Tuesday’s Tidbits

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, FDA, Mental health care, NIH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports

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 Wall Street Journal reports

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.

On a related note, Federal News Network relates

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.

Healthcare Dive informs us

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. 

Good luck.

Monday Roundup

David Ermer–CDC, COVID-19, Federal employment benefits, HIPAA Privacy and Security Rules, NIH, OPM, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, Federal News Network is offering a free e-book on this timely topic.

Fierce Healthcare adds

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.

HHS adds

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.

and

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.

Thanksgiving Weekend Update

David Ermer–Congress, COVID-19, COVID-19 testing, Federal employment benefits, Government Contracting, No Surprises Act, OPM, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

The House of Representatives and the Senate return to Capitol Hill for Committee business and floor voting this week.

The Wall Street Journal adds

Lawmakers return to work this week with a to-do list that includes passing a critical government-funding bill, solidifying access to same-sex marriage and setting priorities for the U.S. military before the start of the new Congress next year.

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.

The Wall Street Journal tells us

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.”

Amen to that sentiment.

STAT New reports

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.

Some 10 to 15% of pregnancies have at least one complication that is linked to later heart disease. In addition to preeclampsia, these include other forms of gestational hypertension; gestational diabetes; preterm delivery; low birth weight; and placental abruption. People who experience miscarriages and stillbirths are also at greater risk of heart disease. Additional reproductive health conditions — including the early arrival of periods, polycystic ovary syndrome, infertility, and early menopause — have also been linked to increased risk.

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:

  1. Provider does not use EHR enabled for electronic PA: 71 percent
  2. Costly/burdensome for providers to buy/upgrade EHR for electronic PA: 71 percent
  3. Lack of interoperability between EHR vendors: 62 percent
  4. Costly for payers to enable PA rules and information to be delivered electronically: 43 percent
  5. Lack of electronic PA solutions on market: 19 percent

This is a surprising outcome considering how vociferously providers object to prior authorization.

Cybersecurity Saturday

David Ermer–Cybersecurity–

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.

The federal agency shared tips for individuals to limit cyber risks while shopping online, and encouraged organizations to review guidance it released last year with the FBI to manage cyberthreats during the holidays.

Happy Thanksgiving 2022

David Ermer–Uncategorized–

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.

The Wall Street Journal adds

The U.S. is heading into its third Covid-19 Thanksgiving in better shape than the last two, but holiday gatherings will provide a test of whether the nation can avoid another major winter surge, epidemiologists and virus experts say.

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.

Monday Roundup

David Ermer–CDC, COVID-19, Federal employment benefits, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, Govexec offers Open Season guidance to annuitants. Annuitants make up half of the FEHB’s enrollment.

From the Omicron and siblings front —

STAT News offers epidemiologist / infectious disease expert views on our situation nearly three years since the beginning of the Covid pandemic.

[W]e wondered if people who work in the infectious diseases sphere are still taking steps to try to avoid catching the virus, and if so, which ones. We also wondered whether — maybe even hoped — they are feeling less stressed about Covid and are starting to lower their guard.

The short answer: Some appear to be, a little. But most are still using multiple measures to try to avoid Covid.

The International Foundation of Employee Benefit Plans reports

The Department of Health and Human Services (HHS) issued the Health+ Long COVID Report highlighting patients’ experience of Long COVID to better understand its complexities and drive creative responses by government leaders, clinicians, patient advocates and others.

The Health+ Long COVID Report builds on the President’s Memorandum on Addressing the Long-Term Effects of COVID-⁠19 and the two previously issued HHS Long COVID reports. 

The report:

  • Provides recommendations on how to deliver high-quality care, and relevant and intentional resources and supports to individuals and families impacted by Long COVID;
  • Compliments the existing landscape of Long COVID scientific literature with the narratives and expertise of caregivers, frontline workers, and people experiencing Long COVID and its associated conditions; and
  • Offers a variety of short-term and longer-term recommendations that come directly from the patient experience. For example, insurance providers should update plan guidelines that align coverage with medical treatments that improve health outcomes for people with Long COVID. Employers should support accommodations for people living with Long COVID that allow them to continue to work and study. Federal agencies should disseminate Long COVID messaging to let people know Long COVID is real and is a serious public health issue.

Fierce Healthcare tells us

Pharmaceutical companies are aiming to continue evolving COVID-19 vaccines as the virus mutates, but the jury is still out on the effectiveness of an annual booster strategy.

For example, Moderna this week announced that it has developed a new booster to battle subvariants BA.5 and BA.4 of omicron that the company said will prove more effective than the booster the government rolled out in September, partly because the new version includes data from human beings, not just animals, as Fierce Pharma reports.

As payers are going to be on the hook for coverage of these products, they’re going to have to push for critical data on how these vaccines are working for members, experts say.

Paul Offit, M.D., the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said insurance companies should hold pharmaceutical companies’ feet to the fire. “They should say, ‘Show me the data. Show me the data as to why everyone needs another dose of vaccine. A yearly dose of vaccine. Who benefits? You’ve done those three or four initially. But prove that you need another dose of vaccine. Prove it.’ Because right now it should always be about the data,” he said in an interview.

He added that payers should ask the same questions of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

The FEHBlog does not expect that this financial burden will shift soon because he expects Congress to provide more Covid funding next month. Nevertheless it’s better to be safe than sorry.

In other vaccine news, MPR relates

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has published an updated recommendation to include the use of Priorix  (measles, mumps and rubella vaccine, live) as an additional option for active immunization for the prevention of measles, mumps and rubella in individuals 12 months of age and older. * * *

The recommendation was based on safety data from 4 randomized controlled clinical studies, 4 observational studies and 1 systematic review. In the randomized controlled trials, participants received at least 1 dose of either Priorix or a US-licensed MMR virus vaccine, live (M-M-R® II).

Results showed that immune responses after Priorix administration were noninferior to those observed with M-M-R II. Additionally, no significant difference in the frequency of vaccine-related serious adverse events was reported in these studies.

Based on these findings, the CDC considers Priorix and M-M-R II to be fully interchangeable. Either vaccine may be administered when an MMR virus-containing vaccine is indicated.

In healthcare executive news, Bloomberg reports

Walmart Inc. health-care executive Cheryl Pegus [a cardiologist with a master’s in public health]  will join JPMorgan Chase & Co.’s Morgan Health venture as a managing director, with aims to improve employer-sponsored health care.

The move creates a vacancy at the nation’s largest retailer, as rivals like Amazon.com Inc. and CVS Health Corp. broaden their reach into the $4 trillion US health-care industry. It’s also a high-profile hire for Morgan Health, which the bank launched last year after shutting its joint venture with Amazon and Berkshire Hathaway Inc, known as Haven.

From the innovations front, the Wall Street Journal informs us

Vending machines stocked with overdose-reversing nasal spray are part of the latest attempt to diminish a record tide of drug deaths.

The Food and Drug Administration and some states have loosened restrictions on drugs including Narcan that are sprayed into the nose to reverse an opioid overdose.

Nonprofits that work with opioid users are distributing more of the drugs as a result. Getting Narcan as close as possible to people at risk for an overdose is essential to saving lives, they said.

“If we hadn’t had that vending machine, I might not have had my brother alive today,” said LuDene LoyaltyGroves, who works at a homeless shelter in Moses Lake, Wash. People staying with her brother in a nearby encampment retrieved Narcan from a vending machine at the shelter and used it to revive him repeatedly, she said.

Weekend update

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

As we barrel toward Thanksgiving, the House of Representatives and the Senate will be on a District / State work break this week.

Concerning Thanksgiving, Bloomberg Prognosis tackles a burning question.

Does turkey actually make you sleepy? It feels like everyone always says that because turkey contains tryptophan it makes you tired, but is that actually true? Madison, New York, New York

The answer to this question is somewhat counterintuitive: Tryptophan can indeed make you sleepy, but the desire for a post-Thanksgiving dinner nap probably isn’t caused by the bird.

The more likely culprit is the very large meal, says Kat Lederle, a sleep therapist in the UK. * * *

[T]he best way to avoid the post-dinner food coma is to pace yourself at the table. Just be sure to save room for dessert. 

From the Federal Employee Benefits Open Season front —

From the Omicron and siblings front, the New York Times reports

As winter looms and Americans increasingly gather indoors without masks or social distancing, a medley of new coronavirus variants is seeding a rise in cases and hospitalizations in counties across the nation.

The Biden administration’s plan for preventing a national surge depends heavily on persuading Americans to get updated booster shots of the Pfizer-BioNTech and Moderna vaccines. Now some scientists are raising doubts about this strategy.

Older adults, immunocompromised people and pregnant women should get the booster shots, because they offer extra protection against severe disease and death, said John Moore, a virologist at Weill Cornell Medicine in New York.

But the picture is less clear for healthy Americans who are middle-aged and younger. They are rarely at risk of severe illness or death from Covid, and at this point most have built immunity through multiple vaccine doses, infections or both.

The newer variants, called BQ.1 and BQ.1.1, are spreading quickly, and boosters seem to do little to prevent infections with these viruses, as they are excellent evaders of immunity.

The Centers for Disease Control reported on Friday

CDC Nowcast projections* for the week ending November 19, 2022, estimate the proportion of ten lineages designated as Omicron with estimates above 1%: BA.5—and five of its sublineages (BQ.1, BQ.1.1, BF.7, BA.5.2.6, and BF.11)—BA.4.6, BA.2, and BA.2.75.

The predominant Omicron lineage is BQ.1, projected to be 25.5% (95% PI 22.1-29.1%). Additionally, other variants represent 3.1% of circulating viruses, largely composed of the Omicron-derived XBB lineage.

The New York Times adds

Diminishing returns from tinkering with the Pfizer-BioNTech and Moderna vaccines call for a new approach to protecting Americans altogether, Dr. Moore and other experts said. A universal vaccine that targets parts of the coronavirus that do not mutate would be ideal, for example. A nasal vaccine might be better at preventing infections than an injected one.

“Chasing variants by tweaking the mRNA vaccines is not a sustainable strategy,” Dr. Moore said. “There’s a need for better vaccine designs, but that needs a change of attitude at the government level.”

NPR Shots discusses the available treatment options for the predominant variants, which include Paxlovid.

Healthcare Dive informs us

A group of 22 states led by Montana Attorney General Austin Knudsen filed a petition Thursday calling on the CMS to repeal its COVID-19 vaccination mandate for healthcare workers, according to a release.

The states argued the requirement has led to worsening staff shortages in the sector, particularly in rural areas.

The federal vaccine mandate covering healthcare workers has faced a flurry of legal challenges since it was first announced last year.

Unfortunately, the government continues to fight last year’s pre-Paxlovid battle in court.

From the U.S. healthcare business front, Fierce Healthcare tells us

Centene has agreed to sell Magellan Specialty Health to Evolent Health, the latest move in its broad value creation plan.

The government insurer said in an announcement that it expects to bank $750 million in the aggregate from the deal. Centene added Magellan Specialty Health, a leading specialty benefit management company, as part of its acquisition of Magellen Health, which closed in January.

Magellan Specialty Health provides utilization management tools to insurers, including for radiology, musculoskeletal, physical medicine and genetic testing. When the transaction closes, Centene and Evolent will enter a multiyear partnership that enables the insurer to extend and build on its work with Magellan Specialty.

“This transaction is another significant milestone in our ongoing portfolio review and value creation plan,” said Sarah London, CEO of Centene, in the release.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From Capitol Hill, Politico tells us about developments in privacy and cybersecurity legislative efforts.

From the cyber vulnerabilities front —

  • The HHS Health Sector Cybersecurity Coordination Center (HC3) issued its monthly vulnerabilities bulletin for October 2022.
  • The Cybersecurity and Information Security Agency (CISA) added another known exploited vulnerability to its catalog.
  • ZDNet reports on a “concerning” tactic that hackers are using to dodge multi-factor authentication.
  • Health IT Security adds “Numerous cloud attacks are successfully exploiting the healthcare sector for financial gain, according to a newly released 2022 Cloud Security Report by cybersecurity vendor Netwrix.”

Cybersecurity Dive warns us

More than one-third of respondents said it took their organization longer to assess the scope, stop and recover from a holiday or weekend attack compared to a weekday, according to a Cybereason survey published Wednesday November 16]. Larger organizations with more than 2,000 employees were even more likely to experience delays.

Organizations would lose more money as a result of a ransomware attack on a weekend or holiday than they were a year ago, according to Cybereason. One-third of respondents said their organization lost more money from a holiday or weekend ransomware attack, up from 13% in 2021.

Organizations in education and travel and transportation reported a greater likelihood of financial losses from a holiday or weekend attack instead of a weekday. About 2 in 5 respondents in those industries said their organization suffered a larger economic impact.

From the ransomware front —

Health IT Security reports

HHS, the Federal Bureau of Investigation (FBI), and the Cybersecurity and Infrastructure Security Agency (CISA) issued a joint cybersecurity advisory about Hive ransomware actors. The ransomware actors have been repeatedly targeting critical infrastructure, especially the healthcare sector since they were first observed in June 2021.

As of November 2022, Hive ransomware actors have victimized more than 1,300 companies globally and gained $100 million in ransom payments. The group has claimed multiple healthcare victims, including an attack on Memorial Health System in August 2021 that resulted in appointment cancellations, clinical disruptions, and EHR downtime. * * *

Healthcare organizations should secure and monitor RDP, install updates for software, firmware, and operating systems as soon as they are released, and maintain offline data backups. In addition, organizations were encouraged to enable PowerShell Logging and install and regularly update antivirus software.

The federal bodies also urged organizations to prepare for the event of a ransomware attack by reviewing the security postures of third-party vendors, implementing a recovery plan, and documenting external remote connections.

In the event of a Hive ransomware attack, organizations should isolate infected systems, secure backups, and turn off other computers and devices to manage the attack. Paying the ransom is also highly discouraged, as it may incentivize threat actors to continue victimizing organizations.

“This is another example of foreign-based, primarily Russian-speaking, hackers attacking U.S. health care, John Riggi, the American Hospital Association’s (AHA) national advisor for cybersecurity and risk, said in a subsequent announcement.

Here is Bleeping Computer’s current Week in Ransomware.

Other news this week are new reports on rising ransomware operations:

From the cybersecurity defenses front

  • The National Institutes of Standards and Technology issued SP 800-125, which is a “Guide to a Secure Enterprise Network Landscape.”
  • Forbes provides a new approach to closing the cybersecurity talent gap.

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’scupational 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.”