Tomorrow afternoon, the House Rules Committee will take up HR 4664, the financial services and general government appropriations bill that includes OPM and FEHB funding. The bill includes the typical FEHB appropriations provisions — the abortion coverage restriction, the contraceptives coverage mandate, and the prohibition against applying full Cost Accounting Standards coverage to experience-rated FEHB plan carriers.
The Federal Benefits Open Season begins next Monday, November 13, and ends on Monday, December 11, 2023. OPM has refreshed the Open Season website with 2024 plan information.
From the public health and research front,
NPR Shots discusses the impact of chronic drug shortages on hospitals and patients.
The Washington Post reports that “the hunt quickens” for vaccines and antibody therapies against opioids. For example,
“The federal government recently awarded an additional $14.8 million for research into a monoclonal antibody that would target fentanyl — the nation’s deadliest street drug — by binding to its molecules before they can invade the brain and shut down breathing. Cessation Therapeutics, a North Carolina biotech company, touts its monoclonal antibody as a way both to prevent overdoses and to treat overdoses and opioid addiction.”
“Whether you snag some vitamin C at the first sign of a cold or stock up on probiotics to keep your gut health in check, you’re not alone in turning to dietary supplements—an estimated 75% of Americans use them.
“Among the various types, vitamin K is gaining popularity due to its potential benefits for healthy aging. Specifically, it is thought to aid in the prevention of age-related conditions such as osteoporosis and cardiovascular disease.”
“Prescriptions for semaglutide jumped 150% in the past year, with an 80% increase in prescriptions written per provider, new data suggest.
“Among more than 350,000 prescribers in the nationwide DrFirst network between December 2022 and June 2023, prescriptions for the weight loss formulation Wegovy rose sixfold while those for Ozempic, the lower-dose version for treating type 2 diabetes, increased by 65%.”
“With nutrient-stimulated hormone therapies for obesity in phase 3 trials and activin-receptor inhibitors in the next upcoming drug class, highly effective treatments for obesity are on the horizon.
“We are at a watershed [moment] brought on by the recent introduction of highly effective antiobesity medications,” said Ania M. Jastreboff, MD, PhD, in a lecture at ObesityWeek.
“Jastreboff, from Yale University and the Yale Center for Weight Management, New Haven, Connecticut, provided an overview of the many nutrient-stimulated hormone-based antiobesity therapies in late phases of development — including dual and triple therapies with glucagon-like peptide 1 receptor agonists (GLP-1 RAs), glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon, and amylin.”
“New research suggests terminating metformin may raise the risk for dementia in older adults with type 2 diabetes, providing more evidence of metformin’s potential neuroprotective effects.”
“T3D-959, an oral dual delta/gamma peroxisome proliferator-activated nuclear receptor (PPAR) agonist, has shown promise in a phase 2 randomized, placebo-controlled study of adults with mild-to-moderate Alzheimer’s disease (AD).”
“Young people today are facing significant challenges to their health and well-being,” said Admiral Rachel Levine, M.D., Assistant Secretary for Health. “We are committed to working closely with our allies and partners across the country to support improvements in adolescent health and well-being.”
“It is critical that we take action for adolescents now,” said Jessica Swafford Marcella, Deputy Assistant Secretary for Population Affairs. “This new Call to Action and accompanying toolkit will inspire collaborative efforts across youth-serving sectors to build a healthier future for America’s young people.”
“Take Action for Adolescents outlines a vision, key principles, eight goals, and a set of initial action steps. It is research-based and was developed with extensive input from adult and youth allies and partners, including nationally recognized adolescent health experts. It is accompanied by a Take Action Toolkit with tips and resources to spur collaboration in states and communities.” * * *
The Office of Population Affairs’ Take Action for Adolescentswebpage features a suite of resources that are easy to download and share.
The Food and Drug Administration announced approving
“Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications:
“Adult patients with:
moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
active psoriatic arthritis;
moderately to severely active Crohn’s disease; and
moderately to severely active ulcerative colitis.
“Pediatric patients 6 years of age and older with:
moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and
active psoriatic arthritis.
“Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.”
Assistant Secretary of Labor for Employee Benefit Security Lisa Gomez announced a proposed rule to improve retirement benefit security under ERISA.
“There’s some good news about flu season this year. Doctors and scientists don’t expect the worst.
“The flu season in the Southern Hemisphere, where the cold-weather illness period wraps up as we head into ours, often serves as a harbinger of what’s to come for us. There, cases picked up a little earlier than usual in some countries but didn’t result in an especially large number of hospitalizations and deaths, say public health experts and doctors.
“Also encouraging: The components in this year’s flu vaccine are a good match to the predominant strain so far.”
“COVID-19 hospitalizations in the U.S. remained relatively steady week over week following five weeks of larger declines, according to data from the Centers for Disease Control and Prevention.
“The U.S. tallied about 16,200 new hospitalizations of people with COVID-19 over the seven days ending Oct. 21, according to provisional data – only 40 hospitalizations less than the total for the previous week and effectively pausing a downward trend that began after hospitalizations totaled close to 21,000 during the week ending Sept. 9. Hospitalizations dipped to a low point of approximately 6,300 in late June before starting to trend back up.
“Relative to population, data points to 4.9 new COVID-19 hospital admissions per 100,000 people for the week through Oct. 21. Among states and territories, Montana saw the highest rate over the week at 10 per 100,000. West Virginia (8.3), the District of Columbia (8.1), and Colorado (7.6) had the next-highest rates. Compared with the week prior, Mississippi had the highest percentage increase in its COVID-19 hospitalization rate at 45%, followed by Kansas(41%), Indiana (40%) and Iowa (32%).
“Among patients visiting a subset of emergency departments, data indicates 1.3% were diagnosed with COVID-19 nationally – a rate down about 5% from the week before. New Mexico(3.1%), Colorado (2.4%) and Arizona (2.3%) saw the highest rates.”
“Tenet Healthcare beat Wall Street expectations on revenue in the third quarter due to cost control measures and sustained revenue growth at its facilities.
“The for-profit operator’s ambulatory care and hospital segments both experienced volume growth, with both divisions’ earnings coming in “well above” Tenet’s expectations, said CFO Dan Cancelmi during a call with investors on Monday.
“Executives raised the lower end of Tenet’s full-year revenue guidance. The operator now expects to capture between $20.3 billion and $20.5 billion this year.”
“For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.
“In the third quarter of 2023, Pfizer recorded $5.6 billion in coronavirus-related inventory write-offs and other charges, plus a $4.2 billion revenue reversal tied to the planned return of some 7.9 million Paxlovid doses from the U.S. government.
“Concerning the inventory write-offs, $4.7 billion of the sum is tied to Pfizer’s antiviral Paxlovid, with the remaining $900 million stemming from the company’s BioNTech-partnered mRNA vaccine Comirnaty, Pfizer said Tuesday.”
Employers are looking to deductible-free health plans as employees report increasing concerns about the cost of healthcare, according to Mercer’s 2023-2024 “Inside Employees’ Minds” survey.
The survey, published Oct. 30, interviewed 4,505 full-time employees in the United States, working for organizations with more than 250 employees.
In 2023, 15% of organizations are offering some employees no-cost health plans, and 18% are using salary-based contributions.
Around 4 in 10 employers offer a medical plan with low or no deductible.
Plans with no deductibles are growing in popularity — UnitedHealthcare’s fastest-growing commercial plans have no annual deductibles, COO Dirk McMahon told investors Oct. 30.
“UnitedHealthcare members in these offerings are receiving more preventive care, while paying about 50% less out of pocket, compared to people enrolled in traditional offerings, and their employers can reduce the total cost of care with an average savings of 11%,” Mr. McMahon said.
According to Mercer’s survey, 79% of workers making between $60,000 and $100,000 each year say they can afford the healthcare their family needs without hardship, compared to 51% of workers making less than $30,000 annually.
Beckers Health IT identifies 121 unicorns (companies with at least a one billion dollar valuation) operating in the healthcare space.
KFF tells us what to watch for in the eleventh Affordable Care Act open enrollment period, which begins tomorrow. Here’s an interesting tidbit from that article:
Private health plans must permit young adults the option of remaining covered as a dependent under their parent’s policy until they turn age 26. Starting in 2024, though, federal Marketplace health plans will officially not be allowed to terminate coverage for young adult dependents mid-year on their 26th birthday. Instead, they will have to continue the dependent coverage through the end of the calendar year. The federal Marketplace has already been keeping these individuals on the plan until the end of the year, and then automatically enrolling them in their own exchange coverage the following year, but this rule codifies that practice.
“The House elected GOP Rep. Mike Johnson of Louisiana as speaker Wednesday, with the staunch conservative overcoming the divisions that had paralyzed the chamber after a band of hard-liners ousted Kevin McCarthy three weeks ago.
“The choice of Johnson, aligned with former President Donald Trump, came after House Republicans nominated and then dumped a series of leadership candidates, prompting some members to wonder whether any colleague could thread the needle in the deeply divided conference. With a speaker now in place, lawmakers can return to work, with many eager to pass aid for Israel and address a looming government-funding deadline next month.”
“A Senate health panel on Wednesday voted to send President Biden’s nominee to lead the National Institutes of Health to the chamber’s floor, moving Monica Bertagnolli one step closer to taking the longtime vacant role of permanent director.
“The Senate HELP Committee advanced her nomination on a 15-6 vote, with many Republicans voting in support and only Chairman Bernie Sanders (I-Vt.) breaking with the Democratic caucus to vote against her. * * *
“Her nomination will now move to the Senate floor for a full vote, though it is unclear when that will be scheduled.”
The NIH National Cancer Institute shares its weekly research highlights.
The American Hospital Association News points out,
“Starting Oct. 25, consumers can preview their 2024 health coverage options at the federally facilitated Health Insurance Marketplace. Open enrollment for the 2024 marketplace runs Nov. 1 through Jan. 15, with coverage starting Jan. 1 for consumers who enroll by midnight on Dec. 15. The Centers for Medicare & Medicaid Services expects that 96% of the website’s customers will have access to three or more insurance issuers and four in five can find coverage for $10 or less per month after subsidies.”
FedWeek calls attention to the fact that the U.S. Office of Personnel Management’s Inspector General has released its annual report identifying top management challenges.
From the Federal Employee Benefits Open Season front, FedSmith provides a healthcare roadmap for federal retirees. Govexec provides its perspective on Open Season planning here.
“So far, 12 million people, or about 3.6 percent of the population, have gotten the shot in the five weeks since it hit pharmacy shelves — though reporting lags mean it’s likely a bit higher, Centers for Disease Control and Prevention Director Mandy Cohen said.
“More people, by far — 16 million — have gotten their annual flu vaccine, Cohen said, attributing the difference to long-held routines.”
“As Americans flock to nearby orchards for festive bouts of autumn apple picking, Insulet is celebrating a particularly bountiful stateside Apple harvest itself.
“The diabetes device maker has earned FDA clearance for the iPhone version of an app allowing users to control their Omnipod 5 insulin pumps from their own smartphones. Meanwhile, the app has been available to Android owners since the pump’s full U.S. launch began a year ago.
“In Insulet’s Monday announcement about the Apple clearance, Eric Benjamin, the company’s chief product and customer experience officer, hailed the impending launch of the app as a “significant milestone in our ongoing effort to provide people with diabetes solutions that improve their lives and help them think less about diabetes.”
“28% of U.S. adults said they are interested in taking prescription GLP-1 drugs like Ozempic, Mounjaro or Wegovy for weight loss, a share relatively consistent with August and April surveys.
“Consumers who have heard “a lot” about the drugs, have weight-related health conditions or have higher incomes are most likely to be interested in taking the medications.
“The impacts of weight loss drugs on the health industry are clear, but other sectors, like food and retail, are likely to feel the effects of changing consumer preferences. Brands that create products and services to help support a more health-conscious consumer will be best-positioned to weather disruption from Ozempic or future weight loss drug innovations.”
“Boston Scientific shared pivotal trial results on Wednesday that showed promising results for its drug-eluting balloon in treating patients with repeat blockages.
“The company’s Agent drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries at one year, according to data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference. Boston Scientific was the study sponsor.”
“Patients with Alzheimer’s disease may have another treatment option in the not-too-distant future, as newly released data appear to support a more convenient version of the closely watched medicine Leqembi.
“Developed by partners Eisai and Biogen, Leqembi is the only Alzheimer’s medicine of its type with a full approval from the Food and Drug Administration. It’s specifically for patients in the early stages of the disease, and is given as an hourlong, intravenous infusion once every two weeks.
“Eisai and Biogen have been testing whether a different form of Leqembi, an under-the-skin injection, can be as safe and effective as the already marketed version. On Wednesday, at a medical conference in Boston, researchers presented results from a study of nearly 400 participants that suggests the two forms are roughly comparable.”
“In the year after the Supreme Court ended the constitutional right to abortion, something unexpected happened: The total number of legal abortions in the United States did not fall. Instead, it appeared to increase slightly, by about 0.2 percent, according to the first full-year count of abortions provided nationwide.
“This finding came despite the fact that 14 states banned all abortions, and seven imposed new limits on them. Even as those restrictions reduced the legal abortion rate to near zero in some states, there were large increases in places where abortions remained legal. Researchers said they were driven by the expansion of telemedicine for mail-order abortion pills, increased options and assistance for women who traveled, and a surge of publicity about ways to get abortions.”
From the U.S. healthcare business front,
Beckers Hospital Review notes, “Newsweek has released the top 600 U.S. hospitals ranked by state, sorted by a score that factors recommendations, patient experience, quality and patient-reported outcome measures.” The article identifies the top hospital on the Newsweek scale in each State and DC.
Beckers Payer Issues tells us how payer accountable care organizations (ACOs) fared in 2022.
Beckers Hospital Review also interviews an executive from a Texas hospital about how the facility is planning to emerge from Chapter 11 bankruptcy.
“An otherwise strong Q3 performance across HCA Healthcare’s businesses was marred by news that the for-profit’s recently integrated physician staffing joint venture will be bleeding tens of millions of dollars per quarter for the foreseeable future.”
“UnitedHealth Group is making a $5 million investment in Enable Ventures, a fund that aims to improve the lives of people with disabilities.
“The investment will back companies that can create better quality of life, offer resources to entrepreneurs with disabilities and provide support to people with disabilities who are unemployed or underemployed. Enable puts a focus on providing the technologies and tools necessary to upskill or reskill people with disabilities to help them enter or reenter the workforce, according to the announcement.
“Catherine Anderson, senior vice president of health equity strategy at UnitedHealth Group, told Fierce Healthcare in an interview that backing Enable aligns with the company’s broader investment strategy around health equity.”
“House Majority Whip Tom Emmer (R., Minn.) dropped his bid to serve as House speaker just hours after he was narrowly elected as the Republican nominee, as stiff resistance from hard-right conservatives reinforced by former President Donald Trump sank the party’s latest pick to run the chamber.
“His withdrawal put the Republicans back to square one for the fourth time, three weeks after hard-liners engineered the ouster of former Speaker Kevin McCarthy (R., Calif.). Republicans regrouped again late Tuesday to map out their next steps, assembling another slate of candidates and holding a fresh forum in the evening. A new vote was expected Tuesday evening.”
The Hill offers a potpourri of articles on this situation.
The American Hospital Association News informs us,
“The Centers for Disease Control and Prevention Oct. 23 released interim guidance for clinicians with limited access to the monoclonal antibody nirsevimab, recently approved to prevent respiratory syncytial virus in children aged 2 and under. The guidance calls for prioritizing 100 milligram doses of the treatment for infants under 6 months old and infants at high risk for severe disease due to underlying health conditions, among other recommendations.”
“Infertility has a new definition in the U.S. — one that could make a big difference to would-be parents who are single or LGBTQ+.
“Last week, the American Society for Reproductive Medicine (ASRM) issued an expanded description of the condition, stating that infertility involves “the need for medical intervention, including, but not limited to, the use of donor gametes or donor embryos in order to achieve a successful pregnancy either as an individual or with a partner.”
It’s worth adding that for 2024, OPM adopted a broad definition of fertility coverage for the FEHBP to serve this purpose.
“People eligible to use the only needle-free flu vaccine available in the United States may be able, next year, to give it to themselves or to eligible children at home.
“AstraZeneca, which makes the vaccine FluMist, announced Tuesday it has submitted to the Food and Drug Administration a supplemental biologics license application that would allow for self-administration of the vaccine by people ages 18 through 49, and would allow people 18 and older to give the vaccine to eligible children. FluMist is only licensed for use in children and adults from the age of 2 to 49 years old.”
“The application, which the FDA is considering, would not mean there would effectively be over-the-counter sales of FluMist, Lisa Glasser, head of AstraZeneca’s U.S. medical affairs for vaccines and immune therapies, told STAT in an interview. Rather, the vaccine, which must be stored at refrigerator temperatures, would be ordered and delivered under appropriate temperature controls, after consultation with a medical professional.
“Glasser said the program, if approved, would not replace the option of getting FluMist in a doctor’s office or at a pharmacy, but would be another alternative for busy families. “It is meant to enhance the ability to access influenza vaccination,” she said. “That’s the goal.”
From the public health and medical research front,
When NIH launched The BRAIN Initiative® a decade ago, one of many ambitious goals was to develop innovative technologies for profiling single cells to create an open-access reference atlas cataloguing the human brain’s many parts. The ultimate goal wasn’t to produce a single, static reference map, but rather to capture a dynamic view of how the brain’s many cells of varied types are wired to work together in the healthy brain and how this picture may shift in those with neurological and mental health disorders.
So I’m now thrilled to report the publication of an impressive collection of work from hundreds of scientists in the BRAIN Initiative Cell Census Network (BICCN), detailed in more than 20 papers in Science, Science Advances, and Science Translational Medicine.1 Among many revelations, this unprecedented, international effort has characterized more than 3,000 human brain cell types. To put this into some perspective, consider that the human lung contains 61 cell types.2 The work has also begun to uncover normal variation in the brains of individual people, some of the features that distinguish various disease states, and distinctions among key parts of the human brain and those of our closely related primate cousins. * * *
All the data represented in this work has been made publicly accessible online for further study. Meanwhile, the effort to build a more finely detailed picture of even more brain cell types and, with it, a more complete understanding of human brain circuitry and how it can go awry continues in the BRAIN Initiative Cell Atlas Network (BICAN). As impressive as this latest installment is—in our quest to understand the human brain, brain disorders, and their treatment—we have much to look forward to in the years ahead.”
“Since the Apple Watch was unveiled in 2014, it has been trumpeted not only as a high tech fashion accessory, but also as a way for people to track their own health and fitness. It has evolved as a popular cardio tool for such uses as heart rate monitoring, recording your ECG, and measuring the oxygen saturation of your blood.
“But now, after nearly a decade of development, the Apple Watch is being leveraged on an entirely new health frontier: Parkinson’s disease, the degenerative brain disorder that affects more than a half million Americans.
“While there is no cure for Parkinson’s and treatment options can be daunting, people with the disease can now turn to technology spawned by the Apple Watch to take an active role in their care much as continuous glucose monitors have helped people manage diabetes better. Over the past year, the Food and Drug Administration has cleared three Apple Watch apps from independent developers to track symptoms associated with Parkinson’s that can help inform treatment decisions for people and their doctors.”
“If you had to pinpoint one subject that stood out at this year’s European Society for Medical Oncology meeting, a massive conference with thousands of people from 140-some countries and 2,500 studies presented, it would be a burgeoning type of cancer treatment called antibody-drug conjugates (ADC)
“The conference opened to the news that Merck had signed one of the biggest licensing deals in industry history — worth up to $22 billion — to partner on three of the compounds from ADC specialist Daiichi Sankyo. GSK followed up with an ADC licensing announcement of its own (if a much smaller one). Multiple ADC studies were presented at the meeting’s top sessions. ADCs were, in short, the belle of the cancer research ball.
“The thing is, ADCs are actually quite an old approach.
“The industry’s been putting ADCs into the clinic for 20 years, and it’s only recently that we’ve really had a breakthrough here,” Susan Galbraith, who leads AstraZeneca’s cancer work, told STAT.
“ADCs are designed to deliver chemotherapy directly to tumors, possibly one day replacing the blunt-force toxic therapies that have been the backbone of cancer care for generations. The idea is that these finely crafted shipments can pack the punch of chemo while minimizing side effects. Experts are still scrutinizing the safety profiles of ADCs — they come with their own side effect concerns, and trials have included some patient deaths — but some studies are showing that patients can tolerate ADCs better than traditional chemo.”
From the U.S. healthcare business front,
Beckers Hospital Review provides us with a link to Healthgrades’s latest rankings of specialty hospitals.
“Since launching in 2018, hospital-owned Civica Rx works with about a third of the nation’s hospitals and manufactures 80 drugs facing shortages, NBC affiliate KSL-TV reported Oct. 22.
“Seven health systems formed the pharmaceutical company after struggling for years with recurring drug shortages. The first goal was to make 14 generics constantly in short supply for hospitals, and 19 systems were founding members.
“Now, some governments and hundreds of hospitals are buying from Civica Rx.
“Dan Liljenquist, the chief strategy officer for Salt Lake City-based Intermountain Health, volunteer board chair of Civica Rx and a former Utah senator, told KSL-TV Civica Rx plans to scale up operations at its Petersburg, Va.-based manufacturing plant.”
“Pittsburgh-based UPMC said it has entered into an integration and affiliation agreement with Washington (Pa.) Health System, according to an Oct. 23 filing.
“The two signed a letter of intent in June regarding the partnership. Unions have criticized the move, saying it would harm both patients and workers.
“UPMC will appoint about one-third of the Washington Health board directors and the system will be renamed UPMC Washington, according to the filing.
“The proposed transaction still has to meet regulatory and closing conditions.”
“Centene raised its 2023 outlook on Tuesday after the health insurer handily beat Wall Street expectations for earnings and revenue in its third quarter, helped by lower medical costs.
“Centene reported a medical loss ratio — a marker of spending on patient care — of 87%, down from the year prior. On a call with investors Tuesday morning, executives chalked the lower medical spending up to significantly more members in Affordable Care Act marketplace plans, who generally require less expensive care than members in Medicaid and Medicare. Centene grew marketplace membership 76% year over year.
“The ongoing effect of Medicaid redeterminations — now almost halfway complete — on membership numbers and care acuity continues to track to Centene’s expectations, CEO Sarah London said on the call. Centene still expects to lose roughly two million members once redeterminations are complete.”
“Teladoc’s third-quarter revenue grew 8% to reach $660 million, boosted by solid performance in its chronic condition management business and steady membership growth as the company now touts 90 million users.
“The telehealth giant, which has been in operation for 20 years, also narrowed its losses this past quarter to a net loss of $57 million, or 35 cents per share, compared to a net loss of $73.5 million, or 45 cents per share, for the third quarter of 2022.”
“Elevance Health’s CarelonRx is the latest pharmacy benefit manager to put biosimilars for popular drug Humira on its formulary, the company said this week.
“Beginning Dec. 1, adalimumab-adbm will be added to each of its commercial formularies, according to a blog post from CarelonRx. Cyltezo will also be added to certain formularies, and both will be offered at parity with Humira.
“Humira has been the bestselling drug in the U.S. for a decade, and PBMs have long awaited biosimilar products to challenge the drug’s dominance in the market. Drugs that treat inflammatory conditions, like Humira, represent a growing piece of overall drug spend.
“Other key PBMs, including Express Scripts and Optum, have taken similar steps. CVS Health launched a new subsidiary, called Cordavis, earlier this year that aims to work alongside drugmakers to bring additional biosimilars to market, with the first product a Humira biosimilar in collaboration with Sandoz.”
“A bid by House Majority Whip Tom Emmer (R., Minn.) to serve as the House Republicans’ pick to be speaker will test whether the strong ties he built recruiting candidates and counting votes will overcome doubts from some anti-establishment lawmakers aligned with former President Donald Trump.
“Candidates are expected to pitch their colleagues at a forum on Monday evening ahead of an internal vote to designate a new Republican speaker nominee as soon as Tuesday morning. Beyond winning the GOP ballot, the speaker nominee will face the uphill battle to unite almost all Republicans to have a chance of winning the House vote, given Republicans’ narrow 221-212 majority. * * *
“To become House speaker designate, the winning candidate must garner a majority of the votes cast within the Republican conference. The internal House GOP conference voting could go multiple rounds, with the candidate receiving the fewest number of votes dropping out after each round until a candidate wins 50% of the vote plus one. After that, the House speaker-designate must win support from a majority in the House, hitting 217 of the 433 House votes if all members show up and cast a vote for an individual.
“In an effort to prevent holdout candidates from delaying the process, GOP Rep. Mike Flood of Nebraska is circulating a unity pledge, which lawmakers can sign saying that they promise to back the party’s speaker designee in a House floor vote. His spokeswoman on Monday morning said that all of the candidates except [Rep. Gary] Palmer [R Alabama] have signed on.”
“Lawmakers from both parties last week revived legislation that would allow most federal employees who began their careers as temporary or seasonal workers to make catch-up contributions to their pensions so that they can retire on time.
“The Federal Retirement Fairness Act (H.R. 5995), introduced by Reps. Derek Kilmer, D-Wash., Gerry Connolly, D-Va., Don Bacon, R-Neb., and David Valadao, R-Calif., would allow employees enrolled in the Federal Employees Retirement System who began their careers in government as temporary workers to make catch-up contributions to their defined benefit pensions to cover for the time before they had permanent positions and were unable to contribute to their retirement accounts. The legislation was last introduced in 2021 but failed to garner support.”
Labor Department Assistant Secretary for Employee Benefits Security Lisa Gomez writes in her blog about Breast Cancer Awareness Month.
“The Food and Drug Administration on Friday approved a new meningococcal vaccine, clearing Pfizer’s shot Penbraya in teenagers and young adults for protection against the five most common disease-causing serogroups.
“Penbraya is the first vaccine available that can provide such broad protection, which may make it more convenient than current options. While meningococcal disease is rare, it can be serious and even deadly.
EMPR adds that the “Food and Drug Administration (FDA) has approved Zituvio™ (sitagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
Medtronic said Monday it received approval from the Food and Drug Administration for an extravascular defibrillator designed to treat abnormal heart rhythms and prevent sudden cardiac arrest, which can lead to death within minutes if not treated immediately.
Unlike traditional implantable cardioverter defibrillators, which have lead wires running between a pulse generator and the heart, Medtronic’s Aurora EV-ICD places a lead outside of the heart and veins.
The Aurora EV-ICD was a PMA submission to the FDA, Medtronic spokesperson Tracy McNulty said in an email. “We estimate the current global EV-ICD market to be between $300-$350 million, and expect the EV-ICD market to reach $1 billion 10 years out from the Aurora launch,” McNulty said.
“Children infected with the Omicron variant of SARS-CoV-2 appear to be infectious for about 3 days after a positive test, researchers found.
“In a small study of 76 kids ages 7 to 18, the median duration of infectivity was 3 days for both vaccinated and unvaccinated children, Neeraj Sood, PhD, of the University of Southern California, and colleagues reported online in a JAMA Pediatrics research letter.
“The vast majority of children who get COVID are symptomatic for 1 to 3 days,” co-author Eran Bendavid, MD, MS, of Stanford University, told MedPage Today. “Basically that correlates with how long the virus is causing disease in their body.”
“Maternal mRNA COVID-19 vaccination during pregnancy was associated with lower risks of poor neonatal outcomes, including neonatal death, according to a population-based retrospective cohort study from Canada.”
“The age women start taking menopausal hormone therapy and the kind they take might affect their chances of developing dementia later in life, a new study found.
“Women have struggled for years with whether to take hormone therapy when they go through menopause. The medication can help relieve troubling symptoms such as hot flashes and night sweats. However, years of conflicting research on whether the therapy can lead to other health problems, including breast cancer, dementia and heart attacks, has left many women confused about what to do.
“This new study suggests that hormone therapy might lower—or at least not raise—your dementia risk if you take it in midlife. For older women, the study found some signs that the medication might raise it.
mHealth Intelligence explains that “The shift to telebehavioral healthcare during the COVID-19 pandemic is linked to fewer disruptions in psychotherapy services, indicating telehealth can be effective in supporting the continuity of these services, a new study shows.”
“Physicians’ decisions to leave their practices is a complex choice “with multiple interdependent factors,” and is not solely impacted by burnout, pay or frustrations with electronic health records, according to a new qualitative study published in the Journal of the American Board of Family Medicine.
“The study, which interviewed physicians who left their ambulatory care practices between 2018 and 2021, found that they were motivated to increase time off, have more flexibility or receive higher earnings. However, other departing physicians reported higher compensation would not have persuaded them to stay.
“Physician practices can better retain clinicians by addressing risk factors for departure including workflow distribution across team members and ensuring adequate staffing, the report said.”
“Roche Holding has agreed to buy the developer of a bowel-disease treatment from Roivant Sciences, a company started by Republican presidential candidate Vivek Ramaswamy, and Pfizer in a deal worth more than $7 billion.
“The Swiss pharmaceutical giant said Monday it would pay $7.1 billion upfront for Telavant Holdings and make a near-term milestone payment of $150 million. Roche said the deal gives it rights to commercialize Telavant’s RVT-3101 drug candidate, which has shown promise for inflammatory bowel disease and could have potential in other indications in the U.S. and Japan.
“The deal is the latest example of a big pharma company turning to the deal table to bolster its pipeline of autoimmune drugs. Merck earlier this year agreed to pay more than $10 billion to buy Prometheus Biosciences, which is developing a drug for inflammatory bowel disease that would compete with Telavant’s candidate.”
“Folx Health, a virtual provider focused on LGBTQ+ health, is now in-network with Cigna, Evernorth and Blue Shield of California.
“Other payer partners include Blue Cross and Blue Shield of Texas and Optum for behavioral health service in Colorado and Florida, according to Folx Health’s website. Through the collaboration, insured patients can use therapy and mental health medication management with Folx’s LGBTQ-specialized clinicians.
“Folx offers virtual primary care, gender-affirming care and mental health services. Making that care in-network will deliver its patients significantly lower out-of-pocket costs, per the company.”
Assured Partners offers HSA and FSA Account Reminders for Year-End.
“GOP Rep. Jim Jordan failed again to win enough votes to be elected House speaker, as divisions hardened for House Republicans, with some lawmakers pursuing new paths to break the impasse that has paralyzed the chamber.
“More than two weeks after former House Speaker Kevin McCarthy (R., Calif.) was ousted, Republicans remained gripped in a fierce internal struggle over his successor. Jordan said he would keep up his campaign, but pushed off any further voting until Thursday at the earliest as mounting GOP defections on his second ballot left Republicans snarled into warring factions over what should happen next.”
The Federal Times informs us that the Senate is considering a bipartisan bill to improve benefits for the families of federal employees who die on the job.
“A bipartisan trio of Senators hope to advance new legislation aimed at improving and “streamlining” federal agencies’ customer service across platforms, in part by adopting practices already employed in the private sector.
“Customer service at agencies that interact with members of the public has been top of mind for lawmakers and administration officials in recent years. During the height of the COVID-19 pandemic, that attention was on electronic means like phone and the Internet, while over the last 18 months, the focus turned toward in-person service as well as backlogs that cropped up over the course of the pandemic.
“The Improving Government Services Act (S. 2866), introduced by Sens. Gary Peters, D-Mich., James Lankford, R-Okla., and John Cornyn, R-Texas, last month but publicized Tuesday, tasks federal agencies that provide services to members of the public to develop annual customer experience action plans and submit them both to the director of the Office of Management and Budget and Congress. The Senate Homeland Security and Governmental Affairs Committee is slated to consider the bill next week.”
MedPage Today discusses today’s confirmation hearing for the President’s nominee to be NIH Director, Dr. Monica Bertagnolli.
“In laying out her vision for the agency, a key theme for Bertagnolli was equity. “NIH can and must support research that is equitable and accessible to all populations,” she said, stressing the need to diversify clinical trials.”
The Internal Revenue Service announced, “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2023, and before October 1, 2024, is $3.22. This is the per belly button fee that FEHB plans will owe for the current 2023 plan year next July 31, 2024.
HHS Office for Civil Rights issued “Resources for Health Care Providers and Patients to Help Educate Patients about Telehealth and the Privacy and Security of Protected Health Information.”
AHIP posted its helpful comments on the proposed mental health parity rule changes. The public comment deadline was yesterday.
Fedsmith offers its guidance on the upcoming Federal Employee Benefits Open Season.
Treatments like Ozempic, Wegovy, and Mounjaro have been hailed for showing 15% to over 20% weight loss in trials, but those are just averages. In reality, there are big variations in how much weight people lose on the therapies, and it’s unclear what explains those differences.
“One way researchers are trying to figure this out is by focusing on genes.
“The variability is so wide that we want to understand what predicts response,” said Lee Kaplan, chief of obesity medicine at the Geisel School of Medicine at Dartmouth. Since genetics is a significant reason people develop obesity, and since early data also show that genetics may contribute to how people respond to bariatric surgery, “that would argue that there’s probably going to be a genetic contribution” to the amount of weight loss people experience on obesity drugs.”
Beckers Hospital Review discusses what the closure of various Walgreen’s and Rite Aid drug stores means for healthcare.
“The closures also disproportionately affect Black and Latino city neighborhoods, as well as rural areas, according to Serena Guo, MD, PhD, an assistant professor at the Gainesville-based University of Florida College of Pharmacy.
“Closure has the potential to worsen disparities in access to pharmacies,” Dr. Guo told MarketWatch.”
“Starting buprenorphine treatment for opioid use disorder through telehealth was associated with an increased likelihood of staying in treatment longer compared to starting treatment in a non-telehealth setting, according to a new study analyzing Medicaid data from 2019-2020 in Kentucky and Ohio. Published in JAMA Network Open, these findings(link is external) add to a growing body of evidence demonstrating positive outcomes associated with the use of telemedicine for treatment of opioid use disorder.
“In Kentucky, 48% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 44% of those who started treatment in non-telehealth settings. In Ohio, 32% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 28% of those who started treatment in non-telehealth settings.”
“Pfizer will price a course of its Covid-19 drug Paxlovid at nearly $1,400 when commercial sales begin later this year, more than double what the U.S. government has paid.
“Pfizer told the pharmacies and clinics that will dispense Paxlovid, in a letter dated Wednesday that was viewed by The Wall Street Journal, that a five-day course of the antiviral will list for $1,390. The U.S. government had paid $529.
“Health plans will probably pay much less than the list price for the pills, and most patients will have a small or no out-of-pocket cost because Pfizer is expected to offer price discounts and help patients with their out-of-pocket charges.
“Pfizer has already faced criticism from doctors and patient advocates that raising the price will limit patient access. Disclosure of the list price will probably fuel further criticism.”
“Amid rising inflation, annual family premiums for employer-sponsored health insurance climbed 7% on average this year to reach $23,968, a sharp departure from virtually no growth in premiums last year, the 2023 benchmark KFF Employer Health Benefits Survey finds.
“On average, workers this year contribute $6,575 annually toward the cost of family premium, up nearly $500 from 2022, with employers paying the rest. Future increases may be on the horizon, as nearly a quarter (23%) of employers say they will increase workers’ contributions in the next two years.
“Workers at firms with fewer than 200 workers on average contribute nearly $2,500 more toward family premiums than those at larger firms ($8,334 vs. $5,889). In fact, a quarter of covered workers at small firms pay at least $12,000 annually in premiums for family coverage.
“This year’s 7% increase in average premiums is similar to the year-over-year rise in workers’ wages (5.2%) and inflation (5.8%). Over the past five years, premiums rose 22%, in line with wages (27%) and inflation (21%).”
“Henry Ford Health and Ascension Michigan have signed an agreement to enter into a joint venture, the latest merger between health systems in Michigan.
“According to the health systems, Ascensions Southeast Michigan and Genesys healthcare facilities will join with Henry Ford’s. * * *
According to the companies, the combined organization would employ around 50,000 team members at more than 550 sites of care across the area.”
“Thirty-nine percent of mergers and acquisitions announced in the third quarter included a hospital or health system that cited financial distress as a driver for deal, according to a report by Kaufman Hall.
“Though M&A activity is continuing to trend back to pre-pandemic levels, the number of hospitals in distress shows the financial strain of the past two years, the report said. Eighteen transactions were announced in the third quarter, compared with just seven in the same period in 2021 and 10 during the third quarter in 2022.
“Increased costs, both for labor and other expenses, has been a significant challenge for smaller and medium-sized health systems. Now, more large systems — with annual revenue of $1 billion or more — are pointing to financial concerns as their reason for dealmaking, according to Kaufman.”
“In the third quarter, we completed a strategic review of our operations, assets, and investments to enhance operating efficiency, refine the focus of our investments in innovation and optimize our physical footprint,” the company wrote. “This resulted in a net charge of $697 million, comprised of the write-off of certain information technology assets and contract exit costs, a reduction in staff including the relocation of certain job functions, and the impairment of assets associated with the closure or partial closure of data centers and offices.”
“Elevance Health posted $1.3 billion in net income during the third quarter, a nearly 20% decrease compared to the same period last year, according to the company’s earnings report published Oct. 18.
“Consumers’ overall satisfaction with health insurers is up 4% over 2023, according to a report from the American Customer Satisfaction Index published Oct. 17.
“Customer satisfaction with insurers reached a score of 76 out of 100, the highest in the index’s history, according to the report.”
“Amazon Pharmacy is launching drone delivery for prescription medication orders with the service initially taking flight in College Station, Texas, the company announced Wednesday.
“The pharmacy deliveries will be dropped, quite literally, outside a consumer’s front door within 60 minutes at no additional cost for eligible Amazon Pharmacy customers, the company said.
“Amazon Pharmacy is teaming up with the online retailer’s drone service, Prime Air, which kicked off commercial deliveries in the same Texas city in December.
“Delivery of medications via drone will be offered in College Station initially and will expand to additional cities in the coming years, an Amazon Pharmacy spokesperson said. The announcement was made this week as part of Amazon’s Delivering the Future event in Seattle focused on its latest innovations.”
“House Republicans’ speaker nominee Rep. Jim Jordan (R., Ohio) won over some pivotal holdouts Monday as broader GOP opposition to his bid appeared to crumble, moving him closer to winning the gavel in a floor vote as soon as Tuesday afternoon.
“I feel real good about the momentum we have. It’s real close,” Jordan told reporters, citing recent endorsements and saying he was ready to move forward on Tuesday at noon. “We’re going to elect a speaker tomorrow; that’s what I think is going to happen.”
The U.S. Office of Personnel Management announced,
“[T]he Biden Administration has exceeded its goal of selecting 5,800 targeted positions helping implement the Bipartisan Infrastructure Law (BIL), a once-in-a-generation investment in America’s infrastructure and competitiveness. Over the last two years, OPM has served as a strategic workforce partner for seven federal agencies and supported surge hiring for key positions, including engineers, scientists, project managers, IT & HR specialists, construction managers, and many more.
“The agencies included in targeted hiring positions are the Department of Agriculture, Department of Commerce, Department of Energy, Department of Homeland Security, Department of the Interior, Department of Transportation, and the Environmental Protection Agency.”
Govexec introduces us to the Partnership for Public Service’s Service to America Medal winners. Mazaal tov to the winners.
Thompson Reuters points out that last week, the Internal Revenue Service “released the final versions of the following 2023 Affordable Care Act (ACA) forms:
“(1) Form 1094-B, Transmittal of Health Coverage Information Returns;
“(2) Form 1094-C, Transmittal of Employer-Provided Health Insurance Offer and Coverage Information Returns;
“A team of scientists is proposing a new explanation for some cases of long Covid, based on their findings that serotonin levels were lower in people with the complex condition.
“In their study, published on Monday in the journal Cell, researchers at the University of Pennsylvania suggest that serotonin reduction is triggered by remnants of the virus lingering in the gut. Depleted serotonin could especially explain memory problems and some neurological and cognitive symptoms of long Covid, they say.
“This is one of several new studies documenting distinct biological changes in the bodies of people with long Covid — offering important discoveries for a condition that takes many forms and often does not register on standard diagnostic tools like X-rays.
“The research could point the way toward possible treatments, including medications that boost serotonin. And the authors said the biological pathway that their research outlines could unite many of the major theories of what causes long Covid: lingering remnants of the virus, inflammation, increased blood clotting and dysfunction of the autonomic nervous system.
“All these different hypotheses might be connected through the serotonin pathway,” said Christoph Thaiss, a lead author of the study and an assistant professor of microbiology at the Perelman School of Medicine at the University of Pennsylvania.
“Second of all, even if not everybody experiences difficulties in the serotonin pathway, at least a subset might respond to therapies that activate this pathway,” he said.”
Last Friday, the Department of Health and Human Services announced,
“[T]he selection of initial next-generation vaccine candidates and more than $500 million in awards for Project NextGen – kick-starting planning for Phase 2b clinical trials and technologies that advance innovative next-generation vaccine and therapeutics platforms.
“The Biden-Harris Administration is committed to keeping people safe from COVID-19,” said HHS Secretary Xavier Becerra. “By investing in next-generation vaccines and treatments, we can improve our ability to respond to new variants, reduce transmission, stop infections, and save lives. Through Project NextGen, we are combining research and development expertise at HHS with the lessons learned throughout the pandemic to protect our nation from COVID-19.”
“The over $500 million announced today builds on the over $1.4 billion awarded in August – accelerating products toward clinical trials and potential commercial availability.”
“The vaccine selections and funding announced today are important steps forward for Project NextGen – with vaccine and therapeutics candidates moving quickly to clinical trials that will start in the coming months,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “The technologies that BARDA is investing in, from intranasal vaccines to self-amplifying mRNA, will bolster our protection against COVID-19 for years to come.”
From the U.S. healthcare business front,
Beckers Payer Issues tells us that UnitedHealth Group executives and the FEHBlog are of one mind.
“UnitedHealth Group wants to lower the price of GLP-1 drugs such as Ozempic and Wegovy, but it needs drug manufacturers to get on board, executives said.
“On an Oct. 13 call with investors, UnitedHealth Group CEO Andrew Witty said prices have to come down for more people to access the drugs.
“We’re very positive about the potential for another tool in the toolbox to help folks manage their weight,” Mr. Witty said. “We recognize that has potential benefits, but we’re struggling, and frankly our clients are struggling, with the list prices which have been demanded of these products in the U.S., which are running at about 10 times the level of prices paid in Western Europe.”
“Novo Nordisk said Monday it will spend up to $1.3 billion to buy an experimental hypertension drug from Singapore-based KBP Biosciences, adding to a string of acquisitions that builds out its metabolic disease business behind the blockbuster diabetes drug Ozempic.
“The pill, called ocedurenone, is in a Phase 3 trial in people with chronic kidney disease and uncontrolled high blood pressure. Results are due next year, and Novo said it plans to begin additional Phase 3 trials in other cardiovascular and kidney disease indications.
“Novo is putting its profits from accelerating Ozempic sales to work, having cut late-summer deals to buy a Danish metabolic startup called Embark Biotech and a Canadian metabolic company called Iversago. That followed on the billion-dollar-plus deals to buy rare disease drug developer Forma Therapeutics in 2022 and genetic medicine company Dicerna in 2021.”
“Bankruptcy will also enable Rite Aid to shrink an unprofitable store footprint, manage a debt load that’s reached nearly $4 billion and regain more favorable trade terms with vendors, the company said in court documents.
“Also Sunday, Rite Aid announced the appointment of Jeffrey Stein as CEO and chief restructuring officer, effective immediately. Stein will also serve as a member of the board of directors and replaces interim CEO Elizabeth “Busy” Burr, who had led the company since January. Burr will remain on the board.”
Fierce Healthcare tells us why Amazon’s chief medical officer believes Amazon can make a big impact in tackling chronic illness.
The medicine in the diabetes drug Mounjaro [the Godzilla of GLP-1 drugs] helped people with obesity or who are overweight lose at least a quarter of their body weight, or about 60 pounds on average when combined with intensive diet and exercise, a new study shows.
By comparison, a group of people who also dieted and exercised but then received dummy shots lost weight initially but then regained some, researchers reported Sunday in the journal Nature Medicine.
“This study says that if you lose weight before you start the drug, you can then add a lot more weight loss after,” said Dr. Thomas Wadden, a University of Pennsylvania obesity researcher and psychology professor who led the study.
The results, which were also presented Sunday at a medical conference, confirm that the drug made by Eli Lilly & Co. has the potential to be one of the most powerful medical treatments for obesity to date, outside experts said.
The FDA has approved Mounjaro as a diabetes treatment but not a weight loss treatment yet.
“An Oxford University researcher and her team showed that digital wearable devices can track the progression of Parkinson’s disease in an individual more effectively than human clinical observation can, according to a newly published paper.
“By tracking more than 100 metrics picked up by the devices, researchers were able to discern subtle changes in the movements of subjects with Parkinson’s, a neurodegenerative disease that afflicts 10 million people worldwide.
“The lead researcher emphasized that the latest findings were not a treatment for Parkinson’s. Rather, they are a means of helping scientists gauge whether novel drugs and other therapies for Parkinson’s are slowing the progression of the disease.”
The Washington Post interviews “physician Rosanne Leipzig, vice chair for education at the Brookdale Department of Geriatrics and Palliative Medicine at the Icahn School of Medicine at Mount Sinai in New York.” Dr. Leipzig is the author of “Honest Aging: An Insider’s Guide to the Second Half of Life.” The reporter described the book as “the most comprehensive examination of what to expect in later life I’ve come across in a dozen years covering aging.”
“The United States faces a “bloody transfusion problem” that is fueling preventable deaths and putting national security at risk, three military and civilian physicians write in a JAMA opinion essay.
“The JAMA op-ed, published Oct. 12, highlights blood transfusions’ importance in emergency care. Emergency transfusions can decrease deaths, especially when given early, the physicians write. But not enough healthcare facilities and emergency vehicles are equipped for the procedures, they add, which presents a “substantial risk to our nation’s security infrastructure.”
“One reason is the national blood supply, which the writers call “tenuous” because of its reliance on volunteers, as well as problems with blood storage and the places where blood is collected and processed.
“The physicians cite a 2020 Health and Human Services report that characterized the national blood supply system as “struggling.” That report said blood availability is hindered by issues with donor recruitment, an aging donor population and problems funding collection centers.”
“Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales.”Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales.
“The company plans to sell the Dexcom G7 CGM at launch and is looking to offer additional CGM systems from other manufacturers, according to the company.
“Customers who want to buy a CGM will be routed to the virtual care platform Wheel, where clinicians will determine a patient’s eligibility and write a prescription. Pharmacy tech provider HealthDyne will receive and process prescriptions, and consumers can then purchase the CGMs on Best Buy’s website for home delivery.”
“The pharmaceutical company is also significantly revising down its revenue forecast to between $58 billion and $61 billion for the year, a $9 billion cut from its previously issued guidance.
“The bulk of that adjustment is due to the return by the U.S. governmentof nearly 8 million treatment courses of Paxlovid labeled under the drug’s emergency clearance. Distribution of that product will be stopped in November as Pfizer shifts to selling Paxlovid commercially, which it now expects to begin on a wide scale in January. The antiviral treatment won full U.S. approval in May.”
The House Republicans have not settled on a new Speaker yet. Roll Call adds, “The delay in the effort to get 217 Republicans to back anyone for speaker is leading some House members to start reconsidering the idea that Speaker Pro Tempore Patrick T. McHenry is little more than a placeholder.”
This morning, the Social Security Administration announced
“Social Security and Supplemental Security Income (SSI) benefits for more than 71 million Americans will increase 3.2 percent in 2024. * * *
“The maximum amount of earnings subject to the Social Security tax (taxable maximum) will increase to $168,600.”
Federal News Network explains how the Social Security announcement impacts federal annuitant cost of living adjustments for 2024.
This afternoon, the Centers for Medicare and Medicaid Services announced Medicare Part B premiums for 2024 and more, e.g., income-adjusted premiums for Parts B and D.
“The standard monthly premium for Medicare Part B enrollees will be $174.70 for 2024, an increase of $9.80 from $164.90 in 2023. The annual deductible for all Medicare Part B beneficiaries will be $240 in 2024, an increase of $14 from the annual deductible of $226 in 2023.
“The increase in the 2024 Part B standard premium and deductible is mainly due to projected increases in health care spending and, to a lesser degree, the remedy for the 340B-acquired drug payment policy for the 2018-2022 period under the Hospital Outpatient Prospective Payment System.
“Beginning in 2023, individuals whose full Medicare coverage ended 36 months after a kidney transplant and who do not have certain other types of insurance coverage can elect to continue Part B coverage of immunosuppressive drugs by paying a premium. For 2024, the standard immunosuppressive drug premium is $103.00.”
FedSmith shares Medicare basics for federal employees and annuitants.
Fierce Healthcare reports on a discussion of Medicare Advantage at the HLTH conference held in Las Vegas this week.
From the public health and research front,
The U.S. Preventive Services Task Force published a draft research plan on prostate cancer screening. The draft plan is open for public comment through November 8, 2023.
“The brain remains both the body’s most important organ and its least understood. But a draft atlas of the human brain published on Thursday gives scientists important insights into how it works and may pave the way for big advances in disease treatment and diagnosis.
This brain map, pieced together by hundreds of researchers from San Diego to Seattle to Stockholm, is essentially a cellular “parts list” of the human brain and a guide to how those pieces are arranged and work together. Scientists say that what they’ve already learned — including a stunning diversity of cell types in the brain — and what they’ll discover in the years to come will improve our understanding of deadly neurological diseases. * * *
“The recent findings, reported across 21 studies published in the journals Science, Science Advances, and Science Translational Medicine, offer some early clues. And there’s more to come. These papers are part of an ongoing undertaking researchers openly compare to the Human Genome Project in both its scope and ambition. That project sequenced the DNA of a dozen blood donors from Buffalo, N.Y. The new brain atlas was constructed from the brains of more than 100 people, including deceased donors and surgical patients.”
The Wall Street Journal seeks to explain the secret of living to 100 years old.
“If you want to live to your 100th birthday, healthy habits can only get you so far.”If you want to live to your 100th birthday, healthy habits can only get you so far.
“Research is making clearer the role that genes play in living to very old age. Habits like getting enough sleep, exercising and eating a healthy diet can help you stave off disease and live longer, yet when it comes to living beyond 90, genetics start to play a trump card, say researchers who study aging.
“Some people have this idea: ‘If I do everything right, diet and exercise, I can live to be 150.’ And that’s really not correct,” says Robert Young, who directs a team of researchers at the nonprofit scientific organization Gerontology Research Group.
“About 25% of your ability to live to 90 is determined by genetics, says Dr. Thomas Perls, a professor of medicine at Boston University who leads the New England Centenarian Study, which has followed centenarians and their family members since 1995. By age 100, it’s roughly 50% genetic, he estimates, and by around 106, it’s 75%.”
“Researchers at Boston-based Harvard Medical School and University of Oxford in England have created an AI tool to forecast which COVID-19 strains will grow in dominance, according to an Oct. 11 article in Nature.
“The tool, called EVEscape, predicts how the virus can evolve through a model of evolutionary sequences alongside biological and structural data, according to an Oct. 11 Harvard news release. EVEscape works to forecast which future COVID-19 strains are most likely to occur.
“Every two weeks, the researchers will release a ranking of COVID-19 variants.
Shares of dialysis service providers fell sharply on Wednesday after Novo Nordisk’s Ozempic showed early signs of success in delaying the progression of kidney disease in diabetes patients.
Colorado-based DaVita’s shares closed down about 17% and U.S.-listed shares of German rival Fresenius Medical ended 17.6% lower.
Novo’s announcement is the latest sign of disruption caused by the success of GLP-1 drugs, which have hit shares of food companies, providers of bariatric surgery and glucose-monitoring device makers.
“Walgreens announced a 2024 earnings outlook below Wall Street expectations on Thursday, two days after announcing a new chief executive officer who the beleaguered retailer says will help with its strategic pivot to healthcare services.
“Along with the release of its fourth-quarter earnings, Walgreens said it expects adjusted earnings per share for its 2024 fiscal year to be between $3.20 to $3.50, below the analyst consensus of $3.71, due to lower profit from COVID-19 testing and vaccines among other factors.
“On a call with investors Thursday morning, Walgreens leadership said the Deerfield, Illinois-based retailer is focused on accelerating the profitability of its U.S. Healthcare division, which includes value-based medical group VillageMD. As part of that, Walgreens plans to close 60 underperforming VillageMD clinics next year.”
“Nearly two years after Mark Cuban launched a mail-order pharmacy with low-cost medications, the entrepreneur and “Shark Tank” star has secured more than a dozen collaborators.
“In September, Mark Cuban Cost Plus Drug Co. penned a deal with Avanlee Care, which runs an app designed to help caregivers for elderly patients. The app, called Ava, will feature an option for its users to order medications from Cost Plus Drugs. Mr. Cuban’s company also teamed up with two fertility health companies to reduce the burden of the pink tax, or inflated prices on women’s products.
“Cost Plus Drugs has also expanded its in-person services by signing deals with pharmacies spanning multiple states and grocery chain pharmacies, such as Kroger. The affiliate network aligns Cost Plus Drugs’ pricing with medications at independent pharmacies.
“In an insurance industry shake-up, Blue Shield of California chose Cost Plus Drugs and a few other vendors to take over services historically filled by CVS Caremark, CVS Health’s pharmacy benefit manager. Mark Cuban’s company is now a preferred pharmacy network for the insurer serving 4.8 million members.”
“St. Louis-based Ascension is focused on rebounding from a $3 billion operating loss (-5.6 percent operating margin) in fiscal year 2023 amid negative outlooks from two ratings agencies.
“Fitch Ratings recently lowered Ascension’s outlook from stable to negative while S&P Global Ratings affirmed its negative outlook for the health system.
“Despite “real progress” to resume a more typical level of operations through significant and durable cost savings initiatives, Ascension saw a new set of operational challenges in FY 2023, Fitch said in a Sept. 26 report. The system hit its 2022 operational goals largely through improved efficiencies and contract labor and productivity initiatives, but additional challenges continued to hinder operations in FY 2023.
“One caveat on the $3 billion operating loss is that it included a one-time, non-cash impairment loss of $1.5 billion as the carrying value of certain assets within Ascension’s markets may not be fully recoverable, according to the health system. When normalized to exclude one-time items, Ascension’s operating loss for FY 2023 was $1.39 billion (-4.9 percent margin) compared to a $1.17 billion loss (-4.2 percent margin) in FY 2022.”
“House Majority Leader Steve Scalise’s bid for speaker was on shaky ground Wednesday as Republicans went back behind closed doors to figure out next steps even after selecting the Louisianan as their nominee during a morning conference meeting.
“Several conservatives said they won’t support Scalise on the floor, even as his top rival for the job, Judiciary Chairman Jim Jordan, R-Ohio, is supporting him and encouraging others to do so. Instead of kicking off the formal nominating speeches and votes on the floor Wednesday after coming into session at 3 p.m., Speaker Pro Tempore Patrick T. McHenry recessed the chamber.” * * *
“The House adjourned for the night before 7 p.m. An advisory from House Democrats said votes were “possible” Thursday, and the chamber is scheduled to gavel back into session at noon.”
On September 18, 2023, the Senate Health Education Labor and Pensions Committee will hold a hearing on the nomination of Dr. Monica Bertagnolli to be Director of the National Institutes of Health.
“The Biden administration on Wednesday released a new requirement for agencies throughout government to think more carefully about expanding competition through their regulatory actions.
“President Biden has targeted antitrust trends in the economy as a key part of his domestic agenda and the White House said the new guidance will help enforce those efforts through an “all-of-government approach to competition.” The Office of Information and Regulatory Affairs document creates frameworks for agencies as they develop and analyze potential regulatory actions.
“OIRA noted that agencies can shape markets through their regulations and urged them to draft those rules to enhance competition.”
Federal New Network explores the role of Janice Underwood, the first-ever governmentwide chief diversity officer and a senior leader at the Office of Personnel Management.
“Sepsis, the body’s extreme response to an infection, affects 1.7 million adults in the United States annually. It stems from fungal, viral, or bacterial infections, similar to what struck Madonna this year, although the singer never said whether she was diagnosed with sepsis. Treatment delays of even a few hours can undermine a patient’s chance of survival. Yet sepsis can be difficult to diagnose because some patients don’t present with common symptoms like fever, rapid heart rate, or confusion.
“A Biden administration rule, finalized in August, ups the ante for hospitals, setting specific treatment metrics that must be met for all patients with suspected sepsis, which could help save some of the 350,000 adults who die of infections annually. Children, too, are affected, with some estimates that 75,000 are treated each year for sepsis, and up to 20% of them die. Hospitals that fail to meet the requirements risk losing potentially millions in Medicare reimbursement for the year.
“Still, because the rule applies broadly, it has triggered pushback for its lack of flexibility.
“Efforts to reduce sepsis deaths are welcome, but “where it gets controversial becomes ‘Is this the best way to do it?’” said Chanu Rhee, an infectious disease physician and associate professor of population medicine at Harvard Medical School.”
“Novo Nordisk (NOVOb.CO) said on Tuesday it will stop a trial studying Ozempic to treat kidney failure in diabetes patients ahead of schedule because it was clear from an interim analysis that the treatment would succeed.
“Novo said the trial would be halted almost a year early based on a recommendation from the independent data monitoring board overseeing the study. Independent monitors can recommend stopping a trial early if there is clear evidence that a drug is going to succeed or fail based on interim analyses. * * *
“The Danish drugmaker said the trial was testing whether the widely used diabetes drug, which contains the active ingredient semaglutide, could delay the progression of chronic kidney disease and lower the risk of death from kidney and heart problems.
“Semaglutide is also the active ingredient in Novo Nordisk’s powerful weight-loss drug Wegovy.
“Barclays analyst Emily Field said in a note that the company’s decision affirmed the view that GLP-1 receptor agonists like Ozempic have “therapeutic benefits far beyond their original intended purpose.”
FEHBlog note — Why then doesn’t Novo Nordisk lower the price of this apparent cure-all?
“People taking semaglutide or liraglutide for weight management are at a higher risk for rare but potentially serious gastrointestinal issues, compared with those taking naltrexone/bupropion, according to a large epidemiologic study.
“Patients” taking either of these glucagon-like peptide-1 (GLP-1) receptor agonists had nine times an elevated risk for pancreatitis. They were also four times more likely to develop bowel obstruction and over 3.5 times more likely to experience gastroparesis.
“The research letter was published online today in the Journal of the American Medical Association.
“Investigators say their findings are not about scaring people off the weight loss drugs, but instead about increasing awareness that these potential adverse outcomes can happen.
“* * * People taking a GLP-1 agonist to treat diabetes might be more willing to accept the risks, given their potential advantages, especially for lowering the risk for heart problems, said Mahyar Etminan, PharmD, MSc, the study’s senior author and an expert in drug safety and pharmacoepidemiology at UBC. “But those who are otherwise healthy and just taking them for weight loss might want to be more careful in weighing the risk–benefit equation.”
“People taking these drugs for weight loss have an approximately 1%–2% chance of experiencing these events, including a 1% risk for gastroparesis, Etminan said.”
The Brown & Brown consulting firm offers a four-step plan for employer action to “focus on their benefits, helping to enable employees with easy access to preventive care, early detection, navigation and support specific to breast cancer.
“The Food and Drug Administration issued an alert on Tuesday about the dangers of treating psychiatric disorders with compounded versions of ketamine, a powerful anesthetic that has become increasingly popular among those seeking alternative therapies for depression, anxiety, post-traumatic stress disorder and other difficult-to-treat mental health problems.”
“A new AI tool diagnoses brain tumors on the operating table;
“A new study describes a method for faster and more precise diagnoses, which can help surgeons decide how aggressively to operate.”
From the U.S. healthcare business front,
The VTDigger lets us know that following regulatory approval, “Blue Cross Blue Shield of Vermont can now move forward with an agreement that will make the Berlin-based nonprofit a subsidiary of the much larger Blue Cross Blue Shield of Michigan.”
“Des Moines, Iowa-based UnityPoint Health and Albuquerque, New Mexico-based Presbyterian Healthcare Services are no longer working toward a merger, the systems announced Wednesday.”
A new analysis finds that more pharmacists are electronically prescribing medications as they assist in managing chronic disease, which offers a peek at the next evolution in primary care.
* * * Lynne Nowak, M.D., Surescripts’ first chief data and analytics officer, told Fierce Healthcare in an interview at HLTH that the findings highlight the potential pharmacists and other clinicians have in addressing those access gaps.
“We’re not saying that pharmacists should be doing the job of a physician,” Nowak said. “They’re not trying to replace them, but just looking at this broader view of a care team and ensuring they’re all connected.”
“Bruce Broussard, CEO of health insurance giant Humana, will step down next year after leading the company for more than a decade.
“Humana named Jim Rechtin — who is the CEO of Envision Healthcare, the controversial physician staffing firm that is working its way through bankruptcy — as Broussard’s replacement. Rechtin will serve as president and chief operating officer starting Jan. 8 and then take over as CEO in the “latter half of 2024,” the company said in a news release.”
“Wentworth, who will become Walgreens CEO effective Oct. 23, is the former CEO of Express Scripts, the pharmacy benefit manager acquired by Cigna in 2018. At Cigna, he led the health services business Evernorth.”
“CVS Health wants to create a “super app” connecting multiple omnichannel modalities of the healthcare experience, including benefits, delivery and retail channels, chief medical officer Sree Chaguturu said Tuesday at the HLTH conference in Las Vegas.
“A super app is a widely adopted mobile or web application that combines multiple services in one platform. Super apps are ubiquitous in Asia, but haven’t taken off in the U.S. due to a fragmented app market, concerns about advertising revenue, the country’s payment system structure and a strict regulatory environment, according to the Harvard Business Review.”
The WTW consulting firm offers an infographic displaying the results of their employer survey of Best Practices in Healthcare.
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