Weekend Update

Congress

Weekend Update

David Ermer–CDC, CMS, Congress, Cybersecurity, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • Reuters adds, “U.S. President Joe Biden will put forth his proposed U.S. spending plan [tomorrow] March 11, according to the White House Office of Management and Budget.”
  • Today, the Department of Health and Human Services posted a letter to healthcare leaders about the Change Healthcare cyberattack.
    • We urge insurance companies and other payers to:
      • Make interim payments to impacted providers. Larger payers in particular have the balance sheet stability to advance payments. Payers have the opportunity to stop-gap the cash flow concerns by stepping in with bridge payments [FEHBlog note — assuming that the payer doesn’t rely on Change Healthcare for backend claims processing.}
      • In particular, for Medicaid plans, consider making interim payments to impacted providers.
      • Ease the administrative burden on providers by simplifying electronic data interchange requirements and timelines and by accepting paper claims. 
      • Pause prior authorizations and other utilization management requirements; use all available leeway on deadlines.
  • The Washington Post further reports,
    • “Federal health officials on Saturday said they would offer emergency funding to physicians, physical therapists and other professionals that provide outpatient health care, following a cyberattack that crippled the nation’s largest processor of medical claims and left many organizations in financial distress.
    • “The Centers for Medicare and Medicaid Services also announced that it would make advance payments available to suppliers that bill through Medicare Part B, which serves a wide array of health-care organizations. Officials had previously announced a similar program to make emergency payments available for hospitals that had been ensnared by the Feb. 21 hack of Change Healthcare, a unit of UnitedHealth Group, and have struggled to get paid for more than two weeks. The emergency funds represent upfront payments made to health-care providers and suppliers based on their expected future claims. * * *
    • “It’s going to help significantly,” added Farzad Mostashari, the CEO of Aledade, the nation’s largest network of independent physician practices. Mostashari had previously warned that as many as 25 percent of physician practices were in financial distress.”

From the public health and medical research front,

  • According to the Centers for Disease Control,
    • “Activity Levels Update:
      • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 20 jurisdictions experienced high or very high activity compared to 26 jurisdictions previous week.
      • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
      • “Influenza test positivity remained stable nationally. COVID-19 and RSV test positivity decreased compared to the previous week.
      • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, has decreased to moderate.
    • “Reported on Friday, March 8th, 2024.“
  • Fortune Well offers advices on pregnancy in advance maternal age (at age 35 or older).
  • The Washington Post tells us,
    • “Tai chi, a gentle Chinese martial art involving slow movements, outperformed moderate aerobic exercise in lowering blood pressure in a recent clinical trial.
    • “An analysis, published in JAMA Network Open, tracked 342 18- to 65-year-olds with prehypertension, or blood pressure that is slightly higher than normal, between late July 2019 and mid-January 2022. * * *
    • “These findings support the important public health value of Tai Chi to promote the prevention of cardiovascular disease in populations with prehypertension,” the researchers conclude. Other research continues to explore the potential benefits of tai chi. The exercises are associated with better balance, fall reduction, and benefits for patients with conditions such as arthritis and fibromyalgia.”
  • Bloomberg discusses measles prevention practices for adults born after 1957.
    • “[Katrine Wallace, an epidemiologist at University of Illinois Chicago] says, adults are sufficiently protected from the measles if one of these four things applies to you:
      • “You had measles at some point in your life.
      • “You were born before 1957.
      • “You’ve had two doses of a measles-containing vaccine if you spend time in a high-risk setting for transmission, like schools or hospitals. 
      • Y”ou’ve had one dose of a vaccine if you don’t spend time in high-risk settings. 
      • “Kids and teens need one or two doses for protection depending on their age.” 
    • If you aren’t sure whether you’ve been vaccinated or had the measles, you can get what’s called an MMR titer test, which is available commercially at various labs for about $129, Wallace advises.
  • The Wall Street Journal delves into the development of individual body organ tests.
    • “Measuring organ age is the latest frontier in the world of biological age, the idea that your body’s physical age can be different from its chronological one. For example, a 50-year-old man hypothetically might have physical health that more closely resembles that of a 53-year-old, with, say, a 51-year-old heart and a 54-year-old brain.
    • “Knowing the age of your organs might one day help you prevent and treat disease. In theory, if you knew that your heart was aging too fast, you could take steps to ward off heart disease.
    • “Heart aging predicts future heart disease, and brain aging predicts future dementia,” says Hamilton Oh, one of the paper’s lead authors and a graduate student at Stanford.
    • “Walking into your doctor’s office and getting a simple test to determine your organ age is likely still a ways off, but the concept is gaining interest among researchers, doctors and people focused on their own longevity and health. Scientists caution that more research is needed before such a technology might be ready for mainstream use. Some also say that parts of the recent study made too many assumptions.”

From the U.S. healthcare business front,

  • The Dispatch informs us,
    • “A 2021 study published by the RAND Corporation found that, even after rebates and other discounts, U.S. prescription drug prices were, on average, nearly twice as high as those in countries including Canada, France, Germany, Japan, and the United Kingdom. A 2024 study, also conducted by the RAND Corporation for the Office of the Assistant Secretary for Planning and Evaluation, similarly found that 2022 drug prices in the U.S. were nearly three times higher than those in the 33 Organisation for Economic Co-operation and Development (OECD) countries used in the comparison.
    • “However, the study also found that, on average, unbranded generic drugs were about a third cheaper in the U.S. than in other comparison countries, meaning Americans are actually paying less for these drugs than they would elsewhere. “This finding suggests that robust price competition in U.S. unbranded generic markets continues to drive savings for consumers and health care payers relative to spending on these drugs in other countries,” the study said. Even though generic drugs make up 90 percent of U.S. prescription volume, the substantially higher cost for brand-name drugs still results in a higher average cost for all drugs in the U.S. than elsewhere, according to the report.”
  • HR Dive lets us know,
    • “Judge J. Campbell Barker of the U.S. District Court for the Eastern District of Texas vacated the National Labor Relations Board’s joint employer rule late Friday. The rule was set to go into effect Monday.
    • “The new rule would be “contrary to law” and “arbitrary and capricious,” Barker ruled. The court had been considering a legal challenge brought in November by the U.S. Chamber of Commerce, along with other business groups. 
    • “Federal agencies and employers now await a possible court decision on the U.S. Department of Labor’s independent contractor rule, also set to go in effect Monday.”

Happy International Women’s Day

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, NIH, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Dulcey Lima on Unsplash

The International Foundation of Employee Benefit Plans celebrates International Women’s Day. “International Women’s Day is an ideal time to pause and reflect on the status of women in the workforce—both how far we’ve come and how far we still need to go to achieve true gender equality. “

Mercer Consulting adds, “Women are hugely concerned about the state of their personal finances – and too often, employers have fallen short of providing the support their people need. For too long, financial health has trailed behind physical and mental health on the list of employers’ priorities. Now is the time to act!” The article explains how to act.

From Washington, DC,

  • The Wall Street Journal reports,
    • The Senate on Friday passed a $460 billion spending bill to keep the U.S. government operating, taking a potential shutdown for several agencies off the table for the rest of the fiscal year.
    • In a 75-22 vote, Senate lawmakers approved budgets for federal agencies including the Agriculture, Justice, Transportation and Interior departments through the end of September, just hours before some agencies were scheduled to run out of money. The vote came after several nervous hours of negotiations over votes on amendments demanded by Republicans as a condition for the final vote.
    • The measure now heads to President Biden for approval.
  • Healthcare Finance News adds,
    • “A 3.34% physician payment reduction began January 1. [spending] The legislation  [includes] a prospective increase of 1.68% to Medicare physician reimbursement effective March 9, according to MGMA.
    • “Medical groups would still be left with a 1.69% reduction in reimbursement for the rest of the year.”
  • Fierce Healthcare informs us,
    • “[On Thursday night,] President Joe Biden promised the country further action on prescription drug prices, insurance coverage and reproductive care access during a State of the Union Address that doubled as an early campaign speech.
    • With a presidential election months away, the White House hasn’t held back from promoting its recent efforts on issues at the front of voters’ minds such as the cost of American healthcare and abortion. Though Biden’s address included several calls for policy support from Congress, he wasn’t shy about making his pitch directly to watching voters who could tip the scales in his office’s favor. * * *
    • “Biden asked Congress to build upon the Inflation Reduction Act (IRA) to increase the number of products subject to Medicare drug price negotiations.
    • Rather than the current 20-drug-per-year limit, Biden asked lawmakers for the authority to negotiate prices for 50 drugs a year, or “500 different drugs over the next decade,” he said.
    • “Additionally, the president called to extend the $2,000 out-of-pocket cap on prescription Medicare drugs (set to go into effect in 2025) to all private insurance.
    • “Per the fact sheets, he is also pushing for a similar expansion of another IRA requirement—that drug manufacturers pay rebates to Medicare for certain drug price increases that exceed inflation—to the commercial market. He illustrated that goal during the address by calling for Medicare’s $35-per-month cap on insulin to apply “to every American.”
  • The U.S. Office of Personnel Management issued its FEHB and PSHB technical guidance to carriers who are preparing 2025 benefit and rates proposals in response to the February 8, 2024, call letter.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “A large clinical trial meant to confirm the benefits of a new ALS medication has instead failed, dealing a major blow to the therapy’s developer as well as patients who had hung their hopes on it.
    • “Amylyx Pharmaceuticals disclosed Friday morning that the drug, known as Relyvrio in the U.S., didn’t meet the trial’s main or secondary goals. Though well-tolerated by participants, Relyvrio was not significantly better than a placebo at changing the trajectory of their disease.
    • “For Amylyx, the results are a monumental setback. The Massachusetts-based biotechnology company was built entirely around Relyvrio, which received approval from the Food and Drug Administration in the fall of 2022. Early sales made Amylyx profitable – a rare victory for any young drugmaker. * * * By the end of September, nearly 4,000 of the roughly 30,000 ALS patients in the U.S. were on Relyvrio, according to Amylyx’s estimates. * * *
    • “Now, the company’s future is unclear. Before Relyvrio’s approval, Amylyx co-founders Justin Klee and Joshua Cohen pledged, at the request of a top FDA official, to pull their drug from the market should confirmatory testing fail.
    • “In a statement, Amylyx said that sometime in the next eight weeks, it will share its plans for Relyvrio, which “may include voluntarily withdrawing [the drug] from the market.” The company also intends to discuss the new results with regulators, doctors and the broader amyotrophic lateral sclerosis community.
    • “In the meantime, Amylyx will pause promoting the product.”
  • STAT News tells us,
    • “In a surprise move, the Food and Drug Administration has called for a meeting of outside advisers to discuss whether an Alzheimer’s drug from Eli Lilly should be approved, even as many outsiders expected the medicine to receive regulatory clearance this month.
    • “The drug, donanemab, succeeded in its Phase 3 trial, resulting in a 35% slowing of Alzheimer’s disease progression versus placebo. But Lilly on Friday said that the FDA expects to call a meeting of an advisory committee to review the trial, saying that the agency had told the company “it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design” of the study.
    • “A date for the meeting has not been set yet.
    • “Lilly previously said a regulatory decision was expected by the end of 2023, but had already pushed that back to the first quarter of 2024. In its statement Friday, it said simply that “the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024.”

From the public health and medical research front,

  • The Hill informs us,
    • “The rash of measles outbreaks around the country has sparked concerns that the U.S. risks losing its status as a country where the disease has been eliminated, a distinction held since 2000.
    • “As of last week, 41 measles cases have been confirmed across 15 states and New York City, according to the Centers for Disease Control and Prevention (CDC). That puts the nation already on track to surpassing the 58 total cases that were detected in 2023.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services unveiled a new Framework to accelerate smoking cessation and reduce smoking- and cessation-related disparities.  This action is part of a broader Department-wide effort to advance the Biden Cancer Moonshot goal of reducing the death rate from cancer by at least half over 25 years.
    • “Every person in America should have access to the tools and programs they need to quit smoking. And we must encourage and assist every person in America who wants to quit smoking to do so,” said Secretary Xavier Becerra. “This framework focuses on advancing equity, engaging communities, and coordinating, collaborating, and integrating evidence-based approaches across every facet of our government and society. The Biden-Harris Administration will continue these efforts until smoking is no longer the leading cause of preventable death in the United States, and the communities that remain the most vulnerable get the help they need.”
    • “The HHS Framework to Support and Accelerate Smoking Cessation – PDF provides a unifying vision and set of common goals to help drive progress towards cessation, especially in populations and communities that experience smoking- and cessation-related disparities. It is focused specifically on supporting and accelerating the cessation of combusted tobacco products, including cigarettes, cigars, little cigars, and cigarillos among people of all ages.”
  • The National Institutes of Health announced,
    • “A topical liquid, silver diamine fluoride (SDF), can stop tooth decay in young children, according to a large clinical trial funded by the National Institutes of Health. The preliminary results, published in Pediatric Dentistry, showed that 54% of cavities stopped progressing after SDF treatment, compared to 21% of those treated with a placebo. The study was funded by the National Institute of Dental and Craniofacial Research (NIDCR), part of NIH.
    • “SDF is cleared by the Food and Drug Administration for treating dental sensitivity and is used off label to treat tooth decay, also known as cavities or dental caries. It can be easily and painlessly swabbed onto cavities and has been widely used for management of tooth decay in other countries for decades. Studies suggest that the silver in SDF kills cavity-causing microbes and helps stop destruction of the tooth, while the fluoride helps to rebuild and strengthen the tooth.
    • “Current treatments for severe early childhood caries rely on restoration and tooth extraction, which can involve general anesthesia,” said lead investigator Margherita Fontana, D.D.S., Ph.D., of the University of Michigan. “These interventions are expensive, cavities often return, and anesthesia can have long-term effects on a developing brain. We didn’t really have any other options until recently — SDF is a game changer.”
  • The New York Times relates,
    • “Increasingly, doctor visits by adolescents and young adults involve mental health diagnoses, along with the prescription of psychiatric medications.
    • “That was the conclusion of a new study that found that in 2019, 17 percent of outpatient doctor visits for patients ages 13 to 24 in the United States involved a behavioral or mental health condition, including anxiety, depression, suicidal ideation, self-harm or other issues. That figure rose sharply from 2006, when just 9 percent of doctor’s visits involved psychiatric illnesses.
    • “The study, published Thursday in JAMA Network Open, also found a sharp increase in the proportion of visits involving psychiatric medications. In 2019, 22.4 percent of outpatient visits by the 13-24 age group involved the prescription of at least one psychiatric drug, up from 13 percent in 2006.”
  • The Wall Street Journal points out,
    • “More parents with young children are taking melatonin to sleep. And some of them are going to the emergency room after their children took melatoninaccidentally. 
    • “The number of children who visited emergency rooms for unsupervised melatonin consumption increased 420% from 2009-2020, federal data showed. Melatonin was implicated in some 7% of recent E.R. visits for children 5 and younger who had taken medication without supervision. 
    • “The good news: Very few of those children were hospitalized. Typically, mild drowsiness, headaches or dizziness are the worst side effects after children consume melatonin, according to America’s Poison Centers.
    • “Adults have long used melatonin, a hormone the brain produces in response to darkness, to regulate their sleep. It is sold widely as a dietary supplement.”
  • The MIT Technology Review lets us know,
    • “As a fetus grows in the womb, it sheds cells into the amniotic fluid surrounding and protecting it. Now researchers have demonstrated that they can use those cells to grow organoids, three-dimensional structures that have some of the properties of human organs—in this case kidneys, small intestines, and lungs. These organoids could give doctors even more information about how fetal organs are developing, potentially enhancing prenatal diagnoses of conditions like spina bifida.
    • “These aren’t the first organoids produced from fetal cells. Other groups have grown them from discarded fetal tissue. But this group is among the first to grow organoids from cells taken from amniotic fluid, which can be extracted without harming the fetus.
    • “The entire concept is really groundbreaking,” says Oren Pleniceanu, a stem cell biologist and head of the Kidney Research Center at Sheba Medical Center and Tel-Aviv University who has also been working on organoids from amniotic fluid. This ability to get fetal cells from the amniotic fluid, “it’s like a free biopsy,” he says. But he points out that there’s still room for improvement when it comes to describing the cells that are present. “It’s not that easy to define which cells these are,” he says.”  

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “The No Surprises Act, which aims to protect patients from costly surprise medical bills is becoming “an unmitigated disaster for employers,” according to the head of the one of the largest industry groups for employer-sponsored health plans. 
    • “The trends are bad and getting significantly worse, and I really do worry that we’re going to see a trend towards much higher inflationary factors,” Shawn Gremminger, president and CEO of the National Alliance for Healthcare Purchaser Coalitions, said at a Georgetown University forum on the No Surprises Act Thursday.
    • “The law has largely protected consumers from “surprise” bills in emergencies and when they receive care from out-of-network medical providers at facilities that are in their insurance networks.
    • “But employers and health insurers that pay the bills say they are increasingly alarmed at high awards private-equity owned providers are winning in arbitration, which they say could lead to higher premiums for both employers and their enrollees, as well as higher out-of-pocket costs for consumers.”
  • How does one square this report with yesterday’s CBO report about the savings that the NSA is producing? Providers generally accept the qualifying payment amounts the No Surprises Act requires them to pay.
  • The Employee Benefit Research Institute posted an Issue Brief about “Health Savings Account Balances, Contributions, Distributions, and Other Vital Statistics: Evidence From the EBRI HSA Database”
  • Healthcare Dive offers details on UHC updates on the Change Healthcare situation.
    • Change Healthcare systems are expected to come back online starting in mid-March, about a month after a cyberattack disabled the technology firm, parent company UnitedHealth Group said Thursday. 
    • Electronic payments will be available beginning March 15, and electronic prescribing is fully functional as of Thursday. Change will start testing its claims network and software on March 18, with plans to restore service through that week.
    • UnitedHealth also said it would give additional financial relief to providers, including advancing funds weekly and expanding the temporary financing program it announced earlier this month.
  • Healthcare Dive also delves into Cigna’s announcement that
    • “Cigna is moving to limit how much health insurance providers and employers have to pay for pricey and in-demand obesity medications.
    • “The insurer plans to cap annual price increases for the drugs, called GLP-1 receptor agonists, at 15% for employers and plans participating in a weight loss management program offered by its pharmacy benefit manager.
    • “It’s the first financial guarantee available in the market for the drugs, according to the payer. Cigna’s health services division Evernorth, which includes PBM Express Scripts, announced the news on Thursday before the insurer’s investor day in New York City.”
  • Business Insurance adds,
    • “Cigna Group’s Evernorth Health Services is launching an outpatient behavioral health practice to integrate mental health services with medical care, Forbes reports. The new service, currently available in six states and Washington, D.C., guarantees an appointment with a clinician matching the patient’s unique goals and preferences within 72 hours. Evernorth plans a nationwide rollout by early 2025.”
  • Beckers Health IT notes,
    • “The average cost per email for patients to message their provider was $39, according to data compiled and reported by Peterson-Kaiser Family Foundation.
    • “KFF examined data from the Health Care Cost Institute on physician and outpatient claims from 2020 and 2021 for patients under the age of 65 years old with employer-sponsored insurance. Billing codes for email interactions were first introduced in 2020 amid the COVID-19 pandemic for providers to bill insurers for at least 5 minutes spent responding to patient-initiated emails.
    • “The analysis focused on email messages associated with charges. Researchers found the average claim for emailed correspondence was $39, and patients paid around $25 out of pocket, according to the report. Depending on their benefits package, some patients paid up to $40 out of pocket.”
  • Per Fierce Healthcare,
    • “Renton, Washington-based Providence closed out its year with a -4.1% operating margin and a $596 million net loss but touted “significant progress in operating performance” and an 8.7% year-over-year gain in total operating revenues outpaced by a 7.3% rise in total operating expenses.
    • “The 51-hospital Catholic system was coming off a year of heavy expenses and organizational upheaval. In 2022, it had logged a -6.4% operating margin from a $1.7 billion operating loss, which included $247 million tied to a restructuring it had launched to address spending, as well as a $2.7 billion net loss (excluding $3.4 billion tied to its split with Hoag Memorial Hospital Presbyterian).
    • “This time around, Providence whittled its operating losses down to about $1.2 billion and highlighted gains in volumes. Specifically, it saw a 4% uptick in acute adjusted admissions, a 5% increase in case-mix adjusted admissions and a 3% decline in length of stay “as access to post-acute care improved.” Non-acute volumes also grew 2% on the back of an 11% increase in outpatient surgeries and procedures.”
  • Beckers Payer Issues points out three BCBS companies reporting 2023 losses “due to ongoing trends such as rising utilization in the Medicare Advantage space and growing demand for weight loss drugs. 

Midweek Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Federal News Network reports,
    • “The House passed a $460 billion package of spending bills Wednesday that would keep money flowing to key federal agencies through the remainder of the budget year. The Senate is expected to take up the legislation before a midnight Friday shutdown deadline.
    • “Lawmakers are negotiating a second package of six bills, including defense, in an effort to have all federal agencies fully funded before a March 22 deadline. In the end, total discretionary spending set by Congress is expected to come in at about $1.66 trillion for the full entire year. 
    • “A significant number of House Republicans have lined up in opposition to the spending packages, forcing House Speaker Mike Johnson, R-La., to use an expedited process to bring the bill up for a vote. That process requires two-thirds of the House to vote for the measure for it to pass.
    • “The House passed the measure by a vote of 339-85.”
  • The American Hospital Association News adds,
    • “The House March 5 voted 382-12 to pass the AHA-supported Preventing Maternal Deaths Reauthorization Act (H.R. 3838), bipartisan legislation that would reauthorize federal support for state-based committees that review pregnancy-related deaths to identify causes and make recommendations to prevent future mortalities. Passed by the House Energy and Commerce Committee last July, the bill also would require the Centers for Disease Control and Prevention to work with the Health Resources and Services Administration to disseminate best practices to prevent maternal mortality to hospitals and other health care providers.”
  • Per an HHS press release,
    • “Today, in support of President Biden’s Unity Agenda, the U.S. Department of Health and Human Services’ Health Resources and Services Administration (HRSA) announced the launch of nearly $50 million for HRSA’s Rural Opioid Treatment and Recovery Initiative and released the initiative’s funding application. Funding will support establishing and expanding comprehensive substance use disorder treatment and recovery services in rural areas, including by increasing access to medications for opioid use disorder, such as buprenorphine. Opioid use disorder is particularly concerning in rural communities and accessing treatment can be challenging due to geographic isolation, transportation barriers, and limited substance use disorder providers. This week, HRSA hosted more than 800 rural community leaders working at the grassroots level to build their communities’ capacity to turn the tide of the opioid epidemic. * * *
    • “Applications will be accepted through May 6, 2024, and the funding opportunity is posted at: https://grants.gov/search-results-detail/349409.
    • “To learn more about other programs under the Rural Communities Opioid Response Program, visit https://www.hrsa.gov/rural-health/opioid-response.”
  • Govexec tells us,
    • “Coming on the heels of debuting its new public-facing repository of high-ranking federal officials, the Office of Personnel Management released guidance last week outlining how agencies should report data to the website and how often. 
    • “The March 1 guidance details how agencies will comply with the Periodically Listing Updates to Management (PLUM) Act, which moved OPM away from maintaining the quadrennial Plum Book after this year to an annually updated website that offers information about senior agency leaders, Senior Executive Service members and other top or non-competitively appointed officials. 
    • “OPM officials launched the new website in January, phasing out the physical Plum Book that dated back to President Eisenhower’s 1952 request for a list of every position his administration would have to fill. 
    • “At the time of its launch, the PLUM reporting website possessed the names, roles and pay levels of more than 8,000 executives, with plans to grow to 10,000 with subsequent updates.”
  • The Hill notes,
    • “Alabama Gov. Kay Ivey (R) signed a bill Wednesday protecting in vitro fertilization (IVF) providers from the state Supreme Court’s recent ruling that frozen embryos are to be considered children. 
    • “The legislation, titled SB 159, will shield IVF providers from lawsuit or criminal charges over the “death or damage to an embryo,” during the IVF process. The bill passed by both the state Senate and House shortly before heading to Ivey’s desk Wednesday night.” 

From the FEHB front,

  • An expert, writing in Govexec, offers tips for federal retirees on making the decision whether or not to enroll in Medicare Part B. FEHBlog tip — Income adjusted Medicare Part B premiums usually are temporary while the Medicare Part B late enrollment penalty is forever.
  • Reg Jones, writing in FedWeek, discusses “Your Federal Benefits in Divorce.”

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

  • HR Morning offers employers guidance on how to improve employee health.
  • The National Institutes of Health announced,
    • “More than 70% of American Indian young adults aged 20-39 and 50% of American Indian teens have cholesterol levels or elevated fat in the blood that put them at risk for cardiovascular disease, suggests a study supported by the National Institutes of Health. In some cases, these levels — specifically high low-density lipoprotein (LDL) cholesterol, often thought of as “bad cholesterol,” — were linked to plaque buildup and cardiovascular events, such as heart attack and stroke.
    • “The findings, published in the Journal of the American Heart Association, came from a 19-year-review of the Strong Heart Family Study, part of the Strong Heart Study — the largest study of cardiovascular health outcomes and risk factors among American Indian adults. Researchers followed more than 1,400 participants, ages 15-39, between 2001-2003 and 2020. At the beginning of the study, 55% of participants ages 15-19 had abnormal cholesterol levels, as did 74% of those ages 20-29, and 78% of those ages 30-39.”
  • and
    • “Four children have remained free of detectable HIV for more than one year after their antiretroviral therapy (ART) was paused to see if they could achieve HIV remission, according to a presentation today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. The children, who acquired HIV before birth, were enrolled in a clinical trial funded by the National Institutes of Health in which an ART regimen was started within 48 hours of birth and then closely monitored for drug safety and HIV viral suppression. The outcomes reported today follow planned ART interruptions once the children met predefined virological and immunological criteria.”
    • “These findings are clear evidence that very early treatment enables unique features of the neonatal immune system to limit HIV reservoir development, which increases the prospect of HIV remission,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “The promising signals from this study are a beacon for future HIV remission science and underscore the indispensable roles of the global network of clinicians and study staff who implement pediatric HIV research with the utmost care.”
  • and
    • “Long-acting, injectable antiretroviral therapy (ART) suppressed HIV replication better than oral ART in people who had previously experienced challenges taking daily oral regimens and was found safe in adolescents with HIV viral suppression, according to two studies presented today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. Both studies were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, in collaboration with other NIH institutes.
    • “The HIV community is just beginning to unpack the enormous potential of long-acting antiretroviral medications for HIV treatment and prevention, and we need population-specific data for everyone to benefit,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “These findings open up new possibilities for millions of people with HIV, particularly those whose health suffers due to challenges of daily pill taking.”
  • MedPage Today lets us know,
    • “Rates of emergency surgery, serious complications, and hospital readmissions were higher among Medicare patients living in primary care shortage areas, according to a cross-sectional retrospective cohort study of data from 2015 to 2019.
    • “Medicare beneficiaries living in areas with the most severe primary care shortages had higher rates of three types of emergency surgeries compared with those living in areas with the least severe shortages (37.8% vs 29.9%; risk ratio [RR] 1.26, 95% CI 1.17-1.37, P<0.001), reported Sara Schaefer, MD, of the University of Michigan in Ann Arbor, and co-authors.
    • “Those in areas with the most severe shortages were also more likely to have serious complications (14.9% vs 11.7%; adjusted RR 1.27, 95% CI 1.12-1.44, P<0.001) and readmissions (15.7% vs 13.5%; adjusted RR 1.16, 95% CI 1.01-1.33, P=0.03), they noted in Health Affairs.
    • “However, beneficiaries in areas with the most and least severe shortages had similar rates of 30-day mortality (5.6% vs 4.8%; adjusted RR 1.17, 95% CI 0.93-1.47, P=0.17) and any complications (25.9% vs 24.5%; adjusted RR 1.05, 95% CI 0.97-1.15, P=0.21).
    • “Schaefer told MedPage Today that what surprised her most about the study was the strength of the association for the primary endpoint. Across multiple iterations of analyses, the trend remained consistent, she said.”
  • Health Day relates that according to “researchers reported March 5 in the American Heart Association journal Circulation: Arrhythmia and Electrophysiology.”
    • “Sugary and diet drinks both appear to increase the risk of atrial fibrillation.
    • “Two liters weekly of diet drinks increased risk by 20%, and sugary drinks raised risk by 10%.
    • “Conversely, one liter weekly of unsweetened fruit or vegetable juice lowered risk by 8%.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Pittsburgh-based UPMC, a 40-hospital system, has reported a 2023 operating loss of $198.3 million (-0.7% operating margin) on revenue of $27.7 billion. 
    • “Those figures compare with a $162.1 million operating gain on revenue of $25.5 billion in 2022. Expenses in 2023, totaling $27.9 billion, were approximately 10% up on 2022. That included a 13.6% jump in insurance claims expenses. 
    • “The healthcare system’s measure of inpatient activity grew 3% over the previous year while average outpatient revenue per workday rose 10% and average physician revenue per weekday grew by 9%.”
  • Beckers Hospital Review points out four U.S. hospitals with uncertain futures.
  • Beckers Hospital Review also reports,
    • “Mark Cuban Cost Plus Drug Co. plans to begin manufacturing epinephrine and norepinephrine this week at its 22,000-square-foot drug facility in Dallas, Mr. Cuban confirmed to Becker’s on March 5. 
    • “The $11 million drug manufacturing plant, which originally planned to start operating in late 2022, will focus on producing injectable drugs that often fall into shortages. 
    • “Epinephrine is an emergency treatment for severe allergy reactions, and norepinephrine is a blood pressure medication. Injection solutions of the former have been in unsteady supply since at least 2012. Neither the FDA nor the American Society of Health-System Pharmacists list norepinephrine as a current shortage. 
    • “Next on the docket are pediatric oncology drugs, according to Fortune and Politico.” 
  • Beckers Payer Issues calls attention to the fact that
    • “Twenty-six states [listed in the BPI article] now have more than half of their Medicare enrollees in Medicare Advantage plans, according to a March 5 report from Chartis, a healthcare advisory services firm. 
    • “Nationwide, half of Medicare-eligible beneficiaries are now enrolled in Medicare Advantage plans.” 

Monday Roundup

David Ermer–CDC, Congress, COVID-19 testing, Cybersecurity, FDA, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • American Hospital Association (“AHA”) News tells us
    • The House and Senate Appropriations Committees March 3 released a package of six appropriations bills that would fund certain federal agencies through fiscal year 2024 and contains certain health care provisions of interest to hospitals. The House is expected to consider the legislation by March 6 and the Senate later this week.  
    • The health care provisions would eliminate Medicaid disproportionate share hospital cuts for FY 2024 and delay FY 2025 DSH cuts to Jan. 1, 2025; extend the Medicare-dependent hospital and enhanced low-volume hospital programs through December 2024; reduce a 3.34% physician payment cut that began Jan. 1; and extend the Community Health Centers, National Health Service Corps, and Teaching Health Centers Graduate Medical Education programs through December.
  • Govexec points out the eight biggest agency and program reforms in this package.
  • STAT News informs us that a “small group of policymakers and business people” spoke out against the three big prescription benefit manager at today’s White House listening session.
    • “The big three [pharmacy benefit managers] are everything wrong with this industry,” said Mark Cuban, who co-founded the Cost Plus Drug Company and is trying to cut out the middlemen with a website that sells mostly generic medicines directly to consumers. As part of the effort, his company is also working with smaller pharmacy benefit managers that do not rely on fees in hopes of appealing to employers.
    • “Along with Cuban, the session also featured remarks from Kentucky Gov. Andy Beshear who, as the state’s attorney general, investigated pharmacy benefit managers; Federal Trade Commission Chair Lina Khan, who is currently probing these companies; and Sandra Clarke, executive vice president and chief operating officer at Blue Shield of California, which is pursuing a new pharmacy model.”
  • The FEHBlog does not understand why the White House does not also listen to the PBMs and their supporters. Perhaps that will be the next listening session.
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced today that all manufacturers participating in the first cycle of Medicare drug price negotiations have responded with counteroffers. This news comes after HHS sent initial offers on February 1, as the agency was empowered to do by President Biden’s lower cost prescription drug law, the Inflation Reduction Act. This law is a cornerstone of the Biden-Harris Administration’s efforts to lower prescription drug costs. * * *
    • “The recently launched website LowerDrugCosts.gov is a resource to help people with Medicare understand how the Inflation Reduction Act may help lower their out-of-pocket drug costs. As part of that effort, today, HHS added 50 state-by-state infographics plus DC and Puerto Rico that are accessible on LowerDrugCosts.gov by clicking on the interactive map. These new, plain language infographics are meant to assist with continuing education and outreach on the new benefits made available through the Inflation Reduction Act.”
  • Beckers Hospital Review reports,
    • “PatientRightsAdvocate.org report from Feb. 29 found that just 689 (34.5%) of 2,000 hospitals it examined were fully compliant with federal price transparency rules. 
    • “That is down from 721 (36%) that were found to be fully compliant from the organization’s last report, released in July.” 

From the Food and Drug Administration (FDA) front,

  • The AHA News relates,
    • “The Food and Drug Administration recently granted emergency use authorization for the first over-the-counter home antigen test to detect both flu and COVID-19. The OSOM Flu SARS-CoV-2 Combo Home Test is authorized for use to detect and differentiate influenza A and B and SARS-CoV-2 in nasal swab specimens from people aged 14 and older when conducted at least twice over three days with at least 48 hours between tests. 
    • “In other news, the FDA last week recommended health care providers monitor patients with the Hintermann Series H3 Total Ankle Replacement system for potential device failure, and patients with certain implantable BioZorb breast tissue markers for potential serious complications.” 
  • eMPR notes,
    • “The Food and Drug Administration (FDA) has approved Rybrevant (amivantamab-vmjw) in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.”

From the public health and medical research front,

  • The New York Times reports,
    • “Alcohol-related liver disease is the leading cause of death from excessive drinking — and while it’s curable in the earliest stages, many people don’t realize they have it until it’s too late to reverse.
    • “Annual deaths caused by the disease are on the rise in the United States, having climbed 39 percent in recent years, according to new data from the Centers for Disease Control and Prevention. Death rates are highest in men and adults aged 50 to 64, though they are increasing more quickly among women and younger adults.
    • “People who are drinking are drinking more heavily than they were before, so I think that is the biggest factor,” said Dr. Jessica Mellinger, an assistant professor of gastroenterology and hepatology at the University of Michigan Medical School. And, she added, “we’re seeing that for the first time in this country, women are drinking as much as men.”
  • The American Medical Association tells us what doctors wish their patients knew about nutrition, which encourages patients to limit alcoholic beverage intake.
  • STAT News lets us know,
    • “Having Covid-19 increases a person’s risk of developing an autoimmune disease in the year after infection, a large study out of South Korea and Japan reports, but vaccination helps decrease that risk.
    • “Researchers used the medical records of 10 million Korean and 12 million Japanese adults to see whether those who had Covid were more likely to be diagnosed with autoimmune inflammatory rheumatic diseases, or AIRDs, in the year following infection. AIRDs include rheumatoid arthritis, systemic lupus erythematosus, Sjögren syndrome, mixed connective tissue disease, vasculitis, and other conditions. The Covid group was compared with an uninfected control group and a group of patients who had influenza during the same period from 2020 to 2022.”
  • The National Institutes of Health Director, in her blog, relates,
    • “We’re living in an especially promising time for biomedical discovery and advances in the delivery of data-driven health care for everyone. A key part of this is the tremendous progress made in applying artificial intelligence to study human health and ultimately improve clinical care in many important and sometimes surprising ways. One new example of this comes from a fascinating study, supported in part by NIH, that uses AI approaches to reveal meaningful sex differences in the way the brain works.
    • “As reported in the Proceedings of the National Academy of Sciences, researchers led by Vinod Menon  at Stanford Medicine, Stanford, CA, have built an AI model that can—nine times out of ten—tell whether the brain in question belongs to a female or male based on scans of brain activity alone. These findings not only help resolve long-term debates about whether reliable differences between sexes exist in the human brain, but they’re also a step toward improving our understanding of why some psychiatric and neurological disorders affect women and men differently.”
  • Per BioPharma Dive,
    • “The effects of an experimental medicine for a common liver disease strengthened with time in a clinical trial, giving the drug’s developer, Akero Therapeutics, a chance to rebound from a setback last year.
    • “Akero previously said the trial hit its main goal. After six months of treatment, 39% of patients with metabolic dysfunction associated steatohepatitis on a low dose of the drug and 41% on a high dose had a meaningful reduction in liver scarring and no worsening of their disease, versus 20% of placebo recipients. New results disclosed Monday show that 75% of those on a high dose and 46% on a low dose hit that mark after two years, compared to 24% of placebo patients.
    • “The most common side effects associated with treatment were mild-to-moderate cases of diarrhea, nausea and increased appetite. The 15 serious adverse events reported were “generally balanced across dose groups,” though Akero didn’t provide specifics. Three patients on the high dose stopped treatment.”

From the U.S. public health front,

  • CNBC and Fierce Healthcare bring us to date on the Change Healthcare situation. Of note,
    • “As a growing number of groups put pressure on the administration, the White House is reportedly considering short-term financial relief to support hospitals navigating the fallout of the cyberattack against Change Healthcare.
    • “The news was first reported by Politico and attributed to an anonymous senior administration official. In a series of recent meetings at the deputy level, the White House’s National Security Council reportedly discussed options that would not require support from Congress. Instead, it is exploring ways to tap into funding programs overseen by Health and Human Services, the Center for Medicare & Medicaid Services and the Department of Veterans Affairs to support healthcare organizations.
    • “This cashflow issue has been at the forefront since the beginning of last week for us,” the senior administration official told Politico. The agency is also reportedly pushing UnitedHealth Group to provide more transparency about when it can restore Change systems.
    • “The Biden administration is also considering whether to declare the hack a “significant cyber incident,” a rarely used designation that would trigger a special crisis management playbook, according to media reports.”
  • The Wall Street Journal adds these tidbits about the impending launch of Perigo’s over the counter female contraceptive pill called Opill.
    • “Dublin-based Perrigo has shipped its Opill to major U.S. retailers and expects it to be widely available by the end of the month. The company said it would sell a one-month pack for $19.99 and a three-month pack for $49.99.
    • “Opill, which uses the hormone progestin to suppress ovulation, was shown to be 98% effective at preventing pregnancy when used as directed, beating out other over-the-counter methods such as condoms and spermicide. Other prescription methods that require a doctor’s visit, such as intrauterine devices, are more effective. * * *
    • “The drugmaker wouldn’t confirm which stores will carry its product, but said all major retailers and online marketplaces would sell it. Pharmacy giant Walgreens is advertising the pill as “coming soon” on its website.
    • “Perrigo will also sell its product on its website, including a six-month pack for $89.99. The company said it would ship the pills in discreet packaging to online buyers.”
  • Becker’s Hospital Review identifies twelve U.S. health systems with strong finances.
  • The FEHBlog tried to keep readers abreast of noteworthy business announcement from last week’s VIVE conference. MedCity News helpfully lists nine of them.

Weekend update

David Ermer–Congress, Federal employment benefits, Mental health care, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington DC,

  • The Hill reports,
    • “Congressional leaders on Sunday finally revealed long-awaited bipartisan bills to fund parts of the government for most of the year, setting off a bicameral sprint to avert looming shutdown threat in less than a week.    
    • “The weekend rollout entails six full-year spending bills to fund a slew of agencies until early fall, including the departments of Agriculture, Interior, Transportation (DOT), Housing and Urban Development (HUD), Veterans Affairs (VA), Justice (DOJ), Commerce and Energy.   
    • “The 1,050-page bipartisan package includes more than $450 billion in funding for fiscal year 2024. Lawmakers have until Friday to pass the legislation or risk a partial government shutdown under a stopgap plan President Biden signed into law this week to buy more time for spending talks.” 
  • KFF discusses the work of the Consumer Financial Protection Bureau.
    • “When President Barack Obama signed legislation in 2010 to create the Consumer Financial Protection Bureau, he said the new agency had one priority: “looking out for people, not big banks, not lenders, not investment houses.”
    • “Since then, the CFPB has done its share of policing mortgage brokers, student loan companies, and banks. But as the U.S. health care system turns tens of millions of Americans into debtors, this financial watchdog is increasingly working to protect beleaguered patients, adding hospitals, nursing homes, and patient financing companies to the list of institutions that regulators are probing.
    • “In the past two years, the CFPB has penalized medical debt collectors, issued stern warnings to health care providers and lenders that target patients, and published reams of reports on how the health care system is undermining the financial security of Americans.
    • “In its most ambitious move to date, the agency is developing rules to bar medical debt from consumer credit reports, a sweeping change that could make it easier for Americans burdened by medical debt to rent a home, buy a car, even get a job. Those rules are expected to be unveiled later this year.”
  • Reg Jones, writing in FedWeek, explains FEHB coverage for children of federal and postal employees.
  • The Washington Post reports how “Yogurt makers may now claim that their products can reduce the risk of Type 2 diabetes, according to new guidance from the Food and Drug Administration — with some caveats.”

From the U.S. public health front,

  • The American Medical Association explains what doctors wish their patient knew about prostate cancer.
  • The Washington Post discusses how to recognize and address mild memory loss.
    • “More than occasional forgetfulness, MCI [mild cognitive impairment] causes problems that disrupt daily life but don’t make it impossible to function, said Ronald Petersen, director of the Mayo Clinic Alzheimer’s Disease Research Center and the Mayo Clinic Study of Aging. It is often but not always a precursor to dementia, he added.
    • “It’s a subtle condition,” said Petersen, who in 1999 led the first study differentiating patients with MCI from healthy subjects and those with dementia. If you miss a golf date once, no worries, he said, but if “that happened a couple of times last week and people in your family are starting to worry about you — well, that may be MCI.”
    • “With MCI, people can still drive, pay their bills and do their taxes — they just do so less efficiently,” Petersen said.
    • “A 2022 study in the journal Alzheimer’s & Dementia projected that 14.4 million people in the United States would have MCI in 2025, and 19.3 million in 2050. An American Academy of Neurology subcommittee estimated that about 1 in 10 people ages 70 to 74 had MCI, and 1 in 4 ages 80 to 84 in 2018. * * *
    • “Both patients and physicians need to be aware of the symptoms of cognitive decline,said Soeren Mattke, director of the Brain Health Observatory at the University of Southern California’s Dornsife Center for Economic and Social Research. “If you wait until someone’s obviously symptomatic — like they can’t find the door to the physician’s office — you’re going to be too late.”
  • Fortune Well offers advice about “7 habits that can help you lose weight—and keep it off—according to experts” and “4 expert-backed steps that will help you reach your fitness goals this year.”

   

Happy Leap Day!

David Ermer–CDC, Congress, Cybersecurity, Government Contracting, Medicare, Mental health care, Obesity, SDOH, U.S. Healthcare–
Photo by Joe Caione on Unsplash

From Washington, DC,

  • Politico reports,
    • “The Senate approved a stopgap funding bill Thursday night for President Joe Biden’s signature, thwarting a partial government shutdown on Saturday and buying more time to finalize half a dozen spending bills that congressional leaders aim to pass next week.
    • “Congress now officially has until March 8 to clear that initial six-bill bundle, which leaders struck a deal on earlier this week. But they’re still working on an agreement to fund the rest of the government, including the military and some of the biggest domestic programs, before a second deadline on March 22. The upper chamber cleared the measure in a 77-13 vote, following votes on four Republican amendments that were defeated on the floor.”
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan concerning Primary Care Interventions for Tobacco and Nicotine Use Prevention and Cessation in Children and Adolescents. The comment period ends on March 27, 2024.
  • The Labor Department’s Office of Federal Contract Compliance Programs created an updated website for the “The Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA) [which] is a law that prohibits federal contractors and subcontractors from discriminating in employment against protected veterans and requires employers take affirmative action to recruit, hire, promote, and retain these individuals.”
  • Yesterday, the Politico Pulse posted a story on a December 2022 Government Accountability Office report, released January 9, 2023, criticizing OPM’s internal controls over FEHB family member eligibility. Here is a link to the GAO’s website for the report which offers August 2023 updates on OPM’s efforts to implement GAO’s recommendations. Here’s are FEHBlog recommendations for GAO and OPM:
    • Family member eligibility hinges on the enrollee’s eligibility. OPM needs to have the payroll offices implement the HIPAA 820 enrollment roster electronic transaction which allows carriers to reconcile premiums to actual headcount. Use of the HIPAA 820 will be a huge step toward confirming the accuracy of family member eligibility and the 50% of FEHB enrollees who have self only coverage.
    • The Politico article suggests that the high cost of a family member eligibility audit discourages OPM from implementing one for the FEHBP. Auditors do their work based on samples. Arrange for a family member eligibility audit using statistically appropriate samples which will disclose, at the very least, the scope of the problem.

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

  • The New York Times reports,
    • “Long Covid may lead to measurable cognitive decline, especially in the ability to remember, reason and plan, a large new studysuggests.
    • “Cognitive testing of nearly 113,000 people in England found that those with persistent post-Covid symptoms scored the equivalent of 6 I.Q. points lower than people who had never been infected with the coronavirus, according to the study, published Wednesday in The New England Journal of Medicine.
    • “People who had been infected and no longer had symptoms also scored slightly lower than people who had never been infected, by the equivalent of 3 I.Q. points, even if they were ill for only a short time.
    • “The differences in cognitive scores were relatively small, and neurological experts cautioned that the results did not imply that being infected with the coronavirus or developing long Covid caused profound deficits in thinking and function. But the experts said the findings are important because they provide numerical evidence for the brain fog, focus and memory problems that afflict many people with long Covid.”
  • and
    • “Alcohol-related deaths surged in the United States by nearly 30 percent in recent years, with roughly 500 Americans dying each day in 2021, according to a new study published by the Centers for Disease Control and Prevention.
    • “The study chronicled a sustained spike in drinking during the Covid pandemic that continued to rise after the shock of the lockdowns of 2020. The incidence of alcohol-related deaths was higher in men, but among women the death rate shot up at a quicker pace.
    • “I think the results of this research are really alarming,” said Dr. Michael Siegel, who is a professor of public health at Tufts University School of Medicine and was not involved in the study. “It shows that there’s been a truly substantial increase in alcohol-related deaths over the last six years.”
  • and
    • “The 2022 outbreak of mpox, previously known as monkeypox, was curbed in large part by drastic changes in behavior among gay and bisexual men, and not by vaccination, according to a new analysis published on Thursday in the journal Cell.
    • “Public health response to outbreaks often relies heavily on vaccines and treatments, but that underestimates the importance of other measures, said Miguel Paredes, lead author of the new study and an epidemiologist at the Fred Hutchinson Cancer Center in Seattle.
    • “Although the Food and Drug Administration approved a vaccinefor mpox in 2019, getting enough doses produced and into arms proved challenging for many months after the outbreak began. Vaccines for new pathogens are likely to take even longer.
    • “The new analysis suggests an alternative. Alerting high-risk communities allowed individuals to alter their behavior, such as reducing the number of partners, and led to a sharp decrease in transmission, Mr. Paredes said. In North America, the outbreak began petering out in August 2022, when less than 8 percent of high-risk individuals had been vaccinated.
    • “Public health messaging can “be really powerful to control epidemics, even as we’re waiting for things like vaccines to come,” he said.”
  • Roll Call adds,
    • “Cases of measles are rising across the country and seem to be striking counties at random, but experts say there is one thing the public health system can do to turn the tide, and that’s to stem the post-pandemic vaccine lag and get parents to vaccinate their kids.
    • “General vaccination rates, including measles vaccination, declined during the COVID-19 pandemic, as people had less access to health care and kids were unable to access in-school vaccine clinics.
    • “That, combined with a new wave of vaccine skepticism and anti-vaccine sentiment has contributed to a wave of unvaccinated kids falling sick with the once-eradicated virus.”
  • MedPage Today tells us,
    • “The benefits of vaccination against respiratory syncytial virus (RSV) for adults ages 60 and older probably outweigh the small risk of vaccine-related Guillain-Barré syndrome (GBS), the CDC’s Advisory Committee on Immunization Practices (ACIP) reaffirmed.
    • “In a presentation on the second day of the ACIP’s 2-day meeting, Amadea Britton, MD, of the CDC’s RSV adult vaccination work group in Atlanta, noted that a small number of cases of Guillain-Barre syndrome had been observed in the clinical trials for both FDA-approved RSV prefusion F protein vaccines, but that it remained unclear whether those cases were actually caused by RSV vaccination or just chance occurrences.”
  • and
    • The CDC has issued new guidance —  its first since 1988 — on identifying and responding to clusters of suicide, as tens of thousands of lives are lost to suicide each year in the U.S.
    • Though suicide clusters are rare, they “can have unique characteristics and challenges,” and “are often highly publicized and can have considerable negative effects on the community, including prolonged grief and elevated fear and anxiety about further deaths,” Michael Ballesteros, PhD, of CDC’s National Center for Injury Prevention and Control (NCIPC), and colleagues wrote in Morbidity and Mortality Weekly Report (MMWR).
  • Beckers Hospital Review informs us,
    • “The CDC is anticipating a shortage of Td vaccines — which protect against tetanus and diphtheria — as the maker of one shot has discontinued production. 
    • “As a result, the CDC has updated guidance for providers and is recommending that they switch to administering Tdap vaccines, which protect against pertussis in addition to tetanus and diphtheria, whenever possible.  
    • “MassBiologics discontinued production of its TdVax shot, and while Sanofi also manufactures a Td vaccine and is working to boost supplies, the CDC anticipates the U.S. could see a shortage of the vaccines later this year. 
    • “Because not everyone can receive the Tdap vaccine, “the limited supply of Td vaccine needs to be preserved for those with a contraindication to receiving pertussis-containing vaccines,” the CDC said in its guidance.” 
  • Medscape notes,
    • “Injectable weight loss drugs like Wegovy, Saxenda, and Zepbound have been getting all the glory lately, but they’re not for everyone. If the inconvenience or cost of weight loss drugs isn’t for you, another approach may be boosting your gut microbiome.
    • “So how does one do that, and how does it work?
    • “In theory, all you have to do is boost your gut microbiome.
    • “There are a lot of different factors naturally in weight gain and weight loss, so the gut microbiome is certainly not the only thing,” said Chris Damman, MD, a gastroenterologist at the University of Washington. He studies how food and the microbiome affect your health. “With that caveat, it probably is playing an important role.”
  • STAT News adds,
    • “New obesity drugs like Wegovy and Zepbound are currently taken once a week, indefinitely. But what if they could be taken once a year instead, like a vaccine?
    • “That’s a question that Novo Nordisk, the pharma company behind Wegovy, is exploring as it faces increased competition from other drugmakers aiming to develop similar GLP-1-based treatments for obesity.
    • “We have a very early think tank on: what would it take us, from a technology point of view and from an ecosystem point of view, to make long-lasting GLP-1 molecules?” Marcus Schindler, Novo’s chief scientific officer, said in an interview with STAT Wednesday. “Could we think about vaccine-like properties, where imagine you had, once a year, an injection with an equivalent of a GLP-1 that really helps you to maintain weight loss and have cardiovascular benefits?”

From the U.S. healthcare business and cybersecurity issues front,

  • Beckers Hospital Review informs us,
    • “Optum’s Change Healthcare confirmed Feb. 29 that it was hacked by a ransomware gang after the group claimed to have stolen massive amounts of data.
    • “Change Healthcare can confirm we are experiencing a cybersecurity issue perpetrated by a cybercrime threat actor who has represented itself to us as ALPHV/Blackcat,” an Optum spokesperson emailed Becker’s on Feb. 29. “We are actively working to understand the impact to members, patients and customers.” * * *
    • “ALPHV/Blackcat, aka BlackCat, claimed responsibility for the hack, posting on its dark web leak site that it stole 6 terabytes worth of Change Healthcare data involving “thousands of healthcare providers, insurance providers, pharmacies, etc,” Bleeping Computer reported Feb. 28. The allegedly stolen data includes medical records, patient Social Security numbers, and information on active military personnel (Change serves some military healthcare facilities).
    • “But as Politico noted Feb. 28: “Ransomware groups, which demand extortion payments in exchange for restoring or not publishing stolen data, often exaggerate their exploits as a negotiating tactic.”
    • “ALPHV/Blackcat, which has been linked to Russia, has been targeting the U.S. healthcare industry since December after the FBI disrupted its operations.”
  • STAT News adds,
    • “The outage caused by the Change Healthcare cyberattack could last weeks, a top UnitedHealth executive suggested in a Tuesday conference call with hospital cybersecurity officers, according to a recording obtained by STAT.
    • “UnitedHealth Group Chief Operating Officer Dirk McMahon said the company is setting up a loan program to help providers who can’t submit insurance claims while Change is offline. He said that program will last “for the next couple of weeks as this continues to go on.”
    • “McMahon’s remarks about the loan program highlight the scope of UnitedHealth’s damage control. UnitedHealth maintained it has “not determined the [cyberattack] incident is reasonably likely to materially impact our financial condition or results of operations,” according to its annual report to investors this week. But doctors and pharmacists are scrambling to find ways to get patients what they need, and to get paid. As of 2022, Change facilitated $1.5 trillion in health care transactions.”
  • HR Brew lets us know,
    • “The cost of healthcare went up last year, according to a new report from Marsh McLennan Agency (MMA), a US-based subsidiary of global brokerage Marsh. The amount that employers spent on health benefits per employee grew by 5.2%, while the estimated cost of employer contributions to premiums increased by more than $1,400, to $11,762.
    • “Healthcare inflation can affect employees, as well, the report noted, with 38% of Americans reporting they put off medical treatment in the last year due to cost concerns. MMA noted that “delayed care is associated with worse health outcomes and higher costs for patients and benefit providers.”
    • “Younger workers appear to be feeling the pinch of high health costs the most, with 74% of millennial and 56% of Gen Z patients canceling doctors’ visits because of high costs, compared to 13% of Baby Boomer patients. Putting off behavioral healthcare, in particular, can be costly for younger age groups, said Monte Masten, chief medical officer with MMA. Given these trends, employer investment in incentives may be warranted, he told HR Brew.”
  • Drug Store News alerts us,
    • “Walgreens’ VillageMD is closing six Chicago clinic locations—five standalone and one co-located with a Walgreens store, per a Telehealth & Telecare Aware report.
    • “The closures in Walgreens’ home state are set to take place April 19. These closures follow on the heels of news last week that VillageMD exited the Florida market.” 
  • Per Fierce Healthcare,
    • “Telemedicine clinic Virta Health believes its members can achieve significant and sustained improvement in weight loss, even if a patient has stopped taking a GLP-1 drug, a newly released paper in Diabetes Therapy shows.
    • “According to the company, it is a first-of-its-kind study offering an opposing viewpoint against clinical trials showing GLP-1 deprescription leading to weight regain. The results have potentially major implications for employers and plans looking to help its members improve health outcomes and fight obesity but that are concerned about rising costs amid increasing demand.
    • “This is unheard of,” said Sami Inkinen, Virta Health CEO and co-founder. “To my knowledge, nobody has published or shown this kind of data to date.”
  • Beckers Health Payer Issues points out five health insurers that “are making commitments to advance a White House initiative to end hunger and reduce diet-related disease by 2030.” 
  • Per BioPharma Dive,
    • “Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders.
    • “Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round announced Thursday, alongside Alaska Permanent Fund Corporation and The Column Group. The investment is the first announced by Cure since it debuted last year with a $350 million fund. Euclidean Capital and Saisei Ventures also participated in the round.
    • “Previously known as Ryne Bio, Kenai’s research aim is to create so-called off-the-shelf cell therapies that replace neurons. The company’s most advanced medicine is made from genetically reprogrammed stem cells and designed to treat Parkinson’s disease by restoring dopamine production.
    • “The medicine has “displayed robust survival, innervation, and behavioral rescue in preclinical models of Parkinson’s disease,” according to Kenai, which claims it could work in inherited forms of the disease as well as in cases where the exact cause isn’t understood.
    • “The company said the funding proceeds will be enough to push the medicine, named RNDP-001, into human testing and through early-stage clinical trials, which should start within the year.”

Midweek update

David Ermer–CDC, Congress, COVID-19 vaccine, HSA, Mental health care, NIH, U.S. Healthcare–
Photo by Manasvita S on Unsplash
  • Roll Call informs us,
    • “Congressional leaders reached an agreement on final fiscal 2024 appropriations bills Wednesday that will pave the way for lawmakers to wrap up the process in two packages in the coming days and weeks, sources familiar with the deal said.
    • “Funding for agencies covered by the Agriculture, Energy-Water, Military Construction-VA and Transportation-HUD bills would be extended from March 1 through March 8, joining the Interior-Enviroment and Commerce-Justice-Science bills in the first tranche. Lawmakers are expected to release text of the stopgap spending measure as soon as Wednesday.
    • “Appropriators are aiming for text for the first tranche by Sunday in order for the House to be able to turn around and vote Wednesday, before Thursday gets swallowed up by President Joe Biden’s State of the Union address. In theory, that would give the Senate time to get the first package to Biden’s desk before the impacts of a partial shutdown on those agencies subject to the new March 8 deadline are felt.
    • “Stopgap funding for the remaining six bills, which had been set to lapse March 9, would last through March 22, giving lawmakers enough time to finish turning the deal into legislative text and getting them through both chambers. That package will consist of the Defense, Labor-HHS-Education, Homeland Security, Financial Services, State-Foreign Operations and Legislative Branch measures.” (FEHBlog note — FEHB appropriations are included in the Financial Services bill.]
  • and
    • “Mitch McConnell’s announcement [today] that he will voluntarily end his record-setting reign as Senate Republican leader drew praise and some derision Wednesday, as a contest to succeed him that was already underway began to move out from behind the scenes.
    • “Potential candidates to replace McConnell include the “three Johns,” as they’re known, who have all served as deputies under McConnell in recent years. South Dakota Sen. John Thune, currently the No. 2 Senate Republican; Wyoming Sen. John Barrasso, the current conference chair; and Texas Sen. John Cornyn, a former GOP whip who termed out of leadership, could all make a run for party leader.” 
  • The Bipartisan Policy Center adds,
    • “An additional factor affecting FY2024, which runs from October 1, 2023, through September 30, 2024, and FY2025 is the Fiscal Responsibility Act or FRA—the bipartisan debt limit deal that set discretionary spending levels for two years. The FRA includes a provision that reduces spending caps in the deal and enforces a sequester (an across-the-board cut) if one or more agencies are covered by a CR after April 30, 2024. There is some uncertainty over whether a full-year CR would trigger this April 30 provision. The executive branch’s Office of Management and Budget (OMB) is ultimately responsible for making that decision.”
  • STAT News reports,
    • “In a bid to combat prescription drug costs, the White House will hold a listening session on Monday in search of ways to reform pharmacy benefit managers, according to people familiar with the plans.
    • “The list of attendees includes representatives from the federal government and industry, who are expected to provide insights into how the largest pharmacy benefit managers determine which medicines are covered by insurers and employers, as well as prices that are paid at pharmacy counters. Critics say these middlemen rely on an opaque process that drives up costs for patients and taxpayers.
    • “Among those invited is Mark Cuban, whose Cost Plus Drug Company is trying to transform the marketplace by avoiding the largest middlemen when reaching benefits agreements with employers. He will “just convey what our experience has been at Cost Plus and, if they ask, [make] suggestions on what we think can make things better,” he told us when asked about his expectations for the meeting.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “Centers for Disease Control and Prevention Director Mandy Cohen, M.D., Feb. 28 endorsed a recommendation by its Advisory Committee on Immunization Practices that adults ages 65 years and older receive an additional updated 2023-2024 COVID-19 vaccine dose. 
    • “Today’s recommendation allows older adults to receive an additional dose of this season’s COVID-19 vaccine to provide added protection,” Cohen said. “Most COVID-19 deaths and hospitalizations last year were among people 65 years and older. An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk.”
    • “CDC continues to recommend that everyone stay up to date on their COVID-19 vaccines, especially people with weakened immune systems.”
  • The Wall Street Journal adds,
    • “The CDC’s final decision ensures most health plans cover the inoculations without an out-of-pocket charge when furnished in-network].
    • “Most Covid-19 deaths and hospitalizations last year were among people 65 years and older. An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk,” CDC Director Dr. Mandy Cohen said.”
  • The National Institutes of Health announced,
    • “Frequent cannabis smoking may significantly increase a person’s risk for heart attack and stroke, according to an observational study supported by the National Institutes of Health. The study, published in the Journal of the American Heart Association, uses data from nearly 435,000 American adults, and is among the largest ever to explore the relationship between cannabis and cardiovascular events.   
    • “The study, funded by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, found that daily use of cannabis — predominately through smoking — was associated with a 25% increased likelihood of heart attack and a 42% increased likelihood of stroke when compared to non-use of the drug. Less frequent use was also associated with an increased risk of cardiovascular events. Weekly users showed a 3% increased likelihood of heart attack and a 5% increased likelihood of stroke.
    • “Around 75% of the study respondents reported that they mainly used cannabis by smoking the drug. Approximately 25% of the respondents reported using cannabis by some method other than smoking, such as vaping, drinking, or eating the drug.
    • “We know that toxins are released when cannabis is burned, similar to those found in tobacco smoke,” said corresponding author Abra Jeffers, Ph.D., a data analyst at Massachusetts General Hospital in Boston and formerly a researcher at the Center for Tobacco Control Research and Education at the University of California, San Francisco, where she conducted the study as part of her postdoctoral work.
    • “We’ve known for a long time that smoking tobacco is linked to heart disease, and this study is evidence that smoking cannabis appears to also be a risk factor for cardiovascular disease, which is the leading cause of death in the United States,” Jeffers said. “Cannabis use could be an important, underappreciated source of heart disease.”
  • MedPage Today lets us know,
    • “Mortality from colorectal cancer (CRC) decreased significantly in patients who were offered early screening with fecal occult blood testing (FOBT), a large prospective cohort study showed.
    • “Cancer-specific mortality decreased significantly by 14% in patients who underwent early screening for CRC, as compared with a control group that received late or no invitations to participate in screening. Excess mortality decreased by 16% in the exposure group.
    • “The results probably underestimated the true impact of screening with FOBT, as some participants in the control group underwent testing, reported Johannes Blom, MD, PhD, of the Karolinska Institutet in Stockholm, and co-authors in JAMA Network Openopens in a new tab or window. Clinicians and patients now have greater confidence that CRC screening reduces the risk of dying of CRC.”
  • The Society for Human Resource Management offers ten tips to Support Mental Health in Multigenerational Workplaces.”
  • MedTech Dive informs us,
    • “Johnson & Johnson has started patient enrollment in a pivotal trial to evaluate its Laminar left atrial appendage (LAA) elimination device for reducing stroke risk due to blood clot formation in the heart, the company said Tuesday.
    • “The investigational device exemption study will enroll 1,500 patients with atrial fibrillation (AFib), a common form of irregular heart rhythm, at up to 100 U.S. sites.
    • “J&J, which acquired privately held Laminar for $400 million in November, is among the medtech companies aiming to challenge Boston Scientific, whose Watchman implant leads the fast-growing market for LAA devices.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review lists the 43 U.S. hospitals listed in Newsweeks top 250 hospital worldwide. U.S. hospital form four of the top five.
    • 1. Mayo Clinic-Rochester (Minn.)
    • 2. Cleveland Clinic
    • 4. The Johns Hopkins Hospital (Baltimore)
    • 5. Massachusetts General Hospital (Boston)
  • Per Healthcare Dive,
    • “Universal Health Services is guiding to a stronger 2024 than analysts had expected after beating Wall Street’s revenue expectations in fourth-quarter results released Tuesday.
    • “The massive for-profit hospital operator expects to bring in revenue between $15.4 billion and $15.7 billion this year, which represents almost 9% year-over-year growth at the midpoint. In comparison, UHS grew revenue almost 7% last year, ending 2023 with $14.3 billion. The system’s profit was $717.8 million, up 6%.
    • “UHS was helped in the fourth quarter from better-than-expected behavioral health volumes, despite continued cost pressures from physician subsidy expenses and the ongoing Medicaid redetermination process.”
  • Per Fierce Healthcare,
    • “Danbury, Connecticut-based Nuvance Health is joining Northwell Health, New York’s largest provider and private employer, under a strategic merger agreement unveiled Wednesday.
    • “The deal, which still requires regulatory signoffs, would create a healthcare network of more than 28 hospitals, over 1,000 care sites, nearly 100,000 staff and 14,500 employed providers, the two nonprofits said in their joint announcement.
    • “This partnership opens a new and exciting chapter for Northwell and Nuvance and provides an incredible opportunity to enhance both health systems and take patient care and services to an even higher level,” Michael Dowling, president and CEO of Northwell Health said in the announcement. “We have similar missions in providing high-quality care for patients in the communities we serve. We look forward to building on the care that Nuvance Health’s 14,000 staff members and providers deliver each and every day.”
  • Health Equity explains why employer matching contributions to employee health savings accounts can be game changer when trying to lower healthcare costs.
    • “When implementing an HSA contribution plan, it’s helpful to structure the program in a way that is not only cost-effective but also encourages adoption. Seed options are a good way to encourage HSA use because they directly help employees with healthcare costs. You can make seed contributions in several ways, such as:
      • A lump sum
      • Smaller amounts throughout the year
      • Or a combination of both tactics
    • “To boost adoption, consider offering an HSA-qualified plan with lower premiums than your regular plan. This way, the choices cost about the same. For instance, you could offer a PPO plan with a $400 monthly premium or an HSA-qualified plan with a $200 monthly premium and an extra $200 monthly employer seed.
    • “It’s not uncommon for organizations to seed the first year of an employee’s HSA to help them transition into the plan, but few make the important switch to a match system to continue encouraging contributions.
    • “According to HealthEquity research, only 12% of employers provide a contribution match compared to 68% who offer a seed.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Congressional leaders emerged from the White House on Tuesday optimistic about avoiding a partial shutdown of several departments and agencies — after a meeting with President Joe Biden that also focused on the importance of aid to Ukraine.
    • “The speaker said unequivocally he wants to avoid a government shutdown,” Senate Majority Leader Charles E. Schumer, D-N.Y., told reporters outside the West Wing, adding he did not believe differences on domestic spending were insurmountable.
    • “When he got back to the Capitol, Schumer told reporters that he made clear to Speaker Mike Johnson, R-La., that avoiding a shutdown would require another continuing resolution. Senate Minority Leader Mitch McConnell, R-Ky., also told reporters at the Capitol that leaders seemed to agree at the White House on the need to avert a shutdown.”
  • The Wall Street Journal relates,
    • “The Justice Department has launched an antitrust investigation into UnitedHealth, owner of the biggest U.S. health insurer, a leading manager of drug benefits and a sprawling network of doctor groups.
    • “The investigators have in recent weeks been interviewing healthcare-industry representatives in sectors where UnitedHealth competes, including doctor groups, according to people with knowledge of the meetings.
    • “During their interviews, investigators have asked about issues including certain relationships between the company’s UnitedHealthcare insurance unit and its Optum health-services arm, which owns physician groups, among other assets. 
    • “Investigators have asked about the possible effects of the company’s doctor-group acquisitions on rivals and consumers, the people said.
    • “Spokespeople for UnitedHealth and the Justice Department declined to comment. UnitedHealth executives have said Optum and UnitedHealthcare don’t favor one another, and routinely work with competitors.” 
  • According to Healthcare Dive,
    • “Proposed Medicare Advantage rates for 2025 could have a steeper impact on health plans’ payment than the government expects, according to a new study funded by a payer lobbying group.
    • “The analysis — backed by the Better Medicare Alliance, which represents payers in the private Medicare program — found MA payment per month per beneficiary could drop by 1% next year if the CMS finalizes the changes. In comparison, the CMS expects payments to MA plans to drop 0.16% under its proposal.
    • “Study authors warned that when government reimbursement drops, MA benefits for seniors like supplemental benefits and lower premiums and cost-sharing also tend to be reduced. Health insurers have made similar arguments in recent earnings calls lobbying against the rate changes, which could reduce profitability of their MA businesses.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Community Living (ACL), announced several new initiatives and resources from ACL’s Direct Care Workforce (DCW) Strategies Center to address the dire shortage of professionals who provide the services many older adults and people with disabilities need to live in the community. These include two technical assistance opportunities to help states strengthen their systems for recruiting, retaining, and developing direct care workers; a national hub to connect states, stakeholders and communities to best practices and other resources related to the direct care workforce; and a webinar series for states and stakeholders focused on a range of direct care workforce topics. These initiatives will help sustain the impact of the $37 billion in American Rescue Plan funding invested to date by states in home and community-based services, and support the comprehensive set of actions and investments included in the President’s executive order to improve care.”
  • Per an OPM press release,
    • “The U.S. Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) released the first-ever government-wide Military-Connected Strategic Plan for FY 2024-2028 to support agencies in their efforts to recruit, hire, and retain military-connected spouses, caregivers, and survivors within the federal government. 
    • “Advancing economic opportunity for military-connected spouses, caregivers, and survivors strengthens our federal workforce and the nation,” said OPM Director Kiran Ahuja. “A good-paying, flexible, and dependable federal job strengthens the economic security of our military families and helps spouses succeed in their own careers, while also supporting their loved ones in uniform. Tackling barriers to recruiting, hiring, and retaining talent also improves our workforce and expands our talent pool to mission-driven public servants who want to give back to their country.” 
  • Federal News Network informs us,
    • “As agencies ramp up recruitment of federal AI professionals, the Office of Personnel Management is highlighting existing workplace flexibilities that can ease the process.
    • “Incentives such as pay bonuses, faster leave accrual, student loan repayments, and telework and remote work can all help agencies more effectively hire AI specialists, OPM said in new federal AI hiring guidance, published Tuesday.
    • “Agencies can extend most — but not all — of the workplace flexibilities to incoming federal AI experts without first needing to get approval from OPM.
    • “For the few flexibilities that require OPM approval — special rates, critical pay and waivers of the recruitment, relocation and retention incentive payment limits — we stand ready to assist agencies and respond to their requests for enhanced compensation tools,” OPM Director Kiran Ahuja said in the guidance.”
  • Beckers Hospital Review adds,
    • “On Feb. 23, Colorado secured a national first by agreeing to establish a price ceiling on a medication, The Denver Post reported. 
    • “The state’s Prescription Drug Affordability Board voted in favor of capping the cost of arthritis drug Enbrel, which has a list price of $1,850.46 for a weekly dose. Colorado legislators createdthe five-member board in 2021 to sniff out medications deemed “unaffordable” and establish a payment limit for state-regulated commercial payers.
    • “By late August, the board will either narrow down an appropriate cost for Enbrel or vote against setting a price ceiling, according to The Denver Post. If established, the price cap would limit how much pharmacies could pay for the drug, and patients and payers would then pay that amount and a fee to cover the pharmacy’s handling costs.” 

From the public health and medical research front,

  • The Food and Drug Administration announced yesterday,
    • “[O]n May 16, 2024, the FDA’s Vaccines and Related Biological Products Advisory Committee will meet to publicly discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.  
    • “The FDA anticipates that changes to the vaccine composition may need to be made based on the currently circulating strains of the virus that causes COVID-19. As the agency has previously stated, barring any new major changes to circulating virus, the FDA expects that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.
    • “Following any potential recommendations to update the 2024-2025 formula, the FDA anticipates that, subject to appropriate regulatory actions, manufacturers will be able to make updated COVID-19 vaccines available in advance of the fall/winter respiratory virus season.”
  • The National Institutes of Health announced today,
    • “People with type 2 diabetes who underwent bariatric surgery achieved better long-term blood glucose control compared to people who received medical management plus lifestyle interventions, according to a new study supported by the National Institutes of Health. The participants who underwent bariatric surgery, also called metabolic or weight-loss surgery, were also more likely to stop needing diabetes medications and had higher rates of diabetes remission up to 12 years post-surgery. Results of the study were published in JAMA(link is external) and funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of NIH.
    • “While there are many factors involved, and not all of them are completely understood, bariatric surgery typically results in greater weight loss that affects a person’s metabolic hormones, which improves the body’s response to insulin and ability to maintain healthy blood glucose levels,” said Dr. Jean Lawrence, NIDDK project scientist. “These results show that people with overweight or obesity and type 2 diabetes can make long-term improvements in their health and change the trajectory of their diabetes through surgery.”
    • “The current study is a follow-up that combined data from four independent single-center randomized trials conducted at clinical sites in the United States. The original trials, which were conducted between May 2007 and August 2013, evaluated the effectiveness of bariatric surgery compared to intensive lifestyle and medication therapy involving oral and injectable diabetes medications including insulin, for adults with type 2 diabetes and overweight or obesity. While some participants in the study were prescribed GLP-1 agonists as part of their medical management of diabetes, these drugs were not specifically examined in the study. The investigators from the four individual studies pooled their data to provide a larger and more geographically diverse data set to evaluate efficacy, durability, and safety of bariatric surgery to treat type 2 diabetes. Follow-up data were collected through July 2022.”
  • The U.S. Preventive Services Task Force preliminarily recommended an inconclusive grade for Screening and Supplementation of Iron Deficiency and Iron Deficiency Anemia During Pregnancy. The public comment period is open until March 25, 2024.
  • The Centers for Disease Control offers important guidance on diabetes and feet.
    • “About half of all people with diabetes have some kind of nerve damage. You can have nerve damage in any part of your body, but nerves in your feet and legs are most often affected. Nerve damage can cause you to lose feeling in your feet.”
  • BioPharma Dive lets us know,
    • “An experimental weight loss drug developed by Viking Therapeutics helped overweight and obese people lose up to 15% of their body weight after 13 weeks of treatment in a mid-stage trial, the company said Tuesday.
    • “The drug, a potential rival to Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, led to greater weight loss over that time period than both of those medicines did in clinical testing. However, Wall Street analysts cautioned the effects of Viking’s therapy need to be confirmed in a larger Phase 3 trial.”

From the U.S. public health front,

  • Beckers Hospital Review points out,
    • “UnitedHealth Group estimates 90% of the 70,000-plus pharmacies in the U.S. using Change Healthcare’s platform have modified electronic claims processing to mitigate effects of the cybersecurity incident that hit the company last week.
    • “The remaining 10% have offline processing workarounds, according to a Feb. 26 statement from UnitedHealth Group, which owns Change Healthcare. The cybersecurity issue, believed to be the work of a foreign nation-state-associated cybersecurity threat actor, caused enterprisewide connectivity issues.
    • “UnitedHealth Group reported Optum Rx and UnitedHealthcare have seen few reports of issues, and fewer than 100 out of the 65 million pharmacy benefit manager members have not been able to get their prescriptions. The company has immediately escalated patients that haven’t been able to access prescriptions to preserve continuity of care.
    • “Since identifying the issue on Feb. 21, Change has worked closely with customers and clients to secure access to medications during the network disruption. The company is also working with law enforcement, Mandiant, Palo Alto Networks, and other third parties to investigate and resolve the issues.
    • “We appreciate the partnership and hard work of all of our relevant stakeholders to ensure providers and pharmacists have effective workarounds to serve their patients as systems are restored to normal,” said the statement. “As we remediate, the most impacted partners are those who have disconnected from our systems and/or have not chosen to execute workarounds.”
    • “The company also noted hospitals and health systems have connections with multiple clearinghouses and manual workarounds to continue providing care.”
  • Per Fierce Healthcare,
    • “Signify Health is expanding its in-home diagnostics offering to include a test for heart arrhythmias.
    • “The CVS Health subsidiary said Tuesday that the prevalence of irregular heartbeats is set to grow alongside an aging population. Atrial fibrillation, the most common type of arrhythmia, can be asymptomatic, and there are likely between 1.26 million and 1.52 million undiagnosed cases.
    • “Patients with a heart arrhythmia who are undiagnosed may face symptoms like shortness of breath, chest pain and rapid or irregular heartbeat, and face potential stroke or diabetes.
    • “Through the program, Signify members who are at risk for an arrhythmia are identified, and then its clinical teams will test for contraindications. Members will asked to wear a continuous ECG patch, which tracks continuous cardiac activity, and, after 14 days, the team will review the results for signs of irregular heartbeat.”
  • and
    • “Highmark is teaming up with Epic and Google Cloud to improve the flow of data between payers and providers to enhance care coordination and drive better outcomes.
    • “The goal, the insurer said, is to arm providers with the most valuable data at the point of care, enabling them to improve patient outcomes and close critical care gaps.
    • “We really need better ways to get the right information in front of the clinicians at the right time,” Richard Clarke, Ph.D., senior vice president and chief analytics officer for Highmark Health, told Fierce Healthcare. 
    • “Epic’s Payer Platform allows for “bidirectional” data sharing between the payer and the provider, he said, and Google Cloud’s technology makes it flexible enough to connect with Highmark’s existing systems readily.”
  • Fortune Well writes about a woman whose recently deceased mother’s estate is saddled with an $81,000 air ambulance bill because her mother declined Medicare Part B coverage.
    • “People who are eligible for Medicare are encouraged to sign up for Part B, unless they have private health insurance through an employer or spouse.
    • “If someone with Medicare finds that they are having difficulty paying the Medicare Part B premiums, there are resources available to help compare Medicare coverage choices and learn about options to help pay for Medicare costs,” Meena Seshamani, director of the federal Center for Medicare, said in an email to KFF Health News.
    • “She noted that every state offers free counseling to help people navigate Medicare.”

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Cybersecurity, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Biden is calling congressional leaders to the White House as the clock ticks toward a partial government shutdown Friday night and a Ukraine aid package remains stuck.
    • “The president has called the meeting for Tuesday, seeking to break a logjam. House and Senate leaders have been working to negotiate the details of 12 funding bills totaling $1.6 trillion for federal agencies, which have been operating on temporary extensions since Sept. 30. Funding for the Transportation Department and several other agencies expires after March 1, which would affect some housing, food and veterans’ programs; the rest expires after March 8.” 
  • STAT News reports,
    • “Congress has abandoned its attempt to reform how pharmacy middlemen operate in an upcoming package to fund the federal government, 11 lobbyists and sources following the talks told STAT.”
  • and
    • “Congress will not move forward with a controversial policy to equalize certain Medicare payments to hospitals and physicians’ offices in an upcoming government funding package, five lobbyists and sources following the talks told STAT.”
  • From an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $36.9 million in notices of funding opportunities for grant programs supporting behavioral health services across the country. Additionally, HHS, through the Centers for Medicare & Medicaid Services (CMS), issued guidance that allows states to expand the pool of behavioral health care providers eligible for enhanced federal Medicaid funding, which will better support this critical workforce as well as improve access to care. The guidance also allows states to claim federal dollars for nurse advice lines.”
  • BioPharma Dive tells us,
    • “The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals’ Simlandi, a biosimilar of the most popular version of AbbVie’s rheumatoid arthritis drug Humira. The drug, which can be directly substituted by a pharmacist, was rejected by the FDA twice before due to manufacturing issues at a plant in Iceland.
    • “The partners didn’t announce a launch date or a price for Simlandi, which will be the 10th Humira biosimilar reach market since Amgen’s Amjevita arrived on Jan. 31, 2023. Some biosimilars have launched at a steep upfront discount while others have a list price only slightly below Humira’s to allow for negotiation over rebates.
    • “Alvotech also announced a stock sale Monday, raising around $166 million at $16.41 a share. The company had $68 million in cash and equivalents on Sept. 30, after recording losses of $275 million on $30 million in revenue through the first nine months of 2023.”
  • HR Dive informs us,
    • “A federal district court has delayed a National Labor Relations joint employer rule effective date to March 11. Friday marks the second time the start date has been delayed; NLRB previously extended a Dec. 26, 2023, start date to Feb. 26.
    • “This new rule establishes a standard for determining if two organizations are joint employers of particular employees; two entities are joint employers when they co-determine the essential terms of an individual’s employment.”
  • The Census Bureau issued a tip sheet on grandparents and co-resident grandchildren 2021.
    • “According to the 2017-2021 ACS, 5-year estimates, 8.0% of children under age 18 lived in their grandparents’ home.
    • “The proportion of children living with only their grandparents or with their grandparents and one or both parents varied across race and ethnicity. For grandchildren who lived with grandparents, it was more common to also live with both parents or their mother in the household than to live with their father or no parent in the household.
    • “Overall, about 38.6% of children under age 18 who lived with grandparents also lived with two parents. Of all race and Hispanic origin groups, Asian grandchildren had the highest percentage (70.9%) in this living arrangement.
    • “About 16.2% of grandchildren under age 18 living with grandparents were in poverty. The percentage was higher for those in grandparent-maintained households (18.6%) compared to parent-maintained households (12.1%).
    • “About 76.1% of all grandchildren under age 18 living with grandparents lived in households that received public assistance, most commonly through the school lunch program.”
  • The tip sheet drew the FEHBlog’s attention due to FEHB coverage of foster children.
  • Health Reform Beyond the Basics offers an an explanation of the ACA Summary of Benefits and Coverage

From the public health and medical research front,

  • The New York Times offers a 2024 guide to COVID symptoms and treatments.
  • CNN points out,
    • “Cases of norovirus are on the rise in the US, on par with seasonal trends, according to the most recent data from the US Centers for Disease Control and Prevention.
    • “In the week ending February 17, more than 12% of tests for norovirus – a common and very contagious virus that causes gastrointestinal symptoms – came back positive, CDC data showed. That’s up from 11.5% the week before. Cases are particularly high in the Northeast, where more than 13% of tests came back positive. Positivity rates in the region have been over 13% since late January.
    • “However, these levels are below what they were at this point last season, when about 15% of tests were positive, both nationally and in the Northeast.
    • “Outbreaks of norovirus are most common in the late fall, winter and early spring, according to the CDC.”
  • HR Daily Advisor identifies eight tips to help employees improve mental health in the face of the winter blues.
  • Medscape lets us know that “Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.”
  • The National Institutes of Health announced,
    • “Results from a large clinical trial funded by the National Institutes of Health show that an intervention for anxiety provided to pregnant women living in Pakistan significantly reduced the likelihood of the women developing moderate-to-severe anxiety, depression, or both six weeks after birth. The unique intervention was administered by non-specialized providers who had the equivalent of a bachelor’s degree in psychology—but no clinical experience. The results suggest this intervention could be an effective way to prevent the development of postpartum mental health challenges in women living in low-resource settings.
    • “In low resource settings, it can be challenging for women to access mental health care due to a global shortage of trained mental health specialists,” said Joshua A. Gordon, M.D., Ph.D., Director of the National Institute of Mental Health, part of NIH. “This study shows that non-specialists could help to fill this gap, providing care to more women during this critical period.”
    • “Led by Pamela J. Surkan, Ph.D., Sc.D.(link is external), of Johns Hopkins Bloomberg School of Public Health, Baltimore, the study was conducted in the Punjab Province of Pakistan between April 2019 and January 2022. Pregnant women with symptoms of at least mild anxiety were randomly assigned to receive either routine pregnancy care or a cognitive behavioral therapy (CBT)-based intervention called Happy Mother-Healthy Baby. The researchers assessed the participants (380 women in the CBT group and 375 women in the routine care group) for anxiety and depression six weeks after the birth of their child.
    • “The researchers found that 9% of women in the intervention group developed moderate-to-severe anxiety compared with 27% of women in the routine care group. Additionally, 12% percent of women in the intervention group developed depression compared with 41% of women in the routine care group.”
  • According to BioPharma Dive,
    • “An experimental obesity drug from Boehringer Ingelheim and Zealand Pharma succeeded in a mid-stage liver disease study, the latest evidence new weight loss medicines could also help people with metabolic dysfunction-associated steatohepatitis, or MASH.
    • “Summary results disclosed Monday show that up to 83% of trial participants treated with the companies’ drug, survodutide, experienced a significant improvement in their disease without worsening liver scarring, compared to about 18% of those given placebo. The drug met its secondary study goals, notably demonstrating a benefit on liver scarring, the companies said.
    • “Boehringer and Zealand didn’t provide many other details, leaving unanswered questions about the magnitude of survodutide’s effect. The companies also didn’t describe safety findings in depth, although they noted treatment “did not show unexpected safety or tolerability issues” at any of the three doses tested. Data will be presented at an upcoming medical meeting.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Elevance Health’s CarelonRx will begin offering a weight management program, providing its members access to digital-first coaching and wellness tools.
    • “Behavioral health and social drivers of health screenings will be included in the offerings, according to a news release. The program will help members that take, as well as those that don’t take, GLP-1 medications. It will be available to ASO-integrated clients.
    • “At CarelonRx, we want to ease the complexities of weight loss and weight management, and support healthier lifestyles for our members,” said Paul Marchetti, president of CarelonRx, in a statement. “Our weight management program is unique because it considers a member’s whole health needs, including pharmacy, medical and social drivers of health data, and creates opportunities for care coordination between nutrition and exercise experts, pharmacists, physicians and health plans.”
  • and
    • “Humana tapped data automation company Veda to improve the accuracy of its provider information and ensure seniors have real-time details about in-network providers. The partnership was announced at the ViVE 2024 conference Monday morning. * * *
    • “Founded in 2015, Veda developed an AI platform that enables payers to transform and ingest provider rosters rapidly, reducing turnaround times from weeks to hours, according to the company.
    • “Veda will use its patented automation technology to analyze, verify and standardize Humana’s data to ensure the information is accurate and comprehensive, along with real-time scoring of data quality.
    • “Accurate provider data is a key component of efficient health plan operations, care delivery, interoperability, and ultimately patient satisfaction,” Meghan Gaffney, Veda co-founder and CEO, said. “By addressing the challenges that members may face with finding in-network care providers, Humana is ensuring their members have access to the timely, high-quality care they deserve.”  
    • “Veda says its platform achieves high data accuracy, ensuring quality across networks as measured by the Centers for Medicare & Medicaid Services (CMS).”
  • and
    • “The cybersecurity incident at Change Healthcare will stretch on for at least another day, according to the latest update from Optum.
    • “The company posted early Monday morning that it is taking multiple angles to get Change’s systems back online, and stressed that it has a “high level of confidence” that other systems within Optum, UnitedHealthcare and UnitedHealth Group are unaffected. * * *
    • “In a statement to CNBC, CVS Health said that while it is continuing to fill prescriptions for customers, it’s not able to process all of its insurance claims. The pharmacy giant added that there is “no indication” that its own systems have been breached.”
  • Reuters notes,
    • “Pharmaceutical companies last year launched new U.S. drugs at prices 35% higher than in 2022, reflecting in part the industry’s embrace of expensive therapies for rare diseases like muscular dystrophy, a Reuters analysis found.
    • “The median annual list price for a new drug was $300,000 in 2023, according to the Reuters analysis of 47 medicines, up from $222,000 a year earlier. In 2021, the median annual price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published in JAMA.”
  • The Society for Human Resource Management relates,
    • “Millions more employees than expected are leaving the workplace in favor of retirement—a phenomenon that stands to have an outsized impact on employers.
    • “The U.S. currently has roughly 2.7 million more retirees than predicted, Bloomberg reports, according to a model designed by an economist at the Federal Reserve Bank of St. Louis. That’s up 80 percent from six months ago, when there were roughly 1.5 million more retirees than anticipated. By contrast, prior to the pandemic, there often were fewer retirees than expected.”

Weekend update

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

From Washington, DC

  • Forbes reports,
    • “Markets are watching as twin deadlines for a government shutdown are approaching on March 1 and March 8. The first deadline impacts four of twelve appropriations areas for the U.S. government, the second the remaining eight.
    • “However, it’s possible that budgets pass in the coming days that avert a shutdown. If not, another continuing resolution, as has avoided previous potential shutdowns, appears likely. Continuing resolutions give lawmakers more time to pass a new budget by essentially rolling forward prior funding measures.
    • “Currently event forecasting site Kalshi, gives an approximately 20% chance of a shutdown by March 4, and estimates that any shutdown before July might last only days. As such, expectations are that a shutdown will likely be avoided and were a shutdown to occur, it would be brief.
    • “However, if no government budget is passed before April, then the Fiscal Responsibility Act may come into effect that could have considerable impact on government spending. That would likely impact economic growth and the trajectory of government debt.”
  • MedTech Dive tells us,
    • The current system for monitoring and recalling medical devices is failing patients, physicians wrote in the journal Health Affairs on Thursday.
    • With the Government Accountability Office (GAO) reviewing device recalls, the physicians looked at the current process to generate suggestions for improving medical device safety in the U.S.
    • The physicians advised the GAO to propose ways to clear barriers to the implementation of unique device identifiers (UDIs) and assess how the FDA can better use the National Evaluation System for Health Technology.

From the public health and medical research front,

  • The Centers for Disease Control updated its Respiratory Illness Activity Levels website on February 23.
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 27 jurisdictions experienced high or very high activity. This number remains stable compared to last week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Influenza test positivity decreased slightly nationally but is increasing in the Northeastern, Mid-Atlantic, and Central parts of the country. COVID-19 and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflect both symptomatic and asymptomatic infections, remain at high levels, particularly in the South, but are trending downward in other areas.”
  • The New York Times reports,
    • “A drug that has been used for decades to treat allergic asthma and hives significantly reduced the risk of life-threatening reactions in children with severe food allergies who were exposed to trace amounts of peanuts, cashews, milk and eggs, researchers reported on Sunday.
    • “The drug, Xolair, has already been approved by the Food and Drug Administration for adults and children over age 1 with food allergies. It is the first treatment that drastically cuts the risk of serious reactions — like anaphylaxis, a life-threatening allergic reaction that causes the body to go into shock — after accidental exposures to various food allergens.
    • “The results of the researchers’ study, presented at the annual conference of the American Academy of Allergy, Asthma and Immunology in Washington, were published in The New England Journal of Medicine.
    • “For a certain population of food allergy patients, this medication will be life-changing,” said Dr. Robert A. Wood, the paper’s first author and director of the Eudowood Division of Pediatric Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center.”
  • NPR Shots points out,
    • “E-bike injuries have surged, sending thousands of Americans to hospitals in recent years, new research shows. 
    • “Electronic bicycle accidents were particularly hard on riders’ heads, especially the majority of those injured who didn’t wear helmets. 
    • “Helmet use declined by almost 6 percent each year between 2017 and 2022, while the number of e-bike riders with head trauma seeking hospital care shot up 49 fold to nearly 8,000 in 2022, according to research published in JAMA Surgery on Wednesday.
    • “It’s a really significant public health problem,” said Dr. Laura Goodman, a pediatric surgeon and trauma medical director of the Children’s Hospital of Orange County, who was not involved with the study.”
  • The Washington Post explains “How to make your hearing aids more effective and less frustrating. In one study, only 29 percent of those with hearing loss used hearing aids.” 
  • Fortune Well informs us,
    • “A large study in China tracked middle-aged and older adults for 20 years, using regular brain scans, spinal taps and other tests.
    • “Compared to those who remained cognitively healthy, people who eventually developed the mind-robbing disease had higher levels of an Alzheimer’s-linked protein in their spinal fluid 18 years prior to diagnosis, researchers reported Wednesday. Then every few years afterward, the study detected another so-called biomarker of brewing trouble.
    • “Scientists don’t know exactly how Alzheimer’s forms. One early hallmark is that sticky protein called beta-amyloid, which over time builds up into brain-clogging plaques. Amyloid alone isn’t enough to damage memory — plenty of healthy people’s brains harbor a lot of plaque. An abnormal tau protein that forms neuron-killing tangles is one of several co-conspirators.
    • “The new research, published in the New England Journal of Medicine, offers a timeline for how those abnormalities pile up.
    • :The study’s importance “cannot be overstated,” said Dr. Richard Mayeux, an Alzheimer’s specialist at Columbia University who wasn’t involved in the research.
    • [However, t]he findings have no practical implications yet.”

From the U.S. healthcare business front,

  • Forbes offers very useful rankings of the largest health insurance companies by U.S. overall, individual coverage, group coverage, and by individual U.S. state.
  • Per BioPharma Dive,
    • “BioMarin Pharmaceutical is struggling to sell the first marketed gene therapy for the most common form of hemophilia, announcing on Thursday minimal revenue from the treatment, called Roctavian.
    • “In its latest earnings report, BioMarin said Roctavian generated $2.7 million in sales during the fourth quarter and $3.5 million in all of 2023, as three total patients — two in Germany and one in the U.S. — were treated last year. New CEO Alex Hardy told analysts the company is seeing progress in “market access,” but is “very mindful of the return on investment” with Roctavian.
    • “Roctavian is one of two important new products for BioMarin, which is reviewing its business under new management and deciding what research to continue supporting. The other, a drug for dwarfism called Voxzogo, is surpassing expectations. Sales totaled $146 million last quarter, more than double the previous period.”
  • CNBC reports on how “new sickle cell gene therapies are a breakthrough, but solving how to pay their high prices is a struggle.”
    • “[Michael] Goodwin [, a 36 year old man with sickle cell disease,] worries about the cost. Vertex Pharmaceuticals’ gene therapy Casgevy lists for $2.2 million, while Bluebird Bio’s treatment Lyfgenia lists for $3.1 million.
    • “I do have insurance, but … I already have medical bills,” he said.
    • “Goodwin’s hesitancy to pursue treatment is no surprise to Dr. Julie Kanter, director of the Adult Sickle Clinic at the University of Alabama at Birmingham.
    • “My guess is even if we opened the gates today to everybody getting this therapy, at most only 10% of those individuals affected by sickle cell would want this therapy,” said Kanter, who also serves as the president of the National Alliance of Sickle Cell Centers. “And even that would be too much for us to manage right this second.”
    • “More than 100,000 Americans have sickle cell disease, according to Centers for Disease Control and Prevention estimates, and between 50% and 60% of them covered are covered by the federal and state insurance program Medicaid.
    • “Kanter said it will take time to ramp up capacity and to set up facilities across the country to treat patients at scale.
    • “We really hope that having the National Alliance of Sickle Cell Centers will allow us to strengthen our centers to generally care better for people living with this disease, which we haven’t been able to do before because the cost is a problem,” she said.