Weekend update

FDA

Weekend update

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • The Medicare open enrollment period began today. It ends on December 7, 2023.

From the public health and research front,

  • Fortune Well informs us
    • The medicine in the diabetes drug Mounjaro [the Godzilla of GLP-1 drugs] helped people with obesity or who are overweight lose at least a quarter of their body weight, or about 60 pounds on average when combined with intensive diet and exercise, a new study shows.
    • By comparison, a group of people who also dieted and exercised but then received dummy shots lost weight initially but then regained some, researchers reported Sunday in the journal Nature Medicine.
    • “This study says that if you lose weight before you start the drug, you can then add a lot more weight loss after,” said Dr. Thomas Wadden, a University of Pennsylvania obesity researcher and psychology professor who led the study.
    • The results, which were also presented Sunday at a medical conference, confirm that the drug made by Eli Lilly & Co. has the potential to be one of the most powerful medical treatments for obesity to date, outside experts said.
  • The FDA has approved Mounjaro as a diabetes treatment but not a weight loss treatment yet.
  • The New York Times tells us,
    • “An Oxford University researcher and her team showed that digital wearable devices can track the progression of Parkinson’s disease in an individual more effectively than human clinical observation can, according to a newly published paper.
    • “By tracking more than 100 metrics picked up by the devices, researchers were able to discern subtle changes in the movements of subjects with Parkinson’s, a neurodegenerative disease that afflicts 10 million people worldwide.
    • “The lead researcher emphasized that the latest findings were not a treatment for Parkinson’s. Rather, they are a means of helping scientists gauge whether novel drugs and other therapies for Parkinson’s are slowing the progression of the disease.”
  • The Washington Post interviews “physician Rosanne Leipzig, vice chair for education at the Brookdale Department of Geriatrics and Palliative Medicine at the Icahn School of Medicine at Mount Sinai in New York.” Dr. Leipzig is the author of “Honest Aging: An Insider’s Guide to the Second Half of Life.” The reporter described the book as “the most comprehensive examination of what to expect in later life I’ve come across in a dozen years covering aging.”
  • The Washington Post also reports,
    • “The United States faces a “bloody transfusion problem” that is fueling preventable deaths and putting national security at risk, three military and civilian physicians write in a JAMA opinion essay.
    • “The JAMA op-ed, published Oct. 12, highlights blood transfusions’ importance in emergency care. Emergency transfusions can decrease deaths, especially when given early, the physicians write. But not enough healthcare facilities and emergency vehicles are equipped for the procedures, they add, which presents a “substantial risk to our nation’s security infrastructure.”
    • “One reason is the national blood supply, which the writers call “tenuous” because of its reliance on volunteers, as well as problems with blood storage and the places where blood is collected and processed.
    • “The physicians cite a 2020 Health and Human Services report that characterized the national blood supply system as “struggling.” That report said blood availability is hindered by issues with donor recruitment, an aging donor population and problems funding collection centers.”

From the U.S. healthcare business front,

  • MedTech Dive points out,
    • “Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales.”Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales.
    • “The company plans to sell the Dexcom G7 CGM at launch and is looking to offer additional CGM systems from other manufacturers, according to the company.
    • “Customers who want to buy a CGM will be routed to the virtual care platform Wheel, where clinicians will determine a patient’s eligibility and write a prescription. Pharmacy tech provider HealthDyne will receive and process prescriptions, and consumers can then purchase the CGMs on Best Buy’s website for home delivery.”
  • BioPharma Dive notes,
    • “Pfizer said on Friday afternoon it plans to cut billions of dollars in spending and lay off staff as it adjusts to lower demand for its COVID-19 drug Paxlovid and vaccine Comirnaty. 
    • “The pharmaceutical company is also significantly revising down its revenue forecast to between $58 billion and $61 billion for the year, a $9 billion cut from its previously issued guidance. 
    • “The bulk of that adjustment is due to the return by the U.S. governmentof nearly 8 million treatment courses of Paxlovid labeled under the drug’s emergency clearance. Distribution of that product will be stopped in November as Pfizer shifts to selling Paxlovid commercially, which it now expects to begin on a wide scale in January. The antiviral treatment won full U.S. approval in May.”

Friday Factoids

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

    From Washington DC

    • The Wall Street Journal reports,
      • “House Republicans chose Rep. Jim Jordan (R., Ohio) as their nominee for speaker, but it remained uncertain whether the fiery ally of former President Donald Trump could avoid the fate of Steve Scalise (R., La.), who also won an internal ballot but then failed to win enough broad party support to claim the gavel. * * *
      • “House Republicans will now break for the weekend with a plan to bring a vote on elevating Jordan to the speakership once they get back, giving him a few days to win over his critics.
      • “I think I can unite the conference,” Jordan said, with supporters pointing to his popularity among grass-roots Republicans.”
    • Govexec informs us,
      • “A bipartisan pair of senators on Thursday proposed legislation that would codify federal employees’ use of remote work in federal law, as well as establish stronger reporting and training requirements for telework and authorize the noncompetitive hiring of military and law enforcement spouses into remote work positions.
      • “The Telework Reform Act (S. 3015), introduced by Sens. James Lankford, R-Okla., and Kyrsten Sinema, I-Ariz., codifies the Office of Personnel Management’s administratively determined definitions of telework and remote work—including the requirement that teleworkers commute to their traditional worksite at least twice per pay period—and institutes a barrage of new reporting requirements for agencies.”
    • The Department of Health and Human Services tells us,
      • “HHS and Pfizer have reached an agreement that extends patient access to Paxlovid, maximizes taxpayer investment, and begins Paxlovid’s transition to the commercial market in November 2023. This agreement builds on HHS and Pfizer’s strong partnership over the last three years that enabled the development, manufacture, and distribution of COVID-19 vaccines and therapeutics at a record pace.
      • “HHS has consistently expressed a shared interest in jointly transitioning Paxlovid to the commercial market while ensuring that the United States taxpayer continues to receive fair and reasonable benefit from the HHS procurement of this product, with a focus on ensuring affordable access for beneficiaries in public programs like Medicare and Medicaid as well as for those who are uninsured. Per the agreement announced today, HHS and Pfizer will begin preparations for Pfizer to transition Paxlovid to the commercial market in November 2023.”
    • NBC News adds
      • “A consensus has emerged among experts who study and treat long Covid: Paxlovid seems to reduce the risk of lingering symptoms among those eligible to take it.
      • “The idea is intuitive, experts say. Paxlovid prevents the coronavirus from replicating, so researchers think it may also reduce the risk of an infection causing inflammation or organ damage, which in turn can lead to chronic illness.
      • “Clinical observations and a large study published in March support that theory. Among the 282,000 people in the study who were eligible for Paxlovid, the drug was associated with a 26% lower risk of long Covid. 
      • “Research definitely backs up that it helps prevent lingering symptoms — it helps prevent long Covid,” said Ashley Drapeau, director of the Long Covid Clinic at the GW Center for Integrative Medicine.”
    • In preparation for the beginning of the Medicare Open Enrollment period on October 15, 2023, the Centers for Medicare and Medicaid Services “released the 2024 Star Ratings for Medicare Advantage (Medicare Part C) and Medicare Part D to help people with Medicare compare health and prescription drug plans * * *.
    • Fierce Healthcare adds,
      • “Approximately 42% of Medicare Advantage plans that offer prescription drug coverage will have a star rating of four or more in 2024, marking yet another substantial decrease from 51% in 2023 and 68% in 2022.”

    In FEHB open season news,

    • The Federal Times offers advice on how to prepare for making Open Season decisions. Surprisingly, the report does not suggest comparing summaries of benefits and coverage which are a product of the Affordable Care Act.
    • Federal News Network provides a helpful interview with John Hatton, a knowledgeable NARFE executive.

    From the public health service front,

    • The New York Times reports,
      • “Over the last several decades, the rates of new cases of lung cancer have fallen in the United States. There were roughly 65 new cases of lung cancer for every 100,000 people in 1992. By 2019, that number had dropped to about 42.
      • “But for all that progress, a disparity is emerging: Women between the ages of 35 and 54 are being diagnosed with lung cancer at higher rates than men in that same age group, according to a report published Thursday by researchers at the American Cancer Society. The disparity is small — one or two more cases among every 100,000 women in that age range than among men — but it is significant enough that researchers want to know more.
      • “The report adds to a mounting body of evidence that emphasizes the lung cancer risks for women in particular.
    • BioPharma Dive points out,
      • “The Food and Drug Administration on Friday approved Pfizer’s Velsipity to treat ulcerative colitis, making it the second pill of its type cleared for use in inflammatory bowel disease, the company said. Velsipity enters a market with several oral and injectable drugs which block the immune response that causes the disease, including one in its class, Bristol Myers Squibb’s Zeposia.
      • “Pfizer acquired the medicine through its $6.7 billion buyout of Arena Pharmaceuticals in 2021. The big drugmaker hopes Velisipity, which slows the entry of white blood cells into the bloodstream, can also work in other immune-related conditions like Crohn’s disease, alopecia areata and eczema.
      • “Pfizer expects to add $25 billion in revenue by 2030 from new products acquired through biotech buyouts and licensings. The additional revenue will help cushion the company against revenue declines from its COVID-19 products as well as loss of patent protection for older drugs.”
    • Per Fierce Healthcare,
      • “The Centers for Medicare & Medicaid Services has decided to remove the national coverage determination (NCD) that limits patients’ ability to qualify for new drugs, giving people with Alzheimer’s symptoms a better path to treating the condition.
      • “The policy means that amyloid PET scans will no longer be limited and will give patients a better chance of being prescribed a drug like Leqembi or Eisai, which clears beta amyloid proteins from the brain to slow the advances of Alzheimer’s.”
    • The National Institutes of Health announced,
      • Reducing overall calorie intake may rejuvenate your muscles and activate biological pathways important for good health, according to researchers at the National Institutes of Health and their colleagues. Decreasing calories without depriving the body of essential vitamins and minerals, known as calorie restriction, has long been known to delay the progression of age-related diseases in animal models. This new study, published in Aging Cell, suggests the same biological mechanisms may also apply to humans.
      • “Researchers analyzed data from participants in the Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy (CALERIE), a study supported by the National Institute on Aging (NIA) that examined whether moderate calorie restriction conveys the same health benefits seen in animal studies. They found that during a two-year span, the goal for participants was to reduce their daily caloric intake by 25%, but the highest the group was able to reach was a 12% reduction. Even so, this slight reduction in calories was enough to activate most of the biological pathways that are important in healthy aging.
      • “A 12% reduction in calorie intake is very modest,” said corresponding author and NIA Scientific Director Luigi Ferrucci, M.D., Ph.D. “This kind of small reduction in calorie intake is doable and may make a big difference in your health.”
    • Health IT Analytics notes,
      • The American Health Information Management Association (AHIMA) announced its Data for Better Health initiative, which aims to revolutionize healthcare through the use of social determinants of health (SDOH) data, this week at the organization’s annual conference, AHIMA23.”

    From the U.S. healthcare business front,

    • Mercer Consulting calls our attention to the “Top 10 health, leave benefit compliance and policy issues in 2024.”
    • Per Healthcare Dive,
      • “UnitedHealth Group reported third-quarter earnings on Friday that beat Wall Street expectations as the payer posted a lower-than-feared medical loss ratio. The insurer’s stabilizing medical costs followed an unexpected surge in outpatient utilization for seniors earlier this year that spooked investors.
      • “The payer’s MLR — the share of premiums spent on healthcare costs — was 82.3%. Medical costs were up compared to 81.6% last year but lower than 83.2% in the second quarter. UnitedHealth expects its medical costs to rise in the fourth quarter as patients weather seasonal illnesses and other factors, said UnitedHealth CFO John Rex on a Friday earnings call.
      • “UnitedHealth raised its 2023 adjusted net earnings per share outlook by about 1% to $24.85 to $25, up from its prior projections of $24.70 to $25. The insurer reported $8.5 billion of profit on revenue of $92.4 billion for the third quarter.”
    • The Wall Street Journal reports,
      • “Health system Kaiser Permanente reached a tentative agreement with unions that would raise wages and increase investment in staffing.
      • “The deal, which the sides announced Friday, would increase wages by 21% over four years, the unions and employer said. Now, it must be ratified by the workers before terms take effect.
      • “If the workers go along, the agreement would end a dispute that led to the largest healthcare labor action on record and prevent a second work stoppage at one of the biggest health systems in the U.S.”

    Midweek Update

    David Ermer–Congress, FDA, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
    Photo by Manasvita S on Unsplash

    From Washington, DC

    • Roll Call reports
      • “House Majority Leader Steve Scalise’s bid for speaker was on shaky ground Wednesday as Republicans went back behind closed doors to figure out next steps even after selecting the Louisianan as their nominee during a morning conference meeting.
      • “Several conservatives said they won’t support Scalise on the floor, even as his top rival for the job, Judiciary Chairman Jim Jordan, R-Ohio, is supporting him and encouraging others to do so. Instead of kicking off the formal nominating speeches and votes on the floor Wednesday after coming into session at 3 p.m., Speaker Pro Tempore Patrick T. McHenry recessed the chamber.” * * *
      • “The House adjourned for the night before 7 p.m. An advisory from House Democrats said votes were “possible” Thursday, and the chamber is scheduled to gavel back into session at noon.”
    • On September 18, 2023, the Senate Health Education Labor and Pensions Committee will hold a hearing on the nomination of Dr. Monica Bertagnolli to be Director of the National Institutes of Health.
    • Govexec tells us,
      • “The Biden administration on Wednesday released a new requirement for agencies throughout government to think more carefully about expanding competition through their regulatory actions. 
      • “President Biden has targeted antitrust trends in the economy as a key part of his domestic agenda and the White House said the new guidance will help enforce those efforts through an “all-of-government approach to competition.” The Office of Information and Regulatory Affairs document creates frameworks for agencies as they develop and analyze potential regulatory actions. 
      • “OIRA noted that agencies can shape markets through their regulations and urged them to draft those rules to enhance competition.” 
    • Federal New Network explores the role of Janice Underwood, the first-ever governmentwide chief diversity officer and a senior leader at the Office of Personnel Management.

    From the public health and research front,

    • KFF informs us,
      • “Sepsis, the body’s extreme response to an infection, affects 1.7 million adults in the United States annually. It stems from fungal, viral, or bacterial infections, similar to what struck Madonna this year, although the singer never said whether she was diagnosed with sepsis. Treatment delays of even a few hours can undermine a patient’s chance of survival. Yet sepsis can be difficult to diagnose because some patients don’t present with common symptoms like fever, rapid heart rate, or confusion.
      • “A Biden administration rule, finalized in August, ups the ante for hospitals, setting specific treatment metrics that must be met for all patients with suspected sepsis, which could help save some of the 350,000 adults who die of infections annually. Children, too, are affected, with some estimates that 75,000 are treated each year for sepsis, and up to 20% of them die. Hospitals that fail to meet the requirements risk losing potentially millions in Medicare reimbursement for the year.
      • “Still, because the rule applies broadly, it has triggered pushback for its lack of flexibility.
      • “Efforts to reduce sepsis deaths are welcome, but “where it gets controversial becomes ‘Is this the best way to do it?’” said Chanu Rhee, an infectious disease physician and associate professor of population medicine at Harvard Medical School.”
    • Reuters reports,
      • “Novo Nordisk (NOVOb.CO) said on Tuesday it will stop a trial studying Ozempic to treat kidney failure in diabetes patients ahead of schedule because it was clear from an interim analysis that the treatment would succeed.
      • “Novo said the trial would be halted almost a year early based on a recommendation from the independent data monitoring board overseeing the study. Independent monitors can recommend stopping a trial early if there is clear evidence that a drug is going to succeed or fail based on interim analyses. * * *
      • “The Danish drugmaker said the trial was testing whether the widely used diabetes drug, which contains the active ingredient semaglutide, could delay the progression of chronic kidney disease and lower the risk of death from kidney and heart problems.
      • “Semaglutide is also the active ingredient in Novo Nordisk’s powerful weight-loss drug Wegovy.
      • “Barclays analyst Emily Field said in a note that the company’s decision affirmed the view that GLP-1 receptor agonists like Ozempic have “therapeutic benefits far beyond their original intended purpose.”
      • FEHBlog note — Why then doesn’t Novo Nordisk lower the price of this apparent cure-all?
    • Medscape adds,
      • “People taking semaglutide or liraglutide for weight management are at a higher risk for rare but potentially serious gastrointestinal issues, compared with those taking naltrexone/bupropion, according to a large epidemiologic study.
      • “Patients” taking either of these glucagon-like peptide-1 (GLP-1) receptor agonists had nine times an elevated risk for pancreatitis. They were also four times more likely to develop bowel obstruction and over 3.5 times more likely to experience gastroparesis.
      • “The research letter was published online today in the Journal of the American Medical Association.
      • “Investigators say their findings are not about scaring people off the weight loss drugs, but instead about increasing awareness that these potential adverse outcomes can happen.
      • “* * * People taking a GLP-1 agonist to treat diabetes might be more willing to accept the risks, given their potential advantages, especially for lowering the risk for heart problems, said Mahyar Etminan, PharmD, MSc, the study’s senior author and an expert in drug safety and pharmacoepidemiology at UBC. “But those who are otherwise healthy and just taking them for weight loss might want to be more careful in weighing the risk–benefit equation.”
      • “People taking these drugs for weight loss have an approximately 1%–2% chance of experiencing these events, including a 1% risk for gastroparesis, Etminan said.”
    • The Brown & Brown consulting firm offers a four-step plan for employer action to “focus on their benefits, helping to enable employees with easy access to preventive care, early detection, navigation and support specific to breast cancer.
    • The New York Times points out,
      • “The Food and Drug Administration issued an alert on Tuesday about the dangers of treating psychiatric disorders with compounded versions of ketamine, a powerful anesthetic that has become increasingly popular among those seeking alternative therapies for depression, anxiety, post-traumatic stress disorder and other difficult-to-treat mental health problems.”
    • and
      • “A new AI tool diagnoses brain tumors on the operating table;
      • “A new study describes a method for faster and more precise diagnoses, which can help surgeons decide how aggressively to operate.”

    From the U.S. healthcare business front,

    • The VTDigger lets us know that following regulatory approval, “Blue Cross Blue Shield of Vermont can now move forward with an agreement that will make the Berlin-based nonprofit a subsidiary of the much larger Blue Cross Blue Shield of Michigan.”
    • Per Fierce Healthcare
      • “Des Moines, Iowa-based UnityPoint Health and Albuquerque, New Mexico-based Presbyterian Healthcare Services are no longer working toward a merger, the systems announced Wednesday.”
    • and
      • A new analysis finds that more pharmacists are electronically prescribing medications as they assist in managing chronic disease, which offers a peek at the next evolution in primary care.
      • * * * Lynne Nowak, M.D., Surescripts’ first chief data and analytics officer, told Fierce Healthcare in an interview at HLTH that the findings highlight the potential pharmacists and other clinicians have in addressing those access gaps.
      • “We’re not saying that pharmacists should be doing the job of a physician,” Nowak said. “They’re not trying to replace them, but just looking at this broader view of a care team and ensuring they’re all connected.”
    • STAT News reports,
      • “Bruce Broussard, CEO of health insurance giant Humana, will step down next year after leading the company for more than a decade.
      • “Humana named Jim Rechtin — who is the CEO of Envision Healthcare, the controversial physician staffing firm that is working its way through bankruptcy — as Broussard’s replacement. Rechtin will serve as president and chief operating officer starting Jan. 8 and then take over as CEO in the “latter half of 2024,” the company said in a news release.”
    • Per Healthcare Dive,
      • “Walgreens has named former Cigna executive Tim Wentworth as its new chief executive officer, the retail pharmacy company announced late Tuesday.
      • “Wentworth is replacing Roz Brewer a little over a month after she announced her unexpected departure from Walgreens.
      • “Wentworth, who will become Walgreens CEO effective Oct. 23, is the former CEO of Express Scripts, the pharmacy benefit manager acquired by Cigna in 2018. At Cigna, he led the health services business Evernorth.”
    • and
      • “CVS Health wants to create a “super app” connecting multiple omnichannel modalities of the healthcare experience, including benefits, delivery and retail channels, chief medical officer Sree Chaguturu said Tuesday at the HLTH conference in Las Vegas.
      • “A super app is a widely adopted mobile or web application that combines multiple services in one platform. Super apps are ubiquitous in Asia, but haven’t taken off in the U.S. due to a fragmented app market, concerns about advertising revenue, the country’s payment system structure and a strict regulatory environment, according to the Harvard Business Review.”
    • The WTW consulting firm offers an infographic displaying the results of their employer survey of Best Practices in Healthcare.

    Monday Roundup

    David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Mental health care, U.S. Healthcare–
    Photo by Sven Read on Unsplash

    From Washington, DC

    • The New York Times reports,
      • “After days of warnings, [Rep. Matt] Gaetz [(R FL)] rose Monday evening [on the floor of the House of Representatives] to bring up a resolution declaring the speakership vacant. That started a process that would force a vote within days on whether to keep Mr. McCarthy in his post. * * *
      • “Under House rules, Mr. McCarthy and his leadership team will need to address the motion within two legislative days — though they could do so sooner.”
    • Roll Call adds,
      • “The Senate will adjourn earlier than planned this week, with no session on Thursday, to allow members to travel to California and pay their respects to the late Sen. Dianne Feinstein. * * *
      • “On Sunday, California Gov. Gavin Newsom appointed Laphonza Butler to fill the remainder of Feinstein’s term. Butler recently led the abortion rights campaign group EMILY’s List and spent 20 years as president of SEIU Local 2015, a home care workers union in California.
      • “Butler will serve until a replacement is elected in a still-unscheduled special election. Three House Democrats — Barbara Lee, Katie Porter and Adam B. Schiff — are running in the March primary for the full, six-year term and can also run in the special election.
      • “Butler is scheduled to be sworn in by Harris on Tuesday. She will become the first openly gay Black woman to serve in the Senate.”
    • Last Thursday, U.S. District Judge John Bates vacated a Trump-era Affordable Care Act rule permitting health plans, including FEHB plans, to use copay assistance accumulators. These accumulators prevent manufacturer assistance used to pay cost-sharing for expensive drugs from counting towards out-of-pocket maximums. While that outcome seems reasonable to the FEHBlog, Judge Bates takes the opposite view in his opinion. The federal government, which is the defendant in the case, has the right to appeal this final judgment.
    • The Institute for Clinical and Economic Research published a “Special Report on Eliquis and Xarelto Submitted to CMS as Part of Public Comment Process on Medicare Drug Price Negotiations.” The report “evaluate[es] the evidence on apixaban (Eliquis®, Bristol-Myers Squibb) and rivaroxaban (Xarelto®, Bayer) for the treatment of nonvalvular atrial fibrillation (NVAF).”
    • BioPharma Dive identifies five Food and Drug Administration to watch for in the fourth quarter of 2023. “By the end of the year, the regulator will decide on new genetic treatments for sickle cell, expanded use of Alnylam’s Onpattro and an inflammatory disease drug from Pfizer.”

    From the public health front,

    • MedPage Today informs us
      • “Maternal COVID vaccination in pregnancy protected young infants against Omicron-associated hospitalization, but few women actually receive the vaccine during pregnancy, according to new data from the CDC.
      • “At least one maternal vaccine dose had an effectiveness of 54% (95% CI 32-68) against COVID-related hospitalization among infants younger than 3 months of age, and an effectiveness of 35% (95% CI 15-51) for infants younger than 6 months, reported researchers led by Regina Simeone, Ph.D., of CDC’s National Center for Immunization and Respiratory Diseases in Atlanta, in the Morbidity and Mortality Weekly Report. * * *
      • “Looking at the COVID shot specifically, women were nine times more likely to receive a bivalent booster if a provider recommended it (63.2% vs 6.8% when a provider did not).”
    • The American Medical Association offers “What doctors wish patients knew about managing anxiety disorders.”
    • STAT News points out,
      • “In a guidance document published Monday in the Federal Register, the CDC is seeking input on its proposal that health providers offer gay and bisexual men who have sex with men, as well as transgendered women, access to a common antibiotic, doxycycline, that they could take after having had unprotected sex to lower their risk of acquiring chlamydia, gonorrhea, or syphilis. Doxycycline is in the tetracycline family of antibiotics.
      • “Studies have show the so-called “doxy PEP” regime — a single, 200-milligram dose taken no later than 72 hours after unprotected sex — can reduce acquisition of chlamydia and syphilis by nearly 80%, and gonorrhea by about 50%. PEP is short for post-exposure prophylaxis.
      • “Doxy PEP is moving STI prevention efforts into the 21st century,” Jonathan Mermin, director of CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, said in a statement. “We need game-changing innovations to turn the STI epidemic around, and this is a major step in the right direction.”

    From the awards front,

    • The Wall Street Journal reports
      • “Katalin Karikó and Drew Weissman won the Nobel Prize in medicine on Monday for an idea that pushed them to the fringes of the scientific establishment before it saved millions of lives during the pandemic. 
      • “Karikó, a molecular biologist, and Weissman, an immunologist, realized during a chance encounter at a University of Pennsylvania a photocopy machine in the 1990s that they could combine their work exploring messenger RNA’s potential in drugs or vaccines. 
      • “Their collaboration was met with skepticism by their colleagues and indifference in the scientific community. Karikó struggled to secure funding for her work. Penn demoted her and sent her to work in an office on the outskirts of campus. 
      • “People wondered, ‘What the hell is wrong with her,’ there must be some reason she’s not on the faculty,” Karikó has said.
      • “Years later, as drugmakers raced to develop vaccines against COVID-19, it was mRNA technology that powered widely used shots from Pfizer–BioNTech and Moderna. The Nobel committee credited Karikó’s and Weissman’s work with saving millions of lives.
      • “The laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times,” the committee said in awarding Karikó, 68, and Weissman, 64, the annual prize in physiology or medicine. Karikó is the 13th woman among 227 people to win the prize.”
      • Bravo.
    • Fierce Healthcare announced its Fierce 50.
      • “The Fierce 50 goes beyond surface-level accolades to delve deep into the monumental impact 50 exceptional individuals and organizations have on the lives of patients. It shines a spotlight on the visionaries and trailblazers who have pioneered groundbreaking therapies, overhauled patient care models, and spearheaded innovative approaches to address the most pressing challenges in biopharma and healthcare.”

    From the U.S. healthcare business front,

    • Beckers Hospital CFO Report tells us,
      • “Hospital margins are moving in the right direction, as the median year-to-date operating margin improved in August to 1.1 percent, according to Kaufman Hall. 
      • “August’s median of 1.1 percent marked an upswing from the 0.9 percent median margin recorded in July, according to Kaufman Hall’s latest “National Hospital Flash Report” — based on data from more than 1,300 hospitals.
      • “Increased revenue offset hospitals’ increased supply and drug expenses in August. Decreased reliance on contract labor helped labor expenses decline on a volume-adjusted basis, while average lengths of stay also fell, by 4 percent month over month.”

    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.”

    Midweek update

    David Ermer–CDC, Congress, COVID-19 testing, FDA, Generative AI, Medical / Rx research, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–
    Photo by Manasvita S on Unsplash

    From Washington, DC

    • Roll Call informs us
      • House Republicans appeared to be moving closer to an agreement Wednesday on an opening bid for stopgap funding legislation that would keep the lights on at federal agencies beyond Sept. 30 and pave the way for their chamber to take up its full-year appropriations bills.
      • At least a handful of conservative holdouts still maintained their opposition as of Wednesday night, which would be enough to sink a revised bill unless GOP leaders are able to change some minds in the next few days. Speaker Kevin McCarthy, R-Calif., is expected to keep the chamber in session on Saturday if necessary.
      • Even if GOP leaders’ new effort is successful, however, it was starting to look more like a bid to reopen the government after a brief shutdown, given the deadline is 10 days away and the Senate is likely to ping-pong a much different bill back to the House.
    • The FEHBlog notes that it would not be unusual for Congress to pass a brief continuing resolution next week to allow for the passage of a longer continuing resolution, thereby side stepping the partial government shutdown.
    • Fierce Healthcare offers details on the House Ways and Means Committee’s No Surprises Act hearing, while Healthcare Dive shares details on the House Oversight and Accountability’s PBM reform hearing. Both hearings were held yesterday.
    • Speaking of the No Surprises Act, the ACA regulators released a proposed rule increasing the government’s NSA arbitration fee from $50 per party to $150 per party next year. The FEHBlog has no idea why the government doesn’t ladder the fee based on the amount in dispute. The government also increased the maximum fee independent dispute resolution entities can charge the parties.
    • MedCity News informs us
      • “FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class 
      • “FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.”
    • and
      • “FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine 
      • “ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.”

    From the public health and medical research fronts,

    • STAT News reports,
      • “The federal government is again offering free Covid-19 tests to Americans, providing a fifth round of free tests in part to meet current needs and in part to stimulate a domestic testing industry that has struggled with cratering demand for rapid diagnostics.
      • “The measure, announced Wednesday, will see rapid tests released from the Strategic National Stockpile. In addition, 12 domestic test manufacturers will receive investments totaling $600 million to help “warm-base” the U.S. capacity for rapid test production, both for Covid and future disease threats. * * *
      • “Households will be entitled to receive four free rapid tests apiece, with ordering at COVIDtests.gov opening on Sept. 25. O’Connell said test shipments are expected to start on Oct. 2.”
    • The FEHBlog thinks that the government is fighting the last pandemic. Why not incent the production of the FDA-approved (last February) at-home tests for Covid or the flu, not just Covid?
    • In any event, the Wall Street Journal points out
      • “Don’t throw out that seemingly outdated at-home rapid Covid-19 test just yet. It may still be good. 
      • “The Food and Drug Administration has been extending expiration dates for some authorized at-home, over-the-counter Covid test kits, meaning some unused tests may still be viable. The agency’s updated list of expiration dates may be useful to those reaching for their stash of Covid-19 tests amid new variants and a recent bump in cases and hospitalizations.”
    • The National Institutes of Health announced,
      • “A trial of a preventive HIV vaccine candidate has begun enrollment in the United States and South Africa. The Phase 1 trial will evaluate a novel vaccine known as VIR-1388 for its safety and ability to induce an HIV-specific immune response in people. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has provided scientific and financial support throughout the lifecycle of this HIV vaccine concept and is contributing funding for this study.”
    • Per NBC News,
      • “Is morning the best time of day to exercise? Research published Tuesday in the journal Obesity finds that early morning activity — between 7 a.m. and 9 a.m. — could help with weight loss. 
      • “My cautious suggestion from this study is that if we choose to exercise in the early morning before we eat, we can potentially lose more weight compared to exercise at other times of the day,” said lead researcher Tongyu Ma, a research assistant professor at The Hong Kong Polytechnic University.”

    From the U.S. healthcare business front,

    • Healthcare Dive tells us
      • “Ochsner Health is launching a pilot program this month that will use generative artificial intelligence to draft “simple” messages to patients.
      • “About a hundred clinicians across the New Orleans-based health system will participate in the first phase of the program, where AI will prepare responses to patient questions unrelated to diagnoses or clinical judgments. The messages will be reviewed and edited by providers before being sent to patients, according to a news release. 
      • “Ochsner is part of an early adopter group of Microsoft’s Azure OpenAI Service, which integrates with the Epic electronic health record. The health system will test the messaging feature over three phases this fall, and Ochsner will collect patient feedback to improve the system.” 
    • Per Fierce Healthcare,
      • “Making sense of mountains of data continues to be an often elusive goal for most of the healthcare system, but Cambia Health Solutions said it hopes its latest effort will allow it to better corral useable information.
      • “Cambia and Abacus Insights, a data management company that tacklesthe challenge of making healthcare networks interoperable, launched a new data aggregating system that processes information for about 3.4 million members across four Blues plans. 
      • “According to an Abacus case study (PDF), “Cambia recognized that to deliver care orchestrated around the unique needs of each individual, data must be actionable. To be actionable, case study data must be understandable, usable, timely, and have clinical utility.”

    Monday Roundup

    David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Mental health care, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
    Photo by Sven Read on Unsplash

    From Washington, DC

    • Roll Call reports
      • “House Republicans unveiled a stopgap funding measure Sunday night that would avoid a partial government shutdown next month and provide border security measures sought by conservatives. But passage even in the GOP-controlled House was already in doubt as some hard-liners came out against the measure Sunday night while the ink on it was barely dry.
      • “The draft continuing resolution would extend current funding through Oct. 31, while cutting 8.1 percent from all nondefense accounts except for the Department of Veterans Affairs and disaster relief. That extension would give lawmakers an extra month to try to complete fiscal 2024 appropriations that are otherwise needed by Sept. 30. * * *
      • “The bill is set for floor consideration this week, along with the fiscal 2024 Defense spending bill that stalled last week when conservative detractors threatened to vote against the rule needed to take it up.”
    • Politico discusses where we stand with the proposed mental health parity rule changes.
      • “The Biden administration’s proposal substantially expands the law Bush signed. It would mandate that insurers analyze the outcomes of their coverage to ensure there’s equivalent access to mental health care and take action to comply if they’re falling short.
      • “Insurers respond: AHIP, the lobbying group for insurers, says the situation is more complicated than Biden makes out, and workforce shortages are behind barriers to access.
      • “For years, health insurance providers have implemented programs and strategies to expand networks and increase access,” AHIP spokesperson Kristine Grow said in a statement.
      • “The administration has set a deadline for comments on its proposed rules for early October; insurers and their allies are asking for more time to respond.
      • “The ERISA Industry Committee, which represents large employers’ benefit interests, joined AHIP, among other associations, employers and health plans, in writing to administration officials to ask that the comment period on the proposed rules be extended. They warned that the rules could create “unnecessary burdens” for providers, insurers and patients and “unintentionally” impede access to care.”
    • The Centers for Medicare and Medicaid Services (CMS) announced on its No Surprises Act website today:
      • “Federal IDR Process update: Certain functions of the Federal IDR Process are temporarily paused in response to the TMA III Court Order.  On September 5, 2023, the Departments directed certified IDR entities to resume making eligibility and conflict of interest determinations and encouraged disputing parties to continue engaging in open negotiations.  The Departments expect to direct certified IDR entities to resume issuing payment determinations for some disputes very soon.”
    • The Office of Management and Budget’s Office of Information and Regulatory Affairs has completed work on a regulation that will affect the FEHB:
      • AGENCY: HHS-CMS RIN: 0938-AT86 Status: Concluded
      • TITLE: Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061) Section 3(f)(1) Significant: No
      • STAGE: Final Rule Economically Significant: No
      • RECEIVED DATE: 03/01/2022 LEGAL DEADLINE: Statutory
      • REVIEW EXTENDED
      • COMPLETED: 09/11/2023 COMPLETED ACTION: Consistent with Change
    • The FEHBlog will be watching the Federal Register for this one.
    • CMS also “finalized a rule to streamline enrollment in the Medicare Savings Programs (MSPs), making coverage more affordable for an estimated 860,000 people.”

    From the public health and medical research fronts,

    • Per Healthcare Dive, “New RSV vaccines can be powerful tools, but rollout poses test; The recently approved shots will slot in alongside vaccines for influenza and COVID-19 this fall, raising communication challenges for public health officials.” The article dives into the details, but health plans can help communicate new vaccines’ benefits to their members with young kids and members who have reached senior citizen status.
    • NPR reports,
      • “The mixture of stimulants like cocaine and meth with highly potent synthetic opioids is a fast-growing driver of fatal overdoses in the U.S.
      • “Since 2010, overdoses involving both stimulants and fentanyl have increased 50-fold, and now account for 32% of U.S. overdoses in 2021 and nearly 35,000 deaths, according to a study published Thursday in the scientific journal Addiction.
      • “We’re now seeing that the use of fentanyl together with stimulants is rapidly becoming the dominant force in the U.S. overdose crisis,” says Joseph Friedman, the lead author of the study and a researcher at UCLA’s David Geffen School of Medicine. “Fentanyl has ushered in a polysubstance overdose crisis, meaning that people are mixing fentanyl with other drugs, like stimulants, but also countless other synthetic substances.”
    • Healio points out that based on a recent research study,
      • “Consumption of added sugar, total sugar, total glucose equivalent and fructose from added sugar and juice were linked to a higher risk for coronary heart disease.
      • “Fructose from vegetables and fruits was not.”
    • The American Medical Association informs us, “What doctors wish patients knew about social isolation.”
    • Health Day notes based on a Swedish study,
      • “Chronic acid reflux — also known as GERD — has long been thought to boost a person’s risk of esophageal cancer
      • “A new study refutes that, finding that only patients with evidence of injury to their esophagus from reflux have a higher cancer risk
      • “Researchers downplayed a “very moderate” increased risk for women, saying that it remains “extremely low.'”
    • MedPage Today calls our attention to a different Swedish study,
      • “Bariatric surgery for obesity was associated with a reduced risk of hematologic cancers in a prospective Swedish study spanning more than three decades.”
    • Per NIH,
      • “Artificial intelligence (AI) and machine learning (ML) can effectively detect and diagnose Polycystic Ovary Syndrome (PCOS), which is the most common hormone disorder among women, typically between ages 15 and 45, according to a new study by the National Institutes of Health. Researchers systematically reviewed published scientific studies that used AI/ML to analyze data to diagnose and classify PCOS and found that AI/ML based programs were able to successfully detect PCOS.
      • “Given the large burden of under- and mis-diagnosed PCOS in the community and its potentially serious outcomes, we wanted to identify the utility of AI/ML in the identification of patients that may be at risk for PCOS,” said Janet Hall, M.D., senior investigator and endocrinologist at the National Institute of Environmental Health Sciences (NIEHS), part of NIH, and a study co-author. “The effectiveness of AI and machine learning in detecting PCOS was even more impressive than we had thought.”

    From the U.S. healthcare business and quality fronts,

    • Beckers Payer Issues reports
      • The National Committee for Quality Assurance has named the best-rated health plans of 2023 based on factors that include care quality, patient satisfaction and efforts to keep improving.
      • The ratings were released Sept. 15 and are based on 2022 data from commercial, Medicare, Medicaid and ACA plans that reported HEDIS and CAHPS results to the NCQA, which cover more than 200 million people. NCQA Accreditation status was also factored in. Plans were rated on a zero- to five-star scale, with five being the highest rating. In total, 1,095 plans received a rating. No Medicaid or Medicare plan received 5-stars this year.
      • Commercial plans that received a five-star rating:
        • Independent Health Association (New York)
        • Kaiser Foundation Health Plan of the Mid-Atlantic States (Washington D.C., Maryland, Virginia)
    • Per Healthcare Dive
      • ‘Hospitals have been required to post their prices for shoppable services online since 2021, but costs shared online rarely correlate to prices hospitals share with consumers on the phone, according to a new secret shopper survey.
      • ‘The study found wide variations when comparing hospitals’ online cash prices for childbirth and brain imaging with prices told to consumers who inquire over the phone.
      • ‘For example, researchers found five hospitals with online prices greater than $20,000 for vaginal childbirth but telephone prices less than $10,000. For a brain magnetic resonance imaging scan, two hospitals said the cost was more than $5,000 over the phone, but the price tag was $2,000 online.’
      • That’s a big bowl of wrong.
    • Reuters reports,
      • “Novo Nordisk (NOVOb.CO) has hired U.S. private contract manufacturer PCI Pharma Services to handle assembly and packaging of Wegovy, a source familiar with the matter said, as it races to boost output of the weight-loss drug to meet demand.
      • “Philadelphia-based PCI, which has 15 facilities in North America, Europe and Australia, is putting together the self-injection pens used to administer Wegovy, said the source, who declined to be named because the information is confidential.”
    • mHealth Intelligence tells us
      • The percentage of asynchronous telehealth claim lines for mental health conditions increased nationwide, with a particularly sharp rise in the Midwest, where it doubled between May and June, according to new telehealth usage data.
      • The data from FAIR Health’s Monthly Telehealth Regional Tracker represents the privately insured population, including Medicare Advantage and excluding Medicare Fee-for-Service and Medicaid. The tracker, launched in May 2020, uses data from FAIR Health to provide insights into month-to-month changes in the volume of telehealth claim lines and audio-only telehealth usage.
      • Nationally, telehealth remained stable at 5.4 percent of claim lines in May and June. In three US regions, telehealth use did not change during this period, but usage fell by 2.4 percent in the Midwest.

    In general business news, HR Dive offers “A running list of states and localities that require employers to disclose pay or pay ranges.”

    Thursday Miscellany

    David Ermer–CDC, CMS, Congress, FDA, Mental health care, Rx coverage, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    From Washington, DC —

    • The American Hospital Association News tells us
      • “The House Energy and Commerce Committee today held a hearing on legislative proposals to prevent and respond to generic drug shortages. In comments submitted last month, AHA urged the committee to reject provisions in its draft legislation proposals that would limit patient access to 340B drugs and consider additional proposals that would protect the supply chain for essential medications.
      • “Witnesses at today’s hearing included representatives from Civica, the American Society for Health System Pharmacists, Healthcare Supply Chain Association, Healthcare Distribution Alliance, and Association for Accessible Medicines.”
    • STAT News adds,
      • “Although shortages are not new, the number of drugs in short supply has grown steadily for about two years. Shortages also have become more difficult to predict and are affecting drugs that are more critical.
      • “Most concerning are the shortages of cancer drugs, which until recently hadn’t been much of a problem for at least a decade. There are 15 cancer drugs currently in short supply, according to the Food and Drug Administration, though the White House this week said one of the key shortage chemotherapies, cisplatin, is nearly back to pre-shortage levels.
      • “Civica Rx members choose which drugs it brings to market. So far, the nonprofit contracts for cyclophosphamide, a chemotherapy that helps treat multiple cancers, and there’s a heightened urgency to determine whether to add more cancer drugs to the list.
      • “Given the drug shortage situation for cancer drugs, we have a working group now,” said Allan Coukell, senior vice president of public policy at Civica Rx. “We’re looking at what would a portfolio of those drugs be.”

    From the Rx coverage front,

    • Forbes reports
      • “Despite misleading headlines, such as “Sudafed, Benadryl and most decongestants don’t work,” * * * [t]here are branded products that include the names Sudafed and Benadryl that do work as nasal decongestants. These contain the active ingredient pseudoephedrine. But because the dangerous illicit substance methamphetamine can be made in illegal laboratories with pseudoephedrine these products were placed behind the counter years ago. In 2005, Congress passed the Combat Methamphetamine Epidemic Act, which requires that pharmacies and other retail stores maintain purchase logs for products that include pseudoephedrine, and it limits the amount of those products an individual can purchase per day. Pseudoephedrine-based drugs are not affected by the FDA panel’s vote. They will remain available behind the counter.”
    • Per Healthcare Dive,
      • “GoodRx has notched a third partnership with a pharmacy benefit manager to integrate its drug coupons at the point of sale, further expanding GoodRx’s access to the commercially insured PBM market.
      • “For eligible members filling a generic medication starting in 2024, the new program will compare GoodRx’s discount price with their price through insurance and apply the lowest cost. The payment will be automatically applied to consumers’ deductibles.
      • “With MedImpact and existing deals with CVS Caremark and Cigna-owned Express Scripts, GoodRx now reaches more than 60% of insured lives through the partnerships, the company said Wednesday.”
    • The Institute for Clinical and Economic Research published an evidence report for gene therapy to treat Metachromatic Leukodystrophy.
      • “Currently available evidence provides greater certainty of substantial net health benefit in pre-symptomatic MLD; evidence also suggests that individuals with early symptomatic disease benefit from treatment —
        • “Using weighted analyses across all patient subpopulations, arsa-cel would achieve common thresholds for cost-effectiveness if priced between $2.3M – $3.9M —
        • “At the September 29 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatment’s comparative clinical effectiveness, other potential benefits, and long-term value for money.”

    From the U.S. public health front,

    • Healio points out
      • Results from the American Association for Cancer Research’s annual Cancer Progress Report revealed that the age-adjusted overall cancer death rate in the U.S. fell by 33% between 1991 and 2020.
      • The report also detailed FDA approvals related to anticancer therapeutics over the past year, the impact of immunotherapy on cancer care in the 21st century and key challenges needed to overcome obstacles patients with cancer still face moving forward.
    • McKinsey notes” “Orthopedic care is among the largest categories in US healthcare; improvements could have far-reaching positive effects. We analyze care pathways to spot opportunities for better coordination.” Check it out.
    • Per Fierce Healthcare,
      • “Xylazine, a powerful veterinary tranquilizer, was detected in drug tests in 34 states from every region of the country, according to a new analysis.
      • “The analysis was conducted by national drug testing lab Millennium Health, looking at more than 160,000 de-identified urine drug test results from more than 73,000 unique patients collected between mid-April and mid-July 2023. 
      • “Xylazine, also known as “tranq,” is a sedative that prolongs and enhances the euphoric effects of illicit fentanyl. Xylazine-associated deaths are on the rise, and nearly all involve illicit fentanyl or fentanyl analogs. The Biden administration designated fentanyl combined with xylazine an emerging threat in April. “
    • and
      • “Loneliness can have major impacts on seniors’ health, worsening comorbidies and even driving mortality, according to a white paper by the Elevance Health Public Policy Institute.
      • “Loneliness in older adults increases the likelihood of depression and dementia as well as worsening outcomes for individuals with hypertension, heart disease and stroke, according to the white paper.
      • “In a survey, the researchers researchers found that:
        • About 28% of respondents had a mental health condition.
        • About 1 in 4 reported having both depression and another mental health condition.
        • Individuals with a mental health diagnosis were more likely to live alone.
        • Individuals with a mental health diagnosis cited limitations to social activities in the past month because of poor health.
      • “Elevance Health hired research and consulting company Health Management Associates to describe the characteristics of 16,000 Medicare beneficiaries with a mental health diagnosis using the 2018 Medicare Current Beneficiary Survey. Some beneficiaries were covered by traditional fee-for-service Medicare, others by Medicare Advantage (MA).”

    From the U.S. healthcare business front,

    • Healthcare Dive reports,
      • “Medical services provided in outpatient settings are notably pricier when delivered in hospital-owned departments compared with ambulatory surgery centers or physicians’ offices, according to a new analysis from a Blue Cross Blue Shield Association subsidiary.
      • “The report, based on data for 133 million Blues members found from 2017 to 2022, also found prices generally grew more rapidly at hospital outpatient departments than at non-hospital outpatient settings.
      • “Researchers said their data supports site-neutral proposals to make care costs the same regardless of where it’s provided. Momentum is building in Congress around the policies, but they face fierce opposition from hospital groups.”
    • and
      • “Out-of-network ground ambulance rides made up a larger percentage of total claim lines than in-network rides between 2018 to 2022, exposing patients to a higher risk of surprise bills, according to an analysis by Fair Health. 
      • “Out-of-network rides made up almost 64% of all ground ambulance claim lines in 2018, decreasing slightly to over 59% in 2022. 
      • “Advanced life support (ALS) services, which provide a higher level of care than basic life support (BLS), comprised a larger share of ground ambulance claims than basic life support services from 2018 to 2022 — another factor that could drive up costs, the research found. About 51% to 52% of ground ambulance claim lines were associated with ALS during the study period.”

    In Social Security and Medicare news,

    • The Detroit Free Press reports,
      • “The odds moved up, based on the latest inflation data, that Social Security benefitscould see a 3.2% cost-of-living adjustment next year. Not sky high but a bit better than average.
      • “To be sure, we’ll need to see one more month of data before the exact inflation adjustment will be known. The next round of Consumer Price Index data for September will be released by the U.S. Bureau of Labor Statistics on Oct. 12.”
    • Per CNET,
      • “Starting in 2024, Medicare Premium costs will be changing — Medicare Part B costs are expected to get more expensive, while Medicare Part D prices are projected to decrease. We’ll tell you how much below. * * *
      • “Due to a new Alzheimer’s treatment coming to the market (Leqembi, from pharmaceutical companies Eisai and Biogen), Medicare beneficiaries are expected to pick up the cost. Therefore, Medicare Part B prices are expected to increase in 2024. The costs are projected to go up from the current $164.90 to $174.80, a nearly $10 increase per month. 
      • “While you may not see a huge difference in the amount you’re paying for Medicare Part D, it still could be slightly lower. The average total monthly Part D premium is projected to decrease from $56.49 in 2023 to $55.50 in 2024, according to the Centers for Medicare & Medicaid Services (CMS). That’s nearly $1 each month.” 

    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.” 

    Tuesday Tidbits

    David Ermer–CDC, CMS, COVID-19, COVID-19 vaccine, FDA, HSA, Medical / Rx research, Rx coverage, SDOH, U.S. Healthcare–
    Photo by Patrick Fore on Unsplash

    From Washington, DC,

    • The American Hospital Association News tells us
      • “As authorized yesterday by the Food and Drug Administration and recommended by its vaccine advisory committee, the Centers for Disease Control and Prevention today recommended a single dose of the updated Moderna and Pfizer COVID-19 vaccines for Americans aged 12 and older, and one or two doses of the updated vaccines for previously vaccinated children aged six months through 4, at least two months after receipt of their last dose. The agency also recommended three doses of the updated Pfizer vaccine and two doses of the updated Moderna vaccine for unvaccinated children under age 5, as authorized by the FDA and recommended by the committee. CDC anticipates the updated vaccines will be available later this week.
      • “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “We very much encourage those who are eligible to consider getting vaccinated.”
    • and
      • The Food and Drug Administration’s independent Nonprescription Drugs Advisory Committee Sept. 12, by unanimous vote, declared oral phenylephrine ineffective as a decongestant. Phenylephrine is a common active ingredient in over-the-counter medications sold under the Nyquil, Tylenol, Advil, Robitussin, Sudafed and Benadryl brands, to name a few. FDA is not bound to the committee’s recommendations, but the agency’s own analysis presented prior to the panel’s meeting concluded that oral phenylephrine formulations are safe but ineffective at standard or even higher doses. The vote paves the way for products containing oral phenylephrine potentially being pulled from shelves until reformulated versions are offered.
    • FEHBlog observation — The class action lawyers should be revving up the old turbobiller.
    • The U.S. Census Bureau announced
      • “The percentage of working-age adults ages 19 to 64 with health insurance coverage increased from 2021 to 2022, primarily driven by an increase in employment-based coverage. This resulted in uninsured rates dropping from 11.6% to 10.8% according to U.S. Census Bureau data released today [September 12]. 
      • “The Health Insurance Coverage in the United States: 2022 report shows that the share of working-age adults with coverage rose across many race and ethnic groups, regions and employment status.”
    • Beckers Hospital Review informs us
      • CMS fined two more hospitals for alleged price transparency violations Sept. 5, marking the third consecutive month the agency has levied fines on noncompliant hospitals.   
      • “According to CMS’ price transparency website:
        • Washington, D.C.-based Saint Elizabeths Hospital was fined $677,440. 
        • Silver Spring, Md.-based Holy Cross Hospital was fined $325,710.
        • Additionally, CMS’ Sept. 8 update of its price transparency website included information of another hospital fined Aug. 22 that was not previously uploaded to the site. Doctors’ Center Hospital Bayamón (Puerto Rico) was fined $102,200.
      • The hospitals have 30 days from the issuance date to appeal the fines. 
      • CMS has now fined 14 hospitals for price transparency violations. To date, three hospitals have appealed their penalties and are under review, according to CMS.”  
    • ICD Monitor relates
      • “To help improve the collection of the social determinants of health (SDoH) Z codes, the Centers for Medicare & Medicaid Services (CMS) Office of Minority Health last week released a new Z code infographic. 
      • “CMS’s goal is to assist providers with understanding and using SDoH terminology in their documentation that will allow for greater alignment for ICD-10-CM Z code capture.  As discussed, CMS believes that greater Z code capture will enhance quality improvement activities and provide further insights into the existing health inequities that hospitals and their community are facing.” 

    From the public health and medical research front,

    • The Wall Street Journal has updated its report on the fall vaccination season.
    • MedTech Dive lets us know,
      • A prospective study published in the journal Lancet Digital Health found that an AI tool paired with a double reading by one radiologist was as good at detecting breast cancer as a double reading by two radiologists, the current standard of care.
      • Researchers at the Capio Sankt Göran Hospital in Stockholm, Sweden, and the Karolinska Institute said the results suggest that AI “has potential for controlled implementation, which would include risk management and real-world follow-up of performance.” 
      • The study used the Insight MMG system for breast cancer detection, made by Seoul, South Korea-based Lunit. The company helped fund the research, in addition to grants from the Swedish Research Council, the Swedish Cancer Society, and Region Stockholm.
    • The American Hospital Association News reports,
      • “The U.S. infant mortality rate was essentially unchanged in 2021, but the number of deaths rose 2% to 19,928, the Centers for Disease Control and Prevention reported Sept. 12. The mortality rate increased for infants of Asian women and declined for infants of Dominican women. Infants of Black women had the highest mortality rate by race at 10.55 per 1,000 live births, while infants born before 28 weeks of gestation had the highest rate by age (353.76). The five leading causes of death were unchanged from 2020, with declines for disorders related to short gestation and low birth weight. Infant mortality rates by state ranged from a low of 2.77 in North Dakota to a high of 9.39 in Mississippi. The U.S. infant mortality rate has generally trended downward since 1995 and has declined 21% since 2005, the most recent high (6.86).”
    • STAT News is now offering a new generation weight loss drug tracker.
      • “STAT has created a new database to track the significant obesity drugs that are on the market and in development. The tracker, which will be updated with developments each quarter, gives a sense of what new mechanisms could hit the market, how they would be taken and how often, and which companies are running the most trials.
      • “A related article details the strategies and challenges of some of these companies.”
      • Roughly seventy drugs are on the tracker currently.

    From the U.S. healthcare business front,

    • Fierce Healthcare tells us, “Shareholders in home health company Amedisys have approved its $3.3 billion union with Optum, even as the feds take a closer look at the deal.”
    • Per Healthcare Dive,
      • “Walgreens is partnering with startup Pearl Health to help primary care physicians manage value-based care, in a bid to expand its reach with community-based providers.
      • “The partnership announced Tuesday [September 12] marries Pearl’s provider enablement technology with Walgreens’ care delivery assets and pharmacy services in an attempt to make it easier for clinical teams to provide the personalized treatment necessary in value-based arrangements, according to the companies.
      • “Walgreens and Pearl will help doctors manage value-based care in traditional Medicare’s accountable care organization program, called ACO REACH, starting in 2024. The two plan to eventually expand to Medicare Advantage and potentially commercial payers and Medicaid down the line.”
    • Per Employee Benefits News,
      • “Saving for retirement is a life-long challenge, and one that seems to be harder for women. While they live on average five years longer than men, they’re saving less.
      • “Bank of America analyzed 565,000 health savings accounts (HSAs), looking at utilization trends across genders and generations. Women’s HSA balances are 15% lower than men’s, with women more likely to spend their HSA savings before retirement and contribute less to their accounts. Overall, men’s average net HSA savings was $128 higher in 2022, and over the years that gap begins to add up.” * * *
      • “Lisa Margeson, managing director of retirement research and insights at Bank of America,  advises employers to at the very least educate their employees on the power of HSAs and how they can use them as retirement savings vehicles. Employer HSA contributions, caregiving benefits and flexibility will also help ensure women can maintain successful careers and save for their future. 
      • “As for women, Margeson encourages them to start their HSAs early, try to put at least a little aside each month and eventually invest that money according to their bank’s capabilities. For those who are uncomfortable with a high-deductible health plan, Margeson points to emergency savings accounts or an interest-bearing savings account as a companion to their retirement plans.”
    • The Society for Human Resource Management offers a breakdown of compensation expenses over the second quarter of this year.
      • “According to the latest Employer Costs for Employee Compensation report, released September 12 by the U.S. Bureau of Labor Statistics (BLS), employers spent just 0.59 percent more on wages and benefits in June 2023 compared to March 2023.
      • “Total employer compensation costs for private-industry workers averaged $41.03 per hour worked. Wages and salaries averaged $28.97 per hour worked, accounting for 70.6 percent of employer costs, while benefits costs averaged $12.06 per hour worked, accounting for the remaining 29.4 percent, according to the report.”