Thursday Miscellany

Thursday Miscellany

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

Photo by Josh Mills on Unsplash

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

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

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

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

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

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

From the public health front

The American Hospital Association reports

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

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

The Wall Street Journal adds

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

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

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

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

The Journal also informs us

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

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

HealthDay tells us

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

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

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

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

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

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

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

The Associated Press reports

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

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

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

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

Intriguing findings.

Tuesday Tidbits

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.

Friday Stats and More

Photo by Sincerely Media on Unsplash

As the late Kenny Rogers sang, “You need to know when to hold them and when to fold them.” The FEHBlog tried to revive his Covid charts, but alas, it was infeasible because the FEHBlog could not show the stats in seven-day weeks as FEHBlog had been doing.

In any event, the Centers for Disease Control continues to issue weekly interpretations of Covid statistics so here we go:

New Reported Cases

As of October 26, 2022, the current 21-day average of weekly new cases (37,683) decreased 25.1% compared with the previous 21-day average (50,328). A total of 97,329,787 COVID-19 cases have been reported in the United States as of October 26, 2022.

CDC Nowcast projections* for the week ending October 29, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are eight lineages designated as Omicron with estimates above 1%: BA.5—and four of its sublineages (BQ.1, BQ.1.1, BF.7, and BA.5.2.6)—BA.4.6, BA.2.75, and BA.2.75.2. The predominant Omicron lineage is BA.5, projected to be 49.6% (95% PI 45.3-53.9%).

The New York Times report on a study finding that Covid rebounds can happen to people have not taken Paxlovid.

“Symptom return is common,” said Dr. Davey Smith, the chief of infectious diseases and global public health at the University of California, San Diego School of Medicine, who led the study. “It doesn’t mean that things are going south. It’s just the natural way the disease goes.” What is surprising, however, is how many people may experience a rebound, he said. * * *

“The good news is that nobody who had their symptoms return needed to go to the hospital or died or even got severe symptoms,” Dr. Smith said. Eighty-five percent of those who had a rebound reported that their symptoms were mild; 15 percent had at least one moderate symptom. * * *

Concerns about rebound symptoms when taking Paxlovid — and another antiviral drug called molnupiravir — appear to have reduced people’s interest in using treatments for Covid. But the new study shows that you can have a rebound with untreated Covid as well. “I hope this can help people to be less afraid of a potential rebound,” Dr. Smith said.

If you do experience a rebound after treatment, there is no evidence that you need to start another course of Paxlovid. Isolate a while longer in case you are contagious to others. And try to manage symptoms with pain and fever-reducing medicines, home remedies and time, Dr. Smith said. “I recommend staying hydrated, watching ‘The Golden Girls’ and eating chicken soup.”

New Covid Hospitalizations

The current 7-day daily average for October 19–25, 2022, was 3,249. This is a 1.0% increase from the prior 7-day average (3,217) from October 12–18, 2022.

New Reported Deaths

The current 21-day average of new deaths (373) decreased 13.7% compared with the previous 21-day average (432). As of October 26, 2022, a total of 1,066,351 COVID-19 deaths have been reported in the United States.

Covid Vaccinations

As of October 26, 2022, 636.9 million vaccine doses have been administered in the United States. Overall, about 266.0 million people, or 80.1% of the total U.S. population, have received at least one dose of vaccine. About 226.9 million people, or 68.4% of the total U.S. population, have completed a primary series.

Of those who have completed a primary series, about 111.8 million people have received a booster dose,* and more than 22.88 million people have received an updated (bivalent) booster dose. But 49.3% of the total booster-eligible population has not yet received a booster dose. Booster dose eligibility varies by age and health condition.

CDC Community Levels

As of October 27, 2022, there are 73 (2.3%) counties, districts, or territories with a high COVID-19 Community Level, 705 (21.9%) counties with a medium Community Level, and 2,439 (75.8%) counties with a low Community Level. Compared with last week, this represents a minor increase (+0.8 percentage points) in the number of high-level counties, a minor increase (+4.4 percentage points) in the number of medium-level counties, and a minor decrease (-5.2 percentage points) in the number of low-level counties. Overall, 46 out of 52 jurisdictions** had high- or medium-level counties this week. California, Delaware, the District of Columbia, Hawaii, North Carolina, and South Carolina are the only jurisdictions to have all counties at low Community Levels.

Here’s this week’s CDC FluView.

Key FluView Points for the week ended October 22:

  • Influenza activity continues to increase. Regions 4 (southeast) and 6 (south-central) are reporting the highest levels of flu activity.
  • The first influenza-associated pediatric death of the 2022-2023 season was reported this week.
  • CDC estimates that, so far this season, there have been at least 880,000 flu illnesses, 6,900 hospitalizations, and 360 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 42 during previous seasons going back to 2010-2011.
  • An annual flu vaccine is the best way to protect against flu. Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with flu.
  • CDC recommends that everyone ages 6 months and older get a flu vaccine annually.
  • There are also prescription flu antiviral drugs that can be used to treat flu illness; those need to be started as early as possible.

The Wall Street Journal adds

  • An estimated 21% of adults have gotten a flu vaccine this year, similar to estimates from the same time last year, the CDC said, basing its estimates off an Ipsos survey conducted in early October. An estimated 22% of children have also gotten a flu shot, according to the CDC’s national immunization survey.
  • It is too early to tell how effective this year’s vaccine will be, the CDC said. But the influenza virus that is being most often reported, a strain of influenza A called H3N2, matches well with the formation of this year’s shot, health experts said.

The CDC has an updated RSV page with prevention and symptom guidance. Yahoo News adds “U.S. officials are working on a respiratory syncytial virus (RSV) vaccine, but until one is available people should exercise caution, especially seniors and parents of young children, the nation’s top infectious disease official said.”

In other virus news, Prescision Vaccinations discusses the severe impact that monkeypox infections can have on immunocompromised people, such as those with HIV or AIDs.

Following up on yesterday’s note on the Kaiser Family Foundation’s 2022 Employer Health Benefit Survey

  • Beckers Payer Issues calls four figures to our attention.
  • Kaiser Family Foundation delves into the survey’s findings about employer sponsored mental health programs.

From the U.S. healthcare business front, BioPharma Dive reports on Gilead’s third quarter earnings report.

The results [which exceeded Wall Street expectations] were, in part, tied to growing sales from Gilead’s cell therapy business, which consists of the marketed cancer drugs Yescarta and Tecartus. Together, sales from the two drugs totaled $398 million in the third quarter, a nearly 80% increase from the same three-month period a year prior. * * *

Third quarter sales of Tecartus were up 72% year over year, reaching $81 million, while those for Yescarta rose 81% to $317 million. Gilead cited the approval of Yescarta as a “second-line” therapy for a type of hard-to-treat lymphoma, which happened in April, as a main reason for the uptick.

Other cell therapy developers have recorded larger sales from their products as well, though not to the same extent as Gilead.

From the Medicare front, the Centers for Medicare and Medicaid Services announced issuing a

final rule that updates Medicare enrollment and eligibility rules to expand coverage for people with Medicare and advance health equity. The final rule, which implements changes made by the Consolidated Appropriations Act, 2021 (CAA), makes it easier for people to enroll in Medicare and eliminates delays in coverage. Among these changes, individuals will now have Medicare coverage the month immediately after their enrollment, thereby reducing any delays in coverage. In addition, the rule expands access through Medicare special enrollment periods (SEPs) and allows certain eligible beneficiaries to receive Medicare Part B coverage without a late enrollment penalty.

To view a fact sheet on the final rule, visit: https://www.cms.gov/newsroom/fact- sheets/implementing-certain-provisions-consolidated-appropriations-act-2021-and- other-revisions-medicare-2

To view the final rule, visit: https://www.federalregister.gov/public-inspection

From the OPM front, Federal News Network offers insights into the recently released Federal Employee Viewpoint Survey.

Tuesday’s Tidbits

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

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

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.

Weekend update

Congress remains on the campaign trail this week.

From the public health front —

  • Fortune Well considers a change in the spread of Omicron. “COVID has splintered into multiple variants dominating different countries at the same time. Experts say these are some scenarios could play out.”
  • The American Medical Association answers patient FAQs about the upcoming winter in which Covid is not expected to eclipse the flu.
  • The FDA encourages Americans, including children, to get the flu vaccine.
  • Fortune Well provides advice on who is a candidate for the monkeypox vaccine now that this vaccine is more widely available.

The Bill and Melinda Gates Foundation says it will commit $1.2 billion to the effort to end polio worldwide.

The money will be used to help implement the Global Polio Eradication Initiative’s strategy through 2026. The initiative is trying to end the polio virus in Pakistan and Afghanistan, the last two endemic countries, the foundation said in a statement Sunday.

The money also will be used to stop outbreaks of new variants of the virus. The announcement was made Sunday at the World Health Summit in Berlin. 

The foundation says in a statement on its website that it has contributed nearly $5 billion to the polio eradication initiative. The initiative is trying to integrate polio campaigns into broader health services, while it scales up use of the novel oral polio vaccine type 2. 

The group also is working to make national health systems stronger so countries are better prepared for future health threats, the statement said. 

From the price transparency front, two consultants from the Berkley Research Group advise in Healthcare Dive

Payers can use hospital transparency data to gain insights regarding the rates hospitals have negotiated with other payers, which potentially can be used during contract negotiations. For example, payers can evaluate the negotiated rates for specific hospitals compared to their competitor health plans to gauge alignment with their proposed rates and discounts. This is illustrated in Figure 2, which shows the average negotiated rates for a CT scan of the abdomen (CPT 74177) for each payer who contracts with Loyola University Medical Center near Chicago, compared to the hospital’s standard billed charge for the procedure. As shown in the graph, the average negotiated rate as a percentage of billed charges (list price) ranges from 3% to 24% (about $200 to $1,800).

The article offers other approaches to using hospital transparency data, e.g., geographic methods.

From the Rx coverage front

Beckers Hospital Review tells us

CVS Health wants to be in charge of the “entire spectrum of someone’s health journey,” the company’s chief executive said at an Oct. 12 event in Boston reported on by the Boston Business Journal.

CEO Karen Lynch pointed to how the company already delivers medication at the pharmacy, finances treatments through insurance company Aetna, provides low-cost urgent care at its MinuteClinics, and now intends to give care at home through its planned $8 billion acquisition of Signify Health, she reportedly said at the Boston College Chief Executives Club meeting.

Ms. Lynch said the company also plans to expand into primary care and expects to announce an acquisition later this year, the Business Journal reported Oct. 13. CVS is rumored to be in exclusive talksto buy Cano Health, a primary care firm focused on seniors.

Ms. Lynch told the crowd CVS has advantages over fellow healthcare disruptor Amazon, which recently agreed to acquire primary care chain One Medical for $3.9 billion, according to the story. “[Customers] really want to trust and engage with companies that have earned the right to be in healthcare,” she said. “I think about Amazon as sort of a transactional company today.”

The American Hospital Association informs us

President Biden today directed the Center for Medicare and Medicaid Innovation to consider new payment and delivery models to lower drug costs and promote access to innovative drug therapies for beneficiaries, and report within 90 days on its plan and timeline for testing selected models. AHA will update members as more information on the plan becomes available.

The White House also released a fact sheet on this executive order.

The American Medical Association issued a research report titled “Competition in Commercial PBM Markets and Vertical Integration of Health Insurers with PBMs.” The report is chock-a-block full of various PBM rankings.

Speaking of the CMS innovation center, the American Hospital Association reports

The Centers for Medicare & Medicaid Services will extend through 2025 the Bundled Payments for Care Improvement Advanced model, which was set to expire this year. CMS launched the alternative payment model in 2018 to test whether bundling Medicare payments for certain inpatient and outpatient care reduces spending and improves quality. The agency expects early next year to request applications from Medicare providers, suppliers and accountable care organizations to participate in the two-year extension, which will include changes to the pricing methodology.

Friday Stats and More

Based on the Centers for Disease Control’s Covid Data Tracker and Thursday as the first day of the week, the FEHBlog presents his weekly chart of new Covid cases for 2022.

The CDC’s weekly interpretation of its Covid statistics reports

As of October 12, 2022, the current 7-day moving average of daily new cases (38,949) decreased 11.9% compared with the previous 7-day moving average (44,233). 

CDC Nowcast projections* for the week ending October 1, 2022 estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are eight designated as Omicron: BA.5, BA.4.6, BQ.1.1, BQ.1, BF.7, BA2.75.2, BA.2.75, and BA.4. The predominant Omicron lineage is BA.5, projected to be 67.9% (95% PI 64.1-71.4%).

The Wall Street Journal points out

New offshoots of the Omicron Covid-19 variant that virus experts say appear to spread easily are on the rise in the U.S., the latest federal data show, underscoring how the virus is mutating and presenting new risks as it proliferates.

Two of the Omicron subvariants, both related to the BA.5 version that drove the most recent U.S. surge, are called BQ.1 and BQ.1.1. They were estimated to represent a combined 11.4% of U.S. Covid-19 cases by mid-October, according to estimates the Centers for Disease Control and Prevention released Friday. * * *

Virus experts said that, because the newer subvariants remain in the Omicron family, updated Covid-19 vaccines in the U.S. should be an important shield against severe illness and death, though data is limited. The bivalent shots were designed to fight the original virus strain as well as the BA.4 and BA.5 Omicron subvariants.

Here is the CDC’s “Daily Trends in Number of New COVID-19 Hospital Admissions in the United States” chart.

The CDC’s summary explains “The current 7-day daily average for October 5–11, 2022, was 3,268. This is a 4.4% decrease from the prior 7-day average (3,419) from September 28–October 4, 2022.”

The Wall Street Journal adds

Nationally, key metrics such as hospitalizations have largely been on a downward trajectory since late July, following a BA.5-fueled summertime surge, but with some recent signs of wavering. Wastewater virus readings have been choppy in recent weeks due to a climb in the Northeast, according to data from Biobot Analytics. The Northeast has also seen a recent rise in new Covid-19 hospital admissions, federal data show.

The FEHBlog presents his weekly chart of new Covid deaths for 2022

The CDC’s summary explains “The current 7-day moving average of new deaths (328) decreased 8.5% compared with the previous 7-day moving average (359).”

The Wall Street Journal adds

The country has recently averaged about 330 newly reported Covid-19 deaths each day, a continued burden falling heavily on the elderly and people with underlying health issues, including compromised immune systems. * * *

The interplay of a changing virus and fading immune protection from earlier infections and vaccine shots has left people vulnerable to repeated cases. These can lead in some cases to long-running symptoms. But virus experts say built-up protections from vaccines and prior infections still matter and can help limit hospitalizations and deaths.

The FEHBlog presents his weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 through the 41st week of 2022:

The CDC’s summary explains

As of October 12, 2022, 627.9 million vaccine doses have been administered in the United States. Overall, about 265.1 million people, or 79.9% of the total U.S. population, have received at least one dose of vaccine. About 226.2 million people, or 68.1% of the total U.S. population, have completed a primary series.

It strikes the FEHBlog as odd that the CDC’s Covid daily reporting does not include dispensing of oral antiviral drugs for Covid treatment, a vital component of the Covid suppression strategy.

Yesterday, the Secretary of Health and Human Services renewed the Covid public health emergency for another 90 days. The American Hospital Association comments

The AHA had urged HHS to renew the public health emergency to continue critical flexibilities hospitals depend on to deliver needed care, and minimize additional disruptions to an “increasingly fragile” health care delivery system.

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

UnitedHealth beat Wall Street expectations on both earnings and revenue in the third quarter with revenue of $80.9 billion, up 12% year over year. The healthcare giant increased its 2022 earnings expectations as a result.

Minnetonka, Minnesota-based UnitedHealth chalked the rise up to an increase in members served by payer UnitedHealthcare and growth in value-based care arrangements and care delivery platforms at Optum. Both businesses reported double-digit growth.

On a call with investors Friday morning, CFO John Rex said that UnitedHealth expects Change Healthcare — the data analytics business UnitedHealth acquired earlier this month despite a challenge from regulators — to be accretive to Optum’s earnings next year, not in 2022 as previously expected.

From the FEHB front

  • Kaiser Health News reports on a “New Generation of Weight Loss Medications Offer Promise — But at a Price.” FEHB plan enrollees will find expanded coverage of the drugs for 2023 due to a sensible OPM requirement in the 2023 call letter.

In other open season news, the Department of Health and Human Services issued a press release on the Medicare Open Enrollment period, which begins on Saturday, October 15.

Thursday Miscellany

From the FEHB front, the Federal Times discusses one of OPM’s 2023 FEHB initiatives, coverage of gender-affirming care.

OPM announced

The Office of Personnel Management (OPM) migrated from the legacy application responsible for the financial management activities of over $1.1+ trillion-dollar trust fund assets to a modernized financial system platform that is managed and maintained by the Department of the Treasury, Bureau of the Fiscal Service’s Administrative Resource Center (ARC).

The partnership between OPM and ARC will result in millions of taxpayer dollars saved, and enable a modernized, secure financial management solution and re-engineered processes to support the administration of the earned benefits program which includes retirement, health, and life insurance. As a result, millions of federal employees, retirees, and their families should have increased confidence in the programs that ensure they can meet their retirement and healthcare and life insurance needs.

Here’s the related ARC press release. ARC is a federal government center of excellence. The FEHBlog is interested in reading more details on the benefits of this new system.

From the public policy front, here are links to AHIP’s press releases from this week on the ACA individual non-discrimination rule, Section 1557, and its favorable reaction to CMS’s idea to create a national provider directory.

Healthcare Dive tells us

A regulatory deadline kicked in Thursday requiring providers and other healthcare entities to be able to share a significantly larger scope of data with patients, despite major provider groups arguing they’re not ready to comply.

As of Thursday, information blocking regulations apply to all electronic health information in a record that qualifies as protected health information under the Health Insurance Portability and Accountability Act.

Previously, providers only had to make available data elements in a specific dataset called United States Core Data for Interoperability.

Time will tell us about the rule’s effect.

From the Medicare front, Forbes offers a deep dive into 2023 adjustments to the Medicare Parts B and D beneficiary income premium adjustments known as IRMMA. IRMAA impacts many federal annuitants, which causes an ongoing material reduction in new federal annuitants signing in for Part B. The kick in the pants is that when an annuitant’s income declines below that IRMMA level which typically happens over time, the Part B premium is unaffordable due to the late enrollment penalty.

From the public health front —

The Centers for Disease Control is calling attention to its patient and provider education materials on sepsis.

The American Hospital Association informs us

More than 2.5 million students in grades 6-12 reported using electronic cigarettes in the past 30 days when surveyed this year, including 14% of high school students and 3% of middle school students, the Centers for Disease Control and Prevention reported today. One in four students who used e-cigarettes used them daily, 8 in 10 used flavored e-cigarettes and over half used disposable e-cigarettes. Since 2014, U.S. youth have used e-cigarettes more than any other tobacco product.

“It’s critical that we work together to prevent youth from starting to use any tobacco product — including e-cigarettes — and help all youth who do use them, to quit,” said Deirdre Lawrence Kittner, director of CDC’s Office on Smoking and Health. 

For more information, see the CDC fact sheet for health care providers and tools to help teens quit.

From the Rx coverage front,

The New York Times informs us

A new medication for A.L.S., the devastating neurological disorder that causes paralysis and death, will have a list price of $158,000 a year, its manufacturer disclosed Friday.

The treatment, to be marketed as Relyvrio, is a combination of two existing drugs and will be available to patients in the United States in about four to six weeks, according to officials of the company, Amylyx Pharmaceuticals.

The Institute for Clinical and Economic Research has observed

Last week, the FDA approved Relyvrio, Amylyx Pharma’s therapy for amyotrophic lateral sclerosis. Even in the absence of definitive proof of efficacy, there are clear benefits to ensuring patients with a rapidly fatal disease have early access to a safe therapy. In a situation like this, we believe the manufacturer has an obligation to price responsibly. ICER concluded that an annual price of $9,100 to $30,700 would be reasonable if the therapy actually works. While awaiting proof, we believe that patients would benefit from a price closer to the price of production of Relyvrio.

Ruh roh.

Fierce Health reports

Beginning this month, the Pennsylvania-based plan and Mark Cuban’s drug company (MCCPDC) will begin to let members and community organizations know about their collaboration and how they can access low-cost drugs, according to a press release. In 2023, Capital Blue Cross members will be able to use their insurance cards at the company’s online pharmacy. 

The online pharmacy launched earlier this year, aiming to disrupt skyrocketing prescription drug prices in the U.S. It currently offers nearly 1,000 generic prescription drugs that it says reflect manufacturer prices plus a 15% fee.  * * *

While initially, MCCPDC was planning to launch its own pharmacy benefit manager, it then scrapped those plans, announcing its first PBM partnership last week. The PBM has no rebates and no spread pricing. Some experts have cautioned that while the company’s effort is effective, it isn’t tackling a more pressing problem—brand-name drug prices, given generic drugs are up to 85% less expensive. The company is hoping to offer brand-name drugs down the line, CNBC reports.

Tuesday Tidbits

From the Federal Employee Benefits Open Season front, OPM released its Open Season press announcement today. Its lede is

Thousands of Enrollees Are Leaving Valuable Savings on the Table During Open Season
Enrollees should use Open Season as a period to conduct a wellness or financial check-up and reassess their health needs and coverage

Among other guidance, OPM recommends

Below we’ve provided sample questions to help you assess how you can utilize Open Season to review your benefits and needs to make an informed decision on coverage:

What are my and/or my family’s expected health care needs for 2023? 

* Questions while reviewing your FEHB plan: Am I expecting a new baby? Do I need surgery? Will my medication need change? Does my plan provide a pharmacy mail order option for prescriptions?

* Questions while reviewing FEDVIP: Do I want coverage for my routine dental care? Will I need a crown or root canal? Does my child need braces? Do I need glasses and/or contact lenses? Am I considering laser vision correction surgery?

* Questions while reviewing FSAFEDS: Do I have out-of-pocket expenses I need to consider, such as deductibles, copays, day care, elder care, or over-the-counter drugs and medicines? Do I have medical expenses that may not be covered by my FEHB plan? Do I plan to send my children (under 13) to in-home care or summer camp? 

OPM does not mention the availability of the FEHB plan’s summary of benefits and coverage (“SBC”), an Affordable Care Act requirement. The FEHBlog recalls visiting friends in Denver who were preparing for their employers’ open season by comparing these short but comprehensive SBCs. For example, the SBCs include a broken-out estimate of the plan’s cost-sharing for having a baby, receiving diabetes treatment for a year, and fixing a broken bone. In addition, the federal government consumer tested the SBCs.

FEHB plans update their SBCs annually in advance of Open Season and post them on their websites, usually on the page with forms and brochures.

The Washington Post has an article on the 2023 Open Season, and Federal News Network offers “a few” other expert views on the 2023 Open Season. Fierce Healthcare adds

Open enrollment is coming soon, and foremost on everybody’s mind as these windows draw nearer is just how much health insurance will cost, according to a survey by Gravie and Wakefield Research.

“Consumers are concerned about the high costs of health coverage impacting their access to healthcare, increasing medical debt and the lack of mental health coverage,” according to a press release from the two companies.

From the Omicron and siblings’ front —

  • Beckers Hospital Review tells us

The CDC revised its “up to date” COVID-19 vaccination term Sept. 30 to include the primary series and the recently authorized omicron-targeting booster.  * * *

The CDC’s website still deems people who are not immunocompromised as “fully vaccinated” two weeks after their second dose of Moderna or Pfizer’s series or two weeks after receiving J&J’s COVID-19 vaccine. 

[However, last Friday’s] decision could update the “fully vaccinated” term that experts have urged regulators to update.

  • HealthLeaders Media reports “Treating COVID-19 patients with Paxlovid significantly reduces hospitalizations and deaths, according to a recent large-scale study by Epic Research.”

AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each new Omicron subvariant.

But that win streak may slowly come to a close as the FDA told healthcare providers on Monday that one of the emerging subvariants, BA.4.6, renders Evusheld almost completely useless.

Nationally, BA.4.6 currently makes up about 13% of new cases, compared to just 1% of cases at the beginning of July, according to the CDC. But in some regions, like in Iowa, Missouri, Kansas and Nebraska, the BA.4.6 subvariant makes up more than 20% of all Covid-19 cases.

  • David Leonhardt writing in the New York Times Morning column discusses “A Public Health Success Story; We revisit the subject of Covid and racial inequities”. Check it out.
  • The NIH Directors Blog considers “Understanding Long-Term COVID-19 Symptoms and Enhancing Recovery.”

From the mental healthcare front, MedPage Today reports

Suicide risk was higher in people recently diagnosed with dementia, especially younger patients, a case-control study in England showed.

Compared with people who didn’t have dementia, suicides rose in people who received a dementia diagnosis in the past 3 months (adjusted OR 2.47, 95% CI 1.49-4.09), according to Danah Alothman, BMBCh, MPH, of the University of Nottingham in England, and colleagues.

For people under age 65, suicide risk within 3 months of diagnosis was 6.69 times (95% CI 1.49-30.12) higher than in patients without dementia, the researchers reported in JAMA Neurology

From the U.S. healthcare business front, Bloomberg reports on giant drug manufacturer Pfizer’s future

Pfizer Inc. emerged from the Covid-19 pandemic as the world’s most visible drugmaker, but its success has left investors impatient for an encore.

The windfall from the pharmaceutical giant’s Covid vaccine almost doubled its revenue in just one year. And now the shot, coupled with Pfizer’s Covid antiviral pill, is poised to make up more than half of its expected $100 billion of sales in 2022. That’s left Pfizer flush with cash — $28 billion it could spend on the kinds of deals that for decades fueled its growth into an American colossus.

The pressure is clearly on for Pfizer to show that the muscle it built during the pandemic won’t atrophy. Big Pharma companies don’t normally double revenue so quickly, and nobody expects that kind of growth to continue. But one thing’s clear: Pfizer can’t go back to the sluggish path it was on for years.

The American Hospital Association informs us

Operating margins for U.S. hospitals and health systems were down 24% in August compared to a year ago, driven in large part by a 7.2% increase in labor expenses, according to data from over 900 hospitals reported yesterday by Kaufman Hall.

“Nine months into a challenging year, margins have fluctuated wildly,” the report notes. “Although most metrics improved from July to August, organizations are still operating with negative margins and well below pre-pandemic levels.”

From the Medicare front, the American Hospital Association adds

Effective Oct. 1 for five years, the Centers for Medicare & Medicaid Services will pay average sales price plus 8%, rather than ASP plus 6%, for biosimilars whose average sales price does not exceed the price of the reference biological product. The payment increase was included in the Inflation Reduction Act of 2022. For new biosimilars that qualify, the five-year period will begin on the first day of the calendar quarter for which ASP payment for that biosimilar begins under Medicare Part B.

From the electronic health records front, STAT News reports

Epic Systems has revamped its widely criticized sepsis prediction model in a bid to improve its accuracy and make its alerts more meaningful to clinicians trying to snuff out the deadly condition.

Corporate documents obtained by STAT show that Epic is now recommending that its model be trained on a hospital’s own data before clinical use, a major shift aimed at ensuring its predictions are relevant to the actual patient population a hospital treats. The documents also indicate Epic is changing its definition of sepsis onset to a more commonly accepted standard and reducing its reliance on clinician orders for antibiotics as a way to flag the condition.

The changes follow the publication of a series of investigations by STAT that found an earlier version of Epic’s tool resulted in high rates of false alarms at some hospitals and failed to reliably flag sepsis in advance. One of the investigations found that the model’s use of antibiotics as a prediction variable was particularly problematic, resulting in late alarms to physicians who had already recognized the condition and taken action to treat it.

Fierce Healthcare looks into “How Google, Mayo Clinic and Kaiser Permanente tackle AI bias and thorny data privacy problems.”

From the telehealth front, Healthcare Dive reports

Telehealth utilization varied by region from June to July of 2022 and rose 1.9% nationally, according to Fair Health’s monthly tracker data out Monday. 

In the West, Midwest and South, telehealth utilization rose 5.7%, 2.5% and 4.9%, respectively, from June to July. In the Northeast, telehealth use fell 3.3% during that period.

Mental health conditions remained the top diagnoses nationally, and psychiatrists also delivered more virtual care in some regions.