Friday Stats and More

CDC

Friday Stats and More

David Ermer–CDC, COVID-19, FDA, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the Centers for Disease Control’s weekly interpretative summary of its Covid statistics:

New Cases — “As of January 4, 2023, the current 7-day average of weekly new cases (67,243) increased 16.2% compared with the previous 7-day average (57,847). A total of 101,094,670 COVID-19 cases have been reported in the United States as of January 4, 2023. * * *

The most prevalent Omicron lineages this week are BQ.1.1, projected to be 34.4% (95% PI 26.7-
43%); XBB.1.5, projected to be 27.6% (95% PI 14.0-46.5); and BQ.1, projected to be 21.4% (95% PI 16.1-27.7%). XBB, BA.5, BN.1, BF.7, and BA.2.75 are all projected to be between 1% and 5% of circulating viruses.”

New Hospitalizations — “The current 7-day daily average for December 28, 2022–January 3, 2023, was 6,519. This is a 16.1% increase from the prior 7-day average (5,613) from December 21–27, 2022.”

New Deaths — “The current 7-day average of new deaths (390) increased 8.3% compared with the previous 7-day average (360). As of January 4, 2023, a total of 1,091,184 COVID-19 deaths have been reported in the United States.”

Vaccinations — “As of January 4, 2023, 665.1 million vaccine doses have been administered in the United States. Overall, about 229.3 million people, or 69.1% of the total U.S. population, have completed a primary series. More than 48.2 million people, or 15.4% of the U.S. population ages five years and older, have received an updated (bivalent) booster dose.”

Politico observes

Though Covid hospitalizations appear to be on the rise nationwide, experts don’t project this Omicron subvariant alone to cause a spike — forecasts from early data suggest they’ll remain fairly steady, Céline Gounder, an infectious disease specialist and senior fellow at the Kaiser Family Foundation, said. * * *

The prediction matches the data from Singapore, where a related subvariant recently became dominant but didn’t result in a spike in hospitalizations and deaths — though that country’s vaccination rate is higher than that of the U.S.

But some individuals — particularly people who are older or pregnant or have weakened immune systems — are at heightened risk from the virus, regardless of larger population trends.

“I’m a bit concerned with it just because it’s coupled with the extremely low booster rates of those over 65,” Katelyn Jetelina, epidemiologist and professor at the University of Texas Health Science Center, said. “Our most vulnerable aren’t as protected.”

The FEHBlog was encouraged to read this American Hospital Association post about a National Institutes for Health / HHS trial:

The Department of Health and Human Services will launch this month a COVID-19 Home Test to Treat telehealth pilot program in Berks County, Pa. Program organizers will work this year with public health departments to expand the program to 100,000 people in vulnerable communities. Telehealth services provider eMed will implement the program, and UMass Chan Medical School will analyze the impact on participating communities.

“At-home testing for COVID-19 is now widely available in the United States, as are antiviral treatments, and this program combines easy home access to both,” said Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering, which will launch the program with HHS’ Administration for Strategic Preparedness and Response.

NPR adds

“What is clearer now, compared to even a year ago, is that we can really blunt the worst of [Omicron] by doing the things that we know work,” Dr. Ashish Jha, the White House coronavirus response coordinator, told NPR in an interview.

That includes getting vaccinated and boosted, especially if you’re older. Most deaths from COVID-19 are occurring in people age 65 or older.

Other precautions include avoiding crowded, poorly ventilated parties, restaurants, bars and other places; testing before gathering; and, yes, putting that mask back on in risky situations. And if you do get sick, check with your doctor about getting treatment quickly.

“It is a time not to let your guard down,” warns Dr. Tina Tan, an infectious disease specialist at Northwestern University.

The good news is the worst appears to be over from the RSV surge that has been making life miserable for many children and their parents. RSV cases have been falling steadily since the end of November, according to the Centers for Disease Control and Prevention.

At the same time, the flu — which also came roaring back this fall after mostly disappearing for the previous two years — looks like it’s finally receding in most places, according to the latest data out Friday from the CDC.

From Capitol Hill, Roll Call reports that Rep. Kevin McCarthy (R CA) has been elected House of Representatives speaker. The 118th Congress, therefore, is in session.

From the Rx coverage front —

STAT News reports

The Food and Drug Administration on Friday approved a new Alzheimer’s disease treatment that moderately slows cognitive decline in people with early-stage disease.

The [intravenously administered] drug, called Leqembi [scientific name lecanemab], was developed by Eisai, the Japanese pharmaceutical company that also developed the first symptomatic treatment for Alzheimer’s 25 years ago.

Leqembi will cost $26,500 per year for a person of average weight, Eisai said. The drug has the potential to be a commercial blockbuster, but only if Medicare can be convinced to pay for it. Unless Medicare changes the way it pays for drugs like Leqembi, Eisai expects a relatively slow rollout. * * *

Eisai restricted the study of Leqembi to people with mild cognitive impairment or early stage Alzheimer’s that also have evidence of amyloid buildup in the brain, confirmed by an imaging scan. The FDA-approved label reflects the same narrowed patient population, estimated to encompass approximately 1 million people in the U.S., or just under 20% currently living with an Alzheimer’s diagnosis.

The label also mandates that patients undergo three additional brain scans during the first 14 weeks of treatment as a precautionary step to monitor for potentially serious brain swelling or bleeding episodes. * * *

Technically, the FDA granted accelerated approval to Leqembi, a faster path to the market based on preliminary evidence that the drug eliminates toxic amyloid. It’s the same controversial, regulatory shortcut that the FDA used to approve Aduhelm. But unlike Biogen, Eisai within days is expected to submit the cognition data from its positive, confirmatory study to the FDA, which will then consider the drug for full, or final, approval.

BioPharma Dive tells us, “The Food and Drug Administration is set to decide by April 13, 2023, whether to approve Alvotech’s biosimilar to AbbVie’s top-selling drug Humira, pending a facility inspection the company said Thursday it is trying to schedule early next year.” This keeps the drug on track to be on the market when the Humira patents are lifted on July 1, 2023.

According to a press release issued on January 5, 2023:

Synergie Medication Collective is a new medication contracting organization founded by a group of Blue Cross and Blue Shield affiliated companies to serve both Blues and select independent health plans. Synergie is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans. These high-cost treatments include multi-million-dollar gene therapies and infusible cancer drugs and represent a substantial portion of overall drug spend, with significant growth in future spend anticipated.

Synergie aims to significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders. With a core philosophy that prioritizes partnership and transparency, Synergie aims to play a key role in ensuring affordable access to treatment for millions of people. * * *

Synergie Medication Collective will go to market in January of 2023.

STAT News reports

For only the second time since launching nearly two years ago, the AMR Action Fund has announced an investment in a fledgling biotech company as it tries to underwrite efforts to develop badly needed medicines for combating antibiotic resistance.

In its latest move, the fund is providing $7.5 million to BioVersys, which is developing an antibiotic to combat a type of bacteria that affects people with compromised immune systems and is increasingly responsible for infections in hospitalized patients. The drug, which is about to enter Phase 2 testing, is targeting hospital-acquired pneumonia, pneumonia associated with ventilators, and blood stream infections that originate from pneumonia.

From the health plan design front, EBRI released a study on cost-sharing trends for medical services from 2013-2020.

From the healthcare business front —

Beckers Hospital Review informs us.

VillageMD, which is majority owned by Walgreens Boots Alliance, completed its acquisition of Summit Health-CityMD Jan. 3, adding more than 2,800 providers to its ranks. 

News of the deal’s completion comes roughly two months after it was announced. On Nov. 7, VillageMD said it entered a definitive agreement to acquire Summit Health-CityMD for $8.9 billion with investments from Walgreens Boots Alliance and Evernorth, the health services portfolio of Cigna.

VillageMD, established in 2013, operates standalone Village Medical practices, full-size Village Medical practices alongside Walgreens pharmacies, and primary care in the home and virtually. 

The combination of Summit Health-CityMD and VillageMD creates one of the largest independent provider groups in the country, according to the companies’ news release. With the buy, VillageMD more than doubles its locations from more than 250 to more than 680 in 26 markets and grows its ranks by more than 2,800 providers. VillageMD declined to share the precise number of providers it now employs, but did say it employs more than 20,000 people. 

The addition also strengthens VillageMD’s footprint in five states. Summit Health and CityMD have locations in New York, New Jersey, Connecticut, Pennsylvania and Central Oregon. 

Fierce Healthcare discusses the Federal Trade Commission’s proposed rule banning post-employment non-compete clauses in employment agreements on healthcare.

Noncompete agreements have become so ubiquitous that a proposed rule published by the Federal Trade Commission (FTC) yesterday [January 5] will affect almost all industries, experts say.

Healthcare will be no exception, Carrie Amezcua, an attorney with the law firm Buchanan Ingersoll & Rooney, told Fierce Healthcare. She said healthcare industry executives should keep a close eye on the debate about the rule.

The public has 60 days to submit comments before the FTC can make it final.

“It could still change—it could still be challenged actually—because it goes too far from what the FTC has the authority to do,” said Amezcua, who usually represents employers in disputes over noncompete agreements.

Backlash to the rule has already begun. In a statement, the U.S. Chamber of Commerce called the regulation “blatantly unlawful.” * * *

Amezcua added: “Insurers are not exempt from the FTC Act. They would be subject to this rule in its final form. And right now, it is written as a complete ban on noncompete agreements, post-employment. You could still have a noncompete during your employment. But you can’t have the provision that says you can’t work for another company for two years after you leave.”

In closing, FedSmith updates us on federal retirement statistics for those interested.

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.

Midweek update

David Ermer–ACA, CDC, NIH, Telehealth–
Photo by JOSHUA COLEMAN on Unsplash

Mercer Marsh Benefits presents the top five trends from its 2023 employer-sponsored health plan survey of 225 insurers located in 56 countries:

  1. Per-person medical cost increases are back to pre-pandemic levels. 68% of insurers expect plan sponsors to prioritize improvements. This is even though double-digit medical cost increases are forecast for some markets.
  2. COVID-19 continues to impact the claims experience. 55% of insurers report an increase in the later-stage illness diagnosis due to deferred care.
  3. Plan modernization has begun. To make coverage more inclusive for those who identify as LGBTQ+, one in two insurers have changed or expect to change eligibility requirements and eligible expenses.
  4. The mental health gaps persist. 16% of insurers report not providing plans that cover mental health services (versus 26% in 2022).
  5. Plan management requires greater rigor. More than one in five insurers in Asia are adjusting their medical plan premiums based on an individual’s COVID-19 vaccination status.

All five main points ring true, but the prime examples for the fourth and fifth points don’t fit the FEHB market.

The American Medical Association points out six often overlooked steps to better health while Rebecca G. Baker, Ph.D., the director of the NIH HEAL Initiative® looks back at a virtual stakeholder briefing to visit the initiative’s progress in resolving chronic pain and opioid misuse issues and to describe future plans. 

From the public health front, the New York Times reports about

a large study published on Tuesday found a surprising trend among adolescents who repeatedly visited the hospital. The patients most likely to reappear in emergency rooms were not patients who harmed themselves, but rather those whose agitation and aggressive behavior proved too much for their caregivers to manage.

In many cases, repeat visitors had previously received sedatives or other drugs to restrain them when their behavior became disruptive. * * *

The results suggest that researchers should focus more attention on families whose children have cognitive and behavioral problems, and who may turn to emergency rooms for respite, Dr. [Anna] Cushing [an author of the study] said.

“I’m not sure we’ve been spending as much time talking about these agitated and behaviorally disregulated patients, at least on a national scale,” she said.

The JAMA study found that overall visits to pediatric emergency rooms for mental health crises increased 43 percent from 2015 to 2020, rising by 8 percent per year on average, with an increase in emergency visits for every category of mental illness. By comparison, emergency room visits for all medical causes rose by 1.5 percent annually.

Nearly one-third of visits were related to suicidal ideation or self-harm, and around one-quarter of patients presented with mood disorders, followed by anxiety disorders and impulse control disorders. Around 13 percent of patients made a repeat visit within six months.

From the telehealth front, Axio informs us

There are few things more stressful than getting a serious medical diagnosis, but pandemic-era changes in virtual care are prompting more patients to obtain a second opinion without leaving home.

Why it matters: The telehealth explosion made it easier to get advice from top doctors across the country — and for health systems to grow business beyond their physical footprints and even treat some of the people seeking consultations.

Case in point: The Clinic, a joint venture between Cleveland Clinic and telehealth giant Amwell, launched in 2020 just before the pandemic began.

The idea was to pair the Cleveland Clinic brand with Amwell’s virtual tools and its existing connections with private insurers to make it easier for patients to get their records reviewed, said Frank McGillin, CEO of The Clinic.

In litigation news, Health Payer Intelligence relates

A United States district court has ruled against Blue Cross Blue Shield of Illinois (BCBSIL), stating that the payer cannot exclude coverage for medically necessary gender-affirming care in its employer-sponsored ERISA health plans.

Lambda Legal and Sirianni Youtz Spoonemore Hamburger PLLC filed a class action lawsuit against BCBSIL on behalf of a 17-year-old transgender man, CP, and his parents. According to the lawsuit, the payer administered discriminatory exclusions of gender-affirming care, violating the anti-discrimination of the Affordable Care Act (ACA), known as Section 1557. * * *

The court determined that BCBSIL is a “health program or activity” that receives federal funds and thus cannot discriminate based on race, national origin, sex, age, or disability in its role in administering ERISA health plans.

From inside the Beltway, Govexec reports

The White House released a plan on Wednesday for how the Biden administration seeks to foster a more open and accountable government.

Transparency is something for which many presidential administrations strive, but success can be elusive, as shown during the Obama and Trump presidencies. Nevertheless, the almost-two year old Biden administration unveiled its first and the fifth overall U.S. Open Government National Action Plan, shared exclusively with Government Executive ahead of its release. This builds on many of the Biden administration’s efforts, including the president’s management agenda. 

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, the National Rural Healthcare Association trumpets the “big rural health advocacy wins in FY23 appropriations bill” that the President will be signing this week. Notably —

Given the devastating outcome of COVID-19 in rural areas, NRHA has been committed to working with Capitol Hill to see an Office of Rural Health created at the Centers for Disease Control and Prevention (CDC). Included in the FY 2023 appropriations bill was $5 million to establish an Office of Rural Health at CDC. The text dictates that the ORH will enhance implementation of CDC’s rural health portfolio, coordinate efforts across CDC programs, and develop a strategic plan for rural health that maps the way forward both administratively and programmatically. This is a massive victory for rural health, and NRHA is looking forward to working with CDC to see this stood up quickly, to ensure rural representation in America’s public health infrastructure.

$3.45 billion for the Rural Community Facilities Program and $2 million for the Rural Hospital Technical Assistance Program through the United States Department of Agriculture Rural Development (RD) programs. 

From the public health front –

  • Beckers Hospital Review tells us

Omicron subvariant XBB is encroaching on BQ.1 and BQ.1.1’s dominance, CDC data shows, as it accounts for 18.3 percent of U.S. cases and makes up more than 1 in 2 infections in the Northeast. 

Subvariants BQ.1 and BQ.1.1, which became the nation’s most pervasive strains in November, are on the decline. 

The FDA began tracking XBB on Nov. 28. The subvariant is a fusion of two other omicron subvariants, BA.2.10.1 and BA.2.75, and it caused a wave of cases in Singapore. Eric Topol, MD, founder and director of Scripps Research Translational Institute in San Diego, wrote Dec. 23 that XBB mutation XBB.1.5 “has the most growth advantage vs. BA.5,” which was causing most COVID-19 cases for months. 

  • Beckers also reports, “The CDC issued a health advisory on Dec. 22 to alert the medical community of a rise in severe strep A infections among children. * * * Read the full advisory and provider recommendations here.”

From the U.S. healthcare business front, the Wall Street Journal challenges non-profit hospital business practices which fail to help the needy.

Many of the nation’s largest nonprofit hospital systems, which give aid to poorer communities to earn tax breaks, have been leaving those areas and moving into wealthier ones as they have added and shed hospitals in the last two decades. 

As nonprofits, these regional and national giants reap $8.8 billion from tax breaks annually, by one Johns Hopkins University researcher’s estimate. Among their obligations, they are expected to provide free medical care to those least able to afford it.

Many top nonprofits, however, avoid communities where more people are likely to need that aid, according to a Wall Street Journal analysis of nearly 470 transactions. As these systems grew, many were more likely to divest or close hospitals in low-income communities than to add them. * * *

Ascension was the most active deal maker in the Journal’s review. Through deals involving 93 hospitals over the past 20 years, Ascension has grown into one of the largest U.S. systems, with $28 billion in revenue and $19.5 billion in cash reserves in its most recent fiscal year, ended June 30.

Among the hospitals Ascension pruned as it grew were those serving some of the poorest neighborhoods of Washington, D.C., and Chicago.

Local elected officials said that when a system exits a market, it can be difficult for remaining facilities to serve the community.

The Journal also questions online advertising for prescription drugs by certain telehealth companies.

In an advertisement on Facebook and Instagram, a middle-aged man holding a dumbbell says testosterone “literally changed my life,” restoring his energy and happiness.

What the October ad from telehealth startup Hone Health doesn’t say is that the unidentified man is an actor who has never used the prescription drug. It doesn’t mention that testosterone is approved by the Food and Drug Administration only for men with specific disorders and that among its risks are heart attacks and stroke.

Similar telehealth companies are flooding TikTok, Instagram and other platforms with ads that don’t conform to longtime standards governing the marketing of prescription drugs and healthcare treatments. They feature actors posing as customers, tout benefits of drugs with no mention of side effects and promote medications for uses not approved by the FDA.

In the two years since the government expanded the scope of medical services allowed via video calls, telehealth companies have been operating largely outside advertising rules that govern drugmakers, a gray area subject to little government oversight or guidance. Instead, the main gatekeepers exercising the power to review or remove telehealth advertising are the social-media giants paid to run the ads.

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.

Friday Stats and More

David Ermer–CDC, COVID-19, HIPAA Privacy and Security Rules, Patient safety–

From the Centers for Disease Control’s Covid data tracker and its weekly interpretative summary of its Covid statistics:

  • New Cases totaled 455.556 this week, down 2.7% from last week.
  • Variants BQ.1.1 and BQ.1 are estimated to represent 78% of Covid / Omicron cases
  • New Hospitalizations averaged 5,010 this week, up 2.3% from last week.
  • New Deaths totaled 2,703, down 13.2% from last week.
  • “As of December 14, 2022, 660.4 million vaccine doses have been administered in the United States. About 228.8 million people, or 68.9% of the U.S. population, have completed a primary series.* More than 44.2 million people, or 14.1% of the U.S. population ages 5 years and older, have received an updated (bivalent) booster dose.”

The CDC reports good news about the efficacy of the bivalent booster here and here.

Pfizer announced the sale $2 billion worth of Paxlovid pills (3.7 million courses) to the federal government and its ongoing research on developing combined mRNA Covid and flu vaccine.

From CDC’s Fluview — “Seasonal influenza activity remains high but appears to be declining in some areas.”

Health Affairs brings us up to date on mpox.

Looking forward, Healthcare Dive reports

  • Leaders at hospitals and health systems across the country are anticipating a potentially turbulent operating environment in the coming year, according to a survey from Deloitte.
  • Among health system leaders, 85% said staffing challenges would have a major impact on their 2023 strategy and 76% said inflation is a significant factor. Other expected headwinds include affordability issues for patients, shrinking margins and continual supply chain disruptions.
  • Deloitte also polled health plan executives and found they face challenges related to inflation and a tight labor market, though are generally in a better financial position than hospitals and health systems.

Speaking of hospitals, Fierce Healthcare informs us

The care given in emergency departments came under fire yesterday with the release of a government study saying that 250,000 Americans die every year due to misdiagnoses.

The findings spurred an immediate response from the president of the American College of Emergency Physicians (ACEP), who questions the study’s veracity and methodology.

Christopher S. Kang, M.D., president of the ACEP, said in a statement that “in addition to making misleading, incomplete and erroneous conclusions from the literature reviewed, the report conveys a tone that inaccurately characterizes and unnecessarily disparages the practice of emergency medicine in the United States.”

One of the authors of the study—David Newman-Toker, M.D., Ph.D., a neurologist at Johns Hopkins University—vehemently defends the methodology and told Fierce Healthcare that “high levels of variation in care (across conditions, across hospitals, across demographic groups) tells us that these errors do not need to be thought of as ‘the price of doing business.’ It tells us that there are already probably ways to get it right.”

The study, conducted by Johns Hopkins for the Agency for Healthcare Research and Quality, states that among 130 million ED visits in the U.S. per year, 7.4 million patients are misdiagnosed. In addition, 2.6 million suffer an adverse event, and about 370,000 suffer serious harm from diagnostic errors.

The teenage daughter of CNN reporter Jake Tapper writes in CNN about her frightening ER experience. The FEHBlog joined his wife at a Dripping Springs TX knitting store holiday event. He mentioned the Alice Tapper story to two nurses who were horrified. In the FEHBlog experience, nurses are the best judge of hospital care across facilities.

In HIPAA news, the American Hospital Association tells us

The Department of Health and Human Services yesterday proposed a standard format for attachments to support electronic health care claims and prior authorization transactions under the Health Insurance Portability and Accountability Act. The standard would apply to all health plans, health care clearinghouses, and providers, who currently lack an efficient and uniform method of sending attachments, which can lead to provider burnout, slow down processing and delay payments or patient care.

“The AHA supports establishing a standard for attachments to reduce the administrative burdens facing clinicians, and we look forward to providing robust commentary after analyzing the rule’s specifics,” said Terrence Cunningham, AHA’s director of administrative simplification policy.

Comments on the rule are due March 21. 

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

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, No Surprises Act, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Politico reports tonight

Top appropriators struck a deal Tuesday night on a government funding framework critical to finalizing a mammoth year-end spending package.

In a statement, retiring Senate Appropriations Chair Patrick Leahy (D-Vt.) said appropriators have “reached a bipartisan, bicameral framework that should allow us to finish an omnibus appropriations bill that can pass the House and Senate and be signed into law by the President.”

Leading negotiators didn’t release those government funding totals in announcing the deal, but appropriators have largely settled on an $858 billion defense budget in recent weeks.

That’s good news. Presumably, Congress still plans to extend the continuing resolution from December 16 to December 23 this week in order to allow time to write and pass the omnibus bill.

From the Omicron and siblings front, Healthcare Dive reports that

In the two years since the COVID-19 vaccine became available for U.S. patients, the country’s vaccination program prevented more than 18.5 million hospitalizations and 3.2 million deaths, according to new research from the Commonwealth Fund and Yale School of Public Health.

Many millions of infections were prevented, preserving hospital resources for patients who otherwise would not have received timely care, the researchers said. The vaccine also saved the country $1.15 trillion in medical costs, kept children in school and allowed businesses to reopen, the study said. 

To arrive at its findings, the study used a computer model of disease transmission, comparing the pandemic trajectory to a simulated scenario without a vaccination program. The results can be used to inform future evidence-based decisions on vaccine use to reduce disease burden, the researchers said.

The FEHBlog has no doubt that the rapidly developed mRNA vaccines pulled us out of a jam in winter 2020 while Paxlovid and other anti-virals saved us from the monstrous Omicron surge in winter 2021.

From the CMS front —

  • CMS has activated the Ground Ambulance and Patient Billing Advisory Committee required by the No Surprises Act. The Committee’s report likely will be released in the second quarter of 2023.
  • CMS released a readout from “We Can Do Better: Advancing Maternity Care Together – the first CMS convening on maternal health since the agency launched its Maternity Care Action plan in July 2022 as part of the Biden-Harris Administration’s Blueprint for Addressing the Maternal Health Crisis. Attendees discussed key actions to improve the health of pregnant and postpartum individuals – including the need for a robust and diverse maternity care workforce and the ability for consumers to easily identify health systems engaged in improving maternal care.”
  • CMS also called attention to the “recently released proposed rule that, if finalized, would modify the current National Council for Prescription Drug Programs (NCPDP) retail pharmacy standards for electronic transactions and expand the applicability of the Medicaid pharmacy subrogation transaction to all health plans.”
  • In related news, EHR Intelligence tells us, “In a recent letter, Health Level Seven International (HL7) called on the National Committee on Vital and Health Statistics (NCVHS) to include FHIR as a data standard for electronic clinical attachments. NSG encourages the public to submit comments on the proposed rule by January 9th, 2023.” The original version of HIPAA enacted over 25 years ago called for this attachments standard, which has been a thorn in CMS’s side.

In other HHS news —

  • HHS’s Agency for Healthcare Quality and Research informs us that the U.S. Preventive Services Task Force has proposed to keep in place the grade A recommendation “that clinicians prescribe pre-exposure prophylaxis with effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV infection.” The original PREP recommendation was made in 2018.
  • The American Hospital Association relates “The Substance Abuse and Mental Health Services Administration today proposed updating opioid treatment program standards and admission criteria to expand access to treatment. According to the agency, the rule would expand the definition of OTP practitioner to include any provider appropriately licensed to dispense and/or prescribe approved medications; no longer require one year of opioid addiction for admission; add evidence-based delivery models such as telehealth; expand patient access to take-home methadone doses, and no longer require annual reports from practitioners with a waiver to prescribe buprenorphine to up to 275 patients. The agency will accept comments on the proposed rule through Feb. 14.” That makes sense to the FEHBlog.

From the drug development front —

The Wall Street Journal reports

A customized Moderna Inc. MRNA 19.63%increase; green up pointing triangle vaccine helped ward off the recurrence of melanoma in a mid-stage trial, a milestone in long-running efforts to use the shots as treatments and a big step in the biotech’s ascent.

The combination of Moderna’s personalized cancer vaccine and MerckMRK 1.78%increase; green up pointing triangle & Co.’s Keytruda cancer immunotherapy reduced patients’ risk of relapse or death by about 44%, versus Keytruda alone, in the 150-volunteer study, the companies said Tuesday.

The results, which the companies said were statistically significant but haven’t been reviewed by independent scientists, suggest promise for an emerging but unproven class of vaccines that aim to treat diseases rather than prevent infections like typical shots.

MedCity News reports

Multiple myeloma can be treated by several drugs but relapse in this type of blood cancer is common and when that happens, patients need other treatment options. Johnson & Johnson is looking to fill that need with a drug that addresses a novel target. The pharmaceutical company is seeking regulatory approval for this molecule and the most up to date clinical data supporting the application were presented during the annual meeting of the American Society of Hematology (ASH).

Patients in the Phase 1/2 clinical trial had some of the toughest cases that progressed after treatment with at least three different therapies, according to Ajai Chari, director of clinical research in the multiple myeloma program at Mount Sinai and an investigator in the study. Despite that, treatment with the J&J drug, talquetamab, led to response rates of up to 74%.

From the healthcare business front, Fierce Healthcare tells us

Operating margins for the three largest for-profit hospital chains exceeded pre-pandemic levels in the third quarter, according to a new analysis that comes as hospital lobbies are pushing for financial relief from Congress. 

The analysis, released Monday by the Kaiser Family Foundation, looked at the latest financial performance for large hospital chains HCA Healthcare, Tenet Healthcare and Community Health Systems. * * *

Kaiser’s analysis comes a day after The Wall Street Journal published a report that showed hospitals received billions of dollars in aid, with some going to profitable systems that didn’t need it. Part of the problem was a mismatch in the federal government’s allocation of the $175 billion Provider Relief Fund passed by Congress at the onset of the pandemic in early 2020, the report said. 

From the tidbits department, the FEHBlog learned at the ABA Washington Health Law Summit today

  • The third Texas Medical Association case filed November 30 and pending before District Judge Kernodle concerns the manner in which the qualifying payment amount is calculated – a new issue which nevertheless could have been joined to the second lawsuit. Go figure.
  • In 2018, Congress passed a law called the Eliminating Kickbacks in Recovery Act (“EKRA”), 18 U.S.C. § 220. The Epstein, Becker and Green law firm explains, “EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.”

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.

    Midweek update

    David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Government Contracting, Mental health care, OPM, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–
    Photo by Manasvita S on Unsplash

    From Capitol Hill, the Wall Street Journal reports

    Senate Democrats celebrated their win in Georgia giving them 51 seats next year, a result that enhances their power by allowing them to more easily advance President Biden’s nominees while also providing slightly more flexibility on legislation.

    Sen. Raphael Warnock’s win in a runoff election over GOP challenger Herschel Walker comes after two years in which Vice President Kamala Harris provided a tiebreaking vote in the 50-50 Senate. * * *

    Since early 2021, the two parties have been operating under a power-sharing agreement with evenly divided committees, which has prevented Democrats from issuing subpoenas to witnesses without GOP support. When nominees have tied in a committee vote, Democrats have been forced to hold an extra procedural vote to finalize their nomination. The Warnock victory will give Democrats a narrow majority on each panel.

    “It’ll be easier for Democrats to move forward with some of their nominees, particularly in the judiciary, and that makes it more difficult for us,” said Sen. Mitt Romney (R., Utah). 

    Roll Call informs us

    The newly minted defense authorization bill for fiscal 2023 [NDAA], made public Tuesday night, provides a shot in the arm to the U.S. defense budget but bars the military from discharging any more troops who refuse COVID-19 vaccine shots in their arms. * * *

    [This bill has been approved by a House-Senate conference committee.] The House is expected to vote on the NDAA as soon as Thursday and the Senate to soon follow suit, perhaps next week.  

    The bill would authorize a 4.6 percent across the board pay increase for military personnel and civilians. However, House and Senate negotiators removed a House-passed “inflation bonus” of an additional 2.4 percent for troops and Defense Department civilians making less than $45,000 a year. * * *

    Also of note, the bill would ban contractors across the government from using Chinese-made semiconductors, after a lengthy phase-in period, an aide with knowledge of the provision said Tuesday. Many federal contractors and other businesses say they are unclear how they will comply.

     Govexec offers two more insights on the NDAA

    Congressional negotiators on Tuesday night finally revealed a compromise version of the annual defense policy bill with the aim of passing it through both the House and Senate this week. But to some lawmakers, federal employee groups and good government experts’ chagrin, the measure did not include [Insight link] a provision aimed at blocking Republican-led efforts to strip potentially tens of thousands of federal employees of their civil service protections.

    and

    The authorization bill compromise text contains provisions [Insight link] that seek to increase transparency and accountability of investigations into Inspectors Generals [IG] and operations of the Council of Inspectors General on Integrity Efficiency (and its integrity committee, specifically); ensure IGs are only removed for justiciable and compelling reasons (and Congress is notified); and limit who can serve as acting IGs. There are also stipulations for notifying Congress when an agency doesn’t provide requested information or assistance to an IG and providing more training opportunities for IGs. 

    In an effort to address persistent watchdog job vacancies, the bill’s text states: “If the president fails to make a formal nomination for a vacant inspector general position that requires a formal nomination by the president to be filled within the period beginning on the later of the date on which the vacancy occurred or on which a nomination is rejected, withdrawn, or returned, and ending on the day that is 210 days after that date, the president shall communicate, within 30 days after the end of such period and not later than June 1 of each year thereafter, to the appropriate congressional committees.” 

    From the federal employee benefits front —

    FedWeek gives us last minute guidance on the Federal Employee Benefits Open Season that ends next Monday December 12.

    The Wall Street Journal offers ideas for use of flexible spending account dollars. The article make a point that was not on the FEHBlog’s radar screen:

    This year’s December FSA spending crunch could be worse than usual. While you’re meant to empty your FSA every year, during the pandemic the government relented on this rule, allowing FSA savers to roll over what they saved in 2020 and 2021, with some accounts swelling to more than $7,000. 

    That special treatment is set to end in 2022, meaning if you have been accumulating money in your FSA, you may need to empty our account by Dec. 31 or you risk losing it all. “Some people might be in for a rude surprise,” says Spiegel.

    Employers are permitted to give workers a little wiggle room—but not much. Some plans include a rollover provision that allows account holders to carry forward a small portion of their savings, although this amount is limited to $570 for 2022. Other plans may allow a spending grace period of up to 10 weeks.  

    From the infectious disease front —

    • The Wall Street Journal brings us up to date on Omicron treatments.
    • The Hill reports on the state of the flu and RSV surges. “Dr. Andrew Pekosz, a virologist and professor at Johns Hopkins Bloomberg School of Public Health, believes the U.S. is still in the “early stages” of a surge in influenza cases, he told Nexstar. * * * “With RSV we seem to be hitting a plateau,” said Pekosz. “Case numbers have not increased significantly for a couple of weeks, but they’re still at a very high level. So the burden of RSV is still great, but we may be closer to the peak there than we are with flu.”
    • Forbes relates, “A newly discovered immune response inside the nose could explain why respiratory illnesses like RSV, Covid, the common cold and flu thrive in winter, according to research published Tuesday in The Journal of Allergy and Clinical Immunology, a finding that challenges the conventional wisdom that infections spread because people are stuck indoors and signposts ways to develop new treatments.”

    From the Rx development and coverage front

    • MPR informs us “The Food and Drug Administration (FDA) has granted Fast Track designation to PH10 for the treatment of major depressive disorder (MDD). * * * Results showed that treatment with PH10 significantly reduced depressive symptoms as early as 1 week based on the 17-item Hamilton Depression Scale (HAM-D-17) scores compared with placebo (P =.022). The intranasal spray was found to be well tolerated, with no serious adverse events reported.”

    Touted by celebrities, raved about by TikTok users, and advertised by med spas, a new class of drugs for treating diabetes and obesity has exploded in popularity for its weight-loss effects, leading to rippling shortages across several of the medications.

    Amid the surge in demand, Eli Lilly and pharmacies have started to tighten access to the latest of this type of drug, tirzepatide, focusing on giving it to people with type 2 diabetes, the only population it’s authorized for so far. But that’s left another set of patients scrambling — people with clinical obesity who turned to the medication as one of their few options for treatment. * *

    There’s much overlap between the two conditions, said Beverly Tchang, an endocrinologist and assistant professor of clinical medicine at Weill Cornell Medicine. “Obesity can lead to diabetes, diabetes can lead to obesity,” she said. “They’re very much intertwined, and to treat one but not the other seems inequitable.” Tchang treats both types of patients and feels the drug shouldn’t be conserved for one group at the expense of the other.

    From the telehealth front, mHealth Intelligence explains

    FAIR Health’s Monthly Telehealth Regional tracker reported no change in telehealth usage in September compared with August and noted that COVID-19 fell in its rankings on top telehealth diagnoses lists in all regions and at the national level.

    The FAIR Health Monthly Telehealth Regional tracker is a complimentary service that analyzes how telehealth activity and use change monthly by tracking various factors such as claim lines, procedure codes, and diagnostic categories. It represents the privately insured population, including Medicare Advantage but excluding Medicare Fee-for-Service and Medicaid beneficiaries.

    From the public health front —

    • MedPage Today informs us “Drug overdose deaths in pregnancy or the postpartum period increased sharply in the U.S. in recent years, with the rise most pronounced at the start of the COVID-19 pandemic in 2020, researchers reported. * * * Jacob S. Ballon, MD, MPH, of Stanford University in California, noted that the study authors did not provide explanations for why the overdose-related death rate rose sharper among the pregnant and postpartum group during the study period, but said it will likely be the basis for further research. “[It’s] an interesting signal,” said Ballon, who was not involved with the study. “But now what do we do with that to explain it or make some sense of it?”
    • Healthcare Dive tells us
    • Increased delays in discharging patients who require additional care after a hospital stay could slow their recovery, potentially harming health outcomes and quality of life, the American Hospital Association cautioned in a report released Tuesday.
    • The inability to discharge patients is putting additional strain on hospitals operating with thin workforces, and health systems are bearing the cost of care for patients who stay excess days without appropriate reimbursement, the AHA said.
    • The association has urged Congress to help offset the costs of care for patients’ additional days in the hospital by creating a temporary per diem Medicare payment targeted to acute, long-term care, rehabilitation and psychiatric facilities.

    From the U.S. healthcare business front —

    Imagine going into your doctor’s office and facing not a staff of overworked doctors and nurses, but an inviting conversation. A talk with a healthcare professional who has plenty of time, isn’t in a hurry and is ready to listen to a recital of the different aches and pains of your life. Someone with expertise in medications dedicated to making your life easier and healthier. A professional who makes and then hands you a cup of coffee before you even start talking.

    With that conversation–easy, low stress–you can begin a level of trust with your doctor’s office that you might not have had before. And the person listening may, in conjunction with the doctors and nurses, find some better paths to helping you get healthier, even if you suffer from a chronic disease.

    That’s the vision that Fergus Hoban has for the American healthcare system. His company, UpStream, provides integrated services for primary care physicians, both independently and as part of networks or bigger healthcare systems. Centered around a prescribing pharmacist, a team of nurses and other professionals work with doctors to provide better care for Medicare patients while at the same time lowering costs.

    LHC Group and UnitedHealth Group have extended their merger agreement as the feds take a deeper look at the deal.

    The agreement was extended until March 28, 2023, and the two companies now expect the merger to close in the first quarter of 2023, according to a filing with the Securities and Exchange Commission.

    That the insurance giant intended to acquire LHC, a home health provider, was announced in March, and the deal is valued at about $5.4 billion. UnitedHealth said it plans to fold LHC into its Optum subsidiary as part of its provider arm, Optum Health, which is one of the country’s largest employers of physicians.

    LHC Group would add 30,000 employees who provide more than 12 million home health services annually.

    • Health Payer Intelligence also tells us about positive provider and payer reactions to the CMS proposed rule to promote widespread use of electronic prior authorizations. As noted here yesterday, “[t]he proposed rule would require the implementation of Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) standard Application Programming Interface (API) and mandates that payers have to explain the specific reason behind a prior authorization denial. Expedited prior authorizations will have to occur within 72 hours and non-urgent prior authorizations will have to be turned around in seven calendar days.”