FEHBlog

Weekend Update

David Ermer–Congress, Medical / Rx research, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Supreme Court holds its final two weeks of oral arguments for the current term this month.

From the public health and medical research front,

  • The Wall Street Journal discusses advances in Alzheimer’s Disease care.
  • NPR Shots explains new approaches to treating lung cancer.
  • Fortune Well lets us know –
    • “Can’t focus on the task at hand or feeling sluggish beyond the afternoon slump? One possible cause: iron-deficiency anemia (IDA). 
    • “About 3 million Americans have anemia, according to the U.S. Centers for Disease and Prevention Disease and Prevention (CDC), and those are just the people who’ve been diagnosed. Many others live with the condition for years without realizing it. * * *
    • “After figuring out the underlying cause, the next plan of action is treatment. For many, iron supplements are the answer. Your doctor may recommend over-the-counter iron pills to replenish the iron stores in your body. However, these tablets are not a one-size-fits-all solution.”  
  • STAT News reports,
    • “Amid the many demands of practicing medicine, doctors can have less time and energy for their patients, and those relationships can suffer. Yet research has shownthat when physicians show empathy, that can generally lead to better clinical outcomes, at least over the near-term. Now, a new study, published Thursday in JAMA Network Open, demonstrates that those benefits can extend longer and be even more effective than some clinical therapies in dealing with lower back pain, which affects half of the U.S. population in any given year.
    • “Researchers at the University of North Texas Health Science Center at Fort Worth, observing patients with lower back pain over the course of 12 months, found that treatment by a “very empathic” physician was associated with better outcomes at the end of that year than treatment by a “slightly empathic” physician. And those positive outcomes were greater than those associated with nonpharmacological treatments (exercise therapy, yoga, massage therapy, spinal manipulation, acupuncture, cognitive behavioral therapy), opioid therapy, and lumbar spine surgery.”

From the U.S. healthcare business front,

  • Beckers Hospital Review lists “27 critical access hospitals to know for 2024.”
    • “These hospitals are vital components of the overall healthcare delivery system, providing quality care to the residents and visitors of rural areas. The small but mighty organizations are working to expand access to specialty care, cut down on patient travel times, and improve community health. 
    • “Critical access hospitals are those that offer 24/7 emergency care and have no more than 25 inpatient beds. While compiling this list, the editorial team examined rankings and awards from several respected organizations, including Healthgrades, the National Rural Health Association and the Chartis Center for Rural Health.”
  • Fierce Healthcare reports,
    • “A year ago, Blue Shield of California joined forces with Accolade and TeleMed2U to launch Virtual Blue, a new plan that centers on virtual care for members with the goal of boosting access.
    • “And with that first year on the books, the insurer is seeing positive results in Virtual Blue, it revealed Friday. Members were more likely to visit their primary care doctors compared to those in a more traditional PPO plan. Blue Shield saw primary care claims increase by 31% in 2023 compared to 2022.
    • “People who enroll in Virtual Blue are able to secure virtual visits with a $0 copayment and can schedule appointments online with their clinician, making it easier to fit critical visits into their daily lives. In-person care is available whenever appropriate or when the member prefers, Blue Shield said.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Uncategorized–

From the cybersecurity policy front,

  • Cybersecurity Dive reports,
    • “FBI Director Christopher Wray said state-linked threat groups are ramping up threat activity against the U.S., and pose a continued risk to key critical infrastructure sectors, in a speech Tuesday before the American Bar Association’s Standing Committee on Law and National Security. 
    • “Threat actors linked with the People’s Republic of China are continuing to build out offensive capabilities, setting up access to various sectors such as the water, energy and telecommunications industries, according to Wray. 
    • “We’re seeing hostile nation states become more aggressive in their efforts to steal our secrets and our innovation, target our critical infrastructure, export their aggression to our shores and front and center is China,” Wray said.”
  • and
    • “The [NIST] National Vulnerability Database is so overwhelmed with a steadily increasing number of software and hardware flaws that the National Institute of Standards and Technology, which maintains the common vulnerabilities and exposures repository, called for a slight pause to regroup and reprioritize its efforts.”The National Vulnerability Database is so overwhelmed with a steadily increasing number of software and hardware flaws that the National Institute of Standards and Technology, which maintains the common vulnerabilities and exposures repository, called for a slight pause to regroup and reprioritize its efforts.
    • “NIST scaled back the NVD program in mid-February, and is currently prioritizing analysis of the most significant or actively exploited vulnerabilities. The slowdown was precipitated by “an increase in software and, therefore, vulnerabilities, as well as a change in interagency support,” NIST said in the announcement.
    • The federal agency is seeking more support from within the government and reassigning staff as it assembles a public-private consortium to address long-term challenges and determine how to improve the NVD program. In the interim, the temporary delays in CVE analysis will result in less detailed analysis of vulnerabilities deemed non-urgent. * * *
  • and
    • “More than two dozen industry stakeholders, including the U.S. Chamber of Commerce, are seeking to extend the deadline to file comments on the Cyber Incident Reporting for Critical Infrastructure Act, according to a letter released Friday. The new deadline would be July 3 if the requested 30-day delay is granted. 
    • “The Cybersecurity and Infrastructure Security Agency issued the notice for CIRCIA, which will require critical infrastructure providers to report significant cyber incidents within 72 hours of discovery and report ransom payments within 24 hours. The notice was published Thursday in the Federal Register and currently has a June 3 deadline for public comments.
    • “The letter, signed by a range of industry groups including the American Bankers Association, National Retail Federation and American Petroleum Institute, is asking for additional time to absorb the complex set of regulations involved in reporting covered cyberattacks and breaches as well as reporting payments to federal authorities.”
  • NextGov relates,
    • “As intelligence agencies work to jettison Chinese cyberspies embedded in critical infrastructure and internet equipment throughout the U.S., a top cybersecurity CEO says that the hackers’ campaign is so robust and widespread that there will be victims targeted in the operation who won’t know they are impacted.
    • “To me, Volt Typhoon is the natural progression of great … Chinese cyberespionage,” said Kevin Mandia, CEO of Google cybersecurity subsidiary Mandiant, who spoke in an exclusive interview with Nextgov/FCW at the Google Cloud Next conference in Las Vegas.”
  • “DoD, GSA, and NASA recently established Federal Acquisition Regulation (FAR) part 40, Information Security and Supply Chain Security. The intent of this RFI is to solicit feedback from the general public on the scope and organization of FAR part 40.” Comments for this case are due by June 10, 2024. For information on how to comment, please visit the Federal eRulemaking portal.
  • Federal News Network lets us know,
    • “Sean Connelly, who has led many of the major federal cybersecurity initiatives over the last decade, is leaving federal service.
    • “Connelly, whose official title is senior cybersecurity architect and Trusted Internet Connections (TIC) program manager for the Cybersecurity and Infrastructure Security Agency, has been instrumental in everything from a major chunk of the lifecycle of the TIC program to the development and advancement of the concepts behind zero trust to the integration of these initiatives with others, including the Einstein and continuous diagnostics and mitigation (CDM) programs.
    • “Federal News Network has learned Connelly’s last day will be April 19. * * *
    • “Sources say Connelly will be joining Zscaler to work on zero trust from an international compliance perspective. He will help non-U.S. governments move toward a zero trust architecture based on the experience of the federal agencies.
    • “Connelly is now the second federal cyber executive to leave to join Zscaler in the last two weeks. Brian Conrad, the former acting director of the Federal Risk Authorization and Management Program (FedRAMP) joined the cyber company in early April to lead Zscaler’s international cloud security compliance program.”

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop informs us,
    • “The Cybersecurity and Infrastructure Security Agency published an emergency directive Thursday in response to a Russian intelligence-linked hacking campaign that breached Microsoft, telling affected federal civilian agencies whose emails were stolen or passwords accessed to reset authentication credentials.
    • “CISA’s directive comes in the week after CyberScoop first reported its existence.
    • “Microsoft and CISA have notified all federal agencies whose email correspondence with Microsoft was identified as exfiltrated by Midnight Blizzard,” the directive reads, referring to Microsoft’s name for the hacking group. “In addition, Microsoft has represented to CISA that for the subset of affected agencies whose exfiltrated emails contain authentication secrets, such as credentials or passwords, Microsoft will provide metadata for such emails to those agencies.
    • “Midnight Blizzard’s successful compromise of Microsoft corporate email accounts and the exfiltration of correspondence between agencies and Microsoft presents a grave and unacceptable risk to agencies,” it continues.”
  • Cybersecurity Dive tells us,
    • “Ivanti Connect Secure devices were exploited and compromised by more threat groups than previously thought, Mandiant said in research released Thursday.
    • “Post-exploitation activity observed by Mandiant includes lateral movement with the aid of open-source tools and multiple custom malware families. 
    • “Mandiant said it observed “eight distinct clusters involved in the exploitation of one or more of” Ivanti’s vulnerabilities CVE-2023-46805, CVE-2024-21887 and CVE-2024-21893, which the vendor first disclosed Jan. 10. This includes five China-linked espionage groups and three financially motivated attackers.”
  • Cyberscoop offers the reflections of Mandiant experts on this cybsercurity landscape.
  • Security Week lets us know,
    • “Palo Alto Networks disclosed [a state-sponsored] vulnerability on Friday, warning that it was aware of limited in-the-wild exploitation and promising patches within the next two days.
    • “Tracked as CVE-2024-3400 (CVSS score of 10/10), the security defect is described as a command injection issue allowing unauthenticated attackers to execute arbitrary code on impacted firewalls, with root privileges.
    • “According to the vendor, all appliances running PAN-OS versions 10.2, 11.0, and 11.1 that have GlobalProtect gateway and device telemetry enabled are vulnerable. Other PAN-OS versions, cloud firewalls, Panorama appliances, and Prisma Access are not affected.”
  • CISA added new known exploited vulnerabilities to its catalog this week.
    • April 11, 2024
      • CVE-2024-3272 D-Link Multiple NAS Devices Use of Hard-Coded Credentials Vulnerability
      • CVE-2024-3273 D-Link Multiple NAS Devices Command Injection Vulnerability
    • April 12, 2024
      • CVE-2024-3400 Palo Alto Networks PAN-OS Command Injection Vulnerability
    • FEHBlog note the CVE references are to the NIST National Vulnerability Database discussed above..
  • The HHS Health Sector Cybersecurity Coordination Center (HC3) posted its “March Vulnerabilities of Interest to the Health Sector.”
    • “In March 2024, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for March are from Ivanti, Microsoft, Google/Android, Apple, Mozilla, Cisco, SAP, VMWare, Adobe, Fortinet, and Atlassian. A vulnerability is given the classification of a zero-day when it is actively exploited with no fix available, or if it is publicly disclosed. HC3 recommends patching all vulnerabilities, with special consideration to the risk management posture of the organization.”

From the ransomware front,

  • TechTarget notes,
    • “Sophos said the majority of cyberattacks it investigated in 2023 involved ransomware, while 90% of all incidents included abuse of remote desktop protocol.
    • “The security vendor published its Active Adversary Report of 2024 Wednesday that drew on data from more than 150 incident response (IR) investigations it conducted in 2023. Breaking down the data set, 88% of the investigations were derived from organizations with fewer than 1,000 employees, while 55% involved companies with 250 employees or fewer. Twenty-six sectors were represented, and manufacturing remained the No. 1 sector to engage the Sophos IR team for the fourth consecutive year.
    • “For the report, Sophos tracked attack types, initial access vectors and root causes, and found that trends have remained consistent for the past two years. While attackers frequently abuse remote desktop protocol (RDPs) and credential access to infiltrate a victim’s network, enterprises continue to leave RDPs exposed and often lack multifactor authentication (MFA) protocols.
    • “Sophos added that enterprises also fell short regarding sufficient log visibility, which can hinder IR investigations.”
  • WIRED reports,
    • “Since Monday [April 8, 2024], RansomHub, a relatively new ransomware group, has posted to its dark-web site that it has 4 terabytes of Change Healthcare’s stolen data, which it threatened to sell to the “highest bidder” if Change Healthcare didn’t pay an unspecified ransom. RansomHub tells WIRED it is not affiliated with AlphV and “can’t say” how much it’s demanding as a ransom payment. * * *
    • “RansomHub initially declined to publish or provide WIRED any sample data from that stolen trove to prove its claim. But on Friday, a representative for the group sent WIRED several screenshots of what appeared to be patient records and a data-sharing contract for United Healthcare, which owns Change Healthcare, and Emdeon, which acquired Change Healthcare in 2014 and later took its name.
    • “While WIRED could not fully confirm RansomHub’s claims, the samples suggest that this second extortion attempt against Change Healthcare may be more than an empty threat. “For anyone doubting that we have the data, and to anyone speculating the criticality and the sensitivity of the data, the images should be enough to show the magnitude and importance of the situation and clear the unrealistic and childish theories,” the RansomHub contact tells WIRED in an email.
    • “We are working with law enforcement and outside experts to investigate claims posted online to understand the extent of potentially impacted data,” Change Healthcare said in an email to WIRED. “Our investigation remains active and ongoing. There is no evidence of any new cyber incident at Change Healthcare.”

From the cybersecurity defenses front,

  • MedCity News discusses four lessons learned from the Change Health cyberattack.
  • According to Dark Reading,
    • The US Cybersecurity and Infrastructure Security Agency (CISA) has given organizations a new resource for analyzing suspicious and potentially malicious files, URLs, and IP addresses by making its Malware Next-Gen Analysis platform available to everyone earlier this week.
    • The question now is how organizations and security researchers will use the platform and what kind of new threat intelligence it will enable beyond what is available via VirusTotal and other malware analysis services.
    • The Malware Next-Gen platform uses dynamic and static analysis tools to analyze submitted samples and determine if they are malicious. It gives organizations a way to obtain timely and actionable information on new malware samples, such as the functionality and actions a string of code can execute on a victim system, CISA said. Such intelligence can be crucial to enterprise security teams for threat hunting and incident response purposes, the agency noted.
  • According to Cybersecurity Dive,
    • “CISOs and other management level cybersecurity executives are gaining more influence and importance as companies have begun to recognize the need for strong cyber governance and oversight, according to a report from Moody’s Ratings. 
    • “About 90% of cybersecurity managers now report to a top level company executive, compared with 62% in 2021. A higher percentage of these cybersecurity executives now report directly to company CEOs, according to the report, which is based on a survey of more than 2,000 organizations around the world that issue debt, including 1,100 in North America. 
    • “The role of the CISO has risen in seniority and visibility within organizations,” Steven Libretti, assistant VP and analyst at Moody’s Ratings, said via email. “This means more direct reporting lines from the cyber manager to the C-suite executives and more frequent cyber briefings to the CEO.”
    • “Moody’s identified a more regular cadence within organizations of CISOs and other cybersecurity managers providing updates to the C-suite and board of directors. About 40% of cyber managers conduct monthly meetings with their CEO, according to the report.” 

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Generative AI, HSA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Washington Post reports,
    • On Thursday, FDA Commissioner Robert Califf appeared before the panel for the first time this Congress, facing a roughly four-hour grilling on a wide range of issues, from the infant formula crisis to tobacco regulation to an abortion pill. 
    • * * * Of note,
      • “The composition of a highly pathogenic strain of bird flu doesn’t appear to be resistant to current treatments already on the market for the flu, Califf said. This comes after a dairy worker in Texas was recently treated for bird flu, which has been identified in dairy cattle for the first time. 
      • “It’s always the case that when you have an actual illness you have to empirically prove that it works,” Califf said. “Fortunately right now, there’s really only one infected human that we know of, so it’s not something that we can test. But it looks good at this point.”
  • House Budget Committee Health Care Task Force (HCTF) Chair Rep. Michael C. Burgess, M.D. (R-TX) wrote an op-ed in the Hill about how to pay for 21st Century medicine.
    • “Medical advances have opened a new world of hope for patients suffering from serious and life-threatening diseases. We need to match our 21st century science with 21st century payment models and offer patients hope without breaking the budget.
    • “My legislation, the Preventive Health Savings Act, offers another new tool to help Congress identify the long-term savings generated by some of these novel therapies and assist in implementing new payment pathways.
    • “We can keep marching forward and saving lives, or we can turn the clock back. Congress needs to address these challenges by anticipating the future instead of wallowing in the past.”
  • Fierce Healthcare adds,
    • Instead of enacting public option plans, states should target reinsurance programs, a new report from the Partnership for America’s Health Care Future argues.
    • The group includes a collection of health plans, hospital groups and pharma companies brought together largely to oppose Medicare for All. This study was authored by three policy experts with the Hoover Institution at Stanford University.
  • OPM could encourage Congress to create a reinsurance pool for gene therapy treatments within FEHBP and PSHBP using the unused portion of the 1% surcharge on FEHB premiums intended to fund OPM’s FEHB / PSHB administrative costs.
  • Assistant Secretary of Labor for Employee Benefit Security Lisa Gomez wrote in her blog about how to unlock the power of prevention in the fight against cancer.
  • The Washington Post points out,
    • “Covid forced the public health field and health-care sector to work toward a shared goal of keeping people from becoming so ill that they overwhelm hospitals. Now, a group of health-care leaders — the Common Health Coalition, which represents physicians, hospitals and insurers — is trying to build upon these collaborations to better prepare localities for future health threats.”
  • Govexec.com informs us,
    • “The Office of Personnel Management issued a final rule Friday that would cull Social Security numbers from any mailed document in an effort to prevent fraud. 
    • “The rule, which was published in the Federal Register, is part of the implementation of the 2017 Social Security Number Fraud Prevention Act and is designed to help protect the identifiers, which can be used in various forms of identity theft. 
    • “The theft and fraudulent use of SSNs can result in significant repercussions for the SSN holder, as well as the entities from which SSNs were stolen,” OPM officials said in the Federal Register notice. “This direct final rule formalizes in regulation OPM’s current practice of safeguarding SSNs in mailed documents and will support efforts to protect individual privacy.”

From the public health and medical research front,

  • The Centers for Disease Control let us know earlier today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, 1 jurisdiction experienced high activity compared to 6 jurisdictions experiencing high activity the previous week. [The outlier jurisdiction is North Dakota.]  No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed influenza are decreasing.  Emergency department visits with COVID-19 and RSV remain stable at low levels.  
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.”
  • The Washington Post offers detailed background on prostate cancer following former NIH Director Francis Collins announced that he has the disease.
  • The Wall Street Journal reports,
    • “The European Union’s drug regulator found no link between the class of medicines behind 
    • “Novo Nordisk’s blockbuster Ozempic and Wegovy treatments and reports of suicidal thoughts in patients.
    • “A study by a European Medicines Agency committee had been looking at potential links between the popular weight-loss and diabetes drugs and reports of suicidal and self-harming thoughts from people using them, but it said Friday that the evidence doesn’t support a causal association.
    • “The U.S. Food and Drug Administration came to the same conclusion in January while British health authorities are carrying out their own review.”
  • Today, the FEHBlog heard an OptumRx speaker at a local conference describe the following demographic characteristics of members of employer sponsored plans who use GLP-1 weight loss drugs.
    • 4 out of 5 are women
    • Average age range is 35-54 with a concentration in the 45 to 54 age range.
    • Average BMI is 35. According to the Cleveland Clinic, “Class III obesity, formerly known as morbid obesity, is a complex chronic disease in which a person has a body mass index (BMI) of 40 or higher or a BMI of 35 or higher and is experiencing obesity-related health conditions.”
  • Bear in mind that most employer sponsored plans do not cover retirees while the FEHBP does. The FEHBlog expects that the speaker provided a useful perspective on GLP-1 use among active employees participating the FEHP. KFF remind us the there are plenty of Medicare beneficiaries using GLP-1 drugs for diabetes.
    • In 2022, Medicare gross total spending reached $5.7 billion on Ozempic (semaglutide), Rybelsus (semaglutide), and Mounjaro (tirzepatide), all of which it covered for diabetes that year, according to just-released Medicare drug spending data [before manufacturer rebates]. That was up from $57 million in 2018. 
  • The Optum speaker also remarked that biosimilar competition caused Abbvie to lower the price of its blockbuster Humira drug by 30% in 2023. He explained that it takes time for biosimilars to gain market share when the brand drug drops its price substantially.
  • Per Fierce Healthcare,
    • “Approximately 40,000 women die of breast cancer in the U.S. each year.
    • “One way of reducing that number is ensuring access to preventive screenings such as mammograms. But health-related social needs can have an impact on a woman’s chance of being up to date with her mammogram. For example, women are less likely to get a mammogram if they feel socially isolated, have lost a job or don’t have reliable transportation, according to a recent Centers for Disease Control and Prevention (CDC) Vital Signs report.”
  • The New York Times provides expert opinions on whether artificial intelligence mammograms are worth the cost.
    • “The Food and Drug Administration has authorized roughly two dozen mammography A.I. products. Some of these are being rolled out to patients in a small number of clinics and tested by other hospitals that want to be certain of the value these tools provide before offering them to patients. 
    • “There is currently no billing code that radiologists can use to charge insurance providers for the technology. That means some centers may punt the cost to patients, charging between $40 to $100 out of pocket for an A.I. analysis. Other hospitals may absorb the cost and offer the additional analysis for free. Still others may keep the technology for research until they are more certain of the value it can provide to patients.
    • “It will take some time for A.I. to become part of routine care, which would lead insurance companies to consider reimbursing their cost. Until then, most patients don’t need A.I. for their mammograms, said Dr. Katerina Dodelzon, a radiologist who specializes in breast imaging at NewYork-Presbyterian/Weill Cornell Medical Center, though it might provide some extra reassurance for those who are particularly anxious about their results.”
  • Medscape tells us,
    • “Early data suggested that several new multicancer early detection (MCED) tests in development show promise for identifying cancers that lack routine screening options.
    • “Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower income countries.
    • “The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. 
    • “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “More than three-fourths of all U.S. doctors are now employed by hospitals, health insurers, private equity or other corporate entities, as rampant consolidation continues to shrink the number of independent physicians, according to new data.
    • “Between 2019 and 2024, more than 44,000 medical practices were acquired, according to the report published Thursday by Avalere Health, commissioned by the Physicians Advocacy Institute. As a result, nearly 60% of medical practices are now owned by corporations.
    • “As of January 2024, physician practice ownership by corporations — including health insurers, pharmacy chains and PE firms — exceeded ownership by hospitals and health systems for the first time, 30.1% to 28.4%. However, hospitals employ more than half of all U.S. physicians, while other corporations employ a little over one-fifth.”
  • MedTech Dive informs us,
    • “Roche has received the Food and Drug Administration’s breakthrough device designation for a blood test to support earlier diagnosis of Alzheimer’s disease, the Swiss drug and diagnostics company said Thursday.
    • “The test, once approved, could help healthcare providers identify whether amyloid pathology, a marker for Alzheimer’s disease, is present or absent in patients.
    • “The Elecsys pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly. * * *
    • “New and emerging Alzheimer’s therapies aimed at slowing cognitive decline in the earlier stages of the disease call for confirmation of amyloid pathology, yet the only methods currently cleared for that task are cerebrospinal fluid (CSF) tests and amyloid positron emission tomography, or PET, scan imaging, according to Roche.”
  • Per BioPharma Dive, while “new postpartum depression drugs are here, diagnosis, treatment hurdles still stand in the way. Two Sage Therapeutics medicines are approved for the condition. But uptake of the first has been minimal, while the launch of the second [which is a pill] is still getting off the ground.”
  • The Employee Benefit Research Institute made available a new paper on high deductible health plans with health savings accounts.
    • “The purpose of this paper is to examine the impact of plan type on use of health care services and spending. The analysis focuses on enrollees in HSA plans and PPO enrollees who are in health plans with deductibles large enough to be HSA eligible as a way of isolating the impact of the HSA on use of health care services.”

Thursday Miscellany

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

From Washington, DC

  • This morning, the Senate Finance Committee held a hearing to “discuss how to update and strengthen Medicare’s guarantee of high-quality health benefits for the next generation of America’s seniors.”
  • Healthcare Dive informs us,
    • “Lawmakers lauded the benefits of telehealth during a hearing Wednesday, but House members also raised questions about cost, quality and access that still need to be answered as a year-end deadline looms.
    • “As a December deadline draws closer, legislators are working to hash out details about extending or making pandemic-era telehealth flexibilities in Medicare permanent. 
    • “During an hours-long House Energy and Commerce subcommittee hearing, lawmakers considered 15 different legislative proposals surrounding telehelath access, noting changes in Medicare will impact decisions of private insurers.
    • “There’s an urgent need to extend these flexibilities because it’s going to run out,” said Rep. Anna Eshoo, D-Calif. “We need to take action on this.” 
  • STAT News adds,
    • “More than a quarter of outpatient antibiotics are inappropriately prescribed, and telehealth could exacerbate the problem: Studies have suggested that virtual visits, on average, result in more antibiotic prescribing than in-person visits. But not all telehealth is created equal — and research is beginning to untangle which approaches are more likely to result in unnecessary antibiotics. In turn, national telehealth guidelines and standards are fighting back by prioritizing safe and effective virtual prescribing practices.
    • “It’s hard to draw conclusions about antibiotic prescribing via telehealth because it comes in so many flavors, said Guillermo Sanchez, a physician assistant and epidemiologist with the office of antibiotic stewardship at the Centers for Disease Control and Prevention. Telemedicine can be provided by direct-to-consumer companies in one-off visits or by large, integrated health systems; via message, phone, or video.
    • “In a recent literature review, Sanchez and his colleagues found studies showing antibiotics were prescribed similarly in virtual and in-person appointments, as well as research that showed higher prescribing in virtual visits — especially for upper respiratory infections that rarely need antibiotics.
    • “But one thing is clear: There’s plenty of room for improvement.”
  • American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention April 11 updated its strategy to improve data exchange with health care organizations and other public health authorities to better detect and monitor public health threats. Among other priorities for 2024-2025, the strategy calls for using the Office of the National Coordinator for Health Information Technology’s Trusted Exchange Framework and Common Agreement to enable faster sharing of data between health care and public health; expanding core data sources to detect and monitor threats, including wastewater, hospitalization and hospital bed capacity; and prioritizing data to address health disparities and promote health equity.”
  • STAT News reports,
    • “Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer has projected — according to a document obtained by STAT.
    • “Medicare’s actuaries expect the drug Leqembi, made by the Japanese drugmaker Eisai and sold in partnership with Biogen, to cost the traditional Medicare program around $550 million in 2024, and the entire Medicare program $3.5 billion in 2025, a spokesperson for the Centers for Medicare and Medicaid Services confirmed to STAT. That projection forecasts a large increase in uptake over the next year and a half.
    • “The estimate was buried in a new CMS document that addressed questions about next year’s payments for Medicare Advantage plans, which cover more than 33 million people and serve as the alternative to the traditional Medicare program.
    • “I think CMS’ estimates demonstrate an incredible demand for Alzheimer’s treatments and possibly suggest broader use than I think was originally conceived,” said Ameet Sarpatwari, an assistant professor of medicine at Harvard Medical School who studies pharmaceutical costs and outcomes. “That raises the question: What are we, as taxpayers, willing to spend on this drug with limited resources?”
  • The U.S. Office of Personnel Management announced,
    • “The U.S. Office of Personnel Management (OPM) issued a final rule today on the Pathways Programs designed to significantly expand opportunities for early career talent in the federal government. The final rule is one of the most significant actions the federal government has taken since the program’s inception 14 years ago. Updates include expanding skills-based hiring through qualifying career programs, raising the ceiling for starting salaries for recent graduates, and easing the path for interns to be converted into permanent positions, including lowering the number of hours required to convert and expanding the time given to agencies to complete such a conversion.  
    • “In addition, OPM will soon release new web-based guidance, an updated Pathways Program Handbook, an updated Pathways Toolkit for federal managers and supervisors, and will host a series of webinars and office hours targeted at HR professionals, hiring managers, educational institutions, and other key stakeholders.”  

From the public health and medical research front,

  • MedPage Today tells us,
    • “The hunt for a signal of excess sudden cardiac deaths among young people after COVID-19 vaccination left Oregon health officials empty-handed, they reported.
    • “Investigators searched death certificates for Oregon residents 16-30 years old who died from cardiac or undetermined causes of death from June 2021 to December 2022 and tried to match these deaths with mandatory statewide records of mRNA COVID vaccination, according to Juventila Liko, MD, and Paul Cieslak, MD, both of the Oregon Health Authority’s Public Health Division in Portland, in the CDC’s Morbidity and Mortality Weekly Report.”
  • The NIH Director in her blog lets us know,
    • “Colorectal cancer is a leading cause of death from cancer in the United States. We know that risk of colorectal cancer goes up with age, certain coexisting health conditions, family history, smoking, alcohol use, and other factors. Researchers are also trying to learn more about what leads colorectal cancer to grow and spread. Now, findings from a new study supported in part by NIH add to evidence that colorectal tumor growth may be driven by a surprising bad actor: a microbe that’s normally found in the mouth.
    • :The findings, reported in Nature, suggest that a subtype of the bacterium Fusobacterium nucleatum has distinct genetic properties that may allow it to withstand acidic conditions in the stomach, infect colorectal tumors, and potentially drive their growth, which may lead to poorer patient outcomes. The discoveries suggest that the microbe could eventually be used as a target for detecting and treating colorectal cancer.”
  • Beckers Hospital Review points out,
    • “The number of ongoing drug shortages in the U.S. is at its highest since 2001 — when the American Society of Health-System Pharmacists began tracking data. There are now 323 medications in low supply. 
    • “The reasons for 3 in 5 shortages are unknown, the ASHP said in a report released April 11. Supply and demand are cited for 14% of shortages, manufacturing problems for 12%, business decisions for 12% and raw material issues for 2%. 
    • “Basic and life-saving products are in short supply, including oxytocin, Rho(D) immune globulin, standard of care chemotherapy, pain and sedation medications and ADHD [attention-deficit/hyperactivity disorder] medications,” the ASHP said. 
    • “The top five drug classes in shortages are central nervous system agents, antimicrobials, hormone agents, chemotherapies, and fluid and electrolyte therapies.” 
  • Mercer Consulting alerts us,
    • “Are you ready for the 75-year plus workforce? That’s the question Dr. Charlotte Yeh from AARP Services Inc. asked our webcast participants when she sat down with Mercer’s Kate Brown to discuss how longevity is changing workforce demographics.
    • “In the last 100 years, the 65+ age group has grown five times faster than the rest of the population. What’s even more surprising are projections that people aged 75+ will constitute the fastest-growing age band in the civilian workforce between now and 2030! As an employer, are you prepared for these changing demographics?
    • “In this conversation, Dr. Yeh debunks common myths about older workers – including their inability to use technology to perform essential job functions. In fact, studies show that age-diverse workforces contribute to increased revenue and profit margins – perhaps not surprising given that people 50 and older, contribute $8.3 trillion dollars to the economy. At the same time, working later in life can provide seniors with purpose and social connections, both essential to health and happiness.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Hospitals and health systems have kicked off the calendar year with a flurry of merger and acquisition deals reflecting several different strategic trends driving providers in 2024.
    • “Twenty transactions were unveiled in the first quarter, marking the highest volume of dealmaking Kaufman Hall’s seen within the sector since 2020, according to a report from the healthcare consulting firm released Thursday.
    • “The deals involved organizations of varying sizes and types, the firm wrote, and appeared motivated by a combination of new and old health system trends — for instance, smaller community systems flocking to larger organizations with stable finances, or portfolio realignments among for-profit and non-profit systems alike.”
  • According to Beckers Hospital Review,
    • “Less than 20% of the nation’s hospitals were recognized for excellent patient safety ratings and the highest level of adherence to federal price transparency rules. 
    • “On April 9, the Health Transformation Alliance, The Leapfrog Group and Turquoise Health honored 472 hospitals across 42 states. Each of the organizations received a Leapfrog “A” safety rating and the highest price transparency score from Turquoise Health. 
    • “We encourage all hospitals to look to these industry leaders in both patient safety and price transparency as a model for how to provide patient-centered, high-quality care,” Robert Andrews, CEO of Health Transformation Alliance, said in a news release. “In following their example and commitment to safety and price transparency, we believe the healthcare industry can collectively strive towards better health outcomes for all.”

From the legal news front,

  • Biopharma Dive reports,
    • “The U.S. Department of Justice on Wednesday accused Regeneron of defrauding Medicare by knowingly inflating the average sales price for its top-selling eye drug Eylea.
    • “In a lawsuit filed in U.S. District Court in Massachusetts, prosecutors alleged Regeneron failed to disclose hundreds of millions of dollars in price concessions given to drug distributors in the form of credit card fee reimbursements. As a result, they said, the average sales price for Eylea, which Medicare uses to set payment to doctors, was higher than it should have been.
    • “Regeneron’s tactics also gave it an unfair competitive advantage over rivals, the Justice Department said. Eye clinics were able to get Regeneron’s drug for the discounted cash price while at the same time reaping the benefits of credit card rewards such as “cash back.” At some practices, doctors took turns using their personal credit cards to buy the drug, the lawsuit said. * * *
    • “In a statement to BioPharma Dive, Regeneron said it believes the allegations are “without merit” and show a “fundamental misunderstanding of drug price reporting standards.” The company added that it will defend itself in court.” 
  • The U.S. Attorney for the Southern District of Florida announced,
    • “On April 10, a substance abuse facility owner was sentenced to four years in federal prison, followed by three years of supervised release, and ordered to pay $4,444,417.65 in restitution, for defrauding the Federal Employees Health Benefits Program (FEHBP) of over $4 million. The sentence comes after the defendant entered a guilty plea in February.
    • “Joseph Toro, 39, of Jupiter, Florida, owned and operated Reawakenings Wellness Center (RWC), a substance abuse facility that treated patients, including FEHBP beneficiaries, from 2013 until January 2018, when RWC was evicted from their location in Miramar, Florida. After the RWC eviction, Toro continued to submit FEHBP insurance claims, using personal identifying information of former RWC patients, for substance abuse treatment that was never provided. To do so, he called the FEHBP hotline, impersonated former patients, and changed their mailing addresses to addresses that he controlled so he could obtain the fraudulent insurance reimbursement checks. For over a year, Toro submitted fraudulent claims on behalf of 29 former RWC patients for over $6.7 million in substance abuse treatment that he knew RWC never provided. As a result of Toro’s fraudulent claims, he obtained nearly $4.2 million in proceeds from the FEHBP. Toro also applied for and obtained a $150,000 Economic Injury Disaster Loan (EIDL) from the U.S. Small Business Administration (SBA) during the COVID-19 pandemic. That application misrepresented that RWC had five employees and grossed over $1.4 million in 2019, when in truth RWC had shut down years prior.”

Midweek Update

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

From Washington, DC

  • Govexec tells us,
  • “The House Oversight and Accountability Committee on Wednesday advanced legislation [HR 7868] aimed at preventing improper payments in the employer-sponsored health insurance program for federal workers, as well as to ensure roughly 1,200 U.S. Customs and Border Protection officers receive the enhanced retirement benefits they were promised. * * *
  • “Rep. Jamie Raskin, D-Md., the committee’s ranking member, sought unsuccessfully to amend the bill to include language that would authorize additional funding go to OPM to cover the cost of the audit, but Committee Chairman James Comer, R-Ky., expressed a willingness to amend the bill before it reaches the House floor authorizing a specific dollar figure, based on analysis from the Congressional Budget Office. The CBO does not “score” legislation until it has advanced out of committee.”
  • A client of the FEHBlog called to his attention today this April 1, 2024, Centers for Medicare and Medicaid Services (CMS) Part D instruction which calmed the FEHBlog’s nerves about the 2025 notice of creditable coverage which FEHB plans must issue:
    • “Creditable Coverage
    • “Consistent with IRA changes, we are revising the regulatory definition of creditable coverage at § 423.56(b) to reflect that discounts paid under the Manufacturer Discount Program are not taken into account when determining actuarial value. Given various concerns raised by commenters and the significant changes to the Part D benefit for CY 2025 as a result of the redesign, CMS will continue to permit use of the creditable coverage simplified determination methodology, without modification to the existing parameters, for CY 2025 for non-EGWP group health plan sponsors not applying for the retiree drug subsidy under section 1860D-22(a) of the Act. The Final Program Instructions also specify that CMS will re-evaluate the continued use of the existing simplified determination methodology or establish a revised one for CY 2026 in future guidance.”
  • The FEHBlog loves simplicity.  
  • Fierce Healthcare informs us,
    • “The Biden administration is proposing a 2.6% increase for inpatient hospitals’ payments for the coming fiscal year, a $3.3 billion increase over the current year’s payout, as well as other policy adjustments intended to shore up surgical care coordination, drug supply, emergency preparedness monitoring, maternal health and care for the underserved.
    • “The potential updates came under Centers for Medicare & Medicaid Services (CMS)’s proposed Inpatient Prospective Payment Systems (IPPS) rule and the Long-Term Care Hospital pay rule, which were unveiled Wednesday afternoon.
    • “Hospitals that participate in the IPPS Quality Reporting Program and meaningfully use electronic records are projected to get a 2.6% increase to payments for fiscal year 2025, which begins in October. The pay raise is based on a projected hospital market basket update of 3%, which is reduced by a projected 0.4 percentage point productivity adjustment, according to a release on the rule.
    • “Long-term care hospitals are looking at a proposed 2.8% pay increase, which is a 1.6% or $41 million bump over the current year. This is “primarily due to the proposed update to the rate partially offset by a projected decrease in high-cost outlier payments in FY 2025 compared to FY 2024,” CMS wrote in a release.”
  • The Washington Post reports,
    • “The Environmental Protection Agency has finalized the nation’s first drinking water standard for “forever chemicals,” a group of persistent human-made chemicals that can pose a health risk to people at even the smallest detectable levels of exposure.
    • “The new rules are part of the Biden administration’s efforts to limit pollution from these per- and polyfluoroalkyl substances, or PFAS, which can persist in the environment for centuries. Exposure to PFAS has been linked to an increased risk of certain types of cancer, low birth weights, high cholesterol, and negative effects on the liver, thyroid and immune system.
    • “EPA officials estimate that the federal rule will reduce PFAS exposure in drinking water for about 100 million people.
    • “This is the first time the EPA has set a drinking water standard for a new contaminant since 1996. Some states — including Maine, Massachusetts, New Jersey and Washington — have already passed drinking water standards for certain PFAS.”
  • Govexec explains employer-sponsored dental benefits for federal employees and annuitants.
  • Reg Jones, writing in Fedweek, discusses “Extended Health Insurance Benefits for Children of Deceased Federal Employees and Retirees.”

From the public health and medical research front,

  • STAT News tells us,
    • “Cancer vaccines have traveled a potholed road over the last decade. But as researchers from different companies and academic institutions presented promising early data at the American Association for Cancer Research annual meeting in San Diego this week, experts said there’s a collective feeling of turning a corner.
    • “There’s a lot more interest in vaccines” now that the technology is improving, said Roy Herbst, chief of medical oncology at Yale Cancer Center.”
  • MedPage Today informs us that “Taking acetaminophen (Tylenol) during pregnancy was not associated with the development of autism or attention deficit-hyperactivity disorder (ADHD) in children, a large Swedish nationwide cohort study found.”
  • The National Institutes of Health informs us,
    • “Researchers at the National Institutes of Health applied artificial intelligence (AI) to a technique that produces high-resolution images of cells in the eye. They report that with AI, imaging is 100 times faster and improves image contrast 3.5-fold. The advance, they say, will provide researchers with a better tool to evaluate age-related macular degeneration (AMD) and other retinal diseases.
    • “Artificial intelligence helps overcome a key limitation of imaging cells in the retina, which is time,” said Johnny Tam, Ph.D., who leads the Clinical and Translational Imaging Section at NIH’s National Eye Institute.”
  • Per a Neurovalens press release,
    • “Modius Stress becomes company’s second product cleared for use in US 
    • “Neurovalens, a global leader in non-invasive neuro-technology, has received medical device clearance from the US Food & Drug Administration (FDA) to treat anxiety with its Modius Stress device.
    • “Based in Belfast, Neurovalens is a health-tech company that specialises in combining neuroscience and technology to tackle a range of global health challenges. 
    • “The company’s medical devices have been designed to deliver non-invasive electrical stimulation to key areas of the brain and nervous system without the need for surgically implanted electrodes. 
    • “Modius Stress is designed to treat anxiety by delivering a small and safe electrical pulse to the head for a period of 30 minutes before bed, during which users can do other activities, such as watching TV or reading.”  
  • Per a Bristol Myers Squibb press release,
    • “Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia. Long-term efficacy data from the trial were presented in a poster titled, “Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F264) at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in Florence, Italy.
    • “We are pleased to see a continued and consistent meaningful reduction in symptoms of schizophrenia across 52-weeks in an outpatient setting, beyond what was seen in the short-term, in-patient five-week trials (EMERGENT-2 and EMERGENT-3),” said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. “We look forward to continued conversations with the FDA and to sharing additional data from the EMERGENT program later this year.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Vertex Pharmaceuticals on Wednesday said it would buy biotechnology company Alpine Immune Sciences and its experimental kidney disease drug for $65 per share, or approximately $4.9 billion in cash.”Vertex Pharmaceuticals on Wednesday said it would buy biotechnology company Alpine Immune Sciences and its experimental kidney disease drug for $65 per share, or approximately $4.9 billion in cash.
    • “Through the deal, which the companies expect to close in the second quarter, Vertex will gain access to povetacicept, a therapy for IgA nephropathy, or IgAN. The drug is set to enter Phase 3 testing by the end of the year. 
    • “The acquisition is the largest in Vertex’s 35-year history and comes as the company works to expand into kidney disease treatment.”
  • Beckers Hospital Review relates,
    • “Three pharmacy benefit managers accounted for nearly 80% of all prescription claims handled in 2023, according to an April 9 report from the Drug Channels Institute.
    • “To compile the list, Drug Channels analyzed estimated total equivalent prescription claims managed across the industry in 2023. CVS Caremark, Express Scripts and OptumRX managed 79% of prescription claims last year, the same percentage as in 2022.” 
  • Beckers Payer Issues lets us know,
    • “AHIP, the American Medical Association and the National Association of ACOs have released a playbook of voluntary best practices for value-based care payment arrangements. 
    • “National Association of ACOs President and CEO Clif Gaus said that in the past decade, value-based care has grown from “almost nothing to an undeniably significant aspect of our health system,” according to a joint April 10 news release from the organizations. 
    • “This iteration of the playbook synthesizes what we’ve learned over the last decade plus, so that payers, physicians, hospitals and ACOs can implement payment and delivery models that improve outcomes and lower costs,” Dr. Gaus said.” 

Tuesday Tidbits

David Ermer–CDC, COVID-19, Cybersecurity, FDA, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital News reports,
    • “Health care leaders and other officials April 9 discussed challenges to rural health care access and potential solutions during an event in Washington, D.C. sponsored by the Coalition to Strengthen America’s Health Care: Protecting 24/7 Care. The AHA is a founding member of the Coalition, which recently rebranded to reflect its renewed focus to protect and strengthen patients’ access to 24/7 care. 
    • “Today’s event hosted by Punchbowl News involved discussions on a range of topics including access, the importance of telehealth, health care innovations and Medicare underpayment, among others. 
    • “You can watch a video of today’s event here. “
  • The Wall Street Journal lets us know,
    • “The U.S. Postal Service said Tuesday it is seeking to raise the price of a stamp by 5 cents, in what would be the fourth increase since the start of 2023. 
    • “The proposed price of 73 cents, up 7.4% from the current price of 68 cents, would still need to be approved by the Postal Regulatory Commission. 
    • “The last increase happened in January 2024, when the cost of a stamp rose from 66 cents to 68 cents. Before that, the agency hiked prices in July 2023 by 3 cents. * * *
    • “The new 5-cent increase would go into effect July 14, the Postal Service said. 
    • “The Postal Service said it also wants to raise prices for other services, including sending a letter outside the U.S., which would cost $1.65, up from $1.55. Mailing a postcard within the U.S. would cost 3 cents more at 56 cents. And sending metered letters, a service used by small businesses, would cost 5 cents more at 69 cents.”
  • MedTech Dive relates,
    • “The Department of Justice filed a consent decree of permanent injunction against Philips on Tuesday in response to the company’s ongoing recall of sleep apnea and respiratory devices.
    • “The settlement would restrict Philips from producing or selling new continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines and other devices in the U.S. until the company meets certain requirements. Philips also faces restrictions on exporting devices that are being provided to patients impacted by the recall “to help ensure remediation of U.S. patients is prioritized over export for commercial distribution.” 
    • “Philips is required to implement a recall remediation plan that the Food and Drug Administration must agree on, including providing patients with new or reworked devices, or a partial refund. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Tuesday statement that the finalization of the decree is a “significant milestone.” 

From the public health and medical research front,

  • KFF notes,
    • “Rates of long COVID have begun to flatten. About 1 in 10 adults with COVID have reported having long COVID since rates fell in 2023, according to a KFF analysis of the latest data from the Centers for Disease Control and Prevention. If the rate continues to hold steady, new forms of prevention or treatment may be important to achieve future reductions in long COVID.
    • “As of March 2024, 7% of all adults (17 million people) reported that they have long COVID. Among the 60% of adults who reported ever having had COVID, roughly 3 in 10 reported having long COVID at some point and about 1 in 10 reported currently having it. The ongoing gap between the two long COVID rates indicates that people are continuing to recover, even as rates stabilize.”
  • US News and World Report informs us,
    • “Measles infections have continued to spread in pockets of the U.S., as the latest nationwide count shows the number of cases have now reached more than 100.
    • “A total of 113 cases have been reported across 17 states as of April 5, according to the most recent figures from the Centers for Disease Control and Prevention, nearly double the total of 58 that for all of 2023.
    • “So far, seven outbreaks have occurred – defined by the CDC as three or more related cases – up from four in 2023. More than 70% of all cases this year have been associated with an outbreak, and approximately half of patients are children under the age of five.
    • “More than 80% of measles infections are among those who are either unvaccinated or with an unknown vaccination status, according to the CDC, while 12% of cases are those who have received only one dose of the measles, mumps and rubella vaccine.
    • “Chicago has had the majority of U.S. cases, with 58 infections as of April 8, according to the most recent figures from the Chicago Department of Public Health.
    • “The majority of measles infections in Chicago have been tied to an outbreak at one of the city’s largest migrant shelters.
    • “In an update released on April 5, CDPH stated measles cases were decreasing in the city, with a total of five new cases reported during the week of March 31 through April 5, compared to 23 infections reported from March 24 through March 30.”
  • The Wall Street Journal reminds us,
    • The fight against dementia actually starts in your 40s.
    • Midlife, not your 70s or 80s, is when brain changes start to occur that can pave the way toward dementia, Alzheimer’s disease and cognitive decline later, according to a growing body of research. 
    • Intervening earlier to improve brain health—and studying the midlife brain more closely—might help people stay sharper in their later years, researchers say. Regular exercise, getting enough sleep and doing activities that keep your brain stimulated are all steps that can help you combat dementia later in life.
    • “Middle age is an opportune time to make lifestyle choices and obtain treatment that will bring an enormous return on investment in old age,” says Terrie Moffitt, a professor of psychology and neuroscience at Duke University.
    • More scientists are looking for clues in the midlife brain because efforts to target dementia in older people have largely failed, says Ahmad Hariri, a professor of psychology and neuroscience also at Duke.
  • Beckers Hospital Review points out,
    • “Surprise pregnancies may be an unexpected side effect experienced by women who use Ozempic or other GLP-1 medications, The Washington Post reported April 5.”Surprise pregnancies may be an unexpected side effect experienced by women who use Ozempic or other GLP-1 medications, The Washington Post reported April 5.
    • “Numerous social media platforms include posts and discussions about unplanned pregnancies while on Ozempic or similar drugs. Although the reports of a possible Ozempic “baby boom” are anecdotal, it is a phenomenon researchers and experts are watching closely. 
    • “Experts speculate that weight loss drugs may impact the absorption of contraceptives, causing birth control failures or that they can affect ovulation and fertility. Others say losing weight can improve chances of pregnancy.”
  • According to Fierce Healthcare,
    • “Supplemental benefits administrator Avesis and Elevance Health subsidiary Amerigroup Georgia have teamed up with Uber Health in a pilot project to tackle the state’s maternal health crisis.
    • “Utilizing community health partners like the Georgia Primary Care Association and federally qualified health centers (FQHCs), hundreds of Amerigroup’s Medicaid members in December 2022 started receiving two individualized nutritional counseling sessions, a scale and $300 of Uber Eats vouchers.
    • “Though the program’s results have not been shared yet, Avesis Senior Manager of Care Transformation Don Trainor said the program has had promising results so far.”
  • The AHA News tells us,
    • “Women with health-related social needs such as food insecurity, housing instability and lack of transportation were less likely to report receiving a mammogram in the past two years when surveyed in 2022, according to a report  released April 9 by the Centers for Disease Control and Prevention. About 66% of women aged 50-74 with at least three health-related social needs were up to date with their mammograms, compared with 83% of women with no health-related social needs. Mammography use also was lower among women without health insurance and a usual source of care.”  

From the U.S. healthcare business front,

  • United Health Group has refreshed its response to the cyberattack against Change Healthcare website.
  • Per Fierce Healthcare,
    • “Artificial intelligence categorization can help stem the flood of patient messages that would otherwise demand physicians’ expensive time, Kaiser Permanente researchers report.
    • “In a recently published JAMA Network Open research letter, members of the system’s research division and medical group outlined a strategy that used real-time natural language processing (NLP) algorithms to attach category labels to messages and then direct them to an appropriate respondent.
    • “The approach, they wrote, allowed 31.9% of the more than 4.7 million patient messages reviewed by program staff to be resolved before reaching the inbox of a specific physician. Instead, these messages were handed by a “regional team” made up of medical assistants or teleservice representatives, pharmacists and other doctors.”
  • and
    • “Consumers expect a simple and easy digital experience, and health plans have plenty of room to improve on that front, according to a new report.
    • “J.D. Power released its inaugural U.S. Health Insurance Experience Study on Tuesday, where it found that 42% of adults with insurance ran into issues using their plan’s website and/or mobile app in the past year.
    • “The study is based on responses from more than 5,500 people enrolled in the 14 largest Medicare Advantage (MA) plans and 15 largest commercial plans. It was conducted alongside Corporate Insight.”
  • Beckers Hospital Review names the “25 drugs at Mark Cuban’s online pharmacy with biggest cost reductions.”

Monday Roundup

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

From Washington, DC

  • The Federal Times tells us,
    • “The federal government again processed a high number of retirement applications last month, even though its overall pace slowed.
    • “In March, the Office of Personnel Management packaged 680 more cases than it did the month before and took in about 850 fewer applications, chopping the backlog by 14%. The rate of processing was slightly slower than in February, but the average case is still being processed in roughly two months or less, which is OPM’s goal, according to the data.”
  • STAT News reports,
    • “For decades, the Food and Drug Administration’s accelerated approval pathway has helped companies get drugs for serious unmet medical needs to patients — and the market — sooner. But about half of cancer drugs approved via this route fail to improve patient survival or quality of life in subsequent clinical trials after more than five years of follow-up, according to new findings presented Sunday at the American Association for Cancer Research annual meeting.
    • “The data come from an analysis of cancer drugs granted accelerated approval over the past decade. In some cases, failure to show clinical benefit didn’t stop the FDA from converting accelerated approvals into full approvals, and the authors note the agency’s conversion decisions have increasingly been based on less stringent evidence of a drug’s benefits.
    • “The study also found evidence that drugs granted accelerated approval, meant to be a temporary designation, are spending less time in limbo. In 2013, it took an average of 9.9 years after accelerated approval for cancer drugs to be pulled from the market if follow-up trials didn’t show a benefit; by 2017, that timing dropped to 3.6 years.
    • “The findings, presented during a press briefing at the AACR meeting, were also published in the Journal of the American Medical Association. The study’s authors say the results aren’t an argument against the use of drugs available via accelerated approval, but underscore the importance of doctors communicating both the potential benefits and uncertainty surrounding these products to patients. They urged drugmakers to more routinely collect quality-of-life data during confirmatory studies, and the FDA to press companies to gather stronger evidence of clinical benefit to support a drug’s full approval.”

From the public health and medical research front,

  • The Washington Post and Consumer Reports explain what to do about jaw pain and when to worry.
  • STAT News lets us know,
    • “Cancer cases among younger people have been rising for years, a trend researchers have struggled to explain. New evidence suggests a significant factor: younger generations seem to be aging faster at the cellular level than their predecessors.
    • “A team of scientists at Washington University in St. Louis tracked data from nearly 150,000 people between the ages of 37 and 54 in the U.K Biobank, a massive biomedical database. They used nine blood-based markers to calculate their biological age, a measure that captures the overall state of a person’s cells and tissues.
    • “Sharing results on Sunday here at the American Association for Cancer Research annual meeting, they found that people born after 1965 were more likely to have a biological age that outpaced their chronological age. People with higher levels of accelerated aging had a 17% increased risk of developing any solid tumor cancer, with higher risk increases for lung, gastrointestinal, and uterine cancer.”
  • and
    • “A controversial heart pump from Abiomed reduced the number of deaths in severe heart attack patients, according to a highly anticipated randomized trial presented at the American College of Cardiology conference and published in the New England Journal of Medicine on Sunday.
    • “The trial, which took 10 years to enroll, followed 355 patients for 180 days in Denmark, Germany, and the United Kingdom who came into the hospital with a heart attack and dangerously low blood flow, known as cardiogenic shock. Half of the patients received standard care, which typically included medication and about 20% of the time included life support, and the other half received Abiomed’s left-sided heart pump, called the Impella, for 48 hours. * * *
    • “Though the Impella pump has been on the market for decades, there has never been a randomized controlled trial proving its benefit. The pump also comes with grave risks, puncturing ventricles or interfering with other heart devices if not properly inserted. Abiomed has been admonished by the Food and Drug Administration for not disclosing these risks to the agency as required under the law. Despite the safety risks and the lack of a randomized trial, the Impella has been widely adopted by interventional cardiologists, becoming a moneymaker for the device maker.
    • Several cardiologists STAT spoke with described Sunday’s results as a “striking” win for a patient population that has few treatment options proven to save lives.
  • and
    • “Novo Nordisk’s Wegovy improved symptoms and physical function in patients who had obesity, diabetes, and a common type of heart failure, boosting Novo’s attempt to get the popular drug approved for yet another usage beyond weight loss.
    • “The study, being presented here on Saturday at the American College of Cardiology conference and published in the New England Journal of Medicine, reports results from the second large trial Novo has conducted on Wegovy in heart failure with preserved ejection fraction, or HFpEF. The first trial, which showed positive results last year, was in patients who had obesity and HFpEF, but not diabetes.
    • “Novo said it submitted the results of these two trials to regulators earlier this year and is seeking approval for a new indication in HFpEF. Wegovy just last month got FDA clearancefor its first usage besides weight loss — preventing cardiovascular complications in people with heart disease.
    • “Wegovy is part of a booming class of diabetes and obesity treatments called GLP-1 drugs that deliver substantial amounts of weight loss, but they’re costly and have been slow to gain widespread insurance coverage. Getting additional indications beyond weight loss could boost drugmakers’ arguments that the drugs are worth their cost and help streamline coverage.”
  • The Wall Street Journal lets us know about “the calming power of rituals. Don’t just tell yourself to calm down: Adopting a routine for stressful moments—as many top athletes and performers do—can measurably reduce your agitation.
    • “A study by researchers at the University of Toronto showed exactly how this works. They taught subjects a physical ritual, then had them complete difficult button-pressing tests designed to induce errors, while monitoring their brain activity. The researchers were able to measure that an electrical response known as error-related negativity, or ERN, was reduced after subjects performed their rituals. In other words, participants were less focused on their mistakes, and that helped them stay closer to the moderate level of arousal ideal for performance under the Yerkes-Dodson law.
    • “No ritual has the power to make rock stars or savants out of us. We still have to contend with the realities of aptitude and proficiency and the discipline of daily practice. But rituals can give us a way to manage our nerves, dial into the skills we’ve worked so hard to achieve and give us that elusive something more that allows us to step into the spotlight and shine.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports
    • “For years now, there has been immense excitement for liquid biopsies—blood tests that can detect cancer early. Eventually, tests like the Galleri developed by Grail could revolutionize the practice of medicine by allowing patients to catch and treat the disease early.
    • “When it comes to colon cancer, though—the second biggest cause of cancer deaths behind lung cancer—blood-based tests have proved disappointing. The latest setback came last week, after privately held Freenome announced top-line results from a clinical study for the early detection of colon cancer among average-risk adults. The results failed to impress investors.  * * *
    • “The key reason Freenome’s results released last week didn’t excite investors is that they indicated the test wasn’t very good at catching precancer signs, which is the main thing doctors are looking for with early screenings. While the clinical study reported an overall 79.2% sensitivity in detecting colorectal cancer, it reported a sensitivity of 12.5% for detecting advanced adenomas, or precancerous polyps. That is far below the 42% sensitivity achieved by Cologuard [, a stool sample test.]”
  • Healthcare IT News discusses Rush Memorial’s virtual intensive care unit.
    • “The virtual ICU has enabled Rush Memorial surgeons to feel comfortable performing more surgeries, knowing there is the clinical expertise to care for those patients in recovery in the ICU.
    • “If you are considering implementing a technology like this to provide needed coverage in your hospital, I highly recommend it,” Tressler advised. “Just be sure you are finding a vendor that has done it before, that has the experience and expertise to help you set it up appropriately, as well as the flexibility to work with your existing workflows.”
  • Per Fierce Healthcare,
    • “Health insurers are gearing up to release their first-quarter results over the next several weeks, and a new analysis from Fitch Ratings finds that ongoing concern about utilization in Medicare Advantage (MA) has made for a cloudy outlook.
    • “The analysts wrote in the insurance dashboard report that payers with a significant presence in the MA space faced elevated medical loss ratios last year amid a spike in care utilization. Others, meanwhile, saw their MLRs decline last year, according to the report.
    • “The significant increase in 4Q23 senior market utilization reported by some companies creates significant uncertainty around profitability for the sector in 2024,” the analysts wrote.
    • “Despite the uncertainty, analysts at Fitch said earlier this year that the spike in utilization would likely be credit-neutral for the industry. In the dashboard report, the authors note that operating earnings before interest, taxes, depreciation and amortization was about 6.8% last year across the seven largest publicly traded insurers.”
    • “That’s a slight decrease from 7% in 2022, according to the report. These seven payers account for about 70% of membership in the U.S., according to the report.”
  • McKinsey & Co. explains how price transparency could affect U.S. healthcare markets.
    • “This article puts price transparency rules in context and explores their implications, including:
      • “the existence of price dispersion in US healthcare that is not explained by differences in quality of care
      • “how price transparency rules address some market inefficiencies driving this price dispersion but leave others unresolved
      • “that patients—if given proper incentives and information—would be interested in shopping for care that amounts to 20 to 25 percent of US healthcare claims spend, potentially unlocking gains in affordability for consumers
      • “the potential for price transparency rules, together with other innovations, such as advances in technology and analytics, to empower patients to shop for care more than ever, helping offset growth in healthcare costs
      • “implications for healthcare industry stakeholders, potential shifts in industry profit pools, and first-mover advantages for organizations that capitalize on this opportunity to improve healthcare for US consumers.”

Weekend Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, SDOH, U.S. Healthcare, Uncategorized–

Today is World Health Day.

  • McKinsey & Co. tells us,
    • “The good news: People are living longer. The bad news: People are spending more time in poor health. Global longevity has risen substantially in the past 60 years, increasing life spans by 20 years on average, but every additional year of life is paid for with an average of six months in ill health. According to a recent report from the McKinsey Health Institute (MHI), a focus on immediately influenceable interventions at the city level can add approximately 20 billion to 25 billion years of higher-quality life at a global level—that’s an average of five additional years per person living in urban areas. All organizations across sectors have a role to play to capture this opportunity, write McKinsey’s Hemant Ahlawat, Erica Hutchins Coe, Pooja Kumar, and Drew Ungerman.”
  • On April 5, 2024, “House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) announced a markup will take place on Wednesday, April 10 at 10:00 am ET to consider a series of legislation,” including
    • H.R. 7868, the FEHB Protection Act: The bill requires federal agencies to verify that an employee is eligible to add a family member to their Federal Employees Health Benefits Program (FEHBP) health coverage plan. This bill also requires the Office of Personnel Management (OPM) to consider coverage of ineligible individuals when conducting FEHBP fraud risk assessments and requires a comprehensive audit be conducted of employee family members currently enrolled in the FEHBP. Finally, the bill requires OPM to disenroll any ineligible individual found to be receiving FEHBP coverage.
  • Congress should be including in H.R. 7868 a provision requiring federal agencies to use the HIPAA 820 electronic enrollment roster transaction which would allow carriers to systematically reconcile individual enrollees with their premium payments. None of the provisions in HR 7868 would provide a greater improvement in internal controls than implementing the HIPAA 820 because half of the FEHB enrollment is self only. Moreover, what is the sense of confirming family member enrollment if the enrollee in question is not paying for family coverage?
  • The current premium reconciliation process known as CLER was implemented in 2001, eleven years before the HIPAA 820 was introduced. The time has long passed for CLER to be replaced by the much more efficient HIPAA 820.

From the FEHB front,

  • FedWeek highlights how FEHB plans coordinate their benefits with other coverage.
  • Tammy Flanagan writing in Govexec discusses the importance of knowing Medicare and FEHB coordination of benefit rules before requesting agency help.
  • In the Federal Times, Reg Jones answers the following question “Will my spouse be covered once I qualify for Medicare Part B?

From the public health and medical research front,

  • The National Institutes of Health announced today,
    • “Adults with heart disease risks who received daily reminders or incentives to become more active increased their daily steps by more than 1,500 after a year, and many were still sticking with their new habit six months later, according to a study supported by the National Institutes of Health that published in Circulation(link is external).
    • “The improvements, which also resulted in an extra 40 minutes of moderate exercise each week, correlated with a 6% reduced risk of premature death and a 10% reduced risk of cardiovascular-related deaths, compared to data from prior studies. The Department of Health and Human Services recommends(link is external) that most adults should get at least 150 minutes of moderate aerobic exercise per week, such as brisk walking, or 75 minutes of vigorous exercise, like fast cycling, or a combination of the two, paired with twice-weekly strength sessions.
    • “Researchers found that while a simple daily reminder was effective in helping people move more, offering financial incentives or point-based rewards, such as in a game, was even more effective. However, combining the two incentives proved most effective. Participants who got both were still logging improvements in activity levels six months after the rewards stopped.
    • “Even moderate exercise can drastically reduce cardiovascular risk, so finding low-cost ways to get people moving and stay in a fitness program that they can do at home is a huge win for public health,” said Alison Brown, Ph.D., R.D., a program officer at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH.”
  • The New York Times offers an interview with Dr. Nora Volkow, the director of the National Institute on Drug Abuse.
    • What’s the big picture on teens and drug use?
      • People don’t really realize that among young people, particularly teenagers, the rate of drug use is at the lowest risk that we have seen in decades. And that’s worth saying, too, for legal alcohol and tobacco.
    • What do you credit for the change?
      • One major factor is education and prevention campaigns. Certainly, the prevention campaign for cigarette smoking has been one of the most effective we’ve ever seen.
      • Some of the policies that were implemented also significantly helped, not just making the legal age for alcohol and tobacco 21 years, but enforcing those laws. Then you stop the progression from drugs that are more accessible, like tobacco and alcohol, to the illicit ones. And teenagers don’t get exposed to advertisements of legal drugs like they did in the past. All of these policies and interventions have had a downstream impact on the use of illicit drugs. * * *
      • “But we don’t want to become complacent. The supply of drugs is more dangerous, leading to an increase in overdose deaths. We’re not exaggerating. I mean, taking one of these drugs can kill you.”
  • Fortune Well explores the non-invasive colorectal cancer screening alternatives to a full blown colonoscopy.
  • The Washington Post reports,
    • “Black and White patients face significant disparities in access to kidney transplants depending on whether their residential neighborhoods and transplant centers were racially segregated, a recent study has found.
    • “The study, published in JAMA Internal Medicine, looked at 162,587 first-time live-donor kidney transplantation candidates in the national transplant registry from January 1995 through December 2021. Participants were tracked for an average of 1.9 years. * * *
    • “Overall, 7.1 percent of Black candidates in segregated neighborhoods received a live kidney transplant over a three-year period, while 9 percent of their Black counterparts in less segregated areas received a transplant. The percentage of White candidates who received similar transplants was similar in highly segregated neighborhoods and more diverse areas during the period — 19.7 percent and 20.1 percent, respectively. * * *
    • “The analysis adds to a growing body of literature about social disparities that affect Black patients’ access to kidney transplantation in the United States. Overall, Black patients are likelier to develop kidney failure than their White counterparts, yet they experience treatment delays and are less likely to get kidneys from live donors.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Four in 10 therapists are planning to raise their fees in 2024, a new survey has found.
    • “Heard, a bookkeeping and accounting firm for therapy practices, surveyed more than 2,260 therapists across all 50 states and D.C. The findings were published in a report on the financial state of private practices. It found that half of therapists are somewhat or very concerned about the economy impacting their practice in the coming year.
    • “At the same time, in last year’s report, 64% of therapists said they were planning to raise their fees in 2023. Yet only a third did.
    • “Despite cash pay popularity, three-quarters of therapists still accept some form of insurance. Aetna was the most common payer with which therapists paneled, followed by Cigna, Blue Cross Blue Shield, Anthem and Oxford. Aetna also had the highest average reimbursement rate at $141 per session, while Humana had the lowest at $96.’ 

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • On April 4, the Cybersecurity and Infrastructure Security Agency (CISA) published its proposed Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) Reporting Requirements rule in the Federal Register. The public comment deadline is June 3, 2024.
  • Cybersecurity Dive summarizes what CISA wants to see in these CIRCIA reports.
  • Cybersecurity Dive reported on April 3,
    • “The state-linked intrusion on Microsoft Exchange Online that led to the theft of about 60,000 U.S. State Department emails last summer “was preventable and should never have occurred”, the Cyber Safety Review Board said Tuesday [April 2] in a report. 
    • “A series of operational and strategic decisions by Microsoft pointed to a corporate culture that deprioritized investments in enterprise security and rigorous risk management, despite the central role the company plays in the larger technology ecosystem, the report said. 
    • “The CSRB urged Microsoft to publicly share its plans to make fundamental, security focused reforms across the company and its suite of products. The board also recommended that all cloud services providers and government partners enact security-focused changes.
  • Cybersecurity Dive added on April 5,
    • “The Cybersecurity and Infrastructure Security Agency is working with Microsoft to investigate and mitigate Midnight Blizzard’s potential impacts on federal agencies. The Russia-linked threat group hacked into senior Microsoft executives’ accounts starting in late November and could pose a larger threat to federal agencies.
    • “As shared in our March 8 blog, as we discover secrets in our exfiltrated email we are working with our customers to help them investigate and mitigate any impacts,” a Microsoft spokesperson said Thursday via email. “This includes working with CISA on an emergency directive to provide guidance to government agencies.”
    • “CISA issued an emergency directive to federal agencies earlier this week on how to mitigate the potential threat from Midnight Blizzard, CyberScoop reported. But the agency has not yet made the directive public. 
    • “CISA officials did not comment on any directive, but confirmed to Cybersecurity Dive it’s working with Microsoft on how to respond to the threat.” 
  • Federal News Network lets us know,
    • “Amid the response to the Change Healthcare ransomware attack, the Department of Health and Human Services is aiming to better organize its healthcare cybersecurity resources and programs.
    • “HHS is creating a  “one-stop shop” for cyber at the department’s Administration for Strategic Preparedness and Response, according to Brian Mazanec, the deputy director for ASPR’s Office of Preparedness. ASPR leads U.S. health and medical preparedness for disasters and other public health emergencies.
    • “We’re really establishing ASPR as that one-stop shop to manage this information sharing across the department, with our partners in industry, with the interagency,” Mazanec said during a March 29 webinar hosted by the HHS-sponsored Regional Disaster Health Response System.”
  • The National Institutes of Standards and Technology announced,
    • “NIST is releasing the initial public draft of Special Publication (SP) 800-61r3 (Revision 3), Incident Response Recommendations and Considerations for Cybersecurity Risk Management: A CSF 2.0 Community Profile, for public comment. This publication seeks to assist organizations with incorporating cybersecurity incident response recommendations and considerations throughout their cybersecurity risk management activities, as described by CSF 2.0. Doing so can help organizations prepare for incident responses, reduce the number and impact of incidents that occur, and improve the efficiency and effectiveness of their incident detection, response, and recovery activities.
    • “The public comment period is open through May 20, 2024. See the publication detailsfor a copy of the draft and instructions for submitting comments.”
  • NIST also issued “a [draft] mapping between the security controls within NIST Special Publication 800-53 Revision 5 and the Cybersecurity Framework version 2.0.”
  • NextGov tells us,
    • “Camille Stewart Gloster, a cyber and technology attorney who has led the White House’s cybersecurity workforce and tech ecosystem strategies since taking up her role in August 2022, will step down Tuesday [April 4].
    • “She told Nextgov/FCW on the sidelines of an International Association of Privacy Professionals event in Washington, D.C. she had no plans as of yet for where she will be heading next.”

From the cyber vulnerabilities and breaches front,

  • HHS’s Health Sector Cybersecurity Coordination Center (HC3) informs us about “Social Engineering Attacks Targeting IT Help Desks in the Health Sector.”
    • “HC3 has recently observed threat actors employing advanced social engineering tactics to target IT help desks in the health sector and gain initial access to target organizations. In general, threat actors continue to evolve their tactics, techniques, and procedures (TTPs) to achieve their goals. HC3 recommends various mitigations outlined in this alert, which involve user awareness training, as well as policies and procedures for increased security for identity verification with help desk requests.”
    • More on this threat can be found on the American Hospital Association news site.
  • On April 4, 2024, CISA added two known exploited vulnerabilities to its catalog.

From the ransomware front,

  • Bleeping Computer’s The Week in Ransomware is back at long last.
  • Cyberscoop reports,
    • “Six weeks after executing an attack that crippled parts of the U.S. health care system, the cybercrime gang linked to the incident has picked up the pace of laundering the proceeds of an alleged ransom payment, even as the hackers implicated in the breach continue to maintain a low profile.  
    • “The ransomware group ALPHV claimed responsibility for the Feb. 21 attack on Change Healthcare, a payment processor that touches 1 in 3 American patient records. The attack on Change limited the ability of pharmacies and health care providers to receive payments and has placed severe strain on the U.S. health care system.
    • “Earlier this month, cybercrime researchers reported that a bitcoin wallet linked to previous ALPHV ransoms had received $22 million, fueling speculation that Change’s parent company, UnitedHealth Group, had ponied up a ransom payment.
    • “Now, ALPHV appears to be moving to further obscure the destination of those funds. 
    • “According to blockchain intelligence firm TRM Labs, funds have recently been moved from bitcoin wallets linked to other ransoms paid to ALPHV, with these funds transferred to multiple other addresses and through a mixer, a tool used to obfuscate transactions that can be tracked on a public ledger. 
    • “Over the last week or so we have seen increased laundering activity,” Ari Redbord, TRM Labs’s global head of policy, told CyberScoop in an email. On March 27, for instance, TRM Labs observed 50 bitcoin — approximately $3.5 million — “move from wallets associated with the group to a mixing service. In addition, between March 22nd & 27th, we saw multiple withdrawals by wallets associated with the ransomware group and sent to a global exchange.”
    • “The FBI declined to comment on the status of its investigation of the incident.” 

From the cyberdefenses front,

  • Cybersecurity Dive relates,
    • “[E[ven as Change [Healthcare] begins to restore its systems, cyberattacks are going to remain a challenge for the industry as healthcare digitizes, creating more potential vulnerabilities for cybercriminals to exploit, experts say. 
    • “The healthcare sector needs to learn from the wide-ranging impacts from the Change attack — and prepare for the next one.
    • “As an industry, there’s been a lot of advancement in cybersecurity, but we’re still pretty far behind where we need to be,” said Steve Cagle, CEO of healthcare cybersecurity firm Clearwater. “We need to face the reality that this is an issue that is here to stay for a long time.”
  • Health IT Security discusses “[h]ow can payers be prepared to manage third-party security incidents. Payers should implement vendor management programs, incident response plans, and training processes to prepare for third-party security incidents.”
  • Security Week points out,
    • “The US National Institute of Standards and Technology (NIST) this week announced  $3.6 million in grants to help address the cybersecurity skills shortage.
    • “As part of the project, 18 education and community organizations across 15 states will be granted roughly $200,000 each to educate future cybersecurity employees.
    • “The agreements will be overseen by NICE, a partnership between organizations in the government, education, and private sectors, which focuses on building cybersecurity workforce through education and training.
    • “The 18 selected organizations will build Regional Alliances and Multistakeholder Partnerships to Stimulate (RAMPS) cybersecurity education and workforce development projects aligned with the needs of local business and nonprofit organizations.”
  • Per Tech Target,
    • “Microsoft officially launched Copilot for Security on Monday [April 1], and while the generative AI tool might bolster security operations, enterprises could face implementation and integration challenges.
    • “The tech giant unveiled Copilot for Security, originally called Security Copilot, in March 2023 to assist security and IT teams with threat detection and response. Following a series of rollout stages for the generative AI (GenAI) tool, Microsoft added a pay-as-you-go pricing model and new capabilities, such as knowledge base integrations and multilanguage support.
    • “Vasu Jakkal, corporate vice president of security, compliance, identity and management at Microsoft, announced the launch in a blog post last month and emphasized that enterprises can use Copilot for Security as a standalone portal or embed the AI tool into existing security products.”
  • HHS’s 405(d) Program now offers a
    • “New Resource: Healthcare Threat Identification Poster!
    • “Cyber hygiene poster highlights threats exist at every level of your organization. Be aware of the threats that face your organization in order to protect PHI.”

Friday Factoids

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Healthcare Dive informs us
    • “The Senate continued to probe the impact of private equity on healthcare delivery this week, launching both an inquiry into PE’s emergency department management practices and holding a subcommittee field hearing on “corporate greed” and PE’s impact on patient care.
    • “The field hearing and request for information come as private equity has increased its investment in healthcare. As of January, more than a quarter of the nation’s rural hospitals and 460 total hospitals in the U.S. were owned by private equity firms, according to a tracker produced by nonprofit watchdog, the Private Equity Stakeholder Project. 
    • “PE-backed physician staffing groups operate nearly one-third of emergency departments across the country, according to letters sent Monday to some of the nation’s largest private equity companies by Sen. Gary Peters, D-Mich., and chair of the Senate’s Homeland Security Committee. * * *
    • “PE firms acquire assets and then seek to sell them for profit, typically within a three- to five-year time frame. The investors may also have limited direct knowledge of healthcare, and the funds are subject to fewer regulations than public companies, according to a 2023 report from the CommonWealth Fund. As a result, the firms tend to have fewer patient-centric guardrails in place compared to traditional healthcare owners and investors.”
  • Fierce Healthcare tells us,
    • “Centers for Medicare & Medicaid Services finalized a host of actions ranging from broker compensation, health equity, mental health, supplemental benefits and biosimiliars, in the Contract Year 2025 Medicare Advantage and Part D final rule Thursday night.
    • “Technical experts and industry execs warned the changes will be consequential for MA plans.
    • “Yesterday’s 2025 Final Rule was one of the more impactful that I can recall in my two-plus decades in the industry,” said Sean Libby, president at BeneLynk. “It is clear that MA plans need a roadmap for health related social needs and health equity.”
    • “It is difficult to put words to the extent and impact of changes codified today,” saidMelissa Newton Smith, senior advisor for Oliver Wyman. “Every MA leadership team needs to be thoughtfully redesigning your stars and quality approach in order to earn quality bonus payments in 2025.”
    • “The primary winners are behavioral health providers, namely Arcadia Healthcare and Universal Health Systems,” said global strategy firm Capstone in a new analysis.
  • Per BioPharma Dive,
    • “The Food and Drug Administration has cleared Bristol Myers Squibb and 2seventy Bio’s multiple myeloma cell therapy for earlier use treating the blood cancer, approving the CAR-T medicine for patients who have previously received at least two previous drug regimens.
    • “The OK comes three weeks after a panel of FDA advisers agreed the benefit of earlier treatment outweighed the risks, including a concern raised by agency reviewers over data indicating an elevated risk of death among treated study participants in the first year of the companies’ main trial.
    • “Overall, trial results showed the CAR-T therapy, Abecma, reduced the risk of disease progression or death by about half, compared to standard regimens. Bristol Myers cited patient crossover from the control arm to treatment as confounding survival data, while the advisory panel noted complications with the “bridging” therapy used prior to CAR-T treatment.”
  • Fierce BioTech lets us know,
    • “As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks, M.D., Ph.D., said the agency is ready to review the shots despite AI-related unknowns.
    • “We are ready to review—we’re open for business,” Marks, director of the FDA’s Center for Biologics Evaluation and Research, said of cancer vaccines at the 2024 World Vaccine Congress (WVC).
    • “We have therapeutic cancer vaccines coming in; I think we would review them very much like we could review potentially a CAR-T cell or other therapeutic products,” Marks said.”
  • Per an FDA press release,
    • “Today, the FDA issued an emergency use authorization (EUA) for CorDx, Inc.’s CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Validation data to support the EUA of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The test can be used for people aged 14 years or older with a self-collected nasal swab specimens and aged 2 years or older when an adult collects the nasal swab specimens.”
  • The Washington Post reports,
    • “A group of public health experts and scientists is calling on the Food and Drug Administration to rescind its controversial approval of a DNA test that promises to predict genetic risk of opioid addiction.
    • “In a letter sent to the agency on Thursday, 31 experts in genetics, addiction, psychiatry and medical-device regulation called the approval of AvertD a mistake that relied on faulty science and puts patients at risk. The group sent a separate letter to the Centers for Medicare and Medicaid Services urging the agency, which oversees government health insurance programs, to deny coverage for the prescription-only test.
    • “The Washington Post last month highlighted concerns about the test’sreliability and the unintended consequences of false results. The letters said a negative test could give patients a false sense of security, or lead doctors to “refrain from prescribing opioids to patients who test positive, even in situations where opioids are beneficial.”
  • MedTech Dive lets us know,
    • “Smiths Medical is recalling more than 2,900 emergency ventilators in the U.S. after receiving reports of a fault linked to eight serious injuries, the Food and Drug Administration said Thursday.
    • “The fault can cause patients to receive the wrong amount of ventilation or too little oxygen, as well as a complete or partial airway obstruction. The FDA categorized the event as a Class I recall because of the risk of serious injury or death.
    • “Smiths Medical, which has faced a series of regulatory actions in recent years, told customers to continue using the Pneupac Parapac Plus 300 and 310 Ventilator Kits but to take precautions.”

From the public health and medical research front,

  • The Centers for Disease Control announced today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains elevated nationally but is decreasing across many areas of the country. This week, 6 jurisdictions experienced high activity compared to 10 jurisdictions experiencing high activity the previous week. No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.   
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.
  • STAT News reports,
    • “The Centers for Disease Control and Prevention urged medical practitioners on Friday to be on the lookout for people who might have contracted H5N1 bird flu from cows. The agency also urged state health departments to rapidly assess any suspected human cases, and recommended that dairy farms with confirmed or suspected outbreaks require workers to use personal protective equipment.
    • “The recommendations were outlined in a health alert network advisory, or HAN in CDC parlance. The advisory is in response to the outbreak of H5N1 avian influenza in at least 16 dairy herds in six states across the country, which has led to at least one human infection so far.
    • “Health care providers should ask themselves “Could this be an H5N1 infection?” if they are faced with a patient with what CDC called a relevant exposure history — for instance, someone who works with dairy cows or lives with someone who works with dairy cows.”
  • Medscape notes,
    • “Cognitive assessments administered via a smartphone app are a reliable and valid way to detect frontotemporal dementia (FTD) in high-risk individuals, new research showed.
    • “Cognitive tests administered remotely on the phone “showed similar findings as our gold standard in-clinic cognitive tests and brain imaging,” study investigator Adam M. Staffaroni, PhD, with the Memory and Aging Center, University of California San Francisco, told Medscape Medical News.
    • “We also provided evidence that these assessments may be useful for detecting early symptoms of the disease at a level that is on par, or perhaps slightly better, than our gold standard in-person tests,” Staffaroni said.
    • “The study was published online on April 1 in JAMA Network Open.

From the U.S. healthcare business front,

  • CNBC reports,
    • “CVS Health on Thursday said its drug plans will cover the first over-the-counter birth control pill in the U.S. at no cost for many health plan sponsors, a decision that could open the door for more people to prevent unintended pregnancies without a prescription. 
    • “The company’s pharmacy benefit manager, CVS Caremark, said the pill will be added to its preventive services oral contraceptives list and will be covered at zero cost for many sponsors. The drug, known as Opill from Perrigo, was available at pharmacies starting April 1, according to a pharmacy update from CVS Caremark dated last week and viewed by CNBC.
    • “Pharmacy benefit managers, or PBMs, maintain lists of drugs covered by health insurance plans and negotiate drug discounts with manufacturers. At most stores, Opill has a retail price of $19.99 for a one-month supply and $49.99 for a three-month supply.” 
    • FEHBlog note — Smart move, CVS Health.
  • The President of the Institute for Clinical and Economic Review comments,
    • “Yesterday Amylyx announced it would remove Relyvrio, a treatment for amyotrophic lateral sclerosis (ALS), from the market. The drug was originally approved in 2022 based on a small phase II trial, well ahead of the conclusion of its phase III trial. The results of that phase III trial were reported last month and unfortunately, the therapy failed to provide any benefit to patients. Historically, a failed trial following FDA approval has not resulted in an automatic revocation of FDA approval or withdrawal of the drug from the market, and post-marketing trial requirements are not consistently used to assess the regulatory status of all approved products. Despite this hole in regulation, Amylyx made the responsible decision to discontinue this drug, and is being rightly lauded for the choice. 
    • “Of course, everyone hopes that treatments approved early with limited evidence will prove effective. But when they don’t, this is how it is supposed to play out: patients get early access to a potentially promising treatment, and then when all the data come in and the benefits fall short, the manufacturer removes the drug from the market. What’s missing from this story though is price: since 2022, the health system paid a steep price for a drug with no proven benefit to patients. When ICER reviewed Relyvrio (prior to FDA approval), we recommended that the manufacturer consider setting the launch price, “close to the cost of production until the benefits of treatment can be adequately evaluated.” Amylyx priced the drug at $158,000 per year, far beyond ICER’s recommended price of $9,100 to $30,700 per year, a price range based on the benefits shown in the small phase II trial. The fact is, that when our health care system allows pricing of treatments far above any reasonable alignment with the benefits they have demonstrated for patients, we do real harm to unseen people in the health care system. Costs increase for everyone without making anyone healthier. And as costs increase, more people forgo care or drop their health insurance all together. 
    • “Even though the story played out as planned this time, the system can be improved to protect all patients and ensure affordability for everyone.”
  • BioPharma Dive relates,
    • “Johnson & Johnson has agreed to acquire Shockwave Medical for approximately $13.1 billion, the companies announced Friday morning. The deal values Shockwave at $335 per share.
    • “J&J said in a statement that Shockwave will expand its “cardiovascular portfolio into two of the highest-growth, innovation-oriented segments of cardiovascular intervention – coronary artery disease and peripheral artery disease.”
    • “Both companies’ boards have approved the transaction, and J&J expects the deal to close in mid-2024.”
  • and
    • “Boehringer Ingelheim is laying off staff in response to sluggish adoption of its Humira biosimilar Cyltezo, a company spokesperson confirmed to BioPharma Dive. Stat first reported the news Thursday.
    • “The German company said it will trim its customer-facing teams in favor of a hybrid in-person and virtual sales model by June 30, but didn’t specify how many jobs are affected. Pharmacy benefit managers, or PBMs, have kept Humira on their coverage lists, resulting in cheaper copycats like Cyltezo falling below their “anticipated potential,” the spokesperson said.
      • “Humira, a blockbuster immune disease drug sold by AbbVie, began facing biosimilar competition in the U.S. last year. Launched in July,Cyltezo is one of more than half a dozen Humira biosimilars now available, but holds an advantage due to its “interchangeable” designation, which allows pharmacists to substitute it for Humira.”
  • Per Healthcare Dive,
    • “Teladoc Health’s long-time chief executive officer Jason Gorevic is leaving the virtual care giant effective immediately, the company said Friday.
    • “Gorevic has been CEO since 2009 and oversaw a period of exponential growth for Teladoc during the COVID-19 telehealth boom. However, he’s departing after the telehealth company struggled to sustain that momentum as the pandemic waned. Teladoc’s stock has sunk significantly since early 2021, and recently hit an eight-year low.
    • “The leadership change is probably coming at the right time, as the company focuses on a longer-term profit growth strategy, Leerink Partners analysts Michael Cherny, Daniel Clark and Ahmed Muhammad wrote in a Friday note.”
  • and
    • “Telehealth company Amwell is in trouble with the New York Stock Exchange for its stock price trading below the minimum standard for listing.
    • “Amwell was a high-flying stock during COVID-19, as the value of telehealth companies soared due to demand for virtually provided medical care. The price of Amwell’s shares peaked at $42.80 in January 2021. However, for the past 30 days, Amwell’s shares have closed at less than $1, sparking a warning notice from the NYSE.
    • “NYSE rules give Amwell six months to regain compliance. In a Thursday release, Amwell said it plans to effect a reverse stock split — when existing shares are consolidated into fewer but more valuable shares, boosting a company’s stock price. Amwell’s board and shareholders will vote on the proposal at an annual meeting later this year.” 
  • In this regard, the FEHBlog heard a health system executive comment at the ABA’s Health Law Section’s Emerging Healthcare Law Issues conference —
    • While the amount of telehealth services has returned a little higher than pre-pandemic 2019 levels, telehealth vendors that hang on will be a lifesaver in the looming physician shortage crisis.