Tuesday’s Tidbits

Rx coverage

Tuesday’s Tidbits

David Ermer–CMS, Electronic health records, FDA, Medicare, Mental health care, NIH, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Federal employee benefits front, Fedweek offers year-end benefits and tax guidance to federal and postal employees and annuitants.

From the medical research and development front,

STAT News reports, “A consensus may be emerging about how to prescribe the new Alzheimer’s drug lecanemab, according to remarks made by both a critic of other Alzheimer’s medicines and the CEO of the company that developed it.”

The National Institutes of Health announced

The protein apolipoprotein E (APOE) plays a key role throughout the body. It helps to transport cholesterol and other fatty molecules, or lipids. The gene that produces APOE comes in a few different varieties. The most common is called APOE3.

The most notorious is APOE4, which has long been linked to an increased risk of dementia in Alzheimer’s disease. People who inherit one copy of the APOE4 gene have up to a fourfold greater risk of developing Alzheimer’s disease dementia. Inheriting two copies of APOE4 elevates the risk up to twelvefold. But despite years of study, scientists have little understanding of how APOE4 affects the human brain and boosts dementia risk. * * *

[NIH] Researchers found evidence that the Alzheimer’s-related gene APOE4 disrupts cholesterol management in the brain and weakens insulation around nerve fibers.

A drug that affects cholesterol led to improved learning and memory in mice with the gene, pointing to a potential new approach for treating dementia in Alzheimer’s disease.

The Wall Street Journal reports

New research has bolstered a once-gutsy idea: Bugs in the digestive system may play a role in depression.

Two studies published Tuesday in the journal Nature Communications found a link between several types of bacteria in the gut and depressive symptoms. Trillions of microorganisms including bacteria, fungi and yeast live in the digestive tract. Research exploring whether they might affect an array of diseases has increased in recent years.

The new studies, conducted among thousands of people in two cities in the Netherlands, are among the largest to date demonstrating potential associations between gut microbiota and mental health.

“Ten years ago if you’d said there was something linking depression and the microbiome, you’d be carried out with a straitjacket,” said Jos Bosch, an associate professor of psychology at the University of Amsterdam who co-wrote both studies. “Now absolutely, it’s very clear there’s a link.”

. . . Researchers who conducted the studies in the Netherlands called their findings a preliminary step toward identifying biological indicators and therapies for depression. The precise relationship between depression and microbes in the gut couldn’t be determined, they said. Depression can cause a person to eat less healthily, Dr. Bosch pointed out, which can lead to changes in the composition of microorganisms in the gut.

“Causality is a bit up in the air,” he said. 

From the mental healthcare front, Fierce Healthcare tells us

While mental health and substance abuse issues have only grown thanks to the pandemic, a bright spot may be forming: The number of providers available to treat these concerns is increasing, a new study shows.

The United Health Foundation, the philanthropic arm of insurance giant UnitedHealth Group, released its annual “America’s Health Rankings” report and in the analysis found that between 2020 and 2021, the number of people who reported that their mental health was poor in 14 of the last 30 days increased by 11%.

In 2020, 13.2% reported frequent mental distress, and that rose to 14.7% in 2021, according to the report.

At the same time, drug-related deaths spiked. The report found that deaths increased by 20% nationwide between 2019 and 2020, reaching 27.9 deaths per 100,000. This is the largest year-over-year increase in more than a decade, according to the report.

The report also found that disparities within drug deaths increased in tandem. Such deaths increased by 45% among multiracial populations and by 43% among Black populations. Drug-related deaths were highest among American Indian/Alaskan Native populations, occurring at a rate nine times higher than the lowest group, Asian patients.

However, the analysis found that the supply of mental health providers reached its highest levels since the report was first published in 2017. The number of mental health providers per 100,000 increased by 7% between 2021 and 2022 and has increased by 40% since the 2017 report.

There are now 305 mental health providers per 100,000, according to the report.

Health Payer Intelligence adds

Having one or more outpatient behavioral health treatment (OPBHT) visits was associated with lower healthcare costs among patients with newly diagnosed behavioral health conditions, a JAMA Network Open study found.

Adults with a behavioral health condition incur 2.8 to 6.2 times greater medical costs than those without one, and nearly a quarter of adults had a behavioral health condition as of 2018. However, behavioral health condition diagnoses are often delayed, and most individuals receive little or no treatment each year.

From the Rx coverage front, STAT News tells us

During 2021, drugmakers substantially raised prices on seven widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $805 million last year, according to a new report.

The drug for which spending increased the most due to a price increase was Xifaxan, which is used to treat both irritable bowel syndrome and a complication of cirrhosis. Salix Pharmaceuticals, a unit of Bausch Health, raised the wholesale price by 7.9%. The net price — after rebates and discounts — rose by 12%, most likely because the company offered fewer concessions than previously.

Consequently, spending for this drug climbed by $174.7 million, according to the report issued by the Institute for Clinical and Economic Review, a nonprofit that assesses the cost effectiveness of medicines. The report noted that the manufacturer disputed the net price and budget impact, which was provided by the SSR Health market research firm, but did not provide corrected estimates.

Of course, PBM formularies are designed to correct these issues.

The Wall Street Journal adds

Emergent BioSolutions Inc., maker of Narcan, a nasal-spray form of naloxone, said Tuesday that the U.S. Food and Drug Administration fast-tracked an application it submitted for an over-the-counter version of its widely used opioid-reversal nasal spray.

The company said it had been working on the application for several months. Emergent said the FDA’s priority review gives the drug an expected approval date of March 29, 2023, putting it first in line for approval ahead of competitors that have announced their planned foray into the market. 

The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of overdose-reversal medications such as Narcan to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl.

Last week, FDA Commissioner Robert Califf said naloxone—which binds to opioid receptors to reverse the effects of opioids—should be as ubiquitous as defibrillators.

From the fraud, waste, and abuse front, mHealth Intelligence reports

As telehealth use exploded across healthcare programs provided by federal agencies, a report by a watchdog committee shows several program integrity risks linked to telehealth billing, including duplicate billing and ordering unnecessary durable medical equipment or laboratory tests.

They found that approximately 37 million individuals used telehealth services from March 2020 through February 2021 in the selected programs administered by the six federal agencies. This represents a massive increase from the 3 million individuals in these programs who used telehealth services the year prior.  

In most programs, telehealth was used primarily to access office visits with a primary care provider or specialist and for behavioral health services, like individual and group therapy and substance use disorder treatment.

Overall, the agencies spent more than $6.2 billion on telehealth services, with Medicare accounting for the highest expenditure at $5.1 billion, followed by TRICARE and the Federal Employees Health Benefits Program, which together spent $1 billion.

But the OIGs found several similar program integrity risks associated with billing for telehealth services across multiple programs. These included “upcoding” telehealth visits by billing for visits longer than they lasted, duplicate billing for the same service, ordering unnecessary durable medical equipment, supplies, or laboratory tests, and billing for services inappropriate or ineligible for telehealth.

From the plan design front, Fierce Healthcare relates

The Biden administration released a proposal which, if finalized, would mandate Medicare Advantage (MA), Medicaid managed care, Affordable Care Act (ACA) plans and state Medicaid agencies implement electronic prior authorization systems by 2026. 

The proposed rule, released Tuesday by the Centers for Medicare & Medicaid Services (CMS), will require payers and states to streamline prior authorization processes and improve the electronic exchange of health data by 2026. It also contains incentives for hospitals and physicians to adopt electronic prior authorization.

“The prior authorization and interoperability proposals we are announcing today would streamline the prior authorization process and promote healthcare data sharing to improve the care experience across providers, patients and caregivers,” CMS Administrator Chiquita Brooks-LaSure said in a statement. 

It is the revised version of a Trump administration rule originally finalized in late 2020 but withdrawn after concerns about costs and a short deadline. That rule only applied to Medicaid managed care, the Children’s Health Insurance Program and ACA plans, while the new version would apply also to MA plans. 

Monday Roundup

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Roll Call reports the FY 2023 National Defense Authorization Act is expected to rescind the Defense Secretary’s 2021 Covid vaccine mandate for U.S. service members. “Congressional leaders are aiming to introduce the final compromise NDAA version as soon as Tuesday, with House floor action possible later in the week.”

From the infectious disease front —

  • Bloomberg Prognosis tells about a study confirming the Paxlovid rebounds have been blown out of proportion.
  • Pfizer has asked the Food and Drug Administration for an emergency use authorization applicable to its bivalent Omicron vaccine designed for children at least six months old and not over four years old.
  • The Health and Human Services Secretary has confirmed reported plans to end the mpox public health emergency when the current declaration expires at the end of January 2023. “But we won’t take our foot off the gas – we will continue to monitor the case trends closely and encourage all at-risk individuals to get a free vaccine.”
  • MedPage Today interviews Demetre Daskalakis, MD, MPH, the deputy coordinator of the White House Monkeypox Response Team, about the course of the illness since it erupted in the summer

Influenza hospitalizations this early in the season are higher than they have been in a decade, according to the CDC, with 14 pediatric deaths reported so far.

“Since October 1, there have already been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu,” said CDC Director Rochelle Walensky, MD, MPH, on a call with reporters on Monday, held in part to kick off National Influenza Vaccination Week. * * *

This year, influenza vaccines are “well matched to the viruses currently circulating,” she added. The flu shots contain protection for two influenza A and two influenza B virus strains. Of influenza A viruses detected and subtyped this season, 79% have been A(H3N2) and 21% have been A(H1N1).

The CDC recommends influenza vaccination particularly for children, immunocompromised individuals, pregnant women, and people 65 and over.

It was not clear if the pediatric deaths reported so far this season involved unvaccinated children, but Fryhofer noted that previous data showed about 80% of influenza deaths occur in unvaccinated persons.

Pregnant women who get the flu shot also protect their newborns, who are not eligible for vaccination before they are 6 months of age, Fryhofer said. “If you’re not doing it for you, do it for your baby.”

  • For context, here are the flu case and death statistics from the last flu season before Covid struck, October 2019 through March 2020.
2019 – 2020 Winter CDC Fluview  3/28/20
Flu Deaths                  24,000 
Flu Cases             39,000,000 

The flu is a highly contagious, dangerous disease.

  • NPR Shots offers consumer advice should they counter pharmacy shelves with a low or no supply of anti-fever drugs.

From the telehealth front, Health Leaders Media tells us

According to a survey commissioned by America’s Health Insurance Plans, almost 70% used telehealth in the past year because it’s more convenient than in-person care, and almost 80% say telehealth makes it easier to seek out care.

Almost 50% used telehealth because they were unable to make an in-person appointment, while 24% said they wanted to save money.

Some 36% used telehealth just once over the past year, while 53% used it between two and five times.

From the mental healthcare front, Health Payer Intelligence reports

 CareFirst BlueCross BlueShield (CareFirst) is providing community-based organizations with nearly $8 million in grants to help improve behavioral healthcare access and quality for underserved youth.

The COVID-19 pandemic exacerbated the mental and behavioral health crisis among children, adolescents, and families. In response, CareFirst is investing in 19 community-based organizations in Maryland, Washington, DC, and Northern Virginia.

“CareFirst recognizes that behavioral health is an essential part of overall health, which includes a continuum of conditions ranging from severe mental health disorders to the emotional, psychological, and social factors that affect a person’s overall wellbeing,” Destiny-Simone Ramjohn, PhD, vice president of community health and social impact at CareFirst, said in the press release.

Kudos

From the Rx coverage front, Fierce Healthcare informs us

Express Scripts, which is part of Cigna’s Evernorth subsidiary, said Monday that it will add biosimilars for Humira to its largest formularies as preferred products available for patients with inflammatory conditions. Like other major PBMs, Express Scripts sees significant potential in biosimilars to help address the massive costs associated with specialty drugs.

Specialty drugs account for just 2% of prescriptions but drive half of drug spending.

In October 2021, Express Scripts announced that it would put Semglee, the first Food and Drug Administration-approved interchangeable insulin biosimilar, on its National Preferred Formulary for 2022. The company estimates that this move generated $20 million in savings in the first year.

From the federal government employee benefits front, Federal News Network relates

The Office of Personnel Management plans to suspend applications for the Federal Long Term Care Insurance Program for two years beginning Dec. 19, in anticipation of a sizeable rate hike.

OPM announced the unusual measure last month in the Federal Register, and noted that federal workers who submit their applications by the deadline will still be considered for enrollment. FLTCIP was created in 2002 and assists with health care costs for participants who need help with daily personal functions, or who have a severe cognitive illness, and covers home care, nursing home or assisted living benefits.

“OPM is suspending applications for coverage in FLTCIP to allow OPM and the FLTCIP carrier to assess the benefit offerings and establish sustainable premium rates that reasonably and equitably reflect the cost of the benefits provided,” the agency wrote.

The program will continue to operate normally for current enrollees, although they will not be able to apply to increase their coverage. There are currently around 267,000 federal workers and retirees participating in the insurance plan, and OPM typically receives only a few thousand applications to enroll per year.

The decision to suspend applications for the program came after John Hancock Life and Health Insurance Co., the contractor that administers the program, informed OPM that it is likely that there will a premium increase sometime next year.

Finally, the Wall Street Journal offers an interesting article about medical research that is “uncovering links between your ‘subjective age’ [as opposed to your chronological age] and your future health and longevity.”

Weekend update

David Ermer–AHRQ, Congress, Federal employment benefits, Medicare, Mental health care, OPM, Rx coverage, Uncategorized–
Thanks to ACK15 for sharing their work on Unsplash.

The House of Representatives and the Senate are in session this week for Committee business and floor voting.

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. * * *

Blue Cross also shared that the health plan’s reimbursement for telehealth and virtual care services is at parity with in-person services. Receiving reimbursement at parity is not only a controversial issue for telehealth providers but also for mental and behavioral healthcare providers, who do not always receive reimbursement at parity with physical care providers.

Kudos.

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.

Thursday Miscellany

David Ermer–ACA, CMS, COVID-19, FDA, Federal employment benefits, Medicare, No Surprises Act, OPM, Rx coverage, Telehealth, U.S. Healthcare–

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.”

From the Omicron and siblings front —

Beckers Hospital Review reports

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. 

MedPage Today informs us

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.

Politico Pulse reports

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?

From the Rx coverage front —

STAT News relates

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. 

and

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.

STAT News reports

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.

Midweek Update

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–

From the federal employment front —

  • 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 cleared to 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.

In other public health news, STAT News tells us

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.

From the U.S healthcare business front —

Healthcare Dive reports

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.

In contrast, Fierce Healthcare reports

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.

Friday Items

David Ermer–AHRQ, CDC, COVID-19, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

The FEHBlog apologizes for the fact that his Grammarly program made a hash out of yesterday’s Miscellany post. The FEHBlog discovered and fixed the problems this afternoon if anyone cares to go back to read that post. Lo siento.

Going forward, the FEHBlog will be posting Covid stats on the first Friday of the month. Here is the CDC’s weekly interpretation of its Covid statistics which focuses on a CDC report on Covid mortality dated November 16, 2022, and summarized below:

The Wall Street Journal adds

Uptake of fall Covid-19 booster shots remains anemic well into November, frustrating public-health experts who blame the lackluster interest on pandemic fatigue and insufficient outreach from officials.

About 31 million people in the U.S. have gotten the updated shots, or roughly 10% of people ages five and older, according to data from the Centers for Disease Control and Prevention. The federal government purchased more than 170 million doses of the new bivalent boosters that target two Omicron subvariants and the original virus strain.

“It has been pretty dismal,” said Rupali Limaye, an associate professor at the Johns Hopkins Bloomberg School of Public Health, who studies vaccine demand and acceptance. * * *

[U]ptake of the modified booster is slow due in part to the limited amount of outreach and type of messaging from health officials, some public-health experts say.

Anecdotally, it sounds like a lot of people are still not aware that the bivalent boosters are available,” said Angela Rasmussen, a virologist at Georgetown University. “If they are, many don’t seem to understand the importance of getting boosted at all—with bivalent or original recipe—and there is a decided lack of urgency in communications about it.” 

Some public-health experts say there must be not just more, but also targeted outreach. Celine Gounder, a senior fellow at the Kaiser Family Foundation, said messaging needs to be more targeted at people age 50 and over who are most at risk. Among adults 65 and older, some 27% have gotten an updated booster dose, CDC data show. 

“You should be thinking of who is most vulnerable and target the efforts there,” said Dr. Gounder, an infectious-disease specialist and epidemiologist.

The following are the key points from this week’s CDC Fluview:

  • Seasonal influenza activity is elevated across the country.
  • The majority of influenza viruses detected this season have been influenza A(H3N2) viruses, but the proportion of subtyped influenza A viruses that are A(H1N1) is increasing slightly.
  • Two more influenza-associated pediatric deaths were reported this week, for a total of seven pediatric flu deaths reported so far this season.
  • CDC estimates that, so far this season, there have been at least 4.4 million illnesses, 38,000 hospitalizations, and 2,100 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 45 during every previous season since 2010-2011.
  • 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.

Medscape offers expert opinions on the “perfect storm” of rampant flu and RSV.

In OPM news, the agency posted its Fiscal Year 2022 Performance and Accountability report this week. The Director’s response to the Inspector General’s list of top management challenges is worth a gander. That response begins on page 125.

From the No Surprises Act front, Beckers Payer Issues tells us

The No Surprises Act has prevented millions of surprise medical bills since January, according to new data from AHIP and the Blue Cross Blue Shield Association. 

The payer associations gathered their data, published Nov. 17, by surveying 84 health insurance providers representing around 57 percent of the national market. 

“Thanks to the No Surprises Act, millions of Americans no longer face a complicated, confusing billing bureaucracy, being harassed by collection agencies, or even potential legal action,” AHIP President Matt Eyles said in a press release. 

AHIP and the BCBS Association also surveyed plans for the number of claims submitted to arbitration under the act. They estimated 275,000 claims have been submitted since January 2022, more than the 17,000 claims predicted by government agencies. 

and

AHIP is backing HHS in a lawsuit over surprise billing arbitration from Texas providers, who have support from the largest associations of providers. 

The trade association filed an amicus brief in Texas Medical Association v. HHS on Nov. 16. 

The lawsuit, filed by the Texas Medical Association in September, challenges the arbitration process established under the No Surprises Act. 

The FEHBlog appreciates AHIP’s amicus brief filing. In the FEHBlog’s opinion, the medical association plaintiffs in the Texas case are making a mountain out of a molehill.

A surprising legal development was the Justice Department’s 11th hour notice of appeal filed today in the antitrust challenge to United Healthcare’s acquisition of Change Healthcare which a federal district judge approved last September.

In other Friday items —

Endpoints reports

The emergence of interchangeable biosimilars since the pathway opened up has been slow. But the FDA on Thursday approved the fourth interchangeable biosimilar, which is also the second interchangeable biosimilar insulin product.

Eli Lilly’s Rezvoglar (insulin glargine-aglr), which converted to an interchangeable after an earlier biosimilar approval in December 2021, follows Viatris’ Semglee in seeking out a niche to compete with Sanofi’s blockbuster Lantus (insulin glargine). * * *

These interchangeable designations mean Semglee and Rezvoglar may be substituted at the pharmacy level for Lantus, without a doctor’s prescription, and as long as the state pharmacy law permits the switch.

USA Today reports

Preterm births last year reached their highest peak since 2007 – with more than 383,000 born before 37 weeks of gestational age in the United States, according to a new report.

In 2021, roughly 10.5% of U.S. babies were born premature, according to the annual March of Dimes “Report Card,” which rated the United States at D+. The score dropped from its C- rating in 2020, when the preterm birth rate saw its first decline in six years, a slight decrease to 10.1%.

The report released this week found disparities widened between white mothers and Native and Black mothers, who are already 62% more likely to have a preterm birth and nearly three times as likely as white moms to die of childbirth-related causes. In 2021, Black mothers saw a 3% increase and Native mothers a 6% increase in preterm births, according to the analysis.

Of all groups, Asian and Pacific Islander mothers saw the largest preterm birth increase – an 8% surge  – even though births to Asian mothers decreased that year, and they have the lowest preterm birth rate overall.

HHS’s Agency for Healthcare Quality and Research capped off antibiotic awareness week by releasing antibiotic stewardship kits for the acute hospital, long-term care, and ambulatory care settings.

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Federal employment benefits, Mental health care, OPM, Rx coverage–
Photo by Josh Mills on Unsplash

Today, November 17, is National Rural Health Day.

Let’s follow up on two posts from this week:

  • On Tuesday, the FEHBlog mentioned that the Internal Revenue Service issued Notice 2022-59 which adjusts the PCORI fee for years “that end on or after October 1, 2022, and before October 1, 2023.” The FEHBlog referenced an adjusted PCORI fee of $2.79 per covered life. Whoops. The FEHBlog referenced the current PCORI fee. The adjusted PCORI fee is $3.00 per covered life. Lo siento.
  • Yesterday, the FEHBlog called to readers’ attention a Congressional Research Service report on federal healthcare laws enacted in the current Congress that expire at the end of 2022. The FEHBlog thought “I should go back and read that report.” Today an email from the Wagner Law firm identified one of these expiring laws, to wit

During the pandemic, Congress allowed telehealth services to be provided to HSA-eligible individuals without cost-sharing and without regard to whether they had met their deductibles under their High Deductible Health Plans. That authorization expired December 31, 2021. Congress then again allowed deductible-free telehealth services to resume from April 1, 2022, through December 31, 2022. Unless this authorization is extended again, plans covering HSA-eligible individuals will have to require that telehealth services be provided to those individuals on the same terms as in-person care, i.e., the deductible must be met before telehealth can be provided without further charge to the patient. [The American Benefits Council has asked Congress to extend this consumer protection.]

From Capitol Hill, Politico brings us up to date on medical association efforts to block or at least reduce a 4.5% cut in Medicare Part B payments to physicians.

From the federal employee benefits front, Tammy Flanagan writing in Govexec discusses the health benefit options available to federal employees who are veterans.

“From the public health front —

  • The Labor Department’s Department’s Occupational Safety and Health Administration offers guidance to employers on controlling seasonal flu outbreaks in the office or plant.
  • The New York Times examines anti-depressant drugs. “The most commonly prescribed medications for depression are somewhat effective — but not because they correct a “chemical imbalance.”

Hospitals have made progress in reducing preventable errors, accidents and injuries over the past decade, according to the Leapfrog Group’s fall 2022 hospital safety grades released Wednesday.

Incidents of falls and trauma and of objects unintentionally left in a body after surgery decreased by about 25% since 2012, according to Leapfrog.

In this year’s fall rankings, 30% of hospitals earned an A grade, 28% earned a B, 36% earned a C, 6% earned a D and 1% earned an F.

From the Rx coverage front,

Today the U.S. Food and Drug Administration approved [Provention Bio’s] Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes. 

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.” 

“From the plan design front, MedCity News tells us “Historically having worked with Medicaid and Medicare Advantage populations, Uber Health is now expanding its services to self-insured employers. The company made the announcement at the HLTH conference in Las Vegas.”

Monday Roundup

David Ermer–ACA, Congress, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Capitol Hill front —

  • Roll Call and Govexec bring us up to date on the lame-duck session’s agenda.
  • The Washington Post tells us about the Administration’s plans to include $10 billion in Covid funding in the omnibus appropriations bill that Congress must pass or extend by December 16.
  • The Wall Street Journal reports “Republicans have won 217 House seats to the Democrats’ 205, according to the Associated Press tally. A party needs 218 for a majority in the chamber, and Republicans were on track for a very narrow margin after they won seats Monday in Arizona, California and New York. ” This development increases the likelihood that Congress will pass an omnibus appropriations bill before year-end.
  • The Congressional Budget Office posted a presentation on its recommended policy approaches to reduce commercial health Insurer payments for hospitals’ and physicians’ services. The presentation is worth a gander because the American Hospital Association, among others, is not pleased with the CBO’s recommendations.

The Federal Employee Benefits Open Season started today, and Govexec offers a checklist to help decision-makers.

From the conferences’ front —

  • The American Medical Association shares developments from its interim meeting which concludes tomorrow.
  • Fierce Healthcare offers a news feed from the HLTH 2022 conference.

From the Affordable Care Act front, the Internal Revenue Service announced the PCORI support fee that health plans must pay for policy years and plan years that end on or after October 1, 2022, and before October 1, 2023. In short, the dollar amount that calendar year plans such as the FEHB plan must pay next July 31 is $3.00 times the average number of covered lives.

From the Alzheimer’s Disease and dementia front, Medscape reports

  • “Dementia prevalence is dropping in the United States, new research shows.”
  • “Of the more than 6 million Alzheimer’s patients in the U.S. age 65 or older, nearly two-thirds are women. A new study may help explain the gender gap — and offer clues to new treatments for helping patients of both sexes fight back.” The FEHBlog has been taking a continuing legal education course on eldercare, and the practicing lawyers teaching the court remarked that 95% of the clients for whom Medicaid nursing home coverage is sought are husbands.
  • “Among older adults who use the US Supplemental Nutrition Assistance Program (SNAP), rates of memory decline appear to be slower than among those who don’t use the program, new research shows.”

The Wall Street Journal informs us

An experimental Alzheimer’s drug from Roche Holding AG failed to significantly slow cognitive decline in long-awaited trials, the latest in a long line of setbacks for a field that has seen little progress in decades.

The drug, called gantenerumab, slightly reduced cognitive decline in people with early Alzheimer’s compared with a placebo across two large and lengthy trials, but the difference wasn’t statistically significant, Roche said Monday. The trials, which lasted more than two years and involved nearly 2,000 participants, compared scores of cognition and function in areas such as memory, orientation and problem-solving. * * *

The news comes just weeks after clinical trial results from a drug developed jointly by Biogen Inc. and Eisai Co. infused fresh hope into a field that has been marked by failure. The Biogen and Eisai drug, called lecanemab, reduced cognitive and functional decline by 27% compared with a placebo. The companies say they plan to provide more detailed study results at an upcoming research conference.

Like lecanemab, Roche’s gantenerumab targets accumulations of beta-amyloid, a protein that is found in the brains of people with Alzheimer’s and is thought to be linked to the disease. Several earlier beta-amyloid-targeting drugs had failed in clinical trials, although each drug acts slightly differently.

Roche Chief Executive Severin Schwan said last month that the Biogen and Eisai results were encouraging, but cautioned that they didn’t shed any light on the likely success of gantenerumab. Roche said Monday that the level of beta-amyloid removal by gantenerumab was lower than expected in the trials.

In other news —

  • Per Fierce Healthcare, Aetna announced a new advanced price care program in cooperation with Crossover Health. The program will launch next January 1 in the Seattle Washington region. “The new hybrid care model is integrated into a health plan and aims to tackle the rising access issues and costs of healthcare with a fixed fee, value-based payment model, executives said.”
  • Milliman offers its thoughts on mental health challenges facing employers.

Happy Veterans’ Day

David Ermer–CDC, COVID-19, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare–

To those who followed our Nation’s colors, thanks for your service. Here’s a Veteran’s Day message from the Veterans Administration Secretary Denis McDonough and the OPM Director Kiran Ahuja.

FedWeek informs us about a recent OPM Inspector General report about the Federal Long Term Care Insurance Program contract.

Projected future income from premiums in the Federal Long-Term Care Insurance Program is not enough to cover projected future claims, an audit by the inspector general’s office at the OPM has found.

It said that while the program over 2017-2019 took in about $2.2 million more than it paid out, boosting a trust fund held by the contractor (the John Hancock insurance company), under current projections those reserves will be depleted by 2048. That’s due to lower long-term interest rates than previously assumed and “higher claims utilization due to longer life expectancies (especially with dementia patients).”

It says that participants “will likely see a large increase in premiums and/or decrease to benefits for the next contract period to help reduce the deficit. As demonstrated at the start of this contract period in 2016, FLTCIP’s large one-time premium increase and/or benefit decrease caused an unexpected hardship to its participants.” That contract is to expire in 2023. * * *

In response, the carrier pointed out that in a letter to participants with the option to purchase additional inflation protection it said “there is a strong likelihood that premium rates for many enrollees may need to increase” while OPM noted that earlier this year it told the carrier to stop active marketing efforts to prospective applicants.

The FEHBlog is glad that this problem is not on his plate.

Because today is a federal holiday, the Centers for Disease Control did not issue an interpretative report on its Covid statistics for this week.

Medscape tells us

Global deaths due to COVID-19 have dropped almost 90% since February, the head of the World Health Organization said Wednesday.

Last week, 9,400 deaths were reported linked to the coronavirus, Director-General Tedros Adhanom Ghebreyesus said.

That’s down from 75,000 a week in February. * * *

The Associated Press reported that more than 2.1 million new cases were reported to WHO for the week ending Sunday. That’s down 15% from the prior week, and the number of weekly deaths fell 10% compared to the prior week.

Beckers Payer Issues adds

The U.S. will extend the COVID-19 public health emergency through at least April 11, 2023, Biden administration officials confirmed to CNBC Nov. 11.

A 12th extension of the PHE since the first in January 2020 is further ensured by a lack of public statement from HHS warning about a termination. The agency last renewed the PHE Oct. 13 for an additional 90 days to Jan. 11, 2023 — it also told states it would provide a notice 60 days before if it did decide to end it, or Nov. 11.

The PHE allows the country to continue operating under pandemic-era policies, which led to a complete overhaul of telehealth and who can use it, fast-tracked approvals of COVID-19 vaccines and treatments, and preserved healthcare coverage for millions of Medicaid beneficiaries nationwide.

The CDC did update its FluView page on November 10 for November 4

Influenza activity continues to increase. Regions 4 (Southeast) and 6 (South-Central) are reporting the highest levels of flu activity, followed by regions 3 (Mid-Atlantic) and 9 (south-central West Coast).

Three influenza-associated pediatric deaths were reported this week.

CDC estimates that, so far this season, there have been at least 2.8 million illnesses, 23,000 hospitalizations, and 1,300 deaths from flu.

The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 44 during every previous season since 2010-2011.

The RSV epidemic has not subsided according to MedPage Today

Children’s hospitals aren’t the only ones drowning in patients with respiratory illness — it’s also general emergency departments (EDs), urgent care clinics, and pediatrician’s offices.

Hit by a surge of respiratory syncytial virus (RSV), flu, and COVID-19, physicians and nurses across the country are calling for help and asking parents to keep children home unless they’re seriously ill.

“It’s just important that people recognize that when you step back and look at the healthcare system as a whole, that volume is high everywhere,” Katie Lockwood, MD, MEd, a primary care physician at Children’s Hospital of Philadelphia, told MedPage Today.

“It’s not as simple as saying, ‘Oh, you shouldn’t go to the ER because we’re busy, or the ER saying you should go to primary care because we’re busy. Everybody is busy,” she added. “One of the things that I had been hearing from my own patients … was how long they were having to wait when they did go to an emergency department, and urgent cares were really full, and we were seeing a lot of volume in [my] office.”

Physicians say that seasonal increases in respiratory illness, which are expected, normally come later in the year. This year’s early surge in RSV-associated hospitalization, according to the CDC, is higher than December and January peak rates in recent years.

From the mental healthcare front, the American Hospital Association reports

The Substance Abuse and Mental Health Services Administration yesterday [Thursday] released National Guidelines for Child and Youth Behavioral Health Crisis Care, which offer guidance and strategies to help communities address gaps in behavioral health crisis services for children and youth. The guidelines recommend that youth in crisis from mental health and substance use disorders receive care in the least restrictive setting possible, and if safe, at home and in the community. They also recommend crisis response systems partner with schools, community organizations and others across the continuum of care; be trained to respond to diverse needs; and reflect the diverse communities they serve.

AHA last year joined the Children’s Hospital Association, American Academy of Pediatrics and the American Academy of Child and Adolescent Psychiatry as a partner in Sound the Alarm for Kids, an initiative urging Congress to enact legislation and increase funding to better support mental health for children and teens.

The 10-digit National Suicide Prevention Lifeline in July transitioned to the 988 Suicide and Crisis Lifeline, meaning individuals experiencing a suicide, mental health or substance use crisis can simply call, chat or text 988 to connect with a trained crisis counselor. For more information, visit the AHA’s 988 resources page. 

From the Rx coverage front, EndPoints discusses the importance of the FDA’s interchangeability tag in facilitating biosimilar competition.

With the growth in biologics spending, the biosimilar market is going to have to find new ways to keep up.

One avenue may open up with new interchangeable biosimilars that can be substituted without a doctor’s note, and which could help bring costs down for some pricier, patient-administered therapies. FDA officials discussed key flexibilities that they can make around the development of interchangeable biosimilars at an Association for Accessible Medicines’ industry conference yesterday in Bethesda, Md.

While the FDA has only signed off on three interchangeable biosimilars so far — Viatris’ insulin Semglee, Boehringer Ingelheim’s Humira interchangeable Cyltezo (launching next year), and Coherus’ Lucentis interchangeable Cimerli — Jacqueline Corrigan-Curay, CDER’s principal deputy center director, explained to the Association of Accessible Medicines’ industry conference yesterday that the agency is willing to work with industry where the science is justified.

From the artificial intelligence front, Health IT Analytics relates

A recent study published in the American Journal of Managed Care found that identifying high-cost members was made easier through the implementation of artificial intelligence (AI) and the analysis of patient demographics.

Identifying high-cost members is essential for payers and providers, as it offers them information on preventing excessive spending. Traditionally, payers and care delivery organizations rely on care management efforts to reduce medical expenditure; however, this can often be challenging due to the limitations of incorporating other data sources, according to the study authors.

In the study, researchers aimed to implement a risk prediction model that uses AI to analyze information such as claims data, demographics, social determinants of health (SDOH) data, and admission, discharge, and transfer alerts (ADT) to better identify high-cost members. * * *

Researchers used data from a Medicaid accountable care organization (ACO) gathered from 61,850 members enrolled between May 2018 and April 2019.

Researchers then estimated risk scores for each member using two separate models. The first model was developed by Medical Home Network and relied on AI to analyze data related to SDOH, and activity related to ADT, along with claims and demographic characteristics. However, the second model, known as the Chronic Illness and Disability Payment System (CDPS) , only used demographic and claims information.

Based on this information, the researchers found that the AI model could perform a more accurate analysis of the highest-risk members and their spending. In addition, they found that those the AI model identified as high-risk had higher spending than those identified by the CDPS model.

Despite these conclusions, researchers noted a few limitations, mainly related to the data coming from a single ACO from a single geographic area and a single 12-month period.

Useful insights.

Midweek Update

David Ermer–AHRQ, CDC, COVID-19, COVID-19 vaccine, FDA, Rx coverage, U.S. Healthcare–

Forbes reports

As the polls pretty much predicted, Tuesday’s midterms turned out to be very close in terms of the balance of power between the two parties. As of this writing [Wednesday evening] it’s still not clear which party controls the House and Senate. But in several states, there were important healthcare issues on the ballot that were settled more decisively. In South Dakota, voters approved an expansion of Medicaid benefits, adding itself to the list of many other states that have bypassed legislatures to expand the program by ballot initiative. Voters in Michigan, California and Vermont approved Constitutional amendments protecting abortion rights while voters in Kentucky rejected an amendment that would have stated abortion rights are not protected in the state. Meanwhile, in Arizona many of the headline races are still too close to call as of this writing, but one vote that isn’t is an overwhelming “Yes” for Proposition 209, which expands property and assets that can’t be collected against medical debt and also reduces the interest rate that can be charged on it. 

From the Omicron and siblings front, protein-based Covid vaccine manufacturer Novovax reports on its third-quarter earnings and the value of its vaccine as a booster. In addition, Novovax says that it has delivered over 94 million doses of its vaccine worldwide.

From the U.S. healthcare business front, we have a trifecta from Healthcare Dive.

Healthcare Dive informs us

More than 30 healthcare associations and advocacy groups joined the American College of Emergency Physicians in asking President Joe Biden to prioritize finding solutions to the problem of overcrowded hospital emergency rooms.

Strained emergency departments are coping with an increase in boarding, a term for when patients are held in the ED longer than they should be because of a lack of available inpatient beds. The problem has led to gridlocked EDs filled with patients waiting, sometimes in life-threatening situations, the ACEP and other groups warned Monday in a letter to the president. “Boarding has become its own public health emergency,” the letter said.

The organizations urged the Biden administration to convene a summit of stakeholders from across the healthcare system to identify immediate and long-term solutions to the boarding problem.

Holy cow!

Healthcare Dive tells us

Elevance Health inked a deal to acquire a specialty pharmacy that caters to patients with complex and chronic conditions like cancer and multiple sclerosis.

The insurer said BioPlus will complement its existing pharmacy benefit manager, IngenioRx, providing patients with specialty drugs and a whole-health approach.

After closing and integrating BioPlus into operations, the company will be able to leverage the insights from both pharmacy and medical benefits, Elevance announced on Wednesday.

Working together, BioPlus’ pharmacy team will be able to identify “a patient who may need behavioral health support or in-home care services” and “seamlessly connect that patient to services to address their whole health needs,” Elevance said.

The deal is expected to close in the first half of 2023. Financial terms of the deal were not disclosed.

Healthcare Dive also explains why Cigna invested $2.5 billion in Walgreen’s combined Village MD / Summit Health primary care company.

Unlike many other primary care physician groups, VillageMD is focused on the commercial market, which brings in two-thirds of its revenue. That plays to Cigna’s strength in the employer market, as the majority of its customers are commercial employers, according to Credit Suisse analyst A.J. Rice.

As part of its investment, Evernorth will develop value-based agreements with VillageMD. The two will work together to optimize sites of care and patient outcomes through VillageMD’s physician network and Evernorth’s health services businesses, which include pharmacy benefit manager Express Scripts, specialty pharmacy Accredo and virtual care provider MDLive.

Beckers Hospital Review discusses how CVS, Amazon and Walgreens are pushing into primary care, and home health care.

From the healthcare quality front

The HHS Agency for Healthcare Quality and Research’s Director offers a blog post about how “AHRQ’s Research and Tools Help Transform Delivery of Primary Care.”

Patient Engagement HIT relates

Personal health record (PHR) use is key to driving patient engagement, with recent JMIR Cancer data showing PHR use among colorectal cancer survivors increasing access to follow-up care and screening by more than 30 percentage points.

Additionally, PHR use increased the proportion of survivors who believed access to certain follow-up cancer screenings was important to their health and well-being, according to researchers from the Regenstrief Institute, the VA, and Indiana University’s schools of medicine and nursing.

PHRs are different from EHRs in that they are patient-facing and give users insights into their own health information. Most PHRs, particularly PHRs “tethered” to the EHR, come with some secure messaging and patient notification systems, giving the technologies even more patient engagement power.

Revcycle Intelligence reports

Hospitals work hard to avoid “never events,” or serious, largely preventable, and harmful events identified by the National Quality Forum (NQF). These never events include performing surgery on the wrong patient or accidentally leaving an item in a patient after an invasive procedure. However, some industry experts are now calling onthe healthcare industry to consider a new set of never events that are administrative in nature, such as aggressive medical debt collection.

Dave A. Chokshi, MD, MSc, FACP, senior scholar at CUNY School of Public Health and Health Policy and former Commissioner at the New York City Department of Health and Mental Hygiene, and Adam L. Beckman, BS, of Harvard’s Medical and Business Schools, identify five new hospital never events in a new JAMA Health Forum article. They say that hospitals should never:

  1. Aggressively pursue medical debt against patients who cannot afford their bills
  2. Spend less on community benefits than it earns in tax breaks from non-profit status
  3. Flout federal requirements for hospitals to be transparent with patients about costs
  4. Compensate hospital workers less than a living wage
  5. Deliver racially segregated care

That approach could get the attention of hospitals.

Finally, Med City News informs us

More than three quarters, or 77%, of reproductive-aged women want birth control pills to be made available without a prescription, provided that research proves the pills safe and effective, a new survey shows.

“Oral contraceptives are the most commonly used method of reversible contraception in the U.S., and studies suggest that [over-the-counter] access would increase use of contraception and facilitate continuity of use in addition to saving time spent on travel, at a doctor’s office, and off work,” the report stated.

Under the Affordable Care Act, most private health insurance plans are required to cover FDA-approved birth control, but it must be prescribed. However, 41% of women at reproductive age are not aware of this. About 70% of women with private insurance said their health plan fully covered their birth control, but about a quarter said they had to pay some out-of-pocket.

The ACA rule also applies to FEHB plans. The FEHBlog is metaphysically certain the ACA regulators would extend this rule to over the counter contraceptive if the Food and Drug Administration can get its act together.