“New Jersey Democratic Gov. Phil Murphy intends to appoint his former chief of staff, George Helmy, to fill the Senate seat that Sen. Bob Menendez will vacate next week, multiple New Jersey media outlets reported Wednesday evening, citing sources.
“Helmy, who has most recently worked as executive vice president and head of external affairs for RWJBarnabas Health, will serve until the end of the 118th Congress. The seat for the full term starting in January will be filled by the winner of the November election between Rep. Andy Kim, the Democratic nominee, and Republican Curtis Bashaw.”
On August 16, the Congressional Budget Office released to the House Oversight and Accountability Committee a report on H.R. 7868, the FEHB Protection Act.
The problematic aspect of the bill is that it focuses on tightening up oversight of family member eligibility when OPM does not give FEHB plans the information to confirm that plan enrollees are paying the proper premium or any premium for their coverage, which creates a yawning gap in internal controls. OPM can cure this problem by implementing the HIPAA 820 enrollment roster transaction.
From the public health and medical research front,
Fortune Well identifies where COVID has been spiking in the U.S. this summer.
“In the four-week period ended Aug. 10, the national test positivity rate was 15.6%. During that time, five states in the South-Central U.S. saw the highest test positivity, 21%. These states collectively make up the CDC’s Region 6:
Arkansas
Louisiana
New Mexico
Oklahoma
Texas
“States in Region 9—Arizona, California, Hawaii, and Nevada—had the next-highest four-week positivity rate, 18.8%. Ten other states across two Midwestern regions were also above the national average. No state—as well as the District of Columbia, Puerto Rico, and the Virgin Islands—had a positivity rate below 10%.”
“The Centers for Disease Control and Prevention is warning clinicians to be on the lookout for a viral disease that is spread by small flies and some types of mosquitoes and that causes sudden fever, severe headaches and chills.
“Cases of Oropouche virus disease have been climbing in South America and the Caribbean in the past two years and turned deadly for the first time this year.
“Though appendectomies have been the gold standard of care since before the turn of the 20th century, doctors have been treating appendicitis with antibiotics since the 1950s, as soon as they became available — a “dark secret” in the surgery world, says David R. Flum, professor of surgery and director of the Surgical Outcomes Research Center at the University of Washington. A 1959 paper detailed the use of antibiotics to treat nearly 500 people (a mix of adults and children) with appendicitis. They were — and still are — often used in people whose appendicitis is so advanced that surgery risks spreading the infection further. The military relied on antibiotics for service members who got appendicitis while in inaccessible locations, like submarines.
“But the treatment didn’t get wider attention until the late 1990s and early 2000s, Flum says, when researchers began to collect data on how often antibiotics don’t work and found that failure was not as common as they thought.
“Then came two large, randomized trials in adults. In the first, published in 2015, 257 adults received an antibiotic treatment. Seventy of those patients, or 27 percent, had to have an appendectomy within one year. But the rest were fine.
“A second, larger study of 1,552 adults had similar results: Twenty-nine percent of the 776 people who received antibiotics underwent surgery within 90 days; 4 percent of people in the antibiotics group had serious adverse events, compared with 3 percent in the appendectomy group. The New England Journal of Medicine published the results in 2020. The same year, the American College of Surgeons added nonoperative management as an option in its guidelines for treating appendicitis.
“It wasn’t a slam dunk, but the studies showed that antibiotics could be a good choice.”
The New York Times discusses “The Painkiller Used for Just About Anything. In huge numbers, older people are taking gabapentin for a variety of conditions, including itching, alcohol dependence and sciatica.”
“It’s crazy how many [off label] indications it’s used for,” said Dr. Michael Steinman, a geriatrician at the University of California, San Francisco, and a co-director of the U.S. Deprescribing Research Network. “It’s become a we-don’t-know-what-else-to-do drug.”
“What has fueled this multipurpose popularity? “The history of gabapentin is really a history of uses getting ahead of the evidence,” said Dr. Joseph Ross, an internist and health policy researcher at Yale School of Medicine.” * * *
Dr. Steinman called it a “sticky” drug. He was an author of a 2022 study on older adults who were prescribed gabapentin after surgery, most commonly hip and knee replacements. One in five refilled the prescription more than three months later, when “presumably their surgical pain has long since resolved,” he said.
As older patients seek to find relief from chronic pain, “we don’t have a lot of great options,” Dr. Steinman said of health care providers. Prescribers try to avoid opioids, and nonsteroidal anti-inflammatories like ibuprofen are recommended only for short-term use.
Some find relief from medical cannabis, topical medications like creams and patches, and non-pharmacological approaches such as acupuncture, therapeutic massage and exercise.
“Often the single best thing I can do for patients with pain is to get them to physical therapy,” Dr. Steinman added.
“Orlando Health has offered to buy Steward Health Care’s three “Space Coast” Florida properties, including three hospitals and a medical practice, for $439 million, according to a court document filed Wednesday.
“Bankrupt Steward Health Care and Orlando Health have entered into a binding asset purchase agreement to sell Rockledge Regional Medical Center, Melbourne Regional Medical Center, Sebastian River Medical Center. The proposed deal also includes Steward Medical Group Practices in East Central Florida.
“According to the court document, filed in U.S. bankruptcy court in the southern district of Texas, Steward designated Orlando Health a “stalking horse bidder,” which is the first to negotiate a purchase agreement with a debtor in bankruptcy. The bidder sets a minimum price and protects the debtor from low bids.
“The purchase agreement for Steward’s northern Florida assets is for $439.42 million in cash, according to the court document.
“Orlando Health’s bid will be subject to higher or better-qualified bids received by August 26, at which time a bankruptcy court-approved auction may occur, according to a press release from Steward Health Care.”
“Steward Health Care System was in such dire straits before its bankruptcy that its hospital administrators scrounged each week to find cash and supplies to keep their facilities running.
“While it was losing hundreds of millions of dollars a year, Steward paid at least $250 million to its chief executive officer, Dr. Ralph de la Torre, and to his other companies during the four years he was the hospital chain’s majority owner.
“Steward filed for bankruptcy in May, becoming one of the biggest hospital failures in decades.” * * *
“The Senate Committee on Health, Education, Labor and Pensions in a bipartisan vote authorized an investigation and subpoenaed de la Torre to testify at a Sept. 12 hearing.”
“The battle to empower the federal government to negotiate lower prices for Medicare enrollees was years in the making. The war has just begun.
“After years of opposition from the pharmaceutical industry and lawsuits seeking to halt the law that led to the new prices, resistance paled and legal efforts failed. The talks settled into a sometimes testy back and forth: hundreds of pages of paperwork, offers and rejected counteroffers, then rounds of meetings in windowless rooms with strict rules on how many people could attend.
During the meetings, many manufacturers lowered counter offers while federal officials moved up from their initial offers, said Meena Seshamani, director of the Center for Medicare and a deputy administrator of Medicare’s parent agency, the Centers for Medicare and Medicaid Services.” * * *
“Round two is just around the corner.
“Companies and officials are already preparing for negotiations over more drugs that could take a bigger bite out of high drug costs, and possibly their bottom lines. Next up are prices of 15 more drugs the government will identify by Feb 1.
“The two sides are also fighting over how the talks should work. Among the drug industry’s demands: clarity on how CMS determines the price of a drug. Drug companies are also fighting the agency’s potential changes for next year, including possibly cutting back the number of in-person meetings to fewer than three.”
“Proactively implementing this rule would save lives by ensuring that your workforce is protected with the most up-to-date heat safety standards,” the lawmakers wrote in a letter to Postmaster General Louis DeJoy.
“The proposed rule, if finalized, would be the nation’s first-ever federal heat rule.”
“Federal employees on official travel will soon enjoy another bump in reimbursable travel costs, as the General Services Administration has increased per diem rates for lodging and meals.
“Starting Oct. 1, the reimbursable daily limit will rise to $178, from $166 last year. This increase marks the third consecutive year feds saw lodging rates go up, while rates for meals and incidental expenses (M&IE) last went up in 2022.
“The standard per diem lodging rate within the continental United States (CONUS) went up from $107 to $110, while the rates for M&IE increased from a range of $59 to $79, to a range of $68 to $92.
‘Agencies [and experience rated FEHB contractors] use per diem rates to reimburse employees for lodging and M&IE during official travel. Even with inflation growth in the U.S. now losing steam, the continued increase in per diem rates reflect the persistent rise in overall costs that Americans face across the board.”
From the public health and medical research front,
The Centers for Disease Control and Prevention tells us,
Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
COVID-19
“Many areas of the country are continuing to experience increases in COVID-19 activity, though other areas are experiencing declines in COVID-19 activity following increases this summer. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.”
“National vaccination coverage for COVID-19, influenza, and RSV vaccines remained low for children and adults for the 2023-24 respiratory illness season. RSV vaccines continue to be available, and updated influenza and COVID-19 vaccines that can provide protection during the 2024–25 respiratory illness season will be widely available in September 2024.”
“Nationally, wastewater detections of SARS-CoV-2 are at the very high level for the second straight week. The highest levels are still in the West and South, followed by the Midwest and the Northeast. The CDC’s latest update, however, shows downward trends from high levels in the South and Midwest.”
“Federal authorities are preparing to approve updated coronavirus vaccines targeting the latest virus variants late next week, a move that could make shots available before Labor Day, according to a federal health official and a person familiar with the plans who spoke on the condition of anonymity to discuss a confidential process.
“The mRNA shots manufactured by Pfizer-BioNTech and Moderna designed to target the KP.2 variant can hit the market within days of approval by the Food and Drug Administration. A third protein-based vaccine made by Novavax, preferred by people who are cautious about mRNA vaccines or who have had bad reactions to them, will probably take longer to be approved and will be distributed in subsequent weeks, according to the federal health official.
“Consumers should be able to start getting shots at pharmacies within a week after approval and at doctor’s offices soon after.”
“The Food and Drug Administration on Friday authorized the first at-home [, over the counter,] syphilis test amid surging cases of the bacterial infection and calls from federal health officials for innovative strategies to detect the disease.
“The manufacturer, NowDiagnostics, anticipates the 15-minute test called First to Know, being available in pharmacies, major retail stores and online as early as September. FDA staff hailed the new product as an advancement in testing for sexually transmitted illnesses but noted that an additional test by a health-care provider is needed to confirm a positive result.
“Syphilis was nearly eliminated in the 1990s, but rates have since soared to a 70-year high. Between 2018 and 2022, cases rose nearly 80 percent, according to the most recent data from the Centers for Disease Control and Prevention.
“Pfizer and BioNTech on Friday said a combination flu and COVID-19 shot they’ve been developing met one of its main goals in a Phase 3 trial but missed another, leaving the vaccine’s future in doubt.
‘The study tested Pfizer and BioNTech’s vaccine against separately administered, marketed COVID and flu shots in more than 8,000 people between the ages of 18 and 64. While the combination vaccine spurred a comparable immune response against COVID and influenza A, it didn’t meet that mark against the “B” strain of the flu.
“As a result, two companies are “evaluating adjustments” that would improve the vaccine’s performance against influenza B while discussing next steps with health authorities.”
“The National Institutes of Health said Thursday that an antiviral often used to treat mpox did not resolve patients’ symptoms faster than placebo in a randomized trial.
“The results are notable because the drug, tecovirimat, has rarely been studied clinically for mpox, despite its wide use during the 2022 and 2023 outbreaks in the U.S. and Europe.”
The American Medical Association shares “Top health tips sleep medicine physicians want you to know.”
“Among a select group of women with uterine factor infertility, uterus transplant was feasible and associated with a high live birth rate after successful graft survival, data from a case series show.
“In an analysis of the Dallas Uterus Transplant Study (DUETS), researchers also found that although adverse events were common, including complications requiring surgical intervention, infants born to women who received a uterine transplant had no congenital abnormalities or developmental delays, though follow-up of the cohort is ongoing.
“We show that uterus transplantation is not only feasible and safe, but also associated with a success rate that is comparable with and even favorable to other infertility treatments,” Liza Johannesson, MD, PhD, of the Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center, told Healio.“[What is] important is that the children born after uterus transplant are healthy and developing normally.”
Medscape offers an interview with a Harvard medical professor about preventing dementia.
“Hello. This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a new report on the preventability of dementia that is both exciting and paradigm-shifting. The new study, published in TheLancet by the Lancet Commission on Dementia, estimates that close to 50% of cases of dementia worldwide can be prevented or delayed by improving 14 modifiable risk factors.”
From the U.S. healthcare business front,
MedCity News discusses the future of retail healthcare.
“Older Americans are having little success getting prescriptions for weight-loss drug Wegovy covered by Medicare despite the federal healthcare program’s decision to pay for patients with obesity at risk of heart disease, according to their doctors.
“In interviews with Reuters, seven obesity and heart disease specialists from various parts of the United States said their prescriptions for the Novo Nordisk (NOVOb.CO), opens new tab drug have been denied repeatedly by the healthcare companies that administer Medicare drug benefits, with some prescriptions approved only following an appeal for each application.”
“Massachusetts’ governor has announced that deals in principle have been reached for Steward Health Care’s four remaining hospitals in Massachusetts.
“Should the deals be finalized, Lawrence General Hospital will operate both campuses of Holy Family in Haverhill and Methuen. Lifespan would take over operations of Morton Hospital and Saint Anne’s Hospital. Boston Medical Center will take over operations of Good Samaritan Medical Center.
“Boston Medical Center also intends to operate Saint Elizabeth’s down the line. The state is first taking control of the hospital through eminent domain, according to an announcement from the governor’s office.”
The American Hospital Association News informs us,
“The Centers for Medicare & Medicaid Aug. 15 announced it negotiated lower prices with drug makers for 10 high-cost, sole-source drugs, with the new prices becoming effective in 2026 for individuals with Medicare Part D coverage. The drugs treat conditions such as heart disease, diabetes and cancer, and about nine million Medicare beneficiaries use at least one of the 10 drugs selected for negotiation. The new prices are estimated to save $1.5 billion in out-of-pocket costs for individuals with coverage. A CMS fact sheet includes more information about the newly negotiated prices. The agency last year announced the first list of 10 Medicare Part D drugs subject to price negotiations.”
“The White House is touting just how much its new Medicare negotiation process cut drug prices. The problem is the numbers it’s using don’t actually mean much.”
“In a striking side-by-side comparison, President Biden tweeted out a graphic showing newly negotiated prices that Medicare will pay for 10 drugs including blood thinners, cancer treatments, and diabetes medications, among others. The table compares the new prices to the list price of the medicines last year, showing discounts ranging from hundreds to thousands of dollars.
“However, Medicare generally doesn’t pay list prices for medications. Currently, prescription drug plans negotiate discounts off of the list prices at a smaller scale than the new program — but those prices are secret, even in a public program.
“The White House did release more meaningful overall numbers tied to the amount Medicare actually pays for drugs that show discounts of roughly 22% on the 10 drugs collectively, compared to what the program paid last year. That’s more modest than the exaggerated discounts based on list prices that show price reductions of up to 79%.”
In any case, why didn’t Congress align the effective dates for the enormous consumer improvements in Part D, discussed yesterday, with the “negotiated prices”?
“The Biden administration on Wednesday announced a new initiative aimed at improving the hiring process for federal job applicants, hiring managers and other agency HR officials alike, as the White House continues to search for ways to speed up the process and better compete for top talent.
“Strategic human capital management has been on the Government Accountability Office’s famed High-Risk List, a biennial report highlighting issues that present potential liabilities of at least $1 billion for the federal government, for more than two decades. In 2021, GAO found that the government had actually regressed in its effort to address difficulties in hiring new federal workers during the final two years of the Trump administration.
“The Office of Personnel Management and Office of Management and Budget worked jointly on the effort, announced Wednesday in a memo to agency heads entitled “Improving the Federal Hiring Experience.” The document encompasses plans to improve strategic workforce planning, making it easier for potential job applicants to find jobs they are interested in and making the hiring process both faster and more transparent for jobseekers, as well as making hiring less agonizing for the hiring managers and other human resources personnel.”
“Today, the U.S. Food and Drug Administration marked a milestone building on Phase I of its voluntary sodium reduction targets and issued draft guidance for Phase II in a data-driven, stepwise approach to help sodium reduction across the food supply. Prior to 2021, consumer intake was approximately 3,400 milligrams per day on average, far higher than the limit recommended by the Dietary Guidelines for Americans of 2,300 milligrams per day for those 14 years and older. If finalized, the new set of voluntary targets would support reducing average individual sodium intake to about 2,750 milligrams per day. This reduction is approximately 20% lower than consumer intake levels prior to 2021.
FedWeek explains the uncommon exceptions to the FEHB Program’s five-year rule which governs whether a federal employee can continue FEHB coverage into a civil service retirement with the full government contribution.
From the public health and medical research front,
“Americans, and especially those under age 35, are changing their tune on alcohol use, with a growing share endorsing the view that moderate drinking is bad for health — and a new study backs them up.
“According to a Gallup poll released Tuesday, almost half of Americans, 45%, say that having one or two alcoholic drinks a day is bad for a person’s health. That’s the highest percentage yet recorded by the survey, which has been conducted 10 times since 2001.”
The National Institutes of Health (NIH) Director, writing in her blog, discusses “Mapping Psilocybin’s Brain Effects to Explore Potential for Treating Mental Health Disorders.”
“Psilocybin is a natural ingredient found in “magic mushrooms.” A single dose of this psychedelic can distort a person’s perception of time and space, as well as their sense of self, for hours. It can also trigger strong emotions, ranging from euphoria to fear. While psilocybin comes with health risks and isn’t recommended for recreational use, there’s growing evidence that—under the right conditions—its effects on the brain might be harnessed in the future to help treat substance use disorders or mental illnesses.
“To explore this potential, it will be important to understand how psilocybin exerts its effects on the human brain. Now, a study in Nature supported in part by NIH has taken a step in this direction, using functional brain mapping in healthy adults before, during, and after taking psilocybin to visualize its impact. While earlier studies in animals suggested that psilocybin makes key brain areas more adaptable or “plastic,” this new research aims to clarify changes in the function of larger brain networks and their connection to the experiences people have with this psychedelic drug.”
“The National Institutes of Health (NIH) has launched a program that will support Native American communities to lead public health research to address overdose, substance use, and pain, including related factors such as mental health and wellness. Despite the inherent strengths in Tribal communities, and driven in part by social determinants of health, Native American communities face unique health disparities related to the opioid crisis. For instance, in recent years, overdose death rates have been highest among American Indian and Alaska Native people. Research prioritized by Native communities is essential for enhancing effective, culturally grounded public health interventions and promoting positive health outcomes.”
The New York Times reports that “In an experiment that surpassed expectations, implants in an ALS patient’s brain were able to recognize words he tried to speak, and A.I. helped produce sounds that came close to matching his true voice.” Truly amazing.
“Employer-sponsored health plan costs are expected to rise 9% in 2025, totaling more than $16,000 per employee before cost-saving measures, according to professional services and consulting company Aon.
“Aon predicts that demand for prescription drugs such as glucagon-like peptide-1 agonists and growth in medical claims for high-cost treatments such as gene and cell therapies are among the main drivers of rising costs for employers.
Janet Faircloth, senior vice president of innovation and integrated solutions for Aon, said employers are expected to apply cost-saving strategies used in previous years, including raising out-of-pocket costs for employees and bidding between insurers for the best price.
For 2024, Aon predicted health plan costs would increase by 8.5%, but the firm projects employer cost-saving efforts are likely to hold the increase to 6.4% overall.
“We generally see a 1% to 2% reduction from the initial trend expectation after employers make their changes,” Faircloth said.
The International Foundation of Employee Benefit Plans released a similar report Thursday, estimating employer-sponsored health plan costs would rise 8% in 2025 due to the same factors Aon cited.
“Health insurers have invested heavily in building out their Medicare and Medicaid businesses in recent years, tempted by the prospect of healthy margins and growing membership in the government-run insurance programs.
“But privately run Medicare Advantage and safety-net Medicaid plans are seeing their profitability shrink amid ongoing operational pressures, creating a sharp reversal in expected fortunes — much to health insurance executives’ chagrin.
“For much of the past year, insurers bemoaned the headwinds in MA as seniors using more medical care caused spending to snowball. But in the second quarter, many payers suggested Medicaid has become a bigger problem, as states remove ineligible beneficiaries from the safety-net coverage, sickening insurers’ risk pools and saddling them with higher costs.”
Beckers Payer Issues illustrates the fact that “The CEOs of the six largest for-profit insurers have different perspectives on Medicare Advantage.”
“Technological medical advancements have shifted an array of procedures previously rendered in inpatient hospitals to ambulatory surgical centers (ASCs). For example, same-day procedures (e.g., cataracts surgery) that do not require an overnight hospital stay and musculoskeletal procedures, such as arthroscopy, are commonly performed at ASCs.
“Because they operate independently of brick-and-mortar hospital facilities, ASCs are considered “off site.” Compared to procedures rendered in hospital outpatient departments, ASC’s receive lower reimbursement. For low-risk procedures, ASCs may be a cost-efficient site of care. Recent market analysis found that procedures at ASCs have grown over time and now account for half of all outpatient surgeries.
“In this brief, we compare employer-sponsored insurance (ESI) ASC reimbursement amounts for a subset of procedures to Medicare fee-for-service (FFS) payment for the same procedures. We find that, on average, ESI pays two times more than Medicare FFS for procedures provided at ASCs. If ESI reimbursed at Medicare average rates, spending would have been nearly $9 billion lower in 2021.”
“Cleveland Clinic saw an operating income of $45.3 million at a 1.2% margin in the second quarter of 2024 for the three months ended June 30, a 312% increase from a $21.4 million operating loss (-0.6% margin) during the second quarter of 2023, according to its Aug. 16 financial report.
“Total revenue for the system was $3.9 billion in the second quarter of 2024, up from $3.6 billion during the same period last year.
“Net income for the health system was $187.8 million for the three months ended June 30, 2024, up from $145.2 million during the second quarter of 2023.
“Expenses increased 8% to $3.7 billion, with salaries, wages and benefits also increasing 8% to $2.3 billion. Cleveland Clinics outstanding and long term debt was $5.4 billion, the report said.”
“Neuronetics said Monday it has agreed to merge with Greenbrook TMS to acquire treatment centers that use its mental health devices.
“Greenbrook provides transcranial magnetic stimulation (TMS) and other mood treatments from 130 sites. Neuronetics sells a TMS device to treat major depressive disorder (MDD).
“William Blair analysts said in a note to investors that the merger changes Neuronetics’ profile “from device-centric to a device-service business operating brick-and-mortar facilities.”
Per Reuters,
“Eli Lilly (LLY.N) has sent cease-and-desist letters to U.S. healthcare providers in recent days to stop the promotion of the compounded versions of its drugs for weight loss and diabetes, as their supply increases, the company said on Wednesday.
“The letters were sent to telehealth companies, wellness centers and medical spas selling compounded versions of the drugmaker’s popular treatments Zepbound and Mounjaro, a spokesperson told Reuters.”
Kevin Moss, writing in Govexec, explains the pros and cons of Medicare Part D coverage for FEHB annuitants over age 65. The key point is that for 2025 the Medicare Part D out of pocket maximum is $2000. Also, Part D members with higher Part D cost sharing can spread out the Part D cost sharing over the plan / calendar year using Medicare Part D’s new Medicare Prescription Payment Plan (MPPP). The MPPP savings coupled with the $2000 out of pocket max could make Part D valuable for folks who otherwise would use manufacturer coupons.
Although not discussed in the Govexec article, Postal Service Health Benefit (PSHB) annuitants over age 65 generally will be required to use the PSHB plan’s Part D EGWP. Those who opt out are ineligible for the PSHB plan’s regular Rx benefits, and there’s no concomitant premium reduction. We are waiting for OPM’s final supplemental PSHB rule which will include the Part D opt out penalty details.
Politico discusses a Biden Harris administration initiative to subsidize standalone Part D plans with a a $15 per Part D member payment to stabilize Part D premiums in consideration of these significant Part D improvements. The article observes,
“The Part D market has two types of plans. One is a standalone plan that only offers drug coverage, and the other is coverage included in a privately run Medicare Advantage plan that covers other health services.
“Medicare Advantage plans can absorb higher costs better than a standalone option, according to a 2023 analysis from the consulting firm Avalere Health.
“Since a Medicare Advantage plan offers a wide array of both medical and drug benefits, it can spread out the cost impact. Standalone plans do not have such flexibility, and the law is causing some to exit the market.”
It’s worth noting that Part D EGWPs absorb the basic Part D premium typically charged to the Medicare beneficiary. Part D EGWPs do not absorb the extra IRMAA tax on high income Medicare beneficiaries.
Last week, the Centers for Medicare and Medicaid Services released 2025 enrollment and disenrollment guidance for Medicare Advantage and Part D plans.
“Among the 167 million people with employer-sponsored insurance in 2022, 3.4 million used at least one of the first 10 drugs identified for Medicare price negotiations, according to a new KFF analysis. Medicare is expected to release the negotiated drug prices, which will go into effect in 2026, by no later than September 1, 2024.
“The most used drug for people with employer-sponsored health insurance was Jardiance, a drug used to treat diabetes and heart failure, which was taken by more than 911,000 enrollees.
In the future, the Medicare program will negotiate prices for additional drugs, which millions more people with employer coverage could also be taking. As the policy currently stands, lowering drug prices in Medicare has no direct effect on private insurance plans, and the indirect effects are still unclear. Some argue lower negotiated prices in Medicare will result in higher prices in private insurance plans, while others suggest Medicare prices could serve as a benchmark and lead to savings.
“The full analysis and other data on health costs are available on the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.”
“This week, the Africa Centres for Disease Control and Prevention (Africa CDC) declared the mpox clade I outbreak a Public Health Emergency of Continental Security, and the World Health Organization (WHO) declared this outbreak a Public Health Emergency of International Concern. The United States government supports those declarations. The United States will continue to work closely with African governments, Africa CDC and WHO to ensure an effective response to the current outbreak and to protect the health and lives of people of the region.” * * *
“The risk to the general public in the United States from clade I mpox circulating in the DRC is very low, and there are no known cases in the United States at this time. Due to efforts over the last nine months, the United States is well prepared to rapidly detect, contain, and manage clade I cases should they be identified domestically. The United States has a robust surveillance system in place, including through clinical testing and wastewater analysis. We continue to encourage those at high risk to get vaccinated with the JYNNEOS mpox vaccine, which has been demonstrated to be safe and highly effective at preventing severe disease from mpox. Those who have already had clade II mpox or are fully vaccinated against mpox are expected to be protected against severe illness from clade I mpox.
“CDC has issued an updated Health Alert Network advisory urging clinicians to consider clade I mpox in people who have been in DRC or neighboring countries in the previous 21 days; clinicians are also asked to submit specimens for clade-specific testing for these patients if they have symptoms consistent with mpox. Given the geographic spread of clade I mpox, the U.S. CDC issued an updated Travel Health Notice on Aug. 7, 2024, recommending travelers to DRC and neighboring countries practice enhanced precautions.”
“The federal interagency National Integrated Heat Health Information System (NIHHIS) today released a National Heat Strategy for 2024-2030. The strategy aims to promote proactive coordination related to heat planning, response, and resilience. * * *
“For more information on the National Heat Strategy, please click here – PDF. To learn more about HHS’ climate change-related efforts, please visit HHS’ Office of Climate Change and Health Equity. To find more information about the federal government’s heat-related initiatives and resources, please visit heat.gov.”
“The Food and Drug Administration on Wednesday approved a new treatment for primary biliary cholangitis, an autoimmune liver disease mainly affecting women that causes decreased liver function, debilitating itching, and fatigue.
“The drug, called Livdelzi, will be sold by Gilead Sciences, following the $4.3 billion acquisition of CymaBay Therapeutics, its developer, earlier this year.
“Regulators cleared Livdelzi for patients with primary biliary cholangitis, or PBC, that doesn’t respond adequately to initial treatment with a commonly used medicine. Gilead estimates there are approximately 130,000 people in the U.S. who are impacted by PBC, of which about 30,000 to 40,000 don’t respond to first-line therapy.
“Competition will come primarily from two drugs: Ipsen’s Iqirvo, which won FDA approval in June; and an older medicine called Ocaliva, developed by Intercept Pharma and recently acquired by Alfasigma, an Italian pharmaceutical firm.
“There’s still a real need out there for patients with PBC today, despite all the new arrivals. We believe Livdelzi can make a real difference for these people,” said Gilead Chief Commercial Officer Johanna Mercier.”
From the public health and medical research front,
The American Hospital Association News lets us know,
“The Centers for Disease Control and Prevention Aug. 13 issued an advisory alerting of an uptick of cases of parvovirus B19 across the U.S. Parvovirus B19 is a seasonal respiratory virus spread by respiratory droplets through symptomatic or asymptomatic individuals. Many people are asymptomatic, but immunocompetent children and adults with symptomatic disease typically develop a biphasic illness, CDC said. The first phase lasts approximately five days and includes symptoms of fever, myalgia and malaise, which develop about a week after infection. During the second phase, children often develop a facial rash which may be followed by reticulated body rash or joint pain one to four days later. For immunocompetent adults, the most common symptoms of parvovirus B19 disease typically occur during the second phase and include a reticular rash on the trunk and joint pain. Parvovirus B19 infection could also lead to adverse health outcomes among people without pre-existing immunity who are pregnant, immunocompromised or have chronic hemolytic disorders.”
Here is a link to the National Cancer Institute’s latest cancer information highlights.
“Two National Institutes of Health (NIH)-supported trials of an experimental malaria vaccine in healthy Malian adults found that all three tested regimens were safe. One of the trials enrolled 300 healthy women ages 18 to 38 years who anticipated becoming pregnant soon after immunization. That trial began with drug treatment to remove malaria parasites, followed by three injections spaced over a month of either saline placebo or the investigational vaccine at one of two dosages. Both dosages of the vaccine candidate conferred a significant degree of protection from parasite infection and clinical malaria that was sustained over a span of two years without the need for a booster dose—a first for any malaria vaccine. In an exploratory analysis of women who conceived during the study, the vaccine significantly protected them from malaria in pregnancy. If confirmed through additional clinical trials, the approach modeled in this study could open improved ways to prevent malaria in pregnancy.
“Spread by Anopheles mosquitoes, malaria parasites, including those of the species Plasmodium falciparum (Pf), can cause illness in people of any age. However, pregnant women, infants and very young children are especially vulnerable to life-threatening disease. Malarial parasitemia in pregnancy is estimated to cause up to 50,000 maternal deaths and 200,000 stillbirths in Africa each year.
“National Institutes of Health (NIH) researchers discover that while artificial intelligence (AI) tools can make accurate diagnoses from textbook-like descriptions of genetic diseases, the tools are significantly less accurate when analyzing summaries written by patients about their own health. These findings, reported in the American Journal of Human Genetics, demonstrate the need to improve these AI tools before they can be applied in health care settings to help make diagnoses and answer patient question.” * * *
“For these models to be clinically useful in the future, we need more data, and those data need to reflect the diversity of patients,” said Dr. Ben Solomon [,the study’s senior author]. “Not only do we need to represent all known medical conditions, but also variation in age, race, gender, cultural background and so on, so that the data capture the diversity of patient experiences. Then these models can learn how different people may talk about their conditions.”
“Beyond demonstrating areas of improvement, this study highlights the current limitations of large language models and the continued need for human oversight when AI is applied in health care.
“These technologies are already rolling out in clinical settings,” Dr. Solomon added. “The biggest questions are no longer about whether clinicians will use AI, but where and how clinicians should use AI, and where should we not use AI to take the best possible care of our patients.”
For many, middle age is associated with midlife crises and internal tumult. According to new research, it is also when the human body undergoes two dramatic bouts of rapid physical transformation on a molecular level.
In a new study, scientists at Stanford University tracked age-related changes in over 135,000 types of molecules and microbes, sampled from over 100 adults. They discovered that shifts in their abundance — either increasing or decreasing in number — did not occur graduallyover time, but clustered around two ages.
“Obviously you change throughout your entire life. But there are two major periods when there are lots of changes: One is when people hit their mid-40s, and one is they hit their 60s,” said Michael Snyder, a geneticist at Stanford University who co-wrote the study, in a phone interview. On average, the changes clustered around the ages of 44 and 60.” * * *
“The exact reason these molecular changes cluster at the mid-40s and 60s is unclear. But the study’s authors say their findings show that from your 40s, people stand to gain particular benefits from taking care of their health. This includes getting regular medical check ups — at least twice a year once you hit your 40s, Shen suggested — as well as making lifestyle adjustments.”
“The U.S. Department of Agriculture said on Tuesday it will expand bird-flu testing of beef entering the food supply as part of its response to the ongoing outbreak among dairy cattle, adding that U.S. beef and dairy products remain safe to consume.
‘USDA officials, in a call with reporters along with staff from other U.S. health agencies, said the tests will begin in mid-September and urged livestock workers to remain vigilant.”
“Elevance and its private equity partner have officially introduced their care delivery platform, called Mosaic Health, after teasing the joint venture earlier this spring.
“Mosaic is comprised of two of Clayton, Dubilier and Rice’s primary care portfolio companies — Apree Health and Millennium Physician Group — along with the care delivery and enablement assets of Elevance’s health services division Carelon.
“However, Mosaic is launching without Carelon’s advanced primary care platform, according to the announcement on Wednesday. Carelon’s assets will join Mosaic subject to ongoing regulatory approvals. An Elevance spokesperson did not respond to a request for comment on the timeline of approvals.”
“Otsuka’s digital health subsidiary has launched its first product, an app-based treatment for major depressive disorder.
“The app, called Rejoyn, is available only by prescription and is intended to be used in addition to medications. It consists of a six-week program with cognitive behavioral therapy-based video lessons and exercises for identifying emotions. Otsuka announced the launch on Tuesday.
“Sanket Shah, president of the Japanese pharmaceutical company’s new Otsuka Precision Health subsidiary, said the treatment was priced at $50 on a cash-pay basis, with the goal of making it accessible. “This is, to be honest, not going to make money,” Shah said in an interview. “We have to put the investment into this to build this out because we do believe in the [digital therapeutics] model and digital solutions and using technology to really help patients.”
“Startup Abridge has notched its largest partnership to date as Kaiser Permanente is making the company’s AI-powered medical note-taking app available to more than 24,000 doctors across its system.
“The integrated nonprofit is rolling out Abridge’s technology at 40 hospitals and more than 600 medical offices in eight states and Washington, D.C., the organization announced Wednesday. The health system’s clinical staff includes 24,600 physicians and 73,600 nurses.
“Kaiser Permanente’s venture arm also is one of Abridge’s investors. The company, founded in 2018, has raised $212.5 million to date, including a $150 million series C funding round in February.
“The health system has worked with Abridge over the past year to implement the AI-based medical documentation technology. Desiree Gandrup-Dupre, senior vice president of care delivery technology services at Kaiser Permanente, said it was the largest implementation to date of ambient listening technology.
“At Kaiser Permanente, we have a long history of successfully deploying proven technologies on a broad scale, as we continue to provide health care and services when, how, and where our patients need it,” Gandrup-Dupre said in a statement.
“The goal is to help doctors reduce time spent on administrative tasks, allowing them to be more present with patients during medical visits, Kaiser Permanente executives said.”
“The Social Security cost-of-living adjustment for 2025 could shrink in 2025 from this year’s 3.2% increase as inflation cools.
“COLA could be 2.6% in 2025, according to Mary Johnson, an independent Social Security and Medicare analyst and former analyst with the Senior Citizens League. The new forecast compares to her forecast in July that called for a 2.7% increase.
“The 2.6% increase would be the lowest COLA since 2021, but average for the past 20 years, Johnson said.”
“The Department of Health and Human Services’ technology office dropped a new proposed rule on Thursday that would require healthcare entities that contract with HHS to use government-certified health information technology.
“One group said the proposed rule could expand ASTP/ONC’s scope beyond setting standards for electronic health records (EHRs) to include data systems used by public health entities and insurers’ information systems. The proposed rule could potentially impact the regulation of artificial intelligence and cybersecurity in healthcare, a source said.
“The Office of the Assistant Secretary of Technology Policy’s proposed rule, “Acquisition Regulation: Information Technology; Standards for Health Information Technology” proposes that health IT meet ONC standards requirements when: solicitations and contracts issued by or on behalf of HHS entities involve implementing, acquiring or upgrading health IT where individually identifiable health information (IIHI) is exchanged; and, health IT is used by healthcare providers, health plans, or health insurance issuers under HHS contracts.
“The proposed rule would also include healthcare providers who have been eligible to participate in CMS’s health IT-focused incentive programs.”
“The Centers for Medicare and Medicaid Services shared a final notice on Wednesday for a new pathway to cover breakthrough medical devices.
“The pathway, called Transitional Coverage for Emerging Technologies (TCET), is intended to expedite Medicare coverage of new medical devices. On average, it takes about five years after a device is authorized by the Food and Drug Administration to gain national Medicare and commercial insurance coverage, according to a survey by the Stanford Byers Center for Biodesign.
“The CMS plans to accept up to five candidates per year for the TCET pathway, with the goal of finalizing a national coverage determination within six months of FDA market authorization for technologies that are accepted. The devices must have the FDA’s breakthrough designation, meaning they provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.
“Medtech lobbying firm Advamed pushed back on the five devices per year cap. CEO Scott Whitaker said in a Thursday statement that the limit “demonstrates clearly to Congress the need for greater resources at CMS” and the exclusion of diagnostics from the pathway is “disappointing.”
The Congressional Research Service posted a legal sidebar titled “Private Equity Investments in Healthcare: Selected Enforcement Issues.”
“A federal judge [who sits on the bench of the U.S. District Court for the Southern District of Ohio] on Thursday tossed out a U.S. Chamber of Commerce lawsuit challenging Democrats’ drug pricing law.”
“The decision is yet another loss for the pharmaceutical industry and its allies, which have filed lawsuits across the country arguing that the Inflation Reduction Act, which created a drug price negotiation program in Medicare, is unconstitutional. So far, they have lost every one.” * * *
“Because the case wasn’t filed in the correct court, Judge Newman didn’t address substantive issues about whether the law is constitutional or not.
“Medicare officials are expected to release the outcome of the price negotiations for the first 10 drugs in the program by Sept. 1.”
“The Postal Service is seeing steady growth in revenue, but not enough to outpace its substantial operating costs.
“USPS saw a $2.5 billion net loss for the third quarter of fiscal 2024 — higher than the $1.7 billion net loss it saw for the same period last year.
“USPS reported $18.8 billion in revenue this quarter — 1% higher than revenue for the same quarter last year. It’s also the agency’s fourth consecutive quarter of revenue growth.
“However, the agency also saw a more than 4% increase in its operating costs, which grew to more than $21 billion for the quarter.
“Postmaster General Louis DeJoy said Thursday that USPS plans to accelerate efforts to cut costs and boost revenue.”
From the public health and medical research front,
“Fewer U.S. adults today say it is important to get children vaccinated than in recent years, according to a Gallup poll published Wednesday.
“In the July survey, only 40 percent of U.S. adults said it is “extremely important” for parents to vaccinate their children, a marked decline from the 58 percent who said the same in 2019 and the 64 percent who said the same in 2001.
“The drop over the last two decades is similarly stark when tracking the combined percentage who said vaccinating children is either “extremely” or “very” important. Taken together, 69 percent of U.S. adults hold this view now, down from 84 percent in 2019 and from 94 percent in 2001.” * * *
“The poll included phone interviews conducted July 1-21, with 1,010 adults. The margin of error is 4 percentage points.”
“Scientists have developed a new weapon against H.I.V.: a molecular mimic that invades a cell and steals essential proteins from the virus.
“A study published in Science on Thursday reported that this viral thief prevented H.I.V. from multiplying inside of monkeys.
“The new therapeutic approach will soon be tested in people, the scientists said. Four or five volunteers with H.I.V. will receive a single injection of the engineered virus. “This is imminent,” said Leor Weinberger, a virologist at the University of California, San Francisco, who led the new study.” * * *
“Asher Leeks, a virologist at Yale University who was not involved in the research, said that it represented a big step forward in the study of so-called cheating viruses. Researchers have been investigating them for decades, but only in recent years have scientists like Dr. Weinberger tried turning them into medical treatments.”
New Cleveland Clinic research shows that consuming foods with erythritol, a popular artificial sweetener, increases risk of cardiovascular events such as heart attack and stroke. The findings, from a new intervention study in healthy volunteers, show erythritol made platelets (a type of blood cell) more active, which can raise the risk of blood clots. Sugar (glucose) did not have this effect.
Published in Arteriosclerosis, Thrombosis and Vascular Biology, the research adds to increasing evidence that erythritol may not be as safe as currently classified by food regulatory agencies and should be reevaluated as an ingredient. The study was conducted by a team of Cleveland Clinic researchers as part of a series of investigations on the physiological effects of common sugar substitutes. * * *
“I feel that choosing sugar-sweetened treats occasionally and in small amounts would be preferable to consuming drinks and foods sweetened with these sugar alcohols, especially for people at elevated risk of thrombosis such as those with heart disease, diabetes or metabolic syndrome,” Dr. Stanley Hazen advises. “Cardiovascular disease builds over time, and heart disease is the leading cause of death globally. We need to make sure the foods we eat aren’t hidden contributors.”
“Millions of people are flocking to drugs like Ozempic and Wegovy to lose weight and treat health problems. Doctors say one group that could benefit from the drugs is missing out: seniors.
“For older people, these medications can help in ways that go beyond losing weight, physicians say. Fewer pounds can lead to more mobility and better balance, allowing older people to become more active. That can boost mood, overall health, and sometimes makes the difference between walking freely or using a wheelchair or cane.
“Doctors say they’re hearing more from older people who are interested in taking the drugs. However, seniors face [Medicare] insurance hurdles to get the drugs covered. And doctors note that older people need to be careful about losing muscle mass when on the drugs, as well as possible interactions with other medications.
“Nine percent of people 65 and older reported taking GLP-1 medications, such as Ozempic, Wegovy and Zepbound, compared with 19% of people ages 50 to 64, according to a May KFF poll.
“These drugs would really benefit seniors but there’s always these additional worries,” says Dr. Sun Kim, an associate professor in the division of endocrinology at Stanford University School of Medicine. “I think sometimes we prioritize the risk over benefit when people get older.”
“Doctors are now capable of saving the lives of babies born at 22 weeks and, in rare cases, a week earlier, with improved techniques to help tiny lungs develop and protect fragile skin and organs. Hospitals with extensive experience resuscitating extremely premature babies report survival rates as high as 67% for babies born at 22 weeks.
“Some U.S. hospitals aren’t sufficiently equipped or capable of pulling off the new advances. Others have chosen not to offer the care, saying it is likely to fail, is expensive—typically more than $100,000 a child, and sometimes much more—and subjects tiny, fragile infants to needless pain and the risk of long-term disabilities.
“Instead, they often provide comfort care: wrapping the newborn in a blanket, placing it on the mother’s chest and sometimes giving medicines to ease the child’s final moments.
“The difference can be a matter of life or death for the roughly 8,000 infants born between 22 and 24 weeks gestation in the U.S. each year.
“Doctors agree that babies born at 25 or 26 weeks can and should be treated as long as they don’t have other complications, while those born at 20 weeks or less are too small to save.
“In between is a “gray zone,” as doctors call it, where newborns’ fate can depend on which hospital happens to be delivering.”
“Since its emergence in 2020, Covid has jumbled the list of the 10 leading causes of deaths in the United States. It roared into third place in 2020 but has now fallen to 10th place, the National Center for Health Statistics reported Thursday.
“Heart disease and cancer remained the first and second leading causes of death, followed by unintentional injuries as No. 3. Overall, deaths in 2023 were 6.1% lower than 2022.
“We’re going in the wrong direction for heart disease. We’re going a tad in the right direction for cancer,” said Eric Topol, founder and director of the Scripps Research Translational Institute. A cardiologist and geneticist, he was not involved in the analysis. “A lot of things that are highest on this list, there’s a lot of things we can do to prevent them. And hopefully we’ll keep seeing the numbers come down. But if you just look at pre-pandemic to now, it’s not a good trend.”
“Eli Lilly shares jumped after the drugmaker reported earnings that trumped analyst estimates and hiked its annual outlook.
“Lilly has become one of the most valuable companies listed in the U.S. due to the popularity of its medications used for obesity.
“Quarterly sales for diabetes drug Mounjaro totaled more than $3 billion, while weight-loss injection Zepbound, which launched late last year, rang in at $1.2 billion. Both figures beating analysts’ estimates.
“The strong quarter was boosted in part by additional supply of the drugs, which had been in shortage, as well as favorable pricing, Lilly said. Mounjaro prices were higher in the U.S., partly because of increased availability of the drug and lower use of savings card programs.”
Following up on a post from yesterday, BioPharma Dive informs us,
“[Mounjaro and Zepbound] are available in all dosage forms in the U.S. What that means is we can bill orders as they’re received,” said Lilly CEO David Ricks on an earnings conference call Thursday. “That does not mean that any pharmacy, or certainly every pharmacy, has all 12 dosage forms sitting on their shelves.”
“Ricks cautioned that, despite the change in status on the FDA’s shortage list, patients may still have to wait a few days to pick up their prescriptions.
“There’s not an abundance of supply. It’s more of a real-time fulfillment situation,” Ricks said. “But product is flowing and it’s flowing at a pretty high rate.”
“Still, he added, “the end pharmacy experience will continue to be choppy.”
Forbes adds,
“More doses of Novo Nordisk’s popular weight loss drug Wegovy are back in stock in the U.S. after years of shortages, according to the FDA, days after all dosage levels of Eli Lilly’s rival injection Zepbound became available. They’re part of a promising and growing class of drugs called GLP-1 agonists, but shortages are set to persist as pharmaceutical companies struggle to ramp up production.”
“As for-profit Tenet Healthcare slims its hospital portfolio, it found an unlikely buyer for its Alabama hospitals: Florida’s Orlando Health.
“Orlando Health draws more than $6 billion in annual revenue and has a profit margin that surpasses most of its peers. A hospital system executive system leader said crossing state lines to buy five Birmingham-area hospitals is part of its focus on serving the Southeastern U.S., even though most of its 17 existing hospitals are still in Florida.
“It’s not at all surprising that a multi-billion dollar health system would have ambitions of expanding beyond its home state. That’s especially true as hospital systems continue to merge at a breakneck pace, increasingly jumping across multiple states to do so. Meanwhile, study after study concludes that hospitals use their newfound market power to drive up prices.”
“As the Medicare Advantage landscape evolves, the success of health systems hinges on their ability to adapt and excel in key areas such as star ratings and appropriate coding.
“Health systems’ greatest opportunity is to enter into full-risk arrangements with health plans, shifting the focus from managing illness to maintaining wellness. However, many systems have not made the necessary investments to thrive in this value-based care model, often missing out on its potential benefits and driving ambivalence toward the MA program, according to SCAN Group CEO Sachin Jain, MD.”
“Centene is exiting six states through its WellCare Medicare Advantage (MA) subsidiary next year, investment bank Stephens has revealed.
“Those six impacted states are Alabama, Massachusetts, New Hampshire, New Mexico, Rhode Island and Vermont, with approximately 12,600 members affected in New Mexico, the most of any state.
“In Vermont, Centene accounts for about 9% of the market share in the state. All told, all market exits will impact around 37,300 members and about 3% of Centene’s current MA membership, a research note from Stephens showed.
“Notably, CVS and UnitedHealthcare both maintain presences across each impacted market,” the brief said.
‘The insurer will still offer its prescription drug plans in these states. Centene commands the most market share for standalone Part D in the country at 29%, data from the Centers for Medicare & Medicaid Services show.
“Walgreens is considering a full sale of its stake in VillageMD, after pouring billions of dollars into the unprofitable primary care chain. The decision, disclosed Wednesday in a securities filing, is a sharp reversal tothe pharmacy behemoth’s past commitment to building out its healthcare delivery offerings.
“Walgreens is “currently evaluating a variety of options” in light of VillageMD’s “substantial ongoing and expected future cash requirements,” the company said in the 8-K. “These options could include a sale of all or part of the VillageMD businesses, possible restructuring options and other strategic opportunities.”
:If Walgreens offloads VillageMD entirely, it would be astep up from management’s previous plans for the value-based medical chain. In June, Walgreens said it would reduce ownership in VillageMD but not eliminate it entirely.”
“Digital Therapeutics developer Big Health this week received Food and Drug Administration clearance for SleepioRx, a prescription treatment for insomnia.
“Big Health already sells a wellness version of the app, called Sleepio, to employers and health plans that make the product available to their members. The app delivers a specialized type of cognitive behavioral therapy for insomnia and the company boasts that it is backed by dozens of studies.”
“Sarepta Therapeutics’ yearly financial outlook and quarterly earnings, including sales of Elevidys, its gene therapy for Duchenne muscular dystrophy, have fallen well short of Wall Street expectations.
“Sarepta reported Wednesday afternoon that Elevidys sales totaled roughly $122 million between April and June, down from the previous quarter and about $20 million below consensus estimates. Overall product sales of about $361 million, and 2025 revenue projections of $2.9 billion to $3.1 billion, were also lower than analysts anticipated.
“Still, executives assured investors that sales should soon climb following the recent decision by the Food and Drug Administration to substantially expand use of Elevidys. The market opportunity ahead of Sarepta is “absolutely massive,” said Dallan Murray, the company’s executive vice president and chief customer officer on a conference call. Sarepta shares initially fell by double digits before rebounding Thursday morning.”
“Zimmer Biomet said Wednesday it agreed to buy Orthogrid Systems, a medtech company that makes artificial intelligence-based surgical guidance systems for total hip replacement.
“Salt Lake City-based Orthogrid uses fluoroscopy imaging to help surgeons track the position of an implant during a hip procedure. It also has two other Food and Drug Administration-cleared solutions for hip preservation and trauma surgeries.
“By using fluoroscopy instead of CT scans, Orthogrid can offer real-time navigation and a more efficient workflow for operating rooms.
“The solution will add to Zimmer’s current suite of tools for hip surgery. The company has its own hip application paired with its Rosa surgical robot that also uses fluoroscopy imaging. Zimmer additionally has a co-marketing agreement with HipInsight, which uses Microsoft Hololens 2 glasses to help surgeons visualize a patient’s pelvic anatomy during surgery.
“Federal agencies have not implemented roughly half of the 428 recommendations that the Government Accountability Office has made to improve preparedness following the COVID-19 pandemic, which has killed 1.2 million Americans.
“In a report published on Aug. 1, the watchdog reviewed its oversight work concerning COVID-19 and the approximately $4.65 trillion Congress provided in response. GAO found that agencies haven’t addressed 220 of its recommendations.
“Reflecting on federal agencies’ emergency response actions and our recommendations can reveal lessons from the COVID-19 pandemic for federal agencies. These lessons can help federal agencies identify actions that successfully facilitated the implementation of the federal response and should be incorporated into future emergency response plans. Other lessons can help federal agencies identify weaknesses in their response to the pandemic and identify areas for improvement,” GAO investigators wrote.”
“Today, to mark National Health Center Week, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded nearly $9 million to 18 HRSA-funded health centers to improve access to life-saving cancer screenings in underserved communities. Health centers will partner directly with National Cancer Institute-Designated Cancer Centers to expedite patient access to cancer care and treatment. These awards advance the Biden Cancer Moonshot mission to prevent 4 million cancer deaths by 2047 and end cancer as we know it. This effort builds on work supported by the 21st Century Cures Act to expand use of proven cancer prevention and early detection strategies to reduce cancer risk in all populations.”
Federal News Network tells us about OPM telework guidance issued today.
“In the federal government’s case, remote work is distinct from telework. Federal employees with remote work agreements perform their job duties at a location away from their normal work site without the expectation of regularly returning to that site. In contrast, federal employees with telework agreements, by OPM’s definition, can perform their work away from the office — but are still expected to come to the worksite “on a regular and recurring basis.”
“OPM’s new guidance doesn’t change the definitions for federal remote work or telework, which are set in law, but rather provides additional clarifying guidance on how agencies should approach their workplace arrangements moving forward. In the document, OPM details what factors agencies should consider as they hammer out their remote work posture — both as it currently exists, as well as what it will look like in the future.
“The guidance builds on the Office of Management and Budget’s April 2023 memo that called on agencies to strike a balance between in-person work and telework, as well as 2021 OPM guidance that told agencies to weave telework and remote work into their workforce culture. Following those documents, OPM said human capital leaders and other senior executives asked for additional guidance on how to ensure agencies are relatively consistent as they consider changes to their remote work arrangements.
“OPM said it’s still up to each agency to determine the right balance for workplace flexibilities, such as remote work, for their employees. Agencies can decide if they want to offer remote work in the first place. They also have the authority to determine how they’d like to use the flexibility, and what positions are potentially good candidates for the alternative workplace arrangements.”
From the public health and medical research front,
“The Centers for Disease Control and Prevention has updated respiratory syncytial virus vaccination recommendations for adults 60 and older. Adults aged 60-74 at increased risk for RSV and all aged 75 and older are recommended a single dose of the GSK, Pfizer or Moderna vaccine. Individuals who previously received a dosage should not seek another.”
“When exposed to a virus, the human body marshals the immune system to fend off the intruder. Sometimes, the defense goes awry, and the body mistakenly turns against itself instead of the attacker.
“This sort of friendly fire drives multi-inflammatory syndrome in children, or MIS-C, a mysterious condition that in rare cases strikes children who have had a severe bout of Covid-19, according to a new study.
“In a subset of children with the syndrome, immune cells become confused by the similarity between a protein carried by the coronavirus, and one found throughout the human body, said Joseph DeRisi, an infectious disease expert and the president of the Chan Zuckerberg Biohub in San Francisco, who led the study. This phenomenon is called molecular mimicry, Dr. DeRisi said.
The study was published on Wednesday in the journal Nature. The results offer the first direct proof that Covid-19 sets off an autoimmune reaction that leads to MIS-C.”
“Antidepressants are one of several classes of medications that can make people more vulnerable to heat by tampering with the body’s internal thermostat or interfering with its cooling strategies. Others include antipsychotics, diuretics, stimulants and heart medications such as beta blockers and ACE inhibitors.
“Many of these drugs are associated with an increased risk of heat-related hospitalizations, a study published in 2020 in the journal PLOS One found. But the extent to which these drugs pose risks isn’t well studied, said Dr. Soko Setoguchi, an epidemiologist at Rutgers University who co-wrote the study. Setoguchi said people should avoid heat, not their medication.”
“Neuralink, a company co-founded by Elon Musk, has successfully implanted a second brain-computer interface device into a human subject, Nature reported Aug. 6.
“During a podcast released Aug. 2, Mr. Musk said the new implant is functioning well, with around 400 of its 1,042 electrodes actively transmitting signals from the person’s brain.
“Although details regarding the recipient or the specifics of the surgery were not disclosed, Mr. Musk said the individual, similar to the first recipient, suffers from a spinal cord injury.
“The procedure comes after Neuralink’s first patient had a number of threads on the implant retracted from his brain shortly after the surgery.”
“New York City-based Hospital for Special Surgery has the lowest hospital wide readmission rate, according to CMS’s Unplanned Hospital Visits database.
“The data, released July 31, is based on provider data for hospital return days, including unplanned readmission measures in 2022.”
The article lists “the 10 hospitals with the highest and lowest hospital wide readmission rates, along with their respective scores.”
“Novo Nordisk is pulling its regulatory submissions to expand the use of its obesity drug Wegovy for a common type of heart failure, saying that waiting for more data on cardiovascular outcomes could bolster its case.
“Trials of Wegovy in the condition, heart failure with preserved ejection fraction (or HFpEF), have primarily looked at the drug’s effects on symptoms and physical function. The company plans to reapply to expand Wegovy’s label early next year when it has more data on complications such as hospitalizations and cardiovascular-related deaths, Martin Lange, Novo’s head of development, said Wednesday on an earnings call.”
“A National Institutes of Health (NIH)- supported study has found race- and sex-based differences in the increased chances of survival from people who received bystander cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest. Average survival benefits for cardiac arrest, when the heart suddenly stops beating, could be three times as high for white adults compared to Black adults and twice as high for men compared to women. The findings published in Circulation.
“CPR saves lives — that, we know,” said Paula Einhorn, M.D., a program officer at NIH’s National, Heart, Lung, and Blood Institute (NHLBI). “Yet the disparities revealed in this research show we need to do more to understand how to ensure equitable outcomes for all patients needing CPR. We’re hoping new insights will lead to better survival * * *.” * * *
“Prior research already found inequities in the frequency with which bystander CPR was being performed in Black and Hispanic individuals compared to white individuals, and with women compared to men in public places. In response, CPR training awareness and programs have expanded nationally, as have online courses. Mannequins resembling a woman’s body have also been designed.
“Evaluating access to and the effectiveness of different types of CPR trainings could be one way to identify differences in survival outcomes and inform solutions, according to researchers. For example, future studies could inquire about whether a bystander received online or in-person training; if they practiced on women mannequins or models with black or brown skin; if multiple bystanders were around, which may indicate a person had additional support; and what kind of support from emergency dispatchers they had — and for how long — which may reveal whether a person was receiving CPR instructions for the first time. Since the arrival times of emergency medical responders were fairly similar among groups, the researchers don’t believe this factored into outcomes observed in the study. Future studies could also explore the role that underlying health conditions may have in the survival outcomes of those who needed CPR.”
“Hospital finances seem to be stabilizing overall — but a closer look shows that there is a widening gap between the highest- and lowest-performing organizations, according to a report released by Kaufman Hall this week.
“For the report, Kaufman Hall examined data from more than 1,300 hospitals. It showed that hospitals’ year-to-date operating margin index held steady at 4.1% in June for the second month in a row.” * * *
“Kaufman Hall also released another report on healthcare finances this week, with this one showing that rising labor costs are here to stay.: * * *
“This aligns with recent research from Strata Decision Technology, which showed that healthcare providers’ labor expenses grew by 5.2% while their non-labor costs rose by 3.3% from June 2023 to June 2024. This resulted in a 4.8% increase in overall expenses during the 12-month period, according to the report.”
“Tenet Healthcare will sell its majority ownership in Birmingham, Alabama-based Brookwood Baptist Health for about $910 million to Orlando Health, the health system said Monday.
“The sale, which is expected to close in the fall of this year, includes 70% of Tenet’s interest in the five-hospital system, as well as affiliated physician practices and other related operations.
“The deal continues Tenet’s streak of divestitures as it looks to deleverage its portfolio. This year, the system has sold nine hospitals to Novant Health, UCI Health and Adventist Health for a combined after-tax profit of $3 billion.”
“CVS Health’sMedicare business continued to struggle in the second quarter, fueling yet another cut to its full-year earnings outlook, a new $2 billion cost-cutting plan and the departure of a top executive.
“CVS bet big on attracting seniors to its Aetna Medicare Advantage health plans last year, adding one million new people to its insurance rolls in 2024. But the gamble began backfiring in the first quarter of the year as seniors used more healthcare services than in the past and the government has become stingier in how much it pays private insurers.
“On Wednesday, CVS said the pressures continued into the second quarter. The company reported total revenue of $91.2 billion in the quarter, up 2.6% from a year ago, and driven in large part by growth in its Medicare and commercial insurance businesses.
But much of the sales increase was eaten up by higher medical costs, and adjusted earnings per share of $1.83 in the quarter were down 17.2% from last year.
“Medicare Advantage costs could rise in the second half of 2024, CVS Health CEO Tom Cowhey told investors.
“On an Aug. 7 call, Mr. Cowhey said costs in inpatient care, dental and pharmacy all rose toward the end of the second quarter. The company’s guidance for the rest of the year reflects that costs in the second half of the year could be higher than the first, the CFO said.” * * *
“Revenues in the company’s health benefits segment are down 40% year over year. The company ousted Aetna President Brian Kane over the financial results. Ms. Lynch and Mr. Cowhey will oversee Aetna’s day-to-day operations until a successor is named.”
“Novo Nordisk shares tumbled 7% in early trading Wednesday after the company reported lower-than-expected revenue from its blockbuster obesity franchise.
“Even as revenue from Wegovy and Ozempic continued to soar, the second-quarter numbers failed to reach the high expectations set by Wall Street, analysts said. Sales of the so-called GLP-1 obesity drugs were about 9% below consensus estimates, according to analysts with the investment bank Jefferies.
“Overall revenue for the second quarter was “borderline in line with expectations,” Stifel analyst Eric Le Berrigaud wrote in a note to clients. But the fact that older products in Novo Nordisk’s portfolio helped offset the disappointing results for obesity drugs “is not so reassuring in the long term,” he wrote. The company’s “sales composition is not good.”
“The first medicine approved for a liver disease known as MASH is off to a faster launch than Wall Street analysts expected, according to quarterly results disclosed Wednesday by developer Madrigal Pharmaceuticals.
“Madrigal said its drug Rezdiffra, which was approved by the Food and Drug Administration in March and became available the following month, generated $14.6 million in U.S. sales in the second quarter. As of June 30, more than 2,000 patients were on treatment and coverage policies were in place for more than 50% of people with commercial health insurance, the company said.
“While only an early snapshot, the results surpassed consensus analysts estimates of about $4 million and have encouraged Madrigal to commercialize Rezdiffra in Europe on its own. An approval decision there is expected next year. “We’re still in the early stages, but we are confident that we’re building the foundation needed to create a blockbuster medicine,” CEO Bill Sibold told analysts.”
“Today, to mark National Health Center Week, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA) released new data showing over 31 million total patients served at HRSA-funded health centers in 2023—an increase of 2.7 million since 2020.
“Community health centers play a pivotal, and growing, role in America’s health care system. They are especially important in our effort to reduce health care disparities in underserved communities,” said HHS Secretary Xavier Becerra. “More than 31 million people across the country – in every U.S. state, territory, and the District of Columbia – depend on health centers, making them a vital resource. The Biden-Harris Administration wants all Americans to have access to high-quality primary health care services, regardless of a patient’s ability to pay, and community health centers help make that possible.”
Beckers Hospital Review delves into the final Medicare acute inpatient prospective payment rule for fiscal year 2025 which was publicized last week.
“Studies being used to decide whether the U.S. should authorize an ecstasy-based drug for traumatized patients missed serious side effects and were marked by bias.
“Three people who were subjects in the studies told The Wall Street Journal that their thoughts of suicide worsened during or after testing, but their downward slides weren’t captured in trial data and therefore not reflected in the final results.” * * *
“FDA staffers have questioned the quality of the study results. Experts advising the agency recommended against approval, saying more safety and effectiveness evidence was needed. The Institute for Clinical and Economic Review, a nonprofit that reviews drugs and their prices, said the evidence was incomplete.
“The FDA told its advisers that it is looking into allegations of study misconduct and missing side effects. It told the Journal that it can’t comment on investigations until they are final, but its findings will be incorporated into its decision on the Lykos treatment.
“Problems with the trials mean the FDA might not be able to assess whether the treatment is safe and effective for everyone, or just some people, said experts advising the agency and bioethicists who spoke to the Journal about its findings.”
From the public health and medical research front,
“The agency’s Nowcast data tracker, which displays COVID-19 estimates and projections for two-week periods, projects the KP.3.1.1 variant accounting for 27.8% of positive infections, followed by KP.3 at 20.1% in the two-week stretch starting July 21 and ending Aug. 3.
“The KP.3.1.1 variant is very similar to other circulating variants in the United States. All current lineages are descendants of JN.1, which emerged in late 2023,” Rosa Norman, a spokesperson at the CDC, previously told USA TODAY.
“At this time, we anticipate that COVID-19 treatments and vaccines will continue to work against all circulating variants. CDC will continue to monitor the severity of variants and will monitor vaccine effectiveness.”
“Some CVS Health Corp. pharmacies are selling out of at-home Covid tests as a summer surge in infections drives up demand.
“As of Friday afternoon [August 2], CVS’s website showed that all brands of tests were out of stock at many locations in cities including Houston, Austin and Reno, Nevada.
“The company said that 91% of its stores have at least one brand of test in stock. While the company “has seen an uptick in purchases” of the tests, it’s “quickly sending product to impacted stores,” a spokesperson said in an email.”
“Intermittent calorie restriction improved executive function and memory measures in cognitively intact older adults, an exploratory pilot study suggested.
“The 8-week randomized clinical trial of 40 overweight, cognitively normal older adults with insulin resistance examined the effect of two interventions — a 5:2 intermittent fasting plan versus a “healthy living” diet based on portion control and calorie reduction guidelines from the U.S. Department of Agriculture — on brain health. The 5:2 intermittent fasting group had 2 days of food intake of 480 calories/day (two meal replacement shakes), and 5 days of a healthy living diet.
“Both interventions improved executive function and memory, with intermittent fasting showing better results on certain cognitive measures, said Dimitrios Kapogiannis, MD, of the National Institute on Aging (NIA) and the Johns Hopkins University School of Medicine in Baltimore, in a poster presented at the Alzheimer’s Association International Conference.” * * *
“Many people think that eating a healthy diet or following an intermittent fasting regimen are good ways to stave off cognitive decline during aging, but our study actually provided supporting evidence,” Kapogiannis told MedPage Today.
“Our study lays the groundwork for larger clinical trials that will examine a variety of dietary interventions that will help people have good brain health and live healthier, longer lives,” he said.”
“More than half of patients hospitalized and treated for pneumonia receive differing diagnoses during their stays, according to a study published in Annals of Internal Medicine.
“Researchers from the University of Utah Health and the nearby VA Healthcare System, both based in Salt Lake City, measured the rates of concordance and discordance in pneumonia diagnoses. They followed three states: initial diagnosis in the emergency department, initial chest image reports and discharge diagnosis.
“Among more than 2 million admissions at VA hospitals across the U.S., 36% of patients were admitted with a pneumonia diagnosis but not a corresponding discharge diagnosis. Another 33% had a discharge diagnosis of pneumonia but not an admission diagnosis. The study focused on admissions between 2015 and 2022.” * * *
“In conclusion, the authors of the latest study said physicians and patients should be aware of this high level of uncertainty about pneumonia diagnoses.
“In this edition of Author Talks, McKinsey Global Publishing’s Querida Anderson chats with Lawrence Ingrassia about his book A Fatal Inheritance: How a Family Misfortune Revealed a Deadly Medical Mystery (Henry Holt and Co./Macmillan Publishers, May 2024). Ingrassia details his family’s battle with numerous cancers, spotlights the pioneers who worked tirelessly to solve the puzzle of genetic mutations, and explores the ongoing advancement in cancer research and development. An edited version of the conversation follows, and you can also watch the full video at the end of this page.”
The Peterson/KFF Health System Tracker considers what drives health spending in the U.S. compared to other countries.
“The United States spends significantly more on healthcare than comparable countries do, and yet has worse health outcomes. Much of the national conversation has focused on spending on retail prescription drugs and insurer profits and administrative costs as key drivers of health spending in the United States. The Inflation Reduction Act, signed into law by President Biden in 2022, includes several provisions aimed at lowering the cost of these prescription drugs. While it is true that many brand-name retail prescription drugs are priced higher in the U.S. than in peer countries, health spending data indicates that other spending categories – particularly hospital and physician payments – are primary drivers of the U.S.’s higher health spending.”
“Only about half of U.S. employers effectively manage health care costs, with nearly all organizations experiencing health plan premium increases, according to Gallagher’s 2024 U.S. Physical & Emotional Wellbeing Report.
“The report, which surveyed 3,552 organizations, found that employers ranked the high costs of medical services (68%) and specialty drugs (44%) as their top health care cost management challenges.” * * *
“All doses of tirzepatide, the drug Eli Lilly sells as Zepbound for obesity and Mounjaro for diabetes, are now available in the U.S. after months of shortages made the in-demand medicine hard to obtain.
“Two dose strengths of Zepbound and another two of Mounjaro had been listed in short supply on a database maintained by the Food and Drug Administration as recently as early last week, before the agency updated the drug’s status to available on Friday.
“Lilly reports second quarter earnings on Thursday, when sales and supply of tirzepatide are likely to be the main focus of analyst questions. The company in April raised its financial forecasts for the year by $2 billion due to revenue growth for Zepbound and Mounjaro, which together brought in $2.3 billion between January and March.”
“Walgreens has once again cut its stake in drug distributor Cencora as the struggling pharmacy chain looks to boost funding.
“The Illinois-based retailer announced last week it was selling more shares in Cencorafor roughly $1.1 billion in proceeds. The sales lower Walgreens’ stake in Cencora to approximately 10% from 12%.
“Walgreens said it will use the money to pay down debt and to fund its operations as it continues to pivot to a health services strategy.”
“Johnson & Johnson said Friday [August 2] it launched Velys Spine, a surgical robot and standalone navigation platform.
“The 510(k)-cleared system, which J&J developed with eCential Robotics, is designed to provide guidance on the placement of screws in freehand and robotic-assisted spine surgeries.
“J&J’s Depuy Synthes plans to make the system available commercially in the first half of 2025. The system will join other Velys offerings J&J has cited as a growth driver in its hip and knee businesses.”
“Steward Health Care will lay off about 1,200 workers in Massachusetts by the end of the month as it moves to close two hospitals in the state.
“The health system will let go 753 employees at its Carney Hospital and 490 workers at its Nashoba Valley Medical Center, according to a Worker Adjustment and Retraining Notification (WARN) report filed with state regulators on July 29.
“On Thursday, a federal judge cleared the way for embattled Steward Health Care to close Carney Hospital and Nashoba Valley Medical Center by the end of August. Those are two of the eight hospitals that the health system operates in the Bay State.”
“For the first time as a public company, Clover Health is announcing its first quarterly net profit, the company said ahead of its second quarter earnings call.
“Clover declared a net income of $7.2 million and an adjusted EBITDA of $36.2 million, both figures a substantial improvement year-over-year.
“I am delighted that our performance continues to validate Clover’s differentiated, technology-centric approach to healthcare, driven by our insurance offering and its ability to generate meaningful returns while leading with physician-choice for our members,” said Clover Health CEO Andrew Toy in a statement. “Through our Clover Assistant technology and integrated care management platform, we aim to empower physicians to improve clinical outcomes and lower the total cost of care for people with chronic diseases. This allows us to partner with a much wider range of physicians than other plans.”
“Insurance revenue also soared 11% higher year-over-year to $349.9 million due to member retention and growth, whereas the company’s medical cost ratio (MCR) improved to 71.3%, down from 77.9% the quarter before.”
“Cigna unveiled the first round of grant winners in a program announced earlier this year that seeks to address the rising tide of mental health needs among youth.
“The funding will be distributed to 22 awardees, Cigna said on Monday. For close to half of the recipients, it’s the first time they’re securing funding from Cigna or its philanthropic arm, the Cigna Group Foundation, according to an announcement.
“Cigna said it will distribute $9 million as part of the program. The organizations will focus on tackling post-pandemic stress and distress among kids aged five to 18, according to the release. There will be a particular emphasis on outreach in schools or related settings, Cigna said.”
“The Centers for Medicare & Medicaid Services Aug. 1 issued a final rule that will increase Medicare inpatient prospective payment system rates by a net 2.9% in fiscal year 2025, compared with FY 2024, for hospitals that are meaningful users of electronic health records and submit quality measure data. This 2.9% payment update reflects a hospital market basket increase of 3.4% as well as a productivity cut of 0.5%. CMS expects overall payments to increase by $2.9 billion, which includes a $200 million decrease in disproportionate share hospital payments (due to a decrease in the uninsured rate), a $300 million increase in new medical technology payments, and a $400 million decrease in rural health payments if the Medicare-dependent hospital and enhanced low-volume adjustment programs are not extended by legislation.
“In a statement shared with the media, Molly Smith, AHA group vice president for public policy, said, “CMS’ payment updates for hospitals will exacerbate the already unsustainable negative or break-even margins many hospitals are already operating under as they care for their patients. The AHA is deeply concerned about the impact these inadequate payments will have on patient access to care, especially in rural and underserved communities.”
“The Centers for Medicare & Medicaid Services Aug. 1 finalized policy changes to the long-term care hospital standard rate payment system that will increase payments by 2.0%, or $45 million, in fiscal year 2025 relative to FY 2024. This includes a 3.0% market basket update, a cut of 0.5 percentage points for productivity, and a cut related to outlier payments, among other policies. Specifically, due to an increase in the outlier threshold, CMS will reduce outlier payments as a percentage of total LTCH PPS standard federal payment rate payments by 0.8%. CMS also finalized a rebasing of the LTCH market basket using a 2022 base year.
“In a statement shared with the media, Molly Smith, AHA group vice president for public policy, said, “We are troubled that the final long-term care hospital outlier threshold is nearly 30% higher than it is currently. Since FY 2021, this figure has increased by more than 180%, which forces these hospitals to absorb hundreds of thousands of dollars in additional losses when caring for the sickest patients. This increase will create serious access issues for patients and put additional burden back on acute-care hospitals and other providers that do not specialize in caring for this unique patient population.”
CMS also posted a guidance alert titled “Clarification of Medicare Secondary Payer (MSP) Recovery Against Awards Made Under the Camp Lejeune Justice Act (CLJA).”
“U.S. Senator Ron Wyden, D-Ore., and U.S. Senator Marsha Blackburn, R-Tenn., today introduced bipartisan legislation to address the persistent shortage of health professionals. The bill, the Health Workforce Innovation Act, provides federal support for innovative, community-led partnerships to educate and train more health care workers, especially in rural and underserved communities.” * * *
“The Health Workforce Innovation Act would establish a new federal grant program to support community health centers and rural health clinics to carry out innovative, community-driven models to train and develop a pipeline of a wide range of allied health professionals, including through partnerships with high schools, community colleges and other entities.” * * *
“A new KFF analysis examines some of the forces that are likely to shape Medicare Part D premiums in 2025, explaining how and why premiums might change.
“Changes to the Part D benefit in the Inflation Reduction Act will mean lower out-of-pocket costs for Part D enrollees but higher costs for Part D plans overall, leading to concerns about possible premium increases. CMS is taking steps to mitigate potential premium increases through a new demonstration program for stand-alone drug plans, as well as payment changes designed to bring greater stability to the Part D market in 2025.
“The Inflation Reduction Act includes a provision to cap growth in the base beneficiary premium to 6%. Although the cap doesn’t apply to the individual premiums that plans charge, it does help to limit premium increases. Actual Part D plan premiums for 2025 will be announced in September. Medicare’s annual open enrollment period runs from October 15 to December 7.”
Tammy Flanagan, writing in Govexec, offers “retirement planning pro-tips for feds, some crucial tips for every stage of your federal career.”
“Gen Xers, born between 1965 and 1980, and millennials, born between 1981 and 1996, are at risk for 17 of the 34 existing cancer types, a new study from the American Cancer Society has revealed.
“An in-depth analysis of data from more than 23 million cancer patients and more than 7.3 million cancer deaths between 2000 and 2019 unveiled that incidence rates for some cancers — pancreatic, kidney, small intestinal cancers, and female liver cancer — were nearly three times higher for patients born in the 1990s than in 1955, according to the study, published July 31 in The Lancet Public Health.
“There were also notable increases among members of these younger generations across breast (estrogen-receptor positive), uterine corpus, colorectal, non-cardia gastric, gallbladder, ovarian, testicular, anal (male), and Kaposi sarcoma (male) cancers.
“Mortality rates have also increased along with the rise in cancer rates for female liver cancer, uterine corpus, gallbladder, testicular, and colorectal cancer, according to the study.
“The results could be “an early indicator of future cancer burden” nationwide, said Ahmedin Jemal, PhD, lead author of the study and senior vice president of surveillance and health equity science at the American Cancer Society.”
“Eli Lilly’s obesity drug Zepbound cut the risk of complications and improved symptoms in patients with a common type of heart failure, making it the second GLP-1 drug to show positive results in the disease area after Novo Nordisk’s Wegovy.
“The Phase 3 trial studied patients who had heart failure with preserved ejection fraction (or HFpEF) and obesity. Some participants also had type 2 diabetes. Over two years, Zepbound cut the risk of major problems — including heart failure-related urgent visits or hospitalizations, intensification of diuretic treatment, or cardiovascular-related deaths — by 38% compared to placebo, Lilly said Thursday.
“Additionally, at one year, people on Zepbound had a 19.5-point improvement on the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS), a measure of symptoms, function, and quality of life. This was a 6.8-point greater improvement than patients on placebo.”
“Although obesity affects more than 1 billion people worldwide, according to a global analysis published in The Lancet, it still lacks a clear “identity” in research, social perception, and the healthcare sector. This lack of clarity hinders accurate diagnoses and treatments, while also perpetuating stigma and prejudice. Specialists argue that obesity is a chronic disease rather than just a condition that leads to other diseases.
“At the latest International Congress on Obesity held in São Paulo from June 26 to 29, The Lancet Commission on the Definition and Diagnosis of Clinical Obesity announced that it is conducting a global study to create a clear definition for obesity. This condition is often wrongly associated solely with individual choices. Ricardo Cohen, MD, PhD, coordinator of the Obesity and Diabetes Specialized Center at the Oswaldo Cruz German Hospital, São Paulo, Brazil, and a key researcher in the study, made the announcement. “The current definition of obesity is too broad and ineffective for our needs,” said Cohen.” * * *
“To address these challenges, The Lancet Commission’s study, which is expected to be published this year, aims to establish clear diagnostic criteria for adults and children. Drawing inspiration from medical disciplines with well-established diagnostic criteria, such as rheumatology and psychiatry, the research has defined 18 criteria for adults and 14 for children.”
The National Institutes of Health’s Director writes in her blog
“More than 200 million people around the world have osteoporosis, a condition that weakens bones to the point that they break easily. Women are at especially high risk after menopause due to declining levels of the hormone estrogen, which helps keep bones strong. While osteoporosis rarely has noticeable symptoms, it can lead to serious injuries when otherwise minor slips and falls cause broken bones that in turn can lead to further fracture risk and fracture-related mortality. So, I’m pleased to share NIH-supported research suggesting a surprising candidate for strengthening bones: a maternal hormone produced in the brain.
“The study in mice reported in Nature shows that this newly discovered hormone maintains and rebuilds bone strength in lactating females, even as estrogen levels dip and calcium is lost to the demands of milk production. 1The findings suggest this hormone—or a drug that acts similarly—could be key to treating osteoporosis and preventing and healing broken bones.
“The findings come from a team led by Holly Ingraham, University of California, San Francisco. The researchers knew from studies in mice and humans that a protein related to parathyroid hormone, which is made in the mammary glands, is the main driver for stripping calcium from maternal bones for milk production. As a result of this process, nursing mothers tend to lose a lot of bone. In humans, this bone loss is 10% on average, compared to nearly 30% in mice. Fortunately, these losses are reversed after lactation ends, suggesting to the researchers there must be some other bone-strengthening factor in play.” * * *
“In future studies, the researchers want to gain insight into the underlying mechanisms of CCN3. They also plan to explore the hormone’s potential for treating bone loss in people at increased risk, including postmenopausal women, breast cancer survivors taking estrogen blockers, and those with other conditions leading to unhealthy bone mass, such as genetic bone disorders, chronic kidney disease, or premature ovarian failure. They suggest that more immediate local uses for CCN3 include fracture repair, cartilage regeneration, and bone improvements for anchoring dental implants. It’s a great example of how finding an answer to a scientific puzzle—like how maternal bones stay strong during breastfeeding—can potentially lead to advances that help many more people.”
“Risk for psychiatric disorder or suicide attempt is particularly high in the first year following hospitalization for heart disease, and patient support is important to lower such risk, researchers reported.
“A large analysis of the U.K. Biobank to understand the prevalence and risk factors for psychiatric disorder or suicide attempt following CVD hospitalization was published in the Journal of the American Heart Association.
“It’s crucial to pay attention to both physical and mental health after a stroke or heart disease diagnosis,” Huan Song, MD, PhD, professor of epidemiology at the West China Biomedical Big Data Center, West China Hospital, Sichuan University in Chengdu, China, said in a press release. “If you or a loved one has been hospitalized for heart disease, be aware that mental health issues may arise during recovery. It’s important to monitor for signs of anxiety, depression or suicidal thoughts. These mental health challenges are common and treatable.”
“The Cigna Group beat investor expectations and reported major growth at Evernorth in its second quarter earnings published Aug. 1.
“Total revenues in the second quarter were $60.5 billion, up 24.6% year over year, and primarily driven by significant growth at Evernorth. The company reported $1.5 billion in net income, up 6%.
“The insurance side of the business, Cigna Healthcare, reported second-quarter revenues of $13.1 billion, up 3.4% from the previous year. As of June 30, Cigna had 19 million total medical members, down 2.4% year over year.
“The company’s medical loss ratio was 82.3% in the second quarter, compared to 81.2 percent during the same period last year.”
“EncircleRx, a program helping employers control the cost of GLP-1 drugs for weight-loss, has reached 2 million enrollees in its first six months.
“Cigna launched the program in March, which it called the “first-ever” GLP-1 management program with a financial guarantee for health plans.
“GLP-1 medications approved for weight loss include Wegovy, Saxenda and Zepbound. These drugs can cost upward of $1,000 a month. On an Aug. 1 call with investors, Cigna CEO David Cordani said GLP-1s are expected to be the No.1 driver of pharmacy benefit trends for plans of all sizes in 2024.
“Eric Palmer, president and CEO of Evernorth, Cigna’s health services business, told investors the program is “growing nicely,” reaching 2 million enrollees.”
“Cigna’s chief executive is pledging to be more aggressive in defending its pharmacy benefit manager amid mounting public criticism of the drug middlemen — and as its PBM, Express Scripts, continues to drive soaring revenue for the insurance giant.
“That includes heavier lobbying in Washington, sponsoring more research into the value of PBMs and working more with independent pharmacists, which have been some of PBMs’ loudest critics, CEO David Cordani told investors on a Thursday morning call to discuss the payer’s second quarter results.
“UnitedHealthcare will launch its national gold-card program on Oct. 1.
“The program will reward contracted provider groups that “consistently adhere to evidence-based care guidelines,” according to an Aug. 1 policy update from UnitedHealthcare. The program will apply to all UnitedHealthcare commercial, individual exchange, Medicare Advantage and community plans.
“The payer said that details on how to determine whether a provider group has qualified for the program will be published Sept. 1. Additional details will be available on UHCprovider.com.”
“After a slow start, the launch of Biogen’s prized drug for Alzheimer’s disease is picking up, which has given company leadership more confidence that it can both drive growth and compete with a rival medicine from Eli Lilly.
“Sales of Biogen’s drug, Leqembi, were $40 million between April and June, more than double the total seen across the first three months of this year. On a Thursday call with reporters, CEO Chris Viehbacher said north of 5,000 people in the U.S. are taking Leqembi, though it’s “hard to know” the exact number because of how the drug is administered. Patient registries have also become “confusing” and less useful sources of information, according to Viehbacher.
“We’re pretty convinced Leqembi is on the right path now,” he said.”
“Shares of Moderna fell nearly 20% on Thursday after the company lowered its 2024 financial forecasts amid slowing sales and growing competition for its vaccines.
“Alongside its second-quarter earnings report, Moderna cut its projected product sales outlook this year from $4 billion to an expected $3 billion to $3.5 billion. The biotechnology company cited multiple reasons for lowering its estimate, from expectations of lower COVID-19 vaccine sales in Europe, to deferred government contracts and tough competition from other vaccine developers. The announcement triggered a stock sell-off and “raises doubt about hitting profitability and cash burn goals,” Jefferies analyst Michael Yee wrote in a research note Thursday.
“Moderna rose to prominence through the development of a COVID-19 shot that was among one of the industry’s most lucrative products a few years ago. But sales have plummeted since, as COVID-19 has transitioned to an endemic disease, more business is taking place in the commercial market and massive bulk government contracts have been harder to secure.”
“An examination of hospital rankings from CMS and U.S. News & World Report suggests a notable overlap in organizations recognized for high performance.
“All but three of U.S. News‘ 2024-25 Honor Roll hospitals also earned top marks in CMS’ Overall Hospital Star Ratings released July 31.”
“While the results are closely aligned, CMS and U.S. News use different methodologies and criteria for their evaluations. CMS assessed more than 4,600 hospitals nationwide on 46 hospital quality measures, assigning 381 hospitals with five stars. Measures are divided into five categories: safety of care, mortality, patient experience, readmission rates, and timely and effective care. Data reporting periods range from July 2019 to April 2022, depending on the measure.”
“Many hospitals have struggled to offer safe and effective care in the years since the COVID-19 pandemic turned their operations upside down.
“The Centers for Medicare and Medicaid Services’ 2024 hospital star ratings, released Wednesday, showed more hospitals than last year performed poorly. That may be, in part, because the data submitted by hospitals was from April 2019 through March 2023 and excluded facilities’ performance on quality metrics from the first half of 2020.
“Last year’s ratings were based on data from 2018 through the beginning of 2022. In effect then, the data determining 2024 performance reflected more of the heart of the pandemic.
“Across peer groups and facility types, nearly 10% of the 2,834 hospitals CMS rated received one star, 21% got two stars, 29% got three stars, 27% earned four stars and 13% got five stars.”
“Jefferson Health and Lehigh Valley Health Network completed a merger Thursday that creates a $15 billion nonprofit health system serving Pennsylvania and New Jersey.
“Jefferson Health CEO Dr. Joseph Cacchione, who is leading the new enterprise, said the provider has its sights set on integrating the organization’s 32 hospitals and more than 700 locations over the next few years. The company will operate under the Jefferson Health brand.”
“Community Health Systems plans to sell its three hospitals in Pennsylvania to nonprofit health system WoodBridge Healthcare for $120 million, exiting the state altogether, the system said Tuesday.
“The deal is expected to close in the fourth quarter, pending regulatory reviews.
“During CHS’ second quarter earnings call last week, CFO Kevin Hammons said the company hoped to sell upwards of $1 billion in assets this year to help pay down its debts. This transaction is part of that divestiture plan, CHS said in a statement.”
“The White House on Wednesday backed proposals to permanently stiffen penalties on synthetic-drug traffickers, monitor machines used to make fentanyl pills and close a loophole that allows criminal groups to easily ship drugs in packages.
“President Biden announced the initiatives as state and federal officials from both politicalparties grapple with how to curb a drug epidemic that has killed more than 300,000 people during his administration.
“The crisis is fueled by fentanyl, the potent synthetic opioid manufactured by Mexican criminal groups and smuggled into the United States. Border security has proved to be a political flash point, with Republicans hammering the White House aboutthe failure to stop fentanyl from entering the country.”
“At a Capitol Hill briefing July 31, hospital and health care leaders shared strategies and stories highlighting the importance of passing the Safety from Violence for Healthcare Employees Act (H.R. 2584/S. 2768), bipartisan legislation that would provide federal protections against violence to hospital workers.
“The panel featured: Mark Boucot, president and CEO of Potomac Valley Hospital in Keyser, W.Va., and Garrett Regional Medical Center in Oakland, Md.; Rachel Culpepper, DNP, RN, general medicine service line director at Indiana University Health West Hospital in Avon, Ind.; and James Phillips, M.D., an emergency room physician in Washington, D.C. and chair of disaster medicine at the American College of Emergency Physicians. Sen. Joe Manchin, I-W.Va., author of the Senate bill, also delivered remarks.
“The Centers for Medicare & Medicaid Services July 31 issued a final rule for fiscal year 2025 for the skilled nursing facility prospective payment system, which will increase aggregate Medicare spending by 4.2% or $1.4 billion compared to FY 2024. This reflects a 3% market basket update, a 1.7 percentage-point increase to counter the agency’s market basket error in FY 2023, and a 0.5 percentage point cut for productivity. CMS also revised its regulations regarding its nursing home enforcement authority to allow the agency to impose additional financial penalties on facilities where health and safety deficiencies are identified.”
The Centers for Medicare & Medicaid Services July 31 released the fiscal year 2025 final rule for inpatient rehabilitation facilities, which will update IRF payments by an estimated 3% overall (or $300 million) in FY 2025. This includes a 3.5% market basket update, which is reduced by a 0.5 percentage point cut for productivity. However, IRF payments will be further decreased by an estimated 0.2% ($20 million) due to the updated outlier threshold.
“The Centers for Medicare & Medicaid Services July 31 issued the final rule for the inpatient psychiatric facility prospective payment system for fiscal year 2025. CMS will increase IPF payments by a net 2.5%, equivalent to $65 million, in FY 2025. This increase includes a market-basket update of 3.3% minus a productivity adjustment of 0.50 percentage points; it also accounts for an update to the outlier threshold so that estimated outlier payments will remain at 2.0% of total payments, resulting in a 0.3% decrease to aggregate payments.”
“Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced more than $68 million in Ryan White HIV/AIDS Program funding to provide family-centered medical care and essential support services for women with low incomes, infants, children, and youth with HIV. This announcement supports and advances the Biden-Harris Administration’s National HIV/AIDs Strategy.” * * *
“HRSA’s Ryan White HIV/AIDS Program provides a comprehensive system of HIV primary medical care, medication, and needed support services to more than 560,000 people with HIV who have low incomes. The program focuses on tailoring approaches to best meet people with HIV and their communities where they are and addressing factors, like access to food, childcare, housing, and transportation that directly affect the ability of patients to enter and stay in care.”
“The Senate Homeland Security and Governmental Affairs Committee on Wednesday unanimously advanced legislation codifying recent changes to the federal hiring process stressing applicants’ skills and experience over educational attainment.” * * *
“By a 10-1 vote, the panel [also] moved legislation expanding the list of federal positions in which employees are “further restricted” from partisan political activity under the Hatch Act. Sen. Rand Paul, R-Ky., was the lone dissenter.
“The bill (S. 4656), introduced by Sen. Chuck Grassley, R-Iowa, and Committee Chairman Gary Peters, D-Mich., would add employees of agency offices of inspectors general to the Hatch Act’s list of employees with additional guard rails on political activity, alongside other oversight agencies like the Office of Special Counsel and Merit Systems Protection Board and national security organizations like the National Security Agency and FBI.”
From the public health and medical research front,
“Patients with early Alzheimer’s disease treated with a medication developed by Eisai and Biogen for up to three years experienced less cognitive decline than what’s expected of untreated patients based on historical data, according to new study results reported Tuesday. The manufacturers said the data support long-term, continuous use of the drug.
“The three-year benefit seen in patients provided Leqembi remains modest — a 31% slowing of cognitive decline, slightly more than a 27% slowing previously seen in an 18-month placebo-controlled trial. It’s still unclear if the new data will convince doctors to use Leqembi continuously, or if the treatment’s benefit is clinically meaningful for patients, experts told STAT. * * *
“Eisai’s argument for continuing Leqembi treatment contrasts with Lilly’s approach to its [similar FDA approved] drug Kisunla. Lilly argues that once amyloid is cleared in treated patients, they can stop the therapy, making Kisunla a more convenient option, and potentially less expensive compared to continuous dosing.”
“The Food and Drug Administration (FDA) has approved Zunveyl (benzgalantamine) for the treatment of mild to moderate dementia of the Alzheimer type in adults.” * * *
“The approval of Zunveyl is a pivotal moment in the fight against Alzheimer disease as it is only the second oral AD treatment to be approved in more than a decade,” said Michael McFadden, CEO of Alpha Cognition. “Zunveyl was designed to address a critical need for a tolerable and effective treatment that can potentially enhance patients’ daily lives with improved long-term outcomes.”
Zunveyl is supplied as 5mg, 10mg, and 15mg delayed-release tablets. The product is expected to be available in the first quarter of 2025.
The National Cancer Institute posted its latest Cancer Information Highlights.
At this link, Beckers Hospital Reviews points out “eight new shortages to know about, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists”
“An unexpected spike in inpatient utilization during the latter half of the quarter, which continued into July, dinged Humana’s finances. Executives cited the effects of the two-midnight rule, which requires insurers to cover inpatient stays when providers expect patients to remain in the hospital for at least two midnights. The company expects this trend to persist through 2024.”
“Medicare Advantage giant Humana expects to lose a “few hundred thousand” members in its marquee business next year, after seriously shrinking its benefits and exiting markets for 2025 in a bid to boost profits, the insurer disclosed Wednesday.
“It’s the first time Humana has estimated membership losses from culling its plans, and squares with past guesses from market watchers. MA margins should improve as a result, setting Humana on the path to a long-term target of at least 3%, management told investors on a call. Currently, analysts peg Humana’s MA margin as basically flat, as the Kentucky-based payer has been rocked by rising medical costs among seniors in the privately run Medicare plans.
“However, Humana also expects to emerge from 2024 stronger from a membership perspective than it previously thought. The insurer now expects to add 225,000 MA members this year, up from its previous forecast of 150,000 new lives.”
“In its first quarter with new CEO Chuck Divita, national telehealth provider Teladoc Health posted a net loss of $838 million in Q2 that included a nearly $800 million impairment charge attributed to falling expectations for its virtual mental health solution, BetterHelp.
“Teladoc is withdrawing its 2024 outlook, and its three-year business outlook based on its Q2 losses. It now expects low single-digit year-over-year revenue growth for 2024. BetterHelp’s revenue in Q2 decreased 9% from Q2 2023, to $265 million.
“Amid slowing growth in recent quarters with a saturated telehealth market and the abrupt departure of longtime CEO Jason Gorevic in April, the company’s net loss skyrocketed in Q2 2024 to $837.7 million, or $4.92 per share, compared to a loss of $65 million, or $0.40 per share, during the same quarter a year ago.” * * *
“Divita said transitioning BetterHelp to accept insurance is the next logical step for the company. Customers that leave the platform cite high out-of-pocket costs and lack of insurance coverage, he noted.
“BetterHelp expects to have the technical capabilities for insurance coverage by year-end and expects insurance contracting to roll out over the course of 2025.”
“GSK on Wednesday lowered its forecast for vaccine sales this year, citing inventory changes and shifting retail prioritization in the U.S. for its shingles shot Shingrix.
“The British pharmaceutical company now expect sales from its vaccines division to increase by low to mid-single digit percentages, down from the high single digit to low double-digit growth it predicted in May.
“Shingrix, now one of GSK’s top products, earned 832 million pounds, or about $1.1 billion, in the second quarter, down from the first three months of the year but up year to date. Sales of Arexvy, the company’s new vaccine for respiratory syncytial virus, totaled 62 million pounds as demand eased along expected seasonal patterns.”
Per MedTech Dive,
“Stryker set another record in the second quarter for installations of its Mako orthopedic robot, ahead of two planned launches of spine and shoulder features later this year.
“As you’ve seen, quarter after quarter, our Mako installations are very high. That leads to future strong demand for hips and knees,” Stryker CEO Kevin Lobo told investors on Tuesday.
“This is the third quarter in a row where management has noted record installations, BTIG analyst Ryan Zimmerman said in a research note.
“Trust in physicians and hospitals decreased sharply during the COVID-19 pandemic, and higher levels of trust were tied to greater odds of getting vaccinated for COVID-19 or influenza, according to a survey study of U.S. adults.
“Among over 400,000 unique respondents, the proportion of adults who agreed they had “a lot of trust” in physicians and hospitals declined from 71.5% in April 2020 to 40.1% in January 2024, reported Roy Perlis, MD, MSc, of Massachusetts General Hospital in Boston, and colleagues in JAMA Network Open. * * *
In regression models, factors associated with lower trust as of the spring and summer of 2023 included being 25 to 64 years of age, female gender, lower educational level, lower income, Black race, and living in a rural setting. Even when the researchers controlled for partisanship, these associations persisted. * * *
“We as physicians and public health officials can talk until we’re blue in the face about things like vaccination and other public health behaviors,” Perlis commented. “But if people don’t trust us, it doesn’t matter — we’re talking to ourselves.” * * *
“Perlis and his team also gathered information about why respondents had low levels of trust. Participants with the two lowest levels of trust identified the following reasons: financial motives over patient care (35%), poor quality of care and negligence (27.5%), influence of external entities and agendas (13.5%), and discrimination and bias (4.5%).”
FEHBlog observation: Wow.
The Society for Human Resource Management tells us,
“The Employment Cost Index (ECI) increased 0.9% in the second quarter of the year, new data finds, after rising 1.2% last quarter, according to Bureau of Labor Statistics data released July 31. Wages and salaries increased 0.9% and benefit costs increased 1% from March 2024. Many economists forecasted that the ECI would rise 1%.
“Year over year, compensation costs in the U.S. for civilian workers—including pay and benefits—rose4.1%, down slightlyfrom the 4.2% year-over-year rise in the first quarter of 2024. Meanwhile, compensation for state and local government workers is up 4.9%.
“Wages and salaries grew 4.2% for the 12-month period ending in June 2024 and rose 4.6% for the 12-month period ending in June 2023, according to the BLS. Benefit costs grew 3.8% over the year and rose 4.2% for the 12-month period ending in June 2023.” * * *
“Although wage growth appears to be slowing, it’s still robust, said Sydney Ross, junior economic researcher at SHRM.
“As shown in the recent JOLTS report, employers are still dealing with a tight labor market and persistent talent shortages across key industries,” she said. “This means there will be more competition between employers for skilled talent, especially for those in specialized industries.”
“The Centers for Medicare & Medicaid Services (CMS) is creating a voluntary demonstration program to support changes to Medicare Part D under the Inflation Reduction Act (IRA).
“The agency also finalized bid information for contract year 2025, with a base beneficiary premium increase of $2.08 for people with Part D.
“The IRA is designed to limit yearly premium increases from contract year 2024 to 2029. Because Part D and prescription drug plans can result in plan price variation for beneficiaries, CMS is creating the Part D Premium Stabilization Demonstration to “improve premium stability for participating stand-alone prescription drug plans,” according to a news release.
“This should result in a smoother rollout in how the IRA requires Medicare to support Part D prescription plans. The program will test whether even more financial requirements would improve the Part D program, a senior CMS official said Monday afternoon.”
Here is the link to the CMS fact sheet for the Part D demonstration project and bid information.
“The Centers for Medicare & Medicaid Services July 30 issued a final rule updating hospice payment rates for fiscal year 2025. Overall, CMS finalized a 2.9% net increase to payments compared with FY 2024. This includes a 3.4% market basket update and a 0.5 percentage point cut for productivity. As a result of this increase, the hospice payment cap will be increased from $33,494.01 to $34,465.34. CMS also finalized adoption of the most recent Office of Management and Budget statistical area delineations, which will affect the wage index used by some providers. In addition, the rule adopts a new patient-level data collection tool to replace the existing Hospice Item Set and also adds two new process measures beginning in FY 2028.”
Here is a link to the CMS fact sheet on the hospice payment rates.
“The Centers for Disease Control and Prevention is launching a $5 million initiative to provide seasonal flu shots this fall to about 200,000 livestock workers in states hardest hit by the bird flu outbreak.
“Workers on poultry, dairy and pig farms are at greatest risk of being simultaneously exposed to seasonal flu and the H5N1 bird flu that has infected at least 172 dairy herds in 13 states, according to the Department of Agriculture. Such exposures raise therare risk of the two viruses exchanging genetic material, a process known as reassortment, to create a new influenza virus that “could pose a significant public health concern by becoming more efficient at spread and potentially more severe,” Nirav Shah, CDC’s principal deputy director, said at a news briefingTuesday. Widespread seasonal flu vaccination would reduce that risk, he said.
“Thirteen farmworkers have been infected in the outbreak. All had mild symptoms and recovered.
Today, the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) released the results of the 2023 National Survey on Drug Use and Health (NSDUH), which shows how people living in United States reported their experience with mental health conditions, substance use and pursuit of treatment. The 2023 NSDUH report includes selected estimates by race, ethnicity and age group. The report is accompanied by two infographics offering visually packaged highlight data as well as visual data by race and ethnicity.
The press release includes key findings from the survey.
MedTech Dive tells us about how a “[p]atient shares a day in the life with diabetes at FDA’s first Home Health Hub meeting. The initiative, led by new CDRH Acting Director Michelle Tarver, is intended to improve health equity by including people’s living conditions in device design.”
The Assistant Secretary of Labor for Employee Benefit Security seeks in her blog to “raise awareness and break the silence surrounding minority mental health.
HHS’s Office for Civil Rights amended its Change Healthcare Cybersecurity Incident FAQ three to read as follows:
“3. Have Change Healthcare or UHG filed a breach report with HHS?
“A: Yes, on July 19, 2024, Change Healthcare filed a breach report with OCR concerning a ransomware attack that resulted in a breach of protected health information. Change Healthcare’s breach report to OCR identifies 500 individuals as the “approximate number of individuals affected”. This is the minimum number of individuals affected that results in a posting of a breach on the HHS Breach Portal. Change Healthcare is still determining the number of individuals affected. The posting on the HHS Breach Portal will be amended if Change Healthcare updates the total number of individuals affected by this breach. HIPAA breach reports filed on the HHS Breach Portal may be amended as the breach report form allows a filer to file an initial breach report or an addendum to a previous report.”
Per a press release from the U.S. Attorney for the District of Massachusetts,
“Burlington County Eye Physicians (BCEP), an ophthalmology practice with locations in New Jersey and Pennsylvania, and Dr. Gregory H. Scimeca, an ophthalmologist and the owner of BCEP, have agreed to pay $469,232 to resolve allegations that they submitted and caused the submission of false claims for payment for medically unnecessary transcranial doppler (TCD) tests to Medicare and the Federal Employee Health Benefit (FEHB) Program in violation of the False Claims Act.
“A TCD test is a noninvasive diagnostic test that can be used to estimate the blood flow through certain blood vessels in the brain. Medicare and the FEHB Program reimburse healthcare providers for both performing the test and for interpreting the test results. When a physician does not perform the test, but interprets the results of the test, they only can bill for their professional services of interpreting the test. A physician cannot bill for interpreting the test when they merely review another physician’s interpretation of the results.”
From the public health and medical research front,
“The suicide rate for U.S. children 8 to 12 years old has steadily climbed in the past decade and a half, with a disproportionate rise among girls, data released Tuesday by the National Institute of Mental Health shows.
“The findings, published in the journal JAMA Network Open, highlight pervasive issues regarding mental health that affect U.S. children daily, the study authors said.
“The authors of the study blame no single reason for the increase, but experts not involved in the study say the problem is multifaceted, citing technology, social media and guns as the main culprits.
“Between 2001 and 2022, 2,241 children ages 8 to 12 — known as preteens — died by suicide. While suicide rates were decreasing until 2007, they increased by about 8 percent each year from 2008 to 2022.
“From 2001 through 2007, 482 children ages 8 to 12 died by suicide at a rate of 3.34 per 1 million “preteens. From 2008 to 2022, the number of suicides in that age group rose to 1,759, with a rate of 5.71 per 1 million.”
“If millions of Americans no longer qualify for a statin or a blood pressure medication based on a new calculator updated to better predict their risk, that could lead to 107,000 more heart attacks and strokes over 10 years, a new study estimates.
“The research paper, published Monday in JAMA, is the second in two months drawing attention to widely used medicines designed to prevent the leading cause of death in the United States.
“The research is creating a buzz in cardiology circles while two medical societies formulate new guidelines to inform practice, weighing the new risk models and existing thresholds that trigger prescriptions.
“This is concerning that we could reverse eligibility for many millions of Americans,” Raj Manrai, assistant professor of biomedical informatics in the Blavatnik Institute at Harvard Medical School and senior author of the new study, said in an interview. “We really need to reexamine the other side of the equation here, which is how those risk estimates are going to be used by patients and physicians to decide who and when individuals receive preventative care, particularly statins and antihypertensive blood pressure medications.”
Per a National Institutes of Health (NIH) press release,
“A new global study sponsored by the National Institute of Allergy and Infectious Diseases has determined that cabotegravir, an antiretroviral medication used for HIV treatment, is safe for use before and during pregnancy. The study analyzed the pregnancy and infant outcomes of using long-acting injectable cabotegravir in more than 300 pregnant women. These findings fill an important knowledge gap that will help increase access to HIV treatment for cisgender women before, during, and after pregnancy.”
NIH also posted a summary of recent medical research developments.
“A new study suggests that an older GLP-1 drug may help protect the brains of people with early Alzheimer’s disease, supporting the case for further research on the class of medications — originally developed for obesity and diabetes — in neurological diseases.
“The Phase 2 randomized trial, led by researchers at Imperial College London, tested Novo Nordisk’s liraglutide, the predecessor to Ozempic and Wegovy, in patients with early Alzheimer’s disease over one year. The study did not meet the primary endpoint of change on a measure of how much sugar the brain uses for energy, but it showed that patients on the drug had nearly 50% less shrinking in parts of the brain that control memory and learning and that treated participants had a slightly slower decline in cognitive function.”
“A growing set of evidence suggests thatusingsemaglutide could lead to decreased substance use, and a large new study shows a promising link between the medication and tobacco use. But experts emphasize that much more research is needed before using the medications off-label for smoking cessation.
“In a study published Monday in the journal Annals of Internal Medicine, researchers tracked the medical records of more than 200,000 people who started medications to treat type 2 diabetes, including nearly 6,000 people using semaglutide medications such as Ozempic.
“Over the course of a year, people who started using semaglutide were significantly less likely to have medical encounters for tobacco use disorders, prescriptions for medications for smoking cessation or counseling for smoking cessation than those who started other diabetes medications such as insulin and metformin.
“The study authors note that the reasons individuals might be less likely to seek medical treatment for tobacco use disorder vary widely; it could suggest that their tobacco use decreased or that they’ve become less willing to seek help to quit smoking, for example.”
“Four pharmaceutical companies involved in the first U.S. negotiations over prices for the Medicare program said they do not expect a significant impact on their businesses after seeing confidential suggested prices from the government for their drugs that will take effect in 2026.
“Top executives from Bristol Myers Squibb (BMY.N), opens new tab, Johnson & Johnson (JNJ.N), AbbVie (ABBV.N), and AstraZeneca (AZN.L), which have five of the 10 drugs chosen for the first wave of negotiations, described their newly informed views on quarterly conference calls.”
“Drug prices are expected to increase 3.81% next year, propelled by expensive cell and gene therapies and glucagon-like peptide agonists.
“The estimate from Vizient, a group purchasing organization, tops the company’s 2024 drug cost growth projection of 3.42%. Vizient uses recent provider purchasing data to forecast what hospitals and health systems might pay for drugs after discounts and rebates.”
“Pfizer’s quarterly results beat Wall Street estimates and the drugmaker raised its outlook, denoting strong demand for its non-Covid products. * * *
“Pfizer’s revenue was boosted by several acquired products and recent commercial launches, which offset a decline from its Covid-19 vaccine Comirnaty, and unfavorable foreign currency translation. Excluding Covid products, revenue rose 14% on the year.
“Chief Financial Officer David Denton said this was the first quarter of top-line growth since the end of 2022, when Pfizer’s Covid-related revenues peaked.
“Pfizer Chief Executive Albert Bourla said in an interview the company is making progress on its strategy to drive growth and improve the company’s share price through dealmaking, including its $43 billion acquisition of cancer-maker; cost-cutting programs; and launching new medicines.
“Shares of Merck fell 9% Tuesday after the company reported that in the second quarter, it saw a decrease in shipments of its HPV vaccine Gardasil in China, a significant market for the drug.
“The company brought in $2.48 billion in sales of Gardasil in the second quarter, slightly lower than estimates of $2.5 billion made by analysts polled by Visible Alpha.
“Despite the Gardasil hit, Merck raised guidance for full-year sales to $63.4 to $64.4 billion from the previously guided $63.1 to $64.3 billion. The company lowered guidance for full-year earnings, though, to $7.94 to $8.04 per share from the previously forecasted $8.53 to $8.65, due to expenses related to the acquisition of ophthalmology-focused biotech EyeBio.”
“Google will not renew its contract with Amazon’s primary care subsidiary One Medical, ending a longstanding agreement that gave Google employees access to discounted medical care, the companies confirmed to Healthcare Dive.
“The contract loss is a major blow for the provider. Google was One Medical’s largest customer, accounting for 10% of its revenue in 2020. That figure dipped slightly in 2021, after which One Medical stopped disclosing its finances publicly.
“The decision is not because One Medical was acquired by Google rival Amazon last year, a Google spokesperson said. The current contract will expire at the end of 2024.”
“Mental telehealth coverage has contracted slightly since the government declared an end to the COVID-19 public health emergency last year, according to a new study published in JAMA.
“The study, which analyzed over 1,000 outpatient mental health treatment facilities, found thatpublicly ownedmental health treatment facilities were less likely to have adopted telehealth services at all, and more likely to have discontinued them after the Biden administration ended the COVID PHE, compared to privately owned facilities.
“The results come as lawmakers are considering whether to permanently expand telehealth flexibilities to providers this year, after the federal government enacted temporary policies that expanded access to telehealth services during the pandemic.”
The Washington Post gives us a heads up on the test run of drones to deliver cardiac care to patients in North Carolina.
“What if the first responder on the scene of a cardiac arrest were a drone carrying an automated external defibrillator?
“When every second counts, public safety professionals are increasingly eyeing drones — which can fly 60 miles an hour and don’t get stuck in traffic — to deliver help faster than an ambulance or EMT.
“Starting in September, 911 callers in Clemmons, N.C., may see a drone winging its way to those suffering a cardiac arrest. Under a pilot program operated jointly by the Forsyth County Sheriff’s Office, local emergency services, the Clinical Research Institute at Duke University and drone consulting firm Hovecon, drone pilots from the sheriff’s department will monitor 911 calls and dispatch drones.”
“Theranos’s ambitions for a finger-prick blood test are finally being realized—by other companies.
“”Since May, needle-phobic people in Austin, Texas, have been able to visit pharmacies for routine medical tests on drops of blood squeezed from their fingertips, rather than the usual way of plunging a needle into a vein in the arm and drawing large vials of blood.
The rise and fall of Theranos—the Silicon Valley startup that promised to revolutionize blood testing but ended dissolved, with its founder Elizabeth Holmes convicted of fraud—cast a pall over the idea that critical medical tests could be run on mere drops of blood.
“Demand for alternatives to standard blood draws never went away, however. And companies—including Becton Dickinson and Babson Diagnostics, which make the tests rolling out in Austin—have been working out technological kinks that foiled Theranos.”
FEHBlog observation: As the old saying goes, timing is everything.
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