Midweek Update

SDOH

Midweek Update

David Ermer–ACA, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, SDOH, U.S. Healthcare–

From Washington, DC

  • CBS News lets us know,
    • “The Biden administration says it has invoked the wartime powers of the Defense Production Act to speed rebuilding of a major American factory of intravenous fluids that was wrecked by Hurricane Helene last month. Damage to the plant in North Carolina has worsened a nationwide shortage of IV fluids, and hospitals say they are still postponing some surgeries and other procedures as a result. 
    • “Some 60% of the nation’s IV supplies had relied on production from the plant, run by medical supplier Baxter, before it was damaged by the storm.”
  • CMS released its “Final 2026 Actuarial Value Calculator Methodology.”
  • CMS announced,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), approved section 1115 demonstration amendments that allow, for the first time ever, Medicaid and Children’s Health Insurance Program (CHIP) coverage of traditional health care practices provided by Indian Health Service (IHS) facilities, Tribal facilities, and urban Indian organizations (UIO). Today’s action is expected to improve access to culturally appropriate health care and improve the quality of care and health outcomes for tribal communities in Arizona, California, New Mexico, and Oregon, and will support IHS, Tribal, and UIO facilities in serving their patients. 
    • “Traditional health care practices have been a way of life in many communities. And they are extremely important for American Indian and Alaska Native populations,” said HHS Secretary Xavier Becerra. “But, too often, health insurance does not cover them. With Medicaid and CHIP’s inclusion of traditional health care practices at certain IHS facilities, we are extending access to culturally appropriate, quality health care in Tribal communities.”
  • The Wall Street Journal reports,
    • “Novavax said federal regulators put a clinical hold on its application for a combination Covid-19 and influenza vaccine and stand-alone flu inoculation, sending shares down sharply.
    • “The vaccine maker on Wednesday said the Food and Drug Administration placed the hold because of a report of a “serious adverse event” of motor neuropathy in one clinical-trial participant outside the U.S., who received the vaccine in January of 2023.
    • “This participant was part of a Phase 2 trial for the combination vaccine that was completed in July 2023 and reported the adverse event in September of this year, the Gaithersburg, Md., company said.
    • “While we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA,” Novavax Chief Medical Officer Robert Walker said. “Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible.”
  • Reg Jones, writing in FedWeek, explains how court orders can impact federal retirement benefits.

From the public health and medical research front,

  • The Wall Street Journal tells us
    • “Frozen shoulder, a painful condition that immobilizes the shoulder joint, tends to strike midlife women.
    • “Treatments for frozen shoulder include steroid injections and physical therapy.
    • “Preliminary data suggests that hormone therapy might help prevent frozen shoulder in midlife women.”
  • and
    • “Scientists hope body tissues grown in labs will become a familiar sight in medicine. 
    • “Researchers around the world are working to grow heart valves, lungs and more from human cells. They have succeeded in bringing some to market such as knee cartilage and skin grafts, but advances for more complicated anatomy have been slow-going for years. 
    • “Now scientists are gaining ground in tissue engineering that could help a host of people who deal with circulatory-system problems.”
  • The American Medical Association offers “four steps to care for patients with prolonged symptoms of Lyme disease.”
  • BioPharma Dive notes,
    • “The Food and Drug Administration on Tuesday approved a new device to treat non-small cell lung cancer, Novocure’s Optune Lua, which creates electric fields that its manufacturer says disrupts malignant cell division. The FDA cleared the device for use with immunotherapy or chemotherapy in people whose cancer has spread and progressed following chemo.
    • “Approval was based on results from “Lunar,” a Phase 3 trial in which people who used the device with standard therapies had a 26% reduced risk of death over a median follow up of around 10 months. The results were controversial, however, because the trial included concurrent care with immunotherapies, which are typically used as a first-line treatment, as well as chemo.”
  • Per MedPage Today,
    • The long-term risk of distant recurrence for women with early breast cancer has declined significantly, a decades-long analysis of clinical trial data showed, largely a result of patients enrolling with lower-risk disease along with improved adjuvant therapy.
  • KFF discusses how “More Mobile Clinics Are Bringing Long-Acting Birth Control to Rural Areas.”
  • Per Health Day,
    • “Most Americans 50 and older don’t place much trust in health advice generated by artificial intelligence, a new survey finds.
    • “About 74% of middle-aged and senior Americans would have very little to no trust in health info generated by AI, the University of Michigan poll found.
    • “At the same time, these older adults have a lot of confidence in their ability to suss out bad info about health matters.
    • “Only 20% said they had little to no confidence they could spot misinformation about a health topic if they came across it.
    • “Among all older adults who’d scanned the web recently for health info, only 32% said it’s very easy to find accurate advice.
    • “Amid this lack of trust, our findings also highlight the key role that health care providers and pharmacists play as trusted health messengers in older adults’ lives, and even the role that friends or family with medical backgrounds can play,” said poll director Dr. Jeffrey Kullgren, an associate professor of internal medicine at the University of Michigan.”

From the U.S. healthcare business front,

  • Fierce Healthcare alerts us that U.S. News and World Report has released its Medicare Advantage and Part D plan ratings.
  • Beckers Hospital Review reports,
    • “UnitedHealth Group is seeing “unusually aggressive and high unit cost asks” from hospitals, CEO Andrew Witty said. 
    • “On an Oct. 15 call with investors, Mr. Witty said UnitedHealth wants to find a “new way of working with hospitals.” 
    • “We want to see less abrasion in the marketplace,” Mr. Witty said. “We believe that ought to come with more competitive rates in the marketplace.” 
    • “UnitedHealth reported its third-quarter earnings Oct. 15. CFO John Rex said medical costs rose in the third quarter, driven by increased pharmacy costs, Medicaid rates and an increase in coding intensity by hospitals.” * * *
    • “Mr. Witty told investors UnitedHealth wants to collaborate with hospitals to drive better value for the healthcare system. The company’s newly launched gold card program, which relaxes prior authorization requirements for some providers, is one example of this collaboration, Mr. Witty said. 
    • “The company is also seeking out partnerships with drug manufacturers to bring down prescription spending, Mr. Witty said. 
    • “Whether that be with drug companies that are interested in new ways of working to bring down costs, or whether that’s with hospital systems who want to work with us to reimagine what the patient experience, what the doctor experience is — [that’s] all part of bringing down the unit cost. Those are areas that are super important for the long run,” Mr. Witty said.” 
  • Per Fierce Pharma,
    • “With Gilead Sciences sprinting to a likely approval next year for its long-acting pre-exposure prophylaxis (PrEP) drug for HIV, the California company has a chance to one-up GSK. While the British company’s long-acting Apretude is injected every two months, Gilead’s answer is dosed just twice a year.
    • “Later this decade, GSK hopes to launch PrEP options that have four and six months of staying power. But, until then, it will do battle with Apretude (cabotegravir long-acting), which has just excelled in several real-world studies.
    • “In two real-world evidence studies of nearly 1,300 people, Apretude has shown better than 99% effectiveness in preventing HIV infections. GSK’s ViiV Healthcare unit also presented findings from the PILLAR implementation study, which show reductions in stigma and anxiety among users of the treatment. The new results are being presented Wednesday through Saturday in Los Angeles during IDWeek 2024.
    • “The results add to the positive momentum for Apretude, which was approved in December 2021 as the first long-acting PrEP option for HIV. The drug offers an alternative to daily pills such as Gilead’s Truvada and its follow-on Descovy.”
  • Investing.com relates,
    • “Aetna, a CVS Health company (NYSE: NYSE:CVS), has introduced a new health plan option called SimplePay Health, aimed at self-insured customers to potentially lower health care costs, enhance health outcomes, and streamline the health care experience. This plan offers a unique payment approach and tools for selecting high-quality health care providers.
    • “SimplePay Health, which is part of Aetna’s expanding portfolio, is designed to offer price certainty and simplicity for members. It features a copay-only structure with no deductibles or coinsurance, providing members with clear cost information for services prior to visits or treatments. The copay encompasses all aspects of a service, such as hospital visits or specialty services like labs.
    • “The plan claims to have resulted in a 60 percent increase in the use of top-quality providers and a 12 percent reduction in total care costs for employers and members. Members are equipped with an app to find providers based on cost and outcome quality, and they receive a single monthly statement summarizing all medical and pharmacy claims, similar to a credit card statement but with no interest and no payment due at the time of service.
    • “Aetna asserts that SimplePay Health enhances the overall health care experience by offering transparent cost insights and quality information to aid members in making informed decisions. Additionally, the plan includes a 0% interest rate line of credit benefit for paying balances, which is integrated into the medical plan.”

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Obesity, SDOH, Telehealth–

From Washington, DC,

  • Govexec informs us,
    • “The Senate on Thursday made progress on advancing bipartisan spending bills for fiscal 2025, though members of both parties acknowledged significant divisions remain between the two sides. 
    • “The chamber’s Appropriations Committee approved three of the 12 annual funding measures Congress must pass each year—those funding the departments of Agriculture and Veterans Affairs, as well as the legislative branch—in unanimous, 27-0 votes. While that marked a significant step forward in the fiscal 2025 process and an accomplishment that has eluded the panel’s House counterpart—which has advanced its bills to date only along partisan lines—the Senate could not come to a bipartisan agreement on how much money to allocate for the remaining nine funding measures.”
  • and
    • “The Senate on Wednesday voted 55-37 to confirm Anne Wagner as the third member of the Federal Labor Relations Authority, finally bringing the agency’s political leadership to nearly full strength.
    • “Similar to the National Labor Relations Board’s role overseeing collective bargaining in the private sector, the FLRA governs labor-management relations at federal agencies, with a three-member board that settles unfair labor practice complaints and other disputes between unions and management.” * * *
    • “Federal employee unions rejoiced at the news that the FLRA’s board was now fully staffed. The last 18 months of deadlock between [Colleen Duffy] Kiko and FLRA Chairwoman Susan Tsui Grundmann has meant the board could only rule in noncontroversial cases.”
  • The American Hospital Association News lets us know,
    • “The Senate Committee on Health, Education, Labor and Pensions held a hearing July 11 on medical debt. The AHA submitted a statement for the hearing that highlighted how the quality of insurance coverage is a driver of medical debt, saying that coverage for many patients is either insufficient or unavailable. The AHA discussed hospital and health system efforts offering financial and other assistance, and that hospitals absorb billions of dollars in losses for patients who cannot pay their bills, mainly due to inadequate commercial insurance coverage. To address the issue, the AHA urged Congress to restrict the sale of high-deductible health plans to individuals with the ability to afford the associated cost-sharing; prohibit the sale of health-sharing ministry products and short-term limited-duration plans that go longer than 90 days; and lower the maximum out-of-pocket cost-sharing limits, among other changes.”
    • That’s nuts, and it’s worth adding that all of the witnesses, except for one, were from the creditor side. Here’s a link to the American Enterprise Institute testimony.
  • The AHA News adds,
    • “The Centers for Medicare & Medicaid Services July 10 announced there will be 133 participants representing 772 practices for its new Making Care Primary Model. Participants in this voluntary model are from Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington. The model, which began July 1 and will run through 2034, seeks to improve care management and care coordination, enable primary care clinicians to partner with health care specialists, and use community-based connections to address patients’ health needs as well as their health-related social needs such as housing and nutrition.”
  • and
    • “The Centers for Medicare & Medicaid Services recently released results of an air ambulance qualifying payment amount calculations audit on Aetna Health in Texas. The report found that Aetna used practices that did not comply with federal requirements, and strongly recommended corrective actions. Specifically, the report found that Aetna failed to “properly calculate the QPA by using claim paid amounts instead of contracted rates, and counting each claim as its own contracted rate, even when the claims were for the same amounts for the same item or service and to the same provider of air ambulance services.” Aetna may also be subjected to future audits.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Research into chronic conditions affecting women is significantly lacking, and the National Institutes of Health and other agencies should do more to investigate issues that lead to worse medical treatment for women, a new report from the National Academies of Sciences, Engineering and Medicine says.
    • “Women are disproportionately affected by chronic illnesses, including Alzheimer’s disease and depression, according to the study requested by NIH’s Office of Research on Women’s Health and published Wednesday.
    • “But inadequate research in women’s health “hinders a comprehensive understanding of the impact on women” of these and other chronic illnesses, the report’s authors write. Further research is needed, particularly for Black women, who are more likely to die of a chronic illness than White women, the study says.”
  • and
    • “Nearly 1 in 10 people infected with the coronavirus during pregnancy developed long covid, according to a study published Thursday in the journal Obstetrics and Gynecology.
    • “Thursday’s study, which highlights the consequences of the virus during pregnancy, suggests long covid is more prevalent among people infected while pregnant than in the population overall. As many as 7 percent of Americans report having symptoms associated with long covid, according to a 2022 report from the Centers for Disease Control and Prevention. Some surveys suggest a far higher incidence of long covid in the general population.” * * *
    • “I was initially surprised at the prevalence of long covid in this population,” said Torri Metz, one of the study’s lead authors and a maternal-fetal medicine specialist at University of Utah Health. “It really drew my attention to the fact I need to have this on my radar when I am seeing patients.”
  • NBC News informs us,
    • “A key mystery behind one of the most common autoimmune diseases may finally have an answer.
    • “Researchers at Northwestern Medicine and Brigham and Women’s Hospital say they’ve discovered a root cause of lupus, a disease that affects hundreds of thousands of people in the U.S. 
    • “Scientists have long suspected that a person’s genetics or hormones may predispose them to lupus, and that the disease may be triggered by environmental factors like a previous viral infection or exposure to certain chemicals.
    • “Now, a study published Wednesday in the journal Nature outlines a clear pathway for how the disease likely develops, pointing to abnormalities in the immune systems of people with lupus.”
  • Neurology Advisor points out,
    • “The prevalence of stroke has increased by 14.6% from 2011 to 2022 among individuals aged 18 to 44 and 15.7% among those aged 65 and younger in the United States, according to a report published in Morbidity and Mortality Weekly Report.
    • “Researchers assessed trends in stroke prevalence between 2011 and 2022, using data from the Behavioral Risk Factor Surveillance System (BRFSS), a state-based surveillance system administered to noninstitutionalized civilian adults in the US in collaboration with the Centers for Disease Control and Prevention (CDC). * * *
    • “Age-standardized prevalence of stroke increased from 2.7% in 2011 to 2013 to 2.9% in 2020 to 2022, marking a 7.8% (95% CI, 4.9%-10.8%) increase in overall stroke prevalence. The researchers noted the highest stroke prevalence (7.7%; 95% CI, 7.5%-7.9%) among individuals aged 65 and older and the lowest prevalence (0.9%; 95% CI, 0.8%-1.0%) among individuals aged between 18 and 44 years.
    • “Stroke was observed to be highest (5.3%; 95% CI, 4.7%-5.9%) among the American Indian or Alaska Native group and lowest among the Asian group (1.6%; 95% CI, 1.2%-2.0%).
    • “With regard to educational level, individuals with a high-school diploma had the highest stroke prevalence (5.2%; 95% CI, 4.8%-5.4%) and those with a college degree or higher had the lowest stroke prevalence (1.7; 95% CI, 1.6%-1.8%).”
  • STAT News relates,
    • “Researchers from the American Cancer Society and International Agency for Research on Cancer estimate 40% of all cancer cases in the United States in people 30 and up were due to “potentially modifiable risk factors,” including cigarette smoking, physical inactivity, consumption of processed meat, viruses, excess body weight, alcohol drinking and more. Data was from 2019 in order to avoid the influence of the pandemic, when cancer diagnoses declined because of delayed care. The results were published in the American Cancer Society’s journal, CA: A Cancer Journal for Clinicians.” * * *
    • “In the study, alcohol was associated with seven cancers: oral cavity, pharynx, larynx, colorectum, and female breast, as well as squamous cell carcinoma in the esophagus, and hepatocellular carcinoma in the liver. Beyond those, “there is accumulating evidence” that alcohol can cause other cancers, such as pancreatic cancer, said lead author Farhad Islami, senior scientific director of cancer disparity research at ACS (which funded the study). 
    • “The increased risk is because of the alcohol in alcoholic beverages, not the type of beverage,” he said. A standard alcoholic beverage in the United States has about 14 grams of pure ethanol. That looks like one 12-ounce serving of 5% ABV beer, a 5-ounce serving of 12% ABV wine, 8-10 ounces of 7% ABV hard seltzer, or 1.5 ounces of 40% ABV liquor. Research suggests the higher a person’s consumption, the higher the risk of cancer.”
  • Here is a link to the NIH Director’s blog titled this week “Sequencing Technique Detects Earliest Signs of Genetic Mutations Underlying Cancer, Aging, and More”
  • The National Institutes of Health announced,
    • “Early findings from a small clinical trial provide evidence that a new cellular immunotherapy approach may be effective in treating metastatic solid tumors. In the trial, researchers from the National Institutes of Health (NIH) genetically engineered normal white blood cells, known as lymphocytes, from each patient to produce receptors that recognize and attack their specific cancer cells. These initial findings are from people with metastatic colorectal cancer who had already undergone multiple earlier treatments. The personalized immunotherapy shrank tumors in some patients and was able to keep the tumors from regrowing for up to seven months. The findings were published July 11, 2024, in Nature Medicine.” * * *
    • “Colon cancer is just one of many solid tumors the researchers are studying. The trial is still ongoing and includes patients with different types of solid cancers.
    • “It’s just the very beginning of converting normal lymphocytes into cells capable of treating the common solid cancers,” Dr. Steven A. Rosenberg, a co-leader of the study, said. “What this study shows is that it’s possible. Once you know it’s possible, you work to improve it.”
  • Here is a link to the All of Us Program’s latest Medical Minutes.

From the U.S. healthcare business front,

  • Beckers Hospital Review tells us,
    • “As more older adults opt for Medicare Advantage plans, reimbursement fights between hospitals and insurers are increasingly centered around those contracts.
    • “According to data shared with Becker’s by FTI Consulting, there were 20 reimbursement disputes between hospitals and insurers that made headlines somewhere in the country during the second quarter, the same amount as the first quarter and slightly lower than the same period in 2023, when 24 contract disputes were reported in national or local media.
    • “Notably, a record number of Q2 disputes (15 of 20) involved Medicare Advantage plans, and 30% of disputes failed to reach a timely agreement, meaning tens of thousands of patients were left without in-network coverage. FTI has tracked media reports regarding negotiations over reimbursement rates during each quarter since early 2022.”
  • BioPharma Dive reports,
    • “On Thursday, the pharmaceutical giant [Pfizer] said it is advancing a once-daily version of an experimental and closely watched medicine called danuglipron. Pfizer based the decision on results from a small clinical trial of healthy volunteers that’s been evaluating how the body interacts with danuglipron. Studies designed to find the optimal dose of the medicine are scheduled for later this year.
    • “Umer Raffat, an analyst at the investment firm Evercore ISI, speculates that with its update Thursday, Pfizer is “likely buying time” to see more data from a backup once-daily drug it’s been developing. “Candidly, the trial that just wrapped up never answered the question on” what dose would be effective enough to compete, he wrote in a note to clients.
    • “In that backdrop, the judicious thing to do from [the] Pfizer perspective was to not overcommit — and that’s exactly what they did today,” Raffat added. They “didn’t kill [danuglipron], they said it may move forward, but not right to [Phase 3].”
  • Beckers Payer Issues adds,
    • “As insurers continue to face major financial pressures related to covering weight loss drugs, many are steering more patients toward bariatric surgery to achieve similar results.
    • “Insurance companies are seeing that they’re getting more reliable outcomes and savings in the long run if they pay for someone to have bariatric surgery,” Christine Ren Fielding, MD, told Becker’s. Dr. Ren Fielding is a professor of surgery at NYU School of Medicine, the director of the NYU Langone Weight Management Program and chief of the system’s division of bariatric surgery.
    • “If you’re a responder to appetite control caused by a GLP-1, then there’s another treatment option that will do exactly the same thing: bariatric surgery. That includes Lap-Band, sleeve gastrectomy, and gastric bypass,” she said. “Bariatric surgery is the old-fashioned way. Insurers are now putting up barriers for people who want to be covered for GLP-1s and taking down barriers for people who want to have surgery.”
  • STAT News informs us,
    • “The Food and Drug Administration rejected Novo Nordisk’s weekly insulin for the treatment of diabetes in a rare setback for the pharmaceutical giant.
    • “The agency has requests related to the manufacturing process and the use of the insulin specifically in type 1 diabetes patients, Novo said in a statement Wednesday. The company, which had submitted an application for the drug for both type 1 and type 2 patients, said it does not expect to be able to fulfill the requests this year.”

Midweek Update

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

From Washington, DC

  • Beckers Payer Issues reports,
    • “Making expanded ACA subsidies permanent would add $335 billion to the national deficit between 2025 and 2034, the Congressional Budget Office estimated. 
    • “Premium tax credits have spurred record enrollment in ACA marketplace plans. These subsidies, implemented in 2021, are set to expire at the end of 2025 unless Congress votes to extend them. 
    • “In a June 24 letter to the chairs of the House ways and means and budget committees, the CBO estimated making subsidies permanent would cost $415 billion overall — the result of a $250 billion increase in spending and a $164 billion decrease in tax revenue. 
    • “These costs would partially be offset by a decline in offers of employment-based insurance, the CBO estimated, resulting in a total add of $335 billion to the budget.  * * *
    • “Payer executives have told investors they are optimistic Congress will cut a deal to extend the subsidies or make them permanent.”
  • Fierce Healthcare tells us,
    • “A leading Democrat and health legislator is urging the Centers for Medicare & Medicaid Services (CMS) to better enforce Medicare Part D program requirements for pharmacy benefit managers.
    • “By evading such requirements, PBMs are threatening the financial health of the country’s smaller pharmacies, Senate Finance Committee Chair Ron Wyden, D-Oregon, wrote to the agency in a letter (PDF).
    • “I am alarmed to hear reports that PBM contracting practices are straining the finances of pharmacies and directly contributing to their closures,” he said. “Specifically, I am concerned PBMs are not adhering to the new rule reining in direct and indirect remuneration (DIR) fees that took effect on January 1 and undermining Medicare’s pharmacy access standards as intended by Congress.”
  • The National Academies of Sciences, Engineering, and Medicine released a report titled “Ending Unequal Treatment: Strategies to Achieve Equitable Health Care and Optimal Health for All” which follows up on a well-known 2003 report on social determinants of health.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. * * *
    • “Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register to Regulations.gov. All written comments should be identified with the docket number and with the title of the guidance document.”
  • Federal News Network informs us,
    • “For more than a week, federal employees enrolled in FSAFEDS have not been receiving payments for approved reimbursement claims made in their Flexible Spending Accounts.
    • “The program suspended all reimbursement payments beginning June 16 as an effort to further strengthen anti-fraud and security measures, Federal News Network confirmed with a government source who explained the issue on the condition of anonymity.
    • “At this time, the FSAFEDS is holding all claims payments out of an abundance of caution,” FSAFEDS wrote Tuesday in a post on X. “FSAFEDS has taken this action due to recently discovered fraudulent claims activity. We are working to resolve and restore all claims payment activities as soon as possible.”
    • “The pause on reimbursement payments, however, has been lifted and payments to employees should resume soon, Federal News Network has learned. FSAFEDS plans to process all reimbursements currently on hold by the end of the week.

From the public health and medical research front,

  • MedPage Today tells us,
    • “All adults ages 75 years and older should receive a single dose of any respiratory syncytial virus (RSV) vaccine, and adults ages 60 to 74 years who are at increased risk of severe RSV disease should receive a vaccine, according to a unanimous 11-0 vote by the CDC’s Advisory Committee on Immunization Practices (ACIP).
    • “Also, people who have already received the RSV vaccine are not recommended to receive a booster, based on data that showed another dose did not improve outcomes.
    • “These recommendations supplant the current recommendation that adults ages 60 and older may receive RSV vaccination after engaging in shared clinical decision-making with their healthcare provider.
    • “There are currently three RSV vaccines available for use in older adults — GSK’s adjuvanted RSV prefusion F protein-based vaccine (Arexvy) Pfizer’s unadjuvanted, bivalent RSV prefusion F protein vaccine (Abrysvo), and Moderna’s mRNA-1345 vaccine (mRESVIA).
  • The American Hospital Association News notes,
    • “The Administration for Strategic Preparedness and Response June 25 announced a flu pandemic preparedness and response strategy in response to the threat of H5N1 bird flu in humans. The strategy, released through ASPR’s Biomedical Advanced Research and Development Authority, has four objectives: strategic implementation and deployment of the national pre-pandemic influenza vaccine stockpile; enhanced protection through novel vaccines; leverage therapeutics through deployment, early availability and development of novel products; and ensure rapid and effective diagnostics tools to inform rapid antiviral prescription and treatment.” 
  • BioPharma Dive calls attention to the fact “Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help? There are no drugs specifically for polycystic ovary syndrome, a chronic condition that can cause infertility. One study is testing whether Wegovy might be beneficial.”
  • Per Fierce Pharma,
    • “[Verona Pharma’s] Ohtuvayre [which the FDA approved for marketing today] becomes the first novel treatment advance in more than a decade for COPD, an inflammatory condition which restricts airflow from the lungs and leaves patients struggling to breathe. Ohtuvayre is approved as an add-on medicine with current therapies.
    • “As a selective dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, Ohtuvayre combines two properties in one medicine, setting it apart in COPD for its ability to both open the airways of patients and reduce their inflammation.
    • “It’s really the first novel mechanism as an inhaled therapy in over 20 years for COPD,” David Zaccardelli, Verona’s CEO said in an interview with Fierce Pharma. “We believe its bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm.”
  • The Washington Post reports,
    • “A few of your favorite ice cream products might no longer be in the freezer this summer after a prominent supplier to brands such as Hershey’s and Friendly’s issued a recall notice over a potential listeria contamination.
    • “Maryland-based Totally Cool recalled products from 13 brands distributed nationwide in retail locations and through direct delivery after sampling by the Food and Drug Administration discovered the presence of Listeria monocytogenes, the bacterium that causes listeria infections, the agency said Monday.
    • “The brands involved were Abilyn’s Frozen Bakery, Amafruits, Chipwich, Cumberland Farms, Dolcezza Gelato, Friendly’s, Hershey’s Ice Cream, Jeni’s, LaSalle, Marco, Taharka Brothers, the Frozen Farmer and Yelloh. More than 65 products were recalled, including ice cream cakes and sandwiches, as well as sorbets, according to a list published by the FDA that includes expiration dates.”

From the U.S. healthcare business front,

  • Kaufmann Hall discusses the state of play in healthcare antitrust enforcement.
  • The Wall Street Journal predicts “The War Over Cheaper Ozempic Won’t End Well for Some Investors. Once Eli Lilly and Novo Nordisk increase supply of weight-loss medications, companies such as Hims & Hers may find it trickier to sell compounded versions of the drugs [due to the nuances of FDA law.]”
  • MedTech Dive points out “Abbott and Dexcom are launching the first over-the-counter CGMs. Here are 7 questions on the new tech. Experts expect the release of new over-the-counter glucose monitors in the U.S. to fuel more widespread use of the devices.”
  • Per Fierce Healthcare,
    • “Blue Shield of California is making it easier for members to access their personal health data through its new Member Health Record.
    • “The platform will combine health data both from claims as well as from providers in one place and is available both online and through Blue Shield’s app so members can connect virtually. The Member Health Record will first launch for a “select group” of Medicare Advantage members and will be rolled out to all of its members by the end of the year.
    • “The health record will include information on lab results, immunizations, diagnoses and conditions alongside historical health data that have been shared with the plan, including details tallied before the member joined Blue Shield.”

Tuesday Tidbits

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

From Washington, DC

  • FedWeek informs us that
    • “Congress has started to craft the appropriations bills and the annual DoD authorization bill, the key measures for decisions on the upcoming year’s federal employee raise and on workplace policy changes.
    • “While it’s generally expected that none of those measures will be enacted into law before the elections — when Congress returns next week from its current recess, it will have only nine scheduled working weeks before November — the measures for the meantime will serve to stake out positions. * * *
    • “The primary bill affecting federal workplace policies, the financial services-general government measure, is set for voting next week at the subcommittee level and the following week for at the committee level.”
  • Federal News Network tells us,
    • “The Office of Personnel Management is working to address a spike in fraudulent activity on hundreds of accounts in a flexible spending account (FSA) program for federal employees.
    • “Several hundred federal employees currently enrolled in FSAFEDS have experienced recent fraudulent activity on their accounts. Scammers have used the employees’ personal information to either create new, fraudulent FSAs, or otherwise make fraudulent reimbursement claims on existing FSAs. * * *
    • “The fraudulent activity in FSAFEDS is relatively limited in scope, since it’s affecting just a few hundred federal employees’ accounts. In total, the scammers have managed to shore up a couple hundred thousand dollars, Politico first reported last week.
    • “Since becoming aware of the fraud, HealthEquity has already taken additional security measures by implementing Login.gov requirements and setting up dual-factor authentication for federal employees to be able to log in to their FSAFEDS accounts. * * *
    • “Agency benefits officers and payroll providers are advising federal employees who use FSAFEDS to review and verify their leave, earnings, and FSA account statements. If employees notice any suspicious charges or activity, they can call FSAFEDS at 877-372-3337.”
  • The Congressional Research Service posted a Legal Sidebar titled “HHS Finalizes Rule Addressing Section 1557 of the ACA’s Incorporation of Title IX” of the Education Amendments of 1972.
  • Newfront reminds us,
    • “IRS Notice 2023-70 adjusts the Patient-Centered Outcomes Research Institute (PCORI) fee to $3.22 per covered individual for health plan years ending on or after October 1, 2023 and before October 1, 2024, which includes 2023 calendar plan years. This represents a $0.22 per covered individual increase from last year’s PCORI fee (from $3.00).
    • “The annual PCORI fee must be reported and paid to the IRS by July 31, 2024, via the second quarter Form 720.”
  • The American Hospital Association News reports,
    • “A coalition of 230 national associations, including the AHA, submitted a letter the week of May 20 to the Federal Trade Commission requesting a stay on the Sept. 4 effective date of the Non-Compete Clause Final Rule to allow for judicial review.
    • “Under Section 705 of the Administrative Procedure Act, agencies ‘may postpone the effective date of action taken by it, pending judicial review’ when ‘justice so requires,'” the letter notes. “We strongly encourage you to exercise this power on the Noncompete Rule as FTC and other agencies recently have on other rulemakings.”
    • “The organizations said a lack of FTC guidance on key pieces of the rule, such as what it means to be in a policymaking position or how the FTC will apply its functional test, has created substantial uncertainty for businesses and employees nationwide. The final rule is currently being challenged in court by several parties, including the U.S. Chamber of Commerce. A decision is expected this summer.”
  • Mercer Consulting discusses how Part D enhancements for 2025 may impact Part D creditable coverage reporting, an OPM requirement for FEHB carriers.
    • “One of the outstanding questions that was addressed by CMS guidance is what the standard Part D coverage actuarial value will be for testing creditable coverage. Helpfully, CMS guidance provided that “discounts paid by manufactures are not included in the [Part D] plan paid amount when making a determination about creditable coverage.”
    • “This helpful clarification confirmed Mercer’s original interpretation that while it may be somewhat harder for some group health plans to pass creditable coverage testing, the passing threshold is not as drastic of an increase as many initial outside reports originally suggested.
    • “In addition, CMS clarified that it will continue to permit use of its 2009 creditable coverage simplified determination methodology, without modification to the existing parameters, for 2025 for group health plan sponsors not applying for the retiree drug subsidy. CMS will re-evaluate the continued use of the existing simplified determination methodology, or establish a revised one, for 2026 in future guidance.”

From the public health and medical research front,

  • The National Institutes of Health lets us know,
    • “Feeding children peanut products regularly from infancy to age 5 years reduced the rate of peanut allergy in adolescence by 71%, even when the children ate or avoided peanut products as desired for many years. These new findings, from a study sponsored and co-funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID), provide conclusive evidence that achieving long-term prevention of peanut allergy is possible through early allergen consumption. The results were published today in the journal NEJM Evidence.
    • “Today’s findings should reinforce parents’ and caregivers’ confidence that feeding their young children peanut products beginning in infancy according to established guidelines can provide lasting protection from peanut allergy,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “If widely implemented, this safe, simple strategy could prevent tens of thousands of cases of peanut allergy among the 3.6 million children born in the United States each year.”
    • “The new research findings come from the LEAP-Trio study, which builds on the seminal results of the Learning Early About Peanut Allergy (LEAP) clinical trial and the subsequent LEAP-On study, both sponsored and co-funded by NIAID.”
  • The HHS OIG issued a report on the inclusiveness of NIH-funded studies.
    • “What OIG Found
      • Two-thirds of the clinical trials in our sample had inclusive enrollment plans, but one-third did not plan to include all racial and ethnic groups.
      • Slightly more than half of clinical trials in our sample were missing required information that would explain the planned target population.
      • Most completed clinical trials in our sample missed planned enrollment targets for underrepresented groups.
      • NIH monitors clinical trial enrollment but has had limited success spurring improvement.
    • W”hat OIG Recommends
      • Hold researchers accountable for clearly describing the rationale for planned study population, as required by NIH policy.
      • Develop additional ways of supporting researchers in meeting inclusion enrollment targets.
      • Promptly take steps to align NIH’s demographic data collection and reporting with the revised OMB requirements and obtain more precise clinical trial inclusion enrollment data.
    • “NIH concurred with the three recommendations.”
  • STAT News reports “Heat waves associated with increased risk of preterm birth in the U.S.”
    • “A new investigation, published on Friday in JAMA Network Open, confirmed the link to early deliveries at a massive scale, in a large cohort study capturing over half of the births that occurred in the United States between 1993 and 2017. Its results shed light on the way existing health inequities may be exacerbated by a worsening climate.
    • “The study looked at more than 53 million singleton births that occurred in the 50 most populous cities in the U.S. during the hottest months of the year. Looking back at heat waves between May and September, researchers counted preterm births (between 28 to 37 weeks of gestation) and early births (between 37 and 39 weeks) within four to seven days of the spike. During that period, there were 2.15 million preterm births, and 5.8 million early births.
    • “After a heat wave, which the study defined as four consecutive days in which the mean temperature was higher than the local 97.5th percentile, preterm births increased by 2%, and early births by 1%. But the distribution of these adverse outcomes was uneven: Mothers who were 29 or younger, had a lower level of education, and belonged to a minority ethnic or racial group saw a 4% increase in preterm births, and a 3% increase in early deliveries.”
  • Medscape seeks to untangle the complex relationship between obesity and cancer.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Merck & Co. is close to a $1.3 billion deal to buy Eyebiotech, a move that would push the big drugmaker into the large and growing market for eye-care. “Merck & Co. is close to a $1.3 billion deal to buy Eyebiotech, a move that would push the big drugmaker into the large and growing market for eye-care. 
    • “Under the terms, Merck would pay the $1.3 billion in cash upfront to acquire the closely held biotech, according to people familiar with the matter. Merck could make an additional $1.7 billion in milestone payments for the company, which goes by the name EyeBio.
    • “The deal could be announced as early as Wednesday, the people said. Merck’s venture arm was an investor in EyeBio. 
    • “EyeBio’s lead drug, Restoret, is in development to treat eye conditions including a form of age-related macular degeneration that leads to blurred vision and potentially blindness. In older people with the disease, known as Wet AMD, a part of the retina wears down, and fluid leaks from blood vessels.” 
  • and
    • “Cancer Is Capsizing Americans’ Finances. ‘I Was Losing Everything.’
    • “Higher drug prices, rising out-of-pocket costs and reduced incomes create economic strain for many patients.”
  • Per BioPharma Dive,
    • “Johnson & Johnson is adding to its portfolio of dual-targeting antibody drugs, announcing on Tuesday a deal to acquire an experimental skin disease medicine for $1.25 billion.
    • “Per deal terms, J&J will buy Yellow Jersey Therapeutics, a spinout newly created by the drug’s developer, Swiss biotechnology startup Numab Therapeutics. The acquisition hands J&J a drug known as NM26 that’s ready for Phase 2 testing in atopic dermatitis, a form of eczema.
    • “In a statement, J&J said NM26 has the potential to offer “distinctive benefits” versus existing treatments for atopic dermatitis, which include Sanofi and Regeneron’s Dupixent and AbbVie’s Rinvoq. The drug targets two proteins, IL-4Ra and IL-31, that are linked to inflammatory diseases.”
  • STAT News relates,
    • “An experimental drug from Insmed Incorporated successfully reduced lung problems among patients with an airway disease in a closely watched Phase 3 trial, sending the company’s share price soaring early Tuesday. 
    • “The drug, brensocatib, reduced so-called pulmonary exacerbations by roughly 20% versus placebo in patients with bronchiectasis, hitting the trial’s primary endpoint. The trial, called the ASPEN study, tested two dosages of the drug, and the company said both significantly cut rates of pulmonary exacerbations.” 
  • Beckers Hospital Review notes,
    • “Novo Nordisk is contesting Sen. Bernie Sanders’ calls to reduce the list prices of Ozempic and Wegovy in the U.S., Bloomberg reports.  
    • “In late April, the Senate Health, Education, Labor, and Pensions Committee, chaired by Mr. Sanders, launched an investigation into Novo Nordisk’s list pricing for GLP-1 drugs. This followed research showing that Ozempic could be manufactured for less than $5 per month, significantly lower than the U.S. list price of nearly $1,000 for a monthly supply.
    • “Mr. Sanders requested information from Denmark-based Novo Nordisk by May 8, but the drugmaker requested an extension to submit its responses. 
    • “In a letter issued to Mr. Sanders May 24, Novo Nordisk said it is prepared to work with lawmakers to address “systemic issues so that everyone who can benefit from its medicines is able to get them,” but argued that focus on its list prices for the drugs is misplaced since it retains about 60% of the list price of Ozempic and Wegovy in the U.S. after rebates and fees are paid to middlemen, Bloomberg reports. 
    • “Novo Nordisk also said that focusing on the cost disparity is unfair because the development of the GLP-1 drugs required billions in upfront investment. The drugmaker said it spent over $10 billion to develop the GLP-1 medicines and that, “under current market conditions, the company expects that net prices will continue to decline for both Ozempic and Wegovy,” Bloomberg reports.”
  • and
    • “Johns Hopkins University Bloomberg Center recently awarded a team of researchers $300,000 to aid them in a “first-of-its-kind” drug supply chain dashboard. 
    • “On May 21, the Washington, D.C.-based college announced $15 million in funding for 40 projects. One of the winning projects is “The Johns Hopkins Drug Supply Chain Data Dashboard: Improving Data Transparency and Increasing Resiliency in the U.S. Pharmaceutical Supply Chain.”
    • “The dashboard “will provide timely insights to tackle drug shortages and supply chain disruptions,” according to Tinglong Dai, PhD, a Johns Hopkins professor of operations management and business analytics who is part of the research team.”
  • HR Dive points out that the recent Fair Labor Standards Act overtime rule changes effective on July 1, 2024. HR Dive shares some its articles about this rule.

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The U.S. National Guard Association informs us,
    • “More than 100,000 drilling National Guardsmen and Reservists who are full-time federal employees would be eligible to purchase TRICARE Reserve Select health care under legislation introduced in both the House and Senate last week.
    • “Most drilling Guardsmen and Reservists have been able to buy low-cost TRS for more than 15 years. But the 2008 law that created the current program excluded these service members from the more-expensive Federal Employees Health Benefits program. This exclusion includes the Guard and Reserve’s dual-status technicians. And while a provision in the fiscal 2020 National Defense Authorization Act lifts this prohibition, the change does not take effect until 2030.
    • “The Servicemember Healthcare Freedom Act of 2024 would allow federal employees to enroll in TRS once the legislation is enacted. The bill was introduced by Sen. Richard Blumenthal, D-Conn., and co-sponsored by Sens. Kyrsten Sinema, I-Ariz., Tina Smith, D-Minn., and John Fetterman, D-Pa., in the Senate. Reps. Jen Kiggans, R-Va., and Andy Kim, D-N.J., introduced the measure in the House. Kim is the Democratic co-chair of the House National Guard and Reserve Caucus.
    • “The legislation affects roughly 113,000 Guardsmen and Reservists, according to a fact sheet from Blumenthal’s office. This figure includes approximately 67,000 Guard and Reserve dual-status technicians, who must be drilling service members to maintain their full-time employment.
    • “Cost is often the big difference between TRS and FEHBP. For example, the widely used FEHBP Blue Cross Basic Option costs $150 a month for a single adult, per Blumenthal’s office. The same TRS coverage is $51.95 a month. The average family of four spent $657.04 each month on health care though FEHBP last year, according to the same fact sheet. Family plans through TRS cost $246.87 a month. * * *
    • “TRS also provides continuity of care during service members’ mobilizations and demobilizations.”
  • The Office of Personnel Management issued a press release about a “New Benefits Administration Letter to Promote the Integrity of the Federal Employees Health Benefits Program.” This was the action discussed in Federal Times and Federal News Network articles that the FEHBlog discussed yesterday. The press release adds,
    • “OPM has proposed legislation in its FY2025 Congressional Budget Justification which would enable OPM consistent access to funds from the Employee Health Benefits Fund to build a Central Enrollment system for the FEHB Program. Current FEHB eligibility determination and enrollment is highly decentralized and requires cooperation between nearly 100 employing offices responsible for determining eligibility and enrolling more than 8 million members. These benefits are delivered by 68 health insurance carriers in 2024.     
    • “Since 2022, and following passage of the Postal Service Reform Act, OPM began developing the Postal Service Health Benefits Program to include a centralized enrollment platform. The PSHB accounts for more than 20 percent of current FEHB enrollees. If funded, OPM could extend this same central enrollment system to all FEHB enrollments, which would allow OPM to manage and make consistent all FEHB enrollments and remove individuals who cease to be eligible for the program. ”   
  • OPM also should provide carriers with HIPAA 820 electronic enrollment rosters to systematically reconcile premiums to individual enrollees, thereby assuring that each enrollee is paying the appropriate premium.
  • WTW, a major consulting firm, posted an article about the final 2025 notice of benefits and payment parameters which calls attention to a point on which the FEHBlog has not yet focused.
    • CMS adopted a rule to remove the regulatory prohibition on issuers from including routine non-pediatric dental services as an essential health benefit (EHB). This change would allow states to update their EHB-benchmark plans to add routine adult dental services as an EHB, removing regulatory and coverage barriers to expanding access to adult dental benefits. 
    • If a self-insured [or any FEHB] plan adopts a state benchmark plan that covers non-pediatric dental as an EHB and that plan covers non-pediatric dental, then the plan could not impose annual or lifetime dollar limits on that coverage (unless the coverage meets the requirements to be an excepted benefit or limited scope dental).
  • The American Hospital Association News reports,
    • “The Federal Trade Commission, Justice Department and Department of Health and Human Services April 18 launched HealthyCompetition.gov, an online portal for the public to report potentially unfair and anticompetitive health care practices. The FTC and the Justice Department’s Antitrust Division plan to review complaints for the appropriate agency to investigate if it raises sufficient concern under antitrust laws or HHS authorities.”
  • HR Dive tells us,
    • “The U.S. Supreme Court held Wednesday that employees challenging discriminatory transfers at work do not need to prove they suffered “significant” harm under Title VII of the Civil Rights Act of 1964; instead, they need only prove harm was done. 
    • “To demand ‘significance’ is to add words to the statute Congress enacted,” the high court ruled in Muldrow v. City of St. Louis. “It is to impose a new requirement on a Title VII claimant, so that the law as applied demands something more than the law as written. That difference can make a real difference for complaining transferees.”
    • “In the case, a police sergeant alleged she was transferred out of the intelligence division because of her sex and given less “prestigious” duties, a worse schedule and fewer job perks.”
  • The U.S. Census Bureau reports,
    • “The percentage of adults age 65 and older covered by both private health insurance and Medicare decreased from 47.9% in 2017 to 39.6% in 2022, reflecting older adults’ increased reliance on Medicare coverage alone.
    • “Dual coverage rates decreased almost every year during that period, except from 2020 to 2021, while rates of Medicare coverage alone significantly increased during the same period, from 37.6% to 44.8%, according to a new analysis of data from the 2023 Current Population Survey Annual Social and Economic Supplement (CPS ASEC). 
    • “Much of the increase in the share of older adults relying solely on Medicare was driven by a drop in the share of those also receiving private coverage.”
  • Although OPM waited much too long to allow FEHB plans the opportunity to offer Part D EGWPs, OPM to its credit has not followed the lead of many private employers which leave their retirees to Medicare alone.
  • The Social Security Administration has made available an interview with its new Commissioner Martin O’Malley who discussed his top priorities: “1) Reduce call wait times, 2) Issue faster disability decisions, 3) Resolve inequities in overpayments and underpayments.”

From the public health and medical research front,

  • Per MedPage Today,
    • “The CDC and FDA are warning about a multistate outbreak of Salmonella typhimuriumopens in a new tab or window infections linked to fresh basil sold at Trader Joe’s stores in over two dozen states.
    • “Twelve cases have been reported across seven states as of April 17, including one hospitalization. Exposure to fresh organic basil from Trader Joe’s prior to illness was confirmed in seven of eight individuals with additional case information.
    • “Miami-based Infinite Herbs, which makes the basil, has agreed to a voluntary recall, and the herbs have been pulled from store shelves.
    • “If you already bought organic basil from Trader Joe’s and removed it from the packaging or froze it and cannot tell if it was Infinite Herbs-brand, do not eat or use it and throw it away,” the FDA said in its statementopens in a new tab or window.
    • “The product was sold in a 2.5-oz clamshell-style container at Trader Joe’s stores in Washington, D.C., and 29 statesopens in a new tab or window, with most east of the Mississippi River. Cases have been reported in Florida, Georgia, Minnesota, Missouri, New Jersey, Rhode Island, and Wisconsin.
    • “An investigation is ongoing to determine whether additional products are linked to the illnesses, the FDA noted.”
  • The NIH Director, in her blog, pointed out,
    • “Pregnancy and childbirth are often thought of as joyful times. Yet, we know that mental health conditions including perinatal depression, anxiety, and post-traumatic stress disorder (PTSD) are common complications during and after pregnancy, and this is contributing to a maternal health crisis in this country.
    • “Now, a trio of NIH-supported studies reported in the journal Health Affairs show that diagnosis and treatment of mental health conditions such as anxiety, depression, and PTSD during pregnancy and in the first year after giving birth rose significantly in Americans with private health insurance from 2008 to 2020. While these are encouraging signs of increasing mental health awareness and service use, these studies also showed that this increase hasn’t happened equally across all demographic groups and states, making it clear there’s more work to do to ensure that people from all walks of life have access to the care they need, regardless of their race, ethnicity, geographic location, financial status, or other factors. * * *
    • “It will be important to learn in future studies more about those who may still not be receiving the mental health care they need. The researchers report plans to look deeper into changes that have taken place at the state level and the impact of the pandemic and the rise of telehealth since 2020. Other recent NIH-supported research suggests that relatively straightforward interventions to reduce postpartum anxiety and depression can be remarkably effective. The key step will be not only identifying interventions that work, but also figuring out how to deliver effective treatments to the people who need them.”
  • According to BioPharma Dive,
    • “Cerevel Therapeutics, a biotechnology company in the midst of being acquired by AbbVie, on Thursday said a Parkinson’s disease treatment it’s developing succeeded in a late-stage clinical trial.
    • “The treatment, called tavapadon, helped keep the disease’s disruptive motor fluctuations at bay, extending the total time of symptom control by just over one hour, compared to a placebo. This difference in “on” time was statistically significant, Cerevel said.
    • “Tavapadon also significantly reduced the amount of “off” time that treated study participants experienced, meeting a secondary goal of the Phase 3 study. People with Parkinson’s often cycle between these “on” and “off” periods as the effects of mainstay drugs like levadopa and carbidopa wane. In Cerevel’s study, tavapadon was given as an adjunctive therapy, meaning it was added on top of levadopa.”
  • The Washington Post reports,
    • “The nation’s largest coalition of obstetricians issued an urgent warning Thursday calling on doctors to expand testing for syphilis during pregnancy amid a surge of cases in recent years.
    • “The American College of Obstetricians and Gynecologists updated its recommendations, advising a routine blood screening at the first prenatal visit and screenings in the third trimester of pregnancy and at birth. This contrasts with previous recommendations, which called for testing in the third trimester exclusively for individuals living in communities with high syphilis rates and for those at risk of syphilis exposure during pregnancy.
    • “We’re always trying to create healthier families, and some of the diseases that we can easily diagnose and treat are things that we should prioritize, especially when they can be devastating to a baby,” said Laura E. Riley, chair of the obstetrician coalition’s immunization work group. Riley helped write the guidance. * * *
    • “In April 2023, the Food and Drug Administration announced a shortage of penicillin in the United States attributed to increased demand.
    • “To combat the ongoing shortages, the FDA granted temporary approval for a French drug, Extencilline, which is used for syphilis treatment but is not FDA-approved. While the Food, Drug, and Cosmetic Act prohibits importing unapproved drugs into the United States, the secretary of Health and Human Services can authorize temporary importation and distribution of such drugs to address shortages until domestic production returns to normal levels.
    • “Riley said the updated guidance from the obstetricians group is essential because it makes physicians aware of the alternative treatment for syphilis amid the shortage.
    • “In June 2023, the maker of penicillin, Pfizer, said it would prioritize making the drug available, with the shortage expected to be relieved within the next few months of this year.”

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • “Elevance Health posted $2.2 billion in net income during the first quarter, a nearly 13% increase compared to the same period last year, according to the company’s earnings report published April 18.
    • “First quarter results reflect disciplined execution of our strategic initiatives during a dynamic time for our industry,” President and CEO Gail Boudreaux said. “We are making significant progress expanding Carelon’s capabilities, scaling our flywheel for enterprise growth, and delivering results for all stakeholders. Given the solid start to the year, we have increased our outlook for full year earnings.”
    • “Total revenues in the first quarter were $42.6 billion, a 1% increase year over year.
    • “Total expenses in the first quarter were $39.6 billion, a 0.2% increase.
    • “Net income was $2.2 billion in the first quarter, up 12.9% from the same period last year. 
    • “Elevance raised its full-year earnings outlook to $37.20 in earnings per share.”
  • Modern Healthcare lets us know,
    • “CVS Health is opening Oak Street Health primary care clinics at its retail pharmacy stores — a move that hasn’t always worked out for competitors.
    • “CVS acquired primary care provider Oak Street last May for $10.6 billion and announced plans to add 50 to 60 Oak Street clinics in 2024. Most of those clinics are expected to be standalone locations, including some located in closed CVS stores. But CVS also is piloting a setup that replaces much of the retail space in existing stores with clinics.
    • “Walgreens executives say they remain confident in the VillageMD investment, although the focus has shifted away from expansion and more toward ramping up profitability in VillageMD’s strongest markets.
    • “CVS may have a different experience. Its expansion plan for Oak Street has a slower pace than what Walgreens tried, said Jack Slevin, vice president of healthcare services equity research at Jefferies. CVS’ model is dedicating a lot of space to the Oak Street clinics and pharmacy operations, which would allow for more patient volume, he said.
    • “[CVS is] giving them enough space that it feels like a true Oak Street location,” Slevin said. “If you look at the Walgreens strategy on the square footage side, it was very much more bolting on a smaller Village practice to a Walgreens store that was going to look very much the same.”
  • The FEHBlog also ran across the following consulting firm opinion pieces that are worth a gander:
    • A Brown and Brown paper on the role of employers in advancing health equity.
    • A RAND paper discussing why employers delay coverage for FDA newly approved drugs.
      • FEHBlog takeaway :”The FDA has steadily increased the speed at which it approves new drugs over the last two decades. In 2023, the agency approved 55 new drugs, up from 21 in 2003. The great majority of drugs are now approved through its accelerated program, leaving the FDA wide open to criticism that its standards are too low and that it is simply acting as a rubber stamp for pharmaceutical companies. Under the accelerated program, the FDA grants approval for the drug to be put on the market and later grants full approval after clinical trials confirm a drug’s effectiveness.”
    • A McKinsey Health Institute paper on improving mental health services for children.
      • “As part of the McKinsey Health Institute’s (MHI’s) Conversations on Health series, Erica Coe and Kana Enomoto, coleaders at MHI, discussed this challenge and how to prioritize the mental health needs of children and adolescents with Zeinab Hijazi, PsyD, the global lead on mental health at UNICEF.”

Weekend Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, SDOH, U.S. Healthcare, Uncategorized–

Today is World Health Day.

  • McKinsey & Co. tells us,
    • “The good news: People are living longer. The bad news: People are spending more time in poor health. Global longevity has risen substantially in the past 60 years, increasing life spans by 20 years on average, but every additional year of life is paid for with an average of six months in ill health. According to a recent report from the McKinsey Health Institute (MHI), a focus on immediately influenceable interventions at the city level can add approximately 20 billion to 25 billion years of higher-quality life at a global level—that’s an average of five additional years per person living in urban areas. All organizations across sectors have a role to play to capture this opportunity, write McKinsey’s Hemant Ahlawat, Erica Hutchins Coe, Pooja Kumar, and Drew Ungerman.”
  • On April 5, 2024, “House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) announced a markup will take place on Wednesday, April 10 at 10:00 am ET to consider a series of legislation,” including
    • H.R. 7868, the FEHB Protection Act: The bill requires federal agencies to verify that an employee is eligible to add a family member to their Federal Employees Health Benefits Program (FEHBP) health coverage plan. This bill also requires the Office of Personnel Management (OPM) to consider coverage of ineligible individuals when conducting FEHBP fraud risk assessments and requires a comprehensive audit be conducted of employee family members currently enrolled in the FEHBP. Finally, the bill requires OPM to disenroll any ineligible individual found to be receiving FEHBP coverage.
  • Congress should be including in H.R. 7868 a provision requiring federal agencies to use the HIPAA 820 electronic enrollment roster transaction which would allow carriers to systematically reconcile individual enrollees with their premium payments. None of the provisions in HR 7868 would provide a greater improvement in internal controls than implementing the HIPAA 820 because half of the FEHB enrollment is self only. Moreover, what is the sense of confirming family member enrollment if the enrollee in question is not paying for family coverage?
  • The current premium reconciliation process known as CLER was implemented in 2001, eleven years before the HIPAA 820 was introduced. The time has long passed for CLER to be replaced by the much more efficient HIPAA 820.

From the FEHB front,

  • FedWeek highlights how FEHB plans coordinate their benefits with other coverage.
  • Tammy Flanagan writing in Govexec discusses the importance of knowing Medicare and FEHB coordination of benefit rules before requesting agency help.
  • In the Federal Times, Reg Jones answers the following question “Will my spouse be covered once I qualify for Medicare Part B?

From the public health and medical research front,

  • The National Institutes of Health announced today,
    • “Adults with heart disease risks who received daily reminders or incentives to become more active increased their daily steps by more than 1,500 after a year, and many were still sticking with their new habit six months later, according to a study supported by the National Institutes of Health that published in Circulation(link is external).
    • “The improvements, which also resulted in an extra 40 minutes of moderate exercise each week, correlated with a 6% reduced risk of premature death and a 10% reduced risk of cardiovascular-related deaths, compared to data from prior studies. The Department of Health and Human Services recommends(link is external) that most adults should get at least 150 minutes of moderate aerobic exercise per week, such as brisk walking, or 75 minutes of vigorous exercise, like fast cycling, or a combination of the two, paired with twice-weekly strength sessions.
    • “Researchers found that while a simple daily reminder was effective in helping people move more, offering financial incentives or point-based rewards, such as in a game, was even more effective. However, combining the two incentives proved most effective. Participants who got both were still logging improvements in activity levels six months after the rewards stopped.
    • “Even moderate exercise can drastically reduce cardiovascular risk, so finding low-cost ways to get people moving and stay in a fitness program that they can do at home is a huge win for public health,” said Alison Brown, Ph.D., R.D., a program officer at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH.”
  • The New York Times offers an interview with Dr. Nora Volkow, the director of the National Institute on Drug Abuse.
    • What’s the big picture on teens and drug use?
      • People don’t really realize that among young people, particularly teenagers, the rate of drug use is at the lowest risk that we have seen in decades. And that’s worth saying, too, for legal alcohol and tobacco.
    • What do you credit for the change?
      • One major factor is education and prevention campaigns. Certainly, the prevention campaign for cigarette smoking has been one of the most effective we’ve ever seen.
      • Some of the policies that were implemented also significantly helped, not just making the legal age for alcohol and tobacco 21 years, but enforcing those laws. Then you stop the progression from drugs that are more accessible, like tobacco and alcohol, to the illicit ones. And teenagers don’t get exposed to advertisements of legal drugs like they did in the past. All of these policies and interventions have had a downstream impact on the use of illicit drugs. * * *
      • “But we don’t want to become complacent. The supply of drugs is more dangerous, leading to an increase in overdose deaths. We’re not exaggerating. I mean, taking one of these drugs can kill you.”
  • Fortune Well explores the non-invasive colorectal cancer screening alternatives to a full blown colonoscopy.
  • The Washington Post reports,
    • “Black and White patients face significant disparities in access to kidney transplants depending on whether their residential neighborhoods and transplant centers were racially segregated, a recent study has found.
    • “The study, published in JAMA Internal Medicine, looked at 162,587 first-time live-donor kidney transplantation candidates in the national transplant registry from January 1995 through December 2021. Participants were tracked for an average of 1.9 years. * * *
    • “Overall, 7.1 percent of Black candidates in segregated neighborhoods received a live kidney transplant over a three-year period, while 9 percent of their Black counterparts in less segregated areas received a transplant. The percentage of White candidates who received similar transplants was similar in highly segregated neighborhoods and more diverse areas during the period — 19.7 percent and 20.1 percent, respectively. * * *
    • “The analysis adds to a growing body of literature about social disparities that affect Black patients’ access to kidney transplantation in the United States. Overall, Black patients are likelier to develop kidney failure than their White counterparts, yet they experience treatment delays and are less likely to get kidneys from live donors.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Four in 10 therapists are planning to raise their fees in 2024, a new survey has found.
    • “Heard, a bookkeeping and accounting firm for therapy practices, surveyed more than 2,260 therapists across all 50 states and D.C. The findings were published in a report on the financial state of private practices. It found that half of therapists are somewhat or very concerned about the economy impacting their practice in the coming year.
    • “At the same time, in last year’s report, 64% of therapists said they were planning to raise their fees in 2023. Yet only a third did.
    • “Despite cash pay popularity, three-quarters of therapists still accept some form of insurance. Aetna was the most common payer with which therapists paneled, followed by Cigna, Blue Cross Blue Shield, Anthem and Oxford. Aetna also had the highest average reimbursement rate at $141 per session, while Humana had the lowest at $96.’ 

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.” 

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–Congress, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, OPM, SDOH, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Politico reports,
    • “Congress is out of town this week and facing another government shutdown deadline with major health care implications.
    • “Lawmakers are confronted with two deadlines — March 1 for funding for the FDA and the VA and March 8 for HHS funding.
    • “It’s a key week for Congressional appropriators. How much progress they make now will determine whether lawmakers have to turn to another temporary spending package.
    • E”ven though Congress is away, negotiations continue, and key lawmakers are “encouraged” about the prospect of reaching a deal.
    • “But as POLITICO’s Caitlin Emma and Jennifer Scholtes report, there’s skepticism about whether the progress is being made quickly enough, according to sources familiar with the talks. Legislative text for some fiscal 2024 measures should ideally be finalized by this weekend to allow time for the Congressional Budget Office to pore over the bills and top lawmakers to calculate their next steps.”
  • Govexec offers a Kevin Moss article about OPM’s recent call letter for 2024 benefit and rate proposals for FEHB and PSHBP coverage. Bear in mind that the article does not appreciate the fact the Part D EGWP plans integrate Medicare and FEHB / PSHB coverage so that if Medicare does not cover a particular drug, like an obesity treatment, the FEHB / PSHB coverage will kick in.
  • FEDWeek discusses an OPM Inspector General report criticizing OPM’s FEHB disputed claims resolution process. The FEHBlog thinks that OPM does a good job with this process. Of course, any process can be improved but at what cost?
  • Healthcare Dive tells us,
    • “The CMS finalized a rule on Tuesday recalculating disproportionate share hospital payments, or reimbursements for hospitals serving a high proportion of low-income patients. Under the new definition, hospitals can only receive reimbursements for services rendered to beneficiaries for whom Medicaid is their primary insurer. 
    • “Congress tasked the CMS with clarifying DSH calculations in its Consolidated Appropriations Act of 2021. The final rule aims to reduce DSH overpayments by limiting hospitals’ ability to receive government and private payer funds for the same service, according to the rule.
    • I”n total, the CMS’ new calculations will result in an $8 billion reduction in DSH payments annually from fiscal year 2024 to 2027, according to the rule.” 
  • Assistant Secretary of Labor for Employee Benefit Security, Lisa Gomez, posted a blog entry about how to use your employer sponsored health benefits to improve heart health.
  • The Government Accountability Office issued a report on maternal health.
    • “Hundreds of women in the U.S. die each year from complications related to pregnancy and childbirth—a crisis exacerbated by COVID-19. The Department of Health and Human Services is working to address the crisis and meet long-term goals such as increasing women’s access to high-quality maternal care.
    • “As of September 2023, HHS hasn’t determined how it’ll measure progress toward achieving its maternal health goals. Following key performance measurement practices—such as setting near-term goals and establishing timeframes for results—would allow the agency to better understand if its efforts are effective. We recommended that HHS do so.”
  • The National Institutes of Health announced,
    • “launch[ing] a clinical trials network to evaluate emerging technologies for cancer screening. The Cancer Screening Research Network (CSRN) will support the Biden-Harris administration’s Cancer Moonshot℠ by investigating how to identify cancers earlier, when they may be easier to treat. Eight groups have received funding from the National Cancer Institute (NCI), part of NIH, to carry out the initial activities of the network.
    • “There are many cancers we still cannot reliably detect until it is so late that they become extremely difficult to treat,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “Emerging technologies such as multi-cancer detection tests could transform cancer screening and help to extend the lives of many more people. We need to be sure that these technologies work and understand how to use them so they benefit everyone.”
    • “Studies are needed, for example, to evaluate the benefits and harms of promising new technologies for cancer screening and to determine how best to incorporate these technologies into the standard of care.”
    • “In 2024, the network will launch a pilot study, known as the Vanguard Study on Multi-Cancer Detection, to address the feasibility of using multi-cancer detection (MCD) tests in future randomized controlled trials. MCDs are blood tests that can screen for several types of cancers. The study will enroll up to 24,000 people to inform the design of a much larger randomized controlled trial. This larger trial will evaluate whether the benefits of using MCD tests to screen for cancer outweigh the harms, and whether they can detect cancer early in a way that reduces deaths.”

From the public health and medical research front,

  • KFF informs us,
    • The United States is knee-deep in what some experts call the opioid epidemic’s “fourth wave,” which is not only placing drug users at greater risk but is also complicating efforts to address the nation’s drug problem.
    • These waves, according to a report out today from Millennium Health, began with the crisis in prescription opioid use, followed by a significant jump in heroin use, then an increase in the use of synthetic opioids like fentanyl.
    • The latest wave involves using multiple substances at the same time, combining fentanyl mainly with either methamphetamine or cocaine, the report found. “And I’ve yet to see a peak,” said one of the co-authors, Eric Dawson, vice president of clinical affairs at Millennium Health, a specialty laboratory that provides drug testing services to monitor use of prescription medications and illicit drugs. * * *
    • Methamphetamine, a highly addictive drug often in powder form that poses several serious cardiovascular and psychiatric risks, was found in 60% of fentanyl-positive tests last year. That is an 875% increase since 2015. * * *
    • Among the report’s other key findings:
      • The nationwide spike in methamphetamine use alongside fentanyl marks a change in drug use patterns.
      • Polydrug use trends complicate overdose treatments. For instance, though naloxone, an opioid-overdose reversal medication, is widely available, there isn’t an FDA-approved medication for stimulant overdose.
      • Both heroin and prescribed opioid use alongside fentanyl have dipped. Heroin detected in fentanyl-positive tests dropped by 75% since peaking in 2016. Prescription opioids were found at historic low rates in fentanyl-positive tests in 2023, down 89% since 2013.
  • MedPage Today points out,
    • “Annual breast cancer screening at ages 40 to 79 resulted in the greatest reduction in mortality, according to a study comparing various screening scenarios.
    • “Using Cancer Intervention and Surveillance Modeling Network (CISNET) estimates of breast cancer screening outcomes published in 2009, 2016, and 2023, mortality was reduced by 41.7% with annual screening starting at age 40 and continuing up to age 79, reported Debra L. Monticciolo, MD, of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, and colleagues.”
  • AP reports,
    • “Emily Hollenbeck lived with a deep, recurring depression she likened to a black hole, where gravity felt so strong and her limbs so heavy she could barely move. She knew the illness could kill her. Both of her parents had taken their lives. 
    • “She was willing to try something extreme: Having electrodes implanted in her brain as part of an experimental therapy.
    • “Researchers say the treatment —- called deep brain stimulation, or DBS — could eventually help many of the nearly 3 million Americans like her with depression that resists other treatments. It’s approved for conditions such as Parkinson’s disease and epilepsy, and many doctors and patients hope it will become more widely available for depression soon.”
  • Fierce Healthcare lets us know,
    • “Given the impact that social factors have on overall health, employers can better manage costs and outcomes by embracing deeper, population-level data analysis, according to a new white paper.
    • “UnitedHealthcare and the Health Action Council (HAC), a nonprofit that represents large and midsize employers, dug into community health data from HAC’s plan sponsors representing 217,779 workers. The analysis found that 52% of adults have at least one social determinant of health risk.
    • “Of that group, 10% faced three or more risks, and 16% had two risk factors. Twenty-six percent have one SDOH risk factor, according to the report.
    • “Craig Kurtzweil, chief data and analytics officer for UnitedHealthcare Employer and Individual, told Fierce Healthcare that the study “gives us a first of its kind sort of view of all the different variables that are impacting the health of various communities and employers.”
    • “As you dive a little bit further, it just becomes a bit remarkable how much of an impact those factors are making,” he said.”
  • Becker’s Hospital Review brings us up to date on prescription drug shortages.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “St. Louis-based Ascension Healthcare brought in $231 million in operating income during its second quarter 2024 ended Dec. 31, compared to an operating loss of $291 million during the prior-year period.
    • “Ascension attributed its operational improvement in part to volume growth. Inpatient admissions increased 0.5% in thesix months ended Dec. 31, with same-facility admissions increasing 1.2% for the same period year over year.
    • “The health system said it slowed the pace of expense growth during the quarter. Total salaries, wages and benefits decreased $152 million in the six months ended Dec. 31, totaling $54.9 million for the quarter, as Ascension outsourced lab services and continued retention programs to reduce dependence on pricey staffing agencies.”
  • STAT News notes,
    • “DarioHealth, which makes apps for managing chronic diseases, today announced it will acquire digital mental health company Twill for $10 million in cash plus stock valued at over $20 million at the end of Tuesday trading. The move is a bet that a consolidated offering can attract a critical mass of large customers in a market where profits have been elusive.
    • “Founded in 2011, Dario started with a diabetes app targeted at consumers before expanding it to hypertension and weight management. It still maintains that direct-to-consumer business but has since shifted its focus to selling its suite of offerings, including a musculoskeletal care program it acquired in 2021, to health plans and employers in the hopes of reaching much larger patient populations. Recent updates aimed at making itself attractive to clients include a new offering built around popular, and expensive, GLP-1 weight loss drugs, and published real world data suggesting its tools can save clients money on downstream health care costs. With Twill, Dario adds a mental health app and related services, addressing a top demand of employers.”
  • Per Fierce Healthcare,
    • “Teladoc offered a weaker-than-expected forecast for 2024, projecting slower revenue growth as the telehealth market has become crowded with digital health players.
    • “The virtual care giant pulled in $661 million in revenue in the fourth quarter of 2024, up 4% from $638 million in the same period a year ago. Access fees revenue grew 4% to $574 million, and other revenue grew 3% to $87 million. U.S. revenue grew 2% to $565 million, and international revenue grew 15% to $96 million.
    • “The company’s BetterHelp virtual mental health business saw flat growth in the fourth quarter, bringing in $277 million. The weakness in BetterHelp sales was the result of lower direct-to-consumer marketing yield.
  • Beckers Payer Issues offers an interview with an Aetna Executive about the company’s Medicare Advantage business.
  • MedCity News calls our attention to a continuing interoperability problem.
    • “The healthcare industry has notoriously struggled with disconnected data systems and a lack of interoperability. When health information cannot be easily exchanged between different systems and providers, it leads to fragmented care, medical errors and delays in treatment — not to mention an incredible amount of frustration and inconvenience for both providers and patients.
    • “Software developers have been working hard in recent years to create tools and data sharing standards that foster a more cohesive and integrated approach. However, these tools have a serious adoption problem, experts said last week during a virtual panel held by Reuters Events.
    • “Alistair Erskine, Emory Healthcare’s chief information and digital officer, pointed out that most provider referrals are still done by fax, even though there are tools available to send them digitally. Most providers use EHRs that are able to pull a patient’s health information and transport it to the EHR of the new provider to whom they’ve been referred, he said.
    • “Despite data sharing standards like FHIR and DICOM — and despite “the fact that the data has already been digitized” — completing a provider referral is still not a smooth process, Erskine remarked. He stated that 98% of referrals are done by fax even though they could “of course” be done electronically.
    • “Even though the standards are there, we have to make sure that people safely log into their systems, and we have to make sure that people are able to find their patient in their systems. And if you navigate from one system to the next, that presents a barrier to entry. It’s easier to just take a piece of paper, write what you need and send it in a fax,” Erskine explained.”

Tuesday Tidbits

David Ermer–Congress, COVID-19, Medical / Rx research, Mental health care, NIH, No Surprises Act, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Beckers Health IT informs us,
    • “U.S. lawmakers introduced bipartisan legislation Feb. 16 to better match patients with their EHRs.
    • “U.S. Reps. Mike Kelly, R-Pa., and Bill Foster, PhD, D-Ill., sponsored the Patient Matching and Transparency in Certified Health IT, or MATCH IT, Act of 2024.
    • “Patient matching errors have led to unnecessary expenses, medical mistakes, and even patient deaths,” Mr. Kelly said in a Feb. 16 news release. “This bipartisan legislation works to improve interoperability between healthcare systems and decrease these fixable matching errors, all while protecting patient privacy.”
  • STAT News tells us,
    • “Nearly four decades after its first conception, the first TIL therapy, an immunotherapy that harvests cancer-fighting immune cells from the patient’s own body, received accelerated approval from the Food and Drug Administration for advanced melanoma. The therapy, called Amtagvi or lifileucel from Iovance, is the first cell therapy approved for a solid tumor.
    • “It’s so exciting and gratifying,” said Allison Betof Warner, a cell therapy researcher and physician at Stanford University who has worked on Amtagvi. “This is a game-changing moment for our field. We’ve seen huge success of cellular therapy for hematologic malignancies, and we’ve yet to capitalize on that for solid tumors. This is hopefully the first of many to come.”
    • “In a Phase 2 clinical trial, titled C-144-01, 153 patients who had already been on a median of three prior lines of therapy received lifileucel, and 31% of them responded to therapy. “These are in very late line patients. They’ve exhausted every standard care option,” Betof Warner said. “The most promising part of this therapy for me is that 42% of patients who responded were still responding for 18 months or longer. It’s truly incredible.”
    • “The therapy is not expected to work for every patient, partially because the regimen has high toxicity. It will also be expensive. The therapy is expected to be priced at $515,000.”
  • Beckers Hospital Review adds, “Buzz for gene therapies is loud, but drugmakers struggle to get treatments off the ground.”
    • “A major barrier for many companies in the space is sheer cost to develop these advanced medical therapies. Though the Biden administration and CMS announced Jan. 30 plans to bring down prices for gene edited therapies, progress will take time. 
    • “The number of patients being treated with the existing gene therapies that are approved and available on the market is expected to decline year over year by nearly 33%, according to Bloomberg.”
  • Per the Food and Drug Administration,
    • “On Friday, the FDA published an Outbreak Advisory for an investigation of E. coli O157:H7 linked to raw cheddar cheese. The FDA recommends that consumers, restaurants, and retailers do not eat, sell, or serve Raw Farm-brand Raw Cheddar Cheese (block or shredded) and to throw it away. This is an ongoing investigation and the FDA will update the Advisory should additional consumer safety information become available.”
  • BioPharma Dive reports,
    • “AstraZeneca’s targeted cancer therapy Tagrisso can now be used alongside chemotherapy to treat a common type of locally advanced or metastatic lung tumor, following a Food and Drug Administration approval Friday.
    • “The FDA cleared Tagrisso together with chemotherapy based on results showing the combination reduced the risk of disease progression or death versus Tagrisso alone, which is currently the first-line standard for non-small cell lung cancer that harbors mutations in a gene known as EGFR.
    • “Over the weekend, meanwhile, AstraZeneca reported new clinical trial data showing Tagrisso outperformed placebo following chemoradiotherapy for Stage 3 EGFR-mutated non-small cell lung cancer that couldn’t be surgically removed. The results, which AstraZeneca will share with regulators, could further support early use of Tagrisso.”

From the public health and medical research front,

  • Axios points out,
    • “More than half of U.S. newborns now appear to be protected by new RSV vaccines, according to updated Centers for Disease Control and Prevention data.
    • “Why it matters: The virus is considered the second leading cause of death worldwide during the first year of a child’s life. The data suggests demand was strong despite broader vaccine skepticism and the potential for confusion over more childhood immunization options.”
  • The Wall Street Journal discusses a related RSV vaccine (Beyfortus) shortage — “A new antibody that protects babies from a deadly virus proved far more popular than drugmaker Sanofi expected.”
    • Beyfortus seller Sanofi in March last year set aggressive targets for how many doses to make, yet still underestimated demand. Some pediatricians delayed ordering immunizations because they didn’t know whether insurers would cover the $495 doses. And the U.S. government decided in August—months after Sanofi had locked in the number of doses it would make—to add the shot to the Vaccines for Children program, a federal initiative that covers children who are uninsured or on Medicaid, buying more than half of the doses.
    • Sanofi said it sought to distribute its shots equitably in the face of “unprecedented” demand and is working to increase supply for the next RSV season. 
  • HHS’s Agency for Healthcare Quality and Research issued a Medical Expenditure Panel Survey about “Characteristics of Young Adults Aged 18-24 Who Had Ever Used an Electronic Nicotine Product, 2021.”
    • “Nearly one-third (30.6 percent) of U.S. adults ages 18-24 reported ever having used an electronic nicotine product.
    • “More than one-third (38.3 percent) of non-Hispanic White young adults reported ever having used an electronic nicotine product, nearly double the rate for Hispanic young adults and 12 percentage points higher than for non-Hispanic Black young adults.”
  • Medpage Today notes,
    • “Nearly all medication abortions obtained via telehealth, whether via video or secure text messaging, were completed without further intervention and without adverse events, the prospective CHAT study found.
    • “Among over 6,000 abortions, 97.7% (95% CI 97.2-98.1) were completed without further intervention, and the completion rate was similar for patients who had video calls (98.3%) or used text messaging (97.4%), reported Ushma Upadhyay, PhD, MPH, of the University of California San Francisco, and colleagues.
    • “Less than 1% of patients had a serious abortion-related adverse event (0.25%) or were treated for an ectopic pregnancy (0.16%), and 1.3% of abortions were followed by emergency department visits, the authors wrote in Nature Medicine.”
  • The FEHBlog has subscribed to a Substack series called “Your Local Epidemiologist.”
    • “Your Local Epidemiologist (YLE)” is written by Dr. Katelyn Jetelina, M.P.H. Ph.D.—an epidemiologist, wife, and mom of two little girls. During the day, she is a senior scientific consultant to several organizations, including CDC. At night, she writes this newsletter. Her main goal is to “translate” the ever-evolving public health world so that people will be well-equipped to make evidence-based decisions. This newsletter is free, thanks to the generous support of fellow YLE community members.”
    • Check it out.
  • Medpage Today offers an expert medical opinion concerning
    • “News surfaced last week suggesting a potential shift in COVID-19 isolation guidanceopens in a new tab or windowfrom the CDC. The planned guidance, which is expected to be released this spring for public comment, indicates a significant switch in how COVID-19 is conceptualized. The guidance would bring COVID-19 into line with how other common respiratory viruses are managed: with isolation recommended until the individual has mild and improving symptoms, and is fever-free (without pharmaceutical aid) for 24 hours.”
    • “With the news of the proposed guidance, many voices rose up to immediately attack the proposed guidance as a capitulation and not evidence-based. This was similar to the refrain from opponents when the federal or state governments dropped or loosened mask requirements or guidance.
    • “I was not one of themopens in a new tab or window.
    • “Indeed, I welcome the proposed guidance change because it reflects the progress that has been made in the management of COVID-19. When evaluating this guidance, it is critical to understand that SARS-CoV-2, the cause of COVID-19, is situated among the myriad respiratory viruses that infect humans.”
  • Medscape lets us know,
    • “Availability of telehealth services for mental healthcare varies widely from state to state, a new study shows. One fifth of all facilities contacted reported no mental telehealth options and wait times for those that did ranged from 4 days to > 2 months, depending on the state.”
  • The National Institutes of Health announced,
    • “To prevent an emerging genomic technology from contributing to health disparities, a scientific team funded by the National Institutes of Health has devised new ways to improve a genetic testing method called a polygenic risk score. Since polygenic risk scores have not been effective for all populations, the researchers recalibrated these genetic tests using ancestrally diverse genomic data. As reported in Nature Medicine, the optimized tests provide a more accurate assessment of disease risk across diverse populations.
    • “Genetic tests look at the small differences between individuals’ genomes, known as genomic variants, and polygenic risk scores are tools for assessing many genomic variants across the genome to determine a person’s risk for disease. As the use of polygenic risk scores grows, one major concern is that the genomic datasets used to calculate the scores often heavily overrepresent people of European ancestry.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “After federal legislation protecting consumers from surprise medical bills was implemented, a growing number of medical claims were in network, according to a new analysis.
    • “The No Surprises Act went into effect on Jan. 1, 2022. From the fourth quarter of 2021 to the first quarter of 2022, in-network care as a percentage of all claim lines nationally increased 2.3%, according to the study by nonprofit Fair Health.
    • “It’s the latest research suggesting No Surprises has been successful in lowering the amount of unexpected out-of-network bills, though the rollout of the law has been tied up in lawsuits, and regulators currently face a backlog of billing disputes between payers and providers.”
  • and
    • “Insurers brace for continued Medicare Advantage medical costs. The big question coming out of the health insurance earnings season is how much elevated utilization among seniors is carrying over into 2024.”
  • EndPoint News points out,
    • “Cigna’s venture unit just made a bet on a startup focused on cardiometabolic conditions that wants to play a role in prescribing GLP-1 medications.
    • “9amHealth said on Tuesday it raised $9.5 million in a Series A extension led by The Cigna Group Ventures. It adds to $16 million from the Series A raised in April 2022 by the startup, which provides virtual visits, prescriptions and lab tests related to conditions like hypertension, type 2 diabetes and weight management.”
    • “Cigna’s investment comes as health plans and pharmacy benefit managers (the PBM Express Scripts is a subsidiary of Cigna) are grappling with how to cover the high cost of GLP-1 medications for conditions like type 2 diabetes and weight loss. It’s among the first investments from an insurance company’s venture arm into a startup prescribing the drugs, which have turned into huge blockbusters and prompted broad conversations about their cost — and benefit — to the healthcare system.”
  • The Wall Street Journal reports,
    • “Pharmaceutical companies are spending billions of dollars to develop drugs that can target cancer like guided missiles.
    • “Therapies known as antibody-drug conjugates, which help deliver chemotherapy directly to tumors, have gotten most of the attention and are farthest along: 
    • “Pfizer’s $43 billion acquisition of biotech Seagen Inc. last year underscored how hot the field has become. 
    • “More quietly, a concept known as radiopharmaceuticals is also gaining ground. In recent months, interest in this space has led to a rise in dealmaking. The idea is similar to ADCs in that a patient receives an old treatment—in this case, a radioactive particle instead of chemotherapy drugs—but it is bound with a molecule that can chase down tumor cells. The technology is at a more nascent stage, but a steady growth of venture capital money and acquisitions by large pharmaceutical companies means this could well become a key part of the fight against cancer in the next decade or so.”
  • HR Dive discusses an EEOC lawsuit against a Georgia retirement community “for firing a 78-year-old receptionist after repeatedly asking her to retire. “The right to decide a retirement age lies with an employee, not their employer,” an EEOC official said.