FEHBlog

Friday Stats and More

David Ermer–COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, Telehealth, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 12th week of 2022:

In the current CDC Covid Data Weekly Tracker, the CDC explains

In February, CDC’s COVID Data Tracker released a Wastewater Surveillance tab, which tracks changes and detections of SARS-CoV-2 viral RNA levels at more than 600 testing sites across the country. Because many people with COVID-19 shed the virus in their feces, wastewater testing can help us monitor COVID-19 in communities. Virus levels in wastewater usually increase four to six days before clinical cases increase, so surveillance results can help communities act quickly to prevent the spread of COVID-19.

Currently, virus levels in wastewater are relatively low across the country. More than half of all sites reporting wastewater data are experiencing a decrease in SARS-CoV-2 levels, but some have reported a modest uptick. These upticks may reflect minor increases from very low levels to levels that are still low. It’s important to note that even a small increase when levels are very low can appear like a dramatic increase in the percent change. However, there is a possibility that some communities might start to see an increase in COVID-19 cases. This could happen for a variety of reasons, like waning immunity, new circulating strains, and eased prevention strategies.

Right now, it’s too early to know if we’ll see a corresponding increase in reported cases across the country. Wastewater data are meant to be used with other COVID-19 surveillance data. CDC encourages local public health officials to watch for sustained increasing levels of the virus in wastewater, and to use wastewater surveillance data with other kinds of data to inform their decisions. CDC continues to encourage people to use COVID-19 Community Levels to find out what actions they should take to protect themselves and others. The whole community can be safe only when we all take steps to protect each other.

Using the same approach, here is the FEHBlog’s latest weekly chart of Covid deaths:

Precision Vaccinations adds that

[T]he 2022 trend data from the CDC indicates pneumonia may soon overtake COVID-19 as the leading cause of respiratory death in the U.S.

Historically, the CDC reported the number of visits to emergency departments with pneumonia as the primary diagnosis averaged about 1.5 million, which led to 47,000 deaths annually.

The good news is pneumonia is a vaccine-preventable disease.

Unfortunately, the percentage of adults who had ever received a pneumococcal vaccination was 25.5% in 2020.

Increasing the pneumococcal vaccination rate is a worthy goal for health plans and primary care providers.

Here’s is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered in the Covid vaccination era:

While recent vaccinations numbers are nothing to crow about, over 75% of Americans age 18 and older are fully vaccinated. Nearly half of the same population and over two-thirds of Americans age 65 and older have received a booster.

Politico adds

The Biden administration could authorize a second Covid-19 booster shot for older Americans within weeks, amid rising concern over a potential resurgence of cases, four people with knowledge of the matter told POLITICO.

The move under consideration by senior health officials would recommend the additional vaccine dose for adults 65 and older, in an effort to better protect high-risk people and stave off a wave of hospitalizations should infections climb rapidly as a result of the spread of the Omicron subvariant, BA.2. Currently, second boosters are only recommended for those with compromised immune systems.

From the No Surprises Act front, last Monday, Federal District Judge Richard Leon heard oral argument on dispositive cross-motions submitted by medical associations and the federal government regulators concerning the status of the qualifying payment amount in the baseball arbitration process. The FEHBlog has heard from a couple of sources who attended the hearing that Judge Leon indicated that he does not plan to put deciding the case on his front burner because the federal regulators advised him about their intent to issue the final, final rule on the Independent Dispute Review process in May 2022. The case is pending in the U.S. District Court for the District of Columbia.

From the telehealth front, mHealth Intelligence informs us

More than two-thirds of telehealth providers said they use audio-only modalities to offer telehealth services, according to a recent survey conducted by the American Medical Association.

The survey polled 2,232 physicians between Nov. 1 and Dec. 31, 2021.

The popularity of telehealth among physicians is apparent, with 85 percent saying they still use it. But 52 percent agreed that their telehealth usage has decreased since they first started offering the services. The top reason for the decrease was that they moved to a hybrid model of care with both in-person and virtual care services.

From the healthcare business front —

Fierce Healthcare reports

Optum has quietly acquired Refresh Mental Health from private equity firm Kelso & Company, Axios reported Thursday.

The company confirmed the deal in a statement to the outlet. The acquisition has not been announced publicly as of yet.

“Optum and Refresh Mental Health are excited to expand effective behavioral care to patients through a more coordinated health system,” the company said in a statement to Axios. * * *

Refresh was founded in 2017 and provides outpatient mental and behavioral health services. It runs 300 locations across 37 states that offer a variety of services including psychiatry and substance abuse treatment.

and

Bicycle Health, a virtual provider for opioid use disorder, is partnering with five additional payers, it said in an announcement provided exclusively to Fierce Healthcare.

The partnerships are with Molina Healthcare and McLaren Health Plans in Michigan, UHC Community Plan in Arizona, Health First Colorado (the state’s Medicaid program) and Blue Cross Blue Shield Texas. In total, these payer partnerships have the potential to reach more than 8 million patients, the company said. Coverage will include medication management, behavioral health (individual or group psychotherapy, medical care), support groups and care coordination.

“From high costs to significant time commitments, many traditional OUD recovery programs just aren’t realistic options for the vast majority of patient experiences,” Bicycle Health CEO and founder Ankit Gupta said in a statement. “We are committed to making science-based, holistic OUD treatment accessible to all who need it—and these partnerships are an exciting step towards that goal.”

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

The recent rise in Covid-19 cases in the U.K. has U.S. health experts watching closely, as the Delta and Omicron variant trends in Europe have tended to presage those in the U.S. * * *

While hospitalizations have risen in the U.K. recently, the number of patients requiring ventilators hasn’t increased at the same pace, according to U.K. health data.

Counts of newly admitted Covid-19 patients in U.S. hospitals are at their lowest recorded level after any prior surge. The seven-day average for newly admitted confirmed cases slid to 1,836 on Wednesday, down from a record that reached 22,000 in January, a Wall Street Journal analysis of federal data shows. The number of hospitalized Covid-19 patients is also nearing a post-surge low.

The American Medical Association informs us

With pregnancy typically comes a whole set of urgent concerns about health, yet despite the widely known threat of COVID-19 pregnant women are among the least likely to be vaccinated to protect against the disease’s most severe outcomes.

The low vaccination rate of pregnant women in the U.S. is concerning because of the increased risk of pregnancy complications due to SARS-CoV-2 infection, which include hospitalization and delivering a pre-term or stillborn infant. Two recent studies highlight the importance of COVID-19 vaccination to protect moms and their babies.

Published in JAMA, the research letter “Durability of Anti-Spike Antibodies in Infants After Maternal COVID-19 Vaccination or Natural Infection” shows that vaccination resulted in significantly greater antibody persistence in infants than in natural infection from SARS-CoV-2. At 6 months old, 57% of infants born to mothers whopu were vaccinated had detectable antibodies, compared with only 8% among infants born to moms infected with SARS-CoV-2.

Additionally, a new study from the Centers for Disease, Control and Prevention (CDC) showed that “infants whose mothers received two doses of an mRNA COVID vaccine during pregnancy are less likely to be admitted to the hospital for COVID in the first six months of their life,” Andrea Garcia, MPH, director of science, medicine and public health at the AMA, said during an episode of the “AMA COVID-19 Update” about supporting vaccination during pregnancy. “Overall, the researchers found that maternal vaccination was 61% effective at preventing infant hospitalization.”

From the federal employees benefits front, Fedweek explains how to perform a cost-benefit analysis of [important] survivor annuity choices facing federal and postal employees.

Also, the Office of Personnel Management announced “federal employees may now receive up to four hours of administrative leave to vote in federal, state, local, tribal, and territorial elections. OPM also announced that federal employees may now use up to four hours of administrative leave per year to serve as non-partisan poll workers or observers.”

From the public health front, the Food and Drug Administration “took additional actions [explained here] as part of the agency’s work to ensure any electronic nicotine delivery system (ENDS) products available for sale have demonstrated that marketing of the products is appropriate for the protection of the public health.”

From the healthcare business front —

Building on earlier search updates that helped users check for in-network providers and languages spoken in office, Google is launching new functionality in the coming weeks that will give users a list of available appointments when searching for a specific provider. 

Google is partnering with CVS’ MinuteClinic as well as online scheduling companies to support the new tool. It will initially roll out nationwide in English, but Jackie DeJesse, product manager at Google, said the project is still in the early stages and will continue to be developed over time. 

  • Becker’s Hospital Review reports

From plans to scale its direct-care delivery service to recruiting new leadership to head its healthcare ecosystem, Amazon continues to strengthen its healthcare presence. Here are six most recent healthcare moves from the company as reported by Becker’s.

1. Amazon Web Services is seeking a physician lead to join its healthcare industry team to engage with key leaders from various healthcare organizations to facilitate their adoption of AWS services for medical imaging, telemedicine and analytics.

2. Aaron Martin, former chief digital officer at Renton, Wash.-based Providence, is leaving the health system March 25 to join Amazon as a vice president of health.

3. Amazon Pharmacy created MedsYourWay, a discount savings card, to help Horizon Blue Cross Blue Shield of New Jersey, Blue Cross Blue Shield of Nebraska, Blue Cross Blue Shield of Alabama, Florida Blue, and Blue Cross and Blue Shield of Kansas members save on prescriptions.

4. Amazon Alexa partnered with Teladoc to get patients connected with physicians via Echo devices.

5. Amazon Web Services will support the effort to donate 50 Medtronic GI Genius intelligent endoscopy modules to facilities that primarily serve communities with low screening rates or where access to this technology is not currently available.

6. Amazon Care rolled out virtual health services nationwide and is preparing to launch in-person services for more than 20 new cities in 2022.

Midweek update

David Ermer–COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Omnicron and siblings front, The Wall Street Journal reports

The BA.2 variant of Covid-19 is a relation of the original Omicron variant known as BA.1, according to Theodora Hatziioannou, an associate professor of virology at Rockefeller University.

The two variants arose around the same time and come from the same ancestor strain. They have many mutations in common, but around 20 mutations differ between the two variants. The differences between this variant and BA.1 can be seen in the spike protein of the virus, Dr. Hatziioannou said.

This was the first time that two competing variants emerged in parallel, according to Mark Zeller, a genomic epidemiologist at the Scripps Research Institute in San Diego, Calif.

Viruses mutate all the time and diversification within a variant is normal. The earlier Delta variant comprised more than 200 sublineages before it was replaced by Omicron, according to Francois Balloux, director of the University College London Genetics Institute.

Becker’s Hospital Review adds

The omicron subvariant BA.2 accounts for more than 1/3 of COVID-19 cases nationwide and more than half of cases in the Northeast, according to the latest variant proportion estimates from the CDC. * * *

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said he would not be surprised to see an uptick in infections in the U.S., though a major surge is unlikely. 

“The extent of it and the degree to which it impacts seriousness of disease like hospitalizations and death remains to be seen,” he told The Washington Post March 22. “I don’t really see, unless something changes dramatically, that there would be a major surge.”

The AMA Morning Rounds tells us

MedPage Today (3/22, Monaco) reports, “People with COVID-19 were more likely to be diagnosed with diabetes in the year following their infection, according to a cohort study using national Department of Veterans Affairs databases.” The study published in The Lancet Diabetes & Endocrinology found that “among 181,280 veterans who tested positive for COVID-19, there was a 40% higher risk for incident diabetes during the post-acute phase of the disease compared with a contemporary control group.” Also, over 12 months, there was “a significantly higher excess burden of new diabetes among those with a positive COVID test…the researchers wrote.”

From the Covid vaccine front the Wall Street Journal informs us

For kids ages 5 to 11, Pfizer and its partner BioNTech released data in the fall showing the vaccine was 90.7% effective at preventing symptomatic Covid-19. The companies also said the vaccine was safe during the testing.

For 12-to-18-year-olds, the vaccine was shown to be 93% effective against hospitalization with Covid-19, CDC researchers reported in the fall. 

A study published by the CDC in March showed that two doses of the Pfizer-BioNTech vaccine were protective against Covid-19-related emergency department and urgent care visits among children and adolescents.

“The vaccine is very effective at protecting against serious disease, hospitalization and death,” said Tina Tan, a pediatric-infectious-disease physician at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Moderna said a new study found that its vaccine’s efficacy against symptomatic infections was 43.7% in children ages 6 months to 2 years, and 37.5% in children ages 2 to 5.

STAT News adds

Moderna announced Wednesday that [based on the above-referenced study] it will ask the Food and Drug Administration to authorize its Covid-19 vaccine for emergency use in children aged 6 months to 6 years, a group for which there are currently no authorized Covid vaccines.

From the medical research front, STAT News tells us

One lesson [from Covid research] is to only trust the most rigorous studies, known as randomized controlled clinical trials. But an equally important one: We need to get much better at conducting these rigorous studies more quickly and cheaply — and that goes beyond the Covid pandemic. This is not just a problem of science, but of infrastructure.

Last week, a clinical trial called TOGETHER produced two potentially important conclusions: A little-discussed experimental drug called peginterferon lambda cut in half the number of Covid-19 patients who ended up going to the emergency room or hospital. And the much-discussed antiparasitic drug ivermectin failed to prevent hospitalization for Covid patients at all.

TOGETHER, like the RECOVERY study conducted in the United Kingdom and REMAP-CAP, conducted basically everywhere but the United States, was a platform study, a streamlined clinical trial that evaluated multiple medicines at once and that use a common placebo group. It’s from these platform studies that doctors have learned perhaps the most about Covid-19.

Another STAT News article explains

Pancreatic cancer has proved one of the most deadly forms of the disease, and the most difficult to crack. It shrugs off immunotherapy drugs and resists chemotherapy, and only about 10% of patients live longer than five years after diagnosis.

But Albert Einstein College of Medicine immunologist and microbiologist Claudia Gravekamp is trying a new, unconventional approach: using Listeria bacteria to develop an immunotherapy that makes pancreatic tumors vulnerable to immune attacks. The resultsfrom her experiments in mice, published Wednesday in Science Translational Medicine, found the therapy can extend survival by 40% — a figure that experts said was very promising, though preliminary, and warranted further research in humans. 

“I’m extremely excited. [The result] feels terrific. We’re very close to a clinical trial,” Gravekamp said. She said the patent for the therapy has been licensed to the New York-based biotech company Loki Therapeutics, which plans to test the new therapy in humans. 

From the healthcare business front

Forbes informs us

Fertility Tech: Alife Health, a startup using artificial intelligence to improve the in-vitro fertilization process, has raised a $22 million Series A round led by Lux Capital, Union Square Ventures and Maveron. The funding will help bring its first two products to market: an AI tool for clinicians to help retrieve mature eggs from the ovary and a patient-facing app. It is also working on an AI tool to help select embryos, which is in the investigational stage. 

Heart Health: Recora Health emerged from stealth this week with $20 million in funding led by SignalFire for its cardiac care management program, which aims to engage patients at home with virtual tools and access to care teams. The company is currently serving 30,000 patients through partnerships with Geisinger and regional insurance plans. 

Healthcare Dive reports

[Health insurer] Centene has appointed Sarah London as its new CEO, effective immediately. She succeeds longtime leader Michael Neidorff, according to a filing with the Securities and Exchange Commission on Tuesday.

London, 41, joined Centene in 2020 from Optum and has a focus on data and technology. She has quickly ascended the ranks at Centene and recently was named vice chairperson. 

Neidorff remains on a medical leave of absence from his role as chairman of the company board.

Tuesday’s Tidbits

David Ermer–Federal employment benefits, OPM, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the government employment front,

Performance.gov informs us that OPM Director Kiran Ahuja is one of three Leads on implementing Priority One of the President’s Management Agenda — “Strengthen and Empower the Federal Workforce.” Good luck, Director Ahuja.

FedSmith identifies “ten steps federal employees should take at least a decade before retiring to ensure they are prepared to head into their golden years.”

Step 2 of 10 is “Enroll or Stay in FEHB.”

If you plan to continue your federal health benefits in retirement, you must be entitled to retire on an immediate annuity and:

be enrolled for the 5 years immediately before retiring or, during all your federal employment since your first opportunity to enroll if less than 5 years.

Coverage under FEHB, Tricare, or the Civilian Health and Medical Program of Uniformed Services (CHAMPUS) all count toward the 5 year requirement.

In yesterday’s post, the FEHBlog pointed out a Fierce Healthcare interview with the CEO of dialysis heavyweight, Davita. Today, Fierce Healthcare reports

Three big players in kidney care—Fresenius Health Partners, Cricket Health, and InterWell Health—plan to form a new value-based care company focused on services for the earlier stages of kidney disease.

The deal, announced Monday morning, will create a company valued at $2.4 billion, according to the companies.

The merger brings together expertise in value-based kidney care contracting of Fresenius Health Partners, a division of Fresenius Medical Care North America, InterWell Health’s network of more than 1,600 nephrologists and startup Cricket Health’s technology-enabled care model and patient engagement platform. Fresenius Medical Care is the world’s largest operator of dialysis centers.

Healthcare Dive delves into the case for hybrid care models, meaning the marriage of hospital systems and telehealth vendors.

Though the pandemic greatly accelerated the use of telehealth, use of pure-play virtual care has waned as COVID-19 cases drop off across the U.S. But telehealth is increasingly being woven into hospitals’ digital roadmaps, and some are even upping their investments in the modality despite moderating visits, experts said at the annual HIMSS healthcare conference.

That’s giving hope to proponents of hybrid care models, who point to the value of meeting patients where they are to lower costs and improve outcomes.

Intriguing.

Health Payer Intelligence reports

The National Committee for Quality Assurance (NCQA) has awarded [health insurer] Centene the Innovation Award for Health Equity for the company’s Health Equity Improvement model.

“Advancing health equity has a real and positive impact on the health of our members across the country,” said Sarah Bezeredi, senior vice president and chief quality officer for Centene. * * *

At its core, the model uses qualitative and quantitative data to target certain health equity gaps. Centene engaged communities and activated community coalitions in order to empower its strategy. The company’s approach included carefully selecting leaders who would help create and promote the model as well as soliciting community feedback.

In Arizona, Centene sent HbA1c at-home testing kits, which became a common method of chronic disease prevention during the pandemic. The kits were outfitted with a range of delivery modalities to cover the spectrum of members’ needs. Members also received telehealth and telemonitoring tools. The payer incentivized compliance with certain diabetes care measures.

The model tackled patient education in addition to delivering access to care interventions. Centene mailed qualifying members resources about the HbA1c test and comprehensive diabetes care measures.

The payer tracked progress using its Health Equity Dashboard, which leverages HEDIS data and other social determinants of health and demographic data to assess care disparities.

“By using a data-driven process, we are identifying disparity reduction opportunities and tracking performance and success year-over-year,” Bezeredi added. 

Mazaal Tov, Centene.

Monday Roundup

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

Readers — The FEHBlog wrote the Weekend Update post yesterday, but the publish button didn’t do the job. As a result, the Weekend update post was not emailed out yesterday but you can read it on our firm’s website.

From Capitol Hill, Roll Call updates us on Administration efforts to obtain additional Covid funding.

House Majority Leader Steny H. Hoyer, D-Md, said last week that lawmakers were looking at other previously appropriated pandemic funding that could be reallocated to pay for the $15.6 billion package lawmakers had agreed on.

The White House is urging Congress to pass the supplemental package [totallling $22.5 billion] without offsets, as it did with bipartisan support early in the pandemic.

But Republicans are unlikely to back any COVID aid package without sufficient offsets.

From the Omicron and siblings front —

  • The Wall Street Journal seeks to inform its readers about available Covid treatments.
  • Medscape explains why doctors are finding hurdles to use Covid pills to treat the disease. “Doctors hailed the pills as a huge advance in the fight against COVID-19 partly because of their convenience compared to other treatments that require infusions or injections. But patients can miss the pills’ short window if they dismiss symptoms like a headache or sniffles and wait [more than five days after symptoms present] to see if they go away before seeking help.” This appear to be where the test to treatment program can help, but where is promised website?

In other healthcare news —

  • Healthcare Dive considers what is holding up the widespread adoption of hospital at home programs.
  • Fierce Healthcare offers an interview with Javier Rodriguez, the CEO of the leading dialysis company DaVita.
  • Health Payer Intelligence discusses AHIP’s views on the advantages of applying value based care approaches to maternity services.

From the upcoming events front

  • AHIP informs us

The Office of Intergovernmental and External Affairs will host a virtual event on Tuesday, March 22nd – 3:30pm-4:30pm to hear from Josh Peck, Deputy Assistant Secretary for Public Engagement, about communications resources to encourage those who are eligible to get their COVID- 19 booster.

Deputy Assistant Secretary Peck will share background and information on how to access resources to support your efforts. Following the presentation there will be time for Q & A.

PEC Brief: Payers

Tuesday, March 22nd | 3:30 – 4:30 PM EDT

Zoom Meeting Link | Passcode: 591497 Meeting ID: 160 756 9170

Dial by your location

+1 669 254 5252 US (San Jose) +1 646 828 7666 US (New York) +1 551 285 1373 US

  • The Centers for Disease Control tells us

Tuesday, March 22nd is Diabetes Alert Day—an annual wake-up call to inform the public about the seriousness of diabetes. Did you know:

  • More than 37 million people in the United States have diabetes, and 1 in 5 of them don’t know they have it.
  • 96 million US adults have prediabetes, but more than 8 in 10 of them don’t know they do.
  • In the last 20 years, the number of adults diagnosed with diabetes has more than doubled as the American population has aged and obesity has increased.

If you have diabetes, you’re not alone! Join us on social media this Diabetes Alert Day to share your tips on living well with diabetes and learn what others are doing too.

WHO: We’ll be talking to our followers (that means YOU too) to hear their tips and strategies on managing diabetes, diabetes-friendly food hacks, and more!

WHEN: Tuesday, March 22nd from 9:30 AM to 5 PM ET.

WHERE: You can find us on Twitter or Facebook when you use or search for #TipsForDiabetes.

WHY: To spread awareness and connect with others who are living with diabetes.

Weekend Update

David Ermer–Congress, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

Today has been the first day of Spring. But, it is the first day of Fall for my youngest son, who is studying medicine at Queensland University in Brisbane, Australia.

The House of Representatives is on a district work break this week. Meanwhile, the Senate will be engaged in committee business and floor voting on Capitol Hill.

Fedweek discusses the highlights of the call letter for 2023 benefit and rate proposal letters that OPM released last week.

OPM has told FEHB carriers to continue with increased levels of telehealth and other services related to the pandemic in the 2023 plan year, while also either ordering or encouraging them to expand benefits for certain other conditions.

While Fedweek gets the facts right, its article overlooks that OPM’s orders diminish FEHB competition which Congress relies upon to control premiums.

From the cost management front, Fierce Healthcare tells us

While prior authorization is a key tool in an insurer’s arsenal as it thinks about managing costs, the process remains a key source of friction with physicians.

Amid a nationwide conversation around addressing physician burnout and stress, plans are seeking ways to grow automated and virtual prior auth technologies to ease those barriers. At eviCore Healthcare, the benefit management arm of Cigna’s Evernorth subsidiary, the team has found one of the keys to success in this endeavor is bringing physicians into the conversation early on.

Eric Gratias, M.D., eviCore’s chief medical officer, told Fierce Healthcare that prior authorization programs are often built by people who, while well-intentioned, lack first-hand knowledge of what a clinical encounter is like.

The company’s own prior authorization technology, intelliPath, is built on collaboration with physicians who are actively practicing, he said.

“That partnership with our provider clients is absolutely critical for our success,” Gratias said.

Good point.

From the Rx coverage front

  • NPR Shots points out significant problems with the distribution of Covid treatments.

[D]ata on COVID treatment utilization, shared with NPR by the U.S. Department of Health and Human Services, indicates that millions of COVID treatments are sitting on shelves unused. 

“We are still in a public health emergency,” said Dr. Derek Eisnor, who leads the government’s distribution of COVID drugs, on a call with national health organizations on March 16. He urged health leaders to try to get the drugs to communities that have a demand for them, rather than let them go to waste. 

“There’s an assumption that there’s not enough of [these drugs] around but it does seem when you look at the numbers that there is a lot around — it’s just not being used,” says Dr. Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security. “They clearly are not getting to people at high enough rates to have their maximum impact.” * * *

It can be hard to know which pharmacies have the pills in stock or which infusion clinics have appointments available. A patient needs to be able to quickly find a clinician, get a diagnosis and prescription, and be able to access the treatment, all within a few days. 

“It’s multifactorial why these drugs are underutilized,” Adalja says. “It’s likely all of those things are playing some role in the discrepancies between what’s been ordered and and what’s actually been administered.”

The Biden administration launched the Test to Treat initiative this month to address these gaps. “We know the challenges that are involved with patients obtaining therapeutics,” said Dr. Meg Sullivan, acting chief medical officer for HHS’ Office of the Assistant Secretary for Preparedness and Response, in a call with clinicians on March 12. The program aims to improve access to rapid testing and to bolster public and provider awareness of available COVID treatments and how to get them.

Here is a link to the HHS website that offers a U.S map that “displays public locations that have received shipments of U.S. Government-procured COVID-19 therapeutics under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) authority. The long-acting antibody combination, Evusheld; monoclonal antibody treatments, bebtelovimab and sotrovimab; as well as the oral antiviral therapies, Paxlovid and molnupiravir are products authorized by the FDA for either prevention (Evusheld) or treatment (Paxlovid, sotrovimab, bebtelovimab, and molnupiravir) of COVID-19.   The locations displayed in the locator have reported available courses within the last seven days.”

The test to treat program’s website is not online yet as far as the FEHBlog can tell.

On March 30, the Food and Drug Administration is bringing together outside experts in neurology to review an experimental drug from Amylyx for the treatment of amyotrophic lateral sclerosis, or ALS. The hearing is expected to be closely watched by ALS patients and their advocates, given the significant need for new treatments for the disease.

But the hearing is likely to garner extra attention because it’s the first meeting of the FDA advisory group since it met in November 2020 and voted unanimously against the approval of Aduhelm, Biogen’s drug for Alzheimer’s disease. The FDA later ignored that recommendation and approved the medication, leading to the resignation of three members of the panel and an uproar over whether the agency had compromised its standards.

Sixteen months removed from all the Aduhelm drama, the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee, restocked with new members, is back to tackle another high-stakes review of a drug targeting a progressive, fatal nervous system disease. The Amylyx treatment — called AMX0035 — isn’t likely to generate the same acrimony as Aduhelm, but it could similarly force the FDA to bend its standards.

Here’s what you need to know about AMX0035, the data from its single clinical trial, and the issues that are likely to take center stage at the FDA advisory panel meeting.

Cybersecurity Saturday

David Ermer–Cybersecurity–

Following up on the President’s signature of the Consolidated Appropriations Act on March 15, Cybersecurity Dive discusses the new critical infrastructure cyberattack reporting requirements. Those requirements will take effect after the Cybersecurity and Infrastructure Security Agency issues implementing regulations. Those regulations, in turn, will let us know whether and to what extent healthcare entities are part of the critical infrastructure subject to the new reporting requirements.

From the vulnerability front, the HHS Cybersecurity Program released its February 2022 vulnerability bulletin on March 18.

Tech Republic reviews the latest vulnerabilities that CISA has added to its catalog.

More specifically, Bleeping Computer informs us

The Federal Bureau of Investigation (FBI) warns of AvosLocker ransomware being used in attacks targeting multiple US critical infrastructure sectors.

This was disclosed in a joint cybersecurity advisory published this week in coordination with the US Treasury Department and the Financial Crimes Enforcement Network (FinCEN).

“AvosLocker is a Ransomware as a Service (RaaS) affiliate-based group that has targeted victims across multiple critical infrastructure sectors in the United States including, but not limited to, the Financial Services, Critical Manufacturing, and Government Facilities sectors,” the FBI said [PDF].

Cybersecurity Dive adds

The FBI and Cybersecurity and Infrastructure Security Agency on Tuesday warned U.S. organizations about Russian state-sponsored threat actors exploiting the PrintNightmare vulnerability, as well as misconfigured account settings used in multifactor authentication (MFA) to launch attacks. 

The threat actors were able to launch an attack against a non-government organization (NGO) dating back to May 2021 using a misconfigured MFA setting set to default. They used the flaw to enroll a new device and gained network access, according to the bulletin. The attackers later exploited the PrintNightmare vulnerability to steal documents after gaining access to the cloud and email accounts. 

Separately, ESET researchers are warning about a third data wiping malware called CaddyWiper, which destroys user data and partition information. The wiper was found Monday on several dozen systems in a limited set of organizations in Ukraine, but does not share code similarities with either HermeticWiper or IsaacWiper.

From the ransomware front

  • Here’s a link to the latest The Week in Ransomware” from the Bleeping Computer.

In early September, researchers with Google’s Threat Analysis Group started tracking a financially motivated hacking group exploiting a since-patched Microsoft vulnerability to gain access to targeted computers. 

Later it became clear that the group is what’s known as an initial access broker — a crew specializing in gaining entry to high-value networks and selling that access to other cybercriminals — and that it is closely affiliated with the notorious Conti ransomware organization.

In findings published Thursday, the Google researchers detail how the group they’re calling “Exotic Lily” employed relatively novel tactics to gain access to targets, and how, at its peak, the hackers sent an estimated 5,000 emails per day to as many as 650 targeted organizations globally.

From the cyberdefense front

  • The HIPAA Journal assesses the March 2022 cybersecurity newsletter from HHS’s Office for Civil Rights, the agency that enforces the HIPAA Privacy and Security Rules.

As the government looks to tighten procurement regulations for critical software, the National Institute of Standards and Technology issued a special publication detailing appropriate ways to assess an organization’s adherence to the agency’s go-to list of enhanced security requirements for protecting controlled but unclassified information.  

“Assessors obtain evidence during the assessment process to allow designated officials to make objective determinations about compliance to the CUI enhanced security requirements,” reads NIST guidance—SP 800-172A—published Tuesday. “The evidence needed to make such determinations can be obtained from various sources, including self-assessments, independent third-party assessments, government-sponsored assessments, or other types of assessments, depending on the needs of the organization establishing the requirements and the organization conducting the assessments.”

  • The Wall Street Journal offers an article by Stuart Madnick, who is the John Norris Maguire Professor of Information Technologies, Emeritus, at the MIT Sloan School of Management and the founding director of the Cybersecurity at MIT Sloan (CAMS) research consortium. Mr. Madnick explains why “[u]nless organizations fix the internal decision-making that allowed a cyberattack to occur, they could be vulnerable to further breaches, researchers say.”

Following up on last week’s post on Google’s acquistion of Mandiant, Cybersecurity Dive puts that transaction in perspective.

“Let’s face it, Google’s in a sort of a death race with AWS and Azure in terms of cloud supremacy, right,” said Garrett Bekker, a principal research analyst with S&P Global’s 451 Research. “To some extent, security is a tool that helps them get there more than an end in and of itself.”

Google’s gobbling up of Mandiant is the latest in a sector feeding frenzy. There were more than 200 M&A deals last year, with aggregate disclosed deal valuations exceeding $55 billion. In the past five years, there were more than 1,000 cybersecurity M&A deals, data from CB Insights show. 

This week recorded a $616.5 million acquisition, with SentinelOne’s plans to add Attivo Networks’ identity security to its XDR suite. 

Friday Stats and More

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly charts of new Covid cases and deaths (a lagging indicator):

The CDC observes in its weekly review of its Covid statistics

COVID-19 cases, hospitalizations, and deaths all continue to decrease in the United States. According to CDC’s COVID Data Tracker, as of March 16, 2022, 76.7% of the total U.S. population has received at least one dose of a COVID-19 vaccine, and 65.3% has completed their primary series. However, only about half of the booster-eligible population has received a booster dose and is considered up to date on their COVID-19 vaccines.

Two new studies show the effectiveness of COVID-19 vaccines and boosters across periods of three variants of concern (Alpha, Delta, and Omicron). CDC released a study today showing that, among adults hospitalized with COVID-19 during the Delta and Omicron waves, those who received two or three doses of the Pfizer-BioNTech or Moderna vaccine had 90–95% less risk of dying or needing a ventilator compared with adults who were not vaccinated. Protection was highest in adults who received a third COVID-19 vaccine dose. A study published in the British Medical Journalexternal icon found that vaccines gave a high level of protection against hospitalization for all variants, but not as much for Omicron among adults who received only a primary series. However, boosters increased protection against Omicron. The study also showed that hospital patients who were vaccinated had much lower disease severity than patients who were not vaccinated.

These studies emphasize the importance of staying up to date with vaccinations—they are our best protection against severe COVID-19 illness. Vaccination is also the safest way to reduce the chance that new variants will emerge. Find a vaccine provider and get your booster dose as soon as you can.

In that regard, here is the FEHBlog weekly chart of Covid vaccinations distributed and administered from the beginning of the vaccination era in late 2020:

Here’s a link to the Food and Drug Administration’s March 18 round of its Covid related activities.

While the bulk of Covid care spending goes to hospitals, Becker’s Hospital Review reports that a “sizable minority” have a significant amount out-of-pocket spending for this care, according to a study published in the American Journal of Managed Care March 16.”

It’s worth adding that the Wall Street Journal reports that

The biggest credit-reporting firms will strip tens of billions of dollars in medical debt from consumers’ credit reports, erasing a black mark that makes it harder for millions of Americans to borrow.

Equifax Inc.,  Experian  PLC and TransUnion are making broad changes to how they report medical debt beginning this summer. The changes, which have been in the works for several months, will remove nearly 70% of medical debt in collections accounts from credit reports.

Beginning in July, the companies will remove medical debt that was paid after it was sent to collections. These debts can stick around on a consumer’s credit report for up to seven years, even if they are paid off. New unpaid medical debts won’t get added to credit reports for a full year after being sent to collections.

The firms are also planning to remove unpaid medical debts of less than $500 in the first half of next year. That threshold could rise, according to people familiar with the matter.

From the compliance front —

  • The Internal Revenue Services issued a notice on how to calculate the No Surprises Act’s Qualified Payment Amount when the health plan does not have enough data to calculate a January 2019 median.
  • The Department of Labor is offering a webinar on March 30 at 11 am that “will help employers, service providers, and benefit professionals understand how the provisions of [the federal mental health partity act] apply to employer-sponsored group health plans and provide information on how to avoid common problems. The webinar runs about 45 minutes to an hour and is limited to 200 participants.

From this week’s healthcare conferences front

  • Fierce Healthcare discusses the electronic medical records interoperability theme of the HIMSS conference.
  • Fierce Healthcare also offers a wrap report on “the most interesting innovations at SXSW 2022: From holograms to the future of psychedelics.”

From the telehealth front

  • Becker’s Payer Issues reports that most consumer driven plans have taken advantage of the IRS offered flexibility to cover telehealth before the “high” annnual deductible.
  • Forbes informs us “Telehealth Accounts For One In Three Mental Health Visits Two Years Into Pandemic.” Whoopee.

From the good works department, the American Medical Association tells us about a North Carolina physician who is talking the diabetes problem.

Dr. [Brian] Klausner is the medical director of WakeMed’s Community Population Health program in Raleigh. He also is a physician champion for DiabetesFreeNC. That is the statewide initiative where AMA partnered with the North Carolina Medical Society and others to support collaborative efforts to end type 2 diabetes in the Tar Heel State.  

Rather than think of the pandemic as having “derailed” diabetes prevention or other population health efforts, Dr. Klausner said that “COVID-19 expedited new perspective in how we can do a better job addressing historic roadblocks to community health initiatives, including those related to diabetes and prevention.”

Thursday Miscellany

David Ermer–COVID-19, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Omicron and siblings front, STAT News reports why “It’s not clear what will happen [with Covid] in the near future in the United States.”

Politico tells us

President Joe Biden announced Thursday that Ashish Jha will be the next White House Covid-19 response coordinator, installing a well-known public health commentator on the administration’s pandemic team.

Jha, the dean of Brown University’s School of Public Health, has been a regular guest across cable and network news throughout the Covid-19 pandemic. He will replace Jeffrey Zients, who has headed the Biden administration’s coronavirus response since January 2021 and will return to private life in April.

The Boston Globe reports “Moderna said late Thursday that it asked the Food and Drug Administration for emergency authorization of a second booster of its coronavirus vaccine for all adults, a significantly broader request than Pfizer and BioNTech filed for their shot this week.”

The White House also announced “launching the Clean Air in Buildings Challenge, a key component of the President’s Plan, that calls on all building owners and operators, schools, colleges and universities, and organizations of all kinds to adopt key strategies to improve indoor air quality in their buildings and reduce the spread of COVID-19. “

From the substance use disorder front, the American Medical Association informs us

CNN (3/16, McPhillips) reports, “Annual drug overdose deaths have reached another record high in the United States as deaths from fentanyl and other synthetic opioids surge to unprecedented levels,” investigators concluded. In fact, “an estimated 105,752 people died of drug overdoses in the 12-month period ending October 2021, according to provisional data published” March 16 by the CDC’s National Center for Health Statistics.

From the public health front, the National Institutes of Health announced

Nearly 100,000 highly diverse whole genome sequences are now available through the National Institutes of Health’s All of Us Research Program. About 50% of the data is from individuals who identify with racial or ethnic groups that have historically been underrepresented in research. This data will enable researchers to address yet unanswerable questions about health and disease, leading to new breakthroughs and advancing discoveries to reduce persistent health disparities.

“Until now, over 90% of participants from large genomics studies have been of European descent. The lack of diversity in research has hindered scientific discovery,” said Josh Denny, M.D., chief executive officer of the All of Us Research Program. “All of Us participants are leading the way toward more equitable representation in medical research through their involvement. And this is just the beginning. Over time, as we expand our data and add new tools, this dataset will become an indispensable resource for health research.”

The genomic data is available via a cloud-based platform, the All of Us Researcher Workbench, and also includes genotyping arrays from 165,000 participants. Whole genome sequencing provides information about almost all of an individual’s genetic makeup, while genotyping arrays, the more commonly used genetic testing approach, capture a specific subset of the genome.

The FEHBlog does participate in All of Us surveys but took a pass on genome sequencing study.

From the healthcare business front, Beckers Payer Issues lets us know

UnitedHealth Group is mounting its defense against the Justice Department’s challenge to its proposed $13 billion acquisition of Change Healthcare, arguing the government’s case is “flawed.”  * * *

“The government’s case rests entirely on speculation and theories unsupported by any past conduct, i.e., that Optum will somehow exploit Change Healthcare’s products and services to secure an unfair advantage for UnitedHealthcare’s health insurance business,” UnitedHealth said in its statement. 

“Optum’s business model and financial success is dependent on providing products and services to external customers, not just UnitedHealthcare,” the company added. “Put simply, any misuse of customer [competitively sensitive information] would be economic suicide for Optum because its sophisticated external customer base would simply cease using Optum’s services and turn to any number of Optum competitors.”

The Justice Department also argued the acquisition would give UnitedHealthcare a monopoly in claims-editing technology, but UnitedHealth said it has agreed to divest the business and plans to ink a purchase agreement in “a matter of weeks.”

Midweek update

David Ermer–COVID vaccine mandate, COVID-19, Electronic health records, HIPAA Privacy and Security Rules, Mental health care, No Surprises Act, U.S. Healthcare–

From the FEHB front, the Office of Personnel Management released the 2023 call letter for benefit and rate proposals and the related technical guidance letter.

OPM is to be congratulated for releasing the two letters simultaneously. Historically, OPM has released the call letter weeks or months before the technical guidance letter. As a result, carriers cannot start preparing their benefit and rate proposals, due May 31, until they receive both letters.

From the Omicron (and sibling) front, the American Medical Association informs us

The New York Times (3/15, Mandavilli) reports about “17 million Americans received the Johnson & Johnson Covid vaccine, only to be told later that it was the least protective of the options available in the United States.” However, “new data suggest that the vaccine is now preventing infections, hospitalizations and deaths at least as well as the Pfizer-BioNTech and Moderna vaccines.” The reasons are unclear, “and not all experts are convinced that the vaccine has vindicated itself.” Still, “the accumulating data nonetheless offer considerable reassurance to recipients of the vaccine and, if confirmed, have broad implications for its deployment in parts of the world.”

From the mental health care front, the American Hospital Association tells us

The Substance Abuse and Mental Health Services Administration yesterday released a toolkit to help health care providers and others prepare for the July 16 launch of 988, the new phone number for anyone experiencing suicidal thoughts or a mental health or substance use crisis to speak, text or chat with a trained crisis counselor. Authorized by the National Suicide Hotline Designation Act of 2020, the three-digit number will operate through the National Suicide Prevention Lifeline’s network of over 200 crisis centers.

“In the longer term, our vision is to build a robust crisis care response system across the country that links callers to community-based providers who can deliver a full range of crisis care services, if needed (like mobile crisis teams or stabilization centers),” SAMHSA notes.

To access the toolkit and other suicide prevention resources, visit SAMHSA’s new 988 website. 

From the U.S. healthcare front, Healthcare Dive reports

The long-term shift from hospital-based care toward more treatment delivered in the home and ambulatory centers picked up pace during the COVID-19 pandemic and is expected to continue to gain momentum, pressuring revenue growth and margins in the hospital sector, according to new research from Moody’s Investors Service.

Reimbursement changes, risk-sharing, investment in outpatient services including ambulatory surgery centers, advances in drugs and medical devices and greater use of at-home acute care services are among the forces driving the movement away from more expensive hospital inpatient care.

Medicare telehealth visits increased 63-fold during 2020, Moody’s said, citing HHS data. Although hospitals are reporting that telehealth use is receding as more patients return to in-person physician visits, it will likely remain above pre-COVID levels, the ratings agency said.

Kaiser Health News looks at the No Surprises Act from the patient’s perspective. It’s an important article because health plans should help their members keep the new law’s billing protections in perspective.

From the provider of the future front, mHealth Intelligence reports

Though a majority (63 percent) of clinicians worldwide expect most of their consultations to be remote within the next decade, 51 percent believe that telehealth will negatively impact their ability to demonstrate empathy with their patients, a new report revealed.

Developed by Elsevier Health and Ipsos, the Clinician of the Future report includes a quantitative survey, qualitative interviews, and roundtable discussions with nearly 3,000 practicing physicians and nurses worldwide. Of the total number of respondents, 434 were from the US. * * *

Empathy from physicians is becoming increasingly important for patients. A vast majority of clinicians (82 percent) surveyed said that soft skills like listening and displaying empathy have become more critical in the last decade. In the US, 76 percent of clinicians agreed with this statement.

Though the importance of soft skills has grown, the report notes that technical skills will be key in the future.

From the HIMSS Conference in Orlando, Florida, Healthcare Dive holds an interview concerning the FEHBlog leading interoperability innovation of 2022, TEFCA:

Healthcare Dive caught up with Mariann Yeager to talk TEFCA at the HIMSS annual healthcare conference in Orlando on Monday. Yeager is CEO of the Sequoia Project, a nonprofit that was selected in 2019 to serve as the recognized coordinating entity (RCE) charged with developing, updating and maintaining the common agreement and overseeing QHINs.

Yeager shared more details on the timeline of TEFCA implementation, why organizations should join the voluntary framework and how the Sequoia Project and the Office of the National Coordinator for Health IT are at the beginning of a long process of monitoring and modernizing a living document that, given uptake, could shape the future of health data exchange for decades into the future.

“We’re really proud of the work that we’ve done,” Yeager said.

Check out the full interview.