Congress returns from the campaign trail on Tuesday to begin its lame duck session. Here is a link to this week’s Congressional Committee schedule. The continuing resolution funding the federal government expires on December 20, 2024.
The Federal Employee Benefits Open Season begins at 12:01 am ET Monday morning.
Here is a link to an Open Season advice column written by Ann Werts in FedSmith. Ms. Werts makes an interesting observation:
“Once you’ve determined what you’re going to compare in the plans you’re considering, there are a couple of great tools you can use to assist you. [Checkbook’s] guidetohealthplans.org is a 3rd party resource that enters the outline of coverage for every federal health plan each year. For a small subscription fee ($15.95), you can access their website to compare any set of plans. Some agencies pay for their employees to use it, so check first to see if it’s available directly through your agency. If not, you can use the code GUIDE20 to receive a 20% discount.
“OPM also provides an online comparison tool. I find it more challenging to use because the output is a 17-column spreadsheet.”
As Leonardo DaVinci observed, “Simplicity is the ultimate sophistication.”
OPM has created an internet portal for Postal Service Health Benefit Plan enrollees to use to compare plans and select a plan. Every PSHBP enrollee should have received a letter about this process. The OPM website explains
“Thank you for your interest in the Postal Service Health Benefits Program!
“Open Season begins on November 11. To get coverage, please visit
“If you have technical issues with your Login.gov account, Login.gov operates a 24/7 contact center via phone or website contact form. Please visit login.gov/contact for more information.”
For those unfamiliar with login,gov, it’s an identity verification tool that the federal government uses with all Americans, not just PSHBP enrollees, to access IRS and Social Security portals as well as the PSHBP enrollment portal.
Here is a link to OPM’s public use files for FEHBP, PSHBP, and FEDVIP.
Kiplinger offers a better 2025 Medicare Parts B and D IRMAA chart compared to the ones in Friday’s CMS fact sheets plus more background on IRMAA.
“Roux-en-Y gastric bypass (RYGB) produces maximal weight loss in patients with obesity compared with other surgical procedures and with weight loss drugs, according to a meta-analysis comparing the efficacy and safety of the different treatment options.
“However, tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide-1 receptor agonist (GLP-1 RA), produces comparable weight loss and has a favorable safety profile, reported principal investigator Jena Velji-Ibrahim, MD, MSc, from Prisma Health–Upstate/University of South Carolina School of Medicine in Greenville.
“In addition, there was “no significant difference in percentage total body weight loss between tirzepatide when comparing it to one-anastomosis gastric bypass (OAGB), as well as laparoscopic sleeve gastrectomy,” she said.”
“Noninvasive surveillance with multitarget stool DNA testing or fecal immunochemical testing (FIT) could potentially match colonoscopy for reducing long-term colorectal cancer (CRC) incidence and mortality. It might also reduce colonoscopies by an estimated 15%-41%.
“The greatest reduction would likely be achieved by annual FIT-based surveillance, especially with FIT FOB-Gold at a threshold of at least 32 µg/g feces, according to findings from the Dutch MOCCAS study published in Gastroenterology.
“In this cross-sectional observational study, the multitarget DNA test outperformed FIT for detecting advanced precursor lesions, especially serrated polyps. According to long-term-impact mathematical modeling, however, DNA-based surveillance would be more costly than colonoscopy surveillance, whereas FIT would save costs.”
From the U.S. healthcare business front,
Altarum recently posted a report on trends in healthcare spending at the U.S. state level, including D.C. from 2019 through 2022.
After hearing reports from health systems about decreasing revenue capture from Medicare Advantage (MA) plans, this graphic dives into some of the trends driving this costly challenge providers are facing. MA plans’ popularity has swelled in recent years as seniors are drawn to the extra benefits and lower out-of-pocket costs. As a result, MA enrollees as a share of total inpatient days roughly doubled across all area types between 2015 and 2022. This trend has likely continued as MA penetration has only grown since 2022. This shift has been tough for providers because most MA plans require prior authorization for certain kinds of care, a burnout-driving and costly administrative demand for providers. Although the number of prior authorizations per MA enrollee has remained stable over recent years, providers are seeing more MA patients, leading to an increased burden. On top of that, the overall prior authorization denial rate jumped to 7.4% in 2022, after hovering around 5.7% for several years prior. These decisions can be overturned, but patients and providers often don’t file appeals, leading to higher rates of uncompensated care and lost revenues for providers. Unfortunately, these higher costs have brought many providers to a breaking point in contract negotiations with MA plans, leading to care disruptions that ultimately hurt patients the most.
“CVS Pharmacy Inc. and the former president of Cigna Corp.’s Express Scripts asked a federal judge to amend an injunction prohibiting her from joining CVS so that it expires at the same time as her noncompete agreement with Cigna.
“CVS notified Amy Bricker on Nov. 6 that it’s terminating her inactive employment status with the company, according to a motion the two filed Thursday in the US District Court for the Eastern District of Missouri. CVS and Bricker argued that fact materially changes the circumstances of the injunction because she “will not, even in the future, perform any active employment duties or responsibilities for CVS.
“It “obviates any need” for the injunction, CVS and Bricker said, and “has the practical effect of interfering with Ms. Bricker engaging in gainful employment for longer than” the Cigna noncompete, which is set to expire Feb. 3.”
“Control of the House has yet to be determined, as a number of critical races remain too close to call, leaving lawmakers — and voters — waiting to see which party will hold the majority next year.
“The sprint to 218 seats, however, is nearing the final stretch, after a handful of additional races were called in the days following election night.
“Republicans had secured 216 seats in the lower chamber as of Friday morning, with Democrats trailing at 204 seats, according to Decision Desk HQ. A total of 15 races have not yet been called: Democrats are leading in eight of the contests, while GOP candidates are ahead in the other seven.”
CMS finally announced the Medicare Part A and B premiums and cost sharing amounts for 2025 today.
Medicare Part A cost sharing
“The Medicare Part A inpatient hospital deductible that beneficiaries pay if admitted to the hospital will be $1,676 in 2025, an increase of $44 from $1,632 in 2024. The Part A inpatient hospital deductible covers beneficiaries’ share of costs for the first 60 days of Medicare-covered inpatient hospital care in a benefit period. In 2025, beneficiaries must pay a coinsurance amount of $419 per day for the 61st through 90th day of a hospitalization ($408 in 2024) in a benefit period and $838 per day for lifetime reserve days ($816 in 2024). For beneficiaries in skilled nursing facilities, the daily coinsurance for days 21 through 100 of extended care services in a benefit period will be $209.50 in 2025 ($204.00 in 2024).”
Medicare Part B premiums
“The standard monthly premium for Medicare Part B enrollees will be $185.00 for 2025, an increase of $10.30 from $174.70 in 2024. The fact sheets also disclose the Medicare Part B Income-Related Monthly Adjustment Amounts (IRMAA).”
Medicare Part B annual deductible
“The annual deductible for all Medicare Part B beneficiaries will be $257 in 2025, an increase of $17 from the annual deductible of $240 in 2024. The increase in the 2025 Part B standard premium and deductible is mainly due to projected price changes and assumed utilization increases that are consistent with historical experience.”
“Many hospitals are not publishing their prices in accordance with the price transparency law, a federal watchdog’s new report found.
“More than a third of the 100 hospitals reviewed by the Health and Human Services Department’s Office of Inspector General did not post machine-readable pricing data files correctly, or at all, as required by the 2021 federal law, according to the report released Friday. Most of the violations were related to disclosing the rates hospitals negotiated with insurers, metadata errors and outdated information. Five hospitals did not post any machine-readable files.
“The OIG analyzed data from 30 hospitals that were part of the country’s three largest health systems, and the rest were part of a random sample of 5,504 facilities. Researchers reviewed hospital websites between Jan. 17, 2023, and March 14, 2023.”
From the public health and medical research front,
The Centers for Disease Control and Prevention announced today.
“COVID-19 activity is stable or declining in most areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southern, southeastern, and mid-Atlantic United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniaehave continued to increase in young children in the United States.”
“COVID-19
Nationally, COVID-19 activity is stable or declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. Across the nation, COVID-19 infections are predicted to decline in some states and grow slowly from a low level in others.
“CDC expects that the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.”
“Nationally, RSV activity remains low. However, continuing signs of increased RSV activity have been detected in the southern, southeastern, and mid-Atlantic United States, particularly in young children. Emergency department visits and hospitalization rates are increasing in young children in some areas.
“Vaccination
RSV, influenza, and COVID-19 vaccines are available to provide protection and play a key role in preventing hospitalizations.
“Health officials say it’s important to get vaccinated ahead of the holidays, when respiratory bugs tend to spread with travel and indoor celebrations.
“Those viruses haven’t caused much trouble so far this fall. But COVID-19 tends to jump in the winter months, a rise that usually starts around Thanksgiving and peaks in January.
“And that coincides with flu season, which tends to start in November or December and peak in January or February.
“It takes the body about 2 weeks to build up immunity after either shot — meaning vaccination is needed before these viruses start spreading.”
“It doesn’t take much: Adding just five minutes of exercise to your daily routine lowers your blood pressure and might cut your odds for heart disease, new research shows.
“The good news is that whatever your physical ability, it doesn’t take long to have a positive effect on blood pressure,” said study lead author Jo Blodgett, from University College London (UCL). “What’s unique about our exercise variable is that it includes all exercise-like activities, from climbing the stairs to a short cycling errand, many of which can be integrated into daily routines.”
“Her team published its findings Nov. 6 in the journal Circulation.”
“Women who take vitamin D supplements during a pregnancy may be giving their kids the legacy of stronger bones, new British research suggests.
“Children whose moms took vitamin D supplements when pregnant had stronger, denser bones at the age of 7 compared to the kids of women who didn’t, a study from the University of Southampton shows.
It’s a head start on bone health that might last a lifetime, said lead researcher Dr. Rebecca Moon.
“This early intervention represents an important public health strategy. It strengthens children’s bones and reduces the risk of conditions like osteoporosis and fractures in later life,” said Moon, a clinical lecturer in child health at the university.”
“Value-based care platform Astrana Health has signed a definitive agreement with private equity firm Prospect Medical Holdings to acquire some of its assets for $745 million.
“Pending regulatory approvals, Astrana would acquire Prospect Health Plan, Prospect Medical Groups, Prospect Medical Systems, RightRx and Foothill Regional Medical Center in Tustin, California.
“In October, Astrana Health finalized its acquisition of management services organization Collaborative Health System from health insurer Centene for an undisclosed price. The company’s latest acquisitions are expected to close in mid-2025, according to a Friday news release from Astrana.
“Astrana and Prospect Medical did not immediately respond to requests for comment.”
Beckers Payer Issues ranks large payers by third quarter medical loss ratio.
“Quest Diagnostics and Elevance Health are broadening their partnership into four more states with the goal of making it easier for patients to access in-network laboratory services.
“Beginning Jan. 1, Quest’s service will be available in-network in four additional states: Colorado, Georgia, Nevada and Virginia. This includes routine lab testing, advanced diagnostics and Quest’s network of pathologists, according to an announcement.
‘Members who need lab services are able to schedule appointments online at one of Quest’s patient service centers as well as access test results and updates through the free myQuest mobile app.”
“Tandem Diabetes Care and Insulet executives this week touted the strong demand they’ve seen for their insulin pumps among people with Type 2 diabetes, tipping that adoption could be even greater than previously believed.
“Tandem CEO John Sheridan said on an earnings call Wednesday that adoption of pumps among the roughly 2 million patients with insulin-intensive Type 2 diabetes in the U.S. is about 5%. Sheridan told investors that Tandem sees that figure growing to more than 25% over the next several years. Just a few quarters ago, the company was projecting a 15% longer-term adoption rate.
“Interest in insulin pumps among people with Type 2 diabetes has made up a solid chunk of new users, helping to propel Tandem to a record quarter in sales.
“More than 30,000 people living in the U.S. with Type 2 use a Tandem pump,” Sheridan said. “If we look at it on a quarterly basis, approximately 5-10% of new customers each quarter have Type 2, which has been a consistent trend throughout the years.”
“Exact Sciences reported third-quarter results that fell short of analyst expectations and cut its guidance for the fourth quarter. The cut, which William Blair analysts called a “shocking guidance update,” contributed to a 23% drop in the diagnostic company’s stock Wednesday.
“TD Cowen analysts said in a note to investors that the third quarter was the third time in five years that Exact Sciences, which sells the Cologuard colorectal cancer screening test, has missed revenue expectations.
“Screening and precision oncology sales were each 1% below Wall Street’s consensus expectations, William Blair analysts wrote in a note to investors Tuesday. Exact Sciences is forecasting a bigger shortfall for the fourth quarter, with the company lowering its total revenue guidance by 11%, or around $85 million, from the prior implied range, according to William Blair.”
“Susie Wiles, who led Donald Trump’s presidential run, will become his White House chief of staff when he retakes the presidency next year, the campaign said Thursday, making her the first woman to hold that role in U.S. history. * * *”
“Those who have worked with her say she is unflappable behind her trademark mirrored sunglasses, avoids the limelight and is quick to give her team credit for her stack of victories.
“Every campaign she’s been involved with, she’s been a calming presence,” longtime Florida lobbyist and Wiles ally Brian Ballard told the Journal. “He saw in her the DNA of a winner.”
Federal News Network interviews principal Thiago Glieger, a principal of RMG Advisors about getting organized for the Federal Employee Benefits Open Season, which starts next Monday.
“U.S. health officials proposed banning an ingredient used in popular oral decongestants, a step toward removing dozens of cold medicines from store shelves.
“The Food and Drug Administration on Thursday proposed removing the ingredient, known as oral phenylephrine, from its list of approved over-the-counter ingredients after determining the drug doesn’t work at relieving stuffy noses.
“The agency took action after The Wall Street Journal had reported that some recent studies found oral phenylephrine in certain medicines was ineffective at relieving nasal congestion. CVS Health had already said it would pull some decongestants containing phenylephrine and no longer sell them.
“After taking public comment, the FDA could issue a final decision that would end sales of medicines containing the ingredient, including certain versions of Benadryl, Mucinex and Tylenol. The agency said it would give drugmakers time to remove the products from the market or reformulate them.
“The earliest a potential ban would take effect is 2026.
“Instead of taking pills that contain phenylephrine to clear congestion, people can take pills made from pseudoephedrine, antihistamines or nasal sprays, including those with phenylephrine. Physicians and pharmacists say the alternatives are effective.”
“The FDA has updated the labels for all GLP-1 receptor agonists, including popular medications Ozempic, Wegovy, Saxenda and Mounjaro, to include a new warning about the risk of pulmonary aspiration during general anesthesia or deep sedation, Medscape reported Nov. 6.
“The updated warning, issued Nov. 5, stems from rare postmarketing reports of patients who experienced pulmonary aspiration, when food or liquid enters the lungs, while undergoing elective surgeries or procedures requiring anesthesia despite following fasting guidelines prior to surgery.”
“Today, the U.S. Department of Health and Human Services (HHS) released the 2021–2023 Progress Report – PDF for the Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. The progress report provides a high-level overview of progress on select federal agency programs, policies, research, and other activities during fiscal years 2021–2023.”
“The progress report features an at-a-glance table of the status of seven core indicators and seven disparities indicators, which were identified in the national plan as a quantitative approach to measuring progress on STI prevention and care in the United States. The most recently available data reveal that seven of the indicators have met or are moving toward annual targets and that seven have not met or are moving away from annual targets. Of this latter group, six indicators relate to syphilis, which is the focus of the National Syphilis and Congenital Syphilis Syndemic Federal Task Force led by HHS Assistant Secretary for Health, Admiral Rachel Levine, M.D.”
From the public health and medical research front,
“Nearly 16% of American adults — that’s close to 1 in 6 — now has diabetes, according to the latest data from the U.S. Centers for Disease Control and Prevention.
“Increasing age and widening waistlines greatly increase the odds for the disease, which happens when the body doesn’t use insulin properly, resulting in high blood sugar levels. If left unchecked, diabetes can be disabling and even life-threatening.
“The vast majority (95%) of diabetes cases are type 2 diabetes, which occurs when the body’s cells no longer respond to insulin as they should. Insulin regulates levels of sugar in the blood. Type 2 diabetes is strongly connected to excessive weight.
“The new data, collected from mid-2021 through mid-2023, found a big rise in diabetes rates since 1999-2000, when 9.7% of adult Americans had the disease.
‘There was a significant gender gap in diabetes rates in 2023: Nearly 1 in 5 men (18%) have the illness, compared to 13.7% of women, according to researchers at the CDC’s National Center for Health Statistics (NCHS).”
“A simple nasal swab might help doctors predict the severity of a person’s COVID infection, a new study suggests.
“More than 70% of people with mild or moderate COVID develop certain antibodies in their nasal cavities that are linked to fewer symptoms, better immune response and faster recovery, researchers reported Nov. 6 in the journal Science Translational Medicine. * * *
“Researchers are working on a nasal swab test that could be used to predict how bad a person’s COVID infection will prove to be.
“Right now, we’re either looking at infection risk before it happens or analyzing the infection course well after recovery,” said researcher Ben Babcock, a doctoral candidate at Emory. “Imagine if we could capture the immune response in real time, right in the clinic. A just-in-time test could give physicians and patients the real-time information they need to make faster, smarter treatment decisions.”
“For months, as human cases of H5N1 bird flu associated with an outbreak of the virus in U.S. dairy cattle have mounted, one question has loomed larger than others: how many human infections are getting missed?
“Farmworkers face some of the most intense exposure to the bird flu virus, but resistance from farmers and a lack of health insurance and paid sick leave in the industry have limited the amount of testing of workers and hampered public health officials’ ability to track where the virus might be spreading. Now, long-awaited results from blood testing conducted by the Centers for Disease Control and Prevention are starting to fill in the picture.
“The findings, published Thursday, suggest that a small but not insignificant number of H5N1 infections are going undetected among people who work with dairy cows. Blood samples taken from 115 farm workers in Michigan and Colorado over the summer found evidence of a recent infection in eight individuals — half of whom recalled being ill around the same time the cows were sick. The other half could not recall having any symptoms.
“Known as serological surveys, the studies involve fishing out antibodies in the blood — molecules made by the immune system in response to a pathogen’s attack that persist long after an infection is over. Finding them is a signal of past contact with a particular virus and helps scientists understand how widely it has spread.
“While the new results suggest that current public health efforts are missing cases, they do not indicate that the strain of H5N1 associated with the dairy cattle outbreak has gained the ability to spread from person to person.”
“Brie and camembert that may potentially be contaminated with listeria are being recalled, the latest in a series of food incidents in the U.S. in recent months.
“Savencia Cheese USA is recalling select soft ripened cheeses after routine testing found the processing equipment at the company’s Lena, Illinois, manufacturing facility may have been contaminated with the bacteria.
“Aldi and Market Basket, a supermarket chain in New England, are among stores that sell the cheeses, but the recalled products only had “limited regional distribution” in the U.S., according to the U.S. Food and Drug Administration.
“The “few retailers” that received them have been informed of the possible contamination and are removing products from shelves, the FDA added.
“There are no confirmed reports of anyone getting sick so far, the agency noted.”
NIH Director Dr. Monica Bertagnolli writes in her blog,
“Digestion involves much more than just your stomach. The digestive process that fuels your body begins in your mouth each time you take a bite of food and chew. An enzyme in your saliva, called amylase, then starts to break down complex carbohydrates—or starches found in many fruits, vegetables, and grains—into simpler sugars to give you their sweet flavor followed by a burst of energy.
“Amylase is the reason we’re so good at turning starch into calories, but it isn’t the same for everyone. There’s plenty of genetic variation in the number of salivary amylase genes (AMY1) our cells carry and, therefore, in how much of this essential starch-busting enzyme people have. Studies have suggested a link between changes in amylase gene copy numbers over time and both the rise of agriculture and starch-heavy diets. Now a study in Science, supported in part by NIH, suggests that extra copies of AMY1 are not only connected to our ability to effectively digest carbs, but also may be more ancient than previously known, arising even before modern humans split from Neanderthals and long before the advent of farming.” * * *
‘The researchers compared the modern-day amylase genes to publicly available DNA sequences from 68 ancient human samples obtained from preserved remains. This revealed that ancient hunter-gatherers already had six to eight AMY1 copies long before people started growing crops and eating high amounts of starch. In fact, genetic variation underlying the production of this enzyme had already spread across Eurasia as far back as 45,000 years ago. However, the new analyses do show an increase in amylase gene copy numbers in the last 4,000 years, as people took up farming.
“The study team went on to uncover evidence that the expansion of amylase genes apparently has a longer history than anyone had suspected. Intriguingly, they found three copies of AMY1 in the DNA of three of six Neanderthals and one Denisovan. Neanderthals and Denisovans are both extinct relatives of early humans. The findings suggest that an extra copy of the amylase gene may have arisen as long as 800,000 years ago. The researchers also described how those first extra AMY1 copies could lead to their continued duplications or deletions to produce the wide variation in amylase gene copy numbers seen among modern humans.
“This variation in amylase genes would have afforded our ancestors dietary flexibility, allowing them to adapt as diets changed over time. But these discoveries aren’t only fascinating from an evolutionary or historical point of view. They may also lead to new understandings of genetic differences among people today, with potentially important implications for our metabolisms, nutrition, and health.”
“Regular practice of yoga can reduce lower-back pain, improve sleep and lessen reliance on pain medication, according to a study conducted by Cleveland Clinic researchers.
“The randomized clinical trial studied 140 Cleveland Clinic employees who had disclosed moderate amounts of pain for at least three months. Participants who engaged in a 12-week virtual yoga program reported feeling less pain and better sleep when compared with those who did not have access to the program.”
“Private equity firms are shifting their focus from providers to healthcare information technology and pharmaceutical services.
“State and federal regulatory scrutiny has deterred private equity investment in healthcare providers, PitchBook analysts said in the company’s latest healthcare services report. But regulatory oversight of healthcare-related private equity deals has slightly cooled as certain state bills stalled in the 2024 legislative session, and the report says analysts expect more private equity activity through the rest of the year.”
“Baxter expects to restart a second IV solutions manufacturing line within the next week, the company announced Nov. 7. Along with the first line that resumed production last week, the two lines comprise approximately 50% of the North Cove, N.C., site’s total pre-Hurricane Helene production of IV solutions and about 85% of one-liter solutions production. Hospitals in clinics most commonly use the one-liter solutions. The earliest the facility could begin shipments is late this month.
“The company said they expect their peritoneal dialysis and irrigation solutions lines to be the next to resume production and would begin by early December. Baxter expects all lines to restart by the end of the year but does not have a timeline on when total production will return to pre-hurricane levels. The company also said today that it has evaluated and approved more than 200 allocation exception requests to support the neonatal and pediatric patient needs.
“In addition, Baxter announced that a second temporary bridge has been installed at the plant and is in use. The bridge will allow traffic for additional trucks and equipment. The first bridge so far has allowed transport of more than 1,000 truckloads of products, Baxter said. Prior to the hurricane, the plant had manufactured approximately 60% — or 1.5 million bags or 95 truckloads — of IV solution used every day in the U.S.”
Beckers Payer Issues ranks the largest payers by 3rd quarter profits.
“CerpassRx, an independent pharmacy benefit manager, is teaming up with Waltz Health to launch a new AI-powered tool that aims to better manage specialty drug spending.
“Called Intelligent Specialty Engine, the tool leans on Waltz’s capabilities to offer clients real-time data analytics and management options that are designed to drive down spending, create greater transparency and improve the experience for both the patient and the plan sponsor.
“The PBM said that the platform is a “unique deployment” of Waltz Health’s Waltz Connect platform, which connects users to a network of both national and regional pharmacies that compete on price. It uses AI to help steer patients to “the most cost-effective and clinically appropriate pharmacies.”
“Sarepta Therapeutics is giving up on an experimental drug for Duchenne muscular dystrophy as sales rocket for its approved gene therapy for the disease.
“The decision to discontinue SRP-5051 was based on several factors, company executives told analysts on a conference call Wednesday. Safety concerns, feedback from the Food and Drug Administration and the “evolving landscape of Duchenne” with the approval of Sarepta’s gene therapy Elevidys all played a role, Chief Scientific Officer Louise Rodino-Klapac told analysts and investors.
“Elevidys revenue climbed to $181 million in the third quarter from $122 million in the second quarter, beating analyst estimates of about $160 million. Sarepta also pulled in $9.5 million in royalties from Roche, which sells the gene therapy outside the U.S.“
“Despite a mission to become a dominant cancer drug player, Gilead Sciences has as of late been locked in on its bread-and-butter antiviral franchise with an eye on the potential of its long-acting HIV med lenacapavir.
“But with its cell therapy unit stalling and antibody-drug conjugate Trodelvy facing challenges, the company’s oncology ambitions were brought back under the spotlight during its third-quarter earnings report.
“Gilead’s once fast-growing cell therapy products have hit a wall as of late with relatively flat sales all year. Over the third quarter, lymphoma treatment Yescarta saw revenue dip 1% to $387 million compared to last year’s third quarter, while its Tecartus counterpart similarly remained flat with 2% growth to $98 million.
“Gilead attributed the Yescarta challenges to “increased in- and out-of-class competition” in the U.S., slightly offset by increased demand in relapsed or refractory large B-cell lymphoma (LBCL) in other regions. In terms of the outside competition, one notable rival includes Bristol Myers Squibb’s rival CD19 CAR-T Breyanzi.”
“Johnson & Johnson received Food and Drug Administration approvalfor its Varipulse pulsed field ablation (PFA) system, joining Boston Scientific and Medtronic in the U.S. market for the fast-growing atrial fibrillation (AFib) treatment.
“Varipulse is approved to treat patients with drug-resistant, recurrent paroxysmal AFib, a common form of abnormal rhythm in the heart’s upper chambers, the company said Thursday. The platform is integrated with J&J’s Carto 3 mapping system in a single device that enables electrophysiologists to view inside the heart to position the catheter.
“We are confident that this eagerly awaited platform will be a valuable tool for physicians in performing safe, effective and efficient AFib procedures with an intuitive and reproducible workflow,” Jasmina Brooks, president of electrophysiology at J&J Medtech, said in a statement.”
President Donald Trump was reelected following an intervening term by another President in the fashion originated in the late 1800s by President Grover Cleveland, who was a Democrat.
“Republicans will win control of the Senate for the next two years, NBC News projects, though control of the House is still up for grabs.
“Senate Republicans ousted Democrats in red states to secure the majority, flipping seats in West Virginia, Montana and Ohio, states that have swung heavily to the GOP. And they held their ground in friendly states like Texas and Florida, assuring them at least 51 seats when the new Congress is sworn in next January.” * * *
“The GOP senators are expected to elect a new leader next week as longtime Republican leader Mitch McConnell, R-Ky., is stepping down from the role after a record 18 years. His current deputy, Sen. John Thune, R-S.D., and former deputy, Sen. John Cornyn, R-Texas, are battling to take the job when the new Congress begins.”
Congress’s lame duck session begins next Tuesday November 12, and it will be a busy time for the legislators. You will recall that on September 26, President Biden signed into law,
“H.R. 9747, the “Continuing Appropriations and Extensions Act, 2025,” which provides fiscal year 2025 appropriations to Federal agencies through December 20, 2024, for continuing projects and activities of the Federal Government.”
“Advamed has asked for Medicare to cover supplemental imaging of patients with heterogeneously and extremely dense breast tissue.
“In a letter sent to the Centers for Medicare & Medicaid Services Friday, the medtech industry group said many individuals with dense breasts currently have to pay out of pocket or forgo potentially life-saving additional testing.
“Advamed made the request two months after the Food and Drug Administration began requiring mammographers to notify patients when they have dense breast tissue. Traditional mammography is less sensitive than other imaging technologies in dense breasts, which increases the risks of imaging to miss cancer.”
From the public health and medical research front,
The American Hospital Association News lets us know,
“The Centers for Disease Control and Prevention Nov. 6 released its annual progress report on health care-associated infections, which showed continued decreases in hospitalizations last year. There was a 16% decrease in hospital-onset methicillin-resistant Staphylococcus aureus, or MRSA; a 15% decrease in central line-associated bloodstream infections, or CLABSI; a 13% decrease in hospital-onset Clostridioides difficile (C. difficile) infection; an 11% decrease in catheter-associated urinary tract infections; and a 5% decrease in ventilator-associated events. The declines align more closely with progress made prior to the COVID-19 pandemic in 2020, the CDC said.
“For inpatient rehabilitation facilities, there was a 14% decrease in hospital-onset C. difficile infection and an 8% increase in CAUTI in 2023, but no significant changes in CLABSI and hospital-onset MRSA standardized infection ratios compared with 2022. Among long-term care hospitals, there was a 13% decrease in hospital-onset C. difficile infections but no significant changes in 2023 SIRs compared with 2022.
“The report recommends facilities continue reinforcing prevention practices and review HAI surveillance data to identify areas for improvement.”
The FDA announced marketing authorization of a form of light therapy as the first-ever treatment for dry age-related macular degeneration (AMD).
LumiThera’s Valeda Light Delivery System generates light at different wavelengths to stimulate and improve the function of retinal mitochondria. The photobiomodulation (PBM) system is the first treatment shown to improve vision loss associated with dry AMD.
“Patients will now be able to try a non-invasive treatment that can help improve their vision earlier in the disease process,” said David Boyer, MD, of Retina Vitreous Associates Medical Group in Beverly Hills, California, in a company statement. “This is an exciting option for patients, and something doctors and patients have been waiting for.”
“Every year, almost 90,000 of these adolescents and young adults (AYAs)—generally defined as people between the ages of 15 and 39—receive a cancer diagnosis. And this group of patients often needs extra help navigating the complexities of cancer care.
“A new study has shown that a program in place for a decade at the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center substantially increased its assistance to AYAs with cancer being treated at the center. For example, there were large increases in the number of AYAs who underwent fertility counseling, a particularly important consideration for this age group. The program also substantially boosted AYA enrollment in clinical trials and helped more AYAs get other care recommended by national guidelines.
“The UNC team is now working to standardize many components of the program so it can be adapted by other cancer centers, explained Jacob Stein, M.D., M.P.H., who presented the findings from an evaluation of the program in September at the American Society of Clinical Oncology’s Quality Care Symposium.
“A lot of [centers] are now reaching out and asking: ‘How do we do this?’” said Dr. Stein. And the timing is right for the wider availability of programs to help AYAs with cancer, he added.
“Studies are showing that cancer is on the rise in younger adults,” he said. “That’s a concerning trend, but there are a lot of folks now engaged and talking about cancer in AYAs in a way that we weren’t 5 or 10 years ago.”
“[H]ow well does telehealth perform when it comes to delivering palliative care for people with cancer, which can rely on a deeper level of connection between patients and providers than may be possible with a virtual visit?
“The results show that “we can successfully deliver … high-quality [palliative] care in person and virtually,” said Joseph A. Greer, Ph.D., of Massachusetts General Hospital, who led the study.
“The study results also have implications for the accessibility of palliative care, Dr. Greer noted. Telehealth provides a way for people with cancer who live in rural areas where there may not be many palliative care providers or who don’t have reliable transportation to receive palliative care.
“Many of us see the potential that telehealth can have, and studies like this go a long way to help provide the evidence” needed to demonstrate that it can be used effectively as part of something as complex as palliative care, said Roxanne Jensen, Ph.D., of NCI’s Healthcare Delivery Research Program, who was not involved in the study.”
“Respiratory syncytial virus vaccines proved highly effective at preventing hospitalization and ED visits in older adults, even in those with immunocompromising conditions, results from an observational analysis showed.
“The findings, published in The Lancet, are consistent with previously reported data on respiratory syncytial virus (RSV) vaccine effectiveness.”
“Nilotinib, a drug approved by the US Food and Drug Administration (FDA) to treat chronic myeloid leukemia, improved biomarkers and cognitive outcomes in patients with dementia with Lewy bodies (DLB) in a phase 2 randomized, double-blind, placebo-controlled trial.
“The findings align with an earlier study that showed possible disease-modifying effects of nilotinib in patients with mild cognitive impairment or Alzheimer’s disease, as previously reported by Medscape Medical News.
“We’re looking at repositioning or repurposing tyrosine kinase inhibitors for neurodegenerative diseases,” said study investigator Raymond Scott Turner, MD, PhD, of Georgetown University School of Medicine in Washington, DC.”
“CVS reported mixed third-quarter results shadowed by heightened medical costs on Wednesday, in the massive healthcare enterprise’s first earnings report with new CEO David Joyner at the helm.
“The Woonsocket, Rhode Island-based company beat Wall Street expectations on revenue of $95.4 billion, up more than 6% year over year. However, CVS’ net income fell to $71 million, down from almost $2.3 billion same time last year, as its Aetna insurance arm continued to struggle with higher spending.
“CVS appointed Steve Nelson, previously the CEO of value-based primary care company ChenMed, as president of Aetna. Nelson also ran UnitedHealthcare, the largest private insurer in the U.S., from 2016 to 2019.”
“The No Surprises Act banned surprise billing and established a final-offer arbitration system, independent dispute resolution (IDR), to resolve disagreements between health plans and providers. One factor that arbiters must consider in the IDR process is the qualifying payment amount (QPA), the median contracted rate for the same or similar service in the same market as computed by health plans. We analyzed public IDR data from 2023 for the most common disputed professional service: evaluation and management of a moderate to severe emergency medicine visit. Providers won 86% of cases, with mean decisions 2.7 times the QPA. Private equity-backed providers won more often and higher monetary awards than other providers. The mean QPA was 2.4 times Medicare payments. Disputes were dominated by a small group of health plans and providers, so payments may not reflect the overall market for emergency services.”
“Novo will have to overcome some upcoming challenges to maintain its sales lead. Lilly, for example, expects to report data from a trial testing the two drugs directly against one another and that’s expected to favor Zepbound. Positive results from a Phase 3 study of a follow-up drug to Wegovy could give Novo a boost, however.”
“As other biopharma giants have divested their generics units to focus on the development and commercialization of innovative drugs, Teva has relied on its copycat business to help trigger its rebound under CEO Richard Francis.
“Wednesday, Teva revealed booming third-quarter sales for its generics and biosimilars. In the U.S., revenue from the knockoffs came in at $1.1 billion, which was a 30% increase year over year, or 7% sequentially. Sales of generics and biosimilars also were up 10% year over year in Europe.
“The figures contributed heavily to Teva’s overall success in the quarter. Its revenue of $4.3 billion topped analysts’ consensus of $4.14 billion and was a 13% gain year over year. With the result, Teva tweaked its annual guidance up by $100 million at both ends to a window of $16.1 billion to $16.5 billion.”
“While employers are prioritizing mental and physical wellbeing programs, employees report that what they really want is financial wellbeing support, according to a new survey.
“The survey was released last week by WTW, a global advisory, broking and solutions company. It included responses from 535 employees at medium and large private sector employers.
“The organization found that 73% of employers prioritize mental wellbeing and 50% prioritize physical wellbeing. However, 66% of employees say that financial wellbeing is their biggest concern. For employers, only 23% of respondents listed this as a priority. This comes as just 41% of employees feel financially secure, according to the survey.”
“The U.S. Department of Health and Human Services (HHS) is proud of the work done by the Task Force on Maternal Mental Health, building on the White House Blueprint on Maternal Mental Health – PDF and the White House Initiative on Women’s Health Research, to develop and deliver recommendations to the Substance Abuse and Mental Health Services Administration’s Advisory Committee for Women’s Services to improve maternal mental health in the U.S.
“Following the one-year anniversary of the Task Force on Maternal Mental Health launch, HHS is expanding efforts to advance maternal mental health and substance use disorder care. HHS is asking interested non-federal organizations to submit a pledge(s) – PDF highlighting new initiative(s) that address challenges and barriers to maternal mental health and substance use disorder care.
“HHS will collect pledges through December 6, 2024, and announce them publicly in early 2025. Questions? Send to TFMMH@hhs.gov.”
“Journey Medical (DERM.O) said on Monday the U.S. Food and Drug Administration has approved its drug for the treatment of a long-term skin condition called rosacea.
“Rosacea is a skin condition causing chronic inflammation of the facial skin and is often classified into four types.
“The oral antibiotic, branded Emrosi, was approved to treat lesions associated with inflammatory rosacea, which causes persistent redness and small pus-filled bumps on the face.”
“Of all the areas the Federal Employee Viewpoint Survey (FEVS) measures, federal employees’ views of senior leadership may be one of the trickier categories to unpack.
“The “leaders lead” category on FEVS typically results in lower scores from federal employees than the category measuring views of immediate supervisors. But the senior leadership score for this year’s survey still increased from 61% to 63% between 2023 and 2024, the Office of Personnel Management reported last month. Looking back a bit further, employees’ views of senior leadership have risen 4% since 2022.
“It’s certainly a positive finding in the governmentwide results of the 2024 FEVS, but looking more deeply at the survey results, there appears to be variation based on how closely situated employees are to their agency’s headquarters.
“In a FEVS data dashboard, OPM’s breakdown of results by each Federal Executive Board (FEB) geographic region shows that federal employees located in the “Eastern” FEB — or those closer to many agency headquarters — have higher scores than those working in the areas covered by the Western FEB, who are for the most part geographically farther from headquarters.”
From the public health and medical research front,
“Reports of cases of pertussis, also known as whooping cough, are currently five times higher compared to last year, according to the Centers for Disease Control and Prevention. The rise indicates the U.S. is returning to pre-pandemic patterns of typically 10,000-plus cases each year, and that mitigation measures such as masking and remote learning during the pandemic lowered transmission, the CDC said. The agency said that vaccination is the best way to prevent pertussis, but it expects cases to continue to increase among vaccinated and unvaccinated populations.”
“If you’ve had a lingering cough recently, there is a chance the culprit wasn’t Covid-19, flu or RSV, but mycoplasma pneumoniae.
“Levels of this milder lung infection—which can lead to “walking pneumonia”—are 10 times greater than last year, according to the Centers for Disease Control and Prevention [“CDC”]. Though the CDC doesn’t officially track the disease, it issued an alert last month noting the rise in cases. Levels of walking pneumonia, so named because patients often feel well enough to go about their normal daily activities, typically peak every three to seven years.
“Chris Edens, lead of the CDC team that tracks Legionella and atypical pathogens, said the agency saw a rise of cases in late spring. It peaked in August, then declined a bit. The decrease might not last, he adds, noting “levels seem to be flattening out or maybe even ticking back up.”
“Cases of walking pneumonia are up across all age groups, with children 17 and under experiencing the largest rise, says Edens.”
The CDC reminds us that November is diabetes month. The agency offered its quick pre-diabetes test.
“A medicine built around a more precise form of CRISPR gene editing appeared to work as designed in its first clinical trial test, developer Beam Therapeutics said Tuesday. But the death of a trial participant could renew concerns about an older drug used alongside Beam’s genetic medicine.
“Beam’s medicine uses a technology known as base editing to activate a gene in stem cells collected from people with sickle cell disease, an inherited blood condition that can cause debilitating pain and a constellation of other symptoms.
“Data shared by Beam from the first handful of patients treated in the trial show the company successfully edited those cells in a laboratory. When later reinfused back into patients’ bodies, they matured into red blood cells that were more durable and less likely to warp into the sharp-edged crescents associated with the disease.
“However, one of the patients died from lung damage that was judged by their physician and the trial’s monitoring committee as related to an old chemotherapy drug commonly used prior to stem cell transplants. The Food and Drug Administration also reviewed the case.
“Called busulfan, this drug is known to be toxic. But it is effective at creating an opening in the bone marrow for newly edited stem cells to take root, a necessary step for infusing gene editing therapies like Beam’s.
“Beam is working on a solution to sidestep busulfan and, on Tuesday, also released data from testing in monkeys showing how it may work.”
“Greater use of virtual mental health care services was linked to a lower risk of suicide-related events, according to a retrospective cohort study.
“The study of more than 16,000 veterans with prior mental health diagnoses showed that a 1% increase in the proportion of mental health care received through telehealth services was associated with a 2.5% decrease in suicide-related events, Kertu Tenso, PhD, of Boston University School of Public Health, and co-authors reported in JAMA Network Open.”
“Ex-smokers with a light lifetime smoking burden had a CVD [cardiovascular disease] risk shortly after quitting similar to those who have never smoked, results from a cohort analysis showed.
“However, findings from the retrospective study suggest that ex-smokers who smoked heavily may need to restrain from smoking for more than 25 years to have a cardiovascular risk similar to those who have never smoked.”
MedCity News suggests “A Recipe for Better Obesity Care: Integrating GLP-1s with Food as Medicine. Nutrition isn’t a supplement — it’s foundational to metabolic health. It’s time we integrate more ‘Food as Medicine’ initiatives alongside the GLP-1 therapies that are gaining traction.”
“Three independent pharmacies have filed separate lawsuits accusing GoodRx, which markets a prescription drug discount card, of conspiring with several pharmacy benefit managers to fix reimbursement fees, the latest skirmish over the opaque pharmaceutical supply chain in the U.S.
“At issue are the behind-the-scenes transactions involving generic drugs, which account for an estimated 90% of the prescriptions written in the U.S. and, consequently, represent a lucrative market. The lawsuits claim, however, that GoodRx and some of the largest PBMs coordinate their reimbursement policies in a way that has deliberately reduced fees for the pharmacies.”
“The “anti-competitive” tactic has contributed to deteriorating finances for a growing number of independent pharmacies, according to the lawsuits, which noted “thousands” of local drug stores have closed in recent years. The pharmacies argued the dispute is one of several over reimbursement fees that, ultimately, favor pharmacies affiliated with the PBMs themselves.
“The upshot of this scheme is that the conspiring PBMs, by coordinating their reimbursement decisions through GoodRx, never pay pharmacies more for generic drugs than any rival PBM has agreed to pay in its separate negotiations with those pharmacies. This is nothing more than price fixing,” argued a lawsuit filed by Community Care Pharmacy, which is based in Michigan and sued only GoodRx.”
“Signify Health is tapping into resources from parent company CVS Health to grow the number of in-home services it can provide.
“Signify conducts in-home health evaluations for patients, and if needed, connects them to primary care or other follow-up services. It works with health plans to identify members who could benefit from an evaluation. CVS acquired Signify a year-and-a-half ago in a $8 billion deal, just a couple of months before closing a $10.6 billion acquisition of primary care provider Oak Street Health.
“Joining CVS — which also includes the core retail pharmacy, insurer Aetna and pharmacy benefit manager Caremark — brought Signify into a larger ecosystem with opportunities to increase its care coordination offerings. In October, CVS ousted former CEO Karen Lynch, who oversaw the Signify deal and other efforts to diversify the parent company’s assets.
“That hasn’t affected Signify President Paymon Farazi’s plans to expand the kinds of services the company can provide as part of its in-home health evaluations. Farazi said in an interview his aspirations for Signify range from adding more diagnostic tests to moving into clinical care.”
MedCity News discusses five healthcare companies which attracted one of its journalist’s attention at the HLTH24 conference.
Per MedTech Dive,
“The Centers for Medicare & Medicaid Services granted transitional pass-through (TPT) payment status to Medtronic and Recor Medicalfor renal denervation devices to treat high blood pressure.
“The TPT program provides additional funding to hospitals to encourage use of new Food and Drug Administration-approved therapies as the CMS gathers cost data to determine future reimbursement rates under the Medicare outpatient prospective payment system. The companies announced the coverage decisions on Friday.
“Jason Weidman, president of Medtronic’s coronary and renal denervation business, called the payment approval for the Symplicity Spyral catheter an “important milestone” for the company’s renal denervation procedure because it will reduce cost barriers for healthcare systems. The company has pegged the market as a $1 billion-plus opportunity.”
“Altamonte Springs, Fla.-based AdventHealth has partnered with Walmart to open a hybrid primary care clinic inside one of its stores [located in Corbin, Kentucky]. * * * Since Walmart shuttered its own retail health clinics and virtual care service, it has been leasing space to health systems, including Chesterfield, Mo.-based Mercy.”
“This update raised the CCTA payment rate from $175 all the way to $357.13.
“CCTA utilization is expected to skyrocket throughout the United States now that the payment rate has increased. One medical society is already celebrating the news.
“We’re thrilled with the CMS’s ruling, which better aligns with the cost of providing CCTA services,” Ahmad Slim, MD, chair of the Society of Cardiovascular Computed Tomography (SCCT) Health Policy and Practice Committee, said in a statement. “This is a huge win for U.S. providers as well as the entire cardiac imaging community, ultimately improving patient access to this essential diagnostic tool, which aligns with the society’s overall mission.”
“Medicare regulators on Friday finalized rules to pay for some mental health apps, a breakthrough for digital therapeutics companies that have struggled for a foothold in the health care system.
“The new rule creates codes that allow clinicians to bill Medicare for providing the apps and related services to their patients. Beginning January 1, 2025, the codes will enable payment for mental health apps authorized by the Food and Drug Administration under a specific regulation that includes just a handful of treatments for conditions like depression and substance use disorder.
“The codes to cover the apps, which regulators call digital mental health treatment devices, were first proposed for the 2025 Centers for Medicare and Medicaid Services Physician Fee Schedule in July and were finalized with some minor changes after comments from industry and the public.”
From the public health and medical research front,
“AstraZeneca said its experimental weight loss pill was well tolerated by patients in an early-stage clinical trial.
“The Anglo-Swedish drugmaker’s closely watched weight loss pill, AZD5004, showed 5.8% weight loss after four weeks of treatment among patients with type 2 diabetes, it said Monday during the ObesityWeek conference in San Antonio, Texas.
“The trial of the once-daily drug—which mimics a gut hormone known as GLP-1 to control blood sugar and suppress appetite—showed no severe side effects among patients with dosages of up to 50mg.
“Investors are paying close attention to the safety and tolerability profile of experimental weight loss drugs. Roche Holding shares slumped 4.5% in early European trading in September after the company said its oral weight-loss drug candidate was generally well tolerated, but some patients showed gastrointestinal side effects.”
“New results from a small study of Viking Therapeutics’ oral obesity drug raised expectations among Wall Street analysts that the experimental tablet could prove superior among the growing ranks of would-be competitors to the popular weight loss treatments Wegovy and Zepbound.
“The updated data, presented over the weekend at a medical conference, showed treatment with the highest dose of Viking’s drug led to an average weight loss of about 8% after just four weeks. Adjusting for the placebo group’s results, the average change was nearly 7%, Viking said Monday.
“Viking had previously disclosed results for the first five doses tested in the study back in March. The new results come from three higher dose groups involving 27 people. Notably, the data showed the higher doses were not associated with meaningfully higher rates of gastrointestinal side effects like vomiting and nausea.”
“Wegovy may significantly reduce hospital admissions for any cause and overall length of stay, according to a new analysis of data from Novo Nordisk’s phase 3 SELECT trial.
“Compared to patients taking a placebo, those taking Wegovy (2.4 milligrams of semaglutide) were less likely to be hospitalized for any reason. Findings presented Nov. 3 during a session at the annual ObesityWeek conference showed admissions for any cause occurred in 33.4% of patients taking Wegovy, compared to nearly 37% in the placebo cohort.
“The new findings are based on an analysis of data from Novo Nordisk’s multicenter, randomized Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity trial (SELECT), which began in 2018 and enrolled more than 17,000 adults in 41 countries.”
The American Medical Association shares top tips that hematologists want their patients to know.
Consumer Reports, writing in the Washington Post, lets us know “How to pick a yogurt that tastes great and is good for you. Beyond traditional and Greek, there’s skyr and kefir, yogurts made with plant milks, and more.”
“Novant Health has completed its purchase of BlueCross BlueShield of South Carolina’s UCI Medical Affiliates, a company that manages and provides administrative services for urgent care centers and physical therapy facilities.
“The acquisition includes 52 urgent care centers and 20 clinics across South Carolina that are part of UCI Medical subsidiaries Doctors Care and Progressive Physical Therapy, according to a news release. Financial details were not disclosed.”
Kaufmann Hall informs us about a recent 14-minute-long podcast,
“Following the COVID-19 pandemic, UMass Memorial Health in Worcester, Massachusetts began to pilot a new hospital-at-home program: one for postpartum patients. Benjamin Hamar, MD, Director of the Maternity Center at UMass Memorial and a member of the Maternal-Fetal Medicine Division, joins the podcast to tell host J. Carlisle Larsen more about the first-in-the-nation model.”
“Novo Nordisk is investing further in obesity and metabolic disease, signing a deal to use Ascendis Pharma’s delivery technology to advance a long-acting GLP-1 drug as well as develop products in diabetes and cardiovascular conditions, Ascendis said Monday.
“Per deal terms, Novo could pay up to $285 million in immediate and milestone-based fees to Ascendis for the GLP-1 drug, depending on its progress toward approval. In addition, Ascendis could receive up to $77.5 million for each additional drug developed.
“Ascendis has won Food and Drug Administration approval of two products using its extended-release technology, both in rare conditions. In partnering with Novo, Ascendis would gain entry into conditions that have blockbuster sales potential.”
“NeuroOne, which disclosed the deal Thursday, will receive $3 million upfront and potentially a $1 million sales milestone in return for an exclusive license to distribute its radiofrequency ablation system.
“The device is designed to identify and ablate the brain tissue that triggers seizure activity. The Food and Drug Administration cleared the device for use in the U.S. in December, and NeuroOne began a limited commercial launch in March.”
“Supermarket chain Kroger has finalized a nearly $1.4 billion agreement to settle the majority of the claims made by states, counties and Native American tribes that accused the company of helping fuel the opioid epidemic.
“Payments are expected to begin early next year. The amount includes up to $1.2 billion for state and local governments where it operates, $36 million to Native American tribes and about $177 million to cover lawyers’ fees and costs.” * * *
“Kroger is one of the country’s largest grocery chains, operating stores in 35 states.
“The finalization of this settlement, originally reached in September 2023, will deliver over $1.2 billion in support of opioid abatement efforts nationwide while resolving nearly all the outstanding opioid-related claims against the company,” a Kroger spokesperson said in a statement.
“The company previously said the settlement is not an admission of wrongdoing or liability
“In addition to the monetary payments, Kroger has agreed to injunctive relief that requires its pharmacies to monitor, report, and share data about suspicious activity related to opioid prescriptions.”
As we all know, the national election is Tuesday. The current Congress will return to Capitol Hill the following Tuesday November 12, to begin its lame duck session. The new Congress will begin on January 3, 2025.
In anticipation of the Federal Employee Benefits Open Season that begins on November 11, OPM has posted 2025 FEHBP and FEDVIP plan comparison tools on its website.
“Elevance Health is the latest Medicare Advantage insurer to dispute its star ratings quality scores in court.
“The health insurance company filed suit against the federal government in the U.S. District Court for the Northern District of Texas on Thursday. According to Elevance Health, the Centers for Medicare and Medicaid Services improperly assessed its quality performance, costing the insurer $375 million in bonus payments. The company won a case regarding its 2024-star ratings on different grounds, which led the agency to recalculate scores across the program.
“Elevance Health wants the court to order CMS to redo its ratings and to provide insurers with the data to “validate the 2025-star ratings calculations and future star ratings calculations,” according to its lawsuit. The insurer also seeks reimbursement the court deems appropriate.”
From the public health and medical research front,
CBS News asks and answers “Do I have COVID, the flu or something else? 2024 symptoms and testing to know.”
“More than 80 percent of emergency departments in United States hospitals are not fully prepared for pediatric cases, a new study finds, despite the fact that children make up about 20 percent of visits each year.
“The new analysis, published Friday in the journal JAMA Network Open, estimated that if every emergency department in the United States had the core features of “pediatric readiness,” more than a quarter of the child deaths that follow E.R. visits could be prevented, a figure that equates to thousands of young lives each year.
“Even in the most ill-prepared states, the cost to ready every emergency room would be less than $12 per child living there, the researchers found.
“You can now find your state and see: How many children who would otherwise die could we expect to save if we implemented universal pediatric readiness at a high level?” said Dr. Craig Newgard, who was the lead author on the paper, and is the director of the Center for Policy and Research in Emergency Medicine at Oregon Health & Science University.”
“Migraine is a surprisingly common problem, affecting an estimated 15 percent of the global population. Scientists don’t know how triggers lead to attacks but have made some progress in treatment: The latest drugs, inhibitors of a body signaling molecule called CGRP first approved for use in 2018, have been a blessing for many. For others, not so much. And it’s not clear why.”
* * * “Despite some failures, CGRP’s successes show that there’s hope for new medicines. CGRP has really paved the way,” says Andrew Russo, a neuroscientist at the University of Iowa in Iowa City who described CGRP as a new migraine target for the Annual Review of Pharmacology and Toxicology in 2015. “It’s a very exciting time for the field.”
“Binge drinking is prevalent across generations, but the dangerous habit is growing among one age group in particular.
“Long associated with college students, binge drinking, defined as having four or more drinks within two hours at least five times per month for women (five drinks for men) is on the rise among older adults. According to The National Survey on Drug Use and Health, 20% of adults aged 60 to 64, reported binge drinking in the last month. For those older than 65, the prevalence of binge drinking is 12%—a rate that has been increasing over the last decade, while binge drinking rates among young adults 18 to 25 have been going down.” * * *
“Pennsylvania’s attorney general sued Prospect Medical Holdings and its former parent company, alleging mismanagement by the hospital chain caused two hospital closures and widespread disruptions to patient care.
“The lawsuit Tuesday argues Prospect broke the terms of its 2016 purchase agreement of four-hospital system Crozer Health, which required Prospect to keep all acute care hospitals open for at least 10 years.
‘In the suit, Attorney General Michelle Henry asks for a preliminary injunction barring Prospect from closing more hospitals and requests an official receiver step in and manage Crozer Health.”
“Zoom, a company that rose to prominence during the COVID-19 pandemic, is looking to expand its presence in healthcare through artificial intelligence.
“The company recently announced plans to incorporateambient AI documentation technology from digital health companySuki in its clinical platform. Zoom plans to use the ambient AItechnology, which turns a recording of a doctor-patient conversation into usable clinical notes in the electronic health record, for virtual and in-person visits.
“It’s the latest move in healthcare from the video teleconferencing company, which has offered telehealth services since 2018.”
“While the median salary increase stayed at 4% in 2024, average increases dropped from 4.3% to 3.9%, according to survey results collected by Salary.com from more than 1,000 HR professionals in the U.S. and Canada.
“The drop is due to fewer companies doling out higher raises, Salary.com found; only 14% of companies gave out raises between 5% and 6.9%, compared with 25% of companies in the previous survey. Additionally, more companies — 38% in 2024, compared to 25% in 2023 — returned to “typical” salary increases in the 3% to 3.9% range.
“Last year, we noted that salary increases might be at a peak, even with 4 percent becoming the norm,” Andy Miller, vice president of compensation consulting at Salary.com, said in an Oct. 29 news release. “While 4 percent remained the median in 2024, further analysis suggests a shift is happening.”
“By factors specified in law, average payment rates under the PFS will be reduced by 2.93% in CY 2025, compared to the average amount these services were paid for most of CY 2024. The change to the PFS conversion factor incorporates the 0% overall update required by statute, the expiration of the temporary 2.93% increase in payment for CY 2024 required by statute, and a relatively small estimated 0.02% adjustment necessary to account for changes in work relative value units (RVUs) for some services. This amounts to an estimated CY 2025 PFS conversion factor of $32.35, a decrease of $0.94 (or 2.83%) from the current CY 2024 conversion factor of $33.29.”
“In accordance with Medicare law, CMS is finalizing an update to OPPS payment rates of 2.9% for hospitals that meet applicable quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.4% reduced by a 0.5 percentage point productivity adjustment.
“In the CY 2019 OPPS/ASC final rule with comment period, CMS finalized a proposal to apply the hospital market basket update to ASC payment system rates for an interim period of five years (CY 2019 through CY 2023). The CY 2024 OPPS/ASC final rule with comment period extended the interim period for an additional two years (through CY 2024 and CY 2025).
“Accordingly, using the hospital market basket update, CMS is finalizing an update factor to the ASC payment rates for CY 2025 of 2.9%. The update applies to ASCs meeting relevant quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.4% reduced by a 0.5 percentage point productivity adjustment.”
“For CY 2025, CMS is increasing the ESRD PPS base rate to $273.82, which CMS expects will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.7%. The CY 2025 ESRD PPS final rule also includes changes to the methodology for calculating the ESRD facility wage index, changes to the Low-Volume Payment Adjustment (LVPA) methodology, and several changes to the ESRD outlier policy.”
Along with the payment rules, CMS offers fact sheets about the following topics
CMS updated the ‘Birthing-Friendly’ designation icons on Care Compare for the first time since rolling out the initiative in October 2023. Hospitals that attested to the Maternal Morbidity Structural measure in the Hospital Inpatient Quality Reporting Program received the designation. The icons will be refreshed using updated data from CY 2023. CMS created the designation to identify hospitals and health systems that participate in a statewide or national perinatal quality improvement collaborative program and that implement evidence-based care to improve maternal health. Eighty percent of pregnancy-related deaths are preventable, and Black, American Indian and Alaska Native, and Native Hawaiian and Pacific Islander people have the highest rates of pregnancy-related death. The ‘Birthing- Friendly’ designation is a step towards ensuring that all pregnant and post-partum people can find high-quality maternity care.
The [Medicare physician fee schedule] rule quickly elicited calls for Congress to overhaul the way Medicare sets payment rates. Federal law requires that any payment increases be offset by equal cuts elsewhere in the program.
“To put it bluntly, Medicare plans to pay us less while costs go up. You don’t have to be an economist to know that is an unsustainable trend, though one that has been going on for decades,” said a statement from Bruce A. Scott, president of the American Medical Association.
“For physician practices operating on small margins already, this means it is harder to acquire new equipment, harder to retain staff, harder to take on new Medicare patients, and harder to keep the doors open, particularly in rural and underserved areas,” Scott said.
“Overall Medicare payments to home health agencies will increase by 0.5%, or $85 million, next year under a final rule released Friday.
“The total amount reflects a 2025 payment increase of 2.7%, or $445 million, according to the rule (RIN 0938-AV28) from the Centers for Medicare & Medicaid Services. But that amount would be offset by an estimated 1.8% payment cut of $295 million as part of a “permanent behavior adjustment” based on the assumption that home health agencies altered their billing and coding activity to maximize reimbursements in previous years.
“The payment offsets are part of a CMS plan to use future rulemaking to recover billions of dollars in apparent overpayments.”
“Beginning Nov. 1 through Jan. 15, individuals and families can enroll in or change their health coverage options through the Health Insurance Marketplace. The Centers for Medicare & Medicaid Services expects that 97% 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. AHA’s #GetCovered page offers resources to help people choose the best coverage for themselves and their families.”
Govexec reports that “Most TSP funds took a tumble in October. Only two portfolios in the federal government’s 401(k)-style retirement savings program ended last month in the black, ending a three-month run of gains.”
“The hospital industry has pushed back against Medicare payment reforms for years, arguing that the policies would financially hurt rural hospitals.
“Two key senators on Friday released a plan to get around that issue by reinvesting some of the money saved from payment reforms to help rural and safety-net hospitals. Hospitals that keep providing services like trauma centers, labor and delivery units, and burn units would get financial bonuses, too.
“The reforms, called “site-neutral” payments, would equalize Medicare payments for some services provided at hospital outpatient departments with what the program pays physician offices for the same services. The hospital industry at large has opposed the policy because it argues hospitals should get paid more because they have to provide round-the-clock care and have higher overhead costs.
“Sen. Maggie Hassan (D-N.H.), who has led efforts on the issue, partnered on the policy proposals with Sen. Bill Cassidy (R-La.), who’s in line to lead the Senate’s health committee if Republicans take control of the chamber next year and sits on the committee that regulates Medicare payments. Hassan’s current GOP partner on a stalled site-neutral bill, Sen. Mike Braun (R-Ind.), is leaving the Senate at the end of this year.”
From the public health and medical research front,
The Centers for Disease Control and Prevention announced today,
COVID-19 activity is declining in most areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southern and southeastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae have increased in the United States, especially in young children.
COVID-19
Nationally, COVID-19 activity has continued declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. National trends in growth of COVID-19 infections are uncertain overall. Decreases are predicted in some states, and slow growth is predicted from a low level in others.
The XEC variant is estimated to comprise 14-22% of circulating viruses as of October 26, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection. Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
Nationally, RSV activity remains low. However, continuing signs of increased RSV activity have been detected in the southern and southeastern United States, particularly in young children. Emergency department visits and hospitalization rates are increasing in young children in some areas.
“The total number of dengue fever cases in the U.S. is now more than double the number recorded all of last year, federal data shows.
“More than 6,800 cases of dengue have been reported nationally so far this year, according to data from the Centers for Disease Control and Prevention (CDC). Of those cases, more than 4,400 were locally acquired and more than 2,300 are travel associated.
“Locally acquired cases mean that those infected have no history of traveling to an area where dengue normally spreads, including tropical and subtropical areas of the world.
“The 6,800 figure is more than double the 3,352 dengue cases reported during all of 2023, CDC data shows.
“Currently, Puerto Rico makes up the bulk of cases this year with more than 4,200 reported there, according to CDC data. Earlier this year, the territory declared a public health emergency amid a rise in dengue case.”
The American Journal of Managed Care lets us know,
“Early smoking cessation post-cancer diagnosis significantly improves survival, with optimal benefits seen when quitting within 6 months.
“The Tobacco Research and Treatment Program at MD Anderson offers free, evidence-based cessation interventions, including counseling and pharmacotherapies.
“The study highlights a reduced mortality risk for patients who quit smoking by 3-, 6-, and 9-months post-treatment.
‘Limitations include potential bias from self-reported abstinence and lack of data on noncancer health conditions.”
“A multistate study of publicly insured children diagnosed as having pneumonia found that one in five did not receive antibiotics, researchers reported yesterday in JAMA Network Open.
“But while children who didn’t receive antibiotics had slightly higher rates of treatment failure than those who did, severe outcomes were rare regardless of antibiotic treatment, the researchers found.
“The study authors say their findings suggest future research should aim to identify children with pneumonia who can be safely managed without antibiotics.”
“Novo Nordisk’s weight loss drug Wegovy helped people with a fatty liver disease called MASH experience improvements in liver scarring and achieve symptom resolution, results the company sees as supporting regulatory approval.
“After 72 weeks in a Phase 3 trial, 37% of patients on Wegovy experienced an improvement in liver scarring, or fibrosis, with no worsening of their disease. That compared with 23% of those on placebo, according to topline results Novo announced Friday.
“Additionally, 63% of people on Wegovy achieved resolution of their symptoms with no worsening of fibrosis, compared with 34% of participants on placebo.
“Novo said the results were statistically significant.
“GLP-1 drugs like Wegovy are increasingly being tested in a range of conditions beyond obesity, including diseases that affect the heart, kidneys, and liver. Wegovy is already approved to prevent cardiovascular complications, and for Novo, proving that the drug helps with even more complications may help it gain broader and more streamlined insurance coverage.”
“Tenet Healthcare posted $5.1 billion in revenue for the third quarter, exceeding analysts’ expectations as the provider’s hospital and ambulatory segments fielded higher-than-expected patient volumes.
“Business in Tenet’s ambulatory care service line was particularly strong, executives said during a Tuesday morning call with investors. Adjusted earnings before interest, taxes, depreciation and amortization for Tenet’s ambulatory surgery centers and surgical hospitals sat nearly 19% higher than this time last year at $439 million.
“Still, the company lowered the upper end ofits 2024 revenue guidance to $20.6 billion to $20.8 billion, compared to prior guidance of $20.6 billion to $21 billion. Analysts from Leerink Partners said the revision was likely due to the performance of Tenet’s hospital portfolio and the timing of several hospital divestitures.”
“The University of Alabama at Birmingham Health System Authority has acquired Ascension St. Vincent’s Health System, effective Nov. 1.
“Under the agreement, UAB Health System assumed ownership of all Ascension St. Vincent’s care sites, including the hospitals at Birmingham, Blount, Chilton, East and St. Clair, as well as the Trussville Freestanding Emergency Department, imaging centers and other clinics that are part of Ascension Medical Group.
“The [U.S. Court of Appeals for the] Third Circuit [sitting in Philadelphia] Wednesday wrestled with the constitutionality of a government drug price negotiation plan, hearing arguments from three drugmakers and the Biden administration over alleged industry harm and violations of property and speech.
“Drugmakers Johnson & Johnson, Bristol-Myers Squibb Co., and AstraZeneca PLC took their challenge against the US government’s Medicare Drug Price Negotiation Program to the US Court of Appeals for the Third Circuit. The plan, created under President Joe Biden’s landmark Inflation Reduction Act, is part of the administration’s efforts to rein in high prescription drug costs by allowing the government to negotiate prices for certain drugs with manufacturers.”
This is the first federal appellate court oral argument on this issue.
From the public health and medical research front,
Dr. Monica Bertagnollo, the NIH Director, writes in her blog,
“In 2021, NIH launched the Researching COVID to Enhance Recovery (RECOVER) Initiative, a nationwide research program, to fully understand, diagnose, and treat Long COVID. We continue to learn more about this condition, in which some people experience a variety of symptoms for weeks, months, or even years after infection with SARS-CoV-2, the virus that causes COVID-19. But we’re still working to understand the underlying reasons why people develop Long COVID, who is most likely to get it, and how best to treat or prevent it.
“Studies have shown that for some people, SARS-CoV-2 doesn’t completely clear out after acute infection. Scientists have observed signs that the virus may persist in various parts of the body, and many suspect that this lingering virus, or remnants consisting of SARS-CoV-2 protein, may be causing Long COVID symptoms in some individuals. Now, in a new study supported by RECOVER, scientists found that people with Long COVID were twice as likely to have these viral remnants in their blood as people with no lingering symptoms. The findings, reported in Clinical Microbiology and Infection, add to evidence that Long COVID may sometimes stem from persistent infection or SARS-CoV-2 protein remnants.” * * *
“More study is needed to understand the causes of Long COVID symptoms in people who test negative for persistent infection, the researchers note. They are conducting follow-up studies in even more people with Long COVID, including those with compromised immune systems. They hope to learn more about what causes some people to be at higher risk for retaining some SARS-CoV-2 protein remnants and Long COVID.”
“Young people with severe obesity who underwent weight-loss surgery at age 19 or younger continued to see sustained weight loss and resolution of common obesity-related comorbidities 10 years later, according to results from a large clinical study funded by the National Institutes of Health (NIH).
“Study participants with an average age of 17 underwent gastric bypass or sleeve gastrectomy weight-loss surgery. After 10 years, participants sustained an average of 20% reduction in body mass index (BMI), 55% reduction of type 2 diabetes, 57% reduction of hypertension, and 54% reduction of abnormal cholesterol. Both gastric bypass and sleeve gastrectomy had similar results.
“The 55% reduction in type 2 diabetes was much higher than the rates observed in adults after weight-loss surgery (18% at seven years and 12.7% at 12 years) in a recently published NIH-funded study.
“Type 2 diabetes tends to progress more rapidly when it occurs in young people, and these findings demonstrate the greater health benefits and durability of bariatric surgery in youth than would be expected in similarly treated adults.”
Question How have autism diagnosis rates changed over time among children and adults seeking care from a network of health systems in the US?
Findings In this cross-sectional study of electronic US health and insurance claims records for over 9 million individuals per year from 2011 to 2022, relative increases in autism diagnosis rates were greatest among young adults compared with all other age groups, female compared with male individuals, and some racial and ethnic minority groups compared with White individuals among children but not adults.
Meaning Patterns of increase in autism diagnosis rates reflect a need for expanded health care services and continued research on sociodemographic disparities among this growing population.
The Institute for Clinical and Economic Review published an Evidence Report on Treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease
Current evidence suggests that tabelecleucel provides a substantial net health benefit when compared to usual care; treatment would achieve common thresholds for cost-effectiveness if priced between $143,900 to $273,700 per treatment cycle. * * *
“EBV+ PTLD is a rare and often fatal cancer associated with solid organ transplant and stem cell transplant,” said ICER’s Vice President of Research Foluso Agboola, MBBS, MPH. “Unfortunately, approximately half of EBV+ PTLD cases are refractory to initial treatment or relapse, resulting in a poor prognosis. The limited evidence on tabelecleucel suggests that it provides important clinical benefits in patients with relapsed refractory EBV+ PTLD, extending survival for patients who otherwise do not usually survive beyond a few weeks to months, with few harms.”
“This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on November 14, 2024. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
After spending decades fixated on a single hypothesis, Alzheimer’s researchers are increasingly searching for new ways to combat the devastating neurologic disease. One such approach — precisely targeting the brain with magnetic pulses — got a boost when mid-stage trial data was presented Thursday.
Scientists reported that patients with mild or moderate Alzheimer’s who received the therapy, known as transcranial magnetic stimulation (TMS), experienced a 44% slowing in their rate of disease progression after a year compared to those given a sham intervention, which mimicked the procedure but delivered no treatment. That finding, which was the study’s main endpoint and was statistically significant, was based on a commonly used disease metric known as Clinical Dementia Rating sum of boxes (CDR-SB).” * * *
“But outside experts were quick to caution that the new results, announced at the Clinical Trials on Alzheimer’s Disease conference in Madrid, should be taken with a grain of salt. That’s because the findings come from a small Phase 2 trial conducted at a single medical center in Italy, with 32 patients completing the trial. Sinaptica, a private biotech in Cambridge, Mass. that is developing the treatment and sponsored the trial, is now planning a larger, multicenter pivotal study in hopes of confirming its findings.”
“Baxter announced Oct. 31 that it has restarted its North Cove, N.C. facility’s highest-throughput IV solutions manufacturing line, which normally accounts for nearly 25% of the site’s total production and approximately 50% of its one-liter IV solutions — the most commonly used size by hospitals and clinics. The earliest new products could begin shipment is late November, Baxter said. The company is continuing to assess and repair equipment at the facility and is working with the Food and Drug Administration to resume operation in phases. Baxter said it does not have a timeline on when production at the facility will be restored to pre-Hurricane Helene levels.”
“Cigna CEO David Cordani threw cold water on speculation that the health insurer is interested in acquiring rival Humana during a call with investors on Thursday.
“Despite reports earlier this fall that the two payers had reopened deal talks, Cigna plans to use excess cash to buy back shares, Cordani said while discussing Cigna’s third quarter results.
“Cigna handily beat Wall Street expectations in the quarter with revenue of $63.7 billion, up 30% year over year after strong demand for specialty drugs spurred growth in its health services division. However, an investment loss of $1 billion tied to the waning value of primary care chain VillageMD drove Cigna’s profit down to $739 million, compared to $1.4 billion same time last year.”
“Employers that implement strategies like value-based drug formularies and tiered provider networks are experiencing lower health care costs, according to a survey by the National Alliance of Healthcare Purchaser Coalitions.
“The survey, which included responses from 188 employers, sheds light on the ongoing challenge of rising health care costs and the various approaches being taken to address this issue, which has significant implications for both businesses and employees.”
“Steward Health Care completed the $245 million sale of its physician group, Stewardship Health, to private equity-owned Rural Healthcare Group.
“As part of the transaction, Kinderhook Industries, the private equity firm that owns Rural Healthcare Group, plans to rebrand the combined company as Revere Medical, Kinderhook said Thursday in a news release. The acquisition adds about 5,000 employed and affiliated Stewardship physicians across nine states to Revere’s network of 17 primary care clinics in Tennessee and North Carolina.
“Revere plans to invest in Stewardship infrastructure and technology and has pledged to allow patients to stay with their doctors, according to the release.
“The Stewardship team is excited for this next chapter with Revere Medical as it provides a committed partner focused on quality care and improving the clinic experience for providers, clinic teams, and patients,” Dr. Joseph Weinstein, president of Stewardship, said in the release.
“The Stewardship sale is one of the last remaining transactions in Steward’s Chapter 11 bankruptcy restructuring.”
“Optum Rx is rolling out a slate of new programs that seek to support independent pharmacies in managing costs and more complex patient needs.
“The first offering under this initiative is Optum’s new Independent Pharmacy Network, which is available as an add-on for its pharmacy benefit management clients. In contracts that select this option, independent and community pharmacies will receive 5% higher reimbursements for generics and 0.2% higher for branded drugs.
“The PBM said this program follows other changes enacted to support independent pharmacies; for instance, it does not collect direct and indirect remuneration, or DIR, fees and removed clawbacks for independent facilities.”
“Teladoc Health had a better quarter than Wall Street expected, posting $640.5 million in revenue and losing less per share than expected, at $0.19. Quarterly revenue decreased by 3% from 2023 and was down slightly from Q2’s $642.4 million.
“In the Q3 earnings call, Teladoc executives stressed the stability of the U.S. virtual care segment, which has gained millions of users since last year. It called BetterHelp a “company in transition,” as the company pivots hard to offset the cost of a $790 million impairment charge in the second quarter.
“BetterHelp, Teladoc’s virtual mental health solution, continue to drag down its performance as the segment’s revenue fell 10% year-over-year, coming in at $256.8 million in Q3.”
“Bristol Myers’ $1.5 billion restructuring initiative that runs through 2025 may not be the end of the company’s ongoing efficiency push.
“BMS management is “reviewing overall spending and prioritizing investments that will deliver the best long-term returns,” CEO Chris Boerner, Ph.D., said during a call Thursday. The New Jersey-based pharma is on track to deliver on its existing $1.5 billion cost-saving target by the end of next year, the CEO confirmed.
“We see the drive for greater operational excellence as a continuous process,” Boerner continued. “As such, we are exploring opportunities to further improve productivity and efficiency over the coming quarters.”
“Later during the call, CFO David Elkins said BMS is “continuing to look for efficiencies in our cost base, and you’ll continue to hear more about that.”
“Sales of GSK’s top-selling vaccines fell sharply during the third quarter amid lower demand, sending shares in the British pharmaceutical company down 3% in U.S. trading Wednesday.
“GSK, which had downgraded its vaccine sales forecasts in July, did so again Wednesday in reporting earnings for the third quarter. The company now expects vaccine sales to decline by low single digits versus last year.
“During the third quarter, sales of GSK’s shingles vaccine dropped by 7% compared to the same period in 2023, while sales of its shot for respiratory syncytial virus, Arexvy, plunged by 72% year over year.
“In a presentation, GSK attributed the drop of Arexvy to several factors, including a narrower recommendation from the Centers for Disease Control and Prevention, prioritization of COVID vaccinations in the U.S. and lower rates of RSV infections this season.
“The decline mirrored that of Pfizer’s competing vaccine Abrysvo, sales of which came in lower this quarter compared to last year’s. Pfizer also cited the CDC recommendation, which focuses on vaccination for adults 75 years or older, as well as those between 60 and 74 years who are at higher risk of disease. Previously, the CDC had urged all adults 60 and older — for whom both Arexvy and Abrysvo are approved — to discuss vaccination with their doctor.”
“Oracle will launch a new artificial intelligence-backed electronic health record next year, the technology giant said Tuesday.
“The EHR will allow clinicians to use voice for navigation and search. It will also integrate the company’s clinical AI agent and tools for data analysis and tracking patient flow through the hospital.
“The new record marks a major health initiative for Oracle, which acquired EHR vendor Cerner for more than $28 billion in 2022. “This isn’t a refurbished Cerner EHR,” Seema Verma, executive vice president and general manager of Oracle Health and Life Sciences, said during the Oracle Health Summit on Tuesday. “Because in this day and age, you can’t leverage modern technology by bolting new innovation to something built in the 1990s.”
Federal News Network reports on the Postal Service Health Benefits Program supplemental rule creating a Medicare Part D EGWP mandate for Postal annuitants over 65, other than those living abroad.
While the FEHBlog thinks that the new, improved 2025 version of Medicare Part D is a good deal for FEHB and PSHB annuitants over age 65, even for those with the IRMAA tax or manufacturer coupons, the FEHBlog objects to the OPM mandate because it penalizes annuitants who opt out of the Plan’s Part D EGWP by barring them from the Plan’s prescription drug benefits without any premium reduction. Although FEHB plans do include penalties for failing to use hospital pre-certification, for example, those penalties top out at $500. Prescription drugs represent 24 cents out of every healthcare dollar according to AHIP. If Congress had intended that OPM impose such a hefty penalty, it would have said so in the Postal Reform Act. The law, however, is silent.
FedSmith offers advice on the upcoming Open Season while FedWeek explains the pros and cons about FEHB / PSHP high deductible plans with health savings accounts.
“The Centers for Medicare & Medicaid Services (CMS) announced today that the Medicare Shared Savings Program (Shared Savings Program) continues to save Medicare money while supporting high-quality care. The Shared Savings Program yielded more than $2.1 billion in net savings in 2023 — the largest savings in the Shared Savings Program’s history. In addition, Shared Savings Program Accountable Care Organizations (ACOs) are providing higher-quality care and supporting policies CMS has adopted to enhance primary care, expand access to accountable care to underserved communities, and prioritize quality care for common chronic conditions.
“In 2023, ACOs in the Shared Savings Program earned shared savings payments (also known as performance payments) totaling $3.1 billion, the highest since the program’s inception more than 10 years ago. In addition, ACOs scored better on many quality measures than other types of physician groups and continued to demonstrate quality improvement. ACOs led by primary care clinicians had significantly higher net per capita savings than ACOs with a smaller proportion of primary care clinicians. These results continue to underscore how important primary care is to the success of the Shared Savings Program.”
“Oracle Health will apply to become a Qualified Health Information Network under the federal government’s health data exchange framework, the technology giant said Monday.
“TEFCA, or the Trusted Exchange Framework and Common Agreement, uses QHINs — which can represent dozens or hundreds of health systems, public health agencies, payers and health IT vendors — to support health information sharing, according to the HHS’ Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT.
“To get official designation, QHINs have to complete technology and security testing and agree to the data sharing rules before being onboarded.TEFCA went live in December with five QHINs, and two more organizations were approved early this year.”
From the public health and medical research front,
“A small tweak in the dosing regimen of Eli Lilly’s Alzheimer’s disease drug Kisunla has reduced brain swelling of patients in a trial, the company said Tuesday.
“In the phase 3 study, 14% of patients who were on the altered dosing plan experienced brain swelling (ARIA-E) events at Week 24 versus 24% of those who received the standard dosing of Kisunla, which was approved by the FDA in July.
‘The difference adds up to a 41% reduction in ARIA-E and could lead to a label change and help convince doctors to prescribe the anti-amyloid therapy, which is competing with another Alzheimer’s drug in its class, Eisai and Biogen’s Leqembi.”
“Edwards Lifesciences’ Early TAVR trial results showed asymptomatic patients with severe aortic stenosis had better outcomes after transcatheter aortic valve replacement than under routine clinical surveillance.
“Analysts said the positive data could help Edwards reaccelerate growth in its TAVR business, where sales have slowed in recent quarters. The data were presented Monday at the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium and published simultaneously in The New England Journal of Medicine.
“The study is the first randomized, controlled trial to look at early intervention with TAVR as a strategy in patients with asymptomatic severe aortic stenosis, according to Edwards. The study was funded by Edwards.”
“Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced that its double-blind, randomized, placebo-controlled global Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post Exposure Prophylaxis (SCORPIO-PEP), met its primary endpoint. Once-daily ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) demonstrated a statistically significant reduction in the proportion of participants with symptomatic SARS-CoV-2 infection after exposure to household contacts with COVID-19 when compared to placebo. Specifically, the primary endpoint assessed COVID-19 symptoms onset through Day 10. Ensitrelvir was well tolerated by study participants and no new safety concerns were identified.
“Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease. Ensitrelvir was granted Fast Track designation by the U.S. Food and Drug Administration in 2023 for the treatment of COVID-19. In Japan, ensitrelvir, known as Xocova®, received emergency regulatory approval in 2022 and full approval in March 2024 for the treatment of COVID-19. Ensitrelvir was also made available in Singapore based on the Special Access Route application in 2023. It remains an investigational drug outside of Japan and Singapore.
“COVID-19 remains an important public health priority, yet there are currently no oral antiviral medications approved for post-exposure prophylactic use. There is a need for convenient, preventive approaches to protect ourselves and those close to us from contracting SARS-CoV-2,” said Simon Portsmouth, MD, FRCP, Senior Vice President, Head of Clinical Development. “These data demonstrate a new potential for post exposure prophylactic use of ensitrelvir, expanding on the breadth of clinical and real-world evidence that establish its activity in those infected with SARS-CoV-2.”
AHRQ’s Medical Expenditures Panel Survey lets us know,
Among adults who reported ever having COVID-19, 13.7 percent reported ever having long COVID.
Women were more likely than men to report ever having long COVID (16.5% vs. 10.5%).
Adults aged 18-34 were less likely than all other age groups to report ever having long COVID (9.8% vs. 13.5%-17.9%).
Adults living in high-income households were less likely to report ever having long COVID (11.0%) than those living in middle-income households (15.6%), low-income or near poor households (17.4%), and those living in poor households (17.2%).
Adults living in a metropolitan statistical area reported lower rates of ever having long COVID than those living outside of a metropolitan statistical area (12.7% vs. 19.7%).
“Elevated body mass index (BMI) in children and young adults was associated with an increased risk of post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID, a large retrospective cohort study suggested.
“Those with obesity had a 25.4% increased risk of long COVID (relative risk [RR] 1.25, 95% CI 1.06-1.48) and those with severe obesity had a 42.1% increased risk (RR 1.42, 95% CI 1.25-1.61) compared with children and young adults who had healthy weight, reported Yong Chen, PhD, of the University of Pennsylvania in Philadelphia, and colleagues.
“Similarly, there was an increased likelihood of encountering any manifestation of potential long COVID symptoms and conditions among those with obesity (RR 1.11, 95% CI 1.06-1.15) and severe obesity (RR 1.17, 95% CI 1.14-1.21), they said in JAMA Network Openopens in a new tab or window.
“To our knowledge, this retrospective cohort study is the first and the largest to explore the association of BMI status with PASC among the pediatric population,” Chen and co-authors wrote. “The findings suggest that PASC may lead to poorer long-term quality of life, affecting physical health, educational achievement, and social development; this underscores the importance of early identification, prevention, and targeted interventions to mitigate these risks.”
The U.S. Preventive Services Task Force (USPSTF) has opened for a public comment the following recommendations:
Population: Pregnant or postpartum persons and women of reproductive age
Recommendation: The USPSTF recommends that clinicians screen for intimate partner violence (IPV) in pregnant and postpartum persons and women of reproductive age. See the “Practice Considerations” section for information on evidence-based multicomponent interventions and for information on IPV in men.
Grade: B Population: Older or vulnerable adults Recommendation The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for caregiver abuse and neglect in older or vulnerable adults. See the “Practice Considerations” section for additional information. Grade: I (inconclusive)
“In 2018, the USPSTF recommended that clinicians screen for IPV in women of reproductive age and provide or refer women who screen positive to ongoing support services. The USPSTF also concluded that the evidence was insufficient to assess the balance of benefits and harms of screening for abuse and neglect in all older or vulnerable adults. The current draft recommendation statement is consistent with the 2018 recommendation. To highlight that the evidence base focused on pregnant and postpartum persons, the USPSTF emphasized this population in this draft recommendation statement. For abuse of older or vulnerable adults, the term “caregiver” was added before abuse or neglect when appropriate to clarify when the focus was on screening for abuse or neglect perpetrated by a caregiver or someone they trust.”
The public comment deadline is November 25, 2024.
Healio relates that “A modified screening with additional questions about suicidal ideation was better at predicting suicide attempts among adolescents than the standard questionnaire, according to findings published in JAMA Network Open.“
“In Appalachia, in the heart of one of the earliest and deadliest waves of the opioid crisis, doctors at West Virginia University’s Rockefeller Neuroscience Institute are conducting a radical experiment. Using focused ultrasound waves, they are resetting cells inside the brain’s reward center, the nucleus accumbens. They hope the procedure can treat addictions ranging from drugs like opioids and methamphetamine to gambling and eating.
“While neuroscientists have long defined addiction as a brain disease, tools to fight the U.S. drug crisis that is behind 100,000 overdose deaths a year have changed little in decades. Most treatment involves medications like methadone and buprenorphine to replace other opioids, or naltrexone to block the part of the brain that feels pleasure from alcohol or opioids. For many addictions, counseling and abstinence-based 12-step programs remain the go-to treatment.
“At RNI’s 30-patient residential-treatment program, more than two-thirds of patients relapse within the first few weeks. Many illicit drugs, including meth and cannabis, don’t have any prescription medications to treat the addiction.
“Now, the institute’s trial using ultrasound is a peek at a future that treats the physical brain, rather than using medication or behavioral approaches to alter outcomes. “We need to inject technology into this,” said Dr. Ali Rezai, a neurosurgeon and executive chair at the institute.
“The RNI team is also studying a pill that monitors vital signs and releases overdose-reversal medication automatically in people who overdose. In another trial, they are monitoring the heart rates, emotions, sleep and cravings of thousands of drug users who are helping to train artificial intelligence to predict a relapse before it occurs, so that recovery coaches can intervene.”
“PfizerPFE punched back against activist investor Starboard Value on Tuesday, delivering positive quarterly results.
“The pharmaceutical company raised its revenue outlook for the year to between $61 billion to $64 billion, up from $59.5 billion to $62.5 billion previously. It also raised its guidance on adjusted annual earnings per share to a range of $2.75 to $2.95, up from $2.45 to $2.65.
“The encouraging third quarter comes as Pfizer faces pressure from activist investor Starboard, which says poor investments in research and dealmaking have helped destroy billions of dollars in market capitalization. The latest earnings highlight Pfizer’s third consecutive quarter with positive results—a bright spot that could bolster the drugmaker, and Chief Executive Albert Bourla’s efforts to revamp the company.
‘Pfizer also beat Wall Street’s expectations on quarterly sales and earnings. The company reported sales totaling $17.7 billion, driven by Covid-19 products and cancer medicines, up from the $14.9 billion forecast by analysts surveyed by FactSet. The Covid-19 antiviral Paxlovid generated $2.7 billion in quarterly sales, while its Covid-19 vaccine Comirnaty sold $1.4 billion, both topping analyst forecasts.”
“CVS Health’s MinuteClinic is becoming an in-network primary care provider for select Aetna plan members.
“Aetna commercial, individual and family health plan members in San Antonio, Houston, Atlanta and south Florida have the option to use MinuteClinic as an in-network primary care provider, with members in North Carolina becoming eligible in the coming weeks, said Dr. Creagh Milford, retail health president at CVS Health.
“CVS has been investing in staffing, technology and training at its MinuteClinic sites for months to expand primary care services in certain markets chosen based on patient density, demographics and existing services in those areas, Milford said.
“We’re seeing a lot of growth in the model,” Milford said. “Our ambition is to move the patient perception and the payer perception from one of an episodic, acute care model toward a longitudal, relationship-based primary care model.”
“CVS is in talks with other health plans to grow the MinuteClinic primary care approach, he said.”
“More than a year has passed since Dana-Farber Cancer Institute dumped Mass General Brigham for a rival hospital chain, but the state’s biggest health care system is making a push now to say when it comes to cancer care, MGB’s still got it.
“Beginning in 2028, Dana-Farber will end its long and nationally acclaimed adult oncology partnership with Brigham and Women’s Hospital. Instead, it will team up with Beth Israel Deaconess Medical Center to open a new freestanding 300-bed, $1.68 billion cancer hospital in the Longwood Medical Area.
“Dana-Farber’s announcement of the divorce in September 2023 stunned executives at the Brigham and rocked the hyper-competitive hospital industry. But now MGB is fighting back by creating what it calls the Mass General Brigham Cancer Institute, which the health system is trumpeting in an intensive marketing campaign.
“The institute won’t be a freestanding hospital. But it will, for the first time, combine the expertise and resources of MGB’s two flagship hospitals, Massachusetts General Hospital and the Brigham, whose cancer operations were previously separated by a firewall because of the latter’s partnership with Dana-Farber.
“What really started as a disruptive event a year ago, saying that Dana-Farber will be exiting after a few years, has now become a new opportunity for us to rethink how we deliver care,” O’Neil Britton, chief integration officer for MGB, said Monday at a round-table discussion at Massachusetts General Hospital with reporters.”
“Exactly three years after an initial FDA green light for the third-line treatment of leukemia, Novartis’ Scemblix has won an accelerated approval to treat newly diagnosed patients.
“Tuesday, the FDA cleared Scemblix to treat patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. The first-line nod marks an important step for the Gleevec follow-up on its way toward reaching the company’s peak sales projection of $3 billion.
“Only about 15% of Ph+ CML patients reach the third-line treatment setting, Victor Bulto, Novartis’ U.S. president, noted in an interview with Fierce Pharma.
“The Swiss drugmaker has its work cut out in this use. While Scemblix has quickly become the standard of care in third-line Ph+ CML because of a lack of alternative treatments, the first-line market will feature a couple hurdles for the new entrant.”
“Paragon Therapeutics, a biotechnology company creator with a web of spinouts, is taking a new startup public to develop an emerging type of cancer immunotherapy.
“The startup, Crescent Biopharma, on Tuesday announced a reverse merger with GlycoMimetics, a struggling, publicly traded developer of oncology and inflammatory disease drugs. In support of the deal, the combined company has raised $200 million in financing from 17 major investment firms — among them Fairmount and Venrock Healthcare Capital Partners — and expects that money to keep it operating through 2027.
“The new company will take the Crescent name, be about 97% owned by Crescent stockholders, and be led by the startup’s interim CEO and Fairmount venture partner Jonathan Violin. Its chief goal will be to advance a group of cancer medicines led by a dual-pronged immunotherapy that simultaneously targets the proteins PD-1 and VEGF.
“GSK will pay $300 million to acquire a bispecific antibody from Shanghai-based Chimagen Biosciences that it believes has the potential to treat autoimmune diseases like lupus.
“The drug, which is currently in Phase 1 testing for cancer in the U.S. and China, is what’s known as a “T cell engager.” It binds to two cell surface proteins called CD19 and CD20, which GSK notes could help deplete malfunctioning B cells.
“In a Tuesday statement, GSK said it plans to begin a Phase 1 trial of Chimagen’s drug sometime next year, assuming the proposed licensing deal clears customary regulatory review.”
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