Midweek Update

OPM

Midweek Update

David Ermer–AHRQ, COVID treatment, COVID-19, HSA, Mental health care, No Surprises Act, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Capitol Hill, the Wall Street Journal reports

Kevin McCarthy and his allies launched a new round of talks late Wednesday with a small but stubborn band of conservative holdouts who have blocked his bid for House speaker, as Republicans sought a path forward following a second day of votes without a winner.

Mr. McCarthy didn’t reach the majority in of three votes on Wednesday, deepening doubts about whether he would ever be able to bring enough Republicans to his side and fueling talk of alternatives.

Twenty GOP lawmakers remained opposed, along with all Democrats, blocking the California Republican from getting the necessary majority of the full House. After the sixth vote, the House adjourned and reconvened at 8 p.m. [at which point the House voted 216 to 214 to call it a day and convene at noon on Thursday.]

A flurry of meetings were taking place by early evening with Republicans shuttling between offices. In one major concession, a McCarthy-aligned super PAC, the Congressional Leadership Fund, agreed to stop picking candidates in primaries where the seat is expected to stay in Republican hands.

From the Omicron and siblings front, we have a man bites dog story.

First Nature informs us that “COVID drug Paxlovid was hailed as a game-changer. What happened?
Insufficient investment and fears about rebound and side effects are driving dowthe n use of a lifesaving antiviral.” The FEHBlog, who has had four Covid vaccinations, points his finger at the government for promoting vaccinations, which, while helpful for older and immunocompromised folks don’t prevent the illness yet, over Paxlovid, a treatment for virtually everyone.

Here’s the twist. CNBC reports

A new antiviral pill for Covid was found to be as effective as Paxlovid at curbing mild to moderate illness among people at high risk of severe disease in a Phase 3 trial in China.

The results, published Wednesday in The New England Journal of Medicine, suggest that the treatment had fewer side effects than Paxlovid, the go-to antiviral for high-risk patients. Around 67% of people who took the experimental pill, called VV116, reported side effects, compared to to 77% who took Paxlovid.

The new pill was also less likely than Paxlovid to cause unexpected side effects due to reactions with other medications, such as those for insomnia, seizures or high blood pressure.

“You have a medication that looks to be just as good as Paxlovid, but less cumbersome,” said Dr. Panagis Galiatsatos, an assistant professor of medicine at Johns Hopkins Medicine in Baltimore.

VV116 is similar to the antiviral remdesivir, which the Food and Drug Administration has approved as an IV infusion. But the team behind the new drug — pharma companies Junshi Biosciences and Vigonvita Life Science — tweaked the formula so that the body can absorb it in pill form, said Dr. Peter Gulick, an associate professor of medicine at Michigan State University. Gilead Sciences, which developed remdesivir, is testing a similar oral version of its drug.

From the Rx coverage front —

  • STAT News reports “Walgreens plans to seek certification to begin providing abortion pills under new Food and Drug Administration rules that allow the drugs to be distributed by retail pharmacies, the company told STAT on Wednesday.” P.S. FEHB plans can only cover abortion drugs when abortion is necessary to save the life of the pregnant woman, or if the pregnancy arises from incest or rape.
  • The Drug Channels blog tells us

For 2022, brand-name drugs’ net prices dropped for an unprecedented fifth consecutive year. What’s more, after adjusting for overall inflation, brand-name drug net prices plunged by almost 9%.

The factors behind declining drug prices will remain in the coming years—and become even stronger due to forthcoming changes in Medicare and Medicaid. Employers, health plans, and PBMs will determine whether patients will share in this ongoing deflation.

Read on for details and make up your own mind. And please pass the news along to the drug pricing flat earthers (#DPFE) who refuse to accept that brand-name drug prices are falling—or that prescription drug spending is a small and stable portion of overall U.S. healthcare expenditures.

  • Health Payer Intelligence tells us

Insulin costs vary based on insurance coverage type and coverage types that lead to high healthcare spending can force patients to ration their insulin supplies, a report from the US Department of Health and Human Services (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) uncovered.

Healthcare spending for individuals who have diabetes—including diabetes treatment, comorbidities, preventive care, and more—amounted to approximately $446 billion total in 2019. Drug costs, including spending on insulin, were responsible for nearly a third of that amount (32 percent).

Insulin users, who tend to be in a more severe stage of the disease, contributed 46 percent of the healthcare spending total among patients with diabetes. Average healthcare spending across the population of insulin users is 4.3 times higher than for non-institutionalized Americans. * * *

Medicare beneficiaries had the highest total out-of-pocket healthcare spending for the drug when compared to privately insured and uninsured individuals’ costs. Medicaid out-of-pocket healthcare spending on insulin was low and hard to estimate.

Most insulin users have either Medicare coverage (52 percent) or private insurance (33 percent). The remainder was covered by Medicaid or reported being uninsured.

It’s worth adding that Medicare covers insulin under Medicare Part B, not Part D.

From the U.S healthcare front —

  • The American Hospital Association relates “U.S. hospitals and health systems continued to experience negative operating margins through November 2022, Kaufman Hall reported today. Median operating margins were down 44% so far this year compared with 2021, as high labor and other costs continued to outpace revenues, according to data from over 900 hospitals.”
  • BioPharma Dive reports “Moderna said Wednesday it will pay $85 million to buy OriCiro Genomics, describing the company’s tools as “best in class” for the synthesis of plasmid DNA.”

From the telehealth front

  • The Agency for Healthcare Quality and Research released a report on the use of telehealth during the Covid era.
  • The Society for Human Resource Management reminds us “Employers [sponsoring health plans including FEHB plans] will have the option to provide pre-deductible coverage of telehealth services for people with high-deductible health plans for another two years [through December 31, 2024].

From the No Surprises Act front, Health Dive digs into the recent CMS report on first-year experience with the NSA’s arbitration process.

The report from regulators provides insight on how the arbitration system is faring so far. It helps paint a picture of how frequently the portal is being used and the types of services payers and providers found themselves fighting over. It also shows what providers have initiated the most disputes.

The vast majority of disputes originated from emergency room visits.

About 81% of disputes (excluding air ambulance services) started in the emergency room.

The entities that initiated the most [arbitrations] were mainly physician staffing and revenue cycle management firms, including TeamHealth and Envision Healthcare, private equity backed practices that staff emergency rooms around the country. As a business strategy, the two work out of network, which can lead to surprise billing if the hospital remains in network, according to a prior study from Yale researchers.

The 10 groups that submitted the most disputes accounted for 75% of all the disputes involving out-of-network emergency services and non-emergency items.

From the public health front, “the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) released the results of its annual National Survey on Drug Use and Health (NSDUH), which shows how people living in America reported about their experience with mental health conditions, substance use, and pursuit of treatment in 2021. The 2021 NSDUH national report includes selected estimates by race, ethnicity, and age group. It is the most comprehensive report on substance use and mental health indicators that SAMHSA has released to date.” This HHS announcement summarizes the survey’s findings.

From the OPM front, Federal News Network reports on OPM’s plans to refresh its website, which in the FEHBlog’s opinion can’t come soon enough. “Aside from overhauling its main website, OPM is also planning to make more updates to its retirement services. It’s the area of the agency that encompasses the most legacy — or outdated — technology in all of OPM, [an OPM spokesperson] said. Bravo.

Happy New Year 2023

David Ermer–ACA, Congress, COVID-19, OPM–

NPR shares its favorite articles with “actionable, evidence-based strategies for cultivating a healthy body and mind.”

Fortune Well identifies “six foods and drinks to choose in the New Year to improve mood, energy, and longevity” and discusses the differences between dry January and damp January.

The American Medical Associations tells us about what doctors wish their patients knew about effective New Years resolutions.

From Capitol Hill, the Wall Street Journal reports

A new era of divided government dawns this week as the 118th Congress begins, with Republicans looking to deploy their power with a fragile majority in the House and Democrats doing the same in the Senate.

The House of Representatives will convene on Tuesday, a date designated by the 20th Amendment of the U.S. Constitution that stipulates Congress should begin each new session at noon on Jan. 3.

The first order of business will be electing a new Speaker. The last time that the election went beyond one ballot was one hundred years ago, but the streak could be broken tomorrow as Roll Call explains.

The Senate whose leadership is not changing will hold a routine opening day tomorrow.

No Congressional Committee hearings will be held this week.

From the Omicron and siblings front, NBC News and Forbes each offer detailed looks at the latest dominant Omicron variant XBB and XBB 1.5. NBC News states

“It’s clear that there’s immune evasive properties of XBB,” said Dr. Isaach Bogoch, an infectious disease physician and epidemiologist at the University of Toronto. “That’s been demonstrated both in laboratory studies and seen clinically in cases and hospitalizations.” 

Given the high level of population immunity in the U.S. — either through infection, vaccination or both — Bogoch and others hope that, even if cases start to rise significantly, there won’t be a dramatic spike in hospitalizations or deaths as seen in previous waves. 

Antibody studies don’t tell the whole story. Other parts of the immune system can protect against the virus and the Covid vaccines should remain effective at preventing severe illness and death from the virus, evidence suggests.

From the FEHB front, the Postal Service’s Inspector General released a “primer” on the 2022 Postal Reform Act, which requires a new Postal Service Health Benefits Program to be launched in two years.

From the Affordable Care Act marketplace, Health Payer Intelligence informs us

Affordable Care Act (ACA) marketplace enrollment has grown 18 percent from last year, with 11.5 million people signing up for coverage as of December 15, 2022, HHS announced.

“Unprecedented investments lead to unprecedented results. Under President Biden’s leadership, we have strengthened the Affordable Care Act Marketplace with continued record affordability, robust competition, and historic outreach efforts – and today’s enrollment numbers reflect that,” HHS Secretary Xavier Becerra said in the press release. * * *

“Thanks to the Inflation Reduction Act, four out of five customers will be able to find a plan for $10 or less. As we head into the new year, there is no greater gift than the peace of mind that comes with having high-quality, affordable health care. There is still time to sign up until January 15 – visit HealthCare.gov today,” Becerra added.

Friday Stats and More

David Ermer–CDC, COVID-19, FDA, No Surprises Act, OPM, Rx coverage–
Photo by Sincerely Media on Unsplash

The CDC’s Covid Data Tracker for the week ended December 29, 2022, informs us:

  • New Covid cases totaled 402,525, down 84,000 cases from the previous week.
  • The daily average of new Covid hospital admissions was 5,,668 up 3.7% from the previous week.
  • New Covid deaths totaled 2,530, down 400 deaths from the previous week.
  • 17.3% of the U.S. population aged 18 and older and 37.5% of the U.S. population aged 65 and older have received the bivalent booster.

The CDC’s weekly Fluview tells us

  • Seasonal influenza activity remains high but continues to decline in most areas.
  • Of influenza A viruses detected and subtyped during week 51, 83% were influenza A(H3N2) and 17% were influenza A(H1N1).
  • Fourteen influenza-associated pediatric deaths were reported this week, for a total of 61 pediatric flu deaths reported so far this season.
  • CDC estimates that, so far this season, there have been at least 20 million illnesses, 210,000 hospitalizations, and 13,000 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system was more than 4 times higher than the highest cumulative in-season hospitalization rate observed for week 51 during previous seasons going back to 2010-2011. However, this in-season rate is still lower than end-of-season hospitalization rates for all but 4 pre-COVID-19-pandemic seasons going back to 2010-2011.
  • The number of flu hospital admissions reported in the HHS Protect system decreased nationally from the week prior for the third week in a row.

From the No Surprises Act front, STAT News reports

Health care providers are swamping the government with billing disputes under the new law that bans surprise medical bills. So far, just 4% have ended in payment. 

That’s according to the Biden administration’s progress report on the No Surprises Act’s so-called independent dispute resolution (IDR) process, in which mediators help out-of-network providers and insurers decide appropriate payment amounts for services. So far, the government is fielding a much higher volume of requests than expected, mostly related to emergency services. Health care providers, air ambulance providers, and companies working for them submitted about 90,000 out-of-network payment disputes between April 15 and Sept. 30, far more than the roughly 17,000 anticipated in a full year. 

Also exceeding expectations is the complexity of the cases and the time it’s taking to reach resolutions, which has led to a severe backlog of disputes awaiting resolution. Of the roughly 23,000 cases closed so far, mediators made payment determinations in about 3,600 — 4% of the 90,000 submissions.

In the FEHBlog’s opinion, providers and payers should focus on resolving cases at the initial open negotiation phase. Last week, the NSA regulators announced that the administration cost for one arbitration would increase from $50 to $350 per party, which should encourage payers and providers to reach the FEHBlog’s conclusion.

From the public health front, the Hill relates according to a new CDC report

  • About 526,000 young Americans could have both Type 1 and Type 2 diabetes by 2060, up from 213,000 in 2017 
  • The expected surge is alarming health officials, who say the increase will disproportionately affect minority populations.
  • A potential factor behind the trend could be an increase in childhood obesity.

These statistics place in context this STAT News story titled “Wegovy [Novo Nordisk’s latest obesity drug] may help teens with obesity lose weight but isn’t a magic bullet.”

“I’m concerned that doctors are going to rush to judgment and employ a medication that is very expensive and has its own side effects without giving proper consideration of what the actual cause of the problem is,” said Robert Lustig, professor emeritus of pediatrics at the University of California, San Francisco. Wegovy costs more than $1,300 per month and can cause nausea, vomiting, and rare cases of pancreatitis.

Lustig said each teen’s obesity is caused by different genetic, environmental, and behavioral factors and requires tailored treatment. He worries that widespread use of Wegovy could lead physicians to overlook the root causes of an individual’s condition.

“Treating the downstream symptoms of the problem is only putting a Band-Aid on the problem, it’s not fixing the problem,” Lustig said. “I’m worried that Wegovy is a Band-Aid.”

Since Wegovy, Saxenda, and other drugs are meant to be taken over the long term to maintain weight loss — potentially the rest of an individual’s life — teenagers would be on the medication for an especially long time, and there isn’t yet information on the effects of the drug over that time span, Lustig added.

The FEHBlog did not realize that these are long-term drugs.

In other Rx coverage news, the Food and Drug Administration on Wednesday

approved Briumvi (ublituximab-xiiy) injection for treating patients with relapsing forms of multiple sclerosis (RMS) in adults. Researchers demonstrated Briumvi’s efficacy in two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either Briumvi or teriflunomide, the active comparator. The primary outcome of both studies was the annualized relapse rate (ARR) over the treatment period. In both studies, Briumvi significantly lowered the ARR compared to teriflunomide. The most common adverse reactions were infusion reactions, including fever, chills, headache, influenza-like illness, elevated heart rate, nausea, throat irritation, reddening of the skin (erythema) and an anaphylactic (allergic) reaction; infections including serious and fatal bacterial, fungal, and new or reactivated viral infections and reduction in immunoglobulins.

From the miscellany department

  • Govexec reports on the Postmaster General’s plans for next year.
  • Milliman suggests “how to understand and impact health plan administrative expenses.”
  • The New York Times Morning column provides good year-end news: After spiking in 2020 and 2021, murders in large U.S. cities had decreased more than 5% this year and gun deaths, injuries, and mass shootings are also down this year. The Times attributes the drop to Covid’s transition to endemic status.

Boxing Day Update

David Ermer–Congress, FDA, OPM, Rx coverage–

Congress is on a State / District work break until January 3, 2023, when the 118th Congress convenes.

Govexec informs us

President Biden on Friday issued an executive order implementing his plan to provide federal civilian employees with an average 4.6% pay raise in January.

As proposed in his fiscal 2023 budget plan last March, the raise provides federal workers with a 4.1% across-the-board raise to basic pay, as well as an average 0.5% increase in locality pay. * * *

The Office of Personnel Management now must publish pay tables outlining the pay raise across all General Schedule pay grades and locality pay areas. Once updated, they will be available on the OPM website. The pay raise will go into effect for the first full pay period of 2023.

From the public health front —

  • The Wall Street Journal spoke with ear, nose, and throat specialists about they treat their own flu and colds.
  • McKinsey Consulting suggests the secret to great health is escaping the healthcare matrix. “The blueprint for achieving a lifetime of great health is increasingly clear and within our control. But unlocking it requires challenging the orthodoxies currently guiding individuals and institutions.”

From the Rx coverage front —

  • The Wall Street Journal delves into health plan strategies for covering million-dollar-plus gene therapies.

A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription. 

Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.

HRT said it would give away one-tenth of its product and sell the rest to pharmacies, public-sector employees and groups that work with drug users at-cost, about $18 a dose. HRT said it plans to produce 2 million doses a year.  * * *

Emergent BioSolutions Inc., maker of the Narcan brand of naloxone nasal spray, said earlier this month that its application for over-the-counter status had received an expected approval date of March 29. The company’s two-dose prescription-only nasal spray was selling at pharmacies recently at a cash price of more than $100 without insurance.

Pocket Naloxone Corp. is applying for a nasal-swab version of the drug it said would be cheaper than nasal-spray versions. The startup said earlier this month that it submitted results to the FDA showing that its drug works more quickly than prescription versions. * * *

Other nonprofits are also working to lower drug prices. Civica Rx, a nonprofit founded in 2018, introduced a cancer drug this year with a recommended price of $171 a month versus more than $3,000 a month without discounts for an older version charged to patients on Medicare Part D. Medicines360, a women’s health group, developed a hormonal intrauterine birth-control device it said it sells to safety-net clinics for $100, about a 90% discount.

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, COVID treatment, COVID-19, COVID-19 testing, FDA, HSA, NIH, OPM, Rx coverage–

From Capitol Hill, the American Hospital Association tells us

The Senate today passed (68-29) an amended version of the $1.7 trillion omnibus appropriations bill that funds the federal government through the end of the current fiscal year. The legislation also includes many provisions affecting hospitals and health systems.

The Senate also passed another short-term continuing resolution through Dec. 30 to allow time for the more than 4,000-page legislation to be enrolled and for President Biden to sign it. This ensures there will be no interruption of services or federal shutdown.

The omnibus spending bill, which includes relief from Medicare cuts and extensions of rural and telehealth programs, as well as the Dec. 30 continuing resolution, now go to the House, which is expected to consider them today . The president is expected to sign the short-term continuing resolution before current funding for the government expires at 11:59 p.m. ET on Dec. 23, and to sign the omnibus later next week.

The Wall Street Journal adds, “House Majority Leader Steny Hoyer (D., Md.) said the House would vote on the bill Friday.”

In other 2023 Consolidated Appropriations Act or omnibus news

  • The Hill reports on “last minute” changes to the omnibus, including provisions assisting nursing and pregnant workers.
  • Mercer Consulting alerts us to a two-year-long extension of telehealth flexibilities available to high deductible plans with health savings accounts.
  • Think Advisor and the Wall Street Journal provide an overview of the Secure 2.0 Act provisions in the omnibus. The Secure 2.0 Act affects 401(k) plans offered to employees and IRAs. The key provision that takes effect for 2023 is an increase in the required minimum distribution age from 72 to 73.
  • The Wall Street Journal reviews the other omnibus provisions affecting businesses.

From the public health front —

Beckers Hospital Review informs us

While the respiratory “tripledemic” continues to slam emergency rooms and children’s hospitals, there are two glimmers of hope on the horizon, according to a Dec. 22 report in The New York Times. 

COVID-19, the flu and respiratory syncytial virus attack the body in different ways, and there are varying levels of disease severity across the U.S. Today, some scientists say RSV has peaked in most parts of the country.

“I think it’s likely that the RSV season has peaked in most parts of the country,” said Virginia Pitzer, ScD, an infectious disease epidemiologist at New Haven, Conn.-based Yale School of Public Health. “I think that there is a light at the end of the tunnel.”

Additionally, there’s reason to believe next winter won’t be as burdensome for the American population and healthcare organizations.

Ironically, the safety precautions used to help stem the pandemic in the past couple of years have also kept adults and children from being exposed to the viruses that typically circulate this time of year, said Dr. Pitzer.

“There was a bit of a buildup of susceptibility at the population level,” she added. “It’s a worse than normal winter, but one that hopefully will not be repeated next year.”STS

The American Hospital Association tells us

The Society for Healthcare Epidemiology of America today recommended hospitals and health systems no longer routinely screen symptom-free patients for COVID-19 upon admission or before procedures and rely instead on enhanced layers of infection prevention interventions.

“The small benefits that could come from asymptomatic testing at this stage in the pandemic are overridden by potential harms from delays in procedures, delays in patient transfers, and strains on laboratory capacity and personnel,” said Thomas R. Talbot, M.D., MPH, the chief hospital epidemiologist at Vanderbilt University Medical Center, and a member of the SHEA Board of Directors. “Since some tests can detect residual virus for a long period, patients who test positive may not be contagious.”

STAT News reports

[According to a CDC report, a] baby born in the U.S. in 2021 has a life expectancy of 76.4 years, down from 77 years in 2020 and the lowest level the CDC has recorded since 1996. The age-adjusted death rate for Covid rose by 22.5% between 2020 and 2021, while death rates from unintentional injuries — one-third of which come from overdoses — rose by 12.3%.

HHS’s Agency for Healthcare Quality and Researched refreshed its Healthcare Cost and Utilization Project Fast Stats website. The site provides “summary statistics on inpatient stays, emergency department visits, and priority topics, by select characteristics.”

From the OPM front, OPM’s medical director, Dr. Ron Kline announced today on Linked In that he is leaving OPM to take a new position beginning January 17, 2023 as

the Chief Medical Officer of the Quality Measurement and Value-Based Incentives Group (QMVIG) at the Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS).

QMVIG is responsible for developing, evaluating and supporting the implementation of quality measurement programs across the entire federally-supported health care continuum. This includes Medicare’s Quality Payment Program and the Inpatient (i.e. Hospital) Quality Reporting Program. These measures and policies guide these innovative programs to improve healthcare quality for all Americans.

Best wishes, Dr. Kline, and thanks for your work with the FEHB over the past 3 1/2 years.

From the Rx coverage and medical research fronts –

MPR reports

The Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for intravenous (IV) use to treat COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

ICER released evidence reports on Alzheimer’s Disease treatments (draft) and hemophilia A and B (final) STAT News explains

The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday.

The Institute for Clinical and Economic Review, or ICER, dug into the evidence for lecanemab and concluded that the drug’s demonstrated benefits, a modest but statistically significant delay in the advance of Alzheimer’s, are worth between $8,500 and $20,600 per year. ICER’s calculations, which could change in response to public comment over the next month, are based on metrics meant to quantify the value of improvements to quality of life.

Eisai, which is leading the effort to commercialize lecanemab, has not disclosed how much it will charge for the medicine, saying only that it will prize affordability and access. That will soon change, as the drug, a twice-monthly infusion, is expected to win a preliminary Food and Drug Administration approval by Jan. 6. * * *

Lecanemab’s safety has come into sharp focus over the past two months after three patients died of major brain bleeds.

Regarding hemophilia therapies, ICER observes

The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of etranacogene dezaparvovec (Hemgenix, CSL Behring,) for hemophilia B. ICER also updated the previous Hemophilia A assessment on valoctocogene roxaparvovec (Roctavian™, BioMarin).  

Key recommendations stemming from the roundtable discussion include:

  • The value of high-impact single and short-term therapies should not be determined exclusively by estimates of long-term cost offsets, particularly when the existing standard of care is acknowledged to be priced significantly higher than reasonable cost-effective levels.
  • Payers should work with manufacturers to develop and implement outcomes-based agreements to address the uncertainty and the high cost of gene therapies for hemophilia.
  • At least one national payer has suggested to patient representatives that step therapy with emicizumab is being considered prior to provision of coverage for Roctavian. Clinical experts and patient experts view this approach as lacking any clinical justification and appears to be only a method for trying to avoid the high one-time fee for gene therapy while assuming that patients may switch insurers before the cost-saving potential of gene therapy is fully realized. In short, step therapy does not appear to be a reasonable consideration for this treatment.

ICER’s detailed set of policy recommendations, including comprehensive considerations for establishing evidence-based prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.

NIH announced

Scientists used patient stem cells and 3D bioprinting to produce eye tissue that will advance understanding of the mechanisms of blinding diseases. The research team from the National Eye Institute (NEI), part of the National Institutes of Health, printed a combination of cells that form the outer blood-retina barrier—eye tissue that supports the retina’s light-sensing photoreceptors. The technique provides a theoretically unlimited supply of patient-derived tissue to study degenerative retinal diseases such as age-related macular degeneration (AMD). 

Amazing.

From the miscellany department, the Wall Street Journal and MedPage Today explore the new AI text tool known as ChatGPT. From the Journal article

If you haven’t yet tried ChatGPT, OpenAI’s new artificial-intelligence chatbot, it will blow your mind. Tell the bot to write you anything—an email apologizing to your boss, an article about the world’s richest hamster, a “Seinfeld” script set in 2022—and it spits out text you’d think was written by a human. Knowledge of the topic, proper punctuation, varied sentence structure, clear organization. It’s all there.

Happy Winter Solstice

David Ermer–Congress, COVID vaccine mandate, COVID-19, FDA, No Surprises Act, OPM, Rx coverage–

Winter is not only coming; winter is here.

From Capitol Hill, the Wall Street Journal reports

Senators were bracing for a late night in the Capitol, as the timing of votes on the $1.65 trillion omnibus spending bill and possible amendments remained uncertain and the Friday night deadline to avoid a government shutdown crept closer. 

The Senate could start voting on amendments later Wednesday, teeing up a late night or early morning of voting, even as they also attend an address to Congress in the evening by Ukrainian President Volodymyr Zelensky. Adding to the pressure, senators are looking to get out of town ahead of winter storms expected in coming days.

“We’re still working on an agreement to vote on amendments and pass the omnibus tonight,” Senate Majority Leader Chuck Schumer (D., N.Y.) said Wednesday night. “We aren’t there yet, we’re making progress.” Once the Senate passes the measure, it would move to the House, which is expected to approve it quickly.

Politico Pulse, STAT News, and the Washington Post offer follow-up stories on the healthcare provisions in the omnibus. Of note, the Washington Post confirms

Congress again rebuffed the White House’s request for new dollars to combat the coronavirus. Last month, Biden administration officials urged lawmakers to approve about $9.25 billion in emergency funds to help ensure access to vaccines and treatments while supporting new research into long covid.

The battle over more funds has been ongoing since the spring, and Republicans have refused to budge, with one Senate GOP aide telling The Health 202 that they want further explanations on how the federal government has spent billions previously allocated for its pandemic response. 

Politico Pulse adds

A long list of measures aimed at tackling the ongoing opioid crisis is in the bill, including $1,575,000,000 in state grants to go toward substance abuse prevention and treatment. It also incorporates significant provisions of the Mainstreaming Addiction Treatment Act, including the elimination of a DEA requirement that clinicians get an extra certification to prescribe buprenorphine, and the NOPAIN Act, which improves access to FDA-approved non-opioid therapies for outpatient surgical procedures.

STAT News explains how the omnibus breathes new life into Medicare’s hospital-at-home program.

What’s more, this week the Senate confirmed the nominations of Rob Schriver to be OPM Deputy Director and Richard Revesz to be director of OMB’s Office of Information and Regulatory Affairs.

From the judicial front –

  • The Society for Human Resource Management tells us, “The 5th U.S. Circuit Court of Appeals recently ruled that the federal government cannot enforce a COVID-19 vaccine mandate on federal contractors. The court’s Dec. 19 decision found that the Biden administration overstepped its authority with the vaccine mandate.”
  • Healthcare Dive discusses the latest hearing before Judge Kernodle in the second Texas Medical Association challenge to the No Surprises Act independent dispute resolution rule. The FEHBlog finds this to be a premature lawsuit at best.

From the public health front

The nose knows why some people still can’t smell long after recovering from Covid-19.

A haywire immune response in the olfactory system was found to explain why some people still can’t smell long after symptoms of the disease have abated, according to a small, peer-reviewed study published Wednesday in the journal Science Translational Medicine. In some cases, the immune or inflammatory response was detected in patients with smell loss up to 16 months after recovery from Covid-19.

Compared with people who can smell normally, patients with long-term smell loss had fewer olfactory sensory neurons, cells in the nose responsible for detecting smells and sending that information to the brain. Patients with lingering loss of smell had an average of 75% fewer of the neurons compared with healthy people, said Brad Goldstein, a study co-author and sinus surgeon at Duke University.

“We think the reduction of sensory neurons is almost definitely related to the inflammation,” Dr. Goldstein said.

  • HHS announced “making an additional supply of Tamiflu available to jurisdictions to respond to an increased demand for the antiviral during this flu season, including through the Strategic National Stockpile (SNS). Jurisdictions will work with their ASPR Regional Teams to evaluate any requests for Tamiflu through the SNS, ensuring that states, territories, and tribes receive the assistance they need without affecting our nation’s preparedness for a future pandemic flu.”
  • Beckers Hospital Review discusses how five payers are addressing maternal health.
  • A JAMA article examines whether “the new CDC Opioid Prescribing Guidelines will help correct the course in pain care.”

From the drug development and distribution front

The Institute for Clinical and Economic Research “posted its revised Evidence Report assessing the comparative clinical effectiveness and value of the following treatments for multiple sclerosis (MS):

Monoclonal Antibodies

  • natalizumab (Tysabri®, Biogen)
  • ofatumumab (Kesimpta®, Novartis)
  • ocrelizumab (Ocrevus®, Genentech)
  • rituximab (Rituxan®, Genentech, and biosimilars)
  • ublituximab (TG Therapeutics)

Oral Therapies

  • dimethyl fumarate (Tecfidera®, Biogen, and generics)
  • diroximel fumarate (Vumerity®, Biogen)
  • monomethyl fumarate (Bafiertam®, Banner Life Sciences)
  • fingolimod (Gilenya®, Novartis)
  • ozanimod (Zeposia®, Bristol Myers Squibb)
  • ponesimod (Ponvory®, Janssen)
  • siponimod (Mayzent®, Novartis)
  • teriflunomide (Aubagio®, Sanofi)

Science reports,

As enthusiasm mounts for a new experimental antibody that appears to slow cognitive decline in some Alzheimer’s patients, a third death linked to the drug during its clinical testing may amplify concerns about its safety. Science has obtained medical records showing a 79-year-old Florida woman participating in an ongoing trial of the antibody died in mid-September after experiencing extensive brain swelling and bleeding, as well as seizures. Multiple neuroscientists who reviewed the records at Science’s request believe her death was likely caused by the antibody, lecanemab.

“The brain swelling and the microhemorrhages … could be a serious side effect of the study medication,” and should be evaluated by trial investigators, says Ellis van Etten, a neuroscientist and neurologist at Leiden University.

Biopharma Dive informs us

  • Pfizer has started dosing patients in a Phase 2 study of its entry into a closely watched class of drugs for treating diabetes and obesity.
  • The dosing of the first patient with the drug, dubbed PF-07081532, triggered a $10 million payment to partner Sosei Heptares, the Japanese drugmaker said Wednesday. Pfizer scientists working with Sosei’s technology discovered the medicine, and Pfizer is responsible for developing it.
  • Pfizer aims to bring a once-daily oral treatment into a class of medicines known as GLP-1 agonists, which stimulate the body to produce insulin by acting on natural body hormones known as glucagon-like peptides. Most of the approved GLP-1 agonists must be injected.

We have a bipartisan Omnibus bill

David Ermer–Congress, COVID treatment, COVID-19, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Capitol Hill, the Washington Post reports

The Senate on Tuesday took the first formal step toward advancing a bipartisan, roughly $1.7 trillion deal to fund the U.S. government, as Democrats and Republicans raced to avert a shutdown in the final days of the year.

Lawmakers voted 70-25 to begin debate on the 4,155-page measure, known in congressional parlance as an omnibus, which would fund key elements of President Biden’s economic agenda, boost defense programs, and provision an additional $44.9 billion in emergency military and economic assistance for Ukraine.

The lumbering Senate sought to move with uncharacteristic haste after congressional leaders released the full text of the bill in the early hours of the morning, capping off months of intense legislating.

Becker’s Hospital CFO Review, the American Hospital Association, and Politico Pulse offer healthcare takeaways from the omnibus. Of note, Congress laid the groundwork for a soft landing following the public health emergency by addressing Medicaid, the AMA’s concern about the impending Medicare Part B cut (“narrowing the cut to 2 percentage points in the year ahead with a scheduled cut of 3.25 percentage points in 2024″) and extending Medicare telehealth flexibilities and most other Pandemic tied flexibilities through 2024.

Govexec and Federal News Network provide omnibus insights on federal agency and employment issues. Of note, Congress implicitly gave the green light to a 4.6% raise for federal employees in 2023, broken out into a 4.1% across-the-board increase and the remainder allocated to locality pay.

Meanwhile, the FEHBlog wishes to point out that the omnibus includes the three now standard FEHB appropriations measures — the Hyde Amendment restrictions on abortion coverage (Division E summary at 63), the prohibition on applying full Cost Accounting Standards coverage to FEHB contracts (Division E summary, p. 93) and the contraceptive coverage mandate (Division E summary at 68).

What’s more, the OPM appropriations measures include the following

Exploring Tools for Prescription Drug Price Transparency in the Federal Employee Health Benefits (FEHB) Program.- OPM is directed to explore and evaluate the benefits and potential overall cost savings resulting from FEHB Carriers’ implementation of Internet-based self-service tools that deliver transparency and clinical decision support on prescription drug costs to its members. OPM is directed to report to the Committees one year after enactment of this Act, contingent on the availability of funding for this study.

In No Surprises Act news, the Internal Revenue Service issued guidance on calculating the qualifying payment amounts in 2023.

For qualifying payment amounts calculated by increasing the median contracted rate for 201913, the qualifying payment amounts for items and services furnished in 2023 are determined by taking the qualifying payment amounts calculated for items and services furnished in 2022 and multiplying the 2022 adjusted qualifying payment amounts by the percentage increase from 2022 to 2023, that is, 1.0768582128.

For example: An item is furnished in 2023. The median contracted rate for the item on January 31, 2019 was $1,500. The 2022 adjusted qualifying payment amount for the item was $1,597 ($1,500 x 1.0648523983). The 2023 adjusted qualifying payment amount for the item is $1,720 ($1,597 x 1.0768582128).

The notice also provides QPA adjustment guidance for plans that began after January 31, 2019.

From the Omicron and siblings front, the Institute for Clinical and Economic Review (ICER) released “an update to the health benefit price benchmark for nirmatrelvir/ritonavir (Paxlovid™, Pfizer) for the treatment of COVID-19.” 

Based on the current evidence, ICER’s health-benefit price benchmark (HBPB) for Paxlovid is $563-$906 per treatment course. 

ICER’s HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.

Of course, at this time, the federal government is covering the cost of Paxlovid for Americans. That may change in 2023 because, contrary to the FEHBlog’s expectation, the omnibus does not appear to include additional funding for Covid vaccines and treatment. However, the FEHBlog is confident that the federal government will find the money if it wants.

From the U.S. healthcare business front, Healthcare Dive tells us

  • Looking to further boost its growing cell therapy business, Gilead Sciences on Wednesday said it plans to acquire Tmunity Therapeutics, a private biotechnology company trying to develop newer, better CAR-T treatments.
  • CAR-T uses genetically engineered T cells to help the body fight diseases like cancer. Gilead currently markets two such products, Yescarta and Tecartus, which it obtained through the $12 billion purchase of Kite Pharma in 2017. Combined, sales of Yescarta and Tecartus were just under $400 million in the third quarter, a nearly 80% increase from the same three-month period a year prior.
  • Gilead said that buying Tmunity should complement Kite’s cell therapy research capabilities by providing a new technology platform, a slate of preclinical- and clinical-stage programs, and a strategic partnership with the University of Pennsylvania. Financial terms of the acquisition weren’t disclosed. The companies expect their deal to close early next year.

In good news, Health Payer Intelligence informs us

The majority of Americans are satisfied with their employer-sponsored health insurance and cited it as the most important benefit an employer can offer, according to a poll conducted by Seven Letter Insight for the Protecting Americans’ Coverage Together (PACT) campaign.

The poll surveyed 2,334 individuals with employer-sponsored health plans between November 14 and November 19, 2022. * * *

Overall satisfaction with employer-sponsored coverage was also high. Most respondents (93 percent) said they were satisfied with their insurance, with 54 percent saying they were highly satisfied. Eighty-seven percent agreed that their plans were affordable, and 73 percent thought their insurance was worth what they paid.

When respondents were asked to describe their employer-sponsored coverage, affordable, high-quality, and comprehensive were the top descriptions, the survey noted.

From the miscellany department —

  • Medscape provides an in-depth look at the progress in the fight against aging.
  • Beckers Hospital Review identifies the top five patient safety issues for 2023.
  • Govexec reports on the progress the federal government’s Merit Systems Performance Board has made since Congress restored the Board’s quorum last May after five years without one.

Midweek Update

David Ermer–ACA, AHRQ, CDC, CMS, Congress, COVID-19, OPM–

From Capitol Hill, the Wall Street Journal reports

The House on Wednesday passed a one-week government funding measure to give congressional negotiators time to complete and pass a full-year omnibus spending bill, overcoming opposition from Republicans who urged postponing any deal until next year, when the GOP will take control of the chamber. * * *

The Senate is expected to next approve the one-week extension [on Thursday December 15]. 

The vote on a one-week continuing resolution, which keeps the government funded at fiscal 2022 spending levels, follows the announcement Tuesday that Democratic and Republican negotiators had reached agreement on a framework and would turn to completing the details. 

From the public health front, Healthcare Dive tells us

  • National health spending grew almost 3% in 2021, reaching $4.3 trillion as big increases in healthcare use and insurance coverage were offset by lower government spending on COVID-19.
  • The year’s growth rate was smaller than the 10% notched in 2020. CMS actuaries chalked the deceleration up to lower federal health spending, which fell 3.5% in 2021 compared to a 37% increase in 2020 as funding to combat the pandemic skyrocketed.
  • Health spending grew at a much slower clip than the nation’s gross domestic product, which increased 11% in 2021 — the largest growth rate since 1984.

Here’s the report which is posted on Health Affairs.

Medscape relates

New more aggressive targets for blood pressure and lipids are among the changes to the annual American Diabetes Association (ADA) Standards of Care in Diabetes — 2023.

The document, long considered the gold standard for care of the more than 100 million Americans living with diabetes and prediabetes, was published December 12 as a supplement in Diabetes Care. The guidelines are also accessible to doctors via an app; last year’s standards were accessed more than 4 million times.

The Agency for Healthcare Quality and Research’s Director is posting a series of four reports concerning the agency’s effort to rethink healthcare quality in view of the fact

In seven years, the United States is expected to reach a demographic tipping point that will redraw the picture of healthcare delivery in America.  

In 2030, all baby boomers [birth dates from 1946 to 1964] will be older than 65, according to the U.S. Census Bureau. Just four years later—in 2034—older adults will outnumber children for the first time in history. The scope of this and future demographic shifts—including our population’s growing racial and ethnic diversity—will profoundly impact how healthcare is accessed, delivered, paid for, and evaluated.

The National Institutes of Health reports “Two randomized, placebo-controlled trials evaluating three Ebola vaccine administration strategies in adults and children found that all the regimens were safe in both age groups, according to results published today in the New England Journal of Medicine.”

Health Payer Intelligence informs us

Privately-insured Americans experienced higher rates of heat-related illness diagnoses in 2021 compared to 2016, in some cases a more than 37 percent increase, according to a report from FAIR Health.

“The Centers for Disease Control and Prevention has identified projected increases in extreme summer heat as one source of adverse health impacts from climate change. However, systematic, national data on trends in heat-related illnesses in the United States have been lacking,” the report began.

From the omicron and siblings front, a subset of public health —

  • The New York Times explores the question — who are the never Coviders? Even if you have never had Covid, you certainly have been impacted mightily by Covid. Nevertheless, it is an interesting article.
  • MedPage Today notes “Long COVID played a role in more than 3,500 deaths in the U.S. since the start of the pandemic, according to data from the CDC’s National Center for Health Statistics (NCHS).” The NCHS report may be overestimating because the first death occurred in April 2020 just after Covid got rolling and the most commonly mentioned term on death certificates with long COVID was “post COVID,” which was mentioned in 89.6% of long COVID-related deaths.” This may be a rare case in which the “retrospectoscope” is cloudy. See Dr. Martin Markary’s opinion piece on long Covid in yesterday’s Wall Street Journal.

From the regulatory front —

  • CMS issued a proposed rule on Medicare Part D changes for 2024.
  • Health Affairs began a series of three informative articles on the proposed 2024 notice of benefit payments and parameters released on Monday.
  • STAT News discusses a feature of the parameters notice that is drawing industry attention. To wit, “The Biden administration signaled Monday that it will require health plans on federal exchanges to cover more of the costs of generic drugs, a small tweak that nevertheless has industry groups divided on how best to manage drug costs.”
  • Health Leaders Media examines the gap that must be bridged to achieve a recent HHS proposed rule’s goal of implementing electronic prior authorization.

In agency event news —

  • OPM issued a press release about its “first government-wide summit for diversity, equity, inclusion, and accessibility (DEIA) on December 6-8, 2022.”
Biden administration outlines how agencies can measure progress toward PMA goals

Weekend update

David Ermer–Congress, Federal employment benefits, No Surprises Act, OPM, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

The House of Representatives and the Senate are in session this week for Committee business and floor voting.

The Wall Street Journal adds

Congressional leaders are set to return to the Capitol on Monday under pressure to negotiate a spending bill that would fund the federal government’s operations beyond Friday.

Negotiators have days to reach a deal on a full-year spending bill or pass a short-term measure delaying the deadline to avoid a partial government shutdown. To reach a longer-term deal, they will have to break the partisan deadlock between Republicans and Democrats, who are split over $26 billion in nondefense spending in talks to craft an omnibus bill. * * *

Senate lawmakers are expected this week to pass a defense policy bill that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19. 

Tomorrow is the last day of the Federal Employee Benefits Open Season. According to OPM, the official end is 11:59 pm “in the location of your electronic enrollment system”

The FEHBlog noticed on Linked In that OPM Director Kiran Ahuja spoke last week at the Milken Institute’s Future of Health Summit.

Director Ahuja spoke about eradicating stigmas surrounding mental health treatment and creating a welcoming work environment for all. 

As the largest employer in the nation, the Federal government must continue to invest in policies, tools, and resources that gives every employee the high quality and accessible mental health supports they need

Hey OPM, why don’t you post the Director’s remarks on opm.gov?

From the infectious disease front, the Secretary of the Treasury has written a letter to the state governors on resources available to combat the tripledemic. The FEHBlog has read articles recommending that we must return to masking and social distancing. The FEHBlog, who is a lawyer, not a health professional, thinks that if we accept this mistaken guidance, we will be tied to masking and social distancing in the winter forever. N.B. This is not a criticism of people who choose to mask social distance. The FEHBlog’s point is that the tripledemic was unavoidable.

From the No Surprises Act (NSA) front, the FEHBlog checked out the docket sheet for the second Texas Medical Association versus the federal NSA regulators challenging the revised final rule implementing the NSA’s independent dispute resolution process without giving the revised rule a chance.

The case is at the cross-summary judgment stage. A summary judgment motion asks the Court to decide the case without a trial because the issues presented are entirely legal.

The federal government filed its motion in early November. The FEHBlog knew the AHIP and employee benefit associations subsequently had filed friends of the court/amici briefs supporting the NSA regulators. The FEHBlog was delighted to read that a group of patient/consumer organizations, including “ALS Association, CancerCare, Epilepsy Foundation, Families USA Action, Hemophilia Federation of America, Leukemia & Lymphoma Society, National Multiple Sclerosis Society, United States Public Interest Research Group, Inc., and Cancer Support Community” also filed an amicus brief supporting the NSA regulators. That is an uplifting amici lineup.

From the U.S. healthcare business front, the Wall Street Journal reports

Amgen Inc. is in advanced talks to buy drug company Horizon Therapeutics PLC. according to people familiar with the matter, in a takeover likely to be valued at well over $20 billion and mark the largest healthcare merger of the year.

The U.S. biotechnology company was the last of three suitors standing in an auction for Horizon, the people said, after French drugmaker Sanofi SA said Sunday it was out of the running.

A deal could be finalized by Monday assuming the talks with Amgen don’t fall apart, the people said.

Horizon develops medicines to treat rare autoimmune and severe inflammatory diseases that are currently sold mostly in the U.S. Its biggest drug, Tepezza, is used to treat thyroid eye disease, an affliction characterized by progressive inflammation and damage to tissues around the eyes.

The company is Nasdaq-listed, but based in Ireland and has operations in Dublin, Deerfield, Ill., and a new facility in Rockville, Md.

Wow-wee.

Friday Stats and More

David Ermer–CDC, COVID-19, Mental health care, OPM, Patient safety, Telehealth–
Photo by Sincerely Media on Unsplash

Based on the Centers for Disease Control’s Covid Data Tracker, the CDC’s weekly interpretation of those new cases, hospitalizations and death statistics shows across-the-board increases. Welcome winter.

New Cases

As of December 7, 2022, the current 7-day average of weekly new cases (65,569) increased 49.6% compared with the previous 7-day average (43,825). A total of 99,241,649 COVID-19 cases have been reported in the United States as of December 7, 2022.

Variant Proportions

CDC Nowcast projections* for the week ending December 10, 2022, estimate the proportion of 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, and XBB. XBB is a recombinant of two BA.2 sublineages.

The two predominant Omicron lineages and the two that are increasing this week are BQ.1.1, projected to be 36.8% (95% PI 34.1-39.6%) and BQ.1, projected to be 31.1% (95% PI 29.0-33.4%) nationally. All other lineages (BA.5, BF.7, XBB, BN.1, BA.5.2.6, and BA.4.6) are decreasing in proportion this week compared to last.

New Hospitalizations

The current 7-day daily average for November 30–December 6, 2022, was 4,844. This is a 13.8% increase from the prior 7-day average (4,256) from November 23–29, 2022.

New Deaths

The current 7-day average of new deaths (426) increased 61.7% compared with the previous 7-day average (263). As of December 7, 2022, a total of 1,080,472 COVID-19 deaths have been reported in the United States.

CNN adds,

Hospitals are more full than they’ve been throughout the Covid-19 pandemic, according to a CNN analysis of data from the US Department of Health and Human Services. But as respiratory virus season surges across the US, it’s much more than Covid that’s filling beds this year.

More than 80% of hospital beds are in use nationwide, jumping 8 percentage points in the past two weeks.

Hospitals have been more than 70% full for the vast majority of that time. But they’ve been 80% full at only one other point: in January, during the height of the Omicron surge in the US. Back in January, about a quarter of hospital beds were in use for Covid-19 patients. But now, only about 6% of beds are in use for Covid-19 patients, according to the HHS data.

From the Omicron countermeasures front, the weekly interpretation tells us

As of December 7, 2022, 657.9 million vaccine doses have been administered in the United States. Overall, about 228.6 million people, or 68.9% of the total U.S. population, have completed a primary series.* More than 42.0 million people, or 13.5% of the U.S. population ages 5 years and older, have received an updated (bivalent) booster dose.

Medscape adds, “Getting at least one dose of a COVID-19 vaccine decreases the chances of having symptoms beyond 3 weeks or developing long COVID, a new analysis shows.”

The weekly interpretation usually encourages more Covid vaccinations. This week, the interpretation opens by touting the use of Paxlovid, to wit —

As we enter the holiday season, it’s important to take steps to protect yourself and others from serious illness with COVID-19, including staying up to date on COVID-19 vaccines and promptly talking to your healthcare provider about treatment options if you test positive for COVID-19.

If you have COVID-19 symptoms:

Test : Use a self-test, locate a test site, or find a Test to Treat location.

Talk: If you test positive, talk to a healthcare professional to determine if you are eligible for treatment, even if your symptoms are mild right now.

Treat: Start treatment within five days of developing symptoms.

Note to Readers: Paxlovid is not a replacement for COVID-19 vaccination. COVID-19 vaccination makes you much less likely to get very sick. Still, some vaccinated people, especially those ages 65 years or older or who have other risk factors for severe disease, may benefit from treatment if they get COVID-19. A healthcare provider will help decide which treatment, if any, is right for you.

That’s the full picture for most folks. Here’s the “real-world data” link if you are interested. Thank you CDC.

Here are the key points from this week’s CDC FluView:

  • Seasonal influenza activity is high across the country.
  • Of the influenza A viruses detected and subtyped during week 48, 76% have been influenza A(H3N2), and 24% have been influenza A (H1N1).
  • Seven influenza-associated pediatric deaths were reported this week, for a total of 21 pediatric flu deaths reported so far this season.
  • CDC estimates that, so far this season, there have been at least 13 million illnesses, 120,000 hospitalizations, and 7,300 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 48 during every previous season since 2010-2011.
  • The number of flu hospital admissions reported in the HHS Protect system increased during week 48 compared to week 47.
  • The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.
  • All viruses collected and evaluated this season have been susceptible to influenza antivirals.
  • An annual flu vaccine is the best way to protect against the flu. Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with the flu.
  • CDC recommends that everyone ages 6 months and older get a flu vaccine annually. Now is a good time to get vaccinated if you haven’t already.
  • There are also prescription flu antiviral drugs that can be used to treat flu illnesses. It’s very important that flu antiviral drugs are started as soon as possible to treat patients who are hospitalized with flu, people who are very sick with flu but who do not need to be hospitalized, and people with flu who are at higher risk of serious flu complications based on their age or health.
  • Multiple respiratory viruses are currently co-circulating with influenza.  Testing is important to determine the appropriate treatment.

From the FEHB front, the FEHBlog was bowled over to discover on reginfo.gov that on November 29, the Office of Personnel Management took a major step forward in implementing the Postal Service Health Benefits Program by submitting a draft interim final rule to OMB’s Office of Information and Regulatory Affairs for its review. This is the final step before the rule is published in the Federal Register. The statutory deadline for so promulgating this rule is April 8, 2023.

From the miscellany department

  • HR Dive discusses a Mercer report on how employers can impact the maternal mortality problem.
    • EBRI offers a useful analysis of telemedicine and its relationship with other healthcare services, enrollee health, and costs.
    • Chain Drug News reports that PCMA, the prescription drug manager trade association, has issued policy recommendations to accelerate patient biosimilar drug use.
    • The Wall Street Journal offers encouraging news about prison programs to resolve inmate addiction issues.

    Two-thirds of people entering prisons and jails have what the Department of Health and Human Services diagnoses as substance-use disorder. For years, the only treatment in all but a handful of detention centers was to detox.

    Some 630 of the roughly 5,000 jails and prisons nationwide now provide medication treatment for opioid use, according to the nonprofit Jail and Prison Opioid Project, up from about 20 in 2015. The drugs include buprenorphine, which tamps cravings for opioids, naloxone, which reverses their effects, and methadone, which eases withdrawal symptoms. Some are taken daily, others can be taken once a month in extended-release versions. The Biden administration said it wants medication available for every drug user in federal custody and at half of state prisons and jails by 2025.