The continuing resolution funding the federal government expires at 11:59 pm on Friday December 16.
The Federal Employee Benefits Open Season ends at 11:59 pm, in the location of the enrollee’s electronic enrollment system, on Monday, December 12, 2022.
The Medicare Open Enrollment period ends this Wednesday, December 7.
From the Rx coverage front, the Wall Street Journal reports on
A shortage in the weight loss drug Wegovy, “missing out on hundreds of millions of dollars in sales and squandering a head start before a rival could begin selling a competing product. * * * [Wegovy manufacturer’ Novo lists Wegovy at $1,349 a month. Some commercial insurers cover the drug.” OPM has encouraged FEHB carriers to offer coverage of this drug.
A CVS Health effort to improve pharmacy efficiency with “a system [currently being tested] that allows pharmacists to process prescriptions in part remotely, a move it said could improve store working conditions and the experience for customers as the company grapples with a shortage of pharmacists.”
From the mental healthcare front, Health Payer Intelligence tells us
Mental healthcare services utilization and network size have grown significantly since 2019 among Blue Cross Blue Shield of Massachusetts (“Blue Cross”) members, according to data from Blue Cross.
Mental healthcare services utilization grew by 100 percent in the timeframe that Blue Cross examined. At the same time, Blue Cross’s mental healthcare network grew by 46 percent.
“As the need for mental health services continues to grow, access to convenient and affordable care is critical,” said Andrew Dreyfus, president and chief executive officer of Blue Cross. “By expanding and diversifying our mental health network, we’re ensuring that our members are able to find and receive the high-quality care they need, when they need it.”
The mental healthcare provider network swelled to a total of 18,000 clinicians. With the growth in utilization, Blue Cross plans to expand its network further. The payer will do this by working with national mental healthcare provider groups as well as expanding its virtual care mental health groups in 2023. * * *
Also worth reading is this Journal article about a 24-year-old military wife who went through drug addiction hell and came out a new person with help from her family, the Missouri prison where she was housed, and a fellow inmate. The article illustrates the importance of Blue Cross of Massachusett’s efforts to expand mental health coverage and various efforts to reduce drug addiction and overdose deaths.
From the medical research front, the Wall Street Journal offers an essay about breast cancer written by a medical historian and breast cancer patient Dr. Lindsey Fitzharris. What grabbed the FEHBlog’s eye is the article’s conclusion:
The cofounders of BioNTech recently announced that vaccines targeting cancer may be available before the end of the decade. Researchers at Duke University are already developing a vaccine that targets mutations commonly arising in people with certain types of advanced breast cancer. Using the same mRNA technology deployed against Covid-19, these types of vaccines would not be administered prophylactically but, rather, used as a treatment to trigger a stronger immune response in patients with locally recurrent or metastatic disease. When it comes to conquering breast cancer, future medical historians will have plenty to write about.
From the innovation front, Senior Living explains how to use Apple AirPods as hearing aids. MedTech Dive adds
Apple AirPods Pro earbuds have the potential to be a hearing aid for adults with mild to moderate hearing loss, according to a paper published in iScience.
Researchers found the earbuds meet four of the five standards for personal sound amplification products and perform comparably to hearing aids in terms of speech perception in quiet environments.
The study suggests that some consumer earbuds can function as hearing aids to potentially further lower the cost and address the stigma associated with the technology.
It’s also worth calling attention to the HHS Agency for Healthcare Quality and Research’s Effective Health Care Program’s website.
The Effective Health Care (EHC) Program improves the quality of health care by providing the best available evidence on the outcomes, benefits and harms, and appropriateness of drugs, devices, and health care services and by helping health care professionals, patients, policymakers, and health care systems make informed health care decisions. The EHC Program achieves this goal by partnering with research centers, academic institutions, health professional societies, consumer organizations, and other stakeholders to conduct research, evidence synthesis, evidence translation, dissemination, and implementation of research findings.
Following reports that patient data was transmitted to Facebook through the use of tracking technology on hospital websitesand within password-protected patient portals, the HHS Office for Civil Rights (OCR) issued a bulletin outlining the dos and don’ts of using tracking tech as a HIPAA-covered entity or business associate.
Covered entities and business associates using tracking tools such as Google Analytics and Meta Pixel should pay close attention to their obligations under HIPAA, OCR noted.
The Cyber Safety Review Board is set to examine the Lapsus$ ransomware gang, the U.S. Department of Homeland Security announced Friday. A prolific group, Lapsus$ has targeted a wide range of global companies and government agencies, sometimes with ruthless digital extortion, since late 2021. * * *
“The CSRB will review how this group has allegedly impacted some of the biggest companies in the world, in some cases with relatively unsophisticated techniques, and determine how we all can build resilience against innovative social engineering tactics and address the role of international partnerships in combating criminal cyber actors,” Mayorkas said Friday during a conference call with reporters. “As cyberthreats continue to evolve, we have to evolve the methods we use to protect ourselves against cybercriminal activity and increase our resilience against future attacks.” * * *
CSRB Deputy Chair Heather Adkins, VP of security engineering at Google, noted that many of the reported targets of Lapsus$ were considered to have very strong cybersecurity programs. These organizations had followed recommended security controls, and in some cases even advanced controls, but still felt a significant impact from the attacks.
Several alleged members of the extortion gang have been arrested, but researchers suspect other affiliates of Lapsus$ remain unaccounted for.
Healthcare Dive offers an interview with the National Coordinator for Health IT, Mickey Tripathi, about federal health information blocking enforcement.
From the cybersecurity breaches/vulnerabilities front —
Health IT Security summarizes recent breaches suffered by healthcare organizations.
ZIP and RAR files have overtaken Office documents as the file most commonly used by cyber criminals to deliver malware, according to an analysis of real-world cyber attacks and data collected from millions of PCs.
The research, based on customer data by HP Wolf Security, found in the period between July and September this year, 42% of attempts at delivering malware attacks used archive file formats, including ZIP and RAR.
The Health Sector Cybersecurity Coordination Center shared an updated CISA / FBI alert about a Cuba ransomware actor.
The Bleeping Computer released its Week in Ransomware.
From the cybersecurity defenses front —
Venture Beat offers Gartner analysts’ eight cybersecurity predictions for 2023.
Health IT Security reports “Connected device security company Ordr published a maturity model to help healthcare organizations evaluate and improve the security of their connected devices. The guide is broken down into five stages of maturity, each with recommended actions and detailed descriptions.”
The Wall Street Journal warns “Companies should do a better job of handling internal cybersecurity complaints before they escalate to whistleblowing, which is becoming more common in the cyber field, lawyers and industry veterans said.”
From the Omicron and siblings front, the Centers for Disease Control’s weekly interpretative summary of its Covid statistics explains
Cases
As of November 30, 2022, the current 7-day average of weekly new cases (43,300) decreased 1.2% compared with the previous 7-day average (43,837). A total of 98,777,220 COVID-19 cases have been reported in the United States as of December 30, 2022.
Variant Proportions
CDC Nowcast projections* for the week ending December 3, 2022, estimate the proportion of lineages designated as Omicron with estimates above 1%: BA.5—and four of its sublineages (BQ.1, BQ.1.1, BF.7, and BA.5.2.6)—BA.4.6,and XBB. XBB is a recombinant of two BA.2 sublineages.
New Hospital Admissions
The current 7-day daily average for November 23–29, 2022, was 4,201. This is a 17.6% increase from the prior 7-day average (3,572) from November 16–22, 2022.
Vaccinations
As of November 30, 2022, 655.3 million vaccine doses have been administered in the United States. Overall, about 267.3 million people, or 80.5% of the total U.S. population, have received at least one dose of vaccine. About 228.4 million people, or 68.8% of the total U.S. population, have completed a primary series.
Of those who have completed a primary series, about 114.8 million people have received a booster dose,* and more than 39.7 million people have received an updated (bivalent) booster dose. But 48.3% of the total booster-eligible population has not yet received a booster dose. Learn more about who is eligible.
Deaths
The current 7-day average of new deaths (254) decreased 32.4% compared with the previous 7-day average (376). As of November 30, 2022, a total of 1,077,303 Covid-19 deaths have been reported in the United States
The CDC also released an encouraging report about Paxlovid’s efficacy.
Summary
What is already known about this topic?
Nirmatrelvir-ritonavir (Paxlovid) is an outpatient antiviral medication recommended for adults with mild-to-moderate COVID-19 who have elevated risk of severe illness.
What is added by this report?
Among U.S. adults diagnosed with COVID-19, including those with previous infection or vaccination, persons who were prescribed Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within 30 days after diagnosis than those who were not prescribed Paxlovid.
What are the implications for public health practice?
Paxlovid should be offered to eligible adults irrespective of vaccination status, especially in groups with the highest risk for severe COVID-19 outcomes, such as older adults and those with multiple underlying health conditions.
Also from the public health front, the CDC’s Fluview tells us
Seasonal influenza activity is high and continues to increase across the country.
Of influenza A viruses detected and subtyped this season, 79% have been influenza A(H3N2) and 21% have been influenza A(H1N1).
Two influenza-associated pediatric deaths were reported this week, for a total of 14 pediatric flu deaths reported so far this season.
CDC estimates that, so far this season, there have been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu.
The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 47 during every previous season since 2010-2011.
The number of flu hospital admissions reported in the HHS Protect system during week 47 almost doubled compared with week 46.
The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.
All viruses collected and evaluated this season have been susceptible to influenza antivirals.
An annual flu vaccine is the best way to protect against flu. Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with flu.
CDC recommends that everyone ages 6 months and older get a flu vaccine annually. Now is a good time to get vaccinated if you haven’t already.
There are also prescription flu antiviral drugs that can be used to treat flu illness; those need to be started as early as possible.
The Wall Street Journal offers a helpful overview of the tripledemic situation.
Scientific meetings about Alzheimer’s disease can be funereal affairs, with researchers from around the world gathering in hopes that the latest in a long line of negative clinical trials might light the path to a long-awaited success.
This year was different. Nearly 2,000 people showed up to the Clinical Trials in Alzheimer’s Disease meeting, a conference record, to hear about lecanemab, a drug from Eisai and Biogen that appears to have broken the decades-long cycle of disappointment.
A packed audience repeatedly burst into applause during Eisai’s lecanemab presentation on Tuesday — with onlookers clapping even when they learned that the results had been concurrently published in the New England Journal of Medicine. Supplemental figures don’t usually don’t draw cheers, but the warm reception underscored how overjoyed researchers were to have any kind of success against Alzheimer’s, even a modest one. * * *
Several researchers compared this moment in Alzheimer’s research to the early days of cancer therapy or HIV treatment — the first drugs aren’t smash hits, but they’re something for scientists and doctors to build on and learn from.
“It’s not like you’ve won the war with lecanemab,” said Eric Siemers, chief medical officer of Acumen Pharma. “We’ve got a lot of work to do. But this is an inflection point. There’s no question about it.”
In that regard, BioPharma Dive points out lessons learned from testing a Roche drug similar to lecanermab.
After one year of treatment, [the Roche drug] gantenerumab reduced amyloid burden in patients only half as well as the trials’ designers had expected based on previous research, said researcher Randall Bateman, a neurology professor at Washington University in St. Louis who helped lead the studies.
Moreover, around half as many gantenerumab patients as predicted tested negative for amyloid over the course of the trial. Almost none tested negative after one year of treatment, and only around a quarter did after more than two years, researchers revealed.
Data for lecanemab and donanemab presented at CTAD, meanwhile, showed stronger amyloid clearance, helping boost confidence in those drugs.
Bateman also pointed to a post-study analysis researchers conducted of Roche’s trials that hinted at better outcomes for trial participants who had higher reductions in amyloid, although this finding wasn’t statistically conclusive.
Taken together with data from other trials, gantenerumab’s results should help researchers as they try to optimize available therapies and develop new ones, Bateman said.
“I see this as one of the missing essential pieces of the puzzle of figuring out how to optimally treat along this pathway for amyloid removal,” he said.
Meanwhile, the New York Times tells us about “A Promising Trial Targets a Genetic Risk for Alzheimer’s Preliminary results offer hope that gene therapy can protect people with a version of the brain disease driven by a particular gene variant.”
From the U.S. healthcare business front, Healthcare Dive reports
Advocate Aurora Health and Atrium Health announced Friday the two providers have closed their merger deal, becoming the nation’s fifth-largest nonprofit health system by revenue.
The new system, Advocate Health, will generate revenue of more than $27 billion and operate 67 hospitals and more than 1,000 sites of care in six states. The system expects to treat nearly 6 million patients each year. * * *
Instead, economists told Healthcare Dive, the FTC is likely to examine insurer overlap in the case of Advocate Health. The combined entity operates in Illinois, Wisconsin, Georgia, North Carolina, South Carolina and Alabama.
The Biden administration will allow agencies to hire employees in certain positions on a temporary basis for up to 10 years, more than doubling the current cap limiting the assignments for those workers.
The Office of Personnel Management issued the rule on Thursday, finalizing a proposal first put forward by the Trump administration. The rule will enable federal agencies to appoint employees in STEM jobs for a decade. OPM said the change would give agencies more flexibility when tackling long-term science, technology, engineering and mathematics projects. Previous regulations required agencies to get special permission from OPM to keep any term employee on staff for longer than four years.
Viet Tran, an OPM spokesman, said the rule showed the administration’s “commitment to STEM hiring.” He added it would allow for more federal, rather than outsourced, hiring.
“With this final rule, agencies have more flexibility and support (and less administrative burden) to hire employees—rather than contractors—for non-permanent STEM positions that agencies expect from the outset to last longer than 4 years but not more than 10 years,” Tran said. “This is another tool to help agencies better compete for talent.”
As the FEHBlog has explained, federal employees can expect a 4.6% pay raise for 2023 with 4.1% of the increase being distributed across the GS schedule and the remaining 0.5% allocated to locality pay. As it turns out, the Society for Human Resource Management tells us
Employers in the U.S. plan to boost salaries an average of 4.6 percent in 2023, up from 4.2 percent this year, according to a new study.
Employers say inflationary pressures and the ongoing challenges of finding and keeping workers are the main reasons for the higher projected increases. Indeed, 3 in 4 of the 1,550 U.S. employers in the latest Salary Budget Planning Report by consultancy WTW say they continue to experience problems attracting and retaining workers.The survey was conducted from Oct. 3 to Nov. 4, 2022.
From the plan design front, a recent Kaiser Family Foundation report explains the growing use of all sizes of employers to provide retiree health benefits through Medicare Advantage plans.
This analysis uses data from the 2022 KFF Employer Health Benefits Survey to examine the extent to which large private and non-federal public employers that offer retiree health benefits are turning to Medicare Advantage and why they are making this shift. However, the Survey does not include information about union-administered benefits. For additional information about methods, see Survey Design and Methods.
Based on the Survey, we find:
Half (50%) of large employers offering retiree health benefits to Medicare-age retirees offer coverage to at least some retirees through a contract with a Medicare Advantage plan, nearly double the share in 2017 (26%).
About 44% of large employers that offer Medicare Advantage coverage to their retirees do not give retirees a choice in coverage options.
Among larger employers with 1,000 or more workers that offer retiree health benefits through a Medicare Advantage plan, the most commonly cited reason they elected this option was the lower cost.
FEHB plans also are implementing integrated Medicare Advantage plans as a cost-saving measure.
From the HHS front, “Today, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra marked the one-year anniversary of HHS’s Overdose Prevention Strategy (Strategy) by announcing the progress the nation has made since the release of the Strategy, showing expanded treatment capacity, lives saved from an overdose, and commitment to long term recovery supports.” Kudos. Here is the fact sheet.
From the Federal Employees Benefit Open Season front, Tammy Flanagan, writing in Govexec, explains the relationship between FEHB and Medicare coverage for the benefit of annuitants over age 65.
From the OPM front, Govexec and Federal News Network discuss an OPM management report released yesterday that includes more details on OPM’s 2022 Federal Employee Viewpoint Survey.
From Capitol Hill, Medpage Today informs us that “Telehealth, Mental Health Likely Topics for the New Congress in 2023, Experts Say.” In this regard, today the bipartisan leadership of the Senate Finance Committee “released a [fifth and final mental health parity] discussion draft including policies aimed at improving mental health parity in Medicare and Medicaid and helping to put access to mental health and substance use disorder (SUD) services on par with physical health care. Mental health parity includes a set of laws aimed at ensuring mental and physical health care are covered equally by health insurance. * * * The full text of the discussion draft is available here. A summary of all provisions released by the committee as a part of the bipartisan mental health effort, including mental health parity, is available here.”
COVID-19 hospitalizations have ticked up nationwide in recent weeks amid concerns of a potential winter surge, according to data tracked by The New York Times.
As of Nov. 29, the nation’s daily hospitalization average was 31,125, up 12 percent over the last 14 days. This figure is still down significantly from the more than 800,000 daily hospitalizations recorded during the peak of last winter’s omicron surge.
People with acute respiratory illness during the pandemic suffered similar levels of poor well-being in the months afterward whether they tested positive for SARS-CoV-2 or not, a registry study showed.
In a cohort of people who all had initial symptoms suggestive of COVID-19, those who had moderate to severe scores at 3 months on the pain, mood, and other quality-of-life measures on the Patient-Reported Outcomes Measurement Information System (PROMIS) scale were actually less likely to have tested positive for the coronavirus as to have had other causes of illness (39.6% vs 53.5%, P<0.001).
From the public health front —
MedPage Today explains how patients can try to distinguish among different respiratory illnesses, including RSV and the flu because at home testing is unavailable.
The Biden administration looks to end its public health emergency declaration for mpox — the virus formerly known as monkeypox until recently — a sign that officials believe they’ve brought the unprecedented outbreak under control, POLITICO’s Adam Cancryn reports.
Health officials are likely to issue a 60-day notice later this week for winding down the declaration, two people with knowledge of the matter told POLITICO, putting it on track to expire by Jan. 31. The decision isn’t yet final and could still change, the people cautioned. * * *
Some administration officials see the potential unwinding of the mpox emergency declaration as a test run for eventually ending the yearslong Covid emergency — a more complex challenge — that Biden aides expect to happen at some point next year.
From the Affordable Care Act and No Surprises Act front
The American Hospital Association (“AHA”) informs us
The Centers for Medicare & Medicaid Services seeks public input on topics related to essential health benefits — items and services that all non-grandfathered health plans in the individual and small group markets must cover under the Affordable Care Act. The agency is requesting feedback on how essential health benefits may need to be updated to reflect changes in medical evidence and scientific advancement, address gaps in coverage and health equity, or remove barriers to accessing services. In particular, CMS seeks feedback on essential health benefits related to maternal health, behavioral health and prescription drug coverage. The agency will publish the request for information in the Dec. 2 Federal Register, with comments accepted for 60 days.
and
AHA today urged the Centers for Medicare & Medicaid Services not to establish a national directory of health care providers and services (NDH) at this time.
“The AHA shares CMS’ goals to improve patient access to provider information and to facilitate health information exchange and data reporting,” the association wrote. “We appreciate the commitment CMS has invested in striving to meet these objectives. However, we are concerned that adding one more provider directory requirement will not support patients in accessing the information they need about their care providers. In fact, adding an additional data source without sufficiently addressing how or why it differs from the myriad provider directories already in existence could further complicate patients’ ability to access accurate information. Meanwhile, such a requirement would add considerable, duplicative burden on providers. Additionally, we have significant reservations about the current state of readiness of the essential technology needed for a centralized data hub such as the NDH.”
Mercer Consulting offers insights on the prescription drug and healthcare spending reports that health plans must submit to the federal government by December 27. Jingle bells.
Healthcare Dive reports that the Texas Medical Association has filed another lawsuit challenging different aspect of the independent dispute resolution rule. Haven’t the TMA lawyers heard about the opportunity available under the Federal Rules of Civil Procedure to amend their existing complaint?
The Food and Drug Administration approved the first therapy using bacteria from stool samples to treat a bowel disorder on Wednesday, paving the way for several similar treatments in development.
The drug, called Rebyota, is given as a one-dose treatment for Clostridium difficile infections, commonly known as C. diff., in which the toxin-producing bacteria disrupts the normal balance in a person’s digestive system. Rebyota is designed to restore balance by introducing good bacteria taken from donor stool samples.
“We are delighted that FDA has approved the first fecal microbiome restoration therapy for recurrent C. diff. This is an enormous step forward for the nearly 200,000 people who battle rCDI each year,” said Christian John Lillis, the executive director of the C. diff advocacy organization the Peggy Lillis Foundation.
Amgen released detailed data on Thursday suggesting an early-stage drug can induce significant weight loss in patients with obesity, with less frequent dosing than current treatments but a safety profile that remains unclear.
The results for the molecule, codenamed AMG133, throw Amgen in a long-gestating race with other major drugmakers that burst into the popular press this year.
Eli Lilly and the diabetes giant Novo Nordisk both market drugs that were recentlyshown to lower body weight by around 15% to 20% after a little over a year. (Lilly’s is currently approved only for diabetes, but it plans to submit for obesity next year.) The injectables have been highly sought after by both obesity specialist physicians, who have long searched in vain for something safe and effective to offer their patients, and celebrities hoping to look svelte in their next appearance.
From the miscellany department —
Beckers Hospital Review interviews a Kaiser Permanente expert about their successful use of remotely monitoring patients with diabetes and high blood pressure. The monitors deliver their results to Kaiser Permanente’s electronic health records for 40,000 members. Kudos.
Beckers also lets us know about large hospital systems that are having a profitable 2022.
Elon Musk’s brain-machine interface company Neuralink aims to put its first implant in a human subject in the next six months, he said during an event Wednesday.
Musk said the company has been “working hard to be ready for our first human,” and has submitted most of the required paperwork to the Food and Drug Administration to launch a study in humans. The company — which is designing a device to translate the brain’s signals into actions — also announced it will first focus specifically on two applications: restoring human vision, and helping people who can’t move their muscles to control devices like smartphones or even return the ability to move to people with severed spinal cords, Musk said.
Though it’s starting with certain parts of the brain, Musk said Neuralink’s long-term goal is to create a system that can translate impulses from the entire brain into actions.
Govexec discusses the outstanding steps that must be taken before a projected 4.6% federal employee pay raise can take effect next month. The FEHBlog expects those steps to be taken.
Reg Jones, writing in FedWeek, reviews the federal retirement process.
Federal News Network reports that “Federal employees forced to work without pay during government shutdowns need to be made whole eventually. But the government’s late payments don’t mean those workers are entitled to damages, [the U.S. Court of Appeals for the Federal Circuit] ruled Wednesday.
From the Omicron and siblings front, the Wall Street Journal informs us
The Food and Drug Administration said a Covid-19 antibody treatment from Eli Lilly & Co. is no longer authorized for use because it isn’t likely to be effective against certain Omicron offshoots now dominant in the U.S.
The subvariants, called BQ. 1 and BQ. 1.1, now cause more than half of new Covid-19 cases in the U.S., the FDA said on Wednesday. Yet Lilly’s drug, bebtelovimab, doesn’t retain neutralizing activity against the subvariants, the company said.
“Lilly and the FDA agree that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate Covid-19 with bebtelovimab in the U.S.,” Lilly said.
Bebtelovimab was among the Covid-19 antibody drugs still authorized for use as a treatment for sick patients, after the FDA pulled clearances of others. Roche Holding AG’s Actemra antibody drug is also still in use as a treatment, though it wasn’t developed specifically for Covid-19.
Evusheld, an antibody drug from AstraZeneca PLC, is still clearedto prevent infections.
The FDA said other Covid-19 treatments are still expected to retain activity against BQ. 1 and BQ. 1.1, including PfizerInc.’s Paxlovid and Gilead Sciences Inc.’s Veklury.
With growing concern about the circulation of vaccine-derived polioviruses in the United States, the Centers for Disease Control and Prevention said Wednesday that it would work with select communities across the country to conduct wastewater surveillance for the viruses.
The launch of the initiative follows the discovery over the summer of vaccine-derived polioviruses circulating in the sewage of a number of counties in and around New York City. That discovery was made after an unvaccinated man in his 20s was partially paralyzed by polioviruses in July. Since then at least 82 genetically linked viruses have been recovered in sewage samples collected from five counties in and around New York.
The CDC said the work will start in two communities: Oakland County, Mich., and an as-yet-unnamed county in the Philadelphia area. The surveillance may later extend to other parts of the country where polio vaccination rates are low or to locations that have ties to the communities in New York state where polioviruses have been found in wastewater.
Heightened expenses, ongoing staffing shortages and fewer patient discharges have hospitals facing negative margins near the end of the year, according to Kaufman Hall’s monthly national flash report out Wednesday.
Median operating margins have been in the red for 10 consecutive months and were down 2% in October from September. Median operating margins were down 13% year over year in October, according to the report.
Total labor expenses rose 3% from September and total expenses rose 1%, while supply and drug expenses did fall slightly during the month.
In that regard, Beckers Hospital CFO Report relates
Cleveland Clinic has reported a more than $1 billion loss for the first nine months of 2022 as salaries increase and inflationary pressures mount.
The 20-hospital health system reported $469.2 million in third quarter net losses, a significant drop from $422.2 million net income last year. Cleveland Clinic’s investment returns were nearly $682 million lower for the third quarter this year than last due to “unfavorable financial markets,” according to the health system’s financial report.
Highmark Health posted a $268 million net loss through the first nine months of 2022 as multiple headwinds drag its finances.
Highmark reported $19.5 billion in revenue, up 22% year-over-year, and $594 million in operating gain. The performance of its equity investment portfolio is a key challenge facing the integrated system, as its financial report includes $670 million in unrealized investment impact driven by a decline in the portfolio.
Saurabh Tripathi, chief financial officer and treasurer of Highmark Health, told Fierce Healthcare that Hihghmark expects to turn that unrealized impact around as the market improves.
Other major headwinds include ongoing supply chain issues, inflation and high labor costs, particularly at its Allegheny Health Network health system. Strong performance at its health plan arm is helping to bolster AHN as it weathers these challenges that providers nationwide are staring down.
“This is where the strength of our portfolio comes in,” Tripathi said. “The insurance side is helping offset those pressures.”
Ah, the benefits of diversification.
From the medical research and development front,
The NIH HEAL Project Initiative’s Director delves into HEAL’s research on preventing opioid addiction.
BioPharma Dive examines “What to make of Eisai and Biogen’s latest Alzheimer’s drug data.” Given the FEHB Program’s demographics, FEHB carriers should keep an eye on this drug which is bound to be an expensive hot seller if the manufacturers can overcome the blowback from their Aduhelm failure.
Congressional leaders and top appropriators are set to meet as early as Wednesday to work through differences on a potential omnibus spending agreement, Senate Majority Leader Charles E. Schumer said Tuesday.
President Joe Biden and Vice President Kamala Harris, along with a few top White House aides, met with Speaker Nancy Pelosi, House Minority Leader Kevin McCarthy, Senate Minority Leader Mitch McConnell and Schumer earlier Tuesday to discuss the lame-duck agenda.
Schumer said the leaders had a “productive discussion” about funding the government, and said all four leaders aim to come together to pass an omnibus.
“We all agreed that it should be done this year, we all agreed we have to work together and everyone has to give a little bit,” he said. “We also…said we would all work toward getting an omnibus as opposed to a CR.”
The prospects of a lame duck omnibus remain murky as Republicans and Democrats have not reached a topline spending agreement. The current continuing resolution runs out Dec. 16, though lawmakers have discussed a stopgap extension of perhaps a week to buy extra time.
The FEHBlog sees these developments as a good sign.
From the Omicron and siblings front, MedPage Today informs us
What happens to people who get reinfected with SARS-CoV-2, the virus that causes COVID-19? A recent paper in Nature Medicinehas been misinterpreted by some as providing evidence that repeat infections are somehow worse than first-time infections.
Here’s the actual situation: second infections are far less dangerous than first infections, with respect to severe, critical, and fatal COVID-19. This is true regardless of vaccination status.
Health Payer Intelligence offers three interesting survey findings about health insurance in our country
“Health insurance coverage disruptions were associated with higher mortality risks for people with private and public insurance, a JAMA Health Forum study found.”
“In two-adult families with and without children, the majority of members had the same type of health insurance coverage, whether they had group plans, non-group plans, or Me,dicaid” according to a brief from the Employee Benefit Researcher Institute (EBRI).
From the public health front, the FEHBlog ran across The PCORI Health Care Horizon Scanning System identifies and monitors developing innovations with potential to change health care. This database can be used by patients, care partners, and others to track advancements in care options.
The rate of gun deaths in the U.S. reached a 28-year high in 2021 after sharp increases in homicides of Black men and suicides among white men, an analysis of federal data showed.
A record 48,953 deaths in the U.S., or about 15 fatalities per 100,000 people, were caused by guns last year, said the analysis published Tuesday in the journal JAMA Network Open. Gun deaths declined in the 1990s, but have been rising steadily over the past decade and skyrocketed during the Covid-19 pandemic, said researchers who conducted the analysis.
Gun-related deaths of women and children have risen, the analysis said, but men remain far more likely to die from guns.
“The disparities are so marked,” said Chris Rees, a co-author of the study and an assistant professor of pediatrics and emergency medicine at Emory University School of Medicine.
The Pentagon is looking to hire hundreds of clinicians and mental health professionals in the coming months, as part of the initial cohort of its worldwide suicide prevention workforce.
Deputy Defense Secretary Kathleen Hicks, speaking Tuesday at a Washington Post Live event, said DoD is building up a “first of its kind” suicide prevention workforce that will eventually reach an end strength of 2,000 personnel.
Hicks said hiring, onboarding and training the suicide prevention workforce is “at the top of the list” of priorities for Defense Secretary Lloyd Austin. This DoD workforce, she added, is expected to outpace any similar effort led by universities or state governments.
“This prevention workforce will be a first of its kind, and we’re going to do it right here in the United States military, because that’s what we owe our people and their families,” Hicks said.
From the medical research and development front, the Wall Street Journal reports
Researchers released new details from a study of a closely watched drug for Alzheimer’s disease on Tuesday, shedding more light on the drug’s risks and benefits as U.S. health regulators weigh approving it.
Eisai Co. and Biogen Inc.’s drug, called lecanemab, slowed cognitive decline by 27% compared with a placebo over 18 months in a study of more than 1,700 people with early-stage Alzheimer’s, researchers reported in the New England Journal of Medicine on Tuesday.
The drug’s effect was moderate, and was associated with swelling and bleeding in the brain, the researchers said. They recommended further, longer study of the drug.
Some 17.3% of patients taking lecanemab had signs of brain bleeding, compared with 9% in the placebo group. Brain swelling occurred in 12.6% of people getting the drug, versus 1.7% who got placebos.
The study data have been eagerly anticipated by Alzheimer’s researchers since Eisai disclosed high-level results in September, raising the hopes of doctors and patients that a new treatment proven to help Alzheimer’s patients is on the horizon.
The companies have asked the U.S. Food and Drug Administration to conditionally approve lecanemab based on an earlier study showing that the drug reduced levels of a protein in the brain called amyloid associated with Alzheimer’s. The agency is expected to make a decision by Jan. 6.
Eisai, which is leading the development of lecanemab, has said it plans to seek full approval using the new study data.
The NIH DIrector’s Blog tells us about the NIH clinical center doctors who are testing 3D-printed miniature, single-use ventilators. Cool.
Google’s health division has inked its first commercial agreement to use its mammography AI research model in real-world clinical practice, with the goal of improving breast cancer screening, Google Health announced Monday.
Google Health has partnered with cancer detection and therapy medtech iCAD on the 5-year deal. Under the agreement, iCAD will work to validate and incorporate Google’s mammography AI — which Google has been building and testing for several years — into its products for use in clinical practices.
From the U.S. healthcare business front, the Wall Street Journal reports
Apoorva Mehta, a co-founder of Instacart Inc., is working on his next act after saying earlier this year that he would step down as executive chairman from the startup he built into a grocery delivery giant once it goes public.
Mr. Mehta earlier this month raised $30 million for Cloud Health Systems, a new healthcare startup aiming to offer consumers medical consultations and other health-related services, according to people familiar with the matter.
When many people are looking to enroll in health benefits, they turn to Google as a source of key information on eligibility, the application process and in-network providers.
In this spirit, the Google Search team has quietly rolled out multiple features for its search engine that aim to make it easier for users to access key information about obtaining Medicaid and Medicare benefits, as well as which doctors locally accept those types of coverage.
The article offers more details on these new Google tools.
From the Omicron and siblings front
Beckers Hospital Review informs us “The CDC has begun tracking omicron subvariant XBB, which is now estimated to account for 3.1 percent of U.S. cases”[, somewhat higher in New York, New Jersey and New England states]. * * * Health experts anticipate the U.S. will see an increase in COVID-19 cases in the winter months as a collection of omicron subvariants circulates, though they have remained optimistic it will be less severe than last winter’s omicron surge.”
The National Institutes of Health discusses its research on the ability of the human body’s immune system to remember a previous Covid infection or vaccination to help ward off, or minimize symptoms during, a future infection.
Fierce Healthcare reports “The U.S. came in dead last compared to 20 other countries when it came to preventing deaths from COVID-19 as well as all-cause deaths, and it appears that relatively low vaccination rates might have played a part in those poor showings, a new study finds. * * * The U.S. continued to experience significantly higher COVID-19 and excess all-cause mortality compared with peer countries during 2021 and early 2022, a difference accounting for 150,000 to 470,000 deaths,” authors of the research letter published in JAMA Network wrote. ‘This difference was muted in the 10 states with highest vaccination coverage; remaining gaps may be explained by greater vaccination uptake in peer countries, better vaccination targeting to older age groups, and differences in health and social infrastructure.’”
From the public health front
Axios tells us “The RSV season normally runs from December to April, peaking in February and March, but this year has seen an earlier onset. [Dr.] Fauci noted that both the RSV and flu seasons have arrived earlier than usual this year. Asked by [Meet the Press host Margaret] Brennan whether the U.S. is “in the worst of it” right now, Fauci replied, “I hope so.”
The American Hospital Association relates “The World Health Organization today recommended a new name for monkeypox that is intended to mitigate a rise in related racist and stigmatizing language associated with the ailment. The WHO’s newly recommended preferred term is “mpox.” The organization recommends a one-year transition period to mitigate confusion that could be caused by the change and allow for ICD and publication updates. The Biden administration voiced its support for the change, stating, ‘We welcome the change by the World Health Organization. We must do all we can to break down barriers to public health, and reducing stigma associated with disease is one critical step in our work to end mpox.’” The FEHBlog also will begin to refer to chickenpox as cpox.
From the regulatory front, MedPage Today informs us
In an effort to enhance care coordination for patients with substance use disorder (SUD), HHS, acting through its Office for Civil Rights and in collaboration with the Substance Abuse and Mental Health Services Administration, proposed changes to “Part 2” rules to better align privacy measures with those of HIPAA on Monday.
If implemented, the proposed rule would allow Part 2 programs to use and share patients’ records following a single signed consent by the patient “for all future uses and disclosures for treatment, payment, and healthcare operations.”
The proposal also aims to strengthen protections around disclosure of SUD treatment records to guard against discrimination and stigma.
The changes were initially called for in the CARES Act of 2020, provisions of which required the HHS secretary to better align the 42 CFR part 2 rule, better known as “Part 2,” with HIPAA’s Privacy, Security, Breach Notification, and Enforcement Rules.
“This proposed rule would improve coordination of care for patients receiving treatment while strengthening critical privacy protections to help ensure individuals do not forego life-saving care due to concerns about records disclosure,” said HHS Secretary Xavier Becerra in a press release.
From the medical research front, we learn from STAT News that
A drug developed by Axsome Therapeutics significantly reduced a common side effect of Alzheimer’s disease — agitation — the company announced Monday.
The therapy, AXS-05, met its primary goal of delaying time to relapse and preventing patients from relapsing. Patients taking the drug had a 3.6-fold lower risk of relapse overall, compared to placebo.
People with Alzheimer’s disease can get restless, upset, or even aggressive as the disease gets worse. Axsome’s trial also showed an improvement on a scale commonly used to measure overall agitation.
* * *
The Food and Drug Administration has granted Axsome breakthrough therapy status for AXS-05 in Alzheimer’s agitation, which could help the company secure an accelerated, additional approval. Company officials said they plan to wait to see data from another Phase 3 trial called ADVANCE-2 before filing a drug application, according to a third-quarter earnings call transcript from Sentieo.
Dr. Thomas Perls has for decades studied so-called super agers, people who live deep into their 90s and beyond, essentially unburdened by the typical diseases of old age. He is convinced that the secret to this remarkable longevity is buried in people’s genes and passed down through generations.
But which genes harbor this power? And if researchers pinpoint the right genes amid thousands in a person’s body, could that knowledge be harnessed to develop drugs that mimic those genes and allow more people to enjoy longer, healthier lives?
That’s the premise behind an ambitious new trial, the SuperAgers Family Study, (superagersstudy.org) that aims to enroll 10,000 people who are 95 years old or older and their children.
From the benefit design front, Beckers Payer Issues offers more insights from a recent AHIP study of prior authorization practices:
Gold-card programs give providers exemptions from certain prior authorization requirements, but providers who have discontinued these programs have found them administratively difficult to implement, according to a Nov. 14 America’s Health Insurance Plans survey. * * *
Here are the top three reasons insurers said they discontinued gold card programs, according to the report:
1. Administratively difficult to implement: 75 percent
2. Reduced quality/patient safety: 50 percent
3. Higher costs without improved quality: 25 percent
From the healthcare business front, Healthcare Dive reports
[Telehealth vendor] Amwell is in advanced discussions to acquire online therapy app Talkspace for roughly $200 million, according to a report from Israeli business publication Calcalist.
The telemedicine company is in talks to pay $1.50 per share for Talkspace, Calcalist reported on Sunday. The price tag would represent a 150% premium over Talkspace’s share price at Friday’s close.
The reported transaction reflects a sharp decline in Talkspace’s value since the therapy company went public last summer at a $1.4 billion valuation.
Other issues emphasized by Democrats, including passing a ban on the sale of assault-style weapons, are a long-shot given their narrow majority in the Senate. Most legislation requires 60 votes to advance in the Senate. In addition, lawmakers are discussing raising the federal debt ceiling, which limits how much the government can borrow.
Congress faces a Dec. 16 deadline to pass legislation that would continue funding the federal government; failure to do so could result in a partial shutdown. Lawmakers must decide whether to approve a short-term bill or reach a deal on more-detailed legislation that would fund the government for the full fiscal year.
The Senate also will be considering the National Defense Authorization Act, which typically includes government procurement law changes.
Tomorrow, the Federal Employee Benefits Open Season will reach its clubhouse turn with two weeks left to go. Although not a part of the Open Season, Federal News Network reports an important development concerning the Federal Employees Long Term Care Insurance Program (FLTCIP.
Those looking to enroll in the FLTCIP will soon have to wait a couple of years before applying.
The Office of Personnel Management said it will suspend all new applications to the program starting on Dec. 19. The suspension will last for the next two years, but those who apply ahead of the start date may still see their applications go through. During that time, current FLTCIP enrollees cannot apply to increase their coverage. The suspension will otherwise not affect the coverage of current enrollees.
* * *
The contract for the insurance program, with John Hancock Life and Health Insurance Company, typically lasts seven years before getting a renewal. The program normally gets a premium hike each time the contract turns over. During the open period for new contract proposals earlier this year, only the current underwriter John Hancock submitted a bid. The current FLTCIP contract will expire on April 30, 2023.
The upcoming suspension on applications will allow OPM “to assess the benefit offerings and establish sustainable premium rates that reasonably and equitably reflect the cost of the benefits provided,” the agency said in a Nov. 18 notice. OPM added that it will only suspend applications when it is in the best interest of the program.
Many are eligible to apply for FLTCIP coverage, including federal employees, U.S. Postal Service employees and annuitants, as well as active and retired members of the uniformed services, and qualified relatives of feds. John Hancock has historically sponsored the program, and Long Term Care Partners, LLC, has administered it.
From the Omnicron and siblings front, the National Institutes of Health announced
Reporting a positive or negative test result just became easier through a new website from the National Institutes of Health. MakeMyTestCount.org, developed through NIH’s Rapid Acceleration of Diagnostics (RADx®) Tech program, allows users to anonymously report the results of any brand of at-home COVID-19 test.
COVID-19 testing remains an essential tool as the United States heads into the holiday season and people navigate respiratory viruses. While taking a rapid COVID-19 test has become commonplace, test results are not often reported. COVID-19 test results provide valuable data that public health departments can use to assess the needs and modify the responses in the local community, the state or the nation.
Lab tests have a well-established technology system for sharing test results. RADx Tech has been working on a system to standardize test reporting for at-home tests in a secure manner. The MakeMyTestCount.org website is built on this system for logging test results.
U.S. life insurers paid a record $100 billion in 2021 in death benefits, fueled by another year of Covid-19 deaths, an industry trade group said.
Payouts rose 11% in 2021 to $100.19 billion, most likely due to the pandemic, according to the American Council of Life Insurers. The increase was on the heels of a 15% year-over-year rise in 2020, when death-benefit payments totaled $90.43 billion.
The ACLI compiles data from annual filings by insurers to state insurance departments. Given limitations in the filings, the group can’t break down causes of death, but it is reasonable to attribute the bulk of the increases to the pandemic, said Andrew Melnyk, ACLI vice president of research and chief economist.
The year-over-year increases are among the largest since the 1918 flu pandemic, when payments surged 41%. They are far above the 4.9% average from 2011 to 2021, the ACLI said.
From the No Surprises Act front, Healthcare Dive reports
House lawmakers expressed their discontent with a final rule on surprise billing and urged federal regulators to make changes.
House Ways and Means Committee Chairman Richard Neal, D-Ma., and ranking member Kevin Brady, R-Texas, sent a letter to HHS Secretary Xavier Becerra and other department heads again expressing disappointment with a much-contested section of the surprise billing ban.
The lawmakers “are severely disappointed to find that the August 2022 final rule violates the No Surprises Act in the same ways as before,” Neal and Brady said in a letter last week.
For Heaven’s sake, Congress should give the revised rule a chance before joining the medical associations in condemning it.
From the public health front, Health Payer Intelligence tells us
The number of Americans with a usual source of care has dropped 10 percent in the last 18 years, with only about three-quarters of people saying they have a regular primary care provider or at least a facility where they know they can access care, according to the Primary Care Collaborative (PCC) and AAFP Graham Center.
The analysis also revealed some health disparities, with folks who are Hispanic, have less than a high school education, are uninsured, and are younger being less likely to have a usual source of care than their counterparts. * * *
“Employers have a very important role to play to ensure that all their employees and their families have ready, convenient access to a usual source of affordable primary care,” said Asaf Bitton, MD, the executive director of Ariadne Labs – Harvard T.H. Chan School of Public Health.
“We applaud those employers who are providing highly accessible virtual and in-person primary care options, and working with preferred provider organizations and health systems to support patients in establishing and maintaining these crucial primary care relationships.”
Cardiovascular disease is responsible for about one in five deaths in women in the U.S., more than any other cause — including all forms of cancer combined. Black women like Shields are particularly vulnerable: In the U.S., Black adults are substantially more likely to die from heart disease than their white, Hispanic, or Asian or Pacific Islander counterparts.
To try to reduce deaths from heart disease, health professionals typically use basic risk calculators, which take about a dozen standard data points to predict a person’s likelihood of having a major event, such as a heart attack or stroke, in the next 10 years.
Regardless of their other risk factors, for the most part, patients who are young and female have a very low chance of having a cardiovascular event in the next 10 years, so they are unlikely to get recommendations for serious lifestyle interventions or medication. But they may still be heading down a path to a fatal event later in life.
These data, however, are all missing from standard cardiovascular disease risk calculators. Some pregnancy complications are listed as part of the comprehensive American Heart Association screening guidelines. But a large national 2014 survey revealed that only 16% of primary care physicians and 22% of cardiologists were using these full guidelines. The failure of health-care providers to screen for these sorts of early warning signs is in keeping with the long-standing pattern in which women’s risk for heart disease is chronically underestimated by medical professionals — as well as by women themselves.
That’s a big bowl of wrong.
From the plan design front, Beckers Payer Issues relates
Providers using EHRs that aren’t enabled for electronic prior authorization and the cost to upgrade to those EHRs are the main barriers preventing automated PA, according to a Nov. 14 America’s Health Insurance Plans survey.
The health insurance trade group conducted an industrywide survey on “prior authorization practices and gold carding experience of commercial plans” between February and April, according to the report. AHIP received responses from 26 plans, covering a total of 122 million commercial enrollees.
Top barriers to automated prior authorization:
Provider does not use EHR enabled for electronic PA: 71 percent
Costly/burdensome for providers to buy/upgrade EHR for electronic PA: 71 percent
Lack of interoperability between EHR vendors: 62 percent
Costly for payers to enable PA rules and information to be delivered electronically: 43 percent
Lack of electronic PA solutions on market: 19 percent
This is a surprising outcome considering how vociferously providers object to prior authorization.
From the cybersecurity policy front, Cybersecurity Dive tells us
The Defense Department officially launched its zero trust strategy and road map Tuesday, part of a larger strategy to overhaul the way federal agencies combat sophisticated threat actors, including those from criminal organizations and rogue nation states.
The DOD will move away from a perimeter-based approach for IT systems defense to a system that essentially assumes the risk of breach during regular interactions and will act accordingly. The plan calls for the Pentagon’s full implementation of the strategy and road map by fiscal 2027. * * *
Microsoft, in a blog post released Tuesday, praised the DOD announcement on zero trust, noting the challenge of collaborating on zero trust amid the difficulties of comparing implementations across various organizations and technology stacks.
“However the level of detail found in the DoD’s strategy provides a vendor-agnostic, common lens to evaluate the maturity of a variety of existing and planned implementations that were derived from the DoD’s unique insights on cybersecurity,” Steve Faehl, federal security CTO at Microsoft, said in the blog post.
From the cybersecurity vulnerabilities front, Forbes offers “A Boiling Cauldron: Cybersecurity Trends, Threats, And Predictions For 2023.”
From the ransomware front, Health IT Security reports
Lorenz ransomware poses a threat to the healthcare sector, particularly larger organizations, the Health Sector Cybersecurity Coordination Center (HC3) warned in its latest analyst note. The human-operated ransomware group has been known to focus on “big-game hunting,” targeting large, high-profile entities rather than private users.
Lorenz threat actors are known to publish data publicly as a tactic to pressure victims during the extortion process. The actors have been observed demanding hefty ransoms, ranging from $500,000 to $700,000.
From the cybersecurity defenses front, Cybersecurity Dive informs us
Cybercriminals are prepared and ready to target online shoppers with fake websites, malicious links and fake charities, the Cybersecurity and Infrastructure Security Agency warned as the holiday shopping season gets underway.
“By following a few guiding principles like checking your devices, shopping from trusted sources, using safe purchasing methods, and following basic cyber hygiene like multifactor authentication, you can drastically improve your online safety when shopping online for gifts this year,” CISA Director Jen Easterly said in a statement.
Federal News Network is offering an Open Season interview with well known FEHB expert Walt Francis on YouTube.
From the Omicron and siblings front, STAT News reports
The updated Covid-19 boosters increase people’s protection against symptomatic infection from the coronavirus, according to some of the first estimates of how the shot is performing in the real world and in people, not just in lab experiments. What’s more, that protection was even stronger when people waited a longer period of time since their last dose of the original shot.
The findings, released Tuesday by the Centers for Disease Control and Prevention, do not, however, address the question of whether the bivalent shot offers greater protection than another shot of the original formulation would have.
Thanksgiving once again comes at a precarious time, as new subvariants take over and the return of cold weather brings people back indoors, often in family gatherings where the virus can easily spread. The holiday last year coincided with the arrival of an early version of the Omicron variant that kicked off an explosive rise in cases and the second-deadliest Covid-19 wave. Only the prior winter, when vaccination efforts were just beginning, saw a higher peak in deaths.
This time around, some virus experts say the lack of a fresh surge triggered by newly ascendant Omicron subvariants is a hopeful sign that built-up immune protection from vaccines and prior infections is helping.
In the FEHBlog’s view, the key difference between last Thanksgiving when the original Omicron was gathering steam and this one is the availability of Pfizer’s Covid pill, Paxlovid.
In public health news
STAT News explains why we don’t have an at-home flu test, and the answer is not a lack of technology.
HealthDay discusses a large study concerning the impact of HDL cholesterol on developing heart disease, which makes significant conclusions. For example, “Blood levels of HDL, the famously “good” kind of cholesterol, may not make a big difference to heart health after all — particularly for Black people.”
The Director of HHS’s Agency for Healthcare Quality and Research posted his observations on AHRQ’s “2022 National Healthcare Quality and Disparities Report: We Still Have Much Work to Do.”
From the Rx coverage front, the Food and Drug Administration announced approving
Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
“Gene therapy for hemophilia has been on the horizon for more than two decades. Despite advancements in the treatment of hemophilia, the prevention and treatment of bleeding episodes can adversely impact individuals’ quality of life,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval provides a new treatment option for patients with Hemophilia B and represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia.”
Most individuals who have Hemophilia B and experience symptoms are men. The prevalence of Hemophilia B in the population is about one in 40,000; Hemophilia B represents about 15% of patients with hemophilia. Many women carriers of the disease have no symptoms. However, an estimated 10-25% of women carriers have mild symptoms; in rare cases, women may have moderate or severe symptoms.
Treatment typically involves replacing the missing or deficient clotting factor to improve the body’s ability to stop bleeding and promote healing. Patients with severe Hemophilia B typically require a routine treatment regimen of intravenous (IV) infusions of Factor IX replacement products to maintain sufficient levels of clotting factor to prevent bleeding episodes.
Hemgenix is a one-time gene therapy product given as a single dose by IV infusion. Hemgenix consists of a viral vector carrying a gene for clotting Factor IX. The gene is expressed in the liver to produce Factor IX protein, to increase blood levels of Factor IX and thereby limit bleeding episodes.
Bloomberg adds that “CSL Behring’s hemophilia B gene therapy, a one-off infusion that frees patients from regular treatments, costs $3.5 million a dose, making it the most expensive medicine in the world.”
In preventive services news, the U.S. Preventive Services Task Force proposed for public comment assigning a B grade to “screening for latent tuberculosis infection in populations at increased risk.” In 2016, the USPSTF recommended screening for LTBI in populations at increased risk (B grade recommendation). The current draft recommendation is consistent with the 2016 USPSTF recommendation. The public comment deadline is December 27, 2022.
The next FEHBlog post will be Cybersecurity Saturday, November 26. Happy Thanksgiving, all.
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