Tuesday’s Tidbits

Federal employment benefits

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Federal Employee Benefits Open Season front, FedSmith provides advice to federal and postal employees and FedWeek provides guidance to all interested parties.

In the Federal Times, Reg Jones answers a reader’s question about whether an annuitant can suspend their FEHBP coverage.

From the Omicron and flu front –

MedPage Today expresses expert views that developing vaccines that prevent the spread of Covid require human challenge trials in which fully informed, vaccinated people are exposed to Omicron.

[M]any experts agree: we need new vaccines to limit the spread of the virus. The current generation of vaccines offers strong protection against serious illness and death, but their edge has dulled against new variants, and they do not always prevent infection and transmission of the virus.

The White House hosted a summit on the issue in July, showcasing the myriad ways researchers are going about developing new vaccines. There are hundreds of candidates in early stages around the world, but the resources devoted to COVID-19 vaccine research are a fraction of what they were 2 years ago. Human challenge trials can greatly speed the selection of the most promising in this field of candidates, providing scientific and economic benefits over uniform reliance on large field studies.

Time will tell.

The Wall Street Journal provides a background story of this year’s flu that compares the spread of the flu vs. the spread of Covid.

How contagious is flu?

Covid-19 is more contagious than influenza, doctors say. One reason is that most people have had flu multiple times and many have gotten multiple flu shots over the years. 

The most common calculation of a virus’s infectiousness is a measure called the R0 (pronounced “R naught”). This metric estimates how many people one contagious person will infect on average. The R0 of influenza is between one and two. R0 data for Covid-19 isn’t definitive, especially as the virus continues to mutate, but studies indicate the number for many Covid strains is higher than for flu. 

From the tidbits department

  • Healthcare Dive offers “five takeaways from the FDA’s list of AI-enabled medical devices. As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates.”
  • The Patient-Centered Outcomes Research Institute (PCORI), which the Affordable Care Act requires health insurers and plans to fund, shares its strategic plan.
  • The Segal Company helpfully reminds cafeteria plan sponsors that “As part of COVID-19 relief, the Consolidated Appropriations Act, 2021 (CAA) permitted plan sponsors to immediately implement certain mid-year changes to their cafeteria plans during the 2020 and/or 2021 plan years without first having to adopt plan amendments. Employers that implemented such relief are required to adopt certain retroactive plan amendments by December 31, 2022.”
  • The Centers for Disease Control calls attention to its U.S. Diabetes Surveillance System website. Check it out.
  • Beckers Hospital Review lists the ten most expensive States for healthcare. The only state with a top 10 population included on Becker’s list is Florida.

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.

Thursday Miscellany

David Ermer–CDC, Congress, Federal employment benefits, OPM, Rx coverage, Telehealth, U.S. Healthcare–

From the Federal Employee Benefits Open Season front, we find guidance from FedSmith, FedWeek, and My Federal Retirement.

From the unusual viruses front —

The American Hospital Association reports that

The Department of Health and Human Services today renewed the nation’s monkeypox public health emergency declaration for another 90 days. When the PHE was announced in August, Centers for Disease Control and Prevention Director Rochelle Walensky, M.D., said the declaration would provide access to resources and flexibilities, expedite state data sharing, and provide more detailed data on testing and hospitalizations. CDC yesterday reported over 28,000 U.S. monkeypox cases since the first confirmed case May 18.

For a more current information on monkeypox, check out these articles from the Hill and MedPage Today.

From the Rx coverage front., Bloomberg reports

Hundreds of community pharmacies are having trouble filling prescriptions for amoxicillin, a common antibiotic that’s often used to treat bacterial infections in children.

Two-thirds of 333 pharmacy owners and managers who responded at the end of October to a National Community Pharmacists Association survey about drug shortages said they were having difficulty getting the antibiotic. The liquid form of the drug has been in limited supply in the US since October, according to the Food and Drug Administration, and it’s also in shortage in other countries

 

Another Bloomberg article attributes the shortage to demand due the RSV epidemic and school age children illnesses plus the generic drug’s low price.

“A lot of that risk is driven by market factors, particularly price,” explained Matt Christian, USP’s director of supply chain insights. In general, antibiotics are generic drugs that have existed for years and tend to be cheaper and have lower margins than newer drugs. That means drug companies have a lot less incentive to set up robust, resilient supply chains  and may be caught short if something goes wrong at a competing supplier.

“Lower priced drugs have a higher risk of shortage,” Christian said. “No margin, no inventory.”

An analysis by the FDA found a similar correlation: Drugs in short supply typically cost less than other medicines. * * *

“If you run out of an antibiotic as ubiquitous as amoxicillin, there is a concern that unnecessarily moving [to a more aggressive antibiotic] can further cause antimicrobial resistance,” Christian said.

Why doesn’t the federal government manufacture amoxicillin?

In other medical development news —

MedPage Today tells us

Hard thresholds for pain medication doses and duration are no longer promoted through the CDC’s new Clinical Practice Guideline for Prescribing Opioids for Pain.

The new guidance — which covers acute, subacute, and chronic pain for primary care and other clinicians — updates and replaces the controversial 2016 CDC opioid guideline for chronic pain. The 2016 guideline was interpreted as imposing strict opioid dose and duration limits and was misapplied by some organizations, leading the guideline authors to clarify their recommendations in 2019.

The 2022 recommendations are voluntary and give clinicians and patients flexibility to support individual care, said Christopher Jones, PharmD, DrPH, MPH, acting director of CDC’s National Center for Injury Prevention and Control in a CDC press briefing. They should not be used as an inflexible, one-size-fits-all policy or law, or applied as a rigid standard of care, or replace clinical judgement about personalized treatment, he emphasized.

More details can be found in the STAT News article.

Bloomberg informs us

In just 15 minutes, a small, handheld blood test can tell doctors whether a patient has likely suffered a concussion or traumatic brain injury — no brain scan required.    

After more than a decade of research, the Abbott Laboratories test is being used for the first time in a real-world setting to evaluate patients at Tampa General Hospital in Florida. Doctors using the test say it’s better at evaluating concussions than the brain scans that have been widely used for the last 30 years.  * * *

[Abbott Labs’] test, called the i-STAT TBI Plasma test, was greenlit by the Food and Drug Administration in 2021 to rule out the need for a CT scan when evaluating mild traumatic brain injuries. * * *

Though Abbott’s test is not yet ready to be used on the sidelines of sporting events, the ultimate goal for Abbott is for every hospital, urgent care clinic, ambulance, school and sporting event to have a portable test available. The company is also working on research that will help doctors know the severity of a concussion or brain injury, for both adults and kids, to aid in diagnoses.

Abbott worked with the Department of Defense to develop the test, which supported development with millions of dollars in funding. More than 450,000 US service members were diagnosed with a traumatic brain injury from 2000 to 2021, according to the CDC. It’s an area the DOD is “very concerned about,” said Beth McQuiston, a neurologist and chief medical officer for Abbott’s diagnostic business.  

Bravo.

From the U.S. healthcare business front

Beckers Payer Issues reports

Cigna raised its annual earnings outlook and reported a 70 percent boost in third quarter profits compared to the same period last year, according to the company’s earnings report published Nov. 3.

“We built on our momentum from the first half of 2022 with strong execution in the third quarter across our businesses and a continued focus on serving customers and clients with our differentiated health and well-being solutions,” CEO David Cordani said.

Healthcare Dive offers an M&A perspective on the Cigna announcement.

The Wall Street Journal reports

Moderna Inc.’s third-quarter revenue fell by nearly a third and the pharmaceutical company cut its outlook, saying as part of its earnings report that supply constraints for its Covid-19 vaccines might sap as much as $3 billion in sales this year.

The Cambridge, Mass.-based company said Thursday that higher costs and a decline in demand for its original Covid-19 vaccine also hit its performance.

Moderna, which three months ago said it projected $21 billion in product sales of its Spikevax vaccine for anticipated delivery this year, now expects between $18 billion and $19 billion. The company said short-term supply constraints will delay some sales into 2023.

Beckers Hospital Review cautions

The third quarter brought little relief to hospitals in what is shaping up to be one of their worst financial years.  

Kaufman Hall’s October National Hospital Flash Report — based on data from more than 900 hospitals — found slightly lower hospital expenses in September did not outweigh lower revenue across the board, with decreases in discharges, inpatient minutes and operating minutes.

The median year-to-date operating margin index for hospitals was -0.1 percent in September, marking a ninth straight month of negative operating margins and a dimmer outlook for their climb back into the black by year’s end. 

Kaufman Hall noted that expense pressures and volume and revenue declines could force hospitals to make “difficult decisions” about service reductions and cuts. 

Meanwhile according to MedCity News, the American Medical Association “blasted the Centers for Medicare and Medicaid Services Tuesday for its 2023 Physician Fee Schedule final rule, which would cut the Medicare payment rate to physicians by nearly 4.5%.” The AMA is demanding that Congress prevent the cut from occuring January 1, 2023.

The article adds

[O]ther organizations applauded it for areas that reflected their respective priorities. For instance, the National Association of ACOs (NAACOS) praised changes to the Medicare Shared Savings Program for 2023 that included providing more time to Accountable Care Organizations before they have to assume financial risk. The final rule also gave advance shared savings payments to ACOs that care for underserved communities. CMS said it expects these changes to increase participation in rural and underserved areas. * * *

[T]he final rule made changes to policies related to telehealth. This includes extending several telehealth services that were temporarily made available during the public health emergency through at least 2023. This will “allow additional time for the collection of data that may support their inclusion as permanent additions to the Medicare Telehealth Services List,” CMS said. The change is in line with comments CMS Administrator Chiquita Brooks-LaSure made at a recent conference. 

The Telehealth Access for America (TAFA), which includes the American Hospital Association, applauded the changes to telehealth, though the group called on Congress to make permanent actions.

In other telehealth news, Healthcare Dive reports

  • COVID-19 diagnoses fell by about 1% to 2% as a share of telehealth claims nationally in August, according to Fair Health’s monthly tracker data out Thursday.
  • In the South and West, COVID-19 fell from the second top diagnosis to the third from July to August. It remained in second place in the Midwest and Northeast.
  • Mental health conditions stayed as the top telehealth diagnoses nationally and in every region, and one hour of psychotherapy remained the top telehealth procedure code.

Tuesday Tidbits

David Ermer–ACA, CMS, FDA, Federal employment benefits, Medicare, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

November is awareness month for diabetes and C. Diff. Looking back at October, Medscape informs us

Maintaining a healthy body weight, being physically active, and following a healthy dietary pattern can help women live longer after breast cancer diagnosis, according to a major new analysis of the latest research.

From the Federal Employee Benefits Open Season front, the Federal Times offers its consumer guide.

It was a big day on the Medicare front —

The American Hospital Association reports

The Centers for Medicare & Medicaid Services [CMS] late today posted a final rule on its website that will increase Medicare hospital outpatient prospective payment system rates by a net 3.8% in calendar year 2023 compared to 2022. This update is based on a market basket percentage increase of 4.1%, reduced by 0.3 percentage points for productivity. [AHA calls the increase insufficient.] * * *

CMS finalized the payment policy for CY 2023 of average sales price (ASP) +6% for drugs and biologicals acquired through the 340B Program as a result of the unanimous Supreme Court decision in American Hospital Association v. Becerra.

CMS also finalized proposals to establish the Rural Emergency Hospital (REH) model, a new provider type for eligible critical access hospitals and small rural hospitals beginning in Jan. 1, 2023. The rule finalized proposals related to model payment, covered services, conditions of participation, and quality measurements.

[and]

The Centers for Medicare & Medicaid Services today released on its website its calendar year 2023 final rule for the physician fee schedule. The rule will cut the conversion factor to $33.06 in CY 2023 from $34.61 in CY 2022, which reflects the expiration of the temporary 3% statutory payment increase; a 0.00% conversion factor update; and a budget-neutrality adjustment.

From HHS.gov

For a fact sheet on the CY 2023 OPPS/ASC Payment System Final Rule (CMS-1772-FC), please visit: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-2

For a fact sheet on Rural Emergency Hospitals, please visit: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-1

For a fact sheet on the CY 2023 Physician Fee Schedule Final Rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule

For a fact sheet on final changes to the CY 2023 Quality Payment Program, please visit: https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2136/2023%20Quality%20Payment%20Program%20Final%20Rule%20Resources.zip 

For a fact sheet on final changes to the Medicare Shared Savings Program, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule-medicare-shared-savings-program

For a CMS blog on behavioral health poliices, please visit: https://www.cms.gov/blog/strengthening-behavioral-health-care-people-medicare-0?check_logged_in=1

What’s more, Beckers Hospital Review informs us

CMS evaluated two and a half years of readmission cases for Medicare patients through the Hospital Readmissions Reduction Program and penalized 2,273 hospitals that had a greater-than-expected rate of return, according to a Nov. 1 report from Kaiser Health News.

The average payment reduction was 0.43 percent, the lowest rate reduction since 2014. Reductions will be applied to each Medicare payment to the affected hospitals from Oct. 1 through next September. It is expected to cost the hospitals $320 million over the 12-month period. 

The report notes that the COVID-19 pandemic caused turmoil in hospitals and that CMS decided to exclude the first half of 2020 from the report due to the chaos. CMS also excluded Medicare patients who were readmitted with pneumonia across all three years because of the difficulty distinguishing them from COVID patients. 

From the Affordable Care Act preventive services front, Healio tells us

The U.S. Preventive Services Task Force has released two final recommendations on the use of hormone therapy for the primary prevention of chronic conditions in postmenopausal people.

The recommendations advocate against the use of menopausal hormone therapy (MHT) through a combination of estrogen and progestin in postmenopausal people, and MHT through estrogen alone in postmenopausal people who have had a hysterectomy.

Both are D-grade recommendations and are consistent with the USPSTF’s previous recommendations on the treatment made back in 2017.

James Stevermer, MD, MSPH, a task force member, also noted in the press release that the recommendations are only for those who are considering hormone therapy to prevent chronic conditions following menopause. 

“Those who wish to manage symptoms of menopause with hormone therapy are encouraged to talk with their health care professional,” he said.

From the prescription drug and vaccine development front —

STAT News reports

Pfizer’s maternal vaccine against the respiratory syncytial virus [RSV] reduced the rate of severe illness in newborns by 81.8%, the company said Tuesday, meeting the goal of a pivotal study.

The company said that it plans to file the data on the vaccine with regulators by the end of the year and that it expects an eight-month review.

RSV is a common cause of illness and infection in young infants. By giving the vaccine during pregnancy, researchers hope antibodies generated by mothers would be transferred to infants. Currently, the pertussis vaccine and the influenza vaccine are given during pregnancy for this reason.

Bloomberg Prognosis tells us

Vertex Pharmaceuticals, a Boston-based biotech company, * * * is testing a non-opioid drug for acute pain. Vertex’s drug, VX-548, aims to block the Nav1.8 sodium channel, which acts like a gate allowing pain signals to travel from the nerves to the brain.

VX-548 met its goals in late-stage trials evaluating the drug in people who underwent a bunionectomy or an abdominoplasty, the formal name for a tummy tuck. Vertex will run the same studies with more patients before seeking regulatory approval. The company hasn’t disclosed when data will be available beyond saying the trials will be quick since patients receive the drug for only 48 hours. Vertex is also testing VX-548 in nerve pain and eventually wants to see if it works for chronic pain.

If VX-548 passes its next big tests, it could offer a new option for people recovering from surgery or other medical procedures. Of course, plenty of other pain drugs that looked promising early on in testing never reached the market.

Fortunately, scientists are investing time and money on a variety of alternatives for pain.

From the Rx coverage front, BioPharma Dive relates

Eli Lilly’s new diabetes medicine Mounjaro outpaced Wall Street sales forecasts during the third quarter, fueled by strong patient demand and widening insurer coverage.

U.S. sales of the drug totaled $97 million between July and September, Mounjaro’s first full quarter on the market since its May 13 approval by the Food and Drug Administration. Payments related to a collaboration agreement with Mitsubishi Tanabe Pharma in Japan pushed global revenue for the quarter to $187 million, well above the consensus analyst forecast of $82 million.

“We have seen unprecedented demand for Mounjaro’s Type 2 diabetes launch in the U.S.,” said Anat Ashkenazi, Lilly’s chief financial officer, on a Tuesday call with analysts. 

Lilly is also conducting a study to support an FDA marketing application for Mounjaro to be prescribed for weight loss.

Notably, Mounjaro showed a potent effect in reducing trial participants’ weight, a benefit that was also observed in a large study specifically assessing it as an obesity treatment. While it’s currently only approved to treat Type 2 diabetes, its potential as a medicine for both chronic conditions has made it one of Lilly’s most important products.

Lilly is currently conducting a second study in obesity and plans to complete an approval application in that indication should results, expected in April next year, also prove positive. 

In U.S. healthcare business news, MedTech Dive reports

Johnson & Johnson agreed to acquire Abiomed, a Danvers, Mass.-based maker of heart pumps, for $16.6 billion. 

The deal will contribute to J&J’s cardiovascular portfolio, complementing its Biosense Webster electrophysiology business, BTIG Analyst Marie Thibault wrote in a research note on Tuesday. 

The deal has already been approved by both companies’ boards of directors and is expected to close before the end of the first quarter of 2023.

Finally, check out the NIH Director’s blog discussing “How the Brain Differentiates the ‘Click,’ ‘Crack,’ or ‘Thud’ of Everyday Tasks.”

If you’ve been staying up late to watch the World Series, you probably spent those nine innings hoping for superstars Bryce Harper or José Altuve to square up a fastball and send it sailing out of the yard. Long-time baseball fans like me can distinguish immediately the loud crack of a home-run swing from the dull thud of a weak grounder. 

Our brains have such a fascinating ability to discern “right” sounds from “wrong” ones in just an instant. This applies not only in baseball, but in the things that we do throughout the day, whether it’s hitting the right note on a musical instrument or pushing the car door just enough to click it shut without slamming.

Now, an NIH-funded team of neuroscientists has discovered what happens in the brain when one hears an expected or “right” sound versus a “wrong” one after completing a task. It turns out that the mammalian brain is remarkably good at predicting both when a sound should happen and what it ideally ought to sound like. Any notable mismatch between that expectation and the feedback, and the hearing center of the brain reacts.

Thursday Miscellany

David Ermer–ACA, CDC, Congress, COVID-19, FDA, Federal employment benefits, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Omicron and siblings front, the National Institutes of Health announced

As SARS-CoV-2 — the coronavirus that causes COVID-19 — continues to spread, its genetic material mutates, leading to viral variants. These changes happen most often in the virus’s spike protein, which allows the virus to attach to and invade cells.

Because most COVID-19 vaccines are targeted to the spike protein, antibodies resulting from vaccinations provide less immune protection against variants. This increases people’s risk of getting COVID-19 despite vaccination.

Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) are exploring a different idea for vaccines. Instead of focusing on the SARS-CoV-2 spike protein, they are studying the virus’s nucleocapsid (N) protein, which rarely mutates.1 The N protein could be the key to creating a future universal vaccine to fight emerging variants.

Fingers crossed.

In other public health news, the American Hospital Association tells us

Overall cancer death rates continued to decline between 2015 and 2019 for men, women and children and all major racial and ethnic groups, according to the latest Annual Report to the Nation on the Status of Cancer. The overall death rate fell an average 2.3% per year in men and 1.9% per year in women, led by declining rates for lung cancer and melanoma. Death rates increased in men for cancers of the pancreas, brain, bones and joints and in women for cancers of the pancreas and uterus. New cancer cases remained stable for men and children between 2014 and 2018, but increased for women, adolescents and young adults. This year’s report also highlights trends in pancreatic cancer, as well as racial and ethnic disparities in incidence and death rates. 

MedCity News points out three reasons why Americans are underutilizing primary care.

From the Federal Employee Benefits Open Season front, OPM informed agency benefit officers

Please see the attached document listing the 84 FEHB plan choices where the enrollee share of premiums for the Self Plus One enrollment type is higher than for the Self and Family enrollment type for the 2023 plan year.

Please share this information with your employees and inform them that enrollees who wish to cover one eligible family member may elect either the Self and Family or Self Plus One enrollment type.

Enrollees should carefully check the 2023 rates of their current plan and any other plan choices they are considering for 2023.  For enrollees wishing to change, they must do so during Open Season, which is held from November 14th through December 12th.

In all of these cases, the self and family premium exceeds the self plus one premium. Nevertheless, these anomalies occur because FEHB family sizes are small and the self plus one government contribution is lower than the self plus family government.

A FedWeek expert identifies eight mistakes to avoid when shopping for a health plan during the Open Season.

The Kaiser Family Foundation released its 2022 Employer Health Benefits Survey.

In 2022, the average annual premiums for employer-sponsored health insurance are $7,911 for single coverage and $22,463 for family coverage. These amounts are each similar to the average premiums in 2021. In contrast to the lack of premium growth in 2022, workers’ wages increased 6.7% and inflation increased 8%.2 This difference may be due to the fact that many of the premiums for 2022 were finalized in the fall of 2021, before the extent of rising prices became clear. As inflation continues to grow at relatively high levels, we could potentially observe a higher increase in average premiums for 2023 than we have seen in recent years.

In other federal employment news,

  • FedWeek offers federal and postal employees advice on getting a head start on planning for retirement.

More federal employees are working onsite and more often this year than last, continuing a downward trend since the mid-2020 peak in offsite work caused by the pandemic, the Federal Employee Viewpoint Survey showed.

Thirty-six percent said they are present at their worksite all of the time, up from 29 percent in 2021 and 17 percent in 2020, while 18 percent said they had not been present onsite this year, down from 22 and 30 percent. The percentage who said they are onsite less than a quarter of the time fell over the three years from 24 to 20 and now 15.

While the share of full-time telework is down, many of those who are continuing to telework do so a substantial portion of their time, however. Those reporting that they telework three or four days a week now stands at 25 percent, up from 11-12 percent in the prior years, while those doing it one or two days a week stands at 17 percent, up from 8 and 10 percent.

and shares statistics on federal employee use of the new paid parental leave benefit as reported in the Federal Employees Viewpoint Survey — “Four percent of employees took at least some of that time over the last year.”

From the Affordable Care Act front, the Kaiser Family Foundation released its annually updated fact sheet on Preventive Services Covered by Private Health Plans under the ACA. “This fact sheet summarizes the federal requirements for coverage for preventive services in private plans, major updates to the requirement, and recent policy activities on this front.”

From the telehealth front —

  • Beckers Hospital Review offers an interview on the topic of “Telesitting, remote maternity care: Where telehealth is going next at Kaiser Permanente.”
  • Fierce Healthcare informs us “COVID-era emergency department patients who had follow-up appointments via telehealth more often returned to the ED or were hospitalized than those who followed up with doctors in person, according to a new retrospective study [published in JAMA Network Open]. * * * The researchers noted their investigation had several limitations, such as no data on certain “complex” social determinants of health like unemployment and whether patients received a follow-up outside of the health system. The findings “need to be considered in the context of a substantial body of science demonstrating the benefits of telemedicine,” such as those that found lower rates of rehospitalization in certain chronic condition populations tied to telehealth use.”
  • Healthcare Dive reports “Teladoc reported better than expected revenue in the third quarter, on the back of its mental health business, BetterHelp, and issued moderate fourth-quarter guidance, leading some industry watchers to say the telehealth vendor is setting itself up for achievable growth after uncertainty contributed to stock losses this year.”

In other U.S. healthcare business news

  • Politico brings us up to date on the low participation rate in the new federal designation of rural emergency hospitals. It’s back to the drawing board.
  • Beckers Payer Issues reports that CareFirst and Johns Hopkins Medicine “have signed a multiyear contract following a dispute over reimbursement rates that would have left hundreds of thousands of people out of network.” Cheers to that.
  • MedTech Dive informs us, “Labcorp lowers 2022 forecasts after Q3 profit falls on labor costs, declining COVID-19 revenue.”
  • Employers should know that the Equal Employment Opportunity slide has updated its workplace notice. HR Dive warns us, “Hang new EEO poster ‘as soon as possible,’ EEOC advises. An EEOC spokesperson also told HR Dive how employers with remote and hybrid employees should handle the poster.”

From the Rx coverage front

  • Reuters relates that “The U.S. Food and Drug Administration has delayed a meeting of its advisory panel to discuss Perrigo Co Plc’s (PRGO.N) over-the-counter (OTC) contraceptive, the drugmaker said on Wednesday. The meeting, scheduled for Nov. 18, was delayed to review additional information, and no new date has yet been set, in a setback for what was expected to be the first approved daily OTC birth control pill in the United States.”
  • STAT News calls our attention to this news

Amid sporadic shortages of a drug that is essential in preparing patients for lifesaving, cancer-fighting treatments, one manufacturer has returned to the market — but is selling its medicine for 10 to 20 times the prices offered by the only other companies with available supplies.

Over the past week, Areva Pharmaceuticals began marketing vials of fludarabine at a wholesale price of $2,736, a much steeper cost than the $272 charged for the same dosage by Fresenius Kabi and the $109 price tag from Teva Pharmaceuticals, according to data from IBM Micromedex, which gathers pricing data that is reported by manufacturers.

The move comes as hospitals around the U.S. grapple with persistent shortages of fludarabine, an older chemotherapy that is used during the run-up to bone marrow transplants in patients with a form of leukemia. More recently, the drug has also become a crucial tool in readying patients to undergo CAR-T cell therapy, a customized approach to fighting some cancers that involves re-engineering patient cells.

That’s a big bowl of wrong.

Let’s conclude with this wonderful piece of Govexec miscellany explaining the genesis of federal government shutdowns in the late 1970s.

Midweek update

David Ermer–ACA, CDC, CMS, COVID-19, FDA, Federal employment benefits, HSA, NIH, OPM, U.S. Healthcare–
Lincoln Memorial in the Fall

From the Federal Employee Benefits Open Season front —

  • FedWeek offers its Open Season report.

  • My Federal Retires explains Open Season options available to those with Medicare coverage.
  • Govexec promotes healthcare flexible savings accounts, which are only available to federal and Postal employees. The FEHBlog was surprised to learn that “less than 20% of active feds have an FSA.” The article explains the mechanics of the FSA, among other things.

In other federal employee benefits news, Reg Jones, writing in the Federal Times, tells us how to calculate federal disability retirement benefits and answers a question about survivor annuitant coverage.

In other OPM news, Govexec tells us how the OPM Director is celebrating Work and Family Month.

From the Omicron and siblings front, Beckers Hospital Review informs us that “Omicron subvariants BQ.1 and BQ.1.1 — dubbed “escape variants” for their immune evasiveness — are steadily gaining prevalence in the U.S. and now account for more than 16 percent of all COVID-19 cases confirmed nationwide, CDC data shows.”

Beckers adds

Data analysis from the Los Angeles-based Smidt Heart Institute at Cedars-Sinai found heart attack deaths rose significantly with COVID-19 surges, including omicron surges.

Heart attack deaths were on the decline before the pandemic. However, during COVID-19 surges, deaths increased — especially among individuals ages 25-44, according to an Oct. 24 release shared with Becker’s.

In other public health news

A new national study has suggested that chemical hair straighteners could pose a small risk for uterine cancer. Rates of the disease are still relatively low, said Dr. Alexandra White, head of the environment and cancer epidemiology group of the National Institute of Environmental Health Sciences and the lead author on the study. The research also did not definitively show that hair straighteners cause cancer. But the findings are cause for concern, she said.

Rates of uterine cancer have been increasing in the United States, particularly for Black and Hispanic women. The number of cases diagnosed each year rose to 65,950 this year, compared to 39,000 15 years ago. Black women are also more likely to have more aggressive cases of the cancer, Dr. White said, and the study showed they were disproportionately more likely to use hair straighteners.

If you have used chemical hair straighteners, you do not need to seek out medical attention or consult your doctor unless you have symptoms for uterine cancer, said Dr. Otis Brawley, an oncologist at Johns Hopkins University. But women should regularly see a gynecologist, and be aware of the risk factors and early signs of the disease. [The article also explains uterine cancer risk factors and symptoms.]

Roll Call tells us

The Biden administration is preparing a comprehensive initiative to fight hepatitis C that would streamline testing and treatment and secure an agreement with drugmakers to bring down the cost of treatment of the disease, which has spiked during the pandemic.

Francis Collins, special project adviser to President Joe Biden and former longtime director of the National Institutes of Health, said Monday the administration hopes to secure some funding this year for the yet to be formally unveiled initiative.

He said he has briefed Biden on the plan, and the Office of Management and Budget is “enthusiastic about figuring out how to fit this into the budgetary requests.”

The National Institutes of Health announced

Long-term use of electronic cigarettes, or vaping products, can significantly impair the function of the body’s blood vessels, increasing the risk for cardiovascular disease. Additionally, the use of both e-cigarettes and regular cigarettes may cause an even greater risk than the use of either of these products alone. These findings come from two new studies supported by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).  

From the Food and Drug Administration front —

BioPharma Dive informs us

The Food and Drug Administration on Tuesday approved a first-of-its-kind treatment for multiple myeloma from Johnson & Johnson, but put restrictions on its use due to the drug’s potentially dangerous side effects.

Healthcare providers offering the drug, which will be sold as Tecvayli, will need to follow guidelines set up in a Risk Evaluation and Mitigation Strategy, or REMS. Prescribers and pharmacies must be certified in the Tecvayli REMS program, which will focus on monitoring and counseling for patients.

The FDA has required REMS for dozens of medicines since the program was authorized by Congress in 2007. The list includes Bristol Myers Squibb’s cell therapy Abecma, which won approval for multiple myeloma last year.

Fierce Pharma relates

AstraZeneca’s long-troubled cancer immunotherapy tremelimumab has finally secured its first FDA approval, but the regulatory blessing comes in what could be an increasingly competitive tumor type.

To be sold under the brand name Imjudo, tremelimumab has won an FDA go-ahead in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi for treating unresectable hepatocellular carcinoma, the most common type of liver cancer.

The FDA nod officially puts an end to the streak of clinical trial failures that tremelimumab endured over recent years in multiple cancer types, including non-small cell lung cancer, head and neck cancer and bladder cancer. But while the CTLA-4 inhibitor has now crossed the regulatory finish line, a commercial fight lies ahead.

From the Medicare front – –

  • STAT News discusses a new CMS policy aimed at controlling dialysis prices.
  • Fierce Healthcare tells us “Starting next year, insurers will not be able to air any television ads for Medicare Advantage (MA) plans before getting approval from federal regulators.” Tough break for Joe Namath.  

From the ACA marketplace front —

  • The Department of Health and Human Services discusses its plans for the upcoming Open enrollment period.
  • Benefits Pro discusses the popularity of alternative health reimbursement accounts which allow employers to offer marketplace coverage to their employees.

Speaking of account-based health plans, the Plan Sponsors Council of America released its 2022 benchmarking survey of health savings accounts.

From the U.S. healthcare business front —

  • Health Data Management assesses whether Amazon and Walmart can build effective value based care models.

Monday Roundup

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

From the Federal Employee Benefits Open Season front, Govexec takes “a closer look at 2023 FEHB premiums.”

On a related note, Health Payer Intelligence informs us

Member experience is key to member retention and, in order to boost member experience, payers must consider whether they are offering easy access to care and straightforward care navigation, according to an Accenture report.

The organization surveyed nearly 21,000 Americans who are consumers of both payers and providers.

Reg Jones, writing in the Federal Times, answers a “lightning round” of cost of living adjustment questions posed by federal and postal employees and annuitants.

In other OPM news, Federal News Network reports

With a fast-approaching deadline to apply for a Public Service Loan Forgiveness limited-time waiver, the Office of Personnel Management said agencies should help federal employees with their applications.

If they have the documentation available, agencies can certify a current employee’s entire work history, including that individual’s time working previously at other agencies.

“The federal employee should present a separate PSLF form for each federal agency and period of employment for which they are seeking certification and the agency official should certify each form as appropriate,” OPM wrote in an Oct. 24 memo.

Employment certification forms are just one of the requirements to apply for the temporary PSLF waiver, which expires on Oct. 31.

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

Younger people have also been less likely to receive boosters than the original vaccinations, and only about one-third of people of all ages have received any booster, The New York Times vaccine tracker indicates. But seniors, who constitute 16 percent of the population, are more vulnerable to the virus’s effects, accounting for three-quarters of the nation’s 1.1 million deaths.

“From the beginning, older people have felt the virus was more of a threat to their safety and health and have been among the earliest adopters of the vaccine and the first round of boosters,” said Mollyann Brodie, the executive director of public opinion at Kaiser Family Foundation, which has been tracking vaccination rates and attitudes.

Now Kaiser’s most recent vaccine monitor survey, published last month, has found that only 8 percent of seniors said they had received the updated bivalent booster, and 37 percent said they intended to “as soon as possible.” As a group, older adults were better informed than younger respondents, but almost 40 percent said they had heard little or nothing about the updated bivalent vaccine, and many were unsure whether the C.D.C. had recommended it for them.

(Currently the C.D.C. recommends that individuals over age 5 receive the bivalent vaccine, which is effective against the original strain of Covid-19 and the Omicron variant, if two months have passed since their most recent vaccination or booster.)

The article adds

Kaiser surveys have found that doctors and other health care professionals are trusted sources of information, and the older population is in frequent contact with them.

“If more providers recognized that four in 10 older adults don’t realize there’s a new booster and they should get it, that’s a lot of opportunity to make an impact,” Dr. Brodie said.

While on patient-provider communications, the Washington Post points out a free National Institute of Aging online resource that helps older adults prepare for doctor’s visits.

From the telehealth front, mHealth Intelligence reports

Telehealth usage has dropped significantly since its peak during the pandemic, with visit volumes falling 37 percent from 73.7 million in the second quarter of 2020 to 46.4 million in the first quarter of 2022, according to a new report by market research firm Trilliant Health.

Further, telehealth’s popularity among patients appears to be waning. Less than half (48.7 percent) of patients who used telehealth in 2021 did so once, and only 6 percent used the care modality five to six times last year.

This data “suggests that expanded availability of virtual care options has not had a widespread impact on consumer preferences,” said Sanjula Jain, Ph.D., senior vice president of market strategy and chief research officer at Trilliant Health, in an email. * * *

Though the overall shifts in telehealth use indicate a move back to in-person care, certain sub-groups continue to flock to telehealth.

Telehealth continues to be widely used to access behavioral healthcare services, the report shows. In Q1 2019, 32.4 percent of all telehealth visits were related to behavioral healthcare. That figure spiked to 59.9 percent by Q1 2022.

For providers, “behavioral health presents the greatest opportunity, and deploying virtual behavioral health services can be a good way to reach broader populations, engage existing customers while bringing in new ones, and provide new revenue opportunities via engagement in other care services,” Jain said.

In addition, telehealth-enabled prescribing is on the rise, according to the report. Around 35 percent of antidepressants and anti-anxiety drugs were prescribed via telehealth in 2020 and 2021, compared to 1 percent in 2019.

In studies news, STAT News discusses the importance of fine-tuning artificial intelligence tools before releasing them for patient use and the cardiovascular differences between women and men.

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.

Tuesday Tidbits

David Ermer–CDC, COVID-19, Federal employment benefits, Medicare, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Let’s lead off with the OPM Inspector General’s new annual report on top management challenges facing the agency. This is the first such report of the current Inspector General Krista Boyd. The report’s FEHB Program concerns focus on prescription drug spending, eligibility issues, and the Postal Service Health Benefits Program.

As the FEHBlog has noted, FEHB prescription drug spending is not a unique FEHB issue. While the Inspector General’s report calls attention to these statistics:

As in prior years, drug costs continue to increase in the FEHBP. Currently, total FEHBP drug
costs (excluding drugs administered in an inpatient hospital setting) represent approximately 32
percent of total health care costs. Approximately 23 percent of total FEHBP health care costs are
attributable to the pharmacy benefit alone (drugs dispensed through outpatient pharmacies). As
of 2021, FEHBP pharmacy benefits represented more than $13 billion annually.

To place these statistics in context, the FEHB again calls attention to the fact that the FEHB Program has a large cadre of annuitants with primary Medicare Parts A and B coverage. This group understandably does not enroll for Medicare Part D prescription drug coverage. As a result, Medicare picks up the bulk of cost of FEHB hospital and doctor expenses for this group, while FEHB covers virtually of the pharmacy spending for this group. The FEHBlog is unaware of any other large employer in this situation because employers who have retiree health coverage generally rely on Medicare Advantage plans.

The saving grace found in Congress’s design of the FEHB Program is that all enrollees are in one risk pool per plan option which allows carriers to compete and also use group insurance principles to spread costs among all enrollees. Medicare prime annuitant and younger enrollees subsidize the more costly people in the middle.

The FEHBlog agrees with the Inspector General that the FEHB has eligility issues principally because OPM in contrast to every other employer in the U.S. reports enrollment and premiums separately. Typically health plans receive enrollment rosters known as HIPAA 820 standard electronic transactions that list each enrolled individual and the premium paid for that individual. This allows the health plan to systematically compare the roster and premiums against their records. A plan for example would know that OPM is paying it for self only coverage when according to the plan’s records the member has self plus one coverage.

OPM has been building a master enrollment index which is one of the steps that OPM has been taking in the right direction. In the FEHBlog’s opinion, implementing the HIPAA 820 standard transaction would take eligibility off of the Inspector General list of management challenges.

As for the Postal Service Health Benefits Program, the FEHBlog has confident that OPM, with support from the Postal Service and carriers, to launch the PSHBP on time January 1, 2025.

Here’s a Govexec article on the report which takes a broader perspective.

From Omicron and siblings front —

  • STAT News reports on the federal government’s and drug manufactures efforts to close the developing treatment gap for immunocompromised folks who contract certain strains for Omicron, e.g., BA 4.2.y and BQ.1

[Monoclonal antibody] Evusheld is still effective against many variants, but it is not possible for physicians to know which strains a patient using it as prophylaxis could be exposed to, an AstraZeneca spokesperson told STAT.

“Variants are rarely dominant for more than a few months — they tend to either evolve further into different subvariants or are replaced by newer variants,” the spokesperson said, adding the company is running early studies on other antibody options. * * *

Complicating the matter, the next potential monoclonal antibody — an Eli Lilly treatment dubbed bebtelovimab — could be ready within two months, but it has already been shown ineffective against the other fast-rising variant, BQ.1. The federal government has purchased 60,000 bebtelovimab doses for uninsured and under-insured patients, according to two people familiar with the HHS monoclonal antibody planning.

In the HHS meeting, officials discussed the prospect that BA.4.6’s rise could render Evusheld ineffective within two months. They laid out the timelines for as many as six potential alternates in the pipeline, according to two people familiar with the discussion.

a new national biodefense strategy, aiming to adapt lessons drawn from the rocky response to the Covid-19 pandemic as it prepares the country for future public health emergencies.

The strategy, which has been long anticipated, includes such goals as strengthening public health workforces both in the United States and globally, and establishing international mechanisms to bolster laboratory safety.

The government’s plan outlines policy targets for more than 20 federal agencies to help the country and world try to prevent epidemics, detect them faster, respond when they occur, minimize their impact, and recover, senior administration officials said on a call with reporters Monday as they previewed the strategy. Oversight for the strategy will be at the White House, under the national security advisor.

  • On a related note, Insurance News Net discusses the pandemic’s adverse impact on the life insurance industry, and Healthcare Dive tells us “The HHS’ current management of the strategic national stockpile and its subsequent relaying of information to Congress is fractured and needs updates to ensure the country is prepared for future public health emergencies, according to a report from the Government Accountability Office.”

From the SDOH front, MedPage Today delves into a CDC Vital Signs reports released yesterday

Influenza-associated hospitalization rates were nearly 80% higher among Black adults compared with white adults from 2009-2010 to 2021-2022, according to a CDC Vital Signs report released Tuesday.

These rates were also 30% higher among American Indian/Alaska Native (AI/AN) adults and 20% higher among Hispanic adults compared with white adults, reported Carla L. Black, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues.

Furthermore, vaccination coverage for influenza has been “consistently lower among Black, Hispanic, and American Indian and Alaska Native adults since 2010,” she noted on a call with reporters.

During the 2021-2022 flu season, vaccination coverage was lower among Hispanic (37.9%), AI/AN (40.9%), Black (42.0%), and other/multiple race (42.6%) adults compared with coverage among white (53.9%) and Asian (54.2%) adults, Black and team said.

From the IRS front, the Service issued its annual notice of inflation adjustments to tax items for the 2023 tax year. The Wall Street Journal adds “The Internal Revenue Service adjusted key tax code parameters for 2023 to reflect higher inflation, raising the standard deduction and the income thresholds where tax rates take effect.” The notice also includes many inflation adjustments to tax-exempt or deductible employees benefits. You will find a handy table of contents at the front of the notice.

From the miscellany department

  • The Justice Department on the Food and Drug Administration’s behalf has asked various federal courts to shut down the e-cigarette operations of six manufacturers.
  • The Justice Department also announced Sutter Health’s agreement “to pay $13 million to settle allegations that it billed government health programs for lab tests performed by others,” said U.S. Attorney Stephanie M. Hinds. ‘Government health care programs [including the FEHB in this case] must be protected, and this office will investigate and pursue health care providers that fail to provide the services paid for by public health care programs.’”

Apple will reportedly enter the health insurance business in 2024 in partnership with a major payer, Forbes reported Oct. 18.

CCS Insight’s chief analyst predicts the tech giant will power the new offering through health data collected by Apple Watches, such as blood pressure, blood oxygen levels, ECG readings and body temperature. The analyst said having access to this data from the beginning gives the company an advantage toward entering the market and cutting costs.

Apple is already a flagship partner in John Hancock’s Vitality program and UnitedHealthcare’s commercial plans.

  • Reg Jones writing in the Federal Times explains how to enroll for Medicare Part without incurring a late enrollment penalty. It’s not hard if you know the rules.