From Washington, DC (note the FEHBlog is back in Texas after a productive week in DC)
The Society for Human Resource Management tells us,
“The National Labor Relations Board (NLRB) announced it will extend the effective date of its joint employer rule to Feb. 26, 2024, to facilitate resolution of legal challenges to the rule.
“The NLRB released the final rule on Oct. 26 with an implementation date of Dec. 26. The rule was published in the Federal Register on Oct. 27.
“U.S. Sen. Bill Cassidy, R-La., sent a letter informing the NLRB that it was out of compliance with the Congressional Review Act’s 60-day threshold rule, which mandates that the implementation of all major federal rules must be delayed 60 days from when they are received by Congress.
The Internal Revenue Service posted for public comment a draft version of the 2024 Employers’ Tax Guide to Fringe Benefits.
From the public health and medical research front,
“The U.S. flu season is underway, with at least seven states reporting high levels of illnesses and cases rising in other parts of the country, health officials say.
“The Centers for Disease Control and Prevention posted new flu data on Friday, showing very high activity last week in Louisiana, and high activity in Alabama, Florida, Georgia, Mississippi, New Mexico and South Carolina. It was also high in the District of Columbia and Puerto Rico, the U.S. territory where health officials declared an influenza epidemic earlier this month. * * *
“Traditionally, the winter flu season ramps up in December or January. But it took off in October last year, and is making a November entrance this year.”
STAT News offers its observations on this development.
“The early signals from influenza suggest the virus is settling back into the seasonal pattern it followed — to the degree the always mercurial bug follows any pattern — before the pandemic, said Alicia Budd, team lead for domestic flu surveillance at the Centers for Disease Control and Prevention. “All I can say is at this point we are at a pretty typical point in flu activity,” she told STAT.
“Overall, the signs to date appear to portend a winter more like what we knew before the arrival of Covid, said Megan Culler Freeman, an assistant professor of pediatrics specializing in infectious diseases at the University of Pittsburgh.
“Last year as early as August, children’s hospitals across the country were full to the gills … because there were so many children with respiratory distress,” Freeman said. “And I would say that this season is starting to feel a lot more normal. Only now, as we’re getting into November — even towards mid- to late- November — we’re starting to see more of our winter volume starting to begin. * * *
“The scientific consensus is still out about whether Covid will be a seasonal virus, transmitting primarily during cold-and-flu season. Many experts think it is heading that way, but hasn’t yet settled into that pattern.”
The American Medical Association explains what doctors wish their patients knew about diabetes 2. Check it out.
“Research suggests that the Novavax [Covid] vaccine is about as safe and effective as the mRNA shots. Its main disadvantage is arriving late to the scene. Vaccine uptake has plummeted since the first shots became widely available in 2021. Nearly 70% of people got the primary vaccines, compared with fewer than 20% opting for the mRNA covid boosters released last year. Numbers have dwindled further: As of Oct. 17, only 5% of people in the United States had gotten the latest covid vaccines, according to the Department of Health and Human Services.
“Daniel Park, an epidemiologist at George Washington University, said low rates might improve if people who felt lousy after their last mRNA shots gave Novavax a try. It protects against severe illness, but researchers struggle to specify just how effective this and other vaccines are, at this point, because studies have gotten tricky to conduct: New coronavirus variants continuously emerge, and people have fluctuating levels of immunity from previous vaccines and infections.
“Still, a recent study in Italy suggests that Novavax is comparable to mRNA vaccines. It remained more than 50% effective at preventing symptomatic covid four months after vaccination. Some data suggests that mixing and matching different types of vaccines confers stronger protection — although other studies have found no benefit.
“Given all this, Park held out for the Novavax vaccine on account of its potentially milder side effects. “Between a demanding full-time job and two young kids at home, I wanted to stay operational,” he said. His arm was sore, but he didn’t have the 24-hour malaise accompanying his last mRNA shot.”
“Eli Lilly’s cardiometabolic drug portfolio is expanding with newly approved therapies. To meet demand for those therapies and additional products to come, the company is building a new $2.5 billion manufacturing site in Germany.
“Construction on the new plant is on track to begin next year. Lilly expects the site will start operations in 2027, becoming its sixth manufacturing site in Europe. The company said it has invested more than $11 billion in its global manufacturing capabilities in the past three years to support the production of medicines across its portfolio.
“Some of Lilly’s capital investments have been closer to the Indianapolis-based drugmaker’s home. Last year, the company committed more than $2 billion to two new facilities in Lebanon, Indiana for the manufacturing of existing products and future ones, the company said in its annual report. Lilly also invested more than $1 billion in a new facility in Concord, North Carolina, for the manufacturing of injectable products and devices. Earlier this year, Lilly pledged to spend an additional $450 million to expand capacity at a site in Research Triangle Park that also makes injectable products, including new blockbuster medicine Mounjaro.”
“AstraZeneca’s new health-tech business, Evinova, launched Monday, with several big-name partnerships already in place and a goal to “better meet the needs of healthcare professionals, regulators and patients.”
“Evinova’s main focus will be helping to optimize their clinical trials for biotechnology companies, pharmaceutical firms and CROs, or contract research organizations, in an effort to reduce the time and costs associated with developing new medicines.
“Two CROs, Parexel and Fortrea, have agreed to offer Evinova’s digital health solutions to their customers. Evinova is also collaborating with Accenture and Amazon Web Services to “accelerate industry adoption and sustain and expand the global reach of its digital products.”
“The financial outlook for major health plans is stable in the face of notable potential headwinds heading into the end of the year, according to a new report from Moody’s Investors Service.
“The Moody’s analysis said earnings in the third quarter were on par with reports from the second quarter and that the industry’s stability is in line with expectations. However, the researchers said they were expecting payers to face different challenges as 2023 got underway.
“A notable trend that emerged in the second quarter was increased utilization in Medicare Advantage (MA), which peaked in the second quarter thanks to a boost in outpatient care. While the trend did stabilize in the third quarter, “it did not get better,” the Moody’s analysts wrote.
“Centene was the lone exception, and it reported a lower medical loss ratio for MA in the third quarter of 2023 compared to the prior-year quarter, according to the report.”
“As the industry continues to debate the promise and risks of artificial intelligence in healthcare, patients are bullish on the potential for generative AI to improve access and even lower healthcare costs.
“More than half (53%) of U.S. consumers believe generative AI could improve access issues and shorten wait times for medical care, according to a survey by Deloitte’s Center for Health Solutions. A little less than half of consumers (46%) say it has the potential to make healthcare more affordable.”
Congress is back home this week to celebrate Thanksgiving. Roll Call has made available a tentative 2024 Congressional calendar.
FedSmith reports that the U.S. Office of Personnel Management issued a final 2024 calendar year locality pay rule last week.
“For 2024, four new locality pay areas have been established by the final regulations. These are:
“Rochester-Batavia-Seneca Falls, NY; and
“Spokane-Spokane Valley-Coeur d’Alene, WA-ID.
“The President will set locality pay rates for these four areas. This usually occurs in late December.”
MedPage Today suggests that Medicare coverage of GLP-1 anti-obesity drugs is the key to lower prices. Medicare coverage would benefit FEHB plans with Medicare Part D EGWPs. While Medicare would pay lower prices for these drugs, the FEHBlog doubts that Medicare coverage will help payers without Medicare Part D EGWPs.
From the public health and medical research front,
“Shortly after a baby is born, doctors clamp the umbilical cord linking the infant to the placenta, which is still inside the mother’s uterus, and then cut it. New research shows that if doctors wait at least two minutes after the birth to clamp the cord, they significantly improve in-hospital survival rates for premature infants.
“Delayed cord clamping — an intervention that can be introduced at relatively little cost — is believed to help because it allows umbilical cord blood, which is rich in iron, stem cells and antibodies, to flow back to the baby. Some experts say that it’s not entirely clear why the strategy seems to help, but that the data is convincing.”
Fortune Well tells us what super-agers can teach us about living longer.
“One hundred year-old Maureen Paldo still lives in the same Chicago home that she and her husband purchased when they married after World War II. Paldo, who’s been widowed for about 30 years, says she still manages the stairs, takes walks as often as possible, and loves to have people come to visit. * * *
“Paldo is participating in a a large, genetic study of elders, called the SuperAgers Study, to help researchers answer some key questions about life span and health span. It may even lead to a longevity pill that could help more of us live healthier, longer lives.
“We still don’t really know why some people live well into their ninth or tenth decades of life with few physical or cognitive problems, while others show decline much sooner. While genetics plays a role, we are still learning about all of protective inherited and natural factors, according to Dr. Sofiya Milman, the study’s chief investigator and Director of Human Longevity Studies at the Institute for Aging Research at Albert Einstein College of Medicine in New York. SuperAgers all seem to have the APoE2 gene variant in common, which protects against Alzheimer’s or dementia, but that’s only a partial explanation.
“In one analysis, Milman’s team compared the lifestyle of centenarians to the lifestyle of a general population group from the same birth years. Those in the general population group didn’t live as long, despite similar rates of tobacco and alcohol use, diet, and exercise.
“What is it that makes the difference?” she asks. “We know enough to know that this is a very valuable group to study because looking at smaller groups of superagers and centenarians have indicated that there’s definitely heritability for healthy aging and healthy longevity.”
“Former National Security Agency Executive Director Harry Coker is one step closer to being the next national cyber director after the Senate Homeland and Governmental Affairs Committee advanced his nomination Wednesday.
“Coker, also a former CIA officer, told the panel during the initial nomination hearing that he would plan on continuing the work of his potential predecessors.
“Coker’s nomination comes after the White House was criticized by experts and policy wonks for not nominating Kemba Walden, the current acting national cyber director, to the permanent role. The Washington Post reported that Walden’s personal debts were the White House’s rationale for declining to nominate her.
“Walden’s last day as the acting cyber chief is Friday, according to an ONCD spokesperson.”
On November 14, 2023, the Cybersecurity and Infrastructure Security Agency (CISA) released
“its first Roadmap for Artificial Intelligence (AI), adding to the significant DHS and broader whole-of-government effort to ensure the secure development and implementation of artificial intelligence capabilities. DHS plays a critical role in ensuring AI safety and security nationwide.”its first Roadmap for Artificial Intelligence (AI), adding to the significant DHS and broader whole-of-government effort to ensure the secure development and implementation of artificial intelligence capabilities. DHS plays a critical role in ensuring AI safety and security nationwide.
“Last month, President Biden issued an Executive Order that directed DHS to promote the adoption of AI safety standards globally, protect U.S. networks and critical infrastructure, reduce the risks that AI can be used to create weapons of mass destruction, combat AI-related intellectual property theft, and help the United States attract and retain skilled talent, among other missions. As part of that effort, CISA’s roadmap outlines five strategic lines of effort for CISA that will drive concrete initiatives and outline CISA’s responsible approach to AI in cybersecurity.”
“Despite these measures, a recent study shows that only 26% of the public sector (compared to 40% of the private sector) have a formal approach to building resilience. Moreover, federal agencies whose mission-set centers on critical infrastructure, such as the Departments of Energy or Transportation, still face challenges to maintain legacy toolsin contrast to the public sector as a whole.
“This is because federal agencies need more support to implement modern monitoring tools that help improve their threat detection and response. Without the proper technology in place to match the challenges of today’s threat landscape, it is difficult to remain resilient when faced with an attack. But how might an organization begin to achieve the resilience required for today’s cyber threats?
“It starts with federal agencies prioritizing observability strategies. Despite its growing popularity, observability is a fresh concept – one that can be difficult to define and see as a path to resilience without first understanding its foundation. The roots of observability can simply be traced down to a collection of logs, metrics and traces by which monitoring systems can more proactively mitigate potential threats.”
From the cybersecurity vulnerability and breaches front,
The HIPAA Journal offers its October 2023 Healthcare Data Breach Report.
“For the second consecutive month, the number of reported data breaches of 500 or more healthcare records has fallen, with October seeing the joint-lowest number of reported data breaches this year. After the 29.4% fall in reported data breaches from August to September, there was a further 16.7% reduction, with 40 data breaches reported by HIPAA-regulated entities in October – the opposite trend to what was observed in 2022, when data breaches increased from 49 in August 2022 to 71 breaches in October 2022. October’s total of 40 breaches is well below the 12-month average of 54 breaches per month (median:52 breaches).”
“The Office of Personnel Management faces a tight deadline to set up a new health insurance marketplace for Postal Service employees and retirees to enroll in new plans, starting next year.
“Now OPM is addressing watchdog concerns about whether the IT infrastructure supporting this new USPS marketplace is following federal cybersecurity requirements.
“OPM’s Office of Inspector General, in a flash audit released Friday, raised concerns about the cybersecurity steps OPM took before launching the IT systems that will run the Postal Service Health Benefits (PSHB) Program. * * *
“The IG report focuses on the steps OPM took to launch Carrier Connect, a system OPM uses to communicate and share data with health care providers. [FEHBLog note — FFF presumably refers to sharing data with FEHB plans.]
“According to the report, OPM officials acknowledged the agency started the assessment and authorization process too late in the security development lifecycle — in the summer of 2023 — and knew they would have to launch Carrier Connect under a provisional authority to operate (ATO).
“IT security was not integrated at the beginning, and as a result, many of the required elements of an authorization to operate (ATO) package were not completed before the system was authorized to operate and placed into production,” the IG report states.”
HHS’s health sector Cybersecurity Coordination Center (HC3) posted a PowerPoint presentation about Emotet malware, which HC3 describes as “the enduring and persistent threat to the health sector.”
This week, CISA added six known exploited vulnerabilities to its catalog on November 13, then another three on November 14, and then finally another three on November 16.
“The ransomware group ALPHV (aka “BlackCat”) has filed a formal complaint with the US Securities and Exchange Commission (SEC), alleging that a recent victim failed to comply with new disclosure regulations. * * *
“Putting aside the sheer audacity of the move, ALPHV may be out of luck with the SEC for two reasons.
“For one thing, in a statement provided to BleepingComputer on Wednesday, MeridianLink stated that it wasn’t yet sure if any consumer personal information was compromised, adding that “based on our investigation to date, we have identified no evidence of unauthorized access to our production platforms, and the incident has caused minimal business interruption.” Exactly what data ALPHV stole and published may affect whether the breach is “material,” per SEC language.
“Second, as noted in its original press release, the new SEC disclosure rule only takes effect on Dec. 18. (Smaller companies will have even more leeway, with an extra 180 days before they have to get on board).
“Future victims of similar attacks will have fewer breaks to count on.
“Using the threat of filing a ‘failure to report’ complaint against its own victim to the SEC is a compelling tactic that could weaponize a government regulation for a cybercriminal group’s benefit,” Tiquet warns. “Disciplinary action from the SEC is not to be taken lightly and fines can be very steep.”
“The group of threat actors claiming responsibility for major attacks against MGM Resorts, Caesars Entertainment and Clorox is composed of experts in social engineering, and federal cyber authorities are prodding more victims to come forward.
“Scattered Spider, which deploys AlphV ransomware in some of its attacks, uses multiple techniques and tools to gain remote access or bypass multifactor authentication, federal cyber authorities warned in a Thursday advisory.
“The FBI and Cybersecurity and Infrastructure Security Agency shared technical details and data gleaned from investigations as recently as this month to help organizations thwart and mitigate attacks. Yet, officials say more information is needed, as a lack of reporting hinders law enforcement’s ability to take action.
“Scattered Spider’s high level of activity underscores the importance of prevention and the need for more victim organizations to report cyberattacks to CISA or the FBI, agency officials said.”
“Scattered Spider’s sophisticated technical cyberattacks begin with sophisticated psychological attacks,” said John Riggi, AHA’s national advisor for cybersecurity and risk. “Scattered Spider employs social engineering techniques to deceive end users into providing their credentials, authentication codes or downloading ‘help desk’ tools on their computers that allow the adversary to gain and maintain persistent access to computer networks. Staff should be advised of help desk verification protocols and that help desk personnel should not be asking staff to divulge their credentials or multi-factor authentication codes. Conversely, the help desk should enhance its verification protocols and challenge questions to ensure they do not improperly reset staff credentials and to help staff distinguish valid help desk interaction from social engineering attempts.
On November 15, 2023, CISA issued a #StopRansomware Advisory regarding Rhysida Ransomware.
On November 13, 2023, CISA posted an update to its Royal Ransomware Advisory.
“The updated advisory provides network defenders with additional information on tactics, techniques, and procedures (TTPs) and indicators of compromise (IOCs) associated with Royal ransomware variants. FBI investigations identified these TTPs and IOCs as recently as June 2023.”
Bleeping Computer’s The Week in Ransomware is back this week.
From the cybersecurity defenses front,
On November 17, CISA posted “the Mitigation Guide: Healthcare and Public Health (HPH) Sector as a supplemental companion to the HPH Cyber Risk Summary, published July 19, 2023. This guide provides defensive mitigation strategy recommendations and best practices to combat pervasive cyber threats affecting this critical infrastructure sector. It also identifies known vulnerabilities for organizations to assess their networks and minimize risks before intrusions occur.”
Forta tells us about Amazon Web Services’ Six Pillars of Cybersecurity.
Dark Reading explains how to build a resilient incident response team.
President Biden on Friday named W. Kimryn Rathmell to be the next director of the National Cancer Institute, where the prominent researcher will help oversee several White House-backed initiatives intended to reduce cancer deaths and accelerateclinical breakthroughs.
Rathmell, an expert in kidney cancer, is the chair of medicine at Vanderbilt University Medical Center in Nashville. The Stanford University-trained physician and scientist has been a member of the National Cancer Institute’s board of scientific advisers since 2018, providing guidance to the institute’s leaders on its scientific research and operations. Rathmell’s new role as head of the cancer institute, which the White House said would begin in December, does not require Senate confirmation.
“The Office of Personnel Management faces a tight deadline to set up a new health insurance marketplace for Postal Service employees and retirees to enroll in new plans, starting next year.
“Now OPM is addressing watchdog concerns about whether the IT infrastructure supporting this new USPS marketplace is following federal cybersecurity requirements.
“OPM’s Office of Inspector General, in a flash audit released Friday, raised concerns about the cybersecurity steps OPM took before launching the IT systems that will run the Postal Service Health Benefits (PSHB) Program.”
The Office of Personnel Management this week proposed new regulations delegating its authority to waive the caps on recruitment and relocation incentive payments to federal employees and job candidates to the agencies themselves, a move the federal government’s HR agency says will ease administrative burdens and accelerate the hiring process. * * *
“Under the new process, each agency would be required to designate an official who would be tasked with reviewing and adjudicating waiver requests. Additionally, the new regulations would eliminate the minimum service period required to receive an incentive payment. Currently set at six months, OPM argued that removal of the minimum time period would allow short-term, yet still difficult to fill positions such as paid internships to become eligible for recruitment and relocation incentives.
“Retention incentive payments would not change under the regulatory proposal, as OPM reported that such changes would require the passage of legislation by Congress.”
The Government Accountability Office issued a report on the composition of the federal workforce.
“The federal government aims to hire and promote a workforce that reflects the diversity of the U.S. population.
“We looked at a decade of federal employment trends. For example, from 2011-2021 there were minor changes in the representation of historically disadvantaged racial groups—like Black or African American and Asians—in the federal workforce. But several of these groups made gains in senior executive service positions.
“The percentage of Hispanic federal workers also increased. But in FY 2021, Hispanic individuals made up 10% of the federal workforce, even though they represented 18% of the civilian labor force.”
“The U.S. Centers for Disease Control and Prevention said on Thursday it has expedited the release of more than 77,000 additional doses of Sanofi (SASY.PA) and AstraZeneca’s (AZN.L) respiratory syncytial virus (RSV) drug Beyfortus.
“The additional doses, which the CDC said will be distributed immediately to physicians and hospitals, will help improve the availability of the drug at a time when a surge in cases of the disease is outpacing supply.
“Beyfortus was approved earlier this year to prevent the disease in infants and toddlers.
“CDC said the agency, along with the U.S. Food and Drug Administration, will continue to be in close contact with the manufacturers to ensure availability of additional doses through the end of this year and early 2024 to meet the demand.”
In FEHB News, Federal News Network offers a lengthy and informative exchange with Kevin Moss from Consumer Checkbook.
From the public health and medical research front,
“Flu activity in many parts of the United States is starting to rise more rapidly, signaling that flu season is on the horizon, the Centers for Disease Control and Prevention reported Friday.
“With Americans set to travel for Thanksgiving gatherings next week, people who’ve been waiting to get a flu shot should think about acting now, Alicia Budd, the CDC’s team lead for domestic flu surveillance, told STAT.
“Really what we’re seeing is a more sharp increase in activity, week over week, and we know from experience when that happens often times we are entering into that period of even more increased activity,” Budd said. “It’s a great time for people to get vaccinated, if they’ve been holding off.”
An estimated 36 million adults in the United States have received the updated COVID-19 vaccine as of Monday according to new data from the federal government. Additionally, about 3.5 million children have also gotten the updated shot, according to the survey, which is a sample size of the U.S. population, from the Centers for Disease Control and Prevention. This is roughly equal to the number of Americans who had received the bivalent booster — which was targeted against different COVID variants — by this time last year.
The Wall Street Journal reports,
“The Food and Drug Administration said it is screening cinnamon shipments from several countries as part of its investigation of illnesses potentially linked to pouches of cinnamon-flavored applesauce.
“The federal agency said this week it believes the cinnamon used in these products could be the source of lead contamination. There have been 34 reports of lead-related illnesses potentially tied to the recalled products.
“The FDA, which has been investigating the lead illnesses since October, said they are potentially linked to contaminated children’s fruit puree and applesauce pouches. WanaBana, Weis Markets and Schnucks brands have recalled cinnamon-flavored fruit puree and applesauce pouches.”
“The rate of premature birth in the United States remains high, especially in the southern region of the country, according to the infant and maternal health nonprofit March of Dimes.
“The group’s annual “report card” on US maternal and infant health, released Thursday, says that the nation’s preterm birth rate – the rate of babies born before 37 weeks gestation – was 10.4% in 2022, down only 1% from 2021’s rate, which was the highest in more than a decade.
“We went from 10.5% to 10.4%. It’s flat,” said Dr. Elizabeth Cherot, president and chief executive officer of March of Dimes. “A slight change is just not big enough in that direction.”
The rate of child and teen cancer deaths in the U.S. fell 24% from 2001 to 2021, according to a CDC report released Thursday. The report looked at death rates, for Black, Hispanic and non-Hispanic whit youths up to 19 years old. These groups comprised 92% of all youth cancer deaths in 2021, the report noted.
Per STAT News, while Wegovy and Zepbound ride high, interest in weight loss drugs that preserve muscle is surging.
[B]iotech startups are hoping to use those [earlier Johns Hopkins] findings to create what they believe will be better weight loss medications. In the last several months, multiple companies have disclosed they are testing drugs that preserve or grow muscle while reducing fat, as shown in the updated STAT Obesity Drug Tracker. They hope that their drugs, possibly when used in conjunction with existing obesity treatments, will result in healthier weight loss.
Rochester, Minnesota-based Mayo Clinic reported increased year-over-year operating revenue and income in its third-quarter earnings, on higher outpatient visits and surgical cases.
The nonprofit posted $4.5 billion in operating revenue, up 8.2% year over year, and $302 million in operating income. Operating expenses rose 4.8% year over year, totaling nearly $4.2 billion.
The earnings mark the third quarter Mayo has posted net income after the operator struggled last year. The health system reported profits last year that were half its 2021 returns, after contract labor expenses increased 37% year over year.
Proceeds from the deal, which is expected to close in the first quarter in 2024, will primarily go toward payingdebt, Tenet said in a news release.
Under the agreement, Dallas-based Tenet’s financial services subsidiary Conifer Health Solutions will also provide revenue cycle management for the hospitals and their related operations under an expanded 15-year contract.
CommonSpirit Health reported a $441 million operating loss in the first quarter of the 2024 fiscal year on increased expenses.
The system expects a California assistance fund — due to be approved later this fall — to offset its operational losses slightly. However, CommonSpirit’s net loss ballooned to $738 million in the quarter as investments faltered, compared to a $413 million loss same time last year, according to its earnings report filed Wednesday
In the report, CommonSpirit also outlined plans to expand its ambulatory care footprint next year after a string of recent outpatient acquisitions in multiple states, despite liquidity concerns.
The U.S. Office of Personnel Management released its Fiscal Year 2023 Agency Financial Report today. Worth reading is the OPM Director’s response to the OPM Inspector General’s Top Management Issues letter.
The Department of Health and Human Services (HHS) issued its proposed 2025 benefit and payment parameters notice. Here is the government’s fact sheet on the proposed rule. Published alongside the proposed rule is HHS’s final guidance on Maximum Annual Limitation on Cost Sharing for the 2025 Benefit Year, which does apply to FEHB plans.
“Under 45 CFR 156.130(a)(2), for the 2025 calendar year, cost sharing for self-only coverage may not exceed the dollar limit for calendar year 2014 increased by an amount equal to the product of that amount and the premium adjustment percentage for 2025. For other than self-only coverage, the limit is twice the dollar limit for self-only coverage. Under § 156.130(d), these amounts must be rounded down to the next lowest multiple of $50. Using the premium adjustment percentage for 2025 of 1.4519093322, and the 2014 maximum annual limitation on cost sharing of $6,350 for self-only coverage, which was published by the Internal Revenue Service on May 2, 2013, the 2025 maximum annual limitation on cost sharing is $9,200 for self-only coverage and $18,400 for other than self-only coverage. This represents an approximately 2.6 percent decrease from the 2024 parameters of $9,450 for self-only coverage and $18,900 for other than self-only coverage.”
“The stopgap bill to keep the government open, passed by the House on Tuesday and the Senate on Wednesday, provides a one-year reprieve from Medicare cuts that would have gone into effect in January for about 800 laboratory services.
“The American Clinical Laboratory Association (ACLA), a trade group whose members include Labcorp and Quest Diagnostics, called the delay “critically needed” to preserve patient access to many of the most commonly ordered lab tests.”
“The White House and the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is releasing several resources to help support federal agencies, states, local and tribal governments to better coordinate health care, public health, and social services. Specifically, the White House is releasing the first-ever U.S. Playbook to Address Social Determinants of Health – PDF.
“Today [the agency] celebrates National Rural Health Day and recognizes the creativity and innovation of leaders across the country working to ensure access to high quality care for over 60 million Americans living in rural communities. National Rural Health Day is the third Thursday of every November and recognizes the efforts of rural providers, communities, organizations, state offices of rural health, and others dedicated to addressing the unique health care needs of rural America.”
In FEHB Open Season news, Tammy Flanigan discusses Open Season and tax savings in Govexec.
From the public health and research front,
The New York Times points out the differences between Influenza A and Influenza B.
“For the first time, a regulator has cleared a treatment using CRISPR, the gene-editing technology, for patients. The regulator is the United Kingdom’s Medicines and Healthcare products Regulatory Agency. The product is Casgevy, a treatment for sickle cell disease and beta thalassemia, two blood disorders. It was developed by CRISPR Therapeutics, the Swiss company co-founded by Nobel laureate Emmanuelle Charpentier, and Vertex Pharmaceuticals, a large Boston-based biotech firm.”
The article covers questions and answers about this significant development.
“Smileyscope has made history by becoming the first virtual reality (VR) device to receive FDA Class II clearance for acute pain. This approval recognizes Smileyscope’s innovative Procedural Choreography™ technique, which uses positive virtual stimuli to reduce pain and anxiety during medical procedures. With this milestone, Smileyscope aims to revolutionize pain and anxiety management, partnering with hospitals and clinicians globally to enhance patient experiences and improve clinical workflows.”
“The Senate passed legislation Wednesday to extend funding for federal agencies, sending the bill to avert a government shutdown to President Biden’s desk just days before the weekend deadline.
“The bill, which passed by an 87-11 vote, represents a marked de-escalation between congressional Democrats and new House Speaker Mike Johnson (R-La.). Without the new spending measure, called a continuing resolution or CR, the government would have shut down just after midnight Saturday, forcing federal workers — including military members and airport security agents — to work without pay or go on furlough on the eve of the Thanksgiving holiday.”
“House lawmakers left town Wednesday for Thanksgiving after a GOP revolt that led to defeat of the rule for floor debate on the final two pieces of legislation the chamber was scheduled to consider.
“Nineteen Republicans voted against the rule for the fiscal 2024 Commerce-Justice-Science spending bill and separate legislation dealing with frozen Iranian assets.
“Combined with all Democrats voting “no,” the measure was rejected on a 198-225 vote, leaving the House with no further business to attend to after dispensing with a series of pending amendments to the fiscal 2024 Labor-HHS-Education appropriations bill.”
The Department of Health and Human Services announced,
“taking the next step in working to ensure greater access to the life-saving services that it provides for people with Limited English Proficiency (LEP) and people with disabilities. In releasing the HHS Language Access Plan, HHS joins agencies across the federal government in prioritizing communication in services to the public. Today’s action supports President Biden’s Executive Orders to advance racial equity and support for underserved communities, which aims to improve access to benefits and services across the Administration, including for people with LEP.”
On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) placed on display at the Federal Registera final rule that will implement portions of section 6101 of the Affordable Care Act, requiring the disclosure of certain ownership, managerial, and other information regarding Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities, commonly known as nursing homes. It also defines the terms private equity company and real estate investment trust, about which information must be disclosed on Form CMS-855A, the Medicare enrollment application. This final rule continues a series of initiatives the Biden-Harris Administration announced in February 2022, designed to improve care and accountability at such facilities.
“The U.S. Postal Service lost $6.5 billion in fiscal 2023 despite initial projections it would break even for the year, and leadership cautioned the agency will once again be in the red in fiscal 2024.
“Looking at only the parts of the operation that USPS leadership considers within its control, losses spiked to $2.3 billion compared to just $500 million in fiscal 2022 and a controllable profit of $1.5 billion in fiscal 2021. At the start of fiscal 2023, USPS forecasted a $4 billion loss. The negative financial numbers occurred despite the Postal Service growing its total revenue by $500 million.
“Postal leadership attributed much of the losses—about $5.6 billion—to two factors: ongoing inflation and a miscalculation of what it must statutorily contribute toward its pension fund. Postmaster General Louis DeJoy also noted USPS is incurring upfront costs as it updates its network as part of his 10-year Delivering for America plan.”
granting marketing authorization to LetsGetChecked for the Simple 2 Test. This is the first diagnostic test for chlamydia and gonorrhea with at-home sample collection to be granted marketing authorization. Prior to today’s authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor’s office. The Simple 2 Test is available over-the-counter (OTC) and is intended for use in adult patients ages 18 years and older. It is the first FDA-authorized test with at-home sample collection for any sexually-transmitted disease other than HIV.
In Open Season news, Reg Jones discusses the FEDVIP and FSAFeds offerings in Fedweek.
From the public health and medical research front,
Clinical trials have shown that lifestyle programs — which include diet, exercise, and behavioral coaching — can help people in danger of developing type 2 diabetes from tipping into a diagnosis of the condition. But there’s been a nagging question of whether such intensive regimens work in the real world.
A study published Wednesday backs up the idea that they can. Researchers behind the work relied on novel statistical approaches to analyze millions of records from England’s National Health Service and found that participants in the NHS’s Diabetes Prevention Program saw improvements in risk factors for type 2 diabetes, indicating that patients can benefit from such initiatives even outside the confines of a controlled experiment.
“Lung cancer survival rates have increased over the past five years, but serious disparities remain among Black and Latino communities, according to the American Lung Association’s 2023 “State of Lung Cancer” report released Tuesday.
“The report highlights the need for better messaging about screening for lung cancer, which is still the nation’s leading cause of cancer-related deaths. The disease claims more than 120,000 lives each year, according to the American Cancer Society, in part because it is most often diagnosed at later stages when the cancer is harder to treat.
“The national survival rate for lung cancer jumped nearly five percentage points, from 21.7 to 26.6 percent, over the last five years, said report author Zach Jump, the national senior director of epidemiology, statistics and research at the American Lung Association.”
“The U.S. spends huge amounts of money on health care that does little or nothing to help patients, and may even harm them. In Colorado, a new analysis shows that the number of tests and treatments conducted for which the risks and costs exceed the benefits has barely budged despite a decade-long attempt to tamp down on such care.
“The state — including the government, insurers, and patients themselves — spent $134 million last year on what is called low-value care, according to the report by the Center for Improving Value in Health Care, a Denver nonprofit that collects billing data from health plans across Colorado. The top low-value items in terms of spending in each of the past three years were prescriptions for opiates, prescriptions for multiple antipsychotics, and screenings for vitamin D deficiency, according to the analysis.”
“Clinical factors are responsible for just 20 percent of individuals’ health outcomes; the remainder can be attributed to factors such as health-related social needs (HRSNs).1 Increasing recognition of the impact of these needs on consumers’ health and livelihoods is driving momentum across the healthcare ecosystem to integrate health and social care, creating opportunities for healthcare entities to design consumer-centric models of care tailored to individual needs and preferences.
This article synthesizes insights gleaned from a survey of more than 5,000 US consumers that highlights how HRSNs are evolving; their potential impact on healthcare use, preferences, and outcomes; and actions healthcare entities may consider to effectively support consumers’ needs.”
“Researchers are coming up with new ways to make medical studies less white.
“They are building trust in groups long ignored by science and working with doctors and patients of color to design better studies. They are opening research sites in more diverse communities and providing stipends to help people participating in their studies pay for gas and child care.
“The efforts are starting to work: More people of color are participating in medical research. That is good news for everyone. Data from clinical trials—used to approve drugs and train artificial intelligence on medical decision-making—until recently failed to include swaths of the population. In the future, more diverse data sets will lead to better treatments and prevention of diseases in people of different backgrounds.
“Without diversity, we lose the ability to address fundamental problems that lead to suffering and loss of life,” said Dr. Carol Horowitz, director of Mount Sinai’s Institute for Health Equity Research.”
“Amazon’s One Medical inked a major partnership with Health Transformation Alliance, expanding access to its primary care services to 67 employers and nearly 5 million employees.
“HTA is a collective of large U.S. employers, and its member companies include Coca-Cola, American Express, Marriott, Boeing and Intel.
“Employers are grappling with rising healthcare costs and expect health benefit expenses to climb 5.4% in 2024, according to Mercer.
“HTA, on behalf of its member companies, saw an opportunity to partner with One Medical to provide access to high-quality primary care services while also addressing inefficiencies and costs in the healthcare system, according to HTA CEO Robert Andrews.”
“Gilead is expanding its collaboration with cancer cell therapy developer Arcellx, announcing Wednesday that subsidiary Kite Pharma has used an option to license a second experimental drug. The partners will also broaden their collaboration on a cell therapy that was the subject of the initial partnership.
“Per deal terms, Gilead will buy $200 million of Arcellx shares, giving it a 13% stake, as well as pay an $85 million cash fee. Arcellx will be owed undisclosed payments on achievement of development milestones “to offset prespecified development costs,” according to Gilead.
“Last year, Gilead paid $225 million upfront and made a $100 million investment in Arcellx to secure access to the first drug in the collaboration, a type of cancer treatment called CAR-T therapy, which engineers a patient’s own immune cells to attack tumors.”
“Members with diabetes spend between $3,300 and $4,600 per year in out-of-pocket costs for chronic disease management, including lost wages, according to a new report from GoodRx Health.
“These out-of-pocket cost estimates accounted for health insurance coverage but still represented 6 to 8 percent of the typical yearly wage in the US.
“The researchers addressed the cost of managing diabetes separately from the cost of complications. They used data from the Medical Expenditure Panel Survey (MEPS) for 2021 and prices across online diabetes medical device suppliers to assess healthcare spending among patients with diabetes.”
“The House passed legislation on Tuesday to keep federal funding flowing into early 2024, after Democrats stepped in to rescue a plan opposed by many Republicans to avert a government shutdown at the end of the week.
“A coalition of Democrats and mainstream Republicans overcame the opposition of G.O.P. conservatives to approve the bill under special expedited procedures that required a supermajority. That approach, hatched by Speaker Mike Johnson, amounted to a gamble that a substantial number of Democrats would rally to help pass a package that Mr. Johnson’s own party was unwilling to back.
“The vote was 336 to 95, clearing the two-thirds threshold required for passage. In the end, 209 Democrats and 127 Republicans joined to pass the bill. Ninety-three Republicans opposed it, as did two Democrats.
“Senator Chuck Schumer of New York, the majority leader, told reporters that he wanted the Senate to vote on the bill “as soon as possible.”
The American Academy of Pediatrics News announced,
“The advisory was issued after the Food and Drug Administration (FDA) received 22 reports of high blood lead levels (BLLs) in children who consumed recalled fruit pouches that contain high levels of lead. The recall includes WanaBana brand apple cinnamon fruit puree pouches, Schnucks brand cinnamon applesauce pouches and Weis brand cinnamon applesauce pouches.”
ICD Monitor points out that “the new Healthcare Common Procedural Coding System (HCPCS) codes were released on Nov. 6. These codes include supplies, medications, implants, surgeries, etc. The latest release contained 553 changes and updates to the coding system . . . .
The Acting NIH Director Lawrence Tabak released his farewell issue of the NIH Directors blog.
“I congratulate Dr. Monica Bertagnolli as she takes the helm as the next permanent NIH director. Dr. Bertagnolli—an outstanding physician scientist—is a strong leader who will bring fresh, bold new ideas to NIH and the biomedical research enterprise. I know she’ll be in good hands thanks to the outstanding staff across NIH and the leadership in the Department of Health and Human Services. I look forward to supporting her efforts and continuing to ensure that NIH research optimizes health for all people.”
From the public health and medical research front,
MedPage Today informs us that early detection is the key to longer survival rates for people afflicted with pancreatic cancer.
“If your hearing begins to decline, your risk of falling may rise.
“Research shows older adults with mild hearing loss are at a greater risk — more than double — of falling. Though it’s not exactly clear how hearing loss increases the risk, it’s known that falls are the top cause of death from injury among people 65 and older.
“Now, new evidence shows that restoring hearing through the use of hearing aids may be protective, especially when people wear them consistently. That’s according to a study published this summer in the Journal of the American Geriatrics Society.”
“Millions of adults struggle for years with chronic low-back pain—a disabling ailment that has no easy fix.
“Common causes include injury, arthritis and degenerative changes in the spine. It tends to start at midlife with the natural wear and tear of aging. But often there is no clearly identifiable physical cause, leaving patients to veer from one ineffective treatment to another—including highly addictive prescription opioids.
“Now, researchers are working on personalized treatment plans that can address physical, emotional and psychological traits in individual patients that influence the pain they are experiencing. Physical therapy, exercise, diet and lifestyle choices often play a role. Some research is also looking at ways to retrain the brain to think differently about pain.
“To be sure, low-back pain can be a sign of something life-threatening, such as cancer, or a severe spine condition that requires surgery. As a result, chronic low-back pain needs to be fully evaluated. But once “red flags” are eliminated, doctors need a more precise way to determine what will work for individual patients, says Dr. Matt Mauck, a researcher and pain-medicine physician at the University of North Carolina Chapel Hill’s UNC Pain Management Center.”
The Institute for Clinical and Economic Review “posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension (PAH).”
“This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC (Midwest CEPAC) on December 1, 2023. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
From the U.S. healthcare business front,
The International Foundation of Employee Benefit Plans announced,
“A new survey report from the International Foundation of Employee Benefit Plans reveals U.S. employer coverage and considerations surrounding glucagon-like peptide-1 (GLP-1) drugs, which have historically been used to treat diabetes. These drugs were also found to cause weight loss and have been subsequently used to treat obesity.
“Among survey respondents, 76% provide GLP-1 drug coverage for diabetes, 27% provide coverage for weight loss, and 13% are considering covering for weight loss.
“In 2023, the average representation of GLP-1 drugs used for weight loss in employers’ total annual claims was 6.9%, according to survey respondents. Those who are covering GLP-1 drugs are relying heavily on utilization management (79%) to control costs. A less common approach (32%) is step therapy. Fourteen percent of employers have no cost control mechanism in place.
“Though GLP-1 drugs have a high price tag, they currently represent only 6.9% of annual claims, according to survey respondents,” said Julie Stich, CEBS, Vice President of Content at the International Foundation. “Employers can take this information into account when designing long-and short-term benefit strategies.”
“Cigna Group is taking a page from billionaire Mark Cuban’s playbook to sell medicines for a set markup, the latest sign that companies that manage drug benefits are responding to pressure from upstart competitors.
“Next year Cigna’s Express Scripts subsidiary will offer employers and health plans the option to pay pharmacies up to 15% above their wholesale costs, plus an extra fee for dispensing the medicines. Employers now typically pay pharmacies based on an average discount, which can result in them paying more for drugs than a pharmacy charges.”
“Elevance Health (ELV.N) and Cigna Group’s (CI.N) Express Scripts unit on Monday settled the last pending claim in a long-running contract dispute, clearing the way for Elevance to appeal the dismissal of its $14.8 billion lawsuit accusing Express Scripts of overcharging it for prescription drugs.”
The Albany Times-Union reports that Empire Blue Cross is changing its name to Anthem Blue Cross.
“The company retains the Blue Cross Blue Shield name and remains part of the Blue Cross Blue Shield Association, which serves one in three insured Americans. * * *
“Empire joined Anthem in 2006, and the new name represents the next stage in the company’s journey to merge with the national brand, benefiting from combined resources and capabilities of its parent company and affiliates, company executives said.”
“BeMe, a digital behavioral health app aimed at teenagers, has inked several partnerships with major payers, including $1.5 million in investment from Blue Cross and Blue Shield of Kansas (BCBSKS).
“Through the investment, BeMe’s platform will be made available to 20,000 teenagers across the Sunflower State. Executives said in an announcement that tools like BeMe will become increasingly critical as youth mental health issues continue to worsen.”
“Senate Majority Leader Chuck Schumer (D-N.Y.) on Monday said he is “pleased” with Speaker Mike Johnson’s (R-La.) plan to avoid a government shutdown.
“Schumer noted that Johnson’s “laddered” stopgap spending bill — which funds four bills through Jan. 19 and the remaining eight through Feb. 2 — is “far from perfect,” but indicated the “clean” measure provides a path to funding the government for the next two months.”
The Department of Health and Human Services tells us,
“Today, amid new data released on substance use across the nation, the Biden-Harris Administration reiterated President Biden’s clear and urgent call for Congress to provide critical additional resources to strengthen addiction treatment and crack down on drug trafficking.
“Today’s new data from the 2022 National Survey on Drug Use and Health (NSDUH) show there were more than 48 million Americans who experienced a substance use disorder in 2022. Of the 48 million Americans struggling with substance use disorder, three out of every four did not get treatment. While the Biden-Harris Administration has made historic progress in expanding access to life-saving public health services and stopping the flow of illicit drugs like fentanyl into American communities, the nation is facing an unprecedented epidemic that requires the full support and funding of Congress.”
“The Office of Personnel Management on Thursday released new guidance spelling out ways that federal agencies can implement a recent executive order aimed at making it easier for military spouses to have a career in public service. * * *
“In a memo to agency heads, OPM Director Kiran Ahuja said the government’s forthcoming strategic plan for hiring and retaining military spouses will be released later this year. But in the meantime, she offered a few avenues where agencies can take action now to improve their performance on the issue.”
“The gap in life expectancy between men and women in the United States grew to its widest in nearly 30 years, driven mainly by more men dying of Covid and drug overdoses, according to a new study in The Journal of the American Medical Association.
“In 2021, women had a life expectancy of 79.3 years, compared with 73.5 years for men, the study found.
“It was unsettling to see,” said Dr. Brandon Yan, a resident physician at the University of California, San Francisco, and lead author of the study, which analyzed death data from the Centers for Disease Control and Prevention.
“We need to understand which groups are particularly losing out on years of life expectancy so interventions can be at least partially focused on these groups,” Dr. Yan said.”
“The decline in life expectancy in the U.S. suggests that advancements in medical treatment are no longer sufficient to counter ongoing public health crises, Yan said. “We have a health care system that is very advanced in treating illnesses and advanced disease. But for the most part … it is not very good when it comes to preventative care.”
FEHBlog note — The English were tracking life expectancy in the late 1600s.
“Thousands of women will avoid suffering breast cancer after a pill that costs 4p a day was approved as a preventive treatment for the disease.
“Almost 300,000 women at higher risk will be eligible for anastrozole, which studies have shown can nearly halve the chances of developing breast cancer if taken daily for five years.
“Campaigners hailed the approval as a “major step forward” in efforts to tackle the disease, which is Britain’s most common cancer, with 47,000 new diagnoses each year. Until yesterday, anastrozole had been licensed for use in Britain only as a treatment, rather than a preventive measure.
“NHS England said 289,000 women in their 50s and 60s at moderate or high risk of breast cancer would now be eligible for the drug. They will include women with a family history of the disease, or who have faulty genes such as BRCA1, the so-called Jolie gene, that put them at greater risk.”
“Like the better-known tamoxifen, anastrozole was first used to treat breast cancer. Then, because risk doesn’t end with treatment, the hormone-blocking drug was also prescribed to prevent cancer’s return. Ten years ago, after a clinical trial showed convincingly that the drug could prevent breast cancer, U.S. oncologists began prescribing it off-label. In the U.K., anastrozole got the nod for this use last week from the country’s Medicines and Healthcare products Regulatory Agency. * * *
“The two drugs approved by the U.S. Food and Drug Administration for prevention, tamoxifen and raloxifene, reduce estrogen in different ways but offer the same kind of protection. Brewster said they are used more often in the U.S. than anastrozole, possibly because of milder side effects. * * *
“These prevention drugs themselves are not without risk. As [Dr. Abenaa] Brewster [a professor of clinical cancer prevention at MD Anderson Cancer Center] puts it, there’s no such thing as free lunch, and when patients are healthy, their tolerance for side effects is understandably lower than when they are in treatment for active disease. Most women tolerate tamoxifen well, but there are rare side effects of uterine cancer or blood clots. Some patients taking anastrozole and raloxifene experience joint stiffness, vaginal dryness, hot flashes, or bone thinning.”
“The changing nature of the drug crisis was predictable, because drug use is historically faddish. In the 1970s, America struggled with heroin. In the ’80s, it was cocaine. In the ’90s and early 2000s, meth. Since then, opioids have taken off.
“One explanation for this is what’s known as generational forgetting: Young people tend to avoid the drug that is currently causing a crisis. But because they don’t have personal experiences with the drugs that caused harm before their time, they are more willing to use those substances.
“Different drugs can also complement each other, and so their popularity can rise simultaneously. Opioids, for example, often cause users to doze off, which can leave those who live on the streets vulnerable to theft or rape. So opioid users sometimes use stimulants, like meth and cocaine, to stay awake. And if they receive treatment for opioid addiction, they may continue using stimulants.
“All of this leads to a revolving door for different kinds of drug crises. It has happened before, and it is happening again.
“Read Jan’s full story, which includes details about the rise of a kind of meth so pure that some are calling it “super meth.”
Mercer Consulting offers a Q&A about weight loss medications with their pharmacy team.
Do these medications have an ROI? When might plan sponsors expect to see benefits from treating obesity as a chronic disease?
Jon Lewis, Mercer Rx Financial Leader: These medications represent a big investment. While everyone talks about the high list prices, it is worth noting something fairly unique here. We do have manufacturer competition which means rebates are playing a role and should be monitored.
In general though, we are looking at somewhere between three to five years before you start to realize any savings. Those who are at higher risk – for example, people with a higher BMI – are likely to produce more savings. With that said, changing eligibility to a narrower BMI does have a rebate impact and should be incorporated into any weight loss strategy.
But these drugs are costly. You would have to have someone who is on the drug long enough to achieve the weight loss, still be employed, and still be maintaining that weight loss over the course of three to five years to see an ROI or some form of savings.
Beckers Hospital Review discusses rural hospitals’ maternity care crisis.
“Peanut-allergic toddlers who stayed on an investigational, epicutaneous immunotherapy skin patch reached higher levels of peanut tolerance during the second year, according to the open-label extension of the EPITOPE trial.”Peanut-allergic toddlers who stayed on an investigational, epicutaneous immunotherapy skin patch reached higher levels of peanut tolerance during the second year, according to the open-label extension of the EPITOPE trial.”
“More complete data from a clinical trial of Novo Nordisk’s Wegovy weight loss drug have rekindled the debate over how the treatment will affect patient demand for medical devices and procedures.
“The findings from the SELECT study, presented at a major heart meetingover the weekend, showed a 20% reduction in risk on a composite goal of heart attack, stroke or cardiovascular death, compared to a placebo, in overweight and obese patients with heart disease. But the data were inconclusive on a narrower measure of cardiovascular death alone.
“The data overall confirm a cardiovascular benefit for patients, but mixed results on secondary endpoints do not alter the outlook for heart device makers such as Boston Scientific, Medtronic and Edwards Lifesciences, Mizuho analyst Anthony Petrone said Monday in a report to clients.”
“At first blush, we see the final SELECT data as neutral for cardiovascular names,” he wrote.
“Novartis is deepening its investment in cancer cell therapy, licensing an experimental project developed by Legend Biotech that is in early-stage trials for two types of lung cancer, the smaller company said Monday.
“Novartis will pay Legend $100 million upfront to secure rights to the cell therapy, called LB2102, and could send Legend up to $1 billion more if clinical, regulatory and commercial milestones are met. Legend will complete Phase 1 testing, after which Novartis will assume development responsibilities.
“Legend said Novartis may use in its development plan its new T-Charge manufacturing platform, which aims to reduce the time it takes to make cancer-fighting cells outside the body as well as improve their durability. Cell therapies like Novartis’ Kymriah can induce long-lasting responses in patients, but they require a weeks long manufacturing process that carries the risk of failure or patient progression.”
“House Speaker Mike Johnson (R., La.) unveiled a two-step short-term spending proposal that would keep money flowing to federal agencies into early next year, in a bid to stave off a partial government shutdown late [this] week.
“* * * According to a document obtained by The Wall Street Journal, if the two-step plan doesn’t pass, House Republicans will turn to what they call a full-year continuing resolution, keeping spending flat—although it would contain “appropriate adjustments to meet our national security priorities.” * * *
“The announcement marks a major test for Johnson, who now needs to sell the plan to House Republicans, a group that has been hard to unify on federal spending. Republicans have a 221-212 majority, with Rep. Gabe Amo of Rhode Island, a Democrat, yet to be sworn in after winning an open seat.”
OPM.gov reminds us that the Federal Benefits Open Season begins at midnight November 13. The Open Season ends on December 11, 2023.
A proposed federal policy aims to protect older Americans from contracting HIV by offering free preventive medication, the latest effort to catch up to much of Europe and Africa in stemming the spread of the virus.
Under the plan from the Biden administration, Medicare would cover patients’ full cost of pre-exposure prophylaxis (PrEP) drugs, which prevent HIV transmission. The drugs would be free in pill form and — for the first time — as long-acting injectables through the government insurance program designed for those 65 and older. Those 50 and over make up half of all people in the U.S. already living with HIV.
“Publishing in the journal Health Affairs, researchers looked at data from the Health Professional Shortage Area (HPSA) program, zeroing in on physician density and mortality. Introduced in 1965, the HPSA program designates areas in need of more physicians and offers bonuses, loan repayment, visa waivers, higher reimbursements and other benefits to doctors who choose to practice and serve Medicare patients in specific communities.
“The researchers analyzed outcomes in HPSAs and areas without the designation between 1978 and 2015, matching 844 shortage counties with similar counties with enough providers. Using a variety of statistical methods designed to sift through dense demographic factors, the analysis yielded few clues that HPSA leads to higher physician numbers or reduces deaths. Some small effects were seen, but the changes were statistically insignificant, the researchers write.”
From the public health and medical/drug research front,
[Novo Nordisk (Novo0] in August had announced that in this trial, called Select, Wegovy reduced the overall rate of major heart problems — heart attacks, stroke, or cardiovascular-related death — by 20%. That finding, which was the primary outcome the trial set out to study, was stronger than many were expecting and led Novo’s stock to surge.
Novo’s obesity drug Wegovy notably cut the risk of heart attacks in a landmark cardio-vascular trial that affirms the treatment offers health benefits beyond weight loss. * * *
But details of the study, including risk reductions for each specific heart complication, were not released until Saturday when they were presented here — before a standing-room-only crowd — as the first major session of the American Heart Association conference.
The overall 20% risk reduction in heart problems translated to 15 complications prevented for every 1,000 patients treated.
Wegovy specifically cut the rate of heart attacks by 28% among patients who were already taking statins and other medications to prevent heart problems, according to the results, simultaneously published in the New England Journal of Medicine. The drug also reduced the rate of cardiovascular-related deaths by 15% and strokes by 7%.
“For the first time, researchers have produced evidence that gene-editing can cut high cholesterol, a major risk factor for the nation’s leading killer.
“Preliminary results from a study involving ten patients born with a genetic condition that causes very high cholesterol found that editing a gene inside the liver can significantly reduce levels of “bad cholesterol.”
“The experimental treatment needs to be tested on more patients who would be followed for much longer to confirm the approach is safe and effective. But the results are being hailed as a potential landmark proof-of-concept that could eventually provide a powerful new way to prevent heart attacks and strokes.
“A new antibiotic, the first to be developed in decades, can cure gonorrhea infections at least as effectively as the most powerful current treatment, a large clinical trial has found. The drug, zoliflodacin, is taken as a single dose, and it has not yet been approved for use in any country.
“But the drug was developed in a way that experts hope will make it widely accessible and will prevent widespread drug resistance. * * *
“Pharmaceutical companies have largely abandoned antibiotic development as unprofitable. The development of zoliflodacin represents a new model: G.A.R.D.P., which is funded by many Group of 20 countries and the European Union, developed the drug in collaboration with an American pharmaceutical company called Innoviva Specialty Therapeutics.
“The nonprofit sponsored the Phase 3 trial of the drug. In exchange, it holds the license to sell the antibiotic in about 160 countries, while Innoviva retains marketing rights for high-income countries.
“I’ll go out on a limb and say that’s probably the only way in which we develop antibiotics going forward, because the old model is simply not going to work,” said Ramanan Laxminarayan, a senior research scholar at Princeton University who chairs the G.A.R.D.P. board.”
“To forestall resistance to zoliflodacin, the drug is being developed only as a treatment for gonorrhea and other sexually transmitted infections (STIs). However, it will be up to regulatory and public health agencies to decide when and how the drug can be used.
“New diagnostics will also be important, says Teodora Wi, an STI specialist at the World Health Organization in Geneva. Tests that can rapidly distinguish gonorrhea from other STIs should be more widely available in the near future, but those able to identify drug resistance are further off. National surveillance programs for antibiotic-resistant gonorrhea could also guide the responsible use of zoliflodacin, Wi adds.”
“Weight loss prescriptions Wegovy, Rybelsus and Saxenda—along with diabetes drug Ozempic, often used off label for weight loss—are driving health costs for employers up by more than $300 per insured worker this year, new data from benefits consultancy Aon says.
“These GLP-1 drug costs are expected to boost healthcare spending through 2025, increasing from $324 per insured member this year up to $500 per insured health plan member in two years, new data from the benefits consultancy Aon says. By comparison, annual spending on such prescriptions in 2021 was $96 per member, Aon data shows.
“Employees, too, can expect higher co-payments, deductibles and premiums deducted from their paychecks because employers almost always shift part of their total premium costs onto workers, though this can vary widely depending on employer.
“Aon’s analysis comes from its Aon Rx claims data from nearly 500 employers and their 4.4 million health plan members. Aon said weight loss prescriptions Wegovy, Rybelsus and Saxenda have led the growth, with health spending contributions from Ozempic, which is approved to treat diabetes but is often prescribed off label by physicians for weight loss.”
“US Senators Mark Warner (D-VA), Bill Cassidy (R-LA), John Cornyn (R-TX), and Maggie Hassan (D-NH) launched a bipartisan Senate healthcare cybersecurity working group. The group will focus on proposing legislative solutions within the Senate Health, Education, Labor, and Pensions (HELP) Committee to strengthen healthcare cybersecurity.
“We are seeing a disturbing rise in cyberattacks on our health care system. These attacks not only put patients’ sensitive health data at risk but can delay life-saving care,” Cassidy stated. “Just like a strong military and police force defends us against physical attacks, we must ensure health institutions can safeguard against increasing cyber threats and protect Americans’ crucial health data.”
“[On November 2, 2023,] [f]ormer National Security Agency Executive Director Harry Coker told members of the Senate Homeland Security and Governmental Affairs Committee that if he’s confirmed as the next national cyber director, he’d largely continue along the same path as his predecessors.
“Coker, who also spent 17 years at the Central Intelligence Agency and had made few public appearances before Thursday’s hearing, expressed appreciation for previous Office of the National Cyber Director work, including the National Cybersecurity Strategy, the subsequent implementation plan and the National Cyber Workforce and Education Strategy.
“If confirmed, I would frankly continue the good work that ONCD has done with its partners,” Coker said. He noted in his opening statement he’s “seen the need for stronger partnerships and collaboration between the public and private sectors” and that collaboration would be “the north star” under his leadership.”
The Cybersecurity and Infrastructure Security Agency (CISA) announced that
“Director Jen Easterly and the Republic of Korea’s Deputy Director of the National Intelligence Service (NIS) Baek Jong-wook signed a Memorandum of Understanding (MoU) outlining areas for collaboration under the bilateral Cyber Framework signed by President Biden and Republic of Korea President Yoon in April.
“The Framework affirms cooperation with Korea in key CISA mission areas, to include sharing technical and operational cyber threat information and best practices in cyber crisis management. In June, senior leaders from both countries determined that CISA and NIS would co-lead a Framework Action Group on critical infrastructure. This Action Group will also bring together Korea’s Ministry of Science and ICT and other USG departments and agencies. ”
The National Institute of Standards and Technology (NIST) informed us on November 9, 2023,
“The final public draft of NIST Special Publication (SP) 800-171r3 (Revision 3), Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations, is now available for public review and comment. * * *
“The public comment period for both drafts is open through January 12, 2024. We strongly encourage you to use the comment template available on each publication details page, and submit your comments to email@example.com.”
NextGov offers an overview of the NIST’s final draft publications.
On November 9, 2023, CISA, the National Security Agency and their partners released.
Organizations can use this guide to assess and measure their security practices relative to the software lifecycle; the suggested practices may be applied across the acquisition, deployment, and operational phases of a software supply chain.
CISA encourages cybersecurity defenders to review this guidance and to speak to their software vendors about implementing its recommendations.
From the cybersecurity breaches and vulnerabilities front,
“Business software maker SolarWinds is denying charges that it lacked adequate cybersecurity controls in the build up to a significant hack of its products in 2020, and accused the U.S. Securities and Exchange Commission of misrepresenting facts in its complaint.
“On Oct. 30, the SEC announced that it had filed charges against SolarWindsalleging the firm defrauded investors by repeatedly misleading them about its cyber vulnerabilities and the ability of attackers to penetrate its systems.
“The SEC’s lawsuit is fundamentally flawed—both legally and factually—and we plan to defend vigorously against the charges,” SolarWinds said. The SEC declined to comment.”
The company initiated precautionary containment measures in response to the cyberattack, a move that’s temporarily halting recurring payments and leading customers to make one-time loan payments online, via phone, email or third parties. The status of customers’ loans were last updated Oct. 31.
Mr. Cooper is the third-largest mortgage servicer in the U.S. with more than 4.3 million customers, according to the company.
Mr. Cooper, the mortgage and loan giant with more than four million customers, has confirmed customer data was compromised during a recent cyberattack.
In an updated notice on its website published Thursday [November 9, 2023], Mr. Cooper said that it was “still investigating what data may have been exposed,” though it remains unclear what kind of cyberattack hit Mr. Cooper’s system
CISA added another known exploited vulnerability to its catalog on November 7 and one more on November 8, 2023.
BusinessTech discusses the vulnerability management lifecycle.
From the ransomware front,
Because Bleeping Computer did not publish the Week in Ransomware yesterday, here is a notable attack featured in Cybersecurity Dive:
“A U.S. subsidiary of China’s largest bank was hit by a ransomware attack Wednesday that resulted in disruption to certain financial services systems, the bank announced Thursday [November 9, 2023].
“The hack disrupted the trading of U.S. Treasuries, forcing the Industrial and Commercial Bank of China Financial Services to send required settlement details to certain parties by a messenger carrying a USB stick, according to Bloomberg.
“The New York City-based firm said it reported the incident to law enforcement and successfully cleared U.S. Treasury trades executed Wednesday and repo financing trades done Thursday.
“The so-called “CitrixBleed” vulnerability (CVE-2023-4966) affects multiple on-premises versions of Citrix NetScaler ADC and NetScaler Gateway application delivery platforms.
“* * * The exploit activity has prompted the US Cybersecurity and Infrastructure Security Agency (CISA) to issue fresh guidance and resources this week on addressing the CitrixBleed threat. CISA warned of “active, targeted exploitation” of the bug in urging organizations to “update unmitigated appliances to the updated versions” that Citrix released last month.”
HHS’s health sector cybersecurity coordination center issued an analyst note on Blacksuit ransomware:
“A relatively new ransomware group and strain known as BlackSuit, with significant similarities to the Royal ransomware family, will likely be a credible threat to the Healthcare and Public Health (HPH) sector. Discovered in early May 2023, BlackSuit’s striking parallels with Royal, the direct successor of the former notorious Russian-linked Conti operation, potentially places the group with one of the most active ransomware groups in operation today. Both Royal and the now-defunct Conti are known to have aggressively targeted the HPH sector, and if their purported ties to BlackSuit prove to be verified, then the sector will likely continue to be attacked profoundly. What follows [in the note] is an overview of the potential new group, possible connections to other threat actors, an analysis of its ransomware attacks, its target industries and victim countries, impact to the HPH sector, MITRE ATT&CK techniques, indicators of compromise, and recommended defense and mitigations against the group.”
“A new report from Sophos on healthcare cybersecurity trends indicates data encryption occurred in 75% of ransomware attacks on healthcare organizations. Only 24% of surveyed healthcare organizations were able to detect an attack in progress and disrupt it before files were encrypted. Sophos says this is the highest rate of encryption and the lowest rate of disruption the company has seen in the past 3 years. Last year, healthcare organizations disrupted 34% of attacks before files were encrypted.
“To me, the percentage of organizations that successfully stop an attack before encryption is a strong indicator of security maturity. For the healthcare sector, however, this number is quite low—only 24%. What’s more, this number is declining, which suggests the sector is actively losing ground against cyber attackers and is increasingly unable to detect and stop an attack in progress,” said Chester Wisniewski, director, field CTO, Sophos.”
From the cybersecurity defenses front,
An ISACA expert discusses how “Cyber Advisors, Security Services Providers Can Use Zero-Sum Game Theory Framework to Benefit Clients.”
Dark Reading explains “How to Outsmart Malware Attacks That Can Fool Antivirus Protection. One of the main challenges for Android users is protecting themselves from malicious applications that can damage devices or perform other harmful actions.”