Happy Leap Day!

Happy Leap Day!

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

Photo by Manasvita S on Unsplash

From Washington, DC,

  • Politico reports,
    • “Congress is out of town this week and facing another government shutdown deadline with major health care implications.
    • “Lawmakers are confronted with two deadlines — March 1 for funding for the FDA and the VA and March 8 for HHS funding.
    • “It’s a key week for Congressional appropriators. How much progress they make now will determine whether lawmakers have to turn to another temporary spending package.
    • E”ven though Congress is away, negotiations continue, and key lawmakers are “encouraged” about the prospect of reaching a deal.
    • “But as POLITICO’s Caitlin Emma and Jennifer Scholtes report, there’s skepticism about whether the progress is being made quickly enough, according to sources familiar with the talks. Legislative text for some fiscal 2024 measures should ideally be finalized by this weekend to allow time for the Congressional Budget Office to pore over the bills and top lawmakers to calculate their next steps.”
  • Govexec offers a Kevin Moss article about OPM’s recent call letter for 2024 benefit and rate proposals for FEHB and PSHBP coverage. Bear in mind that the article does not appreciate the fact the Part D EGWP plans integrate Medicare and FEHB / PSHB coverage so that if Medicare does not cover a particular drug, like an obesity treatment, the FEHB / PSHB coverage will kick in.
  • FEDWeek discusses an OPM Inspector General report criticizing OPM’s FEHB disputed claims resolution process. The FEHBlog thinks that OPM does a good job with this process. Of course, any process can be improved but at what cost?
  • Healthcare Dive tells us,
    • “The CMS finalized a rule on Tuesday recalculating disproportionate share hospital payments, or reimbursements for hospitals serving a high proportion of low-income patients. Under the new definition, hospitals can only receive reimbursements for services rendered to beneficiaries for whom Medicaid is their primary insurer. 
    • “Congress tasked the CMS with clarifying DSH calculations in its Consolidated Appropriations Act of 2021. The final rule aims to reduce DSH overpayments by limiting hospitals’ ability to receive government and private payer funds for the same service, according to the rule.
    • I”n total, the CMS’ new calculations will result in an $8 billion reduction in DSH payments annually from fiscal year 2024 to 2027, according to the rule.” 
  • Assistant Secretary of Labor for Employee Benefit Security, Lisa Gomez, posted a blog entry about how to use your employer sponsored health benefits to improve heart health.
  • The Government Accountability Office issued a report on maternal health.
    • “Hundreds of women in the U.S. die each year from complications related to pregnancy and childbirth—a crisis exacerbated by COVID-19. The Department of Health and Human Services is working to address the crisis and meet long-term goals such as increasing women’s access to high-quality maternal care.
    • “As of September 2023, HHS hasn’t determined how it’ll measure progress toward achieving its maternal health goals. Following key performance measurement practices—such as setting near-term goals and establishing timeframes for results—would allow the agency to better understand if its efforts are effective. We recommended that HHS do so.”
  • The National Institutes of Health announced,
    • “launch[ing] a clinical trials network to evaluate emerging technologies for cancer screening. The Cancer Screening Research Network (CSRN) will support the Biden-Harris administration’s Cancer Moonshot℠ by investigating how to identify cancers earlier, when they may be easier to treat. Eight groups have received funding from the National Cancer Institute (NCI), part of NIH, to carry out the initial activities of the network.
    • “There are many cancers we still cannot reliably detect until it is so late that they become extremely difficult to treat,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “Emerging technologies such as multi-cancer detection tests could transform cancer screening and help to extend the lives of many more people. We need to be sure that these technologies work and understand how to use them so they benefit everyone.”
    • “Studies are needed, for example, to evaluate the benefits and harms of promising new technologies for cancer screening and to determine how best to incorporate these technologies into the standard of care.”
    • “In 2024, the network will launch a pilot study, known as the Vanguard Study on Multi-Cancer Detection, to address the feasibility of using multi-cancer detection (MCD) tests in future randomized controlled trials. MCDs are blood tests that can screen for several types of cancers. The study will enroll up to 24,000 people to inform the design of a much larger randomized controlled trial. This larger trial will evaluate whether the benefits of using MCD tests to screen for cancer outweigh the harms, and whether they can detect cancer early in a way that reduces deaths.”

From the public health and medical research front,

  • KFF informs us,
    • The United States is knee-deep in what some experts call the opioid epidemic’s “fourth wave,” which is not only placing drug users at greater risk but is also complicating efforts to address the nation’s drug problem.
    • These waves, according to a report out today from Millennium Health, began with the crisis in prescription opioid use, followed by a significant jump in heroin use, then an increase in the use of synthetic opioids like fentanyl.
    • The latest wave involves using multiple substances at the same time, combining fentanyl mainly with either methamphetamine or cocaine, the report found. “And I’ve yet to see a peak,” said one of the co-authors, Eric Dawson, vice president of clinical affairs at Millennium Health, a specialty laboratory that provides drug testing services to monitor use of prescription medications and illicit drugs. * * *
    • Methamphetamine, a highly addictive drug often in powder form that poses several serious cardiovascular and psychiatric risks, was found in 60% of fentanyl-positive tests last year. That is an 875% increase since 2015. * * *
    • Among the report’s other key findings:
      • The nationwide spike in methamphetamine use alongside fentanyl marks a change in drug use patterns.
      • Polydrug use trends complicate overdose treatments. For instance, though naloxone, an opioid-overdose reversal medication, is widely available, there isn’t an FDA-approved medication for stimulant overdose.
      • Both heroin and prescribed opioid use alongside fentanyl have dipped. Heroin detected in fentanyl-positive tests dropped by 75% since peaking in 2016. Prescription opioids were found at historic low rates in fentanyl-positive tests in 2023, down 89% since 2013.
  • MedPage Today points out,
    • “Annual breast cancer screening at ages 40 to 79 resulted in the greatest reduction in mortality, according to a study comparing various screening scenarios.
    • “Using Cancer Intervention and Surveillance Modeling Network (CISNET) estimates of breast cancer screening outcomes published in 2009, 2016, and 2023, mortality was reduced by 41.7% with annual screening starting at age 40 and continuing up to age 79, reported Debra L. Monticciolo, MD, of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, and colleagues.”
  • AP reports,
    • “Emily Hollenbeck lived with a deep, recurring depression she likened to a black hole, where gravity felt so strong and her limbs so heavy she could barely move. She knew the illness could kill her. Both of her parents had taken their lives. 
    • “She was willing to try something extreme: Having electrodes implanted in her brain as part of an experimental therapy.
    • “Researchers say the treatment —- called deep brain stimulation, or DBS — could eventually help many of the nearly 3 million Americans like her with depression that resists other treatments. It’s approved for conditions such as Parkinson’s disease and epilepsy, and many doctors and patients hope it will become more widely available for depression soon.”
  • Fierce Healthcare lets us know,
    • “Given the impact that social factors have on overall health, employers can better manage costs and outcomes by embracing deeper, population-level data analysis, according to a new white paper.
    • “UnitedHealthcare and the Health Action Council (HAC), a nonprofit that represents large and midsize employers, dug into community health data from HAC’s plan sponsors representing 217,779 workers. The analysis found that 52% of adults have at least one social determinant of health risk.
    • “Of that group, 10% faced three or more risks, and 16% had two risk factors. Twenty-six percent have one SDOH risk factor, according to the report.
    • “Craig Kurtzweil, chief data and analytics officer for UnitedHealthcare Employer and Individual, told Fierce Healthcare that the study “gives us a first of its kind sort of view of all the different variables that are impacting the health of various communities and employers.”
    • “As you dive a little bit further, it just becomes a bit remarkable how much of an impact those factors are making,” he said.”
  • Becker’s Hospital Review brings us up to date on prescription drug shortages.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “St. Louis-based Ascension Healthcare brought in $231 million in operating income during its second quarter 2024 ended Dec. 31, compared to an operating loss of $291 million during the prior-year period.
    • “Ascension attributed its operational improvement in part to volume growth. Inpatient admissions increased 0.5% in thesix months ended Dec. 31, with same-facility admissions increasing 1.2% for the same period year over year.
    • “The health system said it slowed the pace of expense growth during the quarter. Total salaries, wages and benefits decreased $152 million in the six months ended Dec. 31, totaling $54.9 million for the quarter, as Ascension outsourced lab services and continued retention programs to reduce dependence on pricey staffing agencies.”
  • STAT News notes,
    • DarioHealth, which makes apps for managing chronic diseases, today announced it will acquire digital mental health company Twill for $10 million in cash plus stock valued at over $20 million at the end of Tuesday trading. The move is a bet that a consolidated offering can attract a critical mass of large customers in a market where profits have been elusive.
    • “Founded in 2011, Dario started with a diabetes app targeted at consumers before expanding it to hypertension and weight management. It still maintains that direct-to-consumer business but has since shifted its focus to selling its suite of offerings, including a musculoskeletal care program it acquired in 2021, to health plans and employers in the hopes of reaching much larger patient populations. Recent updates aimed at making itself attractive to clients include a new offering built around popular, and expensive, GLP-1 weight loss drugs, and published real world data suggesting its tools can save clients money on downstream health care costs. With Twill, Dario adds a mental health app and related services, addressing a top demand of employers.”
  • Per Fierce Healthcare,
    • “Teladoc offered a weaker-than-expected forecast for 2024, projecting slower revenue growth as the telehealth market has become crowded with digital health players.
    • “The virtual care giant pulled in $661 million in revenue in the fourth quarter of 2024, up 4% from $638 million in the same period a year ago. Access fees revenue grew 4% to $574 million, and other revenue grew 3% to $87 million. U.S. revenue grew 2% to $565 million, and international revenue grew 15% to $96 million.
    • “The company’s BetterHelp virtual mental health business saw flat growth in the fourth quarter, bringing in $277 million. The weakness in BetterHelp sales was the result of lower direct-to-consumer marketing yield.
  • Beckers Payer Issues offers an interview with an Aetna Executive about the company’s Medicare Advantage business.
  • MedCity News calls our attention to a continuing interoperability problem.
    • “The healthcare industry has notoriously struggled with disconnected data systems and a lack of interoperability. When health information cannot be easily exchanged between different systems and providers, it leads to fragmented care, medical errors and delays in treatment — not to mention an incredible amount of frustration and inconvenience for both providers and patients.
    • “Software developers have been working hard in recent years to create tools and data sharing standards that foster a more cohesive and integrated approach. However, these tools have a serious adoption problem, experts said last week during a virtual panel held by Reuters Events.
    • “Alistair Erskine, Emory Healthcare’s chief information and digital officer, pointed out that most provider referrals are still done by fax, even though there are tools available to send them digitally. Most providers use EHRs that are able to pull a patient’s health information and transport it to the EHR of the new provider to whom they’ve been referred, he said.
    • “Despite data sharing standards like FHIR and DICOM — and despite “the fact that the data has already been digitized” — completing a provider referral is still not a smooth process, Erskine remarked. He stated that 98% of referrals are done by fax even though they could “of course” be done electronically.
    • “Even though the standards are there, we have to make sure that people safely log into their systems, and we have to make sure that people are able to find their patient in their systems. And if you navigate from one system to the next, that presents a barrier to entry. It’s easier to just take a piece of paper, write what you need and send it in a fax,” Erskine explained.”

Happy Super Sunday!

From Washington DC

  • The deadline for submitting comments on the No Suprises Act IDR operation proposed rule closed recently. Here are links to comments from carriers, AHIP, and our FEHB plan trade association, AFHO.
  • 119 comments were submitted in total. 

From the public health and medical research front,

  • Fortune Well discusses prostate cancer cases in the U.S.
    • “Rates of America’s second-deadliest cancer in men are on the rise—and they’ve been building exponentially for almost a decade straight.
    • “Since 2014, U.S. diagnoses of prostate cancer—highly survivable if caught early—have risen 3% annually. Advanced-stage diagnoses have risen 5% year over year.
    • “Adding insult to injury, Black men are being diagnosed with late stages of the condition at two to three times the rate of white men, and are also around 2.5 times more likely to die of it, experts say.”
  • The American Medical Association explains the steps that patients can take to control their blood pressure.
  • NPR considers the simmering debate simmers when doctors should declare brain death.

From the U.S. healthcare business front,

  • The Wall Street Journal warns
  • “Medicare Advantage is facing a bit of a disadvantage.
  • “The private plans have grown in popularity in recent years because many seniors like that they come with no monthly premiums and offer extra benefits, including vision and dental coverage as well as fitness memberships. (It also doesn’t hurt that the plans are marketed aggressively). Now, though, the industry is contending with pressure on both cost, as seniors who held back on procedures during the pandemic rush back, and revenue, as the Biden administration curtails payments to plans.
  • “The more challenging financial picture means companies will need to make some tough decisions about their plans next year—either sacrifice profit margins to continue growing or pull back on benefits to boost profitability. While there are other factors at play, if the current trends continue, plans will have to be more cautious in their offerings going forward. 
  • “At this point, it looks pretty clear that next year’s reduction in benefits is really going to reduce enrollment growth,” says David Windley, an analyst at Jefferies.” 

Midweek update

Photo by Manasvita S on Unsplash

From Washington, DC

  • The Department of Health and Human Services informs us,
    • “On Monday, February 5, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra met virtually with pharmacy CEOs, including Walgreens, CVS, Walmart, and pharmacy leaders, to discuss COVID-19 therapeutics commercialization. Secretary Becerra reconvened pharmacy leaders as a follow-up to his larger meeting with pharmacies, pharmacy benefit managers, and insurers on January 9, 2024.
    • “During the call, Secretary Becerra made it clear that no patient should be charged hundreds of dollars for Paxlovid at the pharmacy counter – stressing the importance of pharmacist education and clear communication to patients. Secretary Becerra re-iterated the Biden-Harris Administration’s commitment to equitable access to COVID-19 therapeutics, reminded pharmacy leaders of the pathways for access that HHS negotiated with Pfizer, and made it clear that HHS would continue to engage with pharmacist leadership as needed.
    • “While HHS is no longer managing the distribution of COVID-19 therapeutics since they transitioned to the commercial market, the Biden-Harris Administration has been closely monitoring the therapeutics commercialization process and remains committed to equitable access to lifesaving COVID-19 therapeutics, including Paxlovid. Thanks to the pathwaysthat HHS negotiated with Pfizer, all individuals on Medicare and Medicaid can receive Paxlovid for free through 2024 and individuals who are uninsured can receive Paxlovid for free through 2028. * * *
    • “To learn more about Paxlovid access, go to Pfizer’s PAXCESS Website
  • Health Payer Intelligence points out a KFF study on how various types of payer cover COVID-19 tests, treatments and vaccines post-public health emergency.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services yesterday released FAQs clarifying coverage criteria and utilization management requirements for Medicare Advantage plans under its final rule for calendar year 2024, which includes provisions intended to increase program oversight and create better alignment between MA and Traditional Medicare. Topics addressed by the FAQs include medical necessity determinations; algorithms and artificial intelligence; internal coverage criteria; post-acute care; the two-midnight benchmark for inpatient admission criteria; prior authorization; and enforcement.”
  • STAT News adds,
    • “In recent months, the federal government has repeatedly told Medicare Advantage insurers that they cannot use artificial intelligence or algorithms to deny medical services the government routinely covers.
    • “But in finalizing a rule to that effect, it also stepped into a thicket of questions from insurers about a technology that is especially difficult to pin down: What is AI? Can it be used at all to make decisions about the coverage of older patients? If so, how?
    • “This week, the federal agency that oversees Medicare sought to boil it all down into a simple directive: Put the circumstances of the individual patient first, and your algorithm second.
    • “An algorithm that determines coverage based on a larger data set instead of the individual patient’s medical history, the physician’s recommendations, or clinical notes would not be compliant” with federal regulations, the government wrote in a memo to Medicare Advantage insurers on Tuesday.”
  • Health plans were using algorithms in claims processing long before AI exploded on the scene. On a related note, Health IT Analytics explores the benefits of predictive analytics in healthcare.
  • The FEHBlog noticed this entry on the OMB Office of Information and Regulatory Affairs website.
AGENCY: OPMRIN: 3206-AO43Status: Pending ReviewRequest EO Meeting
TITLE: Postal Service Reform Act; Establishment of the Postal Service Health Benefits Program 
STAGE: Final RuleSECTION 3(f)(1) SIGNIFICANT: No
** RECEIVED DATE: 02/06/2024LEGAL DEADLINE: None  
From Reginfo.gov
  • This notice pertains to OPM’s effort to finalize the interim final rule establishing the Postal Service Health Benefits Program issued April 6, 2023. OIRA review is the last step in the regulatory process before publication of this “final, final” rule in the Federal Register. OPM had project publishing that rule this month.
  • Drug Channels discusses
    • the latest National Health Expenditure (NHE) data, which measures all U.S. spending on healthcare.
    • As you will see, retail and mail prescription drug spending remain a consistently small share of the $4.5 trillion that we spend on U.S. healthcare. 
    • And contrary to what you might read, drug spending growth was *not* driven by purportedly “skyrocketing” drug prices. In reality, nearly all drug spending growth occurred due to growth in the number of people treated, prescriptions dispensed, and other nonprice factors.

From the public health and medical research,

  • The Washington Post offers an opinion piece by former CDC Director Thomas Frieden about the public health importance of treating hypertension.
  • The Post also provides background on stomach cancer, the disease that cause country singer Toby’s Keith’s death earlier this week.
  • The National Institutes of Health announced,
    • In a recent study of the brain’s waste drainage system, researchers from Washington University in St. Louis, collaborating with investigators at the National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institute of Health (NIH), discovered a direct connection between the brain and its tough protective covering, the dura mater. These links may allow waste fluid to leave the brain while also exposing the brain to immune cells and other signals coming from the dura. This challenges the conventional wisdom which has suggested that the brain is cut off from its surroundings by a series of protective barriers, keeping it safe from dangerous chemicals and toxins lurking in the environment.
    • “Waste fluid moves from the brain into the body much like how sewage leaves our homes,” said NINDS’s Daniel S. Reich, M.D., Ph.D. “In this study, we asked the question of what happens once the ‘drain pipes’ leave the ‘house’—in this case, the brain—and connect up with the city sewer system within the body.” Reich’s group worked jointly with the lab of Jonathan Kipnis, Ph.D., a professor at Washington University in St. Louis. * * *
    • Together, the labs found a “cuff” of cells that surround blood vessels as they pass through the arachnoid space. These areas, which they called arachnoid cuff exit (ACE) points, appear to act as areas where fluid, molecules, and even some cells can pass from the brain into the dura and vice versa, without allowing complete mixing of the two fluids. In some disorders like Alzheimer’s disease, impaired waste clearance can cause disease-causing proteins to build up. Continuing the sewer analogy, Kipnis explained the possible connection to ACE points:  
    • “If your sink is clogged, you can remove water from the sink or fix the faucet, but ultimately you need to fix the drain,” he said. “In the brain, clogs at ACE points may prevent waste from leaving. If we can find a way to clean these clogs, its possible we can protect the brain.”  
  • Medscape lets us know,
    • “Dry January has come to an end — at least for those who jumped on the trendy post-holiday no-booze wagon.
    • “The benefits of drinking less alcohol are well documented. A systematic review of 63 studies, for example, found that reducing or giving up alcohol reduced people’s risk for hospitalization, injuries, and death. The lifestyle change also improved people’s physical and mental health as well as their quality of life.
    • “When it comes to cancer risk, however, the benefits of quitting or cutting back on alcohol remain much less clear, according to a new report from the cancer agency of the World Health Organization (WHO).
    • “After reviewing dozens of studies, the International Agency for Research on Cancer (IARC) concluded that, for most alcohol-related cancers, there is limited evidence to support a link between eliminating or reducing alcohol consumption and lowering of cancer risk.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Citing elevated medical costs, CVS Health on Wednesday cut its 2024 outlook despite posting better revenue and earnings than Wall Street had expected in the fourth quarter.
    • The massive healthcare conglomerate now expects to bring in at least $8.30 in adjusted earnings per share this year, compared to prior guidance of $8.50.
    • “CVS is the latest insurer to post 2024 guidance below investors’ expectations, after Humana released a disappointing earnings outlook last month.”
  • and
    • “Amazon is cutting hundreds of jobs across One Medical and Amazon Pharmacy, the company confirmed on Wednesday.
    • “The goal of the cuts is to “realign” resources to meet the divisions’ goals, Amazon Health Services SVP Neil Lindsay said in an email to staff shared with Healthcare Dive. The company is not disclosing the number of employees or what roles are being impacted by the cuts.
    • “Affected employees will receive financial support and benefit continuation, as well as the opportunity to apply for new roles at Amazon, according to Lindsay. Amazon is not on a hiring freeze and will continue to hire providers and employees for One Medical and Amazon Pharmacy.”
  • Beckers Hospital Review notes,
    • “More than a quarter of the top U.S. hospitals for patient experience fall under Providence’s umbrella, according to a new ranking from PEP Health
    • “The Minneapolis-based AI platform extracts behavioral insights data from patient comments shared on multiple social media and review platforms. To rank the top U.S. hospitals for patient experience in 2024, PEP Health gathered and analyzed more than 30 million online patient reviews shared between Jan. 1 and Dec. 31, 2023.  * * *
    • “On average, the top 30 scored 30% higher in continuity of care, 22% higher in attention to physical and environmental needs, and 17% higher in fast access than their peers. 
    • “Hospitals belonging to Renton, Wash.-based Providence excelled on more than half of the assessment metrics, according to PEP’s report. Although eight of the top 30 hospitals were prefixed with “Providence” — and another, Swedish Medical Center-First Hill in Seattle, is an affiliate — the system could still show improvement in communication and emotional support, per the AI company.”
  • Per BioPharma Dive,
    • “Amgen is a global pharmaceutical company worth more than $160 billion. Nine of its marketed medicines are blockbuster products by annual sales.
    • “Yet, on a Tuesday conference call discussing Amgen’s fourth quarter earnings, all Wall Street analysts wanted to talk about was an experimental drug that only just cleared the first stage of human testing.
    • “More than half of the questions asked by analysts were focused on AMG 133, a promising treatment for obesity that’s drawn attention as a potential competitor to in-demand weight loss medicines from Novo Nordisk and Eli Lilly. While Wall Street often overlooks the present to focus on the future, the intense interest in a drug years away from the market was noteworthy.”
  • Milliman has made available its
    • “sixth annual Milliman Multiemployer Health and Welfare Study, which analyzes financial disclosures for multiemployer health and welfare plans, also known as Taft-Hartley plans. This year’s report includes data for 1,226 plans covering approximately 4.6 million members as of 2021, the most recent year for which data is available. The average plan could pay about one year and three months of benefits and expenses with its net assets, a decrease of approximately one month from 2020.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC

  • STAT News reports
    • “The Biden administration is making its opening offers to pharmaceutical companies in its brand-new Medicare drug price negotiation program on Thursday, administration officials said. And that’s about all they said.
    • “The offers will not be made public unless a manufacturer chooses to publicly disclose information about the talks, a senior administration official said. Companies have until March 2 to either accept the government’s offer or propose a counteroffer. The Biden administration will publish the final prices by Sept. 1 of this year after the negotiation process ends. 
    • “The negotiated prices won’t take effect until 2026. 
    • “The first 10 drugs up for negotiation are Bristol Myers Squibb’s blood thinner Eliquis, Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, Johnson & Johnson’s blood thinner Xarelto, Merck’s diabetes drug Januvia, AstraZeneca’s diabetes drug Farxiga, Novartis’ heart failure treatment Entresto, Amgen’s rheumatoid arthritis drug Enbrel, Johnson & Johnson and AbbVie’s blood cancer treatment Imbruvica, J&J’s anti-inflammatory medicine Stelara, and Novo Nordisk insulins that go by names including Fiasp and NovoLog.”
  • Here is a link to PhRMA’s views on the development.
    • “The bottom line: This process is a black box that allows a few government bureaucrats to make politicized decisions about the value of medicines and with no accountability to patients or the public.”
  • BioSpace adds,
    • “A federal court in Delaware heard arguments Wednesday in a key lawsuit challenging Medicare drug-negotiation provisions of the Inflation Reduction Act (IRA). Reportsfrom inside the courtroom suggested that the judge was skeptical of the arguments raised by plaintiff AstraZeneca, though experts told BioSpace this is just an early step in what could be a protracted series of legal battles.
    • “While no ruling on AstraZeneca’s motion for summary judgment is expected for about a month, court activity will heat up over the next few weeks, as a total of 10 cases from pharma companies and groups have challenged various aspects of the IRA’s Medicare drug-pricing provisions. Other plaintiffs include MerckNovartisJohnson & JohnsonBristol Myers SquibbBoehringer Ingelheim, Novo Nordisk and the lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA).

From the public health and medical research front,

  • MedPage reports,
    • “The updated 2023-2024 COVID-19 vaccine was approximately 54% effective against symptomatic SARS-CoV-2 infection in adults, and was also effective against the JN.1 variant, which became predominant in January, CDC researchers said.
    • “Overall, vaccine effectiveness against symptomatic COVID was 57% for people ages 18 to 49 years and 46% for people ages 50 and older, reported Ruth Link-Gelles, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in the Morbidity and Mortality Weekly Report.”
  • and
    • “Military personnel stationed at Camp Lejeune from 1975 to 1985 had at least a 20% higher risk for a number of cancers than those stationed elsewhere, federal health officials said Wednesdayin a long-awaited study about the North Carolina base’s contaminated drinking water.
    • “Federal health officials called the research one the largest ever done in the U.S. to assess cancer risk by comparing a group who live and worked in a polluted environment to a similar group that did not.”
  • American Hospital Association News tells us,
    • “The Substance Abuse and Mental Health Services Administration Jan. 31 updated it Overdose Prevention and Response Toolkit, which includes basic information on overdose prevention and treatment as well as specific guidance and resources for health care providers and prescribers.”
  • The Institute for Clinical and Economic Review released
    • “its revised Evidence Report assessing the comparative clinical effectiveness and value of iptacopan (Novartis) and danicopan (Alexion Pharmaceuticals) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). While important health benefits for patients were shown in clinical trials for both agents, there is uncertainty about long-term efficacy and safety. ICER’s model for iptacopan, which is already FDA-approved, using a shared-savings approach (described in more detail below), suggests that the drug would need to be priced 70% lower than the current list price to meet commonly accepted thresholds. For danicopan, which is not yet FDA-approved, ICER’s model suggests the price would need to be between $12,300 and $13,100 per year to achieve common thresholds for cost-effectiveness.
    • “This Evidence Report will be reviewed at a virtual public meeting of the California Technology Assessment Forum (CTAF) on February 16, 2024.”
  • NPR discusses aging.
    • I used to flinch at the topic of aging. Is there anything we can do about the inevitable?
    • But recently I’ve been digging into a new wave of longevity research that is making it an exciting time to be an aging human — which is all of us.
    • It turns out, we all age at varying rates. Super-agers may have great genes, but research shows our habits and routines — everything from what we eat and how we move our bodies to who we spend our time with — matter a lot, when it comes to aging well.
    • Now, the next frontier is to target the basic biology of aging and come up with new interventions to slow it down.
    • Many scientists are optimistic that we’re on the cusp of breakthroughs. Not only to help us live longer, but — more importantly — to extend the number of years we live with good health.
    • This is the goal of researchers at the Human Longevity Lab at the Northwestern University Feinberg School of Medicine. They’re recruiting study participants so they can test what kinds of interventions may slow the rate of aging.
  • The reporter describes participating in this study.
  • HealthDay informs us,
    • “Adolescent substance use is associated with psychiatric symptoms, including suicidal thoughts, according to a research letter published online Jan. 29 in JAMA Pediatrics.
    • “Brenden Tervo-Clemmens, Ph.D., from the University of Minnesota in Minneapolis, and colleagues examined associations between commonly used substances and psychiatric symptoms among adolescents in two samples: students from 36 Massachusetts high schools who completed the 2022 to 2023 Substance Use and Risk Factor (SURF) Survey and analogous self-reported items from the 2021 Youth Risk Behavior Survey (YRBS). Data were included for 15,626 SURF participants and 17,232 YRBS participants.
    • “The researchers found significant, moderate dose-dependent associations for alcohol, cannabis, and nicotine use with worse psychiatric symptoms, including suicidal thoughts in SURF and YRBS, depressive or anxiety symptoms and inattention or hyperactivity in SURF, and general mental health in YRBS.” 
  • Memory Care Business notes,
    • “A new global effort is underway to accelerate the prevention, diagnosis and management of Alzheimer’s and other forms of dementia. 
    • “The effort, dubbed the Alzheimer’s Moonshot, was announced by StartUp Health in partnership with the Alzheimer’s Drug Discovery Foundation’s Diagnostics accelerator and Gates Ventures, the private office of entrepreneur Bill Gates. 
    • “The Alzheimer’s effort is among a new series of “moonshots” from StartUp Health. The efforts also have taken aim at other health challenges, such as Type 1 diabetes, with the goal of bringing together like-minded company founders and researchers in those spaces.”
  • The Washington Post reports,
    • “An international team led by scientists at Stanford University has discovered a probable explanation for a decades-old biological mystery: why vastly more women than men suffer from autoimmune diseases such as lupus and rheumatoid arthritis.
    • “Women account for about 80 percent of the people afflicted with autoimmune diseases, a collection of more than 100 ailments that burden a combined 50 million Americans, according to the nonprofit Autoimmune Association. In simple terms, these illnesses manipulate the body’s immune system to attack healthy tissue.
    • “In a paper published Thursday in the journal Cell, researchers present new evidence that a molecule called Xist — pronounced like the word “exist” and found only in women — is a major culprit in these diseases.
    • “Better understanding of this molecule could lead to new tests that catch autoimmune diseases sooner and, in the longer term, to new and more effective treatments, researchers said.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Tenet Healthcare has disclosed a pair of new and completed hospital transactions alongside projections that next week’s 2023 financial report “will be above the high end” of its guidance.”
  • and
    • “New Jersey providers Saint Peter’s Healthcare System and Atlantic Health System have taken the first step toward a merger they said would include “significant investments” in the Catholic system’s service area.”
  • and
    • “Hospitals and health systems closed out the year on a high note with margins up more than 15% from 2022, according to Kaufman Hall.”
    • “The firm’s latest sector-wide monthly report pointed to an increase in year-to-date operating margin index, from 1.9% through November to 2.3% at the end of the year. On a single-month basis, the operating margin index rose from 3.2% to 4.6% at the same cutoffs.
    • “These improved margins indicate that hospitals and health systems are taking the necessary steps to adapt to this new environment,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall, said in a release. “While finances are approaching historic levels, today’s care and business models look very different. Organizations have had to adjust how and where they’re delivering services to better meet patient preferences.”
  • Healthcare Dive lets us know,
    • “Healthcare executives prioritize data considerations when it comes to using generative artificial intelligence, which could prevent them from successfully integrating the hot button technology, according to a report by consultancy Deloitte. 
    • “While 82% of 60 respondents rated data availability, quality and reliability as a top consideration for implementing generative AI, only 45% cited mitigating biases or patient education on the technology and its risks as their greatest considerations when implementing the technology.
    • “Data is important, but the industry needs a “robust overarching framework” that focuses equally on governance, consumer needs and worker concerns, the report’s authors wrote.”
  • STAT News reports,
    • Merck reported earnings for the fourth-quarter and 2023. On 2024 guidance, Merck said it expects sales in the range of $62.7-$64.2 billion, or a 6% increase at the midpoint. Current Street consensus is $63.5 billion. Adjusted earnings are forecast to be between $8.44 and $8.59 per share.
    • More pharma earnings from Roche and Sanofi.
  • and
    • “Novavax, the company whose corporate missteps repeatedly sidelined an effective Covid-19 vaccine, is relying on demand for booster doses to remain solvent. And the latest update isn’t exactly encouraging.
    • “The company said yesterday that it would lay off another 12% of its staff, expanding on a cost-cutting plan disclosed last year. In the end, Novavax will have reduced its workforce by about 30% compared to 2023, part of an effort to reduce its expenses in the months to come.”
  • NewFront offers guidance on correcting mistaken health savings account distributions.


 

Midweek update

Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call informs us
    • “House leadership smoothed the path for consideration of a $78 billion family and business tax break deal Wednesday by committing to a floor vote as soon as next week on a separate bill to boost the state and local tax deduction cap for married couples.”
  • and later
    • “The House on Wednesday night passed a $79 billion family and business tax break bill after several days of uncertainty, teeing it up for consideration in the Senate. 
    • “The package negotiated by House Ways and Means Chairman Jason Smith, R-Mo., and Senate Finance Chair Ron Wyden, D-Ore., easily mustered the two-thirds majority needed to pass, despite GOP drama earlier in the week and previous criticism from Democrats. 
    • “It’s a strong, commonsense, bipartisan step forward in providing urgent tax relief for working families and small businesses,” Smith said on the floor ahead of the 357-70 vote. “Parents in Main Street communities across this country will see lower taxes, more opportunity and greater financial security after we pass this legislation.”
  • Here is a link to today’s hearing held by the House Energy and Commerce Committee’s Health Subcommittee about national healthcare expenditures.
  • Fierce Healthcare tells us,
    • “Medicare Advantage (MA) payments are set to decrease yet again in 2025 as the feds phase in significant changes to risk adjustment.
    • “As those overhauls begin to take effect, benchmark payments are set to decline by about 0.2% on average, according to the latest advance notice released by the Centers for Medicare & Medicaid Services (CMS).
    • “Despite this, the feds said Wednesday that payments to MA plans are expected to increase by 3.7% in 2025, a $16 billion increase over 2024. The payment rate announced today could change by the time the final rate announcement is published, no later than April 1.”
  • The CY 2025 Advance Notice may be viewed by going to: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents and selecting “2025 Advance Notice.”
  • A fact sheet discussing the provisions of the CY 2025 Advance Notice, as well as frequently asked questions, can be viewed here: https://www.cms.gov/newsroom/fact-sheets/2025-medicare-advantage-and-part-d-advance-notice-fact-sheet.
  • Beckers Payer Issues adds,
    • “A bipartisan group of lawmakers is urging CMS to maintain “payment and policy” stability in Medicare Advantage. 
    • “In a letter to CMS Administrator Chiquita Brooks-LaSure, the group of 60 senators asked the agency to “consider the ongoing implementation of program reforms finalized last year and provide stability for the Medicare Advantage program in 2025.”  * * *
    • “The letter comes after two lawmakers, Sen. Elizabeth Warren and Rep. Pramila Jayapal, wrote to the agency urging more action on curbing overpayments to the program. 
    • “Read the full letter here. 
  • Today, OPM posted on the Federal Register website a proposed FEHB rule that “would allow FEHB and PSHB coverage to become effective at the beginning of the pay period that the employee in pay status has an initial opportunity to enroll. This change would occur when the employee becomes eligible for FEHB or PSHB coverage, provided an appropriate request to enroll is received by the employing office within the initial pay period that the employee becomes eligible.”
  • American Hospital News reports,
    • “The Substance Abuse and Mental Health Services Administration Jan. 31 issued a final rule that updates certain regulations for Opioid Treatment Programs and the standards for treatment of opioid use disorder. The rule makes some COVID-19-related flexibilities permanent, including take-home doses of methadone, the ability of an OTP to prescribe medication for OUD via telehealth without an initial in-person physical evaluation, and the removal of certain requirements for admission to an OTP to better align with evidence-based practice.”
  • KFF shares three charts about Medicare drug price negotiations.
  • Federal News Network reports,
    • “The Postal Service is looking to cut $5 billion from its operating costs and grow its revenue by the same amount over the next two years to overcome its long-term financial challenges.
    • “Postmaster General Louis DeJoy is telling the White House and Congress that implementing these plans is necessary to keep USPS from running out of cash in the coming years.
    • “DeJoy, in a Jan.10 letter obtained by Federal News Network, told President Joe Biden and congressional leaders that USPS is “utilizing all of the self-help tools that are available to us,” and trying to get back on track with its “break-even” goal, after years of billion-dollar net losses.
    • “It is evident that to break even and avoid running out of cash in the next several years, we must press ahead on our financial improvement initiatives over the next two years,” DeJoy wrote. “While we have already achieved historic reductions, they are simply not enough to make us financially sustainable.”

From the public health and medical research front,

  • Check out this JAMA Open article to learn why “Paxlovid Is Effective but Underused—Here’s What the Latest Research Says About Rebound and More.”
  • Per Fierce Healthcare,
    • “As artificial intelligence advances in different areas of healthcare, there are concerns that technology and AI-based chatbots will replace the human connections between patients and practitioners.
    • “But, a new study finds promising potential for AI and large language models to enhance mental health therapy at scale by being able to analyze millions of text-based counseling messages to shine a light on what works.
    • “Researchers used AI to analyze more than 20 million text conversations of counseling sessions and successfully predicted patient satisfaction and clinical outcomes, according to a study published this week in the Journal of The American Medical Association (JAMA) Open.”
  • The National Institutes of Health announced,
    • An analysis conducted by the National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH) reveals a substantial increase in the overall use of complementary health approaches by American adults from 2002 to 2022. The study, published in the Journal of the American Medical Association, highlights a surge in the adoption of complementary health approaches for pain management over the same period.
    • Researchers utilized data from the 2002, 2012, and 2022 National Health Interview Survey (NHIS) to evaluate changes in the use of seven complementary health approaches, including yoga, meditation, massage therapy, chiropractic care, acupuncture, naturopathy, and guided imagery/progressive muscle relaxation.
    • The key findings include:
      • The percentage of individuals who reported using at least one of the seven approaches increased from 19.2% in 2002 to 36.7% in 2022.
      • The use of yoga, meditation, and massage therapy experienced the most significant growth from 2002 to 2022.
      • Use of yoga increased from 5% in 2002 to 15.8% in 2022.
      • Meditation became the most used approach in 2022, with an increase from 7.5% in 2002 to 17.3% in 2022.
      • Acupuncture, increasingly covered by insurance, saw an increase from 1% in 2002 to 2.2% in 2022.
    • Additionally, the analysis showed a notable rise in the proportion of U.S. adults using complementary health approaches specifically for pain management. Among participants using any of the complementary health approaches, the percentage reporting use for pain management increased from 42.3% in 2002 to 49.2% in 2022.
    • Despite the findings, the authors acknowledge study limitations, including decreasing NHIS response rates over time, possible recall bias, cross-sectional data, and differences in survey wording.
  • and
    • “Researchers at the National Institutes of Health detected abnormal proteins in the spinal fluid of people with amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD), which could help improve diagnosis of these diseases. The findings were published in Science Translational Medicine.
    • “The proteins in question are built from “cryptic” exons—abnormal portions of RNA, the cell’s instructions for how to build proteins. Cryptic exons occur when TDP-43, a protein that regulates how RNA is processed, stops functioning normally. TDP-43 dysfunction is linked to ALS, FTD, Alzheimer’s disease, and Limbic Associated TDP-43 Encephalopathy (LATE).
    • “The study showed that these mis-spliced sections of RNA can sometimes generate new proteins from the cryptic sequence. The findings advance our understanding of how cryptic exons may be involved in the dementia disease process and could help identify diseases involving TDP-43 dysfunction before symptoms appear. Currently, TDP-43 aggregates in the brain can only be detected at autopsy.”  
  • MedPage Today points out, “Getting clinicians to commit to the Choosing Wisely recommendations somewhat reduced low-value care for older adults in common scenarios, a cluster randomized trial found.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Novo Nordisk has resumed shipping starter doses of its weight-loss drug Wegovy, nearly nine months after manufacturing problems forced it to restrict distribution to maintenance shots in order to ensure that people who had already started taking it could continue, the company said Wednesday.
    • “The resumption of the starter doses, which begin at 0.25 milligrams per week, comes two months after obesity rival Eli Lilly gained U.S. approval for a competing drug, Zepbound, that could threaten to eat away at Novo’s sizable lead in weight-loss treatment.”
  • The Wall Street Journal adds,
    • “Nearly every employer in the country is now grappling with how—and whether—to pay for new weight loss drugs. Needless to say, such decisions are highly important to patients struggling with obesity.
    • “But for Eli Lilly and Novo Nordisk, it actually doesn’t matter, for now, from a financial perspective. They are selling every injection they can make. It won’t change anytime soon.” ***
    • While the companies are both moving as fast as possible, expanding the manufacturing of injectables is complicated. 
    • “You’re talking about billions of pens. That’s not a trivial exercise,” says Guggenheim analyst Seamus Fernandez. “Producing pens is a very complex process that requires precision and lots of attention to safety.” 
    • “That is one reason why developing pills such as Lilly’s orforglipron, which is undergoing clinical trials, is so crucial, he adds. Figuring out how to make oral versions well-tolerated is a challenge, though.”
  • MedTech Dive tells us about the top medtech trends in 2024. “Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year.”
  • Per Healthcare Dive,
    • “Cigna has agreed to sell its Medicare business to Health Care Service Corporation for roughly $3.7 billion, the health insurer announced Wednesday.
    • HCSC is acquiring Cigna’s Medicare Advantage, supplemental benefits and Medicare Part D plans, along with CareAllies, a division that helps providers transition to value-based care. In total, the plans cover 3.6 million people on Medicare.
    • “The companies said they expect the deal — which includes $3.3 billion in cash and $400 million in capital Cigna expects to be freed up — to close in the first quarter of 2025, subject to regulatory approval.”
  • and
    • “Humana plans to expand its primary care network for seniors this year, as the insurer looks to lean on provider capabilities to boost its beleaguered Medicare Advantage business.
    • “In 2024, CenterWell Senior Primary Care plans to enter three new markets in North Carolina and Louisiana, and add additional centers in eight of its current markets in the U.S., the payer announced on Tuesday.
    • “Humana is one of many health insurers racing to build out a provider network to provide convenient access to primary care for its members. But for Humana, this strategy is more important than it might be for its rivals with a broader variety of plans, given Humana has made such a significant bet on Medicare Advantage, said Arielle Trzcinski, a healthcare analyst at market research firm Forrester.”
  • BioPharma Dive lets us know,
    • In 2021, the Food and Drug Administration for the first time approved a medicine meant to slow the progression of Alzheimer’s disease. Developed by partners Biogen and Eisai, the medicine, called Aduhelm, was viewed initially as a needed new treatment option by patients and a potential blockbuster product by Wall Street analysts.
    • “Now, less than three years since that approval, Biogen is fully giving up on the drug. The company said Wednesday it is handing rights to back to Aduhelm’s original developer, Neurimmune, and will redirect much of the money spent on the drug toward other Alzheimer’s therapies in its business.
    • “Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs,” said Christopher Viehbacher, the company’s CEO, in a statement.”
  • Per Beckers Payer Issues,
    • “The share of U.S. employees in healthcare plans funded by their employer rose from 2015 to 2021, a study published in the January issue of Health Affairs found. 
    • “In 2015, 55% of employees were enrolled in self-funded plans, compared to 60% of employees in 2021. Most of the growth occurred in states and counties with lower levels of self-funded enrollment, the study found. 
    • “Groups of rapid growth in self-funded plans were concentrated in Arkansas, New York, Northern California, Pennsylvania and Utah, the study found. 
    • “Elevance Health is the largest administrator of self-funded plans, with around 19% of the total market, according to the study. CVS Health claimed the fastest growing self-funded enrollment from 2015 to 2021. “

Weekend Update

From Washington DC

  • The House of Representatives and the Senate continue to meet on Capitol Hill this week for Committee meetings and floor business. For your information, here’s an interesting meeting:
    • House Energy and Commerce Subcommittee on Health
    • Wednesday January 31, 2024 10:00 AM (EST) | 2123 Rayburn House Office Building, Washington, D.C.
    • Hearing: Health Care Spending in the United States: Unsustainable for Patients, Employers, and Taxpayers
    • Meeting Details
  • Fortune Well discusses the Medicare income adjusted premiums known as IRMAA. In the FEHBlog’s view, the best course is to pay the IRMAA premium because the Medicare Part B is worth the temporary surcharge.

From the public health and medical research front,

  • Medscape discusses research on a urine test that can diagnose lung cancer.
    • “Lung cancer is the deadliest cancer in the world, largely because so many patients are diagnosed late.
    • “Screening more patients could help, yet screening rates remain critically low. In the United States, only about 6% of eligible people get screened , according to the American Lung Association. Contrast that with screening rates for breast, cervical, and colorectal cancer, which all top 70%.
    • “But what if lung cancer detection was as simple as taking a puff on an inhaler and following up with a urine test?
    • “Researchers at the Massachusetts Institute of Technology (MIT), Cambridge, Massachusetts, have developed nanosensors that target lung cancer proteins and can be delivered via inhaler or nebulizer, according to research published this month in Science Advances. If the sensors spot these proteins, they produce a signal in the urine that can be detected with a paper test strip.
    • “It’s a more complex version of a pregnancy test, but it’s very simple to use,” said Qian Zhong, PhD, an MIT researcher and co-lead author of the study.”
  • The American Medical Association reports
    • ‘While the 2018 physical activity guidelines recommend that adults engage in at least 150 to 300 minutes per week of moderate exercise, 75 to 150 minutes each week of vigorous movement or an equivalent combination of both intensities, it turns out that if adults do more than the recommended amount, it can lower their risk of death. Moderate physical activity is defined as walking, weightlifting and lower-intensity exercise. Meanwhile, vigorous exercise is categorized as running, bicycling and swimming.’ 
  • The American Medical Association points out what doctors wish their patient knew about which cold medicines work.

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • Cognoa, maker of the first FDA-approved autism diagnostic tool, announced Highmark has signed on as its first commercial payer partner. 
    • “The tool, Canvas Dx, will now be reimbursed for commercial Highmark members. It aims to enable earlier and more equitable access to diagnosis for children and families without specialists. The tool leverages AI to empower doctors to quickly and accurately diagnose developmental risk without bias, the company claims.
    • “The contract should be seen as “model medical policy,” Dennis Wall, Ph.D., autism researcher and founder of Cognoa, told Fierce Healthcare. Wall hopes the coverage will be replicated across other payers. Highmark will cover the full price, including the total cost of CanvasDx and the time it takes for a provider to administer it.” 
  • STAT News tells us,
    • “At least, as of yesterday [January 25], in terms of market value. Eli Lilly, which has more than doubled in value since 2022, is now worth about $600 billion, eclipsing Elon Musk’s electric car company, which has fallen about 25% since the start of the year.
    • “There’s only so much one can read into the fates of two completely unrelated companies, but here’s a thought: For years, biotech specialists have pointed out that if generalist investors reallocated even 2% of their tech investments into the drug industry, it would make a massive difference for the comparatively small pond that is biotech.
    • “Through that lens, Lilly overtaking Tesla, to the extent it has any meaning at all, points to a future in which fund managers consider treating obesity and Alzheimer’s disease to be a better use of capital than making cars that sometimes don’t work when it’s cold, which would benefit biotech as a whole.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “The House [of Representatives] voted Thursday to clear the fiscal 2024 National Defense Authorization Act and send it to President Joe Biden for his signature.
    • “The conference report was considered under suspension of the rules, which requires a two-thirds majority. The bipartisan package easily cleared that threshold on a 310-118 vote. * * *
    • “The conference report is notable for authorizing a 5.2 percent pay raise for all military personnel, the biggest in two decades, as well as an increase in troops’ basic allowance for housing payments.”
  • Govexec adds that “Under a provision of the fiscal 2024 National Defense Authorization Act, federal agencies would be required to incorporate veterans’ military service when determining eligibility for paid leave.”
  • Back to Roll Call,
    • “The Senate planned to delay its holiday recess and stay in session next week as lawmakers signaled they could be close to a bipartisan border security deal that would clear a path for aid to Ukraine and Israel.
    • “The change in schedule came after several days of intense negotiations among senators of both parties and White House staff who were struggling to reach a deal on immigration policies designed to curb the flow of migrants at the southern border. Republicans have insisted on tougher border security as their price for additional Ukraine aid, part of a broader $110.5 billion supplemental funding package.
    • “We can get this done before we leave,” said Connecticut Sen. Christopher S. Murphy, the lead negotiator for Senate Democrats, after a Thursday morning negotiating session. “I just think if . . . the border is an emergency, if Ukraine is an emergency, then let’s act like it.” ***
    • “Even if the Senate can agree to a package combining border security with military aid to Ukraine and Israel, the measure is unlikely to become law this month. The House recessed for the year Thursday and Speaker Mike Johnson, R-La., appeared unlikely to call the chamber back into session before January.”
  • MedPage Today reviews several drug pricing developments that the Biden Administration announced this morning.
  • What’s more,
    • “HHS released a new data strategy to enhance data capabilities and accelerate progress on cancer moonshot goals,”
  • and
    • “The Biden-Harris Administration announced voluntary commitments from leading healthcare companies to harness the potential and manage the risks posed by AI.”
  • Govexec tells us,
    • “The Office of Personnel Management on Wednesday urged supervisors at federal agencies to take a more active role in managing the performance of new federal employees, including removing those who perform poorly and improving engagement to ensure they have the tools to succeed.”

From the public health and medical research front,

  • The Centers for Disease Control issued a health alert.
    • “to alert healthcare providers to low vaccination rates against influenza, COVID-19, and RSV (respiratory syncytial virus). Low vaccination rates, coupled with ongoing increases in national and international respiratory disease activity caused by multiple pathogens, including influenza viruses, SARS-CoV-2 (the virus that causes COVID-19), and RSV, could lead to more severe disease and increased healthcare capacity strain in the coming weeks. In addition, a recent increase in cases of multisystem inflammatory syndrome in children (MIS-C) following SARS-CoV-2 infection in the United States has been reported
    • “Healthcare providers should administer influenza, COVID-19, and RSV immunizations now to patients, if recommended. Healthcare providers should recommend antiviral medications for influenza and COVID-19 for all eligible patients, especially patients at high-risk of progression to severe disease such as older adults and people with certain underlying medical conditions.
    • “Healthcare providers should also counsel patients about testing and other preventive measures, including covering coughs/sneezes, staying at home when sick, improving ventilation at home or work, and washing hands to protect themselves and others against respiratory diseases.”
  • Mercer Consulting notes,
    • “With the release in August of the first orally administered medication for postpartum depression, now is a good time to review plan coverage and overall employer support for maternal health. While there are risk factors, postpartum mental health issues can happen to anyone within a year of birth and are often made worse by a lack of social support, including from the workplace. Sadly, the Centers for Disease Control and Prevention reported that mental-health conditions have become the leading cause of maternal death, contributing to nearly one in four pregnancy-related deaths.” 
  • The Robert Wood Johnson Foundation shares its five best health equity stories of 2023.
  • EHR Intelligence adds, “The Regenstrief Foundation has awarded LOINC and Health Data Standards at Regenstrief Institute a $4.4 million grant to support a global initiative to standardize social determinants of health (SDOH) data into EHR systems.”
  • The CDC reports about “Teenagers in the United States: Sexual Activity, Contraceptive Use, and Childbearing, 2015–2019.”
    • “In 2015–2019, 40.5% of never-married female teenagers (3.8 million), and 38.7% of never-married male teenagers (3.8 million) had ever had vaginal intercourse with an opposite-sex partner. For females this percentage was stable across the four time points, but for males this percentage decreased from the 2002 (45.7%) and 2011–2015 (44.2%) time points.
    • “For teen males, use of any contraception at first sex increased across the four time points, from 82.0% in 2002 to 92.1% in 2015–2019, while no consistent trend was seen for teen females.
    • “Nearly four out of five female teenagers (77.3%) in 2015–2019 used a method of contraception at first sex. Among female teenagers, ever-use of long-acting reversible contraception, which includes intrauterine devices and contraceptive implants, increased from 5.8% to 19.2% from 2011–2015 to 2015–2019.”
  • Beckers Hospital Review lets us know,
    • “Results from a phase 2 trial found a drug-vaccine combination developed by Merck and Moderna cut the risk of recurrence or death in patients with severe melanomas by 49%.
    • “The experimental therapy involves an mRNA vaccine from Moderna in combination with Merck’s cancer drug Keytruda. Patients with resected stage 3 or 4 melanoma who received the combination therapy were 49% less likely to die or have their cancer return within three years, compared to those who received only Keytruda.
    • “The findings build on results from an earlier phase study that followed patients for two years, the drugmakers said in a Dec. 14 news release.” 
  • Bloomberg Prognosis informs us,
    • “Obesity researchers are only beginning to explore what happens after people lose weight with GLP-1 drugs such as Wegovy or Zepbound. Most trials of the drugs have only lasted a year or so. While some type of long-term drug therapy is likely to be needed — just as it is with other diseases like high blood pressure — exactly what form it will take is a big unknown, says Robert Kushner, an obesity doctor at Northwestern University Feinberg School of Medicine.
    • “This whole idea of maintenance is a huge black hole,” Kushner told my colleague Madison Muller in a recent interview. “We’re going into this area but we don’t have the long-term game figured out.”
  • Per Medscape,
    • “For researchers involved with sleep disorders, developing a pharmacologic treatment for obstructive sleep apnea (OSA) is a bit like searching for the holy grail. P K Schweitzer and colleagues have published the results of the randomized MARIPOSA study assessing a combination of two medicinal products known as AD109, one of the products having an antimuscarinic effect (aroxybutynin), and the other a noradrenergic effect (atomoxetine), in treating this condition. These molecules increase the activity of the dilator muscles in the upper airways by activating the genioglossus muscle with a synergic effect on the upper respiratory tract during sleep. * * *
    • [T]hese results herald important scientific benefits if we consider that Colin Sullivan’s original 1981 research paper, which ushered in the CPAP era, presented the results of just five participants. 
  • The Wall Street Journal reports,
    • “A year and a half of treatment with the new Alzheimer’s drugs has been shown to reduce the chance of progression to mild stage dementia by about 10%. This benefit comes with notable risks, including small patches of brain bleeding and swelling, which can cause falls and confusion and may require stopping the drug. And there are other barriers. The new Alzheimer’s therapies are very expensive—one year of lecanemab therapy is priced at $26,500. They are difficult to deliver, require an extensive work-up to determine eligibility and involve intensive monitoring for side effects. As many as 8 million Americans are estimated to be living with mild cognitive impairment, but only about 8% to 17.4% will meet all the criteria to take one of these drugs, according to a study published last month in the journal Neurology.”

From the U.S. healthcare business front,

  • Merck Consulting looks back at top benefit trends from 2023 that it expects to carry over into 2024.
  • Beckers Hospital Review explains
    • “Healthcare leaders have been talking about the transition to value-based care for years, but without significant movement away from fee for service. That could all change in the next three years.
    • “The current economic climate, with tightening margins and increased costs, is pushing health systems to finally make a move.
    • “We will continue to see margin pressure resulting from reimbursement rates not keeping pace with inflationary trends that are escalating staffing and supply chain costs,” said Cliff Megerian, MD, CEO of University Hospitals in Cleveland. “As a result, you will see health systems optimizing their operations, which may include footprint re-evaluation, increasing focus on value-based care and greater utilization of digital technology, such as remote monitoring and telehealth services.”
    • “Dr. Megerian also sees more partnerships and expanded services as the growth mechanism for health systems instead of the traditional brick-and-mortar projects and acquisitions.”
  • Per Fierce Healthcare,
    • “Most insurer markets are highly concentrated, including many regions where a single payer dominates at least half of the market share, according to a new analysis from the American Medical Association.
    • “The AMA [hardly a neutral observer] released an updated look at concentration in payer markets and found that across product lines, 73% of metropolitan statistical areas were highly concentrated in 2022. In most (90%) regions, a single payer owns a 30% market share, and in 48% of markets, one payer controls at least 50% of the share.
    • “In 11% of markets, a single insurer has a 70% or higher market share, according to the report.”
  • Per Healthcare Dive,
    • “Private equity firm KKR is in talks to buy a 50% stake in healthcare data analytics firm Cotiviti from Veritas Capital, according to The Wall Street Journal. 
    • “The deal, which sources familiar said could be finalized in the coming weeks, would value the health technology company at about $11 billion. Veritas acquired Cotiviti in a take-private deal valued at $4.9 billion in 2018
    • “If the purchase is finalized, it would also rate among the largest U.S. private equity deals announced this year, according to the WSJ.” 

Midweek Update

Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Senate Finance Committee announced,
    • Senate Finance Committee Chairman Ron Wyden, D-Ore., will convene a committee hearing on Tuesday, December 5, 2023 titled “Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective.” The hearing will take place at 10:00 a.m. in Room 215 of the Dirksen Senate Office Building.
  • The American Hospital Association News notes,
    • “The House Energy and Commerce Subcommittee on Health Nov. 29 held a hearing  to explore how medical devices and hospitals are using artificial intelligence and what Congress should consider as AI in health care evolves.”
  • BioPharma Dive reports,
    • “The Food and Drug Administration’s top scientist Namandjé Bumpus will assume the role of principal deputy commissioner when longtime agency leader Janet Woodcock retires from that role in early 2024, according to an announcement Thursday.
    • “Among Bumpus’ priorities when she assumes the role will be “creating a new model” for the FDA’s Office of Regulatory Affairs, the branch that conducts inspections, monitors drug imports, and issues recalls, market withdrawals and safety alerts, Commissioner Robert Califf said in a memo to agency staff.”
  • Sequoia reminds us,
    • “Beginning in 2024, group health plans and carriers will be required to include all covered items and services in their self-service internet-based price comparison tool, as required under the Transparency in Coverage (TIC) Final Rules.
    • “As background, plans must provide participants and beneficiaries with out-of-pocket cost estimates via a user-friendly online self-service tool (and by paper upon request). The intent of this requirement is to provide individuals with real-time cost-sharing information to support making informed health care decisions. Implemented in two phases, the first phase of the price comparison tool required the first 500 items and services (as defined by the DOL) to be published in the tool effective for plan years beginning on or after January 1, 2023, and the second phase will require all other services covered by the plan to be included in the tool effective for plan years beginning on or after January 1, 2024.”

From the public health and medical research front,

  • The Centers for Disease Control announced,
    • CDC’s National Center for Health Statistics released two reports today examining provisional mortality data from 2022. While analysis shows the number and rate of suicides increased for the second year in a row from, overall life expectancy at birth increased by just over a year. This increase regains some of the 2.4 years of life expectancy lost between 2019 and 2021.
    • The findings are featured in two new reports, “Provisional Life Expectancy Estimates for 2022” and “Provisional Estimates of Suicide by Demographic Characteristics: United States, 2022. * * *
    • “The increase of 1.1 years in life expectancy from 2021 to 2022 primarily resulted from decreases in mortality due to COVID-19, heart disease, unintentional injuries, cancer, and homicide. Declines in COVID-19 mortality accounted for approximately 84% of the increase in life expectancy. * * *
    • “The percentage increase in the number of suicides was greater for females (4%) than males (2%), but the provisional 2022 suicide number for males (39,255) was nearly four times that of females (10,194).”
  • Health Day points out,
    • “The prevalence of a highly mutated COVID variant has tripled in the past two weeks, new government data shows.
    • “Now, nearly 1 in 10 new COVID cases are fueled by the BA.2.86 variant, the U.S. Centers for Disease Control and Prevention reported Monday.
    • “The variant is spreading the fastest in the Northeast: Just over 13% of cases in the New York and New Jersey region are blamed on BA.2.86. * * *
    • “So far, preliminary data on the variant suggests it does not trigger more severe illness than previous variants, the WHO said in a recent risk evaluation, but the international agency still noted a recent and “substantial rise” in BA.2.86 cases.
    • “The CDC also noted that BA.2.86 variant poses a “low” public health risk.”
  • and
    • “Personal trainers can help people increase their strength and their fitness.
    • “Could a “brain coach” be just as useful in preventing Alzheimer’s’ disease?
    • “A new study suggests that personalized health and lifestyle changes can delay or even prevent memory loss for older adults at high risk of Alzheimer’s or dementia.
    • “People who received personal coaching experienced a 74% boost in their thinking and memory tests compared with those who didn’t receive such attention.
    • “This is the first personalized intervention, focusing on multiple areas of cognition, in which risk factor targets are based on a participant’s risk profile, preferences and priorities, which we think may be more effective than a one-size-fits-all approach,” said co-lead researcher Dr. Kristine Yaffe, vice chair of research in psychiatry at the University of California, San Francisco (UCSF).”
  • Healio informs us,
    • “One in four adults relied solely on medications to manage chronic pain, highlighting an opportunity to increase use of nonpharmacologic therapies, particularly in men, older adults and those with public insurance, according to researchers.
    • “Findings from this study contribute important information about use of over-the-counter pain relievers, prescriptions nonopioids and exercise, which were found to be some of the most common pain management therapies used by adults with chronic pain,” Stephanie Michaela Rikard, PhD, a health scientist at the CDC, told Healio.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Cigna and Humana are in talks for a combination that would create a new powerhouse in the health insurance industry.
    • “The companies are discussing a stock and cash deal that could be finalized by the end of the year, assuming the talks don’t fall apart, according to people familiar with the matter.”
  • and
    • “A law designed to protect patients from surprise medical bills is contributing to the financial distress of some medical-service providers, which say lengthy billing disputes and payment delays with insurers are hurting their ability to stay afloat. 
    • “The No Surprises Act, which took effect last year, aims to protect patients from surprise medical bills from out-of-network healthcare providers when there are disagreements over reimbursements between insurers and providers. Previously, providers often billed patients to make up for the amounts insurers were unwilling to pay. 
    • “Numerous healthcare businesses, some owned by private equity, said the legislation is contributing to delays and reductions in payments by insurance companies, hurting their cash flows and earnings. A handful of major healthcare-service providers already have filed for chapter 11 protection this year, specifically naming the law as a major reason for their bankruptcies. These include physician-staffing companies Envision Healthcare and American Physician Partners as well as helicopter-ambulance operator Air Methods.”
  • and
    • “There are five tech companies valued at over $1 trillion. In healthcare, the closest contender is  Eli Lilly
    • .”This year it became the first big pharmaceutical to surpass a market capitalization of $500 billion thanks to the popularity of its obesity and diabetes medications and, to a lesser extent, its experimental Alzheimer’s drug. But hanging over Lilly and rival  Novo Nordisk is a reality that puts the brakes on big pharma’s ascent: the patent cliff.
    • “There are several reasons why there isn’t a big pharma company in the trillion-dollar club, but the boom-and-bust nature of drug development is high on the list. Unlike Apple, which hypothetically can make huge margins off the iPhone for perpetuity, U.S. drug companies have a limited period from which to profit from their innovation. As their patents expire and generic competitors enter the market, sales plunge. Pharma executives, overly focused on short-term growth, don’t often prepare their companies for that.”
  • FEHBlog notes on the Journal articles,
    • Cigna and Humana are undoubtedly aware of the firebreathing nature of anti-trust enforcers in the federal government. Cigna is focused on the commercial market while Humana currently is pulling out of that market to focus on government business. Time will tell.
    • Out-of-network doctors and air ambulance companies flying the pirate flag can avoid No Surprises Act problems by joining health plan networks.
    • Lilly’s recent growth has been impressive.
  • Reuters tells us,
    • “UnitedHealth Group on Tuesday forecast 2024 profit broadly in line with Wall Street expectations, indicating that medical costs are likely to remain elevated for the health insurance giant.
    • “The healthcare sector has this year seen a recovery in demand, especially among older patients who started returning to doctors’ clinics and hospitals for procedures they had delayed during the COVID-19 pandemic.”
  • Healthcare Dive adds,
    • “Healthcare insurers could get a slight respite from rising medical costs next year. Global costs are expected to rise 9.9% year over year in 2024, down from a 10.7% increase in 2023, according to a new survey from consultancy WTW released on Tuesday.
    • “However, that decline might not last long. Nearly three-fifths of insurers surveyed anticipate higher medical cost growth over the next three years as new medical technologies, overuse of care and members’ poor health habits drive increased spend.
    • “Many insurers told WTW they are leaning on deductibles, contracted provider networks and telehealth options to manage costs. Others are excluding coverage for healthcare such as fertility treatments or gender re-affirming care.”
  • Beckers Hospital CFO Report identifies the states with the most rural hospital closures.
    • “Since 2005, 104 rural hospitals have closed and more than 600 additional rural hospitals — 30% of all rural hospitals in the U.S. — are at risk of closing in the near future, according to the Center for Healthcare Quality and Payment Reform.”
  • Beckers Hospital Review calls attention to this development,
    • “Mayo Clinic’s board of trustees has given the green light to an initiative dubbed “Bold. Forward. Unbound.,” which involves a $5 billion redesign of Mayo Clinic’s downtown Rochester, Minn., campus. 
    • “The redesign will introduce new facilities that incorporate innovative care approaches and digital technologies, according to a Nov. 28 news release from Mayo, with a pivotal element of these being specialized “neighborhoods.” According to the health system, the neighborhood concept will offer patients a centralized location for all required services related to their specific condition, eliminating the need for navigating between different departments.”
  • Per Fierce Healthcare,
    • “Accountable care organizations do not positively influence treatment and outcomes for chronic mental health conditions for Medicare patients, according to a study in Health Affairs.
    • “For patients newly enrolled in ACOs, they saw no improvements in their depression and anxiety symptoms after one year. These patients were also 24% less likely to have their depression or anxiety treated than patients unenrolled in ACOs, and 9.8% less likely to have an evaluation and management visit for depression or anxiety with a primary care clinician.
    • “Since mental health conditions in Medicare patients are often underdiagnosed and undertreated, some have suspected that mental health illnesses are ideal conditions for ACOs to handle, but the study found that there were no significant differences in any other measures of mental health treatment.”
  • Beckers Hospital Review also names the winners of Forbes 30 under 30 in healthcare for 2024.


 

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC,

  • Roll Call offers a preview of Congress’s actions over the next month, after which point the first session of this 118th Congress will come to a close.
  • Bloomberg provides an update on ongoing efforts to revamp the Nation’s organ transplant system. Here are the highlights:
    • “First contract bid solicitations from HHS expected this fall, and
    • “Multiple vendors to run transplant system for first time.”
  • The Centers for Medicare and Medicaid Services published in today’s Federal Register corrections to its Section 111 reporting civil monetary penalty rule which was issued on October 11, 2023. CMS asserts that the corrections fix “typographical and technical errors in the final rule, and it does not make substantive changes to the policies or the implementing regulations that were adopted in the final rule.”
  • The Department of Health and Human Services announced,
    • “As part of the inaugural meeting of the White House Council on Supply Chain Resilience, President Biden and Secretary of Health and Human Services Xavier Becerra today announced new efforts to bolster the domestic supply chain for essential medicines and medical countermeasures.
    • “President Biden will issue a Presidential Determination broadening HHS’ authorities under Title III of the Defense Production Act (DPA) to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and other critical inputs that have been deemed by the President as essential to the national defense. In addition, HHS will designate a new Supply Chain Resilience and Shortage Coordinator for efforts to strengthen the resilience of critical medical product and food supply chains, and to address related shortages.”
  • The Food and Drug Administration announced,
    • “approv[ing] Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.
    • “Desmoid tumors are non-cancerous but can be locally aggressive. The tumors may invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life. Although surgical removal has historically been the treatment of choice, there is a high risk that the tumor will return or that other health challenges will occur after removal; therefore, systemic therapies (cancer treatment targeting the entire body) are being increasingly evaluated in clinical trials.” 
  • The HHS Inspector General concluded that “The Risk of Misuse and Diversion of Buprenorphine for Opioid Use Disorder in Medicare Part D Continues to Appear Low: 2022.”
  • Govexec tells us,
    • “The U.S. Postal Service is planning to hire just 10,000 temporary employees during the current holiday season as part of a new approach that management has acknowledged comes with some risks. 
    • “The seasonal hiring marks a 64% reduction from the employees brought on in 2022 during what USPS calls its “peak season” when the agency made 28,000 temporary hires. The agency had said it would bring on just 20,000 seasonal workers that year, but a recent USPS inspector general report found it reached a higher tally. 
    • “This will mark the second consecutive year in which the Postal Service significantly reduces its seasonal hiring. In 2021, USPS added 45,000 non-permanent staff for the holiday rush. Postmaster General Louis DeJoy has said additions to the permanent, career workforce has lessened the need for such a surge. In the last two years, the agency has converted 150,000 employees from part-time workers to full-time, career personnel.”
  • Federal News Network informs us,
    • “Participants in [OPM’s] Thrift Savings Plan felt less content with the TSP this year, according to the latest results of the Federal Retirement Thrift Investment Board’s annual satisfaction survey.
    • “Currently, 82% of TSP participants are satisfied with the plan, compared with an 87% satisfaction rate in 2022, the board’s survey of tens of thousands of TSP participants showed.
    • “The slumping satisfaction scores may not come as a surprise after the TSP’s tumultuous transition to a new recordkeeper in June 2022. The 2023 survey, conducted between March and May of this year, was the first time the major update was reflected in the annual participant satisfaction survey.”

From the public health and medical research front,

  • Precision Vaccinations points out,
    • “The World Health Organization (WHO) today reported that the multi-country mpox outbreak continues at a low transmission level in the European Region and the Americas.
    • “The 30th WHO Situation Report, published on November 25, 2023, offers insights regarding the latest epidemiology and a particular focus on the ongoing and evolving epidemiology of mpox in the Democratic Republic of the Congo (DRC).
    • “The WHO confirmed that from January 2022 through October 31, 2023, a cumulative total of 91,788 laboratory-confirmed cases of mpox, including 167 deaths, have been reported from 116 countries/territories/areas.
    • “The countries that have reported the highest cumulative number of mpox cases are the United States (30,771), Brazil (10,967), and Spain (7,647).”
  • Healio notes,
    • “Eating disorder claims in the United States rose 65% as a percentage of all medical claims over the last 5 years, according to a report from FAIR Health, a health care claims repository.
    • “Researchers at FAIR Health evaluated more than 43 billion private health care claims records to investigate trends in eating disorders from 2018 to 2022 based on regional and national levels, demographic and socioeconomic factors and other health conditions. * * *
    • “Key takeaways:
      • “Patients aged 14 to 18 years accounted for most eating disorder claims in 2022.
      • “Overall, 72% of patients with eating disorders were diagnosed with at least one co-occurring mental illness.”
  • Beckers Hospital Review lets us know,
    • “Eli Lilly’s Mounjaro helped patients lose weight more effectively than Novo Nordisk’s Ozempic, according to a preprint study that included more than 40,000 patients. 
    • “The research evaluated 41,223 EHRs of overweight or obese patients taking Mounjaro (tirzepatide) or Ozempic (semaglutide) for Type 2 diabetes. The cohort was restricted to patients with available weight data and those who had not received a glucagon-like peptide-1 receptor agonist prior to May 2022.
    • “Although about 77% of the patients took Ozempic, those who took Mounjaro “were significantly more likely to achieve 5%, 10% and 15% weight loss and experience larger reductions in weight at 3, 6, and 12 months,” the study found.
    • “Truveta, a healthcare data company that collects EHR information from more than 30 systems, conducted the research. It is the first real-world comparative effectiveness study between Mounjaro and Ozempic, Truveta said in a Nov. 27 news release.” 
  • STAT News reports,
    • “The inflammation-targeting therapy Dupixent succeeded in a Phase 3 trial in patients with the chronic lung disease COPD, its developers said Monday, results that could propel the blockbuster medicine into a massive new market.
    • “Dupixent, which is jointly developed by Sanofi and Regeneron Pharmaceuticals, has already racked up approvals for several indications, including asthma, atopic dermatitis, and eosinophilic esophagitis. If approved for COPD, it would be the first biologic treatment for the condition.
    • “The trial, dubbed Notus, was the second Phase 3 trial for Dupixent in COPD, with the companies announcing similarly positive results from the Boreas trial earlier this year. The full data from Boreas were published in the New England Journal of Medicine.”

From the U.S. healthcare business front,

  • Employee Benefit News offers tips on PBM contracting.
  • Per Fierce Healthcare,
    • “Mark Cuban Cost Plus Drug Company has inked its latest partnership, joining forces with Expion Health to address the rising cost of specialty drugs.
    • “Cost Plus Drugs’ pricing model will integrate into Expion’s dynamic pricing technology, harnessing the power of both for speciality medications. Expion’s tool and Cost Plus Drugs’ approach together “equips payers with a sophisticated tool for navigating this modern landscape,” the companies said in the announcement.”
  • and
    • Ayble Health, a digital health platform for patients with chronic gastrointestinal conditions, has announced a new collaboration with the Mayo Clinic.
    • “Ayble is working with the Mayo Clinic Complex Care Program to offer a hybrid care model that matches patients with the appropriate virtual and in-person care based on acuity and need.
    • “By matching the right care for a patient at the right time, the two hope to improve outcomes and costs for digestive diseases. The collaboration is available for large employers and health plans.” 
  • MedCity News calls to our attention,
    • “AI startup Hoppr teamed up with AWS to launch a new foundation model to help bring more generative AI solutions into medical imaging, the companies announced on Sunday at RSNA 2023, the annual radiology and medical imaging conference in Chicago.
    • “The new product, named Grace, is a B2B model designed to help application developers build better AI solutions for medical images — and to build them more quickly. Along with the launch of Grace, Hoppr also announced that it received “a multi-million dollar investment” from Health2047, the American Medical Association’s venture studio.”
  • Per Healthcare Dive,
  • “Advocate Health’s financial performance dipped in the third quarter despite rising patient volumes as the major nonprofit health system navigated higher expenses and declining investment returns.
  • “The operator reported a nine-month operating income of $79.4 million, down from the $85.7 million Advocate recorded through the first half of the year.
  • “Advocate’s investment income also took a hit, falling more than a third from midyear. Overall, the nonprofit’s bottom line dropped to $721.2 million, 28% lower than midyear. * * *
  • “Formed out of a merger between Illinois-based Advocate Aurora Health and North Carolina-based Atrium Health last year, the health system is comprised of three divisions: Advocate Aurora Health, Atrium Health’s Charlotte-Mecklenburg Hospital Authority and Atrium Health Wake Forest Baptist. Together, the divisions operate more than a thousand care sites, including 67 hospitals.”