FEHBlog

Weekend Update

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

Happy first day of Fall 2024!

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Federal News Network tells us
    • “A record number of federal agencies and their chief information officers are getting top marks on how they manage IT and cybersecurity.
    • “A total of 13 agencies [including the U.S. Office of Personnel Management] received an overall A letter grades on a semiannual Federal IT Acquisition Reform Act (FITARA) scorecard.
    • “Another 10 agencies got a B grade for their overall IT and cybersecurity management. Only one agency, the Energy Department, received a C grade. No agencies received a D or an F.
    • “Agencies generally saw lower scores in the previous FITARA scorecard released in February.”
  • KFF Health News gives low marks to the federal agencies responsible for protecting healthcare organizations against cyberattacks.
  • Per a CISA press release,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) published the Federal Civilian Executive Branch (FCEB) Operational Cybersecurity Alignment (FOCAL) Plan today. As the operational lead for federal cybersecurity, CISA uses this plan to guide coordinated support and services to agencies, drive progress on a targeted set of priorities, and align collective operational defense capabilities. The end result is reducing the risk to more than 100 FCEB agencies.
    • “Each FCEB agency has a unique mission, and thus have independent networks and system architectures to advance their critical work. This independence means that agencies have different cyber risk tolerance and strategies. However, a collective approach to cybersecurity reduces risk across the interagency generally and at each agency specifically, and the FOCAL Plan outlines this will occur. CISA developed this plan in collaboration with FCEB agencies to provide standard, essential components of enterprise operational cybersecurity and align collective operational defense capabilities across the federal enterprise.” * * *
    • “The FOCAL Plan was developed for FCEB agencies, but public and private sector organizations should find it useful as a roadmap to establish their own plan to bolster coordination of their enterprise security capabilities. 
    • “The Plan is not intended to provide a comprehensive or exhaustive list that an agency or CISA must accomplish. Rather, it is designed to focus resources on actions that substantively advance operational cybersecurity improvements and alignment goals.”
  • Dark Reading reports,
    • “The Justice Department today [September 19] announced a court-authorized operation to disrupt a botnet affecting 200,000 devices in the United States and abroad.
    • “According to unsealed documents, the botnet, known as Raptor Train, is operated by People’s Republic of China (PRC) state-sponsored hackers working for a company based in Beijing. Known publicly as Integrity Technology Group, it is also known as the advanced persistent threat (APT) group Flax Typhoon in the private sector.
    • A variety of connected and Internet of things (IoT) devices have been affected by the botnet malware, including small-office/home-office (SOHO) routers, Internet protocol cameras, digital video recorders, and network-attached storage (NAS) devices.”

From the cyber vulnerabilities and breaches front,

  • Cybersecurity Dive lets us know,
    • “Ivanti warned Thursday of a critical path traversal vulnerability in Cloud Service Appliance, which is currently facing exploitation attempts by hackers. The vulnerability, listed as CVE-2024-8963, has a CVSS score of 9.4 and allows an unauthenticated hacker to gain access to restricted functionality.
    • “Ivanti previously issued a patch for CSA on Sept. 10., but the company said the path traversal vulnerability was discovered while investigating exploitation linked to an OS command injection vulnerability, listed as CVE-2024-8190. 
    • “The company warned that when the two vulnerabilities are used in conjunction with each other, a hacker can bypass admin authentication and execute arbitrary commands.” 
  • Dark Reading tells us “Security Firm’s North Korean Hacker Hire was not an Isolated Incident; What happened to KnowBe4 also has happened to many other organizations, and it’s still a risk for companies of all sizes due to a sophisticated network of government-sponsored fake employees.” Check out the article.

From the ransomware front,

  • Dark Reading informs us,
    • “Inc ransomware is on the rise, with one well-known threat actor recently using it to target American healthcare organizations.
    • “Vice Society, which Microsoft tracks as Vanilla Tempest, has been active since July 2022. In that time, the Russian-speaking group has made use of various families of ransomware to aid its double extortion attacks, including BlackCat, Hello Kitty, Quantum Locker, Rhysida, Zeppelin — including its own variant — and its own, eponymous program.
    • “In a series of posts on X, Microsoft Threat Intelligence Center (MSTIC) flagged the group’s latest weapon: Inc ransomware.”
  • Per Cybersecurity Dive,
    • “A special legislative committee in Suffolk County, New York, found officials ignored repeated warnings and failed to prepare ahead of a September 2022 ransomware attack that disrupted essential government services for months, in a report released last week.
    • “Officials blamed the ransomware attack on a failure of leadership, including the lack of an incident response plan and a failure to respond to FBI warnings of potential infiltration. 
    • “Suffolk County operated using a variety of IT teams and had no CISO, resulting in a lack of coordination on how to prepare for potential cyber threats. The attack has so far cost the county more than $25 million in remediation costs and other expenses.”
  • Cyberscoop reports on a debate of experts at the 2024 mWISE conference about what more could be done to stop ransomware attacks in the wake of police action and tens of millions in ransom payments over the past year. 

From the cyber defenses front,

  • Cyberscoop points out,
    • “UnitedHealth Group is still in the recovery process months after a ransomware attack on its Change Healthcare subsidiary, with its chief information security officer saying the company has essentially “started over” with regard to its computer systems. 
    • “When I say start over, I really, truly mean start over,” Steven Martin said Thursday at the Mandiant Worldwide Information Security Exchange (mWISE). “The only thing that we kept from the old environment into the new environment was the cables. New routers, new switches, new compute infrastructure, deployed everything from a safe environment, truly started over. I felt like that was the only way that we could really ensure that we ended up with something that we could stand behind for the health care space, because it’s what it deserved.” 
  • Cybersecurity Dive adds,
    • “CEOs and company boards often ask Kevin Mandia, founder and former CEO of Mandiant, how to determine the strength of their CISOs. Above all else, Mandia advises executives to assess their CISO’s disposition.
    • “Do you have a CISO with a security mindset?” “If they don’t have that, you’re probably not going to have a great security program,” Mandia said Wednesday during his opening keynote at the Mandiant Worldwide Information Security Exchange conference in Denver.” * * *
    • “Over the past couple decades Mandia’s crafted a series of five questions designed to help executives and board members test their confidence in a CISO’s ability to excel in their job.
    • “The questions on Mandia’s CISO confidence test include:
      • How would you break into us? What is our weak spot?
      • What is our worst-case scenario?
      • What would you do if the worst-case scenario occurred?
      • How resilient are we? How long would it take to recover our systems and applications?
      • What do you need?
    • “Mandia, who now serves in a strategic security advisor role at Google Cloud, said CEOs should focus on their CISO’s response to these questions as a measure of their demeanor.
    • “I tell CEOs, you don’t even care what the answer is to these questions as long as your CISO actually has one, because at least that means you have the mindset,” Mandia said.”
  • Health Tech offers five steps to follow after a breach.
  • Per Bleeping Computer,
    • “Microsoft announced today that Hotpatching is now available in public preview for Windows Server 2025, allowing installation of security updates without restarting.
    • “Hotpatching deploys Windows security updates without requiring a reboot by patching the in-memory code of running processes without restarting them after each installation.
    • “Among the benefits of Windows Hotpatching, Redmond highlights faster installs and reduced resource usage, lower workload impact because of fewer reboots over time, and improved security protection because it reduces the time exposed to security risks.
    • “Instead of 12 mandatory reboots a year on ‘Patch Tuesday,’ you’ll now only have quarterly scheduled reboots (with the rare possibility of reboots being required in a nominal Hotpatch month),” said Windows Server Director of Product Hari Pulapaka on Friday [September 20].”

Friday Factoids

David Ermer–CDC, FDA, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Healthcare Dive lets us know,
    • The Federal Trade Commission has filed suit against the three largest pharmacy benefit managers in the country for anticompetitive business practices that artificially inflated the price of life-saving insulin drugs.
    • The agency’s administrative complaint alleges CVS’ Caremark, Cigna’s Express Scripts and UnitedHealth’s Optum Rx steered patients toward higher priced insulin in order to bring in larger rebates from pharmaceutical manufacturers.
    • As a result, patients who weren’t eligible for the lower discounted price faced higher costs, the FTC alleges. Caremark, Express Scripts and Optum Rx together control about 80% of U.S. prescriptions.
  • The FTC has decided to try the case in the FTC’s administrative court, instead of a federal district court. Any appeal would be taken to a federal circuit court of appeals, typically the D.C. Circuit.
  • Modern Healthcare adds,
    • “CVS Caremark in a statement said it had worked to drive down insulin prices by creating new formulary options and negotiating discounts on behalf of clients. It pointed to a program available to patients at its network pharmacies offering lower-cost insulin.
    • “Any action that limits the use of these PBM negotiating tools would reward the pharmaceutical industry and return the market to a broken state, leaving American businesses and patients at the mercy of the prices drugmakers set,” a spokesperson said in the statement.
    • “Cigna Chief Legal Officer Andrea Nelson refuted the FTC’s allegations and reiterated the role PBMs such as Express Scripts play in the healthcare system. She said the case could lead to higher drug prices.
    • “Express Scripts intends to vigorously defend itself to protect our ability to lower drug costs for the thousands of clients and the millions of Americans we serve,” Nelson said in a statement.
    • “An OptumRx spokesperson said in a statement its negotiations with drugmakers and other actions have led to lower insulin costs for members.
    • “This baseless action demonstrates a profound misunderstanding of how drug pricing works,” the spokesperson said.”
  • CMS posted the presentation from the agency’s September 10 webinar about group health plan Section 111 reporting.
  • Fierce Healthcare tells us,
    • “The Medicaid unwinding is coming to a close, and a new analysis from KFF finds that while many people have lost coverage during this period, enrollment remains above pre-pandemic levels.
    • “The report estimates that more than 25 million people were disenrolled as part of the Medicaid redeterminations, while more than 56 million renewed coverage successfully. However, while millions have lost coverage, there are about 10 million more people enrolled in Medicaid and the Children’s Health Insurance Program (CHIP) compared to the start of the COVID-19 pandemic.
    • “KFF found that most states completed the redeterminations with higher enrollment than they reported in February 2020. In seven states, enrollment was 30% above pre-pandemic levels.
    • “Also playing a role is the fact that five states—Missouri, Nebraska, North Carolina, Oklahoma, and South Dakota—expanded their Medicaid programs since the pandemic began, COVID-19 said.
    • “There have always been people eligible for Medicaid but not enrolled, as well as people who get dropped from Medicaid for failing to complete regular renewal processes,” the researchers wrote. “During the unwinding period, many states took steps to improve their renewal systems, leading to fewer people getting dropped even though they remain eligible.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced,
    • “Seasonal influenza and RSV activity are low nationally and COVID-19 activity is decreasing in most areas.
    • “COVID-19
      • “There are continued signs of declines in COVID-19 activity in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are decreasing. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
      • “Vaccinations to prevent fall respiratory virus have started for the 2024-25 respiratory illness season with 2.8% of adults 18 years and older reporting receipt of the updated 2024-25 COVID-19 vaccine and 6.8% reporting receipt of an influenza vaccine. Among adults 75 years and older, 33.1% reported ever receiving an RSV vaccine. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.
  • In Covid news, The University of Minnesota’s CIDRAP adds,
    • “Test positivity for COVID was 13.5% last week, down from 14.9% the week before.
    • “Hospitalizations continue to decline but remain highest in seniors, followed by adults ages 50 to 64 and children younger than age 4 years. 
    • “Emergency department visits dropped about 19% compared to the previous week and are now at low levels across much of the country. 
    • “Deaths held steady, and provisional data show that the CDC received reports of 563 COVID deaths for the week ending September 14.
    • “Detections of SARS-CoV-2 in wastewater are still high nationally, according to CDC tacking. The highest levels remain in the West, followed by the Midwest and the South. However, all regions show downward trends.
    • ‘The latest data from WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, show that detections are still high nationally and, in the Midwest, with no significant up or down trend over the past 3 weeks.”
  • NBC News informs us,
    • “The U.S. is experiencing more than four times as many whooping cough cases compared with last year — a spike that some experts attribute to post-pandemic vaccine fatigue. 
    • “With the increase in vaccine hesitancy that has been going on since the Covid-19 pandemic, we’re seeing outbreaks occurring in kids who are not vaccinated,” said Dr. Tina Tan, president-elect of the Infectious Diseases Society of America.
    • “Babies are given the DTaP vaccine, which helps protect against three diseases: pertussis, diphtheria and tetanus. The vaccine works well against diphtheria and tetanus, but is less effective over time for pertussis. 
    • “Advisors to the Food and Drug Administration met Friday to discuss the need for more robust and longer-lasting versions of the whooping cough vaccine. 
    • “Until next generation vaccines are developed, boosters are recommended about every 10 years, starting in the tween years, as kids start middle school. 
    • “It’s the tweens and teens whose immunity against whooping cough has waned that are driving outbreaks in many states, experts say.”
    • “On Thursday, the CDC reported that 14,569 cases of whooping cough had been confirmed so far in 2024. That’s a significant increase over last year’s total of 3,475 cases.”
  • The New York Times reports,
    • “The Food and Drug Administration on Friday authorized at-home use of FluMist, opening the door for needle-shy people to have easy access to a nasal spray vaccine that is potentially lifesaving.
    • “The approval will allow, for the first time, an alternative to the annual flu shot that parents and caregivers can give to children and that adults can use on their own outside of a health-care setting. It would still require a prescription and is expected to be available from an online pharmacy next fall.
    • “AstraZeneca, which makes the treatment, said it would start a FluMist Home website, where people can fill out a questionnaire that will be reviewed by a pharmacist before the treatment is shipped to a person’s home. The mist will remain available from prescribers as an in-office treatment. The current out-of-pocket cost for a dose is about $35 to $45 but may be less depending on insurance coverage.
    • “Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families,” said Dr. Peter Marks, director of the F.D.A.’s vaccine center, which authorized the at-home option.”
  • The American Hospital Association News points out,
    • Drug overdose deaths have dropped by 10% this year compared to last, according to data from the Centers for Disease Control and Prevention. This year also marked an annual decline in overdose deaths for the first time in five years. On Aug. 31, federal agencies awarded an additional $416 million to respond to the overdose crisis and support substance use treatment and recovery services. The AHA remains focused on supporting hospitals and health systems in reducing drug overdose deaths, including by providing resources to enhance opioid stewardship. Learn more from AHA’s Opioid Stewardship Hub.” 
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor miglustat, is approved to treat neurological symptoms associated with NPC in adults and children 2 years of age and older.
    • “Miplyffa is the first drug approved by the FDA to treat NPC. NPC is a rare genetic disease that results in progressive neurological symptoms and organ dysfunction. It is caused by changes in either the NPC1 or NPC2 gene, affecting the necessary transport of cholesterol and other lipids within a cell. As a result, these cells do not function as they should, ultimately causing organ damage. On average, individuals affected by this devastating disease only live for about 13 years.
    • “NPC is a serious disease that leads to enormous adverse impacts on patients and families. Despite extensive research efforts, there have not been approved treatments to meet the significant needs of patients,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM), in the FDA’s Center for Drug Evaluation and Research. “The first-ever approval of a safe and effective drug option for NPC will undoubtedly support the essential medical needs of those suffering.”
  • STAT News lets us know,
    • “A next-generation obesity drug candidate from Novo Nordisk produced modest weight loss, along with a higher rate of some psychiatric side effects like anxiety and sleep disturbances — results that pose a challenge to the pharma giant’s efforts to find novel obesity drugs that could extend its success from its blockbuster Wegovy.
    • “A Phase 2a trial tested monlunabant, a pill that inhibits CB1 receptors that Novo got through its acquisition of Inversago Pharma last year. Those on the lowest dose of 10 mg lost on average 6.4% of their weight at 16 weeks, compared with 0.6% in the placebo group, Novo said Friday. The study also tested higher doses of 20 mg and 50 mg, but Novo said “limited additional weight loss” was seen at these higher doses and did not disclose specific data.”

From the U.S. healthcare business front,

  • Beckers Hospital Review Becker’s has compiled “a list of 189 hospitals with a CMS five-star rating for care transitions” and identified the “top ranked hospitals for coronary bypass in the U.S., according to the WebMD Choice Awards.
  • The Wall Street Journal reports,
    • “A price battle has broken out in the hot market for weight-loss drugs.
    • “Eli Lilly and Novo Nordisk, the pharmaceutical heavyweights selling the popular injections, are each dangling discounts to gain an edge and to induce health plans to pay up. The concessions are slashing as much as half off the price tags of the $1,000-plus-a-month medicines.
    • For people who pay out of pocket, Lilly recently introduced vials of its drug Zepbound that cost as little as $399 a month.
    • Price concessions are a new, major development in the burgeoning market for weight-loss drugs, after high prices and limited supplies led many health plans to refuse coverage and prompted some patients to turn to lower-priced but unapproved custom-made version.
  • MedTech Dive notes,
    • “GE Healthcare has received 510(k) clearance for a tool designed to help clinicians assess people who may have Alzheimer’s disease, the company said Tuesday.
    • “The clearance adds a Centiloid scale tool to GE Healthcare’s Mim software to enable clinicians to determine the density of amyloid plaque in a patient’s brain from PET scans. Amyloid is a protein that, in Alzheimer’s, can clump up into toxic plaques in the brain. Scientists have linked the formation of those plaques to symptoms such as memory loss.
    • “Researchers developed the Centiloid scale, which Eisai and Eli Lilly used during the development of their recently approved Alzheimer’s drugs, to standardize amyloid imaging measures.
  • and
    • “Abbott ramps up Libre 3 production amid shortages. Some people are facing delays in filling prescriptions for the glucose sensor. Abbott expects to resolve the problem soon.” * * *
    • “Some people who use a Freestyle Libre 3 glucose sensor are facing delays getting their prescriptions filled.
    • “Abbott spokesperson Lindsy Delco said the delays are driven by strong demand for the Libre 3 sensors. The company is ramping up production, adding capacity to an existing manufacturing facility this month, and opening a new manufacturing facility later this year, she wrote in an email.” * * *
    • “If people are unable to get Libre 3 sensors through their pharmacy or mail order company, Delco recommended checking back in a few days to see if they have new supply.
    • “If there are prolonged delays, another option is to talk to a healthcare provider about switching to a prescription for Freestyle Libre 3 Plus, Delco said. The Food and Drug Administration cleared the newer version of the sensor last year. It has a 15-day wear time, instead of 14 days for the Libre 3. The Libre 3 Plus has supply at both pharmacies and mail-order companies, according to Abbott.”

Thursday Miscellany

David Ermer–Congress, Obesity, OPM, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Federal News Network lets us know,
    • “The Senate passed a $3 billion supplemental funding bill, allowing the Department of Veterans Affairs to pay veterans’ benefits without delay.
    • “The Senate unanimously passed the supplemental funding bill in a voice vote Thursday. This bill now heads to President Joe Biden’s desk to be signed into law.
    • “VA Secretary Denis McDonough tweeted Thursday that the supplemental funding “will go directly to earned benefits” for about 7 million veterans and their families.”
  • Roll Call reports,
    • “The House is gearing up to go first on a bipartisan stopgap funding package early next week after nailing down the particulars this weekend, lawmakers said Thursday.
    • “The measure would extend current funding levels, with some “anomalies” allowing for higher rates, likely through Dec. 13, a source familiar with the talks said. The plan is to be ready to go with text of the package over the weekend so members can have time to review it before voting early next week.
    • “Rep. Mike Simpson, R-Idaho, a senior Appropriations Committee member, said he expects the continuing resolution to hit the floor around “the first of the week.” The deadline to get a bill through both chambers without triggering a partial government shutdown is Sept. 30, though it is more like Friday, Sept. 27, since that’s the last scheduled day in session.
    • “Simpson said there was some discussion of going an extra week beyond Dec. 13, but that there was basic agreement not to interfere with the holidays. “I’d like to have it done before [Dec. 31] so we can actually have our appropriations staff have a Christmas,” he said.
    • “Senate Majority Leader Charles E. Schumer, D-N.Y., earlier Thursday teed up a separate legislative vehicle in his chamber that could be used to carry a bipartisan deal in case of any House holdups. 
    • “But it appeared that by Thursday afternoon, House Republicans were on board with avoiding a shutdown, even if it meant making tough concessions to the other side.”
  • Healthcare Dive tells us,
    • “On Thursday, a powerful Senate committee voted unanimously to advance two resolutions holding Steward Health Care CEO Ralph de la Torre in contempt for refusing to testify before the committee last week.” * * *
    • “The Senate will consider whether to adopt the measures — civil enforcement, which instructs Senate Legal Counsel to bring a civil suit against de la Torre in the District Court for the District of Columbia; or a criminal contempt resolution, which would refer the matter to the U.S. Attorney for the District of Columbia for criminal prosecution.”
  • Per HHS press releases,
    • Today, the Health Resources and Services Administration (HRSA), an agency within the U.S. Department of Health and Human Services (HHS), announced $240 million in awards to launch and expand mental health and substance use disorder services in more than 400 community health centers across the country that care for more than 10 million people. Health centers are trusted community providers and a primary source of care for individuals across the country who are uninsured, underinsured, or enrolled in Medicaid – making them well-positioned to respond to the urgent need for behavioral health services that are high quality, stigma-free, culturally competent and readily accessible.  These grants will help expand access to needed care to help tackle the nation’s mental health and opioid crises – two pillars of the Biden-Harris Administration’s Unity Agenda for the nation.
  • and
    • Today, the Health Resources and Services Administration (HRSA) at the Department of Health and Hunan Services (HHS) announced the first ever multi-vendor contract awards to modernize the nation’s organ transplant system to improve transparency, performance, governance, and efficiency of the organ donation and transplantation system for the more than 100,000 people on the organ transplant waitlist.
    • The Organ Procurement and Transplantation Network (OPTN) has long faced critiques about lack of transparency, potential for conflicts of interest, IT reliability issues and other structural challenges. As part of the Administration’s transformation of the OPTN, for the first time in 40 years, multiple contractors will provide their expertise and proven experience to improve the national organ transplant system. This transition from a single vendor to multiple vendors to support OPTN operations is a critical step in advancing innovation in the transplant system to better serve patients and their families and implements the bipartisan Securing the U.S. Organ Procurement and Transplantation Network Act signed by the President in September 2023.
  • The U.S. Office of Personnel Management announced the availability of new online resources about the Postal Service Health Benefits Program.
    • Resources include a new landing page with details for PSHB enrollees; information about auto-enrollment where Postal employees will be automatically transitioned from their current plan to a comparable plan in the new PSHB program; and a page providing information on cost savings for enrollees who are also signed up for Medicare Part B or Medicare Advantage through PSHB. 
  • Tammy Flanagan, writing in Govexec, poses a Medicare quiz for federal annuitants.
  • Fedweek offers tips to federal retirees on whom to notify when you move residences.

From the public health and medical research front,

  • The New York Times reports,
    • “This year’s [prestigious] Lasker-DeBakey Clinical Medical Research Award went to three scientists for their work on GLP-1, the hormone that led to drugs like Wegovy (the same compound is the basis for Ozempic), which have transformed the treatment of obesity. They are Dr. Joel Habener, Svetlana Mojsov and Lotte Bjerre Knudsen.
    • “Each of the three honorees played a role at a key moment: finding the new hormone; finding the biologically active shorter form of GLP-1; and, finally, showing that the shorter form elicits weight loss.
    • “Of course, as almost always happens in science, many others also played key roles, and the Lasker Foundation mentioned some as part of its citation. And one of the honorees, Dr. Mojsov, is receiving what many deem a long overdue recognition.”
  • Per Beckers Hospital Review,
    • “Cancer survivors with overweight and obesity showed a 13.9% increased risk of developing a second cancer and a 33.2% increased risk of developing a second cancer related to obesity, according to a study published Sept. 17 in JAMA Open Network. 
    • “Researchers from the American Cancer Society analyzed data from 26,894 cancer survivors in the Cancer Prevention Study II Nutrition study. Participants were surveyed starting in 1992 with follow-up occurring through 2017. Of all participants, 42% were overweight and 17.2% were obese at the time of their first cancer diagnosis.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans informs us,
    • “High-dollar claimants continue to concern employer-sponsored health plans in the U.S. Those that self-fund and purchase medical stop-loss coverage have seen premiums continuing to rise over 10% annually, as reported by the 2024 Aegis Risk Medical Stop-Loss Premium Survey, cosponsored by the International Society of Certified Employee Benefit Specialists. In its 18th edition, this year the survey measured over $1 billion in annual premium across more than 1,100 stop-loss policies and covering more than 1.1 million employees.
    • “When asked about the type of catastrophic health claimants that are their top two or three concerns in the next year, responding plan sponsors cited cancer and specialty pharmacy as the two most prominent. Top claimant concerns include:
      • “Cancer/neoplasms, including leukemia—83%
      • “Specialty pharmacy—50%
      • “Gene and cell therapies—29%
      • “Heart/cardiovascular—27%
      • “Newborn/infant care—24%
      • “Lengthy inpatient hospital stays—23%.
  • Per Beckers Hospital Review,
    • “Five years ago, Dallas-based Tenet Healthcare embarked on a new chapter in the health system’s journey, reducing its debt profile and having its ambulatory surgery center business drive a greater portion of the company’s performance, according to CEO and Chair Saum Sutaria, MD. 
    • “Tenet committed to deleveraging the company, realizing the fair value of assets through divestitures and growing its ambulatory business, United Surgical Partners International, by capitalizing on the shift to outpatient procedures at lower costs.
    • “The proceeds from asset sales reflect their high quality, helping us reduce leverage, which now provides strategic and financial flexibility for future growth,” Dr. Sutaria said Sept. 9 during the Wells Fargo Healthcare Conference. “Our ability to deleverage the company with the types of proceeds we’ve generated … has been very good. We are seeing the company at a place where the leverage generates not only a degree of strategic and financial flexibility, but stability for the organization’s ability to invest in growth over the next few years.”
    • “Tenet, now a 52-hospital system, significantly improved its leverage position this year, selling nine hospitals in high-growth markets in California and South Carolina for a total of $3.9 billion. It also plans to sell its majority stake in five more Alabama hospitals for $910 million this fall. 
    • “Proceeds from these hospital sales are being used to reduce the health system’s debt and expand its outpatient footprint through strategic ASC acquisitions and de novo developments.” 

Midweek update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

It’s World Patient Safety Day

David Ermer–Uncategorized–
  • MedPage Today offers experts recommendations that “‘Failing Wisely’ Can Promote a Safer Healthcare System. — Don’t assume old strategies and new technologies will improve patient safety.”
  • Modern Healthcare reports,
    • “The Centers for Disease Control and Prevention is launching a program to help hospitals reduce diagnostic errors and provide more safe, accurate patient care, the agency announced Tuesday.
    • “Missed, delayed or wrong diagnoses can occur due to a variety of factors, including communication breakdowns and technological issues, said Dr. Preeta Kutty, deputy associate director for science in the division of healthcare quality promotion at the CDC. Every year, diagnostic errors contribute to around 371,000 deaths and 424,000 permanent disabilities, according to a 2023 study published in The BMJ, a peer-reviewed medical journal.
    • “The Agency for Healthcare Research Quality and Centers for Medicare and Medicaid Services worked with the CDC on recommendations for clinicians and healthcare leaders to cut down on those diagnostic errors as part of the new core elements for diagnostic excellence.
    • “The program will add to the CDC’s core elements for antibiotic stewardship and sepsis management.”
  • AHRQ released a report to Congress on September 16,
    • “The number of sepsis-related inpatient stays at non-federal acute care hospitals in the United States increased from 1.8 million in 2016 to 2.5 million in 2021, with a faster rate of increase following the emergence of COVID-19 in 2020, according to a report to Congress by the Agency for Healthcare Research and Quality (AHRQ) at the U.S. Department of Health and Human Services (HHS). The COVID 19 pandemic led to a noticeable rise in sepsis-related hospitalizations, hospital costs, and in-hospital mortality, particularly for patients with a COVID-19 diagnosis.
    • The report, titled “An Assessment of Sepsis in the United States and its Burden on Hospital Care,” responds to language in the Joint Explanatory Statement that accompanied the Consolidated Appropriations Act for Fiscal Year 2023, which directed the agency to conduct a comprehensive set of studies that calculate the morbidity, hospital readmissions, and mortality related to sepsis.  The report examines sepsis among all patients as well as among specific patient populations, including adults, pregnant women, children, and newborns.  The report also examines the association of pandemic-related changes in the healthcare system with the burden of sepsis.”

From Washington, DC,

  • Roll Call tells us,
    • “The House is set to vote Wednesday on Speaker Mike Johnson’s six-month stopgap spending plan despite near certain defeat in the face of GOP defections and almost unanimous Democratic opposition. 
    • “The bill has remained unchanged from last week, when Johnson pulled it from the floor before an expected vote. It includes a controversial elections bill that would require those registering to vote to show proof of citizenship, which Democrats say will make it more difficult for legal voters who can’t obtain the right documentation in time.
    • “Johnson, R-La., confirmed the plan in a statement Tuesday morning. He said that Congress has “an immediate obligation to do two things: responsibly fund the federal government and ensure the security of our elections.”
  • Per STAT News,
    • “The Senate failed again Tuesday to advance legislation that would protect access to in vitro fertilization, the latest partisan battle over reproductive health care amid the 2024 presidential election.  
    • “The 51-44 vote on the Right to IVF Act, which would bar state restrictions on the procedure and require insurance coverage, fell short of the 60 votes needed to pass, just as it did in June — and as Democrats expected it would. For them, the vote put many Senate Republicans on the record again as seemingly opposing broad IVF access and delivered new attack lines for an election that many see as a referendum on reproductive rights.”
  • Fedweek informs us
    • “Plans that will participate in the new Postal Service Health Benefits program, which will replace the FEHB for postal employees and retirees effective in January, will offer largely the same options they have offered in the FEHB, a fact sheet recently posted by the USPS shows.”
  • Healthcare Dive lets us know,
    • “Cigna is following through on promises to more aggressively defend its pharmacy benefit manager.
    • “On Tuesday, the healthcare company’s PBM, Express Scripts, sued the Federal Trade Commission over the agency’s recent report showing how the drug middlemen could be contributing to rising drug prices, calling the report “unfair, biased, erroneous, and defamatory.”
    • “The lawsuit asks a federal judge to order the FTC to withdraw the report and recuse FTC Chair Lina Khan from further action against Express Scripts.
    • “We don’t take this step lightly, but … we cannot let the FTC’s unlawful actions and false information stand,” Andrea Nelson, Cigna’s chief legal officer, said in a statement.”
  • The American Hospital Association News points out,
    • “The Health Resources and Services Administration Sept. 17 told Johnson & Johnson that the company’s publicly announced plans to implement a 340B rebate model “violates J&J’s obligations under the 340B statute, and HRSA expects J&J to cease implementation of it.”  
    • “Because J&J’s rebate proposal, if implemented, violates J&J’s obligations under the 340B statute, it subjects J&J to potential consequences, such as termination of J&J’s Pharmaceutical Pricing Agreement (PPA),” HRSA wrote Sept. 17. In addition, HRSA told J&J that the 340B statute provides for “[t]he imposition of sanctions in the form of civil monetary penalties” on “any manufacturer with an agreement under this section that knowingly and intentionally charges a covered entity a price for purchase of a drug that exceeds the maximum applicable price under subsection (a)(1).”
  • Per HHS press releases,
    • Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced nearly $100 million in awards to grow, support, and strengthen the health workforce and improve access to quality care in high-need areas across the country. The announcement was made in conjunction with an HHS Health Workforce Roundtable convened as part of HHS Secretary Xavier Becerra’s Health Workforce Initiative. * * * “For a list of awards, visit: https://www.hrsa.gov/about/news/fy24-workforce-award-announcements.”
  • and
    • “Today the U.S. Department of Health and Human Services, through its Administration for Community Living (ACL), delivered to Congress a progress report on federal implementation
       of the 2022 National Strategy to Support Family Caregivers
    • “The strategy presents a vision, establishes goals, and provides recommendations for ensuring that family caregivers have the support and resources they need. The strategy also includes commitments from 15 federal agencies to nearly 350 actions to implement these recommendations. Today, nearly all these actions have been completed or are in progress, and federal agencies have committed to almost 40 new actions since the strategy’s release.” * * * “Learn more about the RAISE Family Caregiving Advisory Council at ACL.gov/RAISE and the Advisory Council to Support Grandparents Raising Grandchildren at ACL.gov/SGRG.”

From the public health and medical research front,

  • The New York Times offers tips on training your tendons.
    • “When it comes to exercise, muscles and bones are clearly the stars of the show. But to feel your best and age well, you also need to take a little time each week to exercise the body’s supporting cast: connective tissues like ligaments and tendons, especially if you’ve injured them in the past.
    • “How you do it matters. What works for ligaments doesn’t work for tendons, and vice versa.
    • “Each part responds to different stimulus,” said Jay Dicharry, a professor of physical therapy at Oregon State University and the author of “Running Rewired.” “Just as you don’t treat each of your children the same, you shouldn’t treat all of your body parts the same way.”
  • The National Institutes of Health posted its latest Research Matters newsletter on topic of “Blood test for CVD risk | Smart mask | Heat-seeking mosquitoes.”
  • Per an NIH press release,
    • “Adults who use the prescription drug metformin to treat their type 2 diabetes have a lower risk of developing long COVID or dying after a COVID-19 infection than people with diabetes who take other anti-diabetes medications, according to a large study supported by the National Institutes of Health (NIH). The findings, published in the journal Diabetes Care, were based on health data from millions of U.S. patients and could have broader implications for use of metformin in long COVID prevention generally. The study is part of the NIH-funded Researching COVID to Enhance Recovery (NIH RECOVER) Initiative.”
  • MedTech Dive notes,
    • “A patient with amyotrophic lateral sclerosis has used Synchron’s brain-computer interface (BCI) technology to control his smart home, the company said Monday.
    • “The patient can use Synchron’s BCI and the Tap to Alexa feature on an Amazon Fire tablet to turn on lights, make video calls, play music and shows, read books and buy products online without using his hands or voice. 
    • “Synchron is trialing the integration between its BCI and Alexa to allow people who are severely paralyzed to interact with Amazon’s smart speaker and other connected devices in their homes.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Multispecialty care provider Summit Health is expanding its footprint in New Jersey this fall.
    • “New York-based Summit, part of Walgreens-backed VillageMD, opened a 78,000-square-foot hub facility in Fair Lawn, New Jersey, this week and plans to open another 34,000-square-foot location in Bridgewater in late October, according to a Tuesday news release. Details of the financial investment were not disclosed.
    • “Hub locations are larger than other Summit clinics, which are typically 20,000 square feet or less, and offer more specialties in one place, a spokesperson said. Patients will have access to service lines including gastroenterology, obstetrics and gynecology, orthopedics, urology and dermatology, according to the release.”
  • Per Fierce Healthcare,
    • “Amazon has added virtual behavioral health provider Talkspace to its health conditions program, a service it rolled out in January to help connect customers with virtual care benefits.
    • “Talkspace is Amazon’s second digital health partner following the initial rollout of the health conditions program with virtual-first chronic care provider Omada Health.
    • “The online retail giant launched its health conditions program to collaborate with digital health companies and help customers find and enroll in virtual care benefits available to them through their employer or health plan at no extra cost. With Omada Health, Amazon offered easier access to virtual care benefits for managing conditions like diabetes and hypertension. 
    • “Omada and Amazon announced their collaboration and the rollout of the health conditions program at the 2024 J.P. Morgan Healthcare Conference, marking the first virtual diabetes prevention, diabetes and hypertension provider available in Amazon’s digital health benefits program.
    • “By adding Talkspace to the program, individuals can discover and enroll in their health insurance benefits for mental health services at no extra cost or for a small copay, according to the companies.”
  • and
    • “Cigna is rolling out a new E-Treatment program for its members in partnership with its MDLIVE unit.
      Beginning this month, Cigna members can quickly connect for urgent care from board-certified doctors without the need for phone or video calls. They can connect to MDLIVE’s portal and submit a virtual clinical interview and typically receive a personalized diagnosis and treatment plan within an hour.
    • “The program is designed to assist in a convenient way with many common, low-risk needs like allergies, ear infections, urinary tract infections and respiratory conditions like the flu, Cigna said.
    • “Our customers lead busy lives, and getting care shouldn’t be put on the backburner,” said Heather Dlugolenski, U.S. employer strategy officer at Cigna Healthcare, in the press release. “By offering customers multiple ways to conveniently connect with board-certified clinicians, they can be more effective with their time and continue putting their health and vitality first.”
  • Per FiercePharma,
    • “An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer.
    • “The FDA has greenlighted Novartis’ Kisqali, used in combination with an aromatase inhibitor, for the adjuvant treatment of HR-positive, HER2-negative stage 2 and 3 breast cancer that’s at high risk of recurrence following surgery, the company said Tuesday.
    • “The expanded label separates Kisqali from Lilly’s Verzenio by covering patients who don’t have cancer cells in their lymph nodes. Verzenio’s first-in-class nod in HR+/HER2- breast cancer is limited to patients with nodal involvement. 
    • “Kisqali’s broad indication almost doubles the size of the patient population eligible for postsurgical adjuvant therapy within the CDK4/6 inhibitor class, Novartis noted.
    • “In November, Novartis estimated that an inclusive node-agnostic label in the adjuvant setting could translate into more than $3 billion in additional annual peak sales for Kisqali, bringing the drug’s total peak projection to $7 billion.”
  • MedCity News tells us “Three-quarters of U.S. providers and payers say they have increased their IT spending over the past year, according to a new report from Bain & Company and KLAS Research. Both providers and payers are investing in cybersecurity technology, as well as AI tools.”

Monday Roundup

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

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend Update

David Ermer–Congress, Employee Wellness Programs, Generative AI, Medical / Rx research, Medicare, U.S. Healthcare–

From Washington, DC,

  • The Hill reports,
    • “Rep. Andy Harris (R-Md.) predicted on Friday [September 13] that a government shutdown will be avoided as one looms.
    • “Do you believe that Republicans will be able to avoid a government shutdown?” NewsNation’s Blake Burman asked Harris on “The Hill.” “And do you think shutdowns are useful tools, or not?”
    • “There will not be a government shutdown, you know, one month before an election, that I can tell you,” Harris responded. 
    • “Lawmakers are racing to avoid a shutdown before the end-of-the-month deadline.”
  • Sen. Tim Kaine (D VA) has signed onto a bill as a co-sponsor to mandate FEHB coverage of IVF procedures. The Senate Majority Leader reportedly plans to bring up an IVF mandate bill this coming week.  
  • The American Medical Association’s public website explains various Medicare payment reform laws for its members.

From the public health and medical research front,

  • The AMA points out the top preventive health tips that your internist wants you to know.
  • The New York Times identifies “Three Medical Practices That Older Patients Should Question. Some treatments and procedures become routine despite lacking strong evidence to show that they’re beneficial. Recent studies have called a few into question.”
  • The Washington Post reports,
    • “More than 5 percent of women who get their tubes tied later become pregnant, a new analysis suggests — and researchers say the failure of tubal sterilization procedures, which are widely considered permanent, “may be considerably more common than many expect.”
    • “The study, published in NEJM Evidence, used data from the National Survey of Family Growth, which looks at contraception use, pregnancy and birth outcomes among a representative sample of U.S. women aged 15 to 44. The data was assembled during four waves of data collection from about 4,000 women who had tubal ligations between 2002 and 2015. * * *
    • “When choosing what birth control will work best for them, people consider many different things, including safety, convenience, and how fast they can start to use the method,” says Eleanor Bimla Schwarz, chief of the UCSF Division of General Internal Medicine at Zuckerberg San Francisco General and the study’s first author, in a news release.
    • “This study shows that tubal surgery cannot be considered the best way to prevent pregnancy. People using a contraceptive arm implant, or an IUD are less likely to become pregnant than those who have their tubes tied.”
    • “The researchers call for more inquiry into the “real-world effectiveness” of different forms of contraception.”
  • STAT News informs us from a Barcelona, Spain, oncology conference held this weekend,
    • “An AstraZeneca immunotherapy, given both before and after surgery, improved survival rates in patients with bladder cancer, results that could reshape how muscle-invasive bladder tumors are treated. 
    • “The regimen using Imfinzi, the company’s anti-PD-L1 checkpoint inhibitor, cut the risk of death by 25% compared to treating patients before surgery with chemotherapy alone, researchers reported Sunday. It also lowered the risk of disease recurrence by about a third. 
    • “It really is offering a curative-intent regimen and improving the cure rate in the disease,” Susan Galbraith, AstraZeneca’s head of oncology R&D, told STAT at the European Society for Medical Oncology meeting in Barcelona, using the word “transformative” several times. The results of the Phase 3 NIAGARA trial were presented in a presidential session at the conference and simultaneously published in the New England Journal of Medicine.
    • “Galbraith said the company would talk with regulators about the data, but experts will be watching to see if an ongoing debate about clinical trial design could pose a problem in this case.”
  • and
    • “Patients with advanced cancers often develop a secondary condition that causes them to shed weight, making it even harder to tolerate their cancer treatments. Called cachexia, it’s an under-recognized syndrome that researchers are still trying to tease out, and one that’s attracting more interest from drugmakers.
    • “On Saturday, Pfizer reported that an experimental antibody not only helped cancer patients with cachexia regain some weight versus placebo, but that it also seemed to increase their muscle mass and activity levels, signaling that the added weight translated into meaningful benefits.”
  • and
    • “A targeted immunotherapy being developed by the biotech iTeos Therapeutics and GSK delivered promising response rates in patients with a type of lung cancer, propelling the treatment into a pivotal Phase 3 trial and adding fuel to a broader debate about the validity of the target.
    • “The companies reported on Saturday that their combination of a TIGIT-targeting antibody and GSK’s Jemperli increased the percentage of patients who saw their tumors shrink versus those who received Jemperli alone, meeting the goals of the Phase 2 trial and the expectations that analysts had set for the study to be considered a success.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “Health systems are a large market for artificial intelligence startups, but companies selling to insurers or life sciences firms create value more quickly, according to an analysis by venture capital firm Flare Capital Partners.
    • “Most AI startups selling their products to health systems haven’t progressed past early-stage investment rounds. Just over 5% of those companies have reached a Series C raise or later, compared with nearly 10% of startups in life sciences and about 16% of companies selling to health plans. 
    • “The gap suggests AI startups in the life sciences and health plan markets have been able to create more value for their customers, according to Flare. But those sectors also have higher operating margins and can likely devote more resources — and time — to scale AI products.”\ 

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • Modern Healthcare reports,
    • “The Centers for Medicare and Medicaid Services is planning oversight of third-party healthcare vendors in the wake of the Change Healthcare cyberattack, said Jonathan Blum, the agency’s principal deputy administrator.
    • “Blum, who also serves as chief operating officer for CMS, said at Modern Healthcare’s Leadership Symposium Thursday that the agency is working to determine what levers it can pull to ensure severe disruptions in care like those linked to the cyberattack on the UnitedHealth Group subsidiary aren’t repeated. 
    • “We will step in to help,” Blum said. * * *
    • “CMS declined to provide any details of its oversight strategy, but said it is collaborating with other partners across the Health and Human Services Department to “promote high-impact cybersecurity practices and enhance accountability for healthcare organizations and their vendors.”
  • Per Cybersecurity Dive,
    • “Microsoft plans to boost collaboration on deployment practices, testing and other related issues with its security ecosystem partners following the historic July outage that crashed 8.5 million Windows devices, the company said in a Thursday blog post. 
    • “The plan follows a summit the company held Tuesday with U.S. and European endpoint security partners and government officials to address ways to prevent another widespread outage, which was the result of a faulty software update on the CrowdStrike Falcon platform. 
    • “Microsoft said it will make additional investments in Windows, building on security features in Windows 11. Microsoft and its partners raised additional changes designed to boost security capabilities outside of the kernel mode, including anti-tampering protection and security sensor requirements.”

From the cybersecurity vulnerabilities and breaches front,

  • HHS Health Sector Cybersecurity Coordination Center, which has been quiet lately, posted its report on August vulnerabilities of interest to the health sector.
  • Federal News Network informs us,
    • “Phishing, stolen credentials, and other lapses in basic cybersecurity continue to be a primary avenue available to hackers, including China-linked threat groups such as “Volt Typhoon,” looking to infiltrate U.S. critical infrastructure networks.
    • “That’s the upshot from a new analysis released today [September 13] by the Cybersecurity and Infrastructure Security Agency. The report breaks down the results of 143 Risk Vulnerabilities and Assessments (RVAs) CISA and the U.S. Coast Guard completed in fiscal 2023. The teams probed the cyber defenses of organizations across multiple critical infrastructure sectors.
    • “Ultimately, CISA and Coast Guard teams found they could infiltrate networks using some of the most common attack methods available, such as phishing, valid accounts, and default passwords.
    • “These are really low hanging things that you don’t actually need to be a sophisticated threat actor to take advantage of,” Chris Hilde, chief of risk insights within CISA’s vulnerability management branch, said in an interview with Federal News Network.”
  • CISA added eight known exploited vulnerabilities to its catalog this week.
  • Per Cybersecurity Dive,
    • “An attacker gained access to Fortinet customer data stored on a third-party cloud-based shared file drive, the company said in a Thursday blog post. The cybersecurity company did not specify when the intrusion took place. 
    • “The breach exposed “a limited number of files” including data related to less than 0.3% of Fortinet customers, the company said. Fortinet ended the second quarter with more than 500,000 customers.
    • “To date there is no indication that this incident has resulted in malicious activity affecting any customers,” Fortinet said in its notice about the incident. “Fortinet’s operations, products, and services have not been impacted, and we have identified no evidence of additional access to any other Fortinet resource.”

From the ransomware front,

  • Cybersecurity Dive points out,
    • “Attackers are actively exploiting a critical vulnerability in SonicWall SonicOS, the software powering the security vendor’s firewalls, according to researchers and federal cyber authorities.
    • “The Cybersecurity and Infrastructure Security Agency added CVE-2024-40766 to its known exploited vulnerabilities catalog on Monday. The software defect impacts SonicWall Gen 5 and Gen 6 devices, and Gen 7 devices running SonicOS version 7.0.1-5035 or older.
    • “SonicWall disclosed and patched the improper access control vulnerability, which has a CVSS of 9.3, on Aug. 22. Arctic Wolf and Rapid7 have observed ransomware groups compromising secure sockets layer VPN accounts on SonicWall devices for initial access in ransomware attacks.”
  • SCMedia notes,
    • “The CosmicBeetle ransomware group, also known as NONAME or Spacecolon, may now be an affiliate of RansomHub according to a report by ESET.
    • “The report, published Tuesday, outlines CosmicBeetle’s activities and tactics since its discovery in 2023, although the group is believed to have been active since at least 2020.
    • “In June 2024, an attack using RansomHub’s ransomware and endpoint detection and response (EDR) killer, was investigated by ESET and found to bear similarities to CosmicBeetle’s past activities. This incident led security researchers to say with “medium confidence” that CosmicBeetle has joined RansomHub’s ranks as an affiliate.
    • “The NoName group’s activities identify two critical trends in the current ransomware landscape. First, the complexity of ransomware tools is increasing, and second, ransomware gangs are becoming more organized, experimenting with strategies like affiliate programs and impersonation to extend their reach,” James McQuiggan, a security awareness advocate at KnowBe4, told SC Media in an email.”

From the cybersecurity defenses front,

  • Cybersecurity Dive discusses “How to manage the rising tide of Common Vulnerabilities and Exposures (CVE). As the volume and complexity of vulnerabilities grows, organizations are struggling to manage and mitigate the security defects.”
  • An ISACA commentator explains “Cybersecurity Compliance Essentials: Balancing Technical and Non-Technical Skills.”
  • Intelligent CIO explores “the ever-evolving role of data privacy in the digital landscape.”
  • Per Cybersecurity Dive,
    • “The cyber insurance market is expected to see strong growth over the next few years as malicious threat groups continue to target businesses with more sophisticated capabilities, according to a report released Thursday [September 12] by Moody’s Ratings. 
    • “Pricing has largely stabilized with moderate declines, and competition has increased thanks to the entrance of more insurance firms and investors into the market. Insurers are in a better position to manage losses, but loss ratios could increase if there is an uptick in ransomware and large losses, Moody’s said.
    • “Aggregation risk remains a concern for the insurance industry, as revealed by the global Microsoft Windows outage linked to a faulty CrowdStrike software update. Single point of failure risk will likely lead to changes in policy language and other adjustments as concerns remain about supply chain attacks and businesses’ reliance on connected technologies.”

Friday Factoids

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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