Thursday Miscellany

Obesity

Thursday Miscellany

David Ermer–CDC, CMS, Congress, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Think Advisor lets us know,
    • “The U.S. House of Representatives voted 211-208 on Wednesday to pass H.R. 485, the Protecting Health Care for All Patients Act of 2023.
    • “The bill would prohibit federal health programs — including Medicare, Medicaid and the Federal Employees Health Benefits Program — from using a “quality-adjusted life year” measure or similar measures when allocating resources.
    • “All Republicans who voted supported the bill, and all Democrats who voted opposed it.
    • “The bill was introduced by Rep. Cathy McMorris Rodgers, R-Ore.”
  • Roll Call reports,
    • “House Energy and Commerce Chair Cathy McMorris Rodgers, a 10-term Republican from Washington state who has been a strong advocate for people with disabilities, announced Thursday she would not seek reelection this year.
    • “It’s been the honor and privilege of my life to represent the people of Eastern Washington in Congress. They inspire me every day,’’ Rodgers said in a statement. “After much prayer and reflection, I’ve decided the time has come to serve them in new ways. I will not be running for re-election to the People’s House.”
    • “The announcement comes as Rodgers is leading negotiations with the Senate on a wide-ranging health care package that touches all parts of the industry. The legislation would implement more transparency in data and pricing for prescription drugs and other medical services.”
  • BioPharma Dive informs us,
    • “The CEOs of three major drugmakers defended the prices they charge U.S. patients in a Senate [Health Education Labor and Pensions] committee hearing Thursday, claiming Americans gain access to cutting-edge medicines months or years earlier than people in countries that pay a fraction of the U.S. costs. * * *
    • “Sen. Ben Ray Luján, D-N.M., asked the CEOs to pledge to not block entry of generics or biosimilars to the respective drugs in the spotlight when their primary patents expire, which Merck and Bristol Myers agreed to. That question in the case of Bristol Myers Squibb was focused Opdivo, its cancer immunotherapy rival to Keytruda.
    • “For Merck, Davis committed to open competition with any forthcoming biosimilars of intravenous Keytruda. But he didn’t mention the company is trying to develop and launch a subcutaneous, or under-the-skin, version that would likely extend its market advantage beyond the anticipated 2028 expiration of its main patent. Bristol Myers is also working on subcutaneous Opdivo.
    • “Questioned by Luján on settlements that have pushed the launch of biosimilar Stelara to 2025, J&J’s Duato said the price of the drug will be lower when that happens and added that prices net of rebates have dropped ahead of biosimilar competition.”
  • Bloomberg reports,
    • “The pharmaceutical industry, Trump and Obama administration officials, and others are urging the Biden administration to reconsider a controversial plan for seizing patents on a drug when its cost gets too high, claiming the approach misinterprets decades-old law and threatens the delicate pipeline that produces innovative, life-saving drugs.
    • “Over 500 comments were filed by the Feb. 6 deadline for groups and individuals to weigh in on the Biden administration’s framework for the federal government to use its march-in rights. The proposal lays out the Biden administration’s stance in a longstanding debate over whether price is a justifiable reason for the government to “march in” and take over a patent on technology developed with the help of taxpayer dollars and then license it to an outside manufacturer.
    • “The Biden plan is already drawing blowback from a broad swath of players in the innovation space. A collection of former US Patent and Trademark Office directors and other government officials under the George W. Bush, Obama, and Trump administrations wrote to warn that the proposed framework, if adopted, would prove destabilizing.”
  • Per an HHS press release
    • “The Department of Health and Human Services’ Office of Intergovernmental and External Affairs (IEA) will be hosting a stakeholder webinar TOMORROW, February 9, 2024, from 2 – 3 PM ET to provide an update on patient privacy.  
    • “Today, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), finalized modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR part 2 (“Part 2”), which protect the privacy of patients’ SUD treatment records. Specifically, today’s final rule increases coordination among providers treating patients for SUDs, strengthens confidentiality protections through civil enforcement, and enhances integration of behavioral health information with other medical records to improve patient health outcomes.
    • “Today’s rule was informed by the bipartisan Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that, among other things, required HHS to bring the Part 2 program into closer alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Breach Notification, and Enforcement Rules.
    • “The final rule includes the following modifications to Part 2:
      • “Permits use and disclosure of Part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations.
      • “Permits redisclosure of Part 2 records by HIPAA covered entities and business associates in accordance with the HIPAA Privacy Rule, with certain exceptions.
      • “Provides new rights for patients under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
      • “Expands prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings.
      • “Provides HHS enforcement authority, including the potential imposition of civil money penalties for violations of Part 2.
      • “Outlines new breach notification requirements applying to Part 2 records.”
    • “A fact sheet on the final rule may be found at: https://www.hhs.gov/hipaa/for-professionals/regulatory-initiatives/fact-sheet-42-cfr-part-2-final-rule/index.html“
    • Register in advance for this webinar: REGISTER HERE  
  • Govexec tells us,
    • “The U.S. Postal Service was $2 billion in the red in the first three months of fiscal 2024—typically its busiest and most profitable period of the year—doubling its loss from the same period in the previous year. 
    • “The accelerated losses during the holiday season continue a longstanding trend of poor financial performance for the mailing agency, but mark a troubling sign as its leadership team undertakes significant operational transformations with a promise to right the ship.
    • “In a positive development, however, USPS turned a net profit of $472 million when accounting only for the part of the ledger postal management deems within its control. That figure, which does not include fluctuations in workers’ compensation and amortized payments toward employee retirement accounts, grew from $187 million in the first quarter of the prior year.” 
  • The U.S. Office of Personnel Management announced,
    • “[t]he Finalists for this year’s Presidential Management Fellows (PMF) Program, the federal government’s premier leadership development program. In total, 825 Finalists were selected from more than 7,000 applicants from around the world. 
    • “Presidential Management Fellows are the next generation of federal government leaders,” said Kiran Ahuja, Director of OPM. “The PMF Program gives Fellows the leadership skills and exposure they need to make a difference in government and an impact within their community. Congratulations to all the 2024 PMF finalists. We cannot wait to see what you will accomplish in public service.” 

From the public health and medical research front,

  • Medscape points out,
    • “Brain fog is one of the most common, persistent complaints in patients with long COVID. It affects as many as 46% of patients who also deal with other cognitive concerns like memory loss and difficulty concentrating. 
    • “Now, researchers believe they know why. A new study has found that these symptoms may be the result of a viral-borne brain injury that may cause cognitive and mental health issues that persist for years.
    • “Researchers found that 351 patients hospitalized with severe COVID-19 had evidence of a long-term brain injury a year after contracting the SARS-CoV-2 virus. The findings were based on a series of cognitive tests, self-reported symptoms, brain scans, and biomarkers.” 
  • STAT News reports,
    • “People receiving a double dose of naloxone are no more likely to survive an opioid overdose than people receiving a standard, 4-milligram nasal spray, according to a new study.
    • “The new paper, published Thursday in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, showed no significant difference in survival rates between people who were revived using 4- and 8-milligram sprays of naloxone, commonly known by the brand name Narcan. People receiving the smaller dose also did not require a higher total number of sprays, despite having received just half the initial amount. The researchers found only one major contrast between those receiving different dose sizes: Those who received a double dose were over 2.5 times more likely to experience severe withdrawal symptoms, like vomiting.
    • “The study comes as pharmaceutical companies continue to market expensive high-dose formulations of naloxone, arguing that amid record drug death levels resulting from potent synthetic opioids like fentanyl, it’s essential to deliver as much of the overdose-reversal medication as possible. Public health experts and harm-reduction groups have pushed back, however, charging that the companies have used Americans’ fear of fentanyl as an excuse to sell needlessly expensive naloxone products to cash-strapped public health agencies.”
  • Beckers Hospital Review reports,
    • “Patients who take Ozempic, Mounjaro and Wegovy are less likely to be diagnosed with anxiety or depression compared to those who don’t receive the popular diabetes and weight loss drugs, according to a new study. 
    • “A review of more than 4 million patient records conducted by Epic Research found that diabetic patients are less likely to have anxiety if they are taking any glucagon-like peptide-1 receptor agonist. 
    • “The researchers analyzed five different GLP-1s: tirzepatide (Mounjaro, Zepbound), semaglutide (Ozempic, Wegovy, Rybelsus), dulaglutide (Trulicity), liraglutide (Saxenda, Victoza) and exenatide (Byetta, Bydureon). 
    • “The patients taking GLP-1s for weight loss were compared with those receiving another kind of weight loss drug, and diabetic patients were compared with people not taking a GLP-1.”
  • The American Hospital Association News notes how you can “[l’earn how hospitals and health systems are improving maternal and child health outcomes in this synopsis of the latest resources from AHA’s Better Health for Mothers and Babies initiative. READ MORE.”
  • The NIH Director discusses in her blog “What’s Behind that Morning Migraine? Community-Based Study Points to Differences in Perceived Sleep Quality, Energy on the Previous Day.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • AstraZeneca sees its revenue and core earnings per share growing by double-digit percentages in 2024, the pharmaceuticals major said as it reported fourth-quarter core earnings per share below expectations on higher costs, sending the stock lower.
  • CNBC discusses how “Novo Nordisk, Eli Lilly are tackling weight loss drug supply woes.”
    • “Last week, the Danish drugmaker [Novo Nordisk] said it had more than doubled its supply of lower-dose versions of its weight loss injection Wegovy in January compared to previous months. Supply shortages forced Novo Nordisk to restrict the availability of those lower doses in the U.S. since May. 
    • “But why are those lower doses important? It’s because people are supposed to start Wegovy at a low dose and gradually increase the size over time to mitigate side effects such as nausea. So, more of those low “starter” doses means more new patients can begin treatment with Wegovy. 
    • “The company plans to “gradually” increase the overall supply of Wegovy throughout the rest of the year, executives added on the company’s fourth-quarter earnings call Wednesday.”
  • Per Healthcare Dive,
    • “UnitedHealth’s chief operating officer Dirk McMahon is retiring after more than two decades at the company.
    • “McMahon plans to retire on April 1, the payer said in a Wednesday filing with the Securities and Exchange Commission on Wednesday.
    • “UnitedHealth has yet to name a replacement for McMahon.”
  • and
    • “Walgreens has named a new head of its healthcare unit as the pharmacy chain works to improve its halting finances and shift to delivering more healthcare services.
    • “John Driscoll, the current executive vice president and president of the U.S. Healthcare segment, will be replaced by Mary Langowski, who previously held the chief executive role at chronic condition management company Solera Health. Driscoll will serve in a senior advisory role, Walgreens announced Thursday.”
  • and
    • “Molina Healthcare lost half a million Medicaid members due to redeterminations by the end of 2023, executives said Thursday.
    • “States resumed checking beneficiaries’ eligibility for the safety-net program in April following a pause during the COVID-19 public health emergency. Some 16 million Americans have been disenrolled from Medicaid to date because of the redeterminations. The process is disproportionately impacting insurers with a heavy Medicaid presence like Molina, which brings in 80% of its revenue from the program.
    • “Molina still expects to retain 40% of its Medicaid membership once redeterminations are complete. However, on Thursday the insurer raised its estimate of members gained during COVID from 800,000 to 1 million because of new business adds. That implies a net member loss of 600,000 once redeterminations are complete.” 
  • and
    • “Tenet Healthcare beat Wall Street expectations for revenue in the fourth quarter of 2023 on continued cost control measures and sustained demand for services, particularly in its ambulatory care unit, executives said during an earnings call on Thursday.
    • “CEO Saum Sutaria told investors that Tenet was entering a “new era” in which a higher proportion of its performance was generated by its ambulatory surgical business. Same-facility revenue for ambulatory services grew 9.2% during 2023, above Tenet’s long-term goal of 4% to 6% top line growth.
    • “The Dallas-based for-profit will continue a careful watch on its debt levels, executives said. The company has recently taken steps to reduce its leverage, last week finalizing the sale of three hospitals to Novant Health and announcing the sale of four additional hospitals to UCI Health.”
  • Beckers Payer Issues discusses why it appears that insurers are split in two camps over rising Medicare Advantage costs.

Tuesday’s Tidbits

David Ermer–CDC, Congress, FDA, Medical / Rx research, NCQA, Obesity, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The FEHBlog listened to the House Oversight and Accountability Committee’s markup of HR 6283, the Delinking Revenue from Unfair Gouging Act. Is there such as thing as fair gouging? In any case, the FEHBlog was relieved by the amount of bipartisan opposition to the bill. However, as explained in this STAT News article, the Committee Chairman James Comer (R Ky) steered an amended version of the original bill through his Committee this morning. Like Committee members with doubts about the bill, the FEHBlog looks forward to the Congress Budget Office report on the measure.
  • The American Hospital Association (AHA) News reports
    • “In a statement submitted to the House Ways and Means Committee for a hearing Feb. 6 on chronic drug shortages, AHA recommended Congress enact legislation to diversify manufacturing sites and sources for critical pharmaceutical ingredients; support an increase in end-user and supply chain inventories for critical medications; develop a rating system for drug maker quality management processes; identify essential drugs needing more domestic manufacturing capacity; and require drug makers to disclose where their products are made and when demand for essential drugs spikes.” 
  • and
    • “The Health Resources and Services Administration Feb. 6 requested vendor proposals to support changes to governance, technology and operation of the Organ Procurement and Transplantation Network, as authorized by Congress last year. HRSA also directed the current OPTN vendor, the United Network for Organ Sharing, to standardize and update data reporting for greater accountability and equity in organ procurement and transplant practices. HRSA indicates that the scope and scale of the contract awards will be contingent on final 2024 appropriations.”
  • The Department of Health and Human Services announced,
    • releasing the National Public Health Strategy to Prevent and Control Vector-Borne Diseases in People (VBD National Strategy). As directed by the 2019 Kay Hagan Tick Act—named after the U.S. Senator who died due to complications from a tickborne illness—HHS led a four-year process with civilian agencies and defense departments to deliver this strategy. Co-led by the HHS Office of the Assistant Secretary for Health and the Centers for Disease Control and Prevention, the strategy identifies and describes federal priorities to detect, prevent, respond to, and control diseases and conditions caused by vectors in the United States.
    • “Vector-borne diseases are a global threat, with national security, economic, and health implications for the United States. As the federal government continues to proactively strengthen its response to this threat, HHS and CDC plan to develop future iterations of the VBD National Strategy with opportunities for public engagement. Read the VBD National Strategy.”
  • Beckers Hospital Review tells us,
    • “Respiratory syncytial virus vaccinations could soon extend to adults aged 50-59. 
    • “Arexvy, which was initially approved by the FDA in May 2023 for administration in adults over 60, has been granted priority review in the U.S. for use in adults ages 50-59.
    • “If approved, it will become the first RSV vaccine available for the age group, according to a Feb. 6 news release. 
    • “The FDA is slated to make a decision on the drug’s approval for the new age group by June 7.”

From the public health and medical research front,

  • Medscape informs us,
    • “Lowering the recommended age for baseline prostate-specific antigen (PSA) would reduce prostate cancer deaths by about 30% in Black men without significantly increasing the rate of overdiagnosis, according to new screening guidelines from the Prostate Cancer Foundation.
    • “Specifically, baseline PSA testing in Black men should begin at age 40-45, sooner than current guidelines recommend, and should be followed by regular screening intervals, preferably annually, at least until age 70, a multidisciplinary panel of experts and patient advocates determined based on a comprehensive literature review.”
  • Per the Food and Drug Administration,
    • On Monday, the FDA issued an outbreak advisory warning consumers not to eat, sell, or serve recalled brands of cheeses, sour creams (cremas), or yogurts manufactured by Rizo Lopez Foods, Inc. The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multi-year, multistate outbreak of Listeria monocytogenes infections linked to queso fresco and cotija cheeses manufactured by Rizo Lopez Foods, Inc., of Modesto, California. There are 26 illnesses with 23 hospitalizations in 11 states. The firm has recalled several dairy products and has temporarily ceased the production and distribution of these products while their investigation is ongoing. The FDA’s investigation is ongoing, and the FDA will continue to update this advisory as information becomes available.”
  • Per KFF,
    • “About 1 in 5 adolescents report symptoms of anxiety or depression, according to a KFF analysis of a new federal survey of teen health.
    • “While some teens are getting mental health care, a significant share say they are not receiving the therapy they need due to costs, fear of what others will think, and/or not knowing how to get help.”
  • The American Medical Association lets us know what doctors wish their patients knew about iron deficiency.
  • Healio notes,
    • “Infants aged younger than 3 months and children with a history of prematurity experience the highest rates of hospitalization for respiratory syncytial virus, according to study findings published in Pediatrics.
    • “Last year, two new tools became available to combat RSV, the leading cause of infant hospitalization in the United States: a vaccine for pregnant people and a new monoclonal antibody.” * * *
    • “Most RSV-associated hospitalizations occurred in healthy, term infants,” Meredith L. McMorrow, MD, MPH,a researcher in the CDC’s Coronavirus and Other Respiratory Viruses Division said. “This is why allbabies need protection from either maternal RSV vaccination or nirsevimab during their first RSV season.”
  • Beckers Hospital Review offers five Ozempic updates.

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Sales of Eli Lilly’s diabetes drug Mounjaro exceeded $5 billion in 2023, its first full year on the market, the company said Tuesday, in the latest sign of surging demand for the therapy and other medicines of its kind.
    • “Mounjaro’s fast launch helped drive Lilly’s revenue last year to $34 billion, a 20% increase over 2023. Fourth quarter revenue of $9.4 billion eclipsed analysts’ consensus expectations by 5%, Leerink Partners’ David Risinger wrote in a note to clients.
    • “Lilly said Mounjaro now accounts for 27% of total prescriptions in the U.S. for injectable “incretins,” the fast-selling group of drugs that work by modulating hormones that control insulin production. Sales of an older drug in this class, Lilly’s Trulicity, fell 4% in 2023 to $7 billion, but still led Lilly’s business.
    • “The obesity drug Zepbound, which contains the same active ingredient as Mounjaro, launched in the fourth quarter and brought in sales of $176 million through Dec. 31.”
  • STAT News adds,
    • “Eli Lilly reported during its fourth-quarter earnings call that tirzepatide, which is sold commercially as Mounjaro or Zepbound, succeeded in a Phase 2 test as a treatment for the liver disease MASH. Around 74% of adults in the trial taking the drug were free of MASH after 52 weeks, compared to approximately 13% of the placebo group.”
  • Wait, there’s more from Bloomberg,
    • “Eli Lilly & Co.’s blockbuster diabetes drug Mounjaro, which is commonly used off-label for weight loss, is again in short supply due to increased demand.
    • “There will be limited availability of higher doses of the treatment through early March, according to a US Food and Drug Administration database that tracks shortages. So far, the FDA doesn’t list Mounjaro’s sister drug Zepbound, which is approved for weight loss, on its shortage list, though the two contain the same active ingredient.
    • “The company is continuing to ship all doses to wholesalers, but anticipates intermittent backorders of higher doses over the next month, a Lilly spokesperson said in an emailed statement. 
    • “We recognize this situation may cause a disruption in people’s treatment regimens and we are moving with urgency to address it,” the spokesperson said.”
  • BioPharma Dive points out
    • “The Japan-based pharmaceutical firm Eisai had hoped that, by the end of March, 10,000 patients in the U.S. would be taking its closely watched drug for Alzheimer’s disease. But that goal now seems lofty, following updates in the company’s latest earnings report.
    • “Eisai developed the drug, called Leqembi, in partnership with Biogen, and is leading its commercialization. As with an earlier Alzheimer’s therapy from the two companies, Leqembi’s launch started off slow. Yet Eisai and Biogen have argued that recent decisions from drug regulators and insurers should significantly increase both prescriptions and sales.
    • “Still, growth doesn’t appear to be coming as quickly as the companies want. Eisai recorded 1.1 billion yen, or roughly $7.4 million, in revenue from Leqembi between October and December — around half of what Wall Street analysts had generally expected, according to Michael Yee of the investment bank Jefferies.
    • The company also said Leqembi had been administered to a total of 2,000 U.S. patients as of Jan. 26, with another 8,000 or so on a waiting list. Eisai maintains the 10,000 patient milestone could be hit in a few months, though the team at Jefferies believes it might take longer “given launch dynamics have been slow to begin with.”
  • Beckers Hospital Review reports,
    • “San Francisco-based UCSF Health has signed a $100 million definitive agreement with San Francisco-based Dignity Health to take on two of its hospitals: Saint Francis Memorial Hospital and St. Mary’s Medical Center, both of which are in the city.”San Francisco-based UCSF Health has signed a $100 million definitive agreement with San Francisco-based Dignity Health to take on two of its hospitals: Saint Francis Memorial Hospital and St. Mary’s Medical Center, both of which are in the city.
    • UCSF Health began acquisition talks with Dignity Health, part of Chicago-based CommonSpirit Health, for the two hospitals in July. 
    • “Under the acquisition, which UCSF Health hopes to close by this spring, the hospitals will be renamed UCSF Health Saint Francis Hospital and UCSF Health St. Mary’s Hospital, respectively, according to a Feb. 5 UCSF news release.”
  • Per Healthcare Dive,
    • “Providence will refund payments and forgive outstanding medical debt for nearly 100,000 low-income Washington residents to settle a 2022 lawsuit alleging the health system skirted its charity care obligations, according to a Thursday announcement from Washington Attorney General Bob Ferguson.
    • “The Renton, Washington-based operator will refund approximately $20 million to over 30,000 patients who were billed improperly and forgive $137 million for more than 65,000 additional patients, in what the AG called the “largest resolution of its kind in the country.”
    • “The settlement is the latest win for the AG, who has successfully brought other health systems into compliance with the state’s charity care law, which offers reduced or free medical care for approximately half of Washingtonians based on financial status.”
  • and
    • “Centene has become the second major health insurer to warn investors of an impending funding decrease in Medicare Advantage — if regulators finalize 2025 rates as proposed.
    • “New payment parameters released by the CMS last week would cause Centene’s MA rate to fall 1.3%, CFO Drew Asher said during a Tuesday morning call discussing the payer’s fourth-quarter earnings results.
    • “However, this dip is before Centene risk scores its enrollees, a process which should result in an overall increase in MA reimbursement next year, Asher said. Humana disclosed similar concerns in a filing with the Securities and Exchange Commission on Monday.”

Monday Roundup

David Ermer–AHRQ, CDC, FDA, Generative AI, Medical / Rx research, Obesity, Patient safety, SDOH, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Tomorrow at 10 am, the House Oversight and Accountability Committee will mark up several bills including the FEHB provisions in the DRUG Act, HR 6283. It’s unfortunate that the Committee did not hold a hearing on this disruptive bill. The FEHBlog will be listening to the markup.
  • The Federal Times informs us,
    • “A pair of contracts designed to improve the quality of care in Tricare’s civilian medical networks will take effect Jan. 1, 2025, according to defense officials.
    • “The contracts are moving forward following a Jan. 31 decision in the U.S. Court of Federal Claims affirming the Defense Health Agency’s choice of TriWest Healthcare Alliance as the Tricare West Region’s new manager, denying a protest lodged by incumbent contractor Health Net Federal Services last year.  * * *
    • “Humana Government Business, the incumbent contractor for Tricare’s East Region, will continue in that role under a new deal worth up to $70.8 billion.The new contracts for the two regions have a potential combined value of $136 billion over nine years.”
  • MedTech Dive lets us know
    • “FDA panel recommends new standards for pulse oximeters amid bias concerns.
    • “Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care.”
  • and
    • “Hologic has received regulatory clearance to sell an artificial intelligence (AI)-enabled cervical cancer screening system in the U.S. 
    • “The product, the Genius Digital Diagnostics System, creates digital images of Pap test slides and uses an AI algorithm to identify cells that cytologists and pathologists should review.
    • “Hologic’s clearance, announced on Thursday, comes days after BD partnered with Techcyte to promote a digital, AI-enabled cervical cancer screening test that is yet to come to market.”

From the public health and medical research front,

  • Beckers Hospital Review tells us,
    • “Eli Lilly’s ingredient for Type 2 diabetes medication Mounjaro and its new weight loss drug, Zepbound, significantly lowered patients’ blood pressure by up to 10.6 mmHg, according to a new study published Feb. 5. 
    • “The study recruited about 500 adult patients with a body mass index at or more than 27, or the overweight range. Compared to a placebo, tirzepatide — the active pharmaceutical ingredient of Mounjaro and Zepbound — reduced blood pressure for participants taking 5, 10 and 15 milligrams each week. The patients were not diabetic and either had normal blood pressure or high blood pressure that was under control.” 
  • STAT News reports,
    • “Amgen is trying a unique strategy with its obesity drug candidate: testing whether it can wean patients toward lower or less frequent doses over time.
    • “Very early data hints that Amgen’s candidate, called MariTide, may provide longer-lasting weight loss than highly popular obesity drugs on the market like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. Amgen is already seeing if that means its drug could also be dosed differently from Novo and Lilly’s products, which are costly and expected to be taken consistently for life.
    • “In an ongoing Phase 2 trial, Amgen’s researchers will first titrate participants up on MariTide, but then after some time, see if the drug can still be effective when transitioning patients to a less intensive dosing regimen, executives said in an interview.
    • “Could there be an opportunity for an induction maintenance-type of strategy for a molecule like MariTide?” said Narimon Honarpour, senior vice president of global development at Amgen, referring to a strategy used for anti-inflammatory drugs in which high, rapid doses are given at the start and then lower or less frequent doses are used for maintenance in the long run.”
  • HHS’s Agency for Healthcare Research and Quality released a rapid evidence report about deprescribing to reduce medical harms in older adults.
    • “Deprescribing has emerged as a clinical practice to reduce polypharmacy and use of potentially inappropriate medications (PIMs) and serve as a mechanism for quality improvement and increased patient safety. The purpose of this rapid response is to summarize recent literature on the use of deprescribing to improve the safety of medication use among older adults (age ≥ 65 years).”
  • CBS News reports,
    • “Preterm and early-term births in the U.S. have increased from 2014 to 2022, raising risks to babies, according to new data from the Centers for Disease Control and Prevention.
    • “Data released Wednesday from the CDC’s National Center for Health Statistics shows the preterm birth rate — meaning delivery before 37 completed weeks of pregnancy — rose 12% during that time period, while early-term birth rates, at 37 to 38 completed weeks, rose 20%. 
    • “This is compared to full-term births, which are those delivered at 39 to 40 weeks.
    • “Using data from the National Vital Statistics System, the analysis only looks at singleton births, since multiple births like twins and triplets tend to be born at earlier gestational ages, the authors note.
    • “Gestational age is a strong predictor of short- and long-term morbidity and early mortality,” the authors write. “Births delivered preterm are at the greatest risk of adverse outcomes, but risk is also elevated for early-term compared with full-term births.”
  • MedCity News points out,
    • “Mayo Clinic has entered into a collaboration with TruLite Health — Mayo is helping the Phoenix-based startup develop its software platform designed to address providers’ clinical bias. The health system said it chose to collaborate with TruLite because of the platform’s potential to mitigate health inequities and enhance patient outcomes at the point of care.”
  • Per Fierce Healthcare,
    • “Artificial intelligence can help identify easy to miss patients who might be good candidates for a palliative or hospice care referral, a recent pilot at Mass General Brigham (MGB) revealed.
    • “The results of the findings were presented Friday at the Value-Based Payment Summit.
    • “Timely end-of-life care benefits patients. Patients and their families may also be more open to a conversation about goals of care during a hospital stay, MGB said in presentation slides shown to Fierce Healthcare.” 

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Novo Holdings, the controlling shareholder of Danish drugmaker Novo Nordisk, will buy contract manufacturer Catalent for $16.5 billion in a take-private deal the companies announced Monday.
    • “In a related transaction, Novo Nordisk has agreed pay its parent company $11 billion to take over three Catalent plants in Italy, Belgium and Indiana to help expand production of its GLP-1 drugs Ozempic and Wegovy. Demand for the latter, which is approved in the U.S. for treating obesity, has greatly exceeded supply, forcing Novo Nordisk to restrict access.
    • “Novo Nordisk and Catalent already work together at the three sites, which employ more than 3,000 staff.”
  • and
    • “On Monday, Johnson & Johnson said one of its most closely watched experimental medicines appears to have positive effects on two autoimmune diseases, providing further support to a drug that, by the company’s estimates, could eventually generate billions of dollars in annual sales.
    • “J&J didn’t release any data, but rather said the drug hit the main goals of a mid-stage clinical trial testing it in patients with Sjögren’s disease as well as a late-stage study focused on generalized myasthenia gravis, a rare condition known in short as gMG. The company plans to present more detailed results from both studies at upcoming medical meetings, and to engage with regulators about the path to approval in gMG.”
  • Per Healthcare Dive,
    • “Cano Health filed for Chapter 11 bankruptcy late Sunday, as the beleaguered primary care chain works to bolster its financials. 
    • “The filing is part of a restructuring support agreement with the majority of its lenders. Cano said it expects to emerge from restructuring during the second quarter this year, adding that the process will help it reduce debt and allow it to search for a strategic partner or buyer.
    • “Cano also announced it reached an agreement to receive $150 million in debtor-in-possession financing to fund its operations during restructuring.”
  • and
    • “Medicare Advantage rate changes proposed by regulators last week are upsetting Humana’s funding expectations for 2025.
    • “If finalized as proposed, the MA changes will lower Humana’s benchmark funding by around 160 basis points compared to a flat rate environment, the health insurer disclosed in a filing with the Securities and Exchange Commissionon Monday.
    • “The discrepancy is because the CMS didn’t factor in persistently elevated medical costs into how it calculates rates, Humana said. However, regulators could do so in the final rule. Despite the uncertainty, the insurer reaffirmed its earnings outlook for 2025.”
  • Per Fierce Healthcare,
    • “Rural providers feel financially stable, with most planning to expand existing service lines to increase revenue, a new survey has found (PDF).
    • “The survey was conducted by accounting firm Wipfli and reached 106 rural healthcare organizations across 26 states. Respondents included a mix of critical access hospitals, rural health clinics and others.
    • “Overall, most respondents are cautiously or completely optimistic about their financial viability. About 40% said their financial stability is higher than it was a year ago, and the portion of those who think they are in a better place than they were five years ago also rose compared to 2023. Despite challenges like high inflation, dwindling COVID-19 relief funds and flat reimbursement rates, growing optimism suggests rural providers learned how to manage unpredictability during the pandemic, the report said. * * *
    • Entering 2024, rural healthcare leaders are most concerned about revenue capture, digital capabilities and people management.
  • HR Morning offers nine tips on maximizing core health benefits.
  • The Society for Human Resource Management discusses best practices for hybrid work models.

Midweek update

David Ermer–Congress, COVID treatment, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call informs us
    • “House leadership smoothed the path for consideration of a $78 billion family and business tax break deal Wednesday by committing to a floor vote as soon as next week on a separate bill to boost the state and local tax deduction cap for married couples.”
  • and later
    • “The House on Wednesday night passed a $79 billion family and business tax break bill after several days of uncertainty, teeing it up for consideration in the Senate. 
    • “The package negotiated by House Ways and Means Chairman Jason Smith, R-Mo., and Senate Finance Chair Ron Wyden, D-Ore., easily mustered the two-thirds majority needed to pass, despite GOP drama earlier in the week and previous criticism from Democrats. 
    • “It’s a strong, commonsense, bipartisan step forward in providing urgent tax relief for working families and small businesses,” Smith said on the floor ahead of the 357-70 vote. “Parents in Main Street communities across this country will see lower taxes, more opportunity and greater financial security after we pass this legislation.”
  • Here is a link to today’s hearing held by the House Energy and Commerce Committee’s Health Subcommittee about national healthcare expenditures.
  • Fierce Healthcare tells us,
    • “Medicare Advantage (MA) payments are set to decrease yet again in 2025 as the feds phase in significant changes to risk adjustment.
    • “As those overhauls begin to take effect, benchmark payments are set to decline by about 0.2% on average, according to the latest advance notice released by the Centers for Medicare & Medicaid Services (CMS).
    • “Despite this, the feds said Wednesday that payments to MA plans are expected to increase by 3.7% in 2025, a $16 billion increase over 2024. The payment rate announced today could change by the time the final rate announcement is published, no later than April 1.”
  • The CY 2025 Advance Notice may be viewed by going to: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents and selecting “2025 Advance Notice.”
  • A fact sheet discussing the provisions of the CY 2025 Advance Notice, as well as frequently asked questions, can be viewed here: https://www.cms.gov/newsroom/fact-sheets/2025-medicare-advantage-and-part-d-advance-notice-fact-sheet.
  • Beckers Payer Issues adds,
    • “A bipartisan group of lawmakers is urging CMS to maintain “payment and policy” stability in Medicare Advantage. 
    • “In a letter to CMS Administrator Chiquita Brooks-LaSure, the group of 60 senators asked the agency to “consider the ongoing implementation of program reforms finalized last year and provide stability for the Medicare Advantage program in 2025.”  * * *
    • “The letter comes after two lawmakers, Sen. Elizabeth Warren and Rep. Pramila Jayapal, wrote to the agency urging more action on curbing overpayments to the program. 
    • “Read the full letter here. “
  • Today, OPM posted on the Federal Register website a proposed FEHB rule that “would allow FEHB and PSHB coverage to become effective at the beginning of the pay period that the employee in pay status has an initial opportunity to enroll. This change would occur when the employee becomes eligible for FEHB or PSHB coverage, provided an appropriate request to enroll is received by the employing office within the initial pay period that the employee becomes eligible.”
  • American Hospital News reports,
    • “The Substance Abuse and Mental Health Services Administration Jan. 31 issued a final rule that updates certain regulations for Opioid Treatment Programs and the standards for treatment of opioid use disorder. The rule makes some COVID-19-related flexibilities permanent, including take-home doses of methadone, the ability of an OTP to prescribe medication for OUD via telehealth without an initial in-person physical evaluation, and the removal of certain requirements for admission to an OTP to better align with evidence-based practice.”
  • KFF shares three charts about Medicare drug price negotiations.
  • Federal News Network reports,
    • “The Postal Service is looking to cut $5 billion from its operating costs and grow its revenue by the same amount over the next two years to overcome its long-term financial challenges.
    • “Postmaster General Louis DeJoy is telling the White House and Congress that implementing these plans is necessary to keep USPS from running out of cash in the coming years.
    • “DeJoy, in a Jan.10 letter obtained by Federal News Network, told President Joe Biden and congressional leaders that USPS is “utilizing all of the self-help tools that are available to us,” and trying to get back on track with its “break-even” goal, after years of billion-dollar net losses.
    • “It is evident that to break even and avoid running out of cash in the next several years, we must press ahead on our financial improvement initiatives over the next two years,” DeJoy wrote. “While we have already achieved historic reductions, they are simply not enough to make us financially sustainable.”

From the public health and medical research front,

  • Check out this JAMA Open article to learn why “Paxlovid Is Effective but Underused—Here’s What the Latest Research Says About Rebound and More.”
  • Per Fierce Healthcare,
    • “As artificial intelligence advances in different areas of healthcare, there are concerns that technology and AI-based chatbots will replace the human connections between patients and practitioners.
    • “But, a new study finds promising potential for AI and large language models to enhance mental health therapy at scale by being able to analyze millions of text-based counseling messages to shine a light on what works.
    • “Researchers used AI to analyze more than 20 million text conversations of counseling sessions and successfully predicted patient satisfaction and clinical outcomes, according to a study published this week in the Journal of The American Medical Association (JAMA) Open.”
  • The National Institutes of Health announced,
    • An analysis conducted by the National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH) reveals a substantial increase in the overall use of complementary health approaches by American adults from 2002 to 2022. The study, published in the Journal of the American Medical Association, highlights a surge in the adoption of complementary health approaches for pain management over the same period.
    • Researchers utilized data from the 2002, 2012, and 2022 National Health Interview Survey (NHIS) to evaluate changes in the use of seven complementary health approaches, including yoga, meditation, massage therapy, chiropractic care, acupuncture, naturopathy, and guided imagery/progressive muscle relaxation.
    • The key findings include:
      • The percentage of individuals who reported using at least one of the seven approaches increased from 19.2% in 2002 to 36.7% in 2022.
      • The use of yoga, meditation, and massage therapy experienced the most significant growth from 2002 to 2022.
      • Use of yoga increased from 5% in 2002 to 15.8% in 2022.
      • Meditation became the most used approach in 2022, with an increase from 7.5% in 2002 to 17.3% in 2022.
      • Acupuncture, increasingly covered by insurance, saw an increase from 1% in 2002 to 2.2% in 2022.
    • Additionally, the analysis showed a notable rise in the proportion of U.S. adults using complementary health approaches specifically for pain management. Among participants using any of the complementary health approaches, the percentage reporting use for pain management increased from 42.3% in 2002 to 49.2% in 2022.
    • Despite the findings, the authors acknowledge study limitations, including decreasing NHIS response rates over time, possible recall bias, cross-sectional data, and differences in survey wording.
  • and
    • “Researchers at the National Institutes of Health detected abnormal proteins in the spinal fluid of people with amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD), which could help improve diagnosis of these diseases. The findings were published in Science Translational Medicine.
    • “The proteins in question are built from “cryptic” exons—abnormal portions of RNA, the cell’s instructions for how to build proteins. Cryptic exons occur when TDP-43, a protein that regulates how RNA is processed, stops functioning normally. TDP-43 dysfunction is linked to ALS, FTD, Alzheimer’s disease, and Limbic Associated TDP-43 Encephalopathy (LATE).
    • “The study showed that these mis-spliced sections of RNA can sometimes generate new proteins from the cryptic sequence. The findings advance our understanding of how cryptic exons may be involved in the dementia disease process and could help identify diseases involving TDP-43 dysfunction before symptoms appear. Currently, TDP-43 aggregates in the brain can only be detected at autopsy.”  
  • MedPage Today points out, “Getting clinicians to commit to the Choosing Wisely recommendations somewhat reduced low-value care for older adults in common scenarios, a cluster randomized trial found.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Novo Nordisk has resumed shipping starter doses of its weight-loss drug Wegovy, nearly nine months after manufacturing problems forced it to restrict distribution to maintenance shots in order to ensure that people who had already started taking it could continue, the company said Wednesday.
    • “The resumption of the starter doses, which begin at 0.25 milligrams per week, comes two months after obesity rival Eli Lilly gained U.S. approval for a competing drug, Zepbound, that could threaten to eat away at Novo’s sizable lead in weight-loss treatment.”
  • The Wall Street Journal adds,
    • “Nearly every employer in the country is now grappling with how—and whether—to pay for new weight loss drugs. Needless to say, such decisions are highly important to patients struggling with obesity.
    • “But for Eli Lilly and Novo Nordisk, it actually doesn’t matter, for now, from a financial perspective. They are selling every injection they can make. It won’t change anytime soon.” ***
    • While the companies are both moving as fast as possible, expanding the manufacturing of injectables is complicated. 
    • “You’re talking about billions of pens. That’s not a trivial exercise,” says Guggenheim analyst Seamus Fernandez. “Producing pens is a very complex process that requires precision and lots of attention to safety.” 
    • “That is one reason why developing pills such as Lilly’s orforglipron, which is undergoing clinical trials, is so crucial, he adds. Figuring out how to make oral versions well-tolerated is a challenge, though.”
  • MedTech Dive tells us about the top medtech trends in 2024. “Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year.”
  • Per Healthcare Dive,
    • “Cigna has agreed to sell its Medicare business to Health Care Service Corporation for roughly $3.7 billion, the health insurer announced Wednesday.
    • “HCSC is acquiring Cigna’s Medicare Advantage, supplemental benefits and Medicare Part D plans, along with CareAllies, a division that helps providers transition to value-based care. In total, the plans cover 3.6 million people on Medicare.
    • “The companies said they expect the deal — which includes $3.3 billion in cash and $400 million in capital Cigna expects to be freed up — to close in the first quarter of 2025, subject to regulatory approval.”
  • and
    • “Humana plans to expand its primary care network for seniors this year, as the insurer looks to lean on provider capabilities to boost its beleaguered Medicare Advantage business.
    • “In 2024, CenterWell Senior Primary Care plans to enter three new markets in North Carolina and Louisiana, and add additional centers in eight of its current markets in the U.S., the payer announced on Tuesday.
    • “Humana is one of many health insurers racing to build out a provider network to provide convenient access to primary care for its members. But for Humana, this strategy is more important than it might be for its rivals with a broader variety of plans, given Humana has made such a significant bet on Medicare Advantage, said Arielle Trzcinski, a healthcare analyst at market research firm Forrester.”
  • BioPharma Dive lets us know,
    • In 2021, the Food and Drug Administration for the first time approved a medicine meant to slow the progression of Alzheimer’s disease. Developed by partners Biogen and Eisai, the medicine, called Aduhelm, was viewed initially as a needed new treatment option by patients and a potential blockbuster product by Wall Street analysts.
    • “Now, less than three years since that approval, Biogen is fully giving up on the drug. The company said Wednesday it is handing rights to back to Aduhelm’s original developer, Neurimmune, and will redirect much of the money spent on the drug toward other Alzheimer’s therapies in its business.
    • “Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs,” said Christopher Viehbacher, the company’s CEO, in a statement.”
  • Per Beckers Payer Issues,
    • “The share of U.S. employees in healthcare plans funded by their employer rose from 2015 to 2021, a study published in the January issue of Health Affairs found. 
    • “In 2015, 55% of employees were enrolled in self-funded plans, compared to 60% of employees in 2021. Most of the growth occurred in states and counties with lower levels of self-funded enrollment, the study found. 
    • “Groups of rapid growth in self-funded plans were concentrated in Arkansas, New York, Northern California, Pennsylvania and Utah, the study found. 
    • “Elevance Health is the largest administrator of self-funded plans, with around 19% of the total market, according to the study. CVS Health claimed the fastest growing self-funded enrollment from 2015 to 2021. “

Tuesday Tidbits

David Ermer–CMS, COVID treatment, FDA, Obesity, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced today that
    • “Sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, which was initially announced in February 2023. The model is designed to improve health outcomes, increase access to cell and gene therapies, and lower health care costs for some of the nation’s most vulnerable populations. * * *
    • “Gene therapies for sickle cell disease have the potential to treat this devastating condition and transform people’s lives, offering them a chance to live healthier and potentially avoid associated health issues,” said CMS Administrator Chiquita Brooks-LaSure. “Increasing access to these promising therapies will not only help keep people healthy, but it can also lead to savings for states and taxpayers as the long-term costs of treating sickle cell disease may be avoided.” * * *
    • “For additional information see the fact sheet – PDF and CGT model page.“
  • The American Hospital Association reports,
    • “Paxlovid may no longer be distributed with an emergency use label after March 8, the Food and Drug Administration announced. Providers may dispense unexpired Paxlovid labeled for emergency use to patients through March 8, after which Paxlovid labeled for emergency use must be returned to the manufacturer or disposed of in accord with regulations, the agency said.
    • “The FDA last May approved a new drug application for Pfizer’s Paxlovid to treat adults at high risk of progressing to severe COVID-19. Paxlovid labeled under the new drug application will continue to be authorized for emergency use to treat eligible pediatric patients, the agency said.”
  • Following up on Affordable Care Act FAQ 64, the U.S. Office of Personnel Management issued today a carrier letter no. 2024-03 on contraceptive coverage and patient education.
  • Reuters reports,
    • “Pharmaceutical companies are due to receive by Thursday the U.S. government’s opening proposal for what are expected to be significant discounts on 10 of its high-cost medicines, an important step in the Medicare health program’s first ever price negotiations.
    • “Five Wall Street analysts and two investors told Reuters they expect the negotiations over prices that will go into effect in 2026 to result in cuts ranging from the statutory minimum of 25% to as much as 60% when the final numbers are set in September.
    • “The drugmakers and the government are expected to wait until then to disclose them.” * * *
    • “Pharmaceutical companies and business groups have filed more than half a dozen lawsuits to stop the negotiations from taking place, saying that they are unlawful.
    • “Drug companies say the law’s costs will hurt drug development programs and patients.”
    • “The lawsuits have not slowed the implementation timeline.”
  • Axios points out that CMS’s recent prior authorization proposed rule do not apply to prescription drug claims.
  • The Federal Acquisition Regulation Council published in the Federal Register today a proposed rule
    • “would prohibit contractors and subcontractors from seeking and considering information about job applicants’ compensation history when making employment decisions for certain positions. Under the proposed policy and the proposed regulatory amendments, contractors and subcontractors would also be required to disclose the compensation to be offered to the hired applicant in job announcements for certain positions.”
  • The public comment period ends on April 1, 2024.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “People who are suffering from severe pain but don’t want to risk addiction to an opioid are closer to a new option for treatment.
    • “Vertex Pharmaceuticals on Tuesday reported positive study results for its closely watched non-opioid painkiller. The drug lowered the moderate-to-severe acute pain reported by study volunteers, a sign it could be the first in a new class of painkiller to be approved for use.
    • “But the experimental medicine is more likely to provide an alternative to opioids, rather than supplant them, because it didn’t work better than a widely used opioid drug sold under the brand name Vicodin.
    • “Vertex said it would file for approval from the U.S. Food and Drug Administration by the middle of this year.”
  • STAT News tells us,
    • “Drugs like Ozempic and Wegovy — already game changers for diabetes and obesity — are being studied to treat an entirely different growing health problem: mental health illnesses, including depression and bipolar disorder.
    • “Early data and anecdotes suggest that this class of GLP-1 drugs could help patients feel less depressed and anxious. The treatment may also fight the decline in cognitive and executive function that many people with mental health disorders experience, like worsening memory and losing the ability to focus and plan.
    • “If further research yields positive results, it could drive even more demand for the highly popular GLP-1 treatments, which have increasingly been shown to help with problems across the body, such as heart and kidney complications. And especially if the cognitive benefits are proven out, the GLP-1 drugs would plug a critical gap in current treatments for depression, since most depression drugs help with mood, but close to none address cognitive symptoms that affect memory and attention.”
  • and
    • “The U.S. syphilis epidemic isn’t abating, with the rate of infectious cases rising 9% in 2022, according to a new federal government report on sexually transmitted diseases in adults.
    • “But there’s some unexpected good news: The rate of new gonorrhea cases fell for the first time in a decade.
    • “It’s not clear why syphilis rose 9% while gonorrhea dropped 9%, officials at the U.S. Centers for Disease Control and Prevention said, adding that it’s too soon to know whether a new downward trend is emerging for the latter.
    • “They are most focused on syphilis, which is less common than gonorrhea or chlamydia but considered more dangerous. Total cases surpassed 207,000 in 2022, the highest count in the United States since 1950, according to data released Tuesday.”
  • MedTech Dive calls attention to “four heart device trends shaping the medtech sector in 2024. Medtronic, Boston Scientific and J&J are among the medtech companies advancing treatments in cardiac care for when medicines are not enough.
  • MedCity Dive discusses “How Food as Medicine is Becoming A Core Team Capability. As the food as medicine movement grows, some payers and healthcare organizations are carving out specific roles and teams dedicated to food and nutrition. Doing so can be beneficial considering the significant impact diet can have on health outcomes.”
  • The Washington Post notes,
    • “Older adults spend an average of three weeks every year on doctor’s appointments and other health care outside their homes, according to research published in the Annals of Internal Medicine.
    • “Of those 21 “health care contact days,” 17 involve ambulatory services, such as office visits with primary-care doctors or specialists, testing and imaging, procedures, treatments and therapy. The remaining four days included time spent in an emergency room, hospital, skilled nursing facility or hospice.
    • “The study also found that about 11 percent of people 65 and over spend even more time — 50 or more days each year (nearly one day a week) — obtaining routine health care away from home. The research was based on Medicare data from a nationally representative sample of 6,619 people 65 and older.
    • “The findings represent “not only access to needed care but also substantial time, efforts and cost, especially for older adults and their care partners,” the researchers wrote.”
  • Peterson – KFF Health System Tracker offers a study comparing U.S. life expectancy to other countries.

From the U.S. healthcare business front,

  • Pfizer released its full year 2023 results and reaffirmed its full year 2024 financial guidance provided on December 13, 2023. “The fourth-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com.”
  • Beckers Hospital Review reports,
    • “Nashville, Tenn.-based HCA Healthcare saw revenues of $17.3 billion in the fourth quarter of 2023, up from $15.5 billion over the same period in 2022, according to its financial report released Jan. 30.” 
  • and
    • “Nonprofit Hospitals’ operating margins are far below the pre-pandemic “magic number” of 3% and are in danger of a permanent reset in the 1%-2% range, according to a Jan. 29 report published by Fitch Ratings.
    • “This operating margin reset is worrying some investors, but “hospital downgrades en masse would be unlikely because many systems have built up robust balance sheets and learned to economize on capital spending to a certain degree,” Kevin Holloran, senior director and sector head at Fitch, said.

Thursday Miscellany

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

From Washington DC,

  • Healthcare Dive reports,
    • “A group of bipartisan senators on Wednesday reintroduced a bill that aims to remove barriers to telemental healthcare for Medicarebeneficiaries.
    • “The legislation, introduced by Sens. Bill Cassidy, R-La., Tina Smith, D-Minn., John Thune, R-S.D., and Ben Cardin, D-Md., would remove requirements that telemental health patients see an in-person provider within six months of receiving services via telehealth.
    • “The senators warned the “arbitrary” requirement that patients be seen in-person will limit access to needed care, particularly in rural areas.”
  • The Senate Finance Committee lets us know,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today announced their commitment to working on bipartisan health care legislation to prevent and mitigate shortages of critical generic drugs used by patients and providers in the United States.
    • “In a white paper released today, Wyden and Crapo outline concerns raised by experts at a hearing held in the Finance Committee on December 5, 2023, as well as areas of interest and ideas the Committee is exploring to address the factors contributing to shortages through modifications to the Medicare and Medicaid programs. * * *
    • The white paper can be found here.
  • and
    • “U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Finance Committee Members Chris Coons (D-Delaware), Tom Carper (D-Delaware) and Thom Tillis (R-North Carolina), along with ten of their colleagues, wrote today to President Biden urging him to reject the proposal before the World Trade Organization (WTO) that would waive intellectual property (IP) protections for COVID-19 diagnostics and therapeutics.  Waiving protections afforded by the WTO Agreement on Trade-Related Aspects of IP Rights (TRIPS) could have unintended consequences for the development of new treatments for dangerous diseases, while doing little to improve access to medicine.”
  • HHS’s Human Resource & Services Administration tells us,
    • “Today, Health Resources and Services Administration (HRSA) Administrator Carole Johnson, joined by Rep. Lauren Underwood (D-IL), co-chair of the Black Maternal Health Caucus, launched a year-long Enhancing Maternal Health Initiative. The initiative will strengthen, expand, and accelerate HRSA’s maternal health work to address maternal mortality and maternal health disparities in partnership with mothers, grantees, community organizations, and state and local health officials across the country.
    • “The kick-off event at the Kaiser Family Foundation in Washington, DC, convened HRSA maternal health grantees from 11 states and the District of Columbia, as well as key national organizations and experts, providers, and individuals with lived experience. Attendees shared personal perspectives on maternal health care and support, the innovative ways HRSA grantees are making an impact on maternal health, and how they are addressing maternal mental health. * * * For more information on HRSA’s maternal health work, visit: www.hrsa.gov/maternal-health.”
  • The Government Accountability Office issued a report on OPM’s paid parental leave program.
    • “Starting October 1, 2020, most federal civilian employees became eligible to take up to 12 weeks of paid parental leave for the arrival of a new child whether by birth, adoption, or foster care.
    • “The Office of Personnel Management’s government-wide data showed that most federal employees were aware of the benefit, and the number of employees who took paid parental leave generally aligned with OPM’s initial estimates.
    • “However, OPM’s webpage for federal leave policies is outdated and doesn’t include information about the benefit. We recommended that OPM update guidance on its webpage to help ensure employees better understand their eligibility.”
  • FedWeek explains how to weigh the options if separating from a spouse before federal employee retirement eligibility.
  • Per Healthcare Dive,
    • “The Federal Trade Commission sued to block Novant Health’s $320 million acquisition of two North Carolina hospitals from Community Health Systems on Thursday, alleging the deal threatens to raise consumer prices and reduces incentives to provide quality care.
    • “The antitrust agency said the proposed deal, which was first announced in February of last year, would reduce competition in the region and “increase annual healthcare costs by several million dollars.”
    • “In response to the lawsuit, a representative from Winston-Salem, North Carolina-based Novant said the nonprofit system would “pursue available legal responses to the FTC’s flawed position.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for preventing spontaneous early births, a major health concern for which there are no good treatments.
    • “At the two-day workshop led by the FDA and and the Duke-Margolis Center for Health Policy, experts in maternal and fetal health, as well as advocates, discussed challenges to developing a medicine for preterm births, which affect 1 in every 10 babies in the U.S. and can jeopardize their health.”
  • Per MedTech Dive,
    • “Abbott received approval from the Food and Drug Administration for a rechargeable deep brain stimulation (DBS) system.
    • “Abbott claimed in the Thursday announcement its device, called Liberta RC, is the world’s smallest and has the longest charge of any DBS technology on the market. The company says the device only needs to be recharged 10 times per year under standard settings for most users. 
    • “Earlier this month, Medtronic also received approval for a new DBS system called Percept RC, which has sensing technology to track patients’ response to treatment.”

From the public health and medical research front,

  • HCPLive alerts us,
    • “Despite being the leading cause of death in the US for more than a century, more than half of the respondents to a 2023 survey conducted on behalf of the American Heart Association (AHA) failed to identify heart disease as the leading killer of US adults, according to the AHA’s 2024 Heart Disease and Stroke Statistics report.
    • “Data from the report, which is created annually by the AHA and National Institutes of Health to spotlight the impact of heart disease and stroke in the US and abroad, highlight a lack of awareness surrounding the impact of cardiovascular disease, with additional statistics paint a picture where 51% failed to identify heart disease as the leading cause of death, but also spotlights how advances in care and education have caused death rates from cardiovascular disease to decline by 60% in the last 75 years.”
  • The Society for Human Resource Management offers advice on “a number of policies and strategies employers might want to turn to during this coronavirus and flu surge.”
  • Beckers Hospital Review informs us,
    • “The CDC has rejected findings from Ohio State University researchers that the JN.1 coronavirus variant is more severe than previous strains.
    • “While JN.1 currently accounts for almost 86% of current COVID-19 cases in the U.S., the CDC published a statement Jan. 22 saying that the agency has found “no evidence that it causes more severe disease,” adding that vaccines are still expected to increase protection against the variant as well.
    • “The Ohio State University research, published Jan. 8 in Cell, had focused on two subvariants: BA.2.86 and JN.1. Their study found that it “appears to have increased infectivity of human lung epithelial cells compared to all omicron variants…(which) raises a potential concern about whether or not this virus is more pathogenic,” Shan-Lu Liu, MD, PhD, senior author the study and a virology professor at OSU stated in a news release about the research.  
    • “Since JN.1 is an offspring of BA.2.86, OSU researchers found it had similar results.
    • “While the CDC does not align with this research, the agency did state it “is contributing to the spread of COVID-19 this winter.”
  • STAT News reports,
    • “Building off of some landmark discoveries published last year, researchers have mapped out the biological underpinnings of Parkinson’s disease, creating a framework for medicines that might treat the root of the disease rather than just its symptoms.
    • “Their work, published in the Lancet Neurology, stages Parkinson’s based on the accumulation of a misfolded protein called alpha-synuclein. Funded by the Michael J. Fox Foundation for Parkinson’s Research, the work expands on a 2023 publication that validated an alpha-synuclein diagnostic for the disease.
    • “The new framework still has some gaps, but the researchers believe they’ve set out a path that will allow scientists to discover and rigorously test treatments aimed at the biological causes of Parkinson’s, providing a reliable measure of disease severity that might accelerate the process of drug development.”
  • The Institute for Clinical and Economic Review posted,
    •  “its revised Evidence Repor assessing the comparative clinical effectiveness and value of xanomeline tartrate/trospium chloride (KarXT, Karuna Therapeutics) for the treatment of schizophrenia. 
    • “Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves,” said ICER’s Chief Medical Officer, David Rind, MD. “Among the important side effects of current treatments is weight gain leading to metabolic syndrome. This, in turn, places patients at risk for cardiovascular events and death. KarXT has a novel mechanism of action and, at least in the short run, does not seem to cause weight gain. This may lead to major health benefits compared with existing treatments, however current evidence on benefits and harms is limited.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC (New England CEPAC) on February 9, 2024. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
  • Healio calls our attention to these study findings:
    • “Adults who lose weight in the year after being diagnosed with type 2 diabetes are more likely to achieve diabetes remission.
    • “Weight regain after remission increases the risk for returning to hyperglycemia.” 

From the U.S. healthcare business front,

  • The Raleigh (NC) News and Observer reports,
    • “Facing unsustainable costs, the NC State Health Plan’s board of trustees voted to end all plan coverage of popular weight-loss drugs beginning April 1. Board members met Thursday afternoon to consider options for how the plan could deal with rising costs. In October, the board imposed a moratorium on new prescriptions for one of the drugs, Wegovy, when made solely for weight-loss purposes. The moratorium began Jan. 1. At the conclusion of the lengthy meeting, the board voted 4-3 to exclude all coverage of obesity GLP-1 medications on April 1.
    • This will end coverage for plan members who were grandfathered in and already taking the medications as well. Usage of Wegovy, Saxenda and other drugs by plan members has increased significantly in recent years, as have costs incurred by the plan. The plan spent a projected $102 million on these drugs in 2023, or 10% of its roughly $1 billion in net pharmacy spending last year.
  • It stuns the FEHBlog that Novo Nordisk and Eli Lilly continue to raise prices for their GLP-1 drugs when they have blockbuster aales.
  • The American Hospital News notes,
    • “Hospitals and health systems are prioritizing preserving access to care for patients in rural America, including via access points like hospital outpatient departments that provide essential services for rural and low-income communities, according to a new AHA report released Jan. 25. The report details how hospitals have been a lifeline for struggling rural physician practices helping to keep their doors open, and HOPDs have remained convenient, high-quality access points for rural patients with more complex care needs. Among other findings, hospitals were two and a half times more likely to acquire physician practices in rural areas than other entities, including commercial insurers which are overwhelmingly focuse”d on larger and more profitable markets.”
  • Healthcare Dive points out,
    • “Humana on Thursday released a profit outlook for 2024 that fell well short of Wall Street’s already-diminished expectations, as the health insurer continues to be plagued by high medical spending on seniors.
    • “The Louisville, Kentucky-based payer expects to bring in $16 in adjusted earnings per share in 2024 — a whopping $13 short of analysts’ consensus expectations. In comparison, Humana brought in $26.09 in adjusted earnings per share this year.
    • “Humana also rescinded its earnings target for 2025. The health insurer’s stock plunged 15% in morning trade Thursday following the results.”
  • and
    • “Cleveland Clinic executives applauded the operator’s financial rebound in an annual State of the Clinic address, but signaled it would continue lean operations to chase sustained profitability.
    • “We sustain and advance Cleveland Clinic’s mission by serving patients and managing our resources,” said Tom Mihaljevic, Cleveland Clinic CEO and president, during the Wednesday address. “It is possible to use fewer resources while touching more lives.”
    • “Cleveland Clinic exceeded its revenue projections for 2023, drawing in over $14 billion in revenue on more than 14 million annual patient interactions, according to Mihaljevic.
    • “The Ohio-based nonprofit reported an operating margin of 0.4% for the year — an improvement on the prior year’s performance, when the Clinic reported an operating margin of -1.6% on a $1.2 billion net loss.” 

Midweek Update

David Ermer–ACA, FDA, Medical / Rx research, Obesity, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced that
    • “21.3 million people selected an Affordable Care Act Health Insurance Marketplace plan during the 2024 Open Enrollment Period. Total plan selections include more than five million people — about a fourth — who are new to the Marketplaces and 16 million people who renewed their coverage. Notably, open enrollment continues in four states and Washington, D.C., through January 31.
    • “For decades, when it came to federal programs we could depend on to keep Americans covered, three were always top of mind — Medicare, Medicaid, and Social Security, but now it’s crystal clear that we need to add a fourth — the Affordable Care Act,” said HHS Secretary Xavier Becerra. “Once again, a record-breaking number of Americans have signed up for affordable health care coverage through the Affordable Care Act’s Marketplace, and now they and their families have the peace of mind that comes with coverage. The ACA continues to be a successful, popular, and important federal program to millions of people and their families. As we celebrate the success of this most recent enrollment effort, HHS will double down on the Biden-Harris Administration’s efforts to increase access to quality care and lower costs.”
  • The Peterson-KFF Health System Tracker identifies “Health Cost and Affordability Policy Issues and Trends to Watch in 2024.”

From the public health and medical research front,

  • Beckers Hospital Review informs us,
    • “After discontinuing the use of semaglutide and liraglutide weight-loss medications, a majority of patients were able to maintain the same weight they were at when halting the use — or even continued to lose additional weight after one year, a new study revealed. 
    • “The research, published Jan. 23 in Epic Research, focused on the outcomes of 20,274 patients who were prescribed semaglutide and 17,733 patients prescribed liraglutide, who lost at least five pounds while taking it. 
    • “Sustained weight loss slightly differed for the drugs — 56.2% of patients prescribed semaglutide kept the weight off one year after discontinuation of the drug, while that same outcome was 55.7% of patients who took liraglutide.
    • “While the majority were able to maintain their weight or shed additional pounds, some did not, and the outcomes differed by medication type. 
    • “One year after discontinuation of semaglutide medications, 17.7% regained all the weight they had lost while on the medication, and some even gained additional weight. For liraglutide, 18.7% entirely regained their weight one year after halting use.
  • Medpage Today tells us,
    • “Infants born to unvaccinated mothers who had COVID-19 during pregnancy were at high risk for developing neonatal respiratory distress, the longitudinal, cohort COMP study found.
    • “The odds of developing respiratory distress were threefold higher (OR 3.06, 95% CI 1.08-10.21) in infants born to unvaccinated mothers diagnosed with COVID-19 while pregnant compared with COVID-exposed infants born to COVID-vaccinated mothers, Mary Catherine Cambou, MD, of the University of California Los Angeles (UCLA), and colleagues reported in Nature Communications.
    • “This was not something we were expecting to see, as none of the babies were diagnosed with COVID-19 themselves,” co-author Karin Nielsen-Saines, MD, also from UCLA, told MedPage Today in an email. “We also noted that respiratory distress was not transient and lasted several days.”
    • “However, when pregnant participants had received at least one mRNA vaccine dose prior to SARS-CoV-2 infection, the odds of their infants developing neonatal respiratory distress dropped to 0.33 (95% CI 0.10-0.96) — a 67% decline, the authors pointed out.”
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health have found overactivation in many brain regions, including the frontal and parietal lobes and the amygdala, in unmedicated children with anxiety disorders. They also showed that treatment with cognitive behavioral therapy (CBT) led to improvements in clinical symptoms and brain functioning. The findings illuminate the brain mechanisms underlying the acute effects of CBT to treat one of the most common mental disorders. The study, published in the American Journal of Psychiatry, was led by researchers at NIH’s National Institute of Mental Health (NIMH). 
    • “The findings can help our understanding of how and for which children CBT works, a critical first step in personalizing anxiety care and improving clinical outcomes,” said senior author Melissa Brotman, Ph.D., Chief of the Neuroscience and Novel Therapeutics Unitin the NIMH Intramural Research Program. * * *
    • “This study provide evidence—in a large group of unmedicated youth with anxiety disorders—of altered brain circuitry underlying treatment effects of CBT. The findings could, in time, be used to enhance treatment outcomes by targeting brain circuits linked to clinical improvement. This is particularly important for the subset of children who did not significantly improve after short-term CBT.
    • “The next step for this research is to understand which children are most likely to respond. Are there factors we can assess before treatment begins to make the most informed decisions about who should get which treatment and when? Answering these questions would further translate our research findings into clinical practice,” said Brotman.”
  • BioPharma Dive reports,
    • “An 11-year-old boy who was born deaf can hear after receiving an experimental gene therapy, developer Eli Lilly reported on Tuesday.
    • “The boy, identified as Aissam Dam by The New York Times, was the first participant treated in a small study Lilly is running to test the therapy, which is designed to correct a particular type of inherited hearing loss.
    • “While only from one person, the result is a striking example of gene therapy’s potential. According to Lilly, Dam experienced restored hearing across sound frequencies within a month of treatment. In some frequencies, Dam’s hearing was within the normal range at day 30, Lilly said.
    • “Lilly plans to present full data from Dam, as well as a second participant in its study, at a medical conference in early February.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Elevance Health raked in $6 billion in profit last year on revenue of more than $171 billion — a better performance than Wall Street expected, given that high medical costs have been dogging payers.
    • “The payer beat analysts’ consensus expectations for earnings and revenue in the fourth quarter of 2023, with a topline of $42.7 billion, up 7% year over year. Elevance’s fourth-quarter profit of $831 million was down, however, by 5% year over year.
    • “Elevance chalked its revenue growth up to higher premiums and growth in its pharmacy benefit manager CarelonRx. Analysts said the Indianapolis, Indiana-based payer also benefited from better-than-expected medical costs and higher investment income in the quarter.” 
  • and
    • “Walgreens is considering a sale of its specialty pharmacy business Shields Health Solutions as the struggling retail chain attempts to improve its halting finances, according to a Bloomberg report. 
    • “Shields could be valued at more than $4 billion in a sale, and a deal might appeal to private equity firms or healthcare companies, Bloomberg said, citing sources familiar.
    • “Walgreens is in the midst of a shift to focus on delivering healthcare services to payer, provider and pharmaceutical clients. But the company’s U.S. Healthcare division — which Shields is a part of — isn’t currently profitable.” 
  • and
    • “HCA Healthcare’s outpatient surgery operator Surgery Ventures has acquired majority interests in two ambulatory surgical centers in North Texas, the for-profit hospital operator announced on Monday.
    • “The centers are now affiliated with HCA subsidiary Medical City Healthcare, which runs 19 hospitals and 15 surgery centers in the region.
    • “The purchase comes after HCA, one of the largest hospital operators in the country, has made other recent acquisitions in Texas, which is one of the chain’s largest markets.” 
  • Per BioPhama Dive,
    • “Johnson & Johnson CEO Joaquin Duato sold 2023 as a “remarkable year” on an earnings call with investors Tuesday. But the pharmaceutical giant faces looming difficulties that hang over its performance, including incoming biosimilar competition to its blockbuster immune drug Stelara and a $700 million settlement over claims the company’s talc product caused cancer.
    • “As far as last year goes, J&J narrowly beat Wall Street’s expectations with $85.2 billion in revenue. Pharma sales grow 9.5% in the fourth quarter compared to the same period the year before. Cancer treatments and immunology medicines like Stelara made up the bulk of that revenue.
    • “As one of the largest pharma companies and often the first in the sector to report earnings each quarter, J&J is often considered a sort of bellwether for the industry.”
  • and
    • “Novo Nordisk is adding yet another prospect to its obesity drug pipeline, this time from a biotech company spun out of Harvard University and Zurich University. · EraCal Therapeutics tests compounds in larval zebrafish in a bid to trigger behavioral changes related to appetite while minimizing other effects in the body. The Swiss startup says it’s seen early success in mice and may be able to produce a drug that helps people lose weight without the side effects sometimes seen with current treatments. ·
    • “As part of the deal announced Tuesday, EraCal is eligible for payments worth as much as 235 million euros, or about $256 million, as well as royalties if a product reaches the market. The total includes an unspecified amount of money up front, as well as future payments tied to developmental and commercial milestones.”
  • North Carolina Public Radio reports
    • “The board that oversees the North Carolina State Health Plan will face a heavy decision Thursday when it considers dropping coverage of weight loss medications like Wegovy. * * *
    • “The State Health Plan is the health insurance plan for more than 740,000 teachers, state employees, retirees, and their dependents. It’s a massive health plan that paid more than $4 billion in claims last fiscal year, according to plan data.
    • “But even at that size, the high costs of these GLP-1 medications take an outsized bite of the pie. In 2023, the 24,750 people with prescriptions of Wegovy, Saxenda, and Zepbound cost the plan $102 million after rebates. In 2024, CVS Caremark, the plan’s pharmacy benefits manager, warned those rebates might lessen or go away completely, something that could push total costs north of $170 million. For context, as recently as 2019-20, the plan paid less than $790 million for all pharmacy claims for the entire fiscal year.”
  • Bolton consulting group identifies seven key employee benefit trends for this year.

Tuesday Tidbits

David Ermer–AHRQ, Congress, FDA, Mental health care, NIH, No Surprises Act, Obesity, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Roll Call tells us,
    • “The Senate overwhelmingly voted Tuesday night in favor of the first procedural move needed to avert a partial government shutdown at the end of this week.
    • “The chamber voted 68-13 to end debate on the motion to proceed to the shell legislative vehicle for the stopgap spending measure, which would run to March 1 for four of the dozen annual appropriations bills and until March 8 for the remaining eight.
    • “Leadership in both chambers are in favor of the stopgap measure, which is designed to give appropriators more time to negotiate final fiscal 2024 appropriations bills following the $1.66 trillion topline agreement Speaker Mike Johnson, R-La., and Senate Majority Leader Charles E. Schumer, D-N.Y., announced earlier this month.”
  • Roll Call further informs us,
    • “Congressional leaders and key committee heads are poised to meet with the president at the White House Wednesday to discuss the national security supplemental package that has remained stalled over the lack of agreement on border and immigration policy measures.
    • “White House Press Secretary Karine Jean-Pierre confirmed President Joe Biden’s plans to host the meeting during a Tuesday briefing. 
    • “Speaker Mike Johnson, R-La., House Minority Leader Hakeem Jeffries, D-N.Y., Senate Majority Leader Charles E. Schumer, D-N.Y., and Senate Minority Leader Mitch McConnell, R-Ky., are expected to attend the meeting.”
  • The Wall Street Journal adds,
    • “Top U.S. lawmakers unveiled a bipartisan tax agreement that would revive expired breaks for businesses and increase the child tax credit for low-income families, and they are aiming to push the $78 billion in tax breaks through Congress in the next few weeks. 
    • “The deal comes from Sen. Ron Wyden (D., Ore.) and Rep. Jason Smith (R., Mo.), ideological opponents who found common ground after months of talks. They have a tough task ahead, given skepticism about aspects of the deal in both parties and a tight deadline before tax season starts.”
  • Roll Call notes,
    • “The conservative-controlled Supreme Court could upend how courts handle challenges to the decisions administrative agencies make, in a pair of cases set for oral arguments Wednesday that could change the standards for how Congress writes laws and the federal government implements them.
    • “The challengers to a fishery inspection rule asked the justices to overturn the Chevron doctrine, a nearly 40-year-old legal framework based on a Supreme Court decision that established that judges should defer to the agencies’ interpretations of a law when that law is ambiguous.
    • “Parts of the conservative legal movement have targeted the doctrine for years, casting it as emblematic of the broader power of administrative agencies, and Wednesday’s oral arguments could preview its demise.”
  • STAT News reports,
    • “President Biden has promised to require fair prices from drugmakers that use federally funded research — and now, in a major recent move, said he’ll trigger government “march-in” on patents for drugs that run afoul of that goal.
    • “It’s a simple principle. You shouldn’t pay the highest price in the world for drugs that your tax dollars have already helped create,” Biden said last month as he touted the move at the National Institutes of Health.
    • “But the new NIH director, locked in the center of this debate, isn’t taking any big steps yet.
    • “Our relationship with the pharmaceutical industry, with the industry overall, is really, really critical,” Director Monica Bertagnolli told STAT in an interview. “It’s very difficult, if you can imagine, to implement something broadly that is as effective as we want it to be.”
  • KFF Health News reports that a new federal program to save rural hospitals is experiencing growing pains.
  • The U.S. Preventive Services Task Force announced the appointment of three new members, “Sei Lee, M.D., M.A.S.; Tonette Krousel-Wood, M.D., M.S.P.H.; and Sarah Wiehe, M.D., M.P.H. They are appointed to serve 4-year terms beginning in January 2024.”
  • The National Academies of Science announced,
    • “A new report from the National Academies of Sciences, Engineering, and Medicine says 15 health care services related to intimate partner violence — including reproductive health care, screening for STIs and HIV, forensic medical exams, and mental health care — should be classified by the Health Resources and Services Administration and all U.S. health care systems as essential healthcare services. The report recommends prioritizing access to these healthcare services during public health emergencies, such as a pandemic or natural disasters, using a phased approach.”  
  • Per Forbes,
    • “The FDA approved the use of Casgevy, a therapy that uses CRISPR gene-editing to treat the serious blood disorder transfusion-dependent beta-thalassemia, marking the second major U.S. regulatory approval for the emerging gene-editing technology. The FDA’s approval comes just one month after the regulator approved the use of Casgevy in treating sickle cell disease.”

From the public health and medical research front,

  • Health Day points out,
    • “Despite overall progress against cancer in the United States, Black Americans are still more prone to die of the disease than whites
    • “Data from 2000 to 2020 showed the racial gap in cancer deaths had diminished but was still significant.
    • “Disparities in deaths from breast cancer, prostate cancer and colon cancer in men were especially troubling.”
  • Healthcare IT News explains why “Virtual group therapy enables Geisinger to treat more patients and maintain care continuity. With waits for individual psychotherapy as long as several months and several thousand outstanding orders, the mostly rural health system needed a solution. Combining group therapy and telemedicine [with help from American Well] was the answer.”
  • STAT News reports,
    • “Last fall, the World Health Organization and some national drug regulators urged influenza vaccine manufacturers to drop the component known as B/Yamagata from flu vaccines as quickly as possible, citing the fact that this lineage of flu B viruses appears to have been snuffed out during the Covid-19 pandemic.
    • “It might seem like that request would be as simple as deciding to leave blueberries out of a mixed-fruit smoothie. It turns out it is not.”

From the U.S. healthcare business front,

  • Healthcare Dive discusses trends shaping the health insurance business in 2024.
  • Via Fierce Healthcare, Morgan Health offers three items employers should focus on to manage GLP-1 drug costs.
  • Bloomberg informs us about lawsuits that air ambulance companies have brought against health insurers who allegedly refused to pay No Surprises Act arbitration awards. The insurers have asked the federal district court in Houston to dismiss the cases for lack of subject matter jurisdiction and improper venue.
  • Beckers Hospital Review lets us know,
    • “The Mayo Clinic Diet, a weight loss program developed by the Rochester, Minn.-based health system, is launching a weight loss telemedicine service.
    • “The Mayo Clinic Diet Medical Weight Loss Rx program will offer direct access to weight loss medications, or GLP-1s, via video visits with Amwell Medical Group clinicians, according to a Jan. 16 news release shared with Becker’s.
    • “The program, which is available in beta form to qualifying members, will also provide lab testing to confirm medication suitability, clinical monitoring, insurance support, meal plan options, and coaching and education tools.”
  • Beckers Payer Issues tells us,
    • “Though some contract negotiations with providers came “down to the wire” last year, UnitedHealthcare executives said the payer did not see more contract splits than usual in 2023. 
    • “Brian Thompson, CEO of UnitedHealthcare, told investors on a Jan. 12 call the insurer did not see more contract disruptions than in previous years in 2023.” 

 

Thursday Miscellany

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Roll Call brings us up to date on the FY 2024 appropriations discussions on Capitol Hill.
  • The Department of Health and Human Services announced,
    • “As part of continuing efforts by the Biden-Harris Administration to help people access comprehensive, high-quality health coverage, the U.S. Department of Health and Human Services (HHS) launched a new, online and user-friendly hub for partners to access critical Medicaid and Children’s Health Insurance Program (CHIP) renewal and transition resources.”
  • Tammy Flanagan, writing in Govexec, explains 2024 benefit changes for federal employees and annuitants.
  • Beckers Hospital Review tells us,
    • “The FDA has issued temporary authorization for the importation of a syphilis drug that’s been in short supply since last April. 
    • “Federal regulators have cleared French drugmaker Laboratoires Delbert to import penicillin G benzathine, Bloomberg reported Jan. 10. A shortage of Pfizer’s version of the drug, Bicillin L-A, is estimated to last through June and is the only treatment for congenital syphilis. 
    • “Last April, the CDC said syphilis rates are at their highest since 1950, with nearly 177,000 cases reported in 2021.” 
  • The Canadian Broadcasting Company (CBC) reports
    • “[Canadian] Health Minister Mark Holland says Florida’s plan to import cheaper Canadian pharmaceuticals is a non-starter and the federal government will use its regulatory power to ensure the national drug supply does not face any shortages due to actions by a foreign state.
    • “There is no way we will allow any jurisdiction, be it a state or another foreign jurisdiction, to endanger the Canadian drug supply. That is not an appropriate solution to whatever challenges they may be facing,” Holland said during an official announcement in Nova Scotia of a bilateral health-care deal with the province.
    • “We’re going to do everything in our power to make sure that another country cannot be given the ability to pillage our health system for its own benefit.”
    • “Holland said he will soon travel to Washington, D.C. to make it known to officials there that Canada will not stand idle if Florida or other U.S. states pursue bulk imports that threaten Canadians’ access to medication in any way.”
  • KFF analyzes the Affordable Care Act’s latest open enrollment period.

From the public health and medical research front,

  • The Wall Street Journal lets us know,
    • “Cancer is hitting more young people in the U.S. and around the globe, baffling doctors. Diagnosis rates in the U.S. rose in 2019 to 107.8 cases per 100,000 people under 50, up 12.8% from 95.6 in 2000, federal data show. A study in BMJ Oncology last year reported a sharp global rise in cancers in people under 50, with the highest rates in North America, Australia and Western Europe. 
    • “Doctors are racing to figure out what is making them sick, and how to identify young people who are at high risk. They suspect that changes in the way we live—less physical activity, more ultra-processed foods, new toxins—have raised the risk for younger generations.
    • “The patients are getting younger,” said Dr. Andrea Cercek, who co-directs a program for early-onset gastrointestinal cancer patients at Memorial Sloan Kettering Cancer Center in New York, where Keen was treated. “It’s likely some environmental change, whether it’s something in our food, our medications or something we have not yet identified.” 
  • The National Institutes of Health’s Directors Blog points out “A New Target to Improve the Health and Lives of Childhood Cancer Survivors: Diabetes Prevention.”
  • MedPage Today informs us,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) has updated its adult immunization schedule for 2024 to include recommendations on new vaccines for respiratory syncytial virus (RSV) and meningitis, the mpox (formerly known as monkeypox) vaccine, and the updated COVID-19 vaccines.”
    • The article notes the 2024 changes in this schedule.
    • “In an accompanying editorial, Scott Ratzan, MD, and other members of the Council for Quality Health Communication offered scathing criticism of the CDC’s complex written and visual presentation of the recommendations.”
  • Per Fierce Healthcare,
    • “The Blue Cross Blue Shield Association will lead an effort to improve maternity care in about 600 acute care and pediatric hospitals across the nation, including a push to address racial and ethnic disparities.
    • “Health equity in maternal care will be added to the list of conditions that the insurer’s Blue Distinction Centers focus on, the company said in an announcement. The effectiveness of that care will be measured against industry standards. Blue Distinction Centers comprise hospitals and other providers that the insurer deems deliver high quality care.”
  • The National Institutes of Health announced,
    • “Researchers have linked a decade-long decline in the blood lead levels of American Indian adults to long-term cardiovascular health benefits, including reduced blood pressure levels and a reduction in a marker associated with hypertrophic cardiomyopathy and heart failure. The research, supported by the National Institutes of Health, found that adults who had the greatest reductions in blood lead levels saw their systolic blood pressure fall by about 7 mm Hg, an amount comparable to the effects of blood pressure-lowering medication. Lead exposure is known to harm the health of children by damaging the brain and nervous system and slowing growth and development. It has also been associated with increased risks for heart disease in adults. The findings published in the Journal of the American Heart Association.
    • “This is a huge win for public health, especially since many American Indians can face higher risks for elevated lead levels,” said Anne E. Nigra, Ph.D., the senior study author and an assistant professor of environmental health sciences at Columbia University Mailman School of Public Health, New York City. “Compared to the general U.S. population, American Indian communities experience both a higher burden of cardiovascular disease and elevated metal exposure. We saw that even small decreases in a person’s blood lead levels can have meaningful health outcomes.”
  • Medscape tells us,
    • “In addition to better-known risk factors such as diabetes, stroke, heart disease, and depression, findings of a large study suggested vitamin D deficiency, elevated C-reactive protein (CRP) levels and social isolation increase the risk for young-onset dementia (YOD).”

From the U.S. healthcare business front,

  • STAT News, Fierce Healthcare, and Precision Medicine Online offer summaries of the fourth and final day of the JP Morgan Healthcare Conference, which was held in San Francisco.
  • The Wall Street Journal reports,
    • “Novartis has backed away from its pursuit of Cytokinetics putting a damper on the prospects of a deal for the promising heart-drug developer. 
    • “The Swiss drug giant had been closing in on a purchase of South San Francisco-based Cytokinetics, with an agreement expected as soon as this week, The Wall Street Journal reported Monday. But Novartis, which had been pursuing the biotech for several months, backed away sometime in the past day or two, according to the people.” 
  • The Segal Company offers a helpful white paper on key factors impacting healthcare costs. trends.
  • Beckers Hospital Review notes,
    • “The Cigna Group is getting ready to launch a new program that offers employers and health plan sponsors a way to manage obesity, diabetes and cardiovascular disease using weight loss drugs, or GLP-1s.
    • “EncircleRx is set to launch in the first quarter of 2024 under Evernorth, Cigna’s health services arm. On the company’s website, it describes the program as “the first-ever GLP-1 financial guarantee from a PBM.”
    • “The program works to target the individuals who are at the highest risk, would have the most benefit from meaningful changes from access to the GLP-1, and supports it with the right ongoing clinical and behavioral support,” Eric Palmer, CEO of Evernorth, told investors at the JPMorgan Healthcare Conference Jan. 9. “[The program] makes sure that an individual is prepared to work through all of the effects of going through this kind of life-changing set of therapies and is also set up with the right value-based reimbursement as well.”
  • Per Healthcare Dive,
    • “Billing for patient messages sent to providers has risen in the wake of the COVID-19 pandemic, according to a study published in JAMA. 
    • “Charging for e-visits, or asynchronous messages that require medical decision making and take at least five minutes of clinician time over the course of a week, spiked at the beginning of the pandemic as health systems shifted to virtual care. But billing fell after the early pandemic peak before beginning to steadily increase again in mid-2021. 
    • “More than 470 healthcare organizations billed at least 50 e-visits in the third quarter of 2022, an increase of nearly 40% compared with the same period in the previous year. The upturn suggests organizations now see e-visits as a long-term source of potential revenue, researchers said.” 

Friday Factoids

David Ermer–COVID-19, FDA, Government Contracting, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC,

  • Govexec informs us,
    • “According to the Biden administration’s quarterly update of its progress in fulfilling the President’s Management Agenda, released last month, the White House is keeping pace with its stated goals of strengthening the federal workforce and modernizing customer experience. 
    • “The latest Performance.gov post touts 5,800 new hires targeted for roles created by the Bipartisan Infrastructure Law and promises eight new pooled hiring efforts to support multi-agency hiring in fiscal 2024, amid other milestones situated across multiple strategy goals. 
    • “Likewise, the goal of making it easier for the public to interact with the federal government’s life experience services is progressing with the stand-up of several pilot programs, and its High Impact Service Providers are aligning operations and workforce capacity to eventually begin reporting customer feedback data.” 
  • BioPharma Dive reports,
    • “For the first time, the Food and Drug Administration has authorized a U.S. state to import prescription drugs from Canada, granting Florida preliminary clearance to bulk purchase medicines from wholesalers there.
    • “The decision is a major policy shift for the agency, which has long resisted drug importation efforts on grounds that it couldn’t ensure the safety and supply of medicines shipped from abroad. Supporters have argued that importing drugs from Canada, where medicines cost far less than in the U.S., could help rein in pharmaceutical costs. * * *
    • “The pharmaceutical industry, which has vehemently opposed importation plans, may also sue to block Florida’s plan.
    • “We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” a spokesperson for the industry lobby PhRMA said in an email. “PhRMA is considering all options for preventing this policy from harming patients.”
  • Note the FEHBlog is ambivalent about this decision.
  • The Federal Times discusses a contract protest related delay in implementing new TRICARE contracts.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Covid is surging again, four years after the pandemic began, as a new virus subvariant becomes dominant in the U.S. and as people gather indoors to escape cold weather.
    • “Rising wastewater virus levels and hospitalizations underscore the latest winter Covid surge. One driver is JN.1, the latest offshoot of the virus to take over in the U.S. and an Omicron subvariant. The Centers for Disease Control and Prevention on Friday estimated that JN.1 represents roughly 62% of cases nationwide.
    • “The good news is measures of severe illness—hospitalizations and deaths—remain below last winter’s highs and far lower than the pandemic’s peaks. But the virus remains dangerous for some and a major nuisance for many as people return to work and school after holiday breaks.
    • “The world has seen a steady cycle of new Omicron subvariants ever since that offshoot rapidly took over more than two years ago. When new versions become dominant, it indicates that they have some advantage, whether through their ability to evade immune defenses or easily spread from person to person.”
  • The FEHBlog credits Omicron for being an upper respiratory infection, which is much less dangerous than the initial waves of Alpha and Delta Covid, which were lower respiratory infections.
  • The CDC’s FluView notes,
    • “Seasonal influenza activity is elevated and continues to increase in most parts of the country.
    • “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 continues to increase.
    • “During Week 52, of the 651 viruses reported by public health laboratories, 581 (89.2%) were influenza A and 70 (10.8%) were influenza B. Of the 342 influenza A viruses subtyped during Week 52, 300 (87.7%) were influenza A(H1N1) and 42 (12.3%) were A(H3N2).”
  • Behavioral Health Business discusses
    • “How Fentanyl has changed Opioid Use Disorder Treatment,”
  • and
    • “Top behavioral health trends for 2024.”
  • The American Medical Association offers top health tips obesity medicine physicians want you to know.
  • The National Institutes of Health Director announced in her blog,
    • “Nearly 35 million people in communities across the U.S. have type 2 diabetes (T2D), putting them at increased risk for a wide range of serious health complications, including vision loss, kidney failure, heart disease, stroke, and premature death.1 While we know a lot about the lifestyle and genetic factors that influence diabetes risk and steps that can help prevent or control it, there’s still a lot to learn about the precise early events in the body that drive this disease.
    • “When you have T2D, the insulin-producing beta cells in your pancreas don’t release insulin in the way that they should. As a result, blood sugar doesn’t enter your cells, and its levels in the bloodstream go up. What’s less clear is exactly what happens to cause beta cells and the cell clusters where they’re found (called islets) to malfunction in the first place. However, I’m encouraged by some new NIH-supported research in Nature that used various large datasets to identify key signatures of islet dysfunction in people with T2D.”
  • The NIH further announced,
    • “Semaglutide, a highly popular medication approved by the U.S. Food and Drug Administration to treat obesity and manage type 2 diabetes, was associated with a 49% to 73% lower risk of first-time or recurring suicidal ideations compared to other medications for controlling obesity and type 2 diabetes that work via different mechanisms. These findings provide evidence that semaglutide – which helps regulate appetite and insulin levels by targeting glucagon-like peptide 1 receptors (GLP1R) in the body – does not appear to increase the risk of suicidal ideation, contrary to the claims of some anecdotal reports. Published today in Nature Medicine and paired with a related Research Briefing(link is external), the study was co-led by scientists at Case Western Reserve University and the National Institute on Drug Abuse (NIDA), National Institutes of Health.”
  • Per the American Medical Association,
    • “The AP (1/4, Neergaard) reports, “Seizures during sleep are a potential cause of at least some cases of sudden unexplained death in childhood, or SUDC, researchers at NYU Langone Health reported Thursday after analyzing home monitoring video that captured the deaths of seven sleeping toddlers.” The study “offers the first direct evidence of a seizure link,” although “scientists also have found that a history of fever-related seizures was about 10 times more likely among the children who died suddenly than among youngsters the same age.” The findings were published in the journal Neurology.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “The cost of treating a COVID-19 hospital patient in the hospital rose by 26% over the first two years of the pandemic, more than five times the rate of medical inflation during that time, according to a newly published analysis of 1.3 million admissions.
    • “On average and after adjustments, direct treatment costs for a COVID-19 hospital admission rose from $10,394 in March 2020 to $13,072 in March 2022, a gain that researchers said landed alongside increased use of breathing assistance machines.
    • “Such technologies proved to be costly; stays in which a COVID-19 patient required extracorporeal membrane oxygenation (ECMO), for instance, averaged $36,484 and increased by 35% over the course of the study period, they wrote in JAMA Network Open.
  • Forbes reports,
    • “Health insurance giant Elevance Health said it has agreed to acquire Paragon Healthcare, Inc., a provider of infusion services to patients.
    • “Elevance said Paragon provides infusion services to patients through its “omnichannel model of ambulatory infusion centers, home infusion pharmacies, and other specialty pharmacy services.” Financial terms of the deal for privately held Plano, Texas-based Paragon were not disclosed.
    • “It’s the latest effort by Elevance Health to bolster its specialty pharmacy business and pursue its strategy to treat the whole health of the person. Last year, Elevance Health, which operates Blue Cross and Blue Shield health plans in 14 states, closed on its acquisition of BioPlus, a specialty pharmacy.”
  • Healthcare Dive reports,
    • “Tom Cowhey, a financial executive at CVS who stepped into the interim CFO role late last year, has been permanently named to the post, the company announced on Friday.
    • “In October, Cowhey replaced Shawn Guertin, who served as CFO and president of health services. Guertin, who has been on a leave of absence due to family health reasons, will now officially leave CVS later this year, the company said. 
    • “Cowhey joined CVS in early 2022 after previously serving as CFO of Surgery Partners. Before that, he worked at Aetna in strategy and finance positions, before the health insurer was acquired by CVS.”
  • The American Medical Association lets us know,
    • “Significant changes in the Current Procedural Terminology (CPT®) code set for immunizations reflect the changing nature of how COVID-19 is being addressed as actions transition from a public health emergency response to combatting emerging variants much like the flu.
    • “One significant change involves the consolidation of more than 50 previous codes to streamline reporting of immunizations for COVID-19. A new vaccine-administration code, 90480, was approved for reporting the administration of any COVID-19 vaccine for any patient. This replaces all previously approved, product-specific vaccine-administration codes. * * *
    • “Additionally, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), an advisory group of the FDA, recommended that the COVID-19 vaccine for the 2023–2024 vaccination season be a monovalent vaccine that contains the XBB.1.5 strain, and noted that a number of COVID-19 vaccine products will no longer be recommended for use. The streamlined structure brings greater alignment between CPT and the current COVID-19 vaccine reporting environment.
    • “The new coding system will allow for new vaccines for new variants whenever they come up without having to do a new code,” said Samuel “Le” Church, MD, MPH, a member of the CPT Editorial Panel and vice-chair of its Immunization Coding Caucus.”
  • Mercer Consulting offers seven breakthrough benefit strategies to explore this year.