Midweek Update

Mental health care

Midweek Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, OPM, SDOH, Telehealth, U.S. Healthcare–
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.”

Tuesday Tidbits

David Ermer–Congress, COVID-19, Medical / Rx research, Mental health care, NIH, No Surprises Act, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Beckers Health IT informs us,
    • “U.S. lawmakers introduced bipartisan legislation Feb. 16 to better match patients with their EHRs.
    • “U.S. Reps. Mike Kelly, R-Pa., and Bill Foster, PhD, D-Ill., sponsored the Patient Matching and Transparency in Certified Health IT, or MATCH IT, Act of 2024.
    • “Patient matching errors have led to unnecessary expenses, medical mistakes, and even patient deaths,” Mr. Kelly said in a Feb. 16 news release. “This bipartisan legislation works to improve interoperability between healthcare systems and decrease these fixable matching errors, all while protecting patient privacy.”
  • STAT News tells us,
    • “Nearly four decades after its first conception, the first TIL therapy, an immunotherapy that harvests cancer-fighting immune cells from the patient’s own body, received accelerated approval from the Food and Drug Administration for advanced melanoma. The therapy, called Amtagvi or lifileucel from Iovance, is the first cell therapy approved for a solid tumor.
    • “It’s so exciting and gratifying,” said Allison Betof Warner, a cell therapy researcher and physician at Stanford University who has worked on Amtagvi. “This is a game-changing moment for our field. We’ve seen huge success of cellular therapy for hematologic malignancies, and we’ve yet to capitalize on that for solid tumors. This is hopefully the first of many to come.”
    • “In a Phase 2 clinical trial, titled C-144-01, 153 patients who had already been on a median of three prior lines of therapy received lifileucel, and 31% of them responded to therapy. “These are in very late line patients. They’ve exhausted every standard care option,” Betof Warner said. “The most promising part of this therapy for me is that 42% of patients who responded were still responding for 18 months or longer. It’s truly incredible.”
    • “The therapy is not expected to work for every patient, partially because the regimen has high toxicity. It will also be expensive. The therapy is expected to be priced at $515,000.”
  • Beckers Hospital Review adds, “Buzz for gene therapies is loud, but drugmakers struggle to get treatments off the ground.”
    • “A major barrier for many companies in the space is sheer cost to develop these advanced medical therapies. Though the Biden administration and CMS announced Jan. 30 plans to bring down prices for gene edited therapies, progress will take time. 
    • “The number of patients being treated with the existing gene therapies that are approved and available on the market is expected to decline year over year by nearly 33%, according to Bloomberg.”
  • Per the Food and Drug Administration,
    • “On Friday, the FDA published an Outbreak Advisory for an investigation of E. coli O157:H7 linked to raw cheddar cheese. The FDA recommends that consumers, restaurants, and retailers do not eat, sell, or serve Raw Farm-brand Raw Cheddar Cheese (block or shredded) and to throw it away. This is an ongoing investigation and the FDA will update the Advisory should additional consumer safety information become available.”
  • BioPharma Dive reports,
    • “AstraZeneca’s targeted cancer therapy Tagrisso can now be used alongside chemotherapy to treat a common type of locally advanced or metastatic lung tumor, following a Food and Drug Administration approval Friday.
    • “The FDA cleared Tagrisso together with chemotherapy based on results showing the combination reduced the risk of disease progression or death versus Tagrisso alone, which is currently the first-line standard for non-small cell lung cancer that harbors mutations in a gene known as EGFR.
    • “Over the weekend, meanwhile, AstraZeneca reported new clinical trial data showing Tagrisso outperformed placebo following chemoradiotherapy for Stage 3 EGFR-mutated non-small cell lung cancer that couldn’t be surgically removed. The results, which AstraZeneca will share with regulators, could further support early use of Tagrisso.”

From the public health and medical research front,

  • Axios points out,
    • “More than half of U.S. newborns now appear to be protected by new RSV vaccines, according to updated Centers for Disease Control and Prevention data.
    • “Why it matters: The virus is considered the second leading cause of death worldwide during the first year of a child’s life. The data suggests demand was strong despite broader vaccine skepticism and the potential for confusion over more childhood immunization options.”
  • The Wall Street Journal discusses a related RSV vaccine (Beyfortus) shortage — “A new antibody that protects babies from a deadly virus proved far more popular than drugmaker Sanofi expected.”
    • Beyfortus seller Sanofi in March last year set aggressive targets for how many doses to make, yet still underestimated demand. Some pediatricians delayed ordering immunizations because they didn’t know whether insurers would cover the $495 doses. And the U.S. government decided in August—months after Sanofi had locked in the number of doses it would make—to add the shot to the Vaccines for Children program, a federal initiative that covers children who are uninsured or on Medicaid, buying more than half of the doses.
    • Sanofi said it sought to distribute its shots equitably in the face of “unprecedented” demand and is working to increase supply for the next RSV season. 
  • HHS’s Agency for Healthcare Quality and Research issued a Medical Expenditure Panel Survey about “Characteristics of Young Adults Aged 18-24 Who Had Ever Used an Electronic Nicotine Product, 2021.”
    • “Nearly one-third (30.6 percent) of U.S. adults ages 18-24 reported ever having used an electronic nicotine product.
    • “More than one-third (38.3 percent) of non-Hispanic White young adults reported ever having used an electronic nicotine product, nearly double the rate for Hispanic young adults and 12 percentage points higher than for non-Hispanic Black young adults.”
  • Medpage Today notes,
    • “Nearly all medication abortions obtained via telehealth, whether via video or secure text messaging, were completed without further intervention and without adverse events, the prospective CHAT study found.
    • “Among over 6,000 abortions, 97.7% (95% CI 97.2-98.1) were completed without further intervention, and the completion rate was similar for patients who had video calls (98.3%) or used text messaging (97.4%), reported Ushma Upadhyay, PhD, MPH, of the University of California San Francisco, and colleagues.
    • “Less than 1% of patients had a serious abortion-related adverse event (0.25%) or were treated for an ectopic pregnancy (0.16%), and 1.3% of abortions were followed by emergency department visits, the authors wrote in Nature Medicine.”
  • The FEHBlog has subscribed to a Substack series called “Your Local Epidemiologist.”
    • “Your Local Epidemiologist (YLE)” is written by Dr. Katelyn Jetelina, M.P.H. Ph.D.—an epidemiologist, wife, and mom of two little girls. During the day, she is a senior scientific consultant to several organizations, including CDC. At night, she writes this newsletter. Her main goal is to “translate” the ever-evolving public health world so that people will be well-equipped to make evidence-based decisions. This newsletter is free, thanks to the generous support of fellow YLE community members.”
    • Check it out.
  • Medpage Today offers an expert medical opinion concerning
    • “News surfaced last week suggesting a potential shift in COVID-19 isolation guidanceopens in a new tab or windowfrom the CDC. The planned guidance, which is expected to be released this spring for public comment, indicates a significant switch in how COVID-19 is conceptualized. The guidance would bring COVID-19 into line with how other common respiratory viruses are managed: with isolation recommended until the individual has mild and improving symptoms, and is fever-free (without pharmaceutical aid) for 24 hours.”
    • “With the news of the proposed guidance, many voices rose up to immediately attack the proposed guidance as a capitulation and not evidence-based. This was similar to the refrain from opponents when the federal or state governments dropped or loosened mask requirements or guidance.
    • “I was not one of themopens in a new tab or window.
    • “Indeed, I welcome the proposed guidance change because it reflects the progress that has been made in the management of COVID-19. When evaluating this guidance, it is critical to understand that SARS-CoV-2, the cause of COVID-19, is situated among the myriad respiratory viruses that infect humans.”
  • Medscape lets us know,
    • “Availability of telehealth services for mental healthcare varies widely from state to state, a new study shows. One fifth of all facilities contacted reported no mental telehealth options and wait times for those that did ranged from 4 days to > 2 months, depending on the state.”
  • The National Institutes of Health announced,
    • “To prevent an emerging genomic technology from contributing to health disparities, a scientific team funded by the National Institutes of Health has devised new ways to improve a genetic testing method called a polygenic risk score. Since polygenic risk scores have not been effective for all populations, the researchers recalibrated these genetic tests using ancestrally diverse genomic data. As reported in Nature Medicine, the optimized tests provide a more accurate assessment of disease risk across diverse populations.
    • “Genetic tests look at the small differences between individuals’ genomes, known as genomic variants, and polygenic risk scores are tools for assessing many genomic variants across the genome to determine a person’s risk for disease. As the use of polygenic risk scores grows, one major concern is that the genomic datasets used to calculate the scores often heavily overrepresent people of European ancestry.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “After federal legislation protecting consumers from surprise medical bills was implemented, a growing number of medical claims were in network, according to a new analysis.
    • “The No Surprises Act went into effect on Jan. 1, 2022. From the fourth quarter of 2021 to the first quarter of 2022, in-network care as a percentage of all claim lines nationally increased 2.3%, according to the study by nonprofit Fair Health.
    • “It’s the latest research suggesting No Surprises has been successful in lowering the amount of unexpected out-of-network bills, though the rollout of the law has been tied up in lawsuits, and regulators currently face a backlog of billing disputes between payers and providers.”
  • and
    • “Insurers brace for continued Medicare Advantage medical costs. The big question coming out of the health insurance earnings season is how much elevated utilization among seniors is carrying over into 2024.”
  • EndPoint News points out,
    • “Cigna’s venture unit just made a bet on a startup focused on cardiometabolic conditions that wants to play a role in prescribing GLP-1 medications.
    • “9amHealth said on Tuesday it raised $9.5 million in a Series A extension led by The Cigna Group Ventures. It adds to $16 million from the Series A raised in April 2022 by the startup, which provides virtual visits, prescriptions and lab tests related to conditions like hypertension, type 2 diabetes and weight management.”
    • “Cigna’s investment comes as health plans and pharmacy benefit managers (the PBM Express Scripts is a subsidiary of Cigna) are grappling with how to cover the high cost of GLP-1 medications for conditions like type 2 diabetes and weight loss. It’s among the first investments from an insurance company’s venture arm into a startup prescribing the drugs, which have turned into huge blockbusters and prompted broad conversations about their cost — and benefit — to the healthcare system.”
  • The Wall Street Journal reports,
    • “Pharmaceutical companies are spending billions of dollars to develop drugs that can target cancer like guided missiles.
    • “Therapies known as antibody-drug conjugates, which help deliver chemotherapy directly to tumors, have gotten most of the attention and are farthest along: 
    • “Pfizer’s $43 billion acquisition of biotech Seagen Inc. last year underscored how hot the field has become. 
    • “More quietly, a concept known as radiopharmaceuticals is also gaining ground. In recent months, interest in this space has led to a rise in dealmaking. The idea is similar to ADCs in that a patient receives an old treatment—in this case, a radioactive particle instead of chemotherapy drugs—but it is bound with a molecule that can chase down tumor cells. The technology is at a more nascent stage, but a steady growth of venture capital money and acquisitions by large pharmaceutical companies means this could well become a key part of the fight against cancer in the next decade or so.”
  • HR Dive discusses an EEOC lawsuit against a Georgia retirement community “for firing a 78-year-old receptionist after repeatedly asking her to retire. “The right to decide a retirement age lies with an employee, not their employer,” an EEOC official said.

Friday Factoids

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Mental health care, No Surprises Act, Obesity, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Federal Times reports,
    • “It took 13 years — with some stops, starts and stumbles in between — but as of today, the federal government now has a single website designed to deliver detailed, searchable information about all federal programs.
    • “The Office of Management and Budget flipped the switch Thursday on the new Federal Program Inventory, a platform it’s been building via various pilot efforts since December 2020. Officials acknowledge it doesn’t yet capture every single program: For now, only “domestic assistance” programs are included. But that broad category encompasses most federal spending, ranging from Social Security and Medicare to the smallest community block grant programs.
    • “As of now, the database includes spending and performance data on 2,388 programs, said Diedre Harrison, OMB’s deputy controller.”
  • The FEHBlog cannot locate the FEHBP in this database, FYI. What’s more,
    • “The Treasury Department and the IRS are calling on teleworking employees to return to the office for half of their workdays, starting in a few months.
    • “IRS Commissioner Danny Werfel told employees in an email Thursday that teleworking employees will need to return to the office 50% of the time, on any given month, starting on May 5.
    • “Our top priority, regardless of where employees are located at any point in time, will continue to be meeting our goals of serving taxpayers, ensuring tax compliance and maintaining our vital technology and operations,” Werfel wrote.
    • “The return-to-office plans will only impact IRS executives, managers and non-bargaining unit employees with telework agreements in the National Capital Region. The decision affects IRS headquarters, the agency’s New Carrollton Federal Building and other offices in the Washington, D.C. area.”
  • Healthcare Dive points out,
    • “The federal government received 13 times more surprise billing disputes in the first half of 2023 than it expected to receive in a full year, according to new CMS data.
    • “And the amount is growing each quarter, contributing to a growing backlog and straining the capacity of the system regulators set up to arbitrate disputes over medical bills between providers and health insurers.
    • “Of the 288,810 disputes filed in the first six months of 2023, fewer than half were closed, and arbiters rendered payment decisions in under a third of cases. Of those, providers won 77% of payment determinations, while health plans prevailed in 23% — noteworthy statistics given providers have argued the arbitration process is unfairly weighted toward insurers.”
  • The Commonwealth Fund discusses the status of creating a separate version of the No Surprises Act for ground ambulances.
  • Newfront fills us in on federal claim substantiation rules for flexible spending accounts, health reimbursement accounts, and health savings accounts.
  • The Wall Street Journal reports,
    • “Novartis and Roche Holding said the U.S. Food and Drug Administration approved their Xolair treatment to reduce allergic reactions following the exposure to one or more foods.
    • “The pharmaceutical companies on Friday said Xolair has been approved for patients aged one year and older with the IgE-mediated food allergy.
    • “Patients taking Xolair for food allergies should continue to avoid all foods they are allergic to, the companies added.
    • “Xolair, a prescription biologic medicine that is given as an injection, shouldn’t be taken as an emergency treatment for allergic reactions.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration will decide by June 21 whether to loosen the restrictions surrounding use of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, the company said Friday
    • “Sarepta’s gene therapy, Elevidys, was granted a conditional OK last June for children between 4 and 5 years of age who have Duchenne and can still walk. Sarepta aims to convert that nod to a full approval for all people with Duchenne and a confirmed mutation to a specific gene, even though Elevidys failed to hit its main goal in a study meant to confirm its benefits. 
    • “Sarepta, for its part, has argued that the collective evidence it’s accrued proves Elevidys is impacting the disease. Analysts appear optimistic of its chances, given the agency won’t convene a group of outside experts to review its request.”  

From the public health and medical research front,

  • The Centers for Disease Control tells us
    • In September 2023, CDC’s Advisory Committee on Immunization Practices recommended updated 2023–2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. Many variants co-circulated during fall 2023; the JN.1 lineage became predominant in January 2024. Few estimates of updated 2023–2024 vaccine effectiveness (VE) are available.
    • What is added by this report?
    • Receipt of updated COVID-19 vaccine provided approximately 54% increased protection against symptomatic SARS-CoV-2 infection compared with no receipt of updated vaccine. Vaccination provides protection against JN.1 and other circulating lineages.
    • What are the implications for public health practice?
    • All persons aged ≥6 months should receive updated 2023–2024 COVID-19 vaccine. CDC will continue monitoring COVID-19 VE, including against severe disease and for expected waning.
  • The CDC called attention to its website on RSV prevention.
  • MedCity News offers
    • “Three Tips To Improve Health Plans’ Chronic Conditions Management 
    • “During a virtual panel, leaders from across the industry shared their advice on how health plans can do a better job of achieving their goals for chronic management. For example, one executive said health plans should utilize remote monitoring tools for centralized observation and be wary of using the wrong metrics.” 
  • Benefits Pro lets us know,
    • “Older Americans may forego elective surgeries because they are worried about out-of-pocket expenses and time away from work, along with potential exposure to COVID-19.
    • “This is according to a study by the University of Michigan Institute for Healthcare Policy and Innovation, which discovered that these factors tend to dissuade older Americans from going through with surgeries more than concerns about pain or the recovery process.
    • “Nearly half of those who said they were very concerned about cost and more than half of those who were very concerned about taking time off of work ended up not having a surgery they were considering, the study found. However, those who were concerned about surgery-related pain were just as likely as those with no concerns about pain to go ahead with surgery.”
  • Medscape calls attention to “How the New MRSA Antibiotic Cracked AI’s ‘Black Box.'”
    • “The MIT study is part of the Antibiotics-AI project, a 7-year effort to leverage AI to find new antibiotics. Phare Bio, a nonprofit started by MIT professor James Collins, PhD, and others, will do clinical testing on the antibiotic candidates.
    • “Even with the AI’s assistance, there’s still a long way to go before clinical approval.
    • “But knowing which elements contribute to a candidate’s effectiveness against MRSA could help the researchers formulate scientific hypotheses and design better validation, Lee noted. In other words, because they used explainable AI, they could be better positioned for clinical trial success.”
  • The New York Times reports,
    • “Growing numbers of children and adolescents are being prescribed multiple psychiatric drugs to take simultaneously, according to a new study by researchers at the University of Maryland. The phenomenon is increasing despite warnings that psychotropic drug combinations in young people have not been tested for safety or studied for their impact on the developing brain.
    • “The study, published Friday in JAMA Open Network, looked at the prescribing patterns among patients 17 or younger enrolled in Medicaid from 2015 to 2020 in a single U.S. state that the researchers declined to name. In this group, there was a 9.5 percent increase in the prevalence of “polypharmacy,” which the study defined as taking three or more different classes of psychiatric medications, including antidepressants, mood-stabilizing anticonvulsants, sedatives and drugs for A.D.H.D. and anxiety drugs.”
  • AP reports,
    • “Smoking has surpassed injecting as the most common way of taking drugs in U.S. overdose deaths, a new government study suggests.
    • “The Centers for Disease Control and Prevention called its study published Thursday the largest to look at how Americans took the drugs that killed them.
    • “CDC officials decided to study the topic after seeing reports from California suggesting that smoking fentanyl was becoming more common than injecting it. Potent, illicit versions of the painkiller are involved in more U.S. overdose deaths than any other drug.”

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “CommonSpirit Health cut its operating losses in the three months ended Dec. 31by working with payers to speed the rate of reimbursement for services and implementing cost containment measures, according to earnings released on Thursday.
    • “The Chicago-based health system reported an operating income of $356 million for the quarter. Normalized for the California provider fee program, CommonSpirit logged an operating loss of $87 million. In the same period last year, CommonSpirit reported an operating loss of $440 million.
    • “CommonSpirit said supply and salary inflation continues to vex the system. Salaries and benefit expenses increased $413 million, or 9.3%, year over year, primarily due to higher salary costs.”
  • RevCycle Intelligence adds,
    • “Rural healthcare’s outlook just worsened, according to a new analysis from Chartis, a healthcare advisory firm.
    • “The updated analysis of key indicators such as rural hospital operating margin, facility closures, and loss of access to care and services paints a grim picture for rural hospitals in the US, particularly independent providers.
    • “Half of rural hospitals are operating in the red, the analysis found, and that percentage increased from 43 percent a year ago. More independent rural hospitals are operating at a loss at 55 percent, while 42 percent of health system-affiliated rural hospitals have a deficit. The analysis noted that almost 60 percent of rural hospitals in the US are now affiliated with a health system.
    • “With more rural hospitals facing revenue losses, 418 facilities are “vulnerable to closure,” the analysis showed.
    • “America’s rural hospitals have been battling against drivers of instability for more than a decade, but this newest research suggests this crisis has accelerated quickly to previously unseen levels,” Michael Topchik, national leader of The Chartis Center for Rural Health, said in a statement. “To learn the percentage of rural hospitals in the red has shifted 7 [percent] and now includes half of all rural hospitals is startling and should serve as an urgent call to action for everyone invested in rural healthcare.”
  • Per Fierce Healthcare,
    • “Nearly all healthcare executives believe new digital health technologies are worth the cost, even though they have yet to see a financial return from it, a new survey reveals.
    • “The inaugural Health Pulse Survey was conducted by Ernst & Young and reached more than 100 payer and provider administrative executives across the U.S. It found that the appetite for digital health solutions has risen, particularly since COVID-19. The pandemic was a catalyst for the industry.
    • “COVID prompted a lot of digital health tech investments by payers and providers—it was out of necessity,” Kaushik Bhaumik, EY’s U.S. health technology leader, told Fierce Healthcare. “People had to connect with their patients through digital channels.” 
  • Reuters reports,
    • “A small but rapidly growing number of U.S. adolescents began treatment with Novo Nordisk’s weight-loss drug Wegovy last year, a powerful new tool to address record rates of pediatric obesity, according to data shared exclusively with Reuters.
    • “In the first 10 months of 2023, 1,268 children ages 12 to 17 with an obesity diagnosis started taking Wegovy, according to U.S. insurance claims data compiled by health technology company Komodo Health.”

Thursday Miscellany

David Ermer–ACA, CMS, Employee Wellness Programs, Mental health care, OPM, SDOH, U.S. Healthcare, Wellness–

As you may be able to tell, it’s a late FEHBlog post because the FEHBlog was returning home to Dripping Springs, TX, last night from our Nation’s capital.

In case, here are some highlights from Washington DC.

  • The GAO released a troubling report on our country’s fiscal health this week. Here’s a link to a Wall Street Journal Opinion Watch podcast about the report. The podcast is about 20 minutes long, and it may make your hair stand on edge.
  • Mercer Consulting discusses changes to the RxDC reports due annually on June 1.
    • “CMS released instructions for the third prescription drug data collection (RxDC) reports due June 1, 2024 – and they may cause plan sponsors to reconsider whether they need to make “plan level” submissions, instead of relying on their vendors to make “aggregate” submissions on their behalf. The good news is that the instructions largely mirror prior versions, so plan sponsors should be able to build off prior RxDC reporting efforts. However, for the first time, CMS plans to enforce the “aggregation restriction”—a provision in the 2021 regulations that CMS suspended for the first two reporting cycles. As explained [in the article], the reinstated aggregation restriction may cause headaches for some plan sponsors, who find that they can no longer rely on their PBM’s aggregate submission of pharmacy data but must instead submit plan level data. Other plan sponsors may welcome the opportunity to do a plan level submission so they can obtain otherwise unavailable prescription drug data.”
  • Per Govexec,
    • “With federal budget talks still unresolved less than a month away from Congress’ latest deadline, the Office of Personnel Management said Friday that the decade-long pay freeze for senior political appointees like Vice President Kamala Harris and others will remain in effect.
    • “In a Feb. 9 post, OPM Director Kiran Ahuja said that under January’s continuing resolution that extended federal funding to agencies until March 1 and 8, certain senior political appointees will continue to see their payable pay rates remain at current levels at least through the latter budget deadline, when Congress will have to decide whether it will continue to fund the federal government. 
    • “Future Congressional action will determine whether the pay freeze continues beyond March 8, 2024,” Ahuja said. “Until such time, the OPM guidance issued on Dec. 21, 2023, regarding the pay freeze for certain senior political officials continues to be generally applicable in applying the pay freeze in 2024.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “There isn’t a silver bullet to maintaining mental acuity or warding off dementia [as we age], scientists of aging say. But a combination of genetics, healthy lifestyle habits and factors such as cleaner air and good education have been linked to prolonged mental agility.  * * *
    • “Genetics is thought to play a role in brain maintenance, as does diet, exercise and a person’s risk of vascular disease. More education, mental stimulation and social connectivity have been associated with improved cognitive reserve.
    • “Better brain maintenance and cognitive reserve might help keep symptoms of dementia at bay. Almost 50% of people 40 and older think they will likely develop dementia, according to a 2021 AARP survey. The actual number of U.S. adults 65 and older with dementia is closer to 10%, a 2022 study found. * * *
    • “Sleeping too little—or too much—can also lead to cognitive problems. Activities including yoga and tai chi, the Chinese martial art, could help improve cognitive function, research suggests. 
    • “Hearing loss is a risk factor for dementia, too. Lost hearing might cause the brain to atrophy more quickly and can make people more isolated, said Dr. Dung Trinh, chief medical officer of the Healthy Brain Clinic. Hearing aids can help preserve mental fitness.”
  • AHA News adds,
    • “About half of U.S. health care workers have witnessed racial discrimination against patients and say discrimination against patients is a crisis or major problem, according to a survey released Feb. 15 by the Commonwealth Fund and African American Research Collaborative. Younger workers and workers of color were more likely than their older or white counterparts to say they witnessed discrimination, as were workers at facilities with more patients of color. About six in 10 Black health care workers and four in 10 Latino, Asian American and Pacific Islander workers say they have been discriminated against because of their race or ethnicity. 
    • “While most health care workers see positive efforts from employers to address discrimination, a majority of Black, Latino, and AAPI workers worry about retaliation if they raise discrimination concerns. When asked about potential solutions, more than two-thirds of health care workers thought the following could help: providing an easy way to anonymously report situations involving racism or discrimination; creating opportunities to listen to patients and health care professionals of color; examining treatment of non-English-speaking patients; and training health care staff to spot discrimination.” 
  • Employee Benefit News offers three suggestions on how employers can help employees hold cancer at bay with preventive screenings.
    • “A new report from healthcare platform Color Health shows that although 80% of employers are concerned by rising cancer costs and 96% of benefits leaders agree early detection is the best solution, the majority of focus is devoted to post-diagnosis treatment, rather than evidence-based screenings. 
    • “According to the report, three out of four employers say they are placing more emphasis on screening, early detection and risk prevention efforts, but they are going to have to go beyond their current benefits setup: Only a quarter believe their current health plans meet the screening needs of their workforce, and three-quarters say employees are not being adequately screened by their primary care provider. Leaders report that 40% of employees are not compliant with screenings in general, and for the most deadly forms of cancer — lung and bronchus — the American Lung Association reports that only 6% of people eligible get screened. 
    • “The assumption [has been that] if we cover mammograms and colonoscopies and lung CTs, then people will actually get them, and that’s turned out to be false,” says Othman Laraki, Color Health’s CEO. “The big driver for that is that for non-acute care services, availability is not the same thing as access.” 

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • STAT News reports
    • “Lawmakers are considering increasing doctors’ Medicare pay in an upcoming government funding package, but their policy would only partially offset cuts providers saw earlier this year, three lobbyists and two sources familiar with the talks told STAT.
    • “Physicians’ groups have agitated for Congress to undo a roughly 3.4% Medicare pay cut this year, resulting from the expiration of pandemic-era bonuses lawmakers chose to give the industry.
    • “The cut went into effect on Jan. 1, but a fix hasn’t entirely fallen off of the agenda. A pay increase was discussed in negotiations over a stopgap funding bill earlier this year.
    • “There are more questions than answers at this point in negotiations. It’s unclear what the exact pay increase could be, when it could be passed, and how it could be paid for. The fate of legislation to fund the government is uncertain, too. But the five sources made it clear that an effort to completely offset the 3.4% cut is now off the table.”
  • The New York Times reports,
    • “The Centers for Disease Control and Prevention is considering loosening its recommendations regarding how long people should isolate after testing positive for the coronavirus, another reflection of changing attitudes and norms as the pandemic recedes.
    • “Under the proposed guidelines, Americans would no longer be advised to isolate for five days before returning to work or school. Instead, they might return to their routines if they have been fever free for at least 24 hours without medication, the same standard applied to the influenza and respiratory syncytial viruses.
    • “The proposal would align the C.D.C.’s advice with revised isolation recommendations in Oregon and California. The shift was reported earlier by The Washington Post, but it is still under consideration, according to two people with knowledge of the discussions.
    • “The C.D.C. last changed its policy on isolation in late 2021, when it scaled down the recommended period to five days from 10. If adopted, the new approach would signal that Covid has taken a place alongside other routine respiratory infections.”
  • The Federal Times tells us,
    • “The federal employee retirement backlog shot back up in January, snapping a four-month streak of steadily shrinking caseloads and indicating the government still has trouble getting a handle on its system for processing annuities.
    • “Nearly 13,000 people applied for retirement in January, matching the usual record-high number the Office of Personnel Management receives at the beginning of each calendar year. Traditionally, the retirement claims surge culminates in winter and case workers work through it well into spring.
    • “Last month, the Office of Personnel Management processed roughly 6,400 cases while intaking almost twice that. The overall inventory was 46% higher in January than December. And while processing times again improved last month after steadily quickening, it remains to be seen how the influx will impact speeds in the coming months.
    • “Despite the increases, fewer employees overall retired in 2023 than 2022, 2021 and 2020.”
  • The Society for Human Resource Management lets us know,
    • “Inflation fell in January to 3.1 percent year-over-year, missing some economists’ estimates that it would fall below 3 percent for the first time in nearly three years. 
    • “The Consumer Price Index (CPI) for all items rose 3.1 percent for the 12 months ending in January, before seasonal adjustment, the U.S. Bureau of Labor Statistics (BLS) reported today. That’s down from the unadjusted 3.4 percent annual gain seen in December—and a significant improvement from the 9.1 percent high notched in June 2022. 
    • “Core inflation—which accounts for all items minus food and energy—rose 3.9 percent over the past 12 months, the same for the 12 months ending in December.” 

From the public health and medical research front,

  • The New York Times reports,
    • “Women who develop high blood pressure or diabetes in the course of pregnancy are more likely to give birth to children who develop conditions that may compromise their own heart health at a young age, scientists reported on Monday.
    • “By the time they are 12 years old, these children are more likely to be overweight or to be diagnosed with high blood pressure, high cholesterol or high blood sugar, compared with children whose mothers had complication-free pregnancies.
    • “The research underscores the strong association between healthy pregnancies and child health, though the study stops short of proving a cause-and-effect relationship. The conclusions also offer support for the “fetal origins of adult disease” hypothesis, which suggests that many chronic conditions may have roots in fetal adaptations to the uterine environment.”
  • The American Hospital News points out,
    • “Syphilis infections during pregnancy more than tripled between 2016 and 2022 to 280 cases per 100,000 births, ranging from 46 per 100,000 in Maine to 763 per 100,000 in South Dakota, the Centers for Disease Control and Prevention reported Feb. 13. Rates doubled in seven states and grew fivefold in six states: New Mexico, Colorado, Mississippi, South Dakota, Montana and Alaska. Rates increased across all racial/ethnic and age groups, with the highest rates in mothers who were American Indian and Alaska Native, under age 25 and had no prenatal care.
    • “According to a CDC report last November, over 3,700 mothers passed the infection onto their babies in 2022, 10 times more than in 2012, although timely testing and treatment could prevent most mothers from transmitting the infection to their babies. Congenital syphilis can cause adverse pregnancy outcomes such as fetal and neonatal death, low birthweight, preterm birth, and brain and nerve disorders.”
  • The Wall Street Journal notes,
    • “At a biomedical center here, there’s a man scarfing down Frosted Flakes and tater tots while hooked up to an IV. His job? To help the government figure out what you should eat.
    • “That man, Kevin Elizabeth, a 28-year-old tech worker, is one of 500 Americans who will be living at scientific facilities around the country for six weeks, eating precisely selected meals and undergoing hundreds of medical tests. He is part of a new study, costing $189 million, that is one of the most ambitious nutrition research projects the National Institutes of Health has ever undertaken. * * *
    • “If all goes according to plan, in a few years you’ll be able to walk into your doctor’s office, get a few simple medical tests, answer questions about your health and lifestyle, and receive personalized diet advice, says Holly Nicastro, coordinator for the NIH’s Nutrition for Precision Health study.”
  • On the flip side, MedPage Today explains,
    • “Gastric bypass surgery in people with severe obesity was associated with sustained improvements in cognitive function, inflammation, and comorbidities, according to results of a cohort study in the Netherlands.
    • “At 2 years post-surgery, neuropsychological tests showed improvements of 20% or higher in global cognition (43% of patients), ability to shift attention (40%), episodic memory (32%), verbal fluency (24%), and working memory (11%), reported Amanda J. Kiliaan, PhD, of Radboud University Medical Center in Nijmegen, the Netherlands, and colleagues.
    • “Lower inflammation and adipokine secretion, remission of comorbidities, higher physical activity, and better mood” may have played a role in the sustained improvement in global cognition for that subset of patients, the researchers suggested in JAMA Network Open.”
  • The Washington Post illuminates “How D.C.’s first sobering center could ease drug and alcohol addiction. The facility, part of the District’s response to a worsening opioid epidemic, exceeded 1,000 admissions in just over three months since it opened late last year.”

From the U.S. healthcare business front,

  • Per a Cigna press release,
    • “Cigna Healthcare, the health benefits division of The Cigna Group (NYSE: CI), and HelloFresh*, the world’s leading meal kit company, announce an exclusive collaboration to offer discounted access to HelloFresh’s wholesome, affordable meals to as many as 12 million Cigna Healthcare customers through their employers. The two companies will also team up to support HelloFresh’s Meals with Meaning program, a social impact initiative that provides free meal kits for individuals experiencing food insecurity in local communities.
    • “Business leaders recognize that healthy employees mean a healthy business, and by expanding access to affordable, healthy meals, employers can better cultivate a stronger workforce,” said Heather Dlugolenski, U.S. commercial strategy officer, Cigna Healthcare. “We’re proud to team up with HelloFresh to support the health and vitality of America’s workforce and to make a difference for communities in need.”
  • Per Fierce Healthcare,
    • Chronic care provider Omada Health is expanding its GLP-1 program to better care for patients interested in maintaining weight loss progress while discontinuing usage of the drugs.
    • For patients prescribed to GLP-1 drugs for weight loss, up to 40% of the weight loss can be due to loss of muscle mass. Omada is building upon its weight management solution to help users regain muscle throughout a member’s journey and when the drug is no longer utilized, a solution that would improve health outcomes and allow patients to not stray far from weight-related goals. Members of Omada’s cardiometabolic programs can benefit from the expanded care track, the company said.
  • and
    • “Zocdoc has launched a new guided search to help patients choose and book the right provider with greater confidence. 
    • “The guided search function on the healthcare marketplace and appointment booking platform offers a more tailored set of results based on patients’ unique care needs. When a patient searches for a provider, they are presented with an optional questionnaire to help better understand their symptoms and the type of treatment being sought. The goal is to take the guesswork out of which provider is the best fit.
    • “This search function can also help patients discover more about a provider’s scope of practice and helps providers ensure the patient is a good fit, Zocdoc said. A broad spectrum of specialties have the function available.”
  • Beckers Hospital Review notes,
    • CVS’ Aetna will begin offering in-home care services to its Medicare Advantage members with chronic kidney disease. 
    • Aetna has partnered with Monogram Health, a provider of in-home care management services, according to a Feb. 13 LinkedIn post from Monogram. Under the partnership, Monogram nurse practitioners will provide in-home and virtual specialty provider appointments to eligible Aetna members. 

Thursday Miscellany

David Ermer–COVID-19 vaccine, FDA, HSA, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
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 Merck, Novartis, Johnson & Johnson, Bristol Myers Squibb, Boehringer 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

David Ermer–Congress, COVID treatment, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, OPM, U.S. Healthcare–
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. “

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Politico reports,
    • “The House cleared a stopgap spending bill on Thursday afternoon that officially keeps federal agencies funded through early March, sending the measure to President Joe Biden’s desk. * * *
    • “With parts of the government now funded through March 1 and March 8, leading appropriators have a tremendous amount of work to do in just a matter of weeks. ***
    • “Haggling over the broader spending bills can’t begin in earnest, however, until leading appropriators lock down a deal on funding totals for all 12 of them. It’s a critical next step that has consumed the last couple weeks for Senate Appropriations Committee Chair Patty Murray (D-Wash.) and her House counterpart, Chair Kay Granger (R-Texas).”
  • The American Hospital News informs us,
    • “The Departments of Health and Human Services, Labor, and the Treasury will reopen the public comment period for their proposed rule to improve the No Surprises Act independent dispute resolution process for 14 days beginning Jan. 22 to provide additional time for interested parties to comment.”
  • The Center for Medicare and Medicaid Services announced the Innovation in Behavioral Health (IBH) Model.
    • IBH is focused on improving quality of care and behavioral and physical health outcomes for Medicaid and Medicare populations with moderate to severe mental health conditions and substance use disorder (SUD). Medicare and Medicaid populations experience disproportionately high rates of mental health conditions and/or substance use disorders (SUD), and as a result are more likely to experience poor health outcomes and experiences, like frequent visits to the emergency department and hospitalizations, or premature death. 
    • The IBH Model seeks to bridge the gap between behavioral and physical health; practice participants under the IBH Model will screen and assess patients for select health conditions, as well as mental health conditions and/or SUD, in community-based behavioral health practices. IBH is a state-based model, led by state Medicaid Agencies, with a goal of aligning payment between Medicaid and Medicare for integrated services.
    • CMS will release a Notice of Funding Opportunity (NOFO) in Spring 2024, and up to eight states will be selected to participate. The model will launch in Fall 2024 and run for eight years.
  • The Department of Health and Human Services also issued a fact sheet about steps taken over the last year to expand access to behavioral health by integrating behavioral health with primary care and other physical health and community settings.
  • The U.S. Preventive Services Task Force posted a draft research plan concerning “BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing” for public comment. The public comment deadline is February 14, 2024.

From the public health and medical research front

  • The Kaiser Family Foundation discusses the two healthcare cost crises facing our country.
    • “The cost of health care isn’t a single problem, it’s a multi-dimensional one. That’s one reason we often talk past each other about healthcare costs; we’re talking about different problems. There’s national health spending, consumer out-of-pocket costs, federal health spending (mostly for Medicare and Medicaid), state health spending (mostly Medicaid), employer premiums, and the cost problem currently in vogue—getting better “value” for the health care dollar. Like a Venn diagram with sets that don’t always overlap, each of these are different challenges that often have different and sometimes conflicting solutions. We work on all of these dimensions of health care costs at KFF, but two health cost problems stand out as legitimate health policy crises: Affordability, especially for people who are sick and need a lot of healthcare, and national health spending (the subject of the CMS annual report).”
  • STAT News reports,
    • Mental health care in the United States is in crisis. As the need for care surges — a longstanding trend exacerbated by the Covid-19 pandemic — the demand for therapists far outstrips the supply. In national surveys, more than one in five U.S. adults suffer from mental illness, yet almost half of those in need report receiving no care. People struggling with mental health challenges often spend months on a wait list despite needing immediate care. Others simply can’t afford it. And getting care is even harder for people living in rural areas and people of color. * * *
    • In the face of these issues, there’s growing interest in the use of lay counselors. One scientific journal recently announced a call for papers for a special issue on the subject. In its executive summary for a recent population health summit, the APA [American Psychological Association] declared that the “exclusive reliance on trained mental health care providers when there are severe gaps in support for training of a mental health workforce has left millions untreated.” A number of recent research articles suggest addressing the gap by innovating on the traditional model of mental health treatment, including where and how it is provided and who provides it.
    • Lynn Bufka, associate chief of practice transformation and quality at the APA, believes that an expanded approach to providing mental health care is essential to meet the current need. “We clearly cannot meet the need for mental health services in this country with the existing workforce,” she said. “We’re going have to consider those kinds of models and options in order to get to where we need to be in this country.”
  • STAT New also delves into whether recent scientific findings may lead to a test for long Covid.
    • “Long Covid has long eluded scientists looking for its cause. Not knowing what triggers its persistent and distressing symptoms makes the condition challenging to treat; it’s hard to even say definitively who has it. New research published Thursday in Science has identified proteins present in the blood of people with long Covid that could point the way to a much-needed diagnostic test and possibly to future therapeutic targets.
    • “Scientists at the University of Zurich discovered high levels of proteins involved in the complement system — an important part of the immune system bridging innate and adaptive responses — that were disrupted in people with long Covid symptoms, but not in those who got better after the initial Covid-19 infection or in those who had recovered from long Covid symptoms after six months. The team also found damaged red blood cells and platelets as well as signs of harm to the endothelial cells that line blood vessels.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Drugmakers kicked off 2024 by raising the list prices for Ozempic, Mounjaro and dozens of other widely used medicines. Companies including the maker of Ozempic, and Eli Lilly , which sells Mounjaro, raised list prices on 775 brand-name drugs during the first half of January, according to an analysis for The Wall Street Journal by 46brooklyn Research, a nonprofit drug-pricing analytics group. 
    • “The drugmakers raised prices of their medicines by a median 4.5%, though the prices of some drugs rose by around 10% or higher, according to the research group. The median increase is higher than the rate of inflation, which ticked up to 3.4% in December. * * *
    • “Among the notable increases: The price for Ozempic, a diabetes treatment that many people are taking to lose weight, went up by 3.5% to nearly $970 for a month’s supply. Mounjaro, a diabetes drug in the same class that is also widely used for weight loss, climbed 4.5% to almost $1,070 a month.”
  • Healthcare Dive identifies “Top healthcare trends in 2024; Here’s what industry experts see coming down the pike for hospitals, insurers and digital health companies this year.” The article summarizes Healthcare Dive’s 2024 trend reports from the past few weeks.
  • Healthcare Dive also informs us,
    • “Humana is the latest victim of elevated medical costs in the fourth quarter. The health insurer on Thursday lowered its 2023 profit outlook after members utilized more healthcare than expected as the year drew to a close.
    • “Humana now expects $26.09 in adjusted earnings per share for full-year 2023, according to a financial filing. That’s down from its prior guidance of at least $28.25.
    • “Humana also lowered its expectations for growth in the lucrative Medicare Advantage program. The insurer now expects to increase MA membership 1.8% this year. Previously, Humana said it would outstrip expected industry growth of 6% to 8%.”
  • CVS Health posted a report highlighting opportunities for the future of community pharmacies.

Tuesday Tidbits

David Ermer–AHRQ, Congress, FDA, Mental health care, NIH, No Surprises Act, Obesity, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Roll Call tells us,
    • “The Senate overwhelmingly voted Tuesday night in favor of the first procedural move needed to avert a partial government shutdown at the end of this week.
    • “The chamber voted 68-13 to end debate on the motion to proceed to the shell legislative vehicle for the stopgap spending measure, which would run to March 1 for four of the dozen annual appropriations bills and until March 8 for the remaining eight.
    • “Leadership in both chambers are in favor of the stopgap measure, which is designed to give appropriators more time to negotiate final fiscal 2024 appropriations bills following the $1.66 trillion topline agreement Speaker Mike Johnson, R-La., and Senate Majority Leader Charles E. Schumer, D-N.Y., announced earlier this month.”
  • Roll Call further informs us,
    • “Congressional leaders and key committee heads are poised to meet with the president at the White House Wednesday to discuss the national security supplemental package that has remained stalled over the lack of agreement on border and immigration policy measures.
    • “White House Press Secretary Karine Jean-Pierre confirmed President Joe Biden’s plans to host the meeting during a Tuesday briefing. 
    • “Speaker Mike Johnson, R-La., House Minority Leader Hakeem Jeffries, D-N.Y., Senate Majority Leader Charles E. Schumer, D-N.Y., and Senate Minority Leader Mitch McConnell, R-Ky., are expected to attend the meeting.”
  • The Wall Street Journal adds,
    • “Top U.S. lawmakers unveiled a bipartisan tax agreement that would revive expired breaks for businesses and increase the child tax credit for low-income families, and they are aiming to push the $78 billion in tax breaks through Congress in the next few weeks. 
    • “The deal comes from Sen. Ron Wyden (D., Ore.) and Rep. Jason Smith (R., Mo.), ideological opponents who found common ground after months of talks. They have a tough task ahead, given skepticism about aspects of the deal in both parties and a tight deadline before tax season starts.”
  • Roll Call notes,
    • “The conservative-controlled Supreme Court could upend how courts handle challenges to the decisions administrative agencies make, in a pair of cases set for oral arguments Wednesday that could change the standards for how Congress writes laws and the federal government implements them.
    • “The challengers to a fishery inspection rule asked the justices to overturn the Chevron doctrine, a nearly 40-year-old legal framework based on a Supreme Court decision that established that judges should defer to the agencies’ interpretations of a law when that law is ambiguous.
    • “Parts of the conservative legal movement have targeted the doctrine for years, casting it as emblematic of the broader power of administrative agencies, and Wednesday’s oral arguments could preview its demise.”
  • STAT News reports,
    • “President Biden has promised to require fair prices from drugmakers that use federally funded research — and now, in a major recent move, said he’ll trigger government “march-in” on patents for drugs that run afoul of that goal.
    • “It’s a simple principle. You shouldn’t pay the highest price in the world for drugs that your tax dollars have already helped create,” Biden said last month as he touted the move at the National Institutes of Health.
    • “But the new NIH director, locked in the center of this debate, isn’t taking any big steps yet.
    • “Our relationship with the pharmaceutical industry, with the industry overall, is really, really critical,” Director Monica Bertagnolli told STAT in an interview. “It’s very difficult, if you can imagine, to implement something broadly that is as effective as we want it to be.”
  • KFF Health News reports that a new federal program to save rural hospitals is experiencing growing pains.
  • The U.S. Preventive Services Task Force announced the appointment of three new members, “Sei Lee, M.D., M.A.S.; Tonette Krousel-Wood, M.D., M.S.P.H.; and Sarah Wiehe, M.D., M.P.H. They are appointed to serve 4-year terms beginning in January 2024.”
  • The National Academies of Science announced,
    • “A new report from the National Academies of Sciences, Engineering, and Medicine says 15 health care services related to intimate partner violence — including reproductive health care, screening for STIs and HIV, forensic medical exams, and mental health care — should be classified by the Health Resources and Services Administration and all U.S. health care systems as essential healthcare services. The report recommends prioritizing access to these healthcare services during public health emergencies, such as a pandemic or natural disasters, using a phased approach.”  
  • Per Forbes,
    • “The FDA approved the use of Casgevy, a therapy that uses CRISPR gene-editing to treat the serious blood disorder transfusion-dependent beta-thalassemia, marking the second major U.S. regulatory approval for the emerging gene-editing technology. The FDA’s approval comes just one month after the regulator approved the use of Casgevy in treating sickle cell disease.”

From the public health and medical research front,

  • Health Day points out,
    • “Despite overall progress against cancer in the United States, Black Americans are still more prone to die of the disease than whites
    • “Data from 2000 to 2020 showed the racial gap in cancer deaths had diminished but was still significant.
    • “Disparities in deaths from breast cancer, prostate cancer and colon cancer in men were especially troubling.”
  • Healthcare IT News explains why “Virtual group therapy enables Geisinger to treat more patients and maintain care continuity. With waits for individual psychotherapy as long as several months and several thousand outstanding orders, the mostly rural health system needed a solution. Combining group therapy and telemedicine [with help from American Well] was the answer.”
  • STAT News reports,
    • “Last fall, the World Health Organization and some national drug regulators urged influenza vaccine manufacturers to drop the component known as B/Yamagata from flu vaccines as quickly as possible, citing the fact that this lineage of flu B viruses appears to have been snuffed out during the Covid-19 pandemic.
    • “It might seem like that request would be as simple as deciding to leave blueberries out of a mixed-fruit smoothie. It turns out it is not.”

From the U.S. healthcare business front,

  • Healthcare Dive discusses trends shaping the health insurance business in 2024.
  • Via Fierce Healthcare, Morgan Health offers three items employers should focus on to manage GLP-1 drug costs.
  • Bloomberg informs us about lawsuits that air ambulance companies have brought against health insurers who allegedly refused to pay No Surprises Act arbitration awards. The insurers have asked the federal district court in Houston to dismiss the cases for lack of subject matter jurisdiction and improper venue.
  • Beckers Hospital Review lets us know,
    • “The Mayo Clinic Diet, a weight loss program developed by the Rochester, Minn.-based health system, is launching a weight loss telemedicine service.
    • “The Mayo Clinic Diet Medical Weight Loss Rx program will offer direct access to weight loss medications, or GLP-1s, via video visits with Amwell Medical Group clinicians, according to a Jan. 16 news release shared with Becker’s.
    • “The program, which is available in beta form to qualifying members, will also provide lab testing to confirm medication suitability, clinical monitoring, insurance support, meal plan options, and coaching and education tools.”
  • Beckers Payer Issues tells us,
    • “Though some contract negotiations with providers came “down to the wire” last year, UnitedHealthcare executives said the payer did not see more contract splits than usual in 2023. 
    • “Brian Thompson, CEO of UnitedHealthcare, told investors on a Jan. 12 call the insurer did not see more contract disruptions than in previous years in 2023.” 

 

Monday Roundup

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

From Washington DC,

  • Roll Call reports, “As the calendar turns to a presidential election year with control of both chambers in play, Congress and the White House are facing a full slate of leftovers from 2023, headlined by a stalled emergency supplemental spending request and looming deadlines to keep the government open.”
  • The Wall Street Journal adds,
    • “House Speaker Mike Johnson (R., La.) now has less than two weeks to pass spending legislation needed to avert a partial government shutdown, while contending with many of the same challenges that ultimately took down his predecessor three months ago.
    • “Following a deal with the Democratic-led Senate announced over the weekend, Johnson will try to rally his fellow Republicans this week around a plan for $1.66 trillion in overall discretionary spending for fiscal 2024.   
    • “While Democrats have largely signaled their support for the agreement, hard-line conservatives have blasted the top-line figure, meaning that Johnson almost certainly will have to rely on Democratic votes to pass the measure in the House, where the GOP has a narrow 220-213 majority. Former speaker Kevin McCarthy (R., Calif.) was able to muscle through a short-term spending bill in September and avert a government shutdown, only for eight Republican rebels to then engineer his ouster.
    • “Johnson noted Sunday that he now has an even smaller majority than when McCarthy was the speaker. “We deal with the numbers that we have,” Johnson said on  CBS. “It will be one of the smallest majorities in the history of the Congress, clearly.”
    • “The speaker backed a short-term deal late last year to avoid a Christmas showdown over spending. New deadlines of Jan. 19 and Feb. 2 are now before him, providing the biggest test of his still-fledgling speakership and his ability to wrangle his unruly GOP conference.”
  • Good luck, Mr. Speaker.
  • The American Hospital Association News tells us,
    • “Health and Human Services Secretary Xavier Becerra Jan. 8 appointed as chief competition officer Stacy Sanders, who currently oversees the department’s implementation of the Inflation Reduction Act, long-term care initiatives, policies to promote health care competition and other Medicare work. In this new role, announced by the Biden Administration last month, Sanders will work with the Federal Trade Commission and Department of Justice to address concentration in healthcare markets through data-sharing, reciprocal training programs, and other policy initiatives.”

From the public health and medical research front,

  • Endpoint News informs us,
    • “The crown jewel from Bayer’s 2020 buyout of women’s health biotech KaNDy Therapeutics has proven its worth in the clinic, meeting all primary and secondary endpoints in a pair of Phase III studies.
    • “Bayer says it plans to file the drug, elinzanetant, for regulatory approvals to treat moderate to severe vasomotor symptoms associated with menopause once results from a third Phase III study are in. Those data are expected within the next few months.
    • “Elinzanetant, formerly known as NT-814, hit all four primary endpoints in the OASIS 1 and 2 studies, showing statistically significant reductions in the frequency and severity of VMS symptoms — also known as hot flashes. The company didn’t report any numbers, but it said the drug also did better than placebo on a slate of secondary endpoints, including frequency of VMS at week 1, improvement of sleep disturbance and menopause-related quality of life.”
  • The Institute for Clinical and Economic Review (ICER) released a Final Evidence Report on Treatment for Pulmonary Arterial Hypertension.
    • ICER’s “Independent appraisal committee voted that sotatercept demonstrated a net health benefit when compared to background therapy; sotatercept would achieve common thresholds for cost-effectiveness if priced between $17,900 to $35,400 per year.
  • The Washington Post and Consumer Reports points out “quick fixes for congestion, sneezing and other sinus woes.”

From the U.S. healthcare business front,

  • The National Institutes of Health announced,
    • “Access to residential addiction treatment centers caring for U.S. adolescents under 18 years old in the United States is limited and costly, according to a new study(link is external) supported by the National Institutes of Health. Researchers found that only about half (54%) of the residential addiction treatment facilities that they contacted had a bed immediately available, and for those that had a waitlist, the average estimated time before a bed opened was 28 days. In addition, the average daily cost per day of treatment was $878, with close to half (48%) of the facilities that provided information requiring partial or full payment upfront. On average, the quoted cost of a month’s stay at a residential addiction treatment facility was over $26,000.
    • “Published in Health Affairs, this study was supported by the National Institute on Drug Abuse (NIDA) and the National Center for Advancing Translational Sciences (NCATS), both part of NIH, and led by researchers at Oregon Health & Science University (OHSU). The results build on previous research revealing that only one in four residential treatment centers caring for U.S. adolescents under 18 years old provide buprenorphine, a medication to treat opioid use disorder.
    • “The ability to access timely, evidence-based treatment for addiction can be a matter of life or death, and the current system too often fails young people,” said Nora Volkow, M.D., director of NIDA. “We need to make access to timely, affordable, and evidence-based care the norm across treatment settings.”
  • mHealth Intelligence takes a look at this year’s virtual care trends.
    • “The mood of healthcare stakeholders going into 2024 may be more somber than in the recent past, but the work of integrating virtual care into the US healthcare system is ongoing. Here [in the article] are some key trends healthcare leaders, policy experts, and consultants expect to see in the new year.”
  • MedTech Dive notes,
    • “Procedure volumes increased in the fourth quarter, mostly matching or exceeding the usual seasonal trend, according to Truist Securities’ survey of 50 U.S. hospital administrators.
    • “The survey suggests procedure volumes rose 2% to 3% over the third quarter, with interventional cardiology experiencing the biggest increase. The analysts wrote companies including Boston Scientific, Edwards Lifesciences and Medtronic would benefit from rising cardiology volumes.
    • “Truist also saw positive signs for Intuitive Surgical, tracking improvements in the outlook for capital spending and a rebound in weight loss procedures after pressure from obesity drugs.”
  • and
    • “Boston Scientific said Monday it has agreed to acquire Axonics, maker of devices to treat urinary and bowel dysfunction, for $3.7 billion in cash, or $71 per share.
    • “The acquisition allows Boston Scientific to enter the high-growth sacral neuromodulation market, where it will compete with companies such as Medtronic. 
    • “Stifel analyst Rick Wise, in a note to clients Monday, called the deal a highly complementary fit to Boston Scientific’s urology business, which generated about 14% of its estimated 2023 sales.”