Thursday Miscellany

Federal employment benefits

Thursday Miscellany

David Ermer–AHRQ, Congress, COVID-19, FDA, Federal employment benefits, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, Telehealth–
Photo by Josh Mills on Unsplash

From our Nation’s capital, the Wall Street Journal reports

The Treasury Department began taking special measures to keep paying the government’s bills on Thursday as the U.S. bumped up against its borrowing limit, kicking off a potentially lengthy and difficult debate in Congress over raising the debt ceiling. 

With the federal government constrained by the roughly $31.4 trillion debt limit, the Treasury Department began deploying so-called extraordinary measures. Those accounting maneuvers, which include suspending investments for certain government accounts, will allow the Treasury to keep paying obligations to bondholders, Social Security recipients and others until at least early June, the department said last week.  

That gives lawmakers on Capitol Hill and the Biden administration roughly five months to pass legislation raising or suspending the debt limit. In a letter to congressional leaders on Thursday, Treasury Secretary Janet Yellen said there was “considerable uncertainty” about how long extraordinary measures can last. 

“I respectfully urge Congress to act promptly to protect the full faith and credit of the United States,” Ms. Yellen said. 

From the OPM front, OPM issued “Guidance on Increasing Opportunities for Federal Internships, Fellowships, and Other Early Career Programs” and, according to MeriTalk, held a “virtual job fair organized today by Tech to Gov in partnership with the Office of Personnel Management (OPM) is targeting a wide range of Federal government technology and related positions as part of the government’s goal to restock its tech ranks amid a slowdown in hiring by the private sector.” As daily reports of layoffs at tech companies have been appearing in the news, OPM’s timing for the job fair is opportune.

Today, benefits expert Tammy Flanagan completed her three Govexec columns on federal employee and annuitant benefit changes for this year.

From the Omicron and siblings front,

MedPage Today tells us, “Real-World Data Support Bivalent COVID-19 Boosters in Older Adults — Study from Israel showa ed high level of protection in people 65 and up.” MedPage Today’s medical editor in chief Dr. Jeremy Faust comments

[T]he Israeli data really helps us understand that for 65-years-olds and over, getting a bivalent booster is going to protect against hospitalization. We don’t know how long that’s going to last, and that’s the key. If it turns out that the bivalent booster ends up having a much longer tail of effectiveness than the monovalent did, that’ll be good news, but it’ll depend upon what variants are circulating and other factors, but we are watching that.

Reuters adds

The European Union’s drug regulator has not identified any safety signals in the region related to U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech’s updated COVID-19 shot, the agency said on Wednesday.

On Friday, the U.S. Food and Drug Administration and the Centres for Disease Control and Prevention said that a safety monitoring system had flagged that the shot could possibly be linked to a type of brain stroke in older adults, according to preliminary data.

The FDA’s Vaccines and Related Biological Products Advisory Committee will consider this safety issue at a meeting on January 26.

Also from the FDA front, the Wall Street Journal informs us

U.S. drug regulators rejected Eli Lilly & Co.’s proposed new Alzheimer’s disease treatment, saying they need more data from clinical testing, according to the company.

The setback could delay a potential commercial introduction of the highly anticipated drug by at least several months, if the Food and Drug Administration eventually decides to approve it. * * *

The agency had recently approved another Alzheimer’s therapy. Earlier this month, the FDA gave early approval to a new Alzheimer’s drug from Eisai Co. and Biogen Inc.

Lilly had been hoping for an accelerated FDA approval of donanemab early this year. Now, a midyear filing of a standard drug application means an FDA decision could be pushed back into 2024, based on typical FDA timelines of taking six to 10 months to review new drug applications.

The American Hospital Association relates

In an online survey last November of 1,200 U.S. adults previously vaccinated against COVID-19, 62% had not yet received a bivalent booster dose, most often because they did not know they were eligible or the booster was available, or believed they were immune against infection, the Centers for Disease Control and Prevention reported today. After viewing information about eligibility and availability, over two-thirds of them planned to get a bivalent booster and 29% reported receiving the booster in a follow-up survey in December. To help increase bivalent booster coverage, the report recommends using evidence-based strategies to inform patients about booster recommendations and waning immunity.

From the No Surprises Act front, Healthcare Dive points out

  • Many Americans are still exposed to the potential for a surprise medical bill from an out-of-network ambulance ride, a research report published in Health Affairs found. About 28% of emergency trips in a ground ambulance resulted in a potential surprise bill, according to the research that analyzed commercial insurance claims.
  • About 85% of emergency transports were deemed out of network between 2014 and 2017, researchers found. But two-thirds of those trips are paid in full by insurers, eliminating the risk of a surprise bill.
  • The report shows the difference in pricing by ground ambulance ownership and how that affects patients’ financial exposure. * * *
  • Given the high prevalence for a potential surprise bill, protections like those afforded to consumers in the No Surprises Act may be necessary for both emergency and non-emergency transports, the authors said.

The FEHBlog is puzzled by the author’s extension of NSA protection to non-emergency transports, which the consumer should have time to manage. Congress should not overload the NSA system.

From the telehealth front, Healthcare Dive reports

  • Private insurers paid roughly the same for telehealth and in-person visits during the early days of the COVID-19 pandemic as virtual care surged, according to new research from the Kaiser Family Foundation.
  • Though it’s unclear how payment rates might have changed over the past two years, the findings call into question the argument that telehealth is saving the healthcare system money, researchers said.
  • However, researchers said that perks of telehealth included expanded access and convenience — cost benefits of which were not factored into the study.

Fierce Healthcare tells us

UnitedHealthcare is rolling out a new virtual behavioral health coaching program backed by Optum.

The offering is available as of Jan. 1 for 5 million fully insured members, and self-insured employers can purchase the program as an employer benefit. Through the program, adults with symptoms of mild depression, stress and anxiety can access support for their mental health needs through virtual modules as well as one-on-one video conferences, phone calls or messaging with coaches. * * *

Members who use virtual coaching can connect with a dedicated behavioral health coach for a 30-minute weekly audio or video call and can chat with their coach using in-app messaging between sessions.

The program lasts eight weeks, and each member will complete an assessment at the onset to identify their individual needs. Coaches use cognitive behavioral therapy techniques to assist the patient in crafting an action plan that is personalized to them.

In other UHC news, Beckers Payer Issues relates

The largest employer of physicians in the United States is not HCA, the VA, or Kaiser Permanente — it’s UnitedHealth Group’s Optum.

With at least 60,000 employed or aligned physicians across 2,000 locations in 2023, Optum has cemented itself at the forefront of the quickly changing healthcare delivery landscape. For comparison, Bloomberg reported in 2021 that Ascension employs or is affiliated with 49,000 physicians, HCA has 47,000 and Kaiser has 24,000.

Given that the Affordable Care Act limits health insurers, but not healthcare providers, profits, UHC made a smart move, in the FEHBlog’s opinion.

From the Rx coverage front, STAT News tells us

In a bid to blunt competition and address rising drug costs, Sanofi is offering a warranty that will cover the cost for any hospital if a specific medicine fails to work, marking only the second time a major pharmaceutical company has taken such a step.

In this instance, Sanofi designed a warranty program for its Cablivi medication, which is used to treat aTTP, a rare, life-threatening autoimmune blood disorder that is considered a medical emergency. The cost will be refunded for up to six doses for patients who fail to initially respond or up to 12 doses for patients whose condition worsens.

The move comes after Pfizer began offering warranties for two of its medicines, the first of which debuted in August 2021. At the time, the Pfizer effort was the first of its kind in the pharmaceutical industry. Unlike the Sanofi warranty, however, the Pfizer programs offer refunds to patients — not hospitals — if the medicines fail to work sufficiently.

Although the approaches vary, both companies are signaling their interest in differentiating themselves from competitors, not just responding to complaints about the rising cost of medicines, according to Emad Samad, president of Octaviant Financial, a firm that is promoting the use of warranties in the pharmaceutical industry.

How would these warranties redound to the benefit of third party payers?

From the miscellany front

  • Cigna offers a paper about “Digging into the Unique Drivers and Healthy Behaviors That Impact Vitality.”
  • The U.S. Preventive Services Task Force released a chart of its most impactful 2022 recommendations.
  • Fierce Healthcare reports, “The number of providers serving as [Medicare] accountable care organizations increased slightly this year thanks to the start of a new advanced model and a slew of reforms meant to reverse a slide in participation.”
  • Mercer Consulting digs into “must do” valued based care strategies.
  • The MIT Technology Review considers the prospect of gene editing for the masses using CRISPR 3.0
  • STAT News discusses the “hot mess” of legal issues associated with the FDA’s recent decision to make abortion drugs available at pharmacies.

Midweek update

David Ermer–COVID-19, Federal employment benefits, Government Contracting, OPM, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the federal employment front —

  • Govexec explains how federal employees can calculate their 2023 pay raises.
  • The Federal Times discusses how the Secure 2.0 Act, part of the Consolidated Appropriations Act 2023, affects federal employee retirement programs.

Healthcare Dive identifies key trends for payers and providers in 2023.

This year’s outlook for a large chunk of the healthcare sector remains negative as inflation and pricier labor create difficult operating conditions for nonprofit providers, Moody’s Investor Service said. 

As a result, health systems and hospitals are likely to clash with insurers over desired rate increases to offset higher expenses and providers will look to increase their revenue as much as possible by bargaining for higher rates.

Becker’s Hospital CFO Report fills us in on the highlights of a Fitch Ratings webinar on healthcare

Five things to know:

  1. There will continue to be “extremely contentious” negotiations between healthcare providers and payers, Mr. Holloran said. An “above average” exiting of contracts and networks is expected.
  2. There will be far more labor strikes in 2023 with “very contentious” labor negotiations, Mr. Holloran said. Unions will be quick to move as healthcare systems seek to recruit and retain “on steroids.”
  3. Regional differences will continue to emerge. The fast-growing Southern states of Florida, Texas and Georgia will see significant capital expenditure, for example, while regions with declining populations and others will seek to tighten such expenses.
  4. There will be increased merger and acquisition activity even as the Biden administration takes a harder look at potential anti-competitive behavior. “We know everyone is talking to everyone else” about ways in which they can partner, Mr. Pascaris said. “It’s a very interesting time for M&A as increased levels of stress will likely include greater levels of M&A.”
  5. Healthcare systems cannot spend their way out of financial difficulties because the cost of labor will remain very high. The 75/75 conundrum where most systems’ revenues are fixed at 75 percent and most have a similar 75 percent fixed expense in terms of salaries and supplies is an “unstainable” model, Mr. Holloran said.

From the public health front,

  • The Secretary of Health and Human Services extended the Omicron public health emergency for another 90 days today.
  • STAT News explores “What’s standing in the way of wastewater data becoming a more mainstream public health tool.”

Moderate-to-severe hearing loss was linked with a higher prevalence of dementia, a cross-sectional study of Medicare beneficiaries showed.

Among 2,413 older adults in the National Health and Aging Trends Study (NHATS), dementia prevalence among people with moderate-to-severe hearing loss was higher than it was among people with normal hearing (prevalence ratio 1.61, 95% CI 1.09-2.38), reported Nicholas Reed, AuD, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues.

But among people with moderate-to-severe hearing loss in the study, hearing aid use was associated with a lower prevalence of dementia compared with no hearing aid use (prevalence ratio 0.68, 95% CI 0.47-1.00), they wrote in a JAMA research letter.

The findings support a recent systematic review and meta-analysis that showed treating hearing loss led to cognitive benefits. They also support the availability of over-the-counter hearing aid, which people with mild-to-moderate hearing loss now can purchase directly due to new regulations.

Given the FEHB’s demographics, FEHB plans should take a look at improving health aid coverage for 2024.

From the U.S. healthcare business front

  • Fierce Healthcare reports on today’s events at the J.P. Morgan Healthcare conference.
  • The following Fierce Healthcare report from the conference caught the FEHBlog’s eye today

Fertility benefits are becoming a major lever in the ongoing talent wars, and that’s good news for Progyny.

The eight-year-old company, which provides family building and fertility benefits for employees at large firms, launched with five clients and 110,000 covered lives. Today, Progyny has more than 370 clients with 5.4 million covered lives.

“In the past year given the current macroeconomic environment, inflationary economy an a potential looming recession, despite all that, for Progyny and its members, it’s proven to be a resilient space. People aren’t foregoing and or deferring family building, in light of all those things, and companies aren’t deferring their decisions,” Pete Anevski, Progyny’s CEO, told Fierce Healthcare on the conference sidelines.

From the telehealth front, McKinsey and Company explain how healthcare organizations can tackle the following problem:

Using national claims data,3 we estimate that more than 50 million in-person visits per year could be converted to virtual or telemedicine visits if adoption were extended equally across patient segments. In general, patient segments with limited access to in-person care (for example, those in rural counties and those with lower incomes) have relatively fewer virtual visits. While many believe virtual care can improve access for the underserved, the current imbalance in usage suggests that US healthcare stakeholders could consider designing virtual-care models that address structural barriers so that virtual care is more widely accessible.

Check it out.

Federal procurement contracts, including FEHB contracts, include a clause requiring contractors to support government efforts to combat human trafficking. During the human trafficking awareness month, the Government Accountability Office reports

Tens of millions of people are victims of human trafficking each year, according to one international organization’s estimate. Human trafficking victims are often held in slave-like conditions and forced to work in the commercial sex trade or other types of servitude. The U.S. government has also found forced labor overseas in various industries producing goods imported into the U.S., such as agricultural and seafood industries.

Several U.S. government entities work with international entities to combat human trafficking. Today, for National Human Trafficking Awareness Day (January 11), our blog post looks at our work reviewing these efforts and our snapshot highlighting areas where continued attention is needed.

Thursday Miscellany

David Ermer–ACA, CMS, Congress, COVID-19, Federal employment benefits, Telehealth–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports

Rep. Kevin McCarthy stepped up negotiations with Republican detractors, offering fresh concessions to win support after a third day of House speaker votes yielded no movement toward a winner in the GOP-controlled chamber.

Mr. McCarthy and some of his detractors appeared to be coalescing around a deal, stepping up the pace of discussions as the House marked its 11th round of votes with no winner, the most since just before the Civil War. While most Republicans backed Mr. McCarthy over three days of tallies, 20 continued to oppose him, and it wasn’t known if enough detractors would potentially change their votes to give Mr. McCarthy the gavel. All Democrats supported their pick, Rep. Hakeem Jeffries of New York. 

Shortly after 8 p.m., lawmakers voted 219-213 to adjourn until Friday at noon, with Republicans in favor and Democrats opposed.

Voting is expected to continue into the weekend.

From the Affordable Care Act front, the FEHBlog discovered today that on December 12, 2022, the Department of Health and Human Services announced the maximum 2024 out-of-pocket limits for in-network care offered by FEHB and other group health plans.

[T]he 2024 maximum annual limitation on cost sharing is $9,450 for self-only coverage and $18,900 for other than self-only coverage. This represents an approximately 3.8 percent increase above the 2023 parameters of $9,100 for self-only coverage and $18,200 for other than self-only coverage.

The announcement also covers other ACA topics: the premium adjustment percentage, reduced maximum annual limitation on cost sharing, and required contribution percentage, which apply to marketplace plans.

From the New Year front —

  • Mercer offers strategic planning guidance for health plan and human resources executives.
  • STAT News identifies three drug pricing issues to watch this year — 1. Inflation Reduction Act implementation; 2. Medicare’s lecanemab coverage decision, and 3. Insulin cost protections.
  • Tammy Flanagan writes in Govexec about Federal “Employee Benefit Changes for 2023; How new pay rates, Social Security earnings limits and other factors could affect your retirement planning.” 
  • Bloomberg Prognosis offers a January guide to weight loss.
    • Healio adds, “More physical activity was associated with a lower risk for type 2 diabetes regardless of age, sex, BMI or sedentary time, according to an analysis published in The Journal of Clinical Endocrinology & Metabolism.”

    From the telehealth front —

    Healthcare Dive tells us

    Teladoc Health announced on Thursday it’s launching a new app allowing users to access its full range of services in one place and under one account.

    The app, which includes primary care, mental health and chronic condition management, is meant to integrate all of Teladoc’s assets in one personalized platform, making care navigation and selection easier for consumers,

    Teladoc Chief Medical Officer Vidya Raman-Tangella told Healthcare Dive. The app is available to a select number of Teladoc’s existing clients this month. Teladoc plans to make the app available to the full market later this year.

    Fierce Healthcare adds “Teladoc’s full suite of services will be available in the Spanish language on the mobile app and the website, marking a critical shift with more than 40 million people in the United States reporting they speak Spanish at home.”

    CMS announced adding “a new telehealth indicator on clinician profile pages on Medicare Care Compare and in the Provider Data Catalog (PDC). The new indicator helps beneficiaries and caregivers more easily find clinicians who provide telehealth services.”

    From the post-Dobbs front, the Hill reports

    Two of the biggest pharmacy chains in the country are planning to seek the certification needed to dispense abortion pills in the states where it is legal, according to spokespeople for the companies.

    The decisions by Walgreens and CVS are likely to provide a boost to a new Food and Drug Administration (FDA) policy announced Tuesday that will allow retail pharmacies to dispense mifepristone from a certified prescriber if they meet certain criteria. 

    Until 2021, mifepristone could only be dispensed in person by a physician. The FDA temporarily lifted that requirement because of the COVID-19 pandemic, and the Biden administration made the change permanent in December 2021, paving the way for doctors to prescribe the drug digitally and then mail the pills to patients.

    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.

    Thursday Miscellany

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

    From Capitol Hill, the Wall Street Journal reports

    A top Senate Democrat said that his party planned to introduce an omnibus spending bill Monday, aiming to pressure Republicans to accept a deal or risk an alternative that would freeze government spending at current levels for the full year and cut off the ability to reallocate money in military and other programs.

    Senate Appropriations Committee Chairman Patrick Leahy (D., Vt.) said that the measure would provide military funding at the level Congress is authorizing in its separate defense policy bill—some $858 billion, or roughly a 10% increase—while also paying for what he called a needed increase to nondefense programs.

    “This is a reasonable path forward, and I suggest my Republican friends take it,” Mr. Leahy said. * * *

    If no deal is reached as the end of the year approaches, lawmakers have said they might need to fall back to a so-called continuing resolution, which funds the government at current levels. Various lawmakers have floated stretching funding into early 2023 or for the full fiscal year, which ends in September. 

    The path forward was unclear, as neither House Speaker Nancy Pelosi (D., Calif.) nor Senate Majority Leader Chuck Schumer (D., N.Y.) announced votes on an omnibus bill for next week.

    The Journal adds,

    House lawmakers on Thursday passed a defense policy bill [discussed in yesterday’s FEHBlog post] 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. * * * The legislation is expected to pass the Senate by the end of next week before heading to President Biden’s desk for his signature.

    STAT News tells us

    Key decision makers in Congress are closer than they’ve been in years to revamping the way the government regulates some of the diagnostic tests that patients use to make crucial decisions about their health care [due to the Theranos fiasco].

    If the VALID act passes, the FDA wouldn’t regulate every single clinical test, but only tests considered “high risk” to patients, where the risk to patients of an inaccurate result could cause serious or irreversible harm.

    One example would be a test for breast cancer that could lead a patient to have a mastectomy, Boiani said. Another would be a genetic test that could determine which cancer treatment patients receive, said Jeff Allen, the president and CEO of Friends of Cancer Research.

    From the Federal Employee Benefits Open Season front, Tammy Flanagan writing in Govexec and Drew Friedman writing in Federal News Network offer last minute decision-making tips.

    Investment News provides advice on income adjusted Medicare premium issues.

    Most Medicare beneficiaries will pay the standard Part B premium of $164.90 per month in 2023, down slightly from this year’s monthly premium of $170.10. Medicare Part B covers doctors’ fees and out-patient services. Coupled with a huge 8.7% cost-of-living adjustment in Social Security benefits next year, most retirees will enjoy larger monthly net Social Security benefits after automatic deductions for their Part B premiums in 2023.

    But about 8%, or about 5 million, of the nearly 63 million Medicare beneficiaries will pay more than the standard monthly premium for both Part B and Part D prescription drug plans based on their income. My husband and I are among them.

    For 2023, single beneficiaries with incomes of $97,000 or more and married couples with joint incomes of $194,000 or more pay a Medicare premium surcharge, officially known as an income-related monthly adjustment amount, or IRMAA. The thresholds increased from $91,000 and $182,000, respectively, in 2022, meaning some beneficiaries may avoid IRMAA surcharges altogether in 2023 or pay less than this year due to the inflation adjustments of the income tiers that trigger those surcharges.

    In other health benefits news, Insurance News Net informs us

    The average per-employee cost of employer-sponsored health insurance rose by 3.2% in 2022, according to Mercer’s 2022 National Survey of Employer-Sponsored Health Plans, released today.

    US employers expect a sharper increase of 5.4% in 2023 — and faster cost growth in the years ahead seems likely

     For now, most employers are prioritizing enhancing benefits to attract and retain workers over cost-cutting; enhancements range from adding perks to improving healthcare affordability

     Mental health remains a top concern of employers and employees – and virtual mental healthcare is proving key to improving access to services

    From the Rx development and coverage front, we have three reports from STAT News —

    • Well, this government action didn’t take long. STAT News relates “The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older.”
    • Also according to STAT News, “A year ago, the [Purchaser Business Group on Health] coalition created Emsana Health that, in turn, hatched the EmsanaRx pharmacy benefit manager. [Beginning March 1, 2023,] EmsanaRx will run the technology to ensure prescriptions handled by Cuban Cost Plus Drugs are paid and fulfilled, and report all this information back to the [self-funded] employer. In exchange, EmsanaRx will take a flat 1.5% fee for legal, administrative, and data sharing services, but not charge more than $3 for each insurance claim and will pass along any rebates collected.”
    • Finally from STAT News, “Medicare is willing to reevaluate its coverage of Alzheimer’s drugs in light of a new therapy, called lecanemab, that has shown potentially more promising patient data than its controversial predecessor, Aduhelm, according to the official who oversees the program. “I can’t speak to any specifics, but just to say that our door is really open,” Chiquita Brooks-LaSure, administrator for the Centers for Medicare and Medicaid Services, said Thursday at the Milken Institute Future of Health Summit when asked about how the agency will approach lecanemab. “We will look at it as new data comes.”

    From the public health front —

    An outside group [the Reagan Udall Foundation] that was asked to examine problems at the Food and Drug Administration in the wake of an infant formula crisis this year offered a scathing indictment of the agency’s structure and culture and recommended major restructuring, including possibly breaking up the agency so that oversight of the food system gets more attention. * * *

    In a statement, FDA Commissioner Robert M. Califf said he will review the report and make decisions about the future of the agency with input from experts inside and outside the FDA.

    • The Congressional Research Service issued an “In Focus” report on “Regulating Reproductive Health Services After Dobbs v. Jackson Women’s Health Organization.”
    • Health Payer Intelligence tells us

    Overall, major health outcomes measures are trending in a negative direction, according to America’s Health Rankings Annual Report for 2022.

    The Annual Report examines 23 measures to assess health outcomes trends nationwide, including measures for eight chronic conditions. The data for these measures primarily represented 2021 outcomes, but some measures drew from 2018, 2019, 2020, and 2022.

    A Morning Consult online survey conducted in October 2022 informed the results as well as racial and ethnic subpopulation data and a total of 80 national and state measures to assess the state of healthcare in the US.

    Based on the findings, the coronavirus pandemic has continued to have ripple effects on healthcare. The top three major trends in health outcomes are:

    • Increased drug deaths
    • Increased non-medical drug use
    • Increased premature death

    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.”

    Monday Roundup

    David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
    Photo by Sven Read on Unsplash

    From Capitol Hill, Roll Call reports the FY 2023 National Defense Authorization Act is expected to rescind the Defense Secretary’s 2021 Covid vaccine mandate for U.S. service members. “Congressional leaders are aiming to introduce the final compromise NDAA version as soon as Tuesday, with House floor action possible later in the week.”

    From the infectious disease front —

    • Bloomberg Prognosis tells about a study confirming the Paxlovid rebounds have been blown out of proportion.
    • Pfizer has asked the Food and Drug Administration for an emergency use authorization applicable to its bivalent Omicron vaccine designed for children at least six months old and not over four years old.
    • The Health and Human Services Secretary has confirmed reported plans to end the mpox public health emergency when the current declaration expires at the end of January 2023. “But we won’t take our foot off the gas – we will continue to monitor the case trends closely and encourage all at-risk individuals to get a free vaccine.”
    • MedPage Today interviews Demetre Daskalakis, MD, MPH, the deputy coordinator of the White House Monkeypox Response Team, about the course of the illness since it erupted in the summer

    Influenza hospitalizations this early in the season are higher than they have been in a decade, according to the CDC, with 14 pediatric deaths reported so far.

    “Since October 1, there have already been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu,” said CDC Director Rochelle Walensky, MD, MPH, on a call with reporters on Monday, held in part to kick off National Influenza Vaccination Week. * * *

    This year, influenza vaccines are “well matched to the viruses currently circulating,” she added. The flu shots contain protection for two influenza A and two influenza B virus strains. Of influenza A viruses detected and subtyped this season, 79% have been A(H3N2) and 21% have been A(H1N1).

    The CDC recommends influenza vaccination particularly for children, immunocompromised individuals, pregnant women, and people 65 and over.

    It was not clear if the pediatric deaths reported so far this season involved unvaccinated children, but Fryhofer noted that previous data showed about 80% of influenza deaths occur in unvaccinated persons.

    Pregnant women who get the flu shot also protect their newborns, who are not eligible for vaccination before they are 6 months of age, Fryhofer said. “If you’re not doing it for you, do it for your baby.”

    • For context, here are the flu case and death statistics from the last flu season before Covid struck, October 2019 through March 2020.
    2019 – 2020 Winter CDC Fluview  3/28/20
    Flu Deaths                  24,000 
    Flu Cases             39,000,000 

    The flu is a highly contagious, dangerous disease.

    • NPR Shots offers consumer advice should they counter pharmacy shelves with a low or no supply of anti-fever drugs.

    From the telehealth front, Health Leaders Media tells us

    According to a survey commissioned by America’s Health Insurance Plans, almost 70% used telehealth in the past year because it’s more convenient than in-person care, and almost 80% say telehealth makes it easier to seek out care.

    Almost 50% used telehealth because they were unable to make an in-person appointment, while 24% said they wanted to save money.

    Some 36% used telehealth just once over the past year, while 53% used it between two and five times.

    From the mental healthcare front, Health Payer Intelligence reports

     CareFirst BlueCross BlueShield (CareFirst) is providing community-based organizations with nearly $8 million in grants to help improve behavioral healthcare access and quality for underserved youth.

    The COVID-19 pandemic exacerbated the mental and behavioral health crisis among children, adolescents, and families. In response, CareFirst is investing in 19 community-based organizations in Maryland, Washington, DC, and Northern Virginia.

    “CareFirst recognizes that behavioral health is an essential part of overall health, which includes a continuum of conditions ranging from severe mental health disorders to the emotional, psychological, and social factors that affect a person’s overall wellbeing,” Destiny-Simone Ramjohn, PhD, vice president of community health and social impact at CareFirst, said in the press release.

    Kudos

    From the Rx coverage front, Fierce Healthcare informs us

    Express Scripts, which is part of Cigna’s Evernorth subsidiary, said Monday that it will add biosimilars for Humira to its largest formularies as preferred products available for patients with inflammatory conditions. Like other major PBMs, Express Scripts sees significant potential in biosimilars to help address the massive costs associated with specialty drugs.

    Specialty drugs account for just 2% of prescriptions but drive half of drug spending.

    In October 2021, Express Scripts announced that it would put Semglee, the first Food and Drug Administration-approved interchangeable insulin biosimilar, on its National Preferred Formulary for 2022. The company estimates that this move generated $20 million in savings in the first year.

    From the federal government employee benefits front, Federal News Network relates

    The Office of Personnel Management plans to suspend applications for the Federal Long Term Care Insurance Program for two years beginning Dec. 19, in anticipation of a sizeable rate hike.

    OPM announced the unusual measure last month in the Federal Register, and noted that federal workers who submit their applications by the deadline will still be considered for enrollment. FLTCIP was created in 2002 and assists with health care costs for participants who need help with daily personal functions, or who have a severe cognitive illness, and covers home care, nursing home or assisted living benefits.

    “OPM is suspending applications for coverage in FLTCIP to allow OPM and the FLTCIP carrier to assess the benefit offerings and establish sustainable premium rates that reasonably and equitably reflect the cost of the benefits provided,” the agency wrote.

    The program will continue to operate normally for current enrollees, although they will not be able to apply to increase their coverage. There are currently around 267,000 federal workers and retirees participating in the insurance plan, and OPM typically receives only a few thousand applications to enroll per year.

    The decision to suspend applications for the program came after John Hancock Life and Health Insurance Co., the contractor that administers the program, informed OPM that it is likely that there will a premium increase sometime next year.

    Finally, the Wall Street Journal offers an interesting article about medical research that is “uncovering links between your ‘subjective age’ [as opposed to your chronological age] and your future health and longevity.”

    Weekend update

    David Ermer–AHRQ, Congress, Federal employment benefits, Medicare, Mental health care, OPM, Rx coverage, Uncategorized–
    Thanks to ACK15 for sharing their work on Unsplash.

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

    The continuing resolution funding the federal government expires at 11:59 pm on Friday December 16.

    The Federal Employee Benefits Open Season ends at 11:59 pm, in the location of the enrollee’s electronic enrollment system, on Monday, December 12, 2022.

    The Medicare Open Enrollment period ends this Wednesday, December 7.

    From the Rx coverage front, the Wall Street Journal reports on

    • A shortage in the weight loss drug Wegovy, “missing out on hundreds of millions of dollars in sales and squandering a head start before a rival could begin selling a competing product. * * * [Wegovy manufacturer’ Novo lists Wegovy at $1,349 a month. Some commercial insurers cover the drug.” OPM has encouraged FEHB carriers to offer coverage of this drug.
    • A CVS Health effort to improve pharmacy efficiency with “a system [currently being tested] that allows pharmacists to process prescriptions in part remotely, a move it said could improve store working conditions and the experience for customers as the company grapples with a shortage of pharmacists.”

    From the mental healthcare front, Health Payer Intelligence tells us

    Mental healthcare services utilization and network size have grown significantly since 2019 among Blue Cross Blue Shield of Massachusetts (“Blue Cross”) members, according to data from Blue Cross.

    Mental healthcare services utilization grew by 100 percent in the timeframe that Blue Cross examined. At the same time, Blue Cross’s mental healthcare network grew by 46 percent.

    “As the need for mental health services continues to grow, access to convenient and affordable care is critical,” said Andrew Dreyfus, president and chief executive officer of Blue Cross. “By expanding and diversifying our mental health network, we’re ensuring that our members are able to find and receive the high-quality care they need, when they need it.”

    The mental healthcare provider network swelled to a total of 18,000 clinicians. With the growth in utilization, Blue Cross plans to expand its network further. The payer will do this by working with national mental healthcare provider groups as well as expanding its virtual care mental health groups in 2023. * * *

    Blue Cross also shared that the health plan’s reimbursement for telehealth and virtual care services is at parity with in-person services. Receiving reimbursement at parity is not only a controversial issue for telehealth providers but also for mental and behavioral healthcare providers, who do not always receive reimbursement at parity with physical care providers.

    Kudos.

    Also worth reading is this Journal article about a 24-year-old military wife who went through drug addiction hell and came out a new person with help from her family, the Missouri prison where she was housed, and a fellow inmate. The article illustrates the importance of Blue Cross of Massachusett’s efforts to expand mental health coverage and various efforts to reduce drug addiction and overdose deaths.

    From the medical research front, the Wall Street Journal offers an essay about breast cancer written by a medical historian and breast cancer patient Dr. Lindsey Fitzharris. What grabbed the FEHBlog’s eye is the article’s conclusion:

    The cofounders of BioNTech recently announced that vaccines targeting cancer may be available before the end of the decade. Researchers at Duke University are already developing a vaccine that targets mutations commonly arising in people with certain types of advanced breast cancer. Using the same mRNA technology deployed against Covid-19, these types of vaccines would not be administered prophylactically but, rather, used as a treatment to trigger a stronger immune response in patients with locally recurrent or metastatic disease. When it comes to conquering breast cancer, future medical historians will have plenty to write about.

    From the innovation front, Senior Living explains how to use Apple AirPods as hearing aids. MedTech Dive adds

    • Apple AirPods Pro earbuds have the potential to be a hearing aid for adults with mild to moderate hearing loss, according to a paper published in iScience. 
    • Researchers found the earbuds meet four of the five standards for personal sound amplification products and perform comparably to hearing aids in terms of speech perception in quiet environments.
    • The study suggests that some consumer earbuds can function as hearing aids to potentially further lower the cost and address the stigma associated with the technology.

    It’s also worth calling attention to the HHS Agency for Healthcare Quality and Research’s Effective Health Care Program’s website.

    The Effective Health Care (EHC) Program improves the quality of health care by providing the best available evidence on the outcomes, benefits and harms, and appropriateness of drugs, devices, and health care services and by helping health care professionals, patients, policymakers, and health care systems make informed health care decisions. The EHC Program achieves this goal by partnering with research centers, academic institutions, health professional societies, consumer organizations, and other stakeholders to conduct research, evidence synthesis, evidence translation, dissemination, and implementation of research findings.

    Thursday Miscellany

    David Ermer–ACA, CMS, COVID-19, FDA, Federal employment benefits, Medicare, No Surprises Act, OPM, Rx coverage, Telehealth, U.S. Healthcare–

    From the Federal Employees Benefit Open Season front, Tammy Flanagan, writing in Govexec, explains the relationship between FEHB and Medicare coverage for the benefit of annuitants over age 65.

    From the OPM front, Govexec and Federal News Network discuss an OPM management report released yesterday that includes more details on OPM’s 2022 Federal Employee Viewpoint Survey.

    From Capitol Hill, Medpage Today informs us that “Telehealth, Mental Health Likely Topics for the New Congress in 2023, Experts Say.” In this regard, today the bipartisan leadership of the Senate Finance Committee “released a [fifth and final mental health parity] discussion draft including policies aimed at improving mental health parity in Medicare and Medicaid and helping to put access to mental health and substance use disorder (SUD) services on par with physical health care. Mental health parity includes a set of laws aimed at ensuring mental and physical health care are covered equally by health insurance. * * * The full text of the discussion draft is available here. A summary of all provisions released by the committee as a part of the bipartisan mental health effort, including mental health parity, is available here.”

    From the Omicron and siblings front —

    Beckers Hospital Review reports

    COVID-19 hospitalizations have ticked up nationwide in recent weeks amid concerns of a potential winter surge, according to data tracked by The New York Times.

    As of Nov. 29, the nation’s daily hospitalization average was 31,125, up 12 percent over the last 14 days. This figure is still down significantly from the more than 800,000 daily hospitalizations recorded during the peak of last winter’s omicron surge. 

    MedPage Today informs us

    People with acute respiratory illness during the pandemic suffered similar levels of poor well-being in the months afterward whether they tested positive for SARS-CoV-2 or not, a registry study showed.

    In a cohort of people who all had initial symptoms suggestive of COVID-19, those who had moderate to severe scores at 3 months on the pain, mood, and other quality-of-life measures on the Patient-Reported Outcomes Measurement Information System (PROMIS) scale were actually less likely to have tested positive for the coronavirus as to have had other causes of illness (39.6% vs 53.5%, P<0.001).

    From the public health front —

    MedPage Today explains how patients can try to distinguish among different respiratory illnesses, including RSV and the flu because at home testing is unavailable.

    Politico Pulse reports

    The Biden administration looks to end its public health emergency declaration for mpox — the virus formerly known as monkeypox until recently — a sign that officials believe they’ve brought the unprecedented outbreak under control, POLITICO’s Adam Cancryn reports.

    Health officials are likely to issue a 60-day notice later this week for winding down the declaration, two people with knowledge of the matter told POLITICO, putting it on track to expire by Jan. 31. The decision isn’t yet final and could still change, the people cautioned. * * *

    Some administration officials see the potential unwinding of the mpox emergency declaration as a test run for eventually ending the yearslong Covid emergency — a more complex challenge — that Biden aides expect to happen at some point next year.

    From the Affordable Care Act and No Surprises Act front

    The American Hospital Association (“AHA”) informs us

    The Centers for Medicare & Medicaid Services seeks public input on topics related to essential health benefits — items and services that all non-grandfathered health plans in the individual and small group markets must cover under the Affordable Care Act. The agency is requesting feedback on how essential health benefits may need to be updated to reflect changes in medical evidence and scientific advancement, address gaps in coverage and health equity, or remove barriers to accessing services. In particular, CMS seeks feedback on essential health benefits related to maternal health, behavioral health and prescription drug coverage. The agency will publish the request for information in the Dec. 2 Federal Register, with comments accepted for 60 days. 

    and

    AHA today urged the Centers for Medicare & Medicaid Services not to establish a national directory of health care providers and services (NDH) at this time.

    “The AHA shares CMS’ goals to improve patient access to provider information and to facilitate health information exchange and data reporting,” the association wrote. “We appreciate the commitment CMS has invested in striving to meet these objectives. However, we are concerned that adding one more provider directory requirement will not support patients in accessing the information they need about their care providers. In fact, adding an additional data source without sufficiently addressing how or why it differs from the myriad provider directories already in existence could further complicate patients’ ability to access accurate information. Meanwhile, such a requirement would add considerable, duplicative burden on providers. Additionally, we have significant reservations about the current state of readiness of the essential technology needed for a centralized data hub such as the NDH.”

    Mercer Consulting offers insights on the prescription drug and healthcare spending reports that health plans must submit to the federal government by December 27. Jingle bells.

    Healthcare Dive reports that the Texas Medical Association has filed another lawsuit challenging different aspect of the independent dispute resolution rule. Haven’t the TMA lawyers heard about the opportunity available under the Federal Rules of Civil Procedure to amend their existing complaint?

    From the Rx coverage front —

    STAT News relates

    The Food and Drug Administration approved the first therapy using bacteria from stool samples to treat a bowel disorder on Wednesday, paving the way for several similar treatments in development.

    The drug, called Rebyota, is given as a one-dose treatment for Clostridium difficile infections, commonly known as C. diff., in which the toxin-producing bacteria disrupts the normal balance in a person’s digestive system. Rebyota is designed to restore balance by introducing good bacteria taken from donor stool samples. 

    “We are delighted that FDA has approved the first fecal microbiome restoration therapy for recurrent C. diff. This is an enormous step forward for the nearly 200,000 people who battle rCDI each year,” ​​said Christian John Lillis, the executive director of the C. diff advocacy organization the Peggy Lillis Foundation. 

    and

    Amgen released detailed data on Thursday suggesting an early-stage drug can induce significant weight loss in patients with obesity, with less frequent dosing than current treatments but a safety profile that remains unclear.

    The results for the molecule, codenamed AMG133, throw Amgen in a long-gestating race with other major drugmakers that burst into the popular press this year.

    Eli Lilly and the diabetes giant Novo Nordisk both market drugs that were recentlyshown to lower body weight by around 15% to 20% after a little over a year. (Lilly’s is currently approved only for diabetes, but it plans to submit for obesity next year.) The injectables have been highly sought after by both obesity specialist physicians, who have long searched in vain for something safe and effective to offer their patients, and celebrities hoping to look svelte in their next appearance.

    From the miscellany department —

    Beckers Hospital Review interviews a Kaiser Permanente expert about their successful use of remotely monitoring patients with diabetes and high blood pressure. The monitors deliver their results to Kaiser Permanente’s electronic health records for 40,000 members. Kudos.

    Beckers also lets us know about large hospital systems that are having a profitable 2022.

    STAT News reports

    Elon Musk’s brain-machine interface company Neuralink aims to put its first implant in a human subject in the next six months, he said during an event Wednesday.

    Musk said the company has been “working hard to be ready for our first human,” and has submitted most of the required paperwork to the Food and Drug Administration to launch a study in humans. The company — which is designing a device to translate the brain’s signals into actions — also announced it will first focus specifically on two applications: restoring human vision, and helping people who can’t move their muscles to control devices like smartphones or even return the ability to move to people with severed spinal cords, Musk said.

    Though it’s starting with certain parts of the brain, Musk said Neuralink’s long-term goal is to create a system that can translate impulses from the entire brain into actions.

    Midweek Update

    David Ermer–CDC, COVID-19, FDA, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–

    From the federal employment front —

    • Govexec discusses the outstanding steps that must be taken before a projected 4.6% federal employee pay raise can take effect next month. The FEHBlog expects those steps to be taken.
    • Reg Jones, writing in FedWeek, reviews the federal retirement process.
    • Federal News Network reports that “Federal employees forced to work without pay during government shutdowns need to be made whole eventually. But the government’s late payments don’t mean those workers are entitled to damages, [the U.S. Court of Appeals for the Federal Circuit] ruled Wednesday.

    From the Omicron and siblings front, the Wall Street Journal informs us

    The Food and Drug Administration said a Covid-19 antibody treatment from Eli Lilly & Co. is no longer authorized for use because it isn’t likely to be effective against certain Omicron offshoots now dominant in the U.S.

    The subvariants, called BQ. 1 and BQ. 1.1, now cause more than half of new Covid-19 cases in the U.S., the FDA said on Wednesday. Yet Lilly’s drug, bebtelovimab, doesn’t retain neutralizing activity against the subvariants, the company said. 

    “Lilly and the FDA agree that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate Covid-19 with bebtelovimab in the U.S.,” Lilly said.

    Bebtelovimab was among the Covid-19 antibody drugs still authorized for use as a treatment for sick patients, after the FDA pulled clearances of others. Roche Holding AG’s Actemra antibody drug is also still in use as a treatment, though it wasn’t developed specifically for Covid-19.

    Evusheld, an antibody drug from AstraZeneca PLC, is still cleared to prevent infections.

    The FDA said other Covid-19 treatments are still expected to retain activity against BQ. 1 and BQ. 1.1, including PfizerInc.’s Paxlovid and Gilead Sciences Inc.’s Veklury.

    In other public health news, STAT News tells us

    With growing concern about the circulation of vaccine-derived polioviruses in the United States, the Centers for Disease Control and Prevention said Wednesday that it would work with select communities across the country to conduct wastewater surveillance for the viruses.

    The launch of the initiative follows the discovery over the summer of vaccine-derived polioviruses circulating in the sewage of a number of counties in and around New York City. That discovery was made after an unvaccinated man in his 20s was partially paralyzed by polioviruses in July. Since then at least 82 genetically linked viruses have been recovered in sewage samples collected from five counties in and around New York.

    The CDC said the work will start in two communities: Oakland County, Mich., and an as-yet-unnamed county in the Philadelphia area. The surveillance may later extend to other parts of the country where polio vaccination rates are low or to locations that have ties to the communities in New York state where polioviruses have been found in wastewater.

    From the U.S healthcare business front —

    Healthcare Dive reports

    Heightened expenses, ongoing staffing shortages and fewer patient discharges have hospitals facing negative margins near the end of the year, according to Kaufman Hall’s monthly national flash report out Wednesday.

    Median operating margins have been in the red for 10 consecutive months and were down 2% in October from September. Median operating margins were down 13% year over year in October, according to the report.

    Total labor expenses rose 3% from September and total expenses rose 1%, while supply and drug expenses did fall slightly during the month.

    In that regard, Beckers Hospital CFO Report relates

    Cleveland Clinic has reported a more than $1 billion loss for the first nine months of 2022 as salaries increase and inflationary pressures mount.

    The 20-hospital health system reported $469.2 million in third quarter net losses, a significant drop from $422.2 million net income last year. Cleveland Clinic’s investment returns were nearly $682 million lower for the third quarter this year than last due to “unfavorable financial markets,” according to the health system’s financial report.

    In contrast, Fierce Healthcare reports

    Highmark Health posted a $268 million net loss through the first nine months of 2022 as multiple headwinds drag its finances.

    Highmark reported $19.5 billion in revenue, up 22% year-over-year, and $594 million in operating gain. The performance of its equity investment portfolio is a key challenge facing the integrated system, as its financial report includes $670 million in unrealized investment impact driven by a decline in the portfolio.

    Saurabh Tripathi, chief financial officer and treasurer of Highmark Health, told Fierce Healthcare that Hihghmark expects to turn that unrealized impact around as the market improves.

    Other major headwinds include ongoing supply chain issues, inflation and high labor costs, particularly at its Allegheny Health Network health system. Strong performance at its health plan arm is helping to bolster AHN as it weathers these challenges that providers nationwide are staring down.

    “This is where the strength of our portfolio comes in,” Tripathi said. “The insurance side is helping offset those pressures.”

    Ah, the benefits of diversification.

    From the medical research and development front,

    • The NIH HEAL Project Initiative’s Director delves into HEAL’s research on preventing opioid addiction.
    • BioPharma Dive examines “What to make of Eisai and Biogen’s latest Alzheimer’s drug data.” Given the FEHB Program’s demographics, FEHB carriers should keep an eye on this drug which is bound to be an expensive hot seller if the manufacturers can overcome the blowback from their Aduhelm failure.