Friday Factoids

ACA

Friday Factoids

David Ermer–ACA, CDC, Congress, COVID-19, Generative AI, Medical / Rx research, Rx coverage, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Speaker Mike Johnson reiterated support Friday for the fiscal 2024 spending agreement he negotiated in the face of opposition from members of the House Freedom Caucus, who’ve been lobbying him to toss the deal. 
    • “Johnson, R-La., told reporters that while he is seeking feedback from across his conference, he is committed to the “strong” deal he negotiated with Senate Majority Leader Charles E. Schumer, D-N.Y.
    • “Our topline agreement remains; we are getting our next steps together, and we are working toward a robust appropriations process,” he said.”  * * *
    • “Next week, Congress will face a more pressing Jan. 19 spending deadline for agencies covered under four of the 12 annual appropriations bills. Schumer took the first procedural step needed for a stopgap spending bill Thursday, filing cloture on the motion to proceed to a shell vehicle. 
    • “The Senate’s continuing resolution is expected to last until March, sources familiar with the talks say. But while Johnson has said he is “not ruling out” the need for another continuing resolution, he has not yet said definitively whether or not he would support one. 
    • “And that stopgap measure will be essential to keep the government open, as Senate Appropriations Chair Patty Murray, D-Wash., and House Appropriations Chairwoman Kay Granger, R-Texas, are continuing to negotiate over the final subcommittee allocations, also known as 302(b)s. 
    • “Negotiators will need about a month to wrap up their work after those allocations are finalized, House Appropriations ranking member Rosa DeLauro, D-Conn., said Friday. “
  • Govexec tells us,
    • “The Office of Personnel Management made some of its best progress at reducing the number of pending retirement applications from federal workers last year, reducing the backlog by 34% in 2023 and breaking multiple recent records in the process.
    • “Long a source of frustration for the governmental HR agency, lawmakers and retirees alike, OPM’s inventory of pending retirement claims has been plagued by delays due to the still largely paper-based nature of federal employment records, staffing issues and other challenges. The COVID-19 pandemic exacerbated many of these issues, as the backlog climbed to a high of more than 36,000 pending claims in March 2022.
    • “But OPM moved on multiple fronts last year to improve the process. The agency released its long-awaited IT strategic plan, which includes plans to develop a “digital retirement system,” complete with electronic records and an online retirement application process.
    • “And officials launched a series of short-term fixes aimed at shoring up the current system, including a guide for retirees to follow as they navigate the retirement process, as well as staffing up and coordinating more actively with federal agencies to prepare for the annual wave of new retirement claims that occurs between January and March.”
  • Federal News Network informs us,
    • “The Postal Service says its competitive package business is growing, following its busy year-end holiday season.
    • “USPS says it delivered 130 million more packages in the “peak” first quarter of fiscal 2024, a nearly 7% increase, compared to the same period last year.
    • “USPS delivered more than 1.9 billion packages in the first quarter of fiscal 2023, which covers October through the end of December.
    • “Postmaster General Louis DeJoy, in a video message to employees, said growing the package business is the key to turning around the Postal Service’s long-term financial problems.”
  • KFF analyzes the Food and Drug Administration’s recent decision to allow Florida to import prescription drugs from Canada.
  • Per Fierce Healthcare, AHIP, among others, expressed opposition to the provision in the proposed 2025 Notice of Benefit and Payment Parameters Notice, reducing the number of non-standardized plans that an Affordable Care Act plan carrier can offer from four to two.
    • “AHIP is particularly concerned about the impact of non-standardized plan limits on issuers’ ability to offer broad networks for consumers that want access to a variety of providers and specialists, which is often a key factor in plan selection for those with chronic health conditions,” the lobbying group wrote in comments on the proposed rule.”
  • The U.S. Preventive Services Task Force offers a report on its 2023 accomplishments.

From the public health and medical research front,

  • Becker’s Hospital Review provides three updates on the predominant Omicron strain JN.1.
    • “Disease severity: New findings from a study led by researchers at the Ohio State University indicate BA.2.86 and its close relative, JN.1, may be linked to an increase in disease severity. The research focused on mutations in the spike protein of BA.2.86 and found it can infect human cells that line the lower lung, which is a feature linked to severe symptoms. Researchers emphasized additional research is needed to confirm the findings, since the study used pseudoviruses. 
    • “But from our past experience, we know that infectivity in human epithelial cell lines provides very important information,” Shan-Lu Liu, MD, Ph.D., senior study author and virology professor at OSU, said in a news release. “The concern is whether or not this variant, as well as its descendants including JN.1, will have an increased tendency to infect human lung epithelial cells similar to the parental virus that launched the pandemic in 2020.” 
    • “In late December, the WHO classified JN.1 as a “variant of interest” due to its rapid spread. At the time, the agency said the overall risk to public health posed by the strain remains low, since updated vaccines continue to offer protection against severe illness. The CDC published its latest update on JN.1 Jan. 5, stating, “At this time, there is no evidence JN.1 causes more severe disease.” 
  • The Centers for Disease Control points out,
    • “As seasonal flu activity remains elevated nationally, CDC is tracking when, where and what influenza viruses are spreading and their impact on the public’s health. So far this season, the most commonly reported influenza viruses are type A(H1N1) and type B viruses. According to CDC research, this could mean more severe outcomes among people who are hospitalized with flu.”
  • Here’s a link to the CDC’s latest Fluview report.
    • “Seasonal influenza activity remains elevated in most parts of the country.
    • “After several weeks of increases in key flu indicators, a single week of decrease has been noted.  CDC will continue to monitor for a second period of increased influenza activity that often occurs after the winter holidays.
    • “Outpatient respiratory illness has been above baseline1 nationally since November and is above baseline in all 10 HHS Regions.
    • “The number of weekly flu hospital admissions decreased slightly.”
  • The CDC also announced,
    • “On October 23, 2023, the Centers for Disease Control and Prevention (CDC) issued Health Alert Network (HAN) Health Advisory 499 to provide guidance for prioritization of nirsevimab given the limited supply. Nirsevimab (Beyfortus, Sanofi and AstraZeneca) is a long-acting monoclonal antibody immunization recommended for preventing RSV-associated lower respiratory tract disease in young children.
    • Given the recent increase in nirsevimab supply and the manufacturers’ plan to release an additional 230,000 doses in January, the CDC advises healthcare providers to return to recommendations put forward by the CDC and the Advisory Committee on Immunization Practices (ACIP) on the use of nirsevimab in young children. Infants and children recommended to receive nirsevimab should be immunized as quickly as possible. Healthcare providers should not reserve nirsevimab doses for infants born later in the season when RSV circulation and risk for exposure to RSV may be lower. RSV activity remains elevated nationwide and is continuing to increase in many parts of the country, though decreased activity has been observed in the Southeast.” 
  • Fierce Healthcare reports,
    • “Though prescriptions for antiviral influenza medications have declined somewhat since 2023, perhaps indicating that the United States might be less encumbered by the flu than in recent record-breaking years, healthcare providers still find themselves battling a surge above historic norms, according to data by the Evernorth Research Institute.
    • “Researchers there examined pharmacy claims for more than 32 million people during current and past flu seasons and found an increasing prevalence of antiviral medication prescriptions since Thanksgiving 2023, though that’s tapered off slightly recently. More individuals experience flu symptoms severe enough to send them to physicians’ offices for prescriptions, and most of many of those forced to do so did not get the flu vaccination. Evernorth, a Cigna subsidiary, tries to develop cost-effective delivery systems for pharmacy benefits.
    • “Urvashi Patel, M.D., vice president of the Evernorth Research Institute, told Fierce Healthcare in an email that “since the shift to remote work from the pandemic, many employees who used to get their flu vaccines at the office are no longer able to. This may change as more workers continue to return to the office, but it’s likely a contributor to lower vaccination rates.”
  • The Wall Street Journal shares an employee’s favorable experience with the powerful weight loss drug Mounjaro.
  • Health Day provides the following study notes:
    • “U.S. doctors are prescribing antifungal creams to patients with skin complaints at rates so high they could be contributing to the rise of drug-resistant infections, new research shows.
    • “These are “severe antimicrobial-resistant superficial fungal infections, which have recently been detected in the United States,” noted a team led by Jeremy Gold, a researcher at the U.S. Centers for Disease Control and Prevention.
    • “One of the biggest emerging threats: Drug-resistant forms of ringworm (a form of dermatophytosis).”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth was slammed with medical costs as it closed out 2023. The health insurance behemoth still managed to exceed Wall Street’s financial expectations.
    • “UnitedHealth posted a medical loss ratio of 85% in the fourth quarter — its highest MLR since the COVID-19 pandemic began early 2020.
    • “MLR is a metric of how much payers shell out to cover their members’ medical expenses. Payers tried to shake the effects of higher medical costs all last year as patients who delayed healthcare during the pandemic returned to doctor’s offices.
    • “The bulk of higher costs in the fourth quarter was driven by more seniors using outpatient services, a trend that first appeared in the second quarter of 2023, said UnitedHealth CEO Andrew Witty on a Friday morning call with investors.”
  • Beckers Hospital Review offers an interview with Mayo Health System President “Prathibha Varkey, MBBS, [who] is excited about the future of healthcare,” and an analysis of nurse practitioner pay by specialty.
  • The Washington Post offers an interview with the American Medical Association President Jesse Ehrenfeld, MD.
  • Mercer Consulting offers guidance on network strategies to optimize patient care and save while its sister company, Oliver Wyman, peers into the crystal ball concerning the state of healthcare in 2035.
  • Beckers Payer Issues offers a look at ten updates to the 2024 Medicare Advantage landscape.
  • MedCity News discusses seven JP Morgan Conference news items that you don’t want to miss.
  • BioPharma Dive poses five questions facing the pharmaceutical industry this year. “Many drugmakers hope to compete with Novo and Lilly in obesity, while others seek to win oncology’s next era. Meanwhile, a contentious drug pricing law looms.”
  • Drug Channels shares a guest post titled “Repairing the Patient Journey: How Pharma Can Fix the Obvious–and Not So Obvious–Breaking Points of Nonadherence.”
  • The Wall Street Journal reports,
    • “CVS Health plans to close dozens of pharmacies inside Target stores at a time when pharmacy chains are struggling to grow retail profits.
    • “CVS will close the pharmacies between February and April this year, said a company spokeswoman. The closures are part of CVS’s efforts to pare down its retail footprint “based on our evaluation of changes in population, consumer buying patterns and future health needs,” she said. * * *
    • “CVS has operated pharmacies inside Target stores since late 2015 when it bought the business from the retailer for around $1.9 billion. It has pharmacies in around 1,800 of Target’s more than 1,950 U.S. stores. A Target spokeswoman declined to comment. The latest round of closures account for a small percentage of CVS’s pharmacies at Target stores.” 
  • Per Fierce Healthcare,
    • “Artificial intelligence was dominating CES 2024 this week. From assistive speech tools to pet wearables to AI-enabled pillows to prevent snoring, the majority of companies exhibiting at CES boasted the use of the technology as part of their products.
    • “Digital health companies at the show also are putting AI to use from Intuition Robotics’ AI-enabled ElliQ care companion robot to hearing eyewear.
    • “Amid all this hype, entrepreneur and investor Mark Cuban believes AI will be transformative for healthcare.
    • “There are two types of companies in the world — those who are great at AI and everyone else and either you know how to use it to your advantage or you’re in trouble,” he said during a digital health panel at CES on Thursday.
    • “He added, “I don’t think it will be dominated by five or six big models. I think there will be millions of models. I think we’ll find every company will have a model, every vertical will have its own model, individuals will have their own models, doctors have their own models, and trying to get to the point where it’s more democratic so that specific verticals will be used within healthcare is going to be an evolution and I don’t think we’ve figured all that out.”
  • Healthcare Dive adds
    • “Generative artificial intelligence can be used to pull social determinants of health data, like housing or employment status, from clinician notes to identify patients who need additional support, according to a new study.
    • “Large language models trained by researchers could identify 93.8% of patients with adverse social determinants of health, while official diagnostic codes include that data in only 2% of cases. 
    • “The finely tuned models were also less likely than OpenAI’s GPT-4 to change their determination when demographic information like race or gender was added. Algorithmic bias is a major concern for AI use in healthcare, amid fears the technology could worsen health inequities.” 

Midweek Update

David Ermer–ACA, Congress, COVID-19, Medical / Rx research, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Roll Call reports,
    • ​”Speaker Mike Johnson dropped his adamant opposition to any more short-term funding patches on Wednesday, saying he wouldn’t rule out a continuing resolution even though that’s not his preference.
    • “Johnson, R-La., said it was still “pedal to the metal” on trying to get the fiscal 2024 spending bills done, including the first batch, which is due Jan. 19. But in comments to reporters after a House GOP conference meeting, he appeared to soften his tone on a CR.
    • “I’m not ruling out anything, committing to anything, other than getting these appropriations done,” Johnson said. “And I think we can and we’re pushing everybody hard.” 
    • “Senators on both sides of the aisle Tuesday said it was clear another temporary patch was needed because there just wouldn’t be enough time next week to beat the first deadline, particularly given the cumbersome Senate floor process.
    • “Sources familiar with the discussions said they expect the Senate to move first on a stopgap spending measure, which could make it easier for Johnson to put it on the floor in his chamber if it looks like there’s little choice and time is running out. A March end date is under consideration, sources said.”
  • Senator Chuck Grassley (R Iowa) announced,
    • Sens. Chuck Grassley (R-Iowa) and Mike Braun (R-Ind.) introduced bipartisan legislation to codify rules directing hospitals and insurers to disclose cash prices and negotiated rates to patients before they receive medical care. The Health Care PRICE Transparency Act 2.0 stems from policies implemented via executive order in 2019, and builds on a bill and related effort Grassley pushed last Congress. 
    • “Patients should be able to compare and shop for health care services. However, the pricing information they need when visiting the hospital or working with insurance companies isn’t always available. By strengthening transparency and accountability requirements, our bill would help lower costs for patients through more competition and added sunlight in the health care industry,” Grassley said. 
    • “It’s wrong that the same procedure can be 20 times more expensive in one hospital than in another, and there’s no other industry where consumers are in the dark on the price of what they’re buying. Knowing what health care services cost will lower health care prices because Americans can shop around and get the best deal rather than relying on insurers to negotiate with providers which drives the price up for everything. The Health Care PRICE Transparency Act 2.0 will pull the curtain back and put the power back in the hands of the American people, introducing real market competition into the health care industry and bringing down prices,” Braun said.
    • “Grassley and Braun are joined by Sens. Bernie Sanders (I-Vt.), John Hickenlooper (D-Colo.) and Tina Smith (D-Minn.). 
  • Chief Investment Officer tells us,
    • “President Joe Biden re-nominated Julie Su for Secretary of Labor on Monday. Su has been acting secretary of Labor since March 2023.
    • “Su’s nomination passed through the Senate Committee on Health, Education, Labor and Pensions in April by an 11 to 10 vote. Her nomination then stalled in the Senate, and a full vote was never held. Presidential nominations must be renewed at the start of a new year.”
  • The Society for Human Resource Management adds,
    • “The new independent contractor rule from the U.S. Department of Labor (DOL) could spark an increase in misclassification lawsuits and make businesses less likely to hire gig workers, according to some legal experts.
    • “The final rule restores an earlier standard that required companies to weigh a variety of economic factors together to determine whether a worker is an employee or an independent contractor. It will take effect on March 11.”
  • The Department of Health and Human Services announced,
    • “Under the Biden-Harris Administration, the U.S. Department of Health and Human Services announced today that over 20 million people have selected an Affordable Care Act (ACA) Health Insurance Marketplace plan since the 2024 Marketplace Open Enrollment Period launched on November 1 — a record number of enrollments.
    • “Today’s data represents activity through December 23 (Week 8) for the 32 states using HealthCare.gov and for the 18 states and the District of Columbia with State-based Marketplaces. Total plan selections include more than 3.7 million people (18% of total) who are new to the Marketplaces for 2024, and 16.6 million people (82% of total) who had active 2023 coverage and selected a plan for 2024 coverage or were automatically re-enrolled.  Plan selections so far represent an impressive increase of over 8 million more people who have coverage since President Biden took office.
    • “The 2024 Marketplace Open Enrollment Period runs from November 1, 2023, to January 16, 2024, for states using the HealthCare.gov platform. Consumers who enroll by midnight on January 16 can get coverage that starts February 1, 2024. State-based Marketplace enrollment deadlines vary. State-specific deadlines and other information are available in the State-based Marketplace Open Enrollment Fact Sheet – PDF.”

From the public health and medical research front,

  • ABC News points out,
    • “More than three years into the pandemic, hundreds of Americans are still dying from COVID-19 every week.
    • “For the week ending Dec. 9, the last week of complete data, there were 1,614 deaths from COVID, according to the Centers for Disease Control and Prevention (CDC). The last four weeks of complete data show an average of 1,488 weekly deaths.
    • “By comparison, there were 163 weekly deaths from the flu for the week ending Dec. 9, according to CDC data.
    • “While high, these COVID death figures are still lower than the high of 25,974 deaths recorded the week ending Jan. 9, 2021, as well as weekly deaths seen in previous winters, CDC data shows.”
  • Medscape reports,
    • “Medication people with type 2 diabetes use to manage their blood sugar also appear to protect their hearts and kidneys, according to a new study in JAMA Network Open. 
    • “These pills, known as sodium-glucose cotransport protein 2 (SGLT2) inhibitors, reduce the amount of blood sugar in a kidney by causing more glucose to be excreted in urine.
    • “Chronic kidney disease (CKD) cannot be cured and often leads to renal failure. SGLT2 inhibitor drugs can help stave off this possibility. Acute kidney disease (AKD), on the other hand, is potentially reversible. It typically occurs after an acute kidney injury, lasts for up to 90 days, and can progress to CKD if left unchecked. 
    • “There has been a notable absence of targeted pharmacotherapy to offer protection to these patients,” said Vin-Cent Wu, MD, PhD, a nephrologist at National Taiwan University Hospital in Taipei, and an author of the study.” 
  • Per STAT News,
    • “More hopeful news on the menopause front: Bayer announced on Monday encouraging results in two Phase 3 trials for its non-hormonal drug candidate, elinzanetant, meant to treat hot flashes. The results follow the recent market launch of Veozah, Astellas Pharma’s groundbreaking non-hormonal treatment for hot flashes, which was approved by the U.S. Food and Drug Administration last spring and received approval in the U.K., under the name Veozah, in December.
    • “Elinzanetant is a neurokinin-1 and 3 receptor antagonist, and works by calming down the estrogen receptors in the brain that become hyperactive around menopause, causing hot flashes. The drug, a pill administered once a day, was shown to reduce both the frequency and intensity of hot flashes, and also met the secondary endpoints for improving sleep and quality of life, according to JoAnn Pinkerton, professor of obstetrics and gynecology and director of the Midlife Health at UVA Health, who is a clinical investigator for Bayer’s drug candidate.”

Per the U.S. healthcare business front,

  • Beckers Hospital Review discusses expert concerns about Eli Lilly’s new platform to market their drugs directly to consumers and provides four Ozempic updates.
  • Per Healthcare Dive,
    • “Healthcare providers have kept an eye on rising costs as nationwide labor shortages, inflation and dried up COVID-19 relief funds have pushed health systems’ operating margins into the red.
    • “But, despite hospital executives’ best efforts at cost management, 2024 will not bring a reprieve from razor-thin operating margins for most systems, experts warn.
    • “2024 will not be markedly better and certainly not the V-shaped recovery we’re hoping for,” said Kevin Holloran, senior director at credit agency Fitch Ratings. “Not-for-profit hospital margins are still below both pre-pandemic levels — but more importantly they will trend below the ‘magic number’ operating margin of 3%.”
    • “Analysts are split on how bleak the picture is for the provider sector. The major three major credit agencies — Fitch Ratings, Moody’s Investor Services and S&P Global Ratings — have forecast negative to stable conditions for the year.
    • “However, neither credit agencies nor industry experts predict a full financial turnaround for the embattled industry in 2024. Providers’ individual outlooks hinge on their ability to pull the right combination of levers that lift revenue and shrink costs, experts said.”
  • Health Payer Intelligence explains how one payer tackled the No Surprises Acts’ provider directory accuracy requirements.

Happy New Year!

David Ermer–Congress, COVID-19, Medical / Rx research, Obesity, SCOTUS, U.S. Healthcare, Wellness–

From Washington, DC

Congress returns to legislative and Committee business next week.

The Hill discusses four ways the Fiscal Year 2024 appropriations issues can play out in January.

The Chief Justice, Hon. John Roberts, released his year-end report on the federal judiciary. The report focuses on generative artificial intelligence.

From the public health and medical research front,

  • Fortune Well considers the reigning Omicron subvariant JN.1 or Pirola.
    • “As always, it’s impossible to distinguish COVID from the flu, RSV, and other common winter illnesses like rhinoviruses, enteroviruses, and parainfluenza viruses by symptoms alone. Even with the new, highly mutated COVID variant “Pirola” JN.1, now globally dominant, this remains true. What’s more, it’s possible to have two or more infections at the same time.
    • “As always, testing—at a health care facility or at home, in the case of COVID—is the only true way to determine the source of your illness. And while you should consult your health care provider, if your symptoms are mild and you don’t have other health conditions, the cause may not matter.”
  • The article wades into Pirola specifics.
  • The Washington Post shares what’s known about long Covid.
    • “An analysis of nearly 5 million U.S. patients who had covid, based on a collaboration between The Washington Post and research partners, showed that people infected with the coronavirus’s omicron variant are less likely to develop symptoms typical of long covid than those who had covid earlier in the pandemic. Patients exposed to the coronavirus during the first wave of pandemic illness — from early 2020 to late spring 2021 — were most prone to develop long covid, with 1 in 12 suffering persistent symptoms, the study showed.”
  • The Post points out,
    • “Although HDL helps remove cholesterol from people’s arteries, the researchers wrote that, at very high levels, HDL’s structure and actions change, and it “may become deleterious to health” in various ways.
    • “For more than six years, they tracked 18,668 study participants, all 65 or older and all physically and cognitively healthy at the start of the study. In those years, cognitive dementia was diagnosed in 850 participants (4.6 percent).
    • “Those with very high HDL levels were more likely to have developed dementia than were those with more optimal HDL levels. For instance, the oldest participants with high HDL levels (those 75 or older) were 42 percent more likely to have developed dementia than those with normal HDL levels, and overall, anyone with high HDL levels had a 27 percent increased risk for dementia.”
  • and also offers exercise-based strategies for people experiencing trouble standing up or lying down.
  • Medscape tells us
    • “Researchers made important gains in 2023 in the fight against cardiovascular disease (CVD), according to the American Heart Association’s (AHA’s) annual list of key scientific developments in the field.
    • “Every year, we compile an overview of scientific research that advances our understanding of how to prevent, treat, and manage heart disease and stroke,” Mariell Jessup, MD, AHA chief science and medical officer, said in a news release.
    • “Whether the science points to new ways to treat long-known health conditions, disparities in care, or how to prevent some of our most pressing problems, such as high blood pressure, diabetes, or obesity, the findings help people, healthcare professionals, policymakers, and others make better informed healthcare decisions,” Jessup added.
    • “[The article provides] a brief summary of some of the year’s most noteworthy developments, according to the AHA.”
  • The Wall Street Journal informs us,
    • “One of the best strategies for good health in the new year: Reduce the amount of sugar you eat.
    • “Sugar sneaks into our diet in surprising ways, from coffee drinks you don’t realize are sugar bombs to small amounts that add up in bread or sauces. Looking more closely at nutrition labels and little tricks like putting a few cookies onto a plate rather than eating them straight from the bag can help.
    • “It’s worth the effort, nutrition researchers say. Studies have found that diets high in added sugars are linked to a higher risk of obesity and Type 2 diabetes. 
    • “U.S. guidelines recommend that Americans limit their consumption of added sugars to 10% of daily calories. The American Heart Association recommends a limit of 6% of calories. While overall sugar consumption has decreased in recent years, Americans still get an average of about 13% of their daily calories from added sugars, according to federal data. 
    • “Still, there’s an important distinction between added sugars—which are found in processed foods such as soda, cereal and yogurt, as well as honey and sugar itself—and sugar that occurs naturally in foods like fruit and dairy products. Foods that naturally contain sugar provide nutrients that people need and most Americans aren’t eating enough of them, nutrition researchers say.”

From the U.S. healthcare business front,

  • Medscape reports,
    • “Drugmakers including Pfizer, Sanofi and Takeda Pharmaceutical plan to raise prices in the United States on more than 500 drugs in early January, according to data analyzed by healthcare research firm 3 Axis Advisors.
    • “Excluding different doses and formulations, more than 140 brands of drugs will have their prices raised next month, the data showed. * * *
    • “More drug prices are likely to be announced over the course of January – historically the biggest month for drugmakers to raise prices.
    • “In 2023, drugmakers raised prices on 1,425 drugs, down from 2022, when they raised prices on 1,460 drugs, according to data published by 46brooklyn.
    • “While drugmakers have pared back their price increases for established drugs, prices for newly launched drugs have hit record levels.
    • “In 2022, the price of newly launched drugs topped $220,000 from around $180,000 in the first six months of 2021 suggesting a more than 20% increase. That’s in line with a JAMA-published study on drug prices which showed that between 2008 and 2021 U.S. drug launch prices grew 20% annually.”

Friday Factoids

David Ermer–ACA, AHRQ, Congress, Federal employment benefits, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Endpoints informs us,
    • “In a landmark moment for genetic medicine and sickle cell disease patients, the FDA on Friday approved not just one but two gene therapies for the disease: Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Casgevy, marking the first-ever approval of a CRISPR-based medicine in the US, and Lyfgenia, bluebird bio’s lentiviral gene therapy.
    • “The treatments are approved for sickle cell disease patients 12 years of age and older who experience painful attacks associated with the disease. Vertex will charge $2.2 million in the US for Casgevy, while bluebird will charge $3.1 million for Lyfgenia.
    • “This is the very first time that some patients have ever imagined that they might not have to live their entire lifespan with the consequences of sickle cell disease,” Alexis Thompson, the chief of the division of hematology at Children’s Hospital of Philadelphia and investigator on the clinical trials that led to the therapies’ approvals, told Endpoints News ahead of the announcement.” * * *
    • “ICER, a drug pricing watchdog, has suggested the therapies could be cost-effective at $2 million in the US. Bluebird bio markets a gene therapy as Zynteglo for transfusion-dependent beta thalassemia as well in the US, for which it charges $2.8 million.”
  • Per Fierce Healthcare,
    • “New polling suggests voters would rather work to improve the current U.S. healthcare system and keep the Affordable Care Act in place, rather than drastically overhaul the system in favor of a national public option or Medicare for All.
    • “Three-quarters of survey respondents said they prefer fixing the current health insurance system versus starting fresh with a Medicare for All system, while 64% said Medicare should begin at the age of 60 instead of 65 and 58% believe people should be allowed to purchase health insurance beginning at the age of 50.
    • “Repealing the ACA struck a chord with respondents as just 32% of voters and only 44% of GOP voters said they support repealing the ACA. When asked if ACA subsidies should be extended, 60% said they should while only 41% of Republicans agreed.
    • “Notably, the survey was conducted on behalf of the Partnership for America’s Health Care Future, an industry group created in 2018 comprised of America’s Health Insurance Plan, the American Hospital Association, BlueCross BlueShield Association, the Federation of American Hospitals, PhRMA and other major hospital systems, payers and healthcare advocacy groups that seek to quell support and prevent passage of Medicare for All.” 
  • Healthcare Dive tells us,
    • “Hospitals are up in arms over a bill in the U.S. House of Representatives that would equalize payments for drugs administered in outpatient clinics, regardless of ownership.
    • “The American Hospital Association and the Federation of American Hospitals sent separate letters to Congress this week urging legislators to vote against the bill over the site-neutral provision, arguing it would threaten access to care by cutting hospitals’ Medicare payments.
    • “The bipartisan Lower Costs, More Transparency Act is scheduled to come up for a House vote the week of Dec. 11.”
  • Fierce Healthcare offers more information on this bill (HR 5378).
    • [T]he legislation would ban spread pricing in Medicaid, force PBMs and providers to adopt President Trump-era transparency rules, push closer toward site-neutral payment reform, extend a federal program due to expire and approve funding increases for community health centers.
  • The American Hospital Association News points out,
    • The Medicare Payment Advisory Commission Dec. 8 discussed draft payment update recommendations for 2025, which the commission will vote on in January. The draft recommendations call for Congress to update Medicare payment rates for hospital inpatient and outpatient services by the current law amount plus 1.5%, and transition to a safety-net index policy that would distribute an additional $4 billion to safety-net hospitals. They also propose that Congress:
      • Update 2025 Medicare payments for physicians and other health professional services by 50% of the Medicare Economic Index increase, and enact a non-budget-neutral add-on payment under the physician fee schedule to services provided to low-income Medicare beneficiaries.
      • Reduce the 2025 payment rate for home health agencies by 7%.
      • Reduce the 2025 payment rate for skilled nursing facilities by 3%.
      • Reduce the 2025 payment rate for inpatient rehabilitation facilities by 5%.
  • On December 6, the Biden Administration’s latest semi-annual regulatory agenda was posted. Here is a link to OPM’s agenda. Here are the FEHB rulemakings in process:
    • OPM Proposed Rule Stage Federal Employee Health Benefits Program: Effective Date of Coverage RIN 3206-AO47
    • OPM Proposed Rule Stage Postal Service Health Benefits Program: Additional Requirements and Clarifications RIN 3206-AO59
    • OPM Proposed Rule Stage Federal Employee Health Benefits Program: Decreasing Enrollment Type to Self Only RIN 3206-AO62
    • OPM Final Rule Stage Requirements Related to Air Ambulance, and Agent, and Broker Services, and Provider Enforcement RIN 3206-AO28
    • OPM Final Rule Stage Postal Service Health Benefits Program RIN 3206-AO43
  • Readers can research these rulemakings on regulations.gov by referencing the RIN.

From the public health and medical research front,

  • The Department of Health and Human Services announced
    • “In first-of-its-kind research to examine racial and ethnic disparities in the medical costs of smoking in the United States, the Department of Health and Human Services’ Agency for Healthcare Research and Quality (AHRQ) found that adults from some racial and ethnic populations benefit substantially more than others from tobacco control policies. The research, published today in the journal Tobacco Control, supports President Joe Biden’s April 2023 Executive Order calling for policymakers to examine distributional effects in cost-benefit analyses required in the rulemaking process.  This study helps inform such analyses and will benefit other research in this area.
    • “The study shows that even though adults in specific racial and ethnic populations have a lower ever-smoked rate than White adults and make more attempts to quit, their medical spending associated with smoking was twice as high, with a 41% higher rate of having multiple chronic conditions associated with smoking. * * *
    • “Disparities in medical spending, as well as adverse health outcomes, are continuing to increase over time,” said AHRQ co-author Dr. William Encinosa. “AHRQ’s results indicate that racial and ethnic populations benefit substantially from tobacco control policies, such as tobacco product regulations.”
    • “The article, “Racial and Ethnic Disparities in the Healthcare Costs and Outcomes of Smoking in the United States: 2008-2019,” is published in Tobacco Control and may be found at: https://tobaccocontrol.bmj.com/lookup/doi/10.1136/tc-2023-058136“
  • Medscape notes,
    • “Patients receiving semaglutide for weight loss show a significantly higher rate of continuing the medication at 1 year compared with less effective anti-obesity drugs. However, even among those patients, continuation declines to fewer than half of patients.
    • “We now have effective US Food and Drug Administration-approved anti-obesity medications; [however], this study shows that in a real-world setting, the vast majority of patients discontinued their prescription fills within the first year,” said first author Hamlet Gasoyan, PhD, lead author of the study and a researcher with Cleveland Clinic’s Center for Value-Based Care Research, said in a press statement.
    • “The study was published online today in the journal Obesity.”
  • HR Morning fills us in on cancer benefit trends in 2024 and how employers can support employees fighting cancer.
  • Per MedPage Today,
    • “An outbreak of Clade I mpox virus is currently spreading in the Democratic Republic of the Congo (DRC), and clinicians should be aware of the potential for transmission from people traveling from the Central African country, the CDC said Thursday in a Health Alert Network advisoryopens in a new tab or window.
    • “Of the two distinct mpox subtypes, Clade I is endemic in Central Africa, and appears to be more transmissible and causes more severe infections than the Clade II subtype. So far, no Clade I mpox infections have been detected in the U.S. during surveillance testing. The current threat for Clade I mpox in travelers remains low, the CDC said, in part because there are no direct commercial flights to the U.S. from the DRC.”

From the U.S. healthcare business front,

  • Becker’s Payer Issues explains how BCBS plans are using price transparency data.
    • “It’s been nearly two years since payers have been required to publish the costs of their in-network provider rates for covered items and services, and now Blue Cross Blue Shield plans are using that data to create actionable insights for stakeholders across the healthcare system.
    • “Much of that work is being done by Blue Health Intelligence, the data and analytics arm of the BCBS Association that is collectively owned by 17 BCBS affiliates. Becker’s sat down with BHI CEO Bob Darin to learn how Blues plans around the country are utilizing price transparency data, and the major challenges that still lie ahead.”
  • Check out the interview.
  • HR Dive reports,
    • “The U.S. government published its fall regulatory agenda Wednesday, sharing its rulemaking plans for the remainder of 2023 and early 2024.
    • “Of interest to HR professionals are U.S. Department of Labor updates on wage and hour law, workplace safety and retirement plans. Perhaps most notably, the DOL plans to finalize overtime regulations in April 2024. Final regulations for independent contractor classification — under the Fair Labor Standards Act — hang in the balance, as they were slated to be published in November, per the DOL.
    • “Separately, the U.S. Equal Employment Opportunity Commission said it will finalize Pregnant Workers Fairness Act rules in December.”
  • The Society for Human Resource Management advises
    • “With the end of the year quickly approaching, HR and benefits leaders have yet one more task to add on to their busy end-of-year checklist: reminding employees about approaching deadlines to use up remaining cash in their health care flexible spending accounts (FSAs). ***
    • “So how should employers share end-of-year news about FSAs? And what should they say?
    • “One of the best ways to remind employees is to send multiple emails during the remainder of the year, Dinich said, adding that if company leaders simply raise the issue in a company meeting, anyone who is on leave or out sick won’t get that reminder.
    • “Make sure to reiterate any terms and conditions within that email and advise on checking which expenses are eligible, so that employees can refer back to this when making claims before the end of the year,” he said. “Also ensure that it’s clear when the expiry date is, as some plans are tied to specific dates rather than defaulting to the end of the year.”

Weekend Update

David Ermer–ACA, CDC, Congress, COVID treatment, Medical / Rx research–

From Washington, DC,

  • The Federal Benefits Open Season ends a week from tomorrow.
  • KFF News provides a helpful overview of the recently proposed Affordable Care Act notice of benefit and payment parameters.
  • The New York Times reports,
    • “A small group of Republican senators on Friday called on President Biden to ban travel from China to protect against an outbreak of respiratory illnesses in children there, even as scientists and global and American health officials said there were no signs of a threatening new pathogen.
    • “Instead, those experts said, the evidence so far pointed to a surge of age-old infectious agents such as influenza, driven by the colder weather and China’s emergence from stringent Covid lockdowns. The World Health Organization said last week that China had shared data about its outbreak, including laboratory results from infected children, that did not show any unusual pathogens.
    • “Dr. Mandy Cohen, the director of the Centers for Disease Control and Prevention, echoed that assessment on Friday. She said American officials had also been in touch with Chinese authorities, academic experts and health workers.
    • “What we have all been able to ascertain is that there is no novel pathogen,” she said. “This is all related to upticks of known viruses and bacteria in their pediatric population.”

From the public health front,

  • NPR Shots tells us,
    • “There’s just not much that’s very effective for treating the common cold,” said Dr. Lauren Eggert, clinical assistant professor in the Pulmonary Allergy and Critical Care Division at Stanford University. * * *
    • “She opens a database called UpToDate, which physicians use as a resource when they want to see the summary of evidence for medications targeting specific concerns. The conclusions for cold and flu remedies are disconcerting:
      • “Antihistamines, vitamins and herbal remedies are deemed ineffective.
      • “Cough syrups, decongestants, expectorants, and zinc may have minimal or uncertain benefits.
      • “Nasal sprays and analgesics like Tylenol and ibuprofen may be effective.”
  • The American Medical Association lets us know what doctors wish their patients knew about Covid oral anti-virals, Paxlovid and molnupiravir.
  • Medscape points out,
    • “Breast cancer has a worse prognosis when diagnosed during pregnancy or postpartum. Methods for early detection are needed, as evidenced every day in the multidisciplinary unit for treating pregnancy-associated breast cancer, which operates within the Breast Unit at the Vall d’Hebron University Hospital in Barcelona, Spain.
    • “The team working in this field is led by Cristina Saura, PhD, who is also head of the Breast Cancer Group at the Vall d’Hebron Institute of Oncology (VHIO). The results of a study recently published in Cancer Discovery show, for the first time, that breast milk from breast cancer patients contains circulating tumor DNA (ctDNA) that can be detected by a liquid biopsy of the milk.”

Tuesday Tidbits

David Ermer–ACA, FDA, No Surprises Act, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • This morning, the federal government filed a notice appealing to the D.C. Circuit the HIV and Hepatitis Foundation’s successful challenge to the Trump administration’s co-pay accumulator rule.
  • Yesterday, the federal government moved for the district court to modify its decision to state that the Trump administration rule would remain effective until the ACA regulators reconsidered it in compliance with the court’s order. The plaintiffs reportedly oppose the government’s motion. 
  • The ACA regulators issued
  • The FAQs concern the claims batching limitations under the No Surprises Act and the update to CLAS requirements that health plans, including FEHB plans must use in certain plan publications. The FEHBlog noticed that the ACA regulators have added new languages to CLAS requirements. The CLAS changes will take effect for the 2025 plan year.
  • The American Hospital Association News adds,
    • In response to recent court decisions that set aside certain regulations implementing the No Surprises Act’s Independent Dispute Resolution process, the Centers for Medicare & Medicaid Services Nov. 28 released [ACA] FAQs [63] explaining how certified IDR entities may determine whether a dispute is appropriately batched and clarifying certain other provisions and its policy for extending existing IDR deadlines once the federal IDR portal reopens to all batched disputes and single disputes involving air ambulance services. CMS also rescheduled to Nov. 30 at 3 p.m. ET its webinar to review the FAQs for health care providers and insurers submitting batched or air ambulance claims. To attend the webinar, register here.
  • Get a load of this other AHA News item,
    • A bipartisan group of House members Nov. 28 introduced AHA-supported legislation that would prohibit health insurers from charging fees for standard electronic fund transfers to pay health care providers for services. Commercial insurers often automatically charge health care providers a percentage-based fee for EFT payments. 
    • FEHBlog note — EFT transactions are not free. If the entire cost is shifted onto the insurer, then premiums go up.

From the public health and medical research front,

  • BioPharma Dive informs us,
    • “The Food and Drug Adminsitration is investigating whether CAR-T cell therapies like Novartis’ Kymriah or Gilead’s Yescarta are linked to the risk of new blood cancers after receiving reports of so-called T cell malignancies in people who have received the treatments.
    • “In a statement Tuesday, the agency said it’s weighing “the need for regulatory action” in response to the reports, which came from both clinical testing and safety monitoring tied to commercial use. The identified risk is applicable to all approved CAR-T therapies, although the agency noted that “the overall benefits of these products continue to outweigh their potential risks for their approved uses.”
  • The Wall Street Journal reports,
    • “The U.S. Food and Drug Administration warned of an emerging safety issue involving a continuous positive airway pressure, or CPAP, machine made by Philips.
    • “The FDA issued a safety communication about thermal issues with the Philips Respironics’ DreamStation 2 CPAP machines, which are used to treat forms of sleep apnea, and recommended patients monitor machines.
    • “The agency said it had received reports of issues such as fire, smoke, burns and other signs of overheating. The FDA said it is in discussions with the company about strategies to address the safety issue.”
  • The Washington Post points out,
    • “Scientists have discovered a new type of stem cell in the spine that appears crucial to resolving a long-standing mystery: why far more cancer cells spread to the spine than to other bones in the body.
    • “When breast, lung and prostate cancers metastasize to multiple bones in the body, three to five times more cancer winds up in the spine than in the lower and upper limbs. Scientists have known of this disparity for decades, but the reason for it has remained unclear.
    • “One theory held that differences in blood flow might be the cause. But the new findings suggest an alternative that could have implications for cancer care, spine fusion surgery and osteoporosis, a bone-weakening disease that afflicts about 10 million Americans.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • “releasing a Draft Evidence Report assessing the comparative clinical effectiveness and value of xanomeline tartrate/trospium chloride (KarXT, Karuna Therapeutics) for the treatment of schizophrenia. This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“
  • The ICER announcement also explains how to submit public comments and participate in virtual public meeting on February 9, 2024.

From the U.S. healthcare business front,

  • The Business Group on Health issued a report on nine healthcare cost trends to watch in 2024.
  • Beckers Hospital Review tells us,
    • “Hospitals’ median operating margin was 1.2% through October, marking the third straight month with the same year-to-date median and signaling growing stability.  
    • “The latest figure comes from Kaufman Hall’s November “National Hospital Flash Report,” which is based on data from more than 1,300 hospitals. 
    • “Kaufman Hall said the 1.2% year-to-date median operating margin for October reflects “continued stabilization” among hospitals. In the first 10 months of 2023, hospitals’ net operating revenue per calendar day was up 6%, and total expense per calendar day was up 4% compared to the same time period in 2022.”

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Republicans yanked another fiscal 2024 spending bill before a final vote scheduled for Thursday morning, leaving them empty-handed for the week and stuck at seven out of 12 annual appropriations bills passed.
    • “The $25 billion Financial Services bill [which funds OPM and the FEHBP] ran into trouble with GOP moderates over language that would block the District of Columbia from implementing its 2014 law preventing employment discrimination based on reproductive health decisions, including taking birth control or having an abortion.
    • “The simple analogy is they didn’t have the votes. Shocking,” said Rep. Ryan Zinke, R-Mont., who backs the bill. “Monday, we’ll see if we can have a consensus over the weekend for those people that have a problem with what I think is a very straightforward bill.”
    • “Another issue which contributed to the measure’s demise Thursday, according to a source familiar with the decision, was conservative opposition to allowing the General Services Administration to implement its plan to build a new FBI headquarters in Greenbelt, Md.”
  • As Rosanna Rosannadana would say, “If it’s not one thing, it’s another.”
  • The Society for Human Resource Management informs us,
    • “Employees can funnel an extra $150 into their health flexible spending accounts (FSAs) next year, the IRS announced Nov. 9.
    • “The annual contribution limit is rising to $3,200 in 2024, up from $3,050 in 2023. The hike is still significant, although it’s a smaller boost than the $200 hike seen this year.
    • “If the employer’s plan permits the carryover of unused health FSA amounts, employees can carry over up to $640 in 2024. That’s up $30 over the 2023 carryover amount, which is $610.”
  • Here’s a link to the IRS’s complete list of 2024 inflation adjustments to tax items.
  • STAT News tells us that the Ground Ambulance Committee created by the No Surprises Act wants to cap the cost-sharing for people who use ground ambulances at $100 per trip. The catch is that they have difficulty deciding how much health plans should pay for ground ambulance services.
    • “Some experts say a Medicare benchmark is the simplest administrative solution. Medicare’s payment system for ambulances is outdated, but it’s based on some measure of costs. But that shift would result in a lot of upheaval, especially for ambulance providers that currently are able to bill and collect large sums of money from the biggest insurance companies. * * *
    • “Early next year, the federal ambulance committee will deliver its recommendations to Congress. Key lawmakers have not shown a lot of interest in taking up surprise billing again because it requires a lot of political capital to confront the ambulance and insurance industries.”

In FEHBP news,

  • FedSmith offers its strategy for approaching the FEHB open season which begins next Monday.
  • FedWeek discusses coordinating benefits between FEHB plans and Medicare. The best resource is OPM’s chart found in Section 9 of every FEHB plan’s brochure.

From the public health and research front,

  • The Wall Street Journal reports,
    • “A team of New York surgeons has performed the world’s first whole-eye transplant on a human, a breakthrough that could change vision treatments even though the patient hasn’t regained sight in the grafted eye. 
    • “In the six months since the eye surgery was performed, in conjunction with a partial face transplant, the 46-year-old patient has shown promising signs of health in the eye, the surgical team at NYU Langone Health said Thursday. 
    • “The grafted eye is maintaining normal ocular pressure and has direct blood flow to the retina, the area at the back of the eye that receives light and sends images to the brain. It isn’t known if the patient will regain his sight, but the transplant is still a significant accomplishment, according to Dr. Eduardo D. Rodriguez, director of the Face Transplant Program at NYU Langone.  
    • “We’ve made one major step forward and have paved the way for the next chapter to restore vision,” Rodriguez said. Rodriguez led the May surgery, which lasted 21 hours and included more than 140 surgeons, nurses and other healthcare professionals.” 
  • The Food and Drug Administration announced,
    • “approving Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare and life-threatening blood clotting disorder.”
  • and
    • “approving Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.
    • “The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.” 
  • and
    • clearing for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway, and the first indicated for use in children under 18. Today’s announcement follows clearance of a molecular home test earlier this year.
  • Per Beckers Hospital Review,
    • “Pneumonia patients who took an antibiotic that’s typically reserved as an alternative were less likely to develop Clostridioides difficile infections compared to those taking the recommended drug, according to a study from Veterans Affairs Hospitals. 
    • “The retrospective study analyzed 156,107 patients treated for pneumonia at a VA hospital between 2009 and 2022. Overall, less than 1% of pneumonia patients were diagnosed with a C. diff infection, but among those who had C. diff in the year before contracting pneumonia, 12% developed a new C. diff infection associated with their antibiotic treatment. 
    • “Clinical guidelines recommend azithromycin, and nearly 9 in 10 of the patient cohort received the drug. Of the 13% who received doxycycline, the alternative antibiotic, the drug was associated with reducing C. diff infections by 45%. 
    • “The researchers concluded that, if Legionella pneumonia can be ruled out, clinicians might consider doxycycline as a first-line treatment over azithromycin.”
  • The Wall Street Journal notes,
    • “There is hope for those of us who live (and sleep) in the real world: Getting less than 8 hours of shut-eye a night doesn’t mean you’re doomed to an early grave.
    • “A recent study looking at sleep and longevity found that sleep “regularity”—going to bed and waking up at consistent times with few mid-slumber interruptions—matters more than how long you sleep. Sleeping six hours every night on a consistent schedule was associated with a lower risk of early death than sleeping eight hours with very irregular habits.
    • “The study adds to a growing understanding of the links between sleep and longevity. Research in recent years has shown not only how important sleep is for health and lifespan, but also that the duration of sleep isn’t the only thing that matters.”

From the U.S. healthcare business front,

  • Healthcare Dive points out,
    • “For-profit hospital operators strained by physician fees, payer relations in the third quarter of 2023. Except for HCA, the biggest U.S. health systems all reported lower year-over-year profits in the third quarter.”
  • and
    • “More than 85,000 Kaiser Permanente healthcare workers have a new four-year contract with the nonprofit system after union members overwhelmingly voted to ratify a compromise reached in October following months of labor negotiations and a high-profile strike.”
  • and
    • “Virgin Pulse announced on Thursday it closed its merger with third-party health plan administrator HealthComp. Private equity firms New Mountain Capital and Marlin Equity Partners are new majority and minority owners of the company, respectively, according to a release.”
  • Per Fierce Healthcare,
    • “Optum Rx is shifting eight different insulin products to its preferred formulary in a bid to address affordability, the company said Thursday.
    • “The product selection includes all rapid-acting and short-acting insulin products and some long-acting insulins, according to the announcement. It includes insulins manufactured by Sanofi, Novo Nordisk and Eli Lilly.
    • “Optum’s Tier 1 includes the lowest cash prices that its members will pay, the company said.”
  • and
    • A BCBSA study concludes that the Affordable Care Act’s risk adjustment system works, notwithstanding noteworthy failures.
  • The Wall Street Journal reports,
    • “AstraZeneca raised its full-year guidance for core earnings per share and total revenue excluding Covid-19 medicines despite a lower third-quarter profit that missed forecasts after booking a tax charge compared with a credit for the comparable period.
    • “The Anglo-Swedish pharmaceutical giant said Thursday that it expects core earnings per share to increase by a low double-digit percentage compared with previous guidance of a high single-digit to low double-digit percentage increase.
    • “Total revenue excluding COVID-19 medicines is now expected to increase by a low-teens percentage at constant-exchange rates compared with previous expectations of low double-digit percentage growth.
    • “Total revenue is expected to increase by a mid-single-digit percentage compared with previous guidance of low-to-mid single-digit, it said.”

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.”

Thursday Miscellany

David Ermer–ACA, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • STAT News reports
    • The shortage of cancer drugs is not going away, but it may be easing slightly, a new national survey suggests. Based on questions posed to 29 of its 33 member hospitals, the National Comprehensive Cancer Network said Thursday that 86% of those cancer centers are experiencing a shortage of at least one type of generic chemotherapy drug, down from 90% in May.
  • and adds
    • One of the top health care committees in the Senate is assembling ideas for bipartisan legislation to address drug shortages, three Senate aides and three lobbyists told STAT.
    • The talks, led by Senate Finance Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) are in the early days, but they could move the debate over drug shortage reforms into a new phase. The committee has jurisdiction over Medicare and Medicaid payment policies for hospitals. Other committees that have tried tackling the issue have jurisdiction mostly over the Food and Drug Administration.
  • Two law firms dive into regulatory issues that have puzzled the FEHBlog recently:
  • Miller and Chevalier makes the following observation about the recent federal court decision vacating an HHS rule permitting health plans to use manufacturer copay assistance accumulators. These accumulators prevent the manufacturer coupons from being counted toward out-of-pocket maximums.
    • “Following this ruling, it is unclear what rules will govern the use of co-pay accumulator programs. The prior agency rule, under which plans and issuers were allowed to exclude manufacturer co-pay assistance payments from deductible and out-of-pocket maximum calculations only if a generic drug was available and only to the extent permitted by state law, may be reinstated, but it suffers from the same issues that led the court to vacate the 2020 rule. The government may move for reconsideration of the court’s ruling or for a stay of the ruling, pending an appeal, and an appeal is expected. Further guidance from HHS and CMS is likely forthcoming in the interim. It should be noted that state laws prohibiting co-pay accumulator programs could be susceptible to ERISA pre-emption challenges, and the related guidance may spawn collateral litigation.” 
  • Proskauer explains how the ACA regulators used FAQ 61 to “press play” on the Transparency in Coverage Rule’s Prescription Drug Machine-Readable File Requirement.
    • “Prescription drug machine-readable file: Having concluded that the prescription drug machine-readable file requirement is sufficiently different from the separate CAA prescription drug reporting obligation, the Departments rescinded their prior delayed enforcement policy. The Departments state they intend to release future technical guidance with an implementation timeline that “sufficiently accounts” for prior reliance by plan sponsors on the deferred enforcement policy, suggesting that plan sponsors may have some lead time to gather the necessary information to post the file.
    • “In-network rate machine-readable file: Going forward, the Departments state they intend to exercise enforcement discretion on a case-by-case basis with respect to the requirement that in-network rates be expressed as dollar amounts for items and services covered by arrangements that make it difficult to express the cost as a dollar amount prior to receipt of the item or service.  Because the Departments do not mention future guidance or an implementation guideline, it appears that the revocation of this enforcement safe harbor is immediate.”
  • The Congressional Budget Office issued a call for new research in the area of obesity. In this regard, the Wall Street Journal observes
    • “Big food companies and investors are watching as Ozempic and other similar weight-loss drugs flow to millions of people, upending America’s diet industry and raising new questions about how consumers will eat. 
    • “Executives at food manufacturers from  Campbell Soup to Conagra Brands said they are fielding questions from investors about the drugs’ potential impact as internal teams start to assess consumer behavior and brainstorm ways to respond.
    • “The drugs, which suppress patients’ appetites, have exploded in popularity in the U.S., straining manufacturing capacity. 
    • “Morgan Stanley has projected that 24 million people, or nearly 7% of the U.S. population, will be taking such medications in 2035. 
    • “Those people could cut their daily calorie consumption by as much as 30%, according to the firm, which surveyed over 300 patients. For a person on a 2,000-calorie diet, that could mean eliminating a one-ounce bag of salted potato chips, a bottle of soda and more each day.”
  • Govexec points out,
    • “The Office of Personnel Management on Wednesday reminded federal agencies of recent changes to how to monitor and collect data on the usage of workplace flexibilities like telework and remote work, as the Biden administration prepares to increase in-person work across the federal government this fall.”

From the public health and research front,

  • NBC News tells us,
    • “So-called “good” HDL cholesterol may not be as healthy as experts once thought, a new study suggests. 
    • “The new study, published Wednesday in Neurology, found that having either high or low levels of high-density lipoprotein, or HDL, cholesterol, may increase the risk of dementia in older adults. It’s more evidence showing that keeping HDL cholesterol within a certain range is important for cardiovascular and brain health.  
    • “The relationship between HDL cholesterol and dementia is more complex than we previously thought,” said the study’s lead author, Erin Ferguson, a doctoral student studying epidemiology at the University of California San Francisco. “While the magnitude of this relationship is relatively small, it’s important,”
    • “The results show a correlation between HDL cholesterol and dementia, but do not prove that low or high levels of the lipid directly caused dementia.”
  • The Washington Post reports
    • “Using a host of high-tech tools to simulate brain development in a lab dish, Stanford University researchers have discovered several dozen genes that interfere with crucial steps in the process and may lead to autism, a spectrum of disorders that affects about one in every 36 Americans, impairing their ability to communicate and interact with others.
    • “The results of a decade of work, the findings published in the journal Nature may one day pave the way for scientists to design treatments that allow these phases of brain development to proceed unimpaired.”
  • Health Payer Intelligence points out
    • “Mortality rates among women and children grew between 2018 and 2021, emphasizing the importance of prioritizing preventive care and public health interventions, a report from the United Health Foundation shared.
    • “The America’s Health Rankings 2023 Women and Children Report analyzed data on 122 healthcare measures from 34 data sources. The findings reflect outcomes among women between 18 and 44 and children across the United States.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Froedtert Health plans to acquire full ownership of insurer Network Health from Ascension Wisconsin, the Milwaukee-based health system announced Tuesday. 
    • “The system agreed to buy the remaining 50% stake in the payer, which offers commercial and Medicare plans in 23 counties throughout the state, from Ascension Wisconsin. Froedtert originally acquired its stake in the company in 2014.
    • “Terms of the deal weren’t disclosed, and the health systems said a closing date will be determined after regulatory review and approval.”
  • and
    • “U.S.-based digital health startups raised $2.5 billion across 119 deals in the third quarter this year, marking the second-lowest quarter of funding since the fourth quarter in 2019, according to a report by consultancy and venture capital firm Rock Health.                    “Digital health startups have raised $8.6 billion in 365 deals so far this year, a little more than half of 2022’s total. The results cement a move toward decreased funding compared with pandemic boom years, the report found.                                                                                       “While funding and deal count has fallen significantly, trends have now stabilized for several quarters in a new normal for the digital health sector

Tuesday Tidbits

David Ermer–ACA, CMS, Generative AI, OPM, Telehealth–
Photo by Patrick Fore on Unsplash

From Washington DC,

  • Govexec.com offers an interview with OPM’s Deputy Director Rob Shriver.
  • The American Hospital Association informs us
    • “The Centers for Medicare & Medicaid Services will select up to eight states to participate in a new voluntary all-payer model that aims to curb health care cost growth, improve population health, and advance health equity by reducing disparities in health outcomes. CMS plans to detail requirements for the States Advancing All-Payer Health Equity Approaches and Development Model in a funding opportunity notice this fall. Participating states will receive up to $12 million each to implement the model during one of three start dates, with the model concluding in December 2034. CMS expects to begin the pre-implementation period for the first cohort next summer. The model will build on best practices from the Maryland Total Cost of Care model, the Pennsylvania Rural Health Model, and the Vermont All-Payer ACO Model.

From Harrisburg, PA,

  • The Pennsylvania Department of State announced,
    • “Starting Sept. 5, 2023, registered nurses and licensed practical nurses from other states who hold multistate licenses through the Nurse Licensure Compact m(NLC) will be able to provide in-person and telehealth services to PA patients. * * * Pennsylvania nurses will be able to apply for a multistate license once the compact has been fully implemented.”
  • Here is a link to nurse.org’s “Compact Nursing States List 2023,” which now includes forty states, Guam, and the Virgin Islands.
  • This type of licensing flexibility should help with nursing shortages.

From the Affordable Care Act front, Beyond the Basics provides an updated guide to minimum essential coverage.

From the generative AI front, STAT News now provides a tracking service that serves as a guide to health systems and companies driving the adoption of this important new technology.

Speaking of technology,

  • BioPharma Dive reports
    • “Beam Therapeutics has begun human testing in the U.S. of a first-of-its-kind gene editing medicine for cancer, the company said Tuesday.
    • “Beam, a pioneering developer of a precise gene editing technique known as base editing, said in a short statement that it’s dosed its first patient in a study of the treatment, called BEAM-201. The trial involves patients with an aggressive form of blood cancer known as T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma, or T-ALL/T-LL. It will eventually enroll about 100 participants, according to a federal database.
    • “The study’s start makes BEAM-201 the first base editing therapy to enter clinical testing in the U.S., and marks the first time patients have received a cell therapy made by “multiplex editing,” in which several genes are edited. The edits are designed to eliminate expression of four genes known as CD7, TRAC, PDCD1 and CD52.
    • “Beam claims this approach could lead to a more powerful and durable treatment. In its statement, the company noted BEAM-201’s potential to sidestep a variety of issues associated with cell therapies, like propensity for the modified cells to kill one another, or become weaker as time goes on.
    • “Beam also believes the simultaneous edits could yield a more potent donor-derived, or “off the shelf,” cell therapy. Such allogeneic treatments would be more convenient than the personalized CAR-T therapies on the market, but results to date haven’t proven they’re more powerful at killing cancer cells.”
  • Very Buck Rogers.

From the telehealth front,

  • Per Healthcare Dive,
    • “Approximately one-third of behavioral health patients seeking therapy or medication visits said their clinicians did not offer both telehealth and in-person care, according to a study from nonprofit research organization Rand.
    • “The study, published on Tuesday in Health Affairs, revealed that 45% of behavioral health patients did not believe their clinicians considered their preferences for virtual or in-person care. In addition, 32% of respondents said they did not receive their preferred method of treatment.
    • “Despite the lack of choice offered by providers, many patients undergoing behavioral health therapy preferred in-person visits due to the personal nature of the treatment, the ability to build a rapport with providers, and fears around data security and privacy, the report found.”
  • Such reports explain why hub and spoke telemental services are not a solution for mental health parity.

From the human resources front,

  • The Society for Human Resource Management advises,
    • Even though [last week’s] proposed overtime rule is likely to be challenged in court after it is finalized, employers should start examining how it will affect their workplaces, legal experts say.
    • “I don’t think businesses should act now and make concrete changes,” said Jeff Ruzal, an attorney with Epstein Becker Green in New York City. “A preliminary injunction is likely” after the rule is finalized, he said, but employers “should study and audit the workplace” and prepare for the rule to possibly take effect. They should analyze who is exempt and nonexempt and plan for complying “without jeopardizing the business or payroll.”