FEHBlog

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.

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec informs us,
    • “President Biden on Thursday nominated former Labor Department Secretary Marty Walsh to serve on the U.S. Postal Service board of governors, potentially giving the administration more representation in supervising the mailing agency. 
    • “Walsh, a former Democratic mayor of Boston, would fill one of two vacancies currently open on the governing board. His nomination comes at a pivotal moment for the Postal Service, which, under the leadership of Postmaster General Louis DeJoy, is in the midst of a complete overhaul of the agency’s operations, staffing and pricing strategies. It follows a call earlier this month from dozens of House Democrats who pushed Biden to fill the vacancies to ensure increased oversight of DeJoy’s reforms. * * *
    • “The former secretary’s confirmation would give Biden his sixth nominee to sit on the board that has nine presidentially appointed, Senate-confirmed slots. Lee Moak and Bill Zollars both saw their terms expire in December and their seats have been vacant ever since. Walsh would be the fourth Democrat to sit on the board, joining three Republicans and one independent. Federal statute requires no more than five members of the board be of the same party, meaning Biden could choose another Democrat to fill the remaining vacancy.” 
  • Federal News Network discusses OPM’s February 8, 2024, call letter to FEHB and PSHB carriers for 2025 FEHB and PSHB benefit and rate proposals.
  • Bloomberg tells us that a federal judge in Delaware has thrown out Astra-Zeneca’s constitutional and statutory challenge to the government drug price negotiation provisions of the Inflation Reduction Act.
    • “Because AstraZeneca’s participation in Medicare is not involuntary, AstraZeneca does not have a protected property interest in selling drugs to the Government at prices the Government will not agree to pay. Accordingly, AstraZeneca’ s due process claim fails as a matter of law,” the judge wrote.
    • “Among other cases, Connolly pointed to Dayton Area Chamber Commerce v. Becerra on how “participation in the Medicare program is a voluntary undertaking,” and neither the Inflation Reduction Act nor any other federal law requires AstraZeneca to sell its drugs to Medicare beneficiaries.” * * *
    • “AstraZeneca’s loss is another setback for the pharmaceutical industry among the lawsuits challenging the program. A federal judge in Texas dismissed Nat’l Infusion Ctr. v. Becerra for lack of jurisdiction, and a federal judge in Ohio struck down a preliminary injunction that would have halted the program.
    • “Similar suits brought by manufacturers and industry groups are pending for Johnson & Johnson, Bristol Myers Squibb & Co., Novo Nordisk A/S, Novartis AG, Merck & Co., Boehringer Ingelheim, and the Dayton Area Chamber of Commerce in Ohio.
    • “The case is AstraZeneca Pharm. LP v. Becerra , D. Del., No. 1:23-cv-00931, memorandum opinion 3/1/24 .”
  • The Wall Street Journal reports,
    • “Pharmacy chains CVS and Walgreens will begin dispensing mifepristone, commonly known as “the abortion pill, in coming weeks.
    • The two chains said Friday they received certification to dispense the pills, following a regulatory shift last year to allow bricks-and-mortar pharmacies to offer the pill with a prescription.
    • “The companies said they would distribute the pill in a way consistent with state laws—meaning it won’t be offered in states that don’t allow legal access to abortion through 10 weeks—and will begin rolling out the pill in a handful of states. Both said they wouldn’t make mifepristone available via mail order. The drug is already available via other mail-order pharmacies and telehealth platforms.”
  • According to MedTech Dive,
    • “Boston Scientific said Friday it has received Food and Drug Administration approval for a drug-coated balloon to treat coronary in-stent restenosis, a condition in which a vessel that previously received a stent narrows again due to plaque or scar tissue.
    • “Approval for the device, which received FDA’s breakthrough designation in 2021, was supported by positive results from the prospective, randomized Agent trial that enrolled 600 patients at 40 U.S. sites, the company said.
    • “We view Agent highly favorably for its statistically significant superiority in what is a difficult-to-treat and common [in-stent restenosis] patient population, which we think could enable rapid physician adoption,” BTIG analyst Marie Thibault wrote Friday in a note to clients.”

From the public health and medical research front,

  • The Centers for Disease Control relates,
    • “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, 27 jurisdictions experienced high or very high activity. This number remains stable compared to last week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Influenza test positivity decreased nationally but is increasing in the Central region (including Iowa, Kansas, Missouri, and Nebraska). COVID-19 and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflect both symptomatic and asymptomatic infections, remain at high levels, particularly in the South, but are trending downward.”
  • and more specifically with regard to Covid,
    • “As the 2023-2024 fall and winter virus season ends, it’s clear that the situation surrounding COVID-19 has changed.  It is still an important health threat, but it is no longer the emergency that it once was, and its health impacts increasingly resemble those of other respiratory viral illnesses, including flu and RSV.
    • “CDC released updated Respiratory Virus Guidance in response to the decreasing risk that COVID-19 poses to the population. This updated Guidance includes strategies to protect people at highest risk of getting seriously ill and provides actionable recommendations for people with common viral respiratory illnesses, including COVID-19, flu, and RSV.
    • “Keep reading: CDC’s Updated Respiratory Virus Guidance: What to do When You Are Sick.”
  • The New York Times adds,
    • Americans with Covid or other respiratory infections need not isolate for five days before returning to work or school, the Centers for Disease Control and Prevention said on Friday, a striking sign of changing attitudes toward the coronavirus.
    • People with respiratory illnesses may resume daily activities if they have been fever-free for at least 24 hours without the aid of medications and if their symptoms are improving, agency officials said. 
    • Acknowledging that people can be contagious even without symptoms, the C.D.C. urged those who end isolation to limit close contact with others, wear well-fitted masks, improve indoor air quality and practice good hygiene, like washing hands and covering coughs and sneezes, for five days.
    • The guidelines apply to Covid, influenza and respiratory syncytial virus, among other respiratory ailments, which should make it easier for people to comply, Dr. Mandy Cohen, the C.D.C.’s director, told reporters on Friday.
  • MedPage Today notes,
    • “Early estimates suggest flu shots are performing OK in the current U.S. winter flu season.
    • “The vaccines were around 40% effective in preventing adults from getting sick enough from the flu that they had to go to a doctor’s office, clinic, or hospital, health officials said during a CDC vaccines meeting Wednesday. Children who were vaccinated were roughly 60% less likely to get treatment at a doctor’s office or hospital, they noted.
    • “Officials generally are pleased if a flu vaccine is 40% to 60% effective.”
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health have identified antibodies targeting a hard-to-spot region of the influenza virus, shedding light on the relatively unexplored “dark side” of the neuraminidase (NA) protein head. The antibodies target a region of the NA protein that is common among many influenza viruses, including H3N2 subtype viruses, and could be a new target for countermeasures. The research, led by scientists at the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center, part of NIH, was published today in Immunity.” * * *
    • “These findings show that the NA dark side has unique, previously untapped epitopes that could be applied to the development of new vaccine and therapeutic strategies. They suggest that antibodies targeting the NA dark side could be useful in combination with antivirals or other types of antibodies for interventions against influenza, as they are effective against influenza viruses with drug-resistant mutations. The researchers also note that NA dark side targets could be included in the next generation of broadly protective vaccines against influenza.”
  • Per BioPharm Dive,
    • “Advisers to the Centers for Disease Control and Prevention are weighing updates to their recommendation older adults get vaccinated for respiratory syncytial virus, discussing changes at a meeting Thursdaythat would more forcefully encourage some individuals receive a shot.
    • “At the meeting, the Advisory Committee on Immunization Practices reviewed safety and efficacy data on RSV vaccines sold by GSK and Pfizer, as well as clinical trial data for an experimental shot from Moderna that’s nearing market.
    • “Currently, the CDC recommends adults 60 years or older discuss RSV vaccination with their physician — a process known as “shared clinical decisionmaking.” Advisers debated whether, for some individuals at higher risk, a universal recommendation would be more appropriate. They wanted more data before making a decision, however, likely at a follow-up meeting scheduled for June 26 to June 28.”

From the U.S. healthcare business front,

  • Crains Grand Rapids [Mich.] Business reports,
    • “Perrigo Co. plc expects to introduce the first oral contraceptive available in the U.S. without a physician’s prescription by mid March. 
    • “The company has “activation plans” in place to promote and drive consumer awareness of Opill at retail stores and for online sales when it goes to market, said President and CEO Patrick Lockwood-Taylor. 
    • “We expect Opill to be available to consumers in-store and online within a few weeks,” Lockwood-Taylor said during a Tuesday morning conference call to discuss Perrigo’s latest quarterly results. “You’ll find it in every store, and you’ll find it everywhere online.” 
  • Beckers Hospital Review lets us know,
    • “Cleveland Clinic posted an operating income of $64.3 million in 2023 after posting a $211.3 million loss in 2022, according to its financial report released Feb. 29. 
    • “The health system had a 0.4% operating margin for the year ended Dec. 31 after posting a -1.6% margin in 2022, according to the report. 
    • “Cleveland Clinic said the improved operating performance was driven by an 11.4% increase in operating revenues, “supported by strong patient demand for both inpatient and outpatient services, that outpaced a 9.1% increase in operating expenses in 2023 compared to 2022.”
    • “The system had a total operating revenue of $14.5 billion and total operating expenses of $13.7 billion in 2023. Cleveland Clinic said the growth in expenses was primarily driven by higher patient volumes and inflationary trends that increase salaries, wages and benefits, supply expenses and pharmaceutical costs.” 
  • According to BioPharma Dive,
    • “Pfizer believes the answer to its sliding valuation lies in oncology. 
    • “The company, which is coming off one of the worst years in its history, unveiled on Thursday a new business unit dedicated to cancer research. The division, created in the wake of Pfizer’s $43 billion buyout of Seagen last year, houses a sprawling portfolio of experimental medicines both companies discovered and acquired through deals. It also includes the marketed drugs Pfizer and Seagen have long been selling for a variety of tumor types. 
    • “Pfizer claims the pipeline it now has could produce more than eight blockbuster medicines by 2030, up from five today, and double the number of patients the company’s drugs currently treat. By then, biologic medicines should account for nearly two-thirds of its oncology revenue, up substantially from the 6% they comprise now, Pfizer said. 
    • “To achieve those goals, Pfizer will need steady sales growth and additional approvals for its currently marketed medicines. It will also need a pipeline of 16 experimental drugs across four broad areas of cancer research to come through in testing.” 

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.”

Midweek update

David Ermer–CDC, Congress, COVID-19 vaccine, HSA, Mental health care, NIH, U.S. Healthcare–
Photo by Manasvita S on Unsplash
  • Roll Call informs us,
    • “Congressional leaders reached an agreement on final fiscal 2024 appropriations bills Wednesday that will pave the way for lawmakers to wrap up the process in two packages in the coming days and weeks, sources familiar with the deal said.
    • “Funding for agencies covered by the Agriculture, Energy-Water, Military Construction-VA and Transportation-HUD bills would be extended from March 1 through March 8, joining the Interior-Enviroment and Commerce-Justice-Science bills in the first tranche. Lawmakers are expected to release text of the stopgap spending measure as soon as Wednesday.
    • “Appropriators are aiming for text for the first tranche by Sunday in order for the House to be able to turn around and vote Wednesday, before Thursday gets swallowed up by President Joe Biden’s State of the Union address. In theory, that would give the Senate time to get the first package to Biden’s desk before the impacts of a partial shutdown on those agencies subject to the new March 8 deadline are felt.
    • “Stopgap funding for the remaining six bills, which had been set to lapse March 9, would last through March 22, giving lawmakers enough time to finish turning the deal into legislative text and getting them through both chambers. That package will consist of the Defense, Labor-HHS-Education, Homeland Security, Financial Services, State-Foreign Operations and Legislative Branch measures.” (FEHBlog note — FEHB appropriations are included in the Financial Services bill.]
  • and
    • “Mitch McConnell’s announcement [today] that he will voluntarily end his record-setting reign as Senate Republican leader drew praise and some derision Wednesday, as a contest to succeed him that was already underway began to move out from behind the scenes.
    • “Potential candidates to replace McConnell include the “three Johns,” as they’re known, who have all served as deputies under McConnell in recent years. South Dakota Sen. John Thune, currently the No. 2 Senate Republican; Wyoming Sen. John Barrasso, the current conference chair; and Texas Sen. John Cornyn, a former GOP whip who termed out of leadership, could all make a run for party leader.” 
  • The Bipartisan Policy Center adds,
    • “An additional factor affecting FY2024, which runs from October 1, 2023, through September 30, 2024, and FY2025 is the Fiscal Responsibility Act or FRA—the bipartisan debt limit deal that set discretionary spending levels for two years. The FRA includes a provision that reduces spending caps in the deal and enforces a sequester (an across-the-board cut) if one or more agencies are covered by a CR after April 30, 2024. There is some uncertainty over whether a full-year CR would trigger this April 30 provision. The executive branch’s Office of Management and Budget (OMB) is ultimately responsible for making that decision.”
  • STAT News reports,
    • “In a bid to combat prescription drug costs, the White House will hold a listening session on Monday in search of ways to reform pharmacy benefit managers, according to people familiar with the plans.
    • “The list of attendees includes representatives from the federal government and industry, who are expected to provide insights into how the largest pharmacy benefit managers determine which medicines are covered by insurers and employers, as well as prices that are paid at pharmacy counters. Critics say these middlemen rely on an opaque process that drives up costs for patients and taxpayers.
    • “Among those invited is Mark Cuban, whose Cost Plus Drug Company is trying to transform the marketplace by avoiding the largest middlemen when reaching benefits agreements with employers. He will “just convey what our experience has been at Cost Plus and, if they ask, [make] suggestions on what we think can make things better,” he told us when asked about his expectations for the meeting.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “Centers for Disease Control and Prevention Director Mandy Cohen, M.D., Feb. 28 endorsed a recommendation by its Advisory Committee on Immunization Practices that adults ages 65 years and older receive an additional updated 2023-2024 COVID-19 vaccine dose. 
    • “Today’s recommendation allows older adults to receive an additional dose of this season’s COVID-19 vaccine to provide added protection,” Cohen said. “Most COVID-19 deaths and hospitalizations last year were among people 65 years and older. An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk.”
    • “CDC continues to recommend that everyone stay up to date on their COVID-19 vaccines, especially people with weakened immune systems.”
  • The Wall Street Journal adds,
    • “The CDC’s final decision ensures most health plans cover the inoculations without an out-of-pocket charge when furnished in-network].
    • “Most Covid-19 deaths and hospitalizations last year were among people 65 years and older. An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk,” CDC Director Dr. Mandy Cohen said.”
  • The National Institutes of Health announced,
    • “Frequent cannabis smoking may significantly increase a person’s risk for heart attack and stroke, according to an observational study supported by the National Institutes of Health. The study, published in the Journal of the American Heart Association, uses data from nearly 435,000 American adults, and is among the largest ever to explore the relationship between cannabis and cardiovascular events.   
    • “The study, funded by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, found that daily use of cannabis — predominately through smoking — was associated with a 25% increased likelihood of heart attack and a 42% increased likelihood of stroke when compared to non-use of the drug. Less frequent use was also associated with an increased risk of cardiovascular events. Weekly users showed a 3% increased likelihood of heart attack and a 5% increased likelihood of stroke.
    • “Around 75% of the study respondents reported that they mainly used cannabis by smoking the drug. Approximately 25% of the respondents reported using cannabis by some method other than smoking, such as vaping, drinking, or eating the drug.
    • “We know that toxins are released when cannabis is burned, similar to those found in tobacco smoke,” said corresponding author Abra Jeffers, Ph.D., a data analyst at Massachusetts General Hospital in Boston and formerly a researcher at the Center for Tobacco Control Research and Education at the University of California, San Francisco, where she conducted the study as part of her postdoctoral work.
    • “We’ve known for a long time that smoking tobacco is linked to heart disease, and this study is evidence that smoking cannabis appears to also be a risk factor for cardiovascular disease, which is the leading cause of death in the United States,” Jeffers said. “Cannabis use could be an important, underappreciated source of heart disease.”
  • MedPage Today lets us know,
    • “Mortality from colorectal cancer (CRC) decreased significantly in patients who were offered early screening with fecal occult blood testing (FOBT), a large prospective cohort study showed.
    • “Cancer-specific mortality decreased significantly by 14% in patients who underwent early screening for CRC, as compared with a control group that received late or no invitations to participate in screening. Excess mortality decreased by 16% in the exposure group.
    • “The results probably underestimated the true impact of screening with FOBT, as some participants in the control group underwent testing, reported Johannes Blom, MD, PhD, of the Karolinska Institutet in Stockholm, and co-authors in JAMA Network Openopens in a new tab or window. Clinicians and patients now have greater confidence that CRC screening reduces the risk of dying of CRC.”
  • The Society for Human Resource Management offers ten tips to Support Mental Health in Multigenerational Workplaces.”
  • MedTech Dive informs us,
    • “Johnson & Johnson has started patient enrollment in a pivotal trial to evaluate its Laminar left atrial appendage (LAA) elimination device for reducing stroke risk due to blood clot formation in the heart, the company said Tuesday.
    • “The investigational device exemption study will enroll 1,500 patients with atrial fibrillation (AFib), a common form of irregular heart rhythm, at up to 100 U.S. sites.
    • “J&J, which acquired privately held Laminar for $400 million in November, is among the medtech companies aiming to challenge Boston Scientific, whose Watchman implant leads the fast-growing market for LAA devices.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review lists the 43 U.S. hospitals listed in Newsweeks top 250 hospital worldwide. U.S. hospital form four of the top five.
    • 1. Mayo Clinic-Rochester (Minn.)
    • 2. Cleveland Clinic
    • 4. The Johns Hopkins Hospital (Baltimore)
    • 5. Massachusetts General Hospital (Boston)
  • Per Healthcare Dive,
    • “Universal Health Services is guiding to a stronger 2024 than analysts had expected after beating Wall Street’s revenue expectations in fourth-quarter results released Tuesday.
    • “The massive for-profit hospital operator expects to bring in revenue between $15.4 billion and $15.7 billion this year, which represents almost 9% year-over-year growth at the midpoint. In comparison, UHS grew revenue almost 7% last year, ending 2023 with $14.3 billion. The system’s profit was $717.8 million, up 6%.
    • “UHS was helped in the fourth quarter from better-than-expected behavioral health volumes, despite continued cost pressures from physician subsidy expenses and the ongoing Medicaid redetermination process.”
  • Per Fierce Healthcare,
    • “Danbury, Connecticut-based Nuvance Health is joining Northwell Health, New York’s largest provider and private employer, under a strategic merger agreement unveiled Wednesday.
    • “The deal, which still requires regulatory signoffs, would create a healthcare network of more than 28 hospitals, over 1,000 care sites, nearly 100,000 staff and 14,500 employed providers, the two nonprofits said in their joint announcement.
    • “This partnership opens a new and exciting chapter for Northwell and Nuvance and provides an incredible opportunity to enhance both health systems and take patient care and services to an even higher level,” Michael Dowling, president and CEO of Northwell Health said in the announcement. “We have similar missions in providing high-quality care for patients in the communities we serve. We look forward to building on the care that Nuvance Health’s 14,000 staff members and providers deliver each and every day.”
  • Health Equity explains why employer matching contributions to employee health savings accounts can be game changer when trying to lower healthcare costs.
    • “When implementing an HSA contribution plan, it’s helpful to structure the program in a way that is not only cost-effective but also encourages adoption. Seed options are a good way to encourage HSA use because they directly help employees with healthcare costs. You can make seed contributions in several ways, such as:
      • A lump sum
      • Smaller amounts throughout the year
      • Or a combination of both tactics
    • “To boost adoption, consider offering an HSA-qualified plan with lower premiums than your regular plan. This way, the choices cost about the same. For instance, you could offer a PPO plan with a $400 monthly premium or an HSA-qualified plan with a $200 monthly premium and an extra $200 monthly employer seed.
    • “It’s not uncommon for organizations to seed the first year of an employee’s HSA to help them transition into the plan, but few make the important switch to a match system to continue encouraging contributions.
    • “According to HealthEquity research, only 12% of employers provide a contribution match compared to 68% who offer a seed.”

Tuesday Tidbits

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

From Washington, DC,

  • Roll Call reports,
    • “Congressional leaders emerged from the White House on Tuesday optimistic about avoiding a partial shutdown of several departments and agencies — after a meeting with President Joe Biden that also focused on the importance of aid to Ukraine.
    • “The speaker said unequivocally he wants to avoid a government shutdown,” Senate Majority Leader Charles E. Schumer, D-N.Y., told reporters outside the West Wing, adding he did not believe differences on domestic spending were insurmountable.
    • “When he got back to the Capitol, Schumer told reporters that he made clear to Speaker Mike Johnson, R-La., that avoiding a shutdown would require another continuing resolution. Senate Minority Leader Mitch McConnell, R-Ky., also told reporters at the Capitol that leaders seemed to agree at the White House on the need to avert a shutdown.”
  • The Wall Street Journal relates,
    • “The Justice Department has launched an antitrust investigation into UnitedHealth, owner of the biggest U.S. health insurer, a leading manager of drug benefits and a sprawling network of doctor groups.
    • “The investigators have in recent weeks been interviewing healthcare-industry representatives in sectors where UnitedHealth competes, including doctor groups, according to people with knowledge of the meetings.
    • “During their interviews, investigators have asked about issues including certain relationships between the company’s UnitedHealthcare insurance unit and its Optum health-services arm, which owns physician groups, among other assets. 
    • “Investigators have asked about the possible effects of the company’s doctor-group acquisitions on rivals and consumers, the people said.
    • “Spokespeople for UnitedHealth and the Justice Department declined to comment. UnitedHealth executives have said Optum and UnitedHealthcare don’t favor one another, and routinely work with competitors.” 
  • According to Healthcare Dive,
    • “Proposed Medicare Advantage rates for 2025 could have a steeper impact on health plans’ payment than the government expects, according to a new study funded by a payer lobbying group.
    • “The analysis — backed by the Better Medicare Alliance, which represents payers in the private Medicare program — found MA payment per month per beneficiary could drop by 1% next year if the CMS finalizes the changes. In comparison, the CMS expects payments to MA plans to drop 0.16% under its proposal.
    • “Study authors warned that when government reimbursement drops, MA benefits for seniors like supplemental benefits and lower premiums and cost-sharing also tend to be reduced. Health insurers have made similar arguments in recent earnings calls lobbying against the rate changes, which could reduce profitability of their MA businesses.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Community Living (ACL), announced several new initiatives and resources from ACL’s Direct Care Workforce (DCW) Strategies Center to address the dire shortage of professionals who provide the services many older adults and people with disabilities need to live in the community. These include two technical assistance opportunities to help states strengthen their systems for recruiting, retaining, and developing direct care workers; a national hub to connect states, stakeholders and communities to best practices and other resources related to the direct care workforce; and a webinar series for states and stakeholders focused on a range of direct care workforce topics. These initiatives will help sustain the impact of the $37 billion in American Rescue Plan funding invested to date by states in home and community-based services, and support the comprehensive set of actions and investments included in the President’s executive order to improve care.”
  • Per an OPM press release,
    • “The U.S. Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) released the first-ever government-wide Military-Connected Strategic Plan for FY 2024-2028 to support agencies in their efforts to recruit, hire, and retain military-connected spouses, caregivers, and survivors within the federal government. 
    • “Advancing economic opportunity for military-connected spouses, caregivers, and survivors strengthens our federal workforce and the nation,” said OPM Director Kiran Ahuja. “A good-paying, flexible, and dependable federal job strengthens the economic security of our military families and helps spouses succeed in their own careers, while also supporting their loved ones in uniform. Tackling barriers to recruiting, hiring, and retaining talent also improves our workforce and expands our talent pool to mission-driven public servants who want to give back to their country.” 
  • Federal News Network informs us,
    • “As agencies ramp up recruitment of federal AI professionals, the Office of Personnel Management is highlighting existing workplace flexibilities that can ease the process.
    • “Incentives such as pay bonuses, faster leave accrual, student loan repayments, and telework and remote work can all help agencies more effectively hire AI specialists, OPM said in new federal AI hiring guidance, published Tuesday.
    • “Agencies can extend most — but not all — of the workplace flexibilities to incoming federal AI experts without first needing to get approval from OPM.
    • “For the few flexibilities that require OPM approval — special rates, critical pay and waivers of the recruitment, relocation and retention incentive payment limits — we stand ready to assist agencies and respond to their requests for enhanced compensation tools,” OPM Director Kiran Ahuja said in the guidance.”
  • Beckers Hospital Review adds,
    • “On Feb. 23, Colorado secured a national first by agreeing to establish a price ceiling on a medication, The Denver Post reported. 
    • “The state’s Prescription Drug Affordability Board voted in favor of capping the cost of arthritis drug Enbrel, which has a list price of $1,850.46 for a weekly dose. Colorado legislators createdthe five-member board in 2021 to sniff out medications deemed “unaffordable” and establish a payment limit for state-regulated commercial payers.
    • “By late August, the board will either narrow down an appropriate cost for Enbrel or vote against setting a price ceiling, according to The Denver Post. If established, the price cap would limit how much pharmacies could pay for the drug, and patients and payers would then pay that amount and a fee to cover the pharmacy’s handling costs.” 

From the public health and medical research front,

  • The Food and Drug Administration announced yesterday,
    • “[O]n May 16, 2024, the FDA’s Vaccines and Related Biological Products Advisory Committee will meet to publicly discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.  
    • “The FDA anticipates that changes to the vaccine composition may need to be made based on the currently circulating strains of the virus that causes COVID-19. As the agency has previously stated, barring any new major changes to circulating virus, the FDA expects that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.
    • “Following any potential recommendations to update the 2024-2025 formula, the FDA anticipates that, subject to appropriate regulatory actions, manufacturers will be able to make updated COVID-19 vaccines available in advance of the fall/winter respiratory virus season.”
  • The National Institutes of Health announced today,
    • “People with type 2 diabetes who underwent bariatric surgery achieved better long-term blood glucose control compared to people who received medical management plus lifestyle interventions, according to a new study supported by the National Institutes of Health. The participants who underwent bariatric surgery, also called metabolic or weight-loss surgery, were also more likely to stop needing diabetes medications and had higher rates of diabetes remission up to 12 years post-surgery. Results of the study were published in JAMA(link is external) and funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of NIH.
    • “While there are many factors involved, and not all of them are completely understood, bariatric surgery typically results in greater weight loss that affects a person’s metabolic hormones, which improves the body’s response to insulin and ability to maintain healthy blood glucose levels,” said Dr. Jean Lawrence, NIDDK project scientist. “These results show that people with overweight or obesity and type 2 diabetes can make long-term improvements in their health and change the trajectory of their diabetes through surgery.”
    • “The current study is a follow-up that combined data from four independent single-center randomized trials conducted at clinical sites in the United States. The original trials, which were conducted between May 2007 and August 2013, evaluated the effectiveness of bariatric surgery compared to intensive lifestyle and medication therapy involving oral and injectable diabetes medications including insulin, for adults with type 2 diabetes and overweight or obesity. While some participants in the study were prescribed GLP-1 agonists as part of their medical management of diabetes, these drugs were not specifically examined in the study. The investigators from the four individual studies pooled their data to provide a larger and more geographically diverse data set to evaluate efficacy, durability, and safety of bariatric surgery to treat type 2 diabetes. Follow-up data were collected through July 2022.”
  • The U.S. Preventive Services Task Force preliminarily recommended an inconclusive grade for Screening and Supplementation of Iron Deficiency and Iron Deficiency Anemia During Pregnancy. The public comment period is open until March 25, 2024.
  • The Centers for Disease Control offers important guidance on diabetes and feet.
    • “About half of all people with diabetes have some kind of nerve damage. You can have nerve damage in any part of your body, but nerves in your feet and legs are most often affected. Nerve damage can cause you to lose feeling in your feet.”
  • BioPharma Dive lets us know,
    • “An experimental weight loss drug developed by Viking Therapeutics helped overweight and obese people lose up to 15% of their body weight after 13 weeks of treatment in a mid-stage trial, the company said Tuesday.
    • “The drug, a potential rival to Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, led to greater weight loss over that time period than both of those medicines did in clinical testing. However, Wall Street analysts cautioned the effects of Viking’s therapy need to be confirmed in a larger Phase 3 trial.”

From the U.S. public health front,

  • Beckers Hospital Review points out,
    • “UnitedHealth Group estimates 90% of the 70,000-plus pharmacies in the U.S. using Change Healthcare’s platform have modified electronic claims processing to mitigate effects of the cybersecurity incident that hit the company last week.
    • “The remaining 10% have offline processing workarounds, according to a Feb. 26 statement from UnitedHealth Group, which owns Change Healthcare. The cybersecurity issue, believed to be the work of a foreign nation-state-associated cybersecurity threat actor, caused enterprisewide connectivity issues.
    • “UnitedHealth Group reported Optum Rx and UnitedHealthcare have seen few reports of issues, and fewer than 100 out of the 65 million pharmacy benefit manager members have not been able to get their prescriptions. The company has immediately escalated patients that haven’t been able to access prescriptions to preserve continuity of care.
    • “Since identifying the issue on Feb. 21, Change has worked closely with customers and clients to secure access to medications during the network disruption. The company is also working with law enforcement, Mandiant, Palo Alto Networks, and other third parties to investigate and resolve the issues.
    • “We appreciate the partnership and hard work of all of our relevant stakeholders to ensure providers and pharmacists have effective workarounds to serve their patients as systems are restored to normal,” said the statement. “As we remediate, the most impacted partners are those who have disconnected from our systems and/or have not chosen to execute workarounds.”
    • “The company also noted hospitals and health systems have connections with multiple clearinghouses and manual workarounds to continue providing care.”
  • Per Fierce Healthcare,
    • “Signify Health is expanding its in-home diagnostics offering to include a test for heart arrhythmias.
    • “The CVS Health subsidiary said Tuesday that the prevalence of irregular heartbeats is set to grow alongside an aging population. Atrial fibrillation, the most common type of arrhythmia, can be asymptomatic, and there are likely between 1.26 million and 1.52 million undiagnosed cases.
    • “Patients with a heart arrhythmia who are undiagnosed may face symptoms like shortness of breath, chest pain and rapid or irregular heartbeat, and face potential stroke or diabetes.
    • “Through the program, Signify members who are at risk for an arrhythmia are identified, and then its clinical teams will test for contraindications. Members will asked to wear a continuous ECG patch, which tracks continuous cardiac activity, and, after 14 days, the team will review the results for signs of irregular heartbeat.”
  • and
    • “Highmark is teaming up with Epic and Google Cloud to improve the flow of data between payers and providers to enhance care coordination and drive better outcomes.
    • “The goal, the insurer said, is to arm providers with the most valuable data at the point of care, enabling them to improve patient outcomes and close critical care gaps.
    • “We really need better ways to get the right information in front of the clinicians at the right time,” Richard Clarke, Ph.D., senior vice president and chief analytics officer for Highmark Health, told Fierce Healthcare. 
    • “Epic’s Payer Platform allows for “bidirectional” data sharing between the payer and the provider, he said, and Google Cloud’s technology makes it flexible enough to connect with Highmark’s existing systems readily.”
  • Fortune Well writes about a woman whose recently deceased mother’s estate is saddled with an $81,000 air ambulance bill because her mother declined Medicare Part B coverage.
    • “People who are eligible for Medicare are encouraged to sign up for Part B, unless they have private health insurance through an employer or spouse.
    • “If someone with Medicare finds that they are having difficulty paying the Medicare Part B premiums, there are resources available to help compare Medicare coverage choices and learn about options to help pay for Medicare costs,” Meena Seshamani, director of the federal Center for Medicare, said in an email to KFF Health News.
    • “She noted that every state offers free counseling to help people navigate Medicare.”

Monday Roundup

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Biden is calling congressional leaders to the White House as the clock ticks toward a partial government shutdown Friday night and a Ukraine aid package remains stuck.
    • “The president has called the meeting for Tuesday, seeking to break a logjam. House and Senate leaders have been working to negotiate the details of 12 funding bills totaling $1.6 trillion for federal agencies, which have been operating on temporary extensions since Sept. 30. Funding for the Transportation Department and several other agencies expires after March 1, which would affect some housing, food and veterans’ programs; the rest expires after March 8.” 
  • STAT News reports,
    • “Congress has abandoned its attempt to reform how pharmacy middlemen operate in an upcoming package to fund the federal government, 11 lobbyists and sources following the talks told STAT.”
  • and
    • “Congress will not move forward with a controversial policy to equalize certain Medicare payments to hospitals and physicians’ offices in an upcoming government funding package, five lobbyists and sources following the talks told STAT.”
  • From an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $36.9 million in notices of funding opportunities for grant programs supporting behavioral health services across the country. Additionally, HHS, through the Centers for Medicare & Medicaid Services (CMS), issued guidance that allows states to expand the pool of behavioral health care providers eligible for enhanced federal Medicaid funding, which will better support this critical workforce as well as improve access to care. The guidance also allows states to claim federal dollars for nurse advice lines.”
  • BioPharma Dive tells us,
    • “The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals’ Simlandi, a biosimilar of the most popular version of AbbVie’s rheumatoid arthritis drug Humira. The drug, which can be directly substituted by a pharmacist, was rejected by the FDA twice before due to manufacturing issues at a plant in Iceland.
    • “The partners didn’t announce a launch date or a price for Simlandi, which will be the 10th Humira biosimilar reach market since Amgen’s Amjevita arrived on Jan. 31, 2023. Some biosimilars have launched at a steep upfront discount while others have a list price only slightly below Humira’s to allow for negotiation over rebates.
    • “Alvotech also announced a stock sale Monday, raising around $166 million at $16.41 a share. The company had $68 million in cash and equivalents on Sept. 30, after recording losses of $275 million on $30 million in revenue through the first nine months of 2023.”
  • HR Dive informs us,
    • “A federal district court has delayed a National Labor Relations joint employer rule effective date to March 11. Friday marks the second time the start date has been delayed; NLRB previously extended a Dec. 26, 2023, start date to Feb. 26.
    • “This new rule establishes a standard for determining if two organizations are joint employers of particular employees; two entities are joint employers when they co-determine the essential terms of an individual’s employment.”
  • The Census Bureau issued a tip sheet on grandparents and co-resident grandchildren 2021.
    • “According to the 2017-2021 ACS, 5-year estimates, 8.0% of children under age 18 lived in their grandparents’ home.
    • “The proportion of children living with only their grandparents or with their grandparents and one or both parents varied across race and ethnicity. For grandchildren who lived with grandparents, it was more common to also live with both parents or their mother in the household than to live with their father or no parent in the household.
    • “Overall, about 38.6% of children under age 18 who lived with grandparents also lived with two parents. Of all race and Hispanic origin groups, Asian grandchildren had the highest percentage (70.9%) in this living arrangement.
    • “About 16.2% of grandchildren under age 18 living with grandparents were in poverty. The percentage was higher for those in grandparent-maintained households (18.6%) compared to parent-maintained households (12.1%).
    • “About 76.1% of all grandchildren under age 18 living with grandparents lived in households that received public assistance, most commonly through the school lunch program.”
  • The tip sheet drew the FEHBlog’s attention due to FEHB coverage of foster children.
  • Health Reform Beyond the Basics offers an an explanation of the ACA Summary of Benefits and Coverage

From the public health and medical research front,

  • The New York Times offers a 2024 guide to COVID symptoms and treatments.
  • CNN points out,
    • “Cases of norovirus are on the rise in the US, on par with seasonal trends, according to the most recent data from the US Centers for Disease Control and Prevention.
    • “In the week ending February 17, more than 12% of tests for norovirus – a common and very contagious virus that causes gastrointestinal symptoms – came back positive, CDC data showed. That’s up from 11.5% the week before. Cases are particularly high in the Northeast, where more than 13% of tests came back positive. Positivity rates in the region have been over 13% since late January.
    • “However, these levels are below what they were at this point last season, when about 15% of tests were positive, both nationally and in the Northeast.
    • “Outbreaks of norovirus are most common in the late fall, winter and early spring, according to the CDC.”
  • HR Daily Advisor identifies eight tips to help employees improve mental health in the face of the winter blues.
  • Medscape lets us know that “Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.”
  • The National Institutes of Health announced,
    • “Results from a large clinical trial funded by the National Institutes of Health show that an intervention for anxiety provided to pregnant women living in Pakistan significantly reduced the likelihood of the women developing moderate-to-severe anxiety, depression, or both six weeks after birth. The unique intervention was administered by non-specialized providers who had the equivalent of a bachelor’s degree in psychology—but no clinical experience. The results suggest this intervention could be an effective way to prevent the development of postpartum mental health challenges in women living in low-resource settings.
    • “In low resource settings, it can be challenging for women to access mental health care due to a global shortage of trained mental health specialists,” said Joshua A. Gordon, M.D., Ph.D., Director of the National Institute of Mental Health, part of NIH. “This study shows that non-specialists could help to fill this gap, providing care to more women during this critical period.”
    • “Led by Pamela J. Surkan, Ph.D., Sc.D.(link is external), of Johns Hopkins Bloomberg School of Public Health, Baltimore, the study was conducted in the Punjab Province of Pakistan between April 2019 and January 2022. Pregnant women with symptoms of at least mild anxiety were randomly assigned to receive either routine pregnancy care or a cognitive behavioral therapy (CBT)-based intervention called Happy Mother-Healthy Baby. The researchers assessed the participants (380 women in the CBT group and 375 women in the routine care group) for anxiety and depression six weeks after the birth of their child.
    • “The researchers found that 9% of women in the intervention group developed moderate-to-severe anxiety compared with 27% of women in the routine care group. Additionally, 12% percent of women in the intervention group developed depression compared with 41% of women in the routine care group.”
  • According to BioPharma Dive,
    • “An experimental obesity drug from Boehringer Ingelheim and Zealand Pharma succeeded in a mid-stage liver disease study, the latest evidence new weight loss medicines could also help people with metabolic dysfunction-associated steatohepatitis, or MASH.
    • “Summary results disclosed Monday show that up to 83% of trial participants treated with the companies’ drug, survodutide, experienced a significant improvement in their disease without worsening liver scarring, compared to about 18% of those given placebo. The drug met its secondary study goals, notably demonstrating a benefit on liver scarring, the companies said.
    • “Boehringer and Zealand didn’t provide many other details, leaving unanswered questions about the magnitude of survodutide’s effect. The companies also didn’t describe safety findings in depth, although they noted treatment “did not show unexpected safety or tolerability issues” at any of the three doses tested. Data will be presented at an upcoming medical meeting.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Elevance Health’s CarelonRx will begin offering a weight management program, providing its members access to digital-first coaching and wellness tools.
    • “Behavioral health and social drivers of health screenings will be included in the offerings, according to a news release. The program will help members that take, as well as those that don’t take, GLP-1 medications. It will be available to ASO-integrated clients.
    • “At CarelonRx, we want to ease the complexities of weight loss and weight management, and support healthier lifestyles for our members,” said Paul Marchetti, president of CarelonRx, in a statement. “Our weight management program is unique because it considers a member’s whole health needs, including pharmacy, medical and social drivers of health data, and creates opportunities for care coordination between nutrition and exercise experts, pharmacists, physicians and health plans.”
  • and
    • “Humana tapped data automation company Veda to improve the accuracy of its provider information and ensure seniors have real-time details about in-network providers. The partnership was announced at the ViVE 2024 conference Monday morning. * * *
    • “Founded in 2015, Veda developed an AI platform that enables payers to transform and ingest provider rosters rapidly, reducing turnaround times from weeks to hours, according to the company.
    • “Veda will use its patented automation technology to analyze, verify and standardize Humana’s data to ensure the information is accurate and comprehensive, along with real-time scoring of data quality.
    • “Accurate provider data is a key component of efficient health plan operations, care delivery, interoperability, and ultimately patient satisfaction,” Meghan Gaffney, Veda co-founder and CEO, said. “By addressing the challenges that members may face with finding in-network care providers, Humana is ensuring their members have access to the timely, high-quality care they deserve.”  
    • “Veda says its platform achieves high data accuracy, ensuring quality across networks as measured by the Centers for Medicare & Medicaid Services (CMS).”
  • and
    • “The cybersecurity incident at Change Healthcare will stretch on for at least another day, according to the latest update from Optum.
    • “The company posted early Monday morning that it is taking multiple angles to get Change’s systems back online, and stressed that it has a “high level of confidence” that other systems within Optum, UnitedHealthcare and UnitedHealth Group are unaffected. * * *
    • “In a statement to CNBC, CVS Health said that while it is continuing to fill prescriptions for customers, it’s not able to process all of its insurance claims. The pharmacy giant added that there is “no indication” that its own systems have been breached.”
  • Reuters notes,
    • “Pharmaceutical companies last year launched new U.S. drugs at prices 35% higher than in 2022, reflecting in part the industry’s embrace of expensive therapies for rare diseases like muscular dystrophy, a Reuters analysis found.
    • “The median annual list price for a new drug was $300,000 in 2023, according to the Reuters analysis of 47 medicines, up from $222,000 a year earlier. In 2021, the median annual price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published in JAMA.”
  • The Society for Human Resource Management relates,
    • “Millions more employees than expected are leaving the workplace in favor of retirement—a phenomenon that stands to have an outsized impact on employers.
    • “The U.S. currently has roughly 2.7 million more retirees than predicted, Bloomberg reports, according to a model designed by an economist at the Federal Reserve Bank of St. Louis. That’s up 80 percent from six months ago, when there were roughly 1.5 million more retirees than anticipated. By contrast, prior to the pandemic, there often were fewer retirees than expected.”

Weekend update

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

From Washington, DC

  • Forbes reports,
    • “Markets are watching as twin deadlines for a government shutdown are approaching on March 1 and March 8. The first deadline impacts four of twelve appropriations areas for the U.S. government, the second the remaining eight.
    • “However, it’s possible that budgets pass in the coming days that avert a shutdown. If not, another continuing resolution, as has avoided previous potential shutdowns, appears likely. Continuing resolutions give lawmakers more time to pass a new budget by essentially rolling forward prior funding measures.
    • “Currently event forecasting site Kalshi, gives an approximately 20% chance of a shutdown by March 4, and estimates that any shutdown before July might last only days. As such, expectations are that a shutdown will likely be avoided and were a shutdown to occur, it would be brief.
    • “However, if no government budget is passed before April, then the Fiscal Responsibility Act may come into effect that could have considerable impact on government spending. That would likely impact economic growth and the trajectory of government debt.”
  • MedTech Dive tells us,
    • The current system for monitoring and recalling medical devices is failing patients, physicians wrote in the journal Health Affairs on Thursday.
    • With the Government Accountability Office (GAO) reviewing device recalls, the physicians looked at the current process to generate suggestions for improving medical device safety in the U.S.
    • The physicians advised the GAO to propose ways to clear barriers to the implementation of unique device identifiers (UDIs) and assess how the FDA can better use the National Evaluation System for Health Technology.

From the public health and medical research front,

  • The Centers for Disease Control updated its Respiratory Illness Activity Levels website on February 23.
    • “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, 27 jurisdictions experienced high or very high activity. This number remains stable compared to last week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Influenza test positivity decreased slightly nationally but is increasing in the Northeastern, Mid-Atlantic, and Central parts of the country. COVID-19 and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflect both symptomatic and asymptomatic infections, remain at high levels, particularly in the South, but are trending downward in other areas.”
  • The New York Times reports,
    • “A drug that has been used for decades to treat allergic asthma and hives significantly reduced the risk of life-threatening reactions in children with severe food allergies who were exposed to trace amounts of peanuts, cashews, milk and eggs, researchers reported on Sunday.
    • “The drug, Xolair, has already been approved by the Food and Drug Administration for adults and children over age 1 with food allergies. It is the first treatment that drastically cuts the risk of serious reactions — like anaphylaxis, a life-threatening allergic reaction that causes the body to go into shock — after accidental exposures to various food allergens.
    • “The results of the researchers’ study, presented at the annual conference of the American Academy of Allergy, Asthma and Immunology in Washington, were published in The New England Journal of Medicine.
    • “For a certain population of food allergy patients, this medication will be life-changing,” said Dr. Robert A. Wood, the paper’s first author and director of the Eudowood Division of Pediatric Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center.”
  • NPR Shots points out,
    • “E-bike injuries have surged, sending thousands of Americans to hospitals in recent years, new research shows. 
    • “Electronic bicycle accidents were particularly hard on riders’ heads, especially the majority of those injured who didn’t wear helmets. 
    • “Helmet use declined by almost 6 percent each year between 2017 and 2022, while the number of e-bike riders with head trauma seeking hospital care shot up 49 fold to nearly 8,000 in 2022, according to research published in JAMA Surgery on Wednesday.
    • “It’s a really significant public health problem,” said Dr. Laura Goodman, a pediatric surgeon and trauma medical director of the Children’s Hospital of Orange County, who was not involved with the study.”
  • The Washington Post explains “How to make your hearing aids more effective and less frustrating. In one study, only 29 percent of those with hearing loss used hearing aids.” 
  • Fortune Well informs us,
    • “A large study in China tracked middle-aged and older adults for 20 years, using regular brain scans, spinal taps and other tests.
    • “Compared to those who remained cognitively healthy, people who eventually developed the mind-robbing disease had higher levels of an Alzheimer’s-linked protein in their spinal fluid 18 years prior to diagnosis, researchers reported Wednesday. Then every few years afterward, the study detected another so-called biomarker of brewing trouble.
    • “Scientists don’t know exactly how Alzheimer’s forms. One early hallmark is that sticky protein called beta-amyloid, which over time builds up into brain-clogging plaques. Amyloid alone isn’t enough to damage memory — plenty of healthy people’s brains harbor a lot of plaque. An abnormal tau protein that forms neuron-killing tangles is one of several co-conspirators.
    • “The new research, published in the New England Journal of Medicine, offers a timeline for how those abnormalities pile up.
    • :The study’s importance “cannot be overstated,” said Dr. Richard Mayeux, an Alzheimer’s specialist at Columbia University who wasn’t involved in the research.
    • [However, t]he findings have no practical implications yet.”

From the U.S. healthcare business front,

  • Forbes offers very useful rankings of the largest health insurance companies by U.S. overall, individual coverage, group coverage, and by individual U.S. state.
  • Per BioPharma Dive,
    • “BioMarin Pharmaceutical is struggling to sell the first marketed gene therapy for the most common form of hemophilia, announcing on Thursday minimal revenue from the treatment, called Roctavian.
    • “In its latest earnings report, BioMarin said Roctavian generated $2.7 million in sales during the fourth quarter and $3.5 million in all of 2023, as three total patients — two in Germany and one in the U.S. — were treated last year. New CEO Alex Hardy told analysts the company is seeing progress in “market access,” but is “very mindful of the return on investment” with Roctavian.
    • “Roctavian is one of two important new products for BioMarin, which is reviewing its business under new management and deciding what research to continue supporting. The other, a drug for dwarfism called Voxzogo, is surpassing expectations. Sales totaled $146 million last quarter, more than double the previous period.”
  • CNBC reports on how “new sickle cell gene therapies are a breakthrough, but solving how to pay their high prices is a struggle.”
    • “[Michael] Goodwin [, a 36 year old man with sickle cell disease,] worries about the cost. Vertex Pharmaceuticals’ gene therapy Casgevy lists for $2.2 million, while Bluebird Bio’s treatment Lyfgenia lists for $3.1 million.
    • “I do have insurance, but … I already have medical bills,” he said.
    • “Goodwin’s hesitancy to pursue treatment is no surprise to Dr. Julie Kanter, director of the Adult Sickle Clinic at the University of Alabama at Birmingham.
    • “My guess is even if we opened the gates today to everybody getting this therapy, at most only 10% of those individuals affected by sickle cell would want this therapy,” said Kanter, who also serves as the president of the National Alliance of Sickle Cell Centers. “And even that would be too much for us to manage right this second.”
    • “More than 100,000 Americans have sickle cell disease, according to Centers for Disease Control and Prevention estimates, and between 50% and 60% of them covered are covered by the federal and state insurance program Medicaid.
    • “Kanter said it will take time to ramp up capacity and to set up facilities across the country to treat patients at scale.
    • “We really hope that having the National Alliance of Sickle Cell Centers will allow us to strengthen our centers to generally care better for people living with this disease, which we haven’t been able to do before because the cost is a problem,” she said.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

TWO BIG STORIES with an interlude

  • Good news
  • Cybersecurity Dive reported on Tuesday February 20,
    • “An international group of law enforcement partners said it disrupted LockBit ransomware operations Tuesday, seizing the infrastructure of one of the most prolific ransomware groups in recent history. 
    • “The Department of Justice, working in conjunction with U.K. authorities and other international law enforcement agencies, unsealed indictments against two Russian nationals, Artur Sungatov and Ivan Kondratyev, charging them with deploying LockBit against numerous companies around the U.S. and other targets overseas. 
    • “The FBI and U.K. National Crime Agency, working with multiple partners, also seized numerous public facing websites and servers used by Lockbit. Authorities obtained decryption keys that will allow hundreds of targeted organizations and others to regain their stolen data.”
  • Cyberscoop adds more details on this important take down.
    • “A LockBit representative confirmed the operation in an online message posted on X by VX-Underground, an online malware repository. “FBI pwned me,” the representative said. 
    • “As of today, LockBit are locked out,” Graeme Biggar, the National Crime Agency Director General, said in a statement. “We have damaged the capability and most notably, the credibility of a group that depended on secrecy and anonymity.”
    • Two people were arrested as part of the operation — one in Poland and one in Ukraine — as part of the operation, Europol said in its statement.
  • Dark Reading suggests that “Hubris May Have Contributed to Downfall of Ransomware Kingpin LockBit.”
  • Interlude
  • Cybersecurity reported on Thursday February 22, 2024.
    • “Critical vulnerabilities in ConnectWise ScreenConnect are under active exploitation by threat actors, and there is an urgent need for users to patch their systems, according to security researchers.
    • “ConnectWise ScreenConnect is a remote desktop application widely used by help desks and remote workers. A critical authentication bypass vulnerability, with a CVSS score of 10, could allow an attacker access to critical systems or confidential information. A path transversal vulnerability, with a score of 8.4, could allow an attacker to execute remote code.
    • “ConnectWise on Wednesday urged on-premises partners to immediately upgrade to the latest version of ScreenConnect, after its incident response team began to investigate reports of suspicious activity. The vulnerability applies to on-premises users.”
  • Dark Reading provides more details on this massive vulnerability
    • “Just days after initial exploitation reports started rolling in for a critical security vulnerability in the ConnectWise ScreenConnect remote desktop management service, researchers are warning that a supply chain attack of outsized proportions could be poised to erupt.
    • “Once the bugs are exploited, hackers will gain remote access into “upwards of ten thousand servers that control hundreds of thousands of endpoints,” Huntress CEO Kyle Hanslovan said in emailed commentary, opining that it’s time to prepare for “the biggest cybersecurity incident of 2024.”.
  • Bad News
  • The Wall Street Journal reports yesterday,
    • Pharmacies warned of long waits for customers and U.S. military clinics worldwide have been affected after a cyberattack against one of the country’s largest prescription processors rolled into a third day of downtime.
    • Health industry experts said that a cyberattack against Change Healthcare, part of insurer 
    • UnitedHealth Group’s Optum business, could have severe and lasting consequences should outages continue past the weekend.
    • “It’s a mess, and I believe it’s our Colonial Pipeline moment in healthcare,” said Carter Groome, chief executive of healthcare-focused consulting firm First Health Advisory, referring to a 2021 cyberattack that forced the major fuel artery for the U.S. East Coast to shut down for six days, causing long lines at gas stations. * * *
    • “Parent company UnitedHealth said Thursday in a regulatory filing with the U.S. Securities and Exchange Commission that it identified a cyberattack affecting systems at Change Healthcare on Wednesday. The company suspects a nation-state was behind the attack, the filing said. ***
    • “The American Hospital Association urged healthcare facilities Wednesday to disconnect from Optum and to check their systems for security vulnerabilities.
      • “We recommend that all healthcare organizations that were disrupted or are potentially exposed by this incident consider disconnection from Optum until it is independently deemed safe to reconnect to Optum,” the AHA said.
    • “The association also urged members to test their data backups, check that critical patches are up-to-date and designate staff for shifts to manage manual processes.
    • “There is fragility in our infrastructure and in the lack of redundancy, the lack of rehearsals,” said Theresa Payton, CEO at cybersecurity consulting firm Fortalice.”
  • SC Media brings the stories together as follow:
    • “Security experts have warned for the past couple of days that the two flaws recently uncovered in ConnectWise’s ScreenConnect app could become the major cybersecurity story of 2024 – and that the healthcare and critical infrastructure sectors were especially vulnerable.
    • “Today, we’re inching closer to that reality as SC Media has learned that the recent cybersecurity incident at UnitedHealth’s Change Healthcare that led to slowdowns at pharmacies was caused by a strain of LockBit malware that was used to exploit the vulnerabilities in ConnectWise ScreenConnect.
    • “Toby Gouker, chief security officer at First Health Advisory, stressed that while it was a LockBit strain of malware, it doesn’t mean that the recently taken down LockBit gang was responsible. Gouker said the two flaws were discovered as part of a crowdsourced team for the ConnectWise bugs on Feb. 15 and that the vulnerability notifications went out on Feb. 19.
    • “And that’s where the problems started. As many of you know, malicious actors watch for these announcements to come out,” said Gouker. “They prey on the timeframe between the announcement and when an organization is able to apply the patch. So from the get-go, these actors are working to figure out a way to exploit the disclosed vulnerability and capitalize on it.”
    • “While Goucker stands by his comments, ConnectWise remained somewhat defensive, yet cautious, issuing this statement late Friday night:”
      • “At this time, we cannot confirm that there is a connection between the Change Healthcare incident and the ScreenConnect vulnerability. Our initial review indicates that Change Healthcare appears not to be a ConnectWise direct customer, and our managed service provider partners have yet to come forward, stating Change Healthcare is a customer of theirs.” * * *
  • Here is a link to the CISA notice adding the Connect wise known exploited vulnerability (CVE-2024-1709) to its catalog on February 22. This was the only KEV change announced this week.
  • Optum provided the following update on the Change Healthcare breach this morning
    • Change Healthcare is experiencing a cyber security issue, and our experts are working to address the matter. Once we became aware of the outside threat, and in the interest of protecting our partners and patients, we took immediate action to disconnect Change Healthcare’s systems to prevent further impact. This action was taken so our customers and partners do not need to. We have a high-level of confidence that Optum, UnitedHealthcare and UnitedHealth Group systems have not been affected by this issue.
    • We are working on multiple approaches to restore the impacted environment and will not take any shortcuts or take any additional risk as we bring our systems back online. We will continue to be proactive and aggressive with all our systems and if we suspect any issue with the system, we will immediately take action and disconnect. The disruption is expected to last at least through the day. We will provide updates as more information becomes available.

In other vulnerabilities and breaches news,

  • On February 22, 2024, the HHS Office for Civil Rights announced
    • “On February 14, 2024, the U.S. Department of Health & Human Services Office for Civil Rights issued two Reports to Congress on Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliance and enforcement, specifically, on HIPAA Privacy, Security, and Breach Notification Rule Compliance and Breaches of Unsecured Protected Health Information. These reports are required to be submitted to Congress annually by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. The HIPAA Rules provide the minimum required privacy and security safeguards for protected health information, and give individuals rights with respect to that information, such as the right to access their health information. These reports, delivered to Congress, help regulated entities (such as most health care providers, health plans, and healthcare clearinghouses) and their business associates in their HIPAA compliance efforts by sharing steps taken by OCR to investigate complaints, breach reports, and compliance reviews regarding potential violations of the HIPAA Rules. The reports include important data on the number of HIPAA cases investigated, areas of noncompliance, and insights into trends such as cybersecurity readiness.  * * *
    • “As in previous years, hacking/IT incidents remain the largest category of breaches occurring in 2022 affecting 500 or more individuals, and affected the most individuals, comprising 77% of the reported breaches. Network servers continued as the largest category by location for breaches involving 500 or more individuals at 58% of reported large breaches.
    • “OCR’s 2022 Report to Congress on HIPAA Privacy, Security, and Breach Notification Rule Compliance may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/reports-congress/index.html
    • “OCR’s 2022 Report to Congress on Breaches of Unsecured Protected Health Information may be found at:  https://www.hhs.gov/hipaa/for-professionals/breach-notification/reports-congress/index.html.”
  • Cybersecurity Dive tells us,
    • “Organizations with weak cloud security controls and gaps in cross-domain visibility are getting outmaneuvered by threat actors and struck by intrusions, CrowdStrike said Wednesday in its annual Global Threat Report.
    • “Cloud environment intrusions jumped 75% from 2022 to 2023, as threat actors abused unique cloud features to initiate attacks, the report found.
    • “This is not surprising,” said Adam Meyers, head of counter adversary operations at CrowdStrike. “We’ve seen more and more organizations deploying more and more cloud resources without necessarily having a cohesive or equivalent security posture for their cloud deployments as they do in their traditional enterprise deployments.”
  • Cyber Express informs us
    • “The fusion of Artificial Intelligence (AI) and cybersecurity has ushered in a new era of warfare, one conducted not on physical battlegrounds but in the vast expanse of cyberspace. With the global AI in the cybersecurity market projected to surge to $133.8 billion by 2030, the landscape is undergoing a seismic shift, with both promise and peril on the horizon. 
    • “At the heart of this revolution lies a paradox: while AI bolsters defenses, it also empowers malicious actors, fueling a surge in cybercrime. As cyberattacks grow in both scale and sophistication, the stakes have never been higher, with a staggering $9.22 trillion expected to be drained from the world’s internet users in 2024 alone. * * *
    • “As we navigate this tumultuous terrain, the imperative lies in striking a delicate balance between innovation and vigilance. Harnessing AI’s potential while mitigating its risks demands a multifaceted approach, one rooted in proactive defense, continuous adaptation, and unwavering resilience. 
    • “In the crucible of cyber conflict, AI emerges not merely as a technological marvel but as a beacon of hope, illuminating the path toward a safer, more secure digital future. Only by embracing the transformative power of AI can we hope to outmaneuver the adversaries lurking in the shadows of cyberspace.” 
  • CSO points out,
    • “Attackers prefer compromised valid accounts over phishing or any other infection methods to gain access into victim environments, according to an IBM report.
    • “As defenders increase their detection and prevention capabilities, attackers are finding that obtaining valid credentials is an easier route to achieving their goals, considering the alarming volume of compromised yet valid credentials available — and easily accessible — on the dark web,” IBM said in the report.
    • “The report, which is based on IBM X-Force’s penetration testing data from incidents in 2023, also found security misconfigurations and poor authentication enforcement as top application security risks opening organizations to identity-based attacks.”

From the ransomware front,

  • Tech Crunch identifies the “top 13 ransomware targets in 2024 and beyond.” Education is the top target, and healthcare is ranked number 11.
  • Cybersecurity Dive relates,
    • “The HHS has reached its second-ever settlement related to a ransomware attack, which exposed the protected health information of more than 14,000 people, the agency announced Wednesday. 
    • “Maryland-based Green Ridge Behavioral Health agreed to pay $40,000 and implement a corrective action plan after an investigation found potential violations of the HIPAA rule and lax protections after an attack reported in early 2019, according to the HHS’ Office for Civil Rights.
    • “The settlement comes as ransomware has become a growing and critical threat to healthcare organizations, and regulators have signaled interest in enforcing cybersecurity standards.” 

In other cybersecurity news,

  • SDXCentral calls our attention to the fact that
    • Gartner unveiled the top cybersecurity trends for 2024, including the impact of generative artificial intelligence (genAI), boardroom communication gaps, human risks, third-party security risks, continuous threat exposure and identity-first approaches to security.

Friday Factoids

David Ermer–CDC, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC

  • Roll Call reports on the state of FY 2024 appropriations negotiations on Capitol Hill. Your guess on the impending outcome is as good as mine.
  • The U.S. Office of Personnel Management released
    • “a new Workforce of the Future Playbook today supporting a federal workforce that is inclusive, agile and engaged, and equipped with the right skills to deliver for the American people. The Playbook provides concrete actions that agencies can take to build and equip the workforce of the future, incorporating new strategies and sharing best practices across government. 
    • “OPM is 100% invested in strengthening the federal workforce,” said OPM Director Kiran Ahuja. “This Playbook is just another example of OPM’s ongoing efforts to equip federal agencies with the tools and resources to hire the right talent and strategically plan for their future workforce. The federal government works best when we leverage the full talent of our nation and workforce – this playbook is full of useful strategies to do just that. * * *
    • “Coming soon, OPM will provide guidance through webinars, training, and technical assistance from subject matter experts to support agencies in their implementation of these strategies. The Playbook will serve as the building block for a future workforce that promotes increased effectiveness and efficiency in service to the American people. Periodic updates will be posted to the Workforce of the Future webpage.” 
  • The Department of Justice announced,
    • “Settlements and judgments under the False Claims Act exceeded $2.68 billion in the fiscal year ending Sept. 30, 2023, Acting Associate Attorney General Benjamin C. Mizer and Civil Division Principal Deputy Assistant Attorney General Brian M. Boynton announced today. The government and whistleblowers were party to 543 settlements and judgments, the highest number of settlements and judgments in a single year. Recoveries since 1986, when Congress substantially strengthened the civil False Claims Act, now total more than $75 billion. * * *
    • “Of the more than $2.68 billion in False Claims Act settlements and judgments reported by the Department of Justice this past fiscal year, over $1.8 billion related to matters that involved the health care industry, including managed care providers, hospitals, pharmacies, laboratories, long-term acute care facilities, and physicians. The amounts included in the $1.8 billion reflect recoveries arising only from federal losses, but in many of these cases, the department was instrumental in recovering additional amounts for state Medicaid programs. The recoveries in fiscal year 2023 also reflect the department’s focus on key enforcement priorities, including fraud in pandemic relief programs and alleged violations of cybersecurity requirements in government contracts and grants.”
  • Medscape informs us,
    • “The Food and Drug Administration has granted De Novo classification to a sleep apnea feature developed by Samsung for use via the Health Monitor app, according to a company press release.
    • “The sleep apnea feature will be available on watches in Samsung’s Galaxy series in the third quarter of 2024, according to the press release.
    • “The new feature on the app is designed to help users with no previous diagnosis of sleep apnea to detect moderate to severe symptoms over a two-night period.
    • “The sleep apnea feature allows individuals older than 22 years to track their sleep twice for more than 4 hours within a 10-day period. The feature identifies breathing disruptions.”
  • MedTech Dive adds,
    • “The Food and Drug Administration warned patients against using smartwatches or smart rings that claim to measure blood sugar without piercing the skin. 
    • “Officials published the safety notice Wednesday after learning that people are selling wearables that claim to noninvasively monitor blood glucose. The devices are “manufactured by dozens of companies and sold under multiple brand names,” according to the agency. 
    • “The FDA has never authorized a noninvasive wearable that measures or estimates blood glucose values on its own and is concerned inaccurate readings could lead to errors in the management of diabetes.”
  • Govexec reports,
    • “The U.S. Postal Service has continued to see slower mail delivery across the country, with delays picking up as the agency is in the throes of transforming its entire network. 
    • “Postal management has repeatedly pointed to isolated incidents causing temporary disruptions—rather than any systemic issues—to explain the declining performance, though the trend has now persisted for nearly six months and is causing stakeholders and advocates to question the true root of the problem.
    • “USPS is now delivering just 83% of First-Class mail on time during the current fiscal quarter, its worst rate in three years. That is down from 86% in the first quarter and 91% in both the fourth quarter of fiscal 2023 and the same period last year.”

From the public health and medical research front,

  • The Centers for Disease Control tells us about the changing threat of Covid-19
    • What CDC knows
    • The impact of SARS-CoV-2, the virus that causes COVID-19, has changed dramatically since 2020. Although COVID-19 remains common, when compared to 2020, individual infections are less likely to result in severe illness for most people in the United States. COVID-19 poses the highest risk for older adults, infants, and people with pre-existing medical conditions, and there are multiple ways people and communities can help reduce their risk of infection.
    • What CDC is doing
    • CDC continues to partner with state and local health authorities to collect and share data on COVID-19 community spread, hospitalizations, deaths, and Long COVID.  Additionally, CDC continues to evaluate the effectiveness of prevention and treatment strategies for the virus in order to provide the public the best evidence-based recommendations for reducing their risk from COVID-19.
    • Keep reading: The Changing Threat of COVID-19
  • Medscape notes,
    • Exercising for upwards of 30 minutes most days may help relieve pain in patients who’ve been diagnosed with cancer, according to a study of exercise and pain outcomes from more than 60,000 people, including 10,000 with a history of cancer. 
    • Study participants who’d been diagnosed with cancer and surpassed 150 minutes of moderate activity a week were 16% less likely to report pain than those who did not exercise or who exercised less. Exercise was particularly helpful for those with moderate to severe pain. In general, the more people exercised, the less pain they felt — and that was true for those with and without a history of cancer.
    • “This adds to a large evidence base regarding other benefits of exercise after cancer,” said lead study author Christopher Swain, PhD, a researcher at the University of Melbourne, Australia, who studies how physical activity can protect against cancer. “It would be great for physicians to encourage physical activity” for anyone who’s ever been diagnosed with cancer. 
  • Axios reports,
    • “Americans see poor mental health as one of the biggest threats to public health, ranking just behind obesity and the long-running opioid epidemic, according to the latest Axios-Ipsos American Health Index.
    • “The big picture: Almost 9 out of 10 people say their own emotional wellbeing is very or somewhat good, but they view mental health issues as a serious societal threat that now outranks access to firearms, cancer or COVID-19. 
    • “And unlike many other perceived threats, there’s a pronounced generational split about mental health, registering as a much bigger concern for younger adults.
    • “The poll also found all but a small pocket of Americans largely tuned out a winter COVID-19 wave that saw the second-largest number of cases since the start of the pandemic, and the public is skeptical about handing over their care to artificial intelligence.
    • “By the numbers: Overall, 17% said mental health was the top threat to public health, while 19% said obesity, 24% said opioids and fentanyl, and 15% said it was access to guns.”

From the U.S. healthcare business front,

  • The Employee Benefit Research Institute announced,
    • “New findings released today from the Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey(CEHCS) reported that consumers were overall satisfied with their health plan selection and services, while high deductible plans showed a slight decline in enrollment.
    • “The CEHCS is a survey of privately insured adults that has been conducted annually since 2005. The survey provides reliable national data on the growth of high deductible health plans (HDHP), consumer driven health plans (CDHP) and health savings accounts (HSA) – and the impact on the behavior and attitudes of health care consumers.  The 2023 survey of 2,020 individuals was conducted using an online research panel between Oct. 16 – Dec. 11, 2023. All respondents were between the ages of 21 and 64. * * *
    • “This year’s survey really shows strong evidence that people overall are satisfied with their health insurance.  Satisfaction levels are steady.  We see no majority is complaining and that is key to understanding market needs,” said Paul Fronstin, Ph.D., director, Health Benefits Research, EBRI.
    • “To view the 2023 CEHCS summary report, visit https://www.ebri.org/cehcs-2023.”
  • Chief Healthcare Executive reports,
    • “Nonprofit hospitals are making some progress financially, although the gains remain modest, according to Fitch Ratings.
    • “Of course, it’s saying something that Fitch’s early projections for the 2023 calendar year continue to show operational declines, although they aren’t as steep as 2022.
    • “Overall, Fitch expects the 2023 operating margins to rise into positive territory, albeit barely. The 2023 margins are expected to rise to 0.5% to 0.7%, which remains below pre-pandemic levels.
    • “In 2024, Fitch projects margins should move up to 1.6%.”
  • MedPage Today discusses whether “Artificial intelligence can improve prior authorization.”
    • “Prior authorization has ripple effects on patients and clinicians, but artificial intelligence (AI) has the potential to simplify the process, health policy experts said during an online panel discussion hosted by the Kaiser Family Foundation on Thursday.
    • “Troyen Brennan, MD, a former executive at CVS Care and an adjunct professor at the Harvard T.H. Chan School of Public Health in Boston, defended the process, arguing that it cuts down on unnecessary care. About 15% to 30% of all care in the U.S. healthcare system is ineffective, Brennan said.
    • “Plus, there are “really not any good studies … showing actual harm,” he argued. “There are a lot of surveys from physicians, in particular, that say that there are tremendous delays, but there’s obviously a response bias associated with this.”

Thursday Miscellany

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

From Washington, DC,

  • American Hospital Association (AHA) News reports,
    • “AHA Feb. 22 voiced support for the Child Suicide Prevention and Lethal Means Safety Act (H.R. 7265), legislation that would provide funding for training programs to help health care workers identify patients at high risk for suicide or self-harm. The bill would also provide grants to facilitate suicide prevention training at health professions schools.”  
  • and
    • “Senate Health, Education, Labor & Pensions Committee Ranking Member Bill Cassidy, R-La., Feb. 21 released a report proposing ways to modernize the existing HIPAA framework and protect health and other data not covered by HIPAA. Responding to Cassidy’s request for information on the issue last year, AHA asked Congress to urge the Department of Health and Human Services’ Office for Civil Rights to immediately withdraw a rule that would violate HIPAA and its implementing regulations; explore how to better require entities not covered by HIPAA to protect patient privacy; and strengthen HIPAA preemption.”
  • Roll Call tells us,
    • “The House Democratic Women’s Caucus has asked the biggest insurance association to urge insurers to comply with contraceptive coverage requirements and Biden administration guidance issued in January, according to a letter shared first with CQ Roll Call. * * *
    • “The Democratic Women’s Caucus wrote to AHIP President and CEO Mike Tuffin on Thursday urging the group to have its members follow the suggestions HHS outlined. 
    • “Despite repeated clarification of these requirements from the Departments, multiple investigations — including by the House Oversight Committee — have revealed that plans routinely violate the [2010 health care law] by refusing to cover certain products, imposing administrative hurdles like prior authorizations and step therapy (fail first protocols), and requiring patient cost-sharing,” wrote the 143 House members as well as 13 senators.
    • “The members asked Tuffin to respond if insurance plans will be adopting the standard and when; how plans that will not adopt the standard intend to comply with the coverage requirement and if any member plans have been using techniques to deny coverage as described in the HHS guidance. 
    • “The letter also seeks clarity on which plans have an exceptions process publicly available on their websites for when a therapeutically equivalent product does not work for a patient.
    • “The letter requests a response by March 1.”
  • MedTech Dive notes,
    • Better Therapeutics has received breakthrough device status for a digital therapeutic designed to treat adults with advanced liver disease, the company said Tuesday.
    • The Food and Drug Administration awarded the designation after seeing the results of a clinical trial that linked the digital cognitive behavioral therapy (CBT) to reductions in liver fat.
    • Better Therapeutics won FDA authorization in Type 2 diabetes in July but, like the wider digital therapeutics sector, has struggled to allay concerns about commercialization. The company has discussed substantial doubts about its ability to continue as a going concern. 
  • Mercer Consulting projects “the 2025 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted-benefit health reimbursement arrangements (HRAs) will all rise from 2024 levels. These unofficial 2025 amounts are determined using the Internal Revenue Code (IRC)’s cost-of-living adjustment methods, the US Bureau of Labor Statistics (BLS) published Chained Consumer Price Index for All Urban Consumers (C-CPI-U) values through January 2024, and Mercer’s projected C-CPI-U values for February and March.”
  • “The U.S. Preventive Services Task Force posted today a final research plan on screening for HIV. The draft research plan for this topic was posted for public comment from November 30, 2023, to January 3, 2024. The Task Force reviewed all of the comments that were submitted and took them into consideration as it finalized the research plan. To view the final research plan, please go here.”

From the public health and medical research front,

  • MedPage Today calls our attention to the following
    • “More than 134,000 cancers might have gone undiagnosed during the first 10 months of the COVID-19 pandemic, according to a study of national trends in cancer incidence.
    • “Annual cancer incidence fell almost 30% short of the expected rate from March through December 2020. The difference represented potentially 134,395 undiagnosed cancers during that period. Diagnosis of early- and late-stage cancers declined. Prostate, breast, and lung cancers accounted for the most potential missed cases. Overall, rates of “screenable” cancers decreased by 13.9% versus expected rates. * * *
    • “It is important that we continue to evaluate the trends identified in this study as U.S. cancer incidence data for years after 2020 become available,” the authors wrote. “Pandemic-associated disruptions will continue to affect rates of cancer incidence, and how long it will be until we fully recover is still unknown.”
    • “Beyond incidence, it is important that we measure the pandemic’s contribution to future trends in cancer mortality and survival,” they added. “With a near 10% reduction from expected rates in overall late-stage incidence from March to December 2020, there will undoubtedly — and unfortunately — be a subsequent rise in cancer mortality. How substantial a rise and for how long will provide a more complete picture of the consequences of COVID-19 disruptions on the burden of cancer in the U.S.”

The Wall Street Journal reports that “There’s No Easy Way to Stop Taking Ozempic. Those who go off weight-loss drugs risk regaining weight, but staying on them forever isn’t always a realistic option.” Quite a conundrum. The article discusses approaches to stopping the medicine and alternatives, such as bariatric surgery.

  • The National Institutes of Health announced,
    • “A research project supported by the National Institutes of Health has developed a tool to rapidly and inexpensively diagnose sarcoidosis, a chronic inflammatory disease marked by the growth of tiny lumps called granulomas in the lungs and other organs in the body. The tool, which uses a simple blood test, could allow for selective use of more invasive diagnostic tests often used to identify the disease. The findings published in the American Journal of Respiratory and Critical Care Medicine.
    • “Currently, diagnosing sarcoidosis isn’t a straightforward process, and requires tissue removal and testing with additional screenings to rule out other diseases, such as tuberculosis or lung cancer,” said James Kiley, Ph.D., Director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute, part of NIH. “Using a blood test will help diagnose faster, particularly in those organs that are more challenging to biopsy and with less harm to the patient.”
  • The NIH Director, in her blog discusses “A Potential New Way to Prevent Noise-Induced Hearing Loss: Trapping Excess Zinc.”
    • “Hearing loss is a pervasive problem, affecting one in eight people aged 12 and up in the U.S.1 While hearing loss has multiple causes, an important one for millions of people is exposure to loud noises, which can lead to gradual hearing loss, or people can lose their hearing all at once. The only methods used to prevent noise-induced hearing loss today are avoiding loud noises altogether or wearing earplugs or other protective devices during loud activities. But findings from an intriguing new NIH-supported study  exploring the underlying causes of this form of hearing loss suggest it may be possible to protect hearing in a different way: with treatments targeting excess and damaging levels of zinc in the inner ear.”
  • STAT News points out “Embryo loss is integral to [in vitro fertilization] IVF. [The] Alabama ]Supreme Court]’s ruling equating embryos with children jeopardizes its practice.” For more information, listen to this Advisory Opinions podcast from the Dispatch.

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Fourteen organizations representing providers, payers, consumer technology companies and employers are teaming up to cut through the noise and raise higher standards for finding digital health solutions that work and are worth the investment.
    • “The new Digital Health Collaborative, supported by the Peterson Health Technology Institute, brings together provider groups, purchasers and end users and initial work will focus on pulling together a national purchaser survey, grantmaking and convenings, the organization said.
    • “The Peterson Health Technology Institute formed in July 2023, armed with $50 million in funding, to evaluate digital health technologies and help cut through the hype to identify innovations that actually benefit patients. PHTI focused on providing independent, evidence-based assessments of emerging products, something that is currently lacking in the market.”
  • BioPharma Dive tells us,
    • “Moderna shares rose by as much as 10% Thursday morning after the COVID-19 vaccine developer reported fourth quarter profit that beat Wall Street expectations of a net loss during the final three months of 2023.
    • “Full-year sales of $6.7 billion matched estimated numbers Moderna disclosed in January, but were down by about two-thirds versus 2022 as COVID vaccination rates declined substantially last year. The company has restructured its manufacturing operations in response to match the lower demand.
    • “Moderna forecasts $4 billion in sales this year, with some expected to come from an experimental vaccine for respiratory syncytial virus that’s under regulatory review in the U.S. and several other countries.”
  • McKnight’s Long Term Care News lets us know,
    • “A shortage of registered nurses in the first two years of the pandemic was probably temporary, according to a new report. That’s because the workforce rebounded in 2022 and 2023, the authors said. Even still, a lot of RNs aren’t going back to hospitals and are moving into other settings including nursing homes and long-term care communities, authors of the report said.
    • “The study, published on Feb. 16 in JAMA Health Forum, noted that the workforce of RNs fell by about 100,000 employees in 2021. That decrease was the largest drop in a single year in the past 40 years. In 2022, hiring started to go back up, according to data from the US Bureau of the Census Current Population Survey. 
    • “The data included RNs between the ages of 23 and 69 who were employed between 1982 and 2023. The researchers also used another cohort of data on employment trends by birth year and age to project the age distribution and employment of RNs through the year 2035. There were 455,085 RNs included in the study. In 2022 and 2023, there were 3.35 million full-time RNs, which is 6% higher than in 2019 when there were 3.16 million nurses.”
  • Per Healthcare Dive,
    • “Walgreens is planning to close its remaining VillageMD clinics in Florida as the beleaguered retail giant continues to cut costs.
    • “VillageMD operated 52 clinics in Florida, but 14 have closed to date. The remainder will shutter by March 15, according to multiple news reports citing Walgreens. The closures fully exit VillageMD from Florida, one of its largest markets and a key target for value-based primary care chains given the state’s large population of elderly patients with chronic health needs.
    • “Walgreens did not share details of what’s driving the closures. But analysts say Walgreens may have struggled getting enough doctors and patients into the smaller clinics, which are co-located within Walgreens stores.”
  • Beckers Hospital News notes,
    • “Grubhub has teamed up with CVS Pharmacy to deliver health and wellness products to consumers in 48 states. 
    • “Grubhub users can now access thousands of products on the mobile ordering and delivery platform from more than 6,000 CVS locations nationwide. * * *
    • “CVS is the second national drugstore chain to partner with Grubhub, behind Rite Aid. Walgreens has also teamed up with Doordash and Uber to deliver medications and other health products.”
  • Per HR Dive,
    • “Business advocates and the U.S. Department of Labor can resume their fight over independent contractor regulations, the 5th U.S. Circuit Court of Appeals decided Monday (Coalition v. Su).
    • “The litigation began after the Biden administration in 2021 nixed a Trump-era rule on the issue. Business groups challenged that withdrawal, arguing DOL overstepped its authority. A federal district court judge agreed, and the Biden administration appealed that ruling to the 5th Circuit. The appeals court issued a stay pending DOL’s publication of a new rule.
    • “Biden’s DOL finalized its own version of the regulations in January, with a March 11 effective date, leading the 5th Circuit to lift its stay Monday at the request of the business groups. The court also vacated the lower court’s opinion at DOL’s request, sending it back for the court to revisit.
    • “Considering this and other litigation related to the new regulations, a court could very well put the upcoming rules on hold, an employment law attorney told HR Dive last month; but with the effective date just weeks away, employers should monitor developments closely, he said.”