Weekend update

Rx coverage

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.

Midweek update

David Ermer–CDC, FDA, Rx coverage, Telehealth, U.S. Healthcare–

From the alcohol abuse front, MedPage Today tells us

One out of every eight deaths in Americans ages 20 to 64 resulted from drinking too much alcohol, according to a U.S. population-based study.

Nationally, 12.9% of total deaths per year among adults in this age group were attributed to excessive alcohol consumption from 2015 to 2019, and that number rose to 20.3% of total deaths per year when restricted to people ages 20 to 49, reported Marissa Esser, PhD, MPH, of the CDC in Atlanta, and colleagues.

Alcohol-attributed deaths ranged from 9.3% in Mississippi to 21.7% in New Mexico and were more common among men than women (15% vs 9.4%), the authors wrote in JAMA Network Open.

That is startling.

From the unusual viruses front, Beckers Hospital Review explains

Wastewater testing has found polioviruses genetically tied to a case that left an unvaccinated Rockland County, N.Y., resident paralyzed this summer in at least five of the state’s counties, according to a new CDC report. 

The report, published Oct. 28, is based on wastewater testing from samples collected from March 9 through Oct. 11 from 28 sewersheds serving parts of Rockland County and 12 other counties. Eighty-nine samples, or 8.3 percent of 1,076 samples collected, tested positive for poliovirus type 2. Of those, 82 were linked to the virus isolated from the Rockland County patient who was left paralyzed 

“Although most persons in the United States are sufficiently immunized, unvaccinated or undervaccinated persons living or working in Kings, Orange, Queens, Rockland, or Sullivan counties, New York should complete the polio vaccination series to prevent additional paralytic cases and curtail transmission,” the CDC report said. 

CDC officials recently told CNBC they are considering the use of a novel oral polio vaccine not used in 20 years to halt the outbreak. 

From the opioid epidemic front, Healthcare Dive informs us

CVS Health agreed on Wednesday to pay $5 billion to settle almost all opioid-related lawsuits and claims the company been battling over the past decade that alleged it mishandled prescriptions of the painkillers.

If the deal is finalized, CVS will pay $4.9 billion to states and political entities such as counties and cities, and $130 million to U.S. tribes.

The payments, which depend partially on the number of government entities that agree to join the settlement, will be spread out over the next 10 years beginning in 2023.

Cities, counties and states have filed more than 3,000 lawsuits against drugmakers, distributors and pharmacies for their role in perpetrating the opioid epidemic in the U.S. According to government data, three-fourths of the 92,000 drug overdose deaths in 2020 involved an opioid.

Walgreens and Walmart also have reached deals to settle opioid-related claims, Reuters reported, citing people familiar with the matter. Walgreens will pay $5.7 billion over 15 years and Walmart will pay $3.1 billion, mostly up front, according to the report.

If the settlements from the three companies, which are the largest retail pharmacies in the U.S., become final, it may end much of the yearslong litigation over opioids. Cases still are pending against smaller pharmacies such as Rite Aid.

The deals follow some victories for plaintiffs against the chains. 

In related healthcare business news, Beckers Hospital Review reports

CVS Health raised its annual earnings outlook after beating investor expectations in the third quarter, but the company reported $3.4 billion in losses after agreeing to pay into a global opioid lawsuit settlement starting next year.

The $5 billion settlement will be paid out over 10 years and “substantially resolve all opioid lawsuits and claims against the company by states, political subdivisions, such as counties and cities, and tribes in the United States,” the company said in its Nov. 2 earnings report.

The company’s third quarter EPS is $2.09 and $6.71 for 2022. It also raised its full year guidance and expects adjusted EPS to rise from a range of $8.40-$8.60 to $8.55-$8.65.

“We delivered another outstanding quarter, and have raised full-year guidance as a result. We continue to execute on our strategy with a focus on expanding capabilities in health care delivery, and the announced acquisition of Signify Health will further strengthen our engagement with consumers,” President and CEO Karen Lynch said.

and

Humana reported $1.2 billion in profits during the third quarter and is expecting major increases in Medicare Advantage membership, according to the company’s Nov. 2 earnings report.

The company reported $22.8 billion in third quarter revenues, increasing 10.2 percent from $20.7 billion year over year. Total revenues in 2022 are $70.4 billion

The company expects an annual adjusted EPS guidance of $25 and raised its 2022 earnings outlook to $91.6 billion – $93.2 billion.

Healthcare Dive adds

Los Angeles-based Heal, a provider of primary care through house calls, telemedicine visits and remote patient monitoring, said it has partnered with Cigna Medicare Advantage plans in four states as it continues its national expansion.

The organization is now an in-network provider for Cigna MA enrollees in Illinois, North Carolina, South Carolina and Georgia, effective immediately, it said. Its markets also include Louisiana, New Jersey, New York and Washington.

Heal works with Humana, WellCare, Aetna and UnitedHealthcare insurance plans, according to its website.

Fierce Healthcare relates

Nearly 334,000 physicians, nurse practitioners, physician assistants and other clinicians left the workforce in 2021 due to retirement, burnout and pandemic-related stressors, according to new data [found in the Definitive Healthcare report]. * * *

Hospitals and health systems are spending more money to hire and retain healthcare workers, the report found. These facilities are increasing salaries, offering sign-on bonuses, and expanding benefits to lure in new workers. Hospitals nationwide spent a total of about $97.3 million on employees and physician salaries in 2020, compared with $82.7 million in 2016, according to data from the October 2021 Medicare Cost Report.

From the medical devices front, STAT News tells us

A Food and Drug Administration advisory panel suggested Tuesday that the agency improve how it regulates pulse oximeters, calling for clearer labeling and more rigorous testing of the devices. The widely used instruments monitor blood oxygen levels and have been shown to work less well on patients with darker skin, possibly exacerbating health disparities in many racial and ethnic groups. 

Healthcare Dive points out

Optical sensor solution in fingertip monitors gives medical-grade accuracy of oxygen level measurement across skin tones and while in motion.

A patented SpO2 sensor chipset, integrated processing and reference design capability has uses in other wearable devices, according to BioIntelliSense.

The inability of many fingertip monitors to accurately read blood oxygen levels has caused people with darker skin to wait hours for supplemental oxygen and in some cases has caused deaths.

That’s good news for you.

Moreover, Health IT Analytics reports

A team of Yale University researchers has developed a machine learning (ML)-based clinical decision support tool to personalize recommendations for pursuing intensive or standard blood pressure treatment goals among individuals with and without diabetes.

The tool, described in a study published earlier this week in The Lancet Digital Health, is designed to facilitate shared decision-making between providers and patients with hypertension through a data-driven approach. Hypertension is defined as a sustained blood pressure greater than 140/90 mm Hg and is a leading cause of heart disease and mortality.

From the Rx coverage front, STAT News tells us

A blockbuster weight-loss medicine led to dramatic effects for adolescents diagnosed with obesity, a result that will likely widen the use of an in-demand drug — and fan a debate over whether someone’s body weight should be treated as a disease.

The drug, a weekly injection called semaglutide, led to a 17% reduction in body mass index compared to placebo in a study of about 200 people between the ages of 12 and 18. On average, adolescents treated with semaglutide lost 34 pounds, or 15% of their body weight, over the course of the 68-week study, which was published in the New England Journal of Medicine on Wednesday. Those on placebo gained an average of five pounds, or 3% of their baseline weight.

The trial’s relatively small size and short duration leave outstanding questions about whether semaglutide’s side effects, which include nausea and rare cases of gallstones, will lead to long-term problems, said Julie Ingelfinger, a pediatric nephrologist at Massachusetts General Hospital who was not involved in the study. But the results suggest semaglutide, sold by the Danish drug company Novo Nordisk, could be a powerful tool for adolescents unable to lose weight through diet and exercise.

From the post Dobbs front, the New York Times surveys the landscape and finds increasing use of telemedicine services, such as Aid Access, to obtain abortion pills.

‘

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.

Monday Roundup

David Ermer–COVID-19, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

Kaiser Health News announced the winner of their fourth annual Halloween haiku contest.

Covid, Ebola,
Monkeypox, seasonal flu —
Who needs Halloween?

— Paul Hughes-Cromwick

The Department of Health and Human Services reminds us that the federal healthcare / Obamacare marketplace will be open for business tomorrow. Professor Katie Keith, writing in Health Affairs Forefront, provides all the details.

The U.S. Office of Personnnel Management issued a press release today with a list of senior staff transitions and additional key staff appointments.

From the Omicron and siblings front, Medscape reports

The U.S. National Institutes of Health’s $1 billion RECOVER Initiative has picked Pfizer Inc’s antiviral drug Paxlovid as the first treatment it will study in patients with long COVID, organizers of the study said on Thursday.

The complex medical condition involves more than 200 symptoms ranging from exhaustion and cognitive impairment to pain, fever and heart palpitations that can last for months and even years following a COVID-19 infection.

According to details of the study, posted on Clinicaltrials.gov, the randomized, placebo-controlled trial will test Pfizer’s treatment or a placebo in 1,700 volunteers aged 18 and older.

The Duke Clinical Research Institute is supervising the study, which is scheduled to start on Jan. 1.

The New York Times offers readers background on the RSV epidemic and related matters.

R.S.V. is a common winter virus that typically causes mild cold-like illness in most people, but can occasionally be very dangerous for young children and older adults, said Emily Martin, an associate professor of epidemiology at the University of Michigan School of Public Health.

“The youngest infants have a high risk of coming into the hospital in what we call their first R.S.V. season,” Dr. Martin said. “If a child is born in the summer and they get exposed for the first time in the winter, they are at risk of having more serious disease. But many infants didn’t experience the first R.S.V. season on the regular schedule that they would have, particularly if they were born in or after 2020.”

In a normal prepandemic year, 1 to 2 percent of babies younger than 6 months with an R.S.V. infection may need to be hospitalized. And virtually all children have gotten an R.S.V. infection by the time they are 2 years old.

But many experts believe masking, social distancing, school closures and other precautions taken during the first year or two of the pandemic protected most children from exposure to the virus and other germs. “As a result, there are still many children who are less than 3 years old who’ve never been exposed to R.S.V.,” said Dr. James Antoon, an assistant professor of pediatrics and pediatric hospitalist at Monroe Carell Jr. Children’s Hospital at Vanderbilt University in Nashville, Tenn. “The virus is now playing catch-up in all these kids.”

No good deed, etc.

From the virtual care front, mHealth Intelligence informs us

In collaboration with Mayo Clinic, Memora Health has launched the first phase of a research program focused on virtual postpartum care.

The program aims to improve communication between patients and providers through the addition of new technology to enhance postpartum care.

Memora Health, which offers digital and automated care programs, is working with Mayo Clinic to implement the virtual care program, which will provide the health system’s maternal care teams access to technology that can help them extend care for postpartum patients in the home and between clinic visits.

From the healthcare cost front, Health Payer Intelligence tells us

Dialysis increased monthly spending for privately-covered members with chronic diseases by approximately 292 percent, according to a study published in JAMA Open Network.

The researchers drew their insights from a sample of nearly 12,400 private insurance enrollees over the course of 309,800 enrollee-months. The data from Health Care Cost Institute spanned 2012 to 2019 and was analyzed from late August 2021 to mid-August 2022. Enrollees had employer-sponsored insurance for a year after starting dialysis.

Most enrollees were in preferred provider organization health plans that were self-funded. * * *

Medicare beneficiaries had much lower costs than their employer-sponsored health plan counterparts. The mean spending for enrollees on Medicare in the year after starting dialysis was $80,509, compared to $238,126 for individuals with private healthcare coverage.

“The large costs borne by private insurers to cover enrollees with kidney failure underscore the importance of Medicare becoming a primary payer after 30 months,” the study indicated. “The differences in spending between enrollees receiving dialysis with private insurance and those with Medicare are especially important given growing concerns about the market power of large dialysis organizations and recent policy proposals.”

The level of spending increase post-dialysis initiation that the researchers discovered in this study was higher than previous studies indicated.

The Wall Street Journal adds

Rival drugmakers are seeking to upend Pfizer Inc.’s dominance of the $7 billion worldwide market for pneumonia vaccines, launching what is shaping up to be one of the industry’s fiercest battles.

Merck & Co. has already introduced a new competitor to Pfizer’s Prevnar vaccine franchise, while GSK PLC and VaxcyteInc. are among companies developing shots that aim to win sales by protecting against even more strains of the pneumonia virus.

The companies are all vying for a piece of a lucrative market that Pfizer has commanded for more than a decade and is forecast to reach more than $10 billion annually by 2028, according to Wall Street analysts.

“It is kind of an all-out battle to see who can get this $10 billion that’s out there on the table,” said Louise Chen, an analyst at Cantor Fitzgerald & Co.

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.

Tuesday’s Tidbits

David Ermer–ACA, CDC, COVID-19, Medicare, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

The American Hospital Association reports

The Department of Health and Human Services will launch a national advertising campaign and tour to encourage families to get the updated Pfizer or Moderna COVID-19 vaccine booster to protect themselves against the omicron variants before winter and the holiday season, the White House announced today. As part of the tour, HHS will host pop-up vaccination events, and encourage others to share information on COVID-19 vaccines and host vaccination events.

NPR Shots reflects on Omicron’s staying power.

Whereas alpha, beta, gamma and the other named variants sprouted new branches on the SARS-CoV-2 family tree, those limbs were dwarfed by the omicron bough, which is now studded with a plethora of subvariant stems.

“The children of omicron — so the many direct children and cousins within the diverse omicron family — those have displaced each other” as the dominant strains driving the pandemic, says Emma Hodcroft, a molecular epidemiologist at the University of Bern. “But that same family has been dominating” by outcompeting other strains.

The article delves into the future as well.

From the Rx coverage front —

  • Fierce Healthcare tells us that health insurer Centene announced its third-quarter results and a new PBM contract with Express Scripts.
  • Florida Blue Cross announced a mail-order pharmacy agreement with Amazon.

From the telehealth front —

  • The Federal Times discusses FEHB telehealth coverage available in 2023.

As federal employees prepare to make their selections for next year’s health insurance benefits, some may wonder whether telehealth services, made especially popular and necessary by the COVID-19 pandemic, will stick around.

For the most part, beneficiaries under the Federal Employee Health Benefits program will not see a major drop-off of telehealth options for 2023, said the White House’s Office of Personnel Management’s Edward DeHarde, who leads federal employee insurance operations, in an interview.

  • While the Federal Times article is focused on the hub and spoke telehealth services, STAT News considers the growing practice of pharmaceutical manufacturers making their drugs available to consumers through a third-party telehealth service.

From the tidbits department

  • The Wall Street Journal discusses the impact of health insurance spending on the consumer price index. In short, “The subindex of the consumer-price index is about to turn from a driver of inflation into a deflationary drag.”
  • The U.S. Public Health Service Task Force released for public comment a draft I (or inconclusive_ recommendation: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of visual skin examination by a clinician to screen for skin cancer in [asymptomatic] adolescents and adults.” The comment deadline is November 21, 2022.
  • CNN reports “One in 10 Americans over 65 had dementia, while 22% experienced mild cognitive impairment, the earliest stage of the slow slide into senility, according to a new study conducted between 2016 and 2017.” The study — the first in 20 years — breaks down its results by demographic categories.
  • My Federal Retirement offers its take on Medicare income adjusted premiums, known as IRMAA.

Employees and retirees are to be reminded that the IRMAA determination is usually based on Medicare Part B beneficiary’s federal income tax returns from two years earlier [e.g. 2021 governs 2023]. If a beneficiary’s income has dropped in the following year, then the beneficiary can appeal the IRMAA decision using Social Security Form SSA-44 (Medicare Income-Related Monthly Adjustment Amount -Life-Changing Event), providing proof that the beneficiary has experienced a “life-changing” event such as the death of a spouse or a divorce resulting in a significant decrease in income in the following year.

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.