Monday Report

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Monday Report

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

From Washington, DC

  • The Hill reminds us,
    • “The calendar will officially turn to March this week, putting Congress in the same month as the looming March 14 government shutdown deadline. Despite that date fast-approaching, however, lawmakers in both parties have still not struck a deal to keep the lights on in Washington past the middle of next month — raising the possibility of a shutdown.”
  • Federal News Network notes,
  • HUB International discusses the Labor Department and CMS 2023 Mental Health Parity Compliance reports.
    • While not an exclusive or comprehensive list of all possible violations, the [article’s] list provides some guidance on the types of issues the Departments view as violations (particularly on the NQTL side). Employers should review their plan designs for any potential MHPAEA violations based on the [article’s] enforcement data and work with their providers to rectify any noncompliant design elements.
  • The Labor Department’s Inspector General released a report on Mental Health Parity Enforcement encouraging more resources be given to the enforcers. The FEHBlog believes that this additional cost can be avoided by simplifying the Mental Health Parity rule.
  • The HHS Inspector General reports “Medicare Part D Spending for 10 Selected Diabetes Drugs [including GLP-1 drugs] Totaled $35.8 Billion in 2023, an Increase of 364 Percent From 2019.”
  • MedPage Today tells us,
    • “The FDA approved adaptive deep brain stimulation (DBS) technology (BrainSense adaptive DBS and BrainSense electrode identifier) for people with Parkinson’s disease, Medtronic announced Monday.
    • “Like other DBS devices, the newly approved technology uses a surgically implanted neurostimulator to transmit electrical signals. The adaptive feature adjusts therapy based on a patient’s neural activity in real time, reducing the need to manually adjust stimulation.
    • “Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson’s disease,” said Helen Bronte-Stewart MD, MSE, of Stanford University School of Medicine in California, in a statement. “The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs.”

From the judicial front,

  • Per Govexec,
    • “An independent federal oversight agency has deemed at least some of President Trump’s mass firings of probationary period employees unlawful, creating a pathway for those employees to regain their jobs. 
    • “The Office of Special Counsel, the agency responsible for investigating illegal actions taken against federal employees, issued its decision for six employees, each at different agencies. While the decision was technically limited in scope, it could have immediate impact on all terminated staff at those six agencies and could set a wide-ranging precedent across government. It has not been made public and was provided to Government Executive by a source within the government. OSC, which did not provide the document to Government Executive, verified its authenticity. 
    • “OSC has turned the case over to the quasi-judicial Merit Systems Protection Board for enforcement of its findings and is so far requesting a 45-day stay on the firing decisions. The agency said it will use that time to further investigate the dismissals and determine the best way to mitigate the consequences from the apparent unlawful actions. 
    • “MSPB has three business days to issue a decision on the stay request. If it does not act by that deadline, the stay will go into effect.”
  • It’s worth adding that the Scotusblog explains
    • “The Supreme Court on Friday [February 21] left in place for now an order by a federal judge in Washington, D.C., that instructed President Donald Trump to temporarily reinstate the head of an independent federal agency [the Office of Special Counsel] tasked with protecting whistleblowers from retaliation. The justices did not act on a request from the Trump administration to block the order by U.S. District Judge Amy Berman Jackson, which had restored Hampton Dellinger as head of the Office of Special Counsel for 14 days, beginning on Feb. 12. Instead, the justices explained in a brief order, they put the government’s request on hold until Jackson’s order expires on Feb. 26.”
  • Per Healthcare Dive,
    • “Express Scripts, Caremark and Optum Rx are turning to an appeals court to try to reverse a legal setback in their ongoing feud with the Federal Trade Commission.
    • “The PBMs said on Friday they will ask the 8th Circuit Court of Appeals to halt the agency’s suit against them for allegedly inflating the cost of insulin, three days after a Missouri district judge ruled the FTC’s case could move forward.
    • “The PBMs — known as the “Big Three” for their outsized control of the U.S. prescription drug market — also asked the district judge again for an injunction halting the FTC’s suit pending their appeal. Express Scripts, Caremark and Optum Rx intend to ask the 8th Circuit for an injunction in one week unless the district court complies.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Cardiovascular disease remains the leading cause of death in the United States and accounted for 941,652 deaths in 2022, according to a report published by the American Heart Association.
    • “In the United States in 2022, heart disease and stroke killed more people than all forms of cancer and accidental deaths. Coronary heart disease was the leading cause of death attributable to cardiovascular disease (39.5 percent), followed by stroke (17.6 percent), other cardiovascular diseases (17 percent), hypertensive diseases (14 percent), heart failure (9.3 percent) and diseases of the arteries (2.6 percent), the AHA said. More people died of cardiovascular causes in 2022 than 2021, when there were 931,578 cardiovascular deaths, according to the report.
    • “The report also notes that between 2017 and 2020, nearly half of U.S. adults (48.6 percent) had some form of cardiovascular disease. According to the AHA, 59 percent of non-Hispanic Black women and 58.9 percent of non-Hispanic Black men had cardiovascular disease.
    • “Advances in clinical diagnosis and treatment have lessened the burden of heart disease over time, but more needs to be done to treat major risk factors, including obesity, high blood pressure and diabetes, said Keith Churchwell, a physician and clinical professor of medicine at the Yale School of Medicine who serves as volunteer president of the American Heart Association.”
  • The American Medical Association lets us know “what doctors wish patients knew about cancer screening and prevention.”
  • Healio informs us,
    • “Paxlovid may not decrease the risk for hospitalization or death in older adults vaccinated against COVID-19 as much as previously thought, according to research published in JAMA.
    • “Since the strongest predictor of severe COVID-19 is advanced age, it has been crucial to obtain evidence on whether the results of the Pfizer trials” — which showed Paxlovid reduced COVID-19 hospitalizations and deaths in unvaccinated adults — “generalized to older and vaccinated populations,” John Mafi, MD, MPH, associate professor-in-residence of medicine at the David Geffen School of Medicine at UCLA, said in a press release.
    • “At best, Mafi and colleagues wrote, Paxlovid could reduce COVID-19-related hospitalization by 1.3 percentage points, or 4 times less than the 5.5 percentage-point risk reduction reported in Pfizer’s original trial among unvaccinated adults.
    • “Our study effectively rules out the notion that Paxlovid causes large reductions in hospitalization in vaccinated older adults,” Mafi said. “While we cannot rule out a small reduction in COVID-19 hospitalization, our results indicate that, at best, Paxlovid’s potential effect on COVID-19 hospitalization among vaccinated older adults is four times weaker than the effect originally reported in Pfizer’s 2022 clinical trial.”
  • Consumer Reports< writing in the Washington Post, explores “How to keep your bones strong. Worried about osteoporosis? Here are the tests, moves, meds and foods you need to know about.”
  • The Wall Street Journal reports,
    • Frozen shakes served in hospitals and nursing homes have been recalled after being linked to a deadly outbreak of listeria, resulting in 12 deaths and sickening at least 38 people in 21 states.
    • The shakes, sold under the brands Lyons ReadyCare and Sysco Imperial, were made in the same facility in Fort Wayne, Ind., and have been recalled by both companies.
    • Listeria can cause serious illness, especially in newborns, older people, and those with weakened immune systems, and can survive on surfaces for long periods.
  • and
    • “Red-light therapy, a treatment involving exposure to low levels of red or near-infrared light, is gaining popularity for its purported benefits in weight loss, antiaging and mood balance.
    • “While some research shows promise in areas like dermatology and mood disorders, more evidence is needed to confirm its broader health benefits.
    • “Consumers should be cautious when purchasing red-light therapy devices, as there are no established standards for wavelength, intensity and length of treatment, and some products may not be effective or safe.”

From the U.S. healthcare business front,

  • The American Hospital Association News fills us in on its ongoing rural healthcare leadership conference.
  • Per BioPharma Dive,
    • “Summit Therapeutics and Pfizer on Monday said they will test an experimental Summit immunotherapy with Pfizer’s antibody drug conjugates in trials evaluating two of the sector’s most closely watched types of cancer medicines.
    • “Pfizer will oversee the clinical trials, which will involve Summit’s ivonescimab and multiple different Pfizer ADCs against certain solid tumors. The two companies will retain commercialization rights to their respective products, Summit said.
    • “According to Summit, the deal “will allow us to quickly advance beyond our promising late-stage development plan,” which already includes multiple studies in lung cancer. The companies didn’t provide specifics, but said the trials will begin in the middle of the year and aim to find “potentially landscape-changing combinations.”
  • Beckers Payer Issues relates,
    • Bon Secours Mercy Health and Cigna Healthcare will be out of network across eight Virginia hospitals [listed in the article] on April 1.
    • Almost all of Cigna’s business with Bon Secours is through employer-sponsored plans that are self-funded. If Bon Secours Mercy Health leaves our network, OAP and PPO members will be affected.
  • Beckers Hospital Review discusses “the twofold challenge of an older population — and how systems are adapting.”
    • “In less than a decade, older Americans are projected to outnumber children for the first time in U.S. history, sparking conversations about the need for age-friendly healthcare. 
    • “At the same time, declining birth rates and longer life expectancies — half of babies born in 2020 are expected to live past 100 years — pose potential workforce challenges.
    • “Becker’s connected with four health system leaders [in this article] to explore the challenges this demographic shift presents and how they are preparing to address it.”

Weekend Update

David Ermer–CDC, Congress, Generative AI, U.S. Healthcare–

From Washington, DC

  • Roll Call updates on this week’s activities on Capitol Hill/

From the public health front,

  • The Wall Street Journal reports,
    • “Measles outbreaks across Texas and New Mexico have sickened nearly 100 people, with more cases expected, according to state health officials.
    • “The disease has spread through the South Plains region of Texas since late January, the Texas Department of State Health Services said Friday. Ninety cases have been identified to date in the state. Five patients were vaccinated, and the rest were unvaccinated or their status was unknown, the agency reported. 
    • “Due to the highly contagious nature of this disease, additional cases are likely to occur in the outbreak area and the surrounding communities,” the agency said. 
    • “The disease has been found across several counties in Texas, but the largest cluster of patients, 51, has been in Gaines County on the western border, according to health department data.  
    • “The New Mexico Department of Health has reported a measles outbreak that has infected nine people in Lea County, which borders Gaines County in Texas. The agency has begun contact tracing among those who developed symptoms to try to minimize the spread and has offered free vaccinations. 
    • “Among the 90 known cases in Texas, 77 were among people under 17 years old. Sixteen patients had to be hospitalized, the state said. 
    • “Last year, the Centers for Disease Control and Prevention reported 285 cases of measles nationwide, across 33 states that included Texas and New Mexico. The CDC counted 16 outbreaks, defined as three or more related cases, that accounted for about 198 out of the 285 people who fell ill. By comparison, in 2023, four outbreaks were reported among 59 individual illnesses.”
  • The New York Times lets us know six things E.R. doctors wish you’d avoid.
  • The Washington Post informs us,
    • “Forty-four percent of rural Medicare patients must drive an hour or more for surgery, a recent analysis in JAMA finds. The study shows that patients in rural areas typically drive 55 minutes to a hospital — far longer than their counterparts in more populous areas.
    • “The research used beneficiary data from Medicare to identify patients 65 to 99 years old who had any of a list of common surgeries between 2010 and 2020. The study looked at about 12.3 million surgery admissions overall, 2.6 million of which were in rural areas.
    • “The number of rural Medicare beneficiaries who traveled more than 60 minutes for their procedure rose from 36.8 percent in 2010 to 44.1 percent in 2020, with the median travel time climbing from 47 minutes to 55 minutes. Among nonrural Medicare beneficiaries, travel times were lower, with a median of 20 minutes’ travel in 2010 vs. 23 minutes in 2020.
    • “Travel times depended on the risk involved in surgery; median times for low-risk procedures such as appendectomies and hernia repair were lower than for higher-risk surgeries like aortic valve repair or a liver resection.”
  • The Wall Street Journal discusses the growing lack of public trust in the medical profession. It strikes the FEHBlog that health insurers can contribute toward restoring that trust by encouraging the use of primary care physicians and reducing prior authorization requirements.

From the U.S. healthcare business front,

  • The Washington Post explains why GLP-1 weight loss drugs also are reshaping the economy.
  • Per Healthcare Dive,
    • “Orlando Health will close Rockledge Hospital and four outpatient facilities in Brevard, Florida on April 22, just months after buying the 298-bed facility from bankrupt Steward Health Care. 
    • “The health system blamed the closure on Steward, saying in a statement that “years of neglect” had left the Rockledge’s electrical, plumbing and heating, ventilation and air conditioning systems failing. 
    • “Orlando plans to demolish Rockledge and replace it with a new facility, as it would cost more to renovate and repair Rockledge than to build a hospital from the ground up, the system said.”
  • Per BioPharma Dive,
    • “Bluebird bio, a pioneering gene therapy developer that in recent years has struggled to stay afloat, has agreed to be acquired and taken private in a deal with investment firms Carlyle Group and SK Capital.
    • “Under an agreement announced Friday, Bluebird will sell to the two firms for $3 per share upfront. Bluebird shareholders could receive an additional $6.84 per share via a so-called contingent value right, should its currently marketed gene therapies reach $600 million in net yearly sales by the end of 2027.
    • “The deal values Bluebird at just over $29 million upfront, and potentially about $96 million if the CVR is redeemed.”
  • Per Modern Healthcare,
    • “Hartford HealthCare, which operates seven hospitals and a network of physicians, behavioral health services and other providers in Connecticut, is partnering with the artificial intelligence-driven virtual health provider K Health to improve access to primary care. On April 1, the organizations will launch HHC 24/7, a virtual health platform powered by K Health, designed to make “comprehensive, personalized primary care available anytime and anywhere.” The service will be fully integrated with Hartford HealthCare. Terms of the partnership were not disclosed.”

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity history, policy, and law enforcement fronts,

  • American Hospital Association (AHA) News reminds us,
    • “Nearly one year after the cyberattack on Change Healthcare, the AHA released a report highlighting the continued need for health care organizations to strengthen cybersecurity efforts and mitigate risk.  
    • “The cyberattack on Change Healthcare in February 2024 disrupted health care operations on an unprecedented national scale, endangering patients’ access to care, disrupting critical clinical and eligibility operations, and threatening the solvency of the nation’s provider network,” the report said.  
    • “Among other areas, the report highlights lessons learned, including how third-party cyber risk is the most significant and disruptive cyber threat to health care; actions health care organizations can take to mitigate cyber risk; and resources from the AHA and federal government that can assist organizations with strengthening cybersecurity efforts.”
  • Cyberscoop lets us know,
    • “Republican leaders on a key House committee are canvassing the public for input on how best to move forward in Congress’ longstanding quest to tackle national data privacy and security standards.
    • “House Energy and Commerce Committee Chair Brett Guthrie, R-Ky., and Vice Chair John Joyce, R-Pa., issued a Request for Information on Friday that seeks guidance on how to best develop legislation to protect the digital data of Americans across an ever-widening range of essential services.
    • “Leadership in digital technologies, including artificial intelligence, underpins U.S. economic and national security, provides American consumers with access to lower cost goods and services, and enables small businesses to reach markets around the world,” Guthrie and Joyce said in a statement. “However, the challenge of providing clear digital protections for Americans is compounded by the fast pace of technological advancement and the complex web of state and federal data privacy and security laws, which in some cases create conflicting legal requirements.”
    • “Both Guthrie and Joyce are part of a Republican committee working group on data privacy, and the request includes questions that could guide lawmakers as they eye potential legislation. They include how to account for different roles and services that collect personal data, when a company should disclose the collection, processing, or transfer of user data, and what lessons can be learned from existing privacy frameworks in other countries.”
  • and
    • “One of the most notable elements of the monumental hack of major telecommunications companies is just how “indiscriminate” it was in its pursuit of data, a top FBI official said Wednesday.
    • “The FBI has been investigating the breach, which it has blamed on Chinese government hackers commonly known as Salt Typhoon.
    • “What we found particularly remarkable in our investigation is the gigantic and seemingly indiscriminate collection of call records and data about American people, like your friends, your family, people in your community,” Cynthia Kaiser, deputy assistant director in the bureau’s cyber division, said at the 2025 Zero Trust Summit, presented by CyberScoop.
    • “Kaiser characterized the breach as “a different level of insidiousness” from Beijing, one that reflects its “ambition and reckless aggression in cyberspace.”
  • Cybersecurity Dive tells us,
    • “The Securities and Exchange Commission on Thursday unveiled a revamped anti-fraud unit to protect retail investors in emerging technologies, reflecting the Trump administration’s evolving approach to cryptocurrency and cybersecurity.
    • “The Cyber and Emerging Technologies Unit, led by Laura D’Allaird, will have about 30 fraud specialists from across the agency and replaces the Crypto Assets and Cyber Unit. The revised CETU will complement a crypto task force launched in January under the leadership of Commissioner Hester Peirce.
    • “The unit will not only protect investors, but will also facilitate capital formation and market efficiency by clearing the way for innovation to grow,” Acting SEC Chairman Mark Uyeda said in a statement. “It will root out those seeking to misuse innovation to harm investors and diminish confidence in new technologies.”
  • Per a Justice Department news release,
    • Health Net Federal Services Inc. (HNFS) of Rancho Cordova, California and its corporate parent, St. Louis-based Centene Corporation, have agreed to pay $11,253,400 to resolve [government] claims [under the federal False Claims Act] that HNFS falsely certified compliance with cybersecurity requirements in a contract with the U.S. Department of Defense (DoD) to administer the Defense Health Agency’s (DHA) TRICARE health benefits program for servicemembers and their families. In 2016, Centene acquired all of the issued and outstanding shares of Health Net Inc., HNFS’s corporate parent, and assumed the liabilities of HNFS.
  • Per an HHS news release,
    • “Today [February 20], the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a $1,500,000 civil money penalty against Warby Parker, Inc., a manufacturer and online retailer of prescription and non-prescription eyewear, concerning violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule, following the receipt of a breach report regarding the unauthorized access by one or more third parties to customer accounts.” * * *
    • “OCR’s investigation found evidence of three violations of the HIPAA Security Rule, including a failure to conduct an accurate and thorough risk analysis to identify the potential risks and vulnerabilities to ePHI in Warby Parker’s systems, a failure to implement security measures sufficient to reduce the risks and vulnerabilities to ePHI to a reasonable and appropriate level, and a failure to implement procedures to regularly review records of information system activity.” * * *
    • “The Notice of Proposed Determination may be found at: https://www.hhs.gov/sites/default/files/ocr-warby-parker-npd.pdf – PDF
    • “The Notice of Final Determination may be found at: https://www.hhs.gov/sites/default/files/ocr-warby-parker-nfd.pdf – PDF“

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop lets us know,
    • “Salt Typhoon gained initial access to Cisco devices as part of the Chinese nation-state threat group’s sweeping attacks on U.S. telecom networks, the company confirmed Thursday [February 20] in a threat intelligence report.
    • “Cisco Talos, the networking vendor’s threat intelligence unit, said it observed one instance where Salt Typhoon likely exploited a seven-year-old critical vulnerability in Cisco IOS XE (CVE-2018-0171). Yet, researchers asserted Salt Typhoon gained initial access to Cisco devices with legitimate login credentials in all other incidents it’s investigated to date.
    • “The report marks the first time Cisco acknowledged the role its equipment played in Salt Typhoon’s attack spree on telecom networks. Recorded Future last week said five additional telecom networks were hit by Salt Typhoon via a pair of other vulnerabilities in Cisco IOS XE (CVE-2023-20198 and CVE-2023-20273) between early December and late January.
    • “Cisco Talos said it hasn’t identified any evidence to confirm Salt Typhoon’s exploitation of other known Cisco vulnerabilities. The company declined to answer questions.” 
  • The Cybersecurity and Infrastructure Security Agency added five known exploited vulnerabilities to its catalog this week.
    • February 18, 2025
      • CVE-2025-0108 Palo Alto PAN-OS Authentication Bypass Vulnerability
      • CVE-2024-53704 SonicWall SonicOS SSLVPN Improper Authentication Vulnerability
      • The Palo Alto KVE is discussed here, and the Sonicwall KVE is discussed here.
    • February 20, 2025
      • CVE-2025-23209 Craft CMS Code Injection Vulnerability
      • CVE-2025-0111 Palo Alto Networks PAN-OS File Read Vulnerability
      • The Craft KVE is discussed here, and the Palo Alto KVE is discussed here.
    • February 21, 2025
      • CVE-2025-24989 Microsoft Power Pages Improper Access Control Vulnerability
      • The Microsoft KVE is discussed here.
  • Cybersecurity Dive informs us
    • “Horizon3.ai researchers on Wednesday released technical details and a proof-of-concept (PoC) exploit for four critical Ivanti vulnerabilities that were first disclosed and patched last month.
    • “The absolute patch-traversal flaws impact Ivanti Endpoint Manager and, according to Horizon3.ai, could allow unauthenticated attackers to manipulate the Ivanti EPM machine account credential into being deployed in relay attacks, potentially leading to server compromise.
    • “Ivanti products have become popular targets for attackers in recent years, as a wide range of cyber threat actors have exploited both zero-day and known vulnerabilities to compromise devices at the network edge and gain access to victim.”
  • Security Week relates,
    • In a fresh report published Wednesday, Mandiant threat hunter Dan Black warns that several APT groups have perfected the abuse of Signal’s “linked devices” feature that enables the privacy-themed chat and voice messenger to be used on multiple devices concurrently.
    • By tricking users into scanning malicious QR codes embedded in phishing pages or disguised as group invite links, Mandiant says APT groups linked to the Kremlin are secretly adding their own device as a linked endpoint. 
    • Once this connection is established, every message sent by the user is duplicated to the attacker’s device in real time, effectively bypassing Signal’s heralded end-to-end encryption without having to break the underlying cryptography.
  • Dark Reading offers an oddball article about state-of-the-art phishing software Darcula version 3 that can be purchased.

From the ransomware front,

  • AHA News reports,
    • “A joint advisory released Feb. 19 by the FBI, Cybersecurity and Infrastructure Security Agency, and the Multi-State Information Sharing and Analysis Center warns of cybercriminal activity by the Ghost ransomware group. The agencies identified actions as recently as last month by the group, which originates from China. 
    • “Since 2021, Ghost actors have targeted victims with outdated software and firmware, compromising organizations in more than 70 countries. Their victims include critical infrastructure, health care, schools and technology companies, among other organizations. 
    • “Ghost actors exploit well-known vulnerabilities and target networks where available patches have not been applied,” said Scott Gee, AHA deputy national advisor for cybersecurity and risk. “They simply ‘hack before we patch.’ This group is also leveraging legitimate cybersecurity tools such as Cobalt Strike to enable access and other tools for privilege escalation. It is recommended that patching policies be reviewed to achieve maximum efficiency and speed. It is also recommended that network security tools be set to alert for activation of Cobalt Strike and privilege escalation applications.” 
  • Bleeping Computer reports,
    • “An unknown leaker has released what they claim to be an archive of internal Matrix chat logs belonging to the Black Basta ransomware operation.
    • “ExploitWhispers, the individual who previously uploaded the stolen messages to the MEGA file-sharing platform, which are now removed, has uploaded it to a dedicated Telegram channel.
    • I”t’s not yet clear if ExploitWhispers is a security researcher who gained access to the gang’s internal chat server or a disgruntled member.
    • “While they never shared the reason behind this move, cyber threat intelligence company PRODAFT said today that the leak could directly result from the ransomware gang’s alleged attacks targeting Russian banks.
    • “As part of our continuous monitoring, we’ve observed that BLACKBASTA (Vengeful Mantis) has been mostly inactive since the start of the year due to internal conflicts. Some of its operators scammed victims by collecting ransom payments without providing functional decryptors,” PRODAFT said.”

From the cybersecurity defenses front,

  • Security Week shares a conversation with Kevin Winter, Global CISO at Deloitte, and Richard Marcus, CISO at AuditBoard.
  • Here’s a link to Dark Reading’s CISO Corner.
  • HelpNet Security points out cyber hygiene habits that many still ignore.

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, OPM, U.S. Healthcare–

Happy Washington’s Birthday (one day early)

First in war, first in peace, first in the hearts of his country

From Washington, DC,

  • “The American Medical Association News reports,
    • “The U.S. Senate voted 52-48, after a 10-hour “vote-a-rama” session, to adopt a budget resolution for fiscal year 2025 focusing on the border, military and energy. The bill would authorize roughly $340 billion in spending and be fully offset by corresponding spending cuts. The budget resolution is a blueprint for one of two budget reconciliation bills the Senate hopes to enact this year, with the second focusing on extending tax cuts and cutting spending.
    • “Meanwhile, the House of Representatives next week plans to vote on its own budget resolution focusing on the Trump administration’s agenda on border security, defense, energy and taxes. The budget resolution calls for $2 trillion in spending cuts that could potentially impact Medicaid and other key health care programs. The proposal also allows for up to $4.5 trillion in spending for tax cuts. President Trump this week expressed his preference for the House’s one-bill approach.” * * *
    • “Both chambers must pass a common budget resolution to move forward with the reconciliation process.”
  • MSN lets us know,
    • “President Donald Trump warned drugmakers in a private meeting [yesterday] that tariffs are coming and said companies should hustle to move overseas manufacturing to the US, according to two people familiar with the conversation.
    • “Trump also didn’t commit to pushing Congress to water down a drug pricing program enacted under President Joe Biden that the pharmaceutical industry has been seeking relief from. 
    • “The president’s tone suggests the pharmaceutical industry’s bid to win an ally in the White House might be more difficult than executives had hoped. Despite his pro-business leanings, Trump had a rocky relationship with drug companies in his first term, at one point accusing them of “getting away with murder” on the price of medicines.” 
  • The Wall Street Journal informs us,
    • The U.S. Food and Drug Administration declared that the shortage of Novo Nordisk’s weight-loss medications Wegovy and Ozempic has been resolved, according to its website.
    • The FDA announcement confirms that the U.S. supply of both prescription-only drugs now meets or exceeds the current and projected demand in the country, Danish pharmaceutical company Novo Nordisk said Friday.
    • The popularity of Novo Nordisk’s blockbuster GLP-1 drugs had forced the FDA to include Wegovy and Ozempic in its official shortage list, despite the company’s efforts to ramp up production.
    • Ozempic, which treats diabetes, and Wegovy, sold for obesity, have spent over two years on the FDA’s list. During that time, compounding pharmacies–those which produce custom medications–were legally entitled to produce copies of both semaglutide drugs, which were also cheaper than Novo Nordisk’s versions.
    • The regulator’s decision to take them off of the shortage list means that compounding pharmacies will need to stop making and selling knock offs.
  • Modern Healthcare adds
    • “The Food and Drug Administration issued a notice on Friday classifying its recall of the Boston Scientific Accolade pacemaker devices as the most serious type of recall.
    • “To date, 832 injuries and two deaths tied to the devices have been reported. The recall affects about 13% of Accolade devices manufactured before September 2018.
    • “The pacemakers treat slow heart rhythms by pacing the upper and lower chambers of the heart and adjusting the pacing rate to meet the body’s needs. Due to a manufacturing issue with the battery cathode, the pacemakers might enter safety mode under certain conditions, and as a result may not properly regulate the heart’s rhythm and rate, according to the FDA.”
  • Govexec tells us,
    • “The Office of Personnel Management is laying off its entire procurement team as the federal government’s human resources agency continues to reduce its footprint.
    • “Employees were informed Friday that their positions were being “abolished” and they would be separated from federal service in 60 days. The decision is separate from the ostensibly for-cause firings that OPM kicked off internally earlier this month and have subsequently swept up agencies throughout the government. 
    • “The employees impacted by Friday’s moves received reduction-in-force notices from acting OPM Director Charles Ezell, who said he was issuing the layoffs due to three separate executive orders issued by President Trump.” 
  • The IRS issued guidance about “Health Coverage Reporting Required by Sections 6055 and 6056,” the IRS 1095-B and 1095-C forms following up on a statutory change that occurred last December.

From the judicial front,

  • Politico reports.
    • “A federal judge blocked President Donald Trump’s bid to deprive federal funding from programs that incorporate “diversity, equity and inclusion” initiatives.
    • “U.S. District Judge Adam Abelson ruled that Trump’s policy likely violates the First Amendment because it penalizes private organizations based on their viewpoints. And the judge said the policy is written so vaguely that it chills the free speech of federal contractors concerned they will be punished if they don’t eliminate programs meant to encourage a diverse workforce.
  • Per Govexec,
    • “A federal judge in Washington, D.C., on Friday ended a weekslong-halt on the Trump administration’s plan to put the vast majority of employees at the U.S. Agency for International Development on administrative leave, denying unions’ request to issue a preliminary injunction in the case.
    • “The American Foreign Service Association and the American Federation of Government Employees sued to block the apparent effort to decimate the agency and reposition it under the auspices of the State Department. More than 2,000 employees were briefly placed on paid administrative leave before the court’s initial intervention earlier this month, and another 2,000 workers mostly stationed overseas also are on the at-least-temporary chopping block.
    • “U.S. District Judge Carl Nichols, a Trump appointee, had devoted most of his attention during hearings to concerns regarding the continued safety of those overseas workers stationed in high-risk regions. But recent filings from Peter Marocco, the agency’s day-to-day chief under Acting Administrator and Secretary of State Marco Rubio, stating that overseas employees will continue to have access to security-related systems like the SAFE Alert system and the SCRY Panic smartphone app, assuaged the judge’s fears.”
  • Beckers Hospital Review relates,
    • “The Trump administration plans to defend the ACA requirement that requires insurers to fully cover certain preventive services for their members. 
    • “On Feb. 18, the Justice Department filed a brief with the Supreme Court, arguing in favor of maintaining the Biden administration’s stance regarding the landmark case that centers on whether employers can exclude covered services on religious grounds. Specifically, the case addresses the authority of the U.S. Preventive Services Task Force (USPSTF) in mandating coverage for preventive services, including medications such as PrEP for HIV prevention.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated across the country. COVID-19 activity is elevated in many areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is elevated in many areas of the country. Though wastewater levels are high, emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity remains elevated across the country. Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “RSV
      • “RSV activity remains elevated but is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
    • “Additional Respiratory Illnesses
      • “Pertussis
        • “Reported cases of whooping cough (pertussis) continue to be elevated nationwide. Whooping cough is very contagious and can spread easily from person to person. Babies younger than 1 year old are at highest risk of severe disease and complications. The best way to prevent complications from whooping cough is to get vaccinated. Learn more: About Whooping Cough | Whooping Cough | CDC.
      • “Mycoplasma pneumoniae
        • “Respiratory infections caused by the bacteria Mycoplasma pneumoniae have declined from their peak in late 2024 but remain high nationwide, especially in young children. M. pneumoniae infections are generally mild but can sometimes be severe, causing what’s known as “walking pneumonia.” Most people will recover without medicine, but some need antibiotics to get better. Learn more: About Mycoplasma pneumoniae Infection | M. pneumoniae | CDC.
      • “Group A Strep
        • “Respiratory infections caused by group A Streptococcus bacterium, such as strep throat and scarlet fever, are elevated nationwide. This is typical for this time of year. Healthcare providers can do a quick test to see if someone has strep throat or scarlet fever and if treatment with antibiotics can help. Learn more: About Strep Throat | Group A Strep | CDC.
    • Season Outlook
      • “The CDC has determined that the highest hospital demand for COVID-19, flu, and RSV to date this season occurred during the week ending February 1, 2025, and it was lower than the peak demand from last season. However, influenza activity remains high in most areas.
      • “The peak hospital demand due to COVID-19 during this fall and winter respiratory season was lower than all previous seasons, and nearly 50% lower than the peak demand last season.
      • “CDC does not anticipate producing additional respiratory disease outlook updates during the remainder of the 2024-2025 season. Read the entire 2024-2025 Respiratory Season Outlook – February Update (2/19/2025)”
  • Per Medscape, “A weekly alcohol intake exceeding the limits recommended by US guidelines was associated with an increased risk for coronary heart disease (CHD) among young and middle-aged men and women. Women had a higher risk for CHD than men, especially when heavy episodic drinking was involved.”
  • ABC News reports,
    • “Rates of drug overdose deaths decreased in the United States for the first time since the COVID-19 pandemic began, according to new federal data published early Thursday.
    • “The rate of overdose deaths fell from 32.6 deaths per 100,000 people in 2022 to 31.3 per 100,000 people in 2023, a 4% decrease, according to the report from the Centers for Disease Control and Prevention’s National Center for Health Statistics.
    • “Dr. Aitzaz Munir, an assistant professor of psychiatry at Rutgers New Jersey Medical School and associate program director for the Rutgers Addiction Medicine Fellowship Program, told ABC News the drop in the overdose death rate was “surprising” to him but a positive sign.”
  • The National Cancer Institute lets us know,
    • “Women who are pregnant routinely undergo prenatal blood testing to screen their fetuses for chromosomal disorders such as Down syndrome. However, in rare cases, this noninvasive prenatal testing (NIPT) will result in an abnormal or inconclusive finding that isn’t related to the fetus but rather, to the mother’s DNA. 
    • “The results of a study of more than 100 women with unusual NIPT findings but a normally developing fetus now show that such findings can have serious implications for the mother. Nearly half of the women in the study turned out to have cancer Exit Disclaimer, the researchers reported December 5 in the New England Journal of Medicine.
    • “Most of these cancers were only detected through whole-body magnetic resonance imaging (MRI), which is not yet routinely used by doctors to follow up on abnormal NIPT results. In contrast, standard diagnostic tests, such as physical exams and blood work, missed many of the cancers.
    • “These cancers tend to be truly hidden,” said co-lead investigator Amy Turriff, M.S., of the National Human Genome Research Institute. “Our study found that whole-body imaging is critical to sufficiently evaluate women who receive these [abnormal] results for cancer.”
    • “I hope [these findings] will increase awareness of these types of results and what should be done to triage these patients to the appropriate levels of care,” said Neeta Vora, M.D., of the University of North Carolina School of Medicine, who studies prenatal genetic testing and maternal cancers but was not involved in the study.”

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies the most common reasons for hospitalizations.
    • “Maternal and neonatal stays accounted for 22% of hospitalizations in 2021, a recent KFF report found.
    • “The report is based on data from the American Hospital Association annual survey, the American Medical Association physician practice benchmark survey, the Census Bureau delineation files and population estimates, the healthcare cost and utilization project national inpatient samples, RAND hospital data and other sources.
    • “Maternal stays accounted for 1 in 10 hospitalizations and neonatal stays accounted for the same; hospital stays for mothers and newborns were recorded separately. Medicaid covered about 41% of births nationally.
    • “Other hospitalizations were categorized as medical (50%), surgical (18%), injury (5%), and mental health and substance abuse (5%) discharges.”
  • Per AIS Health,
    • “When it comes to how the country’s three dominant PBMs cover the blockbuster drug Humira (adalimumab) and its many biosimilars, one year has made a major difference.  
    • “As of 2025, AbbVie’s Humira either “has or will vanish from PBMs’ standard formularies,” Drug Channels CEO Adam Fein, Ph.D., wrote in his annual post analyzing which drugs were excluded on the standard commercial formularies offered by The Cigna Group’s Express Scripts, CVS Health Corp.’s Caremark and UnitedHealth Group’s Optum Rx, as of January 2025.”
  • Kauffman Hall offers an infographic about “The State of Trust in Public Health in AmericaMedCity”
  • MedCity News shares seven announcements from the VIVE Conference, a few of which already were included in the FEHBlog.
  • Per Fierce Pharma,
    • “Pfizer is pulling further away from the gene therapy field with its decision to discontinue hemophilia product Beqvez.
    • “The New York pharma is ending global development and commercialization of Beqvez less than a year after an FDA approval for the gene therapy to treat hemophilia B. The one-time treatment carried a list price of $3.5 million per person.
    • “Several reasons led to the discontinuation, including limited interest from patients and doctors toward hemophilia gene therapies to date, a Pfizer spokesperson told Fierce Pharma in a statement.
    • “No patients seem to have received commercial Beqvez since its FDA nod in April 2024. The Pfizer spokesperson said the company will communicate the news to patients and providers that are in the treatment qualification process, adding that the company remains committed to supporting those who received the med in any clinical trial.
    • “Following Beqvez’s exit from the market, Pfizer has no commercial or clinical-stage gene therapies left in the works, according to its website. The spokesperson confirmed that the company doesn’t have any active gene therapy programs at the moment.”

Thursday Report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Republicans moved to take their first step Thursday toward funding new spending on border security and the military, while Democrats prepared to put GOP lawmakers on the record on uncomfortable issues at the start of President Trump’s new term.
    • ‘The Senate was set to start a series of votes related to Republicans’ budget blueprint aimed at unlocking $342 billion in spending—and the same amount of offsetting cuts—over four years, which is expected to culminate in the plan’s passage sometime Friday morning. 
    • “The process of debating and amending the budget resolution was slated to begin late Thursday. A budget resolution—if passed by both chambers—unlocks a process known as budget reconciliation, which allows the Senate to bypass its filibuster rules and pass legislation with a simple majority instead of the 60-vote threshold for most measures. The process would allow Republicans to pass Trump’s fiscal agenda later this year without needing Democratic help. The Senate and House then would have to agree on final legislation. 
    • “But the reconciliation process also will empower Democrats to propose as many amendments as they want, leading to what is expected to be an all-night “vote-a-rama.” While the amendments are nonbinding, they offer a rare chance for the minority party to force the majority to follow its lead.
    • “Democrats are going to hold the floor all day long—and all night long—to expose how Republicans want to cut taxes for billionaires while gutting things Americans care about most: healthcare, jobs, public safety, national security, housing, education,” Senate Minority Leader Chuck Schumer (D., N.Y.) said.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, joined Sen. Amy Klobuchar (D-Minn.) in reintroducing the Safe and Affordable Drugs from Canada Act. The bipartisan bill would allow Americans to safely import prescription drugs from Canada – lowering costs, increasing access and strengthening competition in the pharmaceutical market. 
    • “Congress must take an all-of-the-above approach to lowering the price of prescription drugs. Our commonsense, bipartisan bill would provide Americans increased access to safe, affordable prescription drugs available in Canada, while boosting much-needed competition in the pharmaceutical industry,” Grassley said. 
    • “Americans pay the highest prices in the world for prescription drugs,” Klobuchar said. “Our bipartisan legislation would save Americans money by allowing them to import their medications from pharmacies in Canada. Brand-name prescription drugs that we invent here in America cost more than twice as much in the United States as in Canada. Americans deserve better. Building on my legislation to allow Medicare to negotiate lower prescription drug costs, I will continue to work to increase competition in the pharmaceutical market, so Americans no longer get ripped off by Big Pharma.” 
    • “Find bill text HERE.” 
  • Fierce Pharma tells us,
    • “As the second Trump administration settles in, the U.S.’ top pharmaceutical trade group is drafting its ambitions for the next four years ahead of a planned meeting with the president on Thursday.
    • “The sit-down between President Donald Trump and leaders from the Pharmaceutical Research and Manufacturers of America (PhRMA) will provide the trade group’s head, Stephen Ubl, and CEOs from several of the world’s top drugmakers with a potential avenue to sway the commander in chief’s views on policies affecting the industry, Bloomberg reported, citing people close to the matter.
    • “In particular, the industry wants to garner support for adjustments to certain drug pricing provisions baked into 2022’s Inflation Reduction Act (IRA), the news service said.” * * *
    • “As for what that government-industry collaboration might look like, PhRMA this week released its 2025 policy agenda (PDF), which broadly seeks to promote pro-innovation regulatory and trade positions, challenge features of the IRA price negotiations, curb hospital drug markups and clamp down on pharma middlemen.”
  • Yesterday, the Congressional Research Service posted an In Focus paper on U.S. healthcare spending and coverage.
  • Tammy Flanagan, writing in Govexec, explains “What happens to my insurance when I leave the federal government?”
  • NCQA has opened its HEDIS measures public comment period.
    • “NCQA’s public comment period is open and ready for your input.
    • “NCQA seeks public feedback on proposed new measures, changes to existing measures and measure retirements, and NCQA acknowledges that the health care policy environment is rapidly evolving at this time. Reviewers are asked to submit comments to NCQA in writing via the Public Comment website by 5:00 p.m. (ET), Thursday, March 13. NCQA will take into account all comments received and the evolving environment as NCQA moves forward to prepare the final versions of these measures.
    • “NCQA seeks comments on the following:
      • “Three new HEDIS measures.
      • “Revising six HEDIS measures.
      • “Retiring one HEDIS measure.
      • “Cross-cutting item for HEDIS to align with federal standards for race and ethnicity.
      • “Three new measures for the Diabetes Recognition Program.” * * *
    • The public comment period ends at 5:00 p.m. (ET) on Thursday, March 13. Visit My NCQA to submit comments. For details on proposed changes, visit the NCQA website.
  • Per an HHS news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) took action to support President Trump’s executive orders defending children and restoring biological truth in civil rights and health information privacy enforcement.
    • “As directed by President Trump’s Executive Order 14187, “Protecting Children from Chemical and Surgical Mutilation,” HHS OCR rescinded prior Administration guidance entitled “HHS Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy,” issued March 2, 2022 (“2022 OCR Notice and Guidance”).  This rescission supports Administration policy in Executive Order 14187 that HHS will not promote, assist, or support “the so-called ‘transition’ of a child from one sex to another, and it will rigorously enforce all laws that prohibit or limit these destructive and life-altering procedures.”  This rescission also aligns with Administration policy in Executive Order 14168, “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.”
    • “Today’s rescission provides important notice to the regulated community that the 2022 OCR Notice and Guidance no longer represents the views or policies of HHS OCR,” said OCR Acting Director Anthony Archeval.  “The rescission is a significant step to align civil rights and health information privacy enforcement with a core Administration policy that recognizes that there are only two sexes:  male and female.”
    • “Under the prior Administration, HHS through OCR provided notice to the public of how OCR intended to interpret civil rights and health information privacy authorities to protect the chemical and surgical mutilation of children, what the prior Administration referred to as “gender-affirming care.” Section 5 of Executive Order 14187 specifically directs HHS to rescind this guidance.
    • “OCR’s action is part of a larger initiative to defend women and children and restore biological truth to the federal government.
    • “OCR’s rescission of the 2022 OCR Notice and Guidance is available here: https://www.hhs.gov/sites/default/files/ocr-rescission-february-20-2025-notice-guidance.pdf – PDF“

From the judicial front,

  • Govexec informs us,
    • “A federal judge on Thursday denied the National Treasury Employees Union and other federal employee unions’ request to block the mass firings of their members who are probationary employees, future large-scale layoffs across agencies pursuant to a Trump executive order and any renewal of the “deferred resignation” program for federal employees. 
    • “U.S. District Judge Christopher R. Cooper, an Obama appointee, said in his preliminary ruling that the unions likely must first bring their claims before the Federal Labor Relations Authority, whose chairwoman Trump recently fired ahead of the expiration of her term. 
    • “Although district court review may appear more efficient or convenient to NTEU, its preference does not insulate its claims from the [Federal Service Labor-Management Relations Statute] review scheme,” Cooper wrote.”
  • FEHBlog note — This is the same legal outcome that occurred in the preliminary injunction challenge to the Fork in the Road program in federal district court in Boston.
  • Reuters reports,
    • “Regeneron (REGN.O) has won a court ruling that will make it harder for U.S. authorities to win a lawsuit accusing it of paying illegal kickbacks through a charity to promote the use of its expensive eye drug Eylea.
    • In a unanimous opinion, on Tuesday, a three-judge panel of the 1st U.S. Circuit Court of Appeals found that the United States must prove that the alleged kickbacks directly caused Medicare, the federal health insurance program for Americans aged 65 and older, to make payments for Eylea that it otherwise would not have made.
    • “The government had argued that proving illegal kickbacks alone would be enough.
    • “We are pleased with the decision from the appellate court and look forward to presenting our case to a jury,” Regeneron said in a statement.”

From the U.S. public health and medical research front,

  • ABC News lets us know,
    • “Nature versus nurture: Scientists are gathering more evidence on which has more of an impact on human well-being amid the aging process.
    • “While both environmental exposures and genetics are known to play important roles in shaping human aging, living conditions and lifestyle choices impact human health much more than genetics, according to a new study published Wednesday in Nature Medicine.
    • “Researchers from Oxford Population Health used data from nearly 500,000 participants in the U.K. to assess the influence of 164 environmental factors and genetic risk scores for 22 age-related diseases and premature death, according to the paper.
    • “The data showed that environmental factors accounted for 17% of the variation in risk of death, compared to less than 2% explained by genetic predisposition.
    • “Smoking, socioeconomic status, physical activity and living conditions had the most impact on mortality and biological aging, the study found.”
  • Per Medscape,
    • “A new analysis of long COVID patients has identified five distinct subtypes that researchers say will help doctors diagnose the condition.
    • “The new five-type index, developed by federal researchers with the National Institutes of Health’s RECOVER COVID Initiative, identified the most common symptoms in 14,000 people with long COVID, with data from an additional 4000 people added to the updated 2024 index.
    • “By using the index, physicians and researchers can better understand the condition, which is difficult to treat and diagnose because no standard definitions or therapies have been developed. Doctors can use the index to offer more targeted care and help patients manage their symptoms more effectively.”
  • STAT News relates,
    • “Four years after Apple announced a study to explore how its products could be used to support people with asthma, an application developed from that research is now available to the public.
    • “Called Asthma Tool, the free software allows users to track their symptoms and triggers and to use wearable devices to monitor vitals, like resting heart rate, for signs that asthma may be acting up.” * * *
    • “Asthma Tool is an outgrowth of Apple’s Asthma Digital Study with insurer Anthem (now Elevance Health) and researchers at the University of California Irvine School of Medicine. Apple announced the study alongside two other research projects in 2020, saying it hoped to investigate how the Apple Watch’s new feature for measuring blood oxygen could be used in future health applications. In 2023, the collaborators released preliminary data suggesting that the asthma study helped Medicaid beneficiaries stay out of the emergency department.
    • “Despite the promising data, Apple has so far chosen not to release an asthma product on its own. The new Asthma Tool was released by CareEvolution, a clinical trials software company that developed the app used in the asthma study. The product is available as a module through the company’s MyDataHelps platform that lets people collect data for personal tracking and allows them to participate in research. MyDataHelps can be used on the web and or as an app on Apple or Android smartphones.”
  • The American Journal of Managed Care points out,
    • “The rollout of 2 major interventions to prevent severe respiratory syncytial virus (RSV) in infants—the RSV prefusion F (RSVpreF; ABRYSVO) vaccine for pregnant individuals and the monoclonal antibody nirsevimab (Beyfortus) for newborns—has shown high uptake in a recent cohort study.
    • “Conducted at a single academic center, the study found that 64% of eligible pregnant individuals received the RSVpreF vaccine, while 70% of eligible infants received nirsevimab before hospital discharge.
    • “This retrospective cohort study is published in JAMA Network Open.“
  • Per Health Day,
    • “A blood test can help people with irritable bowel syndrome cut out specific trigger foods most likely to worsen their condition, a new study suggests.
    • “About 60% of IBS patients who followed a diet guided by the results of the blood test wound up suffering less stomach pain, researchers reported recently in the journal Gastroenterology.
    • “By comparison, 42% of IBS patients who didn’t get the blood test experienced a reduction in stomach pain, results show.
    • “The test “requires additional validation but could move us one step closer to a ‘precision nutrition’ approach, in which providers can offer personalized dietary recommendations to each patient with IBS,” researcher Dr. William Chey, chief of gastroenterology and hepatology at the University of Michigan, said in a news release.
    • “The blood test, called inFoods IBS, tests for the potential of 18 foods to worsen IBS symptoms in specific patients. These include wheat, oat, rye, whole egg, yeast, cow’s milk, black tea, cabbage, corn, grapefruit, honey, lemon and pineapple.
  • NBC News reports that “mRNA vaccines show promise in pancreatic cancer in early trial. Personalized mRNA vaccines show promise as pancreatic cancer treatment, a phase 1 clinical trial published Wednesday in Nature found.”
  • Per Healio,
    • “Patients with COPD had better inhaler adherence when invited to enroll in a program that lowers cost sharing for maintenance inhalers and offers medication management services, according to results published in JAMA Internal Medicine.
    • “These findings contribute to the limited evidence of interventions that can improve inhaler adherence in COPD, a disease with high morbidity whose costs are disproportionately incurred by Medicare, and the even more limited evidence addressing cost-related nonadherence, a growing concern given the high prices of inhalers,” Sumit D. Agarwal, MD, MPH, PhD, physician and health economist at Brigham and Women’s Hospital, and colleagues wrote.” * * *
    • “To better align insurance coverage with clinical benefit, insurers might consider selectively lowering cost sharing and providing medication management services for clinically effective, high-value services,” Agarwal and colleagues wrote.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Community Health Systems’ losses widened in 2024 to $516 million, up from $133 million in 2023, as the health system struggled with cost pressures, including rising medical specialist fees and payer denials.
    • “The system also attributed its losses to divestitures. CHS has been chasing at least $1 billion in profits from hospital sales as it looks to pay down debt, but sales have dinged the provider’s operating income.
    • “This year, CHS expects to take in between $12.2 billion and $12.6 billion in revenue, with adjusted earnings before interest, taxes, depreciation and amortization ranging from $1.5 billion to $1.6 billion. The health system could upwardly revise its EBITDA projections if state supplemental payment programs are approved as planned, CHS CFO Kevin Hammons told investors Wednesday morning.”
  • Beckers Hospital CFO Report adds,
    • “Franklin, Tenn.-based Community Health Systems expects to offload two North Carolina hospitals and two Florida hospitals in the first quarter for about $540 million in gross proceeds, executives said during the company’s fourth-quarter earnings call on Feb. 19.
    • “CHS plans to sell ShorePoint Health Port Charlotte (Fla.) and certain assets of ShorePoint Health Punta Gorda to Altamonte Springs, Fla.-based AdventHealth for $265 million in cash. The deal is expected to close in the first quarter, subject to regulatory approvals and closing conditions.
    • “The for-profit system also plans to sell Lake Norman Regional Medical Center in Mooresville, N.C., to Duke University Health System. Durham, N.C.-based Duke aims to purchase the 123-bed hospital and its related assets for about $280 million.”
  • Modern Healthcare reports,
    • “CVS Health’s MinuteClinic is collaborating with Emory Healthcare Network to extend primary care services to more patients in Georgia.
    • “With the new partnership, MinuteClinic now offers in-network primary care services at all 35 clinics in the state to most payers through Emory’s integrated network. Patients also have access to Emory’s network of acute care, specialty care, labs, radiology and diagnostic services, according to a Thursday news release.
    • “A CVS spokesperson said the Emory collaboration marks the first time MinuteClinic has expanded into primary care services in partnership with a health system. The 35 locations are co-branded.”
  • Per a Talkspace news release,
    • “We closed out 2024 with a strong fourth quarter, delivering revenue and adjusted EBITDA growth as expected. We continued to broaden our reach, drive awareness and adoption, enhance the provider and member experience, and deliver high-quality care. I’m proud of all that Talkspace has accomplished this year to build a sustainable, profitable business,” said Dr. Jon Cohen, CEO of Talkspace.
    • “Dr. Cohen continued, “Over the last three years, we’ve undergone a significant strategic shift, focusing on the payor market and growing our total covered lives to nearly 200 million. We’ve leveraged our well-known brand to drive awareness of Talkspace as an affordable way to access care for not just commercially insured adults, but also teens, seniors, and active members of the military. Talkspace has established a clear competitive advantage in the marketplace with the comprehensive nature of our solution, and we remain dedicated to meeting the escalating demand for accessible, high-quality behavioral health services in the U.S.”
  • From a Him and Hers news release,
    • “Hims & Hers today announced its plans to introduce at-home lab testing through its platform. The new capability will empower customers to take control of their health with deeper insights and enable providers to access a breadth of data and biomarkers that can help identify risk of disease before it develops, for more precise clinical decision-making. 
    • “The company has acquired an at-home lab testing facility, Sigmund NJ LLC marketed as Trybe Labs, which will allow Hims & Hers to support at-home blood draws and more comprehensive whole-body testing. The acquisition will broaden the company’s ability to offer a wide range of personalized treatments, supplements and medications and accelerate the expansion into new high-impact clinical categories including low testosterone, perimenopausal and menopausal support.”

Midweek Report

David Ermer–Congress, FDA, Medical / Rx research, Mental health care, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Republicans said they would stick with their plan to vote on a narrow part of President Trump’s agenda focused on border security and military spending, brushing off his comments that he favored a broader approach led by House Republicans.
    • “Senate Majority Leader John Thune (R., S.D.) said the Senate’s budget blueprint, which is up for a vote starting on Thursday, would give Trump another way to enact his domestic agenda, positioning it as a backup plan if the broader House package stalls. The House framework also includes trillions of dollars for tax relief and partially offsetting spending cuts.” * * *
    • “House and Senate Republicans are using a process called reconciliation that allows them to pass their plan through the Senate with a simple majority rather than the 60 votes usually required, allowing them to bypass Democratic opposition. But they have been working on different tracks. Both chambers of Congress have been racing to finish their versions of the budget framework, one of which would need to be passed by both houses and signed into law by Trump before work begins on the nitty-gritty of the underlying bill.”
  • Modern Healthcare reports,
    • “Dr. Mehmet Oz has agreed to divest stakes worth millions of dollars in numerous healthcare companies, including UnitedHealth Group and HCA Healthcare, if he is confirmed as administrator of the Centers for Medicare and Medicaid Services.
    • “In an ethics agreement posted by the Office of Government Ethics Wednesday, President Donald Trump’s pick to lead CMS said he would end investments in many companies within 90 days of confirmation. He also said upon confirmation, he would resign from numerous advisory positions he holds.”
  • Healthcare Dive informs us,
    • “The Federal Trade Commission will continue to use stricter guidelines inked by the Biden administration in reviewing corporate mergers, FTC Chair Andrew Ferguson notified staff on Tuesday, in a setback for healthcare M&A.
    • “The guidelines finalized in 2023 raised the bar for antitrust review, and as such have been broadly opposed by the private sector. Their preservation complicates expectations that the Trump administration will take a looser stance toward combating consolidation.
    • “Ferguson said he felt the need to clarify the FTC’s M&A review process given a flood of new premerger filings the agency received after new submission requirements went into effect earlier this month.”

From the judicial front,

  • Per Modern Healthcare,
    • “The Federal Trade Commission’s legal action against the three largest pharmacy benefit managers will move forward after a federal judge rejected their bid to halt the case.
    • “In a court filing Tuesday, U.S. District Judge Matthew Schelp denied a request by CVS Health’s CVS Caremark, Cigna’s Express Scripts and UnitedHealth Group’s OptumRx for a preliminary injunction in the FTC’s in-house case examining their influence over insulin costs.”
  • The Wall Street Journal alerts us,
    • “The implementation of the Corporate Transparency Act, which requires millions of companies to disclose their true ownership to the government, is back on after a federal judge in Texas reversed an injunction he issued last month.
    • “The Treasury Department’s Financial Crimes Enforcement Network, which oversees the enforcement of the law, on Tuesday issued a notice that extended the filing deadline for most companies to March 21. FinCEN said it recognized that companies may need additional time to comply. 
    • “Judge Jeremy Kernodle of the Eastern District of Texas, in a ruling this week, granted the U.S. government’s request to stay a national injunction issued on Jan. 7. Kernodle cited a U.S. Supreme Court ruling in favor of the Treasury issued in January by Justice Samuel Alito, which overturned a lower court order that was blocking enforcement of the CTA in another case challenging the constitutionality of the law.”

From the public health and medical research front,

  • Healthcare Dive tells us,
    • “U.S. hospitals are busier than they were before the COVID-19 pandemic, according to a study published Wednesday in JAMA Open Network. If occupancy trends continue to rise as expected, the nation could be on the brink of a bed shortage.
    • “Average hospital occupancy rates were up 11% in 2024 compared to 2019, due mostly to a declining supply of staffed beds rather than an increase in hospitalizations. The average supply of staffed beds fell from 802,000 beds between 2009 and 2019 to 674,000 beds between May 2023 and April 2024.
    • “Without changes to the projected hospitalization rate or existing bed supply, the U.S. is poised to experience an adult bed shortage by 2032, with some states experiencing a shortage before that time, according to the study.”
  • Per Healio,
    • “Antidepressants were more effective than placebo in reducing anxiety symptoms among adults with moderate to severe generalized anxiety disorder, according to a review published in Cochrane Database of Systematic Reviews.
    • “The research shows that antidepressants are highly effective at treating generalized anxiety disorder, at least in the specific circumstances seen in trials,” Giuseppe Guaiana, MD, MSc, PhD, FRCPC, associate professor of psychiatry in the Schulich School of Medicine & Dentistry at Western University in London, Ontario, Canada, and chief of psychiatry at St. Thomas Elgin General Hospital in St. Thomas, Canada, said in a press release. “For people with generalized anxiety disorder and no other conditions, we have good evidence that antidepressants lead to clinically meaningful improvements over a 1- to 3-month period compared to placebo.”
  • The National Cancer Institute lets us know,
    • “A form of nivolumab that can be injected under the skin (subcutaneous) has gained approval from the Food and Drug Administration (FDA). The approval allows the injectable version to be used for most of the same patient groups as the original formulation, which is given as an infusion through a vein (intravenous or IV).
    • “Experts say the injectable version of nivolumab, also called Opdivo Qvantig, will make the treatment quicker and easier for patients to get. The injection takes less than 5 minutes, compared with about 30 minutes for the infusion.” 
  • Per MedPage Today,
    • “Higher calcium intake was consistently associated with a reduced risk of colorectal cancer (CRC) across calcium sources and tumor sites, according to a cohort study using data from the NIH-AARP Diet and Health Study.
    • “Among over 470,000 participants who were cancer-free at baseline, higher total calcium intake was associated with a lower risk of CRC (HR 0.71, 95% CI 0.65-0.78, P<0.001 for trend), reported Erikka Loftfield, PhD, MPH, of the National Cancer Institute, and colleagues.
    • “Dairy, nondairy, and supplemental sources contributed a mean of 42.1%, 34.2%, and 23.7% of total calcium intake, respectively, they noted in JAMA Network Open.”

From the U.S. healthcare business front,

  • Healthcare Finance News reports,
    • “It remains a challenging time for the nation’s rural hospitals. The percentage of such hospitals operating with negative margins is slightly lower than it was last year, at about 46%.
    • “At the same time the number of rural hospitals deemed at risk of closure has increased.
    • “According to a new Chartis report, the national median operating margin for rural hospitals is 1%, but the median margin is negative in 16 states. At the state level, all three of Connecticut’s rural hospitals are operating in the red, and 87% of Kansas’ rural hospitals are in the red, followed by Washington (76%), Oklahoma (70%) and Wyoming (70%). 
    • “At the other end of the spectrum, Alaska (15%) and Wisconsin (19%) are the only states in which the percentage of rural hospitals in the red is less than 20%.”
  • Fierce Healthcare relates,
    • “Sutter Health will invest $1 billion to expand its services across Northern California’s East Bay region, including a new flagship campus in Emeryville.
    • “The health system announced Wednesday that the campus will feature a new medical center with up to 200 beds as well as a regional destination for ambulatory care. The plans also leave room for future expansion, according to the announcement.
    • “The ambulatory services complex at the 12-acre campus will feature a wide array of specialties and will offer imaging and laboratory services. It expects to welcome its first patients as early as 2028, Sutter said.
    • “The 335,000-square-foot medical center will include labor and delivery, surgical services, intensive care, emergency care and neonatal intensive care. The facility will be designed with the potential to add additional patient rooms in the future.
    • “Sutter is targeting a 2032-33 opening date for the medical center, according to the announcement.”
  • and
    • “Humana’s senior-focused primary care division is charting a course for further expansion throughout 2025, the company announced Wednesday.
    • “Those expansion plans include centers in four new markets: Augusta and Savannah in Georgia, North Carolina’s Triad Region and Wichita, Kansas. Between CenterWell and Conviva, the team plans to open between 20 and 30 new centers in existing markets, too, across 11 states.
    • “That number includes CenterWell facilities that are co-located at Walmart stores, with 11 remaining locations in that partnership set to open by the end of this year.
    • “With our expansion efforts, we’re taking a thoughtful approach to growth, seeking out communities that would benefit from our holistic and personalized senior care model,” said Sanjay Shetty, M.D., president of Humana’s CenterWell healthcare services segment, in a press release.”
  • Fierce Healthcare adds from the VIVE conference,
    • “Value-based care company Lumeris rolled out new AI technology for primary care doctors that produces personalized, next-best actions at both the patient and population levels. 
    • “Dubbed “Tom,” and described as a Primary Care as a Service solution embedded in clinical workflows and is designed to extend the primary care team’s reach across patient management areas including prevention and wellness, care coordination, social determinants of health, population health and chronic disease management.
    • “Tom reduces burnout by automating time-consuming tasks, according to the company, and the tech can support physicians to help health systems manage larger patient panels without sacrificing care quality. 
    • “Unlike traditional analytics-based systems, Lumeris’ AI tool executes next-best actions, including scheduling screenings and appointments, monitoring medication adherence, conducting post-discharge outreach, and sharing patient education, according to the company.
    • “The tech can initiate an interactive, patient-specific outbound call or text based on best next action such as following up post discharge, answer questions about medications and identify and reach out to close preventive gaps in care. The tech also will summarize patient text and voice interactions into relevant notes and actions into the practice’s workflow.”

Tuesday Report

David Ermer–CDC, Congress, Electronic health records, FDA, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–

From Washington, DC

Capitol Hill News

  • Roll Call lets us know,
    • “The Senate took its first procedural step Tuesday on a budget blueprint that would pave the way for a filibuster-proof border security, defense and energy package, a key part of President Donald Trump’s legislative agenda.
    • “Once GOP leaders were certain of a critical mass of senators returning to Washington in time, they teed up a vote on the motion to proceed to the fiscal 2025 budget resolution, which was agreed to on a mostly party-line, 50-47 vote. Only a simple majority is needed to proceed and to eventually adopt the framework on a final vote, but Republicans don’t expect any Democrats to help them advance it, making every GOP vote count.  
    • “Once a budget resolution is adopted in both chambers, key congressional committees can get to work on writing the actual reconciliation bill — which is immune to a filibuster, like the budget resolution — to implement their fiscal priorities.
    • “The initial Senate plan laid out in the fiscal 2025 resolution envisions spending boosts for defense and border security, domestic energy incentives and offsets to pay for the package. It doesn’t address the 2017 tax cuts expiring at the end of the year, instead promising to come back with a second budget reconciliation process later this year to deal with the tax pieces of the GOP agenda.”

White House News

  • Fierce Healthcare tells us,
    • “A new executive order signed by President Trump aims to expand access to in vitro fertilization (IVF) and make it more affordable.
    • “The order directs the Domestic Policy Council to make policy recommendations to protect IVF access and “aggressively” reduce the associated costs for treatment. The policies should focus on ensuring reliable access to IVF and addressing areas that exacerbate the out-of-pocket and health plan costs associated with the care.
    • “These are treatments that have become unaffordable for many Americans,” Will Scharf, the White House staff secretary, said at a press conference on Tuesday.”
  • Per MedPage Today,
    • “The Trump administration’s efforts to address the causes of chronic diseases will all be based on “unbiased science,” HHS Secretary Robert F. Kennedy Jr. said Tuesday.
    • “We will convene representatives of all viewpoints to study the causes for the drastic rise in chronic disease,” Kennedy said in a speech to HHS employees. “Some of the possible factors we will investigate were formally taboo or insufficiently scrutinized — the childhood vaccine schedule; electromagnetic radiation; glyphosate; other pesticides; ultra-processed foods … SSRIs [selective serotonin reuptake inhibitors] and other psychiatric drugs; PFAS [per- and polyfluoroalkyl substances]; PFOA [perfluorooctanoic acid]; microplastics — nothing is going to be off-limits.”
    • “Whatever belief or suspicion I have expressed in the past, I’m willing to subject them all to the scrutiny of unbiased science,” Kennedy said in the speech, a portion of which was posted on Xopens in a new tab or window. “That is going to be our template — unbiased science. That’s something that will make us all proud of this agency and of our role in restoring American health.”
    • “Let’s commission research that will satisfy all the stakeholders once and for all,” he continued. “Let’s use protocols that we all agree on in advance and not alter the outcomes of studies when they’re halfway through [because] they look inconvenient. Let’s all depoliticize these issues and reestablish a common ground for action and renew the search for existential truths with no political impediments and no preconceptions.”

Postal Service News,

  • Govexec informs us,
    • “Postmaster General Louis DeJoy will soon step down as head of the U.S. Postal Service, creating an opening for the agency’s governing board to fill as it is in the midst of implementing controversial and sweeping reforms to its operations. 
    • “DeJoy has requested the USPS board begin its process to find a successor just months after telling Congress he would remain in the post “until somebody hauls me out of here.” The postmaster general has faced significant criticism since his appointment to the role in 2020 for his efforts to slow down mail delivery, raise prices and consolidate mail processing while also winning some plaudits for creating a vision he said would eliminate the agency’s financial troubles. 
    • “Postmasters general serve no fixed terms and are chosen by the board. President Biden while in office faced some calls to fire DeJoy, a long-time Republican donor who came to USPS after running a successful private sector logistics company, though he could only be removed by the board or on his own volition. 
    • “DeJoy said “much critical work” remains to implement his vision for the agency, but he decided it was time to start the process of identifying a successor.”

Food and Drug Administration News

  • Fierce Pharma relates,
    • “Two years on, Bavarian Nordic’s $380 million vaccine M&A move appears to be paying off.
    • “The Danish company’s chikungunya vaccine, Vimkunya, has now crossed the FDA finish line, heating up the competition with Valneva by countering with a label that covers a broader population.
    • ‘The FDA approved Vimkunya’s use in people who are at least 12 years old, marking the first chikungunya vaccine that can be given to those younger than 18. With the nod, Bavarian Nordic also picked up a priority review voucher (PRV) under the FDA’s tropical disease PRV program; the company plans to monetize the PRV “when appropriate,” it said in a Friday press release.”

From the judicial front,

  • The AP, via Federal News Network, reports,
    • “A federal judge refused Tuesday to immediately block billionaire Elon Musk and the Department of Government Efficiency from accessing government data systems or participating in worker layoffs. 
    • “U.S. District Judge Tanya Chutkan found that there are legitimate questions about Musk’s authority but said there isn’t evidence of the kind of grave legal harm that would justify a temporary restraining order. 
    • “The decision came in a lawsuit filed by 14 Democratic states challenging DOGE’s authority to access sensitive government data. The attorneys general argued that Musk is wielding the kind of power that the Constitution says can only be held by those who are elected or confirmed by the Senate. 
    • “The Trump administration, for its part, has maintained that layoffs are coming from agency heads, and asserted that despite his public cheering of the effort Musk isn’t directly running DOGE’s day-to-day operations himself.” 
  • Per STAT News,
    • “California officials were dealt a setback by a federal judge who ruled that a controversial law banning so-called pay-to-delay deals between pharmaceutical companies is, in part, unconstitutional and so cannot be enforced against agreements that had no link to the state.
    • “In his ruling, U.S. District Court Judge Troy Nunley determined that the state law, which was enacted in 2019, violated the Dormant Commerce Clause of the U.S. Constitution because it would extend to pay-to-delay agreements that happened outside of California and, therefore, attempted to regulate interstate commerce.”

From the public health and medical research front,

  • The Wall Street Journal offers its perspective on bird flu. “With so much H5N1 virus circulating across the U.S., scientists worry we are a few mutations away from a potential human pandemic.”
  • Beckers Hospital Review discusses hospitalizations for measles outbreaks.
  • CNN reports,
    • “The best way to stay protected against measles is to get vaccinated, according to experts. The measles, mumps and rubella (MMR) vaccine is 93% effective against measles after one dose and 97% effective against measles after two, according to the CDC.
    • “Officials’ guidance says children should get two doses of the MMR vaccine: the first dose between 12 and 15 months and the second around age 4, before starting school.
    • “When people consider their choice about vaccinating their child, it isn’t just about their own individual child, but this is a public health issue. … If we just stop thinking about the health of the population, we are going to see more and more vaccine-preventable illness, outbreaks occur,” said Dr. Christina Johns, a pediatric emergency physician at PM Pediatrics.
    • “Older children or adults can also get vaccinated if they didn’t get the vaccine as a child, she says. However, people born before 1957 are likely to have been naturally infected and thus already have immunity, according to the CDC.
    • “CDC guidance also indicates that if someone is exposed to measles, getting the MMR vaccine within 72 hours could induce some protection or result in less serious illness.”
  • The National Cancer Institute blogs about “Many Men with Metastatic Prostate Cancer Are Not Getting the Recommended Treatments, Study Finds.”
  • Beckers Hospital Review tells us,
    • “Investments in primary care are declining and fewer clinicians are entering the field at a time when chronic disease rates are rising, according to a new report from researchers at the American Academy of Family Physicians. 
    • “The report, “The Health of US Primary Care: 2025 Scorecard Report — The Cost of Neglect,” points to underlying challenges contributing to a lack of access to primary care in the U.S., including insufficient funding and reimbursement rates. This marks the third edition of the scorecard report, led by researchers at the AAFP’s Robert Graham Center for Policy Studies in Primary Care. The report is co-funded by the Milbank Memorial Fund and The Physicians Foundation and is based on national and state-level data tracking primary care performance, workforce trends and reimbursement patterns.”
  • A National Institutes of Health online newsletter discusses “Dementia in the U.S. | Contact lenses slow myopia in kids | New malaria target.”
  • The HHS Inspector General released a report titled “Not All Medicare Enrollees Are Continuing Treatment for Opioid Use Disorder.”
  • Per BioPharma Dive,
    • “An experimental Duchenne muscular dystrophy gene therapy from Solid Biosciences showed potential in a small clinical trial, leading the biotechnology company to quickly raise funds on the findings.
    • “Three months after treatment with Solid’s therapy, SGT-003, the first three participants in an early-stage clinical trial produced higher-than-normal levels of a tiny protein linked to muscle function, Solid said Tuesday. No serious side effects were observed so far, the company added.
    • “Solid claims the results, while early, suggest SGT-003 could be more potent than Sarepta Therapeutics’ Elevidys, the only approved Duchenne gene therapy. The company intends to discuss an accelerated approval pathway with U.S. regulators later this year. Solid’s share price rose by as much as 79% Tuesday morning before settling back to trade up 40%. It announced a $200 million stock offering alongside the study results.”

From the U.S. healthcare business front,

  • CIGNA Healthcare announced,
    • “Specialty medications used to treat rare, chronic, and complex diseases are often administered via injection or infusion. While some patients need to receive these medications in a hospital setting, most patients can use options that are more affordable and more convenient. These include infusion centers not affiliated with hospitals, qualified physician’s offices, or administration in the patient’s home by a trained nurse. When appropriate, guiding patients to these non-hospital settings can make specialty treatment easier to access while reducing health care costs.
    • “Although some treating physicians have concerns about the quality and safety of alternative sites, new research published in the Journal of Clinical Pathways found that patients who received specialty medication treatments at non-hospital outpatient settings are less likely to experience adverse reactions or seek care at the emergency room than those treated at hospital outpatient settings. They are also less likely to be hospitalized within a week following treatment. These findings are based on a retrospective analysis of Cigna Healthcare claims data from more than 122,000 patients who received nearly 1 million injections or infusions of 72 specialty drugs between January 1, 2021, and October 31, 2023.
    • “This research clearly demonstrates that administering specialty medications in non-hospital settings is safe and effective,” said Dr. Jeff Langsam, national director of oncology and senior medical director of specialty pharmacy at Cigna Healthcare. “The convenience and comfort of these less intensive care settings also enhance the patient’s experience.”
  • Fierce Healthcare adds,
    • “CVS Health has named Ed DeVaney as president of its pharmacy benefit manager, CVS Caremark.
    • “DeVaney has served as interim president of Caremark since December 2024. The president’s role was vacated when David Joyner took over as CEO of CVS Health in October.
    • “CVS said that DeVaney joined the company in 2005 and held roles across Caremark and the company’s Aetna division. Prior to taking over as interim president, DeVaney was Caremark’s president of employer and health plans, where he led the team’s work to grow and retain its PBM customers.”
  • Beckers Health IT explains how artificial intelligence tools are being integrated into electronic health records.
  • Beckers Payer Issues discusses the healthcare stop loss market.

Happy Presidents Day

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Mount Rushmore Photo by Laura Nyhuis on Unsplash

From Washington, DC

  • Milliman explains how to navigate the new mental health parity rules which are under a legal challenge before the U.S. District Court for the District of Columbia.
  • Per Fierce Pharma,
    • “Pfizer’s two-year run with the only 5-in-1 meningococcal vaccine on the U.S. market has come to an end. Now, GSK is ready to play catch-up after nabbing its own FDA approval. 
    • “The FDA approved the British drugmaker’s Penmenvy vaccine to protect people ages 10 to 25 against meningococcal serogroups A, B, C, W and Y (MenABCWY), which together cause the most invasive meningococcal disease (IMD) cases globally. The shot mixes the antigenic components of GSK’s established meningococcal vaccines Bexsero and Menveo, which target MenB and MenACWY, respectively, to offer broader coverage in fewer doses.”
  • MedPage Today adds,
    • “The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children with diabetes, the agency announced Friday [February 14].
    • “Like its reference counterpart, insulin aspart (Novolog), the biosimilar helps lower mealtime blood sugar spikes to improve glycemic control. The approval is for both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial.
    • “For the millions of people who rely on daily injections of insulin for treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications,” said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research (CDER), in a statement.

From the U.S. public health and medical research front,

  • Beckers Clinical Leadership identifies America’s priciest health conditions.
  • Medscape notes,
    • “The CDC recommends everyone age 6 months or older get a flu vaccine, although so far this year, fewer adults have gotten the shot, compared to last year. The adult flu vaccination rate this season is 44%, down from 48% last season. According to the National Foundation for Infectious Diseases, “as long as influenza (flu) viruses are circulating in your community, it’s not too late to get vaccinated against flu.”
  • The New York Times offers “New Insights into Older Hearts. Heart disease is more common in people over 65, but treatments are better than ever. That can complicate decision-making for older heart patients.”
  • Consumer Reports, writing in the Washington Post, explains “How to keep your eyes healthy and your vision sharp. Cataracts, dry eyes, glaucoma and other eye problems become more common with age. Knowing the early signs and acting fast can make a difference.”
  • Per Healio,
    • There is evidence that GLP-1s can ameliorate psychiatric and neurologic symptoms.
    • More clinical trials on the direct and indirect effects of GLP-1s and their mechanisms of action are needed.
  • and
    • “American Indian and Alaska Native women face substantially higher risk for heart disease, particularly during reproductive-age years.
    • “Generational trauma, violence and racism have compounded [pregnancy] risks.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CommonSpirit Health’s quarterly net patient revenue dipped for the first time in months.
    • “The health system saw net patient revenue of $8.9 billion in the second quarter of fiscal 2025, a 5% drop from the year-ago period, according to its earnings report released Friday. Net patient revenue, or revenue from providing healthcare services after contractual discounts, makes up most of providers’ total operating revenue and can have a big impact on the bottom line.
    • “The results were markedly different from last year, when CommonSpirit was one of several systems that saw big increases in net patient revenue due to higher utilization and improved payer rates.
  • Beckers Hospital Review shares more insights on CommonSpirit Health’s second quarter report.
  • Beckers Payer Issues discusses the adverse impact of the Inflation Reduction Act on payers.
  • Fierce Healthcare relates,
    • “As obesity rates rise across the U.S., a new study from UnitedHealthcare and the Health Action Council examines the financial costs that this growing “epidemic” may cause for employers.
    • “The report (PDF) notes that 75% of adults in U.S. are either overweight or obese, up from 50% in 1990. Obesity rates grew fastest among younger adults, according to the report.”The HAC represents about 230 self-funded employers, and, among its members, about a quarter (26%) have been diagnosed with obesity. The obese population accounts for 46% of the employers’ medical spend, according to the report.
    • “Per member per month costs for obese employees were more than double on average compared to those who were not obese, the study found. Per member per month costs for those with obesity averaged $973, compared to $421 for non-obese workers.”
  • and
    • “As both regulatory and market forces are pushing the industry toward more transparency in healthcare pricing, MultiPlan sees opportunities to be a bigger player in data and tech for providers, payers and employers.
    • “The data analytics company, which has been in the market for 45 years, launched a rebrand at the ViVE 2025 digital health conference on Monday.
    • “Rebranded Claritev, the company is focused on developing new products and technologies that provide data insights to a broader swath of the healthcare market. Providing “actionable insights” to healthcare organizations will be a key part of the company’s growth, Travis Dalton, chairman, CEO and president, told Fierce Healthcare in an interview in the lead-up to the ViVE 2025 event.”
  • MedTech Dive informs us,
    • “Medtronic has bought nano surface technology from Nanovis for use in its next-generation spine fusion implants.
    • “Nanovis, which disclosed the deal Tuesday [February 11], has developed nanotechnology to improve the speed and consistency of bone growth. The company has its own portfolio of spine devices.
    • “Medtronic will use the technology to develop PEEK interbody spine fusion devices that enhance implant fixation. The technology could help bone grow and fuse with the implant.”
  • The Wall Street Journal reports,
    • “If you need a prescription filled in the coming years, don’t be surprised if it flies in and lands in your backyard. 
    • “Hospitals and doctors are increasingly experimenting with the use of drones to deliver medications, lab tests and supplies to patients being treated at home. Some are testing whether drones can be used to deliver organs for transplant more quickly and cheaply. And in some cities, a 911 call today could set off a drone carrying a defibrillator, Narcan spray or tourniquet to the scene of an emergency ahead of the arrival of paramedics.” * * *
    • “One of the challenges in this space five to 10 years ago was that there wasn’t a really clear regulatory framework. Over the last 18 months this has solidified, especially in the U.S. There is now a clear path to scale,” says Adam Woodworth, chief executive officer of Wing, the drone-service unit of Google’s parent Alphabet GOOGL.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • Cyberscoop lets us know,
    • “Cybercrimes could be punished more harshly under a new bill from a pair of senators that seeks to amend U.S. criminal code on computer fraud.
    • “The Cyber Conspiracy Modernization Act from Sens. Mike Rounds, R-S.D., and Kirsten Gillibrand, D-N.Y., would modify the Computer Fraud and Abuse Act (CFAA) to establish a specific penalty for conspiracy and boost penalties for violators. 
    • “As cyber technologies continue to rapidly evolve, we need more people working to secure cyberspace as well as harsher penalties for those perpetrating these crimes,” Rounds said in a statement. “As chairman of the Senate Armed Services Committee’s Subcommittee on Cybersecurity, I am committed to working on policies that strengthen the United States’ ability to respond quickly and decisively to cyberattacks which have been on the rise.”
    • “Under current law, the Department of Justice can only charge conspiracy to commit cybercrimes through a general statute unrelated to the CFAA. Individuals charged under the general conspiracy statute face a maximum five-year penalty.”
  • Cybersecurity Dive informs us,
    • “President Donald Trump plans to nominate Sean Cairncross, a former official at the Republican National Committee, as the next national cyber director, according to a list of planned nominees obtained by Cybersecurity Dive. 
    • “Those nominees are expected to be sent imminently to the Senate to be considered for the confirmation process. 
    • “Cairncross would be the first major nominee for a top cybersecurity role since the Trump administration took office. 
    • “He is founder and president of the Cairncross Group, a strategic consultancy based in Washington, D.C.
    • “Cairncross previously worked as CEO of the Millennium Challenge Corp., an independent government agency that works to reduce poverty by promoting economic growth across the globe.”
  • Federal News Network notes,
    • “A former cyber executive at the Department of Homeland Security and the Energy Department has joined the Cybersecurity and Infrastructure Security Agency.
    • “Karen Evans is now “senior advisor for cybersecurity” at CISA, an agency spokesman confirmed to Federal News Network today. Evans posted about joining CISA on LinkedIn last night.
    • “A CISA spokesman did not confirm whether Evans would be elevated to a permanent role at the agency. But multiple sources said Evans is likely to either be named as executive assistant director for cybersecurity at CISA or move on to a top position at DHS headquarters.
    • “During the first Trump administration, Evans was DHS CIO between June 2020 and January 2021. She also served as assistant secretary for cybersecurity, energy security and emergency response at the Energy Department between 2018 and 2020.”
  • NextGov/FCW offers background on OPM’s new Chief Information Officer, Greg Hogan.
  • Per a Justice Department news release,
    • The Justice Department today [February 10] unsealed criminal charges against Roman Berezhnoy, 33, and Egor Nikolaevich Glebov, 39, both Russian nationals, who allegedly operated a cybercrime group using the Phobos ransomware that victimized more than 1,000 public and private entities in the United States and around the world and received over $16 million in ransom payments. Berezhnoy and Glebov were arrested this week as part of a coordinated international disruption of their organization, which includes additional arrests and the technical disruption of the group’s computer infrastructure.
    • From May 2019, through at least October 2024, Berezhnoy, Glebov, and others allegedly caused victims to suffer losses resulting from the loss of access to their data in addition to the financial losses associated with the ransomware payments. The victims included a children’s hospital, health care providers, and educational institutions.

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop reports,
    • Microsoft threat researchers discovered a series of what they are calling “device code” phishing attacks that allowed a suspected Russia-aligned threat group to gain access to and steal data from critical infrastructure organizations, the company said in research released Thursday.
    • The group, which Microsoft tracks as Storm-2372, has targeted governments, IT services and organizations operating in the telecom, health, higher education and energy sectors across Europe, North America, Africa and the Middle East.
    • Microsoft observed attackers generating a legitimate device code sign-in request and then duping targeted users to input the code into a login page for productivity apps. By exploiting the device code authentication flow, Storm-2372 has gained access to targeted systems, captured authentication tokens and used those valid tokens to achieve lateral movement and steal data.
    • “They’ve been successful in these attacks, though Microsoft itself is not affected,” Sherrod DeGrippo, director of threat intelligence strategy at Microsoft, said in a video summarizing the report’s findings.
  • and
    • “Salt Typhoon, the Chinese nation-state threat group linked to a spree of attacks on U.S. and global telecom providers, remains active in its intrusion and has hit multiple additional networks worldwide, including two in the United States, Recorded Future said in a report released Thursday [February 13].
    • “Recorded Future’s Insikt Group observed seven compromised Cisco network devices communicating with Salt Typhoon infrastructure on five telecom networks between early December and late January. The compromised companies include an unnamed U.S. internet service provider and telecom company, a U.S.-based affiliate of a U.K. telecom provider, a large telecom provider in Thailand, an Italy-based ISP and a South Africa-based telecom provider.
    • “Salt Typhoon’s ongoing attack spree underscores the enduring challenge global cyber authorities and network defenders confront in trying to thwart the nation-state group’s activities. U.S. and White House officials in December warned they may never know if the group has been completely booted from networks.” 
  • Cybersecurity Dive relates,
    • “The FBI and Cybersecurity and Infrastructure Security Agency on Wednesday [February 12] warned Ransomware gangs are adapting to stronger enterprise defenses and increased law enforcement pressure with more sophisticated tactics, according to Huntress’ 2025 Cyber Threat Report.
    • In 75% of the ransomware incidents Huntress observed in 2024, threat actors used remote access Trojans (RATs), while 17.3% of attacks featured abused of remote monitoring and management products like ConnectWise ScreenConnect, TeamViewer and LogMeIn.
    • In an effort to evade EDR protections, threat actors are shifting to data theft and extortion attacks instead of deploying ransomware and increasingly relying on “living off the land” techniques with legitimate system administrator tools. that hackers are abusing buffer overflow vulnerabilities to launch malicious attacks against organizations. 
    • “Buffer overflow vulnerabilities occur when a hacker gains access or writes information outside of the memory buffer, according to the advisory from the FBI and CISA. 
    • “Buffer overflow vulnerabilities are prevalent issues in memory-safety software design that can lead to data corruption, program crashes, exposure of sensitive data and remote code execution.
  • Per Bleeping Computer,
    • “Attackers are now targeting an authentication bypass vulnerability affecting SonicWall firewalls shortly after the release of proof-of-concept (PoC) exploit code.
    • “This security flaw (CVE-2024-53704), tagged by CISA as critical severity and found in the SSLVPN authentication mechanism, impacts SonicOS versions 7.1.x (up to 7.1.1-7058), 7.1.2-7019, and 8.0.0-8035, used by multiple models of Gen 6 and Gen 7 firewalls and SOHO series devices.
    • “Successful exploitation enables remote attackers to hijack active SSL VPN sessions without authentication, which grants them unauthorized access to targets’ networks.
    • “SonicWall urged customers to immediately upgrade their firewalls’ SonicOS firmware to prevent exploitation in an email sent before disclosing the vulnerability publicly and releasing security updates on January 7.”
  • CISA added seven known exploited vulnerabilities to its catalog this week.
  • The DC Health Link cybersecurity breach lawsuit settlement is explained here.

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Ransomware gangs are adapting to stronger enterprise defenses and increased law enforcement pressure with more sophisticated tactics, according to Huntress’ 2025 Cyber Threat Report.
    • “In 75% of the ransomware incidents Huntress observed in 2024, threat actors used remote access Trojans (RATs), while 17.3% of attacks featured abuses of remote monitoring and management products like ConnectWise ScreenConnect, TeamViewer and LogMeIn.
    • “In an effort to evade EDR protections, threat actors are shifting to data theft and extortion attacks instead of deploying ransomware and increasingly relying on “living off the land” techniques with legitimate system administrator tools.”
  • Dark Reading tells us,
    • “A recent RA World ransomware attack utilized a tool set that took researchers by surprise, given that it has been associated with China-based espionage actors in the past.
    • “According to Symantec, the attack occurred in late 2024. The tool set includes a legitimate Toshiba executable named toshdpdb.exe that deploys on a victim’s device. It then connects to a malicious dynamic link library (DLL) that deploys a payload containing a PlugX backdoor.
    • “The threat actors in this case used the tool kit to ultimately deploy RA World ransomware inside an unnamed Asian software and services company, demanding a ransom of $2 million. No initial infection vector was found. However, the attacker claimed they compromised the victim’s network by exploiting a Palo Alto PAN-OS vulnerability (CVE-2024-0012), according to Symantec.”
    • “The attacker then said administrative credentials were obtained from the company’s intranet before stealing Amazon S3 cloud credentials from its Veeam server, using them to steal data from its S3 buckets before encrypting computers,” added the researchers, who hypothesized that based on tactics, techniques, and procedures, the attacker could be China-linked Emperor Dragonfly, aka Bronze Starlight, a group that has been known to deploy ransomware to obscure intellectual property theft in the past.”
  • Reuters reports,
    • “The United States joined Australia and Britain in targeting Russia-based Zservers service provider for its role in supporting the Lockbit ransomware attacks, the U.S. Department of Treasury said on Tuesday [February 11], citing national security concerns.
    • “U.S. Treasury’s Office of Foreign Assets Control also designated two Russian nationals who they said were key administrators for Zservers, a bulletproof hosting services provider or BPH, it added.
    • “Ransomware actors and other cybercriminals rely on third-party network service providers like Zservers to enable their attacks on U.S. and international critical infrastructure,” wrote Bradley Smith, acting Under Secretary of the Treasury for Terrorism and Financial Intelligence.
    • “The action follows joint U.S., UK and Australia cyber sanctions last year targeting the Evil Corp ransomware group, Treasury added.”

From the cybersecurity defenses and business front,

  • Per Cyberscoop,
    • “Identity security giant CyberArk has acquired Boston-based Zilla Security, a cloud-native identity governance and administration startup, in a deal worth up to $175 million.
    • “The acquisition, announced Thursday [February 13], includes $165 million in cash and a $10 million earn-out contingent on performance milestones. Zilla’s co-founders, CEO Deepak Taneja and Nitin Sonawane, along with their team, will join CyberArk. Zilla’s flagship products — Zilla Comply and Zilla Provisioning — will be integrated into CyberArk’s Identity Security Platform as standalone offerings.
    • Founded in 1999, CyberArk has traditionally built its reputation on securing privileged access across enterprise systems. In recent years, the company has bolstered its portfolio through a series of acquisitions, the most significant being the $1.54 billion purchase of machine identity firm Venafi last year. Together with this latest move, CyberArk seeks to expand its reach into modern identity security — an area increasingly critical as organizations shift toward hybrid and cloud-based environments.
  • An ISACA expert discusses how to define a security incident.
    • “[W]hat is a good definition of a security incident? In my opinion, I believe the NIST definition from NISTIR 8183A Vol. 3 is an amazing definition for small and medium-sized organizations. It states, “An occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits or that constitutes a violation or imminent threat of violation of security policies, security procedures, or acceptable use policies.” The “or potentially” does a lot of heavy lifting here but is still a much better definition than those that allow people to more easily wiggle their way out of filling out a ticket for a potential incident. A common occurrence is cherry-picking more vague definitions that don’t have the built-in safeguards and controls around the definition such as the NIST SP 800-53 Rev. 5 for a non-federal system. 
    • “Besides the fact that leveraging this definition means that occurrences such as false positives and security investigations properly follow the ticketing process instead of being undocumented events, there are other helpful points to this definition. The terms “Confidentiality, Integrity and Availability” being in the definition ensures that incidents such as DDOS attacks are not reported as simply “outages” or “infrastructure changes.” The phrase “Constitutes a violation or imminent threat of violation of” expands the scope of what should be monitored and have alerts in place as well as points more eyes inward on internal incidents, which is a wonderful steppingstone toward zero trust.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

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

From Washington, DC,

  • Kaufmann Hall considers health policy in the second Trump administration.
  • Fierce Healthcare lets us know,
    • “The Department of Health and Human Services (HHS) is firing up to 5,200 probationary employees today, as part of an unprecedented cutting of jobs across the federal government.
    • “Of the impacted workers, 1,300 are employed by the Centers for Disease Control and Prevention (CDC) while a sizeable portion work for the National Institutes of Health (NIH). Employees were given four weeks paid administrative leave and notified on the morning of Feb. 14, as first reported by the Associated Press.” * * *
    • “The Department of Veterans Affairs announced layoffs Thursday affecting more than 1,000 federal workers, in a move the Trump administration said would save $98 million per year.”
  • The Wall Street Journal notes,
    • The Trump administration’s effort to slash the federal workforce is pushing employees into a challenging job market, where their age and lack of corporate experience can hold them back.
    • Federal workers are also facing an environment where hiring for white-collar jobs has slowed.
    • Despite the availability of state and local government jobs, many of these positions take place outside offices and aren’t a good match for federal workers’ experience.
  • The American Hospital Association News tells us,
    • “President Trump Feb. 13 signed a presidential memorandum ordering the development of a comprehensive plan for “restoring fairness in U.S. trade relationships and countering non-reciprocal trading arrangements.”
    • “The announcement directs the U.S. Trade Representative and the Secretary of Commerce, in consultation with the secretaries of a number of U.S. agencies, to develop plans for reciprocal tariffs on every country that taxes U.S. imports and submit a report to the president. In addition, within 180 days of the memo, the director of the Office of Management and Budget will assess all fiscal impacts on the federal government and the impacts of any information collection requests on the public and deliver an assessment in writing to the president.
    • “For more information, see the presidential memo and fact sheet.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • COVID-19
      • “COVID-19 activity is elevated in many areas of the country. Though wastewater levels are high, emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.”
    • Influenza
    • RSV
      • “RSV activity remains elevated but is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.”
    • Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • Beckers Clinical Leadership points out,
    • “A farmer in Mercer County, Ohio, has tested positive for H5N1 influenza, marking the state’s first human case of bird flu. 
    • “The worker had direct contact with deceased commercial poultry, according to a Feb. 12 news release from the Ohio Department of Health.”
  • Per Medscape,
    • “How long will vaccine protection last? A simple blood test may have the answer. Researchers at Stanford School of Medicine, Stanford, California, have identified a molecular signature in the blood that appears days after vaccination and predicts the durability of the immune response. Published in Nature Immunology in January, this discovery could transform vaccine development, testing, and personalization of vaccines. The study also offers insights into why some vaccines provide lifelong immunity while others lose effectiveness within months.”
  • Per Healio
    • “The percentage of U.S. adults with obesity did not significantly rise from 2013 to 2023, though a small uptick in the rate of obesity was seen for children and adolescents, according to data published in JAMA.
    • “From 2013 to August 2023, there were small increases in obesity in children and adolescents aged 2 to 19 years, driven by increases among males and children aged 2 to 5 years,” Samuel D. Emmerich, DVM, an epidemiologist at the CDC National Center for Health Statistics, told Healio. “In adults aged 20 years and older, severe obesity increased slightly, driven by increases among women and middle-aged adults. There were no significant changes in any other subgroups, in high weight-for-length or in high waist circumference.”
  • Per HCPLive,
    • “New research is shedding light on a heightened risk of colorectal cancer (CRC) in patients with both nonadvanced and advanced adenomas detected during colonoscopy, highlighting the importance of surveillance colonoscopy in this population and the need for more frequent screening among those with advanced adenomas.
    • “Leveraging data from the Minnesota Colon Cancer Control Study, the present analysis found individuals with adenomas at colonoscopy, regardless of whether or not they were advanced, were at a greater risk of developing CRC than those with no adenomas. Additionally, findings showed participants with advanced adenomas were at increased risk of both CRC mortality and all-cause mortality.
    • “Studies have reported the association of advanced adenomas with increased risk of CRC and CRC-related death over the following 5 to 15 years compared with having no advanced adenomas. The association of nonadvanced adenomas with CRC incidence and mortality after colonoscopy is less clear,” Aasma Shaukat, MD, MPH, a gastroenterologist and Robert M. and Mary H. Glickman Professor of Medicine at New York University Grossman School of Medicine, and colleagues wrote. “However, to our knowledge, no studies have evaluated the association of adenomas and advanced adenomas with all-cause mortality.”
  • Health Day adds,
    • “You may be less likely to develop an especially lethal form of colon cancer if you’re a longtime consumer of yogurt, new research finds.
    • “Folks who ate two or more servings of yogurt per week for years had 20% lower odds for an aggressive type of tumor typically found on the right side of the colon, researchers reported Feb. 12 in the journal Gut Microbes.
    • “The tumors’ tissues also tested positive for a bacterium commonly found in yogurt, called Bifidobacterium.
    • “It has long been believed that yogurt and other fermented milk products are beneficial for gastrointestinal health,” co-senior author Dr. Tomotaka Ugai, a pathologist at Mass General Brigham in Boston, noted. “Our new findings suggest that this protective effect may be specific for Bifidobacterium-positive tumors.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Johnson & Johnson’s halt of U.S. sales of a new heart-rhythm device due to safety concerns is hobbling a major strategic push by the company into one of the industry’s fastest-growing markets.
    • “The healthcare company paused use of the device, known as Varipulse, last month after receiving reports of neurovascular events in several patients. The company didn’t explain what the events were, but several strokes have been reported to a federal device-safety database, and doctors’ concerns are centered on strokes.
    • “J&J has been racing to catch up to competitors in the fast-growing market for medical devices treating irregular heart rhythms, and to revive the company’s medical-device business generally. 
    • “Rivals Boston Scientific and Medtronic have dominated the market for so-called pulsed-field ablation devices, which research firm Clarivate estimates will reach about $12 billion by 2032, from $1.6 billion last year. 
    • “More than 10 million Americans have the heart-rhythm disorder that the devices treat. 
    • “This is a huge hit for J&J,” said Dr. John Mandrola, an electrophysiologist at Baptist Health in Louisville, Ky., who treats patients with heart-rhythm problems. “The market’s so big, and this just sets them back.”
  • Beckers Payer Issues lists major health insurers by 2024 medical loss ratios.
  • Kaufmann Hall takes a look at “Navigating Health Systems Through a Decade of Change” via a conversation with Rich Liekweg, CEO of BJC Health System in Missouri, and Nick Barto, president of BJC Health System.