Midweek Update

Cybersecurity

Midweek Update

David Ermer–CMS, Congress, COVID-19, Cybersecurity, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson, R-La., and his top lieutenants on Wednesday morning moved to quell reservations among their conference about the emerging $1.2 trillion-plus final spending package headed for a vote likely on Friday, while their Democratic counterparts did likewise in a separate meeting.
    • “Appropriators were scrambling under a tight timeline to finish drafting the measure, which is taking longer than expected due to a last-minute decision to write a full-year Homeland Security bill. But Johnson told reporters after a GOP conference meeting that text is expected as soon as Wednesday afternoon.
    • “Other sources expected the bill drop to slip to Thursday, with the standard “reading out” of the DHS title, to catch any errors before posting, not even expected to begin until later Wednesday. But no matter: Lawmakers said they expect the chamber to vote as soon as Friday, regardless of a 72-hour review rule. * * *
    • “Final passage wouldn’t come until this weekend at the earliest, and senators are working to accommodate Sen. Susan Collins, R-Maine, who has never missed a vote but will be attending her mother’s funeral on Saturday. That could push votes off until Sunday or Monday, though few are worried at this point about the effects of such a brief funding lapse. 
    • “I don’t think we’ll do a [continuing resolution],” Johnson said.”
  • The American Hospital Association (AHA) News informs us,
    • “The House Energy and Commerce Committee March 20 unanimously passed AHA-supported legislation to reauthorize through 2029 the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 7153), which provides grants to help health care organizations offer behavioral health services for front-line health care workers. The bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. Without congressional action, the law will expire at the end of this year.”
  • and
    • “Congress should address any statutory constraints that prevent the Centers for Medicare & Medicaid Services and Department of Health and Human Services from adequately helping hospitals and other health care providers impacted by the Change Healthcare cyberattack, AHA said a letter submitted to the House Ways and Means Committee for a hearing March 20 with HHS Secretary Xavier Becerra on fiscal year 2025 funding for HHS.”
  • Govexec tells us,
    • “The top senator with direct oversight of the U.S. Postal Service is calling on its leadership to pause its overhaul of the agency’s mailing network due to potential impacts they are having on delivery, rejecting USPS assertions that is has provided transparency. 
    • “USPS should not continue its nationwide operational reforms until it can prove the changes will not negatively impact mail service, Sen. Gary Peters, D-Mich., who chairs the Senate Homeland Security and Governmental Affairs Committee, said in a letter to Postmaster General Louis DeJoy. Agency leadership said in response to the letter it has offered volumes of documents and many staff-level briefings to Congress, though Peters said USPS ignored many of his requests for additional information on its efforts and left Congress uncertain about the fallout that could befall postal customers.”
  • On March 18, 2024, the Office of Management and Budget’s Office of Information and Regulatory Affairs received for final regulatory review an OPM proposed rule with additional requirements and clarifications for the Postal Service Health Benefits Program (RIN 3206-AO59).
  • The AHA News tells us,
    • “U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., and should only use other plastic syringes made in China until they can transition to alternatives, the Food and Drug Administration announced March 19, citing potential quality and performance issues. The recommendations do not apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, FDA said. The agency advises health care providers to confirm the manufacturing location by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization.”
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa M. Gomez, posted on her blog about “Health and Money Smarts for Women.”
  • Fierce Healthcare lets us know,
    • “The Employee Retirement Income Security Act, or ERISA, is turning 50 this year and lawmakers are curious to hear about how the law could be updated to increase coverage affordability and care access.
    • “Payers and providers, it turns out, have very different ideas on where Congress should focus its efforts.
    • “In response to the House Committee on Education and the Workforce’s January request for information, lobbying groups representing both sides of the industry weighed in on the act that outlines federal guidelines for employee benefit plans, including employer-sponsored group health plans.”
    • The article delves into these comments.
  • Newfront offers insights about 2024 RxDC reporting considerations. The reports are due June 1, 2025.
  • The Congressional Budget Office released a presentation about “The Federal Perspective on Coverage of medications to treat obesity. Assuming Congress allows Medicare to cover anti-obesity medications (AOM),
  • “The future price trajectory of AOMs is highly uncertain.
    • “CBO expects semaglutide to be selected for price negotiation by the Secretary of Health and Human Services within the next few years, which would lower its price (and potentially the prices of other drugs in the AOM class).
    • “CBO expects generic competition for semaglutide and tirzepatide to start in earnest in the second decade of a policy allowing Medicare Part D to cover AOMs.
    • “New AOMs are expected to become available. The new drugs might be more effective, have fewer side effects, or be taken less frequently or more easily than current medications. Those improvements could translate to higher prices, on average, even if prices decline for drugs that exist today.”
  • See also the Beckers Hospital Review article below on the next generation of AMOs.
  • Healthcare Dive tells us,
    • “The Medicare Advisory Payment Commission, which advises Congress on Medicare policy, is recommending boosting hospital payment rates by 1.5% in 2025 and base physician payment rates by 1.3% above current law, according to its annual report released Friday. 
    • “MedPAC suggested tying the rate of physician payment increasesmoving forward to the Medicare Economic Index, an annual measure of practice cost inflation. MedPAC suggested payments increase “by the amount specified in current law plus 50% of the projected increase in the MEI.”
    • “Provider groups, including the Medical Group Management Association and American Medical Association, have said the proposed payment increases are inadequate.”

From the public health and medical research front,

  • The Washington Post reports,
    • “More than two-thirds of young children in Chicago could be exposed to lead-contaminated water, according to an estimate by the Johns Hopkins Bloomberg School of Public Health and the Stanford University School of Medicine.
    • “The research, published Monday in the journal JAMA Pediatrics, estimated that 68 percent of children under the age of 6 in Chicago are exposed to lead-contaminated drinking water. Of that group, 19 percent primarily use unfiltered tap water, which was associated with a greater increase in blood lead levels.
    • “The extent of lead contamination of tap water in Chicago is disheartening — it’s not something we should be seeing in 2024,” lead author Benjamin Huynh, assistant professor of environmental health and engineering at the Johns Hopkins Bloomberg School of Public Health, said in a news release.”
  • The Wall Street Journal relates,
    • “Debi Lucas had a tremor in her arm. Her feet froze when she tried to walk and she fell into her coffee table, busting her lip. 
    • “She went to a neurologist who thought she had Parkinson’s disease. Doctors normally diagnose the neurodegenerative condition by symptoms. Lucas, 59, had them. 
    • “But the neurologist, Dr. Jason Crowell, couldn’t be sure. The symptoms might be related to a traumatic brain injury Lucas suffered in a car accident decades earlier, he thought. Or they might be from her medications. 
    • “To find an answer, Crowell turned to a new test: a skin biopsy that can detect an abnormal protein people with Parkinson’s have inside their nerves. He took samples of skin near her ankle, knee and shoulder and sent them to a lab. 
    • “The results confirmed that Lucas has Parkinson’s. The diagnosis was scary, but Lucas finally knew what was causing her symptoms. “I was glad to have a name on it,” she said. 
    • “The test sped her diagnosis, said Crowell, a movement-disorders neurologist at the Norton Neuroscience Institute in Louisville, Ky. “It just gives me more confidence,” he said. 
    • “The skin test is an important part of progress researchers are making against Parkinson’s, the second-most common age-related neurodegenerative condition, which is on the rise and a major driver of disability, dementia and death. The test Lucas received, made by CND Life Sciences, a medical technology company in Scottsdale, Ariz., is one of a few in use or development to allow doctors to diagnose Parkinson’s based on biology rather than symptoms that can take years to appear“.
  • Medscape explains “why a new lung cancer treatment is so promising.”
  • MedPage Today notes,
    • “The FDA has approved aprocitentan (Tryvio), making it the first endothelin receptor antagonist for the treatment of high blood pressure (BP), Idorsia Pharmaceuticals announced on Wednesday.
    • “The once-daily oral medication is indicated in combination with other antihypertensive drugs to lower BP in adult patients who do not have their BP controlled with other therapies.
    • “It is believed that some people may respond better to the drug’s novel mechanism, as aprocitentan is a dual endothelin receptor antagonist that works differently than conventional diuretics, renin-angiotensin-aldosterone system antagonists, calcium channel blockers, and beta-blockers used to lower BP.”
  • Beckers Hospital Review considers the three generations of weight loss drugs.
    • “Anita Courcoulas, MD, defines GLP-1s as “generation one;” dual GLP-1 and GIPs as the second; and a triple threat of GLP-1, GIP and GCGRs as the third generation of weight loss drugs. 
    • “Dr. Courcoulas is chief of Pittsburgh-based UPMC’s minimally invasive bariatric and general surgery program. She told Becker’s the next class of anti-obesity medications are finally reaching weight loss outcomes seen from gastric sleeve and bypass procedures, the two most common surgeries for trimming pounds. * * *
    • “Dr. Courcoulas said the biggest unknown is long-term durability of these medications, a concern other bariatric experts have raised. 
    • “She expects GLP-GIP-GCGR medications to gain approval and enter the U.S. market next year. 
    • “I think it’s very exciting to realize there are medications that are under investigation now that could come to market that could have even better weight loss results than the two drug [classes] we’re seeing now,” Dr. Courcoulas said.”
  • The National Institutes of Health announced,
    • “SARS-CoV-2, the virus that causes COVID-19, can damage the heart even without directly infecting the heart tissue, a National Institutes of Health-supported study has found. The research, published in the journal Circulation, specifically looked at damage to the hearts of people with SARS-CoV2-associated acute respiratory distress syndrome (ARDS), a serious lung condition that can be fatal. But researchers said the findings could have relevance to organs beyond the heart and also to viruses other than SARS-CoV-2.
    • “Scientists have long known that COVID-19 increases the risk of heart attack, stroke, and Long COVID, and prior imaging research has shown that over 50% of people who get COVID-19 experience some inflammation or damage to the heart. What scientists did not know is whether the damage occurs because the virus infects the heart tissue itself, or because of systemic inflammation triggered by the body’s well-known immune response to the virus.
    • “This was a critical question and finding the answer opens up a whole new understanding of the link between this serious lung injury and the kind of inflammation that can lead to cardiovascular complications,” said Michelle Olive, Ph.D., associate director of the Basic and Early Translational Research Program at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH. “The research also suggests that suppressing the inflammation through treatments might help minimize these complications.”
  • and
    • “An investigational gene therapy for a rare neurodegenerative disease that begins in early childhood, known as giant axonal neuropathy (GAN), was well tolerated and showed signs of therapeutic benefit in a clinical trial led by the National Institutes of Health (NIH). Currently, there is no treatment for GAN and the disease is usually fatal by 30 years of age. Fourteen children with GAN, ages 6 to 14 years, were treated with gene transfer therapy at the NIH Clinical Center and then followed for about six years to assess safety. Results of the early-stage clinical trial appear in the New England Journal of Medicine. 
    • “The gene therapy uses a modified virus to deliver functional copies of the defective GAN gene to nerve cells in the body. It is the first time a gene therapy has been administered directly into the spinal fluid, allowing it to target the motor and sensory neurons affected in GAN. At some dose levels, the treatment appeared to slow the rate of motor function decline. The findings also suggest regeneration of sensory nerves may be possible in some patients. The trial results are an early indication that the therapy may have favorable safety and tolerability and could help people with the rapidly progressive disease.
    • “One striking finding in the study was that the sensory nerves, which are affected earliest in GAN, started ‘waking up’ again in some of the patients,” said Carsten G. Bonnemann, M.D., senior author and chief of the Neuromuscular and Neurogenetic Disorders of Childhood Section at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH. “I think it marks the first time it has been shown that a sensory nerve affected in a genetic degenerative disease can actually be rescued with a gene therapy such as this.”
  • Lifesciences Intelligence reports,
    • “Recently, JAMA Network Open published a study analyzing the association between a healthy diet, sleep duration, and type 2 diabetes (T2D) risk. The study data revealed that habitual short sleep duration was linked to an increased probability of T2D by as much as 41%.
    • “Using data on 247,867 individuals from the UK biobank, researchers divided patients into groups based on their sleeping habits. The stratified groups included normal (7–8 hours per night), mildly short (6 hours per night), moderately short (5 hours per night), and extremely short (3–4 hours per night).
    • “Across all study participants, only 3.2% were diagnosed with T2D; however, the adjusted hazard ratios revealed that the prevalence of T2D was higher among shorter sleep groups. More specifically, the increased probability of T2D was identified in those who slept 5 hours or less per night. Those in the moderate short sleep group were 16% more likely to have a T2D diagnosis. Additionally, those in the extremely short sleep group had a 41% greater likelihood of being diagnosed with T2D.”

From the U.S. healthcare business front,

  • BioPharma Dive relates,
    • “Orchard Therapeutics said Wednesday it will offer a new gene therapy to children with a rare, devastating disease at a record-setting wholesale price of $4.25 million. 
    • “The therapy, Lenmeldy, won Food and Drug Administration approval on Monday to treat patients with early-onset metachromatic leukodystrophy, or MLD. The disease, which most often attacks infants between six months and two years of age, robs patients of the ability to walk, talk and function in the world, killing most of its earliest victims within five years of onset.
    • “Lenmeldy’s price tag will leapfrog those of the two most expensive gene therapies available in the U.S. Sarepta Therapeutics sells its Elevidys treatment for Duchenne muscular dystrophy for $3.2 million, while CSL and UniQure’s hemophilia treatment Hemgenix costs $3.5 million.”
  • MedPage Today lets us know,
    • “Despite being a growing percentage of the physician workforce, women physicians continued to be paid less than their male colleagues, a strong body of evidence shows.
    • “While the gender pay gap decreased by 2% from 2021 to 2022 — from 28% to 26% — the gap was still significant, according to online networking service Doximity’s 2023 physician compensation reportopens in a new tab or window.
    • “Women doctors in 2022 earned nearly $110,000 less per year than men physicians, on average, after adjusting for specialty, location, and years of experience. Data from individual states have backed up this figure, too. For instance, in 2022, the Maryland State Medical Society conducted a survey and found that women doctors in Maryland are paid about $100,000 less annually than men.”
  • Beckers Hospital Review lists ten common issues in pharmacies.
  • United Healthcare updated its Change Healthcare cyberattack response website today.
  • HR Daily Advisor explains how companies are exploring the limitations of employee assistance plans amid the country’s mental health crisis.
  • Forbes reports,
    • “Medical diagnosis and procedure codes are so numerous and varied that Debbie Beall, manager of coding at Houston Methodist in Texas, needs a 49-person team to translate the medical notes written by the system’s 1,600 clinicians into the codes needed to bill insurers.
    • “There is a medical code for every imaginable scenario – from “burn due to water-skis on fire” to “spacecraft collision injuring occupant” — and their specificity determines how much the insurance companies pay. Each team member processes anywhere from 70 to 250 claims per day, depending on the complexity, she said. That’s why Beall is so excited about the possibility of using artificial intelligence to speed up the job.
    • “There’s no way I’m ever going to replace coders completely with an AI system,” Beall told Forbes. But for run-of-the-mill procedures performed multiple times a day in a hospital, like X-rays and EKGs? “Yes, an AI engine can do that.”
    • “Beall was one of the first dozen or so people to test a prototype of an AI-powered medical coding tool from electronic health records giant Epic Systems, which had $4.6 billion in revenue in 2022. Based on GPT-4, the large language model that powers the viral chatbot ChatGPT, Epic’s coding assistant prototype ingests and summarizes clinician notes and then tees up the “most likely” diagnosis codes and procedures codes, along with suggestions of “other potential codes,” according to mock ups viewed by Forbes that did not include real patient information. * * *
    • “While Epic has so far focused on using generative AI in back office functions, it has also been working on a patient-facing application that wouldn’t require human review. Krause told Forbes a tool that would help explain the patient’s bill, including their deductible and outstanding balance, could be rolled out by November. “We feel like that’s a fairly benign place to start. It’s not about healthcare at that point, but it’s really about their billing,” he said. “That’s not going to harm a patient in any way.”

   

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy,

  • Cyberscoop reports,
    • “A cyberattack on a payment processor that has crippled large parts of the U.S. health care system is inspiring calls in Washington to urgently implement cybersecurity regulations for the sector, setting up a showdown with hospital and health care groups that are stridently arguing against such a move. 
    • “As these companies have become so large, it is creating a systemic cybersecurity risk,” Sen. Ron Wyden, an Oregon Democrat, said Thursday during a Senate Finance Committee hearing featuring Health and Human Services Secretary Xavier Becerra, whose agency is responsible for overseeing the health care industry’s digital security standards. * * *
    • “The incident has reinvigorated conversations among policymakers in Washington about how to improve the health care sector’s security posture. HHS has proposed a voluntary set of cybersecurity standards and is working to develop mandatory rules, but these are unlikely to come into effect soon. 
    • “Until mandatory rules are in place, industry critics like Wyden want sharper action. “The next step has got to be fines and accountability for negligent CEOs, which will enable HHS to protect patients and our national security,” he said Thursday.”
  • Cybersecurity Dive adds,
    • ‘Ransomware remains a persistent threat, despite law enforcement actions aimed at disrupting the infrastructure threat actors rely on to conduct their attacks, according to the Office of the Director of National Intelligence’s latest annual threat assessment.
    • “Transnational organized criminals involved in ransomware operations are improving their attacks, extorting funds, disrupting critical services and exposing sensitive data,” said the report, which was publicly released Monday. “Important U.S. services and critical infrastructure such as healthcare, schools and manufacturing continue to experience ransomware attacks.”
    • “National intelligence leaders warned that the ransomware problem is worsening and is growing more difficult to combat.”
  • In this regard, the Wall Street Journal considers “Why Are Data Breaches Still Rising If Companies Are So Focused on Cybersecurity.”
    • “Evolving Ransomware Attacks * *. * First, after a slight drop [in 2022], [ransomware] attacks are on the rise again due to the emergence of ransomware gangs that franchise their malware and make it available to budding cybercriminals. This trend is allowing more criminals, even those with minimal computer knowledge, to get into the ransomware game.”
    • “Second, these attacks are becoming more damaging in that many attackers are now stealing their victims’ data, in addition to just locking it up. I refer to this new approach as Ransomware 2.0. The hackers threaten to disclose the private information if they don’t receive a ransom payment. This results in large leaks of corporate and consumer data that didn’t occur before.
    • “Cloud misconfiguration: More companies now store and maintain their corporate data in the cloud via services such as Amazon Web Services, Google Cloud and Microsoft Azure to avoid the expense of having to own and operate their own data centers. This is making the cloud an attractive target for hackers. In fact, 82% of breaches in 2023 involved data stored in the cloud, according to a recent IBM report.
    • “Cybercriminals are taking advantage of the fact that many organizations migrated rapidly to the cloud without fully understanding all of the configuration settings and establishing procedures to keep their data safe. As a result, errors and glitches in these settings are common, and many companies have no idea that their sensitive information is exposed to the public internet until it is too late. Such misconfigurations have become one of the most common security issues when deploying new cloud-based applications.
    • “Exploitation of vendor systems: Almost every company, especially large companies, rely on a network of vendors to provide services ranging from maintaining the air conditioning to updating software packages. These vendors often have special access to the company’s computers, which I refer to as “side doors,” similar to a passkey given to the cleaning crew. 
    • “As large companies have become better prepared to repel cyberattacks, hackers have shifted their attention to vendors, often much smaller companies with limited cyber defense resources and expertise. Attackers exploit those weaknesses to first get into the vendor’s system, then use the vendor’s privileged access to get into the computer systems of every company that uses the vendor.” 

From the cyber vulnerabilities and breaches front,

  • Cybersecurity Dive tells us,
    • “The Cybersecurity and Infrastructure Security Agency was hit by a cyberattack earlier this year after a yet-to-be identified threat actor intruded the agency’s systems by exploiting critical vulnerabilities in Ivanti products.
    • “About a month ago, CISA identified activity indicating the exploitation of vulnerabilities in Ivanti products the agency uses,” a CISA spokesperson told Cybersecurity Dive Friday. Threat actors started widely exploiting a pair of zero-day vulnerabilities in Ivanti Connect Secure and other remote access VPNs in early December.
    • “The impact was limited to two systems, which we immediately took offline. We continue to upgrade and modernize our systems, and there is no operational impact at this time,” the spokesperson said.”
  • It happens to the best of us.
  • SC Media informs us,
    • “StopCrypt, the most common ransomware family of 2023, has a new variant leveraging more advanced evasion tactics.
    • “StopCrypt, also known as STOP/DJVU, surpassed the LockBit ransomware family in detections in 2023, according to Trend Micro’s 2023 Annual Cybersecurity Report published last week. STOP typically targets smaller targets with an average ransom payment size of $619 in the first half of 2023, according to a mid-year report by Chainalysis.
    • “SonicWall reported Tuesday that a new StopCrypt variant employes several evasion tactics in a multi-stage shellcode deployment process, including a long delay loop, dynamic API resolution and process hollowing, or the replacement of code in a legitimate executable to malicious code. * * *
    • “The STOP variant described by SonicWall bears similarities to a variant discovered by PCrisk researchers last year, which was originally submitted through VirusTotal. Similarities include the “.msjd” file extension and the ransom note, including the threat actor’s contact information.”
  • UHC continues to update it Change Healthcare cyberattack response site. The new feature is a “how-to video on the temporary funding process for UnitedHealthcare providers.”

From the cybersecurity defenses front,

  • Healthcare IT News offers an interview with Cliff Steinhauer, director of information security and engagement at the National Cybersecurity Alliance about early lessons learned from the Change Healthcare situation.
  • SC Media offers an expert article on the same topic.
  • Tech Target makes available ten best practices for deploying patches.

Midweek Update

David Ermer–CMS, Cybersecurity, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Federal News Network builds on OPM’s March 12 press release about the Postal Service Health Benefits Program launch in January 2025.
  • STAT News calls attention to healthcare points that you might have missed in the President’s FY 2025 budget. For example,
    • “The budget proposes for the first time a change to the law that would let pharmacists fill prescriptions for brand-name biologics with biosimilars without doctor permission. The measure is part of the administration’s plan to lower drug costs. * * *
    • “Besides budget boosts for behavioral health services, research, and the 988 crisis hotline, the administration is asking Congress for legislative changes to make mental health care more accessible. Those include eliminating Medicare’s 190-day lifetime limit on psychiatric services in hospitals, which it estimates would cost the program $2.9 billion over 10 years. * * *
    • “Medicare would also have to cover three behavioral health visits without cost-sharing, a move that could cost $1.5 billion over a decade. Biden wants to extend this requirement to private insurers as well, at an estimated cost of $428 million over that time.”
  • HealthDay informs us,
    • The White House on Wednesday launched a nationwide call for more training and better access to the lifesaving opioid overdose drug naloxone.
    • Called the Challenge to Save Lives from Overdose, the initiative urges organizations and businesses to commit to train employees on how to use opioid overdose medications, to keep naloxone in emergency kits and to distribute the drug to employees and customers so they might save a life at home, work or in their communities.
    • “Today, we’re calling on organizations and businesses — big and small, public and private — across the country to help ensure all communities are ready to use this lifesaving tool to reduce opioid deaths,” the White House said in a fact sheet announcing the new initiative. “As the drug supply has gotten more dangerous and lethal, we’re asking allies to join us because we all must do our part to keep communities safe.”
  • The CDC is offering free webinars on the RxDC process on March 27 and April 3.

From the Change Healthcare situation front,

  • United Healthcare updated its Change Healthcare situation response website this afternoon.
  • The HHS Office for Civil Rights, which enforces the HIPAA Privacy and Security Rule, issued a Dear Colleague letter about the Change Healthcare situation and announced opening an investigation of UHC about cyberattack and its fallout.
  • The Congressional Research Service posted an insight report titled “The Change Healthcare Cyberattack and Response Considerations for Policymakers.’
  • The American Medical Association explained how providers can navigate the Change Healthcare situation.

From the public health and medical research front,

  • The New York Times reports,
    • “Early detection of colon cancer can prevent a majority of deaths from this disease, possibly as much as 73 percent of them. But just 50 to 75 percent of middle-aged and older adults who should be screened regularly are being tested.
    • “One reason, doctors say, is that the screening methods put many people off.
    • “There are two options for people of average risk: a colonoscopy every 10 years or a fecal test every one to three years, depending on the type of test.
    • “Or, as Dr. Folasade P. May, a gastroenterologist at UCLA Health puts it, “either you take this horrible laxative and then a doctor puts an instrument up your behind, or you have to manipulate your own poop.”
    • “But something much simpler is on the horizon: a blood test. Gastroenterologists say such tests could become part of the routine blood work that doctors order when, for example, a person comes in for an annual physical exam. * * *
    • “A study published on Wednesday in The New England Journal of Medicine found that a blood test searching for such [colon cancer] DNA called Shield and made by the company Guardant Health detected 87 percent of cancers that were at an early and curable stage. The false positive rate was 10 percent.
    • “But there is a caveat to the blood test: While it detects cancers, it misses most large polyps, finding just 13 percent of them. In contrast, the fecal test detects 43 percent and a colonoscopy finds 94 percent, Dr. Carethers said.
    • “While polyps are usually harmless, a few can turn into cancers, so doctors want to find all of them and remove them to prevent cancers from forming.”
  • The Department of Health and Human Services posted a fact sheet on in vitro fertilization across our country.
  • BioPharma Dive tells us,
    • “Merck on Wednesday announced plans to start clinical trials testing a newer version of its vaccine for human papillomavirus, or HPV, as well as a different regimen of the shot it currently sells.
    • “The trials are bids to improve upon vaccines Merck currently markets as Gardasil and Gardasil 9. One will test a shot meant to provide protection against more strains of HPV. The other will evaluate a single-dose regimen of Gardasil 9. Both studies should begin in the fourth quarter of this year. 
    • “Gardasil is approved for use against genital warts and to prevent several cancers caused by stains of HPV. The vaccine is one of Merck’s top-selling products and still growing. It generated $8.9 billion in sales in 2023, up 29% from the previous year.” 
  • STAT News informs us,
    • “For four decades, researchers and companies searched for ways to replace the broken blood-clotting genes that cause hemophilia, a multibillion dollar effort designed to turn a chronic, sometimes debilitating disease into a curable one. 
    • “But the first two gene therapies have so far been met with crickets. Only a handful of patients with hemophilia B, the rarer form of the disease, appear to have been treated worldwide since Hemgenix was approved in November 2022. After Roctavian was approved for hemophilia A last June, only three patients were treated through the rest of the year.
    • “The issue doesn’t appear to be access. Hemgenix and Roctavian, marketed by the Australian biotech CSL Behring and the San Francisco biotech BioMarin, are Malibu-mini-mansion expensive: $3.5 million and $2.9 million, respectively. But current hemophilia treatments can run over $1 million per year. So most insurers have been happy to pay the lump sum.
    • “​​You can’t blame the payers this time,” said Michael Sherman, former chief medical officer of the nonprofit insurer Harvard Pilgrim.” 
  • The National Cancer Institute posted research highlights.
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health (NIH) have discovered that symptoms of attention-deficit/hyperactivity disorder (ADHD) are tied to atypical interactions between the brain’s frontal cortex and information processing centers deep in the brain. The researchers examined more than 10,000 functional brain images of youth with ADHD and published their results in the American Journal of Psychiatry. The study was led by researchers at NIH’s National Institute of Mental Health and National Human Genome Research Institute. * * *
    • “The findings from this study help further our understanding of the brain processes contributing to ADHD symptoms—information that can help inform clinically relevant research and advancements.”
  • The Institute for Clinical and Economic Review published a “Final Evidence Report on Treatments for Paroxysmal Nocturnal Hemoglobinuria. — Independent appraisal committee voted that current evidence is not adequate to demonstrate a net health benefit for iptacopan over C5 inhibitor; committee voted that the evidence is adequate to demonstrate a net health benefit for add-on danicopan compared to C5 inhibitor alone.”
  • Medscape relates,
    • “Chronic smoking remains a major cause of premature mortality on a global scale. Despite intensified efforts to combat this scourge, a quarter of deaths among middle-aged adults in Europe and North America are attributed to it. However, over the past decades, antismoking campaigns have borne fruit, and many smokers have quit before the age of 40 years, enabling some case-control studies.
    • “Among those abstainers who made the right choice, the excess mortality attributable to smoking over a lifetime would be reduced by 90% compared with controls who continued smoking. The estimated benefit is clear, but the analysis lacks nuance. Is smoking cessation beneficial even at older ages? If so, is the effect measurable in terms of magnitude and speed of the effect? An article published online on February 8, 2024, in The New England Journal of Medicine Evidenceprovided some answers to these questions.”

From the HIMSS conference front,

  • Healthcare IT News reports “Samsung focuses on intuitive mobile tech and wearables at HIMSS24. These technologies can help cure healthcare worker burnout, patient confusion and inefficient communications between care teams, says a top exec and nurse.”
  • Forbes explains why AI is taking center stage at the conference.
    • “At the HIMSS conference in Orlando, healthcare leaders, including CIOs, CMIOs, CNIOs, and other C-suite members, were focused on AI as the central theme. They explored how healthcare organizations can better utilize their clinical data. They identified security, AI platforms, and workforce optimization as the three main areas for healthcare AI development.”
  • In related news, Health IT Analytics lets us know,
    • “Researchers from Mount Sinai have been awarded a four-year, $3 million grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) to develop artificial intelligence (AI)-driven prediction models to flag risk of cardiovascular disease events in patients with obstructive sleep apnea.
    • “The American Heart Association (AHA) indicates that obstructive sleep apnea increases patients’ risk of cardiovascular disease, including coronary artery disease, hypertension and stroke. The use of continuous positive airway pressure (CPAP) machines is often prescribed to treat sleep apnea, but evidence to suggest the benefits of CPAP use in relation to cardiovascular event rates is limited.
    • “To bridge this gap, the research team will build machine learning (ML) tools to identify obstructive sleep apnea patients at high risk for atherosclerosis progression and cardiovascular events like stroke and heart attack.”

In other U.S. healthcare business news,

  • The Wall Stree Journal reports,
    • “People seeking a popular new weight-loss drug will have a new home-delivery option from a familiar name: Amazon.com.
    • “Amazon Pharmacy, which has sold prescription medicines online since 2020, will now handle some of the home delivery of anti-obesity therapy Zepbound and other Eli Lilly drugs that are ordered through the drugmaker’s new direct-to-consumer service, the companies said Wednesday.
    • “The service, called LillyDirect, connects patients with telehealth services specializing in obesity that can write prescriptions for Zepbound or another weight-loss drug. The service also arranges for a prescription to be processed and mailed directly to customers.” 
  • The Society for Human Resource Management notes,
    • “According to the latest Employer Costs for Employee Compensation report, released March 13 by the U.S. Bureau of Labor Statistics (BLS), employers spent 3.8 percent more on wages and benefits in December 2023 compared to September 2023.
    • “Total employer compensation costs for private-industry workers averaged $43.11 per hour worked in December 2023. Wages and salaries averaged $30.33 per hour worked and accounted for 70.4 percent of employer costs, while benefit costs averaged $12.77 per hour worked and accounted for the remaining 29.6 percent, according to the BLS report.
    • :That’s a significant jump from the total employer compensation costs for those same workers last fall, and one indicating that despite slowing compensation growth over the past year, bigger hikes are not yet over.”

Tuesday Tidbits

David Ermer–COVID-19, Cybersecurity, Electronic health records, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, OPM, Patient safety, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Because this is the FEHBlog, the lede tonight necessarily is OPM’s announcement naming the carriers who are currently prepared Postal Service Health Benefit Program benefit and rate proposals. Good luck to them all.
  • FedWeek notes,
    • “President Biden has issued an open letter to federal employees thanking them for their “tireless service on behalf of our country.”
  • and
    • “While seeking a January 2025 raise of 2 percent (see related story), the White House’s fiscal 2025 budget proposal cites several initiatives related to federal pay.
    • “In addition to year-to-year pay increases, the Administration is pursuing structural reforms to enhance the competitiveness of the Federal pay system,” it says.
  • Reg Jones, writing in Fedweek, fills us in on benefits available upon the death of a federal employee or annuitant.
  • The Department of Health and Human Services provided a readout from “Biden-Harris Administration Convening with Health Care Community Concerning Cyberattack on Change Healthcare. Leaders from HHS, White House, DOL, and the health care community convened to discuss ways to mitigate harms to patient and providers caused by the cyberattack.”
  • The Food and Drug Administration “advised consumers in Some Medicines and Driving Don’t Mix to make sure they know if their prescription or over-the-counter medication can cause side effects that may make it unsafe to drive. Most medications won’t affect consumers’ ability to drive safely or operate other heavy machinery, but some do.”
  • The Buck consulting firm points out why “maintaining creditable coverage may prove difficult for some employer sponsored plans in 2025.”
  • STAT News discusses the treatment impact of new federal methadone rules.
    • “The federal government is reforming methadone care for the first time in over two decades. But how far do the changes actually go?
    • “To many methadone clinics, the Biden administration’s recent refresh of the rules governing opioid treatment programs represents an unprecedented opportunity to offer care that is more compassionate and responsive to patients’ needs. To many patient advocates, however, it simply nibbles around the edges. 
    • “The reality is likely somewhere in between: It will depend, in large part, on whether state-level regulators embrace the changes, and whether individual clinics actually implement them. In reform-oriented states, and at patient-centered clinics, the new rules could make a world of difference for people seeking addiction treatment.” 
  • The Office of National Coordinator for Healthcare Information Technology, Micky Tripathi, in his blog, looks forward to “HTI-2 & ONC’s Commitment to Furthering the Vision of Better Health Enabled by Data.”

From the public health and medical research front,

  • BioPharma Dive reports,
    • “Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of amyloid protein from the brains of patients enrolled in a small clinical trial, the company said Monday.
    • “A majority of patients receiving the highest dose of the drug, which is specially designed to penetrate brain tissue, saw their amyloid levels drop below detectable levels after 12 weeks, Roche executives said in an investor presentation on the pharmaceutical giant’s neurology pipeline.”
  • Reuters tells us, “Pfizer  said on Tuesday its drug, Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen [in 2023].
  • MedPage Today lets us know,
    • “Pragmatic implementation of an automated online behavioral obesity treatment program that included 9 months of active maintenance helped people with overweight or obesity lose a clinically significant amount of weight by 12 and 24 months, a randomized trial showed. * * *
    • “This pattern persisted at 24 months, reported J. Graham Thomas, PhD, of the Weight Control and Diabetes Research Center in Providence, Rhode Island, and colleagues in JAMA Internal Medicine.
    • “This study shows that a fully automated online obesity treatment program can produce beneficial results for many patients in real-world primary care settings,” Thomas told MedPage Today. “We were encouraged to find that the online weight-loss program performed just as well in real-world primary care practices as it does in our previous highly controlled clinical trials.”
    • “These patients lost weight “at rates comparable” to those seen in studiesopens in a new tab or window in which the researchers were completely hands-on in every aspect of the program, he added.
    • “Because the treatment program is online and fully automated, Thomas said it is quite practical for widespread implementation across primary care practices. “The data show that the primary care clinicians were able to implement the program independently, and patients were able to use it successfully.”
  • Beckers Hospital Review adds,
    • “Hospital transplant departments have strict cutoffs for patients with higher body mass indexes because of the increased risk of complications, but GLP-1s such as Ozempic and Wegovy are helping more patients be eligible for surgery. 
    • “Potential transplant donors and diabetic patients who otherwise would not be able to undergo surgery because of their BMI are now quickly dropping weight. Popular GLP-1s, including Ozempic, and GLP-1s and glucose-dependent insulinotropic polypeptides, such as Mounjaro and Zepbound, are dramatically helping these weight loss efforts.” 
  • Medscape cautions,
    • “Novo Nordisk’s CEO on Friday said the company was working with authorities in several countries to tackle counterfeit versions of its popular diabetes drug Ozempic, as new reports emerge of patient harm across the world.
    • “This is something we take very seriously,” Lars Fruergaard Jorgensen, CEO of the Danish drugmaker, told Reuters. * * *
    • “Jorgensen, echoing comments from the FDA’s Califf, also said compounded semaglutide in the United States was a serious health issue, and that the raw materials, or active pharmaceutical ingredients (API), for these products were coming from unregulated facilities in Asia and elsewhere. 
    • “We don’t know them, and we have really no insights or ability to understand what the API is in a certain compounded product,” he said.
    • “While fake drugs often do not contain any of the medication advertised, compounded drugs are custom-made medicines that are based on the same ingredients as branded drugs. Because Wegovy and Ozempic are in short supply, they can be legally produced by licensed pharmacies in the U.S.
    • “Further reports obtained by Reuters through FOIA requests show that one person died last year from abnormal blood clotting after taking a drug that was advertised as compounded semaglutide. Three others suffered severe vomiting and nausea, sensory loss in their legs, and a drop in blood platelet levels.”
  • The U.S. Census Bureau announced,
    • “An additional 573,000 people died in the United States during the first year of the COVID-19 pandemic but “excess mortality” at the national level masks substantial variations by state, age, sex, and race and ethnicity, according to new U.S. Census Bureau research recently published in Demography.
    • “Excess mortality” refers to deaths from any cause above what is expected from recent mortality trends.
    • “This research shows the pandemic widened the mortality gap between the nation’s Black and White populations and completely erased the mortality advantage of the Hispanic population in relation to the non-Hispanic White population.”
  • The National Institutes of Health announced‘,
    • “Two phase 2 clinical trials to test the safety and effectiveness of three treatments for adults with autonomic nervous system dysfunction from long COVID have begun. The autonomic nervous system acts largely unconsciously and regulates bodily functions, such as heart rate, digestion and respiratory rate. Symptoms associated with autonomic nervous system dysfunction have been among those that patients with long COVID say are most burdensome. The trials are part of the National Institutes of Health’s Researching COVID to Enhance Recovery (RECOVER) Initiative, a nationwide research program to fully understand, diagnose and treat long COVID. Other RECOVER phase 2 clinical trials testing treatments to address viral persistence and neurological symptoms, including cognitive dysfunction (like brain fog), launched in July 2023. * * *
    • “People 18 years of age and older who are interested in learning more about these trials can visit https://trials.RECOVERCovid.org/autonomic or ClinicalTrials.gov and search identifier NCT06305793, NCT06305806 and NCT06305780. Please do not contact the NIH media phone number or email to enroll in these trials.”
  • The Wall Street Journal warns,
    • “Ultra-processed foods may not only affect our bodies, but our brains too.
    • “New research suggests links between ultra-processed foods—such as chips, many cereals and most packaged snacks at the grocery store—and changes in the way we learn, remember and feel. These foods can act like addictive substances, researchers say, and some scientists are proposing a new mental-health condition called “ultra-processed food use disorder.” Diets filled with such foods may raise the risk of mental health and sleep problems. 
    • “The science is still early and researchers say there is a lot they don’t know. Not all ultra-processed foods are equal, some scientists say, adding that some might be good for you. A diet high in ultra-processed foods has been linked with obesity, Type 2 diabetes, cancer and cardiovascular disease, but researchers are still figuring out exactly why, beyond calorie counts and nutrient composition. 
    • “Makers of foods such as processed meats and muffins defend their products, and note that there isn’t a consistent, universally accepted definition of ultra-processed food.”

From the HIMSS Conference in Orlando,

  • HIMSS offers an article about “Google Cloud’s debut of new genAI advancements for healthcare at HIMSS24. In total, the company is offering its cloud clients updates to Vertex AI Search, Healthcare Data Engine and MedLM, designed to improve patient care.”

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Nearly half of U.S. workers don’t have the benefits they need at work, according to the results of a survey by Perceptyx, an employee experience company. Of the 1,500 full-time employees surveyed, 59% said they had “benefits envy” of friends’ and family members’ healthcare coverage.
    • “When it comes to benefits equity, the survey found that medical, maternity and mental health are the “magic trifecta,” Emily Killham, senior director of people analytics, research and insights at Perceptyx, said. “When employees have access to all three, women and men feel equally that their needs are met.”
    • “Yet 53% of those surveyed said they don’t have mental health coverage, 51% don’t have maternity leave, and 25% don’t have any medical benefits, per the results.”
  • Beckers Hospital Review informs us,
    • “Healthgrades recognized 832 hospitals with its 2024 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 79 of those hospitals received both awards. 
    • “The dual recipients spanned 27 states. Texas had the most dual recipients with 13 honorees — including four Baylor Scott and White Health and four Houston Methodist hospitals.”
    • The article lists the dual recipients.
  • Beckers Payer Issues relates,
    • “Selective contracting with primary care physicians may be one factor behind lower per-patient expenses in Medicare Advantage, a study published in the March edition of Health Affairs found. 
    • “The study examined 4,456,037 traditional Medicare patients who visited 151,679 primary care physicians. The physicians who participated in Medicare Advantage networks had $433 lower costs per patient than the regional average of physicians. 
    • “The quality measures for physicians participating in Medicare Advantage were similar to the regional average, the study found. 
    • “Physicians who did not participate in any MA networks cost $1,617 more per patient per year than those participating in MA networks, and they had lower quality measures. 
    • “The findings suggest that “managed care tools, particularly selective contracting with primary care physicians” contribute to lower costs in Medicare Advantage, the authors concluded. Though the differences in cost are most likely attributable to differences in practice style, that could also serve as a mechanism for plans to select healthier patients, the authors wrote.” 
  • Health Payer Intelligence adds,
    • “The average Medicare Advantage premium has remained low and stable, with many beneficiaries choosing plans with a zero-dollar monthly premium, according to data from eHealth, Inc.
    • “eHealth’s seventh annual Medicare Index Report includes data from over 190,000 applications for Medicare insurance products submitted to eHealth during the annual enrollment period for 2024 coverage.
    • “The average monthly premium for Medicare Advantage plans chosen by eHealth customers for 2024 is $9, the same as last year and up slightly from $6 in 2022. The popularity of plans with zero-dollar premiums contributed to the low average.”
  • HealthDay informs us,
    • “The cost to American families of caring for a child with a mental health condition jumped by almost a third between 2017 and 2021.
    • “It now costs an average $4,361 more per year for a U.S. family to care for a child with a mental health condition, compared to families without such children, a new study has found.” 

Weekend Update

David Ermer–CDC, CMS, Congress, Cybersecurity, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • Reuters adds, “U.S. President Joe Biden will put forth his proposed U.S. spending plan [tomorrow] March 11, according to the White House Office of Management and Budget.”
  • Today, the Department of Health and Human Services posted a letter to healthcare leaders about the Change Healthcare cyberattack.
    • We urge insurance companies and other payers to:
      • Make interim payments to impacted providers. Larger payers in particular have the balance sheet stability to advance payments. Payers have the opportunity to stop-gap the cash flow concerns by stepping in with bridge payments [FEHBlog note — assuming that the payer doesn’t rely on Change Healthcare for backend claims processing.}
      • In particular, for Medicaid plans, consider making interim payments to impacted providers.
      • Ease the administrative burden on providers by simplifying electronic data interchange requirements and timelines and by accepting paper claims. 
      • Pause prior authorizations and other utilization management requirements; use all available leeway on deadlines.
  • The Washington Post further reports,
    • “Federal health officials on Saturday said they would offer emergency funding to physicians, physical therapists and other professionals that provide outpatient health care, following a cyberattack that crippled the nation’s largest processor of medical claims and left many organizations in financial distress.
    • “The Centers for Medicare and Medicaid Services also announced that it would make advance payments available to suppliers that bill through Medicare Part B, which serves a wide array of health-care organizations. Officials had previously announced a similar program to make emergency payments available for hospitals that had been ensnared by the Feb. 21 hack of Change Healthcare, a unit of UnitedHealth Group, and have struggled to get paid for more than two weeks. The emergency funds represent upfront payments made to health-care providers and suppliers based on their expected future claims. * * *
    • “It’s going to help significantly,” added Farzad Mostashari, the CEO of Aledade, the nation’s largest network of independent physician practices. Mostashari had previously warned that as many as 25 percent of physician practices were in financial distress.”

From the public health and medical research front,

  • According to the Centers for Disease Control,
    • “Activity Levels Update:
      • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 20 jurisdictions experienced high or very high activity compared to 26 jurisdictions previous week.
      • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
      • “Influenza test positivity remained stable nationally. COVID-19 and RSV test positivity decreased compared to the previous week.
      • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, has decreased to moderate.
    • “Reported on Friday, March 8th, 2024.“
  • Fortune Well offers advices on pregnancy in advance maternal age (at age 35 or older).
  • The Washington Post tells us,
    • “Tai chi, a gentle Chinese martial art involving slow movements, outperformed moderate aerobic exercise in lowering blood pressure in a recent clinical trial.
    • “An analysis, published in JAMA Network Open, tracked 342 18- to 65-year-olds with prehypertension, or blood pressure that is slightly higher than normal, between late July 2019 and mid-January 2022. * * *
    • “These findings support the important public health value of Tai Chi to promote the prevention of cardiovascular disease in populations with prehypertension,” the researchers conclude. Other research continues to explore the potential benefits of tai chi. The exercises are associated with better balance, fall reduction, and benefits for patients with conditions such as arthritis and fibromyalgia.”
  • Bloomberg discusses measles prevention practices for adults born after 1957.
    • “[Katrine Wallace, an epidemiologist at University of Illinois Chicago] says, adults are sufficiently protected from the measles if one of these four things applies to you:
      • “You had measles at some point in your life.
      • “You were born before 1957.
      • “You’ve had two doses of a measles-containing vaccine if you spend time in a high-risk setting for transmission, like schools or hospitals. 
      • Y”ou’ve had one dose of a vaccine if you don’t spend time in high-risk settings. 
      • “Kids and teens need one or two doses for protection depending on their age.” 
    • If you aren’t sure whether you’ve been vaccinated or had the measles, you can get what’s called an MMR titer test, which is available commercially at various labs for about $129, Wallace advises.
  • The Wall Street Journal delves into the development of individual body organ tests.
    • “Measuring organ age is the latest frontier in the world of biological age, the idea that your body’s physical age can be different from its chronological one. For example, a 50-year-old man hypothetically might have physical health that more closely resembles that of a 53-year-old, with, say, a 51-year-old heart and a 54-year-old brain.
    • “Knowing the age of your organs might one day help you prevent and treat disease. In theory, if you knew that your heart was aging too fast, you could take steps to ward off heart disease.
    • “Heart aging predicts future heart disease, and brain aging predicts future dementia,” says Hamilton Oh, one of the paper’s lead authors and a graduate student at Stanford.
    • “Walking into your doctor’s office and getting a simple test to determine your organ age is likely still a ways off, but the concept is gaining interest among researchers, doctors and people focused on their own longevity and health. Scientists caution that more research is needed before such a technology might be ready for mainstream use. Some also say that parts of the recent study made too many assumptions.”

From the U.S. healthcare business front,

  • The Dispatch informs us,
    • “A 2021 study published by the RAND Corporation found that, even after rebates and other discounts, U.S. prescription drug prices were, on average, nearly twice as high as those in countries including Canada, France, Germany, Japan, and the United Kingdom. A 2024 study, also conducted by the RAND Corporation for the Office of the Assistant Secretary for Planning and Evaluation, similarly found that 2022 drug prices in the U.S. were nearly three times higher than those in the 33 Organisation for Economic Co-operation and Development (OECD) countries used in the comparison.
    • “However, the study also found that, on average, unbranded generic drugs were about a third cheaper in the U.S. than in other comparison countries, meaning Americans are actually paying less for these drugs than they would elsewhere. “This finding suggests that robust price competition in U.S. unbranded generic markets continues to drive savings for consumers and health care payers relative to spending on these drugs in other countries,” the study said. Even though generic drugs make up 90 percent of U.S. prescription volume, the substantially higher cost for brand-name drugs still results in a higher average cost for all drugs in the U.S. than elsewhere, according to the report.”
  • HR Dive lets us know,
    • “Judge J. Campbell Barker of the U.S. District Court for the Eastern District of Texas vacated the National Labor Relations Board’s joint employer rule late Friday. The rule was set to go into effect Monday.
    • “The new rule would be “contrary to law” and “arbitrary and capricious,” Barker ruled. The court had been considering a legal challenge brought in November by the U.S. Chamber of Commerce, along with other business groups. 
    • “Federal agencies and employers now await a possible court decision on the U.S. Department of Labor’s independent contractor rule, also set to go in effect Monday.”

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the Change Healthcare situation front,

  • United Healthcare updated its Change Healthcare situation website yesterday. The website details the wide variety of constructive steps that UHC is taking to remedy the situation.
  • Cybersecurity Dive notes,
    • “The devastation caused by the attack against Change are especially pronounced in an industry rife with ransomware attacks. To date, at least five hospital systems with 49 hospitals between them have been impacted by ransomware attacks this year, according to Callow.
    • “AlphV’s involvement is a particularly sour development after a law enforcement action in December shut down the infrastructure of the ransomware group, also known as BlackCat.
    • “Following the takedown, it emerged within hours and remained active, targeting and threatening new victims ever since.
    • “The FBI on Friday [March 1] said it’s aware of the ongoing incident impacting Change and is engaged with the Cybersecurity and Infrastructure Security Agency, the Department of Health and Human Services and other partners who are providing assistance. The agency declined to comment on anything related to AlphV.
    • “AlphV is notorious for the scope of its reach, its high-profile victims, and the nearly $300 million in ransom payments it received as of September. AlphV is the second-most prolific ransomware as a service group in the world, according to the FBI and CISA.
    • “LockBit, another ransomware as a service group that reestablished operations within days of a global law enforcement effort dismantled the group’s infrastructure, remains the most prolific criminal group in the field.”

From the cyber vulnerabilities and breaches front,

  • NextGov reports,
    • “Government facilities were the third largest critical infrastructure sector targeted by ransomware attacks in 2023, according to cybercrime statistics released Wednesday by the FBI.
    • “The agency’s Internet Crime Complaint Center, or IC3, unveiled the findings in its annual report that unpacks complaints, financial losses and other metrics used to determine the severity of cybercrime activities reported to federal authorities.
    • “Of the 1,193 complaints IC3 received from organizations belonging to U.S.-designated critical infrastructure sectors, government facilities came in third place with 156 complaints, while critical manufacturing and healthcare centers took the second and top spots, respectively.
    • “Of the 16 critical infrastructure sectors, IC3 reporting indicated 14 sectors had at least 1 member that fell to a ransomware attack in 2023,” the report adds.
    • “LockBit, ALPHV/BlackCat, Akira, Royal and Black Basta were the top ransomware gangs tied to those critical infrastructure complaints, the report added.”
  • Cybersecurity Dive tells us on March 6,
    • “A new state-linked threat actor has joined the ConnectWise ScreenConnect fray, capitalizing on already rapidly exploited security flaws to deploy malware, Kroll Cyber Threat Intelligence researchers said Tuesday.
    • “The new malware, which Kroll dubbed ToddlerShark, was used during post-compromise threat activity linked to two vulnerabilities in ScreenConnect, including CVE-2024-1709, which has a CVSS score of 10. 
    • “The ToddlerShark malware shares several similarities to BabyShark malware, which Palo Alto Networks researchers previously identified as targeting U.S. national security think tanks. That malware is linked to a group tracked by Kroll researchers as KTA082, but is also known as Kimsuky.”
  • Cyberscoop points out on March 8,
    • “In January, Microsoft disclosed that Russian hackers had breached the company’s systems and managed to read emails belonging to senior executives. Now, the company has revealed that the breach was worse than initially understood and that the Russian hackers accessed Microsoft source code. 
    • “Friday’s revelation — made in a blog post and a filing with the Securities and Exchange Commission — is the latest in a string of breaches affecting the company that have raised major questions in Washington about Microsoft’s security posture. The company’s filing with the SEC describes the incident as ongoing, stating that “the threat actor used and continues to use information it obtained to gain, or attempt to gain, unauthorized access to some of the Company’s source code repositories and internal systems.”
    • “Microsoft has linked the attack to the hacking group it tracks as Midnight Blizzard but is more popularly known as Cozy Bear. The group is believed to be a unit of Russia’s foreign intelligence service SVR and one of the Kremlin’s most capable hacking units.” 
  • Security Week relates on March 7, “Cisco Patches High-Severity Vulnerabilities in VPN Product: High-severity flaws in Cisco Secure Client could lead to code execution and unauthorized remote access VPN sessions.
  • SC Media adds on March 6,
    • “Apple issued two emergency patches (iOS 17.4) for iPhone zero-days on March 5 that the company said in an advisory may have been exploited in the wild.
    • “Security pros said it was a serious issue because nation-state threat actors tend to exploit iOS zero-days to launch spyware attacks on high-risk individuals such as journalists, opposition politicians, and dissidents.”
  • Tech Target discusses the “Top 10 types of information security threats for IT teams.”

From the cybersecurity defense front,

  • CISA and NSA released Cybersecurity Information Sheets on Cloud Security Best Practices on March 7.
  • Forbes explains “Expert Cybersecurity Strategies For Protecting Remote Businesses.”
  • Tech Republic adds,
    • A new White House report focuses on securing computing at the root of cyber attacks — in this case, reducing the attack surface with memory-safe programming languages like Python, Java and C# and promoting the creation of standardized measurements for software security.
    • The report urges tech professionals to:
      • Implement memory-safe programming languages.
      • Develop and support new metrics for measuring hardware security.
      • This report, titled Back to the Building Blocks: A Path Toward Secure and Measurable Software, is meant to convey to IT pros and business leaders some of the U.S. government’s priorities when it comes to securing hardware and software at the design phase. The report is a call to suggested action, with advice and loose guidelines.
    • “Even if every known vulnerability were to be fixed, the prevalence of undiscovered vulnerabilities across the software ecosystem would still present additional risk,” the report states. “A proactive approach that focuses on eliminating entire classes of vulnerabilities reduces the potential attack surface and results in more reliable code, less downtime and more predictable systems.”

From the cybersecurity policy front,

  • Cyberscoop reports,
    • “Cybersecurity professionals can expect fresh reading materials in the coming months from the Office of the National Cyber Director, which aims to issue an update to the national cybersecurity strategy implementation plan before the summer is over, a White House cyber official said Tuesday.
    • “The implementation plan outlines how the White House will accomplish the goals outlined in the national cybersecurity plan and is supposed to be a “living document”that is updated as initiatives are complete or new initiatives are added. The implementation plan 2.0 is expected “late spring, early summer,” said Brian Scott, deputy assistant national cyber director for cyber policy and programs.
    • “Speaking at the ICS-focused security conference S4x24 in Miami, Scott also noted that cybersecurity pros can expect an update on software liability reform in the next implementation plan release, and the Biden administration is currently looking at developing a framework around software liability. The White House is also convening a symposium of law professors at the end of March around the issue, he said.
    • “The administration is committed to working with Congress to develop legislative action to incentivize development of software with more secure code,” Scott said.”
  • Per Dark Reading, “The US National Security Agency (NSA) delivered its guidelines for zero-trust network security this week, offering a more concrete roadmap towards zero-trust adoption. It’s an important effort to try to bridge the gap between desire for and implementation of the concept.”
  • NextGov calls attention to the fact that
    • “Two years after the White House teased an executive order on identity theft in public benefits during the 2022 State of the Union, such an order hasn’t materialized, leaving stakeholders frustrated at the lack of action to address vulnerabilities and prevent fraudsters from siphoning off government money.
    • “We continue to work in this area very rigorously across government,” Clare Martorana, the federal chief information officer, told Nextgov/FCW at an event this week when asked about the state of the executive order. “This is top of mind for all of us. We want to make sure that we accelerate people’s use of digital [to access government], but safely, securely.”
  • Security Week reports on March 8,
    • “The US cybersecurity agency CISA has laid out key actions for securing open source software (OSS) following a two-day OSS security summit where it has convened with community leaders.
    • “Steps that CISA will take in partnership with the community include promoting the Principles for Package Repository Security, a framework outlining security maturity levels for package repositories and a new effort to enable collaboration and information sharing with open source software infrastructure operators.
    • “Furthermore, CISA will publish materials from the summit’s tabletop exercise, so that the open source community can use the lessons learned to improve vulnerability and incident response.”
  • A client told me that he is very impressed by the security features of Windows 11 professional. This Journal of Accountancy article explains that Windows 11 includes a new Microsoft AI feature co-pilot to help office workers navigate Microsoft Office products.
    • “For example, you can tell Copilot to create a PowerPoint presentation based on some information you provide. Copilot can also create emails and email replies. Do you have that colleague who sends five emails pertaining to the same subject? You can ask Copilot to summarize all emails from that person.
    • “Copilot also can help you prepare for a meeting. Or if you join a Teams meeting late, Copilot will generate a summary of what you missed.
    • “Copilot can create budget proposals, project timelines, agendas, SWOT analyses, etc. And because it can answer questions and understand commands using natural language processing, you don’t need to know how to write computer code to use it.”
  • Cool.

Thursday Miscellany

David Ermer–Cybersecurity, HSA, Medical / Rx research, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Congressional Budget Office posted a presentation about “CBO’s Approach to Estimating the Budgetary Effects of the No Surprises Act of 2021.”
    • “This presentation describes CBO’s approach to estimating the budgetary effects of the No Surprises Act. The stated aim of the No Surprises Act was to protect patients from surprise billing. The law:
    • “Established protections for patients receiving out-of-network care,
    • “Established an arbitration process for resolving payment disputes, and
    • “Directed arbiters to consider the qualifying payment amount, defined as the median in-network rate, as the benchmark for payment (with other factors).
    • “CBO projected that reductions in prices paid to providers would reduce insurers’ costs, in turn reducing premiums by roughly 1 percent and reducing federal deficits from 2021 to 2030 by a total of $17 billion.”
  • The Internal Revenue Service warned consumers to “Beware of companies misrepresenting nutrition, wellness and general health expenses as medical care for FSAs, HSAs, HRAs and MSAs.”
  • Fedweek tells us,
    • “In a series of recent reports, the OPM inspector general’s office said it has identified misspending in the FEHB program, which adds to the cost of premiums both for the enrollees and the government, but that legal barriers prevent the program from recouping some of that amount.
    • “A report covering the last three months of 2023 is typical in noting that the FEHB program is precluded from pursuing cases under the Anti-Kickback Statute, which makes it illegal for health care providers to knowingly and willfully accept bribes or other forms of remuneration in return for activities such as patient referrals.”
  • Query me this. How can there be misspending when Congress decided in 1996 not to apply this law to the FEHBP because it is operated by commercial entities? It’s sour grapes.
  • Federal News Network informs us,
    • The Office of Personnel Management’s retirement backlog made huge improvements in claims processed for February reaching 10,025, the highest number since April 2023. OPM received  8,794 claims in February and managed to process more than 3,000 claims compared to January.
    • After seeing a large increase in the inventory backlog in January, OPM made small improvements shrinking the backlog by 1,231  to a total of 19,591 claims in February. With a slight decrease in the backlog, OPM is still over 6,000 claims above the steady goal of 13,000.
    • OPM also saw improvements for the average processing time for February,  reaching 47 days, setting a new record.

From the public health and medical research front,

  • STAT News reports good news,
    • “A new monoclonal antibody product to protect against respiratory syncytial virus was 90% effective at preventing little children from being hospitalized with RSV, according to new data from the first season it was in use.
    • “The data, published Thursday in Morbidity and Mortality Weekly Report, a Centers for Disease Control and Prevention publication, looked at how well Beyfortus worked in the children whose parents managed to secure a scarce dose of the drug. These are the first real-world data showing how effective the product was in the United States.
    • “It’s basically really good news,” said Sean O’Leary, a professor of pediatrics at the University of Colorado School of Medicine and a pediatric infectious diseases specialist at Children’s Hospital Colorado. “In some clinical trials we see some level of effectiveness … but then when it’s rolled out in the real world, for any number of potential reasons, things don’t work out as well as they had in the clinical trials.”
    • “In this case, it’s great. The point estimate they came up with is even better than in the clinical trials,” said O’Leary, who was not involved in the study.
    • “AstraZeneca and Sanofi jointly developed Beyfortus, which is sold in the U.S. by Sanofi.”
  • and
    • “A pill being developed by Danish drugmaker Novo Nordisk may lead to greater weight loss than the obesity therapy Wegovy, the company reported Thursday, citing early data.
    • “In a Phase 1 trial, participants experienced an average of 13.1% weight loss after 12 weeks of taking the experimental oral medicine amycretin, according to data presented at an investor meeting. In comparison, in an earlier Phase 3 trial of the injectable drug Wegovy, people taking Wegovy lost about 6% of their body weight over the same time period. * * *
    • “Novo Nordisk isn’t the only pharma company working on a pill. An experimental pill being developed by Eli Lilly led to 14.7% weight loss in a 36-week, Phase 2 trial. Pfizer had been developing an oral medication, as well, but opted to shut down that product’s developmentdue to disappointing trial results.
    • “Many other companies are also testing oral obesity drugs, according to the STAT Obesity Drug Tracker.”

From the U.S. healthcare business front,

  • Beckers Hospital Review considers why healthcare cyberattacks last so long.
    • “The cyberattack on Change Healthcare that has caused disruptions across a wide swath of the industry has entered its third week. But why do these IT outages last so long?
    • “It’s a combination of ensuring that the hackers are no longer in the system and securing the vulnerability that allowed them to breach it in the first place, according to John Riggi, national advisor for cybersecurity and risk at the American Hospital Association.
    • “The victim must figure out how the bad guys broke into their network, where they are, throw them out and then seal that technical ‘hole,'” Mr. Riggi told Becker’s. * * *
    • “But Mr. Riggi, who spent more than two decades at the FBI, said it could take even longer to fully recover. “These disruptions could linger for several months or a year, and legacy systems that may not have been backed up or destroyed during the attack may become totally unrecoverable,” he said.”
  • United Healthcare offers a March 7 update on its Change Healthcare cyber response website.
  • Beckers Hospital Review also names ten drugs poised to be best seller this year and discusses “Newsweek‘s 2024 “America’s Greatest Workplaces for Women” ranking, which includes hospitals and health systems.”
  • Business Insurance reports,
    • While inflation in the general economy has slowed since 2022, workers compensation payment growth is still at levels higher than in 2020, experts with the Workers Compensation Research Institute said Tuesday.
    • Changes in medical care utilization and mix of services continue to affect workers comp pricing, and the recent trend of health care labor shortages, especially in nursing, is also contributing to higher costs, panelists said during a session at the 2024 WCRI Issues & Research Conference.
  • The Hill relates,
    • Drugmaker Boehringer Ingelheim plans to cap the out-of-pocket costs for all its inhalers at $35 per month after coming under fire from Democratic lawmakers over pricing. 
    • The company announced Thursday that the program will start June 1. It’s aimed at patients with employer-sponsored insurance, and those who are underinsured and uninsured, meaning they likely have to pay cash. 

Monday Roundup

David Ermer–CDC, Congress, COVID-19 testing, Cybersecurity, FDA, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • American Hospital Association (“AHA”) News tells us
    • The House and Senate Appropriations Committees March 3 released a package of six appropriations bills that would fund certain federal agencies through fiscal year 2024 and contains certain health care provisions of interest to hospitals. The House is expected to consider the legislation by March 6 and the Senate later this week.  
    • The health care provisions would eliminate Medicaid disproportionate share hospital cuts for FY 2024 and delay FY 2025 DSH cuts to Jan. 1, 2025; extend the Medicare-dependent hospital and enhanced low-volume hospital programs through December 2024; reduce a 3.34% physician payment cut that began Jan. 1; and extend the Community Health Centers, National Health Service Corps, and Teaching Health Centers Graduate Medical Education programs through December.
  • Govexec points out the eight biggest agency and program reforms in this package.
  • STAT News informs us that a “small group of policymakers and business people” spoke out against the three big prescription benefit manager at today’s White House listening session.
    • “The big three [pharmacy benefit managers] are everything wrong with this industry,” said Mark Cuban, who co-founded the Cost Plus Drug Company and is trying to cut out the middlemen with a website that sells mostly generic medicines directly to consumers. As part of the effort, his company is also working with smaller pharmacy benefit managers that do not rely on fees in hopes of appealing to employers.
    • “Along with Cuban, the session also featured remarks from Kentucky Gov. Andy Beshear who, as the state’s attorney general, investigated pharmacy benefit managers; Federal Trade Commission Chair Lina Khan, who is currently probing these companies; and Sandra Clarke, executive vice president and chief operating officer at Blue Shield of California, which is pursuing a new pharmacy model.”
  • The FEHBlog does not understand why the White House does not also listen to the PBMs and their supporters. Perhaps that will be the next listening session.
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced today that all manufacturers participating in the first cycle of Medicare drug price negotiations have responded with counteroffers. This news comes after HHS sent initial offers on February 1, as the agency was empowered to do by President Biden’s lower cost prescription drug law, the Inflation Reduction Act. This law is a cornerstone of the Biden-Harris Administration’s efforts to lower prescription drug costs. * * *
    • “The recently launched website LowerDrugCosts.gov is a resource to help people with Medicare understand how the Inflation Reduction Act may help lower their out-of-pocket drug costs. As part of that effort, today, HHS added 50 state-by-state infographics plus DC and Puerto Rico that are accessible on LowerDrugCosts.gov by clicking on the interactive map. These new, plain language infographics are meant to assist with continuing education and outreach on the new benefits made available through the Inflation Reduction Act.”
  • Beckers Hospital Review reports,
    • “PatientRightsAdvocate.org report from Feb. 29 found that just 689 (34.5%) of 2,000 hospitals it examined were fully compliant with federal price transparency rules. 
    • “That is down from 721 (36%) that were found to be fully compliant from the organization’s last report, released in July.” 

From the Food and Drug Administration (FDA) front,

  • The AHA News relates,
    • “The Food and Drug Administration recently granted emergency use authorization for the first over-the-counter home antigen test to detect both flu and COVID-19. The OSOM Flu SARS-CoV-2 Combo Home Test is authorized for use to detect and differentiate influenza A and B and SARS-CoV-2 in nasal swab specimens from people aged 14 and older when conducted at least twice over three days with at least 48 hours between tests. 
    • “In other news, the FDA last week recommended health care providers monitor patients with the Hintermann Series H3 Total Ankle Replacement system for potential device failure, and patients with certain implantable BioZorb breast tissue markers for potential serious complications.” 
  • eMPR notes,
    • “The Food and Drug Administration (FDA) has approved Rybrevant (amivantamab-vmjw) in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.”

From the public health and medical research front,

  • The New York Times reports,
    • “Alcohol-related liver disease is the leading cause of death from excessive drinking — and while it’s curable in the earliest stages, many people don’t realize they have it until it’s too late to reverse.
    • “Annual deaths caused by the disease are on the rise in the United States, having climbed 39 percent in recent years, according to new data from the Centers for Disease Control and Prevention. Death rates are highest in men and adults aged 50 to 64, though they are increasing more quickly among women and younger adults.
    • “People who are drinking are drinking more heavily than they were before, so I think that is the biggest factor,” said Dr. Jessica Mellinger, an assistant professor of gastroenterology and hepatology at the University of Michigan Medical School. And, she added, “we’re seeing that for the first time in this country, women are drinking as much as men.”
  • The American Medical Association tells us what doctors wish their patients knew about nutrition, which encourages patients to limit alcoholic beverage intake.
  • STAT News lets us know,
    • “Having Covid-19 increases a person’s risk of developing an autoimmune disease in the year after infection, a large study out of South Korea and Japan reports, but vaccination helps decrease that risk.
    • “Researchers used the medical records of 10 million Korean and 12 million Japanese adults to see whether those who had Covid were more likely to be diagnosed with autoimmune inflammatory rheumatic diseases, or AIRDs, in the year following infection. AIRDs include rheumatoid arthritis, systemic lupus erythematosus, Sjögren syndrome, mixed connective tissue disease, vasculitis, and other conditions. The Covid group was compared with an uninfected control group and a group of patients who had influenza during the same period from 2020 to 2022.”
  • The National Institutes of Health Director, in her blog, relates,
    • “We’re living in an especially promising time for biomedical discovery and advances in the delivery of data-driven health care for everyone. A key part of this is the tremendous progress made in applying artificial intelligence to study human health and ultimately improve clinical care in many important and sometimes surprising ways. One new example of this comes from a fascinating study, supported in part by NIH, that uses AI approaches to reveal meaningful sex differences in the way the brain works.
    • “As reported in the Proceedings of the National Academy of Sciences, researchers led by Vinod Menon  at Stanford Medicine, Stanford, CA, have built an AI model that can—nine times out of ten—tell whether the brain in question belongs to a female or male based on scans of brain activity alone. These findings not only help resolve long-term debates about whether reliable differences between sexes exist in the human brain, but they’re also a step toward improving our understanding of why some psychiatric and neurological disorders affect women and men differently.”
  • Per BioPharma Dive,
    • “The effects of an experimental medicine for a common liver disease strengthened with time in a clinical trial, giving the drug’s developer, Akero Therapeutics, a chance to rebound from a setback last year.
    • “Akero previously said the trial hit its main goal. After six months of treatment, 39% of patients with metabolic dysfunction associated steatohepatitis on a low dose of the drug and 41% on a high dose had a meaningful reduction in liver scarring and no worsening of their disease, versus 20% of placebo recipients. New results disclosed Monday show that 75% of those on a high dose and 46% on a low dose hit that mark after two years, compared to 24% of placebo patients.
    • “The most common side effects associated with treatment were mild-to-moderate cases of diarrhea, nausea and increased appetite. The 15 serious adverse events reported were “generally balanced across dose groups,” though Akero didn’t provide specifics. Three patients on the high dose stopped treatment.”

From the U.S. public health front,

  • CNBC and Fierce Healthcare bring us to date on the Change Healthcare situation. Of note,
    • “As a growing number of groups put pressure on the administration, the White House is reportedly considering short-term financial relief to support hospitals navigating the fallout of the cyberattack against Change Healthcare.
    • “The news was first reported by Politico and attributed to an anonymous senior administration official. In a series of recent meetings at the deputy level, the White House’s National Security Council reportedly discussed options that would not require support from Congress. Instead, it is exploring ways to tap into funding programs overseen by Health and Human Services, the Center for Medicare & Medicaid Services and the Department of Veterans Affairs to support healthcare organizations.
    • “This cashflow issue has been at the forefront since the beginning of last week for us,” the senior administration official told Politico. The agency is also reportedly pushing UnitedHealth Group to provide more transparency about when it can restore Change systems.
    • “The Biden administration is also considering whether to declare the hack a “significant cyber incident,” a rarely used designation that would trigger a special crisis management playbook, according to media reports.”
  • The Wall Street Journal adds these tidbits about the impending launch of Perigo’s over the counter female contraceptive pill called Opill.
    • “Dublin-based Perrigo has shipped its Opill to major U.S. retailers and expects it to be widely available by the end of the month. The company said it would sell a one-month pack for $19.99 and a three-month pack for $49.99.
    • “Opill, which uses the hormone progestin to suppress ovulation, was shown to be 98% effective at preventing pregnancy when used as directed, beating out other over-the-counter methods such as condoms and spermicide. Other prescription methods that require a doctor’s visit, such as intrauterine devices, are more effective. * * *
    • “The drugmaker wouldn’t confirm which stores will carry its product, but said all major retailers and online marketplaces would sell it. Pharmacy giant Walgreens is advertising the pill as “coming soon” on its website.
    • “Perrigo will also sell its product on its website, including a six-month pack for $89.99. The company said it would ship the pills in discreet packaging to online buyers.”
  • Becker’s Hospital Review identifies twelve U.S. health systems with strong finances.
  • The FEHBlog tried to keep readers abreast of noteworthy business announcement from last week’s VIVE conference. MedCity News helpfully lists nine of them.

Cybersecurity Saturday

David Ermer–Cybersecurity–

So much has happened with the Change Healthcare situation over the past week that the FEHBlog has discussed the situation in FEHBlog posts during the week.

To recapitulate, the ScreenConnect-related vulnerability was not the cause of the Change Healthcare situation. “Change Healthcare can confirm we are experiencing a cyber security issue perpetrated by a cybercrime threat actor who has represented itself to us as ALPHV/Blackcat,” said Tyler Mason, vice president at UnitedHealth, in a statement to TechCrunch on Thursday.”

  • Change Healthcare, which handles backend claims operations for many health plans, among other services, has created a temporary funding assistance for providers dealing with claim payment delays due to the Change Healthcare situation.
    • “We understand the urgency of resuming payment operations and continuing the flow of payments through the health care ecosystem. While we are working to resume standard payment operations, we recognize that some providers who receive payments from payers that were processed by Change Healthcare, may need more immediate access to funding.   
    • “We are mobilizing Optum Financial Services to help our Change Healthcare colleagues and customers support the most impacted providers.  
    • “For provider organizations impacted by that payer system outage, we’ve established a temporary funding assistance support program to help with short-term cash flow needs. You can now choose to receive short-term temporary funding assistance from us.
    • “Once standard payment operations resume, the funds will simply need to be repaid.  We have been able to estimate your average weekly payments, which will be the basis for the support. Our plan is to take this week by week with people re-upping for funding each week as needs persist.” 
  • The Change Healthcare website about the program includes FAQs.

In other vulnerability and ransomware news,

  • Cybersecurity Dive reports,
    • A patch issued to mitigate vulnerabilities in Ivanti Connect Secure does not eradicate the threat if a malicious actor previously gained access to their computer network, researchers from Mandiant warned on Tuesday.
    • A suspected espionage actor linked to the People’s Republic of China has utilized living off the land techniques and deployed novel malware to in an attempt to maintain persistence despite system upgrades, factory resets and patch deployment, according to Mandiant.  
    • Ivanti released an enhanced external integrity checker tool on Tuesday. The company and Mandiant researchers are urging organizations to run the new tool to confirm if they are still protected against additional intrusions.  
  • Here is a link to a related CISA notice published on Thursday February 29.
  • Per Statescoop,
    • “The Cybersecurity and Infrastructure Security Agency on Thursday released an advisory warning of known cyberattack techniques and indicators of compromise to help public sector organizations better protect themselves against ransomware, specifically from the threat actor Phobos.
    • “The advisory says that since 2019, Phobos, a ransomware-as-a service provider, has targeted the IT systems of municipal and county governments, emergency services, education institutions, public health care systems and other critical infrastructure. Ransomware-as-a-service, or RaaS, allows those with minimal technical expertise to launch ransomware attacks by using pre-developed tools.
    • “Randy Rose, vice president of security operations and intelligence at the Center for Internet Security, an Upstate New York nonprofit that runs the federally funded Multi-State Information Sharing and Analysis Center, said he’s seen a growing frequency of RaaS cyberattacks across the public sector in recent years.
    • “Phobos is pretty standard ransomware,” Rose told StateScoop. “We do see them across the [state, local, tribal and territorial] sector, which is one of the reasons why we pay a lot of attention to them.”
  • Bleeping Computer adds,
    • “CISA ordered U.S. Federal Civilian Executive Branch (FCEB) agencies to secure their Windows systems against a high-severity vulnerability in the Microsoft Streaming Service (MSKSSRV.SYS) that’s actively exploited in attacks.
    • “The security flaw (tracked as CVE-2023-29360) is due to an untrusted pointer dereference weakness that enables local attackers to gain SYSTEM privileges in low-complexity attacks that don’t require user interaction.”
  • Here’s a link to related CISA addition of this known exploited vulnerability on February 29.
  • American Hospital Association News adds,
    • “Perhaps the most important point to mention at this moment is that we do not have any indication this alert is in any way related to the Change Healthcare breach,” said John Riggi, AHA’s national advisor for cybersecurity and risk. “Nevertheless, this remains a significant threat being actively exploited by sophisticated foreign adversaries targeting previously published vulnerabilities in the Ivanti Connect Secure VPN and Policy Secure services. According to the alert, threat actors are able to bypass authentication controls and maintain undetected, root-level persistent access. The alert references multiple cyber threats related to the Chinese government. Organizations still using these Ivanti services should implement described patches and consider the significant risk of adversary access to, and persistence on, Ivanti Connect Secure and Policy Secure gateways when determining whether to continue operating these devices in an enterprise environment.”
  • For keen ransomware insights listen to or read the transcript of this podcast conversation between Duke University professor Mike Munger and King’s College, London, professor Anja Shortland. 

From the cybersecurity policy and defenses front,

  • Dark Reading informs us,
    • “The US National Institute of Standards and Technology (NIST) has released the latest draft of its well-regarded Cybersecurity Framework (CSF) this week, leaving companies to mull how a few significant changes to the document affects their cybersecurity programs.
    • “Between the new “Govern” function to incorporate greater executive and board oversight of cybersecurity, and the expansion of the best practices beyond just those for critical industries, cybersecurity teams will have their work cut out for them, says Richard Caralli, senior cybersecurity adviser at Axio, an IT and operational technology (OT) threat management firm.”
  • Here is a link to the NIST CSF 2.0 website.
  • Health IT Security adds,
    • “Surveyed healthcare organizations that used the National Institute of Standards and Technology (NIST) Cybersecurity Framework (CSF) as their primary framework saw lower cyber insurance premium increases compared to those that had not adopted the NIST CSF, the 2024 edition of the Healthcare Cybersecurity Benchmarking Study revealed.
    • “The study is the result of an ongoing collaboration between healthcare risk management solutions company Censinet, KLAS Research, the American Hospital Association (AHA), and the Healthcare and Public Health Sector Coordinating Council (HSCC). These groups interviewed 54 payer and provider organizations and 4 healthcare vendors between September and December 2023 to gather data for the study. * * *
    • “Once again, supply chain risk management remained the NIST CSF category with the lowest coverage, despite the prevalence of third-party data breaches in healthcare. What’s more, the study noted that higher coverage of supply chain risk management is associated with smaller increases in cyber insurance premiums.
    • “Surveyed organizations that used the NIST CSF as their primary security framework saw a 6 percent increase in cyber insurance premiums, compared to an 18 percent increase among organizations that did not use the NIST CSF as their primary framework.
    • “Higher coverage within the NIST CSF categories related to cyber resiliency is especially correlated with lower increases in cybersecurity premiums,” the study stated.”
  • CISA offers password advice.

Happy Leap Day!

David Ermer–CDC, Congress, Cybersecurity, Government Contracting, Medicare, Mental health care, Obesity, SDOH, U.S. Healthcare–
Photo by Joe Caione on Unsplash

From Washington, DC,

  • Politico reports,
    • “The Senate approved a stopgap funding bill Thursday night for President Joe Biden’s signature, thwarting a partial government shutdown on Saturday and buying more time to finalize half a dozen spending bills that congressional leaders aim to pass next week.
    • “Congress now officially has until March 8 to clear that initial six-bill bundle, which leaders struck a deal on earlier this week. But they’re still working on an agreement to fund the rest of the government, including the military and some of the biggest domestic programs, before a second deadline on March 22. The upper chamber cleared the measure in a 77-13 vote, following votes on four Republican amendments that were defeated on the floor.”
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan concerning Primary Care Interventions for Tobacco and Nicotine Use Prevention and Cessation in Children and Adolescents. The comment period ends on March 27, 2024.
  • The Labor Department’s Office of Federal Contract Compliance Programs created an updated website for the “The Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA) [which] is a law that prohibits federal contractors and subcontractors from discriminating in employment against protected veterans and requires employers take affirmative action to recruit, hire, promote, and retain these individuals.”
  • Yesterday, the Politico Pulse posted a story on a December 2022 Government Accountability Office report, released January 9, 2023, criticizing OPM’s internal controls over FEHB family member eligibility. Here is a link to the GAO’s website for the report which offers August 2023 updates on OPM’s efforts to implement GAO’s recommendations. Here’s are FEHBlog recommendations for GAO and OPM:
    • Family member eligibility hinges on the enrollee’s eligibility. OPM needs to have the payroll offices implement the HIPAA 820 enrollment roster electronic transaction which allows carriers to reconcile premiums to actual headcount. Use of the HIPAA 820 will be a huge step toward confirming the accuracy of family member eligibility and the 50% of FEHB enrollees who have self only coverage.
    • The Politico article suggests that the high cost of a family member eligibility audit discourages OPM from implementing one for the FEHBP. Auditors do their work based on samples. Arrange for a family member eligibility audit using statistically appropriate samples which will disclose, at the very least, the scope of the problem.

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

  • The New York Times reports,
    • “Long Covid may lead to measurable cognitive decline, especially in the ability to remember, reason and plan, a large new studysuggests.
    • “Cognitive testing of nearly 113,000 people in England found that those with persistent post-Covid symptoms scored the equivalent of 6 I.Q. points lower than people who had never been infected with the coronavirus, according to the study, published Wednesday in The New England Journal of Medicine.
    • “People who had been infected and no longer had symptoms also scored slightly lower than people who had never been infected, by the equivalent of 3 I.Q. points, even if they were ill for only a short time.
    • “The differences in cognitive scores were relatively small, and neurological experts cautioned that the results did not imply that being infected with the coronavirus or developing long Covid caused profound deficits in thinking and function. But the experts said the findings are important because they provide numerical evidence for the brain fog, focus and memory problems that afflict many people with long Covid.”
  • and
    • “Alcohol-related deaths surged in the United States by nearly 30 percent in recent years, with roughly 500 Americans dying each day in 2021, according to a new study published by the Centers for Disease Control and Prevention.
    • “The study chronicled a sustained spike in drinking during the Covid pandemic that continued to rise after the shock of the lockdowns of 2020. The incidence of alcohol-related deaths was higher in men, but among women the death rate shot up at a quicker pace.
    • “I think the results of this research are really alarming,” said Dr. Michael Siegel, who is a professor of public health at Tufts University School of Medicine and was not involved in the study. “It shows that there’s been a truly substantial increase in alcohol-related deaths over the last six years.”
  • and
    • “The 2022 outbreak of mpox, previously known as monkeypox, was curbed in large part by drastic changes in behavior among gay and bisexual men, and not by vaccination, according to a new analysis published on Thursday in the journal Cell.
    • “Public health response to outbreaks often relies heavily on vaccines and treatments, but that underestimates the importance of other measures, said Miguel Paredes, lead author of the new study and an epidemiologist at the Fred Hutchinson Cancer Center in Seattle.
    • “Although the Food and Drug Administration approved a vaccinefor mpox in 2019, getting enough doses produced and into arms proved challenging for many months after the outbreak began. Vaccines for new pathogens are likely to take even longer.
    • “The new analysis suggests an alternative. Alerting high-risk communities allowed individuals to alter their behavior, such as reducing the number of partners, and led to a sharp decrease in transmission, Mr. Paredes said. In North America, the outbreak began petering out in August 2022, when less than 8 percent of high-risk individuals had been vaccinated.
    • “Public health messaging can “be really powerful to control epidemics, even as we’re waiting for things like vaccines to come,” he said.”
  • Roll Call adds,
    • “Cases of measles are rising across the country and seem to be striking counties at random, but experts say there is one thing the public health system can do to turn the tide, and that’s to stem the post-pandemic vaccine lag and get parents to vaccinate their kids.
    • “General vaccination rates, including measles vaccination, declined during the COVID-19 pandemic, as people had less access to health care and kids were unable to access in-school vaccine clinics.
    • “That, combined with a new wave of vaccine skepticism and anti-vaccine sentiment has contributed to a wave of unvaccinated kids falling sick with the once-eradicated virus.”
  • MedPage Today tells us,
    • “The benefits of vaccination against respiratory syncytial virus (RSV) for adults ages 60 and older probably outweigh the small risk of vaccine-related Guillain-Barré syndrome (GBS), the CDC’s Advisory Committee on Immunization Practices (ACIP) reaffirmed.
    • “In a presentation on the second day of the ACIP’s 2-day meeting, Amadea Britton, MD, of the CDC’s RSV adult vaccination work group in Atlanta, noted that a small number of cases of Guillain-Barre syndrome had been observed in the clinical trials for both FDA-approved RSV prefusion F protein vaccines, but that it remained unclear whether those cases were actually caused by RSV vaccination or just chance occurrences.”
  • and
    • The CDC has issued new guidance —  its first since 1988 — on identifying and responding to clusters of suicide, as tens of thousands of lives are lost to suicide each year in the U.S.
    • Though suicide clusters are rare, they “can have unique characteristics and challenges,” and “are often highly publicized and can have considerable negative effects on the community, including prolonged grief and elevated fear and anxiety about further deaths,” Michael Ballesteros, PhD, of CDC’s National Center for Injury Prevention and Control (NCIPC), and colleagues wrote in Morbidity and Mortality Weekly Report (MMWR).
  • Beckers Hospital Review informs us,
    • “The CDC is anticipating a shortage of Td vaccines — which protect against tetanus and diphtheria — as the maker of one shot has discontinued production. 
    • “As a result, the CDC has updated guidance for providers and is recommending that they switch to administering Tdap vaccines, which protect against pertussis in addition to tetanus and diphtheria, whenever possible.  
    • “MassBiologics discontinued production of its TdVax shot, and while Sanofi also manufactures a Td vaccine and is working to boost supplies, the CDC anticipates the U.S. could see a shortage of the vaccines later this year. 
    • “Because not everyone can receive the Tdap vaccine, “the limited supply of Td vaccine needs to be preserved for those with a contraindication to receiving pertussis-containing vaccines,” the CDC said in its guidance.” 
  • Medscape notes,
    • “Injectable weight loss drugs like Wegovy, Saxenda, and Zepbound have been getting all the glory lately, but they’re not for everyone. If the inconvenience or cost of weight loss drugs isn’t for you, another approach may be boosting your gut microbiome.
    • “So how does one do that, and how does it work?
    • “In theory, all you have to do is boost your gut microbiome.
    • “There are a lot of different factors naturally in weight gain and weight loss, so the gut microbiome is certainly not the only thing,” said Chris Damman, MD, a gastroenterologist at the University of Washington. He studies how food and the microbiome affect your health. “With that caveat, it probably is playing an important role.”
  • STAT News adds,
    • “New obesity drugs like Wegovy and Zepbound are currently taken once a week, indefinitely. But what if they could be taken once a year instead, like a vaccine?
    • “That’s a question that Novo Nordisk, the pharma company behind Wegovy, is exploring as it faces increased competition from other drugmakers aiming to develop similar GLP-1-based treatments for obesity.
    • “We have a very early think tank on: what would it take us, from a technology point of view and from an ecosystem point of view, to make long-lasting GLP-1 molecules?” Marcus Schindler, Novo’s chief scientific officer, said in an interview with STAT Wednesday. “Could we think about vaccine-like properties, where imagine you had, once a year, an injection with an equivalent of a GLP-1 that really helps you to maintain weight loss and have cardiovascular benefits?”

From the U.S. healthcare business and cybersecurity issues front,

  • Beckers Hospital Review informs us,
    • “Optum’s Change Healthcare confirmed Feb. 29 that it was hacked by a ransomware gang after the group claimed to have stolen massive amounts of data.
    • “Change Healthcare can confirm we are experiencing a cybersecurity issue perpetrated by a cybercrime threat actor who has represented itself to us as ALPHV/Blackcat,” an Optum spokesperson emailed Becker’s on Feb. 29. “We are actively working to understand the impact to members, patients and customers.” * * *
    • “ALPHV/Blackcat, aka BlackCat, claimed responsibility for the hack, posting on its dark web leak site that it stole 6 terabytes worth of Change Healthcare data involving “thousands of healthcare providers, insurance providers, pharmacies, etc,” Bleeping Computer reported Feb. 28. The allegedly stolen data includes medical records, patient Social Security numbers, and information on active military personnel (Change serves some military healthcare facilities).
    • “But as Politico noted Feb. 28: “Ransomware groups, which demand extortion payments in exchange for restoring or not publishing stolen data, often exaggerate their exploits as a negotiating tactic.”
    • “ALPHV/Blackcat, which has been linked to Russia, has been targeting the U.S. healthcare industry since December after the FBI disrupted its operations.”
  • STAT News adds,
    • “The outage caused by the Change Healthcare cyberattack could last weeks, a top UnitedHealth executive suggested in a Tuesday conference call with hospital cybersecurity officers, according to a recording obtained by STAT.
    • “UnitedHealth Group Chief Operating Officer Dirk McMahon said the company is setting up a loan program to help providers who can’t submit insurance claims while Change is offline. He said that program will last “for the next couple of weeks as this continues to go on.”
    • “McMahon’s remarks about the loan program highlight the scope of UnitedHealth’s damage control. UnitedHealth maintained it has “not determined the [cyberattack] incident is reasonably likely to materially impact our financial condition or results of operations,” according to its annual report to investors this week. But doctors and pharmacists are scrambling to find ways to get patients what they need, and to get paid. As of 2022, Change facilitated $1.5 trillion in health care transactions.”
  • HR Brew lets us know,
    • “The cost of healthcare went up last year, according to a new report from Marsh McLennan Agency (MMA), a US-based subsidiary of global brokerage Marsh. The amount that employers spent on health benefits per employee grew by 5.2%, while the estimated cost of employer contributions to premiums increased by more than $1,400, to $11,762.
    • “Healthcare inflation can affect employees, as well, the report noted, with 38% of Americans reporting they put off medical treatment in the last year due to cost concerns. MMA noted that “delayed care is associated with worse health outcomes and higher costs for patients and benefit providers.”
    • “Younger workers appear to be feeling the pinch of high health costs the most, with 74% of millennial and 56% of Gen Z patients canceling doctors’ visits because of high costs, compared to 13% of Baby Boomer patients. Putting off behavioral healthcare, in particular, can be costly for younger age groups, said Monte Masten, chief medical officer with MMA. Given these trends, employer investment in incentives may be warranted, he told HR Brew.”
  • Drug Store News alerts us,
    • “Walgreens’ VillageMD is closing six Chicago clinic locations—five standalone and one co-located with a Walgreens store, per a Telehealth & Telecare Aware report.
    • “The closures in Walgreens’ home state are set to take place April 19. These closures follow on the heels of news last week that VillageMD exited the Florida market.” 
  • Per Fierce Healthcare,
    • “Telemedicine clinic Virta Health believes its members can achieve significant and sustained improvement in weight loss, even if a patient has stopped taking a GLP-1 drug, a newly released paper in Diabetes Therapy shows.
    • “According to the company, it is a first-of-its-kind study offering an opposing viewpoint against clinical trials showing GLP-1 deprescription leading to weight regain. The results have potentially major implications for employers and plans looking to help its members improve health outcomes and fight obesity but that are concerned about rising costs amid increasing demand.
    • “This is unheard of,” said Sami Inkinen, Virta Health CEO and co-founder. “To my knowledge, nobody has published or shown this kind of data to date.”
  • Beckers Health Payer Issues points out five health insurers that “are making commitments to advance a White House initiative to end hunger and reduce diet-related disease by 2030.” 
  • Per BioPharma Dive,
    • “Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders.
    • “Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round announced Thursday, alongside Alaska Permanent Fund Corporation and The Column Group. The investment is the first announced by Cure since it debuted last year with a $350 million fund. Euclidean Capital and Saisei Ventures also participated in the round.
    • “Previously known as Ryne Bio, Kenai’s research aim is to create so-called off-the-shelf cell therapies that replace neurons. The company’s most advanced medicine is made from genetically reprogrammed stem cells and designed to treat Parkinson’s disease by restoring dopamine production.
    • “The medicine has “displayed robust survival, innervation, and behavioral rescue in preclinical models of Parkinson’s disease,” according to Kenai, which claims it could work in inherited forms of the disease as well as in cases where the exact cause isn’t understood.
    • “The company said the funding proceeds will be enough to push the medicine, named RNDP-001, into human testing and through early-stage clinical trials, which should start within the year.”