Thursday Miscellany

Congress

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Speaker Mike Johnson said Thursday that Republicans are considering a new approach to stopgap funding that would extend pieces of current appropriations for different time periods, effectively setting up a series of funding cliffs while avoiding a single deadline that could trigger a partial government shutdown for all agencies.
    • “With current funding for the entire government set to expire on Nov. 17, Johnson has proposed a CR to extend funding through Jan. 15, though that date is the federal Martin Luther King Day holiday. But the Louisiana Republican said at a press conference some GOP members raised the idea of a “laddered CR” to extend funding on a piecemeal basis.”
  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released a discussion draft including policies aimed at expanding mental health care under Medicaid and Medicare and reducing prescription drug costs for seniors at the pharmacy counter. The package also includes essential Medicaid and Medicare provisions that will expire this year, as well as changes to Medicare payment to support physicians and other professionals. The Committee intends to advance these legislative proposals, in addition to pharmacy benefit manager (PBM) reforms previously passed out of the Committee in July, and pursue full Senate passage and enactment. As part of that process, the Committee intends to hold a markup on Wednesday, November 8 at 10 a.m. In keeping with Finance Committee rules, the Chairman’s Mark will be released 48 hours in advance of the markup.”
  • It was a very busy day for the Centers for Medicare and Medicaid Services. We learned from the American Hospital Association that
    • The Centers for Medicare & Medicaid Services Nov. 2 issued a final rule that increases Medicare hospital outpatient prospective payment system rates by a net 3.1% in calendar year 2024 compared to 2023. This includes a 3.3% market basket update, offset by a 0.2% cut for productivity.
    • In a statement shared with the media, AHA Executive Vice President Stacey Hughes said “The AHA is concerned that CMS has again finalized an inadequate update to hospital payments. Today’s increase for outpatient hospitals of only 3.1% comes in spite of persistent financial headwinds facing the field. Most hospitals across the country continue to operate on negative or very thin margins that make providing care and investing in their workforce very challenging day to day. Hospitals’ and health systems’ ability to continue caring for patients and providing essential services for their communities may be in jeopardy, which is why the AHA is urging Congress for additional support by the end of the year.” 
    • The rule also finalizes several changes to the hospital price transparency rule, including requiring a new standard format with an additional data element and a completeness and accuracy affirmation statement. CMS also makes updates to streamline the enforcement process. Compliance dates for the changes range from Jan. 1, 2024, to Jan. 1, 2025. Most formatting changes take effect July 1, 2024.
  • and
    • “Following last year’s unanimous Supreme Court decision in favor of the AHA and others, the Department of Health and Human Services Nov. 2 issued a final rule outlining the agency’s remedy for the unlawful payment cuts to certain hospitals that participate in the 340B Drug Pricing Program. 
    • “HHS’ final rule contains two central components. First, HHS will repay 340B hospitals that were unlawfully underpaid from 2018 to 2022 in a single lump sum payment. The final rule contains the calculations of the amounts owed to the approximately 1,600 affected 340B covered entity hospitals. Second, HHS finalizes a policy to recoup funds from those hospitals that received increased rates for non-drug services from 2018 to 2022. HHS will recoup these funds by adjusting the outpatient prospective payment system conversion factor by minus 0.5% starting in calendar year 2026 (one year later than HHS had originally proposed and as AHA advocated), making this adjustment until the full amount is offset, which the department estimates to be 16 years.
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “Following years of litigation and a unanimous Supreme Court win, the AHA is very pleased that 340B hospitals finally will be reimbursed in full for what HHS unlawfully withheld from them for five years. The one-time, lump-sum repayment hospitals will soon receive will help them to continue providing high-quality care to their patients and communities. However, HHS made a grievous mistake in choosing to claw back billions of dollars from America’s hospitals, especially those that serve rural, low-income and other vulnerable communities. HHS decided to ignore hundreds of comments from hospitals and other providers explaining why this Medicare cut is both illegal and unwise. The AHA will continue to review this rule and consider all available options going forward.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 2 released its calendar year 2024 final rule for the physician fee schedule. The rule will cut the conversion factor by 3.4%, to $32.74 in CY 2024, as compared to $33.89 in CY 2023. This reflects the expiration of the 2.5% statutory payment increase for CY 2023; a 1.25% statutory payment increase for 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a budget-neutrality adjustment. 
    • “As urged by the AHA, CMS addressed the fact that on Jan. 1 practitioners who render telehealth services from home would have been required to report their home address on enrollment and claims forms. The agency delayed this provision until Jan. 1, 2025, and solicits comments on the issue for future rulemaking.
    • “In addition, the agency finalized a revised definition of the substantive portion of a split (or shared) visit. Specifically, for CY 2024, for purposes of Medicare billing, the definition of “substantive portion” means more than half of the total time spent by the physician and non-physician practitioner performing the split (or shared) visit or a substantive part of the medical decision-making.
    • “CMS finalized its proposals to advance access to behavioral health services. First, CMS will implement regulations as directed by the Consolidated Appropriations Act of 2023 to create a new benefit category for marriage and family therapists and mental health counselors under Part B, who will be eligible to provide telehealth services and behavioral health integration services. CMS also established new payment codes for mobile psychotherapy for crisis services as required by the CAA. Separately, the agency will apply an adjustment to psychotherapy services payments billed with a new increased complexity code and will increase the payment rate for the substance use disorder bundle.”
  • What’s more, AHA News reports,
    • “The AHA, joined by the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System, Nov. 2 sued the federal government to bar enforcement of an unlawful, harmful and counterproductive rule that has upended hospitals’ and health systems’ ability to share health care information with the communities they serve, analyze their own websites to enhance accessibility, and improve public health.  * * *  
    • “Today’s lawsuit challenges a “Bulletin” issued by HHS’ Office for Civil Rights. The December 2022 “Bulletin” restricts hospitals from using standard third-party web technologies that capture IP addresses on portions of hospitals’ public-facing webpages that address health conditions or health care providers. For example, under HHS’ new rule, if someone visited a hospital website on behalf of her elderly neighbor to learn more about Alzheimer’s disease, a hospital’s use of any third-party technology that captures an IP address from that visit would expose that hospital to federal enforcement actions and significant civil penalties.”  
  • The U.S. Office of Personnel Management announced “the recipients of the 2023 Presidential Rank Awards (PRA) chosen by President Joe Biden. The PRAs are one of the most prestigious awards in the career civil service, recognizing the important contributions of public servants across the federal government.” Congratulations to the recipients.   

In FEHB news, FedWeek discusses the relationship between FEHBP and FEDVIP plans.

  • “FEDVIP is the “secondary” payer to any benefits provided under an FEHB plan. If you are enrolled in both FEDVIP and FEHB, you must provide your FEHB enrollment information during the FEDVIP enrollment process (which takes place online, on www.benefeds.com). It’s a good idea to provide your FEHB information to the medical office that is providing the dental or vision services under FEDVIP.
  • “Also, if you change your FEHB health plan during the year, you need to notify BENEFEDS immediately. If you fail to provide this information, payment of claims will be delayed.”

From the public health and research front,

  • The U.S. Preventive Services Task Force released its final research plan for “Healthy Diet, Physical Activity, and/or Weight Loss to Prevent Cardiovascular Disease in Adults: Behavioral Counseling Interventions.”
  • The NIH Director’s Blog discusses “How Double-Stranded RNA Protects the Brain Against Infection While Making Damaging Neuroinflammation More Likely.”
    • “The findings show how this tricky balance between susceptibility to infection and inflammation in the brain works in both health and disease. It also leads to the tantalizing suggestion that treatments targeting these various players or others in the same pathways may offer new ways of treating brain infections or neuroinflammatory conditions, by boosting or dampening dsRNA levels and the associated immune responses. As a next step, the researchers report that they’re pursuing studies to explore the role of dsRNA-triggered immune responses in ALS and Alzheimer’s, as well as in neuropsychiatric symptoms sometimes seen in people with lupus.”
  • The Food and Drug Administration released
    • “data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. The findings, which were collected between March and June 2023, show that 10% of U.S. middle and high school students (2.8 million youth) reported current use of any tobacco product.
    • “Among U.S. high school students, current overall tobacco product use declined during 2022-2023 (16.5% to 12.6%). This decline was primarily attributable to reduced e-cigarette use (14.1% to 10%), which translates to 580,000 fewer high school students who reported current use of e-cigarettes in 2023. Among high school students, declines in current use were also observed during 2022-2023 for cigars and overall combustible tobacco smoking, representing all-time lows.”
    • “It’s encouraging to see this substantial decline in e-cigarette use among high schoolers within the past year, which is a win for public health,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “But we can’t rest on our laurels. There’s more work to be done to build on this progress.”  

From the U.S. healthcare business front

  • Per Healthcare Dive
    • “Cigna has hiked its membership expectations for 2023. The health insurer previously expected to lose commercial members in the back half of the year, prepping for an economic downturn that might cause Americans to lose their jobs — and subsequently, their insurance.
    • “But the expected economic downturn has yet to materialize, leading Cigna to say on Thursday it expects to add at least 1.6 million members this year, up 200,000 lives from previous forecasts.
    • “We’ve not seen the disenrollment levels we incorporated into our prior outlook,” said CFO Brian Evanko on a Thursday call with investors. Cigna also raised its revenue and adjusted earnings per share outlook for 2023, after releasing third-quarter earnings.”
  • and
    • “Amwell posted a growing net loss in the third quarter as the telehealth firm notched another hefty goodwill impairment charge.
    • “The Boston-based company’s losses reached $137.1 million — a 94% increase from the same period in 2022 —  including $78.9 million in impairment charges linked to sustained decreases in its share price and market capitalization. Revenue declined 11% year over year to $61.9 million. 
    • “But a recent contract with the Department of Defense’s Health Agency that aims to digitize the military healthcare system “fortifies our path to profitability,” expanding Amwell’s reach within the public sector, CEO Ido Schoenberg said on a call with investors Wednesday.”
  • BioPharma Dive adds
    • “Novo Nordisk and Eli Lilly on Thursday reported strong sales growth for their rival GLP-1 metabolic disease drugs, setting up a 2024 showdown as the latter company’s latest product Mounjaro nears approval as a weight-loss rival to Novo’s Wegovy.
    • “Both companies cautioned about potential supply constraints, however. Wegovy still has limited availability at the starter dose, and Lilly CEO David Ricks said there is a need to increase manufacturing capacity “pretty dramatically from the current levels.
    • “Wegovy sales jumped nearly five-fold to 21.7 billion Danish krone, or about $3.1 billion, through the first nine months of this year, according to Novo. Sales of Ozempic, which is approved as a diabetes drug but used off-label in weight loss, were 65.7 billion krone, a 58% rise. * * *
    • “Lilly on Thursday revealed equally promising sales numbers for Mounjaro, which is so far approved only as a blood sugar-lowering agent for people with Type 2 diabetes. Sales of the dual-acting drug were $3 billion for the first nine months of 2023, which will be its first full year on the market. It is now Lilly’s second-biggest seller after another GLP-1 drug called Trulicity, sales of which have declined as Mounjaro’s have grown.
    • “A Food and Drug Administration decision on approving Mounjaro, known also as tirzepatide, in obesity should come by the end of 2023 * * *.”
  • The Wall Street Journal points out
    • “Both Lilly and Denmarks Novo Nordisk, which makes Ozempic and its sister drug Wegovy, are struggling to meet skyrocketing demand for their medications. There is no quick fix for that given the complexity of building out manufacturing capacity for the injections. Both companies are investing billions of dollars a year to try to catch up. * * *
    • “Keeping up with demand requires investments in factories that take years to build. Morgan Stanley analysts recently forecast the global anti-obesity market would be worth $77 billion by 2030. Mounjaro, Ozempic and Wegovy are injectables, which are complex to manufacture. Some oral medications currently in clinical trials, such as Lilly’s orforglipron, are smaller molecules, which are simpler to make. Supply constraints may only be truly remedied whenorals come to the market, the analysts said.”

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19 testing, Federal employment benefits, Medicare, OPM, Patient safety, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call tells us, “The Senate on Wednesday voted 82-15 to pass the first three of its fiscal 2024 appropriations bills in a “minibus” as the House tees up votes this week on three of its remaining seven fiscal 2024 appropriations bills.”
    • The minibus included “the fiscal 2024 Military Construction-VA, Agriculture, and Transportation-HUD appropriations bills.” 
  • The Centers for Medicare and Medicaid Services issued its “calendar year 2024 Home Health Prospective Payment System (HH PPS) Rate Update final rule.”
  • Per Fierce Healthcare, the rule
    • increases the 2024 home health payments by 0.8%, or $140 million.
    • “The $140 million increase in estimated payments for CY 2024 reflects the effects of the CY 2024 home health payment update percentage of 3% ($525 million increase), an estimated 2.6% decrease that reflects the effects of the permanent behavioral assumption adjustment ($455 million) and an estimated 0.4% increase that reflects the effects of an updated FDL ($70 million increase),” the unpublished rule said.
    • “CMS expects increasing the rate will bring home health payments in line with statutory payment authority.”
  • BioPharma Dive informs us,
    • “An experimental sickle cell disease treatment made with CRISPR technology is one step closer to approval in the U.S., following a meeting Tuesday in which advisers to the Food and Drug Administration seemed generally comfortable with its safety.
    • “Made up of scientists and physicians, the advisory panel spent hours discussing highly technical questions around how best to assess the risk that CRISPR — the gene editing technique often likened to a pair of scissors — might make unwanted, or “off-target,” cuts to DNA.
    • “Ultimately, the panel appeared convinced that Vertex Pharmaceuticals, which developed the sickle cell treatment, had done enough to show the therapy is safe, although they pointed to several avenues for further study.”
  • Reuters adds, “Analysts have been optimistic the therapy, which is a first-of-its-kind product to reach the FDA for review, will win the health regulator’s nod by Dec. 8.”
  • On a related note, an article in Health Affairs Scholar prognosticates,
    • “Despite the potential of gene therapy to transform the lives of patients with rare genetic diseases, serious concern has been raised about the financing of the high up-front costs for such treatments and about the ability of the employer-sponsored insurance system in the United States, particularly in small firms, to pay for discoveries of this type. In this paper, we provide a conceptual framework and empirical evidence to support the proposition that, at present, private group insurance financing of cost-effective gene therapies is not only feasible and competitively necessary in the labor market for employers, regardless of group size, but also that, currently, the number of US workers in small firms who might be stressed by very high-priced claims is a tiny fraction of the group market for genetic treatments. The current system of employer-paid self-insurance supplemented by stop-loss coverage should be able to facilitate the use of new cost-effective gene therapies. Other alternative methods of financing that have been proposed may not be urgently needed. There are, however, some concerns about the long-term resilience of this system if stop-loss premiums continue to have high growth.”
  • The Society for Human Resource Management reminds us,
    • “Employers are required to use the latest version of Form I-9 beginning today.
    • “The new form from U.S. Citizenship and Immigration Services has been available for use since August but becomes mandatory for all employers as of Nov. 1. 
    • “The new I-9 does not make any new changes to employer or employee obligations involved in the verification of work authorization. Cosmetic changes include the reduction of Sections 1 and 2 to a single page, slight revisions to the Lists of Acceptable Documents, and a new box that eligible employers must check if the employee’s documents were examined remotely under the newly authorized alternative procedure for qualified E-Verify employers.”

In FEHB news, as we approach the Open Season,

  • FedSmith offers its perspective on factors to consider when selecting an FEHB plan during Open Season.
  • FedWeek offers retired OPM executive Reg Jones’s views on the upcoming Open Season.
  • The Federal Times highlights the fine points of fertility coverage in 2024 FEHB plans.

From the public health and research front,

  • The Centers for Disease Control reminds us,
    • Every U.S. household can order 4 more free COVID-19 self-tests. 
    • Self-tests (also called at-home tests and over-the-counter tests) are one of several tools that protect you and others by reducing the chances of spreading COVID-19.
    • Self-tests can be taken at home or anywhere, are easy to use, and produce rapid results.
    • You can place an order 
      • Online at COVIDTests.gov
      • By calling 1-800-232-0233 (TTY 1-888-720-7489)
      • By calling or emailing the Disability Information and Access Line (DIAL) at 1-888-677-1199 or DIAL@usaginganddisability.org (for people with disabilities)
  • The Washington Post reports,
    • “Dying from heart failure and ineligible for a human heart transplant, Lawrence Faucette knew that the last chance he had at extending his life was to receive a heart transplanted from a pig. The 58-year-old man said from his Baltimore hospital bed in September that he was “hoping for the absolute best,” but understood that he was the second person in the world to undergo the procedure — and the highly experimental surgery did not guarantee that he would get more time with his wife and two sons.
    • “We’re going to do the best we can,” he said in a video posted by the University of Maryland School of Medicine. “Now at least I have hope. And now I have a chance.”
    • “Faucette died Monday, nearly six weeks after the surgery, becoming the second patient to die after receiving a genetically modified pig heart, medical school officials announced Tuesday.”
  • RIP, Mr. Faucette.
  • The Wall Street Journal reports,
    • “The rate of babies dying in the U.S. increased significantly for the first time in two decades, raising new alarms about maternal-infant health in America.
    • “The nation’s infant mortality rate rose 3% from 2021 to 2022, reversing a decadeslong overall decline, the Centers for Disease Control and Prevention said Wednesday. The rate increased from 5.44 infant deaths for every 1,000 births to 5.6 in 2022, a statistically significant uptick. * * *
    • “The death rate increased significantly for babies born to American Indian and Alaska Native women, babies born to white women, babies born to women ages 25 to 29 years, male babies and preterm babies.
    • “Changes in the rates for other groups weren’t significant, though the agency’s data showed that mortality rates among racial groups in the U.S. remain wide. The rate for babies born to Black mothers was more than double that of white mothers.”
  • STAT New calls attention to the fact that
    • “Most lung cancer screening guidelines hinge on how much people smoked tobacco and when they last smoked, but the American Cancer Society now says it doesn’t matter how long ago they quit. On Wednesday, the ACS released guidance recommending that anyone with a significant smoking history get an annual low-dose CT scan for lung cancer.
    • “The new guidelines also expand the age range for lung cancer screening to 50 through 80, instead of 55 through 74, and lower the smoking history requirement from 30 cigarette pack years to 20 pack years or more. That means the equivalent of a pack a day for 20 years, which includes two packs a day for 10 years or four packs a day for five years. Most private insurance plans are required to cover screening guidelines with an A or B-grade recommendation from the U.S. Preventive Services Task Force, though some organizations do follow ACS guidelines.
    • “These recommendations bring the ACS’ new age range and smoking history requirements in line with that of the task force’s lung cancer guidelines, which were updated in 2021. However, the task force still only extends lung cancer screening eligibility to patients who quit smoking within the last 15 years. 
    • One of the main reasons the ACS wanted to strike the years-since-quit requirement from their guidelines was that many former smokers are still at high risk for lung cancer regardless of when they quit smoking. “The more we dug into the data, the more we saw there was no real evidence for that criterion,” said Robert Smith, the senior vice president of early detection science at the American Cancer Society.”
  • The Lown Institute issued a report on unnecessary heart stent procedures in the U.S.
    • “Every seven minutes, a Medicare patient receives an unnecessary coronary stent at a U.S. hospital, a new report finds. The Lown Institute, an independent think tank, examined the overuse of percutaneous coronary interventions (coronary stent or balloon angioplasty) at 1,733 general hospital inpatient and outpatient facilities and found more than 229,000 procedures met the criteria for overuse.
    • “While coronary stents can be lifesaving for someone having a heart attack, years of research shows that stents for stable heart disease provide no benefit over optimal medication therapy. Across all hospitals, Lown estimates that more than one in five stents were placed unnecessarily in Medicare patients from 2019 to 2021, at a cost of $2.44 billion.
    • “When physicians continue a practice despite the evidence against it, it becomes more dangerous than useful,” said Dr. Vikas Saini, a cardiologist and president of the Lown Institute. “The overuse of stents is incredibly wasteful and puts hundreds of thousands of patients in harm’s way.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • CVS Health beat Wall Street expectations for earnings and revenue in the third quarter, as growth in pharmacy benefits offset higher spending in its health insurance segment.
    • The Rhode Island-based healthcare behemoth continues to wrangle with headwinds including higher-than-expected healthcare utilization, a pharmacist strike and lost bonus payments in Medicare Advantage.
    • As a result, interim CFO Tom Cowhey cautioned investors on a Wednesday morning call to expect 2024 earnings at the low end of the company’s guidance.
  • and
    • “Humana reported growing medical costs in its insurance segment during the third quarter as a result of increased medical utilization among Medicare Advantage members and higher-than-anticipated COVID-19 admissions.
    • “The payer expects higher levels of utilization to continue for the remainder of the year, and is now forecasting its 2023 medical loss ratio (MLR) will outpace prior guidance. Humana is projecting an MLR of 87.5% for 2023, up from the 86.6% to 87.3% range it previously expected.
    • “Humana’s shares slid following the earnings release Wednesday, despite the insurer beating Wall Street expectations on revenue of $26.4 billion and profit of $1.1 billion.
  • Forbes reports that biopharma giant “GSK shares rose on Wednesday after the pharma giant upgraded its profit guidance for the second time this year amid booming demand for its new vaccine for respiratory syncytial virus (RSV).”

Weekend update

David Ermer–CDC, Congress, COVID-19, Mental health care, U.S. Healthcare, Uncategorized–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC,

  • The federal marketplace open enrollment period for Affordable Care Act coverage will open on November 1. This enrollment opportunity closes on December 15.
  • The Wall Street Journal reports, “Insurers spar With Biden Administration over coverage for mental-health care; New requirements aim to reduce out-of-pocket costs for treatment; insurers cite a shortage of mental-health providers.” Per the Journal,
    • “A landmark law, the Mental Health Parity and Addiction Equity Act of 2008, helped curtail arbitrary annual limits imposed by insurers on mental-health coverage. Insurers aren’t supposed to put such limits on mental-health visits if they don’t also have similar limits on doctor visits for a chronic condition like asthma. They also aren’t supposed to impose higher copayments and deductibles or more restrictive prior authorization requirements for mental health care.
    • “But the promise of out-of-pocket parity remains far more elusive. The reasons are complex: There is a shortage of mental health clinicians, with an estimated 350 individuals for every one mental-health provider, according to Mental Health America.”
  • The legal issue is that the law requires parity in quantitative treatment limits (QTL), which health plan compliance with the law has created. The regulators, however, created a separate nonquantitative treatment limitation category, which includes network adequacy, prior authorization, and many, many other factors. The regulators in the proposed rule demand that the QTL parity factors be applied to all NQTLs. That is an infeasible, pointless task, in the FEHBlog’s opinion. The regulators need to try again.
  • On a related note, the Washington Post informs us,
    • “Beginning in January, Medicare [Part B], for the first time, will allow marriage and family therapists and mental health counselors to provide services. This cadre of more than 400,000 professionals makes up more than 40 percent of the licensed mental health workforce and is especially critical in rural areas.
    • “Medicare is also adding up to 19 hours a week of intensive outpatient care as a benefit, improving navigation and peer-support services for those with severe mental illness, and expanding mobile crisis services that can treat people in their homes or on the streets.”

From the public health front,

  • NBC News notes,
    • “A new Covid variant has become dominant in the U.S., but relatively few people have thus far gotten the new shots that could offer some protection against it.
    • “The variant, called HV.1, replaced EG.5 as the country’s most prevalent this week, according to data released Friday by the Centers for Disease Control and Prevention.
    • “The two variants are genetically similar versions of omicron.
    • “HV.1 makes up around 25% of Covid cases now, up from around 1% at the beginning of August. EG.5, meanwhile, represents nearly 22% of cases, down from 24% at the start of the month.
    • “Both are descendants of the XBB variant. The updated Covid vaccines from Pfizer and Moderna, which became available last month, target a different XBB descendant, called XBB.1.5.
    • “But disease experts say the new shots should offer cross-protection against the currently dominant strains. Dr. Scott Roberts, an infectious disease specialist at Yale Medicine, said that although the vaccine is not a “perfect match” for HV.1, “it’s still a good match because it’s still within the same family of variants.”
  • WTOP, a news radio station in Washington DC, reports,
    • “We’ve already been receiving warnings from the CDC that there are RSV cases in the Southeast, which is kind of an indication to us that it’s going to be moving our way soon,” said Dr. Christine Ashburn, a pediatrician with Kaiser Permanente’s Mid Atlantic Group.
    • “While an increase in RSV cases could be coming soon,  Ashburn says she doesn’t think it’ll be as bad as last year, which saw hospital systems across the region — and the country — overrun with cases in infants. * * *
    • “Ashburn says looking for early signs of this illness in infants and small children is key.
    • “Watch for fast, rapid breathing,” she said. “Sometimes in babies, you’ll even see the area around their chest sinking in as they’re breathing.”
    • “She also said flared nostrils, prolonged fever, and even rhythmic grunting — or any signs of respiratory distress — are signs your baby is struggling to get air.
    • “If you think your child could be suffering from RSV, it’s imperative you make an appointment with your health care provider,” she said.
    • “Dr. Ashburn said she’s also optimistic about a new antibody treatment for RSV, AstraZeneca’s Beyfortus™ (or nirsevimab, generically), which is designed to help prevent and mitigate the illness’s effects.”
  • Vox adds
    • Demand for Beyfortus currently exceeds supply. But as the need for the drug becomes more predictable, and as other monoclonal RSV antibodies in development make it onto the market, we can expect supply to better meet that demand. 
    • It’s more complicated to fix the fragmented US health care system that creates big barriers to Beyfortus access for some kids, [Dr. Sean] O’Leary [a pediatric infectious disease specialist at the University of Colorado’s medical school] said. That system is structured such that many pediatricians have to take huge financial risks to keep Beyfortus in stock. For patients who get care at those practices, access will likely be a little touch-and-go until demand also stabilizes and pediatricians can better forecast how much to stock. * * *
    • One dose costs a doctor’s office nearly $500 — and as a totally novel immunization, its popularity was hard to forecast. “For a medium-sized practice, they might have to spend $250,000 to cover their [privately insured”] patient population,” O’Leary said. “And that is not money they have lying around.”
    • “It’s not that pediatricians and family docs don’t want to do the right thing,” he added — but the financial risk of just keeping Beyfortus on the shelves is a barrier.
  • However, according to a 2018 survey about vaccine financing billing practices at medical practices serving adults
    • Of 242 practices approached, 43% (n=104) completed the survey. Reported payment levels and perceived profit varied by payer type. Only for preferred provider organizations did a plurality of respondents report profiting on adult vaccination services. Over half of respondents reported losing money vaccinating adult Medicaid beneficiaries. One-quarter to one-third of respondents reported not knowing about Medicare Part D payment levels for vaccine purchase and vaccine administration, respectively. Few respondents reported negotiating with manufacturers or insurance plans on vaccine purchase prices or payments for vaccination.
  • FEHBlog note: It’s no wonder that chain pharmacies are the principal distributors of vaccines.

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “AbbVie Inc. raised its profit outlook for this year and next as demand for newer biologic drugs helped fill the gap left by falling Humira sales, but investors were disappointed as Botox sales missed estimates.
    • “Adjusted earnings will be $11.19 to $11.23 a share this year, up from the earlier range of $10.86 to $11.06, AbbVie said Friday in a statement. Profit for 2024 will be at least $11 a share, up from the earlier view of at least $10.70, the drugmaker said.
    • “However, sales of Botox, Juvaderm and other aesthetics products were $1.24 billion, missing the average sales estimate by about $100 million. Shares of the North Chicago, Illinois-based drugmaker dropped as much as 5.6% at the New York market open, their biggest intraday loss since April.”
  • Reuters points out,
    • “Healthcare companies who profit from treating obese and overweight patients are trying to convince investors that powerful new weight-loss drugs won’t shrink their businesses.
    • “The global market for obesity drugs could reach as much as $100 billion within a decade due to the effectiveness of Novo Nordisk’s (NOVOb.CO) Wegovy and similar medicines.
    • “Such forecasts have prompted a sell-off in a wide range of companies from makers of bariatric surgery devices to companies whose products address the health issues created by excess weight, from diabetes to sleep apnea.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Govexec tells us,
    • “The Senate Homeland Security and Governmental Affairs Committee on Wednesday voted to advance a pair of measures aimed at improving federal employees’ death benefits and agency customer service more broadly.
    • “The Honoring Civil Servants Killed in the Line of Duty Act (S. 3029); sponsored by Sens. Kyrsten Sinema, I-Ariz., Bill Hagerty, R-Tenn., Alex Padilla, D-Calif., and Josh Hawley, R-Mo.; would increase the amount of money the family of a federal worker who died of injuries sustained while on the job for the first time since 1997. Death gratuity payments would increase from the current $10,000 to $100,000, while the amount the federal government covers for funeral expenses would increase from $800 to $8,800. * * *
    • “The committee also voted 10-1 to advance legislation aimed at improving public-facing federal agencies’ customer service. The Improving Government Services Act (S. 2866), introduced by Committee Chairman Gary Peters, D-Mich., and Sens. James Lankford, R-Okla., and John Cornyn, R-Texas, would require agencies that provide services to members of the public to develop annual customer service action plans that outline strategies to adopt “human-centered” practices that reduce administrative burdens as well as practices already employed in the private sector like online services and call-back functions at call centers.”
  • The House Budget Committee announced,
    • “Its Health Care Task Force (HCTF) hit the ground running with its inaugural Member roundtable. This roundtable brought together Director Phillip Swagel of the nonpartisan Congressional Budget Office (CBO), independent experts, and stakeholders to discuss CBO’s methods for analyzing policies that impact drug development in the United States, including the Inflation Reduction Act (IRA).
    • “Led by Rep. Michael Burgess M.D. (R-TX), the HCTF Member roundtable examined potential refinements and improvements to CBO’s drug development model to ensure future analysis is capturing additional factors and subsequent real-world effects of policies impacting medical innovation in the United States.
    • Health Care Task Force Chairman Michael Burgess (R-TX) published an op-ed in the Washington Times sharing the Task Force’s goals with the American people ahead of today’s roundtable.
  • MedPage Today informs us,
    • “By a 14-0 vote, the [Centers for Disease Control’s] Advisory Committee on Immunization Practices (ACIP) recommended the two-dose Jynneos vaccine for mpox prevention in adults at risk for infection, which typically passes through close skin-to-skin contact, including sex. * * *
    • “Groups considered at-risk for mpox include men who have sex with men (MSM) and transgender or nonbinary people who in the past 6 months have had a new diagnosis of a sexually transmitted disease, multiple sex partners, engaged in sex work, or who had sex in association with a large public event in a region where mpox is circulating. Also people who anticipate exposure to those risks and the partners of these individuals.
    • “The committee also voted 10-4 in favor of recommending the newly approved pentavalent meningococcal vaccine (Penbraya) when both the MenACWY and bivalent MenB vaccines are indicated at the same visit. It’s the first vaccine to provide protection against the five meningococcal serogroups (A, B, C, W, and Y; MenABCWY) responsible for most cases of invasive meningococcal diseases globally.
    • “The pentavalent vaccine gained approval earlier this month for individuals ages 10 to 25 years, based on phase III trial data in previously unvaccinated individuals that showed non-inferior immune responses and comparable safety with MenABCWY when compared with vaccination with the MenACWY (Menveo) and MenB (Trumenba) vaccines.
    • “While meningitis is rare in the U.S., mortality is 10% to 15%. Most cases occur among children younger than 1 year, adolescents and young adults ages 16 to 23, and adults older than 85.”
  • HR Dive reports,
    • “The National Labor Relations Board published Thursday a rule updating the standard for determining when multiple employers may be considered joint employers under the National Labor Relations Act.
    • “NLRB’s new joint employer rule retains much of the same details from its 2022 proposed rule, specifying that an entity may be considered a joint employer of another employer’s employees if the two share or codetermine essential terms and conditions of employment. Per the rule, joint employers may possess or exercise direct or indirect control over one or more essential terms and conditions of employment.
    • “Changes from the proposed rule include an exhaustive list of seven categories of employment terms or conditions that the board will consider essential for the purposes of its joint employer analysis, as well as a description of those it will consider “irrelevant” for such analysis. The final rule also addresses joint employers’ bargaining obligations. The rule is scheduled to be published in the Federal Register tomorrow; it will take effect 60 days after that.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • “Contract negotiations between payers and providers are becoming more public, and the number of communities affected across the country is growing, according to data published Oct. 25 by FTI Consulting.
    • “Notably, disputes reported in the media during the third quarter involved Medicare Advantage plans more than ever previously recorded, standing at 15 total.
    • “In whole numbers, it may not be shocking, but each of these disputes can affect a few thousand to tens of thousands of people, so it’s significant,” Adam Broder, managing director of FTI’s strategic communications segment, told Becker’s. “Medicare Advantage is being scrutinized by federal regulators, and I think these disputes are a mirror of that on the local level with some hospitals feeling the pinch.”
  • The FEHBlog notes the number of Medicare Advantage plan disputes should be hardly surprising as those plan’s premiums, etc., are constrained by CMS.
  • Per Fierce Healthcare,
    • “Payers’ “increasingly aggressive behavior,” a spike in physician expenses and recruitment are front of mind for executives at Universal Health Services (UHS).
    • “The King of Prussia, Pennsylvania-based for-profit system came out slightly ahead of analyst estimates this quarter with a $167 million profit ($2.55 per diluted share).
    • “Much of the success came from a continued rise in patient volumes, particularly on the acute care side of the business where patients are seeking care after delaying procedures during the pandemic, Chief Financial Officer Steve Filton told investors during a Thursday morning earnings call. 
    • “While key to the company’s 6.8% year-over-year increase in net revenues, that recaptured care was largely lower acuity services that held same-facility revenue per adjusted admission to a “somewhat more muted” 0.4% year-over-year increase, Filton explained.
    • “That trend isn’t expected to last much longer. “Over time, we would expect our volumes to moderate a little bit, but also our revenue per adjusted admission to come up,” Filton told investors.” 
  • Per Healthcare Dive,
    • “Community Health Systems missed Wall Street expectations for earnings per share in its third quarter earnings this week, despite rising patient admissions and efforts to control labor expenses.
    • “The operator posted a net loss of $91 million in the third quarter, compared to net loss of $42 million from the prior year period. [For-profit CHS, which spans 76 owned or leased affiliate hospitals and more than 1,000 sites of care, has been in the red for the past three quarters.] 
    • “The losses come even as same facility admissions, which rose 3.7% year over year, reached their highest levels since the fourth quarter of 2019, CHS CEO Tim Hingtgen said during a Thursday morning call with investors.”

In judicial news,

  • Reuters reports,
    • “A U.S. appeals court has rejected legal challenges to a $2.67 billion settlement that resolves civil antitrust claims that Blue Cross Blue Shield Association and member plans conspired to drive up health insurance costs.
    • “A three-judge panel of the 11th U.S. Circuit Court of Appeals unanimously upheld Alabama-based U.S. District Judge R. David Proctor’s August 2022 approval of the settlement, which followed nearly a decade of litigation involving allegations from individual policyholders, businesses and others.
    • “The appeals court’s order on Wednesday spurned challenges to the insurance subscribers’ deal from Home Depot and others. One objector fought the $667 million in legal fees and expenses that are part of the settlement.
    • “Writing for the panel, Chief Circuit Judge William Pryor said Home Depot had not persuaded the court that the settlement would harm the power of antitrust enforcers or others to bring claims against Blue Cross Blue Shield in the future.”

Midweek update

David Ermer–Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “The House elected GOP Rep. Mike Johnson of Louisiana as speaker Wednesday, with the staunch conservative overcoming the divisions that had paralyzed the chamber after a band of hard-liners ousted Kevin McCarthy three weeks ago.
    • “The choice of Johnson, aligned with former President Donald Trump, came after House Republicans nominated and then dumped a series of leadership candidates, prompting some members to wonder whether any colleague could thread the needle in the deeply divided conference. With a speaker now in place, lawmakers can return to work, with many eager to pass aid for Israel and address a looming government-funding deadline next month.”
  • STAT News tells us,
    • “A Senate health panel on Wednesday voted to send President Biden’s nominee to lead the National Institutes of Health to the chamber’s floor, moving Monica Bertagnolli one step closer to taking the longtime vacant role of permanent director.
    • “The Senate HELP Committee advanced her nomination on a 15-6 vote, with many Republicans voting in support and only Chairman Bernie Sanders (I-Vt.) breaking with the Democratic caucus to vote against her. * * *
    • “Her nomination will now move to the Senate floor for a full vote, though it is unclear when that will be scheduled.”
  • The NIH National Cancer Institute shares its weekly research highlights.
  • The American Hospital Association News points out,
    • “Starting Oct. 25, consumers can preview their 2024 health coverage options at the federally facilitated Health Insurance Marketplace. Open enrollment for the 2024 marketplace runs Nov. 1 through Jan. 15, with coverage starting Jan. 1 for consumers who enroll by midnight on Dec. 15. The Centers for Medicare & Medicaid Services expects that 96% of the website’s customers will have access to three or more insurance issuers and four in five can find coverage for $10 or less per month after subsidies.”
  • FedWeek calls attention to the fact that the U.S. Office of Personnel Management’s Inspector General has released its annual report identifying top management challenges.

From the Federal Employee Benefits Open Season front, FedSmith provides a healthcare roadmap for federal retirees. Govexec provides its perspective on Open Season planning here.

From the public health front,

  • Politico reports,
    • “So far, 12 million people, or about 3.6 percent of the population, have gotten the shot in the five weeks since it hit pharmacy shelves — though reporting lags mean it’s likely a bit higher, Centers for Disease Control and Prevention Director Mandy Cohen said.
    • “More people, by far — 16 million — have gotten their annual flu vaccine, Cohen said, attributing the difference to long-held routines.”
  • From Fierce BioTech,
    • “As Americans flock to nearby orchards for festive bouts of autumn apple picking, Insulet is celebrating a particularly bountiful stateside Apple harvest itself.
    • “The diabetes device maker has earned FDA clearance for the iPhone version of an app allowing users to control their Omnipod 5 insulin pumps from their own smartphones. Meanwhile, the app has been available to Android owners since the pump’s full U.S. launch began a year ago.
    • “In Insulet’s Monday announcement about the Apple clearance, Eric Benjamin, the company’s chief product and customer experience officer, hailed the impending launch of the app as a “significant milestone in our ongoing effort to provide people with diabetes solutions that improve their lives and help them think less about diabetes.”
  • Morning Consult informs us,
    • “28% of U.S. adults said they are interested in taking prescription GLP-1 drugs like Ozempic, Mounjaro or Wegovy for weight loss, a share relatively consistent with August and April surveys. 
    • “Consumers who have heard “a lot” about the drugs, have weight-related health conditions or have higher incomes are most likely to be interested in taking the medications.
    • “The impacts of weight loss drugs on the health industry are clear, but other sectors, like food and retail, are likely to feel the effects of changing consumer preferences. Brands that create products and services to help support a more health-conscious consumer will be best-positioned to weather disruption from Ozempic or future weight loss drug innovations.”
  • Per MedTech Dive,
    • “Boston Scientific shared pivotal trial results on Wednesday that showed promising results for its drug-eluting balloon in treating patients with repeat blockages.
    • “The company’s Agent drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries at one year, according to data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference. Boston Scientific was the study sponsor.”
  • BioPharma Dive lets us know,
    • “Patients with Alzheimer’s disease may have another treatment option in the not-too-distant future, as newly released data appear to support a more convenient version of the closely watched medicine Leqembi.
    • “Developed by partners Eisai and Biogen, Leqembi is the only Alzheimer’s medicine of its type with a full approval from the Food and Drug Administration. It’s specifically for patients in the early stages of the disease, and is given as an hourlong, intravenous infusion once every two weeks.
    • “Eisai and Biogen have been testing whether a different form of Leqembi, an under-the-skin injection, can be as safe and effective as the already marketed version. On Wednesday, at a medical conference in Boston, researchers presented results from a study of nearly 400 participants that suggests the two forms are roughly comparable.”
  • The New York Times reports,
    • “In the year after the Supreme Court ended the constitutional right to abortion, something unexpected happened: The total number of legal abortions in the United States did not fall. Instead, it appeared to increase slightly, by about 0.2 percent, according to the first full-year count of abortions provided nationwide.
    • “This finding came despite the fact that 14 states banned all abortions, and seven imposed new limits on them. Even as those restrictions reduced the legal abortion rate to near zero in some states, there were large increases in places where abortions remained legal. Researchers said they were driven by the expansion of telemedicine for mail-order abortion pills, increased options and assistance for women who traveled, and a surge of publicity about ways to get abortions.”

From the U.S. healthcare business front,

  • Beckers Hospital Review notes, “Newsweek has released the top 600 U.S. hospitals ranked by state, sorted by a score that factors recommendations, patient experience, quality and patient-reported outcome measures.” The article identifies the top hospital on the Newsweek scale in each State and DC.   
  • Beckers Payer Issues tells us how payer accountable care organizations (ACOs) fared in 2022.
  • Beckers Hospital Review also interviews an executive from a Texas hospital about how the facility is planning to emerge from Chapter 11 bankruptcy.
  • Per Fierce Healthcare,
    • “An otherwise strong Q3 performance across HCA Healthcare’s businesses was marred by news that the for-profit’s recently integrated physician staffing joint venture will be bleeding tens of millions of dollars per quarter for the foreseeable future.”
  • and
    • “UnitedHealth Group is making a $5 million investment in Enable Ventures, a fund that aims to improve the lives of people with disabilities.
    • “The investment will back companies that can create better quality of life, offer resources to entrepreneurs with disabilities and provide support to people with disabilities who are unemployed or underemployed. Enable puts a focus on providing the technologies and tools necessary to upskill or reskill people with disabilities to help them enter or reenter the workforce, according to the announcement.
    • “Catherine Anderson, senior vice president of health equity strategy at UnitedHealth Group, told Fierce Healthcare in an interview that backing Enable aligns with the company’s broader investment strategy around health equity.”

Tuesday Tidbits

David Ermer–CMS, Congress, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “House Majority Whip Tom Emmer (R., Minn.) dropped his bid to serve as House speaker just hours after he was narrowly elected as the Republican nominee, as stiff resistance from hard-right conservatives reinforced by former President Donald Trump sank the party’s latest pick to run the chamber.
    • “His withdrawal put the Republicans back to square one for the fourth time, three weeks after hard-liners engineered the ouster of former Speaker Kevin McCarthy (R., Calif.). Republicans regrouped again late Tuesday to map out their next steps, assembling another slate of candidates and holding a fresh forum in the evening. A new vote was expected Tuesday evening.”
  • The Hill offers a potpourri of articles on this situation.
  • The American Hospital Association News informs us,
    • “The Centers for Disease Control and Prevention Oct. 23 released interim guidance for clinicians with limited access to the monoclonal antibody nirsevimab, recently approved to prevent respiratory syncytial virus in children aged 2 and under. The guidance calls for prioritizing 100 milligram doses of the treatment for infants under 6 months old and infants at high risk for severe disease due to underlying health conditions, among other recommendations.”
  • STAT News tells us,
    • “Infertility has a new definition in the U.S. — one that could make a big difference to would-be parents who are single or LGBTQ+.
    • “Last week, the American Society for Reproductive Medicine (ASRM) issued an expanded description of the condition, stating that infertility involves “the need for medical intervention, including, but not limited to, the use of donor gametes or donor embryos in order to achieve a successful pregnancy either as an individual or with a partner.”
  • It’s worth adding that for 2024, OPM adopted a broad definition of fertility coverage for the FEHBP to serve this purpose.
  • Also from STAT News,
    • “People eligible to use the only needle-free flu vaccine available in the United States may be able, next year, to give it to themselves or to eligible children at home.
    • “AstraZeneca, which makes the vaccine FluMist, announced Tuesday it has submitted to the Food and Drug Administration a supplemental biologics license application that would allow for self-administration of the vaccine by people ages 18 through 49, and would allow people 18 and older to give the vaccine to eligible children. FluMist is only licensed for use in children and adults from the age of 2 to 49 years old.”
    • “The application, which the FDA is considering, would not mean there would effectively be over-the-counter sales of FluMist, Lisa Glasser, head of AstraZeneca’s U.S. medical affairs for vaccines and immune therapies, told STAT in an interview. Rather, the vaccine, which must be stored at refrigerator temperatures, would be ordered and delivered under appropriate temperature controls, after consultation with a medical professional.
    • “Glasser said the program, if approved, would not replace the option of getting FluMist in a doctor’s office or at a pharmacy, but would be another alternative for busy families. “It is meant to enhance the ability to access influenza vaccination,” she said. “That’s the goal.”

From the public health and medical research front,

  • The NIH Directors blog points out,
    • When NIH launched The BRAIN Initiative® a decade ago, one of many ambitious goals was to develop innovative technologies for profiling single cells to create an open-access reference atlas cataloguing the human brain’s many parts. The ultimate goal wasn’t to produce a single, static reference map, but rather to capture a dynamic view of how the brain’s many cells of varied types are wired to work together in the healthy brain and how this picture may shift in those with neurological and mental health disorders.
    • So I’m now thrilled to report the publication of an impressive collection of work from hundreds of scientists in the BRAIN Initiative Cell Census Network (BICCN), detailed in more than 20 papers in Science, Science Advances, and Science Translational Medicine.1 Among many revelations, this unprecedented, international effort has characterized more than 3,000 human brain cell types. To put this into some perspective, consider that the human lung contains 61 cell types.2 The work has also begun to uncover normal variation in the brains of individual people, some of the features that distinguish various disease states, and distinctions among key parts of the human brain and those of our closely related primate cousins. * * *
    • All the data represented in this work has been made publicly accessible online  for further study. Meanwhile, the effort to build a more finely detailed picture of even more brain cell types and, with it, a more complete understanding of human brain circuitry and how it can go awry continues in the BRAIN Initiative Cell Atlas Network (BICAN). As impressive as this latest installment is—in our quest to understand the human brain, brain disorders, and their treatment—we have much to look forward to in the years ahead.”
  • Per STAT News,
    • “Since the Apple Watch was unveiled in 2014, it has been trumpeted not only as a high tech fashion accessory, but also as a way for people to track their own health and fitness. It has evolved as a popular cardio tool for such uses as heart rate monitoring, recording your ECG, and measuring the oxygen saturation of your blood.
    • “But now, after nearly a decade of development, the Apple Watch is being leveraged on an entirely new health frontier: Parkinson’s disease, the degenerative brain disorder that affects more than a half million Americans.
    • “While there is no cure for Parkinson’s and treatment options can be daunting, people with the disease can now turn to technology spawned by the Apple Watch to take an active role in their care much as continuous glucose monitors have helped people manage diabetes better. Over the past year, the Food and Drug Administration has cleared three Apple Watch apps from independent developers to track symptoms associated with Parkinson’s that can help inform treatment decisions for people and their doctors.”
  • and
    • “If you had to pinpoint one subject that stood out at this year’s European Society for Medical Oncology meeting, a massive conference with thousands of people from 140-some countries and 2,500 studies presented, it would be a burgeoning type of cancer treatment called antibody-drug conjugates (ADC)
    • “The conference opened to the news that Merck had signed one of the biggest licensing deals in industry history — worth up to $22 billion — to partner on three of the compounds from ADC specialist Daiichi Sankyo. GSK followed up with an ADC licensing announcement of its own (if a much smaller one). Multiple ADC studies were presented at the meeting’s top sessions. ADCs were, in short, the belle of the cancer research ball.
    • “The thing is, ADCs are actually quite an old approach.
    • “The industry’s been putting ADCs into the clinic for 20 years, and it’s only recently that we’ve really had a breakthrough here,” Susan Galbraith, who leads AstraZeneca’s cancer work, told STAT.
    • “ADCs are designed to deliver chemotherapy directly to tumors, possibly one day replacing the blunt-force toxic therapies that have been the backbone of cancer care for generations. The idea is that these finely crafted shipments can pack the punch of chemo while minimizing side effects. Experts are still scrutinizing the safety profiles of ADCs — they come with their own side effect concerns, and trials have included some patient deaths — but some studies are showing that patients can tolerate ADCs better than traditional chemo.”

From the U.S. healthcare business front,

  • Beckers Hospital Review provides us with a link to Healthgrades’s latest rankings of specialty hospitals.
  • Moreover, Beckers Hospital Review reports,
    • “Since launching in 2018, hospital-owned Civica Rx works with about a third of the nation’s hospitals and manufactures 80 drugs facing shortages, NBC affiliate KSL-TV reported Oct. 22. 
    • “Seven health systems formed the pharmaceutical company after struggling for years with recurring drug shortages. The first goal was to make 14 generics constantly in short supply for hospitals, and 19 systems were founding members. 
    • “Now, some governments and hundreds of hospitals are buying from Civica Rx. 
    • “Dan Liljenquist, the chief strategy officer for Salt Lake City-based Intermountain Health, volunteer board chair of Civica Rx and a former Utah senator, told KSL-TV Civica Rx plans to scale up operations at its Petersburg, Va.-based manufacturing plant.” 
  • and
    • “Pittsburgh-based UPMC said it has entered into an integration and affiliation agreement with Washington (Pa.) Health System, according to an Oct. 23 filing.
    • “The two signed a letter of intent in June regarding the partnership. Unions have criticized the move, saying it would harm both patients and workers.
    • “UPMC will appoint about one-third of the Washington Health board directors and the system will be renamed UPMC Washington, according to the filing.
    • “The proposed transaction still has to meet regulatory and closing conditions.”
  • Per Healthcare Dive,
    • “Centene raised its 2023 outlook on Tuesday after the health insurer handily beat Wall Street expectations for earnings and revenue in its third quarter, helped by lower medical costs.
    • “Centene reported a medical loss ratio — a marker of spending on patient care — of 87%, down from the year prior. On a call with investors Tuesday morning, executives chalked the lower medical spending up to significantly more members in Affordable Care Act marketplace plans, who generally require less expensive care than members in Medicaid and Medicare. Centene grew marketplace membership 76% year over year.
    • “The ongoing effect of Medicaid redeterminations — now almost halfway complete — on membership numbers and care acuity continues to track to Centene’s expectations, CEO Sarah London said on the call. Centene still expects to lose roughly two million members once redeterminations are complete.”
  • Per Fierce Healthcare,
    • “Teladoc’s third-quarter revenue grew 8% to reach $660 million, boosted by solid performance in its chronic condition management business and steady membership growth as the company now touts 90 million users.
    • “The telehealth giant, which has been in operation for 20 years, also narrowed its losses this past quarter to a net loss of $57 million, or 35 cents per share, compared to a net loss of $73.5 million, or 45 cents per share, for the third quarter of 2022.” 
  • and
    • “Elevance Health’s CarelonRx is the latest pharmacy benefit manager to put biosimilars for popular drug Humira on its formulary, the company said this week.
    • “Beginning Dec. 1, adalimumab-adbm will be added to each of its commercial formularies, according to a blog post from CarelonRx. Cyltezo will also be added to certain formularies, and both will be offered at parity with Humira.
    • “Humira has been the bestselling drug in the U.S. for a decade, and PBMs have long awaited biosimilar products to challenge the drug’s dominance in the market. Drugs that treat inflammatory conditions, like Humira, represent a growing piece of overall drug spend.
    • “Other key PBMs, including Express Scripts and Optum, have taken similar steps. CVS Health launched a new subsidiary, called Cordavis, earlier this year that aims to work alongside drugmakers to bring additional biosimilars to market, with the first product a Humira biosimilar in collaboration with Sandoz.”

Monday Roundup

David Ermer–Congress, COVID-19, Federal employment benefits, HSA, Medical / Rx research, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC

  • The Wall Street Journal reports
    • “A bid by House Majority Whip Tom Emmer (R., Minn.) to serve as the House Republicans’ pick to be speaker will test whether the strong ties he built recruiting candidates and counting votes will overcome doubts from some anti-establishment lawmakers aligned with former President Donald Trump.
    • “Candidates are expected to pitch their colleagues at a forum on Monday evening ahead of an internal vote to designate a new Republican speaker nominee as soon as Tuesday morning. Beyond winning the GOP ballot, the speaker nominee will face the uphill battle to unite almost all Republicans to have a chance of winning the House vote, given Republicans’ narrow 221-212 majority.  * * *
    • “To become House speaker designate, the winning candidate must garner a majority of the votes cast within the Republican conference. The internal House GOP conference voting could go multiple rounds, with the candidate receiving the fewest number of votes dropping out after each round until a candidate wins 50% of the vote plus one. After that, the House speaker-designate must win support from a majority in the House, hitting 217 of the 433 House votes if all members show up and cast a vote for an individual.
    • “In an effort to prevent holdout candidates from delaying the process, GOP Rep. Mike Flood of Nebraska is circulating a unity pledge, which lawmakers can sign saying that they promise to back the party’s speaker designee in a House floor vote. His spokeswoman on Monday morning said that all of the candidates except [Rep. Gary] Palmer [R Alabama] have signed on.”
  • Govexec tells us
    • “Lawmakers from both parties last week revived legislation that would allow most federal employees who began their careers as temporary or seasonal workers to make catch-up contributions to their pensions so that they can retire on time.
    • “The Federal Retirement Fairness Act (H.R. 5995), introduced by Reps. Derek Kilmer, D-Wash., Gerry Connolly, D-Va., Don Bacon, R-Neb., and David Valadao, R-Calif., would allow employees enrolled in the Federal Employees Retirement System who began their careers in government as temporary workers to make catch-up contributions to their defined benefit pensions to cover for the time before they had permanent positions and were unable to contribute to their retirement accounts. The legislation was last introduced in 2021 but failed to garner support.”
  • Labor Department Assistant Secretary for Employee Benefits Security Lisa Gomez writes in her blog about Breast Cancer Awareness Month.
  • BioPharma Dive informs us,
    • “The Food and Drug Administration on Friday approved a new meningococcal vaccine, clearing Pfizer’s shot Penbraya in teenagers and young adults for protection against the five most common disease-causing serogroups.
    • “Penbraya is the first vaccine available that can provide such broad protection, which may make it more convenient than current options. While meningococcal disease is rare, it can be serious and even deadly.
  • EMPR adds that the “Food and Drug Administration (FDA) has approved Zituvio™ (sitagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
  • Per Medtech Dive,
    • Medtronic said Monday it received approval from the Food and Drug Administration for an extravascular defibrillator designed to treat abnormal heart rhythms and prevent sudden cardiac arrest, which can lead to death within minutes if not treated immediately.
    • Unlike traditional implantable cardioverter defibrillators, which have lead wires running between a pulse generator and the heart, Medtronic’s Aurora EV-ICD places a lead outside of the heart and veins.
    • The Aurora EV-ICD was a PMA submission to the FDA, Medtronic spokesperson Tracy McNulty said in an email. “We estimate the current global EV-ICD market to be between $300-$350 million, and expect the EV-ICD market to reach $1 billion 10 years out from the Aurora launch,” McNulty said.

From the public health / research front,

  • MedPage Today points out,
    • “Children infected with the Omicron variant of SARS-CoV-2 appear to be infectious for about 3 days after a positive test, researchers found.
    • “In a small study of 76 kids ages 7 to 18, the median duration of infectivity was 3 days for both vaccinated and unvaccinated children, Neeraj Sood, PhD, of the University of Southern California, and colleagues reported online in a JAMA Pediatrics research letter.
    • “The vast majority of children who get COVID are symptomatic for 1 to 3 days,” co-author Eran Bendavid, MD, MS, of Stanford University, told MedPage Today. “Basically that correlates with how long the virus is causing disease in their body.”
  • and
    • “Maternal mRNA COVID-19 vaccination during pregnancy was associated with lower risks of poor neonatal outcomes, including neonatal death, according to a population-based retrospective cohort study from Canada.”
  • Health Day notes,
    • “Gun homicide rates went down in 2022, following increases reported during the pandemic.
    • “But race still played an outsized role, with Black people continuing to have the highest firearm homicide rates, and by a wide margin.
    • “American Indian/Alaska Natives were the only groups to see an increase again in 2022.
  • The Wall Street Journal reports
    • “The age women start taking menopausal hormone therapy and the kind they take might affect their chances of developing dementia later in life, a new study found.
    • “Women have struggled for years with whether to take hormone therapy when they go through menopause. The medication can help relieve troubling symptoms such as hot flashes and night sweats. However, years of conflicting research on whether the therapy can lead to other health problems, including breast cancer, dementia and heart attacks, has left many women confused about what to do.
    • “This new study suggests that hormone therapy might lower—or at least not raise—your dementia risk if you take it in midlife. For older women, the study found some signs that the medication might raise it.
  • mHealth Intelligence explains that “The shift to telebehavioral healthcare during the COVID-19 pandemic is linked to fewer disruptions in psychotherapy services, indicating telehealth can be effective in supporting the continuity of these services, a new study shows.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Physicians’ decisions to leave their practices is a complex choice “with multiple interdependent factors,” and is not solely impacted by burnout, pay or frustrations with electronic health records, according to a new qualitative study published in ​​the Journal of the American Board of Family Medicine.
    • “The study, which interviewed physicians who left their ambulatory care practices between 2018 and 2021, found that they were motivated to increase time off, have more flexibility or receive higher earnings. However, other departing physicians reported higher compensation would not have persuaded them to stay.
    • “Physician practices can better retain clinicians by addressing risk factors for departure including workflow distribution across team members and ensuring adequate staffing, the report said.”
  • The Wall Street Journal reports,
    • “Roche Holding has agreed to buy the developer of a bowel-disease treatment from Roivant Sciences, a company started by Republican presidential candidate Vivek Ramaswamy, and Pfizer in a deal worth more than $7 billion.
    • “The Swiss pharmaceutical giant said Monday it would pay $7.1 billion upfront for Telavant Holdings and make a near-term milestone payment of $150 million. Roche said the deal gives it rights to commercialize Telavant’s RVT-3101 drug candidate, which has shown promise for inflammatory bowel disease and could have potential in other indications in the U.S. and Japan. 
    • “The deal is the latest example of a big pharma company turning to the deal table to bolster its pipeline of autoimmune drugs. Merck earlier this year agreed to pay more than $10 billion to buy Prometheus Biosciences, which is developing a drug for inflammatory bowel disease that would compete with Telavant’s candidate.”
  • Per Fierce Healthcare
    • “Folx Health, a virtual provider focused on LGBTQ+ health, is now in-network with Cigna, Evernorth and Blue Shield of California.
    • “Other payer partners include Blue Cross and Blue Shield of Texas and Optum for behavioral health service in Colorado and Florida, according to Folx Health’s website. Through the collaboration, insured patients can use therapy and mental health medication management with Folx’s LGBTQ-specialized clinicians. 
    • “Folx offers virtual primary care, gender-affirming care and mental health services. Making that care in-network will deliver its patients significantly lower out-of-pocket costs, per the company.”
  • Assured Partners offers HSA and FSA Account Reminders for Year-End.

Weekend update

David Ermer–Congress, Medical / Rx research, U.S. Healthcare–
Lincoln Memorial in the Fall

From Washington DC,

  • The Wall Street Journal adds.
    • “GOP lawmakers are heading into another week without a speaker will try to overcome deep divisions long enough to unify behind a new candidate, after colleagues soured on conservative firebrand Rep. Jim Jordan (R., Ohio) following a string of unsuccessful floor votes. 
    • “With the race now rebooted, nine Republican lawmakers are angling for the speaker job, jumping into the race before a Sunday deadline. 
    • “Rep. Tom Emmer (R., Minn.), who serves as the House’s majority whip, has announced a run. He already locked up an endorsement from former Speaker Kevin McCarthy (R., Calif.), who remains a popular and influential party member despite his sudden ejection from the speakership on Oct. 3. Other candidates include Kevin Hern of Oklahoma, who leads the conservative Republican Study Committee group, Byron Donalds of Florida, a political newcomer with ties to former President Donald Trump, and longtime lawmaker Pete Sessions of Texas. * * *
    • “Candidates are expected to pitch their colleagues at a forum on Monday evening ahead of an internal vote to designate a new Republican speaker nominee as soon as Tuesday morning.”
  • The full House is scheduled to meet at 11 a.m. on Tuesday.

From the public health/research front,

  • The American Medical Association suggests seven steps that women should take to improve blood pressure control and identifies the top health tips that infectious disease doctors want their patients to know.
  • Fortune Well reports,
    • “It’s been a month since a Maryland man became the second person to receive a transplanted heart from a pig — and hospital video released Friday shows he’s working hard to recover.
    • “Lawrence Faucette was dying from heart failure and ineligible for a traditional heart transplant because of other health problems when doctors at the University of Maryland School of Medicine offered the highly experimental surgery.
    • “The Maryland team last year performed the world’s first transplant of a heart from a genetically altered pig into another dying man. David Bennett survived just two months before that heart failed, for reasons that aren’t completely clear, although signs of a pig virus later were found inside the organ. Lessons from that first experiment led to changes before this second try, including better virus testing.
    • “Attempts at animal-to-human organ transplants — called xenotransplants — have failed for decades, as people’s immune systems immediately destroyed the foreign tissue. Now scientists are trying again using pigs genetically modified to make their organs more humanlike.
    • “In Friday’s hospital video, Faucette’s doctors said the pig heart has shown no sign of rejection.”
  • Per FiercePharma,
    • “Last year, a first-of-its-kind head-to-head clinical trial between two PD-1 inhibitors went in GSK’s favor. Now, the British pharma has some new patient survival data to celebrate.
    • “Compared with Merck’s market-leading Keytruda, GSK’s Jemperli demonstrated a 25% lower risk of death in patients with newly diagnosed nonsquamous non-small cell lung cancer (NSCLC), according to new data unveiled today, Oct. 20, at the European Society for Medical Oncology (ESMO) 2023 Congress.
    • “The data come from an updated analysis of the phase 2 PERLA trial, which was the first global, head-to-head study of two PD-1 inhibitors.
    • “The number doesn’t bear statistical significance because the trial wasn’t designed to show superiority. It does, however, further prove that Jemperli behaves in a similar way as Keytruda does, Hesham Abdullah, M.D., who leads GSK’s oncology drug development, said in an interview with Fierce Pharma.”
  • MedTech Dive informs us,
    • “Shortages of medical devices and therapies are compromising patient care by delaying treatment and driving unsafe practices, according to a survey of healthcare professionals conducted by the patient safety nonprofit ECRI and the Institute for Safe Medication Practices.
    • “The survey found that supply shortages have caused surgical cases to be rescheduled, postponed or canceled and that a lack of endotracheal tubes and pulmonary artery catheters is on the cusp of impacting the ability to provide adequate clinical care.
    • “ECRI and the Institute for Safe Medication Practices used the findings to call for “long-term, nationally coordinated solutions” to stop persistent shortages.”

In human resources news,

  • Per HR Dive,
    • “UPS will expand an ‘emergency child care initiative’ for U.S.-based front-line workers, the company announced Tuesday. The program, a partnership with Patch Caregiving, was piloted from August 2022 through January at a Northern California site. 
    • “According to UPS, 80% of eligible employees participated in the emergency daycare program, which helped the company avoid more than 120 unplanned absences. UPS also reported a significant reduction in employee turnover in the pilot group — from 31% to 4%.
    • “UPS will expand the program to additional shifts at the California pilot site and some Pennsylvania facilities this quarter. It will add additional facilities in 2024.”

Friday Factoids

David Ermer–CMS, Congress, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Wall Street Journal reports
    • “Rep. Jim Jordan withdrew his bid to become House speaker Friday, after the fiery conservative lost a pair of public and private votes, sending divided House Republicans back to the starting line in their weekslong quest to elect a leader and pass urgent legislation. * * *
    • “Jordan’s departure from the race has swung the door open for broader competition. Already Republican Study Committee Chairman Kevin Hern (R., Okla.) and Rep. Pete Sessions (R., Texas) had announced interest in the job, while House Majority Whip Tom Emmer (R., Minn.) was quickly endorsed by McCarthy. A handful of others also were considering bids.”
  • Healthcare Dive informs us,
    • “Sens. Kevin Cramer, D-N.D., and Angus King Jr., I-Maine, sent a letter to CMS Administrator Chiquita Brooks-LaSure on Thursday, asking the agency to withhold its controversial staffing mandate for long-term care facilities. 
    • “The CMS proposal issued last month would require nursing facilities, including veterans homes, to have at least one registered nurse on duty at all times and provide three hours of care per resident per day, with 0.55 hours coming from registered nurses. An analysis from KFF last month found 81% of nursing facilities nationwide would need to hire additional staff to meet the requirements.
    • “In the letter, the senators warned that many markets, including their home states, may not have enough nurses to meet requirements, which could cause some long-term care facilities to close and disrupt care for veterans.”
  • The American Hospital Association News announces,
    • “Oct. 28 is National Prescription Drug Take Back Day, an opportunity for the public to safely dispose of unwanted or expired tablets, capsules, patches and other solid forms of prescription drugs. The Saturday event offers free and anonymous disposal of unneeded medications at almost 5,000 local drop-off locations nationwide. Over more than 10 years, the Drug Enforcement Administration event has collected 8,650 tons of old, unwanted or expired medications, including opioid and other drugs susceptible to diversion, misuse and abuse. DEA offers posters and other materials to help hospitals and other partners promote the event in their community. Collection sites should be open from 10 a.m. to 2 p.m. local time.”

From the public health front,

  • HealthDay tells us,
    • “Two servings of red meat a week raise your risk of type 2 diabetes by 62%, new research shows.
    • “The risk applies to both processed and unprocessed red meat. 
    • “Replacing one daily serving of red meat with nuts, legumes or dairy can significantly reduce diabetes risk, researchers say.”
  • The Wall Street Journal reports,
    • “A potential blockbuster weight-loss drug still years away from U.S. regulatory approval is already being sold online, another example of a thriving gray market for unapproved weight-loss medications, according to a Wall Street Journal review.
    • “The Journal found hundreds of merchants offering the new drug, which is being developed by Eli Lilly and is called retatrutide. Most appear to be Chinese sellers shipping directly to U.S. consumers from sites such as Made-in-China.com. Some of the sites, including ones that appear to be based in the U.S., have marketed their products via posts on  Facebook, LinkedIn and Reddit. A handful have run paid ads on Instagram and Google. A fitness influencer has offered it for sale via his newsletter.  * * *
    • “In a statement, the FDA said it would continue to investigate reports of suspect counterfeit drugs to determine the public health risks and the appropriate regulatory response. 
    • “Excitement over retatrutide jumped in June when Lilly reported Phase 2 trial results that showed the drug led to an average weight loss of up to 24% over 48 weeks. That could prove better than Lilly’s already-approved drug Mounjaro. Researchers in a Lilly-funded study showed that tirzepatide, Mounjaro’s active ingredient, is the most effective medication currently being prescribed for weight loss.”  
  • The Journal adds
    • “Much of the focus has understandably been on obesity drugs’ sticker price—more than $10,000 annually—and how their usage by millions of Americans could create a budgetary crisis. 
    • “But an analysis by the American Enterprise Institute shows that the net price—what the manufacturers get—is much lower.
    • “The discount for GLP-1 drugs such as Wegovy, Ozempic, Mounjaro and Rybelsus ranged from 48% to 79%, according to the study. Ozempic, for example, is listed at $936 a month, but the manufacturer received $290 on average. Interestingly, Wegovy, currently the only one of those drugs approved by the Food and Drug Administration for obesity, had the smallest discount.
    • “Once Eli Lilly’s Mounjaro, which is approved for diabetes but frequently prescribed off-label for weight loss, gets an expected FDA nod for obesity this year, “competition for formulary placement will likely put downward pressure on net prices for those indications in that scenario,” wrote the authors of the analysis.”
  • The FEHBlog continues to believe that the prices should be lower.

From the U.S healthcare business front.

  • Per Fierce Healthcare,
    • “It shouldn’t come as much of a surprise that employers are putting a focus on managing healthcare costs in the coming year. And a new analysis from WTW highlights some of the areas in which they’re aiming to address these expenses.
    • “The consultancy surveyed 457 employers representing 7.3 million workers in June and July, and it found that 62% of firms are planning to roll out programs to address cost and mental health as part of a broader strategy around health and wellness.
    • “More than two-thirds of companies (69%) said they’ll be focusing on costs, and 63% said they’ll be addressing mental health care, according to the report.
    • “Regina Ihrke, senior director for health and benefits at WTW, told Fierce Healthcare that while employers are highly concerned about potential healthcare costs increases, they’re trying to strike a balance between managing those costs and designing a benefits package that draws in and retains top talent.”
  • and
    • “Ilant Health, a new virtual provider targeting obesity treatment, has launched out of stealth with $3 million in funding. 
    • “Founded on the belief that obesity care will only transform healthcare if it is part of the system, Ilant plans to partner with employers and payers. The startup is led by Elina Onitskansky, who previously served as senior vice president and head of strategy at Molina Healthcare.”
  • Mhealth intelligence considers whether retailers have the inside track on virtual care and identifies technologies that support payer claim processing systems.

Thursday Miscellany

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Mental health care, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Washington, DC,

  • The Wall Street Journal reports,
    • Republican speaker nominee Rep. Jim Jordan was weighing whether to embark on a third-floor vote after a plan to temporarily put caretaker speaker Rep. Patrick McHenry in charge of the House ran into sharp objections from conservatives.
    • “I am still running for speaker, and I plan to go to the floor and get the votes and win this race,” Jordan said initially after leaving a heated closed-door meeting of House Republicans. The Ohio conservative said the plan to elect a temporary speaker didn’t have the support of the conference.
    • In the evening, Jordan met in a House office with detractors. As some trickled out, there was no sign he had managed to change their minds, and Jordan wouldn’t say after the meeting whether he still intended to hold another floor vote. 
  • The New York Times adds, “Mr. Jordan said he would push for another vote to become speaker, scheduled for Friday at 10 a.m., even though he was bleeding support and calls were increasing for him to step aside.”
  • The Society for Human Resource Management informs us,
    • “The U.S. Supreme Court has agreed to hear two cases that will impact the power of federal agencies to implement regulations on employers.
    • “On Oct. 13, the court decided to hear Relentless v. Department of Commerce, in which the owners of three fishing companies in Rhode Island and Massachusetts sued to challenge the federal government’s authority to require them to partially pay for federal monitors on their boats. The justices willconsider that case in tandem with a similar case, Loper Bright Enterprises v. Raimondo, which involves the same requirement for fishing companies in New Jersey.
    • “In both cases, the justices will decide whether to overturn the long-standing Chevron precedent, which holds that when Congress wrote a statute without a clear meaning, courts should defer to the federal agency applying the law, unless its directives were unreasonable. Federal departments and agencies that enforce employment laws could be impacted.”
  • In yesterday’s post, the FEHBlog called attention to AHIP’s public comments on the proposed rule, making changes to the current mental health parity rules. AHIP asked the regulators to try again. Per Fierce Healthcare,
    • “The Blue Cross Blue Shield Association (BCBSA) echoed AHIP in its comments, arguing that additional clarity around the changes is necessary. The organization said it could lead patients to care that is not recommended, worsening outcomes.
    • “We share the administration’s goal of expanding access to affordable mental health support, but we’re concerned it could become harder—not easier—for patients to get the care they need,” said David Merritt, BCBSA’s senior vice president of policy and advocacy, in a statement.
    • “This rule could push us in the wrong direction by forcing health plans to remove important protections that ensure patients are receiving safe, medically necessary, effective care,” Merritt added. “We’ll continue to work with our partners, the administration and Congress to improve both access and quality for Americans.”
    • “The Alliance for Community Health Plans said the updates create “an entirely new regulatory schema” that would actually impede insurers looking to address mental health parity.
    • “The ERISA Industry Committee, or ERIC, said many of the proposals “reflect an overreach of agency authority under the statute” and that they would be burdensome for employer-sponsored health plans. The changes, ERIC said, could drive up costs for families and force significant changes to benefit designs.
    • “Unfortunately, the proposed regulations are so unworkable, it is unclear how compliance could ever be achieved while continuing to offer these important benefits,” said James Gelfand, CEO of ERIC, in a statement. “The Departments’ proposals are written in a way that sets plans up to fail.”
  • The FEHBlog agrees.
  • Reuters tells us,
    • “The U.S. health regulator [the Food and Drug Administration] has approved Hyloris Pharmaceuticals’ drug for post-operative pain, the Belgium-based company said on Wednesday, adding that it expects to launch the non-opioid treatment in the United States by early next year.
    • “The injectable drug, branded as Maxigesic IV, was approved as a post-operative drug in hospitals or when patients cannot take medicine orally.
    • “Maxigesic IV, a combination of paracetamol with ibuprofen solution for infusion, helps reduce pain and inflammation without the risk of opioid addiction that resulted in more than half a million deaths in the U.S. during 1999 to 2020.”

From the public health front,

  • HHS’s Agency for Healthcare Research and Quality posted for public comment an Effective Health Programs abstract on caring for Long Covid. The comment period ends on November 17, 2023.
  • Healio points out,
    • “Data show CMS’ Million Hearts CVD Risk Reduction Model, which provided payments for CVD risk assessment and reduction, reduced incidence of first-time MIs and strokes over 5 years without significant changes in Medicare spending.
    • “The results support clinical guidelines for CVD preventive care,” G. Greg Peterson, PhD, MPA, a principal researcher with Mathmatica, told Healio. “Current guidelines in the U.S., similar to those in other countries, recommend that health care practitioners calculate CVD risk scores and use the scores to engage patients in discussions about CVD prevention. Although previous studies of CVD risk scoring interventions have shown improvement in CVD risk factor control, this is the first study of a CVD risk score-focused intervention to demonstrate declines in CVD events.”
  • Health Day lets us know,
    • “Fluctuating blood pressure can be a harbinger for both dementia and heart disease, a new study finds.
    • “Ups and downs within 24 hours or even over several days or weeks were linked with impaired thinking, researchers from Australia reported.
    • “Higher variations in systolic blood pressure, the top number, were linked with stiffening of the arteries, which is associated with heart disease.
    • “Clinical treatments focus on hypertension while ignoring the variability of blood pressure,” said lead author Daria Gutteridge, a PhD candidate at the University of South Australia’s Cognitive Aging and Impairment Neuroscience Laboratory.”
  • The National Institutes of Health announced,
    • “A research team funded by the National Institutes of Health has developed a smartphone app that can track and analyze a person’s ability to move from one place to another, known as locomotion and other types of movements. Human motion analysis is used to evaluate patients with movement difficulties, to help clinicians plan surgery, and to assess the results of treatment procedures. The research team believes that using the app costs about 1% of conventional motion analysis techniques and works 25 times faster. The study appears in PLOS Computational Biology.
    • “Researchers tested their app, called OpenCap, with 100 participants. Using two or more smartphones, the app recorded sufficient quality videos to allow for web-based, artificial intelligence analysis of muscle activations, joint loads and joint movements. Data collection took 10 hours for the 100 participants, and computation of results took 31 hours. Traditionally, locomotion analysis requires fixed lab space and more than $150,000 worth of equipment, including eight or more specialized cameras to capture three-dimensional images. The captured data also takes several days to analyze by a trained expert.
    • “While current technology is too expensive for routine clinical use, according to the investigators, the app could potentially be used to help screen for disease risk, inform rehabilitation decisions, and track improvements in motion following treatment.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • CVS Health is pulling some of the most common decongestants from its shelves and will no longer sell them, after advisers to U.S. health regulators recently determined that an ingredient doesn’t work.
    • The products contain [as the only active ingredient] oral phenylephrine, an almost-century-old ingredient in versions of decongestants and over-the-counter pills, syrups and liquids to clear up congested noses.
    • An advisory panel to the Food and Drug Administration last month declared that the ingredient was ineffective when taken orally. The FDA had said in its own analysis that the oral phenylephrine formulations are safe but ineffective at standard or even higher doses.
    • The FDA hasn’t made a decision yet nor asked manufacturers or retailers to remove products from store shelves. CVS is removing phenylephrine products voluntarily.
  • Beckers Hospital Review informs us,
    • “In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection. “In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection. 
    • “Rite Aid has more than 2,000 stores in 17 states. Of the 154 planned closures, about 40 are Pennsylvania locations. Many stores in California and New York will also close, and additional store closings may be forthcoming as Rite Aid looks to shed about $4 billion in debt. 
    • “The Philadelphia-based company previously said it secured $3.45 billion from lenders to fund operations through the bankruptcy restructuring, with McKesson Corp. as the largest creditor. Alongside the bankruptcy filing, Rite Aid announced Jeffrey Stein as its new CEO and chief restructuring officer.”