Weekend update

CDC

Weekend update

David Ermer–CDC, Congress, COVID-19 vaccine, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Capitol Hill, the House of Representatives and the Senate will be in session this week for Committee business and floor voting.

From the Omicron and siblings front, Scientific American discusses how often people should receive the Covid vaccine.

  • “The bivalent booster now available in the U.S. came out in September 2022. It was formulated to cover the COVID-causing virus’s Omicron strains BA.4 and BA.5 and the original strains from 2020. After an initial wave of people received the booster in the fall and early winter, the rate of vaccinations has dropped.
  • “A number of fully vaccinated and boosted people would like another booster for additional protection, Schaffner says, but a much larger population has not yet received any booster at all. Only 16.7 percent of the U.S. population(about 55 million people) have had the latest one—far fewer than officials had hoped. “That’s clearly been a source of considerable disappointment to everyone in public health,” Schaffner says. “The current public health thrust is not to give people an additional booster but to get people to take the firstbivalent booster.”
  • “The CDC says it continues to monitor emerging data but maintains its recommendation of one updated COVID vaccine for eligible people aged six months and older. “Too few people, particularly those who are older and at high risk for severe COVID-19, have taken advantage of getting an updated COVID-19 vaccine. And we encourage eligible individuals to speak with their health care provider and consider receiving one,” says CDC representative Kristen Nordlund.”

From the U.S. healthcare business front —

  • Medscape considers whether doctors will start retiring en masse soon.
    • “The double whammy of pandemic burnout and the aging of baby boomer physicians has, indeed, the makings of some scary headlines. A recent surveyby Elsevier Health predicts that up to 75% of healthcare workers will leave the profession by 2025. And a 2020 study conducted by the Association of American Medical Colleges (AAMC) projected a shortfall of up to 139,000 physicians by 2033.
    • “We’ve paid a lot of attention to physician retirement,” says Michael Dill, AAMC’s director of workforce studies. “It’s a significant concern in terms of whether we have an adequate supply of physicians in the US to meet our nation’s medical care needs. Anyone who thinks otherwise is incorrect.”
  • Revcycle Intelligence discusses healthcare mergers and acquisitions that occurred in the first quarter of 2023.
    • “Healthcare merger and acquisition activity generated $12.4 billion in the first quarter of 2023, marking a significant year-over-year increase, according to a Kaufman Hall report.
    • “The M&A Quarterly Activity Report revealed there were 15 transactions in Q1 2023, down only slightly from the post-pandemic high of 17 in Q4 2022. The number of transactions increased compared to Q1 2022, when 12 deals were announced.
    • “The seller or smaller party had an average revenue of $827 million in Q1 2023, falling below the average size of $852 million in Q4 2022. One mega-merger was announced in Q1 2023—a transaction where the smaller party has an annual revenue exceeding $1 billion. This year’s mega-merger was between New Mexico-based Presbyterian Health Services and Iowa-based UnityPoint Health.”

From the fraud, waste, and abuse front, Fierce Healthcare reports

  • “Eighteen people, some of them practicing medical doctors, were criminally charged with participating in healthcare fraud schemes that exploited the COVID-19 pandemic and allegedly raked in $490 million.
  • “The schemes resulted from false billings to federal programs and theft from federally funded pandemic programs, according to the Department of Justice in a news release.
  • “In the widespread fraud takedown, federal authorities also targeted suppliers of COVID-19 over-the-counter tests who exploited federal partners by shipping tests to patients who did not want or need them. And the feds went after individuals who filed fraudulent claims to the Provider Relief Fund (PRF) and the manufacturers and distributors of fake COVID-19 vaccination record cards.
  • T”wo of the most significant criminal cases in this latest sweep were filed by federal prosecutors in the Central District of California.
  • “Dr. Anthony Hao Dinh allegedly bilked the federal government out of $150 million and he used these fraud proceeds for high-risk options trading, losing over $100 million, according to the Justice Department in an announcement on April 20.

From the healthy living front

  • The Wall Street Journal tells us,
    • “An ounce of prevention may be worth a pound of cure, but medical schools have traditionally given little weight to instruction on how to help patients live healthier lives.
    • “The future could look different as schools and residency training programs have begun to embrace a field known as lifestyle medicine, weaving teaching on nutrition, exercise and other healthy behaviors into the core curriculum of medical education. This new push aims to provide doctors with tools to tackle chronic but often preventable conditions such as heart disease, stroke and diabetes that affect six in ten adults in the U.S.
    • “Incorporating lifestyle medicine into medical-school curricula can resolve the inadequacies that exist in preparing physicians for the growing challenge of chronic disease,” says Jennifer Trilk, professor of biomedical sciences and director of lifestyle-medicine programs at the University of South Carolina School of Medicine Greenville, which in 2017 became the first medical school in the U.S. to incorporate more than 80 hours of lifestyle-medicine training over four years of undergraduate education.”
  • NPR Shots offers an explanation of “Unraveling a hidden cause of [female] UTIs — plus how to prevent them.
  • Fortune Well explains why “a diet rich in certain foods may help protect against miscarriage, new research says. Here’s what to eat—and avoid—if you’re pregnant or trying to conceive.

Friday Factoids

David Ermer–CDC, Congress, COVID-19, End of the PHE, NE, Federal employment benefits, SCOTUS, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the end of the PHE front, the CDC’s daily Covid tracker continues to point down; flu activity remains low nationally, and OPM released its end of PHE guidance for FEHB carriers yesterday.

From the post-Dobbs front, the Wall Street Journal reports,

  • “The Supreme Court on Friday allowed the widely used abortion pill mifepristone to remain on the market indefinitely, granting emergency requests from the Biden administration and the brand-name manufacturer of the drug.
  • “The high court blocked the effect of a lower-court order that was poised to limit access to the pill, which is used in more than half of U.S. abortions. The Supreme Court’s action wasn’t a decision on the merits of the case; instead, the justices were deciding whether the pill could remain available during a continuing legal challenge brought by antiabortion groups.
  • “The court’s order was unsigned and provided no reasoning, as is typical in emergency actions. But it indicated that FDA-approved access to mifepristone would remain until litigation concludes in the lower courts and the Supreme Court itself has an opportunity to review those decisions—a timeline that likely will take many months.”

From the U.S. healthcare business front —

  • STAT News informs us,
    • Patient volumes are back in a big way, at least for the country’s largest for-profit hospital operator.
    • HCA Healthcare beat Wall Street’s expectations of profitability in the first quarter of 2023, as more people flocked to HCA’s hospitals, surgery centers, and physician clinics. Inpatient admissions, all types of surgeries, and emergency room visits were each up significantly in the first quarter of this year, compared with the same period last year, when the Omicron variant of the coronavirus stymied a lot of patient care.
  • The American Hospital Association adds,
    • Financial reserves play an important role for not-for-profit hospitals and health systems in ensuring that they can continue to serve their communities in the face of challenging operational and financial headwinds, according to a new report prepared for the AHA by Kaufman Hall. The report explains how financial reserves enable struggling not-for-profit hospitals and health systems to make needed investments, borrow at affordable interest rates, cover operating expenses and remain available to their communities as surging labor and supply costs, investment losses and other challenges persist. 

From Capitol Hill, STAT News reports,

  • Amid a scramble to assemble a health care policy package in the Senate, a pair of key senators have significantly changed a proposal to cap insulin costs.
  • The new legislation by Senate Diabetes Caucus co-chairs Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine) would cap insured patients’ insulin costs at $35 per month for at least one insulin of each type and dosage form, and require pharmacy benefit managers to pass through rebates they collect from insulin manufacturers to the insurance plans that employ them.
  • The legislation also includes several provisions related to biosimilar policy. The bill would create a new, expedited pathway for the Food and Drug Administration to consider biosimilars that would be alternatives to biologics without adequate competition and would allow Medicare drug plans to put biosimilars on their formularies as soon as they come on the market.
  • That is a major shift from the version of the bill that the senators released last year, which was structured differently around offering incentives to get drug manufacturers to voluntarily lower the prices of insulin.

Politico discusses a bipartisan bill to shift some Medicare coverage to home.

From the miscellany front, Healthcare Dive offers a potpourri of wrap-up stories on the HIMSS conference that ended yesterday.

    Monday Roundup

    David Ermer–ACA, CDC, CMS, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
    Photo by Sven Read on Unsplash

    The HIMSS conference is being held this week in Chicago. The HIMSS organization is providing the publich with morning and afternoon session updates.

    From the regulatory front, the Department of Health and Human Services released the final 2024 Notice of Benefit and Payment Parameters which is applicable to qualified health plans in the marketplaces.

    From the US healthcare business front

    • Healthcare Dive reports
      • Hospital and health system merger and acquisition activity remained consistent in the first quarter of 2023 with 15 healthcare industry transactions, a slight drop from 17 in the fourth quarter of 2022, according to a new report from hospital consultancy Kaufman Hall. The 15 transactions comprised $12.4 billion in total transacted revenue, down from the high of $12.7 billion in 2018.
      • Mergers and acquisitions are trending toward cross-regional partnerships, and the size of the smaller party in mergers is increasing to between $250 million and $750 million in annual revenue, according to the report.
      • Realignment of for-profit health system portfolios continued in the first quarter of 2023, particularly for high financial and operational performing health systems.
    • AHIP issued a report finding that hospital markups on specialty drugs cost patients thousands of dollars.
    • Beckers Hospital CFO Reports identifies 22 US hospitals that are cutting care.
    • Beckers Payer Issues informs us that
      • UnitedHealthcare’s plans to implement a gold-card program in 2024 might cut another 10 percent of its prior authorization volumes on top of a 20 percent reduction that will roll out this summer, UnitedHealthcare CEO Brian Thompson said during UnitedHealth Group’s April 14 earnings call, which was transcribed by Seeking Alpha.
      • The payer plans to implement the national gold-card program in early 2024 for care provider groups that meet eligibility requirements, according to a March 29 company news release. The gold-card status applies for most UnitedHealthcare members across commercial, Medicare Advantage and Medicaid. 
      • Qualifying care provider groups “will follow a simple notification process for most procedure codes rather than the prior authorization process,” according to the release. 

    From the public health front, Medpage Today reports

    • Chronic pain continued to affect more than one in five U.S. adults, new CDC survey data showed.
    • During 2021, an estimated 51.6 million adults (20.9%) had chronic pain lasting 3 months or longer, and 17.1 million (6.9%) had high-impact chronic pain — pain severe enough to restrict daily activities — reported S. Michaela Rikard, PhD, of the CDC’s National Center for Injury Prevention and Control, and co-authors.
    • Pain prevalence was higher in adults who were American Indian or Alaska Native, who identified as bisexual, or who were divorced or separated, the researchers said in Morbidity and Mortality Weekly Report.

    From the Rx coverage front, the Institute for Clincical and Economic Research released a Final Evidence Report on Lecanemab for Alzheimer’s Disease.

    • — Independent appraisal committee voted that currently available evidence is not adequate to demonstrate a net health benefit for lecanemab when compared to supportive care —
    • — Using best estimates from current data, ICER analyses suggest lecanemab would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year —
    • — Manufacturers should release all patient-level data to help patients, clinicians, researchers, and regulators understand more about the link between amyloid reduction and cognitive outcomes

    Lecanemab is an FDA approved drug that the CDC is considering for Medicare coverage beyond clinical testing. The VA has agreed to cover FDA marketing label uses for the drug in its patient population which overlaps with FEHBP.

    From the medical research front, a National Institutes of Health study outlines “opportunities to achieve President Biden’s Cancer Moonshot goal of reducing cancer death rates in the United States. Accelerated progress is needed to achieve Cancer Moonshot goal of cutting the age-adjusted cancer death rate by at least 50% over 25 years, NIH study says.”

    • The study was conducted by researchers in NCI’s Division of Cancer Epidemiology and Genetics, the Center for Cancer Research, and their collaborators, using data from NCI’s Surveillance, Epidemiology, and End Results (SEER) Program and the Centers for Disease Control and Prevention’s National Center for Health Statistics. The researchers examined trends in age-standardized cancer incidence, survival, and mortality rates from 2000 to 2019 for all cancers combined, as well as for the six cancers that together account for 57% of cancer deaths: lung, colorectal, pancreatic, breast, prostate, and liver. They then projected the overall cancer death rate in 2047 based on the assumption that current trends would continue.
    • According to their analysis, because of decreasing cancer incidence and improvements in survival, age-adjusted death rates from all cancers combined declined by 1.4% per year from 2000 to 2015 and by 2.3% per year from 2016 to 2019. These declines reflect substantial reductions in deaths from lung cancer (-4.7% per year during 2014–2019), as well as colorectal cancer (-2.0% per year during 2010–2019) and breast cancer (-1.2% per year during 2013–2019).
    • Trends in prostate, pancreatic, and liver cancer death rates have been less promising. Death rates from prostate cancer had declined strongly (-3.4% per year during 2000–2013), but the decline has slowed (to -0.6% per year during 2013–2019). Death rates from pancreatic cancer have been increasing (0.2% per year during 2006–2019). Death rates from liver cancer, which had been increasing for decades, recently began to decline (-0.5% per year during 2016–2019). Death rates from all other cancer types combined have declined (-1.7% per year during 2016–2019).

    Late Week Miscellany

    David Ermer–ACA, CDC, COVID-19, FDA, No Surprises Act, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    Dear FEHBlog readers — The FEHBlog wrote a quick blog post for Thursday but overlooked hitting the publish button, so here are the two items from Thursday and the remainder from Friday.

    Wednesday afternoon, the Affordable Care Act regulators issued ACA FAQ 59 about the Braidwood Management decision. The FAQs expressly endorsed OPM’s informal administration action last Friday using FEHB Act Section 8902(d) to endorse the U.S. Preventive Services Task Force recommendations that the decision rejected because they had no federal government endorsement. The FEHBlog wonders why HHS hasn’t pulled this page out of OPM’s playbook.

    Wednesday night, the U.S. Court of Appeals for the Fifth Circuit (2-1 decision) stayed a portion of the abortion pill injunction on statute of limitations grounds in a 42-page opinion. The Fifth Circuit opinion allows the abortion pill to stay on the market with reinstated in-person medical visit prerequisites and without delivery by mail. The Attorney General has stated that he will ask the Supreme Court to weigh in. Axios reports that the Supreme Court would decide quickly.

    Axios was correct because the Wall Street Journal reported that today

    • The Supreme Court temporarily blocked lower court orders that would have limited access to the abortion drug mifepristone beginning Saturday, preserving the pill’s availability while the justices weigh the Biden administration’s emergency request to leave current Food and Drug Administration approvals in place during a continuing legal battle with antiabortion groups.
    • In a pair of orders Friday, Justice Samuel Alito, who oversees emergency matters for the lower courts that limited or suspended approval of the widely used abortion pill, gave the antiabortion groups until noon Tuesday to file briefs in response to appeals by the FDA and Danco Laboratories LLC, which makes the branded version Mifeprex.
    • The temporary orders expire at 11:59 p.m. Wednesday, suggesting a high court decision on whether and to what extent mifepristone will remain available during litigation may come by then.

    In other judicial news, the American Hospital Association informs us

    • The U.S. Supreme Court today unanimously reversed a 9th Circuit decision that impliedly stripped federal district courts of jurisdiction over constitutional challenges to the Federal Trade Commission structure, procedures and existence. Ruling in the FTC case and another case involving the Securities and Exchange Commission, the Supreme Court said, “The statutory review schemes set out in the Securities Exchange Act and Federal Trade Commission Act do not displace a district court’s federal-question jurisdiction over claims challenging as unconstitutional the structure or existence of the SEC or FTC.”
    • As a result of this decision, parties may bring claims in federal court alleging that “the structure, or even existence, of an agency violates the Constitution” without having to first go through costly and time-consuming administrative proceedings before the SEC or FTC.

    Turning now to the federal employment front –

    • Govexec tells us
      • Office of Management and Budget guidance released Thursday tasks agencies with developing a new system to monitor their “organizational health and organizational performance” on an ongoing basis. With the new system comes an expectation that federal agencies will rely less on telework and remote work, although that must be balanced with the need to compete for talent with private sector employers who continue to offer similar workplace flexibilities, wrote OMB Deputy Director for Management Jason Miller in a blog post accompanying the memo.
    • Federal News Network reports OPM’s implementation of the Postal Service Health Benefits Program.

    From the public health front

    • The Centers for Disease Control begins to bring down the curtain on its now bi-weekly review of its Covid statistics and updates us on the bird flu situation.
    • The Food and Drug Administration announced granting emergency use authorization to an improved Covid test.
    • The Robert Wood Johnson Foundation offers various perspectives on achieving joyful, healthy births for all, a worthy goal.
    • Medscape identifies troubling trends in colorectal cancer data recently released by the American Cancer Society.

    From the regulatory front —

    • Mercer Consulting offers advice on the recent instructions concerning RxDC reporting for the 2022 reference year due June 1.
    • Healthcare Finance tells us
      • The Office of Civil Rights is providing a 90-day transition period for healthcare providers to come into compliance with the HIPAA Rules regarding telehealth, according to the Department of Health and Human Services OCR. 
      • The transition period will be in effect beginning on May 12 and will expire at 11:59 p.m. on August 9.
      • OCR said it would continue to exercise its enforcement discretion and not impose penalties on covered providers for noncompliance during the 90- day transition period. 
      • During the public health emergency, providers did not have to be licensed in the state where the patient was located. They were allowed to treat patients in other states. 
      • Also, under the PHE, non-HIPAA-compliant platforms were allowed as long as they were not public facing.
      • Both of these flexibilities are coming to an end with the PHE on May 11, with providers now getting a 90-day grace period.
      • Other telehealth provisions expire at the end of 2023 and 2024

    From the Rx coverage front —

    • Fierce Healthcare informs us that Cigna’s Express Scripts unveiled two new programs on Thursday, Copay Assurance and ClearCare Rx, which reminds the FEHBlog of OPM’s transparent pharmacy pricing program.
    • The Institute for Clinical and Economic Research (ICER) published an
      • Evidence Report on Treatments for Non-Alcoholic Steatohepatitis [liver inflammation]
        • — Evidence suggests that both resmetirom and obeticholic acid improve liver histology without evidence yet demonstrating improved long-term outcomes; obeticholic acid has more concerning side effects —
        • — Current evidence suggests that resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year, while obeticholic acid would achieve these thresholds if priced between $32,800-$40,700 per year —
        • — At the April 28 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatments’ comparative clinical effectiveness, other potential benefits, and long-term value for money —

    From the U.S. healthcare business front

    • Beckers Payer Issues reports, “UnitedHealth Group posted revenues of $91.9 billion in the first quarter of 2023, up 15 percent from $80.1 billion over the same period last year, according to the company’s earnings report released April 14.”
    • Beckers Hospital Review ranks 29 physician specialties by annual compensation.

    Friday Factoids

    David Ermer–ACA, CDC, COVID-19, FDA, Federal employment benefits, OPM, U.S. Healthcare–
    Photo by Sincerely Media on Unsplash

    Happy 75th World Health Day!

    OPM announced

    Voice of America’s Asian American Changemakers series premiered its final episode recently, featuring the work of the U.S. Office of Personnel Management and the leadership of Director Kiran Ahuja. Asian American Changemakers is a character-driven docuseries highlighting the lives and experiences of Asian Americans in the political and public arena.  * * *

    Watch the full Asian American Changemakers episode here and learn more about opportunities to serve at opm.gov.   

    OPM also informed FEHB carriers that “The recent opinion in Braidwood Management, Inc. v. Becerra, — F. Supp. 3d —, 2023 WL  2703229 (N.D. Tex.), in the U.S. District Court for the Northern District of Texas, pertains to the preventive services requirement under the Affordable Care Act; it does not impact the preventive services requirements for FEHB Carriers.”  Regardless, and as the FEHBlog anticipated, writers in Health Affairs suggest sensible administrative law approaches to repairing the Braidwood management problem. For example, “the HHS Secretary could authorize the director of the Agency for Health Care Research and Quality or the CDC director to review and adopt the Task Force’s recommendations, which the CDC director now does before ACIP’s immunization recommendations become effective.” No wonder HHS appealed Braidwood Management to the Fifth Circuit without requesting a stay of the district court’s decision.

    In other judicial news, the Washington Post reports

    • “A federal judge in Texas blocked U.S. government approval of a key abortion medication Friday, siding with abortion foes in an unprecedented lawsuit and potentially upending nationwide access to the pill widely used to terminate pregnancies.
    • “The highly anticipated ruling puts on hold the Food and Drug Administration’s approval of mifepristone, a medication first cleared for use in the United States in 2000. The ruling will not go into effect for seven days to give the government time to appeal.”

    Later today, per the AP, “A federal judge in Washington state on Friday ordered U.S. authorities not to make any changes that would restrict access to the abortion medication mifepristone in 17 Democratic-led states that sued over the issue, countering a ruling by a judge in Texas on the same day that ordered a hold on federal approval of the drug.”

    From the healthcare of the near future front —

    • Medscape relates
      • “US regulators may soon clear blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening.
      • “Most recently, Guardant Health, Inc., announced the completion of its US premarket approval application for its Shield blood test to screen for CRC. Approval by the US Food and Drug Administration (FDA) would position Guardant to later secure Medicare coverage for its test.
      • “Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.
      • I”f these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.”
    • A Wall Street Journal essay digs into why “doctors are turning to artificial intelligence to help them make the best decisions for patients.

    From the public health front –

    • Fierce Healthcare informs us “Black mothers living in the least vulnerable areas of the U.S. are more likely to die or have worse birth outcomes compared to white mothers living in the most vulnerable areas, a sweeping new study has found.”
    • Fierce Healthcare tells us “Reports of serious patient safety events among healthcare facilities in 2022 rose 19% from 2021 with falls, the most common such event, rising nearly 27%, according to data reported to The Joint Commission and released Tuesday.”

    Monday Roundup

    David Ermer–CDC, COVID-19, FDA, Rx coverage–
      Photo by Sven Read on Unsplash

      From the Omicron and siblings front, Kaiser Family News reports

      More than three years into the COVID-19 pandemic, about half (53%) the public says they would likely get an annual COVID-19 vaccine if offered similar to an annual flu shot, the latest KFF COVID-19 Vaccine Monitor finds. This includes about a third (32%) who would be “very likely” to do so.
      The findings provide a window into the potential uptake of an annual COVID-19 vaccine, which the Food and Drug Administration has raised as a potential option to provide future protection from the virus. 

      * * *

      • Nearly a quarter (23%) of adults say they’ve gotten the latest bivalent COVID-19 booster, which has been available since September. Similar shares say they have received an earlier booster shot (25%) or have gotten their initial course of vaccinations but no booster (25%). That leaves slightly more than a quarter (27%) who say that they are either partially vaccinated or not vaccinated at all.
      • Half (49%) of adults say they’ve heard at least something about the Biden administration’s plan to end the COVID-19 public health emergency on May 11.

      * * *

      Nearly a third (32%) of all adults nationally say they have never tested positive for COVID-19 or never thought they’ve had the virus, and the new survey examines their experiences. This never-had-it group includes nearly half (46%) of adults ages 65 and older, who generally had earlier access to the vaccines due to their high risks.

      In other public health news

      • “The U.S. Department of Health and Human Services (HHS) released a National Cancer Plan, developed by the National Institutes of Health’s (NIH) National Cancer Institute (NCI). The plan provides a framework for everyone—across the federal government and all of society—to collaborate in ending cancer as we know it, and to realize the vision laid out by President Joe Biden and First Lady Jill Biden’s Cancer Moonshot.”
      • Reuters informs us
        • “The U.S. National Institute on Aging (NIA) is funding a 6-year, up to $300 million project to build a massive Alzheimer’s research database that can track the health of Americans for decades and enable researchers to gain new insights on the brain-wasting disease.
        • “The NIA, part of the government’s National Institutes of Health (NIH), aims to build a data platform capable of housing long-term health information on 70% to 90% of the U.S. population, officials told Reuters of the grant, which had not been previously reported.”
      • Bloomberg Prognosis looks back at the perfect storm of serious ailments that afflicted children worldwide last year. The culprit was socially distancing the kids.

      In FDA and drug development news

      • BioPharma Dive points out five FDA drug decisions to watch for in this quarter. “By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy, two vaccines for RSV and a closely watched ALS drug.”
      • “The U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.”
      • The Wall Street Journal offers a fascinating look at how Lilly reengineered its drug development business. The article explained that in the last decade, Lilly focused on non-interference with the patent status of existing blockbuster drugs, e.g., squeezing the last egg out of the golden goose. Late last decade, Lilly redirected its focus to bringing new drugs to market regardless of patent concerns. As a result, Lilly is close to receiving FDA market approval for the “King Kong” of obesity drugs Mounjaro.

      People who are overweight are flocking to the drug Ozempic to slim down. Looming is an even more powerful weight-loss treatment.

      The drug Mounjaro helped a typical person with obesity who weighed 230 pounds lose up to 50 pounds during a test period of nearly 17 months. 

      No anti-obesity drug has ever safely made such a difference. In the coming months, it is widely expected to get the go-ahead from U.S. health regulators to be prescribed for losing weight and keeping it off, and some patients are already using it unapproved for that purpose.

      The advance of Mounjaro, which is already on the market to treat Type 2 diabetes, has excited doctors and patients who have been waiting decades for effective treatments, while helping turn its maker, Eli Lilly & Co., into the most valuable standalone pharmaceutical company in the U.S. with a market value of more than $300 billion.

      Friday Factoids

      David Ermer–ACA, CDC, CMS, Congress, COVID-19, Medicare, OPM, Rx coverage, SDOH, U.S. Healthcare–
      Photo by Sincerely Media on Unsplash

      The various Covid-19 pandemic-related mandates are tied to the end of the public health emergency and the end of the national emergency. The Administration has told us to expect the end of both emergencies on May 11.

      The CDC’s Covid data tracker and weekly review support ending the emergencies.

      Congress has passed a bill (House Joint Resolution 7) which the President has agreed to sign ending the national emergency upon signing. Mercer Consulting explains:

      During the NE, group health plans have been required to extend certain participant deadlines that would have expired during the “Outbreak Period,” which began March 1, 2020, and will end 60 days after the end of the NE. These deadlines related to:

      • Special enrollment rights under HIPAA
      • COBRA elections, payments and notifications
      • Benefit claims, appeals and external reviews

      Employers will have less time to prepare for the end of the Outbreak Period relief if, as the pending legislation would require, the NE ends before May 11, 2023. Other COVID-19 relief measures, described in this post, are tied to the PHE and are not impacted by the pending legislation.

      This week, regulators provided FAQs and a blog to assist employers preparing for the NE and PHE to end. The FAQs provide many helpful examples illustrating how the extended deadlines available during the Outbreak Period will wind down. However, the FAQs assume that the NE will end on May 11 and the Outbreak Period 60 days later, on July 10. Assuming President Biden signs the legislation ending the NE earlier than May 11, the dates in the FAQs will need to be adjusted.

      Any deadline adjustments for these three mandates impact employers directly and group health plans indirectly. The three mandates had have had limited FEHBP impact.

      Following up on Thursday’s post, MedPage Today offers a broader perspective on Thursday’s Senate Finance Committee PBM hearing. The hearing’s theme was “transparency.” For over ten years, OPM has required FEHB carriers covering most enrollees to use a strict drug pricing transparency system. This has allowed the FEHB to avoid certain practices criticized at the hearing, such a spread pricing, and it facilitates OPM Inspector General audits of the PBMs. However, it takes Congress to address the key economic concern about rebates inflating drug prices discussed at the hearing:

      Karen Van Nuys, PhD, of the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California in Los Angeles, highlighted her 2021 JAMA Internal Medicine research letter that found that Medicare would have saved $2.6 billion in 2018 on 184 drugs if patients had purchased them without insurance at Costco.

      CMS finalized its Medicare Advantage and Medicare Part D payment policies for 2024 today. Of note, Fierce Healthcare reports,

      The Biden administration finalized a proposal to raise Medicare Advantage payments by 3.32% in 2024, slightly above the 1% raise that it proposed. 

      The final payment rule released Friday comes after an intense lobbying campaign from insurers who claimed that the original advance notice released in February would amount to a cut to plans. The agency also finalized changes to the MA risk adjustment model, but will instead phase the changes in over three years as opposed to implementation next year.

      CMS also offered a fact sheet on the final actions.

      From the SDOH front, Health Payer Intelligence informs us

      OMB’s 1997 Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity (Directive No. 15). The directive regulates consistency in federal data-sharing and the 1997 iteration emphasized that data gathering practices should seek to mirror the nation’s diversity.

      OMB’s directive requires that data collection include two category options for ethnicity (Hispanic or Latino and Not Hispanic or Latino) and five for race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, and white). In contrast, the Centers for Disease Control and Prevention (CDC) includes over 900 categories for these two designations.

      The directive does not include any requirement to indicate sexual orientation and gender identity (SOGI) data. Very few regulations or standardizing entities do.

      OMB will release changes to Directive No. 15 in 2024.

      Several associations, including AHIP and BCBSA, have commented on the importance of OMB including changes to Directive No. 15 that facilitate health insurer efforts to reduce social determinants of health-related health disparities.

      From the miscellany department —

      • EBRI posted Fast Facts on “High-Cost Health Care Claimants: Health Care Spending and Chronic Condition Prevalence Among Top Spenders.”

      Midweek Update

      David Ermer–CDC, Congress, COVID-19, FDA, OPM, Rx coverage, SDOH, U.S. Healthcare–

      From Washington, DC —

      Roll Call reports on the state of the debt ceiling negotiations and Senator Bernie Sanders’s encounter today with the Moderna CEO Stéphane Bancel at a Senate hearing that Senate Sanders chaired. The FEHBlog can’t understand why Senator Sanders and his majority colleagues are flipping their lids over a $100 price per vial increase on a low-cost vaccine.

      Fierce Healthcare tells us,

      The Medicare Payment Advisory Commission’s recent breakdown of the hospital sector’s financial viability largely struck a different tone from the doom and gloom industry groups have voiced as of late.

      The independent commission advises Congress on year-to-year Medicare policy adjustments, which are largely based on data from 2020 and 2021, preliminary data for 2022 and trend projections for upcoming years. It released its annual report to Congress last week.

      With the exception of additional support for safety-net providers—which industry group America’s Essential Hospitals (AEH) has already criticizedfor “overlooking” uncompensated care delivered to non-Medicare patients—the group largely told Congress that most hospitals will manage their finances and recommended that lawmakers stay the course with 2024’s inpatient prospective payment system (IPPS) and outpatient prospective payment system (OPPS) rules.

      “The Commission anticipates that a 2024 update to hospital payment rates of current law plus 1% would generally be adequate to maintain FFS beneficiaries’ access to hospital inpatient and outpatient care and keep IPPS and OPPS payment rates close to the cost of delivering high-quality care efficiently,” the group wrote in its report (PDF).

      This decision must have the American Hospital Association flipping its lid.

      The Department of Health and Human Services announced an organ procurement and transplantation network modernization initiative that “includes the release of new organ donor and transplant data; prioritization of modernization of the OPTN IT system; and call for Congress to make specific reforms in the National Organ Transplant Act.” More background on his announcement is available at Roll Call.

      From the Rx coverage front

      STAT News reports

      An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients.

      By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 3-5 vote (with one abstention) the same experts concluded that the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval.

      The FDA is not required to follow the recommendation of its outside advisors, but often does. The mixed votes suggest the FDA will likely grant Biogen accelerated approval for tofersen based on preliminary evidence. This would allow the company to market the drug while it collects additional data to confirm its benefit.

      Benefits Pro offers guidance on employer-sponsored health plan coverage of the new weight loss drugs, Mounjaro, Saxenda, and Wegovy. OPM has already decided that FEHB carriers will oprovidecoverage of one or more of these drugs in their 2024 formularies. Currently, carriers are developing their 2024 benefit and rate proposals.

      The FEHBlog has flipped his lid because he discovered that OPM hhadrefreshed its FEHB carrier website. This merits further investigation.

      The Wall Street Journal reports

      Federal health regulators are nearing a decision on whether to authorize a second round of the Omicron-targeted booster shots for the elderly and other people at high-risk of severe Covid-19, people familiar with the agency’s deliberations said.

      Food and Drug Administration officials could make the decision within a few weeks, the people said.

      The officials are moving toward authorizing the second jabs of the Omicron-targeted shots for people who are 65 years and older or who have weakened immune systems, though the officials haven’t reached a final decision and could change their mind, one of the people said.

      The Centers for Disease Control and Prevention would then have to recommend the shots for them to become widely available. 

      From the primary care front, Healthcare Finance informs us

      People are shifting away from traditional primary care providers, with about three in 10 foregoing primary care altogether between 2016 and 2022, according to FAIR Health’s new analysis of private claims data.

      That number, though, ranged from a high of 43% in Tennessee to a low of 16% in Massachusetts, suggesting significant regional variations. Of the providers who performed primary care services in that time, 56% were physicians, while 44% were nonphysicians. * * *

      The analysis pointed to evidence showing that primary care improves health regardless of age, sex, race, ethnicity, education, employment, income, health insurance and smoking status. It has also been reported that a gain of 10 additional primary care physicians per 100,000 people is associated with an increase in life expectancy by 51.5 days.

      Guiding members to primary care providers is a vital health plan task, in the FEHBlog’s opinion.

      From the miscellany department —

      • Health IT Analytics highlights, “Researchers from Utica University recently leveraged socioeconomic data to gain insights into generational poverty and other health equity barriers that impact patients’ ability to prioritize their health to improve clinical outcomes.”Hela
      • Health Payer Intelligence relates, “The National Alliance of Healthcare Purchaser Coalitions (National Alliance) has announced the publication of its playbook which aims to encourage biosimilar adoption among employers.”
      • EHR Intelligence informs us, “Nuance Communications, a Microsoft company, has announced Dragon Ambient eXperience (DAX) Express, the first clinical documentation application to combine conversational and ambient artificial intelligence (AI) with OpenAI’s newest model, ChatGPT-4.:

      Thursday Miscellany

      David Ermer–ACA, CDC, CMS, COVID treatment, COVID-19, COVID-19 testing, FDA, Federal employment benefits, Medicare, No Surprises Act, Patient safety, Rx coverage, U.S. Healthcare–
      Photo by Josh Mills on Unsplash

      The Wall Street Journal reported this morning that maternal mortality cases in the U.S. spiked in 2021, rising from around 850 to 1200 nationwide. From examining Journal reader comments, the FEHBlog ran across a helpful breakdown of maternal deaths per U.S. state.  The lowest maternal death rate is in California, and the highest maternal death rate is in Louisiana.  The breakdown points out what the States with the lowest rates are doing right and what the States with the highest rates are doing to remedy the problem. Healthcare is local.

      The FEHBlog also was directed to this article from the T.H. Chan public health school at Harvard:

      October 21, 2022 – Women in the U.S. who are pregnant or who have recently given birth are more likely to be murdered than to die from obstetric causes—and these homicides are linked to a deadly mix of intimate partner violence and firearms, according to researchers from Harvard T.H. Chan School of Public Health.

      Homicide deaths among pregnant women are more prevalent than deaths from hypertensive disorders, hemorrhage, or sepsis, wrote Rebecca Lawn, postdoctoral research fellow, and Karestan Koenen, professor of psychiatric epidemiology, in an October 19 editorial in the journal BMJ.

      The U.S. has a higher prevalence of intimate partner violence than comparable countries, such violence is often fatal, and it frequently involves guns, Lawn and Koenen noted. They cited one study that found that, from 2009–2019, 68% of pregnancy-related homicides involved firearms. That study also found that Black women face substantially higher risk of being killed than white or Hispanic women.

      I also located the CDC’s website on keeping new mothers alive.

      This evening the Journal discussed why our country’s maternal mortality rate is so high.

      Finally, STAT News reports that this afternoon the Centers for Disease Control announced preliminary 2022 maternal mortality figures.

      Deaths of pregnant women in the U.S. fell in 2022, dropping significantly from a six-decade high during the pandemic, new data suggests.

      More than 1,200 U.S. women died in 2021 during pregnancy or shortly after childbirth, according to a final tally released Thursday by the Centers for Disease Control and Prevention. In 2022, there were 733 maternal deaths, according to preliminary agency data, though the final number is likely to be higher.

      Officials say the 2022 maternal death rate is on track to get close to pre-pandemic levels. But that’s not great: The rate before Covid-19 was the highest it had been in decades.

      The CDC counts women who die while pregnant, during childbirth, and up to 42 days after birth. Excessive bleeding, blood vessel blockages, and infections are leading causes.

      Covid-19 can be particularly dangerous to pregnant women, and experts believe it was the main reason for the 2021 spike. Burned out physicians may have added to the risk by ignoring pregnant women’s worries, some advocates said.

      In 2021, there were about 33 maternal deaths for every 100,000 live births. The last time the government recorded a rate that high was 1964.

      What happened “isn’t that hard to explain,” said Eugene Declercq, a long-time maternal mortality researcher at Boston University. “The surge was Covid-related.”

      The FEHBlog’s goal is to provide perspective on this vital issue.

      From the Omicron and siblings front, MedPage Today informs us

      An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19.

      By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to reduce the risk of hospitalization or death in outpatients at risk for severe outcomes.

      “Besides oxygen, Paxlovid has probably been the single most important treatment tool in this epidemic, and it continues to be,” said Richard Murphy, MD, MPH, of the White River Junction VA Medical Center in Hartford, Vermont.

      The Mercer consulting firm considers employer approaches to coverage of Covid tests following the end of the public health emergency.

      Employers have some important decisions to make over the next two months before the COVID Public Health Emergency (PHE) comes to an end on May 11. One is how to handle cost-sharing for PCR and other COVID tests and related services provided by a licensed healthcare or otherwise authorized provider. Under the PHE, group health plans had to cover testing received either in- or out-of-network at no cost to participants. 

      We recently polled recipients of our New Shape of Work newsletter to ask whether they planned to impose cost-sharing requirements once allowed. Of the more than 1,000 readers who responded, about half indicated that their organization will  not make any change when the PHE ends:  22% will continue to cover PCR testing at 100% both in- and out-of-network, and 29% say that they require COVID testing at their worksites and provide it at no cost.  Only about a fourth (26%) will now require cost-sharing from participants even when they use an in-network facility for testing; about another fourth (23%) will add a cost-sharing requirement only for out-of-network services.   

      Personally, the FEHBlog would opt for restoring a cost-sharing requirement only for out-of-network services.

      From the Rx coverage front

      • STAT News tells us, “Following the lead of its rivals, Sanofi will cut the price of its most widely prescribed insulin in the U.S. by 78% and also place a $35 cap on out-of-pocket costs for commercially insured patients who take the treatment, which is called Lantus. The moves will go into effect on Jan. 1, 2024.”
      • The Mercer consulting firm offers its perspective on coverage of the new era of weight loss drugs, e.g., Ozempic.

      For plans covering weight-loss medications, adding prior authorization criteria can help manage cost growth. These include requirements such as a certain body mass index (BMI), co-morbid conditions, enrollment in a behavior modification program, and/or reduced calorie diet. Upon initiation of therapy, patients and clinicians should partner to create a comprehensive plan to achieve goals and use the medication purposefully alongside a targeted and managed lifestyle program. The plan should include a discussion regarding medication discontinuation when/if goals are met to prevent relapse and weight regain/ weight cycling. Medical nutrition therapy (MNT) with a registered dietitian should be covered; ideally 14 in-person or telenutrition sessions.

      Cognitive-behavioral therapy, self-monitoring, motivational interviewing, structured meal plans, portion control and goal setting are recommended interventions. Ideally, patients would progress from dietary intervention (covered MNT or weight management solution), to weight loss medications, and then, potentially, to bariatric surgery.  

      In recognition of Patient Safety Awareness Week, the Partnership to Fight Infectious Disease announced, making March 18 a day of action to raise awareness of the need to #squashsuperbugs so that we can all do our part to prepare and perhaps even prevent a future pandemic due to antibiotic resistance.

      From the No Surprises Act front, Fierce Healthcare reports

      An “astronomical” number of surprise billing arbitration dispute cases is impacting the Centers for Medicare & Medicaid Services (CMS), a top agency official said.

      Education and communication are integral to an “orderly transition” in the handling of independent dispute resolutions for out-of-pocket charges, the official said. The agency has grappled with legal issues and implementation hiccups surrounding a controversial process for settling feuds between payers and providers on out-of-network charges.

      “We are seeing more than expected number of disputes getting to that last stopgap part, which is the independent dispute resolution part,” said Ellen Montz, director of CMS’ Center for Consumer Information and Insurance Oversight. Montz spoke during a session Wednesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C. 

      The agency is also seeing a lot of ineligible cases that don’t qualify for the dispute resolution process, which requires a third party to choose between out-of-network charges submitted by the payer and provider. 

      These ineligible cases require “a lot of casework, phone calls and back and forth to determine eligibility,” Montz said. 

      From the Medicare front, Healthcare Dive tells us

      The group that advises Congress on Medicare policy is recommending updating base physician payment rates by 1.45% for 2024, according to its annual March report out Wednesday.

      The Medicare Advisory Payment Commission, or MedPAC, did not make recommendations for ambulatory surgery center payment updates or for Medicare Advantage plans.

      The commission did note concern with MA plan coding intensity, and said Medicare now spends more on MA enrollees than it would have spent had those enrollees remained in fee-for-service plans.

      The FEHBlog doubts that this MedPAC report made anyone happy.

      From the federal employee benefits front, FedWeek reminds folks that while the dependent care flexible spending accounts available to federal employees typically are used for child care, they also can be used for senior care in certain circumstances.

      Tuesday’s Tidbits

      David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medicare, NIH, Rx coverage, U.S. Healthcare–

      Happy Pi Day!

      Photo by Patrick Fore on Unsplash

      From the Omicron and siblings front —

      • The Wall Street Journal reports
        • In the three years since Covid-19 surfaced in the U.S., most Americans have been infected and are largely back to their prepandemic routines and workaday lives. 
        • Scientists, still in the dark about what the virus will do in the long term, warn it is too early to sound the all clear. Despite the success of a global effort to decode the SARS-CoV-2 virus and create vaccines and treatments to combat it, there remains uncertainty about how the virus will behave, the path of its mutations and Covid-19’s long-term effects. 
        • Covid-19 vaccines are widely available, but researchers don’t yet know enough about how the virus might change or how long immunity lasts to be certain who should get future boosters or how often. The unknowns could have public-health consequences in the years ahead, virus experts said.
        •  “A big question is how will that play out over time?” Bronwyn MacInnis said of the virus’s mutations. She is director of pathogen genomic surveillance at the Broad Institute of MIT and Harvard, a biomedical research center in Cambridge, Mass. “Are there other tricks we have yet to see?” she said. * * *
        • “Any time someone talks about Covid, I think it’s good to start with a lot of humility,” Moderna Chief Executive Officer Stéphane Bancel said. “It’s still a new virus. So we don’t know everything.”
      • The Food and Drug Administration (FDA) announced amending “the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.”
      • Yesterday, The FDA took the following steps concerning the Johnson and Johnson (Jannsen) vaccine.
        • The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning conveying that reports of adverse events following use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination. The Fact Sheet for Recipients and Caregivers was also revised to include information about myocarditis and pericarditis following the administration of the Janssen COVID‑19 Vaccine. An additional revision to the Fact Sheets was made to include that facial paralysis (including Bell’s Palsy) has been reported during post-authorization use. Also, the scope of authorization for a booster dose of the Janssen COVID-19 Vaccine has been revised to reflect that the vaccine may be administered as a first booster dose at least 2 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine. The FDA reissued the letter of authorization for the Janssen COVID-19 Vaccine to revise the scope of authorization related to the administration of a booster dose and the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Janssen Biotech, Inc. to include myocarditis and pericarditis.  
        • The Janssen COVID-19 Vaccine is authorized for emergency use for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The letter of authorization and revised fact sheets are available on the FDA’s website.

      From the Rx coverage front —

      • Fierce Healthcare offers its insights into why the Veterans Administration decided to offer the new Alzheimer’s Disease drug Leqembi to its patients who are eligible for the drug under the FDA’s guidance. Fierce Healthcare does not expect to CMS to follow this approach later this year. Currently, Medicare covers the drug when offered in a clinical trial, while the FDA’s approach is much broader.
      • The Wall Street Journal reports,

        • Novo Nordisk A/S is set to cut the U.S. list prices for several insulin drugs by up to 75%, the latest big drugmaker to make steep price reductions amid pressure to curb diabetes treatment costs.

        • Novo, one of the biggest sellers of insulin in the U.S. and around the world, said Tuesday it would cut the list price of its NovoLog insulin by 75% and the prices for Novolin and Levemir by 65% starting in January 2024. 

        • In addition, Novo plans to cut prices for its unbranded insulin products to match the reduced price of Novo’s corresponding brands.

      • The Centers for Disease Control issued a Vital Signs report titled “Progress Toward Eliminating HIV as a Global Public Health Threat Through Scale-Up of Antiretroviral Therapy and Health System” over the period 2004 through 2022.
        • What is already known about this topic?
        • The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) began providing HIV antiretroviral therapy (ART) worldwide in 2004. [At that time, George W. Bush was President.} Through viral load suppression, effective ART improves health outcomes and prevents transmission.
        • What is added by this report?
        • By 2022, approximately 20 million persons with HIV infection in 54 countries received PEPFAR-supported ART (62% CDC-supported); this number represents an increase of 300-fold from 66,6550 in 2004. During 2015–2022, viral load suppression rates increased from 80% to 95% among those who received testing.
        • What are the implications for public health practice?
        • To eliminate HIV as a global public health threat, achievements must be sustained and expanded to reach all subpopulations. PEPFAR remains committed to tackling HIV while strengthening public health systems and global health security.

      In recognition of Patient Safety Awareness Week, Beckers Hospital Review highlights

      Healthgrades recognized 864 hospitals with its 2023 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 83 of those hospitals received both awards. 

      The dual recipients spanned 28 states. Texas had the most dual recipients with 12 honorees — including three Baylor Scott and White Health hospitals. 

      From the medical research front,

      • NIH researchers compared a new genetic animal model of Down syndrome to the standard model and found the updated version to be more similar to the changes seen in humans. The new mouse model shows milder cognitive traits compared to a previously studied Down syndrome mouse model. The results of this study, published in Biological Psychiatry, may help researchers develop more precise treatments to improve learning and memory in people with Down syndrome.
      • The NIH DIrectors in his blog, explains
        • “The human brain is profoundly complex, consisting of tens of billions of neurons that form trillions of interconnections. This complex neural wiring that allows us to think, feel, move, and act is surrounded by the blood-brain barrier (BBB), a dense sheet of cells and blood vessels. The BBB blocks dangerous toxins and infectious agents from entering the brain, while allowing nutrients and other essential small molecules to pass right through.
        • “This gatekeeping function helps to keep the brain healthy, but not when the barrier prevents potentially life-saving drugs from reaching aggressive, inoperable brain tumors. Now, an NIH-funded team reporting in the journal Nature Materials describes a promising new way to ferry cancer drugs across the BBB and reach disease sites [1]. While the researchers have not yet tried this new approach in people, they have some encouraging evidence from studies in mouse models of medulloblastoma, an aggressive brain cancer that’s diagnosed in hundreds of children each year.” 

      Thanks, research mice.

      From the healthcare costs front, the New York Times reports, “Most older cancer patients received invasive care in the last month of their lives, a new study finds. That may not be what they wanted.”

      The health care system could improve end-of-life care. When palliative care is introduced soon after a diagnosis, patients have a better quality of life and less depression, a study of people with metastatic lung cancer found. Though they were less likely to undergo aggressive treatment, they survived longer.

      Palliative care doctors, skilled in discussions of serious illness, are scarce in some parts of the country, however, and in outpatient practices.

      Nomi Health announced today that “Diabetes costs U.S. employers approximately $245 billion a year — more than double what the entire American automotive industry is worth. * * *Employers spend more than $175 billion annually on direct medical and pharmacy costs for diabetic members, in addition to nearly $70 billion on indirect costs from employee absenteeism, reduced productivity and diabetes-related disability, the research showed.”

      Additional findings from Nomi Health’s Trends in Spend Tracker research include:

      • Cost of care for diabetics is increasing twice as fast as for non-diabetics, and it’s growing at a staggering clip of nearly 20% year over year, reaching more than $20,000 average per member per year (PMPY) for employers in 2020-21.
      • A diabetes diagnosis means higher costs for patients, too, who spend about 240% more annually on medical bills and nearly 450% more on pharmacy expenses than non-diabetics.
      • The high cost of diabetes extends to the chronic conditions associated with the disease, which often cost more than the diabetes itself. Care for diabetics with ketoacidosis or kidney disease in 2020-21 cost employers 252% above the average, or $68,325 average PMPY.

      This retrospective cohort analysis was conducted by Artemis — a leading benefits analytics platform acquired by Nomi Health last year

      From the post-Dobbs front, Healthcare Dive relates

      Senate Democrats are urging the largest retail pharmacies in the U.S. to ensure access to the abortion pill mifepristone amid ongoing confusion over legal access to the pill.

      On Monday, 18 Democrats sent letters to seven of the biggest pharmacy chains in the country requesting more information about their plans to provide customers access to mifepristone — currently an open question for some chains as pressure from anti-abortion lawmakers and lawsuits target the legality of medication abortion.