Thursday Miscellany

Federal employment benefits

Thursday Miscellany

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

From Washington, DC,

  • The House Republicans have not settled on a new Speaker yet. Roll Call adds, “The delay in the effort to get 217 Republicans to back anyone for speaker is leading some House members to start reconsidering the idea that Speaker Pro Tempore Patrick T. McHenry is little more than a placeholder.”
  • This morning, the Social Security Administration announced
    • “Social Security and Supplemental Security Income (SSI) benefits for more than 71 million Americans will increase 3.2 percent in 2024. * * *
    • “The maximum amount of earnings subject to the Social Security tax (taxable maximum) will increase to $168,600.”
  • Federal News Network explains how the Social Security announcement impacts federal annuitant cost of living adjustments for 2024.
  • This afternoon, the Centers for Medicare and Medicaid Services announced Medicare Part B premiums for 2024 and more, e.g., income-adjusted premiums for Parts B and D.
    • “The standard monthly premium for Medicare Part B enrollees will be $174.70 for 2024, an increase of $9.80 from $164.90 in 2023. The annual deductible for all Medicare Part B beneficiaries will be $240 in 2024, an increase of $14 from the annual deductible of $226 in 2023. 
    • “The increase in the 2024 Part B standard premium and deductible is mainly due to projected increases in health care spending and, to a lesser degree, the remedy for the 340B-acquired drug payment policy for the 2018-2022 period under the Hospital Outpatient Prospective Payment System.
    • “Beginning in 2023, individuals whose full Medicare coverage ended 36 months after a kidney transplant and who do not have certain other types of insurance coverage can elect to continue Part B coverage of immunosuppressive drugs by paying a premium. For 2024, the standard immunosuppressive drug premium is $103.00.”
  • FedSmith shares Medicare basics for federal employees and annuitants.
  • Fierce Healthcare reports on a discussion of Medicare Advantage at the HLTH conference held in Las Vegas this week.

From the public health and research front,

  • The U.S. Preventive Services Task Force published a draft research plan on prostate cancer screening. The draft plan is open for public comment through November 8, 2023.
  • STAT News informs us,
    • “The brain remains both the body’s most important organ and its least understood. But a draft atlas of the human brain published on Thursday gives scientists important insights into how it works and may pave the way for big advances in disease treatment and diagnosis.
    • This brain map, pieced together by hundreds of researchers from San Diego to Seattle to Stockholm, is essentially a cellular “parts list” of the human brain and a guide to how those pieces are arranged and work together. Scientists say that what they’ve already learned — including a stunning diversity of cell types in the brain — and what they’ll discover in the years to come will improve our understanding of deadly neurological diseases. * * *
    • “The recent findings, reported across 21 studies published in the journals Science, Science Advances, and Science Translational Medicine, offer some early clues. And there’s more to come. These papers are part of an ongoing undertaking researchers openly compare to the Human Genome Project in both its scope and ambition. That project sequenced the DNA of a dozen blood donors from Buffalo, N.Y. The new brain atlas was constructed from the brains of more than 100 people, including deceased donors and surgical patients.”
  • The Wall Street Journal seeks to explain the secret of living to 100 years old.
    • “If you want to live to your 100th birthday, healthy habits can only get you so far.”If you want to live to your 100th birthday, healthy habits can only get you so far.
    • “Research is making clearer the role that genes play in living to very old age. Habits like getting enough sleep, exercising and eating a healthy diet can help you stave off disease and live longer, yet when it comes to living beyond 90, genetics start to play a trump card, say researchers who study aging.
    • “Some people have this idea: ‘If I do everything right, diet and exercise, I can live to be 150.’ And that’s really not correct,” says Robert Young, who directs a team of researchers at the nonprofit scientific organization Gerontology Research Group. 
    • “About 25% of your ability to live to 90 is determined by genetics, says Dr. Thomas Perls, a professor of medicine at Boston University who leads the New England Centenarian Study, which has followed centenarians and their family members since 1995. By age 100, it’s roughly 50% genetic, he estimates, and by around 106, it’s 75%.” 
  • Beckers Clinical Research points out
    • “Researchers at Boston-based Harvard Medical School and University of Oxford in England have created an AI tool to forecast which COVID-19 strains will grow in dominance, according to an Oct. 11 article in Nature. 
    • “The tool, called EVEscape, predicts how the virus can evolve through a model of evolutionary sequences alongside biological and structural data, according to an Oct. 11 Harvard news release. EVEscape works to forecast which future COVID-19 strains are most likely to occur. 
    • “Every two weeks, the researchers will release a ranking of COVID-19 variants. 
    • “The rankings are available here.

From the U.S. healthcare business front,

  • Reuters tells us,
    • Shares of dialysis service providers fell sharply on Wednesday after Novo Nordisk’s Ozempic showed early signs of success in delaying the progression of kidney disease in diabetes patients.
    • Colorado-based DaVita’s shares closed down about 17% and U.S.-listed shares of German rival Fresenius Medical ended 17.6% lower.
    • Novo’s announcement is the latest sign of disruption caused by the success of GLP-1 drugs, which have hit shares of food companies, providers of bariatric surgery and glucose-monitoring device makers.
    • FEHBlog note: That is wiggly whack.
  • Healthcare Dive informs us
    • “Walgreens announced a 2024 earnings outlook below Wall Street expectations on Thursday, two days after announcing a new chief executive officer who the beleaguered retailer says will help with its strategic pivot to healthcare services.
    • “Along with the release of its fourth-quarter earnings, Walgreens said it expects adjusted earnings per share for its 2024 fiscal year to be between $3.20 to $3.50, below the analyst consensus of $3.71, due to lower profit from COVID-19 testing and vaccines among other factors.
    • “On a call with investors Thursday morning, Walgreens leadership said the Deerfield, Illinois-based retailer is focused on accelerating the profitability of its U.S. Healthcare division, which includes value-based medical group VillageMD. As part of that, Walgreens plans to close 60 underperforming VillageMD clinics next year.”
  • Per Beckers Hospital Review,
    • “Nearly two years after Mark Cuban launched a mail-order pharmacy with low-cost medications, the entrepreneur and “Shark Tank” star has secured more than a dozen collaborators. 
    • “In September, Mark Cuban Cost Plus Drug Co. penned a deal with Avanlee Care, which runs an app designed to help caregivers for elderly patients. The app, called Ava, will feature an option for its users to order medications from Cost Plus Drugs. Mr. Cuban’s company also teamed up with two fertility health companies to reduce the burden of the pink tax, or inflated prices on women’s products.
    • “Cost Plus Drugs has also expanded its in-person services by signing deals with pharmacies spanning multiple states and grocery chain pharmacies, such as Kroger. The affiliate network aligns Cost Plus Drugs’ pricing with medications at independent pharmacies. 
    • “In an insurance industry shake-up, Blue Shield of California chose Cost Plus Drugs and a few other vendors to take over services historically filled by CVS Caremark, CVS Health’s pharmacy benefit manager. Mark Cuban’s company is now a preferred pharmacy network for the insurer serving 4.8 million members.”  
  • and
    • “St. Louis-based Ascension is focused on rebounding from a $3 billion operating loss (-5.6 percent operating margin) in fiscal year 2023 amid negative outlooks from two ratings agencies. 
    • “Fitch Ratings recently lowered Ascension’s outlook from stable to negative while S&P Global Ratings affirmed its negative outlook for the health system. 
    • “Despite “real progress” to resume a more typical level of operations through significant and durable cost savings initiatives, Ascension saw a new set of operational challenges in FY 2023, Fitch said in a Sept. 26 report. The system hit its 2022 operational goals largely through improved efficiencies and contract labor and productivity initiatives, but additional challenges continued to hinder operations in FY 2023.
    • “One caveat on the $3 billion operating loss is that it included a one-time, non-cash impairment loss of $1.5 billion as the carrying value of certain assets within Ascension’s markets may not be fully recoverable, according to the health system. When normalized to exclude one-time items, Ascension’s operating loss for FY 2023 was $1.39 billion (-4.9 percent margin) compared to a $1.17 billion loss (-4.2 percent margin) in FY 2022.” 

Friday Factoids

David Ermer–Congress, COVID-19 vaccine, Federal employment benefits, Medical / Rx research, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 6 reopened the No Surprises Act’s Independent Dispute Resolution [IDR] portal to out-of-network providers and group health plans initiating new single payment disputes under the No Surprises Act’s independent dispute resolution process, including single disputes involving bundled payment arrangements. The agency also released new guidance for processing these disputes.
    • “New and in-progress batched disputes and new air ambulance disputes remain temporarily suspended while the Departments of Health and Human Services, Labor and the Treasury update their guidance and operations to align with recent court orders, including an Aug. 24 ruling that set aside certain regulations implementing the IDR process and an Aug. 3 ruling that vacated nationwide a federal fee increase and batching rule for the process.”
  • In that regard, the federal regulators issued ACA FAQ 62 today, which focuses on No Surprises Act issues.
  • What’s more, a No Surprises Act IDR operations proposed rule is still undergoing review at OMB’s Office of Information and Regulatory Affairs.
  • BioPharma Dive informs us,
    • “The National Institutes of Health on Thursday said it will provide funding for three clinical trials of experimental ALS drugs, part of a broader push by the federal government to support the development of treatments for rare neurodegenerative diseases. * * *
    • “Until recently, the FDA had approved just two main medicines for the disease. Clinical testing had shown the drugs respectively offered modest benefits on function and survival.
    • “But in the last year or so, two more treatment options received nods from the FDA. Amylyx Pharmaceuticals’ Relyvrio is now cleared for the broad ALS population, while Biogen’s Qalsody is specifically for the small portion of patients who have mutations in a gene called SOD1.”
  • Per Pharmaceutical Technology,
    • “The US Food and Drug Administration (FDA) has issued a draft guidance to aid sponsors in developing biologics and drugs for stimulant use disorders. * * *
    • “FDA Center for Drug Evaluation and Research Substance Use and Behavioral Health deputy center director Marta Sokolowska said: “Currently there is no FDA-approved medication for stimulant use disorder. When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps. 
    • “The guidance is one of the actions within the agency’s Overdose Prevention Framework, which includes appropriate prescribing of prescription stimulants as well as the development of evidence-based treatments for stimulant use disorder.”
  • Federal News Network points out,
    • “The Office of Personnel Management’s retirement claims backlog saw some improvement in September. OPM cut its backlog by 2,111 claims, hitting a new six-year low point in its overall inventory. OPM received 6,768 claims in September, and managed to process 8,879, shrinking the backlog to the lowest it has been in six years: 15,852.”
  • The Wall Street Journal reports,
    • “The U.S. Postal Service wants to raise the price of a stamp in what would be the third increase in a year.
    • “The postal service proposed a price of 68 cents, up 3% from the current price of 66 cents. If approved by the Postal Regulatory Commission, the price increase would go into effect on Jan. 21. 
    • “The agency raised stamp prices to 63 cents from 60 cents in January 2023. Six months later, the price of a stamp went up again, by 3 cents.”

From the public health and research front,

  • Medscape notes,
    • “Around 4 million Americans received the updated COVID-19 shots in September, according to the U.S. Department of Health and Human Services (HHS), even as some people have found it difficult to book vaccination appointments or find the vaccines at no cost.”
  • NBC News reports,
    • “People who take popular drugs for weight loss, such as Ozempic or Wegovy, may be at an increased risk of severe stomach problems, research published Thursday in the Journal of the American Medical Association finds.
    • “The brief report is the first study of its kind, the researchers say, to establish a link between the use of such drugs, called GLP-1 agonists, for weight loss and the risk of such gastrointestinal conditions. GLP-1 agonists include semaglutide — the drug found in Ozempic and Wegovy — and liraglutide, the drug used in Saxenda. Both drugs are made by Novo Nordisk. 
    • “Although rare, the incidence of these adverse events can happen. I’ve seen it happen,” said lead author Mohit Sodhi, a medical student at the University of British Columbia Faculty of Medicine in Vancouver. “People should know what they’re getting into.” 
  • Get a load of this good news. Per ALM Benefits Pro,
    • “World Mental Health Day is right around the corner and this year, there’s good news to share. The mental health of U.S. employees is finally on the rise nearly three years after the pandemic. A new study shared by Leapsome, a people enablement platform based in Germany, found that 88% of U.S. employees rate their mental health as being good or very good. 
    • “The massive improvements in mental health took place largely over the past year, with 47% of U.S. workers reporting that their mental health had improved within the last 12 months, according to the study.”
  • STAT News notes,
    • “The grand plan for Moderna’s future in respiratory viruses is to market a single shot that would protect against Covid-19, influenza, and RSV, using the scalability of mRNA to craft a first-of-its-kind product. And the first step — establishing the promise of its combination flu and Covid vaccine — is moving on as planned.
    • “Yesterday Moderna said its combo shot measured up to established flu and Covid vaccines in generating immune responses against each virus. The next step is to take that combination to Phase 3, which could lead to approval by 2025. At the same time, Moderna is awaiting FDA approval for its RSV vaccine and testing a combination that would protect against all three viruses.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Amgen on Friday closed its $27.8 billion acquisition of Horizon Therapeutics, about one month after securing clearance from U.S. antitrust regulators who had challenged the deal.
    • “With the acquisition’s completion, Amgen gains access to 12 drugs that had combined sales of $1.8 billion over the first six months of 2023. The company said it will update its sales guidance for the rest of the year when it reports third-quarter earnings.
    • “The deal is the largest in Amgen’s history, surpassing in dollar terms the 2001 buyout of Immunex. That acquisition gave Amgen Enbrel, a long-lasting blockbuster that, like several of its other major drugs, could lose market exclusivity in the coming years. That looming patent cliff has pushed the company to restock its pipeline via dealmaking.”
  • Per Fierce Healthcare,
    • “UnitedHealthcare’s Surest, which axes deductibles and provides upfront pricing data to members, is the fastest growing product among its commercial plan lineup. And a new analysis offers a look as to why.
    • “The insurance giant released Thursday an Impact Study examining some of the results Surest has seen to date and notes that members enrolled in these plans had 6% fewer emergency department visits and 13% fewer inpatient hospital admissions compared to those who were not enrolled in a Surest plan at the same employer.
    • “In addition, members enrolled in Surest plans had a 20% increase in visits to a physician and a 9% jump in preventive physical exams compared to those in other commercial plans.”
  • and
    • “Cigna’s Evernorth is launching a new, value-based care management program for its behavioral health network.
    • “The company said in an announcement that this marks a key step in collaboration with providers as the industry pushes for standardized benchmarks in behavioral health. About 44,000 providers will participate in the program at launch, according to Evernorth.
    • “Ultimately, if payers and providers align on how to measure success in treatment, it will drive better care, lower costs, and lead to improvements in collaboration. It should also ease administrative burdens for providers, according to the announcement, as at present they use a wide array of measures across multiple payers.”

Friday Factoids

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Efforts to pass a stopgap funding measure before Saturday night’s deadline were sputtering in both chambers Friday, with lawmakers openly predicting a partial government shutdown was inevitable. The only question appeared to be how long the funding lapse would last.”Efforts to pass a stopgap funding measure before Saturday night’s deadline were sputtering in both chambers Friday, with lawmakers openly predicting a partial government shutdown was inevitable. The only question appeared to be how long the funding lapse would last.
    • “Border security talks in the Senate stalled Friday ahead of a key procedural vote Saturday, casting doubt on whether there would be the required 60 votes to end debate on a seven-week stopgap bill.
    • “Meanwhile, House Republicans huddled to discuss remaining options after their last shot at a 31-day continuing resolution chock full of spending cuts and restrictive border policies fell flat on the floor earlier Friday.
    • “None of the options — taking up a Senate bill that hasn’t even passed yet, or a “clean” CR extending current funding levels for a week or two, appeared to be gaining much steam, at least yet.”
  • The Washington Post adds
    • “After a two-hour meeting with the Republican caucus, House Speaker Kevin McCarthy (R-Calif.) said he would support a clean continuing resolution without major funding cuts if it did not include either the $12 billion in Ukraine and disaster relief funding that has bipartisan Senate support or the border security legislation that House Republicans have demanded.”
  • Today, OPM issued a press release about 2024 FEHB premiums and a white paper with 2024 Open Season highlights. The highlights include a list of the plans terminating their participation in the FEHB for 2024. The Compass Rose Benefits Group added a standard option. The FEHBlog noticed that Blue Cross FEP and Kaiser Permanente have unveiled their 2024 FEHB benefits on their websites.
  • FedWeek informs us
    • “OPM has said it will soon administer its Federal Employee Benefits Survey to some 100,000 federal employees who will be notified by email and will have up to six weeks to respond.
    • “The purpose of the FEBS is to measure the importance, adequacy and value of employee benefits to assess if employees believe the available benefits meet their needs. The FEBS will also help us to evaluate whether federal employees understand the flexibilities and benefits available to them,” OPM said in a memo to agencies on chcoc.gov.”
  • Per MedTech Dive,
    • “A proposed rule issued on Friday by the Food and Drug Administration would bring laboratory-developed tests under the agency’s purview, closing a regulatory loophole.
    • “Laboratory-developed tests are designed, manufactured and used within a single clinical laboratory. The FDA has exempted these tests from some regulatory requirements, such as premarket review, but it now seeks to bring all tests under one regulatory framework.
    • “The agency said the changes should better protect public health by ensuring the safety and effectiveness of tests. But it is “unclear if and when the FDA will finalize the rule as it will likely face opposition,” analysts with TD Cowen wrote in a research note on Friday.”
  • Healthcare Dive tells us
    • “The Center for Medicare and Medicaid Innovation, which aims to reduce spending or improve quality of care, increased net federal spending during its first 10 years of operation, and it will likely continue to boost spending over its next decade, according to a report by the Congressional Budget Office. 
    • “The CBO estimated that CMMI’s activities increased direct spending by $5.4 billion, or about 0.1% of the net spending on Medicare, between 2011 and 2020. 
    • “CMMI’s work is projected to increase net federal spending by $1.3 billion, or 0.01% of net spending on Medicare from 2021 to 2030, according to the report.” 
  • The IRS posted draft instructions and forms of 1095-B and 1095-C forms for 2023
  • HHS requests comments on mandating health plan coverage with no-cost sharing and no prescription requirements for low-cost preventive supplies, most of which OPM already mandates for FEHBP. The public comment period will likely expand the list.  The public comment deadline will be in early December. 

From the public health and medical research fronts,

  • The Food and Drug Administration announced,
    • “granting de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers. The test can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer. The test, which is the first of its kind to be granted FDA marketing authorization, evaluates DNA extracted from a blood sample to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer.”  
  • Biopharma Dive lets us know
    • “Shares in Structure Therapeutics jumped Friday after the San Francisco-based biotechnology company released results from a small study of an experimental weight loss drug that appear competitive to rival programs from Eli Lilly and Pfizer.
    • “Over the 28-day Phase 1 trial, people taking the highest doses of Structure’s drug lost about 5% of their weight compared to the study’s start, up to around 10 pounds. There were side effects, most commonly mild nausea and vomiting, but no participants stopped treatment as a result, the company said.
    • “Dubbed GSBR-1290, Structure’s drug is a GLP-1 agonist, similar to the much in-demand diabetes and obesity medicines Ozempic and Wegovy. Unlike those, however, GSBR-1290 is taken orally rather than by injection, potentially meaning greater convenience.”
  • and
    • “A cancer drug combination developed by Johnson & Johnson succeeded in an important late-stage trial testing the new regimen against a widely used medicine from AstraZeneca.
    • “According to J&J, treatment with its approved drug Rybrevant and an experimental therapy called lazertinib kept a common type of metastatic lung tumor at bay for longer than AstraZeneca’s Tagrisso alone. The results were from an interim analysis of the study, which is continuing to study patient survival.
    • “J&J’s trial, called Mariposa, has been followed closely by analysts as it could offer J&J a chance to compete with AstraZeneca in a large cancer drug market. J&J didn’t share any specific data in its statement Thursday, but said it plans to submit the study results for presentation at an upcoming medical conference.”
  • Beckers Clinical Leadership points out,
    • “Transport accidents are the leading cause of death for most children while opioids and major cardiovascular disease are the most common leading cause of death for adults, according to a report from USA Facts, a nonprofit organization that conducts data analysis.
    • “The “America in Facts 2023″ report, published in September, used CDC data to calculate the leading causes of death by age for the time periods 2001 to 2002 and 2020 to 2021.”
  • From the Econtalk Podcast
    • “We spend too much of our health care focus on lifespan and not enough on healthspan–the quality of our life as we get older. So argues Dr. Peter Attia, author of Outlive: The Science and Art of Longevity. Attia speaks with EconTalk’s Russ Roberts about what kills us, what slows us down as we age, and the weapons we have to allow us to live better and longer.”
    • Check it out at this link.

In judicial news,

  • Politico reports
    • “A federal judge on Friday denied business groups’ move to halt Medicare’s new drug price negotiation program while multiple lawsuits challenging its constitutionality wind through the courts.
    • “The decision by Judge Michael J. Newman, a Trump appointee, in Ohio’s Southern District preserves the Biden administration’s power to begin haggling with drug companies over the prices of 10 medications. Manufacturers of products that CMS chose for the first tranche of negotiations have until Oct. 1 to agree to the talks.
    • “The Court is not convinced that granting Plaintiffs preliminary injunctive relief will protect them from imminent and irreparable harm,” Newman wrote in his opinion. “Any economic harm — which, on its own, is insufficient to satisfy this prong of a preliminary injunction analysis — will not occur for years in the future.” * * *
    • “Newman denied DOJ’s motion to dismiss to give the chambers the chance to address his concerns, though the government can refile.”

2024 FEHBP Premiums Announced!

David Ermer–Federal employment benefits, OPM, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • OPM posted 2024 premiums for FEHB plans today.
  • Here are the highlights from the related Federal News Network article:
    • “Starting in January, federal employees and retirees will pay an average of 7.7% more toward their health premiums, according to data the Office of Personnel Management released Wednesday. * * *
    • “The government will contribute 5% more toward FEHB premiums in 2024.”
    • The government contribution is 72% of the enrollment weighted average premium capped at 75% of the selected plan’s premium per 5 U.S.C. Sec. 8906.
    • OPM always emphasizes that the average increase can be lowered by enrollees selecting lower-priced plans during the Open Season, which runs from November 13 to December 11, 2023.
    • This is the last Open Season before the Postal Service Health Service Health Benefits Program launches on January 1, 2025/
    • The surprising number to the FEHBlog is the following:
      • “FEHB participants will see a total of 159 plan options in 2024, offered across 69 health carriers. That’s far fewer than this year’s total of 271 plan options.
      • “The roughly 41% decrease in plan options is mainly due to the exit of health carrier Humana from the FEHB program. Humana is exiting the program over the next two years.”
    • OPM also posted 2024 FEDVIP premiums today. Per Federal News Network, “Premiums will rise for FEDVIP dental plans by 1.4% on average, while vision plans will go up by 1.1%, OPM said.”
    • Here are links to the Govexec and Federal Times articles on this OPM announcement.
  • The Department of Health and Human Services provided a readout from HHS Secretary Xavier Becerra’s meeting with national health insurance leaders about the current Covid vaccine campaign.
  • The Wall Street Journal reports
    • “House Speaker Kevin McCarthy (R., Calif.) rebuffed a bipartisan short-term funding bill from the Senate in favor of a House Republican plan driven by conservatives, as dim prospects for a deal raised the likelihood of a partial government shutdown starting this weekend.
    • “Many lawmakers now anticipate that Congress will fail to fund the government past Sept. 30, a lapse that will partially close federal agencies and temporarily withhold pay for federal workers and active duty-military personnel.”

From the public health front,

  • Here is a link to the National Cancer Institute’s latest bulletin of research highlights.
  • The National Institutes of Health informs us about its decision to fund
    • “a first-of-its-kind community-led research program to study ways to address the underlying structural factors within communities that affect health, such as access to safe spaces, healthy food, employment opportunities, transportation, and quality health care. Through the NIH Common Fund Community Partnerships to Advance Science for Society (ComPASS) program, NIH made 26 awards to community organizations and a coordinating center, totaling approximately $171 million over five years, pending the availability of funds. Through these awards, ComPASS will enable research into sustainable solutions that promote health equity to create lasting change in communities across the nation.”

From the U.S. healthcare business front,

  • MedCity News tells us,
    • “Yet another retailer is making moves in healthcare. This time it’s Costco, which announced Monday that it is partnering with virtual health marketplace Sesameto provide Costco members with discount pricing for medical care. But its move is a little different from other retailers like Walgreens and CVS Health, one expert said.
    • “Sesame’s platform provides access to thousands of independent clinicians across all 50 states. Through the partnership, Costco members will have access to $29 per virtual primary care visit and $79 per virtual mental health therapy visit. They’ll also have access to health checkups — which include a standard lab panel and a virtual follow-up consultation — for $72. In addition, they’ll receive 10% off on other Sesame services, including in-person care. Sesame’s usual prices (for those accessing the company outside of Costco) vary, but a primary care visit can often be around $45, said Michael Botta, co-founder and president of Sesame.
    • “Sesame does not accept insurance, so all of the services are offered via cash pay, meaning the partnership will mostly benefit patients who are uninsured or enrolled in high-deductible health plans.”
  • Fierce Healthcare points out,
    • Amazon announced this week that it would invest up to $4 billion in artificial intelligence company Anthropic as the AI arms race heats up.
    • The two companies are forming a strategic collaboration to advance generative AI, and the startup selected AWS as its primary cloud provider. Along with the hefty investment, Amazon also took minority ownership in the two-year-old start-up.
  • and
    • “As new primary care models, including retail health clinics, continue to scale, the national supply of clinical providers will become even more constrained. For health systems, hospitals and medical groups, competition for the shrinking pool of nurses and doctors will intensify, according to a new analysis.
    • “Patients have more choices than before with the increasing supply of new entrants like CVS, Amazon and Walmart, and this is also leading to care becoming more fragmented and disintermediated from the traditional care journey, said Sanjula Jain, Ph.D., chief research officer and senior vice president of market strategy at healthcare analytics company Trilliant Health.
    • “Patient panel sizes for new primary care entrants—like Walgreens’ VillageMD, CVS’ Oak Street Health and Amazon’s One Medical —average 584 patients per provider, which is far lower than the current patient-to-provider ratio of 944. These ratios suggest that the U.S. would need an additional 218,000 primary care providers to meet the needs of every American under the new entrant primary care model, according to Trilliant Health’s “2023 Trends Shaping the Health Economy” report.”
  • Per Healthcare Dive,
    • “Centene is laying off 2,000 employees — a little over 3% of its workforce — as the health insurer struggles with headwinds from Medicaid redeterminations and Medicare Advantage star ratings.
    • “The layoffs were confirmed to Healthcare Dive by a company spokesperson. Centene has recently sold off assets, including AI platform Apixio and UK 

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal reports, “House Speaker Kevin McCarthy laid out a map for passing legislation to keep the government funded past Oct. 1, but immediately ran into new roadblocks from spending hawks and fresh grumbling that he should be ousted from his post.” The FEHBlog anticipates that Congress will pass a continuing resolution before the end of the month.
  • The Centers for Medicare and Medicaid Services announced,
    • “the list of 34 prescription drugs for which Part B beneficiary coinsurances may be lower between October 1 – December 31, 2023. Some people with Medicare who take these drugs may save between $1 and $618 per average dose starting October 1, 2023, depending on their individual coverage.  * * *
    • “CMS has released information about these 34 Part B drugs and biological products in the quarterly Average Sales Price (ASP) public files, available here. A fact sheet is available here.”
  • Healthcare Dive informs us,
    • “Healthcare legislation being hashed out on the Hill is taking aim at pharmacy benefit managers, but the policies — while potentially worthwhile — are unlikely to have more than modest effects on the cost of prescription drugs in the U.S., experts say. us,
    • “Eliminating all PBM profits would only reduce total drug-related spending by “several percentage points,” since operating margins for the three biggest PBMs averaged roughly 4% of revenues last year, according to a new report from the Brookings Schaeffer Initiative on Health Policy.
    • “Lowering spending further would require “fundamental market changes” like changing drug patent protections or the way drug prices are regulated, the report says — measures sure to face heavy opposition from pharmaceutical companies.”
  • Per Becker’s Hospital Review,
    • “Cisplatin, a drug used for multiple types of cancer that’s been in a severe shortage for months, is close to returning to 100 percent of pre-shortage supply levels, the White House said Sept. 12. * * *
    • “In June and July, the FDA allowed China-based Qilu Pharmaceutical to temporarily import cisplatin. These lots have already been distributed, according to the FDA. The agency also worked with domestic drugmakers to increase their manufacturing capacity. 
    • “These actions brought the cisplatin supply back to nearly 100 percent of the pre-shortage levels and are greatly alleviating the shortages of carboplatin,” according to a post from the White House’s Office of Science and Technology Policy.”
  • The Federal Times writes about the impending premium increases in the Federal Long Term Care Insurance Program.

From the public health and research front,

  • The American Medical Association released a letter supporting the CDC’s “universal recommendation for the 2023-2024 COVID-19, XBB.1.5 containing vaccine.”
  • The National Cancer Institute informs us
    • “Testing for the presence of cancer-causing types of the human papillomavirus (HPV) is now a standard part of screening for cervical cancer, sometimes with simultaneous Pap tests (known as co-testing). But cervical cancer screening is recommended to stop at age 65 in many places and, for a variety of reasons, many older adults stop getting screened for cervical cancer well before that age. 
    • “Results from a population-based study conducted in Denmark, however, suggest that it may be worthwhile for some individuals between ages 65 and 69 to get tested for HPV: those who haven’t had cervical cancer screening for at least 5 years.
    • “In the new study, about 62% of women who were invited to undergo this “catch-up” testing for HPV (intervention group) had a test within the next year. In a comparison group of women not invited for catch-up testing, only about 2% had either a Pap test or an HPV test over the next year.”
  • The Wall Street Journal reports
    • “The first artificial womb to gestate a human baby is fast approaching reality.
    • “Food and Drug Administration regulators will weigh next week how scientists should conduct the first human tests of bag-like wombs, meant to nurture babies born so premature that modern medicine struggles to keep them healthy. * * *
    • “Philadelphia-based Vitara Biomedical has said that it is working on an artificial womb and is close to human clinical trials. A company executive said at a biotech symposium last year that the firm is commercializing the research of one of two U.S. groups known to be testing the technology on lambs. The other U.S. group says it is still a few years off from human trials.”
  • Forbes notes, “The Marcus Autism Center in Atlanta has launched its biomarker-based device that has been authorized by the FDA to aid in the diagnosis of autism in children between 16 and 30 months of age.” 

From the U.S. healthcare business front,

  • BioPharma Dive tells us,
    • “After pulling off a biomedical triumph with its COVID-19 vaccine, Moderna on Wednesday put out a roadmap for investors that promises billions of dollars from new medicines.
    • “The company aims to launch as many as 15 new products in the next five years, including four by 2025. In 2027, Moderna expects $8 billion to $15 billion in respiratory product sales. And on Wednesday, it forecast another $10 billion to $15 billion in annual sales from new treatments for cancer and rare and latent diseases it hopes to introduce by 2028.”
  • Beckers Payer Issues points out,
    • “Humana, Aetna and Molina are not renewing their contracts with senior companionship company Papa following allegations of abuse against patients or company employees, Bloomberg reported Sept. 11.
    • “In May, Bloomberg Businessweek published a report detailing allegations of abuse against seniors and Papa employees based on 1,200 complaints submitted to the company. The complaints included allegations of sexual abuse and assault, harassment, or unsafe living conditions.
    • “A spokesperson for Papa declined to provide a comment to Bloomberg about specific contracts, but said the company has grown its client base this year and is selling programs for next year.” 

Monday Roundup

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

From Washington DC,

  • The Office of Personnel Management issued a Benefit Administration Letter providing guidance about an Enrollee Decision Period for Federal Long Term Care Insurance Program enrollees. The Enrollee Decision Period started today and ends on November 9, 2023.
  • The Food and Drug Administration announced
    • “approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.”
  • Roll Call adds
    • “Advisers to the Centers for Disease Control and Prevention are scheduled to discuss on Tuesday recommendations for who should receive the vaccines and when, with CDC Director Mandy Cohen expected to sign off shortly thereafter. 
    • “Drugmakers say they’re ready to begin shipping the shots immediately in accordance with the CDC’s pending guidelines.”
  • STAT News tells us, “Sen. Bernie Sanders (I-Vt.) will hold a confirmation hearing next month for Dr. Monica Bertagnolli, President Biden’s nominee to run the National Institutes of Health, he said Friday.”

From the public health front,

  • MedPage Today reports
    • “Anesthesiologists are sharply divided over how to handle the growing number of surgical patients on GLP-1 receptor agonists, given that the drugs can raise the risk of aspiration during surgery.
    • “While the leading U.S. anesthesiology society suggests that patients stop taking injectable versions of the medications for 7 days ahead of surgeryopens in a new tab or window, some anesthesiologists are turning to alternative strategies such as intubating all at-risk patients, even for minor procedures.
    • “Other anesthesiologists are calling for patients to stay off the drugs for weeks, not days, or titrate down to lower doses.
    • “This topic is being heavily discussed in the anesthesia community right now, and it’s very polarizing,” Michael Gulak, MD, a resident anesthesiologist at the University of Toronto, told MedPage Today.”

From the U.S. healthcare business front,

  • Beckers Hospital Review informs us
    • “Nonprofit hospital expenses continued to grow last year while liquidity fell to pre-pandemic levels, according to Moody’s Investor Services. 
    • “In a Sept. 7 report, Moody’s outlined 2022 fiscal year trends based on data from 218 health systems. The report noted operating margins fell to”unsustainable levels” as median operating cash flow margin was 4.9 percent and median operating margin was -0.3 percent amid labor shortages and inconsistent patient volumes.
    • “While the industry shows signs of stabilizing in 2023, the labor environment will remain challenging,” the report states.”
  • Per Benefits Pro,
    • “Hospitals in the United States faced unprecedented challenges during the COVID-19 pandemic, and those challenges have left them floundering in the face of increased costs and workforce shortages. According to the most recent Costs of Caring report from the American Hospital Association, this combination of factors has resulted in a 17.5% increase in overall hospital expenses between 2019 and 2022. “Further exacerbating the situation is the fact that the staggering expense increases have been met with woefully inadequate increases in government reimbursement,” the report states, leading to consistently negative margins and over half of hospitals ending 2022 at a financial loss.
    • “Even so, hospital expenses per inpatient day have been steadily trending upwards for years in the U.S., whether for-profit, non-profit, or state/local government. Research from KFF shows that in 1999, the average adjusted expenses per inpatient day for state/local government hospitals was $1,004. Non-profits were at $1,139, and for-profits were at $999. As of 2021, state/local government stands at $2,742—a 173% increase. Non-profits are at $3,013 (164.5%) and for-profits at $2,296 (129.8%).”
  • MedCity News points out
    • While there are fewer rural residents enrolled in Medicare Advantage plans than micropolitan or metropolitan residents, MA enrollment in rural areas is growing much more rapidly, new research shows.
    • The KFF report, published Thursday [September 7], defines rural areas as having less than 10,000 people, micropolitan areas as having 10,000 to 50,000 people and metropolitan areas as having at least 50,000 people. The findings come when Medicare Advantage growth overall is on the rise, accounting for more than half of eligible Medicare beneficiaries in 2023.
  • Healthcare Dive relates
    • Walmart is considering buying a majority stake in value-based medical chain ChenMed, according to a Bloomberg report published Friday.
    • The retail giant is in discussions with ChenMed regarding a transaction that would value the Miami-based primary care clinic operator at several billion dollars, Bloomberg reported, citing sources familiar.
    • Terms of the deal aren’t finalized, and talks could fall through or a different buyer could emerge, Bloomberg’s sources said.
    • If a deal is announced, Walmart would become the latest retail operator to bag a primary care operator, following in the footsteps of rivals including CVS, Amazon and Walgreens.
    • ChenMed operates a network of more than 125 clinics for Medicare-eligible seniors in 15 states, according to the company’s website.

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Government Contracting, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Federal News Network offers its periodic update on the bills pending before Congress of interest to federal employees.
  • American Hospital Association News tells us that today
    • “The Department of Health and Human Services’ Office for Civil Rights released a proposed rule intended to update and clarify requirements under Section 504 of the Rehabilitation Act that prohibit discrimination on the basis of disability in programs receiving financial assistance from the department, including health care. According to HHS, the proposed rule would ensure that medical treatment decisions are not based on biases or stereotypes about individuals with disabilities; prohibit the use of value assessment methods that place a lower value on life-extension for individuals with disabilities when used to limit access or to deny aids, benefits and services; establish enforceable standards for accessible medical diagnostic equipment; and clarify obligations for accessible web and mobile applications and obligations to provide services in the most integrated setting appropriate to an individual’s needs. The rule will be published in the Sept. 14 Federal Register, with comments accepted for 60 days.”
  • The Federal Times points out
    • “The Office of Personnel Management received a small surge of retirement claims in July and August after applications had been falling steadily for months since January.
    • “The time it took the government to process retirements increased sharply in July to 85 days before falling back down to 74 days in August, according to data kept by OPM.
    • “Overall, the agency is sitting on an inventory of nearly 18,000 cases after it reduced its working caseload to new lows this year. About this time last year, there were 29,000 pending cases.
    • “Still, despite efforts to dispatch focus teams to address backlogs, the agency is failing to hit its target time or inventory goals, leaving retirees to wonder whether their case will be one that ends up sitting in limbo for longer. Ideally, retirement applications are processed in 60 days or fewer.”
  • CMS released its 2022 report on covered entity compliance with the HIPAA electronic transactions.
    • The transaction types experiencing the most violations during the 2020 and 2021 compliance reviews were specific to 835 [the claim transaction], 271 [Health Care Eligibility Response], and 277 [Claim Status Response] transactions. This changed slightly in 2022 as the most common transaction types experiencing violations are now 835, 271, and 834 [EOB] transactions.
    • CMS is sharing updated 2022 violation findings insights to inform and educate the industry, encourage widespread compliance, and assist covered entities with preparing for compliance reviews.
  • The Society for Human Resource Management relates,
    • The U.S. Equal Employment Opportunity Commission (EEOC) has released an updated deadline for employers to submit their demographic data. The EEO-1 Component 1 data collection for 2022 will start on Oct. 31, and the deadline for employers to file their EEO-1 reports is Dec. 5.
    • All private employers that have at least 100 employees are required to file the EEO-1 form annually, detailing the racial, ethnic and gender composition of their workforce by specific job categories.
    • Likewise, federal government contractors and first-tier subcontractors with 50 or more employees and at least $50,000 in contracts must file EEO-1 reports. State and local governments and public school systems are exempt.
  • KFF reports
    • “Over the past two years, the federal government has provided about $1 billion from the American Rescue Plan and Bipartisan Safer Communities Acts to launch the number, designed as an alternative to 911 for those experiencing a mental health crisis. After that infusion runs out, it’s up to states to foot the bill for their call centers.
    • “We don’t know what Congress will allocate in the future,” said Danielle Bennett, a spokesperson for the federal Substance Abuse and Mental Health Services Administration, which oversees 988. “But the hope is that there will be continued strong bipartisan support for funding 988 at the level it needs to be funded at and that states will also create funding mechanisms that make sense for their states.”
    • “Only eight states have enacted legislation to sustain 988 through phone fees, according to the National Alliance on Mental Illness, which is tracking state funding for the system. Others have budgeted short-term funding. But many predominantly rural states, where mental health services are in short supply and suicide rates are often higher than in more urban states, have not made long-term plans to provide support.”
  • MedPage reports,
    • When pseudoephedrine moved “behind-the-counter” nearly 20 years ago, it left oral phenylephrine (with brands including Sudafed PE and Suphedrine PE) as the only nasal decongestant available without pharmacy assistance. But there’s one big problem: phenylephrine doesn’t work, the FDA has finally determined.
    • FDA reviewers released the results of their long-running review of the evidence this week as background for a meeting of the Nonprescription Drugs Advisory Committee to be held on September 11 and 12.
    • The article explains the conundrum this finding creates for the FDA.

From the public health front,

  • MedPage reports that “the global incidence of early-onset cancer has increased by 79% over the past three decades, researchers reported.
    • “In a comment posted on Science Media Centre, Dorothy C. Bennett, MA, PhD, of St. George’s, University of London, cautioned that the increase in new cases of early-onset cancer is based on absolute numbers, rather than age-standardized rates.
    • “The world human population increased by 46% between 1990 and 2019, which explains part of the increase in total case numbers,” she said, adding that the increase in numbers of cancer deaths in this age group (28%) was notably lower than the number of new diagnoses, “which is below the increases in total population and case numbers, indicating a fall in the average cancer death rate in this group.”
  • Per the American Heart Association,
    • Obesity-related cardiovascular disease deaths tripled between 1999 and 2020 in the U.S.
    • Such deaths were higher among Black individuals (highest among Black women) compared with any other racial group, followed by American Indian/Alaska Native people.
    • Black adults who lived in urban communities experienced more obesity-related cardiovascular disease deaths than those living in rural areas, whereas the reverse was true for all other racial groups.
  • McKinsey Health offers a podcast about getting to the bottom of the teen health crisis.

From the U.S. healthcare business front,

  • Fierce Healthcare notes, “Employers’ health benefits costs are set to rise 5.4% next year, but this spike isn’t as high as may have been feared given inflationary pressures in the broader economy, according to a new analysis from Mercer.”
  • STAT News interviews “Amazon’s chief medical officers on where the company’s health care bets are headed next.”
  • Healthcare Dive informs us,
    • “Telehealth sessions comprised 5.4% of claim lines in June, the same amount as the prior month, according to Fair Health’s Monthly Telehealth Regional Tracker.
    • “Mental health conditions continued to top the list of Fair Health’s five most common telehealth diagnoses for June. The median allowed amount billed for a one-hour psychotherapy visit was $103.
    • “But Fair Health’s tracker showed regional variations. Although telehealth use decreased overall by 2.4% in the Midwest, asynchronous telehealth claim lines for mental health conditions more than doubled in the region from 15.9% in May to 36% in June. In asynchronous telehealth, providers collect data or medical images for review, instead of meeting with a patient in real time.” 
  • Per Health Affairs,
    • “Intensive care units (ICUs) are increasingly used for hospital care, yet out-of-pocket spending for ICU hospitalizations remains poorly understood, particularly among the nearly half of the US population with commercial health insurance. Using 2008–19 MarketScan data, we compared 1,441,810 hospitalizations involving ICU services with 13,011,208 hospitalizations that did not involve ICU services.
    • “Average cost sharing, adjusted for patient and admission factors, increased from $1,137 per hospitalization in 2008 to $1,539 in 2019, or a 34 percent increase. This was driven by increasing deductibles, which rose by 163 percent.
    • “Across twenty clinical conditions whose hospitalizations commonly occurred in both ICU and non-ICU settings, ICU admission was associated with $155 higher cost-sharing (13.0 percent higher) relative to cost sharing in non-ICU hospitalizations.
    • “Patients with high-deductible plans faced the highest cost-sharing relative to those with other plan types.
    • “Patients who received out-of-network hospital care encountered higher cost-sharing relative to those admitted to in-network hospitals with in-network clinicians.”

Happy Labor Day!

David Ermer–Congress, COVID-19 testing, Federal employment benefits, Mental health care, OPM, U.S. Healthcare–

Way back in the day, OPM routinely would announce the next year’s FEHB premiums around Labor Day. The announcement was known as OPM’s Labor Day press release. Currently, the announcement is made in the last week of September.

Tammy Flanagan writes in Govexec about federal employee benefit issues confronting couples who both work for Uncle Sam, specifically

  • “Should we carry two self only plans under the Federal Employees Health Benefits program or one self plus one plan if we don’t need to cover children?
  • “Do we need to provide survivor annuities for each other?”

Check it out.

The Senate returns from its August State work break tomorrow for a shortened week of Committee business and floor voting. The House of Representatives returns to the Nation’s Capital next Tuesday.

From the public health front,

  • The Washington Post reports
    • “The Centers for Disease Control and Prevention on Friday [September 1] issued a national alert warning health-care professionals to watch out for infections of Vibrio vulnificus, a rare flesh-eating bacteria that has killed at least 13 people on the Eastern Seaboard this year.
    • “Although infections from the bacteria have been mostly reported in the Gulf Coast, infections in the eastern United States rose eightfold from 1988 to 2018, the CDC said. In the same period, the northern geographic range of infections has increased by 30 miles every year. This year’s infections came during a period of above-average coastal sea surface temperatures, the agency said.
    • “Up to 200 people in the United States every year report Vibrio vulnificus infections to the CDC. A fifth of the cases are fatal, sometimes within one or two days of the onset of illness, according to the agency.”
  • The Wall Street Journal tells us
    • “A two-decade decline in [prostate cancer] death rates has stalled. Some doctors worry deaths could rise in coming years.
    • “We’re finding them with disease not contained in the prostate but also in the bones, in the lymph nodes,” said Dr. James Porter, a urological surgeon in Seattle. “That’s a recent phenomenon.” 
    • “The pendulum swing hits at a fundamental problem in screening for all cancers: Testing too many people leads to more invasive procedures some patients don’t need. Testing too few misses opportunities to catch cases while there is a better chance treatment will work.
    • “Groups including the American Cancer Society are reviewing their own guidance for prostate-cancer screening. Many doctors want to better target the test, limiting screening for some men while encouraging high-risk groups including Black men or those with a strong family history to get testing earlier. 
    • “PSA recommendations have been ping-ponging back and forth, and what’s been lost in that is the high-risk people,” said Dr. Heather Cheng, director of the Prostate Cancer Genetics Clinic at Fred Hutchinson Cancer Center in Seattle. She is helping to review the American Cancer Society’s prostate-cancer screening guidelines. 
    • “Cheng and other doctors working to better calibrate screening said the risks of overdiagnosis have declined. More doctors now monitor low-risk tumors for growth before rushing a man into surgery or radiation. Better imaging tools have reduced biopsies.”
  • In other words, the problem is not necessarily the screening test; rather the problem may be the reaction of the medical community to screening results.  
  • NPR Shots informs us,
    • “The idea of food as medicine dates back to the ancient Greek doctor Hippocrates, and a new study adds to the evidence that a diet full of fruits and vegetables can help improve heart health. The research comes amid an epidemic of  diet-related disease, which competes with smoking as a leading cause of death.
    • “Researchers evaluated the impact of “produce prescriptions,” which provide free fruits and vegetables to people with diet related diseases including diabetes, obesity and hypertension. The study included nearly 4,000 people in 12 states who struggle to afford healthy food. They received vouchers, averaging $63 a month, for up to 10 months, which could be redeemed for produce at retail stores or farmers markets, depending on the location. 
    • “Health care providers tracked changes in weight, blood pressure and blood sugar among the participants. “We were excited to see improvements,” says study author Kurt Hager, an instructor at UMass Chan Medical School.
    • “Among adults with hypertension, we saw that systolic blood pressure decreased by 8 mm Hg and diastolic blood pressure decreased by about 5 mm Hg, which could have a meaningful impact on health outcomes,” Hager says.
    • “Among people with uncontrolled diabetes, their A1C levels, which is a 2-3 month average of their blood sugar, also declined significantly, by about .6 percent. “The reductions we saw in blood sugar were roughly half of that of commonly prescribed medications, which is really encouraging for just a simple change in diet,” Hager says.” 
  • Fortune Well explains how to deal with the uncertainty that serves as the root of anxiety.
    • “Uncertainty is life’s promise to us all. For more than twenty years, I have watched people rise from unspeakable pain to venture again into a future that withholds all certainty. I work with people who have endured shocking traumas and, predictably, our early conversations are filled with interrogative pleas for a certain safety: “How can I be absolutely sure nothing like this will ever happen again?” they ask me.
    • “The answer is: they cannot.
    • “After many years, the thing that still takes my breath away is the grace and courage of people who accept this truth and say: I rise again not because I know for sure, but because I hope anyway.”
  • The New York Times offers a reminder about how to use at home COVID tests effectively. Bear in mind that Paxlovid should be taken within five day after showing Covid symptoms.

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Congress remains on its August State/District workbreak this week. The Senate reconvenes on September 5, and the House reconvenes the following Tuesday, September 12.
  • The Hill adds
    • “Speaker Kevin McCarthy (R-Calif.) said on Sunday he does not want short-term stopgap funding to butt up to the holidays as lawmakers struggle to come to an agreement over appropriations levels in the midst of a push by conservatives cut federal spending.” 

From the public health front —

  • The Wall Street Journal reports
    • “Scientists obsessed with aging are sketching a road map of how our bodies change as we grow old in the hopes that it will lead to treatments that could help us live longer, healthier lives.
    • “They call this road map the “hallmarks of aging”—a set of biological features and mechanisms linked to our inexorable march toward death. Over the past decade, the hallmarks have helped guide the development of drugs that clear away cells that have stopped dividing and gene therapies that appear to restore cells to a more youthful state.
    • “Scientists in Europe codified nine hallmarks in a 2013 paper in the journal Cell that is widely cited in the aging field. They include shortening of telomeres (DNA segments at the ends of chromosomes); cell senescence, when cells stop dividing; and breakdowns in how cells regulate nutrients.
    • “The hallmarks appear to manifest with age and accelerate aging when enhanced. They are interconnected in ways researchers are trying to understand. Some believe this could unlock insights into why we age.” 
  • Becker’s Payers Issues explains how health insurers have responded to the tragic Maui wildfire.

From the FEHB front,

  • Federal News Network updates us on a fertility coverage issue that has attracted the attention of Democrat members of Congress. The FEHBlog expects that in 2024, common sense will prevail here because OPM has mandated unlimited coverage of artificial and intrauterine insemination. OPM can always clarify the situation with one of its carrier letters.

From the U.S. healthcare business front,

Tuesday Tidbits

David Ermer–FDA, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington DC —

  • FedScoop reports
    • “Amid scrutiny of the retirement services division within the Office of Personnel Management, congressional inquiries to the agency have grown drastically, according to a February letter sent by Retirement Services Associate Director Margaret Pearson.
    • “According to the missive, which was sent in response to questions from House lawmakers, OPM’s Congressional, Legislative, and Intergovernmental Affairs branch received more than 9,000 congressional inquiries in 2022, compared with more than 3,000 in 2020. In other words, the number of inquiries from Congress to the agency has approximately tripled in three years.”
  • Fedsmith adds
    • “The latest data from the Office of Personnel Management (OPM) show that the backlog of outstanding retirement claims now stands at 17,047, 4.1% higher than at the end of June. The number of incoming claims was much higher in July than in June, 7,261 versus 4,854, respectively, a difference of 50%. Although OPM still processed nearly the same number of claims in July (6,584) as in June (6,609), this served to drive the backlog higher.
    • “Another contributing factor was that the monthly average processing time was higher in July than in June. It took OPM 85 days on average in July to process retirement applications versus 74 days in June. July was the second-highest monthly average processing time so far in 2023, second only to January (93 days).”
  • The Labor Department’s Assistant Secretary for Employee Benefits Security, Lisa Gomez, blogs about the ACA regulator’s proposed amendments to the federal mental health and substance use disorder rule. Why must all of the pressure to improve mental health care be placed on health plans?
  • Federal News Network says,
    • “The Postal Service is falling short of its goal to turn around its financial losses this year, but is pointing to an ongoing shakeup of its nationwide delivery network as a critical part of its plan to break even by the end of the decade.
    • “Postmaster General Louis DeJoy said Tuesday that “more aggressive cost reductions to operations” are needed to keep USPS’ long-term financial goals within reach — and that USPS reshaping its nationwide delivery network is key to those savings.
    • “This undertaking is massive and long overdue, and time is of the essence if we wish to enjoy the benefits of this cherished institution for years to come,” DeJoy told the USPS Board of Governors.
    • “USPS reported a $1.7 billion net loss for the third quarter of fiscal 2023, and is expected to see a net loss for the entire fiscal year.”

From the public health and Rx coverage fronts–

  • STAT News informs us
    • “The momentum around weight loss drugs is about to get even bigger in the wake of Novo Nordisk’s announcement that its semaglutide drug Wegovy cut the risk of cardiovascular disease by 20% in its large SELECT trial.
    • “The full results of the study, funded by Novo, will be presented at the American Heart Association meeting in November. Doctors and researchers say they expect the findings to have a big impact on how clinicians approach the treatment of both obesity and cardiovascular disease, as well as increase the likelihood that prescriptions for obesity drugs will be covered by insurance.
    • “But experts who spoke with STAT also cautioned that the long-term safety and efficacy of Wegovy and other weight loss drugs remain unknown. The SELECT study has yet to be peer-reviewed, and not enough information is yet available to make independent assessments of the results.”
  • The Wall Street Journal adds,
    • “The surging demand for GLP-1s has prompted analysts to raise their forecasts for the global obesity market, with Morgan Stanley recently revising its estimate to $77 billion in annual sales by 2030, up from $54 billion.
    • “For now, doctors are prescribing more of Mounjaro and Wegovy than the companies can make, with a lack of manufacturing capacity frequently leading to shortages. Eli Lilly on Tuesday reported $980 million in Mounjaro sales in the second quarter, trouncing analyst estimates of $740 million on FactSet. The Mounjaro beat allowed the company to raise its annual guidance as well. Mounjaro is approved for diabetes and is expected to receive Food and Drug Administration approval for obesity treatment this year, though doctors are already prescribing it off-label.”
  • The Wall Street Journal also lets us know,
    • “Women are closing a gender gap, but it isn’t a good one: They’re catching up to men when it comes to problem drinking.
    • “Women’s drinking, on the rise for the past two decades, jumped during the pandemic as women reported more stress. Although men still drink more alcohol than women and have higher alcohol-related mortality rates, doctors and public health experts say women are narrowing that divide.
    • “Alcohol-related emergency department visits, hospitalizations and deaths are increasing faster for women than for men. And studies suggest that women are more susceptible to alcohol-related liver inflammation, heart disease and certain cancers.”
  • Independence Blue Cross announced,
    • ” Independence Blue Cross (Independence) and the Colorectal Cancer Alliance (the Alliance) announced the launch of 45+ Reasons, a campaign to get more than 5,000 Black Philadelphians ages 45-75 screened for colorectal cancer to reduce the significantly higher incidence and mortality rates of Black Americans. The campaign supports the Cycles of Impact initiative launched by Independence and the Alliance in 2022.
    • T”he campaign is a flagship program of Philadelphia’s Accelerate Health Equity, a city-wide initiative to produce tangible improvement in health inequities, and ultimately achieve measurable, positive changes in health outcomes in Philadelphia. Colorectal cancer screening and treatment is a priority area for Accelerate Health Equity.”
  • The All of Us Program released its August 2023 newsletter.
  • Fierce Healthcare tells us,
    • “There has been a 2% rise in maternity care deserts since 2020—meaning 1,119 additional counties, a new analysis suggests.
    • “The latest 2022 report on maternity care deserts, put together by nonprofit March of Dimes (PDF), relied mostly on 2019-20 data for its analysis.
    • “It classified more than a third of all U.S. counties as maternity care deserts in the report. These were defined as counties with no hospitals or birth centers offering obstetric care and no obstetric providers. 
    • “Nationwide, 5% of counties have less maternity access than two years ago while 3% shifted to higher access. Florida had the most women impacted by improvements to maternity care access, while Ohio had the most women impacted by overall reductions in access to care.” 

From the U.S. healthcare business front —

  • BioPharma Dive relates
    • “Eli Lilly became the most valuable healthcare company in the U.S. after a stock price surge Tuesday morning propelled the Indianapolis drugmaker’s market value above $500 billion for the first time in its 147-year history.
    • “Shares jumped 15% on second-quarter earnings that showed the company’s revenue rose by 28%, driven by fast sales of its diabetes medicine Mounjaro. The drug has attracted intense interest for its potential as an obesity treatment, a use for which it’s expected to earn Food and Drug Administration approval later this year.”
  • STAT News reports that Sage Therapeutics finds itself under financial pressure due to the FDA’s decision to approve its new drug for postpartum depression but not other types of depression.
    • “Sage’s chief business officer, Chris Benecchi, declined to name a price or a price range for Zurzuvae, saying that the company is working together with its partner Biogen to “determine adjustments for thinking on price given the PPD label.” Sage expects the drug to be available in the fourth quarter following its scheduling by the Drug Enforcement Administration because of the drug’s low potential for misuse.
    • “Sage hosted the pre-market call without Biogen, raising analysts’ eyebrows as the two companies signed a commercialization deal in 2020 valued at over $1.5 billion, predicated on the hope that zuranolone would become a blockbuster drug for major depression. Despite many questions about what exactly would be needed for the drug to get FDA approval for major depression and whether Biogen would continue its partnership with Sage, Greene declined to give any insight into how committed Sage and Biogen are to pursuing the MDD indication, or whether Biogen was going to vacate the partnership.”
  • Healthcare Dive offers five takeaways from the health insurers’ second-quarter earnings.
    • “Major health insurers saw their shares dip coming into the second quarter, as investors prepared themselves for skyrocketing medical costs due to seniors returning for outpatient care.
    • “But health insurers generally outperformed market expectations in the quarter, helped by cost control measures.”
  • Meanwhile, the American Hospital Association’s President takes these health insurers to task in U.S. News and World Report for imposing cost control measures.