Friday Stats and More

COVID-19

Friday Stats and More

David Ermer–CDC, CMS, COVID-19, Medicare, OPM, U.S. Healthcare–
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.

Thursday Miscellany

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

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

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

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

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

Fingers crossed.

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

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

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

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

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

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

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

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

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

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

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

In other federal employment news,

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

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

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

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

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

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

From the telehealth front —

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

In other U.S. healthcare business news

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

From the Rx coverage front

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

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

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

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

That’s a big bowl of wrong.

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

Midweek update

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

From the Federal Employee Benefits Open Season front —

  • FedWeek offers its Open Season report.

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

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

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

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

Beckers adds

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

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

In other public health news

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

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

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

Roll Call tells us

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

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

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

The National Institutes of Health announced

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

From the Food and Drug Administration front —

BioPharma Dive informs us

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

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

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

Fierce Pharma relates

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

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

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

From the Medicare front – –

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

From the ACA marketplace front —

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

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

From the U.S. healthcare business front —

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

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.

Monday Roundup

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

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

On a related note, Health Payer Intelligence informs us

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

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

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

In other OPM news, Federal News Network reports

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

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

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

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

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

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

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

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

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

The article adds

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

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

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

From the telehealth front, mHealth Intelligence reports

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

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

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

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

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

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

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

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

Weekend update

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

Congress remains on the campaign trail this week.

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

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

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

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

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

From the Omicron and siblings’ front

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

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

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

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

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

In other vaccine news, MedPage Today reports

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

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

From the monkeypox front, Medpage Today adds

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

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

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

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

From the SDOH front, Beckers Payer Issues relates

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

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

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

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

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

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

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

Read the full letter here.

Interesting approach.

From the miscellany department —

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

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

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

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

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

Friday Stats update

David Ermer–COVID-19, Uncategorized–

Heavens to Betsy! The Centers for Disease Control this week stopped posting daily updates of new Covid cases and death which were the basis for the FEHBlog’s Friday Covid charting. The FEHBlog’s work travel has not allowed him time to consider a new approach to his Covid charting.

Alternatively, there’s the CDC’s weekly interpretation of its Covid statistics. The interpretation notes

CDC is using multiple surveillance systems to monitor variants in the United States. Data from each system plays an important role in helping us understand the emergence of new variants, whether they’re entering the United States and spreading, and which variants are most prevalent within communities. On October 20, 2022, COVID Data Tracker added a new Variant Summary page, which summarizes three systems that are being used to monitor variants. For more information on these systems, see A Closer Look.

Have a great weekend.

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.

Tuesday Tidbits

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

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

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

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

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

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

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

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

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

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

From Omicron and siblings front —

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

From the miscellany department

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

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

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

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

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