FEHBlog

Monday Roundup

David Ermer–Congress, COVID-19, FDA, Mental health care, Rx coverage, U.S. Healthcare–
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

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 testing, Mental health care, Telehealth–

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.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From Capitol Hill, Roll Call informs us

The Senate voted overwhelmingly Thursday to pass the final defense authorization bill for fiscal 2023, clearing the sweeping measure for President Joe Biden’s signature.

If Biden signs the NDAA into law, as he is expected to do, it would be the 62nd straight fiscal year that the defense policy measure has been enacted.

The Senate’s final NDAA passage vote was 83-11, and 60 votes were required. The House passed the bicameral compromise on Dec. 8.

Of note to FEHB carriers in the bill, as noted last week, is the Chinese-made semiconductor provision. The law requires a FAR rule to implement the provision within three years, and the FAR rule cannot take effect until December 2027, five years after enactment, which will occur when the President signs the bill.

The New York Times adds

The Biden administration on Thursday stepped up its efforts to impede China’s development of advanced semiconductors, restricting another 36 companies and organizations from getting access to American technology.

The action, announced by the Commerce Department, is the latest step in the administration’s campaign to clamp down on China’s access to technologies that could be used for military purposes and underscored how limiting the flow of technology to global rivals has become a prominent element of United States foreign policy. * * *

Among the most notable companies added to the list is Yangtze Memory Technologies Corporation, a company that was said to be in talks with Apple to potentially supply components for the iPhone 14.

On Thursday, Congress passed a military bill including a provision that will prevent the U.S. government from purchasing or using semiconductors made by Y.M.T.C. and two other Chinese chip makers, Semiconductor Manufacturing International Corporation and ChangXin Memory Technologies, because of their reported links to Chinese state security and intelligence organizations.

The Wiley law firm helpfully offers details on this important provision.

From the cyber vulnerabilities front —

The Cybersecurity Infrastructure and Security Agency (CISA) added five known exploited vulnerabilities and then one more to its catalog.

Healthcare Dive reports

The HHS’ Office of Information Security has released a report looking at the implications of automation for healthcare cybersecurity and how criminals are using artificial intelligence in their hacking activities.

Cyberattackers are using AI to build better malware, the office said. The technology includes machine learning-enabled penetration testing tools, AI-supported password guessing and data to enable impersonation on social networking platforms.

Hackers are also using automated software to identify valuable information such as emails, passwords, credit cards and personal data, according to the report.

The Healthcare Sector Cybersecurity Coordination Center issued this sector alert:

Citrix released patches for a vulnerability that impacts both their Application Delivery Controller and Gateway platforms. This vulnerability allows a remote attacker to completely compromise a target system. These vulnerabilities are known to be actively exploited by a highly capable state-sponsored adversary. Furthermore, the Department of Health and Human Services is aware of U.S. healthcare entities that have already been compromised by the exploitation of this vulnerability. HC3 strongly urges all healthcare and public health organizations to review their inventory for these systems and prioritize the implementation of these patches.

Forbes explains “Why Employee-Targeted Digital Risks Are The Next Frontier Of Enterprise Cybersecurity.”

From the ransomware front —

Bleeping Computer’s The Week in Ransomware has a long introduction which begins

To evade detection by security software, malware developers and threat actors increasingly use compromised code-signing certificates to sign their malware.

This trend was illustrated this week when Microsoft disclosed during the December Patch Tuesday that developer accounts were compromised to sign malicious, kernel-mode hardware drivers in the Windows Hardware Developer Program.

Health IT Security reports

The HHS Health Sector Cybersecurity Coordination Center (HC3) issued two new analyst notes detailing the tactics and indicators of compromise for LockBit 3.0 and BlackCat. The LockBit ransomware family and the BlackCat ransomware variant have been observed targeting the healthcare sector.

Healthcare organizations should remain vigilant and apply recommended mitigations to reduce risk.

CISA released an update to its Cuba ransomware advisory.

From the cybersecurity defenses front

  • Health IT Security tells us

Organization executives are doubling down on investments toward cybersecurity reliance as an uptick in data security breaches jeopardizes business operations and overwhelms industries, including the healthcare sector, according to a recent Cisco report.

The “Security Outcomes Report, Volume 3: Achieving Security Resilience” revealed that 96 percent of executives consider security resilience crucial, with 62 percent of organizations surveyed reporting a data security event that impacted business in the past two years.

When asked to elaborate on the types of resilience-impacting incidents, over half the respondents reported data breaches and system outages. Further, ransomware events and distributed denial of service (DDoS) attacks impacted more than 46 percent of surveyed organizations.

The report also indicated that the state of security resilience among organizations is mixed less than 40 percent confident their organization would fare well during a cybersecurity event.

  • Forbes identifies ten qualities of a good security program and delves into “Tackling Mental Health And Burnout In Cybersecurity.”

Friday Stats and More

David Ermer–CDC, COVID-19, HIPAA Privacy and Security Rules, Patient safety–

From the Centers for Disease Control’s Covid data tracker and its weekly interpretative summary of its Covid statistics:

  • New Cases totaled 455.556 this week, down 2.7% from last week.
  • Variants BQ.1.1 and BQ.1 are estimated to represent 78% of Covid / Omicron cases
  • New Hospitalizations averaged 5,010 this week, up 2.3% from last week.
  • New Deaths totaled 2,703, down 13.2% from last week.
  • “As of December 14, 2022, 660.4 million vaccine doses have been administered in the United States. About 228.8 million people, or 68.9% of the U.S. population, have completed a primary series.* More than 44.2 million people, or 14.1% of the U.S. population ages 5 years and older, have received an updated (bivalent) booster dose.”

The CDC reports good news about the efficacy of the bivalent booster here and here.

Pfizer announced the sale $2 billion worth of Paxlovid pills (3.7 million courses) to the federal government and its ongoing research on developing combined mRNA Covid and flu vaccine.

From CDC’s Fluview — “Seasonal influenza activity remains high but appears to be declining in some areas.”

Health Affairs brings us up to date on mpox.

Looking forward, Healthcare Dive reports

  • Leaders at hospitals and health systems across the country are anticipating a potentially turbulent operating environment in the coming year, according to a survey from Deloitte.
  • Among health system leaders, 85% said staffing challenges would have a major impact on their 2023 strategy and 76% said inflation is a significant factor. Other expected headwinds include affordability issues for patients, shrinking margins and continual supply chain disruptions.
  • Deloitte also polled health plan executives and found they face challenges related to inflation and a tight labor market, though are generally in a better financial position than hospitals and health systems.

Speaking of hospitals, Fierce Healthcare informs us

The care given in emergency departments came under fire yesterday with the release of a government study saying that 250,000 Americans die every year due to misdiagnoses.

The findings spurred an immediate response from the president of the American College of Emergency Physicians (ACEP), who questions the study’s veracity and methodology.

Christopher S. Kang, M.D., president of the ACEP, said in a statement that “in addition to making misleading, incomplete and erroneous conclusions from the literature reviewed, the report conveys a tone that inaccurately characterizes and unnecessarily disparages the practice of emergency medicine in the United States.”

One of the authors of the study—David Newman-Toker, M.D., Ph.D., a neurologist at Johns Hopkins University—vehemently defends the methodology and told Fierce Healthcare that “high levels of variation in care (across conditions, across hospitals, across demographic groups) tells us that these errors do not need to be thought of as ‘the price of doing business.’ It tells us that there are already probably ways to get it right.”

The study, conducted by Johns Hopkins for the Agency for Healthcare Research and Quality, states that among 130 million ED visits in the U.S. per year, 7.4 million patients are misdiagnosed. In addition, 2.6 million suffer an adverse event, and about 370,000 suffer serious harm from diagnostic errors.

The teenage daughter of CNN reporter Jake Tapper writes in CNN about her frightening ER experience. The FEHBlog joined his wife at a Dripping Springs TX knitting store holiday event. He mentioned the Alice Tapper story to two nurses who were horrified. In the FEHBlog experience, nurses are the best judge of hospital care across facilities.

In HIPAA news, the American Hospital Association tells us

The Department of Health and Human Services yesterday proposed a standard format for attachments to support electronic health care claims and prior authorization transactions under the Health Insurance Portability and Accountability Act. The standard would apply to all health plans, health care clearinghouses, and providers, who currently lack an efficient and uniform method of sending attachments, which can lead to provider burnout, slow down processing and delay payments or patient care.

“The AHA supports establishing a standard for attachments to reduce the administrative burdens facing clinicians, and we look forward to providing robust commentary after analyzing the rule’s specifics,” said Terrence Cunningham, AHA’s director of administrative simplification policy.

Comments on the rule are due March 21. 

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 testing, FDA, NIH, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports

The Senate passed an $858 billion defense-policy bill [National Defense Authorization Act] on Thursday that authorizes U.S. military leaders to purchase new weapons and would increase pay for service members, checking a major item off Congress’s year-end to-do list.

The House passed the legislation last week with 350 votes in favor and 80 votes against. It now goes to President Biden’s desk for his signature.

The Journal also provides information on the NDAA’s key provisions.

The Washington Post adds,

The Senate late Thursday approved a measure to fund the government through Dec. 23, securing a one-week deadline extension that gives Democrats and Republicans one final opportunity to work out a longer-term spending deal.

The 71-19 vote — coming a day after the House adopted it — sends the stopgap to President Biden and staves off a federal government shutdown that otherwise would have occurred after midnight this Friday.

From the Omicron and siblings front, the American Hospital Association informs us,

The Department of Health and Human Services today recommended governors take certain actions to prepare for a potential further increase in COVID-19 cases and hospitalizations this winter, and has pre-positioned N-95 masks, gloves, gowns and ventilators at strategic locations should states need them, the Biden Administration announced.

The Administration also announced that all U.S. households can now order four more free at-home COVID-19 tests, which will begin shipping the week of Dec. 19.

From the public health front, AP reports

The number of U.S. deaths dropped this year, but there are still more than there were before the coronavirus hit.

Preliminary data — through the first 11 months of the year — indicates 2022 will see fewer deaths than the previous two COVID-19 pandemic years. Current reports suggest deaths may be down about 3% from 2020 and about 7% vs. 2021.

The National Institutes of Health announced

The percentage of adolescents reporting substance use in 2022 largely held steady after significantly declining in 2021, according to the latest results(link is external) from the Monitoring the Future survey(link is external) of substance use behaviors and related attitudes among eighth, 10th, and 12th graders in the United States. Reported use for almost all substances decreased dramatically from 2020 to 2021 after the onset of the COVID-19 pandemic and related changes like school closures and social distancing. In 2022, reported use of any illicit drug within the past year remained at or significantly below pre-pandemic levels for all grades, with 11% of eighth graders, 21.5% of 10th graders, and 32.6% of 12th graders reporting any illicit drug use in the past year.

The Monitoring the Future survey is conducted each year by researchers at the University of Michigan, Ann Arbor, and funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

From the Rx coverage front –

BioPharma Dive takes a “deep dive” reporting on a recently approved drug called to treat ALS or Lou Gehrig’s disease. “Amylyx Pharmaceuticals’ Relyvrio is in high demand in clinics across the U.S. Though some patients are already getting it, insurance and out-of-pocket costs remain a source of anxiety. * * * In the clinical trial that led to its approval, Relyvrio appeared to slow the functional decline associated with ALS. The trial also found patients treated with the drug lived a median of five months longer than those given a placebo. While Relyvrio’s benefits have been called modest, the drug has become a vital source of hope for many ALS patients.”

BioPharma Dive also lets us know that

  • Yet another competitor for the top-selling inflammatory disease drug Humira will be waiting in the wings after Fresenius Kabi won U.S. approval of its copycat version called Idacio.
  • The Food and Drug Administration cleared the medicine for all the eligible indications of Humira, Fresenius Kabi said Wednesday. Due to a previous patent settlement with AbbVie, the company won’t launch Idacio in the U.S. until July.
  • Idacio, developed by Fresenius Kabi SwissBioSim, is currently available in 37 countries after initially launching in 2019. Fresenius Kabi said it has made selling biosimilars worldwide a priority.

Health Affairs Forefront offers Parts 1 and 2 of its insights on drug pricing reform enacted this past summer’s federal budget reconciliation act.

From the regulatory front

  • The FEHBlog noticed that the HHS press release concerning the 2024 Medicare Part D proposed rule (posted yesterday) lacked links to the proposed rule and the fact sheets. So here are the missing links:

The proposed rule can be accessed at the Federal Register at https://www.federalregister.gov/public-inspection/2022-26956/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program. Comments on the proposed rule are due by February 13, 2023.

View the fact sheet on the proposed rule here.

  • Health Affair’s Forefront’s second article on Monday’s proposed 2024 ACA benefit and payments parameter rule is here. This article concerns risk adjustment.

From the telehealth front, Health Payer Intelligence relates that

  • Most patients who had a telehealth visit didn’t need an in-person follow-up appointment in the next three months, according to new research from Epic. The trend was reflected in almost every specialty included in the study.
  • For specialties that required follow-ups, the additional visits were likely due to patients needing additional, not duplicative, care, Epic researchers said. That’s because high follow-up rates were only present in specialties that require regular hands-on care, such as obstetrics and surgery.
  • The study is the latest addressing whether telehealth results in duplicative care, instead of replacing an in-person encounter. The question is being debated by lawmakers as they consider how much telehealth flexibility should be allowed once the COVID-19 public health emergency expires.

In innovation news, Fierce Healthcare discusses

ElliQ, [which is] a voice-operated care companion for the elderly, is getting an update with 2.0 hardware and software including a companion app for family members and caregivers.

The robot, called the first proactive AI care companion and a Time Best Invention of 2022, was developed to address the loneliness epidemic in older adults and has shown the ability to decrease loneliness by 80%, according to the company. * * *

Interventions like the ones ElliQ performs are shown to improve the quality of life for seniors living alone by 80% through increasing fitness and facilitating social connections, according to a recent McKinsey report.

The first ElliQ impact studies have shown that 80% of users report a reduction in loneliness, 82% experienced better mental health and 90% feel overall better since using the robot.

Midweek Update

David Ermer–ACA, AHRQ, CDC, CMS, Congress, COVID-19, OPM–

From Capitol Hill, the Wall Street Journal reports

The House on Wednesday passed a one-week government funding measure to give congressional negotiators time to complete and pass a full-year omnibus spending bill, overcoming opposition from Republicans who urged postponing any deal until next year, when the GOP will take control of the chamber. * * *

The Senate is expected to next approve the one-week extension [on Thursday December 15]. 

The vote on a one-week continuing resolution, which keeps the government funded at fiscal 2022 spending levels, follows the announcement Tuesday that Democratic and Republican negotiators had reached agreement on a framework and would turn to completing the details. 

From the public health front, Healthcare Dive tells us

  • National health spending grew almost 3% in 2021, reaching $4.3 trillion as big increases in healthcare use and insurance coverage were offset by lower government spending on COVID-19.
  • The year’s growth rate was smaller than the 10% notched in 2020. CMS actuaries chalked the deceleration up to lower federal health spending, which fell 3.5% in 2021 compared to a 37% increase in 2020 as funding to combat the pandemic skyrocketed.
  • Health spending grew at a much slower clip than the nation’s gross domestic product, which increased 11% in 2021 — the largest growth rate since 1984.

Here’s the report which is posted on Health Affairs.

Medscape relates

New more aggressive targets for blood pressure and lipids are among the changes to the annual American Diabetes Association (ADA) Standards of Care in Diabetes — 2023.

The document, long considered the gold standard for care of the more than 100 million Americans living with diabetes and prediabetes, was published December 12 as a supplement in Diabetes Care. The guidelines are also accessible to doctors via an app; last year’s standards were accessed more than 4 million times.

The Agency for Healthcare Quality and Research’s Director is posting a series of four reports concerning the agency’s effort to rethink healthcare quality in view of the fact

In seven years, the United States is expected to reach a demographic tipping point that will redraw the picture of healthcare delivery in America.  

In 2030, all baby boomers [birth dates from 1946 to 1964] will be older than 65, according to the U.S. Census Bureau. Just four years later—in 2034—older adults will outnumber children for the first time in history. The scope of this and future demographic shifts—including our population’s growing racial and ethnic diversity—will profoundly impact how healthcare is accessed, delivered, paid for, and evaluated.

The National Institutes of Health reports “Two randomized, placebo-controlled trials evaluating three Ebola vaccine administration strategies in adults and children found that all the regimens were safe in both age groups, according to results published today in the New England Journal of Medicine.”

Health Payer Intelligence informs us

Privately-insured Americans experienced higher rates of heat-related illness diagnoses in 2021 compared to 2016, in some cases a more than 37 percent increase, according to a report from FAIR Health.

“The Centers for Disease Control and Prevention has identified projected increases in extreme summer heat as one source of adverse health impacts from climate change. However, systematic, national data on trends in heat-related illnesses in the United States have been lacking,” the report began.

From the omicron and siblings front, a subset of public health —

  • The New York Times explores the question — who are the never Coviders? Even if you have never had Covid, you certainly have been impacted mightily by Covid. Nevertheless, it is an interesting article.
  • MedPage Today notes “Long COVID played a role in more than 3,500 deaths in the U.S. since the start of the pandemic, according to data from the CDC’s National Center for Health Statistics (NCHS).” The NCHS report may be overestimating because the first death occurred in April 2020 just after Covid got rolling and the most commonly mentioned term on death certificates with long COVID was “post COVID,” which was mentioned in 89.6% of long COVID-related deaths.” This may be a rare case in which the “retrospectoscope” is cloudy. See Dr. Martin Markary’s opinion piece on long Covid in yesterday’s Wall Street Journal.

From the regulatory front —

  • CMS issued a proposed rule on Medicare Part D changes for 2024.
  • Health Affairs began a series of three informative articles on the proposed 2024 notice of benefit payments and parameters released on Monday.
  • STAT News discusses a feature of the parameters notice that is drawing industry attention. To wit, “The Biden administration signaled Monday that it will require health plans on federal exchanges to cover more of the costs of generic drugs, a small tweak that nevertheless has industry groups divided on how best to manage drug costs.”
  • Health Leaders Media examines the gap that must be bridged to achieve a recent HHS proposed rule’s goal of implementing electronic prior authorization.

In agency event news —

  • OPM issued a press release about its “first government-wide summit for diversity, equity, inclusion, and accessibility (DEIA) on December 6-8, 2022.”
Biden administration outlines how agencies can measure progress toward PMA goals

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, No Surprises Act, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Politico reports tonight

Top appropriators struck a deal Tuesday night on a government funding framework critical to finalizing a mammoth year-end spending package.

In a statement, retiring Senate Appropriations Chair Patrick Leahy (D-Vt.) said appropriators have “reached a bipartisan, bicameral framework that should allow us to finish an omnibus appropriations bill that can pass the House and Senate and be signed into law by the President.”

Leading negotiators didn’t release those government funding totals in announcing the deal, but appropriators have largely settled on an $858 billion defense budget in recent weeks.

That’s good news. Presumably, Congress still plans to extend the continuing resolution from December 16 to December 23 this week in order to allow time to write and pass the omnibus bill.

From the Omicron and siblings front, Healthcare Dive reports that

In the two years since the COVID-19 vaccine became available for U.S. patients, the country’s vaccination program prevented more than 18.5 million hospitalizations and 3.2 million deaths, according to new research from the Commonwealth Fund and Yale School of Public Health.

Many millions of infections were prevented, preserving hospital resources for patients who otherwise would not have received timely care, the researchers said. The vaccine also saved the country $1.15 trillion in medical costs, kept children in school and allowed businesses to reopen, the study said. 

To arrive at its findings, the study used a computer model of disease transmission, comparing the pandemic trajectory to a simulated scenario without a vaccination program. The results can be used to inform future evidence-based decisions on vaccine use to reduce disease burden, the researchers said.

The FEHBlog has no doubt that the rapidly developed mRNA vaccines pulled us out of a jam in winter 2020 while Paxlovid and other anti-virals saved us from the monstrous Omicron surge in winter 2021.

From the CMS front —

  • CMS has activated the Ground Ambulance and Patient Billing Advisory Committee required by the No Surprises Act. The Committee’s report likely will be released in the second quarter of 2023.
  • CMS released a readout from “We Can Do Better: Advancing Maternity Care Together – the first CMS convening on maternal health since the agency launched its Maternity Care Action plan in July 2022 as part of the Biden-Harris Administration’s Blueprint for Addressing the Maternal Health Crisis. Attendees discussed key actions to improve the health of pregnant and postpartum individuals – including the need for a robust and diverse maternity care workforce and the ability for consumers to easily identify health systems engaged in improving maternal care.”
  • CMS also called attention to the “recently released proposed rule that, if finalized, would modify the current National Council for Prescription Drug Programs (NCPDP) retail pharmacy standards for electronic transactions and expand the applicability of the Medicaid pharmacy subrogation transaction to all health plans.”
  • In related news, EHR Intelligence tells us, “In a recent letter, Health Level Seven International (HL7) called on the National Committee on Vital and Health Statistics (NCVHS) to include FHIR as a data standard for electronic clinical attachments. NSG encourages the public to submit comments on the proposed rule by January 9th, 2023.” The original version of HIPAA enacted over 25 years ago called for this attachments standard, which has been a thorn in CMS’s side.

In other HHS news —

  • HHS’s Agency for Healthcare Quality and Research informs us that the U.S. Preventive Services Task Force has proposed to keep in place the grade A recommendation “that clinicians prescribe pre-exposure prophylaxis with effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV infection.” The original PREP recommendation was made in 2018.
  • The American Hospital Association relates “The Substance Abuse and Mental Health Services Administration today proposed updating opioid treatment program standards and admission criteria to expand access to treatment. According to the agency, the rule would expand the definition of OTP practitioner to include any provider appropriately licensed to dispense and/or prescribe approved medications; no longer require one year of opioid addiction for admission; add evidence-based delivery models such as telehealth; expand patient access to take-home methadone doses, and no longer require annual reports from practitioners with a waiver to prescribe buprenorphine to up to 275 patients. The agency will accept comments on the proposed rule through Feb. 14.” That makes sense to the FEHBlog.

From the drug development front —

The Wall Street Journal reports

A customized Moderna Inc. MRNA 19.63%increase; green up pointing triangle vaccine helped ward off the recurrence of melanoma in a mid-stage trial, a milestone in long-running efforts to use the shots as treatments and a big step in the biotech’s ascent.

The combination of Moderna’s personalized cancer vaccine and MerckMRK 1.78%increase; green up pointing triangle & Co.’s Keytruda cancer immunotherapy reduced patients’ risk of relapse or death by about 44%, versus Keytruda alone, in the 150-volunteer study, the companies said Tuesday.

The results, which the companies said were statistically significant but haven’t been reviewed by independent scientists, suggest promise for an emerging but unproven class of vaccines that aim to treat diseases rather than prevent infections like typical shots.

MedCity News reports

Multiple myeloma can be treated by several drugs but relapse in this type of blood cancer is common and when that happens, patients need other treatment options. Johnson & Johnson is looking to fill that need with a drug that addresses a novel target. The pharmaceutical company is seeking regulatory approval for this molecule and the most up to date clinical data supporting the application were presented during the annual meeting of the American Society of Hematology (ASH).

Patients in the Phase 1/2 clinical trial had some of the toughest cases that progressed after treatment with at least three different therapies, according to Ajai Chari, director of clinical research in the multiple myeloma program at Mount Sinai and an investigator in the study. Despite that, treatment with the J&J drug, talquetamab, led to response rates of up to 74%.

From the healthcare business front, Fierce Healthcare tells us

Operating margins for the three largest for-profit hospital chains exceeded pre-pandemic levels in the third quarter, according to a new analysis that comes as hospital lobbies are pushing for financial relief from Congress. 

The analysis, released Monday by the Kaiser Family Foundation, looked at the latest financial performance for large hospital chains HCA Healthcare, Tenet Healthcare and Community Health Systems. * * *

Kaiser’s analysis comes a day after The Wall Street Journal published a report that showed hospitals received billions of dollars in aid, with some going to profitable systems that didn’t need it. Part of the problem was a mismatch in the federal government’s allocation of the $175 billion Provider Relief Fund passed by Congress at the onset of the pandemic in early 2020, the report said. 

From the tidbits department, the FEHBlog learned at the ABA Washington Health Law Summit today

  • The third Texas Medical Association case filed November 30 and pending before District Judge Kernodle concerns the manner in which the qualifying payment amount is calculated – a new issue which nevertheless could have been joined to the second lawsuit. Go figure.
  • In 2018, Congress passed a law called the Eliminating Kickbacks in Recovery Act (“EKRA”), 18 U.S.C. § 220. The Epstein, Becker and Green law firm explains, “EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.”

Monday Roundup

David Ermer–ACA, Congress, COVID-19, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Govexec reports

Congress will vote this week on a seven-day stopgap funding bill to avoid a shutdown Friday evening and buy negotiators more time to reach a deal on full-year appropriations. 

Top lawmakers voiced optimism on Monday for the first time in weeks as they inched toward an agreement on setting line-by-line funding levels across the government. The current continuing resolution is set to expire late Friday, while the new measure would push that back by one week and set the new deadline just two days before Christmas.

“Over the weekend, appropriators held positive and productive conversations, enough that both sides are moving forward in good faith to reach a deal,” Senate Majority Leader Chuck Schumer, D-N.Y., said Monday. He advised his colleagues to prepare to take “quick action” on a one-week CR “so we can give appropriators more time to finish a full funding bill before the holidays.” * * *

“We’re trading serious suggestions back and forth,” said Sen. Richard Shelby, R-Ala., who serves as ranking member on the Senate Appropriations Committee. “The main thing is, fund the government. Don’t shut it down.” 

WisPolitics tells us

On Monday, U.S. Sen. Ron Johnson (R-Wis.) and U.S. Sen. Rick Scott (R-Fla.) sent a letter to Gene Dodaro, Comptroller General of the Government Accountability Office (GAO), requesting an audit of health care providers under the Federal Employees Health Benefits (FEHB) Program. Following reports on similar programs, GAO uncovered potential fraud through improper payments causing an increase in the cost of the FEHB Program.

“GAO’s previous work on similar issues in the Medicare program and the Veterans Community Care program has uncovered a number of potentially ineligible providers, flagged weaknesses in provider vetting controls, and made valuable recommendations for improving program integrity and managing the potential risk to the care of Medicare enrollees and veterans, respectively, from ineligible providers,” explained the senators.

FEHB is an employer-sponsored health benefits program with strong controls. The FEHBlog does not expect the GAO to find similar problems in FEHB.

Govexec reports that the incoming Republican Chair of the House Oversight and Reform Committee says that his Committee will return “to its primary duty to root out waste, fraud, abuse, and mismanagement in the federal government.”

From the regulatory front —

  • The Department of Health and Human Services issued its proposed 2024 Notice of Benefit and Payment Parameters as the Affordable Care Act (ACA) requires. Here’s the Fact Sheet.
  • The Internal Revenue Service finalized the rule that it first issued in December 2021 to modify Form 1095-B and 1095-C following the Tax Cuts and Jobs Act sunsetting the ACA’s individual penalty for failure to maintain essential coverage during the tax year. The final rule makes some helpful tweaks to the 2021 modifications.

Today the FEHBlog attended the first day of the American Bar Association’s Washington Health Law Summit. Of note, there was a talk about the looming end of the Covid public health emergency, which, according to Politico reporters, is likely to occur in the first half of 2023. A “soft landing” is predicted, which is the outcome the FEHBlog also expects.

Others spoke about healthcare worker burnout / the workforce problem. Two speakers noted that a noticeable increase in hospital code calls for security assistance compounds the problem. The FEHBlog had not heard of that factor.

Following up on yesterday’s healthcare business post, Healthcare Dive tells us

Amgen on Monday said it has agreed to acquire Ireland-based drugmaker Horizon Therapeutics, outlasting rival suitors Sanofi and Johnson & Johnson in takeover negotiations that were first disclosed last month.

The deal values Horizon at $27.8 billion on a fully diluted basis. In dollar terms, it’s the largest in Amgen’s four-decade history, eclipsing a 2002 acquisition of Immunex that gave the California biotechnology company rights to Enbrel, its top-selling drug and for years one of the most lucrative pharmaceutical products.

While buying Horizon is not likely to give Amgen its next Enbrel, it does hand the company a portfolio of rare and immune disease drugs that are projected to bring in sales of $3.6 billion this year.

Enbrel will lose market exclusivity at the end of this decade and Amgen, like other pharmas facing looming patent cliffs, has turned to dealmaking to hunt for new products. In August, it spent $4 billion to acquire ChemoCentryx and its inflammatory disease drug Tavneos.

Per terms of the acquisition, Amgen will pay $116.50 per Horizon share, a roughly 20% premium to their closing price Friday and 48% higher than what they were worth before Horizon disclosed it was in deal talks. 

Weekend update

David Ermer–Congress, Federal employment benefits, No Surprises Act, OPM, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

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

The Wall Street Journal adds

Congressional leaders are set to return to the Capitol on Monday under pressure to negotiate a spending bill that would fund the federal government’s operations beyond Friday.

Negotiators have days to reach a deal on a full-year spending bill or pass a short-term measure delaying the deadline to avoid a partial government shutdown. To reach a longer-term deal, they will have to break the partisan deadlock between Republicans and Democrats, who are split over $26 billion in nondefense spending in talks to craft an omnibus bill. * * *

Senate lawmakers are expected this week to pass a defense policy bill that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19. 

Tomorrow is the last day of the Federal Employee Benefits Open Season. According to OPM, the official end is 11:59 pm “in the location of your electronic enrollment system”

The FEHBlog noticed on Linked In that OPM Director Kiran Ahuja spoke last week at the Milken Institute’s Future of Health Summit.

Director Ahuja spoke about eradicating stigmas surrounding mental health treatment and creating a welcoming work environment for all. 

As the largest employer in the nation, the Federal government must continue to invest in policies, tools, and resources that gives every employee the high quality and accessible mental health supports they need

Hey OPM, why don’t you post the Director’s remarks on opm.gov?

From the infectious disease front, the Secretary of the Treasury has written a letter to the state governors on resources available to combat the tripledemic. The FEHBlog has read articles recommending that we must return to masking and social distancing. The FEHBlog, who is a lawyer, not a health professional, thinks that if we accept this mistaken guidance, we will be tied to masking and social distancing in the winter forever. N.B. This is not a criticism of people who choose to mask social distance. The FEHBlog’s point is that the tripledemic was unavoidable.

From the No Surprises Act (NSA) front, the FEHBlog checked out the docket sheet for the second Texas Medical Association versus the federal NSA regulators challenging the revised final rule implementing the NSA’s independent dispute resolution process without giving the revised rule a chance.

The case is at the cross-summary judgment stage. A summary judgment motion asks the Court to decide the case without a trial because the issues presented are entirely legal.

The federal government filed its motion in early November. The FEHBlog knew the AHIP and employee benefit associations subsequently had filed friends of the court/amici briefs supporting the NSA regulators. The FEHBlog was delighted to read that a group of patient/consumer organizations, including “ALS Association, CancerCare, Epilepsy Foundation, Families USA Action, Hemophilia Federation of America, Leukemia & Lymphoma Society, National Multiple Sclerosis Society, United States Public Interest Research Group, Inc., and Cancer Support Community” also filed an amicus brief supporting the NSA regulators. That is an uplifting amici lineup.

From the U.S. healthcare business front, the Wall Street Journal reports

Amgen Inc. is in advanced talks to buy drug company Horizon Therapeutics PLC. according to people familiar with the matter, in a takeover likely to be valued at well over $20 billion and mark the largest healthcare merger of the year.

The U.S. biotechnology company was the last of three suitors standing in an auction for Horizon, the people said, after French drugmaker Sanofi SA said Sunday it was out of the running.

A deal could be finalized by Monday assuming the talks with Amgen don’t fall apart, the people said.

Horizon develops medicines to treat rare autoimmune and severe inflammatory diseases that are currently sold mostly in the U.S. Its biggest drug, Tepezza, is used to treat thyroid eye disease, an affliction characterized by progressive inflammation and damage to tissues around the eyes.

The company is Nasdaq-listed, but based in Ireland and has operations in Dublin, Deerfield, Ill., and a new facility in Rockville, Md.

Wow-wee.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front, Cyberscoop reports on the highlights of the cybersecurity provisions of the bipartisan National Defense Authorization Act that the House of Representatives passed this week and the Senate is expected to pass next week.

The December 7 FEHBlog quote included the following Roll Call quote:

Also of note, the bill would ban contractors across the government from using Chinese-made semiconductors, after a lengthy phase-in period, an aide with knowledge of the provision said Tuesday. Many federal contractors and other businesses say they are unclear how they will comply.

The Cyberscoop article does not treat this provision as a highlight of the bill. The FEHBlog turned to ComputerWorld, which provides more details on this provision —

While the draft legislation still provides for [Chinese made semiconductor] restrictions to be enacted, contractors now have five years to comply with them, rather than the two years stipulated in an earlier version of the proposal, and the language of the new draft leaves room for waivers to the restrictions under certain circumstances.

Cyberscoop adds

There are a few major exclusions in the combined House and Senate versions, too.

[For example,] FedScoop’s John Hewitt Jones reports that the NDAA left out an amendment to codify a software bill of materials, or SBOM, in the federal procurement process. Lawmakers removed it following strong criticism from industry.

That piece of the legislation would have required “all holders of existing covered contracts and those responding to requests for proposals from the U.S. Department of Homeland Security to provide a bill of materials and to certify that items in the bill of materials are free of vulnerabilities or defects,” Hewitt Jones reported.

Health IT Security tells us

Experts gathered in Boston on December 5 and 6 for the HIMSS Healthcare Cybersecurity Forum to explore topics such as risk quantification, clinical perspectives on cybersecurity, and medical device security.

Speakers included leaders from the Health Sector Coordination Council (HSCC), Northwell Health, Forrester, the Federal Bureau of Investigation, the National Institute for Standards and Technology (NIST), and more.

The presentations collectively showed that healthcare cybersecurity experts are well aware of the risks facing the sector. However, more collaboration, communication, and balance are needed to effectively tackle those risks and emerge stronger as an industry.

The Cybersecurity Infrastructure and Security Agency (CISA) offers a readout from the December 6 meeting of its Cybersecurity Advisory Committee:

[CISA] Director [Jen] Easterly led a discussion with committee members on the CSAC’s strategic focus for 2023.   

“I truly appreciate the caliber of experts who have taken the time to participate in this committee and, moreover, for their continuous work in helping CISA become the Cyber Defense Agency our nation needs and deserves,” said CISA Director Jen Easterly. “I look forward to working with the Committee in the new year to ensure we are continuing to build a more cyber resilient nation to confront the challenges we face in cyber space.”   

“In a time of critical cybersecurity threats, CISA is in a unique position to make a meaningful impact on our Nation’s security,” said the CSAC Chair and Chairman, President & CEO of Southern Company, Tom Fanning. “The Committee members and I look forward to providing strategic recommendations to CISA’s Director Jen Easterly in the coming year to advance CISA’s mission, as they continue to strengthen the cybersecurity posture of the United States.” 

From the cyber vulnerabilities front —

HHS’s Health Sector Cybersecurity Coordinating Center (HC3) released the following documents on this topic:

CISA added one more known exploited vulnerability to its catalog.

Cybersecurity Dive looks back at the log4shell cybersecurity crisis that first gained widespread public attention in December 2021.

One year after the disclosure of a critical vulnerability in the Apache Log4j logging utility, the nation’s software supply chain remains under considerable threat as federal authorities and the information security community struggle to transform how it develops, maintains and consumes applications in a more secure fashion. 

The vulnerability, dubbed Log4Shell, allowed unauthenticated and untrained threat actors to gain control over applications using a single line of code. 

Thus far, many of the initial fears of catastrophic cyberattacks have failed to materialize, but federal authorities warn this constitutes a long-term threat that must be carefully monitored and fully remediated to prevent a major security crisis. 

From the ransomware front —

Cybersecurity Dive reports, “Ransomware attacks shift beyond US borders; U.S.-based organizations remain the top target for ransomware gangs, but the scale of that misfortune is waning, according to Moody’s.” Here’s the Moody report on 2023 Global Cyber Risk.

HC3 released an analyst report on Royal ransomware. “Royal is a human-operated ransomware that was first observed in 2022 and has increased in appearance. It has demanded ransoms up to millions of dollars. Since its appearance, HC3 is aware of attacks against the Healthcare and Public Healthcare (HPH) sector. Due to the historical nature of ransomware victimizing the healthcare community, Royal should be considered a threat to the HPH sector.”

The Bleeping Computer’s Week in Ransomware informs us

This week has been filled with research reports and news of significant attacks having a wide impact on many organizations.

Last week, Rackspace suffered a massive outage on their hosted Microsoft Exchange environment, preventing customers from accessing their email. On Tuesday, Rackspace finally confirmed everyone’s fears that a ransomware attack caused the outage.

However, today [December 9] they began warning customers to be on the lookout for targeted phishing emails and to monitor their credit reports and banking account statements for suspicious activity. This warning could indicate that the ransomware operation likely stole data in the attack.

From the cyber defenses front —

CISA provides us with

a Phishing Infographic to help protect both organizations and individuals from successful phishing operations. This infographic provides a visual summary of how threat actors execute successful phishing operations. Details include metrics that compare the likelihood of certain types of “bait” and how commonly each bait type succeeds in tricking the targeted individual. The infographic also provides detailed actions organizations and individuals can take to prevent successful phishing operations—from blocking phishing attempts to teaching individuals how to report successful phishing operations.

ZDNet also discusses how people can identify and deter phishing attacks.

The National Institute of Standards and Technology issued Special Publication (SP) 1800-34, which offers organizations guidance on verifying that the internal components of the computing devices they acquire are genuine and have not been tampered with.