Tuesday Tidbits

U.S. Healthcare

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.” 

 

King Day Weekend Update

David Ermer–Congress, Medical / Rx research, SDOH, U.S. Healthcare–

Happy King Day. Dr. King would have been 95 years old today.

From Washington DC,

  • Roll Call adds
    • “House and Senate leaders have agreed to extend temporary government funding in two batches, through March 1 and March 8, according to a source familiar with the plan.
    • “The decision comes as lawmakers face a Friday, Jan. 19 deadline to clear a temporary spending bill for four of the dozen annual appropriations bills — Agriculture, Energy-Water, Military Construction-VA and Transportation-HUD. The remaining eight bills’ stopgap funds expire after Feb. 2 under the most recent interim spending law.”
  • The Wall Street Journal reports,
    • Medicare patients lining up to fill pricey prescriptions at the pharmacy counter this year will realize some good news: For the first time, there is a ceiling on how much they will pay in 2024 for their Part D drugs.
    • Changes brought about by the 2022 Inflation Reduction Act mean that people on Part D plans now pay no more than roughly $3,300 on drugs annually—a number that could shift a bit based on whether they take brand or generic medications. In 2025, that cap will change again to a flat $2,000.
  • Patient Engagement HIT informs us,
    • “Transportation access continues to be a leading social determinant of health, with new CDC data showing it affected 5.7 percent of adults over the course of 12 months.
    • “The report, which used 2022 data, also showed that women were more likely than men to face transportation access barriers, with 6.1 percent and 5.3 percent reporting as much, respectively. * * *
    • “Younger adults rather than older adults, for example, were more likely to face challenges related to transportation access, with 7 percent of 18-34-year-olds reporting problems compared to 4.5 percent of those over age 65. Odds of transportation-related barriers decreased with age, the CDC researchers said.
    • “Moreover, racial disparities persisted, with American Indian/Alaska Native adults being the most likely to report a lack of reliable transportation. Of those respondents, 17.1 percent said they faced barriers in the previous 12 months.
    • “That compares to 9.2 percent of Black respondents, 7.6 percent of other or multiple-race respondents, 6.9 percent of Hispanic respondents, 4.8 percent of White respondents, and 3.6 percent of Asian respondents who said the same.”

From the public health and medical research front,

  • The Washington Post and Consumer Reports tell us “How to prevent shingles and what to do if you get it.”
    • “Shingrix, a two-dose shingles vaccine that was approved by the Food and Drug Administration in 2017, can reduce the incidence of shingles and its complications significantly. “The vaccine, the one we have available today, is spectacularly effective,” says William Schaffner, an infectious-disease specialist at Vanderbilt University Medical Center in Nashville.
    • “But only about 30 percent of adults eligible for this vaccine have gotten it, according to 2022 report by the Government Accountability Office. If you’re wondering about the effects and risks of shingles and whether Shingrix is right for you, [the article provides] what you need to know.
  • The New York Times reports,
    • “Marijuana is neither as risky nor as prone to abuse as other tightly controlled substances and has potential medical benefits, and therefore, should be removed from the nation’s most restrictive category of drugs, federal scientists have concluded.
    • “The recommendations are contained in a 250-page scientific review provided to Matthew Zorn, a Texas lawyer who sued Health and Human Services officials for its release and published it online on Friday night. An H.H.S. official confirmed the authenticity of the document. * * *
    • “President Biden urged federal officials to “expeditiously” re-examine marijuana classification in October 2022, when he also issued pardons for those charged with marijuana possession under federal law.”
  • Fortune Well identifies “seven immune-boosting foods to eat when you’re sick with COVID or flu.”

From the U.S. healthcare business front

  • Benefits Pro points out,
    • “A new report from Humana finds that “value-based care,” which focuses on quality of care and patient experience with deeper patient engagement, that is provided to Medicare Advantage members kept patients healthier and lowers costs.
    • “The new report is part of an annual assessment of the model, which stresses a more personal approach, more time spent with patients, and more coordinated care than traditional fee-for-service models of care. The model also puts an emphasis on prevention and lifestyle changes to help patients manage their health.
    • “The tenth-annual report on the efficacy of the value-based model for Medicare Advantage members noted that the U.S. health system has faced some significant challenges in recent years, including the COVID pandemic, a stressed workforce, and growing awareness of inequities in health care. The Humana analysis acknowledges challenges remain but found better scores on measurements across the board for patients in the value-based care model.”
  • Per Forbes,
    • “On November 13, 2023, women’s health advocates – including entrepreneurs and investors – celebrated a positive step forward for the industry; that day, the White House announced the first-ever Initiative on Women’s Health Research. The goal of the Initiative is to engage the federal government and private and public sectors to fund women’s health, spur innovation, close research gaps, and improve diagnosis, disease prevention, education, treatment, and more.
    • “This Initiative, however, was not the only new and noteworthy event in women’s health recently. In 2023 alone, women’s health startups saw gains in their average deal sizes, in the percentage of healthcare venture capital funding they raised, and in the attention they received. If these trends continue, 2024 could be the long-awaited and much-needed transformative year, bringing attention, capital, and recognition to this historically overlooked, underinvested, and undervalued space.”

Friday Factoids

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.” 

Midweek Update

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

From Washington, DC

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

From the public health and medical research front,

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

Per the U.S. healthcare business front,

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

Tuesday Tidbits

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

From Washington, DC,

  • Govexec updates us on FY 2024 appropriations actions on Capitol Hill.
  • Roll Call tells us,
    • “A consistent drip of members announcing they will not seek reelection combined with a desire to portray Capitol Hill as a toxic place everyone wants to flee can create a narrative that there’s a mass exodus underway from the House. 
    • “But that’s not the real story, at least not yet. 
    • “Up to this point, 38 House members have decided not to seek another term. Indiana Republicans Greg Pence and Larry Buschon and Colorado Republican Doug Lamborn were the latest to announce, just in the last few days. Overall, that’s just a few more than average, and that’s with an asterisk. * * *
    • “In order to make comparisons across cycles, the tally does not include resignations (or expulsions) because those seats will be filled by Election Day and will have new incumbents likely running in the regular election. So the 38 does not include the seats of former Reps. George Santos of New York and Kevin McCarthy of California and soon-to-be former Reps. Bill Johnson of Ohio and Brian Higgins of New York.
    • “North Carolina Democrats Kathy Manning, Wiley Nickel, and Jeff Jackson are included in the 38, but they likely would have run for reelection if Republicans hadn’t redrawn their districts to make them virtually unwinnable for a Democrat. Without redistricting forcing their hands, the number of members not seeking reelection would be remarkably average.”
  • The Hill reports,
    • “Sen. Bernie Sanders (I-Vt.) and a group of Senate Democrats on Monday announced an investigation into the high costs of asthma inhalers.
    • “Sanders, chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, sent letters to the CEOs of the four biggest manufacturers of inhalers sold in the United States — AstraZeneca, Boehringer Ingelheim (BI), GlaxoSmithKline (GSK) and Teva — demanding information and documents on internal strategic communications, patient assistance programs and the costs involved in the manufacturing of inhalers.”
  • American Hospital Association News reports,
    • “The Department of Health and Human Services’ Office for Civil Rights Jan. 9 released a final rule that partially rescinds a sweeping 2019 rule that was held unlawful by three federal district courts. The new rule restores the longstanding process for enforcing federal conscience laws, and strengthens protections against conscience and religious discrimination. 
    • “The AHA last year submitted comments supporting the Administration’s approach, adding that conscience protections for health care professionals “are longstanding and deeply rooted in our health care delivery system.”
  • HR Dive notes,
    • “The U.S. Department of Labor announced Tuesday a final rule revising its interpretation of the Fair Labor Standards Act’s classification provision to determine whether a worker may be considered an independent contractor.
    • “The final rule largely tracks the agency’s October 2022 proposed rule. It retains the multifactor, “totality-of-the-circumstances” framework for analyzing independent contractors’ status included in that proposal.
    • “Under this framework, DOL will consider six nonexhaustive factors when examining the relationship between a worker and a potential employer:
      • Worker’s opportunity for profit or loss.
      • Investments made by the worker and the employer.
      • Degree of permanence of the work relationship.
      • Nature and degree of control over performance of the work.
      • Extent to which the work performed is an integral part of the employer’s business.
      • Use of the worker’s skill and initiative.
    • “The rule will be published in the Federal Register on Wednesday, Jan. 10, and is slated to take effect March 11, officials said.”

From the public health and medical research front,

  • The National Institutes of Health announced,
    • “Researchers have discovered that a protein called phosphorylated α-synuclein, which is associated with several neurodegenerative diseases such as Parkinson’s disease and Lewy body dementia, is also involved in the normal processes of how neurons communicate with each other in a healthy brain. The research, published in Neuron, was funded in part by the National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institutes of Health.   
    • “Phosphorylation is a process where a phosphate ion is added to a specific amino acid, or building block, of a protein, in this case the protein α-synuclein. This addition can change the shape of that protein, causing it to change its level of activity. Most studies of phosphorylated α-synuclein have studied its role in certain neurological disorders such as Parkinson’s disease and Lewy body dementia, where it builds up in protein clumps called Lewy bodies. These clumps are thought to be toxic to neurons, and one of the prevailing hypotheses is that the phosphorylation of the protein α-synuclein triggers these diseases.
    • “In most studies to date, the mere presence of α-synuclein phosphorylation is assumed to be a marker for pathology for certain disorders, like Parkinson’s and Lewy Body dementias,” said Beth-Anne Sieber, Ph.D., program director, NINDS. “Recently, there has been considerable interest in developing drugs that prevent α-synuclein phosphorylation as a way of treating these disorders. These findings challenge the current hypotheses about how these disorders may originate in the brain and may give insight into how we might better treat them.”
  • The Hill reports,
    • “The American Red Cross sounded the alarm Sunday over a severe blood shortage facing the U.S. as the number of donors dropped to the lowest levels in two decades. 
    • “The Red Cross said in an announcement that the number of people donating blood in the U.S. dropped 40 percent over the last 20 years, which can majorly disrupt those needing emergency blood transfusions and other operations. The organization added there was a 7,000-unit shortfall in blood donations between Christmas Day and New Year’s Day alone.  * * *
    • “The organization is urging people to sign up to donate blood and are encouraging people to do so by working with the NFL, which is offering a chance to win a trip for two people to Super Bowl LVIII in Las Vegas.
    • “The organization said anyone who signs up to donate blood in January will be automatically entered for a chance to win.”
  • Healio points out,
    • “Two doses of the recombinant zoster vaccine provided strong protection over 4 years, even in patients taking corticosteroids who are at higher risk for herpes zoster, also known as shingles, according to researchers.
    • “Currently, the CDC recommends that adults aged 50 years and older receive two doses of the recombinant zoster vaccine (RZV) separated by a period of 2 to 6 months.”
  • and
    • “Rates of HPV vaccine initiation before age 13 increased among boys and girls from 2018 to 2021.
    • “Rates of HPV vaccine series completion also increased but remained below 40% in both groups.”

From the U.S. healthcare business front

  • Beckers Payer Issues points out,
    • “Aetna President Brian Kane said CVS Health is still in the “early innings” of integrating the payer into the company, the Hartford Business Journal reported Jan. 8.
    • CVS Health acquired Aetna in 2018. Mr. Kane told the news outlet that Aetna’s integration into the company was slowed by the COVID-19 pandemic. He said significant changes are likely in the next five years and that there will be a “really tight ecosystem between payer, provider and pharmacy.”
    • He said the key to the integration will be leveraging CVS Health’s “various businesses and technology platforms to improve patient care and lower costs.” 
  • Per BioPharma Dive,
    • “Over the span of five months, biotechnology startup Aiolos Bio launched, raised initial funding from venture investors and negotiated a $1 billion buyout by GSK.
    • “The acquisition, announced by GSK on Tuesday, marks a rapid return on investment for Aiolos’ blue-chip backers, which included Atlas Venture and Bain Capital Life Sciences. They could receive up to $400 million more if certain regulatory milestones are met.
    • “Based in San Francisco and London, Aiolos was founded last year around an experimental antibody for treating asthma that the company licensed in August from China’s Jiangsu Hengrui Pharmaceuticals. The biologic drug, dubbed AIO-001, shares a target with Amgen and AstraZeneca’s approved medicine Tezspire, but Aiolos claims its version could be given less frequently.”
  • Beckers Hospital Review lets us know,
    • “Stephen Dorner, MD, chief clinical and innovation officer of Mass General Brigham Healthcare at Home, told Becker’s that the more home-based care models are scaled, the more opportunity there is to move the needle and flatten the curve of healthcare costs in the U.S.  
    • “Boston-based Mass General Brigham, which runs one of the largest home hospital programs in the country, has had more than 2,500 home hospital admissions since January 2022, saving 13,300 acute care facility-based bed days. 
    • “But, the journey first began with two pilot programs launched in 2017, evolving through iterative processes to identify sustainable models. By 2019, the health system began to recognize the strategic importance of the home-based care model, and prioritized refining best practices and modifying them for scalability.
    • “The core strategies, according to Dr. Dorner, involved transforming manual processes into standardized workflows and focusing on translating strong clinical practices from traditional facilities to home-based care without sterilizing the comfort of the home environment.”
  • Healthcare Dive adds,
    • “Medicare patients treated in acute hospital-at-home programs had low levels of mortality and rarely needed to return to facilities for care, according to a new study published in Annals of Internal Medicine. 
    • “Researchers found that 0.5% of patients in the study died while receiving acute care in their homes, while 6.2% had to go back to the hospital for at least 24 hours.
    • “The results could help make the case to continue supporting hospital-level care delivered at home, researchers said. A waiver that expanded the programs at the height of the COVID-19 pandemic is set to expire at the end of the year.”
  • and
    • “Most nonprofit hospitals and health systems had enough cash on hand to cover operating expenses for an extended period of time in 2022, according to a new analysis from KFF.
    • “On average, hospitals and systems reported having 218 days of cash on hand in 2022 — S&P Global Ratings generally considers 218 days to be a “very strong” level of cash, according to the report. Nearly three-quarters of nonprofit hospitals had “strong” levels of cash on hand, while about one in 10 had “vulnerable” or “highly vulnerable” levels of cash on hand.
    • “The metric, which estimates the number of days that an entity could cover their cash expenses using available reserves, offers nuance to reports that show struggling nonprofit hospitals, the authors wrote. Though hospitals broadly reported negative operating margins in 2022, the KFF study said many had a “large financial cushion” as of 2022 to help weather challenges.”
  • Drug Channels discusses 2024 developments among the big three prescription benefit managers.

Monday Roundup

David Ermer–Congress, Medical / Rx research, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC,

  • Roll Call reports, “As the calendar turns to a presidential election year with control of both chambers in play, Congress and the White House are facing a full slate of leftovers from 2023, headlined by a stalled emergency supplemental spending request and looming deadlines to keep the government open.”
  • The Wall Street Journal adds,
    • “House Speaker Mike Johnson (R., La.) now has less than two weeks to pass spending legislation needed to avert a partial government shutdown, while contending with many of the same challenges that ultimately took down his predecessor three months ago.
    • “Following a deal with the Democratic-led Senate announced over the weekend, Johnson will try to rally his fellow Republicans this week around a plan for $1.66 trillion in overall discretionary spending for fiscal 2024.   
    • “While Democrats have largely signaled their support for the agreement, hard-line conservatives have blasted the top-line figure, meaning that Johnson almost certainly will have to rely on Democratic votes to pass the measure in the House, where the GOP has a narrow 220-213 majority. Former speaker Kevin McCarthy (R., Calif.) was able to muscle through a short-term spending bill in September and avert a government shutdown, only for eight Republican rebels to then engineer his ouster.
    • “Johnson noted Sunday that he now has an even smaller majority than when McCarthy was the speaker. “We deal with the numbers that we have,” Johnson said on  CBS. “It will be one of the smallest majorities in the history of the Congress, clearly.”
    • “The speaker backed a short-term deal late last year to avoid a Christmas showdown over spending. New deadlines of Jan. 19 and Feb. 2 are now before him, providing the biggest test of his still-fledgling speakership and his ability to wrangle his unruly GOP conference.”
  • Good luck, Mr. Speaker.
  • The American Hospital Association News tells us,
    • “Health and Human Services Secretary Xavier Becerra Jan. 8 appointed as chief competition officer Stacy Sanders, who currently oversees the department’s implementation of the Inflation Reduction Act, long-term care initiatives, policies to promote health care competition and other Medicare work. In this new role, announced by the Biden Administration last month, Sanders will work with the Federal Trade Commission and Department of Justice to address concentration in healthcare markets through data-sharing, reciprocal training programs, and other policy initiatives.”

From the public health and medical research front,

  • Endpoint News informs us,
    • “The crown jewel from Bayer’s 2020 buyout of women’s health biotech KaNDy Therapeutics has proven its worth in the clinic, meeting all primary and secondary endpoints in a pair of Phase III studies.
    • “Bayer says it plans to file the drug, elinzanetant, for regulatory approvals to treat moderate to severe vasomotor symptoms associated with menopause once results from a third Phase III study are in. Those data are expected within the next few months.
    • “Elinzanetant, formerly known as NT-814, hit all four primary endpoints in the OASIS 1 and 2 studies, showing statistically significant reductions in the frequency and severity of VMS symptoms — also known as hot flashes. The company didn’t report any numbers, but it said the drug also did better than placebo on a slate of secondary endpoints, including frequency of VMS at week 1, improvement of sleep disturbance and menopause-related quality of life.”
  • The Institute for Clinical and Economic Review (ICER) released a Final Evidence Report on Treatment for Pulmonary Arterial Hypertension.
    • ICER’s “Independent appraisal committee voted that sotatercept demonstrated a net health benefit when compared to background therapy; sotatercept would achieve common thresholds for cost-effectiveness if priced between $17,900 to $35,400 per year.
  • The Washington Post and Consumer Reports points out “quick fixes for congestion, sneezing and other sinus woes.”

From the U.S. healthcare business front,

  • The National Institutes of Health announced,
    • “Access to residential addiction treatment centers caring for U.S. adolescents under 18 years old in the United States is limited and costly, according to a new study(link is external) supported by the National Institutes of Health. Researchers found that only about half (54%) of the residential addiction treatment facilities that they contacted had a bed immediately available, and for those that had a waitlist, the average estimated time before a bed opened was 28 days. In addition, the average daily cost per day of treatment was $878, with close to half (48%) of the facilities that provided information requiring partial or full payment upfront. On average, the quoted cost of a month’s stay at a residential addiction treatment facility was over $26,000.
    • “Published in Health Affairs, this study was supported by the National Institute on Drug Abuse (NIDA) and the National Center for Advancing Translational Sciences (NCATS), both part of NIH, and led by researchers at Oregon Health & Science University (OHSU). The results build on previous research revealing that only one in four residential treatment centers caring for U.S. adolescents under 18 years old provide buprenorphine, a medication to treat opioid use disorder.
    • “The ability to access timely, evidence-based treatment for addiction can be a matter of life or death, and the current system too often fails young people,” said Nora Volkow, M.D., director of NIDA. “We need to make access to timely, affordable, and evidence-based care the norm across treatment settings.”
  • mHealth Intelligence takes a look at this year’s virtual care trends.
    • “The mood of healthcare stakeholders going into 2024 may be more somber than in the recent past, but the work of integrating virtual care into the US healthcare system is ongoing. Here [in the article] are some key trends healthcare leaders, policy experts, and consultants expect to see in the new year.”
  • MedTech Dive notes,
    • “Procedure volumes increased in the fourth quarter, mostly matching or exceeding the usual seasonal trend, according to Truist Securities’ survey of 50 U.S. hospital administrators.
    • “The survey suggests procedure volumes rose 2% to 3% over the third quarter, with interventional cardiology experiencing the biggest increase. The analysts wrote companies including Boston Scientific, Edwards Lifesciences and Medtronic would benefit from rising cardiology volumes.
    • “Truist also saw positive signs for Intuitive Surgical, tracking improvements in the outlook for capital spending and a rebound in weight loss procedures after pressure from obesity drugs.”
  • and
    • “Boston Scientific said Monday it has agreed to acquire Axonics, maker of devices to treat urinary and bowel dysfunction, for $3.7 billion in cash, or $71 per share.
    • “The acquisition allows Boston Scientific to enter the high-growth sacral neuromodulation market, where it will compete with companies such as Medtronic. 
    • “Stifel analyst Rick Wise, in a note to clients Monday, called the deal a highly complementary fit to Boston Scientific’s urology business, which generated about 14% of its estimated 2023 sales.”

Weekend Update

David Ermer–Congress, Cybersecurity, Medical / Rx research, Mental health care, OPM, SCOTUS, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

The FEHBlog was tied up with family business yesterday so Cybersecurity Saturday appears below the Weekend Update

From Washington, DC,

  • Congress is back to work on Capitol Hill. The Wall Street Journal describes the situation as “Battered Congress Has Two Weeks to Fix Three Big Problems: Talks to stop a government shutdown, fix the border and fund Ukraine converge on Capitol Hill.”
  • The Journal adds this evening,
    • “Congressional leaders reached a bipartisan deal on Sunday setting a roughly $1.6 trillion federal spending level for the year, but the pact drew quick criticism from some conservatives, and it remained unclear whether lawmakers would be able to quickly pass legislation averting a government shutdown.”
  • Congress does not have any hearings scheduled for this week.
  • The Washington Post reports,
    • “The Supreme Court said Friday it will review a case (No. 23-727) challenging Idaho’s strict abortion ban, which the Biden administration says conflicts with a federal law [EMTALA] requiring emergency room doctors to perform the procedure in some circumstances.”
  • Federal News Network provides more background to reduce retirement program overpayments.
    • “For OPM, many of the improper payments that the agency makes through retirement services may stem from limited data, on account of not using enough analytics to identify beneficiaries who have died and therefore are no longer entitled to the benefits, [Linda] Miller, [Audient Group CEO] said.
    • “There is more than one way of identifying people who have passed away — looking at Social Security, obituary data and more accurate information on deaths,” Miller said. “OPM doesn’t use much of that data, so the reports are likely less accurate.”

From the public health and medical research front,

  • Fortune Well offers us four strategies for older folks to get good quality sleep and an approach to adding beneficial thirty-second-long micro-workouts to your day.
  • Govexec tells us,
    • “The Veterans Affairs Department will soon begin funding research into the use of psychedelics such as MDMA and mushrooms to treat PTSD and depression, the first time the agency has done so since the 1960s. 
    • “The announcement answers the call from some veterans and researchers who have long advocated for the potential medical benefits of MDMA and psilocybin, or psychoactive mushrooms. VA on Friday issued a request for applications to its network of researchers, collaborating with academic institutions to solicit proposals to study the impact of using the compounds to treat post-traumatic stress disorder and depression in veterans.” 

From the U.S. healthcare front,

  • STAT News reminds us that the JP Morgan Healthcare Conference will be held this week in San Fransico.
    • “Nonprofit hospitals often get overshadowed at the J.P. Morgan Healthcare Conference, the health care industry’s swankiest investor meeting whose agenda is dominated by drugmakers and biotech companies.
    • “But hospitals are still the largest part of America’s health care economy, commanding nearly a third of the country’s $4.7 billion health care tab. And similar to last year, when hospitals touted their plans for expansion and hiking prices, they will have a rosy picture to sell to financiers as patients flock to their facilities.”
  • The American Medical Association informs us, “What doctors wish patients knew about scope of practice.”
  • Health Payer Intelligence points out,
    • “Despite efforts to reduce drug costs through Medicare negotiation for 10 common medications, the US still pays more for these drugs than almost any other nation, even after factoring in discounts and rebates, according to a Commonwealth Fund chart pack.
    • “The researchers used 2021 data from IQVIA and the Medicare Payment Advisory Commission (MedPAC) to assess how US drug prices differed from international trends. With this information, the researchers compiled 12 charts that situate the drug prices in the United States compared to other countries.”
  • Per Fierce Healthcare,
    • “Duluth, Minnesota-based Essentia Health and Marshfield, Wisconsin-based Marshfield Clinic Health System have scrapped their plan to merge into a 25-hospital Midwest system.
    • “The two nonprofit health systems said in a statement that they have “engaged in meaningful discussion” over the last two years about how the organizations could combine their unique strengths.
    • “We have decided that a combination at this time is not the right path forward for our respective organizations, colleagues and patients,” the health systems said in a statement posted to Essentia Health’s website Friday.”
  • BioPharma Dive reports,
    • “Metagenomi, a biotechnology startup working to identify new CRISPR enzymes for editing genes, has filed to go public.
    • “Backed by healthcare investors and pharmaceutical firms including Novo Nordisk’s parent company and Bayer’s venture arm, Metagenomi most recently raised a $275 million Series B round. The startup is also partnered with Moderna and Ionis Pharmaceuticals.
    • “The Emeryville, California-based biotech is one of at least three life sciences companies to publicly plan for an initial public offering so far this year. Should it successfully price an IPO, its performance could serve as an early barometer for the sector in 2024.”
  • The Society for Human Resource Management notes HR trends for which we should be prepared in 2024

Cybersecurity Saturday

HealthcareIT Today offers a boatload of cybersecurity predictions for 2024.

From the cybersecurity vulnerabilities front,

  • HHS’s Health Sector Cybersecurity Coordination Center (HC3) released its December 2023 monthly vulnerabilities report on January 4:
    • In December 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for December are from Microsoft, Google/Android, Apple, Mozilla, Cisco, SAP, VMWare, Adobe, Fortinet, and Atlassian. A vulnerability is given the classification of a zero-day when it is actively exploited with no fix available or if it is publicly disclosed. HC3 recommends patching all vulnerabilities with special consideration to the risk management posture of the organization.”
  • The Cybersecurity and Infrastructure Security Agency added two more known exploited vulnerabilities to the catalog on January 2.
  • Cybersecurity Dive reported on January 5,
    • “A critical vulnerability in Apache OFBiz was hit with a surge in exploitation attempts in recent weeks, which could allow attackers to take control of affected systems and launch supply chain attacks, according to researchers from SonicWall. 
    • “Apache OFBiz is an open source enterprise resource system that is used in a wide range of software, including Atlassian Jira, which is used by more than 120,000 companies. “Jira uses a customized OFBiz Entity Engine that does not implement the vulnerable framework module,” a spokesperson for Atlassian told Cybersecurity Dive via email.
    • “The authentication bypass vulnerability, listed as CVE-2023-51467, has a CVSS score of 9.8 and could expose sensitive data or allow an unauthenticated attacker to execute arbitrary code.”

From the ransomware front,

  • Here’s a link to the Bleeping Computer’s Week in Ransomware.

From the cyber defenses front,

  • The Wall Street Journal offers tips for security computers for personal and small business use.
  • An ISACA expert explains,
    • “As the digital realm continues to expand, it is axiomatic that cybersecurity threats are escalating concurrently. The fight against cybercrime has transformed from an optional frontline battle to a mandatory survival skill for businesses and individuals. Unfortunately, humans have now surpassed machines as the most favored targets for cybercriminals. An effective approach that merges change management methodology with cybersecurity procedures is needed to combat this.”
  • Security Intelligence offers a wholisitc approach to information and operational technology.

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.

Thursday Miscellany

David Ermer–AHRQ, CDC, COVID treatment, COVID-19, FDA, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Govexec informs us,
    • “Published last month, OPM’s annual report to Congress covers the 2022 fiscal year, which ended in September 2022, meaning it covers a period of time when agencies were developing and beginning implementation of re-entry plans after a two-year period of maximum telework during the COVID-19 pandemic, but before the Biden administration’s concerted push beginning last spring to increase “meaningful in-person work” across government.
    • “In a message accompanying the report, OPM Director Kiran Ahuja acknowledged that the snapshot of telework as represented by the data may not be current, given the shift in the last year toward more in-person work, but she stressed that changes made this year will improve agencies’ data collection and OPM’s analysis going forward.
    • “With COVID-19 no longer the primary driver in workforce decisions, federal agencies are closely examining the balance of in-person and virtual work to maximize mission delivery—including making increases to meaningful in-person work while also utilizing flexible work arrangements as a strategic tool to enhance organizational performance,” she wrote. “To support this work, OPM has been engaging with agencies to improve the quality of government-wide and agency-specific telework data. OPM anticipates that future reports will reflect these improvements.”
  • HHS’s Agency for Healthcare Research and Quality issued a report about the value of respectful maternity care.
  • BioPharma Dive points out five Food and Drug Administration decisions to watch out for this first quarter of 2024.
    • “The agency could approve a closely watched Alzheimer’s disease drug, as well as what could be the first medicine for a prevalent liver disease and a new kind of cancer therapy. Also on deck are verdicts for a drug at the heart of a multibillion dollar buyout and a linchpin asset for one biotech’s oncology plans.”

From the public health and medical research front,

  • The New York Times reports,
    • “As Covid rises again, killing about 1,500 Americans each week, medical researchers are trying to understand why so few people are taking Paxlovid, a medicine that is stunningly effective in preventing severe illness and death from the disease.
    • “A study of a million high-risk people with Covid found that only about 15 percent who were eligible for the drug took it. If instead half of the eligible patients in the United States had gotten Paxlovid during the time period of the research, 48,000 deaths could have been prevented, the authors of the study, conducted by the National Institutes of Health, concluded.
    • “It’s not because people don’t know about the drug — most do — but the reluctance seems to come from doctors worried about interactions with other drugs and people wary of a possible rebound case or the metallic aftertaste.” * * *
    • “Reasons for not prescribing or taking it have varied: Doctors balk at the long list of medications not to be mixed with Paxlovid, including common drugs meant to lower blood pressure or prevent blood clots. Patients tend to complain about the drug’s metallic aftertaste. Many wave off the drug in the early days of Covid, when symptoms tend to be mildest, bypassing the chance to limit early viral growth. * * *
    • “Federal officials still have more than one million free doses out to pharmacies, and the medication will be free through 2024 for Medicaid and Medicare patients. But in recent weeks, officials have handed distribution of the drug off to Pfizer, which has priced it at about $1,400 per course, though private insurers are expected to cover some portion of the price and Pfizer is offering co-payment assistance.“
  • Fierce BioTech tells us,
    • “Researchers at Roche have developed a novel antibiotic with the ability to fight a dangerous drug-resistant bacteria that kills in up to 60% of infections.
    • “In a pair of articles published Jan. 3 in Nature, Roche and Harvard University scientists described how they developed a new antibiotic that is effective against carbapenem-resistant acinetobacter baumannii—also known as CRAB—in mice. The drug, zosurabalpin, works by interrupting construction of the bacteria’s outer membrane.
    • “The ongoing research into zosurabalpin, as well as a second novel class of antibiotics being developed by Roche in human clinical studies, will help uncover new biology about the construction of bacterial membranes,” Michael Lobritz, M.D., Ph.D., global head of infectious diseases at Roche Pharma Research & Early Development, said in a statement provided to Nature. “Our goal is to contribute new innovations to overcome antimicrobial resistance, one of the biggest infectious disease challenges to public health.”
    • “CRAB is a common culprit in hospital-acquired sepsis and other infections, and is at the top of the list of both the World Health Organization’s and the Centers for Disease Control’s “priority pathogens” for which new drugs are urgently needed.” 

From the U.S. healthcare business front,

  • BioPharma Dive points out,
    • “Eli Lilly wants to make it easier for people to access its medicines for obesity, diabetes and migraine, announcing Thursday the launch of a website designed to support home delivery of drugs like its in-demand weight loss treatment Zepbound.
    • “The company’s new service, dubbed LillyDirect, relies on online pharmacy providers like Eversana and Truepill to deliver prescribed Lilly medicines. A website provides access to telehealth services through which people can consult with an independent physician. If prescribed a Lilly medicine, LillyDirect is also meant to help patients more easily access the company’s savings cards.
    • “LillyDirect currently supports 14 of the pharmaceutical company’s medicines, 12 of which are various formulations and types on insulin. Notably, the service also offers Zepbound, which the FDA approved for weight loss in November, and Lilly’s migraine medicine Emgality.”
  • Reuters reports
    • “CVS Health (CVS.N) said on Wednesday it will remove AbbVie’s (ABBV.N) blockbuster rheumatoid arthritis drug Humira from some of its lists of preferred drugs for reimbursement as of April 1, and will recommend biosimilar versions of the medicine instead.
    • “CVS said Hyrimoz and an unbranded version of Humira, both from Swiss drugmaker Sandoz (SDZ.S), will be covered across all its formularies, while branded and unbranded near copies of the drug from India’s Biocon (BION.NS) will be covered on some reimbursement lists.
    • “CVS also announced that AbbVie and CVS-owned company Cordavis, which launched in August, will produce a co-branded version of Humira that will be made available to customers in the second quarter of this year. While most biosimilars are near copies of the branded drug, the Cordavis version will be identical to Humira in its formulation, CVS said.”
  • Healthcare Dive notes,
    • “Walgreens beat Wall Street expectations on earnings per share and revenue in its first quarter, as the pharmacy giant continues to push through “growing pains” amid its shift to healthcare services, according to CEO Tim Wentworth.
    • “The chain’s U.S. Healthcare segment posted sales of $1.9 billion compared with $989 million in the prior-year period, boosted by primary care chain VillageMD’s acquisition of Summit Health and growth in other business units. But the segment still reported a $96 million adjusted operating loss, compared with a $152 million loss last year. 
    • “Walgreens is nearly halfway through its plan to close 60 VillageMD clinics as the provider focuses on density in “high opportunity” markets, Wentworth said during an earnings call.” 
  • The Wall Street Journal reports,
    • “Health insurance companies say they want to offer more services directly to customers. But that requires dropping the cumbersome technology that has defined the industry in favor of the smartphone-app experience users have come to expect.
    • “Kaiser Permanente Chief Digital Officer Nari Gopala said he is working to remove friction from the company’s digital-pharmacy experience, including introducing prescription-refill reminders. “The experience itself is like what you’re used to as a consumer in other industries, like how you order your coffee or groceries,” Gopala said.
    • “Kaiser, an integrated health system with insurance and hospital components, is one of a number of firms revamping technology in the hopes of encouraging more people to get their medications through the mail rather than picking them up in retail pharmacies.”
  • United Healthcare discusses, “Recently launched initiatives by Optum Rx enable more than 26,000 in-network community and independent pharmacies with expanded support to strengthen access to care and improve outcomes for the patients they serve.”
  • Beckers Hospital Review lets us know,
    • “Since launching in January 2021 with about 100 generics, Mark Cuban Cost Plus Drug Co. now offers more than 2,000 drugs, including about a dozen brand-name medications. 
    • “The company has also grown to offer discounted drug prices through more than 4,000 affiliated pharmacies, including those in Kroger and Meijer grocery stores. 
    • “Cost Plus Drugs is targeting inflated drug prices through multiple lenses. It markets medications at their acquisition cost and adds a $5 shipping fee, a $5 pharmacy labor fee and a 15% markup. Other pharmaceutical companies are taking notice of the transparency marketing effect. 
    • “The company’s conservative drug pricing model is buttressed with a “yes, and” approach to its collaborations and partnerships, which include four pharmacy benefit managers. 
    • “In recent months, Cost Plus Drugs has struck collaboration deals with an elderly care business, two fertility health companies, a digital health company and a mail-order pharmacy.” 
  • Per Fierce Healthcare,
    • “A “pivotal year for price transparency” closed out with most—but not all—of the healthcare industry publishing their data publicly and at a higher quality, price transparency data startup Turquoise Health wrote in a state-of-the-industry report released Thursday.
    • “Across a total of 6,357 hospitals, 5,763 (90.7%) posted a machine-readable file (MRF) with at least some necessary service rates in 2023. This was an increase of 562 hospitals over the end of 2022, with Turquoise noting that most of the additions “were individual hospitals, often with unique MRF formats.”
    • “Turquoise gave 2,634 of the hospitals posting MRFs a five-star rating for publishing “a complete MRF that contains cash, list and negotiated rates for a significant quantity of items and services,” the group wrote. That list of top scorers grew 24% from the end of 2022, and now represent more than half of the total hospital field. * * *
    • “The number of payers publishing their data has grown from an initial 67 back in July 2022 to 170 in January 2023, and now to 205 as of November 2023, according to the report. Turquoise also noted that “the quality and breadth of their files have also improved” over the past several months — welcome news for researchers and other stakeholders who previously critiqued payers’ unwieldy data releases.”