Midweek Update

Medical / Rx research

Midweek Update

David Ermer–Congress, COVID-19, Medical / Rx research, No Surprises Act, Obesity, U.S. Healthcare–

From Washington DC,

  • The Washington Examiner points out that four special elections for the House of Representatives will be held in 2024 before the national election on November 5, 2024. Three of the seats are being vacated by Republicans, and one by a Democrat. Due to the Republican’s already slim margin in the House, every vote does count.
  • The American Hospital News reports that the No Surprises Act regulators plan to the public comment deadline for the Federal Independent Dispute Resolution Operations proposed rule, which is currently set for next Tuesday, January 2, 2024. The FEHBlog found the referenced regulator’s notice of this decision on the CMS No Surprises Act website. The official notice, however, has not been posted in the Federal Register yet.

From the public health and medical research front,

  • Bloomberg reports,
    • “Cytokinetics Inc. said its experimental drug helped patients with a genetic heart ailment in a closely watched trial.
    • “The drug improved exercise capacity and oxygen uptake in patients with the heart condition, compared with those getting a placebo, Cytokinetics said Wednesday in a statement. * * *
    • “Aficamten is a once-daily pill for hypertrophic cardiomyopathy, or HCM, a genetic disease in which abnormally thick heart muscle interferes with pumping. As many as 1 in 500 people have it, though many go undiagnosed, according to the American Heart Association, and it’s regarded as the most common cause of sudden cardiac death in young people and competitive athletes. * * *
    • “Cytokinetics plans to submit the drug for clearance in the second half of 2024, Chief Executive Officer Robert Blum said on a conference call.”
  • Medscape tells us,
    • “Glucagon-like peptide-1 (GLP-1) agonists, like semaglutide, liraglutide, and the newly US Food and Drug Administration–approved tirzepatide, not only are gaining popularity among the public for weight loss but also are the focus of considerable attention from gastroenterology researchers.
    • “The robust interest in GLP-1 agonists was on full display here at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting [held in mid-December], with investigators sharing results on which agent is most effective for weight loss, how they compare to bariatric surgery for weight loss or prevention of metabolic dysfunction–associated steatotic liver disease, and their potential role to prevent regain after weight-loss surgery.”

From the U.S. healthcare business front,

  • STAT News presents three issues to “watch in pharma in 2024.”
    • Obesity
    • Paying for gene and cell curative therapies, and
    • Drug pricing
  • The journalist raises an interesting point on the second topic.
    • “One possibility may be so-called value-based or outcomes-based agreements, in which coverage and reimbursement are linked to the extent to which a drug is actually effective. Simply put, the manufacturer and the payer take on a level of risk. If the drug does not do as well as expected, the manufacturer reimburses the payer for a portion or all the costs.
    • “This approach is not new. Over the past few years, more drug companies and payers have explored such deals, although they do not always work. Disputes can emerge over the way data is collected and evidence of effectiveness is captured, disagreements over incentive mechanisms and financial terms, and the availability of useful outcome measures.
    • “Another issue is the Medicaid Best Price requirement. This refers to the stipulation that a pharmaceutical company must offer its best price to Medicaid and other U.S. government health programs. But this can pose a dilemma for a drugmaker if its value-based agreement lowers the price to a payer and, therefore, must be lowered to Medicaid and others, diminishing its revenue.”

Tuesday Tidbits

David Ermer–Congress, Medical / Rx research, Mental health care, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Federal News Network informs us
    • “Agencies don’t have to worry about a 1% sequestration on discretionary funds kicking in for a few more months.
    • “The Office of Management and Budget says the requirement to reduce discretionary spending under the Fiscal Responsibility Act (FRA), signed into law in June, wouldn’t take effect until “after full year appropriations are enacted, or April 30, whichever comes first.”
    • “OMB will take no action on Jan. 1, 2024, and no additional action should be taken by agencies to reduce impacted discretionary funding, even though a short-term continuing resolution will be in effect at that time,” OMB wrote in frequently asked questions on 2024 discretionary spending sent to agencies on Dec. 22. “If any discretionary appropriation account remains on a short-term CR past April 30, OMB is required to issue a final sequestration report that compares the annualized appropriation levels provided by all discretionary appropriations bills under current law as of April 30 against the [FRA’s] section 102 interim spending limits. A breach of the section 102 spending limits would require OMB to order a sequestration to bring the current law discretionary appropriations in line with those interim spending limits.”
  • Govexec identifies the federal agencies with the greatest increases and decreases in employee morale in 2023 according to OPM’s 2023 Federal Employee Viewpoint Survey.
  • Fedweek offers a summary of OPM’s current regulatory activities.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Immune-boosting drugs have revolutionized cancer care. Now doctors are experimenting with cutting them off.  
    • “Immunotherapies unleash the immune system on tumors. They have extended the lives of people with melanoma, lung and bladder cancers. They have also been a boon for drugmakers, generating global sales of $44 billion in 2022, according to Leerink Partners analysts. 
    • “But some patients are getting more of the drugs than they need, exposing them to side effects and costs they could avoid without risking their cancer recurring. Preliminary research suggests taking the drugs at a lower dose or for a shorter period could be sufficient, but drugmakers haven’t funded the studies needed to confirm the findings. 
    • “We don’t know when to stop,” said Dr. Jedd Wolchok, an oncologist focused on melanoma at Weill Cornell Medicine in New York. * * *
    • “Recalibrating care toward less treatment is a fraught undertaking. Drug companies won’t fund studies exploring whether patients can do as well with less of their products, doctors said. Some doctors and patients worry about pulling back before exhausting their best chance to beat the disease.
    • “There was this dogma that more is better,” said Dr. Mark Ratain, an oncologist at the University of Chicago. 
    • “He is trying to recruit cancer patients to study whether they could do as well with less of Merck’s Keytruda or Bristol-Myers Squibb’s Opdivo, so-called immune checkpoint inhibitors. After three years, he has found just 60 of the 260 patients he wants, and most medical centers have declined to join the trial. “It was going to be difficult to convince people,” he said.”
  • Beckers Payer Issues interviews Kofi Essel, MD, Elevance Health’s first food as medicine program director. Dr Essel “sat down with Becker’s to discuss how Elevance is building a food as medicine strategy intended to eventually touch and improve the lives of its more than 47 million members nationwide.” Check it out.
  • MedPage Today tells us,
    • “The 988 lifeline routes callers to a network of more than 200 state and local call centers that are financially supported by the Substance Abuse and Mental Health Services Administration (SAMHSA), as well as state and local governments. In its first year, according to a July press release from SAMHSA, the lifeline answered nearly 5 million calls, texts, and chats from people looking for help with suicide, mental health, and substance use-related crises; that’s 2 million more contacts than the lifeline received in the previous 12 months, when it was a 10-digit phone number. (That 10-digit number — 800-273-8255 — is still in operation.)
    • “So far, 1.5 years in, things seem to be going well overall, said Michele Gilbert, MPH, senior policy analyst at the Bipartisan Policy Center in Washington, D.C. “Luckily, the implementation of 988 has seen some real success,” Gilbert said in a phone interview. “A lot of the operations have gone relatively smoothly.”
    • “Debbie Plotnick, MSS, executive vice president for state and federal advocacy for Mental Health America, agreed. “We have seen tremendous increases in the number of people who call, and even more importantly, what has improved dramatically is the wait time to speak to an actual human being,” she told MedPage Today. “Going back a couple of years, it could have been up to, like, 2 minutes, and now it’s within 30 or 40 seconds that you are actually connected to a live human being.”
    • “That decrease in wait time may not sound like a lot, but it’s actually “huge,” Plotnick said. “If you’re at the point where you’re going to hurt yourself and you don’t know if anybody in the world cares, 2 minutes can really feel like an eternity. But now calls are being answered very quickly.” She also praised the lifeline’s addition of text and chat options, as well as special lines for veterans, for Spanish speakers, and for LGBTQ+ callers.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • “The median hospital operating margin rose to 2% in November after holding steady at 1.6% in September and October, but escalating expenses — including rising drug costs — remain a concern as 2023 draws to a close, according to a Dec. 21 report from Syntellis Performance Solutions, which includes data from more than 1,300 hospitals.
    • “U.S. hospitals began the year with a median operating margin of -0.9%, but that figure has steadily increased and looks set to end the year at a healthier level around the 2% mark in December. November was the ninth consecutive month of positive operating margins. 
    • “While the median hospital margin remains far below pre-pandemic levels, it has shown significant progress in recent months as hospitals continue their recovery after more than a year of negative results. 
  • The Wall Street Journal reports,
    • “Drug company Bristol-Myers Squibb struck a $4.1 billion deal to buy  RayzeBio in a bet on a re-emerging cancer drug technology.
    • “RayzeBio develops radiopharmaceutical drugs, which use targeted forms of radiation that are delivered directly to cancer cells. Earlier products using the technology struggled commercially, but further research led to another wave of promising therapies that can attack tumors while limiting damage to surrounding healthy cells.  * * *
    • “Bristol said the RayzeBio deal is slated to close in the first half of 2024.”
  • and
    • AstraZeneca has agreed to buy Gracell Biotechnologies for a transaction value of $1.2 billion, as part of the former’s efforts to grow its cell therapies business.
    • The acquisition will help grow AstraZeneca’s pipeline of cell therapies for potential treatment of cancer and autoimmune diseases.
    • The transaction is expected to close in the first quarter of next year, AstraZeneca said. 

Holiday Weekend Update

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

The FEHBlog trusts that everyone is enjoying the holiday season

From Washington, DC,

  • Congress is out of town this week.
  • On December 22, 2023, the President signed into law H.R. 2670,
    • “the “National Defense Authorization Act for Fiscal Year 2024,” which authorizes fiscal year 2024 appropriations principally for Department of Defense programs and military construction, Department of Energy national security programs, Department of State, and Intelligence programs; specifies authorities relating to the U.S. Armed Forces; extends the Foreign Intelligence Surveillance Act; and other matters.”
  • Congress convenes for the second session of this 118th Congress in the first full week of January 2024.

From the public health and medical research front,

  • The American Medical Association tells us what doctors wish their patients knew about the current reigning Omicron sub-variant, JN.1.
  • Medscape points out,
    • “Gut bacteria are stronger together when it comes to preventing infectious diseases.
    • “When a large, diverse community of gut bacteria compete with pathogens for nutrients, the pathogens may not have enough fuel to colonize and invade the body, according to a new study in Science.
    • “The more microbes there are, the more different nutrients they’re likely to eat, increasing the chances of nutrient overlap with the pathogen. The greater the overlap, the better the host is protected, the study found.
    • “The nutrients available to the pathogen are limited,” said lead study author Frances Spragge, a researcher in the Department of Biochemistry, University of Oxford, Oxfordshire. “So, its invasion is blocked.”
    • “It makes sense, said Thomas Schmidt, PhD, professor of microbiology and immunology at the University of Michigan, Ann Arbor. (Schmidt was not involved in the study.) “It’s kind of no surprise that competition for resources is what is providing the colonization resistance,” Schmidt said. “But we didn’t have evidence that that was the case.”
    • “The study is among the first to take a systematic approach to addressing competition between pathogens and specific host microbes, Schmidt said. It’s a step toward identifying microbes that could be useful in treating infections.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Bristol Myers Squibb has agreed to acquire Karuna Therapeutics for $14 billion, betting that the biotechnology company’s experimental schizophrenia drug will become a top-selling medicine.
    • “Per deal terms announced Friday [December 22], Bristol Myers will pay $330 a share for Karuna, a roughly 53% premium to its closing price on Dec. 21. Net of the cash that Karuna has on hand, the deal is worth about $12. 7 billion.
    • “The acquisition hands Bristol Myers a closely watched medicine known as “KarXT” that’s currently being reviewed by the Food and Drug Administration as a potential treatment for schizophrenia. The drug is a newer type of medication that doesn’t work like available schizophrenia treatments. It’s already succeeded in three mid- to late-stage trials and, if approved by regulators, could be launched by the end of 2024.
    • “KarXT is also in advanced testing as an adjunctive therapy to existing schizophrenia drugs and as a potential treatment for psychosis in patients with Alzheimer’s disease.
    • “The FDA is expected to make a decision on its use in schizophrenia by Sept. 26 of next year.”

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Medical / Rx research, No Surprises Act, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Govexec informs us,
    • “President Biden on Thursday issued an executive order implementing his plan to provide civilian federal workers with an average 5.2% pay raise next month.
    • “As first proposed in his fiscal 2024 budget plan last March, the increase amounts to a 4.7% across-the-board boost to basic pay, alongside an average 0.5% increase in locality pay. As authorized in the fiscal 2024 National Defense Authorization Act, which Biden is expected to sign this week, military service personnel also will see an average 5.2% pay raise next year.
    • “An average 5.2% pay increase marks the largest authorized for federal workers since the Carter administration adopted a 9.1% average raise in 1980, as well as a 0.6% increase over last year’s raise, which itself marked a 20-year high.”
  • STAT News reports
    • “Lawmakers are facing down a Jan. 19 deadline to renew a variety of expiring health care programs, so they just tucked away an extra $1.8 billion in a Medicare reserve fund in the NDAA, a Senate aide confirmed. They achieved the savings by extending the Medicare sequester’s end date, and then used some of the funds to pay for World Trade Center Health Program policies to support 9/11 survivors and first responders.
    • “The additional savings went to the Medicare piggy bank, formally known as the Medicare Improvement Fund, referred to in wonky circles as the MIF. Lawmakers will be able to pull from the MIF early next year as they weigh how to fund community health centers and stave off pay cuts to safety-net hospitals. It’s not a fortune, but it’s also nothing to sneeze at, given hospitals are panicked about the prospect of a payment policy passing that would save the federal government $3.7 billion over the next decade. It also gives them some wiggle room if they need to do another short-term extension of the programs.”
  • The American Hospital Association News relates,
    • “The Departments of Health and Human Services, Labor and Treasury Dec. 15 reopened the federal independent dispute resolution portal to process all dispute types. Given the significant backlog resulting from the suspension of operations, the agencies today further extended the deadlines to March 14, 2024, for any IDR deadlines that fell in the suspension timeframe of Aug. 3 through Dec. 14, 2023, or currently have an initiation deadline between Dec. 15, 2023, and March 13, 2024. CMS announced extensions for additional dispute processes, including additional response time for requests for information, extension requests for offer submissions, and additional time to select a certified IDR entity for disputes.”
  • A bipartisan group of Senators sent a letter to the ACA regulators telling them
    • “We are writing in support of the recent decision from the U.S. District Court for the District of Columbia that vacated the 2021 Notice of Benefit and Payment Parameters (NBPP) Final Rule provision that permitted the use of copay accumulator adjustment programs (AAPs) and remanded to the U.S. Department of Health and Human Services (HHS) to interpret the definition of “cost-sharing.” * * *
    • We are disappointed in HHS’s decision to file a notice of appeal of the decision and HHS’s articulated intention to not take any enforcement action against health insurance issuers or health plans that fail to count copay assistance toward the patient’s maximum annual limitation on cost-sharing. Instead of appealing the court’s ruling, we urge you to adopt policies from the 2020 NBPP that strike the right balance of preserving a plan’s ability to control costs while also putting the patient first.”
  • The 2020 NBPP permitted copay accumulators as long as State law did not object. “To date, 19 states, the District of Columbia, and Puerto Rico have banned or limited the use of copay accumulators.
  • Bloomberg reports,
    • “Some of the largest US hospital chains and most prestigious academic medical centers have violated federal rules by not posting the prices they charge for care, according to records obtained by Bloomberg News.
    • “For-profit HCA Healthcare Inc., the nation’s largest hospital system, and big nonprofit operators including Ascension and Trinity Health have been cited for failing to make prices fully available to the public, enforcement letters Bloomberg obtained through a public records request show. So have marquee facilities such as New York Presbyterian Weill Cornell Medical Center, Emory University Hospital and the Hospital of the University of Pennsylvania.
    • “The records reveal the challenges US regulators face as they try to force long-hidden prices into the open to address decades of rising medical expenses. Since 2021, hospitals have been required to be more transparent about what they charge. However, government data show that among 1,750 hospitals regulators evaluated as of early December, about 1,300 facilities — nearly 20% of the hospitals in the US — have been warned they violated rules. 
    • “Most corrected errors after they were pointed out, and officials charged with enforcing the rules say they’ve seen more hospitals complying. Regulators are also working to make the price data more useful.”
  • The U.S. Preventive Services Task Force released a final research plan for prostate cancer screening. Its most recent March 2018 recommendation fell below the A or B level grades required for no-cost coverage when provided in-network. The next stage will be a proposed 2024 recommendation.
    • “The Task Force keeps recommendations as current as possible by routinely updating existing recommendations and developing new recommendations. A multistep process is followed for each recommendation. The Task Force uses gold standard methods to review the evidence and is transparent at each step of the recommendation development process.”

From the public health and medical research front,

  • HR Dive relates,
    • “Physical health in the U.S. has worsened since the onset of the COVID-19 pandemic, a shift that could have detrimental effects on employers, according to Gallup survey results released Dec. 14. 
    • “Both obesity and diabetes are on the rise, Gallup found. The percentage of U.S. adults Gallup determined to have diabetes is 38.4%, up 6 percentage points from 2019 and a hair behind the record high 39.9% recorded last year. The number of respondents who said they have diabetes hit a new high of 13.6%, an increase of 1.1 points since 2019, per Gallup. 
    • “These health effects have practical implications for the U.S. economy. After controlling for factors such as age, income and education, workers with poor physical health — and poor wellbeing generally — suffer greatly enhanced levels of unplanned absenteeism and healthcare utilization (and associated costs) than do their counterparts,” Dan Witters, research director of the Gallup National Health and Well-Being Index, said.”
  • Per Medscape,
    • “A new frontier of brain-based therapies — from GLP-1 agonist drugs thought to act on reward and appetite centers to deep brain stimulation aimed at resetting neural circuits — has kindled hope among [obese] patients like Smith and the doctors who treat them. The treatments, and theories behind them, are not without controversy. They’re expensive, have side effects, and, critics contend, pull focus from diet and exercise. 
    • “But most agree that in the battle against obesity, one crucial organ has been overlooked.
    • “Obesity, in almost all circumstances, is most likely a disorder of the brain,” said Casey Halpern, MD, an associate professor of neurosurgery at the University of Pennsylvania. “What these individuals need is not simply more willpower, but the therapeutic equivalent of an electrician that can make right these connections inside their brain.”
  • The Wall Street Journal similarly reports,
    • “What if the best way to treat your chronic back pain is by retraining your brain?
    • “That’s the premise of a novel approach to chronic pain. Many people feel pain even after a physical injury has healed or when doctors can’t find a physical cause. The approach, called “pain reprocessing therapy,” tries to train the brain not to send false pain signals. Some early results are promising.
    • “In a study published last year in JAMA Psychiatry, 66% of a group of people who did the therapy for a month were pain-free or nearly pain-free up to a year later.
    • “The treatment is still largely in the research stages and typically not covered by insurance, but is being performed in a growing number of centers, including the VA Eastern Colorado Health Care System, which plans to start two clinical trials of the technique next year.” 
  • The American Hospital Association News reports,
    • “A CDC study released Dec. 21 found low COVID-19 and flu vaccination coverage for most adults, and low RSV vaccination coverage for adults aged 60 and older. Antiviral treatments are also being underused, and COVID-19 rebound can happen whether patients receive any, the study said. Among other findings, the report said that most nursing home residents have not received an updated COVID-19 vaccine or RSV vaccine for residents aged 60 and older using shared clinical decision-making.”
  • Unfortunately, Patient Engagement HIT points out,
    • “Few Providers Use [ICD-10] Z-Codes to Document Social Determinants of Health.
    • “Use of Z-codes to document social determinants of health is low, and there are differences in which patients get a Z-code documented, two unrelated studies showed.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “The labor outlook is stabilizing for U.S. nonprofit hospitals as employment increases and healthcare job openings decline, according toa new report from Fitch Ratings. 
    • “Hospital and ambulatory healthcare services payrolls have risen for 22 and 34 consecutive months respectively, according to the credit ratings agency. Wage growth has remained “relatively flat” at 4%. 
    • “Though the statistics indicate the hot labor market is cooling, Fitch said recruitment is still“hyper-competitive.” Health systems may need to offer higher salaries and better benefits to attract talent and dissuade skilled labor from seeking early retirement, the report said.” 
  • BioPharma Dive notes
    • “As ALS research booms, one treatment center finds itself in the spotlight.
    • “Mass General’s Healey Center is at the forefront of ALS research and care.
    • “Still, the complexities of the disease and of drug development have brought hard-felt losses.”
  • Per Fierce Healthcare,
    • “Two of southern California’s largest pediatric providers are planning to come together in 2024.
    • “The parent companies of Children’s Hospital of Orange County (CHOC) and Rady Children’s Hospital-San Diego announced Wednesday an agreement to merge under the new banner of Rady Children’s Health.
    • “The arrangement, which is subject to regulatory review, stands to help the organizations improve patient outcomes, increase access to care, accelerate treatment research and bolster their clinical and nonclinical workforces, the children’s hospitals said in their joint reveal.”

Monday Roundup

David Ermer–Congress, Generative AI, Medical / Rx research, No Surprises Act, SDOH, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The New York Times reports,
    • “The prospects for passing legislation to speed military aid to Ukraine this year are fading, as Republicans balk at striking a quick deal on immigration policy changes they have demanded in exchange for allowing the bill to move forward.
    • “After a weekend of intensive bipartisan border talks yielded progress but no breakthrough, Senator Chuck Schumer, Democrat of New York and the majority leader, acknowledged on Monday that negotiators were still far from completing a deal.
    • “It’s going to take some more time to get it done,” he said on the Senate floor on Monday afternoon, laying out plans for the week that made no mention of any votes on the aid package for Ukraine.”
  • Govexec tells us that “The Senate on Monday voted 50-11 to confirm former Maryland Gov. Martin O’Malley as commissioner of the Social Security Administration, ending a drought of more than two years in which the embattled agency lacked a permanent leader at the helm.”
  • Fierce Healthcare informs us,
    • “The Biden administration on Monday released amended fees related to independent dispute resolution under the No Surprises Act.
    • “In the amended final rule, CMS said it will instead set an administrative fee of $115 for disputes that are subject to the rule. A separate rule, which is up for comment until Jan. 2, adjusts the fees for disputes initiated after Jan. 1, 2025. * * *
    • “In addition, CMS outlined ranges for certified IDR entity fees, which the arbiters charge for determinations. Under the rule, the agency finalized a range of between $200 and $840 for a single determination and between $268 and $1,173 for batch rulings.
    • “These fees are also set annually, and IDRs can request to update them once each year, which the feds must approve.”
    • The rule takes effect on January 20, 2023.

From the public health and medical research front,

  • STAT News points out,
    • “As more data emerges that obesity drugs like Wegovy can reduce complications from heart and kidney problems as well, scientists have been wondering whether these benefits are driven by weight loss alone or also by other mechanisms.
    • “A new study suggests that one possible contributor is the drugs’ ability to reduce inflammation independent of weight loss.
    • “In mice experiments, scientists found that the treatments, known as GLP-1-based drugs, acted through the brain to reduce inflammation throughout the body. This was over a short period of time before the mice lost weight, according to the study, published Monday in Cell Metabolism.
    • “Though the researchers only studied mice, and didn’t look at how much the reduced inflammation translates to actual health benefits, they detailed a previously unknown mechanism of GLP-1 drugs that may help explain their effects on organs throughout the body.
    • “This is a new model for the anti-inflammatory actions of GLP-1” drugs, said Daniel Drucker, senior author of the study and a senior scientist at the Lunenfeld-Tanenbaum Research Institute.”
  • JAMA Pediatrics provides good news:
    • “Question  Is maternal influenza vaccination during pregnancy associated with a reduction in influenza-associated hospitalizations and emergency department (ED) visits in infants younger than 6 months?
    • “Findings  In this case-control study of 3764 infants younger than 6 months, maternal vaccination was associated with a reduction in influenza-associated hospitalizations and ED visits in infants. Vaccine effectiveness was highest among hospitalized infants, those younger than 3 months, and those born to mothers vaccinated in the third trimester.
    • “Meaning  The findings in this study indicate that maternal influenza vaccination during pregnancy provided important protection for the infant in the first few months of life before infants are eligible for vaccination.”
  • The American Medical Association shares what doctors wish their patients knew about social drivers of health.

From the U.S. healthcare business front,

  • Bloomberg reports
    • “We’re seeing wide price variation even in the same hospitals on the same day based upon the negotiated prices by the differing health insurance carriers or health plans,” said Cynthia Fisher, founder and chairman of the philanthropic group Patient Rights Advocate, , which provides free price data for nearly all of the more than 6,000 hospitals in the US. “For the employers, this is eye-opening.”
    • “Patient Rights Advocate on Dec. 11 introduced a hospital pricing search tool for the public. The organization pointed to prices for an injection of cancer drug Rituximab at Rush University Medical Center in Chicago that ranged from $899.33 for the Cigna Basic/Premier medical plan for Rush employees administered through Allegiance Benefit Plan Management Inc. by the Cigna Group, to $9,260.13 for the Cigna One Health HMO.
    • “If they’re able to offer it at a tenth of the price, why should one employer pay 10 times more?” Fisher said.
    • “Cigna didn’t respond to a request for comment, and a spokesman for Rush said the hospital wasn’t “in a position to speak to something that specific so rapidly.”
    • “Being able to easily compare prices will protect health plans from billing errors and fraud by hospitals and insurers, Fisher said. “The employers and unions that design health plans will be able to benefit from being well-informed about their choices and decisions to seek the best quality of care at the lowest possible prices,” she said.
  • Beckers Hospital Review identifies the thirteen out of twenty most popular prescription drugs that are in shortage and the 25 largest health systems by number of physicians.
  • Healthcare IT News calls attention to the fact that “Now that telemedicine is mainstream, artificial intelligence is helping healthcare providers with imperatives such as patient triage. Early results are promising.”
  • According to Reuters,
    • “High cost, logistical issues and the prospect of potential treatment advances are holding back adoption of the first gene therapies for hemophilia, experts said this week during the American Society of Hematology’s (ASH) annual meeting.
    • “Experimental options discussed at the San Diego meeting included personalized treatments and next-generation gene therapies, many still in the earliest stages of testing.”
  • Benefits Pro lets us know about a “Cigna report [that] outlines the benefits, challenges of value-based care. The Cigna paper suggests that physicians, patients, and health plans tend to recognize the good aspects of VBC, but that change has been slow nonetheless in the private sector.”
  • Per Fierce Healthcare,
    • “Kroger is piloting value-based primary care clinics as it joins a growing list of retailers looking to cash in on the booming sector of senior-focused medical care.
    • “The grocery chain has teamed up with Better Health Group, a provider network, to shift some of its in-store clinics, called The Little Clinic, into primary care centers for seniors, in addition to offering regular services.
    • “Better Health Group is rolling out the value-based model at eight of Kroger’s Altanta-area stores.
    • “The clinics today provide a full range of services from your acute, convenient care to primary care-like functions. About 60% of patients that we see in the clinic don’t have an assigned or designated primary care provider. So, there’s a huge opportunity just in general to serve patients and provide longitudinal care,” said Jim Kirby, chief commercial officer for Kroger Health, in an interview with Fierce Healthcare.”

Weekend update

David Ermer–Congress, COVID-19, Medical / Rx research, Mental health care–

From Washington, DC,

  • The Wall Street Journal adds,
    • “Senate negotiators failed Sunday to reach a deal on a framework for border-security measures that Republicans have demanded as a condition of passing new funding for Ukraine, further slimming the chances of any vote before Christmas.”Senate negotiators failed Sunday to reach a deal on a framework for border-security measures that Republicans have demanded as a condition of passing new funding for Ukraine, further slimming the chances of any vote before Christmas.
    • “The lack of a breakthrough by the self-imposed weekend deadline underscored the difficulties facing the Senate talks, even after the Biden administration signaled it was prepared to make significant concessions on immigration policy. Many Republicans not involved in the discussions have expressed skepticism in recent days about any deal, while progressive Democrats have raised concerns that the White House was bowing to conservative demands.
    • “We’ve got lots of issues to work through, in which there are many different ways to try and address and solve problems,” Sen. Kyrsten Sinema (I., Ariz.) told reporters Sunday evening. “We have to choose the one that works the best and that allows us to earn the votes of both houses [of Congress] and both parties,” she said.”
  • Govexec tells us,
    • “Federal employees must proactively take steps to make their work travel more sustainable under new guidance from the Biden administration, which the White House said would save taxpayer money and help take on the climate change crisis. 
    • “Workers on official business will have to prioritize taking public transit, renting electric vehicles or even riding bikes under a new memorandum from the Office of Management and Budget and a General Services Administration bulletin that updated the Federal Travel Regulation. Agencies should also consider not sending employees on business trips at all, with GSA noting, “In every case, the trip not taken is the least expensive and most sustainable.” 

From the public health front,

  • The University of Minnesota’s CIDRAP tells us,
    • Levels of three main respiratory viruses—SARS-CoV-2, flu, and respiratory syncytial virus (RSV)—remain elevated or are rising, but so far hospital occupancy remains stable, the US Centers for Disease Control and Prevention (CDC) said today [December 15] in its latest data updates.
    • Though levels this year are tracking behind last year at the same time, the CDC—expecting further impact from the viruses—yesterday sent an alert to health providers that underscored an urgent need to vaccinate more people against the three diseases to reduce severity and the potential impact on healthcare systems.
    • In a respiratory virus snapshot today, the CDC said COVID-19 indicators remain elevated and are increasing in some regions, such as the Midwest. The CDC said it expects the proportion of JN.1 viruses, part of the BA.2.86 family, to continue to increase. Scientists and CDC officials are closely watching JN.1, because of mounting evidence of its immune-evasive potential.
    • Meanwhile, flu activity is increasing in most parts of the country. And though RSV activity declined a bit in southeastern states, levels remain high nationally, with trends still rising in other parts of the country as hospitalizations continue to increase in older adults and young children.
  • NPR Shots discusses the use of CPR.
    • “After studying CPR for sixty years, physicians have a sense of which factors tend to be associated with survival. The first is age. I wrote before that older patients do worse with CPR, on average. But that relationship cuts both ways; younger patients sometimes do much better. In 2017, researchers studying a group of about 2,000 patients in Austria found that survival after cardiac arrest at thirty days was around 25% for patients under age 65, but only 4% for patients over 65. A study conducted in Toronto of patients aged 2 to 45 with cardiac arrest found a survival rate of 21%, while average survival for all age groups from cardiac arrest tends to be about 10%.
    • “Another factor is chronic illness. In 2014, researchers examined the effects of diseases like heart failure, cancer, cirrhosis, and kidney failure on the odds of survival in patients that received CPR. Patients with chronic illnesses were significantly less likely to survive to hospital discharge than those without them. The more severe the illness, the less likely was survival. And among the survivors, patients with a chronic illness tended to live just a few more months, while healthier patients often lived for several years. * * *
    • “When you’re young, it might make sense to choose everything, CPR and all. As you age, if you value life above all else, then perhaps you may still opt for CPR, defibrillation, intubation, and everything else a hospital can do when your heart stops, regardless of the odds of futility, or even harm. 
    • “The harm can be considerable. As I wrote in May, CPR can cause bleeding in the lungs, lacerations to the liver, and fractured ribs or sternum. Many survivors of CPR sustain damage to their brains, and may never be quite the same again. All of these outcomes become more likely with age, frailty, or chronic illness – and the likely harm of CPR may begin to outweigh its potential benefit. 
    • “If instead you hope for a gentler, quieter death at the end of your life, with minimal medical interventions, then CPR might not be for you.”
  • The article includes a picture of a person who has no noCPR tattooed on their chest.
  • In the wake of the autopsy results on actor Matthew Perry, Fortune Well discusses ketamine.
    • “What is ketamine?
      • “Ketamine is an anesthetic used by medical providers and veterinarians with some hallucinogenic effects, according to the U.S. Drug Enforcement Administration. A dissociative drug similar to psychedelics like nitrous oxide, it makes users feel detached from their pain, as well as their environment, distorting perception of sight and sound.
    • “What is ketamine approved to treat?
      • “It’s been approved by the U.S. Food and Drug Administration, in low doses, for use as a short-acting anesthetic in humans and animals, and as a nasal spray (esketamine) for treatment-resistant depression in conjunction with another oral antidepressant, according to the DEA. It’s a fast-acting antidepressant, used to bridge the gap while waiting for SSRIs to kick in, which can take weeks.
    • “Can ketamine be used for depression?
      • “Ketamine is only FDA approved for use as a nasal spray in treatment-resistant depression. But it’s increasingly used “off label” for treating depression, suicidal ideation, and chronic pain, according to the U.S. National Institutes of Health’s National Library of Medicine. An increasing number of clinics offer infusions for the treatment of depressions. Patients are monitored during and after the infusion.
    • “Is it possible to abuse ketamine?
      • “It can be used illegally to get high—via an injectable, liquid mixed with other liquids, or a powder to be snorted, mixed in drinks, or smoked. On the street it’s sometimes known by the names Cat Tranquilizer, Cat Valium, Jet K, Kit Kat, Purple, Special K, Special La Coke, Super Acid, Super K, Horse Trank, and Vitamin K. An overdose can lead to loss of consciousness and dangerously slowed breathing, according to the DEA. * * *
    • “What are signs of a ketamine overdose?

Friday Factoids

David Ermer–FDA, HSA, Medical / Rx research, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services, Labor, and the Treasury Dec. 15 reopened the federal independent dispute resolution portal to process all dispute types, including previously initiated batched disputes, new batched disputes, and new single disputes involving air ambulance services. The departments also have extended the applicable deadlines to initiate new batched disputes and new single disputes involving air ambulance services, resubmit disputes determined by certified IDR entities to be improperly batched, and select or reselect a certified IDR entity. For details, see the [lengthy] announcement. 
  • In Department of Health and Human Services news,
  • and
    • “A paper published today in JAMA Network Open addresses the use of healthcare algorithms and provides the healthcare community with guiding principles to avoid repeating errors that have tainted the use of algorithms in other sectors. * * *
    • “The paper, Guiding Principles to Address the Impact of Algorithm Bias on Racial and Ethnic Disparities in Health and Health Care, may be found in JAMA Network Open is available here. The journal also links to an accompanying podcast interview of panel co-chairs Marshall Chin, MD, MPH, and Lucila Ohno-Machado, MD, PhD, MBA. The final EPC report, Impact of Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare, can be found here.”

In Food and Drug Administration news,

  • From Bio-Pharma Dive,
    • “The Food and Drug Administration on Thursday broadened use of a drug Merck & Co. acquired in a $1 billion buyout four years ago, clearing Welireg for use in people whose kidney tumors have progressed following treatment with two other types of medicines. 
    • “Approval was based on a trial that compared Welireg to an older therapy called everolimus. Merck’s drug reduced the risk of cancer progression or death by 25% compared with everolimus and shrank or eliminated tumors in 22% of people who received it. Welireg hasn’t yet proven it can help kidney cancer patients live longer, however. 
    • “Merck inherited Welireg when it bought biotechnology company Peloton Therapeutics. Since then, the drug’s been cleared for use in a rare condition called von Hippel-Lindau disease and now kidney cancer. Merck is studying its potential in other settings as well.”
  • From MedTech Dive,
    • “Glaukos Corporation received Food and Drug Administration approval for a drug-releasing implant that is designed to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The implant was approved for single administration per eye.
    • “The device continuously delivers a formulation of travoprost, an established treatment for high pressure in the eye, to provide patients with an alternative to eye drops and remove the risk that noncompliance with the treatment regimen will affect outcomes.
    • “Glaukos failed to secure approval for repeat dosing but plans to work with the FDA to change the label. The wholesale acquisition cost (WAC) is $13,950 per dose, or implant, well above analysts’ expectations. William Blair analysts estimated the price would fall in a range of from $3,000 to $4,000 per implant, while BTIG analysts said they modeled a price of $5,000.”
  • and
    • “Medtronic has gained the first approval from the Food and Drug Administration for a pulsed field ablation (PFA) system to treat atrial fibrillation (AFib), pulling ahead of other medtech companies in the race to bring the technology to the U.S. market.
    • “The treatment approach has garnered attention as a safer alternative to radiofrequency and cryoablation techniques for addressing the abnormal heart rhythm, and Boston Scientific and Johnson & Johnson are pursuing the market.
    • “Medtronic, in announcing the FDA’s approval for its PulseSelect PFA system, said the device has demonstrated a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent AFib patients.”

From the public health and medical research front,

  • The New York Times offers readers’ perspectives on its article about the high and climbing number of pedestrian deaths occurring at night. “Readers share concerns like headlight glare, streetlight design and the aging of American motorists.”
  • HealthDay informs us,
    • “Diabetes drugs, including Ozempic, do not appear to increase the risk of birth defects
    • “Babies born of moms using drugs to control their type 2 diabetes had no greater risk of birth defects than those whose moms used insulin.
    • “Diabetes medications have grown in popularity over the past decade, particularly those in Ozempic’s class.”
  • The Director of the National Institute of Diabetes and Digestive and Kidney Diseases posted his Winter 2023 report.
  • Per Medscape,
    • “Living in food deserts and food swamps — areas with no access to healthy food, and areas with a plethora of unhealthy food options — may raise the risk of dying from postmenopausal breast cancer, a novel ecological study has found. 
    • “Food deserts and food swamps are both bad, but it’s worse in food swamps,” Malcolm Bevel, PhD, MSPH, with Augusta University in Georgia, told Medscape Medical News. 
    • “He presented his research here at the San Antonio Breast Cancer Symposium (SABCS) 2023.” 

From the U.S. healthcare business front,

  • KFF unveiled its updated
    • “Health Spending Explorer, an interactive tool that allows users to explore trends in health spending by federal and local governments, insurers, nursing care, hospital, and other service providers, and consumers.
    • “The tool captures just-released 2022 data from the federal government, when national health expenditures totaled nearly $4.5 trillion. Overall spending rose 4.1% in 2022, with almost all categories of health spending experiencing growth. This rise was muted by lower federal public health spending related to the pandemic. Meanwhile, consumers’ out-of-pocket costs rose 6.6%, a large but less dramatic increase than in 2021.”
  • The Health Care Cost Institute reports,
    • “Healthcare spending continues to grow, and prices are the primary driver. Without addressing high and growing prices, efforts to make care more affordable will not be successful. One way to understand what is going on with prices in employer-sponsored insurance (ESI) is to compare negotiated rates paid in that market to Medicare payments for the same services. New analysis from the Health Care Cost Institute finds that, in 2021, ESI payments for outpatient services were, on average, 287 percent higher than Medicare payments.”
  • Beckers Hospital Review identifies the 25 largest health systems in the U.S. by number of beds, and provides the reasons for fourteen hospital closures.
  • Using the American Medical Association’s health insurance market concentration report, Beckers Payer Issues identifies the cities with the most competitive Medicare Advantage markets.
  • Reuters reports,
    • “Bluebird bio (BLUE.O) said on Thursday a large insurer had agreed to cover its newly approved sickle cell disease gene therapy, easing some investor worries about resistance from other payers over the high price of the treatment.
    • “Bluebird’s treatment, Lyfgenia, was approved along with another gene therapy Casgevy from partners Vertex Pharmaceuticals (VRTX.O) and CRISPR Therapeutics (CRSP.BN).
    • “Bluebird’s price of $3.1 million is nearly $1 million higher than its rival, despite Lyfgenia having a serious safety warning about blood cancer risk. That had raised concerns over whether it would get enough coverage from insurers versus its rival.”
  • and
    • “Drugmaker Novo Nordisk paid U.S. medical professionals at least $25.8 million over a decade in fees and expenses related to its weight-loss drugs, a Reuters analysis found. It concentrated that money on an elite group of obesity specialists who advocate giving its powerful and expensive drugs to tens of millions of Americans.”
  • The Employee Benefit Research Institute factors health savings accounts into the retirement funding picture for Americans.
  • Per Fierce Healthcare,
    • “Two months ago, Elevance Health and Blue Cross and Blue Shield of Louisiana hit the pause button on a potential $2.5 billion merger in the midst of regulatory scrutiny.
    • “The insurers brought the deal back to life this week, though, with BCBSLA filing an updated application on Thursday seeking to reorganize as a for-profit, which would allow it to be purchased by Elevance Health. Per the New Orleans Times-Picayune, many of the plan’s initial proposals remain, but BCBSLA has made changes to the planned nonprofit foundation that will roll out should it be finalized.
    • “The newspaper reported that the Accelerate Louisiana Initiative will receive 91% of the proceeds from the merger.
    • “In a joint statement to Fierce Healthcare, the companies said that the new “filing reflects the input and vision of our communities to ensure that we deliver on these commitments.”
  • and
    • “While its merger with Humana may have fallen through for now, Cigna is attracting plenty of interest for the rumored sale of its Medicare Advantage business, Bloomberg reported.
    • Sources close to the matter told the outlet that Health Care Service Corp. and Elevance Health are “competing” to scoop up the MA segment. Cigna is expecting that the final bids will be submitted next week, according to the report.
    • “Cigna’s Medicare Advantage unit could sell for more than $3 billion, according to Bloomberg. The article noted that talks with HCSC and Elevance Health may not ultimately lead to a sale.
    • “That Cigna was shopping for a potential buyer for its MA business was first reported in early November by Reuters. That report mentioned that Cigna could ultimately elect to hang on to the MA unit if it didn’t find an appealing deal.
  • The Institute for Clinical and Economic Review listed their top ten stories of 2023.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek update

David Ermer–CDC, Congress, COVID-19, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call informs us,
    • “Congress appears poised to leave town before Christmas without a topline spending agreement, which could doom the chances of getting full-fledged fiscal 2024 appropriations bills done in January.
    • “If there’s no deal on spending limits this week, lawmakers will essentially be out of time to work out the details of the 12 annual appropriations bills by Jan. 19, the first of two deadlines set in the last continuing resolution. The next deadline is Feb. 2, leaving little time to complete the last, larger batch of bills, particularly with the House scheduled to be in recess the week of Jan. 22.
    • “House Republicans remain far apart from both parties in the Senate and House Democrats on the total allocations appropriators have to parcel out to the dozen subcommittees so they can wrap up their bills.”
  • Health Affairs Forefront informs us,
    • Today, Micah Hartman and colleagues at the Centers for Medicare and Medicaid Services (CMS), including the National Health Expenditure Accounts Team, released their 2022 healthcare spending report.
    • The team finds that healthcare spending in the US grew 4.1 percent from 2021, reaching $4.5 trillion in 2022, which is a faster rate of growth than in 2021 but slower than in 2020.
    • They determine that the rate of growth has become more consistent with the prepandemic average annual growth rate of 4.4 percent.
    • Among other findings, they determine that the health share of GDP returned to a nearly prepandemic level in 2022, although this result was partly influenced by economywide inflation. 
    • In 2022, the insured share of the population reached 92.0 percent (a historic high), as private health insurance and Medicaid enrollment continued to experience strong growth.
  • Here’s a link to the CMS Fact Sheet on this report.
  • “The U.S. Department of Health and Human Services (HHS) through the Office of the National Coordinator for Health Information Technology (ONC) today finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule. This follows the release of the HTI-1 proposed rule in April 2023. The HTI-1 final rule advances patient access, interoperability, and standards.”
    • Here’s a link to the Fierce Healthcare article on this action.
  • Health Affairs Forefront offers an article by two top government experts on what’s next with TEFCA.

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

  • Beckers Hospital Review points out,
    • “JN.1 is now the fastest-growing COVID-19 variant in the U.S., accounting for around 21% of cases, data from the CDC shows.
    • “The strain is closely related to BA.2.86, which first caught experts’ attention over the summer because of its large number of mutations in the spike protein. JN.1 has a single additional change in its spike protein, the L455S mutation, which experts say has some immune-evasion properties worth keeping an eye on.
    • “The continued growth of JN.1 suggests that it is either more transmissible or better at evading our immune systems,” the CDC said in a recent update about the variant. “At this time, there is no evidence that JN.1 presents an increased risk to public health relative to other currently circulating variants.” 
  • The New York Times reports,
    • “The nausea and vomiting that often define the first trimester of pregnancy are primarily caused by a single hormone, according to a study published on Wednesday in the journal Nature. Researchers said that the discovery could lead to better treatments for morning sickness, including rare, life-threatening cases of it.
    • “The study confirms prior research that had pointed to the hormone, called GDF15. The researchers found that the amount of hormone circulating in a woman’s blood during pregnancy — as well as her exposure to it before pregnancy — drives the severity of her symptoms.”
  • The New York Times also offers an expert opinion on how to close the large addiction treatment gap.
    • “The single most important thing lawmakers and health officials could do to usher in such changes is to improve their oversight of the addiction treatment industry. Too many states have not updated their regulations for addiction treatment facilities since the 1960s or ’70s. Many rely instead on independent accrediting agencies to separate good programs from bad ones. That approach frequently fails, as secret shopper studies and innumerable investigative reports have shown. “Accrediting organizations should feel humiliated by what we’ve seen from facilities that have their stamp of approval,” said Keith Humphreys. “But their incentive is to accredit everyone, because that’s how they get paid.”
  • Medscape notes,
    • “New recommendations to screen for heart failure, peripheral arterial disease (PAD), and type 1 diabetes risk, along with new obesity management guidance, are among many updates to the American Diabetes Association’s (ADA’s) Standards of Care for 2024.
    • “The Standards of Care are essentially the global guidelines for the care of individuals with diabetes and those at risk,” ADA chief scientific and medical officer Robert Gabbay, MD, PhD, said during a briefing announcing the new Standards.”
  • Per MedPage Today,
    • “A high-dose recombinant influenza vaccine (Flublok Quadrivalent) was more protective than an egg-based standard-dose influenza vaccine in adults, according to results of a cluster-randomized, observational study.
    • Among adults ages 50 to 64, the high-dose vaccine was 15.3% more effective in preventing influenza than the standard-dose vaccine (95% CI 5.9-23.8, P=0.002) and 15.7% more effective against influenza A (95% CI 6.0-24.5, P=0.002), reported Nicola Klein, MD, PhD, from the Kaiser Permanente Vaccine Study Center in Oakland, California, and colleagues in the New England Journal of Medicine.
    • “Although the relative benefit of the high-dose vaccine appears to be modest, “reducing breakthrough influenza cases by 15% would provide a substantial public health benefit, especially during more severe influenza seasons,” Klein told MedPage Today in an email.”
  • and
    • Moderna’s mRNA-based RSV vaccine was effective at preventing RSV-associated lower respiratory tract disease in adults ages 60 and older, according to results of the randomized ConquerRSV trial.
    • The mRNA-1345 vaccine was 83.7% effective (95.88% CI 66%-92.2%) in preventing RSV-associated lower respiratory tract disease with at least two signs or symptoms, and similarly effective (82.4%) against lower respiratory tract disease with at least three signs or symptoms (96.36% CI 34.8%-95.3%), Eleanor Wilson, MD, of Moderna in Cambridge, Massachusetts, and colleagues reported in the New England Journal of Medicine. * * *
    • “An important consideration will be how much protection an mRNA vaccine provides during subsequent RSV seasons and whether subsequent boosting will be appropriate,” Angela Cohn, MD, and Aron Hall, DVM, MSPH, from the National Center for Immunization and Respiratory Diseases at the CDC in Atlanta, wrote in an accompanying editorial. “Such questions about duration of immunity, along with reactogenicity and cold-chain considerations, remain important areas for further evaluation in the implementation of mRNA vaccines.”
  • The National Institute on Drug Abuse announced,
    • The percentage of adolescents reporting they used any illicit substances in 2023 continued to hold steady below the pre-pandemic levels reported in 2020, with 10.9% of eighth graders, 19.8% of 10th graders, and 31.2% of 12th graders reporting any illicit drug use in the past year, according to the latest results from the Monitoring the Future survey. Reported use for almost all substances decreased dramatically between 2020 and 2021, after the onset of the COVID-19 pandemic and related changes like school closures and social distancing. In 2022, most reported substance use among adolescents held steady at these lowered levels, and these latest data show that this trend has continued into 2023.

From the U.S. healthcare business front,

  • We have another report on healthcare spending trends.
    • “Greater use of diagnostic testing and advances in medical technology and treatments are among the factors pushing medical trends higher than the rate of inflation, according the 45th National Healthcare Trend Survey, published by Buck, a Gallagher company, an integrated HR, pensions, and benefits consulting, technology, and administration services firm. The company has been monitoring medical trend factors used by health insurers and third-party administrations to project employers’ future healthcare costs since 1999.
    • “The survey of nearly 100 health insurers and health plan administrators covering more than 100 million plan participants predicts even higher medical trend factors in the future due to providers renegotiating higher fees with insurers, as well as other changes occurring in the healthcare industry. Compared to the prior survey released in May 2023, the latest trends are up 50 to 100 basis points.”
  • Reuters reports,
    • “More than a quarter of 152 employers surveyed by the Business Group on Health said they would use virtual providers to oversee obesity drug prescriptions next year.
    • “Boeing (BA.N), Hilton (HLT.N), and Fortune Brands (FBIN.N) are among companies that have signed up for or expanded deals with virtual healthcare providers, according to sources familiar with the matter.
    • “Truist analyst Jailendra Singh forecasts the market for virtual obesity drug management could reach $700 million in 2024 and grow to as much as $9 billion longer term, assuming providers charge around $30 per member, per month, and $50 for physician appointments.”
  • The Wall Street Journal reports,
    • “Pfizer PFE  shares tumbled to their lowest close in more than nine years, after the giant drugmaker overestimated Covid-19 vaccine use and the company was forced to warn about its prospects.
    • “Shares fell 6.7% on Wednesday because the company, which has lost $140 billion in market cap this year, said its revenue could fall next year and issued 2024 guidance below analyst expectations.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, FDA, Medical / Rx research, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Hill reports,
    • “Congress is struggling to lock down a deal on government funding with just days until lawmakers are set to leave town for the rest of the year, as both chambers appear to have given up on passing their own spending bills.
    • “Lawmakers had been hopeful leadership would strike a deal last week on an overall top-line level for government funding in fiscal 2024 as part of the annual appropriations process. But as negotiations continue, lawmakers say leadership is cutting it close. Congress is staring down a shutdown deadline next month, with little legislative time on the calendar.” 
  • Healthcare Dive explains the features of the Lowers Costs, More Transparency bill passed last night by the House of Representatives. The wide bi-partisan margin supporting the bill gives it more likelihood of success in the Senate.
  • American Hospital Association News tells us,
    • “The House Dec. 12 voted 386-37 to pass AHA-supported legislation (H.R. 4531) that would reauthorize key SUPPORT Act programs for patients with substance use disorder and permanently extend required Medicaid coverage for medication-assisted treatments. The Senate Health, Education, Labor & Pensions Committee today advanced its own SUPPORT Act reauthorization bill (S. 3393).”
  • Healthcare Dive informs us,
    • “Nationwide health data exchange under TEFCA, the Trusted Exchange Framework and Common Agreement, is now operational, the HHS’ Office of the National Coordinator for Health Information Technology announced on Tuesday.
    • “Five Qualified Health Information Networks, or QHINs, completed the onboarding process and are ready for data exchange: eHealth Exchange, Epic Nexus, Health Gorilla, KONZA and MedAllies.
    • “The go-live marks a significant milestone that’s been years in the making, HHS leaders said at a signing event. “I feel like we’re watching the Big Bang occur in 2023,” said Secretary Xavier Becerra.”
  • Yippee! Now, true interoperability begins. Bye, bye fax machines.
  • HHS also announced,
    • “release[ing] HHS’s National Plan to Address Alzheimer’s Disease: 2023 Update – PDF. The National Plan is a roadmap of strategies and actions of how HHS and its partners can accelerate research, expand treatments, improve care, support people living with dementia and their caregivers, and encourage action to reduce risk factors. It highlights the progress made in 2023, which was an historic year for the treatment of Alzheimer’s disease and related dementias (ADRD) and care for people with this condition.”
  • The U.S. Preventive Services Task Force is proposing to retain its Grade B recommendation that
    • “Clinicians provide or refer children and adolescents age six years or older with a high body mass index (BMI) (≥95th percentile for age and sex) to comprehensive, intensive behavioral interventions.”
    • The public comment period is open until January 16, 2024.
  • MedPage adds that
    • “To reap the “moderate net benefit,” kids should have 26 or more contact hours with the behavioral interventions for up to a year, [the USPSTF] advised.
    • “USPSTF fell short of recommending pharmacologic therapy, citing a lack of evidence. This did not mean the group recommended against this type of treatment; however, behavioral interventions should be the primary effective intervention for kids’ weight loss, the task force said.”
  • The CDC offers five healthy eating tips for the holidays.
  • The GAO issued a report on the rocky implementation of the No Surprises Act’s independent dispute resolution process.

From the public health and medical research front,

  • Beckers Hospital Review points out the fifteen states (and New York City), up from ten the previous week, with the highest rates of respiratory disease.
    • “Two states — Louisiana and South Carolina — reported “very high” respiratory virus activity levels. Thirteen states — Alabama, California, Colorado, Florida, Georgia, Mississippi, Nevada, New Jersey, New Mexico, North Carolina, Tennessee, Texas and Wyoming — and New York City reported “high” activity levels, which are a measure of the weekly percentage of visits to an outpatient healthcare provider or emergency department for fever and cough or sore throat.” 
  • Per STAT News,
    • “The sickle cell community has for the past few days been buzzing with news of the first-ever approved gene therapies for the devastating disease. Meanwhile, researchers at the American Society of Hematology meeting on Tuesday are reporting advances in a less expensive and more established strategy proven to cure patients: bone marrow transplant.
    • “This approach has been around for decades but required patients to have a well-matched donor and endure a hefty dose of chemotherapy, ruling out transplant as an option for the vast majority of patients. In a mid-stage trial, however, researchers said sickle cell patients who were given a gentler course of chemo and an infusion of half-matched cells fared well: They had less pain, and 95% of participants were alive two years after transplant and only 7% of recipients experienced a severe reaction caused by transplanted immune cells attacking their new home.”
  • and
    • “One of the toughest subtypes of acute leukemia involves a genetic alteration in the KMT2A gene. Many cancers with this genetic alteration end up relapsing or don’t respond to treatment, but new data presented at the annual American Society of Hematology meeting offer hope of a new targeted therapy for these patients.
    • “The study, called the Phase 2 Augment-101 trial, tested Syndax’s revumenib in patients with relapsed or refractory leukemia with these KMT2A genetic rearrangements. Overall, about 63% of the patients responded to the treatment, with many able to receive a potentially curative stem cell transplant later on, which is often the ultimate goal for patients with relapsed or refractory patients, said Ibrahim Aldoss, a hematologist-oncologist at City of Hope and the study’s presenter, in an interview.”
  • The New York Times asks why since 2009 pedestrian deaths at night continue climb?
    • “[P]ut together, it’s clear that there’s been a particularly American mix of technological and social changes over the past decade and a half. And they have all come on top of a road system and an ingrained culture that prioritizes speed over safety. Whatever has happened over this time has reversed years of progress on daytime pedestrian fatalities, too, leading to a modest increase in deaths. Nighttime, however, has the potential to amplify so many of these new risks.
    • “A transportation system that’s safer by design — as in many European countries — might better absorb any one of these dangers. Distracted drivers are safer at lower speeds. People out at night are safer with well-lit crosswalks.”
  • The New York Times furthermore reports,
    • “Zepbound, the newly approved weight loss drug, hit the market this month. People seeking out the medication may have to stay on it for the foreseeable future — potentially, for the rest of their lives — if they want to keep the weight off, new research confirms.
    • “A study published Monday followed 670 people who had taken tirzepatide, the compound in Zepbound and the diabetes drug Mounjaro, for 36 weeks. Eli Lilly, the company that makes both drugs, funded the study. Tirzepatide regulates insulin levels and slows down the emptying of the stomach. It also acts on areas of the brain that control hunger and appetite. As a result, people can lose significant weight: On average, the study participants lost around 20 percent of their body weight during that time.
    • “After that, half of the participants continued to take a high dose of tirzepatide for a year while the other half received a placebo shot. Those in the study also underwent lifestyle counseling, ensuring that they were eating fewer calories and exercising regularly.
    • “People who continued taking tirzepatide for an additional year lost, on average, another 5.5 percent of their body weight. Those who were switched to the placebo, however, gained 14 percent of their body weight on average. Those on the placebo also tended to have higher cholesterol, blood sugar and blood pressure than they did while taking tirzepatide, said Dr. Louis Aronne, the lead author on the study and the director for the Comprehensive Weight Control Center at Weill Cornell Medicine.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Optum Rx is launching a new weight management program aimed at improving outcomes and addressing affordability.
    • “The cost of GLP-1 drugs amid continued high demand is a key focus for pharmacy benefit managers and plan sponsors, especially as individual therapies can top $10,000 per year. Through the Optum Rx Weight Engage program, the PBM is aiming to support employers and other clients in designing benefits for their membership.
    • “The team will review the client’s goals to build a tailored program that will deploy clinical solutions as well as patient monitoring and motivation and support tools, the company said. Members can connect to an obesity management specialist who will direct them to the appropriate clinical services.”
  • Healthcare Dive reports,
    • “Healthcare prices typically rise faster than inflation, but 2023 may have bucked that trend.
    • “The cost of shoppable medical services at hospitals increased 2% in the first three quarters of the year, according to new data from Turquoise Health released Tuesday. That’s in line with the 1.9% overall growth of the economy.
    • “The findings — some of the first from new price transparency data disclosing the once-secret negotiated rates between health insurers and providers — illustrate how overall economic inflation could be catching up to faster health cost growth.”
  • STAT News notes,
    • “In its latest bid to police the pharmaceutical industry, the U.S. Federal Trade Commission sought to block Sanofi from licensing a Pompe disease treatment made by another drug company. And in response, Sanofi is ending the deal.
    • “Sanofi sought the rights to the medication from Maze Therapeutics, but the regulator argued the deal — valued at $775 million — would eliminate a “nascent competitor” that could, otherwise, challenge the monopoly Sanofi has in the market for Pompe disease treatments, according to an FTC statement. The agency had filed a complaint in a federal court in Boston and also planned to seek a preliminary injunction.”
  • BioPharma Dive adds,
    • “The scuttled deal came on the same day that the regulator gave final clearance to Pfizer’s $43 billion acquisition of Seagen, which had faced close scrutiny from the antitrust regulator. To ease the FTC’s concerns, Pfizer has agreed to donate royalties from sales of the cancer drug Bavencio to the American Association for Cancer Research.”
  • Beckers Hospital Review points out six innovative hospitals.
  • According to BioPharma Dive,
    • “AstraZeneca on Tuesday reached a deal to acquire vaccine developer Icosavax in a deal worth up to $1.1 billion. 
    • “Per deal terms, AstraZeneca will acquire Icosavax’s shares at $15 apiece, and could add another $5 per share to the buyout if certain milestones and sales targets are met. The upfront payment from AstraZeneca represents an equity value of about $838 million and a premium of about 43% to Icosavax’s closing price on Monday. The acquisition would reach $1.1 billion if AstraZeneca eventually makes the future payouts, which are known as “contingent value rights.”  
    • “Icosavax has been developing an experimental shot that simultaneously targets respiratory syncytial virus and human metapneumovirus, another lung infection. The biotech released Phase 2 study results on Tuesday showing the vaccine spurred an immune response against both viruses without causing any serious adverse events. AstraZeneca will now take over late-stage development, and, if successful, commercialization.”