Thursday Miscellany

AHRQ

Thursday Miscellany

David Ermer–AHRQ, COVID-19, Electronic health records, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports
    • “The Office of Personnel Management had a busy year, managing to push out plenty of proposed regulations during 2023 that aim to reform federal hiring and improve workforce challenges.
    • “Even more plans and changes appear to lie ahead, though many may come in smaller bites, and require leadership from chief human capital officers (CHCOs) and other workforce experts in government.
    • “We are fundamentally rethinking hiring in government,” OPM Director Kiran Ahuja said during a Dec. 12 CHCO Council meeting. “Our big focus has been on utilizing pooled hiring, where multiple agencies with the same need can take advantage of one hiring action … It is so incredible of a tool that we have at our disposal right now.”
  • Govexec identifies the five agencies that did the most hiring in the fiscal year that ended September 30, 2023, with support from the White House.
  • The U.S. Preventive Services Task Force released for public comments a draft research plan to form a recommendation on medication to reduce breast cancer risk. The public comment deadline is January 31, 2024.
  • HHS’s Agency for Healthcare Research and Quality posted “Social and Structural Determinants of Maternal Morbidity and Mortality: An Evidence Map.” That’s certainly worth a gander.
  • Bloomberg reports,
    • “The US Food and Drug Administration has seized thousands of units of counterfeit Ozempic, Novo Nordisk A/S’s diabetes drug that’s been adapted into a blockbuster weight-loss treatment, and warned against using them.
    • “The regulator advised wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute or sell products labeled with lot number NAR0074 and serial number 430834149057.
    • “The FDA and Novo are testing the seized products and don’t yet have information about the drugs’ identity, quality, or safety.”
  • Kiplinger provides a useful overview of Medicare Part B and D’s income-adjusted premiums for 2024, known as IRMAA. The 2024 IRMAA is calculated based on the taxpayer’s 2022 adjusted gross income. The article explains how to obtain an IRS redetermination of 2024 IRMAA due to a life-changing event, for example.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Covid-19 infections and hospitalizations are rising this holiday season, mostly in people who have had the virus before. 
    • “A newer Omicron subvariant known as JN.1 is the culprit behind almost half of new cases in the U.S. The World Health Organization classified JN.1 as a variant of interest on Dec. 19 and said it was spreading rapidly worldwide. 
    • “The Centers for Disease Control and Prevention said the variant’s speedy spread suggests it is either more transmissible than other circulating variants or better at evading our immune systems. But existing vaccines, treatments and tests still work against it, the CDC said.”
  • Beckers Hospital Review identifies the ten States where COVID hospital admissions are the highest and where COVID hospital admissions are rising the fastest.
  • Fierce Healthcare considers whether GLP-1 patients can stop taking the drug and keep the weight off.
    • “While the current clinical paradigm for GLP-1 treatment requires lifelong medication at the highest dose, Calibrate is exploring whether members can be transitioned off of medication while sustaining their results,” shared a Calibrate spokesperson in a statement with Fierce Healthcare. “Accordingly, Calibrate is the first and only program with a proactive plan to get members off of medication.”
    • “That program, Calibrate says, was designed with evidence-based lifestyle interventions and is a more realistic approach for patients who don’t want to stay on GLP-1s forever. The company pointed to a 2018 study in The Obesity Society that shows 10% weight loss is the average attainable weight patients can realistically attain.
    • “Unlike the STEP 1 trial, where participants regained two-thirds of their prior weight loss after ceasing semaglutide utilization but continuing lifestyle intervention, Calibrate conducted its own analysis of 512 of its members to see if it’s possible to keep the weight off through the Calibrate program by tapering the drug’s usage. Its results showed that 93% sustained greater than 10% weight loss six to 12 months after beginning to taper off GLP-1 drugs.
    • “Calibrate advises speaking with a doctor to determine if GLP-1 tapering is appropriate for them but said it could be advisable at a normal BMI or if a patient plateaus for more than three months at a maximum dose of a GLP-1 medication.”
  • NBC News reports,
    • “Eating fewer carbohydrates can slow weight gain over time. But it’s not enough to just cut back on carbs. 
    • “An analysis of data from nearly 125,000 healthy adults revealed that replacing refined carbs — white bread, white rice or sugary cereals —with whole grain foods and cutting back on animal-based fats and proteins appeared to lessen the amount of weight people gained over a four-year period, according to the report published Wednesday in JAMA Network Open. 
    • “When it comes to a low-carbohydrate diet, quality is paramount,” said the study’s senior author, Dr. Qi Sun, an associate professor in the departments of nutrition and epidemiology at the Harvard T.H. Chan School of Public Health. “The things people need to pay attention to are high-quality carbohydrates.”
  • Health Day lets us know,
    • “Colon cancer screening is a known lifesaver, but the benefit may be even bigger than experts previously assumed
    • “New statistical analysis finds recommended screening cuts the 10-year incidence of the disease from 1% to 0.5%, double that of prior estimates
    • “Mentioning this to patients should boost colon cancer screening rates, researchers hope.”
  • Medscape tells us that cardiologists are not happy with the Lown Institute’s recent report about the overutilization of coronary stents.
    • “Lown “used an extremely liberal definition of overuse,” said Wayne Batchelor, MD, FACC, chair of the Interventional Council at the ACC, noting that overuse covered any stent placed during a nonemergency.
    • “We don’t just do procedures to try to save lives in very acute situations,” he said. “We also do procedures to try to improve symptoms and quality of life,” said Batchelor, director of Interventional Cardiology at the Inova Schar Heart and Vascular Institute in Fairfax, Virginia.
    • “Batchelor said that drawing conclusions from claims data alone in this report is improper because “it’s devoid of all the clinical information that a doctor and patient would want to discuss to make a decision as to whether or not a stent would provide a meaningful benefit to the patient.”
  • and
    • discusses changes to the adult vaccination schedule for 2024.

From the U.S. healthcare business front,

  • Health IT Analytics brings us up to date on the Fast Healthcare Interoperability Resource (FHIR).
    • “Using standardized application programming interface (API) standards, FHIR allows developers to create apps that transcend this document-based environment. Applications can be plugged into a basic EHR operating system and feed information directly into the provider workflow, avoiding pitfalls of document-based exchange, which often requires providers to access data separately.
    • “But FHIR APIs require health IT developers to publish FHIR endpoints in a standardized format, according to a 2022 blog post written by Office of the National Coordinator (ONC) officials. By developing the Lantern tool — which consumes public endpoint data, tests the accessibility of these endpoints, and then reports capability information to a public-facing dashboard — ONC worked with health IT stakeholders to form consensus around a standard format to publish FHIR endpoint lists.
    • “A slew of providers, developers, and vendors have created tools that leverage the data standard. The use cases for the standard are nearly limitless and include some of the major challenges preventing healthcare organizations from increasing patient engagement, developing robust population health management programs, and diving into advanced, intelligent clinical decision support.”

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.”

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.”  

Friday Factoids

David Ermer–ACA, AHRQ, Congress, Federal employment benefits, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Endpoints informs us,
    • “In a landmark moment for genetic medicine and sickle cell disease patients, the FDA on Friday approved not just one but two gene therapies for the disease: Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Casgevy, marking the first-ever approval of a CRISPR-based medicine in the US, and Lyfgenia, bluebird bio’s lentiviral gene therapy.
    • “The treatments are approved for sickle cell disease patients 12 years of age and older who experience painful attacks associated with the disease. Vertex will charge $2.2 million in the US for Casgevy, while bluebird will charge $3.1 million for Lyfgenia.
    • “This is the very first time that some patients have ever imagined that they might not have to live their entire lifespan with the consequences of sickle cell disease,” Alexis Thompson, the chief of the division of hematology at Children’s Hospital of Philadelphia and investigator on the clinical trials that led to the therapies’ approvals, told Endpoints News ahead of the announcement.” * * *
    • “ICER, a drug pricing watchdog, has suggested the therapies could be cost-effective at $2 million in the US. Bluebird bio markets a gene therapy as Zynteglo for transfusion-dependent beta thalassemia as well in the US, for which it charges $2.8 million.”
  • Per Fierce Healthcare,
    • “New polling suggests voters would rather work to improve the current U.S. healthcare system and keep the Affordable Care Act in place, rather than drastically overhaul the system in favor of a national public option or Medicare for All.
    • “Three-quarters of survey respondents said they prefer fixing the current health insurance system versus starting fresh with a Medicare for All system, while 64% said Medicare should begin at the age of 60 instead of 65 and 58% believe people should be allowed to purchase health insurance beginning at the age of 50.
    • “Repealing the ACA struck a chord with respondents as just 32% of voters and only 44% of GOP voters said they support repealing the ACA. When asked if ACA subsidies should be extended, 60% said they should while only 41% of Republicans agreed.
    • “Notably, the survey was conducted on behalf of the Partnership for America’s Health Care Future, an industry group created in 2018 comprised of America’s Health Insurance Plan, the American Hospital Association, BlueCross BlueShield Association, the Federation of American Hospitals, PhRMA and other major hospital systems, payers and healthcare advocacy groups that seek to quell support and prevent passage of Medicare for All.” 
  • Healthcare Dive tells us,
    • “Hospitals are up in arms over a bill in the U.S. House of Representatives that would equalize payments for drugs administered in outpatient clinics, regardless of ownership.
    • “The American Hospital Association and the Federation of American Hospitals sent separate letters to Congress this week urging legislators to vote against the bill over the site-neutral provision, arguing it would threaten access to care by cutting hospitals’ Medicare payments.
    • “The bipartisan Lower Costs, More Transparency Act is scheduled to come up for a House vote the week of Dec. 11.”
  • Fierce Healthcare offers more information on this bill (HR 5378).
    • [T]he legislation would ban spread pricing in Medicaid, force PBMs and providers to adopt President Trump-era transparency rules, push closer toward site-neutral payment reform, extend a federal program due to expire and approve funding increases for community health centers.
  • The American Hospital Association News points out,
    • The Medicare Payment Advisory Commission Dec. 8 discussed draft payment update recommendations for 2025, which the commission will vote on in January. The draft recommendations call for Congress to update Medicare payment rates for hospital inpatient and outpatient services by the current law amount plus 1.5%, and transition to a safety-net index policy that would distribute an additional $4 billion to safety-net hospitals. They also propose that Congress:
      • Update 2025 Medicare payments for physicians and other health professional services by 50% of the Medicare Economic Index increase, and enact a non-budget-neutral add-on payment under the physician fee schedule to services provided to low-income Medicare beneficiaries.
      • Reduce the 2025 payment rate for home health agencies by 7%.
      • Reduce the 2025 payment rate for skilled nursing facilities by 3%.
      • Reduce the 2025 payment rate for inpatient rehabilitation facilities by 5%.
  • On December 6, the Biden Administration’s latest semi-annual regulatory agenda was posted. Here is a link to OPM’s agenda. Here are the FEHB rulemakings in process:
    • OPM Proposed Rule Stage Federal Employee Health Benefits Program: Effective Date of Coverage RIN 3206-AO47
    • OPM Proposed Rule Stage Postal Service Health Benefits Program: Additional Requirements and Clarifications RIN 3206-AO59
    • OPM Proposed Rule Stage Federal Employee Health Benefits Program: Decreasing Enrollment Type to Self Only RIN 3206-AO62
    • OPM Final Rule Stage Requirements Related to Air Ambulance, and Agent, and Broker Services, and Provider Enforcement RIN 3206-AO28
    • OPM Final Rule Stage Postal Service Health Benefits Program RIN 3206-AO43
  • Readers can research these rulemakings on regulations.gov by referencing the RIN.

From the public health and medical research front,

  • The Department of Health and Human Services announced
    • “In first-of-its-kind research to examine racial and ethnic disparities in the medical costs of smoking in the United States, the Department of Health and Human Services’ Agency for Healthcare Research and Quality (AHRQ) found that adults from some racial and ethnic populations benefit substantially more than others from tobacco control policies. The research, published today in the journal Tobacco Control, supports President Joe Biden’s April 2023 Executive Order calling for policymakers to examine distributional effects in cost-benefit analyses required in the rulemaking process.  This study helps inform such analyses and will benefit other research in this area.
    • “The study shows that even though adults in specific racial and ethnic populations have a lower ever-smoked rate than White adults and make more attempts to quit, their medical spending associated with smoking was twice as high, with a 41% higher rate of having multiple chronic conditions associated with smoking. * * *
    • “Disparities in medical spending, as well as adverse health outcomes, are continuing to increase over time,” said AHRQ co-author Dr. William Encinosa. “AHRQ’s results indicate that racial and ethnic populations benefit substantially from tobacco control policies, such as tobacco product regulations.”
    • “The article, “Racial and Ethnic Disparities in the Healthcare Costs and Outcomes of Smoking in the United States: 2008-2019,” is published in Tobacco Control and may be found at: https://tobaccocontrol.bmj.com/lookup/doi/10.1136/tc-2023-058136“
  • Medscape notes,
    • “Patients receiving semaglutide for weight loss show a significantly higher rate of continuing the medication at 1 year compared with less effective anti-obesity drugs. However, even among those patients, continuation declines to fewer than half of patients.
    • “We now have effective US Food and Drug Administration-approved anti-obesity medications; [however], this study shows that in a real-world setting, the vast majority of patients discontinued their prescription fills within the first year,” said first author Hamlet Gasoyan, PhD, lead author of the study and a researcher with Cleveland Clinic’s Center for Value-Based Care Research, said in a press statement.
    • “The study was published online today in the journal Obesity.”
  • HR Morning fills us in on cancer benefit trends in 2024 and how employers can support employees fighting cancer.
  • Per MedPage Today,
    • “An outbreak of Clade I mpox virus is currently spreading in the Democratic Republic of the Congo (DRC), and clinicians should be aware of the potential for transmission from people traveling from the Central African country, the CDC said Thursday in a Health Alert Network advisoryopens in a new tab or window.
    • “Of the two distinct mpox subtypes, Clade I is endemic in Central Africa, and appears to be more transmissible and causes more severe infections than the Clade II subtype. So far, no Clade I mpox infections have been detected in the U.S. during surveillance testing. The current threat for Clade I mpox in travelers remains low, the CDC said, in part because there are no direct commercial flights to the U.S. from the DRC.”

From the U.S. healthcare business front,

  • Becker’s Payer Issues explains how BCBS plans are using price transparency data.
    • “It’s been nearly two years since payers have been required to publish the costs of their in-network provider rates for covered items and services, and now Blue Cross Blue Shield plans are using that data to create actionable insights for stakeholders across the healthcare system.
    • “Much of that work is being done by Blue Health Intelligence, the data and analytics arm of the BCBS Association that is collectively owned by 17 BCBS affiliates. Becker’s sat down with BHI CEO Bob Darin to learn how Blues plans around the country are utilizing price transparency data, and the major challenges that still lie ahead.”
  • Check out the interview.
  • HR Dive reports,
    • “The U.S. government published its fall regulatory agenda Wednesday, sharing its rulemaking plans for the remainder of 2023 and early 2024.
    • “Of interest to HR professionals are U.S. Department of Labor updates on wage and hour law, workplace safety and retirement plans. Perhaps most notably, the DOL plans to finalize overtime regulations in April 2024. Final regulations for independent contractor classification — under the Fair Labor Standards Act — hang in the balance, as they were slated to be published in November, per the DOL.
    • “Separately, the U.S. Equal Employment Opportunity Commission said it will finalize Pregnant Workers Fairness Act rules in December.”
  • The Society for Human Resource Management advises
    • “With the end of the year quickly approaching, HR and benefits leaders have yet one more task to add on to their busy end-of-year checklist: reminding employees about approaching deadlines to use up remaining cash in their health care flexible spending accounts (FSAs). ***
    • “So how should employers share end-of-year news about FSAs? And what should they say?
    • “One of the best ways to remind employees is to send multiple emails during the remainder of the year, Dinich said, adding that if company leaders simply raise the issue in a company meeting, anyone who is on leave or out sick won’t get that reminder.
    • “Make sure to reiterate any terms and conditions within that email and advise on checking which expenses are eligible, so that employees can refer back to this when making claims before the end of the year,” he said. “Also ensure that it’s clear when the expiry date is, as some plans are tied to specific dates rather than defaulting to the end of the year.”

Tuesday Tidbits

David Ermer–AHRQ, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • The Medicare open enrollment period ends on Thursday, December 7. The Federal Benefits Open Season ends next Monday, December 11. While the Affordable Care Act open enrollment period continues into next month, December 15 is the last day to enroll if you want your coverage to begin on January 1, 2024.
  • FEHB open season changes take effect on January 1, 2024, for annuitants and on January 14, 2024, for federal employees. January 14 is the beginning of the first pay period in 2024.
  • Govexec tells us,
    • “In a memo to agency heads on Friday, OPM Associate Director for Workforce Policy and Innovation Veronica Hinton announced that the government’s HR agency had added shared certification functionality to the agency-facing portion of USAJOBS through a tool called Talent Pools.
    • “The Office of Personnel Management is proud to announce a new USAJOBS feature, Talent Pools, to ‘advertise’ available shared certificates of candidates across government,” Hinton wrote. “These certificates, issued under delegated examining procedures through the Competitive Service Act or an OPM-run cross government hiring action, contain candidates who have applied to an open announcement, have been assessed and are available for agencies’ consideration.”
    • “Hinton argued that the new feature should be a boon to agency hiring managers and job applicants alike by removing unnecessary and often duplicative red tape.”
  • Federal News Network informs us,
    • “Federal employees working in cyber now have a way to develop skills, while also seeing what it’s like to work at another agency.
    • “In the hopes of boosting retention of cyber employees, the Office of Personnel Management launched a new platform Monday for agencies to advertise openings in the cyber workforce rotation program.
    • “The rotation program lets agencies offer temporary assignments to federal employees who are currently working in IT, cyber or cyber-related positions in government. Eligible employees can apply for and work at a different agency for between six months and one year before returning to their home agency.
    • “The cyber rotations will advance career opportunities and support employee engagement, satisfaction and retention,” OPM said.”
  • The U.S. Preventive Services Task Force released two draft recommendation statements for public comment.
    • “Grade B — The USPSTF recommends exercise interventions to prevent falls in community-dwelling adults age 65 years or older who are at increased risk for falls.
    • Grade C — The USPSTF recommends that clinicians individualize the decision to offer multifactorial interventions to prevent falls to community-dwelling adults age 65 years or older who are at increased risk for falls. Existing evidence indicates that the overall net benefit of routinely offering multifactorial interventions to prevent falls is small. When determining whether this service is appropriate for an individual, patients and clinicians should consider the balance of benefits and harms based on the circumstances of prior falls, presence of comorbid medical conditions, and the patient’s values and preferences.”
    • The public comment period on the draft recommendation statements and the related draft evidence reviews ends on January 8, 2024. These recommendations would continue the current grades for these recommendations, last issued in 2018.

From the public health and medical research front,

  • Per Beckers Hospital Review,
    • “Leapfrog is winding down 2023 by recognizing 132 hospitals with its Top Hospital Award, a distinction for hospitals that demonstrate the highest performance in the U.S. on quality and patient safety. 
    • “Awarded hospitals are divided into four groups: general hospitals (34), children’s hospitals (8), rural hospitals (15) and teaching hospitals (75). Methodologies for the awards in each category can be found here. Seventeen more hospitals were awarded this year compared to last.”
    • The article lists all 132 recognized hospitals by state.
  • and
    • United Health Foundation released its 2023 America’s Health Rankings Dec. 5, which analyzes the overall health of the 50 states and this year identifies a record-high and rising prevalence of chronic conditions. 
    • For the 2023 rankings, UHF analyzed 87 measures across five categories of health: social and economic factors, physical environment, behaviors, clinical care and health outcomes. This year, eight chronic conditions — arthritis, depression, diabetes, asthma, cancer, cardiovascular diseases, chronic obstructive pulmonary disease and chronic kidney disease — reached their highest levels since America’s Health Rankings began tracking these measures in 1990. 
  • STAT News reports,
    • “Given the widespread acceptance that the current flu vaccines could use improvement, are mRNA shots the answer? As the scientific world waits for published data on which to formulate conclusions, STAT spoke to influenza and vaccine experts who see some significant benefits of applying mRNA technology to the production of flu vaccine — but also some serious challenges mRNA manufacturers will face breaking into this already crowded market.” 
    • In short, it’s messy.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health, the nation’s largest drugstore chain, will move away from the complex formulas used to set the prices of the prescription drugs it sells, shifting to a simpler model that could upend how American pharmacies are paid. 
    • “Under the plan, CVS’s roughly 9,500 retail pharmacies will get reimbursed by pharmacy-benefit managers and other payers based on the amount that CVS paid for the drugs, in addition to a limited markup and a flat fee to cover the services involved in handling and dispensing the prescriptions. Today, pharmacies are generally paid using complex measures that aren’t directly based on what they spent to purchase specific drugs.
    • “A similar payment model, sometimes known as “cost plus,” has been promoted by entrepreneur Mark Cuban’s eponymous pharmacy company, among others, which have said it brings greater clarity and accountability to drug pricing.  * * *
    • “The company will call the payment model CostVantage. When it starts rolling out next year, the new prices will first become available to consumers paying cash for their prescriptions using an array of drug discount cards. 
    • “In 2025, the setup will be incorporated into CVS pharmacies’ contracts with pharmacy-benefit managers covering drugs paid for under employer plans.
    • “CVS will also introduce a new option for clients of its PBM, CVS Caremark, that will work in tandem with the new retail pharmacy-payment scheme. The new PBM product, called TrueCost, will be based on the net cost of drugs with defined fee structures, the company said. Employers and other clients will have the choice to use it or not.”
  • Fierce Healthcare adds,
    • “After spending nearly $20 billion to pick up Signify Health and Oak Street Health this year, CVS rebranded its health services business to “CVS Healthspire” as it plots its long-term growth strategy.
    • “During the Forbes Healthcare Summit in New York City on Monday, CVS chief executive officer Karen Lynch said Healthspire will encompass CVS’ pharmacy services business, its care delivery assets, including home health company Signify Health and Medicare-focused primary care player Oak Street Health, as well as its new Cordavis operation. Cordavis is a new segment CVS launched in August that aims to work with drugmakers to bring additional biosimilars to market.”
  • BioPharma Dive points out,
    • “Johnson & Johnson expects its pharmaceuticals division will bring to market 20 new therapies for cancer, immune and neurological diseases by 2030, an outlook that underpins the industry giant’s forecast for sales growth of between 5% and 7% through the end of the decade.
    • “Seven of those anticipated drugs have the potential to earn more than $5 billion each in peak annual sales, J&J said Tuesday as part of a business review held three months after the company split off its consumer division. The separation left J&J slimmer, but focused on its higher-margin pharmaceuticals and medical device businesses.
  • Per Healthcare Dive,
    • “Next year is set to be another “make or break” year for nonprofit hospitals as they continue to weather staffing shortages and heightened inflation, according to a report from credit ratings agency Fitch Ratings released on Tuesday.
    • “The outlook for the sector is still “deteriorating” — a rating that’s been in place since August 2022. Fitch does not forecast credit downgrades en masse in the coming year. However, downgrades and negative outlooks will likely continue to outpace upgrades and positive outlooks.
    • “The single largest differentiator in performance will be hospitals’ ability to attract and retain staff in a hypercompetitive landscape, said Kevin Holloran, Fitch senior director and sector head, in a statement.” 

Friday Factoids

David Ermer–AHRQ, CDC, COVID-19, Medical / Rx research, OPM, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Yesterday, OPM’s Office of Inspector General posted its Semi-annual Report to Congress for September 30, 2023. OPM has not yet posted its Management Response thereto.
  • The HHS Office of Inspector General also issued its latest Semi-annual Report to Congress.
  • Federal News Network reports that federal employees in Japan continue to experience healthcare access problems.
  • The Director of HHS’s Agency for Healthcare Research and Quality explains how the Biden Administration is tackling financial strains on healthcare consumers.

From the public health and medical research front,

  • Beckers Clinical Leadership tells us,
    • “CDC Director Mandy Cohen, MD, said the season of respiratory syncytial virus is in “full swing” as flu slowly begins and COVID-19 leads the most hospitalizations and deaths, CNN reported Nov. 30. 
    • “What to know about COVID-19, RSV and flu:
      • “COVID-19: Dr. Cohen said while COVID-19 is “relatively low,” it remains the primary reason for new respiratory admissions and deaths. In November, each week saw between 14,000 and 18,000 hospitalizations and about 1,000 deaths. 
        • “The CDC revealed a new wastewater data tracking dashboard to track local and national trends per variant, and the dashboard also tracks mpox viruses. 
        • “Between Nov. 1 and Nov. 20, the most recent CDC information available, the proportion of wastewater sites reporting high increases of SARS-CoV-2 samples grew from 22% to 32%. During the same time, the proportion of wastewater sites finding decreasing samples slimmed from 60% to 49%. 
      • RSV: “Hospitalizations for RSV have been slightly rising, with RSV accounting for 0.5% of all hospitalizations in late October and 0.8% as of Nov. 18, according to the CDC. Ten states and New York City are reporting high levels of respiratory virus activity. Louisiana and South Carolina reported “very high” respiratory virus activity levels and Alabama, California, Colorado, Florida, Georgia, Mississippi, New Mexico and Texas are seeing “high” levels.
      • Flu: “The flu season is beginning as national estimates reveal 3.9% of healthcare visits were for flu for the week ending Nov. 25, a 0.2 percentage point increase from the prior week.  Most of the U.S. is reporting an increase in flu, with hot spots appearing in the South Central, Southeast, Mountain and West Coast regions. Twenty-five states and territories are reporting minimal flu activity.
        • “Hospitalizations for flu have grown for the third consecutive week.” 
  • The Wall Street Journal reports,
    • “The Centers for Disease Control and Prevention is urging people to avoid eating certain cantaloupe products amid a salmonella outbreak that has resulted in at least two deaths in the U.S.
    • “At least 117 people across 34 states have become sick after eating contaminated cantaloupe since mid-October, according to the CDC. At least 61 people have been hospitalized and two have died in Minnesota. The federal agency said the number of people sickened by the outbreak is likely much higher.
    • “The agency said it’s particularly concerned about the outbreak because the illnesses have been severe and some have occurred in long-term-care facilities and child-care centers. Fourteen people in long-term-care facilities and seven children who attended child-care facilities have been sickened, the CDC said.”
  • STAT News informs us,
    • “Advances in treatments for congenital heart abnormalities mean more patients are living into adulthood, with over 2 million adults estimated to have the condition in the U.S. But that means more are also developing heart failure as they grow older — and many aren’t receiving proper care.
    • “A new study published this week in the Journal of the American Heart Association found that while hospitalizations of adults with congenital heart disease stayed stable from 2010 to 2020, the proportion of admissions for those who have heart failure more than doubled from 6.6% to 14%.
    • “These patients with heart failure also had worse outcomes after hospitalization, with an 86% higher risk of death, a 73% higher risk of major heart and brain complications, and a 26% higher risk of hospital readmission.
    • “The findings suggest that adults with congenital heart disease who also have heart failure are an especially high-risk population, and they may need closer monitoring and unique treatment regimens.”
  • Health Day offers these key takeaways from recent study results:
    • “Sticking to your scheduled mammograms can significantly reduce your risk of death from breast cancer
    • “Women who got all their scheduled mammograms had a 66% to 72% reduced risk of breast cancer death
    • “Regular mammograms make it more likely that breast cancers can be caught early, when they are more treatable.”
  • Mercer Consulting discusses why an end to HIV in our country is in sight and shares five ways to address HIV in the workplace.
  • The American Hospital Association News adds
    • “Nine out of 10 people receiving medical care for HIV through the Ryan White HIV/AIDS Program in 2022 were virally suppressed, meaning they cannot sexually transmit the virus if they take their HIV medication as prescribed, according to the latest annual data from the Health Resources and Services Administration program.”

From the U.S. healthcare business front,

  • EBRI posted Fast Facts about the changing nature of primary care in our country.
    • “Among users of primary care, 95–97 percent utilized it in an office setting prior to 2020, but only 86 percent did so from 2020–2021 as employees began using telemedicine (7–8 percent) and urgent care clinics (3–4 percent) with greater frequency due to the COVID-19 pandemic.
    • “There has been a consistent downward trend in the share of employees whose primary care office visits are at a general/family practice, falling from 42 percent in 2013 to 37 percent in 2021. In addition, primary care office visits at internal medicine providers have fallen from 21 percent in 2013 to 17 percent in 2021.
    • “Finally, the provision of primary care by a medical doctor has fallen from 9 percent in 2013 to 4 percent in 2021. In contrast, primary are provision by nurse practitioners and physician assistants has risen over time. The share of employees whose primary care office visits have been with a physician assistant rose from 2 percent in 2013 to 6 percent in 2021.
    • “The corresponding change for nurse practitioners has been from 4 percent in 2013 to 16 percent in 2021.”
  • BioPharma Dive lets us know,
    • “Pfizer will not advance a twice-daily dose of an experimental obesity drug into further testing after results from a mid-stage study showed high rates of gastrointestinal side effects and participant dropout. 
    • “Treatment did lead to significant weight loss compared to placebo over the course of the Phase 2b study. Placebo-adjusted reductions in body weight ranged from 8% to 13% at 32 weeks, Pfizer said in a statement Friday. Discontinuation rates were more than 50% on some drug doses, however.
    • “Moving forward, Pfizer will turn its focus to a once-daily version that’s currently being tested in a study meant to determine how the drug’s processed by the body. Data are expected in the first half of next year.”
  • Healthcare Dive reports,
    • “Community Health Systems announced on Friday it has completed the sale of three Florida hospitals to Tampa General Hospital for about $294 million in cash.
    • “The deal includes 120-bed Bravera Health Brooksville, 124-bed Bravera Health Spring Hill and 128-bed Bravera Health Seven Rivers, as well as their associated assets, physician clinic operations and outpatient services, according to a press release.
    • “The sale allows the for-profit hospital operator to “deliberately focus our resources in markets that we deem as most investable and that can produce greater growth and returns over the long term,” CHS CEO Tim Hingtgen said during a call with investors shortly after the divestiture was announced this summer.” 
  • MedCity News explains how payers can break down barriers that prevent access to value-based virtual care.
  • Per Fierce Healthcare,
    • Daniel Jones, who pens the investment newsletter Crude Value Insights, wrote in an analysis that because Cigna and Humana have fairly different focuses despite both being large health plans, there is potential that the merger could be viewed as more of a vertical deal than a horizontal one, which is less likely to stymie competition.
    • Cigna is a far smaller player in the Medicare Advantage space while Humana’s insurance business is overwhelmingly centered in MA. Humana, meanwhile, has limited reach in the commercial market, where Cigna has a far greater footprint.
  • Beckers Payer Issues adds,
    • “The sale of Cigna’s Medicare Advantage business would remove one hurdle in the company’s reported goal to merge with Humana, and Health Care Service Corp. might be part of that equation, Bloomberg reported Nov. 29.”

Thursday Miscellany

David Ermer–ACA, AHRQ, CDC, COVID-19, FDA, Telehealth, U.S. Healthcare–

From Washington, DC —

  • Medscape tells us
    • “The US Food and Drug Administration (FDA) [on July 31] cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.
    • “The device helps identify lesions in real time, and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.”
  • MedPage Today lets us know,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously — 10 to 0 — in favor of nirsevimab (Beyfortus) for protecting a wide swath of at-risk infants from respiratory syncytial virus (RSV).
    • “At a meeting on Thursday, ACIP recommended that all infants younger than 8 months who are born during or approaching their first RSV season receive one dose of nirsevimab.
    • “The advisory committee also voted 10-0 to recommend that children 8 to 19 months who are at increased risk of severe RSV and approaching their second RSV season receive one dose of the monoclonal antibody against RSV.
    • As a result of this action, FEHB plans and health plans generally must cover the preventive service with no cost sharing when delivered in-network.
  • The Labor Departments Office of Federal Contract Compliance Programs announced
    • “a final rule titled “Pre-enforcement Notice and Conciliation Procedures.”
    • “The final rule modifies the agency’s earlier rule, “Nondiscrimination Obligations of Federal Contractors and Subcontractors: Procedures to Resolve Potential Employment Discrimination” which took effect on December 10, 2020. * * *
    • “To learn more, read Acting Director Michele Hodge’s blog about the final rule here. You can also read the Final Rule here.  
    • “The final rule will take effect on September 5, 2023.”

From the public health front —

  • UPI reports, “In examining real-world data on the long-term health of elderly patients who received the COVID-19 vaccine, researchers at Brown University and Boston-based Hebrew SeniorLife determined that the Moderna variety was the safest and most effective for older adults.”
  • The Washington University School of Medicine announced,
    • “Scientists at Washington University in St. Louis have developed a breath test that quickly identifies those who are infected with the virus that causes COVID-19. The device requires only one or two breaths and provides results in less than a minute.
    • “The study is available online in the journal ACS Sensors. The same group of researchers recently published a paper in the journal Nature Communications about an air monitor they had built to detect airborne SARS-CoV-2 — the virus that causes COVID-19 — within about five minutes in hospitals, schools and other public places.”
  • MedPage Today informs us
    • “Thymectomy carried a substantially increased risk of all-cause mortality and cancer for adults, a “landmark” study showed.
    • “Adults who had undergone thymectomy had at least double the risk of all-cause mortality and cancer at 5 years post-surgery compared with matched patients who had undergone cardiothoracic surgery without thymectomy * * *.
    • “Incidental thymectomy is common during cardiothoracic surgery due to the pyramid-shaped organ’s location in the chest in front of the heart where surgeons need to access the surgical field.
    • “While the thymus plays a critical role in normal immune system development, it was thought to be safe to remove in adulthood, “particularly since the thymus naturally involutes with age,” the researchers noted.
    • “Their conclusion from the study was that the thymus continues to be functionally important for human health in adulthood.”
  • HHS’s Agency for Healthcare Research and Quality has made available a
    • “Toolkit for Improving Perinatal Safety, a second bundle of AHRQ tools is available to improve the safety culture of labor and delivery (L&D) units. The second bundle provides resources that align the toolkit’s adaptive care processes with the clinical care processes recommended in the Alliance for Innovation on Maternal Health (AIM) program.
    • “The new tools are designed to help L&D units reduce obstetric hemorrhage and severe hypertension in pregnancy, two leading known causes of preventable maternal mortality and severe maternal morbidity in the United States.”
  • On a related note, Fierce Healthcare reports
    • “To improve maternal and infant healthcare, Health Care Service Corporation announced the launch of a program that will rely in part on the cooperation of local groups to ensure its success.”To improve maternal and infant healthcare, Health Care Service Corporation announced the launch of a program that will rely in part on the cooperation of local groups to ensure its success.
    • “HCSC said it wants to increase access to providers and reduce gaps in healthcare as well as engage and educate residents about maternal and infant well-being. The customer-owned health insurer plans to install the program in the states in which it operates: Illinois, Montana, New Mexico, Oklahoma and Texas.
    • “The initiative will first launch in the Lone Star State, HCSC said.
    • “We’re collaborating with trusted community organizations and partners, leveraging their knowledge, experience and talents on a local level,” HCSC Chief Clinical Officer Monica Berner, M.D., said in a press release. “We seek to build healthier communities by using our resources to respond to societal needs.”
  • KFF News points out that “Doctors Sound Alarm About Child Nicotine Poisoning as Vapes Flood the US Market.”

From the U.S. healthcare business front —

  • Beckers Payers Issues notes
    • “The Cigna Group raised its year-end revenue projections to $190 billion and reported a 6 percent decrease in shareholders’ net income, according to the company’s second quarter earnings published Aug. 3.
    • “Total revenues in the second quarter were $48.6 billion, up 7 percent year over year.
    • “In the second quarter, net income was nearly $1.5 billion, down 6 percent from $1.6 billion year over year. The company cited an absence of income from recently divested businesses, including the sale of businesses to Chubb in six countries and divestiture from a joint venture in Turkey.
    • “Evernorth pharmacy revenues rose 7 percent year over year to $35.2 billion. The insurance side of the business, Cigna Healthcare, reported second-quarter revenues of $12.7 billion, up 11 percent from the previous year.
    • “The company’s medical loss ratio was 81.2 percent in the second quarter, compared to 80.7 percent during the same period last year.”
  • Healthcare Dive adds
    • “Investors were concerned about medical cost trends coming into the second quarter, but health insurers have largely bucked the worst of rising expenses. Cigna, one of the last major payers to report earnings, was no different.
    • “We planned and priced for more normalized levels of utilization this year. Our year-to-date claims experience has been broadly in line with this expectation,” Cigna CFO Brian Evanko said in a Thursday morning call with investors.”
    • Cigna’s medical loss ratio, or how much of the premium dollar is spent on patient care, was 81.2% in the second quarter, according to new financial results — better than analysts expected.
  • Healthcare Dive also reports
    • “Telehealth company Amwell lowered its 2023 revenue outlook after missing analyst expectations and racking up another non-cash goodwill impairment charge in the second quarter.
    • “The company now expects to bring in revenue between $257 million and $263 million for the year, compared with earlier guidance of $275 million to $285 million, Amwell said in second-quarter results released Wednesday. 
    • “Amwell’s revenue declined 3% year over year to $62.4 million in the quarter. The telehealth vendor posted a net loss of $93.5 million, which included a $27.3 million goodwill impairment charge to make up for the “sustained decrease” in Amwell’s stock and market capitalization, according to an SEC filing.”
  • Fierce Healthcare lets us know
    • “UnitedHealthcare tapped 66 not-for-profit organizations spread over 12 states to receive grant funding to help expand access to care.
    • “The $11.1 million in grant funding, which falls under UnitedHealthcare’s Empowering Health program, aims to help improve the healthcare options of individuals living in underserved communities by addressing the social determinants of health, the insurance giant said. Specifically, it’ll target food insecurity, social isolation, behavioral health issues and health literacy efforts.
    • “Some of the organizations to receive funds include the Upstate Foundation in Syracuse, New York, CHRIS 180 in Atlanta and Trellis in Minneapolis and Saint Paul.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, COVID-19, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, OPM, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The Department of Labor announced
  • STAT News adds,
    • “The new rule would force insurers to evaluate their own networks to measure not just whether they’re offering adequate mental health and addiction coverage but also whether patients are truly accessing it.
    • “This rule will ensure that we have true parity,” Neera Tanden, President Biden’s domestic policy advisor, said during a press call. “It will help ensure we finally fulfill the promise of mental health parity required under the law, to ensure that mental health is covered just like physical health.”
  • The public comment deadline will occur in late September.
  • The FEHBlog notes that health plans cannot coerce providers into their networks. The FEHBlog thought that hub and spoke tele-mental health networks would fill the gap, but that apparently hasn’t happened.
  • AHIP announced
    • “AHIP, the American Medical Association (AMA), and the National Association of ACOs (NAACOS) today announced the release of data-sharing best practices that organizations may voluntarily adopt to support a sustainable future for value-based care. The playbook, The Future of Sustainable Value-Based Care and Payment: Voluntary Best Practices to Advance Data Sharing, is intended to advance the adoption of value-based care arrangements in the private sector that could have a greater impact on the quality and equity of care and ease participation by fostering voluntary alignment of data sharing practices.”
    • Check it out.
  • The National Coordinator for Health Information Technology released on July 20, 2023,
    • “ONC Standards Bulletin 2023-2 (SB23-2) [which] describes the background of United States Core Data for Interoperability (USCDI) and the development of the USCDI Version 4 (USCDI v4) * * *. USCDI is a standard developed and adopted by ONC on behalf of the U.S. Department of Health and Human Services (HHS) that sets the technical and policy foundation for the access, exchange, and use of electronic health information to support nationwide, interoperable health information exchange. USCDI benefits a wide range of entities, individuals, and other interested parties, including federal agencies supporting health and healthcare, hospitals, research organizations, clinicians, and health IT developers. ONC publishes new versions of USCDI annually, with a draft version in January and a final version in July. This publishing cadence keeps pace with medical, technological, and policy changes. USCDI v4 includes new data elements that advance the Biden-Harris Administration’s priorities of advancing equity, diversity, and access across all healthcare settings.
    • “SB23-2 describes the ONC approach for the continued expansion of USCDI, as well as the specific priorities for adding new data elements to USCDI v4. This bulletin also includes discussion of the feedback received on the Draft USCDI v4, including recommendations received from the ONC Health IT Advisory Committee (HITAC).”
  • The U.S. Preventive Services Task Force gave a draft inconclusive grade for “screening for speech and language delay and disorders in children age 5 years or younger.” The USPSTF previously gave the same grade to the screening service in 2015. The public comment deadline is August 21, 2023.
  • FedSmith notes that the OPM final rule expanding FEDVIP eligibility will add “over 70,000 federal employees and 118,000 Postal employees” to the pool of employees eligible for FEDVIP.

From the public health front —

  • U.S. News reports
    • “Both coronavirus emergency department visits and test positivity increased, according to CDC data. The agency no longer tracks COVID-19 cases. Instead, it focuses on hospitalizations and deaths, which don’t yet show an increase.
    • “The CDC reported last week that it was the first time since January that COVID-19 metrics showed an increase. The uptick is small, but it’s a notable reversal after months of declining coronavirus numbers.
    • “Certain COVID-19 indicators continued their recent rise last week, according to data from the Centers for Disease Control and Prevention.”
  • HHS’s Agency for Healthcare Research and Quality issued a roundtable report about “Optimizing Health and Function as We Age.”
  • Yahoo News tells us,
    • “Drugmaker Pfizer Inc said over 30 drugs, including injections of painkiller fentanyl and anesthetic lidocaine, may see supply disruption after a tornado destroyed a warehouse at its Rocky Mount, North Carolina, plant last week.
    • “The company sent a letter late last week to its hospital customers saying it had identified around 64 different formulations or dosages of those more than 30 drugs produced at the plant that may experience continued or new supply disruptions.
    • “The company has placed limits on how much supply of those drugs its customers can buy.”
  • Medscape shares CDC guidance about the two new RSV vaccines for adult that the FDA and CDC recently approved.
    • “Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinician, say authors of a Centers for Disease Control and Prevention report published Friday.
    • “Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.“

From the U.S. healthcare business front,

  • BioPharma Dive informs us,
    • “Biogen on Tuesday said it will eliminate 1,000 jobs as part of a cost-cutting drive that it expects will save $1 billion in annual operating expenses by 2025.
    • “The company plans to invest $300 million of those savings into product launches as well as research and development, which it has spent the first half of this year reorganizing under new CEO Chris Viehbacher.
    • “There’s been a complete redesign of Biogen,” Viehbacher said on a conference call with analysts. “This is an opportunity to make sure that in this year, before we get into [new] product launches, that we are truly fit for growth.”
  • STAT News lets us know that “As Alzheimer’s drugs hit the market, the race for early detection blood tests heats up” and offers an interview with the American Medical Association’s new president Dr. Jesse Ehrenfeld.
  • Fierce Health relates,
    • “Teladoc’s second-quarter revenue jumped 10% to $652 million, boosted by strong growth in its BetterHelp direct-to-consumer mental health segment.
    • “The telehealth giant also narrowed its losses this past quarter to a net loss of $65 million, or a loss of 40 cents per share, compared to a loss of $3 billion for the second quarter of 2022. Both results beat Wall Street estimates.
    • “The Zacks Consensus Estimate for Teladoc’s second-quarter earnings per share was pegged at a loss of 44 cents and revenue of $649 million.”

In low-value care news, the National Institutes of Health tells us, “A device known as a pessary, thought promising for reducing preterm birth risk due to a short cervix, appears no more effective than usual medical care, according to a study funded by the National Institutes of Health. A pessary is a rounded silicone device that fits around a cervix that has shortened, to keep it from opening and leading to miscarriage or preterm birth. The device is typically removed before the 37th week of pregnancy.”

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, FDA, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front —

  • Health Affairs launched a new publication called Health Affairs Scholar. Health Affairs also made available its lead article in the new publication titled “Ten Health Policy Challenges for the Next Ten Years.”
  • MedPage Today reports
    • “An increase in pediatric type 2 diabetes cases that began during school closures amid the COVID-19 pandemic has not returned to baseline, according to a retrospective study.
    • “Compared with the year before COVID emerged, the number of new pediatric type 2 diabetes cases ballooned during the first year of the pandemic (March 2020 through February 2021; P=0.005), and then jumped again during the second year (March 2021 through February 2022; P=0.0006), reported Esther Bell-Sambataro, MD, of Nationwide Children’s Hospital and the Ohio State University in Columbus, during ENDO 2023opens in a new tab or window, the annual meeting of the Endocrine Society.”
  • The Food and Drug Administration adds
    • “Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. These approvals provide a new class of medicines taken by mouth to treat pediatric type 2 diabetes. Metformin, the only other oral therapy available for the treatment of children with type 2 diabetes, was first approved for pediatric use in 2000.
    • “Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, M.D., M.P.H., associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”
  • Also from the FDA
    • “Today, the U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients. 
    • “We believe this guidance and the launch of the pilot program are important steps towards addressing safety risks posed by the use of poorly performing laboratory-developed tests,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments.”
  • The National Institutes of Health informs us
    • “A recent follow-up analysis of data from an international, National Institutes of Health-funded clinical trial suggests daily low-dose aspirin increases the risk of anemia in people age 65 years and older by approximately 20%. Given these findings, older adults on low-dose aspirin and their care providers may want to consider periodic monitoring of red blood cells or hemoglobin. Anemia in older adults is associated with functional decline, increased fatigue, disabilities, depressive symptoms, and cognition problems.
    • “Published in the Annals of Internal Medicine, scientists from the Aspirin in Reducing Events in the Elderly (ASPREE) study examined the effect of long-term low-dose aspirin use on incident anemia and the effect of aspirin on changes in hemoglobin concentration, as well as ferritin levels, as an indicator of iron deficiency. The researchers found that low-dose aspirin led to increased incident anemia in otherwise healthy older adults at enrollment, independent of major bleeding.”
  • The U.S. Preventive Services Task Force released a new recommendation — “Adults 64 years or younger, including pregnant and postpartum persons: Screen for anxiety. Grade: B” — and reissued a 2014 recommendation — “Adults, including pregnant and postpartum persons, and older adults (65 years or older): Screen for major depressive disorder (MDD). Grade: B.”
  • ICD10 Monitor alerts us
    • “The Centers for Disease Control and Prevention (CDC) released the ICD-10-CM codes for the 2024 fiscal year (FY) on Friday, June 16. This release included 395 additions, 25 deletions, and 13 revisions. The deletions are due to the expansion of the diagnosis codes. The total ICD-10-CM codes for FY 2024 is 74,044. These codes will be effective starting with Oct. 1, 2023, visits or discharges.”

From the federal employment front —

  • FedWeek tells us
    • “A hearing set for this week on three high-profile work backlogs likely will add to the pressure from House Republicans for agencies to reduce their levels of telework.
    • “The hearing in the House federal workforce subcommittee will “examine the backlogs of military and civil service personnel records requests, the Social Security Administration’s customer service line and disability claims, and passport backlogs. This hearing will also examine what steps agencies are taking to clear backlogs and provide timely service and support to the American people,” according to the panel.”
  • Govexec reports
    • “An advisory council dedicated to examining issues related to federal employee compensation issued no new recommendations for changes to the map of locality pay areas in a newly released report, instead urging quick implementation of proposals that already received a green light from the president’s pay agent.
    • “In a report dated Feb. 4 but only published by the Office of Personnel Management this month, the Federal Salary Council said none of the regions currently being studied by the Bureau of Labor Statistics regarding the pay disparity between federal workers and private sector employees currently meet the criteria to become locality pay areas.
    • “Instead, the council, which is made up of a mix of presidentially appointed federal human resources experts and representatives of unions and other federal employee organizations, focused its report on reiterating a series of recommendations approved last December by the president’s pay agent, a body made up of OPM Director Kiran Ahuja, Office of Management and Budget Director Shalanda Young and then-Labor Secretary Marty Walsh. But in order for those recommendations to be implemented, OPM must first issue regulations.
    • “In terms of discreet additions to the map of locality pay areas, the salary council urged swift action to implement the new locality pay areas of Fresno, Calif.; Reno, Nev.; and Spokane, Wash. Additionally, Dukes and Nantucket counties, Mass., would join the Boston locality pay area; Huron County, Mich., will join the Detroit locality pay area; and Pacific and San Juan counties, Wash., would be included in the Seattle locality pay area. And Greensville County and the city of Emporia in Virginia would both become part of the Richmond locality pay area.”
  • and
    • “The U.S. Postal Service is preparing layoff notices that could take effect in September, notifying staff earlier this month of the potential for workforce reductions. 
    • “USPS is allowing impacted workers to apply for lateral or downgraded positions, anticipating it can absorb the employees elsewhere. The changes will affect non-union staff in the logistics division serving in management positions. James Lloyd, a USPS director for labor relations policies and programs, said the reductions were developed “based on an evaluation of staffing criteria and manager levels” by headquarters personnel.”

From the U.S. healthcare business front —

  • HHS’s Agency for Healthcare Quality and Research released its annual update to the Compendium of U.S. Health Systems.
    • “The Compendium of U.S. Health Systems includes information on U.S. health systems, defined in this analysis to include at least one hospital and at least one group of physicians providing comprehensive care, and who are connected with each other and with the hospital through common ownership or joint management. The Compendium is updated on a regular basis, with the newest files released in June 2023:
    • “2021 Compendium (New)
    • “2020 Compendium (New)
    • “2018 Compendium“
  • Beckers Hospital Review ranks 35 health systems by revenue.
  • BioPharma Dive reports
    • “Eli Lilly has agreed to buy Dice Therapeutics for about $2.4 billion in a deal that gives the pharmaceutical giant a promising oral autoimmune disease drug in clinical testing.”
    • “Lilly will buy Dice, a young biotechnology company that went public in 2021, for $48 per share in cash, the companies announced Tuesday. The purchase price equates to a roughly 42% premium to Dice shares’ closing price Friday and about 40% above the average trading price over the last month.
    • “The deal is expected to close in the third quarter, pending regulatory clearance and the tender of a majority of Dice’s outstanding stock.”

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, Congress, COVID-19, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC, the House Rules Committee held a four-hour hearing on the debt ceiling compromise bill (HR 3746) this afternoon. The Wall Street Journal adds

“House Republican leaders projected confidence Tuesday that the debt-ceiling deal struck with President Biden would draw enough support to pass, while some conservative lawmakers angrily denounced the agreement.

“The bill advanced (7-6 vote) past a closely watched procedural hurdle in the Rules Committee late Tuesday, and a final House vote is expected as soon as Wednesday night. While the bill appears on track to gain sufficient Republican and Democratic votes to pass the House and then the Senate by the June 5 deadline, it could still run into procedural obstacles, complicating the race to avoid an unprecedented default.”

From the public health front —

  • The University of Minnesota informs us
    • “[As of last Friday] the two main metrics that the Centers for Disease Control and Prevention (CDC) uses to track US COVID-19 activity—hospitalizations and deaths—continue to decline, according to the latest data. Hospitalizations for COVID are down 11% compared to a week ago, and deaths from the virus are down 13.3%.
    • “The hospitalization map, which reflects activity by county, replaces the CDC’s earlier community levels, and there are currently only a few hot spots, some in Texas and in small portions of Nebraska and Louisiana.
    • “Early indicators—regional test positivity and emergency department (ED) visits—also show no signs of increase. Test positivity at the national level is 4.3%, down 0.7% from a week ago. The only region showing a slight increase is the part of the Southwest that includes California, Nevada, and Arizona. Only 0.5% of ED visits last week were due to COVID, down 10.8% from the previous week. There are no major rises in COVID positivity in wastewater surveillance.”
  • HHS’s Agency for Healthcare Quality and Research issued a report on “Treated Prevalence of Commonly Reported Health Conditions, 2016 to 2020.”
  • PBS informs us,
    • “The United States grew older, faster, last decade.
    • “The share of residents 65 or older grew by more than a third from 2010 to 2020 and at the fastest rate of any decade in 130 years, while the share of children declined, according to new figures from the most recent census.
    • “The declining percentage of children under age 5 was particularly noteworthy in the figures from the 2020 headcount released Thursday. Combined, the trends mean the median age in the U.S. jumped from 37.2 to 38.8 over the decade.
    • “America’s two largest age groups propelled the changes: more baby boomers turning 65 or older and millennials who became adults or pushed further into their 20s and early 30s. Also, fewer children were born between 2010 and 2020, according to numbers from the once-a-decade head count of every U.S. resident. The decline stems from women delaying having babies until later in life, in many cases to focus on education and careers, according to experts, who noted that birth rates never recovered following the Great Recession of 2007-2009.”

From the Rx coverage front —

  • Fierce Healthcare updates us on the soaring employee demand for anti-obesity drugs.
  • Also, Fierce Healthcare relates,
    • “Optum Rx is rolling out new programs aimed at supporting independent and rural pharmacies in closing care gaps beginning in June.
    • “The pharmacy benefit manager said Tuesday that the new initiatives will focus on three key areas: helping patients in underserved areas connect to community resources, improving maternal and fetal health by boosting access to key supplies and deploying community pharmacies to address healthcare deserts.
    • :The new initiatives kick off what Optum said is a “broader, industry-leading commitment to bridge resource gaps in the community.”
    • “These initiatives provide opportunities not only to help patients but also to offer appropriate compensation that recognizes the clinical expertise and unique capabilities our community and independent pharmacy partners have to meet the needs of their patients,” said Heather Cianfrocco, CEO of Optum Rx, in the release.”

From the medical and prescription drug research front

  • The NIH Director’s blog tells us,
    • “Biomedical breakthroughs most often involve slow and steady research in studies involving large numbers of people. But sometimes careful study of even just one truly remarkable person can lead the way to fascinating discoveries with far-reaching implications.
    • “An NIH-funded case study published recently in the journal Nature Medicine falls into this far-reaching category [1]. The report highlights the world’s second person known to have an extreme resilience to a rare genetic form of early-onset Alzheimer’s disease. These latest findings in a single man follow a 2019 report of a woman with similar resilience to developing symptoms of Alzheimer’s despite having the same strong genetic predisposition for the disease [2].
    • “The new findings raise important new ideas about the series of steps that may lead to Alzheimer’s and its dementia. They’re also pointing the way to key parts of the brain for cognitive resilience—and potentially new treatment targets—that may one day help to delay or even stop the progression of Alzheimer’s.”
  • BioPharma Dive reports
    • “An experimental hemophilia drug developed by Pfizer significantly reduced bleeding frequency compared to on-demand or preventive clotting factor proteins, the drugmaker said Tuesday. Called marstacimab, the drug was not associated with the kind of dangerous blood clotting that has delayed or sidelined similarly acting drugs from Novo Nordisk and Bayer.
    • “If approved, marstacimab would compete with established medicines like Roche’s Hemlibra as well as newer treatments like CSL Behring’s gene therapy Hemgenix and Sanofi’s long-acting drug Altuviiio. These therapies offer options for patients beyond regular infusions of engineered clotting factor proteins.
    • “Marstacimab requires a weekly subcutaneous shot, while Hemlibra can be administered subcutaneously as infrequently as once every four weeks after an initial dosing phase. Gene therapies like Hemgenix, or another from BioMarin Pharmaceutical that’s now under review, are intended to be a one-and-done treatment, although their long-term durability has not been proven.”

From the U.S. healthcare business front

  • Per Healthcare Dive
    • “Nonprofit hospital operator Ascension Healthcare reported a loss from operations of $1.8 billion on revenue of $21.3 billion for the nine months ending March 31, as it struggled with higher operating costs and sustained revenue challenges driven by continued impacts of the COVID-19 pandemic and inflationary pressures.
    • “An improvement in total surgical volumes, especially outpatient surgeries and emergency room visits, didn’t outpace growing expenses for Ascension, which increased by $804 million year over year in the nine-month period.”
  • Per Fierce Healthcare
    • “Advocate Health, the newly formed marriage of major nonprofits Advocate Aurora Health and Atrium Health, reported a $10.4 million operating income (0.1% operating margin) and $578.7 million net gain in its first-ever Q1 earnings report, released Tuesday.
    • “The 67-hospital entity tallied more than $7.54 billion in total revenue during the three months ended March 1 thanks to year-over-year increases across each of its major divisions—Advocate Aurora Health, Atrium Health’s Charlotte-Mecklenburg Hospital Authority and Atrium Health Wake Forest Baptist.”

From the litigation front, STAT News reports, “A federal appeals court ruled Tuesday Purdue Pharma can shield its owners — members of the wealthy Sackler family — from thousands of lawsuits over the role the company played in the opioid crisis in exchange for a contribution of up to $6 billion to a proposed bankruptcy settlement. * * * The U.S. Court of Appeals for Second Circuit, though, ruled a U.S. bankruptcy court was correct in approving the immunity and, moreover, that it was “equitable and appropriate under the specific factual circumstances of this case.” The decision reverses a ruling made last December by a federal judge had sided with the U.S. Trustee. The case now goes back to U.S. bankruptcy court to approve the settlement, although the U.S. Trustee could ask the U.S. Supreme Court to review the appeals court ruling.”