Weekend update

Rx coverage

Weekend update

David Ermer–Congress, FDA, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC —

  • While on August recess, Congress is holding four out-of-town hearings.
  • The recently proposed mental health parity rule was published in the Federal Register last Thursday. The deadline for public comments is October 2, 2023.
  • WTOP reports,
    • “President Joe Biden has asked Cabinet officials to “aggressively execute” plans to bring federal employees back to their offices, ending a precedent of remote work that started during the COVID-19 pandemic three years ago, according to multiple sources.
    • “Axios first reported that White House Chief of Staff Jeff Zients sent an email on Friday to every member of the Cabinet saying federal agencies must return to in-person work “because it is critical to the well-being of our teams and will enable us to deliver better results for the American people.”
    • “Zients said remote work won’t be completely eliminated, but that in-person time will be prioritized to “build a strong culture, trust, and interpersonal connections” within agencies, according to The Washington Post.”

From the public health front —

  • Fortune Well provides more background on the new Sage Therapeutics drug that the Food and Drug Administration approved to treat post-partum depression last Friday.
    • “In trials, zuranolone [trade name Zurzuvae] showed a “rapid reduction of depressive symptoms starting as early as day three—after two doses of medicine—and showed continued improvement through day 15,” Deligiannidis said, adding that the drug continues to work even after patients stop taking it, for 45 days in all.
    • “The fast-acting, temporary nature of the drug stands in contrast to standard-of-care antidepressants that might otherwise be prescribed. Such medications—typically SSRIs, or selective serotonin reuptake inhibitors, which increase serotonin levels in the brain—usually take four to six weeks to begin to work, and two to three months to fully kick in, according to Deligiannidis. * * *
    • “Because zuranolone is a controlled substance, the U.S. Drug Enforcement Administration now has 90 days to assign a schedule to it. Earlier this week, Chepke predicted it would be designated a Schedule IV drug or one with a low potential for abuse and dependence like Xanax, Valium, Ativan, and Ambien.
    • “From there, he anticipated it would soon be in the hands of prescribers and patients, where it’s sorely needed. * * *
    • “Sage Therapeutics and co-developer Biogen had also applied for approval to use the drug in cases of major depressive disorder. The federal agency on Friday did not issue a ruling on such use.”
  • NPR Shot tells us “Testing your genes for cancer risk is way cheaper now — and it could save your life.”

From the Rx coverage front —

  • The FEHBlog wants to point out the Center for Biosimilars website, which is chock-a-block full of useful articles on this important topic.
  • BioPharma Dive reports
    • “The Food and Drug Administration on Friday approved a second medicine for a common type of vision loss, clearing a drug developed by biotechnology company Iveric Bio for geographic atrophy.
    • “The monthly eye injection, which will be sold as Izervay, is meant to slow the progression of the condition, which Iveric and its new owner, Japanese drugmaker Astellas Pharma, estimate affects 1.5 million people in the U.S.
    • “The FDA’s decision on Izervay follows about six months after the agency greenlighted the first geographic atrophy treatment, Apellis Pharmaceuticals’ Syfovre. Both drugs work by blocking a part of the immune system, slowing the growth of eye lesions and, in theory, preserving vision. Such a benefit on visual function hasn’t been proven yet, however.
    • “The medicines are expected to become blockbuster sellers.”

From the U.S. healthcare business front —

  • KFF News offers “An Early Look at What is Driving Health Costs in 2024 ACA Markets.”
    • “This updated analysis of marketplace insurers’ early rate filings are requesting a median premium increase of 6% for 2024, which they say is largely due to price increases for medical care and prescription drugs. Insurers’ rate requests are preliminary and may change during the review process before being finalized in late summer.
    • “In addition to inflation’s impact on medical costs, insurers say the higher premiums are a result of growth in the utilization of health care, which fell in 2020 but has since returned to more normal levels.
    • “The analysis is available on the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.”
  • Although the FEHB is affected by the same cost drivers, OPM’s wise decision to approve the use of Part D EGWPs in the FEHB for 2024 will offset these cost drivers to a substantial extent.

Friday Factoids

David Ermer–COVID-19, FDA, HSA, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The Food and Drug Administration announced today
    • “approv[ing Sage Therapeutic’s] Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a healthcare provider in certain healthcare facilities.
  • STAT News informs us
    • “A new White House task force on drug shortages held a rare in-person meeting last Friday with representatives from hospitals, drugmakers, pharmacies, and others in the drug supply chain to brainstorm policies for stemming shortages of cancer drugs.
    • “The meeting at the Eisenhower Executive Office Building focused on immediate steps that could help alleviate shortages, such as allowing temporary importation of drugs from other countries, according to an attendee and three others with knowledge of the discussion. It also touched on purchasing issues.”
  • HR Dive relates
    • “The National Labor Relations Board on Wednesday reversed its Trump-era stance that allowed employers to maintain certain handbook policies, such as those mandating a respectful workplace (Stericycle, Inc. and Teamsters Local 628).
    • “The shift means all policies that restrict employee speech and actions must be reviewed — “and very likely rewritten,” according to Peter Spanos, a partner at law firm Taylor English.”

From the public health front —

  • The Leapfrog Group now offers ratings on maternity care services.
  • Health Day relates,
    • “A micronutrient in human breast milk may provide significant benefit to developing newborn brains, according to new research that sheds light on the link between nutrition and brain health.
    • “Scientists looked at this sugar molecule in rodents and in human neurons. They said the micronutrient, called myo-inositol, may lead to improved infant formulas.
    • “The current research does indicate that for circumstances where breastfeeding is not possible, it may be beneficial to increase the levels of myo-inositol in infant formula,” said study co-author Thomas Biederer.
    • “Myo-inositol may also play a part in the aging brain, according to the research conducted at the Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA) at Tufts University in Boston.”
  • STAT News lets us know,
    • “Early-stage cancer diagnoses decreased by nearly 20% in the first year of the Covid-19 pandemic. A new study published in Lancet Oncology emphasizes how, because of disruptions in care, patients were more likely to get diagnosed with deadly metastatic disease — across nearly all cancer types.
    • “This study is the most comprehensive analysis of cancer diagnoses during the pandemic, using a nationwide registry that captures over 70% of all cancers in the United States. The starkest decline was observed after the initial shutdowns, with the regular 70,000 monthly cancer diagnoses (captured by the study’s inclusion criteria) being cut in half in April 2020.”
  • KFF News offers polling data on consumer interest in the new injectable weight loss drugs and their attitudes toward pharmaceutical companies and “A Look at the Latest Suicide Data and Change Over the Last Decade” in our country.

From the U.S. healthcare business front —

  • The Kaiser Foundation announced
    • “For the quarter ending June 30, 2023, Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals, and their respective subsidiaries (KFHP/H) reported operating revenues of $25.2 billion and operating expenses of $24.4 billion compared to operating revenues of $23.5 billion and operating expenses of $23.4 billion in the same period of the prior year. Operating income was $741 million for the second quarter of the year compared to operating income of $89 million in the second quarter of 2022.
    • “Like all health systems, Kaiser Permanente is experiencing ongoing cost headwinds and volatility driven by inflation, labor shortages, and the lingering effects of the pandemic on access to care and service.
    • “Due to favorable financial market conditions, Kaiser Permanente benefited from strong investment income with other income (net of other expenses) of $1.3 billion for the second quarter, compared to a $1.4 billion loss in the second quarter of 2022. For the second quarter, net income was $2.1 billion compared to a net loss of $1.3 billion in the same period of 2022.”
  • Healthcare Dive points out
    • “Patrick Conway is stepping up as CEO of UnitedHealth pharmacy benefit manager OptumRx effective immediately, according to a Thursday post on the executive’s LinkedIn, as part of a leadership shakeup at the healthcare giant.
    • “Conway is replacing Heather Cianfrocco, who is pivoting to president of Optum. Cianfrocco will lead the division’s pharmacy and care delivery capabilities, per UnitedHealth’s website.
    • “Cianfrocco replaces John Prince as Optum president. Prince has departed the company to serve as a senior advisor to private equity firm TPG, according to his LinkedIn.”
  • EBRI announced
    • “A new research report published today by the Employee Benefit Research Institute (EBRI) found that cost-sharing shifted from deductibles to copayments and coinsurance among enrollees in HSA-eligible health plans for a number of services impacted by IRS Notice 2019-45. The report, “The Impact of Expanding Pre-Deductible Coverage in HSA-Eligible Health Plans on Employee Choice of Health Plan and Cost Sharing,” analyzed claims data to quantify the effect of expanding pre-deductible coverage on enrollee choice of health plan and cost-sharing.
    • “In response to IRS Notice 2019-45, three-quarters of large employers and health plans offering HSA-eligible health plans expanded pre-deductible coverage for medications and services that prevent the exacerbation of chronic conditions. As a result, it is not surprising that when examining medical claims, cost-sharing shifted from deductibles to copayments and coinsurance for enrollees in HSA-eligible health plans,” explained Paul Fronstin, Ph.D., director, Health Benefits Research, EBRI. “The percentage of cost sharing paid through deductibles fell for antidepressants, insulin and other glucose-lowering agents, statins, beta blockers and inhaled corticosteroids.”
  • Health Payer Intelligence updates us on the status of provider challenges to the No Surprises Act’s arbitration rules.
    • “The legal challenges highlight the difficulties of prioritizing affordable healthcare for consumers. With payers and providers holding opposing views, federal policymakers must reach a conclusion that benefits both sides and improves costs for consumers.
    • “If federal agencies cannot establish reasonable guidelines for the IDR process, Americans may face an inflationary federal IDR process that results in higher premiums and healthcare costs, according to Georgetown University’s O’Neill Institute.
    • “There is a strong urgency to determine concrete guidelines, given the high amount of disputes that payers and providers have submitted through September 2022, a CMS report indicated.”
  • Behavioral Health Business reports
    • “The Cigna Group (NYSE: CI) has seen a historic but expected rise in behavioral health benefits utilization in recent years. 
    • “These insights, presented by the health care insurance and service conglomerate’s executives, echo others made by UnitedHealth Group (NYSE: UNH) executives on their second-quarter earnings call. 
    • “As it relates to what we’re seeing in terms of trends in terms of utilization, behavioral health has certainly been growing at a strong clip, not just this year, but for the past few years,” Brian Evanko, The Cigna Group’s CFO said Thursday on the company’s second-quarter earnings call. “Part of that is by design as we engage with our customers. And over time, that’s a good thing because the more utilization we see in behavioral health services, [the more] it helps to defray core medical costs.”

Midweek Update

David Ermer–ACA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC —

  • MedPage Today informs us
    • “In a letter to the American public, the heads of the Drug Enforcement Administration (DEA) and FDA acknowledged ongoing stimulant drug shortages [to treat ADHD] and recounted their initiatives to improve access — while calling for efforts to diminish potential overuse and misuse of these powerful medications.”
  • and
    • “Jeanne Marrazzo, MD, will be the next director of the National Institute of Allergy and Infectious Diseases (NIAID), NIH Acting Director Lawrence Tabak, DDS, PhD, announced on Wednesday.
    • “Dr. Marrazzo brings a wealth of leadership experience from leading international clinical trials and translational research, managing a complex organizational budget that includes research funding and mentoring trainees in all stages of professional development,” Tabak said in a press release. “I look forward to welcoming Dr. Marrazzo to the NIH leadership team.”
  • FedWeek explains why the federal long-term care insurance program is the “Zeppo Marx” of federal employee benefits programs and offers information about deferred annuities available to federal employees.
    • Conundrum “If you are eligible for a deferred annuity, you may elect a survivor annuity. However, you won’t be eligible either to participate in the Federal Employees Health Benefits program or acquire Federal Employees’ Life Insurance coverage.”

From the public health front —

  • From Healthcare Dive, we have an opinion piece titled, “Strengthening primary care the key to fixing healthcare system woes. Primary care advocates Ann Greiner and Shawn Martin argue the U.S. needs to turn around decades of underinvestment in its primary care chassis.” Check it out.
  • The Wall Street Journal reports that some large employer-sponsored health plans, such as the University of Texas, are canceling coverage of GLP-1 agonistes, like Wegovy, for weight loss treatment due to the high cost of the drugs. The UT plan will continue to cover these drugs, like Ozempic, for diabetes treatment.
    • “The prescription-drug benefit plan for state government employees in Connecticut now requires members to obtain anti-obesity drugs through Intellihealth, a Connecticut-based, anti-obesity medical practice that offers telehealth and app-based care.  
    • “The state’s costs for the GLP-1 anti-obesity drugs for plan members have risen 50% since 2020, and are on track for $30 million annually by the end of this year, said Connecticut State Comptroller Sean Scanlon.
    • “To me, saying we’re not going to cover these anymore was a nonstarter, because these drugs do work. People want to take them,” he said.”
  • The University of Michigan’s employee health benefits program raised the deductible on Wegovy from $20 to $45.
    • “Denmark-based Novo Nordisk charges a list price of $1,349 for roughly a month’s supply of each Wegovy and Saxenda. A related drug, Ozempic, is approved to treat Type 2 diabetes and costs about $930 a month, but isn’t typically covered by insurance plans for weight loss in people without diabetes.” That price differential doesn’t make sense to the FEHBlog.
  • MedPage Today tells us
    • “An investigational vaccine that contains the nucleoprotein of the influenza A virus appeared promising as a universal flu shot that could protect against multiple strains, regardless of annual mutations, a phase IIa dose-finding study showed.”
  • CNN informs us
    • “Artificial intelligence found more breast cancers than doctors with years of training and experience and cut doctors’ mammogram reading workload almost in half, a new early-stage study found.
    • “This doesn’t mean your hospital will let a computer determine whether you have cancer any time soon. There’s still a lot more research to do, but the study, published Tuesday in the journal The Lancet Oncology, shows that AI is safe to use in breast cancer detection and could make doctors even more effective at finding cancer than they are now.”

From the U.S. healthcare front

  • Healthcare Dive reports
    • “CVS Health announced a company-wide restructuring initiative on Wednesday after the healthcare giant’s profit fell 37% year over year to $1.9 billion in the second quarter.
    • “As part of the restructuring, the Woonsocket, Rhode Island-based company plans to terminate certain initiatives. That should allow it to reallocate resources to growth areas like healthcare services and technology, CEO Karen Lynch said on a Wednesday call with investors.
    • “CVS lowered its 2024 adjusted earnings per share target from $9 to between $8.50 and $8.70 as a result of cost pressures — flat from its 2023 guidance range. CFO Shawn Guertin also told investors to “no longer rely” on the company’s target of $10 for 2025.”
  • and
    • “Humana beat Wall Street expectations on earnings and revenue in the second quarter, reporting a topline of $26.7 billion, up 13% year over year, and profit of $959 million, up 38% year over year.
    • “Rising medical utilization earlier in the quarter appears to have stabilized based on recent claims activity, management said. The payer on Wednesday reiterated the 2023 medical loss ratio guidance of between 86.3% and 87.3%.
    • “Humana also raised its Medicare Advantage membership growth expectations following the quarter. The Louisville, Kentucky-based health insurer now expects to add 825,000 MA members in 2023.”
  • Fierce Healthcare relates
    • “Amazon Clinic is expanding to all 50 states, including nationwide telehealth services to offer access to clinicians through its website and mobile app.
    • “The online retail giant unveiled Amazon Clinic back in November as a virtual medical clinic to provide care for 35 common health concerns like urinary tract infection, pink eye, and acid reflux. Launched as a message-based virtual consultation service, Amazon Clinic connects consumers with licensed clinicians who can diagnose, treat and prescribe medication for a range of common health and lifestyle conditions.
    • “The service was available in 34 states and has now been expanded nationwide and to Washington, D.C., along with the addition of video visits with providers on Amazon.com and the mobile app, the company announced in a blog post on Tuesday.
    • “Amazon Clinic is currently cash pay and does not yet accept insurance, the company said.” 
  • Beckers Payer Issues points out
    • “The first wave of UnitedHealthcare’s previously announced 20 percent reduction in prior authorization requirements takes effect Sept 1. 
    • “The remainder of the reductions will occur Nov. 1, according to an Aug. 1 post on UnitedHealthcare’s website. 
    • “The prior authorization code eliminations will take place on Sept. 1 and Nov. 1 for Medicare Advantage, commercial, Oxford, and individual exchange plans. Eliminations for community plans will take place Nov. 1. “
  • and
    • “UnitedHealthcare controls almost one-quarter of the Medicare Part D plan market, according to an analysis from KFF.
    • “The analysis, published July 26, compared market share in 2023 for major payers offering both Medicare Advantage plans and stand-alone Part D plans.
    • “Most payers analyzed, aside from Kaiser Permanente, offer both standalone plans and Medicare Advantage policies, according to KFF. CVS Health, Centene and Cigna have greater enrollment in standalone Part D plans than Medicare Advantage options, while UnitedHealthcare and Humana have more Medicare Advantage members.”
  • Benefits Pro reassures us
    • “When the Affordable Care Act was passed in 2010, it was assumed that many employers would drop workplace health insurance in response. However, a new study by the Employee Benefit Research Institute found that starting in 2015, both the percentage of employers offering health insurance and the percentage of workers eligible for such coverage began to increase.
    • “It should then come as no surprise that the percentage of workers and their families being covered by employment-based health insurance has been relatively steady over the long term,” the report said.”

Midweek update

David Ermer–Congress, COVID-19, Federal employment benefits, Generative AI, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Mount Rushmore

From Washington, DC —

  • STAT News reports
    • “Senators on the Finance Committee on Wednesday nearly unanimously passed a bill to clamp down on drug middlemen but kicked the can down the road on some of the more challenging policies.
    • “The bill would offer some more transparency into the business practices of pharmacy benefit managers, ensure PBMs aren’t skimming off of the money they send to insurers, prohibit them from overcharging insurers, and ensure certain fees in the Medicare program aren’t tied to a drug’s price.”
  • From the Senate Finance Committee, “click here for more information on the legislation, including a description of the Chairman’s Mark and a section-by-section summary.”
  • The House Ways and Means Committee relates,
    • “Congresswoman Nicole Malliotakis, a member of the House Committee on Ways and Means, today announced her legislation, the Protecting Patients from Middlemen Act, passed out of the full committee and will be included in the committee’s Health Care Price Transparency Act of 2023.
    • “Specifically, Malliotakis’ legislation, which was introduced in partnership with Rep. Brad Wenstrup (OH-02), would prohibit prescription drug plans and Pharmacy Benefit Managers (PBMs) in Medicare Part D or Medicare Advantage from charging patients more in drug cost-sharing that the net price of the drug.”
  • AHA News tells us,
    • “The House Ways and Means Committee July 26 voted 25-16 to pass the Health Care Price Transparency Act (H.R. 4822), legislation that would impose additional site-neutral payment cuts and regulatory burdens on off-campus hospital outpatient departments, impose additional Medicare sequester cuts on hospitals, and codify and make changes to hospital price transparency regulations. * * *
    • “In other action today, the committee voted 23-17 to pass the Providers and Payers COMPETE Act (H.R. 3284), AHA-opposed legislation that would impose new regulatory responsibilities on the Department of Health and Human Services regarding consolidation.”
  • Federal News Network informs us,
    • “Federal retirees, and employees looking to retire, have some new resources to help them through the often long and thorny retirement process.
    • “A new series of video tutorials from the Office of Personnel Management lays out, step by step, a couple of key items on the federal retirement to-do list.
    • “With the three new videos, OPM said it hopes to reduce the number of errors from federal retirees when trying to log in to manage their online retirement accounts. And in theory, the videos should also help reduce wait times at retirement services call centers, OPM said, now that more detailed information is readily available to feds who get caught up in some of the early steps of the process.”
  • Forbes reports
    • “The FDA has approved Octapharma’s drug Balfaxar, which is used by patients who require surgery but have seen a reduction in blood clotting factors due to being treated with the blood thinner warfarin.” 

From the public health front —

  • Employee Benefits News offers expert views on the current state of Covid.
  • The National Institutes of Health announced
    • “Researchers have found that people with obstructive sleep apnea have an increased cardiovascular risk due to reduced blood oxygen levels, largely explained by interrupted breathing. Obstructive sleep apnea has long been associated with an increased risk of cardiovascular issues, including heart attack, stroke, and death, but the findings from this study, partially supported by the National Institutes of Health and published in the American Journal of Respiratory and Critical Care Medicine, show the mechanism mostly responsible for the link.
    • “These findings will help better characterize high-risk versions of obstructive sleep apnea,” said Ali Azarbarzin, Ph.D., a study author and director of the Sleep Apnea Health Outcomes Research Group at Brigham and Women’s Hospital and Harvard Medical School, Boston. “We think that including a higher-risk version of obstructive sleep apnea in a randomized clinical trial would hopefully show that treating sleep apnea could help prevent future cardiovascular outcomes.”
  • Medscape considers where exercise boosts cognition.
  • Fierce Healthcare lets us know,
    • “One in three counties in the U.S. is considered a maternal healthcare desert.
    • “Since that statistic was dropped back in October 2022 by March of Dimes, care in corners of the country has only continued to dry up. In response to the crisis, providers are using every seed in their seed bag and looking to “multimodal” technology strategies to predict health emergencies before they happen.
    • “Those multimodal approaches combine telehealth, remote patient monitoring (RPM) and text messages to identify high-risk patients. High blood pressure monitoring and hypertension screening are currently recommended for pregnant patients by the U.S. Preventive Services Task Force, as heart disease and stroke are two of the leading causes of maternal mortality.
    • “Lucienne Ide, M.D., is the CEO of the digital health company Rimidi. She sees the country teetering on an inflection point.
      • “We’re at this fork in the road of looking at what we could do with technology, identifying high-risk women and getting them into the programs where we’re proactively and earlier identifying something dangerous and doing something about it,” Ide told Fierce Healthcare.
      • “But the alternate narrative is really, really bad, and it’s going to get worse. It’s not like, ‘Here we are today, and we could do better.’ No, here we are today, and it’s going to get worse, but we can actually do better,” she said.

From the U.S. healthcare business front —

  • Per Fierce Healthcare,
    • “As hospitals acquire ambulatory care centers, consumers are more likely to be forced to pay outpatient facility fees for routine care traditionally covered by physician offices at lower costs.
    • “These new costs, appearing seemingly out of nowhere to the average consumer through out-of-pocket spending and premium increases, can add up to hundreds or thousands of dollars in additional expenses for a patient, according to a report from Georgetown University’s Center on Health Insurance Reforms.
    • “Outpatient facility fees cover a hospital’s operational expenses. But when hospitals acquire physician practices, that usually generates another outpatient facility bill, eventually passing on the cost to the patient. Consumers are often unaware that they are now responsible for an extra cost.”
  • Healio reports that the growth of telehealth in cancer care continued after the initial surge during the COVID-19 pandemic.
  • Per Healthcare Dive, the path toward reducing physician burnout is widening.
    • “Amazon has become the latest tech giant to announce a clinical documentation service that allows providers to automatically create medical notes using generative AI.
    • “The Amazon Web Services tool announced Wednesday, called HealthScribe, allows providers to build clinical applications that use speech recognition and generative AI to create transcripts of patient visits, identify key details and create summaries that can be entered into an electronic health record.
    • “HealthScribe is being previewed for two specialties: general medicine and orthopedics. An Amazon spokesperson said AWS could expand to additional specialties based on client feedback. HealthScribe costs users a set amount per second of audio processed each month.”

Tuesday Tidbits

David Ermer–ACA, Generative AI, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front,

  • Health Affairs reports
    • “National health expenditures are projected to grow 5.4 percent, on average, over the course of 2022–31 and to account for roughly 20 percent of the economy by the end of that period. The insured share of the population is anticipated to exceed 92 percent through 2023, in part as a result of record-high Medicaid enrollment, and then decline toward 90 percent as coverage requirements related to the COVID-19 public health emergency expire. The prescription drug provisions of the Inflation Reduction Act of 2022 are anticipated to lower out-of-pocket spending for Medicare Part D enrollees beginning in 2024 and to result in savings to Medicare beginning in 2031.”
  • The U.S. Preventive Health Services Task Force gave an inconclusive grade to screening for lipid disorders in children and adolescents 20 years or younger.
  • The Wall Street Journal offers ways to protect yourself and your family against the ill effects of forever chemicals that may be in your tap water or else in your homes.

From the regulatory front,

  • The Food and Drug Administration “published a safety communication to warn consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, and Well-Being Reality. The devices have not been reviewed by the FDA. The safety and effectiveness of these devices have not been established to diagnose, treat, or cure medical conditions.”
  • HMFA informs us
    • “Hospital price transparency regulations are undergoing changes heading into their fourth year as CMS seeks to step up enforcement while making compliance more straightforward.
    • “As part of the 2024 proposed rule for hospital outpatient payments, CMS is adding to the requirement for hospitals to maintain a machine-readable file of their charges for services. In addition, enforcement actions against hospitals would be publicized even before assessment of civil monetary penalties.
    • “CMS said the impetus for the proposed technical requirements is feedback from “interested parties” that the files would be more beneficial if they were more standardized.
    • “In particular, IT specialists have indicated that the current flexibilities and lack of encoding specifications hinder the machine-readability of the data in the files, presenting a barrier to the intended use of the data,” CMS wrote. “Additionally, hospitals have asked us for more specificity on how they should publicly display their standard charge information, with an emphasis on how they should explain and display their payer-specific negotiated charges.”
    • “The agency also said enforcement would be easier if the files were more consistent.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “In the past 10 years, there has been a dramatic shift in physician practice ownership as less than half of doctors now work in private practices, according to a new analysis.
    • “Between 2012 and 2022, the share of physicians working in private practices fell by 13 percentage points from 60.1% to 46.7%.
    • “In contrast, the share of physicians working in hospitals as direct employees or contractors increased from 5.6% to 9.6% in the same 10-year time period, and the share of physicians working in practices at least partially owned by a hospital or health system increased from 23.4% to 31.3%, according to a benchmark analysis the American Medical Association. * * *
    • “In 2022, 4.5% of physicians worked in a practice owned by a private equity group, similar to the percentage in 2020 when the AMA first added private equity to the analysis.
    • “According to the analysis, there also has been a redistribution of physicians from small to large practices. The share of physicians in small practices (10 or fewer physicians) shrank from 61.4 % to 51.8% between 2012 and 2022. Conversely, the share of physicians in large practices (50 physicians or more) grew from 12.2% to 18.3% in the same 10-year time period.
    • “The shares of physicians in mid-sized practices (those with 11 to 24 and 25 to 49 physicians) remained relatively stable over the last decade.”
  • BioPharma Dive informs us,
    • “Biotechnology startup creator Flagship Pioneering is teaming up with Pfizer to develop 10 new drug candidates, with each company pledging to invest $50 million in the new effort.
    • “Together, Flagship and Pfizer will take stock of the technologies available to the former firm and its affiliated startups, hunting for opportunities to develop medicines aligned with Pfizer’s research priorities. Per deal terms announced Tuesday, Pfizer will fund the development of selected medicines, each of which it can choose to acquire later.
    • “The collaboration involves Flagship’s “Pioneering Medicines” initiative, which has struck similarly structured deals in the recent past with Novo Nordisk and the Cystic Fibrosis Foundation.”
  • Healthcare Dive relates,
    • “Teladoc Health is expanding its partnership with Microsoft, announcing plans to add artificial intelligence tools for clinical documentation to its telehealth platform for hospitals and health systems.
    • “The companies will work to integrate Microsoft Azure’s OpenAI Service and Cognitive Services and Microsoft-owned Nuance’s Dragon Ambient eXperience into its Solo platform, allowing physicians to automatically transcribe clinical notes during virtual patient exams.
    • “Teladoc’s medical group also plans to use DAX Express, a version of the medical scribe that uses the large language model GPT-4 and doesn’t require human authentication, the New York-based telehealth vendor said. Financial terms of the deal were not disclosed.”

From the Rx coverage front, the Drug Channel blog delves into the biosimilars’ challenge to Humira. The article illustrates the relatively new distinction between low-list drug prices and high-list drug prices. Low list prices do not include a manufacturer rebate. The FEHBlog understands that the distinction is driven by the Inflation Reduction Act.

Monday Roundup

David Ermer–ACA, COVID-19, FDA, Generative AI, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front —

  • The Wall Street Journal reports
    • “Parents have a new tool to protect their newborns from a common but potentially deadly respiratory virus that sends tens of thousands of babies to the hospital each year.
    • “The Food and Drug Administration on Monday approved the first drug to protect all infants against respiratory syncytial virus. RSV is the leading cause of hospitalization of infants in the U.S., killing as many as 300 children under the age of 5 each year.  
    • “The FDA said it approved the drug Beyfortus from Sanofi and AstraZeneca based on studies that found it safely prevented the lower respiratory tract infections caused by the virus. * * *
    • “While Beyfortus isn’t a vaccine, it has a similar objective. The injection gives infants antibodies to neutralize the virus before their immune systems are mature enough to generate them on their own.  * * *
    • “Sanofi plans to make Beyfortus available in time for this year’s RSV season. Before the drug can become widely available, CDC advisers will need to recommend the drug’s use.”  
  • The FEHBlog’s favorite columnist on Covid, the New York Times David Leonhardt, let us know, “The United States has reached a milestone in the long struggle against Covid: The total number of Americans dying each day — from any cause — is no longer historically abnormal.” Consequently, the pandemic era is over.
  • In other Covid news, Medscape tells us,
    • “An air monitor made by researchers at Washington University in St. Louis can detect COVID-19 virus in a room with an infected person within 5 minutes. 
    • “The project was a collaboration among researchers from the university’s engineering and medical schools. Nature Communications published the results of their work in the journal’s Monday edition. * * *
    • “The team tested their device both in laboratory experiments where they released aerosolized SARS-CoV-2 into a room-sized chamber, as well as in the apartments of two people who were COVID-positive.
    • “There is nothing at the moment that tells us how safe a room is,” Washington University neurology professor John Cirrito, Ph.D., in a statement. “If you are in a room with 100 people, you don’t want to find out 5 days later whether you could be sick or not. The idea with this device is that you can know essentially in real-time, or every 5 minutes if there is a live virus in the air.”
    • “Their goal is to develop a commercially available air quality monitor, the researchers said.” 
  • Cigna discusses how to help women to stay on track with screenings for common cancers.
  • KFF explains why different BMI standards apply to older folks. For example,
    • “Epidemiologic research suggests that the ideal body mass index (BMI) might be higher for older adults than younger adults. (BMI is a measure of a person’s weight, in kilograms or pounds, divided by the square of their height, in meters or feet.)
    • “One large, well-regarded study found that older adults at either end of the BMI spectrum — those with low BMIs (under 22) and those with high BMIs (over 33) — were at greater risk of dying earlier than those with BMIs in the middle range (22 to 32.9).
    • “Older adults with the lowest risk of earlier deaths had BMIs of 27 to 27.9. According to World Health Organization standards, this falls in the “overweight” range (25 to 29.9) and above the “healthy weight” BMI range (18.5 to 24.9). Also, many older adults whom the study found to be at the highest mortality risk — those with BMIs under 22 — would be classified as having “healthy weight” by the WHO.
    • “The study’s conclusion: “The WHO healthy weight range may not be suitable for older adults.” Instead, being overweight may be beneficial for older adults, while being notably thin can be problematic, contributing to the potential for frailty.”
  • According to STAT News,
    • “At the turn of the century, nearly 18 million women in the United States were battling hot flashes, night sweats, and other symptoms of menopause with hormones. But in 2002, the therapy went into a free-fall when a landmark trial suggested treating menopause with estrogen and progesterone increased the risk of breast cancer and cardiovascular disease. The study was shut down early — and a year later, prescriptions had plummeted to nearly half what they had been in 2001.
    • “More than two decades later, menopause experts have come to think about the results of the trial very differently. Newer research points to more benefits than risks for many healthy women under 60 treating menopause symptoms with hormone therapy. But many women who are good fits still aren’t getting treatment. “The pendulum has been slowly — too slowly — swinging back,” said OB-GYN Mike Green, chief medical officer of menopause telehealth company Winona. 
    • “Winona is part of a new generation of virtual-first health care companies aiming to give that pendulum a push. In the last five years, more than a dozen telehealth companies have started up to serve women in and approaching menopause, including with hormone therapy. 
    • “Women fall through the cracks,” said internist Lisa Larkin, president-elect of The Menopause Society and founder of concierge women’s health network Ms. Medicine. “That’s why the telemedicine business is booming.” 

From the Alzheimer’s Disease front,

  • Medscape tells us,
    • “Eastern and southeastern areas of the US have the highest rates of Alzheimer’s disease (AD), new research shows.
    • “Investigators at Rush University in Chicago, Illinois, found AD prevalence was highest in Maryland, New York, Mississippi, and Florida. At the county level, Miami-Dade in Florida, Baltimore in Maryland, and the Bronx in New York were among the US counties with the highest prevalence of the disease.
    • “Such geographical variations may be due to the unique make-up of regional populations, study investigator Kumar Rajan, PhD, professor of Medicine and director of Rush Institute for Healthy Aging, Rush University Medical Center, in Chicago, told Medscape Medical News.”
  • STAT News relates,
    • Medicare on Monday proposed ending restrictions on how many PET scans patients can receive to detect amyloid plaques in their brains, which will offer physicians more options as they treat patients with a new drug to slow the progression of dementia.
    • The agency that oversees Medicare had previously restricted coverage to a single scan for patients who participated in clinical studies. Advocates had warned that it could cause issues related to a new class of Alzheimer’s drugs designed to clear those plaques.
  • BioPharma Dive calls our attention to
    • “A closely watched experimental drug for Alzheimer’s disease slowed the decline patients typically experience by about half a year in a key clinical trial, according to new results released Monday.
    • “The drug, called donanemab, is being developed by Eli Lilly and works in a similar way as two other medicines recently approved in the U.S. to treat Alzheimer’s. These therapies are designed to break up clusters of “amyloid beta,” a mutated protein that forms toxic brain plaques and has long been viewed as a root cause of the disease. * * *
    • “Along with its presentation, Lilly disclosed it had completed its approval application to the FDA and expects a verdict by the end of the year. The results were also published in the medical journal JAMA.”
  • Reuters adds,
    • “Alzheimer’s disease experts are revamping the way doctors diagnose patients with the progressive brain disorder – the most common type of dementia – by devising a seven-point rating scale based on cognitive and biological changes in the patient.
    • “The proposed guidelines, unveiled by experts on Sunday in a report issued at an Alzheimer’s Association conference in Amsterdam, embrace a numerical staging system assessing disease progression similar to the one used in cancer diagnoses. They also eliminate the use of terms like mild, moderate and severe.”

From the generative AI front, Fierce Healthcare explains how Blue Cross licensee HCSC is using AI to speed up prior authorization.

From the U.S. healthcare business front,

  • The American Hospital Association informs us,
    • “The Federal Trade Commission July 14 voted 3-0 to withdraw two antitrust policy statements related to enforcement in health care markets, calling the 1996 and 2021 statements outdated. The Department of Justice withdrew the same statements in February.  
    • “AHA is deeply disappointed that the FTC made the same mistake as the DOJ in withdrawing antitrust guidelines for hospitals and other health care providers,” said AHA General Counsel & Secretary Melinda Hatton. “Over the years, AHA has urged both federal antitrust agencies to modernize the guidelines to accommodate the need for more flexibility in enforcement actions to support hospitals’ ability to navigate a changing healthcare landscape. And AHA was instrumental in securing appropriate ACO guidance that allowed hospitals to fully participate in that important program. Withdrawing all the guidance without consultation with the field is both unnecessary and reckless.”
  • According to STAT News,
    • “Sanofi will license a new CRISPR enzyme from the startup Scribe Therapeutics in a bid to be the first to develop a safer, simpler, and more scalable cure for sickle cell disease.
    • “The French drugmaker will pay Scribe $40 million upfront and promise another $1.2 billion in potential milestones to license a DNA-cutting enzyme called CasX for use in a potential single-infusion treatment for the serious blood disorder — what’s known as in vivo therapy. CasX was discovered in CRISPR pioneer Jennifer Doudna’s lab, which subsequently spun out Scribe. * * *
    • “The company will have competition on tackling sickle cell in new ways. In 2021, Novartis started collaborating with the Gates Foundation to develop an in vivo therapy. The base editing company Beam Therapeutics has presented data on an approach that still requires cells to be edited outside the body but is much less toxic. And Sana Biotechnology has a program that hopes to target stem cells with virus-like particles. None of the companies, however, have yet begun clinical trials. 

In employment news,

  • HR Dive reports,
    • “The Occupational Safety and Health Administration published Friday its final electronic recordkeeping rule requiring employers with 100 or more employees in certain industries to submit information from the agency’s Forms 300 and 301 once per year.
    • “OSHA’s rule also updates its system for determining which industries are subject to the information submission requirement. In a departure from the proposed rule, OSHA has retained the requirement for employers with 250 or more employees to electronically submit information from Form 300A once per year. Additionally, employers with 20 to 249 employees in certain designated industries will continue to be required to electronically submit information from Form 300A once per year.
    • “Per the rule, the agency will post data gathered via these submissions on a public website, with identifying information — such as employees’ names and contact information — removed. The final rule is effective Jan. 1, 2024.”

Midweek update

David Ermer–CMS, Congress, COVID-19, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC —

  • Politico reports,
    • “The Senate Finance Committee is releasing the next in its parade of legislation targeted at pharmacy benefit managers — an industry that Democrats and Republicans on Capitol Hill argue drives up the cost of drugs.
    • “Sens. Catherine Cortez Masto (D-Nev.) and Thom Tillis (R-N.C.) — along with Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) — plan to unveil legislation that would require PBMs, which manage prescription drugs for health insurers, to report a broader range of data about their business practices. The lawmakers seek comment on their proposal.
    • “The bill would require PBMs to submit annual reports to the Medicare drug plans that detail information about the treatments the plan covers, the discounts PBMs negotiate with drugmakers on medicines and the fees they collect.
    • “It’s the latest in a plan from Wyden and Crapo, who released a roadmap in April of PBM-focused legislation they want the committee to pursue.”
  • The Senate Finance Committee adds,
    • “Senate Finance Committee Chair Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) today announced that the committee will mark up legislative proposals to modernize and enhance federal prescription drug programs on Wednesday, July 26th at 2 p.m. The committee package will focus on addressing pharmacy benefit manager practices that have grown increasingly complex and opaque in recent years at the expense of patients and taxpayers.”
  • The American Hospital Association further informs us,
    • “The House Education & Workforce Committee July 12 voted 39-0 to pass legislation (H.R. 4509) that would require off-campus hospital outpatient departments to obtain a separate unique health identifier and include it on all claims for services billed to commercial group health plans or their enrollees. The legislation would prohibit the health plan from paying the claim and the hospital from collecting payment from the plan enrollee if the claim excludes the identifier, and impose civil monetary penalties on hospitals that violate the requirement. * * *
    • “In other action, the committee also passed bills that would strengthen price transparency requirements for commercial group health plans (H.R. 4507); require that the plans’ contracts with service providers allow the employer/plan fiduciary to access all de-identified claims and encounter data (H.R. 4527); and require the plans to further report to the employer/fiduciary their financial arrangements with pharmacy benefit managers (H.R. 4508).”

From the public health front —

  • Beckers Clinical Leadership and Infection Control tells us,
    • “After identifying a new COVID-19 omicron subvariant — EU.1.1, a descendant of XBB.1.5 — in late June, its growth has slowed, according to the CDC. 
    • “Right now, the subvariant accounts for only 1.1 percent of cases in the U.S., data shows. Nationwide, hospitalizations and deaths both continue to decline. The CDC’s most recent data shows that hospitalizations decreased by 0.8 percent as of July 1, and deaths decreased by 9.1 percent in the same one-week period.
  • CNN reports
    • Childhood cancer diagnoses in the US have been trending up for more than a decade, according to a study published Tuesday in the Journal of the National Cancer Institute.
    • There were 14,381 new childhood cancer diagnoses in the US in 2019: about 177 new cases for every 1 million children and teens up to age 19. Incidence rates have dropped since reaching a peak in 2016 but are still about 8% higher than they were in 2003, when there were about 165 new cases for every 1 million children and teens.
    • “Overall, cancer is very rare in children and adolescents, and the increases were small,” said Dr. David Siegel, a pediatric oncologist and an epidemiologist with the US Centers for Disease Control and Prevention’s cancer division who was the lead author of the study. “Past studies have also reported increased survival rates. So the combination of increases in incidence and decreases in deaths means that there are more and more cancer survivors that need long-term care and resources.”
  • The U.S. Census Bureau issued a report examining “Racial/Ethnic Disparities in Disability by Health Condition.”
    • “The data show patterns in health-related disability among adults age 40 and older and key differences by sex, race and Hispanic origin.
      • “Among findings:
      • “Women were more likely than men to have health conditions that limited their daily activities.
      • “Asian (non-Hispanic) adults reported the lowest rates (17.2%) of disability-related health conditions.
      • “Black (non-Hispanic) adults (31.8%) and those reporting Other or multiple-race non-Hispanic identity (42.9%) were among those with higher rates.
  • The All of Us Program released its July 2023 Medical Minutes.

From the Rx coverage front

  • Per Healthcare Dive,
    • Major pharmacy benefits manager CVS Caremark is partnering with drug discounter GoodRx on a joint program to bring down out-of-pocket drug costs, the companies announced Wednesday.
    • Commercially insured customers will be able to pay GoodRx’s discounted pricing when filling commonly prescribed generic prescriptions at in-network pharmacies. The payments will be automatically applied to their deductibles and out-of-pocket limits.
    • The program, called Caremark Cost Saver, will be available for tens of millions of CVS Caremark clients’ members at in-network pharmacies starting January 2024.
  • Per Beckers Payer Issues,
    • ‘About two-thirds of patients who take popular weight loss drugs end their regimen within a year, according to a Prime Therapeutics study released July 11.
    • ‘Prime, a pharmacy benefit manager owned by 19 Blue Cross Blue Shield companies, analyzed pharmacy and medical claims of 4,255 patients who took GLP-1 receptor agonists — such as Ozempic and Wegovy — for weight loss in 2021. The study found only 32 percent of patients continued their weight loss treatment after one year. 
    • “The majority of patients aren’t getting the value of the product and there’s waste, especially with an expensive therapy,” Patrick Gleason, PharmD, Prime’s assistant vice president for health outcomes and a co-author of the analysis, told Reuters. “I was a little bit surprised by the persistency rate.”
  • STAT News delves into how Medicare Advantage plans are approaching the FDA’s approval of the infused Alzheimer’s drug Leqembi. The most illuminating part of the article concerns the Mayo Clinic.
    • As a condition of coverage, Medicare rolled out a new patient registry to collect more information from physicians prescribing Leqembi. Information is supposed to be submitted every six months. Physicians who had previewed the registry said it appeared to function, though many clinics are still finalizing protocols for prescribing Leqembi.
    • “I’m not sure it’s sufficiently detailed to answer the [coverage with evidence development] questions that the [national coverage decision] put forth. We and others would need to collect more detailed information to understand the true benefits and risks of the medicine,” said Ronald Petersen, the director of the Mayo Clinic Alzheimer’s Disease Research Center.
    • Mayo Clinic isn’t prescribing Leqembi yet, as it’s planning to launch an Alzheimer’s treatment clinic in October, Petersen said. He said there has been interest from patients, but it “hasn’t been a landslide.”
    • Petersen is hoping to start a new research study at Mayo Clinic to do more detailed monitoring on patients. To start, Mayo physicians will likely only agree to treat patients in the geographic area close to the facility so they can oversee the follow-up appointments.
    • “We’d be more than happy to share our data with broader communities or merge it with data from CMS. It is incumbent upon all of us to share data to learn from each other what works,” Petersen said.

From the U.S. healthcare business front —

  • MedPage Today points out
    • “Private equity acquisitions of U.S. physician practices have risen dramatically over the last decade, driving up consumer prices in the process, according to a new report.
    • “In 2012, there were 75 private equity deals for physician practices across a range of specialties; in 2021, there were 484, marking a more than six-fold increase, Richard Scheffler, PhD, of the University of California Berkeley, and colleagues found.
    • “Over the entire period, the largest number of deals occurred in dermatology (376), ophthalmology (276), gastroenterology (120), and primary care (118), collectively accounting for 81% of the activity, Scheffler and colleagues wrote in the report, a joint effort by the American Antitrust Institute, the Nicholas C. Petris Center on Health Care Markets and Consumer Welfare at the University of California Berkeley, and the Washington Center for Equitable Growth.”

In telehealth news,

  • Fierce Healthcare tells us,
    • “While payers should cover telehealth, where these services are the most valuable still requires investigation, according to a study in Information Systems Research.
    • “The Centers for Medicare & Medicaid Services made the rules about telehealth usage more flexible during the COVID-19 pandemic, and some lawmakers want to make those changes permanent. But that should not mean giving providers carte blanche approval in using the new technology, nor should payers cover all uses of telehealth, suggests a study by researchers with the University of Texas.
    • “Telehealth should not be regarded as a one-size-fits-all solution to virtualize healthcare,” the study said.
    • “Despite that, however, the study also states that “insurance plans should expand their telehealth coverage to include more providers and close the healthcare access divide in rural locations, which can reduce subsequent hospitalizations and unnecessary costs.”
    • “The authors argue that telehealth’s benefits can be seen in treating conditions and diseases with “high virtualization potential” such as mental health, skin problems, metabolic conditions and musculoskeletal diseases. However, telehealth did not significantly reduce visits to specialists or emergency departments for circulatory, respiratory or infectious diseases.
    • “Indranil Bardhan, Ph.D., one of the authors of the study, said in a press release that “people believed that telehealth would be the next big thing, the future of healthcare. But our research shows that its impact is not as straightforward as people might think. It’s more nuanced.”

Tuesday Tidbits

David Ermer–Congress, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The Senate Health Education Labor and Pensions Committee held its Superbugs hearing today.
  • STAT News informs us
    • “The witnesses largely seemed to organize behind the Pasteur Act in terms of how Congress should respond. This bipartisan legislation, which has been introduced in both the House and Senate, would encourage drug development by creating a subscription-style business model. In other words, the U.S. government would offer upfront payments to drugmakers in exchange for responsible stewardship policies and unlimited access to their antibiotics. A similar model has been successfully piloted in England over the past year, with the National Health Service planning a wider rollout to more pharmaceutical companies and to Northern Ireland, Scotland and Wales.
    • “The goal, as STAT has previously reported, is to enable pharmaceutical companies to recover their costs and make a profit — without predicating this on large volumes of antibiotics being prescribed. Helen Boucher, Dean of Tufts University School of Medicine, testified that this law would recognize these drugs “for their value, not for their use. It de-links incentives for overusing antibiotics.”
  • The Government Accountability Office released “a new report on the agency’s key findings and recommendations with an eye toward helping federal agencies be better prepared for future emergencies. GAO has regularly reported on the accountability and effectiveness of the federal government’s $4.7 trillion pandemic response since 2020.”
  • Per the White House,
    • “Today, in the continued efforts to fight the dangerous and deadly combination of xylazine mixed with fentanyl, the White House Office of National Drug Control Policy (ONDCP) released a National Response Plan to coordinate a whole-of-government response against this threat. Earlier this spring, ONDCP Director Dr. Gupta used an executive designation authority to designate fentanyl combined with xylazine as an emerging threat to the United States and proactively address this dangerous threat head-on.”
    • “Read the full National Response Plan to Fentanyl Combined with Xylazine HERE.
    • “Read about the Biden-⁠Harris Administration’s efforts to crack down on illicit fentanyl supply chains HERE.
    • “Read the Biden-Harris Administration’s National Drug Control Strategy HERE.”

From the public health front —

  • Federal News Network reports that twelve House of Representatives members are asking the Postal Service about steps being taken to protect letter carriers against the effects of high outdoor heat following the death of a letter carrier who passed away while delivering the mail in Texas.
    • “Eugene Gates Jr., a 66-year-old letter carrier in Texas, died June 20 while delivering mail during a heat wave with temperatures as high as 115 degrees. * * *
    • “The National Association of Letter Carriers, which represented Gates, said he collapsed and died in a customer’s yard while delivering mail. Gates, an Army veteran, served as a letter carrier for 36 years.
    • “Eugene was a dedicated letter carrier with a long and successful Postal Service career,” NALC National President Brian Renfroe said in a statement. “He will be greatly missed.”
  • STAT News tells us,
    • Weight loss medications from Novo Nordisk are being investigated by the European Medicines Agency after several reports of suicidal risks were referred to the watchdog, Bloomberg News reports. The regulator is looking at adverse events noted by the Icelandic Medicines Agency, including two cases of suicidal thoughts linked to the drugs Saxenda and Ozempic. One additional case relating to thoughts of self-injury has been raised in connection with Saxenda. The agency is investigating the possible side effects in relation to patients who have used medicines containing the active ingredients semaglutide or liraglutide for weight loss. Novo’s hit weight loss drug Wegovy also contains semaglutide.
  • The Bloomberg article adds,
    • “Wegovy is currently available in the US with a warning and precaution for suicidal behavior and ideation on the label. While clinical trials of Wegovy did not support an increased risk of suicidal behavior, suicidal ideation, or other psychiatric adverse events, clinical trials of other weight management drugs have reported suicidal behavior and ideation, a spokesperson for the Food and Drug Administration said Monday.
    • “If newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence,” the spokesperson said.”

From the medical research front,

  • According to the National Science Foundation —
    • “While it’s known that sleep plays a crucial role in strengthening memory, scientists are still decoding how the process plays out in the brain overnight.
    • “U.S. National Science Foundation-supported research led by scientists at UCLA and Tel Aviv University offers new evidence from inside the human brain supporting the dominant theory of how the brain consolidates memory during sleep.
    • “The researchers found that targeted deep brain stimulation during a critical time in the sleep cycle improved memory consolidation. The result came from a novel “closed loop” system that delivered electrical pulses in one brain region that activated the cerebral cortex, synchronized with brain activity recorded in another area, the hippocampus.
    • “The research, published in Nature Neuroscience, could offer new clues to how deep brain stimulation during sleep could help patients with memory disorders, said study co-author and physician-scientist Itzhak Fried of UCLA.”

From the Medicare front, NerdWallet identifies four Medicare policies that “should come with warning labels.” Number 1 is the Part B late enrollment penalty. The article encourages picking up Part B at the first opportunity, even if health expenses at the time are modest. Granted, this article is aimed at people, like the FEHBlog, who have Medicare without supplemental employer coverage. Nevertheless, federal employees should consider the advice too.

From the Rx coverage front

  • Beckers Hospital Review notes
    • “The FDA is allowing 10 more lots of cisplatin from a China-based pharmaceutical company to be imported to the U.S. to ease the ongoing cancer drug shortage, Bloomberg reported July 10. The additional lots are set to arrive next week. 
    • “In June, federal regulators cleared four lots of cisplatin from Qilu Pharmaceutical. While the version of the drug is unapproved in the U.S., it is similar to the approved version distributed across the country. 
    • “We will continue the importation until manufacturers can meet all needs,” Chanapa Tantibanchachai, an FDA spokesperson, told Bloomberg.
    • “Shortages of the essential cancer drug began in February and have caused some cancer centers to ration cisplatin and carboplatin, another cancer drug in shortage, treatments for patients. More recently, there have been signs of supplies stabilizing.” 
  • Fierce Healthcare discusses a recent HHS report on approaches to avoiding drug shortages.
  • Following up on its recent report about the lead-covered cabling problem in our country, the Wall Street Journal points out
    • “Supplies are running out for a key antidote for life-threatening lead poisoning.
    • “The drug, named dimercaprol, has been a go-to treatment for years for the worst cases of lead poisoning. But doctors have had to scrounge for dwindling doses since the medicine’s sole manufacturer for the U.S. declared bankruptcy in February.
    • “Now that some parts of the country don’t have any supplies left, doctors have been forced to turn to other, less preferred treatments.
    • “We’re using whatever we can get, knowing it will help, but not knowing if it’s doing as good of a job,” said Dr. Diane Calello, who directs the New Jersey Poison Control Center at Rutgers New Jersey Medical School.”

In U.S. healthcare business news

  • Beckers Payer Issues tells us
    • “The Cigna Group’s network of behavioral health providers grew by more than 30 percent in 2022, according to the company’s 2022 Environmental, Social, and Governance Report.
    • “The July report said the behavioral health network has grown to include more than 300,000 mental health and substance use providers, doubling its size over the past four years. The company also nearly doubled its virtual care network, which has grown to include more than 163,000 virtual behavioral health providers. In-network providers who support cultural and race-related counseling were increased.
    • “For behavioral health providers that specifically work with children, Cigna added 27,000 providers to its network in 2022, or an increase of 19 percent. It also increased the numbers of facilities treating children by 8 percent to 2,700 total.”
  • The Wall Street Journal delves into high-priced “clinics cater[ing] to a growing number of people obsessed with fighting aging.”
    • “Practitioners at Healthy Longevity Clinic, which has locations in Boca Raton, Fla., and Prague, build patients a personalized “longevity road map.” Those maps can include recommendations for diet, exercise, sleep and supplements. Patients are encouraged to stick with the program for at least a year, over which time their bill can run between $25,000 to more than $100,000, says Petr Sramek, the clinic’s chief executive.
    • “Longevity-clinic treatments aren’t often covered by health insurance. Some providers say they work with insurers to get coverage for medications or laboratory tests. 
    • “Many clinics use membership-based models in an effort to keep client loads low enough that providers can spend time with each patient. Others are fee-for-service or use a combination of the two.”

Monday Roundup

David Ermer–Medicare, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front

  • The New York Times reports,
    • “Drowning is the leading cause of death for children ages 1 to 4, according to the Centers for Disease Control and Prevention. Deaths are likely to surge this month, as they do every July, with children drowning just feet from their parents without a scream, struggle or splash. A 4-year-old at a Texas hotel pool, a 5-year-old in a California river, a 6-year-old at a Missouri lake and a 10-year-old at an Indiana public pool all drowned just this past week. * * *
    • “The National Institutes of Health recently published a call for research proposals to examine drowning prevention, writing that “little is known” about what intervention strategies work. The C.D.C. said it planned to do an in-depth analysis of childhood drownings in several states to better understand the contributing factors.
    • “But epidemiologists point to an array of factors that could make it increasingly difficult to close the gap, including shrinking recreation department budgets, a national lifeguard shortage and an era of distraction on pool decks as parents juggle child supervision with laptops and cellphones when they work from home.”
  • and
    • “When Dr. Benjamin Han, a geriatrician and addiction medicine specialist, meets new patients at the School of Medicine at the University of California, San Diego, he talks with them about the usual health issues that older adults face: chronic conditions, functional ability, medications and how they’re working.
    • “He asks, too, about their use of tobacco, alcohol, cannabis and other nonprescription drugs. “Patients tend to not want to disclose this, but I put it in a health context,” Dr. Han said.
    • “He tells them, “As you get older, there are physiological changes and your brain becomes much more sensitive. Your tolerance goes down as your body changes. It can put you at risk.”
    • “That’s how he learns that someone complaining about insomnia might be using stimulants, possibly methamphetamines, to get going in the morning. Or that a patient who has long taken an opioid for chronic pain has run into trouble with an added prescription for, say, gabapentin. * * *
    • “Aging boomers “still use drugs far more than their parents did, and the field wasn’t ready for that.”
    • “Evidence of a growing problem has been stacking up. A study of opioid use disorder in people over 65 enrolled in traditional Medicare, for instance, showed a threefold increase in just five years — to 15.7 cases per 1,000 in 2018 from 4.6 cases per 1,000 in 2013.”
  • Fierce Healthcare informs us,
    • “Americans are likely to skip important health screenings, and women have a less positive outlook than men regarding their current and future health prospects, according to a survey released by Aflac.
    • “The survey, based on about 2,000 employed adults, examined attitudes, habits and opinions about health and preventive care and found that half of adults have avoided at least one common health screening. These screenings include tests for certain diseases.
    • “But for the 51% of respondents who said they have had cancer, that diagnosis came following a routine checkup or screening. For Hispanic survey respondents, 72% of individuals said a diagnosis was discovered at a routine checkup.
    • “Skipping regular checkups is common among individuals who feel healthy. One in 4 respondents said they miss routine checkups. Reasons cited include a conflict with work hours, the individuals are “not thinking about it,” a general dislike for going to the doctor’s office, insurance issues, fear of hearing bad news and the time commitment required.”
  • In the FEHBlog’s view, the best action for a health plan to take in response to these concerns is to connect members with in-network primary care providers.

From the Medicare front, Beckers Payer Issues points out that “Caps on Medicare prescription drug costs will save Part D enrollees a collective $7.4 billion in 2025, according to a report from HHS’ Office of the Assistant Secretary for Planning and Evaluation.  The report, published July 7, broke down expected savings from price caps by state. An estimated 18.7 million people, around 1 in 3 Medicare Part D enrollees, will save on drug costs in 2025. The average annual saving per person is estimated at $396.08.” That’s good news for FEHB and PSHBP plans with Part D EGWPs.

From the Rx coverage front, Fierce Healthcare notes

  • “On the heels of a similar announcement from Optum Rx, pharmacy benefit management giant Express Scripts said Monday that it will add three biosimilars to its formulary to compete with Humira.
  • “The PBM announced that it will include Boehringer Ingelheim’s Cyltezo and two biosimilars produced by Novartis’ Sandoz in its National Preferred Formulary. Humira, a drug for people with inflammatory conditions, is the top-selling pharmaceutical product in the world and has been viewed as a key target for savings thanks to biosimilar products.
  • “Express Scripts said its trend data show that anti-inflammatory drugs accounted for nearly 25% of total drug spending for its commercial business last year. An analysis from its parent company, Evernorth, found that increased biosimilar competition could save $225 billion to $375 billion over the next decade.”

Those savings will benefit FEHB and PSHBP plans.

From the employment front, the Society for Human Resource Management discusses steps that employers can take to support employees who have children with developmental disabilities.

STAT News and its readers offer 27 healthcare reads and podcasts for the beaches and mountains.

 

Friday Factoids

David Ermer–ACA, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The White House kicked off its Friday with a bunch of new healthcare measures, none of which impact the FEHB. Roll Call offers a useful overview of the measures.
  • Here is a link to the related Affordable Care Act FAQ 60, which discusses the No Surprises Act measures, which are explained in the separate White House press release. To maintain one’s sanity, read the No Surprise Billing section of that press release before reading the FAQ. That will help you decide the relevance of the FAQ to your work.
  • In combing through the various press releases, the FEHBlog did run across this link to an HHS report to Congress on the No Surprises Act, which may be worth a gander.
    • “This first report focuses largely on establishing a baseline and a framework for further evaluation. The report details key trends in factors that will be important to evaluate NSA effects, including the implementation and impacts of state surprise billing laws already in effect; trends in market consolidation and concentration; the impact of market consolidation and concentration on prices, quality, and spending; and trends in OON billing. This report also describes a conceptual framework for considering the healthcare market effects of NSA, as well as describing potential methodologic approaches (and their limitations) for estimating these effects. Subsequent reports will implement these approaches.”
  • STAT News reports
    • “Medicare is planning to send $9 billion in lump-sum payments to more than 1,600 hospitals that participate in a drug discount program [known as 340B] after the Supreme Court found the program underpaid them for prescription drugs, the agency announced on Friday.
    • “To pay for the restitution, Medicare would slash all hospitals’ payments for other items and services by 0.5% for the next 16 years.”
    • The FEHBlog paraphrases the Bible, “First it giveth, then it taketh away.”
  • The Society for Human Resource Management tells us
    • “The U.S. Equal Employment Opportunity Commission (EEOC) has postponed the deadline for employers to file their 2022 EEO-1 reports, which list workforce demographic data, including race and sex.
    • “An announcement on the EEOC’s website explained: “The EEOC is currently completing a mandatory, three-year renewal of the EEO-1 Component 1 data collection by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). Accordingly, the EEOC has updated the tentative opening of the 2022 EEO-1 Component 1 data collection to the Fall of 2023.”
    • “A more precise date was not available. Previously, the tentative deadline for filing was in mid-July.”

Let’s wrap us this Friday with potpourri:

  • Politico interviews the income president of the American Medical Association Jesse Ehrenfeld, MD.
  • Benefits Pro discusses Rx optimization programs.
  • Health IT Analytics explains “How Elevance Health and MVP Health Care are leveraging data analytics. The two payers share how they leverage data analytics, predictive modeling, and data quality frameworks to improve outcomes for members.”
  • MedPage Today points out
    • “As research interest in the therapeutic potential of psychedelics has grown — with academic centers popping up across the country, and compounds already in developmen — the FDA recently caught up, issuing a draft guidance on managing clinical trials of these drugs.
    • “The draft guidance was released on June 23, as one of the largest U.S. psychedelic conferences was underway. It outlined the agency’s views on best practices in clinical trial design for psychedelic drugs — including psilocybin, lysergic acid diethylamide (LSD), and methylenedioxymethamphetamine (MDMA) — in the treatment of medical conditions, including psychiatric or substance use disorders.
    • “In an email to MedPage Today, an FDA spokesperson called psychedelics “a very active and challenging area of drug development.”
    • “As an emerging area of drug development, there is limited experience as to the configuration of programs that may support approval of a psychedelic drug,” the spokesperson wrote. “The guidance presents foundational constructs that all sponsors, including academic sponsor-investigators, studying the therapeutic potential of psychedelic drugs should consider.”
  • The Wall Street Journal questions whether people should be judgmental about other people who lose weight with the new generation of weight loss drugs.
    • “Elizabeth Owen didn’t let her husband’s comments dissuade her from taking Ozempic. (John Owen, 60, who had recommended his wife continue to exercise and eat healthy to lose the weight, says he was just telling her to do what he would have done in her situation.) At 5’2” and 142 pounds, she was the heaviest she had ever been, despite regular workouts with a personal trainer.
    • “Owen, who lives in Orlando, Fla., says she has been embarrassed to tell her personal trainer about taking Ozempic. She did tell a good friend, who told her the drug would make her sick.
    • “She has lost 34 pounds so far and takes a small maintenance dose. Recently, John’s doctor advised him to lose weight and prescribed Wegovy, which he’s taking. 
    • “Friends and family also are starting to ask about her treatment in a more positive way, she says. 
    • “They’re curious because I’m maintaining the weight loss,” she says. “A year later, they all want to know why.”