Thursday Miscellany

Mental health care

Thursday Miscellany

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

Today, November 17, is National Rural Health Day.

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

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

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

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

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

“From the public health front —

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

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

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

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

From the Rx coverage front,

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

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

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

Monday Roundup

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

From the Capitol Hill front —

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

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

From the conferences’ front —

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

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

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

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

The Wall Street Journal informs us

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

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

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

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

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

In other news —

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

Happy Veterans’ Day

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

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

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

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

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

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

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

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

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

Medscape tells us

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

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

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

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

Beckers Payer Issues adds

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

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

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

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

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

Three influenza-associated pediatric deaths were reported this week.

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

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

The RSV epidemic has not subsided according to MedPage Today

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

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

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

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

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

From the mental healthcare front, the American Hospital Association reports

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

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

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

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

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

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

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

From the artificial intelligence front, Health IT Analytics relates

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

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

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

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

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

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

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

Useful insights.

Thursday Miscellany

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

The HCP-LAN, which promotes alternate / value-based payment methods, held a summit this week. RevCycle Intelligence reports

Photo by Josh Mills on Unsplash

Value-based payment levels barely moved in 2021, with some movement in the downside financial risk category, according to the latest data from the Health Care Payment Learning and Action Network (HCP LAN).

The majority of healthcare payments—59.5 percent—from 63 commercial plans, five state Medicaid programs, and Medicare were tied to value and quality in some capacity, the annual APM Measurement Effort report showed this year. The remaining 40.5 percent of payments stemmed from fee-for-service models.

The proportion of healthcare payments in fee-for-service models is actually up slightly from the 2020 results when 39.3 percent of payments were tied to the models. However, this does not indicate a backslide for the healthcare industry, according to value-based care expert Andréa E. Caballero, MPA.

America’s Health Insurance Plans (AHIP) and the Alliance of Community Health Plans also offer their perspectives on the LAN Summit.

Healthcare Dive looks forward to the HLTH conference that will be held in Las Vegas next week. “Representatives from major healthcare players will discuss private equity, value-based care, digital health funding and more at the fifth annual conference.”

From the Federal Employees Benefits Open Season front, FedWeek discusses the interaction of FEHB and Medicare.

From the public health front

The American Hospital Association reports

Infants under 6 months old had the highest COVID-19 hospitalization rates among Americans under age 65 during March 20-Aug. 31, when the omicron BA.2 and BA.5 variants predominated, the Centers for Disease Control and Prevention reported today. Based on data from the COVID-19-Associated Hospitalization Surveillance Network, the study found infants under 6 months old had hospitalization rates similar to adults aged 65-74. 

“COVID-19 vaccination during pregnancy might provide protection to infants younger than 6 months old who are currently ineligible for vaccination,” CDC said. “To protect themselves and their infants, people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future should stay up to date on COVID-19 vaccinations, as recommended by CDC and the American College of Obstetricians and Gynecologists.”

The Wall Street Journal adds

High rates of hospitalization with RSV are hitting the youngest children especially hard, part of an unseasonably early surge in respiratory infections. 

Some 3.0 people for every 100,000 were hospitalized with respiratory syncytial virus the week ended Nov. 5, according to federal data from 12 states. The rate is the highest since the winter just before the pandemic, when some 2.7 people per 100,000 were hospitalized in January 2020. The hospitalization rate declined from 3.4 hospitalizations per 100,000 in the week ended Oct. 29.

Babies under six months old have the highest RSV-related hospitalization rate, data from the Centers for Disease Control and Prevention show, at 145 hospitalizations per 100,000 infants. Infants six to 12 months old were hospitalized at a rate of 63 for every 100,000 children that age. For adults, the hospitalization rate is 0.6 per 100,000 people.

RSV is a common virus that most children encounter by their second birthday. Reinfections can occur at any age. Most people experience mild, cold-like symptoms and recover in a week or two. But RSV can be serious for some infants and older adults, causing bronchitis and pneumonia.

The Journal also informs us

AstraZeneca PLC said it had dropped plans to submit its Covid-19 vaccine to the Food and Drug Administration for approval, ending a long-running ambition to eventually sell the shot in the U.S. despite initial setbacks.

The Cambridge, England-based pharmaceutical company said Thursday that there would likely be a lack of demand in the U.S., where it said primary vaccination needs had been met. It would continue to focus its efforts on ensuring the availability of the vaccine, called Vaxzevria, elsewhere, including seeking its approval as a booster shot, the company said.

HealthDay tells us

The risk for death from infective endocarditis (IE) increased twofold among young U.S. residents aged 15 to 44 years during 1999 to 2020, according to a research letter published online Nov. 9 in the Journal of Internal Medicine.

Laura McLaughlin, M.D., from the Columbia University Irving Medical Center in New York City, and colleagues characterized trends in mortality rates from IE among young U.S. residents (aged 15 to 44 years) and in relation to drug abuse using the Multiple Cause of Death Data from the U.S. Centers for Disease Control and Prevention between 1999 and 2000. Age-adjusted mortality rates standardized to 2000 U.S. census per 100,000 persons were reported. * * *

“The number of young people in the United States who die of infective endocarditis is increasing, and the ongoing opioid epidemic, specifically injectable drug abuse, appears to be a significant cause,” a coauthor said in a statement.

The Centers for Disease Control released its current / 2021 National and State Healthcare-Associated Infections (HAI) Progress Report.

From the plan design front, the International Foundation of Employee Benefit Plans offers suggestions from an expert panel on four steps for evaluating your plan’s diabetes coverage.

From the mental healthcare front, the Senate Finance Committee released its “Fourth Bipartisan Discussion Draft on Mental Health Proposes More Integration Between Mental and Physical Health Care, Bolsters Crisis Care.” The bill appears to focus on Medicare and Medicaid coverage. The Committee explains

This discussion draft on the mental health integration is the fourth legislative draft the Finance Committee has released since kicking off its bipartisan mental health initiative. The first, released in May, focused on telehealth policies. The second, released in June, focused on youth mental health. The third, released in September, focused on expanding the mental health care workforce. Other discussion drafts may be released. The committee is committed to fully paying for any mental health package with bipartisan, consensus-driven offsets. 

The Associated Press reports

Mindfulness meditation worked as well as a standard drug for treating anxiety in the first head-to-head comparison.

The study tested a widely used mindfulness program that includes 2 1/2 hours of classes weekly and 45 minutes of daily practice at home. Participants were randomly assigned to the program or daily use of a generic drug sold under the brand name Lexapro for depression and anxiety.

After two months, anxiety as measured on a severity scale declined by about 30% in both groups and continued to decrease during the following four months. 

Study results, published Wednesday in the journal JAMA Psychiatry, are timely. In September, an influential U.S. health task force recommended routine anxiety screening for adults, and numerous reports suggest global anxiety rates have increased recently, related to worries over the pandemic, political and racial unrest, climate change and financial uncertainties.

Intriguing findings.

Monday Roundup

David Ermer–AHRQ, CDC, COVID treatment, COVID-19, FDA, Federal employment benefits, Mental health care, NIH, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, the Federal Times offers a detailed report on FEHB infertility coverage. The article answered one of the FEHBlog’s outstanding questions:

In October, the White House Office of Personnel Management, which acts the human relations department for the federal workforce, unveiled four new plan options that will provide some form of assisted reproductive technology, or ART, for a total of 18 FEHB plan options in 2023.

Those are offered by carriers Triple S-Salud, UPMC Health Plan, Indiana University Health Plan, Foreign Service Benefit Plan, and Health Net of California Southern.

One new plan option, under CDPHP, will provide a non-FEHB benefit for discounted ART.

From the Omicron and siblings front —

The New York Times tells us “People who took the antiviral drug Paxlovid within a few days after being infected with the coronavirus were less likely to be experiencing long Covid several months later, a large new study found.” The federal government should be promoting Paxlovid and flu treatments at least as much as it promotes vaccines.

Because winter is coming the Centers for Disease Control reminds us about the importance of home ventilation.

Improving ventilation can help you reduce virus particles in your home and keep COVID-19 from spreading. You may or may not know if someone in your home or if a visitor to your home has COVID-19 or other respiratory viruses. Good ventilation, along with other preventive actions, can help prevent you and others from getting and spreading COVID-19 and other respiratory viruses.

Health IT Analytics reports

Researchers from New York University’s Machine Learning for Good Laboratory (ML4G Lab), Carnegie Mellon University, and the New York City Department of Health and Mental Hygiene (NYC DOHMH) have developed an automated machine-learning system designed to detect rare or previously unseen disease clusters.

According to the press release shared with HealthITAnalytics via email, current automated systems used to identify public health threats rely on “syndromic surveillance” to detect existing threats but can fall short of identifying new ones.

“Existing systems are good at detecting outbreaks of diseases that we already know about and are actively looking for, like flu or COVID,” said NYU Professor Daniel B. Neill, PhD, director of the ML4G Lab, in the press release. “But what happens when something new and scary comes along? Pre-syndromic surveillance provides a safety net to identify emerging threats that other systems would fail to detect.”

Bravo.

With the new year less than two months away, Med City New informs us “Consumer research firm Forrester recently predicted major trends that would shape healthcare in 2023. Healthcare stakeholders should prepare for key changes, such as care becoming even more inaccessible for rural patients[, more remote patient monitoring for chronically ill patients] and additional retail entrants into the clinic space.

On a related note, Becker’s Hospital Review identifies the ten states with the most rural hospitals at immediate risk of closure — 1. Mississippi 24; 2. Tennessee 17, and 3. Kansas 16.

In other U.S. healthcare business news

Healthcare Dive reports

  • VillageMD has agreed to acquire medical practice Summit Health for $8.9 billion including debt, the primary care provider announced Monday.
  • VillageMD, which is majority owned by pharmacy chain Walgreens, and Summit Health, the parent company of CityMD, plan to combine their provider locations and VillageMD’s experience with value-based care to help accelerate the transition to risk for payer clients.
  • Cigna’s health services division Evernorth is also taking a stake in the deal, and will become a minority owner in VillageMD at the deal’s close, expected in the first quarter of 2023.

Fierce Healthcare summarizes 3rd quarter earnings reports from major health insurers.

Fierce Healthcare also announced its ten 2022 Women of Influence in Health award winners.

This year’s honorees cover the breadth of the industry, from providers to payers to health tech, and represent some of the industry’s largest companies as well as up-and-coming innovators. Each has been pivotal in helping their organizations—and their patients—navigate some of the most complicated years that we’ve ever faced.

Kudos to the winners.

The Goverment Accountability Office released a report titled “Private Health Insurance: Markets Remained Concentrated through 2020, with Increases in the Individual and Small Group Markets.”

Several companies may be selling health insurance in a given market, but, as we previously reported, most people usually enroll with one of a small number of insurers. Known as market concentration, this can result in higher premiums due to less competition in the market.

We found this pattern continued in 2019 and 2020, with the markets for individuals and for small employers generally becoming more concentrated. Specifically, three or fewer health insurers held at least 80% of the market share for both of these markets in at least 42 states.

From the healthcare quality front, the HHS Agency for Healthcare Quality and Research released

  • a draft Evidence Map of Social and Structural Determinants of Health Risk Factors for Maternal Morbidity and Mortality; the public comment deadline is December 4, 2022.

Also, Fierce Healthcare tells us

The Center for Medicare and Medicaid Innovation (CMMI) released a report Monday updating its strategic vision for implementing value-based care, including detailing its progress since the vision was released last year. One of the key new strategies focused on creating greater care coordination between primary care doctors and specialists, especially surrounding the types of models the center puts out.

From the mental healthcare front, the National Institutes of Health’s NIH in the News for November 2022 features an article on clinical depression for patients.

From the medical device front, the Wall Street Journal reports

A Medtronic PLC medical device reduced the blood pressure of people with tough-to-treat hypertension in a closely watched study, but not significantly beyond what medications achieved.

The device cut a crucial measure of blood pressure by only about two points more than the average reduction in study volunteers who didn’t get the procedure, researchers said Monday.

Despite falling short of the study’s main efficacy goal, Medtronic said it has completed its application to the Food and Drug Administration for approval of the device, based on its safety and ability to meet certain secondary goals in the latest study as well as positive data from earlier studies.

If the FDA approves it, the device could offer a new, nonmedication treatment option for people with blood pressure that remains high despite treatment with drugs. It could also be a big-selling product for Medtronic. * * *

Medtronic’s experimental device, Symplicity Spyral, is used to perform a minimally invasive procedure known as renal denervation. 

In renal denervation, doctors insert a spiral-shaped catheter into an artery near the patient’s groin, through which a generator delivers radio-frequency energy to nerves in arteries near the kidneys. These nerves can become overactive and fuel high blood pressure. The device essentially burns these nerves so that they don’t contribute to high blood pressure.

Renal denervation has potential to be a one-time treatment, though researchers are still following patients to see how the benefit lasts.

Weekend update

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

Congressional election day is Tuesday. The lame duck session will be next Monday.

Also next Monday, the Federal Employee Benefit Open Season will kick off. OPM has made the 2023 FEHBP and FEDVIP plan comparison tools available. Check them out.

Govexec reports on OPM Director Kiran Ahuja’s speech last Wednesday Wednesday at the annual meeting of the National Academy of Public Administration.” Ms. Ahuja said “the federal government’s HR agency is hard at work finding ways to improve the federal government’s personnel systems and shifting toward becoming a modern leader on strategic human capital issues.”

From the Rx coverage front, NPR Shots tells us

If you were prescribed medicine to lower your risk of a heart attack or stroke, would you take it? 

Millions of Americans are prescribed statins such as Lipitor, Crestor or generic formulations to lower their cholesterol. But lots of people are hesitant to start the medication. 

Some people fret over potential side effects such as leg cramps, which may be – or may not be – linked to the drug. As an alternative, dietary supplements, often marketed to promote heart health, including fish oil and other omega-3 supplements (Omega-3’s are essential fatty acids found in fish and flaxseed), are growing in popularity. 

So, which is most effective? Researchers at the Cleveland Clinic set out to answer this question by comparing statins to supplements in a clinical trial. They tracked the outcomes of 190 adults, ages 40 to 75. Some participants were given a 5 mg daily dose of rosuvastatin, a statin that is sold under the brand name Crestor for 28 days. Others were given supplements, including fish oil, cinnamon, garlic, turmeric, plant sterols or red yeast rice for the same period.

The maker of Crestor, Astra Zeneca sponsored the study, but the researchers worked independently to design the study and run the statistical analysis.

“What we found was that rosuvastatin lowered LDL cholesterol by almost 38% and that was vastly superior to placebo and any of the six supplements studied in the trial,” study author Luke Laffin, M.D. of the Cleveland Clinic’s Heart, Vascular & Thoracic Institute told NPR. He says this level of reduction is enough to lower the risk of heart attacks and strokes. The findings are published in the Journal of the American College of Cardiology.

“Oftentimes these supplements are marketed as ‘natural ways’ to lower your cholesterol,” says Laffin. But he says none of the dietary supplements demonstrated any significant decrease in LDL cholesterol compared with a placebo. LDL cholesterol is considered the ‘bad cholesterol’ because it can contribute to plaque build-up in the artery walls – which can narrow the arteries, and set the stage for heart attacks and strokes.

“Clearly, statins do what they’re intended to do,” the study’s senior author Steve Nissen, M.D., a cardiologist and Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic told NPR.

Forbes informs us

In healthcare contexts, American consumers have historically tended to abandon their consumerism skills, often entering the doctor’s office or insurance process helpless, overwhelmed, and at the mercy of the system. Even when consumers have high expectations for their healthcare experiences, they’re often disappointed.

New research suggests that those days may be over. According to the 2022 Patient Access Journey Report, released last week from Kyruus, “Patients are consumers first.”

For the sixth year in a row, Kyruus has surveyed 1,000 consumers across geographies and generations to understand their preferences for selecting and accessing healthcare services. This year’s report focuses on three aspects of the healthcare consumer experience: search, selection, and action. 

The latest findings suggest consumers, in fact, now weigh similar factors in choosing their healthcare providers and service sites as they do with other types of services. * * *

Healthcare provider websites have a two-to-one advantage in consumer trust compared with health insurance sites. Forty-four percent of consumers surveyed said that they view healthcare provider websites as the most trustworthy source for information about healthcare providers or services, compared with 20% who rated health insurance providers as the most trustworthy. But the percentage of respondents who said health insurance providers were the most trustworthy sources of information jumped nine points since 2021.

From the miscellany department

  • NPR Shots explains what to watch for in the RSV surge and answers about treatment options
  • MedPage Today calls our attention to models leading to a favorable Covid conclusion

The U.S. probably won’t see a major surge in COVID deaths this winter, according to new models from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Seattle.

By Feb. 1, 2023, daily deaths are projected to be at a high point of 335, which pales in comparison to the approximate 2,500 daily deaths seen during the Omicron surge around the same time last year, according to a recently published IHME policy brief.

  • The Wall Street Journal discusses the Menty B (mental breakdown) hashtag in use in Instagram and Tik Tok and a boarding high school in Massachusetts which replaced their students smart phones with light phones. The school also banned teachers from using smart phones while teaching. Everyone’s happier.

Weekend update

David Ermer–Congress, COVID-19, Mental health care, Telehealth, U.S. Healthcare–

Congress remains on the campaign trail with the November 8 election just nine days away.

The Federal Employees Benefits Open Season starts two weeks from tomorrow.

From the Omicron and siblings front, Fortune Well tells us about the Zoe Health Study, a study of Covid symptoms among five million people.

Getting vaccinated against COVID reduces your risk of severe illness, hospitalization, and death if you do catch the disease—but according to new research, it could also dictate which batch of the milder, more common symptoms of the virus you end up getting. It’s thought that a large proportion of cases are still asymptomatic.

In an update to the ongoing Zoe Health Study, which has collected data from almost 5 million participants since 2020, researchers said they had identified symptoms that had emerged in recent weeks, noting that they appeared to differ depending on vaccination status. 

“Generally, we saw similar symptoms of COVID-19 being reported overall in the app by people who had and hadn’t been vaccinated,” the research team said in its update. “However, fewer symptoms were reported over a shorter period of time by those who had already had a jab, suggesting that they were falling less seriously ill and getting better more quickly.”

Precision Vaccinations informs us

As World Pneumonia Day approaches on November 12th, the ongoing effort to reduce fatalities from infectious diseases has never been more urgent.

Pneumonia is an infection of the lungs that needlessly affects millions worldwide each year. Most of the people affected by pneumonia in the U.S. are adults.

Previous U.S. CDC data indicates 47,000 people died from pneumonia in the U.S. in 2020.

And that negative trend continues today.

According to the National Center for Health Statistics (NCHS) Mortality Surveillance data available on October 27, 2022, 9.2% of infectious disease fatalities that occurred during week #42 were due to pneumonia, influenza, and/or COVID-19 (PIC).

Among the 2,128 PIC deaths reported last week, 1,164 listed pneumonia as an underlying or contributing cause of death on the death certificate, 949 had COVID-19, and 15 listed influenza.

Pneumonia always has been a killer. The FEHBlog’s Dad referred to the disease as “the old man’s friend.” He was not alone. A 2018 medical editorial explains

The term “old man’s friend” is often used when referring to pneumonia. Searching for it on Google yields 16,400 results in 0.33 s for this combination.

The term is attributed to William Osler, who in the first edition of his book The Principles and Practice of Medicine (1892) wrote:

In children and in healthy adults the outlook is good. In the debilitated, in drunkards and in the aged the chances are against recovery. So fatal is it in the latter class [i.e. the elderly] that it has been termed the natural end of the old man [1].

In the 9th edition, published after Osler himself already died (in 1919 from pneumonia at the age of 70 years [2]), this excerpt was rephrased as “.. . one may say that to die of pneumonia is almost the natural end of old people” [3]. But that was 100 years ago. Fortunately, a lot changed for the better in the century that followed.

Today, pneumonia still affects many ‘old’ men. Medical progress made since William Osler’s time has resulted in survival rate for hospitalized pneumonia that now sits above 90–95%. However, longer-term mortality is high. The reasons for this are still largely unknown. A hypothesis from the editors of Pneumonia? Perhaps chronic inflammation leading to silent progression of cardiac disease is an underlying mechanism.

In mental healthcare news, the Wall Street Journal reports

Mental-health screenings for kids are expanding across the country. But as more children are identified as needing assistance, families can face a tough time getting help from resources that are already stretched thin.

and

Startups [i.e., this site] are prescribing ketamine online to treat serious mental-health conditions, raising concern among psychiatrists about the safety of taking the mind-altering anesthetic without medical supervision, sometimes at high doses that raise risks of side effects.

The first story illustrates an issue for which telehealth is a solution, while the story shows why telehealth cannot replace in-person care.

In U.S. healthcare business news, Bloomberg relates

VillageMD, which is majority owned by Walgreens Boots Alliance Inc., is exploring a deal to merge with Warburg Pincus-backed Summit Health, according to people familiar with the matter. 

The acquisition by primary-care provider VillageMD of Summit, a health-care network and the parent of CityMD, would value the combined entity at between $5 billion to $10 billion, said the people, who asked to not be identified because the matter isn’t public.

An agreement could be reached in the coming weeks, though talks could still fall apart, the people added. Representatives for VillageMD, Walgreens and Warburg Pincus declined to comment, while Summit Health didn’t immediately respond to a request for comment. 

Weekend update

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

Congress remains on the campaign trail this week.

This is Red Ribbon Week, “an ideal way for people and communities to unite and take a visible stand against drugs.”

Speaking of illegal drugs, the Wall Street Journal tells the stories of three “high achieving” New York City dwellers who died on one day in March 2021 due to fentanyl-laced cocaine delivered by a single dealer.

New York City authorities have been warning of the risks of unknowingly taking fentanyl in cocaine and of its increased presence in cocaine seized by police. Health officials put up posters and sent drink coasters to clubs warning cocaine users to start with a small dose and to have naloxone, an opioid reversal drug, on hand to counter an overdose. They are handing out fentanyl testing strips that can be used to test cocaine and other drugs for fentanyl’s presence.

Multiple people died within hours from tainted cocaine in Long Island, N.Y., and in Newport Beach, Calif., last year. Nine were killed in Washington, D.C., in January. Law-enforcement officials said dealers often use coffee grinders or other basic equipment to cut drugs and prepare them for sale, which can result in deadly batches.

From the FEHB front, Tammy Flanagan, writing in Govexec, advises federal and postal employees and annuitants on how to prepare for the upcoming Federal Employee Benefits Open Season. The FEHBlog’s advice is to stack your plan’s summary of benefits and coverage which is available on all FEHB plan websites against other plans in which you are interested. The summary of benefits and coverage, which is an Affordable Care Act requirement, is four double-sided pages including consumer-tested practical information.

From the Omicron and siblings’ front

  • STAT News reports “FDA’s vaccines chief [Peter Marks, MD] sees the possibility of more Covid boosters — sooner than he’d like.”

Pfizer is considering hiking the price of its COVID-19 vaccine by roughly four times what it currently charges as it prepares for sales in the U.S. to shift from government contracts to the private market.

The pharmaceutical company is targeting between $110 and $130 per adult vaccine dose after that transition, said Angela Lukin, Pfizer’s head of global primary care and U.S. president, on an analyst and investor call Thursday.

“We feel confident that this range will be seen as highly cost effective and definitely one that will help to enable and ensure appropriate access and reimbursement to the vaccine,” Lukin said on the call. Discussions with insurers are still in early stages, she added.

No doubt this charming development seeks to pressure Congress to add more federal Covid dollars in the lame-duck session following the November 8 Congressional election.

In other vaccine news, MedPage Today reports

  • The CDC’s vaccine advisors updated their recommendations to clarify when to administer the 20-valent conjugate pneumococcal vaccine (PCV20; Prevnar 20) in adults who previously received the 13-valent conjugate vaccine (PCV13; Prevnar 13).
  • Three doses of hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG; Heplisav-B) notched a perfect mark when it came to seroprotection for people with HIV who had never before been vaccinated against the hepatitis B virus (HBV), early results of a phase III trial showed.

In prescription drug development news, Fierce Healthcare points out “three drugs are set for FDA determinations soon.” The article explains why Optum says payers should take notice.

From the monkeypox front, Medpage Today adds

Cases of monkeypox are continuing to decline in the U.S., but the disease is still disproportionately affecting people of color, a White House official said.

“In the U.S., about 27,635 cases were reported as of yesterday,” Demetre Daskalakis, MD, White House National Monkeypox Response deputy coordinator, said at an online briefing Thursday. “We continue to have a decrease over time — we’re about 85% down from where we were at the peak of the outbreak. So that’s a lot of hopeful news, that we continue to see monkeypox going under better and better control.”

From the mental healthcare front, the Department of Health and Human Services “through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced more than $100 million this week in funding from the Bipartisan Safer Communities Act (BSCA) to states and territories for mental health emergency preparedness, crisis response, and the expansion of 988 Suicide & Crisis Lifeline services. BSCA, signed into law by President Biden earlier this year, provided unprecedented funding to address the nation’s mental health crisis and make our communities safer.”

From the maternal care front, Health Payer Intelligence informs us Blue Cross and Blue Shield of Michigan has “decided to go beyond traditional maternal healthcare benefits, such as prenatal and postpartum care coverage. They teamed up with a virtual care provider for women and family health, Maven, to offer a suite of solutions that integrated family care and maternal healthcare.”

From the SDOH front, Beckers Payer Issues relates

In a letter to HHS Secretary Xavier Becerra and Management and Budget Office Director Shalanda Young, AHIP explained its vision for how demographic data can be improved and standardized across the healthcare system. 

Five things to know about the association’s recommendations for improving demographic data:  

1. Current challenges with demographic data include the lack of specificity for questions on race. AHIP highlights that current census and HHS standards do not include an option for people to identify as Arab, Middle Eastern or North African. Additionally, AHIP recommends options should be tailored to the local area, depending on the populations that live there. 

2. Current demographic questions do not have an “I choose not to respond” option. AHIP advises that a lack of information about how demographic information is used can lead to a lack of trust from patients. 

3. Current regulations that require multiple providers and payers to collect demographic information lead to inconsistent results and greater burden on patients, AHIP says.

4. To reduce burdens on providers and patients, AHIP wants demographic data to be electronic and able to be shared with other places in the healthcare system with patient consent. 

5. AHIP wants a wide range of government agencies to adopt its recommendations for demographic data collection, which include questions on race, ethnicity, language preference, sexual orientation, gender, diability status, veteran status and spirtual beliefs. 

Read the full letter here.

Interesting approach.

From the miscellany department —

  • STAT New discusses weaknesses in traditional Medicare catastrophic coverage. FEHBlog suggests that Congress stop permitting Medicare supplemental plans to impose pre-existing condition limitations unless circumscribed by state law.
  • The Society for Human Resources Management tells us

Employee 401(k) contributions for 2023 will top off at $22,500—a $2,000 increase from the $20,500 cap for 2022—the IRS announced on Oct. 21. Plan participants age 50 or older next year can contribute an additional $7,500, up $1,000 from 2022. * * *

he limit on total employer-plus-employee contributions to defined contribution plans will increase to $66,000 in 2023, up by $5,000 from $61,000 in 2022. “This limit usually increases by $1,000 at a time but now it’s jumping five steps in one year,” Sit said.

The IRS announced the 2023 adjustments for 401(k) and similar defined contribution plans, and for defined benefit pension plan, in Notice 2022-55.

  • The American Hospital Association reports “The AHA and American Medical Association Oct. 19 filed a friend-of-the-court brief in support of a Texas Medical Association lawsuit claiming the revised independent dispute resolution process for determining payment for out-of-network services under the No Surprises Act skews the arbitration results in commercial insurers’ favor in ways that violate the compromise Congress reached in the Act.”
  • Business Insurance tells us “The U.S. Department of Justice has asked for more details on CVS Health Corp.’s proposed $8 billion deal to buy Signify Health, in a possible indication that the transaction will face a longer deal review rather than a quick approval, Reuters reports. The deal, announced last month, was expected to face a tough antitrust review even though the two companies do not compete directly in any market, according to experts.”
  • Following up on last Thursday’s post, RSV is a type of common cold according to the CDC.

Thursday Miscellany

David Ermer–AHRQ, CDC, COVID-19, Mental health care, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the OPM front, an OPM press release informs us

The U.S. Office of Personnel Management (OPM) released government-wide results of the 2022 OPM FEVS today. The OPM FEVS is an employee survey that tracks how federal employees view their current work environment, including management, policies, and new initiatives. OPM FEVS is an unmatched government data asset that assists agencies to hire and support the skilled workforce needed to serve the American people.

According to Gallup, employee engagement for the total U.S. workforce has declined for the past two years by a total of four percentage points, the first time it has dropped in over a decade. The OPM FEVS government-wide employee engagement index dropped one percentage point from 2020 to 2021, and then stabilized above pre-pandemic levels at 71 percent in 2022. In 2019, this metric stood at 68 percent.

Additional highlights from the 2022 OPM FEVS government-wide results include:

* The Performance Confidence Index, which measures employees’ view that their work unit can achieve goals and produce at a high level, remains high at 84 percent.

* The 2022 OPM FEVS includes a new Diversity, Equity, Inclusion and Accessibility (DEIA) Index, which shows 69 percent of respondents report positive perceptions of agency practices related to DEIA.

* The 2022 OPM FEVS newly evaluates Innovation and to what extent leadership encourages and supports new ideas and innovative approaches. The survey scores show success and opportunities for innovation encouragement, with 64 percent of employees consistently looking for new ways to improve work and 56 percent noting that management encourages innovation.

In other encouraging news, Federal News Network reports

Suicides across the active duty U.S. military decreased over the past 18 months, driven by sharp drops in the Air Force and Marine Corps last year and a similar decline among Army soldiers during the first six months of this year, according to a new Pentagon report and preliminary data for 2022.

The numbers show a dramatic reversal of what has been a fairly steady increase in recent years.

The shift follows increased attention by senior military leaders and an array of new programs aimed at addressing what has been a persistent problem in all the services, although it’s unclear what impact any of the programs had or if pandemic-related restrictions played any role in the decline.

On a related note —

  • The actuarial consulting firm WTW released the employer survey findings

Two out of three U.S. employers (67%) plan to make employee mental health and emotional wellbeing programs and solutions one of their top three health priorities over the next three years. Additionally, the number of employers that intend to offer designated mental health days could triple from 9% currently to 30% in the next two years.

  • The U.S. Surgeon General offers best practices for designing employer-sponsored mental health programs.

From the Omicron and siblings, front MedPage Today tells us

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously Thursday to add COVID-19 vaccination to its panel of routine immunizations for both kids and adults. The 15-0 vote does not mandate vaccination for children or adults or prevent unvaccinated children from attending school; it’s simply an annual update to the child and adult immunization schedules, panelists pointed out.

The ACIP decision does mandate that health plans cover Covid vaccines without member cost sharing after the public health emergency expires, likely next year.

In other public health news, the Wall Street Journal reports

Physicians are reporting unseasonably high numbers of respiratory illnesses in children, straining many children’s hospitals before the typically busier winter months.

Juan Salazar, physician in chief at Connecticut Children’s Medical Center in Hartford, Conn., said a sharp increase in cases of respiratory syncytial virus, or RSV, has filled up hospital beds at his facility, creating capacity issues. 

RSV is an easily transmissible virus that infects the respiratory tract. The virus spreads through droplets from coughing and sneezing and on surfaces. Positive tests for RSV have been on the rise across the U.S., according to the Centers for Disease Control and Prevention. The rise in cases has come ahead of the typical winter peak for such illnesses, hospital officials said. 

For most people, RSV amounts to a cold, and nearly all children come in contact with the virus by the age of two, health authorities said. But it can be severe for some infants and older adults, especially for those that have pre-existing health conditions. 

Much like influenza, RSV cases were flattened during the first year of the Covid-19 pandemic. The respiratory virus that typically circulates in the fall and winter then rebounded in the summer of 2021.  

Is RSV the official name for the common cold? Calling Dr. Google. Perhaps people should choose to wear N-95 masks in the winter.

From the Rx coverage front

The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma) for the treatment of obesity.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, ICER’s Chief Medical Officer. “As such, obesity, and its resulting physical health, mental health, and social burdens is not a choice or failing, but a medical condition. The development of safe and effective medications for the treatment of obesity has long been a goal of medical research that now appears to be coming to fruition. With a condition affecting more than 40% of adults in the US, the focus should be on assuring that these medications are priced in alignment with their benefits so that they are accessible and affordable across US society.”

Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations

This report is worth a gander because OPM is requiring coverage of next-gen obesity drugs for 2023.

It turns out that October is health literacy month.

  • The Labor Department’s Assistant Secretary for Employee Benefits offers employees five tips for making health benefits work.
  • The HHS Agency for Healthcare Quality and Research gives healthcare providers a complete literacy manual, 2nd edition.

Of course, October is also breast cancer awareness month, and Yale New Haven hospital issued with newsletter with advice on that critical topic.

Breast cancer is the second most common cancer among American women, except for skin cancer – but millions of women are surviving the disease, thanks in part to regular screening, early detection and improvements in treatment.

“Compared to 15 or 20 years ago, the proportion of early-stage breast cancers we are seeing in our clinics is significantly higher. We can directly attribute this to the improvements in screening technologies, in mammography, tomosynthesis, breast MRI, breast ultrasound and computer-assisted detection methods over the years,” said Meena Moran, MD, chief of Breast Radiation Oncology for the Smilow Cancer Network. “Another major factor attributing to earlier detection over the last two decades is the overall increased awareness of breast cancer and the importance of screening in the general population.”

From the miscellany department —

  • The International Foundation of Employee Benefit Plans discusses “Optimizing Outcomes and Containing the Costs of Surgery.”
  • Reg Jones writing in the Federal Times, provides the math on calculating Social Security benefits, especially early retirement benefits.

Midweek update

David Ermer–CDC, CMS, COVID-19, Mental health care, NCQA, NIH, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From the Omicron and siblings front —

Novovax announced that

the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

“The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “According to CDC data, almost 50 percent of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults.”

Reuters adds

Moderna Inc said on Wednesday its COVID-19 vaccine booster targeting the BA.1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months.

Omicron-tailored shots by Pfizer Inc  and Moderna are already authorized by regulators in several countries. The United States has given the go-ahead for booster vaccines that target the currently circulating BA.4 and BA.5 subvariants of Omicron.

The New York Times provides an update on the new Omicron variants, including this critical point

Fortunately, Paxlovid works against these new variants. The mutations that make them spread so quickly are changes to the surface of the virus where it locks onto cells and where antibodies attach to it. Paxlovid attacks the virus in a different way. It detects the virus after it’s inside the cell and is replicating, and these new subvariants seem to be just as vulnerable to Paxlovid as the earlier variants.

Health Payer Intelligence reports

Federal funding was crucial in enhancing access to coronavirus resources during the initial phases of the pandemic, but questions remain about what will occur when the public health emergency ends and how it will impact consumer healthcare spending, according to a Kaiser Family Foundation brief.

The end of the public health emergency is still undetermined. However, experts have projected that it will end in 2023. The scheduled termination has been pushed back multiple times. Its final termination will signal the end of various flexibilities and protections that have been tied to the declaration.

Additional Covid funding is likely to occur in the Congressional lame-duck session following the November 8 election, in the FEHBlog’s opinion.

From the U.S. healthcare business front —

Fierce Healthcare tells us

Patient volumes continue to remain below pre-pandemic levels for hospitals and health systems this year as COVID-19 likely accelerated a shift to outpatient settings, a new report finds. 

Consulting firm Kaufman Hall released its “2022 Healthcare Performance Improvement” report (PDF), which outlines the barriers hospitals and health systems face in a rough year financially. Another key obstacle continues to be workforce shortages, as more and more facilities shift resources to retain staff. 

“Healthcare leaders must navigate short-term challenges that continue to pressure revenue and expenses, while also adapting organizational strategy to match larger transformations in the way care is delivered,” said Kaufman Hall Managing Director Lance Robinson in a statement on the report. 

and offers a discussion of an expert-touted hybrid approach to compensating primary care providers. In the FEHBlog’s view, adequately paying PCPs is critically important to resolving SDOH and mental health issues adversely impacting our country.

In the regard

  • A National Institutes of Health study uncovered racial disparities in advanced cardiac care.
  • STAT News reports on another SDOH study

When Sarka Lisonkova and her colleagues set out to study disparities in the birth outcomes of people who’ve used methods like IVF, they figured that any inequities that existed would be narrower in this group. After all, it can be expensive to get pregnant with medical assistance, and wealth is tied to better outcomes.

Instead, the researchers reported Wednesday, the racial and ethnic disparities for some metrics were even wider for babies of parents who had used IVF or other fertility treatments than among children who were conceived “spontaneously.”

One key finding: while neonatal mortality rates were twice as high among spontaneously conceived children of Black women versus white women, they were four times as high among infants of Black women conceived through technologies like IVF, according to the researchers’ study, which was published in the journal Pediatrics.

  • The National Committee for Quality Assurance gives us an update on their efforts to stratify HEDIS measures results by racial and ethnic categories.

In other U.S. healthcare business news, Healthcare Dive reports

As the U.S. heads toward a possible recession, Elevance Health CEO Gail Boudreaux said the insurer is preparing for a possible economic decline.

“Certainly we’re mindful of an economic downturn. We’re planning for it in our businesses,” Boudreaux said on a Wednesday call with investors to discuss third-quarter earnings.

Job losses spurred by a recession could cut into commercial enrollment for insurers who generate revenue from selling health coverage to employers of all sizes. About half of the U.S. population relies on employer-based insurance for coverage.

Elevance’s profit climbed to $1.6 billion for the third quarter, a 7% increase compared with the prior-year period on a bigger membership base of 47.3 million members.

Becker’s Payer Issues tells us

Despite little growth in the cost of medical services over the last year, inflation has finally caught up with healthcare.

As of September, medical services costs have risen 6.5 percent year over year, according to a Bureau of Labor Statistics report released Oct. 13. 

Analysts like Fitch have said the rise in costs will lead to payers raising insurance premiums across the board because of the growing cost pressures on providers, including workforce disruptions.

Studies have already confirmed employers are preparing for higher healthcare expenditures next year because of inflation. Aon analysts said Aug. 18 that U.S. employers’ healthcare costs are expected to rise by an average of 6.5 percent, or $13,800 per employee, in 2023.

“The only 100 percent sure way to keep within budget as the medical industry (especially hospitals) demand more and more is to raise premiums, increase deductibles, higher copays and coinsurance,” James Gelfand, president of the ERISA Industry Committee, told The Washington Post Oct. 14. “Employers hate to do this, but the medical-industrial complex demands an ever-increasing share of workers’ wages.”

The rise in insurance costs could begin to appear when employees sign up for employer-sponsored coverage during their next enrollment period, a trend that could continue through at least 2024, according to the Post.

STAT News reports

A large commercial insurer’s decision to cover a controversial class of software-based treatments for psychiatric and other conditions could prove to be a landmark moment in the development of these so-called prescription digital therapeutics, which until now had been unable to secure coverage from insurers skeptical that the new technologies are as effective as their makers claim.

Pittsburgh-based Highmark quietly put in place a policy in August describing when these treatments may be “medically necessary,” which paves the way for the health insurer to be the first to cover the category for a population of millions of members.

The policy indicates Highmark’s intention to pay for claims only for prescription digital therapeutics cleared by the Food and Drug Administration when prescribed by a clinician within the appropriate specialty and used as indicated on product labels. Highmark is currently negotiating with product developers about how much it will pay for individual treatments and over details such as what constitutes an “episode of care,” said Matt Fickie, a senior director at Highmark, which has 6 million members in Pennsylvania, Delaware, West Virginia, and New York. “That’s the part that is sticky and that requires additional work,” he told STAT.

From the Rx coverage front —

STAT News informs us

After an extraordinary three-day hearing, an expert panel of advisers to the U.S. Food and Drug Administration voted on Wednesday to uphold an effort by the regulator to withdraw a controversial drug for preventing premature births.

The 14-to-1 vote came after the agency and Covis Pharma, the manufacturer of the drug, offered highly contrasting views of reams of clinical evidence — which they parsed in excruciating detail — in order to settle the fate of the treatment, known as Makena.

The FDA successfully persuaded the panel that the medication should be withdrawn because the results of a clinical trial, which was required when the agency approved Makena [on an accelerated basis] in 2011, failed to show the expected benefit. For its part, Clovis maintained that a follow-up trial showed its drug did benefit a select subset of patients — including Black women — but struggled to convince the panel that the drug should remain available while a lengthy follow-up study is run to confirm its argument.

The sentiment among most panelists was reflected in remarks by Susan Ellenberg, a professor emeritus of biostatistics, medical ethics, and health policy at the Perelman School of Medicine at the University of Pennsylvania, who said “unmet need is not a basis for keeping a drug available when you don’t know if it works.”

The FDA Commissioner, Robert Califf, MD, is the final decision maker.

The NCQA has created

A new website adds two key resources in the fight against antibiotic resistance:

* A How-To Toolkit: Webinars and written summaries outline best practices, emerging trends and lessons from the field about savvy stewardship of antibiotics.

* An “Honor Roll”: Learn which health plans’ management of antibiotics leads the industry.

From the No Surprises Act front, CMS today issued updated guidance on how to initiate an NSA arbitration. The new guidance reflects the revised final independent dispute resolution rule published this past summer.