1 medications, such as Ozempic, Wegovy and Zepbound, compared with 19% of people ages 50 to 64, according to a May KFF poll.
    • “These drugs would really benefit seniors but there’s always these additional worries,” says Dr. Sun Kim, an associate professor in the division of endocrinology at Stanford University School of Medicine. “I think sometimes we prioritize the risk over benefit when people get older.” 
  • and
    • “Doctors are now capable of saving the lives of babies born at 22 weeks and, in rare cases, a week earlier, with improved techniques to help tiny lungs develop and protect fragile skin and organs. Hospitals with extensive experience resuscitating extremely premature babies report survival rates as high as 67% for babies born at 22 weeks.
    • “Some U.S. hospitals aren’t sufficiently equipped or capable of pulling off the new advances. Others have chosen not to offer the care, saying it is likely to fail, is expensive—typically more than $100,000 a child, and sometimes much more—and subjects tiny, fragile infants to needless pain and the risk of long-term disabilities. 
    • “Instead, they often provide comfort care: wrapping the newborn in a blanket, placing it on the mother’s chest and sometimes giving medicines to ease the child’s final moments.
    • “The difference can be a matter of life or death for the roughly 8,000 infants born between 22 and 24 weeks gestation in the U.S. each year.
    • “Doctors agree that babies born at 25 or 26 weeks can and should be treated as long as they don’t have other complications, while those born at 20 weeks or less are too small to save.
    • “In between is a “gray zone,” as doctors call it, where newborns’ fate can depend on which hospital happens to be delivering.”
  • STAT News tells us,
    • “Since its emergence in 2020, Covid has jumbled the list of the 10 leading causes of deaths in the United States. It roared into third place in 2020 but has now fallen to 10th place, the National Center for Health Statistics reported Thursday. 
    • “Heart disease and cancer remained the first and second leading causes of death, followed by unintentional injuries as No. 3. Overall, deaths in 2023 were 6.1% lower than 2022.
    • “We’re going in the wrong direction for heart disease. We’re going a tad in the right direction for cancer,” said Eric Topol, founder and director of the Scripps Research Translational Institute. A cardiologist and geneticist, he was not involved in the analysis. “A lot of things that are highest on this list, there’s a lot of things we can do to prevent them. And hopefully we’ll keep seeing the numbers come down. But if you just look at pre-pandemic to now, it’s not a good trend.”
  • Per Healio,
    • “The Simplera Continuous Glucose Monitor features a one-hand, two-step insertion process for the sensor that does not require additional tape.
    • “The [recently] FDA-approved device is part of Medtronic’s smart multiple daily injection system.

From the U.S. healthcare business front,

  • The Wall Street Journal relates,
    • “Eli Lilly shares jumped after the drugmaker reported earnings that trumped analyst estimates and hiked its annual outlook.
    • “Lilly has become one of the most valuable companies listed in the U.S. due to the popularity of its medications used for obesity.
    • “Quarterly sales for diabetes drug Mounjaro totaled more than $3 billion, while weight-loss injection Zepbound, which launched late last year, rang in at $1.2 billion. Both figures beating analysts’ estimates.
    • “The strong quarter was boosted in part by additional supply of the drugs, which had been in shortage, as well as favorable pricing, Lilly said. Mounjaro prices were higher in the U.S., partly because of increased availability of the drug and lower use of savings card programs.”
  • Following up on a post from yesterday, BioPharma Dive informs us,
    • “[Mounjaro and Zepbound] are available in all dosage forms in the U.S. What that means is we can bill orders as they’re received,” said Lilly CEO David Ricks on an earnings conference call Thursday. “That does not mean that any pharmacy, or certainly every pharmacy, has all 12 dosage forms sitting on their shelves.”
    • “Ricks cautioned that, despite the change in status on the FDA’s shortage list, patients may still have to wait a few days to pick up their prescriptions.
    • “There’s not an abundance of supply. It’s more of a real-time fulfillment situation,” Ricks said. “But product is flowing and it’s flowing at a pretty high rate.”
    • “Still, he added, “the end pharmacy experience will continue to be choppy.”
  • Forbes adds,
    • “More doses of Novo Nordisk’s popular weight loss drug Wegovy are back in stock in the U.S. after years of shortages, according to the FDA, days after all dosage levels of Eli Lilly’s rival injection Zepbound became available. They’re part of a promising and growing class of drugs called GLP-1 agonists, but shortages are set to persist as pharmaceutical companies struggle to ramp up production.”
  • STAT News notes,
    • “As for-profit Tenet Healthcare slims its hospital portfolio, it found an unlikely buyer for its Alabama hospitals: Florida’s Orlando Health.  
    • “Orlando Health draws more than $6 billion in annual revenue and has a profit margin that surpasses most of its peers. A hospital system executive system leader said crossing state lines to buy five Birmingham-area hospitals is part of its focus on serving the Southeastern U.S., even though most of its 17 existing hospitals are still in Florida. 
    • “It’s not at all surprising that a multi-billion dollar health system would have ambitions of expanding beyond its home state. That’s especially true as hospital systems continue to merge at a breakneck pace, increasingly jumping across multiple states to do so. Meanwhile, study after study concludes that hospitals use their newfound market power to drive up prices.”
  • Per Beckers Hospital Review
    • “As the Medicare Advantage landscape evolves, the success of health systems hinges on their ability to adapt and excel in key areas such as star ratings and appropriate coding. 
    • “Health systems’ greatest opportunity is to enter into full-risk arrangements with health plans, shifting the focus from managing illness to maintaining wellness. However, many systems have not made the necessary investments to thrive in this value-based care model, often missing out on its potential benefits and driving ambivalence toward the MA program, according to SCAN Group CEO Sachin Jain, MD.”
  • Fierce Healthcare adds,
    • “Centene is exiting six states through its WellCare Medicare Advantage (MA) subsidiary next year, investment bank Stephens has revealed.
    • “Those six impacted states are Alabama, Massachusetts, New Hampshire, New Mexico, Rhode Island and Vermont, with approximately 12,600 members affected in New Mexico, the most of any state.
    • “In Vermont, Centene accounts for about 9% of the market share in the state. All told, all market exits will impact around 37,300 members and about 3% of Centene’s current MA membership, a research note from Stephens showed.
    • “Notably, CVS and UnitedHealthcare both maintain presences across each impacted market,” the brief said.
    • ‘The insurer will still offer its prescription drug plans in these states. Centene commands the most market share for standalone Part D in the country at 29%, data from the Centers for Medicare & Medicaid Services show.
  • Per Healthcare Dive,
    • “Walgreens is considering a full sale of its stake in VillageMD, after pouring billions of dollars into the unprofitable primary care chain. The decision, disclosed Wednesday in a securities filing, is a sharp reversal to the pharmacy behemoth’s past commitment to building out its healthcare delivery offerings.
    • “Walgreens is “currently evaluating a variety of options” in light of VillageMD’s “substantial ongoing and expected future cash requirements,” the company said in the 8-K. “These options could include a sale of all or part of the VillageMD businesses, possible restructuring options and other strategic opportunities.”
    • :If Walgreens offloads VillageMD entirely, it would be a step up from management’s previous plans for the value-based medical chain. In June, Walgreens said it would reduce ownership in VillageMD but not eliminate it entirely.”
  • STAT News lets us know,
    • “Digital Therapeutics developer Big Health this week received Food and Drug Administration clearance for SleepioRx, a prescription treatment for insomnia.
    • “Big Health already sells a wellness version of the app, called Sleepio, to employers and health plans that make the product available to their members. The app delivers a specialized type of cognitive behavioral therapy for insomnia and the company boasts that it is backed by dozens of studies.”
  • Per BioPharma Dive,
    • “Sarepta Therapeutics’ yearly financial outlook and quarterly earnings, including sales of Elevidys, its gene therapy for Duchenne muscular dystrophy, have fallen well short of Wall Street expectations.
    • “Sarepta reported Wednesday afternoon that Elevidys sales totaled roughly $122 million between April and June, down from the previous quarter and about $20 million below consensus estimates. Overall product sales of about $361 million, and 2025 revenue projections of $2.9 billion to $3.1 billion, were also lower than analysts anticipated.
    • “Still, executives assured investors that sales should soon climb following the recent decision by the Food and Drug Administration to substantially expand use of Elevidys. The market opportunity ahead of Sarepta is “absolutely massive,” said Dallan Murray, the company’s executive vice president and chief customer officer on a conference call. Sarepta shares initially fell by double digits before rebounding Thursday morning.”
  • Per MedTech Dive,
    • “Zimmer Biomet said Wednesday it agreed to buy Orthogrid Systems, a medtech company that makes artificial intelligence-based surgical guidance systems for total hip replacement. 
    • “Salt Lake City-based Orthogrid uses fluoroscopy imaging to help surgeons track the position of an implant during a hip procedure. It also has two other Food and Drug Administration-cleared solutions for hip preservation and trauma surgeries. 
    • “By using fluoroscopy instead of CT scans, Orthogrid can offer real-time navigation and a more efficient workflow for operating rooms.
    • “The solution will add to Zimmer’s current suite of tools for hip surgery. The company has its own hip application paired with its Rosa surgical robot that also uses fluoroscopy imaging. Zimmer additionally has a co-marketing agreement with HipInsight, which uses Microsoft Hololens 2 glasses to help surgeons visualize a patient’s pelvic anatomy during surgery. 
    • “By comparison, Stryker’s Mako total hip application uses CT imaging, while J&J’s Velys hip navigation uses fluoroscopy.”