FEHBlog

Midweek update

Photo by JOSHUA COLEMAN on Unsplash

Mercer Marsh Benefits presents the top five trends from its 2023 employer-sponsored health plan survey of 225 insurers located in 56 countries:

  1. Per-person medical cost increases are back to pre-pandemic levels. 68% of insurers expect plan sponsors to prioritize improvements. This is even though double-digit medical cost increases are forecast for some markets.
  2. COVID-19 continues to impact the claims experience. 55% of insurers report an increase in the later-stage illness diagnosis due to deferred care.
  3. Plan modernization has begun. To make coverage more inclusive for those who identify as LGBTQ+, one in two insurers have changed or expect to change eligibility requirements and eligible expenses.
  4. The mental health gaps persist. 16% of insurers report not providing plans that cover mental health services (versus 26% in 2022).
  5. Plan management requires greater rigor. More than one in five insurers in Asia are adjusting their medical plan premiums based on an individual’s COVID-19 vaccination status.

All five main points ring true, but the prime examples for the fourth and fifth points don’t fit the FEHB market.

The American Medical Association points out six often overlooked steps to better health while Rebecca G. Baker, Ph.D., the director of the NIH HEAL Initiative® looks back at a virtual stakeholder briefing to visit the initiative’s progress in resolving chronic pain and opioid misuse issues and to describe future plans. 

From the public health front, the New York Times reports about

a large study published on Tuesday found a surprising trend among adolescents who repeatedly visited the hospital. The patients most likely to reappear in emergency rooms were not patients who harmed themselves, but rather those whose agitation and aggressive behavior proved too much for their caregivers to manage.

In many cases, repeat visitors had previously received sedatives or other drugs to restrain them when their behavior became disruptive. * * *

The results suggest that researchers should focus more attention on families whose children have cognitive and behavioral problems, and who may turn to emergency rooms for respite, Dr. [Anna] Cushing [an author of the study] said.

“I’m not sure we’ve been spending as much time talking about these agitated and behaviorally disregulated patients, at least on a national scale,” she said.

The JAMA study found that overall visits to pediatric emergency rooms for mental health crises increased 43 percent from 2015 to 2020, rising by 8 percent per year on average, with an increase in emergency visits for every category of mental illness. By comparison, emergency room visits for all medical causes rose by 1.5 percent annually.

Nearly one-third of visits were related to suicidal ideation or self-harm, and around one-quarter of patients presented with mood disorders, followed by anxiety disorders and impulse control disorders. Around 13 percent of patients made a repeat visit within six months.

From the telehealth front, Axio informs us

There are few things more stressful than getting a serious medical diagnosis, but pandemic-era changes in virtual care are prompting more patients to obtain a second opinion without leaving home.

Why it matters: The telehealth explosion made it easier to get advice from top doctors across the country — and for health systems to grow business beyond their physical footprints and even treat some of the people seeking consultations.

Case in point: The Clinic, a joint venture between Cleveland Clinic and telehealth giant Amwell, launched in 2020 just before the pandemic began.

The idea was to pair the Cleveland Clinic brand with Amwell’s virtual tools and its existing connections with private insurers to make it easier for patients to get their records reviewed, said Frank McGillin, CEO of The Clinic.

In litigation news, Health Payer Intelligence relates

A United States district court has ruled against Blue Cross Blue Shield of Illinois (BCBSIL), stating that the payer cannot exclude coverage for medically necessary gender-affirming care in its employer-sponsored ERISA health plans.

Lambda Legal and Sirianni Youtz Spoonemore Hamburger PLLC filed a class action lawsuit against BCBSIL on behalf of a 17-year-old transgender man, CP, and his parents. According to the lawsuit, the payer administered discriminatory exclusions of gender-affirming care, violating the anti-discrimination of the Affordable Care Act (ACA), known as Section 1557. * * *

The court determined that BCBSIL is a “health program or activity” that receives federal funds and thus cannot discriminate based on race, national origin, sex, age, or disability in its role in administering ERISA health plans.

From inside the Beltway, Govexec reports

The White House released a plan on Wednesday for how the Biden administration seeks to foster a more open and accountable government.

Transparency is something for which many presidential administrations strive, but success can be elusive, as shown during the Obama and Trump presidencies. Nevertheless, the almost-two year old Biden administration unveiled its first and the fifth overall U.S. Open Government National Action Plan, shared exclusively with Government Executive ahead of its release. This builds on many of the Biden administration’s efforts, including the president’s management agenda. 

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill, the National Rural Healthcare Association trumpets the “big rural health advocacy wins in FY23 appropriations bill” that the President will be signing this week. Notably —

Given the devastating outcome of COVID-19 in rural areas, NRHA has been committed to working with Capitol Hill to see an Office of Rural Health created at the Centers for Disease Control and Prevention (CDC). Included in the FY 2023 appropriations bill was $5 million to establish an Office of Rural Health at CDC. The text dictates that the ORH will enhance implementation of CDC’s rural health portfolio, coordinate efforts across CDC programs, and develop a strategic plan for rural health that maps the way forward both administratively and programmatically. This is a massive victory for rural health, and NRHA is looking forward to working with CDC to see this stood up quickly, to ensure rural representation in America’s public health infrastructure.

$3.45 billion for the Rural Community Facilities Program and $2 million for the Rural Hospital Technical Assistance Program through the United States Department of Agriculture Rural Development (RD) programs. 

From the public health front –

  • Beckers Hospital Review tells us

Omicron subvariant XBB is encroaching on BQ.1 and BQ.1.1’s dominance, CDC data shows, as it accounts for 18.3 percent of U.S. cases and makes up more than 1 in 2 infections in the Northeast. 

Subvariants BQ.1 and BQ.1.1, which became the nation’s most pervasive strains in November, are on the decline. 

The FDA began tracking XBB on Nov. 28. The subvariant is a fusion of two other omicron subvariants, BA.2.10.1 and BA.2.75, and it caused a wave of cases in Singapore. Eric Topol, MD, founder and director of Scripps Research Translational Institute in San Diego, wrote Dec. 23 that XBB mutation XBB.1.5 “has the most growth advantage vs. BA.5,” which was causing most COVID-19 cases for months. 

  • Beckers also reports, “The CDC issued a health advisory on Dec. 22 to alert the medical community of a rise in severe strep A infections among children. * * * Read the full advisory and provider recommendations here.”

From the U.S. healthcare business front, the Wall Street Journal challenges non-profit hospital business practices which fail to help the needy.

Many of the nation’s largest nonprofit hospital systems, which give aid to poorer communities to earn tax breaks, have been leaving those areas and moving into wealthier ones as they have added and shed hospitals in the last two decades. 

As nonprofits, these regional and national giants reap $8.8 billion from tax breaks annually, by one Johns Hopkins University researcher’s estimate. Among their obligations, they are expected to provide free medical care to those least able to afford it.

Many top nonprofits, however, avoid communities where more people are likely to need that aid, according to a Wall Street Journal analysis of nearly 470 transactions. As these systems grew, many were more likely to divest or close hospitals in low-income communities than to add them. * * *

Ascension was the most active deal maker in the Journal’s review. Through deals involving 93 hospitals over the past 20 years, Ascension has grown into one of the largest U.S. systems, with $28 billion in revenue and $19.5 billion in cash reserves in its most recent fiscal year, ended June 30.

Among the hospitals Ascension pruned as it grew were those serving some of the poorest neighborhoods of Washington, D.C., and Chicago.

Local elected officials said that when a system exits a market, it can be difficult for remaining facilities to serve the community.

The Journal also questions online advertising for prescription drugs by certain telehealth companies.

In an advertisement on Facebook and Instagram, a middle-aged man holding a dumbbell says testosterone “literally changed my life,” restoring his energy and happiness.

What the October ad from telehealth startup Hone Health doesn’t say is that the unidentified man is an actor who has never used the prescription drug. It doesn’t mention that testosterone is approved by the Food and Drug Administration only for men with specific disorders and that among its risks are heart attacks and stroke.

Similar telehealth companies are flooding TikTok, Instagram and other platforms with ads that don’t conform to longtime standards governing the marketing of prescription drugs and healthcare treatments. They feature actors posing as customers, tout benefits of drugs with no mention of side effects and promote medications for uses not approved by the FDA.

In the two years since the government expanded the scope of medical services allowed via video calls, telehealth companies have been operating largely outside advertising rules that govern drugmakers, a gray area subject to little government oversight or guidance. Instead, the main gatekeepers exercising the power to review or remove telehealth advertising are the social-media giants paid to run the ads.

Boxing Day Update

Congress is on a State / District work break until January 3, 2023, when the 118th Congress convenes.

Govexec informs us

President Biden on Friday issued an executive order implementing his plan to provide federal civilian employees with an average 4.6% pay raise in January.

As proposed in his fiscal 2023 budget plan last March, the raise provides federal workers with a 4.1% across-the-board raise to basic pay, as well as an average 0.5% increase in locality pay. * * *

The Office of Personnel Management now must publish pay tables outlining the pay raise across all General Schedule pay grades and locality pay areas. Once updated, they will be available on the OPM website. The pay raise will go into effect for the first full pay period of 2023.

From the public health front —

  • The Wall Street Journal spoke with ear, nose, and throat specialists about they treat their own flu and colds.
  • McKinsey Consulting suggests the secret to great health is escaping the healthcare matrix. “The blueprint for achieving a lifetime of great health is increasingly clear and within our control. But unlocking it requires challenging the orthodoxies currently guiding individuals and institutions.”

From the Rx coverage front —

  • The Wall Street Journal delves into health plan strategies for covering million-dollar-plus gene therapies.

A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription. 

Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.

HRT said it would give away one-tenth of its product and sell the rest to pharmacies, public-sector employees and groups that work with drug users at-cost, about $18 a dose. HRT said it plans to produce 2 million doses a year.  * * *

Emergent BioSolutions Inc., maker of the Narcan brand of naloxone nasal spray, said earlier this month that its application for over-the-counter status had received an expected approval date of March 29. The company’s two-dose prescription-only nasal spray was selling at pharmacies recently at a cash price of more than $100 without insurance.

Pocket Naloxone Corp. is applying for a nasal-swab version of the drug it said would be cheaper than nasal-spray versions. The startup said earlier this month that it submitted results to the FDA showing that its drug works more quickly than prescription versions. * * *

Other nonprofits are also working to lower drug prices. Civica Rx, a nonprofit founded in 2018, introduced a cancer drug this year with a recommended price of $171 a month versus more than $3,000 a month without discounts for an older version charged to patients on Medicare Part D. Medicines360, a women’s health group, developed a hormonal intrauterine birth-control device it said it sells to safety-net clinics for $100, about a 90% discount.

Cybersecurity Saturday

The American Hospital Association informs us

The Healthcare Cyber Communications Center, FBI, Cybersecurity & Infrastructure Security Agency and National Security Agency in December warned of new ransomware strains and other cyber threats targeting health care.

  • The FBI and CISA warned of the “Cuba” Ransomware threat.
  • HC3 warned of the Royal ransomware threat.
  • HC3 warned that a new ransomware strain known as Blackcat was also targeting health care and appeared to be the successor of the notorious Russian speaking REvil ransomware gang.
  • HC3 also warned of the latest version of the LockBit ransomware, known as LockBit 3.0. The LockBit “ransomware as service” in its various forms has targeted health care since 2019.
  • The NSA advised of an advanced persistent threat known as APT5, which may be affiliated with the Chinese government, targeting the Citrix Application Delivery Controller which then provides the adversary broad network access.

“Our cyber adversaries believe we may pause for the holidays, which may result in their increased targeting of hospitals and health systems as we have seen around past holidays,” said John Riggi, AHA national advisor for cybersecurity and risk. “But our hospitals never close and our network defenders never cease their vigilance.

Cybersecurity Dive provides guidance on the same topic.

Health IT Security reports

HITRUST plans to release version 11 of its cybersecurity framework (CSF) in January with new and improved features for managing emerging cybersecurity threats and reducing certification efforts, the organization announced.

As previously reported, HITRUST can help healthcare organizations improve their security postures and manage third-party risk. The HITRUST CSF is a risk and compliance-based framework that aims to provide structure and guidance across a variety of data privacy and security regulations and standards, helping organizations reduce burden and complexity.

Specifically, CSF v11 offers improved control mappings and precision in order to reduce certification efforts by 45 percent. In addition, the new version “enables the entire HITRUST assessment portfolio to leverage cyber threat-adaptive controls that are appropriate for each level of assurance.”

CSF v11 also includes expanded authoritative sources, including the National Institute of Standards and Technology (NIST) SP 800-53, Rev 5, and the Health Industry Cybersecurity Practices (HICP) standards.  

HITRUST also developed artificial intelligence-based standards development capabilities to assist its assurance experts in mapping and maintaining authoritative sources. HITRUST said that this AI-based toolkit will reduce maintenance and mapping efforts by up to 70 percent.

In event news, CMS announced

The National Standards Group (NSG), on behalf of the Department of Health and Human Services (HHS), issued a Notice of Proposed Rulemaking (NPRM) CMS-0053-P. The proposed rule, if finalized, would make a regulatory change that would implement requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Patient Protection and Affordable Care Act (Pub. L. 111-148).

This webinar will provide a public forum for CMS to hear feedback on the proposed rule. The call will cover the following topics:

• Background on the current standards
• What the proposed rule would do
• How to submit comments on the proposed rule

Note: Feedback received during this call is not a substitute for formal comments on the rule. See the proposed rule for information on submitting comments.

This free webinar will be held on January 25, 2023, at 2 pm ET. You can register here.

From the vulnerabilities front, the Healthcare Sector Cybersecurity Coordination Center issued an Analyst Note last Thursday. According to the Executive Summary:

HC3 is closely tracking hacktivist groups which have previously affected a wide range of countries and industries, including the United States Healthcare and Public Health (HPH) sector. One of these hacktivist groups—dubbed ‘KillNet’—recently targeted a U.S. organization in the healthcare industry. The group is known to launch DDoS attacks primarily targeting European countries perceived to be hostile to Russia, and operates multiple public channels aimed at recruitment and garnering attention from these attacks.

From the ransomware front, Cybersecurity Dive reports

  • CrowdStrike researchers discovered a new exploit method by Play ransomware actors that can bypass URL rewrite mitigations released by Microsoft in October, according to a Tuesday blog post from the incident response firm. Microsoft’s updates were designed to mitigate ProxyNotShell vulnerabilities.
  • Crowdstrike researchers discovered the new method while investigating Play ransomware activity. The entry vector was suspected to be zero-day vulnerabilities CVE-2022-41080 and CVE-2022-41082, according to the blog. 
  • While investigating the attacks, researchers found threat actors entered through Outlook Web Access (OWA) and leveraged Plink and AnyDesk in order to maintain access.

Bleeping Computer’s The Week in Ransomware is available here. After sharing its thoughts on the Microsoft issue, Bleeping Computer adds

TrendMicro also confirmed this week our September report that a Conti cell known as Zeon rebranded to Royal Ransomware.

Other reports this week shed light on various ransomware operations:

From the cybersecurity defenses front

  • Healthcare IT News offers a roundup of strategies and next steps for improving cybersecurity in 2023.
  • The Wall Street Journal reports that Chief Information Officers and Chief Information Security Officers are working together to better align their respective positions.

Omnibus bill passes

Per Roll Call, the House of Representatives followed the Senate by passing the Consolidated Apppropriations Act 2023 and the one week further extension of the continuing resolution to December 30, 2023. The 117th Congress has completed its work.

The Centers for Disease Control will not be published its weekly interpretation of Covid statistics until next year as today and next Friday precede three day weekends.

The CDC did update its Covid data tracker and Fluview which happens on Thursdays. The new daily Covid cases and deaths for the week ending December 22 averaged approximately 69,600 cases and 420 deaths. “Seasonal influenza activity remains high but is declining in most areas.” As noted in yesterday post, RSV cases appear to have peaked.

In No Surprises Act news, the Labor Department’s Employee Benefit Administration announced this afternoon

  • Effective January 1, 2023, the administrative cost for holding an arbitration under an independent dispute resolution process will increase from $50 per party to $350 per party. That should tamp down the number of NSA arbitrations.
  • ACA FAQs 56 concerning the NSA prescription drug reporting that health plans, including FEHB plans, are scheduled to submit next Tuesday, December 27, for the 2020 and 2021 plan years. Significantly,

For the 2020 and 2021 data submissions that are due by December 27, 2022, the Departments will not take enforcement action with respect to any plan or issuer that uses a good faith, reasonable interpretation of the regulations and the Prescription Drug Data Collection (RxDC) Reporting Instructions in making its submission. The Departments are also providing a submission grace period through January 31, 2023, and will not consider a plan or issuer to be out of compliance with these requirements provided that a good faith submission of 2020 and 2021 data is made on or before that date.

  • Initial Report on the Independent Dispute Resolution Process: April 15 – September 30, 2022.

The FEHBlog will release Cybersecurity Saturday on December 24 and the Holiday weekend update on December 26. Merry Christmas and of course Jingle Bells.

Thursday Miscellany

From Capitol Hill, the American Hospital Association tells us

The Senate today passed (68-29) an amended version of the $1.7 trillion omnibus appropriations bill that funds the federal government through the end of the current fiscal year. The legislation also includes many provisions affecting hospitals and health systems.

The Senate also passed another short-term continuing resolution through Dec. 30 to allow time for the more than 4,000-page legislation to be enrolled and for President Biden to sign it. This ensures there will be no interruption of services or federal shutdown.

The omnibus spending bill, which includes relief from Medicare cuts and extensions of rural and telehealth programs, as well as the Dec. 30 continuing resolution, now go to the House, which is expected to consider them today . The president is expected to sign the short-term continuing resolution before current funding for the government expires at 11:59 p.m. ET on Dec. 23, and to sign the omnibus later next week.

The Wall Street Journal adds, “House Majority Leader Steny Hoyer (D., Md.) said the House would vote on the bill Friday.”

In other 2023 Consolidated Appropriations Act or omnibus news

  • The Hill reports on “last minute” changes to the omnibus, including provisions assisting nursing and pregnant workers.
  • Mercer Consulting alerts us to a two-year-long extension of telehealth flexibilities available to high deductible plans with health savings accounts.
  • Think Advisor and the Wall Street Journal provide an overview of the Secure 2.0 Act provisions in the omnibus. The Secure 2.0 Act affects 401(k) plans offered to employees and IRAs. The key provision that takes effect for 2023 is an increase in the required minimum distribution age from 72 to 73.
  • The Wall Street Journal reviews the other omnibus provisions affecting businesses.

From the public health front —

Beckers Hospital Review informs us

While the respiratory “tripledemic” continues to slam emergency rooms and children’s hospitals, there are two glimmers of hope on the horizon, according to a Dec. 22 report in The New York Times. 

COVID-19, the flu and respiratory syncytial virus attack the body in different ways, and there are varying levels of disease severity across the U.S. Today, some scientists say RSV has peaked in most parts of the country.

“I think it’s likely that the RSV season has peaked in most parts of the country,” said Virginia Pitzer, ScD, an infectious disease epidemiologist at New Haven, Conn.-based Yale School of Public Health. “I think that there is a light at the end of the tunnel.”

Additionally, there’s reason to believe next winter won’t be as burdensome for the American population and healthcare organizations.

Ironically, the safety precautions used to help stem the pandemic in the past couple of years have also kept adults and children from being exposed to the viruses that typically circulate this time of year, said Dr. Pitzer.

“There was a bit of a buildup of susceptibility at the population level,” she added. “It’s a worse than normal winter, but one that hopefully will not be repeated next year.”STS

The American Hospital Association tells us

The Society for Healthcare Epidemiology of America today recommended hospitals and health systems no longer routinely screen symptom-free patients for COVID-19 upon admission or before procedures and rely instead on enhanced layers of infection prevention interventions.

“The small benefits that could come from asymptomatic testing at this stage in the pandemic are overridden by potential harms from delays in procedures, delays in patient transfers, and strains on laboratory capacity and personnel,” said Thomas R. Talbot, M.D., MPH, the chief hospital epidemiologist at Vanderbilt University Medical Center, and a member of the SHEA Board of Directors. “Since some tests can detect residual virus for a long period, patients who test positive may not be contagious.”

STAT News reports

[According to a CDC report, a] baby born in the U.S. in 2021 has a life expectancy of 76.4 years, down from 77 years in 2020 and the lowest level the CDC has recorded since 1996. The age-adjusted death rate for Covid rose by 22.5% between 2020 and 2021, while death rates from unintentional injuries — one-third of which come from overdoses — rose by 12.3%.

HHS’s Agency for Healthcare Quality and Researched refreshed its Healthcare Cost and Utilization Project Fast Stats website. The site provides “summary statistics on inpatient stays, emergency department visits, and priority topics, by select characteristics.”

From the OPM front, OPM’s medical director, Dr. Ron Kline announced today on Linked In that he is leaving OPM to take a new position beginning January 17, 2023 as

the Chief Medical Officer of the Quality Measurement and Value-Based Incentives Group (QMVIG) at the Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS).

QMVIG is responsible for developing, evaluating and supporting the implementation of quality measurement programs across the entire federally-supported health care continuum. This includes Medicare’s Quality Payment Program and the Inpatient (i.e. Hospital) Quality Reporting Program. These measures and policies guide these innovative programs to improve healthcare quality for all Americans.

Best wishes, Dr. Kline, and thanks for your work with the FEHB over the past 3 1/2 years.

From the Rx coverage and medical research fronts –

MPR reports

The Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for intravenous (IV) use to treat COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

ICER released evidence reports on Alzheimer’s Disease treatments (draft) and hemophilia A and B (final) STAT News explains

The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday.

The Institute for Clinical and Economic Review, or ICER, dug into the evidence for lecanemab and concluded that the drug’s demonstrated benefits, a modest but statistically significant delay in the advance of Alzheimer’s, are worth between $8,500 and $20,600 per year. ICER’s calculations, which could change in response to public comment over the next month, are based on metrics meant to quantify the value of improvements to quality of life.

Eisai, which is leading the effort to commercialize lecanemab, has not disclosed how much it will charge for the medicine, saying only that it will prize affordability and access. That will soon change, as the drug, a twice-monthly infusion, is expected to win a preliminary Food and Drug Administration approval by Jan. 6. * * *

Lecanemab’s safety has come into sharp focus over the past two months after three patients died of major brain bleeds.

Regarding hemophilia therapies, ICER observes

The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of etranacogene dezaparvovec (Hemgenix, CSL Behring,) for hemophilia B. ICER also updated the previous Hemophilia A assessment on valoctocogene roxaparvovec (Roctavian™, BioMarin).  

Key recommendations stemming from the roundtable discussion include:

  • The value of high-impact single and short-term therapies should not be determined exclusively by estimates of long-term cost offsets, particularly when the existing standard of care is acknowledged to be priced significantly higher than reasonable cost-effective levels.
  • Payers should work with manufacturers to develop and implement outcomes-based agreements to address the uncertainty and the high cost of gene therapies for hemophilia.
  • At least one national payer has suggested to patient representatives that step therapy with emicizumab is being considered prior to provision of coverage for Roctavian. Clinical experts and patient experts view this approach as lacking any clinical justification and appears to be only a method for trying to avoid the high one-time fee for gene therapy while assuming that patients may switch insurers before the cost-saving potential of gene therapy is fully realized. In short, step therapy does not appear to be a reasonable consideration for this treatment.

ICER’s detailed set of policy recommendations, including comprehensive considerations for establishing evidence-based prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.

NIH announced

Scientists used patient stem cells and 3D bioprinting to produce eye tissue that will advance understanding of the mechanisms of blinding diseases. The research team from the National Eye Institute (NEI), part of the National Institutes of Health, printed a combination of cells that form the outer blood-retina barrier—eye tissue that supports the retina’s light-sensing photoreceptors. The technique provides a theoretically unlimited supply of patient-derived tissue to study degenerative retinal diseases such as age-related macular degeneration (AMD). 

Amazing.

From the miscellany department, the Wall Street Journal and MedPage Today explore the new AI text tool known as ChatGPT. From the Journal article

If you haven’t yet tried ChatGPT, OpenAI’s new artificial-intelligence chatbot, it will blow your mind. Tell the bot to write you anything—an email apologizing to your boss, an article about the world’s richest hamster, a “Seinfeld” script set in 2022—and it spits out text you’d think was written by a human. Knowledge of the topic, proper punctuation, varied sentence structure, clear organization. It’s all there.

Happy Winter Solstice

Winter is not only coming; winter is here.

From Capitol Hill, the Wall Street Journal reports

Senators were bracing for a late night in the Capitol, as the timing of votes on the $1.65 trillion omnibus spending bill and possible amendments remained uncertain and the Friday night deadline to avoid a government shutdown crept closer. 

The Senate could start voting on amendments later Wednesday, teeing up a late night or early morning of voting, even as they also attend an address to Congress in the evening by Ukrainian President Volodymyr Zelensky. Adding to the pressure, senators are looking to get out of town ahead of winter storms expected in coming days.

“We’re still working on an agreement to vote on amendments and pass the omnibus tonight,” Senate Majority Leader Chuck Schumer (D., N.Y.) said Wednesday night. “We aren’t there yet, we’re making progress.” Once the Senate passes the measure, it would move to the House, which is expected to approve it quickly.

Politico Pulse, STAT News, and the Washington Post offer follow-up stories on the healthcare provisions in the omnibus. Of note, the Washington Post confirms

Congress again rebuffed the White House’s request for new dollars to combat the coronavirus. Last month, Biden administration officials urged lawmakers to approve about $9.25 billion in emergency funds to help ensure access to vaccines and treatments while supporting new research into long covid.

The battle over more funds has been ongoing since the spring, and Republicans have refused to budge, with one Senate GOP aide telling The Health 202 that they want further explanations on how the federal government has spent billions previously allocated for its pandemic response. 

Politico Pulse adds

A long list of measures aimed at tackling the ongoing opioid crisis is in the bill, including $1,575,000,000 in state grants to go toward substance abuse prevention and treatment. It also incorporates significant provisions of the Mainstreaming Addiction Treatment Act, including the elimination of a DEA requirement that clinicians get an extra certification to prescribe buprenorphine, and the NOPAIN Act, which improves access to FDA-approved non-opioid therapies for outpatient surgical procedures.

STAT News explains how the omnibus breathes new life into Medicare’s hospital-at-home program.

What’s more, this week the Senate confirmed the nominations of Rob Schriver to be OPM Deputy Director and Richard Revesz to be director of OMB’s Office of Information and Regulatory Affairs.

From the judicial front –

  • The Society for Human Resource Management tells us, “The 5th U.S. Circuit Court of Appeals recently ruled that the federal government cannot enforce a COVID-19 vaccine mandate on federal contractors. The court’s Dec. 19 decision found that the Biden administration overstepped its authority with the vaccine mandate.”
  • Healthcare Dive discusses the latest hearing before Judge Kernodle in the second Texas Medical Association challenge to the No Surprises Act independent dispute resolution rule. The FEHBlog finds this to be a premature lawsuit at best.

From the public health front

The nose knows why some people still can’t smell long after recovering from Covid-19.

A haywire immune response in the olfactory system was found to explain why some people still can’t smell long after symptoms of the disease have abated, according to a small, peer-reviewed study published Wednesday in the journal Science Translational Medicine. In some cases, the immune or inflammatory response was detected in patients with smell loss up to 16 months after recovery from Covid-19.

Compared with people who can smell normally, patients with long-term smell loss had fewer olfactory sensory neurons, cells in the nose responsible for detecting smells and sending that information to the brain. Patients with lingering loss of smell had an average of 75% fewer of the neurons compared with healthy people, said Brad Goldstein, a study co-author and sinus surgeon at Duke University.

“We think the reduction of sensory neurons is almost definitely related to the inflammation,” Dr. Goldstein said.

  • HHS announced “making an additional supply of Tamiflu available to jurisdictions to respond to an increased demand for the antiviral during this flu season, including through the Strategic National Stockpile (SNS). Jurisdictions will work with their ASPR Regional Teams to evaluate any requests for Tamiflu through the SNS, ensuring that states, territories, and tribes receive the assistance they need without affecting our nation’s preparedness for a future pandemic flu.”
  • Beckers Hospital Review discusses how five payers are addressing maternal health.
  • A JAMA article examines whether “the new CDC Opioid Prescribing Guidelines will help correct the course in pain care.”

From the drug development and distribution front

The Institute for Clinical and Economic Research “posted its revised Evidence Report assessing the comparative clinical effectiveness and value of the following treatments for multiple sclerosis (MS):

Monoclonal Antibodies

  • natalizumab (Tysabri®, Biogen)
  • ofatumumab (Kesimpta®, Novartis)
  • ocrelizumab (Ocrevus®, Genentech)
  • rituximab (Rituxan®, Genentech, and biosimilars)
  • ublituximab (TG Therapeutics)

Oral Therapies

  • dimethyl fumarate (Tecfidera®, Biogen, and generics)
  • diroximel fumarate (Vumerity®, Biogen)
  • monomethyl fumarate (Bafiertam®, Banner Life Sciences)
  • fingolimod (Gilenya®, Novartis)
  • ozanimod (Zeposia®, Bristol Myers Squibb)
  • ponesimod (Ponvory®, Janssen)
  • siponimod (Mayzent®, Novartis)
  • teriflunomide (Aubagio®, Sanofi)

Science reports,

As enthusiasm mounts for a new experimental antibody that appears to slow cognitive decline in some Alzheimer’s patients, a third death linked to the drug during its clinical testing may amplify concerns about its safety. Science has obtained medical records showing a 79-year-old Florida woman participating in an ongoing trial of the antibody died in mid-September after experiencing extensive brain swelling and bleeding, as well as seizures. Multiple neuroscientists who reviewed the records at Science’s request believe her death was likely caused by the antibody, lecanemab.

“The brain swelling and the microhemorrhages … could be a serious side effect of the study medication,” and should be evaluated by trial investigators, says Ellis van Etten, a neuroscientist and neurologist at Leiden University.

Biopharma Dive informs us

  • Pfizer has started dosing patients in a Phase 2 study of its entry into a closely watched class of drugs for treating diabetes and obesity.
  • The dosing of the first patient with the drug, dubbed PF-07081532, triggered a $10 million payment to partner Sosei Heptares, the Japanese drugmaker said Wednesday. Pfizer scientists working with Sosei’s technology discovered the medicine, and Pfizer is responsible for developing it.
  • Pfizer aims to bring a once-daily oral treatment into a class of medicines known as GLP-1 agonists, which stimulate the body to produce insulin by acting on natural body hormones known as glucagon-like peptides. Most of the approved GLP-1 agonists must be injected.

We have a bipartisan Omnibus bill

From Capitol Hill, the Washington Post reports

The Senate on Tuesday took the first formal step toward advancing a bipartisan, roughly $1.7 trillion deal to fund the U.S. government, as Democrats and Republicans raced to avert a shutdown in the final days of the year.

Lawmakers voted 70-25 to begin debate on the 4,155-page measure, known in congressional parlance as an omnibus, which would fund key elements of President Biden’s economic agenda, boost defense programs, and provision an additional $44.9 billion in emergency military and economic assistance for Ukraine.

The lumbering Senate sought to move with uncharacteristic haste after congressional leaders released the full text of the bill in the early hours of the morning, capping off months of intense legislating.

Becker’s Hospital CFO Review, the American Hospital Association, and Politico Pulse offer healthcare takeaways from the omnibus. Of note, Congress laid the groundwork for a soft landing following the public health emergency by addressing Medicaid, the AMA’s concern about the impending Medicare Part B cut (“narrowing the cut to 2 percentage points in the year ahead with a scheduled cut of 3.25 percentage points in 2024″) and extending Medicare telehealth flexibilities and most other Pandemic tied flexibilities through 2024.

Govexec and Federal News Network provide omnibus insights on federal agency and employment issues. Of note, Congress implicitly gave the green light to a 4.6% raise for federal employees in 2023, broken out into a 4.1% across-the-board increase and the remainder allocated to locality pay.

Meanwhile, the FEHBlog wishes to point out that the omnibus includes the three now standard FEHB appropriations measures — the Hyde Amendment restrictions on abortion coverage (Division E summary at 63), the prohibition on applying full Cost Accounting Standards coverage to FEHB contracts (Division E summary, p. 93) and the contraceptive coverage mandate (Division E summary at 68).

What’s more, the OPM appropriations measures include the following

Exploring Tools for Prescription Drug Price Transparency in the Federal Employee Health Benefits (FEHB) Program.- OPM is directed to explore and evaluate the benefits and potential overall cost savings resulting from FEHB Carriers’ implementation of Internet-based self-service tools that deliver transparency and clinical decision support on prescription drug costs to its members. OPM is directed to report to the Committees one year after enactment of this Act, contingent on the availability of funding for this study.

In No Surprises Act news, the Internal Revenue Service issued guidance on calculating the qualifying payment amounts in 2023.

For qualifying payment amounts calculated by increasing the median contracted rate for 201913, the qualifying payment amounts for items and services furnished in 2023 are determined by taking the qualifying payment amounts calculated for items and services furnished in 2022 and multiplying the 2022 adjusted qualifying payment amounts by the percentage increase from 2022 to 2023, that is, 1.0768582128.

For example: An item is furnished in 2023. The median contracted rate for the item on January 31, 2019 was $1,500. The 2022 adjusted qualifying payment amount for the item was $1,597 ($1,500 x 1.0648523983). The 2023 adjusted qualifying payment amount for the item is $1,720 ($1,597 x 1.0768582128).

The notice also provides QPA adjustment guidance for plans that began after January 31, 2019.

From the Omicron and siblings front, the Institute for Clinical and Economic Review (ICER) released “an update to the health benefit price benchmark for nirmatrelvir/ritonavir (Paxlovid™, Pfizer) for the treatment of COVID-19.” 

Based on the current evidence, ICER’s health-benefit price benchmark (HBPB) for Paxlovid is $563-$906 per treatment course. 

ICER’s HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.

Of course, at this time, the federal government is covering the cost of Paxlovid for Americans. That may change in 2023 because, contrary to the FEHBlog’s expectation, the omnibus does not appear to include additional funding for Covid vaccines and treatment. However, the FEHBlog is confident that the federal government will find the money if it wants.

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

  • Looking to further boost its growing cell therapy business, Gilead Sciences on Wednesday said it plans to acquire Tmunity Therapeutics, a private biotechnology company trying to develop newer, better CAR-T treatments.
  • CAR-T uses genetically engineered T cells to help the body fight diseases like cancer. Gilead currently markets two such products, Yescarta and Tecartus, which it obtained through the $12 billion purchase of Kite Pharma in 2017. Combined, sales of Yescarta and Tecartus were just under $400 million in the third quarter, a nearly 80% increase from the same three-month period a year prior.
  • Gilead said that buying Tmunity should complement Kite’s cell therapy research capabilities by providing a new technology platform, a slate of preclinical- and clinical-stage programs, and a strategic partnership with the University of Pennsylvania. Financial terms of the acquisition weren’t disclosed. The companies expect their deal to close early next year.

In good news, Health Payer Intelligence informs us

The majority of Americans are satisfied with their employer-sponsored health insurance and cited it as the most important benefit an employer can offer, according to a poll conducted by Seven Letter Insight for the Protecting Americans’ Coverage Together (PACT) campaign.

The poll surveyed 2,334 individuals with employer-sponsored health plans between November 14 and November 19, 2022. * * *

Overall satisfaction with employer-sponsored coverage was also high. Most respondents (93 percent) said they were satisfied with their insurance, with 54 percent saying they were highly satisfied. Eighty-seven percent agreed that their plans were affordable, and 73 percent thought their insurance was worth what they paid.

When respondents were asked to describe their employer-sponsored coverage, affordable, high-quality, and comprehensive were the top descriptions, the survey noted.

From the miscellany department —

  • Medscape provides an in-depth look at the progress in the fight against aging.
  • Beckers Hospital Review identifies the top five patient safety issues for 2023.
  • Govexec reports on the progress the federal government’s Merit Systems Performance Board has made since Congress restored the Board’s quorum last May after five years without one.

Monday Roundup

Photo by Sven Read on Unsplash

From Capitol Hill, STAT News reports

Leaders in Congress have reached a sweeping deal to ease Medicare pay cuts to doctors, make major changes to post-pandemic Medicaid policy, and to help prepare for future pandemics.

Lawmakers are aiming to pass a health care policy package along with legislation to fund the federal government by Friday. The details of the omnibus spending package were confirmed by two lobbyists and two congressional aides.

The bill’s text is not yet finalized, and the deal is still subject to changes.

Details may be found in the article.

Following up on last Friday’s post on emergency medical care, MedPage Today counters

The New York Times reported last week that a newly released federal government study believes that up to 250,000 people die in the U.S. annually due to misdiagnoses made in emergency rooms.

However, in a large document obtained by Inside Medicine that is not yet public, one expert contributing to an internal review of the report prior to its publication found a “fatal flaw” in the methodology behind some of the most crucial and eye-catching findings. Other major concerns were brought up by other reviewers and technical experts, which the study authors did not fully address prior to the release of the report. The technical expert concerned about the “fatal flaw” wrote that results were, “Headline grabbing, yes, but this is at best gravely misleading, given the concerns….”

Emergency medicine organizations have already pointed out major problems in the report. One thing not yet pointed out is that the magnitude of the findings fail every whiff test imaginable. If the findings of the report were somehow to be true, that would mean that 8.6% of all deaths in the U.S. — that is, 250,000 out of 2.9 million deaths (2019, the last pre-pandemic year) — are caused by mistakes and misses in ERs. That’s preposterous, on its face. * * *

This report seems unfamiliar with the idea that what we seek in medicine is net benefit. This report counts only the misses, but none of the saves ERs routinely make by following evidence-based medicine developed by emergency physicians, cardiologists, neurologists, and other experts working together. This report seems to think that abiding by the principle of balancing risks and harms is somehow synonymous with medical error. * * *

Here is the internal review and here is the link to the federal government’s report

In medical billing news, MedCity News informs us

Nearly 40% of Americans struggle to understand their medical bills, a recent survey showed. But the respondents also shared a few ways providers and insurers could step in to make bills less confusing.

The survey was released Friday by AKASA, an AI developer for healthcare operations. It was conducted online in March by YouGov and included responses from 2,026 U.S. adults. * * *

How can providers and insurers help? Survey respondents shared several ways:

  • About 27% said it would be beneficial to receive a call from the physician’s office or hospital staff before the medical procedure, explaining terms of payments and the payment plans available. 
  • Another 12% said they’d like an online calculator that can show cost ranges for procedures.
  • About 11% said it would be helpful to receive an email from their insurer that walks through the bill after they receive care.
  • About 9% said they’d like the payer to call and walk them through the bill.
  • Another 9% said they want access to live online customer service through their health plan’s website.
  • Additionally, 8% want a call from the physician’s office or hospital staff that explains the bill after receiving services.  

From the Rx coverage front, STAT News discusses current prescription drug shortages.

The Wall Street Journal adds

Medicines to lower fevers, clear congestion and ease aches and pains are in high demand this winter as the U.S. is experiencing a surge in pediatric cases of RSV, influenza and Covid-19. Parents and caregivers are struggling to find over-the-counter fever reducers such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil) as well as amoxicillin, an antibiotic prescribed to treat common childhood ailments such as ear or upper respiratory infections. Both CVS Health Corp. and Walgreens Boots Alliance Inc. announced they have imposed purchase limits on children’s cold and flu medicines. * * *

Manufacturers are producing at full capacity [in contrast to the baby formula shortage] and directing inventory to where it is most needed, the Consumer Healthcare Products Association, which represents producers of over-the-counter medications. “However, we understand it might be frustrating for parents to quickly locate these products from their usual pharmacy or retailer due to intermittent out-of-stocks,” the group said. A spokeswoman for Johnson & Johnson, whose brands include pain relievers Tylenol and Motrin, said that while some products might be less readily available, the company isn’t experiencing widespread shortages of children’s Tylenol or Motrin.

From the mental health care front —

  • The Department of Health and Human Services announced “the annual release of the Department’s National Plan to Address Alzheimer’s Disease: 2022 Update – PDF. Through the National Plan, HHS and its federal partners work to improve the trajectory of Alzheimer’s disease and related dementias (ADRD) research, support people living with dementia and their caregivers, and encourage action to reduce risk factors.”
  • HR Dive explains how employers can help resolve the “unspoken crisis” in men’s mental health.

From the fraud, waste, and abuse front, Fierce Healthcare reports

In a development in what’s being billed as one of the largest healthcare fraud schemes ever, a federal grand jury [on November 14] convicted the owner of a laboratory that performs sophisticated genetic tests of bilking Medicare out of hundreds of millions of dollars.

The crime involved telemarketers allegedly lying to Medicare recipients by ensuring them that they were covered for expensive genetic cancer tests, according to the Department of Justice (DOJ). * * *

The convicted individual—Minal Patel, 44, of Atlanta, the owner of LabSolutions LLC—personally pocketed $27 million of the $187 million that the scheme raked in from Medicare from July 2016 through August 2019.

Patient brokers, call centers and telemedicine companies also allegedly cashed in, as Patel paid them kickbacks and bribes after the Medicare beneficiaries agreed to take the tests, DOJ said. The patient brokers allegedly obtained signed doctors’ orders recommending the tests from telemedicine companies. Patel made the patient brokers sign contracts that misleadingly stated that the brokers were performing legitimate advertising services for LabSolutions.

At last week’s ABA Health Law Section Washington Health Law Summit, the FEHBlog learned about a recent federal anti-health care fraud law called the Eliminating Kickbacks in Recovery Act (“EKRA”). The law is directed at patient brokers, laboratories etc. in situations involving, for example, opioid misuse or this one. EKRA criminalizes fraud against private sector health plans as well as the federal treasury. Here’s a law firm’s article about EKRA if you are interested.

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

Two South [New] Jersey hospitals have signed a letter of intent to merge into a system of more than 10,000 employees and over $2.2 billion in annual revenues.

Camden, New Jersey-based Cooper University Health Care and Cape May Court House, New Jersey-based Cape Regional Health System said in a Wednesday announcement they’ll be working toward a definitive merger agreement in March and then regulatory approvals that “could take until the first quarter of 2024.”

Should the agreement come to pass, the joined system would comprise 900 licensed beds across the organizations’ two flagship hospitals, six urgent care centers and over 130 ambulatory locations across eight counties.

From the federal employment front, Federal News Network relates

Leaders in the Biden administration called for “major reforms” to the federal pay system, building on a not-so-new conversation around issues with the compensation system for much of the federal workforce.

The current structure for determining pay for the 1.5 million federal employees on the General Schedule is inherently flawed, the President’s Pay Agent said in its annual report to the president.

“As has been noted in earlier pay agent reports and discussed in other venues, we believe there is a need to consider major legislative reforms of the white-collar federal pay system, which continues to utilize a process requiring a single percentage adjustment in the pay of all white-collar civilian federal employees in each locality pay area without regard to the differing labor markets for major occupational groups,” the pay agent said in the Dec. 19 report. “The current pay comparison methodology used in the locality pay program ignores the fact that non-federal pay in a local labor market may be very different between different occupational groups. As currently applied, locality payments in a local labor market may leave some mission-critical occupations significantly underpaid while overpaying others.”

The pay agent, composed of Office of Personnel Management Director Kiran Ahuja, Labor Secretary Marty Walsh and Office of Management and Budget Director Shalanda Young, issued its annual report ahead of the planned 4.6% pay raisefor the federal workforce in 2023.

Weekend update

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

The Wall Street Journal explains

Lawmakers will return to the Capitol this week with a singular focus of passing a sweeping bipartisan spending bill to avert a shutdown and fund the government through September, despite opposition from many House Republicans.

The massive bill is expected to total around $1.7 trillion and could be released as early as Monday. It would fund government agencies and programs and allow those agencies to distribute grants and contracts to the private sector. 

Because it is the last piece of legislation that Congress will pass in this session, lawmakers have spent weeks lobbying to attach other bills, including funding for Ukraine, changes to tax policy and a measure to update how Congress deals with disputes over certifying presidential-election results. * * *

The Senate is expected to vote on the bill first. Senate Minority Leader Mitch McConnell (R., Ky.) has been part of the negotiations and set a deadline of Thursday to reach a deal—a day before the money runs out—but he said his patience was limited and that he wouldn’t allow talks to stretch past Christmas. 

From the Omicron and siblings front, NPR Shots provides insights on Paxlovid.

The Centers for Disease Control and Prevention recommends treatment for patients at risk of severe disease, hospitalization and death, which includes anyone who’s 50 and older (risk increases with age), people who are unvaccinated and people with certain medical conditions, such as obesity, chronic lung disease, heart disease or a weakened immune system.

But exceptions can be made. A colleague who is under 50 told her doctor she was feeling worse each day after her positive COVID test and had a history of pneumonia. The doctor wrote a Paxlovid prescription. * * *

[In addition to you doctor or pharmacist, t]he federal government has a “Test to Treat” locator to see where you can be tested for free and, if you test positive and are eligible, leave with the drug. Spots include community health centers and some pharmacies. 

Pharmacies may also send the pills to your home for prescriptions the doctor calls in. Walgreens just announced free Paxlovid delivery via Door Dash and UberEATS; CVS will send it the same day for a fee. * * *

Since Paxlovid has to be taken within five days of symptoms starting to work, you might contact your doctor’s office to find out what steps to take if you test positive and think you need the drug. * * *

Paxlovid is the best option for reducing the risk of severe disease. The last monoclonal antibody treatment for COVID-19 lost its FDA authorization last month because it is ineffective against currently circulating variants. That leaves Paxlovid; remdesivir, which requires an outpatient infusion over three days at a hospital or treatment center; and molnupiravir [the other pill], which studies put at only 30% effective in treating the virus. In addition, some doctors are treating immunocompromised patients with convalescent plasma.

Bloomberg Prognosis discusses expiration dates on at-home Covid tests.

The Food and Drug Administration has extended the shelf-lives of 14 brands of tests. Consumers can look up their specific brand and even the lot number to see the correct expiration dates. Brands including iHealth, from a subsidiary of Andon Health in China, Abbott Laboratories’ BinaxNow and ACON Labs Inc.’s Flowfex now last up to 12  months, 15 months and 21 months, respectively. The FDA advises against using at-home Covid tests past their expiration date.

Health plans and Medicare continue to provide at-home Covid tests at no cost, and the federal government resumes mailing out free at-home Covid tests tomorrow.

From the telehealth front —

mHealth Intelligence tells us

Implementing a telehealth navigator program helped improve video visit attendance, providing clinics with a positive financial return, according to a new study published in JAMA Network Open.

The COVID-19 pandemic dramatically drove up the use of telehealth. Like many other healthcare provider organizations, Boston-based Beth Israel Deaconess Medical Center implemented and scaled telehealth visits. But they found that technical issues could hamper video visits, prompting some video visits to be converted into audio-only visits via the telephone, according to the study authors.

The medical center implemented a patient navigator pilot program to reduce barriers to video visit attendance. Through the program, a patient navigator contacted patients one day before their video visit appointment to provide technical support. The navigator went through the steps required for the patient to connect to their visit and addressed frequently asked questions.

The Wall Street Journal reports

Remote treatment of mental-health problems surged in the pandemic, as in-person treatment became difficult while pandemic-driven isolation increased anxiety and depression.

Digital mental-health companies plunged in, promising to provide millions with access to high-quality care by video, phone, and messaging.

Many of the businesses, however, put a premium on growth. Investor-backed, they deployed classic Silicon Valley tactics such as spending heavily on advertising and expansion while often using contractors instead of employees to control costs. A strategy designed for mundane businesses such as food delivery, the formula can be badly suited to the sensitive activity of treating mental-health problems.

No bueno. The article is focused on stand-alone telemental health services.

In the spirit of the Season, Bloomberg Prognosis tackles the question of “Eggnog Made With Raw Eggs Safe.”

“Eggnog may be safely made at home by using egg substitutes, whole, liquid or pasteurized eggs,” Darin Detwiler, a food-safety expert at Northeastern University, says. “These products need no further cooking to kill harmful bacteria.”

Pasteurized eggs are gently heated in their shells to a high-enough temperature to kill any bacteria without cooking the egg. They are pretty widely available, though the texture isn’t always exactly the same as an unpasteurized egg.  

If you are making eggnog the old-fashioned way, Detwiler has some advice for that, too.

“Cook the egg mixture to 160℉ and refrigerate it quickly in several small containers,” he says. “Then it will cool quickly.”

Jingle bells, all.