Thursday Miscellany

Congress

Thursday Miscellany

David Ermer–CDC, CMS, Congress, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Govexec tells us,
    • “The Senate Homeland Security and Governmental Affairs Committee on Wednesday voted to advance a pair of measures aimed at improving federal employees’ death benefits and agency customer service more broadly.
    • “The Honoring Civil Servants Killed in the Line of Duty Act (S. 3029); sponsored by Sens. Kyrsten Sinema, I-Ariz., Bill Hagerty, R-Tenn., Alex Padilla, D-Calif., and Josh Hawley, R-Mo.; would increase the amount of money the family of a federal worker who died of injuries sustained while on the job for the first time since 1997. Death gratuity payments would increase from the current $10,000 to $100,000, while the amount the federal government covers for funeral expenses would increase from $800 to $8,800. * * *
    • “The committee also voted 10-1 to advance legislation aimed at improving public-facing federal agencies’ customer service. The Improving Government Services Act (S. 2866), introduced by Committee Chairman Gary Peters, D-Mich., and Sens. James Lankford, R-Okla., and John Cornyn, R-Texas, would require agencies that provide services to members of the public to develop annual customer service action plans that outline strategies to adopt “human-centered” practices that reduce administrative burdens as well as practices already employed in the private sector like online services and call-back functions at call centers.”
  • The House Budget Committee announced,
    • “Its Health Care Task Force (HCTF) hit the ground running with its inaugural Member roundtable. This roundtable brought together Director Phillip Swagel of the nonpartisan Congressional Budget Office (CBO), independent experts, and stakeholders to discuss CBO’s methods for analyzing policies that impact drug development in the United States, including the Inflation Reduction Act (IRA).
    • “Led by Rep. Michael Burgess M.D. (R-TX), the HCTF Member roundtable examined potential refinements and improvements to CBO’s drug development model to ensure future analysis is capturing additional factors and subsequent real-world effects of policies impacting medical innovation in the United States.
    • Health Care Task Force Chairman Michael Burgess (R-TX) published an op-ed in the Washington Times sharing the Task Force’s goals with the American people ahead of today’s roundtable.
  • MedPage Today informs us,
    • “By a 14-0 vote, the [Centers for Disease Control’s] Advisory Committee on Immunization Practices (ACIP) recommended the two-dose Jynneos vaccine for mpox prevention in adults at risk for infection, which typically passes through close skin-to-skin contact, including sex. * * *
    • “Groups considered at-risk for mpox include men who have sex with men (MSM) and transgender or nonbinary people who in the past 6 months have had a new diagnosis of a sexually transmitted disease, multiple sex partners, engaged in sex work, or who had sex in association with a large public event in a region where mpox is circulating. Also people who anticipate exposure to those risks and the partners of these individuals.
    • “The committee also voted 10-4 in favor of recommending the newly approved pentavalent meningococcal vaccine (Penbraya) when both the MenACWY and bivalent MenB vaccines are indicated at the same visit. It’s the first vaccine to provide protection against the five meningococcal serogroups (A, B, C, W, and Y; MenABCWY) responsible for most cases of invasive meningococcal diseases globally.
    • “The pentavalent vaccine gained approval earlier this month for individuals ages 10 to 25 years, based on phase III trial data in previously unvaccinated individuals that showed non-inferior immune responses and comparable safety with MenABCWY when compared with vaccination with the MenACWY (Menveo) and MenB (Trumenba) vaccines.
    • “While meningitis is rare in the U.S., mortality is 10% to 15%. Most cases occur among children younger than 1 year, adolescents and young adults ages 16 to 23, and adults older than 85.”
  • HR Dive reports,
    • “The National Labor Relations Board published Thursday a rule updating the standard for determining when multiple employers may be considered joint employers under the National Labor Relations Act.
    • “NLRB’s new joint employer rule retains much of the same details from its 2022 proposed rule, specifying that an entity may be considered a joint employer of another employer’s employees if the two share or codetermine essential terms and conditions of employment. Per the rule, joint employers may possess or exercise direct or indirect control over one or more essential terms and conditions of employment.
    • “Changes from the proposed rule include an exhaustive list of seven categories of employment terms or conditions that the board will consider essential for the purposes of its joint employer analysis, as well as a description of those it will consider “irrelevant” for such analysis. The final rule also addresses joint employers’ bargaining obligations. The rule is scheduled to be published in the Federal Register tomorrow; it will take effect 60 days after that.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • “Contract negotiations between payers and providers are becoming more public, and the number of communities affected across the country is growing, according to data published Oct. 25 by FTI Consulting.
    • “Notably, disputes reported in the media during the third quarter involved Medicare Advantage plans more than ever previously recorded, standing at 15 total.
    • “In whole numbers, it may not be shocking, but each of these disputes can affect a few thousand to tens of thousands of people, so it’s significant,” Adam Broder, managing director of FTI’s strategic communications segment, told Becker’s. “Medicare Advantage is being scrutinized by federal regulators, and I think these disputes are a mirror of that on the local level with some hospitals feeling the pinch.”
  • The FEHBlog notes the number of Medicare Advantage plan disputes should be hardly surprising as those plan’s premiums, etc., are constrained by CMS.
  • Per Fierce Healthcare,
    • “Payers’ “increasingly aggressive behavior,” a spike in physician expenses and recruitment are front of mind for executives at Universal Health Services (UHS).
    • “The King of Prussia, Pennsylvania-based for-profit system came out slightly ahead of analyst estimates this quarter with a $167 million profit ($2.55 per diluted share).
    • “Much of the success came from a continued rise in patient volumes, particularly on the acute care side of the business where patients are seeking care after delaying procedures during the pandemic, Chief Financial Officer Steve Filton told investors during a Thursday morning earnings call. 
    • “While key to the company’s 6.8% year-over-year increase in net revenues, that recaptured care was largely lower acuity services that held same-facility revenue per adjusted admission to a “somewhat more muted” 0.4% year-over-year increase, Filton explained.
    • “That trend isn’t expected to last much longer. “Over time, we would expect our volumes to moderate a little bit, but also our revenue per adjusted admission to come up,” Filton told investors.” 
  • Per Healthcare Dive,
    • “Community Health Systems missed Wall Street expectations for earnings per share in its third quarter earnings this week, despite rising patient admissions and efforts to control labor expenses.
    • “The operator posted a net loss of $91 million in the third quarter, compared to net loss of $42 million from the prior year period. [For-profit CHS, which spans 76 owned or leased affiliate hospitals and more than 1,000 sites of care, has been in the red for the past three quarters.] 
    • “The losses come even as same facility admissions, which rose 3.7% year over year, reached their highest levels since the fourth quarter of 2019, CHS CEO Tim Hingtgen said during a Thursday morning call with investors.”

In judicial news,

  • Reuters reports,
    • “A U.S. appeals court has rejected legal challenges to a $2.67 billion settlement that resolves civil antitrust claims that Blue Cross Blue Shield Association and member plans conspired to drive up health insurance costs.
    • “A three-judge panel of the 11th U.S. Circuit Court of Appeals unanimously upheld Alabama-based U.S. District Judge R. David Proctor’s August 2022 approval of the settlement, which followed nearly a decade of litigation involving allegations from individual policyholders, businesses and others.
    • “The appeals court’s order on Wednesday spurned challenges to the insurance subscribers’ deal from Home Depot and others. One objector fought the $667 million in legal fees and expenses that are part of the settlement.
    • “Writing for the panel, Chief Circuit Judge William Pryor said Home Depot had not persuaded the court that the settlement would harm the power of antitrust enforcers or others to bring claims against Blue Cross Blue Shield in the future.”

Midweek update

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

From Washington, DC

  • The Wall Street Journal reports,
    • “The House elected GOP Rep. Mike Johnson of Louisiana as speaker Wednesday, with the staunch conservative overcoming the divisions that had paralyzed the chamber after a band of hard-liners ousted Kevin McCarthy three weeks ago.
    • “The choice of Johnson, aligned with former President Donald Trump, came after House Republicans nominated and then dumped a series of leadership candidates, prompting some members to wonder whether any colleague could thread the needle in the deeply divided conference. With a speaker now in place, lawmakers can return to work, with many eager to pass aid for Israel and address a looming government-funding deadline next month.”
  • STAT News tells us,
    • “A Senate health panel on Wednesday voted to send President Biden’s nominee to lead the National Institutes of Health to the chamber’s floor, moving Monica Bertagnolli one step closer to taking the longtime vacant role of permanent director.
    • “The Senate HELP Committee advanced her nomination on a 15-6 vote, with many Republicans voting in support and only Chairman Bernie Sanders (I-Vt.) breaking with the Democratic caucus to vote against her. * * *
    • “Her nomination will now move to the Senate floor for a full vote, though it is unclear when that will be scheduled.”
  • The NIH National Cancer Institute shares its weekly research highlights.
  • The American Hospital Association News points out,
    • “Starting Oct. 25, consumers can preview their 2024 health coverage options at the federally facilitated Health Insurance Marketplace. Open enrollment for the 2024 marketplace runs Nov. 1 through Jan. 15, with coverage starting Jan. 1 for consumers who enroll by midnight on Dec. 15. The Centers for Medicare & Medicaid Services expects that 96% of the website’s customers will have access to three or more insurance issuers and four in five can find coverage for $10 or less per month after subsidies.”
  • FedWeek calls attention to the fact that the U.S. Office of Personnel Management’s Inspector General has released its annual report identifying top management challenges.

From the Federal Employee Benefits Open Season front, FedSmith provides a healthcare roadmap for federal retirees. Govexec provides its perspective on Open Season planning here.

From the public health front,

  • Politico reports,
    • “So far, 12 million people, or about 3.6 percent of the population, have gotten the shot in the five weeks since it hit pharmacy shelves — though reporting lags mean it’s likely a bit higher, Centers for Disease Control and Prevention Director Mandy Cohen said.
    • “More people, by far — 16 million — have gotten their annual flu vaccine, Cohen said, attributing the difference to long-held routines.”
  • From Fierce BioTech,
    • “As Americans flock to nearby orchards for festive bouts of autumn apple picking, Insulet is celebrating a particularly bountiful stateside Apple harvest itself.
    • “The diabetes device maker has earned FDA clearance for the iPhone version of an app allowing users to control their Omnipod 5 insulin pumps from their own smartphones. Meanwhile, the app has been available to Android owners since the pump’s full U.S. launch began a year ago.
    • “In Insulet’s Monday announcement about the Apple clearance, Eric Benjamin, the company’s chief product and customer experience officer, hailed the impending launch of the app as a “significant milestone in our ongoing effort to provide people with diabetes solutions that improve their lives and help them think less about diabetes.”
  • Morning Consult informs us,
    • “28% of U.S. adults said they are interested in taking prescription GLP-1 drugs like Ozempic, Mounjaro or Wegovy for weight loss, a share relatively consistent with August and April surveys. 
    • “Consumers who have heard “a lot” about the drugs, have weight-related health conditions or have higher incomes are most likely to be interested in taking the medications.
    • “The impacts of weight loss drugs on the health industry are clear, but other sectors, like food and retail, are likely to feel the effects of changing consumer preferences. Brands that create products and services to help support a more health-conscious consumer will be best-positioned to weather disruption from Ozempic or future weight loss drug innovations.”
  • Per MedTech Dive,
    • “Boston Scientific shared pivotal trial results on Wednesday that showed promising results for its drug-eluting balloon in treating patients with repeat blockages.
    • “The company’s Agent drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries at one year, according to data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference. Boston Scientific was the study sponsor.”
  • BioPharma Dive lets us know,
    • “Patients with Alzheimer’s disease may have another treatment option in the not-too-distant future, as newly released data appear to support a more convenient version of the closely watched medicine Leqembi.
    • “Developed by partners Eisai and Biogen, Leqembi is the only Alzheimer’s medicine of its type with a full approval from the Food and Drug Administration. It’s specifically for patients in the early stages of the disease, and is given as an hourlong, intravenous infusion once every two weeks.
    • “Eisai and Biogen have been testing whether a different form of Leqembi, an under-the-skin injection, can be as safe and effective as the already marketed version. On Wednesday, at a medical conference in Boston, researchers presented results from a study of nearly 400 participants that suggests the two forms are roughly comparable.”
  • The New York Times reports,
    • “In the year after the Supreme Court ended the constitutional right to abortion, something unexpected happened: The total number of legal abortions in the United States did not fall. Instead, it appeared to increase slightly, by about 0.2 percent, according to the first full-year count of abortions provided nationwide.
    • “This finding came despite the fact that 14 states banned all abortions, and seven imposed new limits on them. Even as those restrictions reduced the legal abortion rate to near zero in some states, there were large increases in places where abortions remained legal. Researchers said they were driven by the expansion of telemedicine for mail-order abortion pills, increased options and assistance for women who traveled, and a surge of publicity about ways to get abortions.”

From the U.S. healthcare business front,

  • Beckers Hospital Review notes, “Newsweek has released the top 600 U.S. hospitals ranked by state, sorted by a score that factors recommendations, patient experience, quality and patient-reported outcome measures.” The article identifies the top hospital on the Newsweek scale in each State and DC.   
  • Beckers Payer Issues tells us how payer accountable care organizations (ACOs) fared in 2022.
  • Beckers Hospital Review also interviews an executive from a Texas hospital about how the facility is planning to emerge from Chapter 11 bankruptcy.
  • Per Fierce Healthcare,
    • “An otherwise strong Q3 performance across HCA Healthcare’s businesses was marred by news that the for-profit’s recently integrated physician staffing joint venture will be bleeding tens of millions of dollars per quarter for the foreseeable future.”
  • and
    • “UnitedHealth Group is making a $5 million investment in Enable Ventures, a fund that aims to improve the lives of people with disabilities.
    • “The investment will back companies that can create better quality of life, offer resources to entrepreneurs with disabilities and provide support to people with disabilities who are unemployed or underemployed. Enable puts a focus on providing the technologies and tools necessary to upskill or reskill people with disabilities to help them enter or reenter the workforce, according to the announcement.
    • “Catherine Anderson, senior vice president of health equity strategy at UnitedHealth Group, told Fierce Healthcare in an interview that backing Enable aligns with the company’s broader investment strategy around health equity.”

Tuesday Tidbits

David Ermer–CMS, Congress, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “House Majority Whip Tom Emmer (R., Minn.) dropped his bid to serve as House speaker just hours after he was narrowly elected as the Republican nominee, as stiff resistance from hard-right conservatives reinforced by former President Donald Trump sank the party’s latest pick to run the chamber.
    • “His withdrawal put the Republicans back to square one for the fourth time, three weeks after hard-liners engineered the ouster of former Speaker Kevin McCarthy (R., Calif.). Republicans regrouped again late Tuesday to map out their next steps, assembling another slate of candidates and holding a fresh forum in the evening. A new vote was expected Tuesday evening.”
  • The Hill offers a potpourri of articles on this situation.
  • The American Hospital Association News informs us,
    • “The Centers for Disease Control and Prevention Oct. 23 released interim guidance for clinicians with limited access to the monoclonal antibody nirsevimab, recently approved to prevent respiratory syncytial virus in children aged 2 and under. The guidance calls for prioritizing 100 milligram doses of the treatment for infants under 6 months old and infants at high risk for severe disease due to underlying health conditions, among other recommendations.”
  • STAT News tells us,
    • “Infertility has a new definition in the U.S. — one that could make a big difference to would-be parents who are single or LGBTQ+.
    • “Last week, the American Society for Reproductive Medicine (ASRM) issued an expanded description of the condition, stating that infertility involves “the need for medical intervention, including, but not limited to, the use of donor gametes or donor embryos in order to achieve a successful pregnancy either as an individual or with a partner.”
  • It’s worth adding that for 2024, OPM adopted a broad definition of fertility coverage for the FEHBP to serve this purpose.
  • Also from STAT News,
    • “People eligible to use the only needle-free flu vaccine available in the United States may be able, next year, to give it to themselves or to eligible children at home.
    • “AstraZeneca, which makes the vaccine FluMist, announced Tuesday it has submitted to the Food and Drug Administration a supplemental biologics license application that would allow for self-administration of the vaccine by people ages 18 through 49, and would allow people 18 and older to give the vaccine to eligible children. FluMist is only licensed for use in children and adults from the age of 2 to 49 years old.”
    • “The application, which the FDA is considering, would not mean there would effectively be over-the-counter sales of FluMist, Lisa Glasser, head of AstraZeneca’s U.S. medical affairs for vaccines and immune therapies, told STAT in an interview. Rather, the vaccine, which must be stored at refrigerator temperatures, would be ordered and delivered under appropriate temperature controls, after consultation with a medical professional.
    • “Glasser said the program, if approved, would not replace the option of getting FluMist in a doctor’s office or at a pharmacy, but would be another alternative for busy families. “It is meant to enhance the ability to access influenza vaccination,” she said. “That’s the goal.”

From the public health and medical research front,

  • The NIH Directors blog points out,
    • When NIH launched The BRAIN Initiative® a decade ago, one of many ambitious goals was to develop innovative technologies for profiling single cells to create an open-access reference atlas cataloguing the human brain’s many parts. The ultimate goal wasn’t to produce a single, static reference map, but rather to capture a dynamic view of how the brain’s many cells of varied types are wired to work together in the healthy brain and how this picture may shift in those with neurological and mental health disorders.
    • So I’m now thrilled to report the publication of an impressive collection of work from hundreds of scientists in the BRAIN Initiative Cell Census Network (BICCN), detailed in more than 20 papers in Science, Science Advances, and Science Translational Medicine.1 Among many revelations, this unprecedented, international effort has characterized more than 3,000 human brain cell types. To put this into some perspective, consider that the human lung contains 61 cell types.2 The work has also begun to uncover normal variation in the brains of individual people, some of the features that distinguish various disease states, and distinctions among key parts of the human brain and those of our closely related primate cousins. * * *
    • All the data represented in this work has been made publicly accessible online  for further study. Meanwhile, the effort to build a more finely detailed picture of even more brain cell types and, with it, a more complete understanding of human brain circuitry and how it can go awry continues in the BRAIN Initiative Cell Atlas Network (BICAN). As impressive as this latest installment is—in our quest to understand the human brain, brain disorders, and their treatment—we have much to look forward to in the years ahead.”
  • Per STAT News,
    • “Since the Apple Watch was unveiled in 2014, it has been trumpeted not only as a high tech fashion accessory, but also as a way for people to track their own health and fitness. It has evolved as a popular cardio tool for such uses as heart rate monitoring, recording your ECG, and measuring the oxygen saturation of your blood.
    • “But now, after nearly a decade of development, the Apple Watch is being leveraged on an entirely new health frontier: Parkinson’s disease, the degenerative brain disorder that affects more than a half million Americans.
    • “While there is no cure for Parkinson’s and treatment options can be daunting, people with the disease can now turn to technology spawned by the Apple Watch to take an active role in their care much as continuous glucose monitors have helped people manage diabetes better. Over the past year, the Food and Drug Administration has cleared three Apple Watch apps from independent developers to track symptoms associated with Parkinson’s that can help inform treatment decisions for people and their doctors.”
  • and
    • “If you had to pinpoint one subject that stood out at this year’s European Society for Medical Oncology meeting, a massive conference with thousands of people from 140-some countries and 2,500 studies presented, it would be a burgeoning type of cancer treatment called antibody-drug conjugates (ADC)
    • “The conference opened to the news that Merck had signed one of the biggest licensing deals in industry history — worth up to $22 billion — to partner on three of the compounds from ADC specialist Daiichi Sankyo. GSK followed up with an ADC licensing announcement of its own (if a much smaller one). Multiple ADC studies were presented at the meeting’s top sessions. ADCs were, in short, the belle of the cancer research ball.
    • “The thing is, ADCs are actually quite an old approach.
    • “The industry’s been putting ADCs into the clinic for 20 years, and it’s only recently that we’ve really had a breakthrough here,” Susan Galbraith, who leads AstraZeneca’s cancer work, told STAT.
    • “ADCs are designed to deliver chemotherapy directly to tumors, possibly one day replacing the blunt-force toxic therapies that have been the backbone of cancer care for generations. The idea is that these finely crafted shipments can pack the punch of chemo while minimizing side effects. Experts are still scrutinizing the safety profiles of ADCs — they come with their own side effect concerns, and trials have included some patient deaths — but some studies are showing that patients can tolerate ADCs better than traditional chemo.”

From the U.S. healthcare business front,

  • Beckers Hospital Review provides us with a link to Healthgrades’s latest rankings of specialty hospitals.
  • Moreover, Beckers Hospital Review reports,
    • “Since launching in 2018, hospital-owned Civica Rx works with about a third of the nation’s hospitals and manufactures 80 drugs facing shortages, NBC affiliate KSL-TV reported Oct. 22. 
    • “Seven health systems formed the pharmaceutical company after struggling for years with recurring drug shortages. The first goal was to make 14 generics constantly in short supply for hospitals, and 19 systems were founding members. 
    • “Now, some governments and hundreds of hospitals are buying from Civica Rx. 
    • “Dan Liljenquist, the chief strategy officer for Salt Lake City-based Intermountain Health, volunteer board chair of Civica Rx and a former Utah senator, told KSL-TV Civica Rx plans to scale up operations at its Petersburg, Va.-based manufacturing plant.” 
  • and
    • “Pittsburgh-based UPMC said it has entered into an integration and affiliation agreement with Washington (Pa.) Health System, according to an Oct. 23 filing.
    • “The two signed a letter of intent in June regarding the partnership. Unions have criticized the move, saying it would harm both patients and workers.
    • “UPMC will appoint about one-third of the Washington Health board directors and the system will be renamed UPMC Washington, according to the filing.
    • “The proposed transaction still has to meet regulatory and closing conditions.”
  • Per Healthcare Dive,
    • “Centene raised its 2023 outlook on Tuesday after the health insurer handily beat Wall Street expectations for earnings and revenue in its third quarter, helped by lower medical costs.
    • “Centene reported a medical loss ratio — a marker of spending on patient care — of 87%, down from the year prior. On a call with investors Tuesday morning, executives chalked the lower medical spending up to significantly more members in Affordable Care Act marketplace plans, who generally require less expensive care than members in Medicaid and Medicare. Centene grew marketplace membership 76% year over year.
    • “The ongoing effect of Medicaid redeterminations — now almost halfway complete — on membership numbers and care acuity continues to track to Centene’s expectations, CEO Sarah London said on the call. Centene still expects to lose roughly two million members once redeterminations are complete.”
  • Per Fierce Healthcare,
    • “Teladoc’s third-quarter revenue grew 8% to reach $660 million, boosted by solid performance in its chronic condition management business and steady membership growth as the company now touts 90 million users.
    • “The telehealth giant, which has been in operation for 20 years, also narrowed its losses this past quarter to a net loss of $57 million, or 35 cents per share, compared to a net loss of $73.5 million, or 45 cents per share, for the third quarter of 2022.” 
  • and
    • “Elevance Health’s CarelonRx is the latest pharmacy benefit manager to put biosimilars for popular drug Humira on its formulary, the company said this week.
    • “Beginning Dec. 1, adalimumab-adbm will be added to each of its commercial formularies, according to a blog post from CarelonRx. Cyltezo will also be added to certain formularies, and both will be offered at parity with Humira.
    • “Humira has been the bestselling drug in the U.S. for a decade, and PBMs have long awaited biosimilar products to challenge the drug’s dominance in the market. Drugs that treat inflammatory conditions, like Humira, represent a growing piece of overall drug spend.
    • “Other key PBMs, including Express Scripts and Optum, have taken similar steps. CVS Health launched a new subsidiary, called Cordavis, earlier this year that aims to work alongside drugmakers to bring additional biosimilars to market, with the first product a Humira biosimilar in collaboration with Sandoz.”

Monday Roundup

David Ermer–Congress, COVID-19, Federal employment benefits, HSA, Medical / Rx research, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC

  • The Wall Street Journal reports
    • “A bid by House Majority Whip Tom Emmer (R., Minn.) to serve as the House Republicans’ pick to be speaker will test whether the strong ties he built recruiting candidates and counting votes will overcome doubts from some anti-establishment lawmakers aligned with former President Donald Trump.
    • “Candidates are expected to pitch their colleagues at a forum on Monday evening ahead of an internal vote to designate a new Republican speaker nominee as soon as Tuesday morning. Beyond winning the GOP ballot, the speaker nominee will face the uphill battle to unite almost all Republicans to have a chance of winning the House vote, given Republicans’ narrow 221-212 majority.  * * *
    • “To become House speaker designate, the winning candidate must garner a majority of the votes cast within the Republican conference. The internal House GOP conference voting could go multiple rounds, with the candidate receiving the fewest number of votes dropping out after each round until a candidate wins 50% of the vote plus one. After that, the House speaker-designate must win support from a majority in the House, hitting 217 of the 433 House votes if all members show up and cast a vote for an individual.
    • “In an effort to prevent holdout candidates from delaying the process, GOP Rep. Mike Flood of Nebraska is circulating a unity pledge, which lawmakers can sign saying that they promise to back the party’s speaker designee in a House floor vote. His spokeswoman on Monday morning said that all of the candidates except [Rep. Gary] Palmer [R Alabama] have signed on.”
  • Govexec tells us
    • “Lawmakers from both parties last week revived legislation that would allow most federal employees who began their careers as temporary or seasonal workers to make catch-up contributions to their pensions so that they can retire on time.
    • “The Federal Retirement Fairness Act (H.R. 5995), introduced by Reps. Derek Kilmer, D-Wash., Gerry Connolly, D-Va., Don Bacon, R-Neb., and David Valadao, R-Calif., would allow employees enrolled in the Federal Employees Retirement System who began their careers in government as temporary workers to make catch-up contributions to their defined benefit pensions to cover for the time before they had permanent positions and were unable to contribute to their retirement accounts. The legislation was last introduced in 2021 but failed to garner support.”
  • Labor Department Assistant Secretary for Employee Benefits Security Lisa Gomez writes in her blog about Breast Cancer Awareness Month.
  • BioPharma Dive informs us,
    • “The Food and Drug Administration on Friday approved a new meningococcal vaccine, clearing Pfizer’s shot Penbraya in teenagers and young adults for protection against the five most common disease-causing serogroups.
    • “Penbraya is the first vaccine available that can provide such broad protection, which may make it more convenient than current options. While meningococcal disease is rare, it can be serious and even deadly.
  • EMPR adds that the “Food and Drug Administration (FDA) has approved Zituvio™ (sitagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
  • Per Medtech Dive,
    • Medtronic said Monday it received approval from the Food and Drug Administration for an extravascular defibrillator designed to treat abnormal heart rhythms and prevent sudden cardiac arrest, which can lead to death within minutes if not treated immediately.
    • Unlike traditional implantable cardioverter defibrillators, which have lead wires running between a pulse generator and the heart, Medtronic’s Aurora EV-ICD places a lead outside of the heart and veins.
    • The Aurora EV-ICD was a PMA submission to the FDA, Medtronic spokesperson Tracy McNulty said in an email. “We estimate the current global EV-ICD market to be between $300-$350 million, and expect the EV-ICD market to reach $1 billion 10 years out from the Aurora launch,” McNulty said.

From the public health / research front,

  • MedPage Today points out,
    • “Children infected with the Omicron variant of SARS-CoV-2 appear to be infectious for about 3 days after a positive test, researchers found.
    • “In a small study of 76 kids ages 7 to 18, the median duration of infectivity was 3 days for both vaccinated and unvaccinated children, Neeraj Sood, PhD, of the University of Southern California, and colleagues reported online in a JAMA Pediatrics research letter.
    • “The vast majority of children who get COVID are symptomatic for 1 to 3 days,” co-author Eran Bendavid, MD, MS, of Stanford University, told MedPage Today. “Basically that correlates with how long the virus is causing disease in their body.”
  • and
    • “Maternal mRNA COVID-19 vaccination during pregnancy was associated with lower risks of poor neonatal outcomes, including neonatal death, according to a population-based retrospective cohort study from Canada.”
  • Health Day notes,
    • “Gun homicide rates went down in 2022, following increases reported during the pandemic.
    • “But race still played an outsized role, with Black people continuing to have the highest firearm homicide rates, and by a wide margin.
    • “American Indian/Alaska Natives were the only groups to see an increase again in 2022.
  • The Wall Street Journal reports
    • “The age women start taking menopausal hormone therapy and the kind they take might affect their chances of developing dementia later in life, a new study found.
    • “Women have struggled for years with whether to take hormone therapy when they go through menopause. The medication can help relieve troubling symptoms such as hot flashes and night sweats. However, years of conflicting research on whether the therapy can lead to other health problems, including breast cancer, dementia and heart attacks, has left many women confused about what to do.
    • “This new study suggests that hormone therapy might lower—or at least not raise—your dementia risk if you take it in midlife. For older women, the study found some signs that the medication might raise it.
  • mHealth Intelligence explains that “The shift to telebehavioral healthcare during the COVID-19 pandemic is linked to fewer disruptions in psychotherapy services, indicating telehealth can be effective in supporting the continuity of these services, a new study shows.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Physicians’ decisions to leave their practices is a complex choice “with multiple interdependent factors,” and is not solely impacted by burnout, pay or frustrations with electronic health records, according to a new qualitative study published in ​​the Journal of the American Board of Family Medicine.
    • “The study, which interviewed physicians who left their ambulatory care practices between 2018 and 2021, found that they were motivated to increase time off, have more flexibility or receive higher earnings. However, other departing physicians reported higher compensation would not have persuaded them to stay.
    • “Physician practices can better retain clinicians by addressing risk factors for departure including workflow distribution across team members and ensuring adequate staffing, the report said.”
  • The Wall Street Journal reports,
    • “Roche Holding has agreed to buy the developer of a bowel-disease treatment from Roivant Sciences, a company started by Republican presidential candidate Vivek Ramaswamy, and Pfizer in a deal worth more than $7 billion.
    • “The Swiss pharmaceutical giant said Monday it would pay $7.1 billion upfront for Telavant Holdings and make a near-term milestone payment of $150 million. Roche said the deal gives it rights to commercialize Telavant’s RVT-3101 drug candidate, which has shown promise for inflammatory bowel disease and could have potential in other indications in the U.S. and Japan. 
    • “The deal is the latest example of a big pharma company turning to the deal table to bolster its pipeline of autoimmune drugs. Merck earlier this year agreed to pay more than $10 billion to buy Prometheus Biosciences, which is developing a drug for inflammatory bowel disease that would compete with Telavant’s candidate.”
  • Per Fierce Healthcare
    • “Folx Health, a virtual provider focused on LGBTQ+ health, is now in-network with Cigna, Evernorth and Blue Shield of California.
    • “Other payer partners include Blue Cross and Blue Shield of Texas and Optum for behavioral health service in Colorado and Florida, according to Folx Health’s website. Through the collaboration, insured patients can use therapy and mental health medication management with Folx’s LGBTQ-specialized clinicians. 
    • “Folx offers virtual primary care, gender-affirming care and mental health services. Making that care in-network will deliver its patients significantly lower out-of-pocket costs, per the company.”
  • Assured Partners offers HSA and FSA Account Reminders for Year-End.

Weekend update

David Ermer–Congress, Medical / Rx research, U.S. Healthcare–
Lincoln Memorial in the Fall

From Washington DC,

  • The Wall Street Journal adds.
    • “GOP lawmakers are heading into another week without a speaker will try to overcome deep divisions long enough to unify behind a new candidate, after colleagues soured on conservative firebrand Rep. Jim Jordan (R., Ohio) following a string of unsuccessful floor votes. 
    • “With the race now rebooted, nine Republican lawmakers are angling for the speaker job, jumping into the race before a Sunday deadline. 
    • “Rep. Tom Emmer (R., Minn.), who serves as the House’s majority whip, has announced a run. He already locked up an endorsement from former Speaker Kevin McCarthy (R., Calif.), who remains a popular and influential party member despite his sudden ejection from the speakership on Oct. 3. Other candidates include Kevin Hern of Oklahoma, who leads the conservative Republican Study Committee group, Byron Donalds of Florida, a political newcomer with ties to former President Donald Trump, and longtime lawmaker Pete Sessions of Texas. * * *
    • “Candidates are expected to pitch their colleagues at a forum on Monday evening ahead of an internal vote to designate a new Republican speaker nominee as soon as Tuesday morning.”
  • The full House is scheduled to meet at 11 a.m. on Tuesday.

From the public health/research front,

  • The American Medical Association suggests seven steps that women should take to improve blood pressure control and identifies the top health tips that infectious disease doctors want their patients to know.
  • Fortune Well reports,
    • “It’s been a month since a Maryland man became the second person to receive a transplanted heart from a pig — and hospital video released Friday shows he’s working hard to recover.
    • “Lawrence Faucette was dying from heart failure and ineligible for a traditional heart transplant because of other health problems when doctors at the University of Maryland School of Medicine offered the highly experimental surgery.
    • “The Maryland team last year performed the world’s first transplant of a heart from a genetically altered pig into another dying man. David Bennett survived just two months before that heart failed, for reasons that aren’t completely clear, although signs of a pig virus later were found inside the organ. Lessons from that first experiment led to changes before this second try, including better virus testing.
    • “Attempts at animal-to-human organ transplants — called xenotransplants — have failed for decades, as people’s immune systems immediately destroyed the foreign tissue. Now scientists are trying again using pigs genetically modified to make their organs more humanlike.
    • “In Friday’s hospital video, Faucette’s doctors said the pig heart has shown no sign of rejection.”
  • Per FiercePharma,
    • “Last year, a first-of-its-kind head-to-head clinical trial between two PD-1 inhibitors went in GSK’s favor. Now, the British pharma has some new patient survival data to celebrate.
    • “Compared with Merck’s market-leading Keytruda, GSK’s Jemperli demonstrated a 25% lower risk of death in patients with newly diagnosed nonsquamous non-small cell lung cancer (NSCLC), according to new data unveiled today, Oct. 20, at the European Society for Medical Oncology (ESMO) 2023 Congress.
    • “The data come from an updated analysis of the phase 2 PERLA trial, which was the first global, head-to-head study of two PD-1 inhibitors.
    • “The number doesn’t bear statistical significance because the trial wasn’t designed to show superiority. It does, however, further prove that Jemperli behaves in a similar way as Keytruda does, Hesham Abdullah, M.D., who leads GSK’s oncology drug development, said in an interview with Fierce Pharma.”
  • MedTech Dive informs us,
    • “Shortages of medical devices and therapies are compromising patient care by delaying treatment and driving unsafe practices, according to a survey of healthcare professionals conducted by the patient safety nonprofit ECRI and the Institute for Safe Medication Practices.
    • “The survey found that supply shortages have caused surgical cases to be rescheduled, postponed or canceled and that a lack of endotracheal tubes and pulmonary artery catheters is on the cusp of impacting the ability to provide adequate clinical care.
    • “ECRI and the Institute for Safe Medication Practices used the findings to call for “long-term, nationally coordinated solutions” to stop persistent shortages.”

In human resources news,

  • Per HR Dive,
    • “UPS will expand an ‘emergency child care initiative’ for U.S.-based front-line workers, the company announced Tuesday. The program, a partnership with Patch Caregiving, was piloted from August 2022 through January at a Northern California site. 
    • “According to UPS, 80% of eligible employees participated in the emergency daycare program, which helped the company avoid more than 120 unplanned absences. UPS also reported a significant reduction in employee turnover in the pilot group — from 31% to 4%.
    • “UPS will expand the program to additional shifts at the California pilot site and some Pennsylvania facilities this quarter. It will add additional facilities in 2024.”

Friday Factoids

David Ermer–CMS, Congress, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Wall Street Journal reports
    • “Rep. Jim Jordan withdrew his bid to become House speaker Friday, after the fiery conservative lost a pair of public and private votes, sending divided House Republicans back to the starting line in their weekslong quest to elect a leader and pass urgent legislation. * * *
    • “Jordan’s departure from the race has swung the door open for broader competition. Already Republican Study Committee Chairman Kevin Hern (R., Okla.) and Rep. Pete Sessions (R., Texas) had announced interest in the job, while House Majority Whip Tom Emmer (R., Minn.) was quickly endorsed by McCarthy. A handful of others also were considering bids.”
  • Healthcare Dive informs us,
    • “Sens. Kevin Cramer, D-N.D., and Angus King Jr., I-Maine, sent a letter to CMS Administrator Chiquita Brooks-LaSure on Thursday, asking the agency to withhold its controversial staffing mandate for long-term care facilities. 
    • “The CMS proposal issued last month would require nursing facilities, including veterans homes, to have at least one registered nurse on duty at all times and provide three hours of care per resident per day, with 0.55 hours coming from registered nurses. An analysis from KFF last month found 81% of nursing facilities nationwide would need to hire additional staff to meet the requirements.
    • “In the letter, the senators warned that many markets, including their home states, may not have enough nurses to meet requirements, which could cause some long-term care facilities to close and disrupt care for veterans.”
  • The American Hospital Association News announces,
    • “Oct. 28 is National Prescription Drug Take Back Day, an opportunity for the public to safely dispose of unwanted or expired tablets, capsules, patches and other solid forms of prescription drugs. The Saturday event offers free and anonymous disposal of unneeded medications at almost 5,000 local drop-off locations nationwide. Over more than 10 years, the Drug Enforcement Administration event has collected 8,650 tons of old, unwanted or expired medications, including opioid and other drugs susceptible to diversion, misuse and abuse. DEA offers posters and other materials to help hospitals and other partners promote the event in their community. Collection sites should be open from 10 a.m. to 2 p.m. local time.”

From the public health front,

  • HealthDay tells us,
    • “Two servings of red meat a week raise your risk of type 2 diabetes by 62%, new research shows.
    • “The risk applies to both processed and unprocessed red meat. 
    • “Replacing one daily serving of red meat with nuts, legumes or dairy can significantly reduce diabetes risk, researchers say.”
  • The Wall Street Journal reports,
    • “A potential blockbuster weight-loss drug still years away from U.S. regulatory approval is already being sold online, another example of a thriving gray market for unapproved weight-loss medications, according to a Wall Street Journal review.
    • “The Journal found hundreds of merchants offering the new drug, which is being developed by Eli Lilly and is called retatrutide. Most appear to be Chinese sellers shipping directly to U.S. consumers from sites such as Made-in-China.com. Some of the sites, including ones that appear to be based in the U.S., have marketed their products via posts on  Facebook, LinkedIn and Reddit. A handful have run paid ads on Instagram and Google. A fitness influencer has offered it for sale via his newsletter.  * * *
    • “In a statement, the FDA said it would continue to investigate reports of suspect counterfeit drugs to determine the public health risks and the appropriate regulatory response. 
    • “Excitement over retatrutide jumped in June when Lilly reported Phase 2 trial results that showed the drug led to an average weight loss of up to 24% over 48 weeks. That could prove better than Lilly’s already-approved drug Mounjaro. Researchers in a Lilly-funded study showed that tirzepatide, Mounjaro’s active ingredient, is the most effective medication currently being prescribed for weight loss.”  
  • The Journal adds
    • “Much of the focus has understandably been on obesity drugs’ sticker price—more than $10,000 annually—and how their usage by millions of Americans could create a budgetary crisis. 
    • “But an analysis by the American Enterprise Institute shows that the net price—what the manufacturers get—is much lower.
    • “The discount for GLP-1 drugs such as Wegovy, Ozempic, Mounjaro and Rybelsus ranged from 48% to 79%, according to the study. Ozempic, for example, is listed at $936 a month, but the manufacturer received $290 on average. Interestingly, Wegovy, currently the only one of those drugs approved by the Food and Drug Administration for obesity, had the smallest discount.
    • “Once Eli Lilly’s Mounjaro, which is approved for diabetes but frequently prescribed off-label for weight loss, gets an expected FDA nod for obesity this year, “competition for formulary placement will likely put downward pressure on net prices for those indications in that scenario,” wrote the authors of the analysis.”
  • The FEHBlog continues to believe that the prices should be lower.

From the U.S healthcare business front.

  • Per Fierce Healthcare,
    • “It shouldn’t come as much of a surprise that employers are putting a focus on managing healthcare costs in the coming year. And a new analysis from WTW highlights some of the areas in which they’re aiming to address these expenses.
    • “The consultancy surveyed 457 employers representing 7.3 million workers in June and July, and it found that 62% of firms are planning to roll out programs to address cost and mental health as part of a broader strategy around health and wellness.
    • “More than two-thirds of companies (69%) said they’ll be focusing on costs, and 63% said they’ll be addressing mental health care, according to the report.
    • “Regina Ihrke, senior director for health and benefits at WTW, told Fierce Healthcare that while employers are highly concerned about potential healthcare costs increases, they’re trying to strike a balance between managing those costs and designing a benefits package that draws in and retains top talent.”
  • and
    • “Ilant Health, a new virtual provider targeting obesity treatment, has launched out of stealth with $3 million in funding. 
    • “Founded on the belief that obesity care will only transform healthcare if it is part of the system, Ilant plans to partner with employers and payers. The startup is led by Elina Onitskansky, who previously served as senior vice president and head of strategy at Molina Healthcare.”
  • Mhealth intelligence considers whether retailers have the inside track on virtual care and identifies technologies that support payer claim processing systems.

Thursday Miscellany

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Mental health care, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Washington, DC,

  • The Wall Street Journal reports,
    • Republican speaker nominee Rep. Jim Jordan was weighing whether to embark on a third-floor vote after a plan to temporarily put caretaker speaker Rep. Patrick McHenry in charge of the House ran into sharp objections from conservatives.
    • “I am still running for speaker, and I plan to go to the floor and get the votes and win this race,” Jordan said initially after leaving a heated closed-door meeting of House Republicans. The Ohio conservative said the plan to elect a temporary speaker didn’t have the support of the conference.
    • In the evening, Jordan met in a House office with detractors. As some trickled out, there was no sign he had managed to change their minds, and Jordan wouldn’t say after the meeting whether he still intended to hold another floor vote. 
  • The New York Times adds, “Mr. Jordan said he would push for another vote to become speaker, scheduled for Friday at 10 a.m., even though he was bleeding support and calls were increasing for him to step aside.”
  • The Society for Human Resource Management informs us,
    • “The U.S. Supreme Court has agreed to hear two cases that will impact the power of federal agencies to implement regulations on employers.
    • “On Oct. 13, the court decided to hear Relentless v. Department of Commerce, in which the owners of three fishing companies in Rhode Island and Massachusetts sued to challenge the federal government’s authority to require them to partially pay for federal monitors on their boats. The justices willconsider that case in tandem with a similar case, Loper Bright Enterprises v. Raimondo, which involves the same requirement for fishing companies in New Jersey.
    • “In both cases, the justices will decide whether to overturn the long-standing Chevron precedent, which holds that when Congress wrote a statute without a clear meaning, courts should defer to the federal agency applying the law, unless its directives were unreasonable. Federal departments and agencies that enforce employment laws could be impacted.”
  • In yesterday’s post, the FEHBlog called attention to AHIP’s public comments on the proposed rule, making changes to the current mental health parity rules. AHIP asked the regulators to try again. Per Fierce Healthcare,
    • “The Blue Cross Blue Shield Association (BCBSA) echoed AHIP in its comments, arguing that additional clarity around the changes is necessary. The organization said it could lead patients to care that is not recommended, worsening outcomes.
    • “We share the administration’s goal of expanding access to affordable mental health support, but we’re concerned it could become harder—not easier—for patients to get the care they need,” said David Merritt, BCBSA’s senior vice president of policy and advocacy, in a statement.
    • “This rule could push us in the wrong direction by forcing health plans to remove important protections that ensure patients are receiving safe, medically necessary, effective care,” Merritt added. “We’ll continue to work with our partners, the administration and Congress to improve both access and quality for Americans.”
    • “The Alliance for Community Health Plans said the updates create “an entirely new regulatory schema” that would actually impede insurers looking to address mental health parity.
    • “The ERISA Industry Committee, or ERIC, said many of the proposals “reflect an overreach of agency authority under the statute” and that they would be burdensome for employer-sponsored health plans. The changes, ERIC said, could drive up costs for families and force significant changes to benefit designs.
    • “Unfortunately, the proposed regulations are so unworkable, it is unclear how compliance could ever be achieved while continuing to offer these important benefits,” said James Gelfand, CEO of ERIC, in a statement. “The Departments’ proposals are written in a way that sets plans up to fail.”
  • The FEHBlog agrees.
  • Reuters tells us,
    • “The U.S. health regulator [the Food and Drug Administration] has approved Hyloris Pharmaceuticals’ drug for post-operative pain, the Belgium-based company said on Wednesday, adding that it expects to launch the non-opioid treatment in the United States by early next year.
    • “The injectable drug, branded as Maxigesic IV, was approved as a post-operative drug in hospitals or when patients cannot take medicine orally.
    • “Maxigesic IV, a combination of paracetamol with ibuprofen solution for infusion, helps reduce pain and inflammation without the risk of opioid addiction that resulted in more than half a million deaths in the U.S. during 1999 to 2020.”

From the public health front,

  • HHS’s Agency for Healthcare Research and Quality posted for public comment an Effective Health Programs abstract on caring for Long Covid. The comment period ends on November 17, 2023.
  • Healio points out,
    • “Data show CMS’ Million Hearts CVD Risk Reduction Model, which provided payments for CVD risk assessment and reduction, reduced incidence of first-time MIs and strokes over 5 years without significant changes in Medicare spending.
    • “The results support clinical guidelines for CVD preventive care,” G. Greg Peterson, PhD, MPA, a principal researcher with Mathmatica, told Healio. “Current guidelines in the U.S., similar to those in other countries, recommend that health care practitioners calculate CVD risk scores and use the scores to engage patients in discussions about CVD prevention. Although previous studies of CVD risk scoring interventions have shown improvement in CVD risk factor control, this is the first study of a CVD risk score-focused intervention to demonstrate declines in CVD events.”
  • Health Day lets us know,
    • “Fluctuating blood pressure can be a harbinger for both dementia and heart disease, a new study finds.
    • “Ups and downs within 24 hours or even over several days or weeks were linked with impaired thinking, researchers from Australia reported.
    • “Higher variations in systolic blood pressure, the top number, were linked with stiffening of the arteries, which is associated with heart disease.
    • “Clinical treatments focus on hypertension while ignoring the variability of blood pressure,” said lead author Daria Gutteridge, a PhD candidate at the University of South Australia’s Cognitive Aging and Impairment Neuroscience Laboratory.”
  • The National Institutes of Health announced,
    • “A research team funded by the National Institutes of Health has developed a smartphone app that can track and analyze a person’s ability to move from one place to another, known as locomotion and other types of movements. Human motion analysis is used to evaluate patients with movement difficulties, to help clinicians plan surgery, and to assess the results of treatment procedures. The research team believes that using the app costs about 1% of conventional motion analysis techniques and works 25 times faster. The study appears in PLOS Computational Biology.
    • “Researchers tested their app, called OpenCap, with 100 participants. Using two or more smartphones, the app recorded sufficient quality videos to allow for web-based, artificial intelligence analysis of muscle activations, joint loads and joint movements. Data collection took 10 hours for the 100 participants, and computation of results took 31 hours. Traditionally, locomotion analysis requires fixed lab space and more than $150,000 worth of equipment, including eight or more specialized cameras to capture three-dimensional images. The captured data also takes several days to analyze by a trained expert.
    • “While current technology is too expensive for routine clinical use, according to the investigators, the app could potentially be used to help screen for disease risk, inform rehabilitation decisions, and track improvements in motion following treatment.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • CVS Health is pulling some of the most common decongestants from its shelves and will no longer sell them, after advisers to U.S. health regulators recently determined that an ingredient doesn’t work.
    • The products contain [as the only active ingredient] oral phenylephrine, an almost-century-old ingredient in versions of decongestants and over-the-counter pills, syrups and liquids to clear up congested noses.
    • An advisory panel to the Food and Drug Administration last month declared that the ingredient was ineffective when taken orally. The FDA had said in its own analysis that the oral phenylephrine formulations are safe but ineffective at standard or even higher doses.
    • The FDA hasn’t made a decision yet nor asked manufacturers or retailers to remove products from store shelves. CVS is removing phenylephrine products voluntarily.
  • Beckers Hospital Review informs us,
    • “In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection. “In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection. 
    • “Rite Aid has more than 2,000 stores in 17 states. Of the 154 planned closures, about 40 are Pennsylvania locations. Many stores in California and New York will also close, and additional store closings may be forthcoming as Rite Aid looks to shed about $4 billion in debt. 
    • “The Philadelphia-based company previously said it secured $3.45 billion from lenders to fund operations through the bankruptcy restructuring, with McKesson Corp. as the largest creditor. Alongside the bankruptcy filing, Rite Aid announced Jeffrey Stein as its new CEO and chief restructuring officer.”

Midweek Update

David Ermer–ACA, Congress, COVID treatment, Federal employment benefits, Medical / Rx research, NIH, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC,

  • The Wall Street Journal reports,
    • “GOP Rep. Jim Jordan failed again to win enough votes to be elected House speaker, as divisions hardened for House Republicans, with some lawmakers pursuing new paths to break the impasse that has paralyzed the chamber.
    • “More than two weeks after former House Speaker Kevin McCarthy (R., Calif.) was ousted, Republicans remained gripped in a fierce internal struggle over his successor. Jordan said he would keep up his campaign, but pushed off any further voting until Thursday at the earliest as mounting GOP defections on his second ballot left Republicans snarled into warring factions over what should happen next.”
  • The Federal Times informs us that the Senate is considering a bipartisan bill to improve benefits for the families of federal employees who die on the job.
  • Govexec tells us,
    • “A bipartisan trio of Senators hope to advance new legislation aimed at improving and “streamlining” federal agencies’ customer service across platforms, in part by adopting practices already employed in the private sector.
    • “Customer service at agencies that interact with members of the public has been top of mind for lawmakers and administration officials in recent years. During the height of the COVID-19 pandemic, that attention was on electronic means like phone and the Internet, while over the last 18 months, the focus turned toward in-person service as well as backlogs that cropped up over the course of the pandemic.
    • “The Improving Government Services Act (S. 2866), introduced by Sens. Gary Peters, D-Mich., James Lankford, R-Okla., and John Cornyn, R-Texas, last month but publicized Tuesday, tasks federal agencies that provide services to members of the public to develop annual customer experience action plans and submit them both to the director of the Office of Management and Budget and Congress. The Senate Homeland Security and Governmental Affairs Committee is slated to consider the bill next week.”
  • MedPage Today discusses today’s confirmation hearing for the President’s nominee to be NIH Director, Dr. Monica Bertagnolli.
    • “In laying out her vision for the agency, a key theme for Bertagnolli was equity. “NIH can and must support research that is equitable and accessible to all populations,” she said, stressing the need to diversify clinical trials.”
  • The Internal Revenue Service announced, “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2023, and before October 1, 2024, is $3.22. This is the per belly button fee that FEHB plans will owe for the current 2023 plan year next July 31, 2024.
  • HHS Office for Civil Rights issued “Resources for Health Care Providers and Patients to Help Educate Patients about Telehealth and the Privacy and Security of Protected Health Information.”
  • AHIP posted its helpful comments on the proposed mental health parity rule changes. The public comment deadline was yesterday.
  • Fedsmith offers its guidance on the upcoming Federal Employee Benefits Open Season.

From the public health front,

  • STAT News reports,
    • Treatments like Ozempic, Wegovy, and Mounjaro have been hailed for showing 15% to over 20% weight loss in trials, but those are just averages. In reality, there are big variations in how much weight people lose on the therapies, and it’s unclear what explains those differences.
    • “One way researchers are trying to figure this out is by focusing on genes.
    • “The variability is so wide that we want to understand what predicts response,” said Lee Kaplan, chief of obesity medicine at the Geisel School of Medicine at Dartmouth. Since genetics is a significant reason people develop obesity, and since early data also show that genetics may contribute to how people respond to bariatric surgery, “that would argue that there’s probably going to be a genetic contribution” to the amount of weight loss people experience on obesity drugs.”
  • Beckers Hospital Review discusses what the closure of various Walgreen’s and Rite Aid drug stores means for healthcare.
    • “The closures also disproportionately affect Black and Latino city neighborhoods, as well as rural areas, according to Serena Guo, MD, PhD, an assistant professor at the Gainesville-based University of Florida College of Pharmacy. 
    • “Closure has the potential to worsen disparities in access to pharmacies,” Dr. Guo told MarketWatch.”
  • The National Institutes of Health announced,
    • “Starting buprenorphine treatment for opioid use disorder through telehealth was associated with an increased likelihood of staying in treatment longer compared to starting treatment in a non-telehealth setting, according to a new study analyzing Medicaid data from 2019-2020 in Kentucky and Ohio. Published in JAMA Network Open, these findings(link is external) add to a growing body of evidence demonstrating positive outcomes associated with the use of telemedicine for treatment of opioid use disorder.
    • “In Kentucky, 48% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 44% of those who started treatment in non-telehealth settings. In Ohio, 32% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 28% of those who started treatment in non-telehealth settings.”
  • HealthDay points out,
    • “Researchers have identified a link between attention-deficit/hyperactivity disorder (ADHD) in adults and dementia.
    • “The risk of dementia is three times higher in adults with ADHD, according to a large study of Israelis who were followed for 17 years.
    • “More research is needed to verify the findings and understand the link.”
  • The Wall Street Journal reports,
    • “Pfizer will price a course of its Covid-19 drug Paxlovid at nearly $1,400 when commercial sales begin later this year, more than double what the U.S. government has paid.
    • “Pfizer told the pharmacies and clinics that will dispense Paxlovid, in a letter dated Wednesday that was viewed by The Wall Street Journal, that a five-day course of the antiviral will list for $1,390. The U.S. government had paid $529.
    • “Health plans will probably pay much less than the list price for the pills, and most patients will have a small or no out-of-pocket cost because Pfizer is expected to offer price discounts and help patients with their out-of-pocket charges.
    • “Pfizer has already faced criticism from doctors and patient advocates that raising the price will limit patient access. Disclosure of the list price will probably fuel further criticism.”

From the U.S. healthcare business front,

  • KFF reports,
    • “Amid rising inflation, annual family premiums for employer-sponsored health insurance climbed 7% on average this year to reach $23,968, a sharp departure from virtually no growth in premiums last year, the 2023 benchmark KFF Employer Health Benefits Survey finds.
    • “On average, workers this year contribute $6,575 annually toward the cost of family premium, up nearly $500 from 2022, with employers paying the rest. Future increases may be on the horizon, as nearly a quarter (23%) of employers say they will increase workers’ contributions in the next two years.
    • “Workers at firms with fewer than 200 workers on average contribute nearly $2,500 more toward family premiums than those at larger firms ($8,334 vs. $5,889). In fact, a quarter of covered workers at small firms pay at least $12,000 annually in premiums for family coverage.
    • “This year’s 7% increase in average premiums is similar to the year-over-year rise in workers’ wages (5.2%) and inflation (5.8%). Over the past five years, premiums rose 22%, in line with wages (27%) and inflation (21%).”
  • Per WXYZ.com (Detroit MI),
    • “Henry Ford Health and Ascension Michigan have signed an agreement to enter into a joint venture, the latest merger between health systems in Michigan.
    • “According to the health systems, Ascensions Southeast Michigan and Genesys healthcare facilities will join with Henry Ford’s. * * *
    • According to the companies, the combined organization would employ around 50,000 team members at more than 550 sites of care across the area.”
  • Healthcare Dive adds,
    • “Thirty-nine percent of mergers and acquisitions announced in the third quarter included a hospital or health system that cited financial distress as a driver for deal, according to a report by Kaufman Hall. 
    • “Though M&A activity is continuing to trend back to pre-pandemic levels, the number of hospitals in distress shows the financial strain of the past two years, the report said. Eighteen transactions were announced in the third quarter, compared with just seven in the same period in 2021 and 10 during the third quarter in 2022.
    • “Increased costs, both for labor and other expenses, has been a significant challenge for smaller and medium-sized health systems. Now, more large systems — with annual revenue of $1 billion or more — are pointing to financial concerns as their reason for dealmaking, according to Kaufman.”
  • Beckers Payer Issues notes,
    • “In the third quarter, we completed a strategic review of our operations, assets, and investments to enhance operating efficiency, refine the focus of our investments in innovation and optimize our physical footprint,” the company wrote. “This resulted in a net charge of $697 million, comprised of the write-off of certain information technology assets and contract exit costs, a reduction in staff including the relocation of certain job functions, and the impairment of assets associated with the closure or partial closure of data centers and offices.”
    • “Elevance Health posted $1.3 billion in net income during the third quarter, a nearly 20% decrease compared to the same period last year, according to the company’s earnings report published Oct. 18.
  • and
    • “Consumers’ overall satisfaction with health insurers is up 4% over 2023, according to a report from the American Customer Satisfaction Index published Oct. 17. 
    • “Customer satisfaction with insurers reached a score of 76 out of 100, the highest in the index’s history, according to the report.” 
  • Per Fierce Healthcare,
    • “Amazon Pharmacy is launching drone delivery for prescription medication orders with the service initially taking flight in College Station, Texas, the company announced Wednesday.
    • “The pharmacy deliveries will be dropped, quite literally, outside a consumer’s front door within 60 minutes at no additional cost for eligible Amazon Pharmacy customers, the company said.
    • “Amazon Pharmacy is teaming up with the online retailer’s drone service, Prime Air, which kicked off commercial deliveries in the same Texas city in December.
    • “Delivery of medications via drone will be offered in College Station initially and will expand to additional cities in the coming years, an Amazon Pharmacy spokesperson said. The announcement was made this week as part of Amazon’s Delivering the Future event in Seattle focused on its latest innovations.”

Tuesday Tidbits

David Ermer–Congress, COVID-19, Federal employment benefits, Medical / Rx research, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Rep. Jim Jordan (R., Ohio) failed to win enough votes Tuesday to be elected House speaker after more Republicans than expected joined Democrats in declining to back him, setting up lawmakers for an unpredictable second round of balloting.
    • “The favorite of the Republican base and ally of former President Donald Trump saw 20 GOP lawmakers break with him in the first round Tuesday afternoon, many more than the handful the GOP nominee could afford to lose. Democrats backed their pick, Minority Leader Hakeem Jeffries (D., N.Y.), while the Republican holdouts scattered their votes among other GOP figures.
    • “The result deflated hopes for a quick resolution of intraparty fighting * * *.
    • “After the failed vote, Republicans huddled in small groups to discuss their options. One approach would be to give more power to Speaker Pro Tempore Patrick McHenry (R., N.C.), if enough Republicans and Democrats supported the idea.”
  • The Federal Times shares the dates and deadlines to remember for FEHB open enrollment.

From the public health and research front,

  • Beckers Hospital Review informs us,
    • New weekly COVID-19 admissions are down for the fourth week straight, according to the latest data from the CDC. Meanwhile, flu and respiratory syncytial virus are starting to rise. 
    • COVID-19: COVID-19 metrics declined in the U.S. for the week ending Oct. 7. A total of 16,766 new COVID-19 admissions were reported this week, marking an 8.2% decline from the week prior. Emergency department visits related to the disease were also down nearly 18%. The decline in activity comes after about three months of steady increases in hospitalizations. Based on past trends, however, experts predict the nation may see another winter uptick in December or January — the same time of the year flu tends to peak. 
    • RSV: Cases of RSV have been slowly rising in the U.S. Overall, the positivity rate remains much lower than this time last year, though some hospitals in the South have started to see RSV hospitalizations increase. Holtz Children’s Hospital in Miami has seen a “five-fold increase for influenza and a two-fold increase for RSV,” the hospital’s chief medical officer, Barry Gelman, MD, told a local news outlet in a report earlier this month. 
    • Flu: Flu activity remains low nationally, with a positivity rate of 1.1% for the week ending Oct. 7. CDC officials told NBC News activity will likely ramp up over the next few weeks. Just over 1,100 patients with lab-confirmed flu were admitted to the hospital for the week ending Oct. 7, up slightly from the week prior. Most cases reported so far this season are influenza A.
    • Hospitalizations for flu, COVID-19 and RSV are projected to peak at the end of January. With that timeline, hospitals may see similar levels of capacity and resource strain as last respiratory virus season since peaks may overlap. Health experts have been optimistic that a collection of vaccines and a new monoclonal antibody for RSV would largely prevent severe illness and minimize capacity strain on hospitals. However, significant hurdles in accessing the shots may prevent them from reaching those most at risk of severe illness before virus season is in full swing. 
  • CIDRAP from the University of Minnesota tells us,
    • “A meta-analysis today in Antimicrobial Stewardship & Healthcare Epidemiology estimates a vaccine effectiveness (VE) of 69% for three doses of COVID-19 vaccine against long COVID, while two doses offer 37% efficacy.
    • “Led by researchers at the University of Iowa, the meta-analysis involved 24 studies on COVID-19 VE against long COVID among recipients of at least two doses of a vaccine before or after infection from December 2019 to June 2023.
    • “With the ongoing COVID-19 pandemic, a considerable proportion of individuals who have recovered from COVID-19 infection have long-term symptoms involving multiple organs and systems,” the researchers wrote.”
  • Healio points out,
    • “Adhering to a healthy lifestyle could reduce coronary health disease risk [by 25%] regardless of genetic susceptibility to abdominal obesity.
    • “The more favorable lifestyle included factors like a healthy diet and sleep habits.”
  • The NIH Directors Blog lets us know,
    • “Each year in the U.S., more than 500,000 people receive treatment for burn injuries and other serious skin wounds. To close the most severe wounds with less scarring, doctors often must surgically remove skin from one part of a person’s body and use it to patch the injured site. However, this is an intensive process, and some burn patients with extensive skin loss do not have sufficient skin available for grafting. Scientists have been exploring ways to repair these serious skin wounds without skin graft surgery.
    • “An NIH-funded team recently showed that bioprinted skin substitutes may serve as a promising alternative to traditional skin grafts in preclinical studies reported in Science Translational Medicine. The approach involves a portable skin bioprinter system that deposits multiple layers of skin directly into a wound. The recent findings add to evidence that bioprinting technology can successfully regenerate human-like skin to allow healing. While this approach has yet to be tested in people, it confirms that such technologies already can produce skin constructs with the complex structures and multiple cell types present in healthy human skin.”
  • The Washington Post discusses improving the availability of primary care in our country.
  • STAT News interviews the scientist who made Novo Nordisk an obesity drug powerhouse, Dr. Lotte Bjerre Knudsen.
    • “When the company invented a once-weekly version of the drug, called semaglutide, she spearheaded research to understand its biological impact on metabolism, cardiovascular and kidney health, and the brain. In clinical trials, semaglutide cut a person’s food intake by up to 35%, more than double the effect of liraglutide.
    • “Knudsen’s team conducted studies suggesting it achieves such dramatic results by modifying overlapping neural pathways involved in food intake, reward drives, and energy expenditure — studies that have helped prove that one molecule can, in fact, have multiple biologies. What the brain does with GLP-1 and what the gut does are two very different things. Drugs like liraglutide and semaglutide just happen to harness them both, separately, at the same time.
    • “Those lessons have led Knudsen to ask if GLP-1 might have other roles in the brain that could be exploited to therapeutic ends. One of the most promising areas she’s now focusing on is Alzheimer’s disease. Other researchers have their sights set on seeing if these drugs might help people with addiction and alcohol use disorders control their cravings.
    • “The science here is still early, Knudsen emphasized. But the fact that it exists at all owes much to her singular determination. “I’m actually quite patient,” she said. “When it comes to slowly working to progress something that could be important in the future, that needs to take its time.”

From the U.S. healthcare business front,

  • STAT News notes,
    • “Here at ObesityWeek, one of the largest conferences on obesity, Novo Nordisk and Eli Lilly are displaying more than a dozen studies that together carry the message: Our blockbuster weight loss treatments will be worth it for society.
    • “But experts point out that much of this company-funded research does not include the cost of the drugs themselves, which sell at more than $10,000 per year in the U.S. and are meant to be taken indefinitely. * * *
    • “As more economic analyses emerge, these questions of how worth it the new obesity drugs are will continue to be top of mind for clinicians, said Jamy Ard, president-elect of The Obesity Society and co-director of the Atrium Health Wake Forest Baptist Weight Management Center.
    • “We are stewards of the resources,” said Ard, who has consulted for Novo and Lilly. “If we are skeptical about the cost-effectiveness of the treatment, where we know that our patient populations can’t afford a certain therapy, then we’re not going to prescribe it. We’re not going to encourage health plans to approve the treatment or make treatment available to people if we think that there are better ways to spend those health care dollars.”
    • In the FEHBlog’s view, the manufacturers are not taking into account the rapidly growing number of people who may receive a prescription for these drugs.
  • Per Healthcare Dive,
    • “One Medical has quietly rebranded the senior care clinics it acquired from its 2021 buy of Iora Health to “One Medical Seniors” in an effort to better synchronize the two businesses.
    • “The rebrand, and ongoing efforts to expand the ability of One Medical clinics to treat a wider variety of patient populations, are likely to help the primary care provider nab more clients, analysts said.
    • “People need to know who they’re doing business with or receiving care from. And that’s especially true when you look at the senior population,” said Arielle Trzcinski, a principal analyst at Forrester who focuses on the digital and retail health markets. “So being able to apply the One Medical brand to Iora — it’s a trusted brand. So there’s an opportunity for net new customers.”
  • MedCity News observes,
    • “Rite Aid filed for Chapter 11 bankruptcy protection on Sunday amid decreasing sales, billions of dollars in debt and more than a thousand lawsuits claiming the chain filled illegal prescriptions for opioids. In order for the company to get back on its feet, experts say it will have to start acting more like its competitors, such as Walgreens and CVS, by leaning more into care delivery, forging strong payer partnerships, and improving its digital offerings.”

Monday Roundup

David Ermer–Congress, COVID-19, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republicans’ speaker nominee Rep. Jim Jordan (R., Ohio) won over some pivotal holdouts Monday as broader GOP opposition to his bid appeared to crumble, moving him closer to winning the gavel in a floor vote as soon as Tuesday afternoon.
    • “I feel real good about the momentum we have. It’s real close,” Jordan told reporters, citing recent endorsements and saying he was ready to move forward on Tuesday at noon. “We’re going to elect a speaker tomorrow; that’s what I think is going to happen.”
  • The U.S. Office of Personnel Management announced,
    • “[T]he Biden Administration has exceeded its goal of selecting 5,800 targeted positions helping implement the Bipartisan Infrastructure Law (BIL), a once-in-a-generation investment in America’s infrastructure and competitiveness. Over the last two years, OPM has served as a strategic workforce partner for seven federal agencies and supported surge hiring for key positions, including engineers, scientists, project managers, IT & HR specialists, construction managers, and many more. 
    • “The agencies included in targeted hiring positions are the Department of Agriculture, Department of Commerce, Department of Energy, Department of Homeland Security, Department of the Interior, Department of Transportation, and the Environmental Protection Agency.”
  • Govexec introduces us to the Partnership for Public Service’s Service to America Medal winners. Mazaal tov to the winners.
  • Thompson Reuters points out that last week, the Internal Revenue Service “released the final versions of the following 2023 Affordable Care Act (ACA) forms:
    • “(1) Form 1094-B, Transmittal of Health Coverage Information Returns;
    • “(2) Form 1094-C, Transmittal of Employer-Provided Health Insurance Offer and Coverage Information Returns;
    • “(3) Form 1095-B, Health Coverage; and
    • “(4) Form 1095-C, Employer-Provided Health Insurance Offer and Coverage.
    • The forms do not contain substantive changes.”

From the public health front,

  • The New York Times reports,
    • “A team of scientists is proposing a new explanation for some cases of long Covid, based on their findings that serotonin levels were lower in people with the complex condition.
    • “In their study, published on Monday in the journal Cell, researchers at the University of Pennsylvania suggest that serotonin reduction is triggered by remnants of the virus lingering in the gut. Depleted serotonin could especially explain memory problems and some neurological and cognitive symptoms of long Covid, they say.
    • “This is one of several new studies documenting distinct biological changes in the bodies of people with long Covid — offering important discoveries for a condition that takes many forms and often does not register on standard diagnostic tools like X-rays.
    • “The research could point the way toward possible treatments, including medications that boost serotonin. And the authors said the biological pathway that their research outlines could unite many of the major theories of what causes long Covid: lingering remnants of the virus, inflammation, increased blood clotting and dysfunction of the autonomic nervous system.
    • “All these different hypotheses might be connected through the serotonin pathway,” said Christoph Thaiss, a lead author of the study and an assistant professor of microbiology at the Perelman School of Medicine at the University of Pennsylvania.
    • “Second of all, even if not everybody experiences difficulties in the serotonin pathway, at least a subset might respond to therapies that activate this pathway,” he said.”
  • Last Friday, the Department of Health and Human Services announced,
    • “[T]he selection of initial next-generation vaccine candidates and more than $500 million in awards for Project NextGen – kick-starting planning for Phase 2b clinical trials and technologies that advance innovative next-generation vaccine and therapeutics platforms.
    • “The Biden-Harris Administration is committed to keeping people safe from COVID-19,” said HHS Secretary Xavier Becerra. “By investing in next-generation vaccines and treatments, we can improve our ability to respond to new variants, reduce transmission, stop infections, and save lives. Through Project NextGen, we are combining research and development expertise at HHS with the lessons learned throughout the pandemic to protect our nation from COVID-19.” 
    • “The over $500 million announced today builds on the over $1.4 billion awarded in August – accelerating products toward clinical trials and potential commercial availability.”
    • “The vaccine selections and funding announced today are important steps forward for Project NextGen – with vaccine and therapeutics candidates moving quickly to clinical trials that will start in the coming months,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “The technologies that BARDA is investing in, from intranasal vaccines to self-amplifying mRNA, will bolster our protection against COVID-19 for years to come.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us that UnitedHealth Group executives and the FEHBlog are of one mind.
    • “UnitedHealth Group wants to lower the price of GLP-1 drugs such as Ozempic and Wegovy, but it needs drug manufacturers to get on board, executives said. 
    • “On an Oct. 13 call with investors, UnitedHealth Group CEO Andrew Witty said prices have to come down for more people to access the drugs. 
    • “We’re very positive about the potential for another tool in the toolbox to help folks manage their weight,” Mr. Witty said. “We recognize that has potential benefits, but we’re struggling, and frankly our clients are struggling, with the list prices which have been demanded of these products in the U.S., which are running at about 10 times the level of prices paid in Western Europe.” 
  • Per Biopharma Dive,
    • “Novo Nordisk said Monday it will spend up to $1.3 billion to buy an experimental hypertension drug from Singapore-based KBP Biosciences, adding to a string of acquisitions that builds out its metabolic disease business behind the blockbuster diabetes drug Ozempic.
    • “The pill, called ocedurenone, is in a Phase 3 trial in people with chronic kidney disease and uncontrolled high blood pressure. Results are due next year, and Novo said it plans to begin additional Phase 3 trials in other cardiovascular and kidney disease indications.
    • “Novo is putting its profits from accelerating Ozempic sales to work, having cut late-summer deals to buy a Danish metabolic startup called Embark Biotech and a Canadian metabolic company called Iversago. That followed on the billion-dollar-plus deals to buy rare disease drug developer Forma Therapeutics in 2022 and genetic medicine company Dicerna in 2021.”
  • Fierce Healthcare tells us why Amazon’s chief medical officer believes Amazon can make a big impact in tackling chronic illness.