King Day Weekend Update

Congress

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.

Happy New Year!

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

From Washington, DC

Congress returns to legislative and Committee business next week.

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

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

David Ermer–Congress, COVID-19, Medical / Rx research, No Surprises Act, Obesity, U.S. Healthcare–

From Washington DC,

  • The Washington Examiner points out that four special elections for the House of Representatives will be held in 2024 before the national election on November 5, 2024. Three of the seats are being vacated by Republicans, and one by a Democrat. Due to the Republican’s already slim margin in the House, every vote does count.
  • The American Hospital News reports that the No Surprises Act regulators plan to the public comment deadline for the Federal Independent Dispute Resolution Operations proposed rule, which is currently set for next Tuesday, January 2, 2024. The FEHBlog found the referenced regulator’s notice of this decision on the CMS No Surprises Act website. The official notice, however, has not been posted in the Federal Register yet.

From the public health and medical research front,

  • Bloomberg reports,
    • “Cytokinetics Inc. said its experimental drug helped patients with a genetic heart ailment in a closely watched trial.
    • “The drug improved exercise capacity and oxygen uptake in patients with the heart condition, compared with those getting a placebo, Cytokinetics said Wednesday in a statement. * * *
    • “Aficamten is a once-daily pill for hypertrophic cardiomyopathy, or HCM, a genetic disease in which abnormally thick heart muscle interferes with pumping. As many as 1 in 500 people have it, though many go undiagnosed, according to the American Heart Association, and it’s regarded as the most common cause of sudden cardiac death in young people and competitive athletes. * * *
    • “Cytokinetics plans to submit the drug for clearance in the second half of 2024, Chief Executive Officer Robert Blum said on a conference call.”
  • Medscape tells us,
    • “Glucagon-like peptide-1 (GLP-1) agonists, like semaglutide, liraglutide, and the newly US Food and Drug Administration–approved tirzepatide, not only are gaining popularity among the public for weight loss but also are the focus of considerable attention from gastroenterology researchers.
    • “The robust interest in GLP-1 agonists was on full display here at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting [held in mid-December], with investigators sharing results on which agent is most effective for weight loss, how they compare to bariatric surgery for weight loss or prevention of metabolic dysfunction–associated steatotic liver disease, and their potential role to prevent regain after weight-loss surgery.”

From the U.S. healthcare business front,

  • STAT News presents three issues to “watch in pharma in 2024.”
    • Obesity
    • Paying for gene and cell curative therapies, and
    • Drug pricing
  • The journalist raises an interesting point on the second topic.
    • “One possibility may be so-called value-based or outcomes-based agreements, in which coverage and reimbursement are linked to the extent to which a drug is actually effective. Simply put, the manufacturer and the payer take on a level of risk. If the drug does not do as well as expected, the manufacturer reimburses the payer for a portion or all the costs.
    • “This approach is not new. Over the past few years, more drug companies and payers have explored such deals, although they do not always work. Disputes can emerge over the way data is collected and evidence of effectiveness is captured, disagreements over incentive mechanisms and financial terms, and the availability of useful outcome measures.
    • “Another issue is the Medicaid Best Price requirement. This refers to the stipulation that a pharmaceutical company must offer its best price to Medicaid and other U.S. government health programs. But this can pose a dilemma for a drugmaker if its value-based agreement lowers the price to a payer and, therefore, must be lowered to Medicaid and others, diminishing its revenue.”

Tuesday Tidbits

David Ermer–Congress, Medical / Rx research, Mental health care, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Federal News Network informs us
    • “Agencies don’t have to worry about a 1% sequestration on discretionary funds kicking in for a few more months.
    • “The Office of Management and Budget says the requirement to reduce discretionary spending under the Fiscal Responsibility Act (FRA), signed into law in June, wouldn’t take effect until “after full year appropriations are enacted, or April 30, whichever comes first.”
    • “OMB will take no action on Jan. 1, 2024, and no additional action should be taken by agencies to reduce impacted discretionary funding, even though a short-term continuing resolution will be in effect at that time,” OMB wrote in frequently asked questions on 2024 discretionary spending sent to agencies on Dec. 22. “If any discretionary appropriation account remains on a short-term CR past April 30, OMB is required to issue a final sequestration report that compares the annualized appropriation levels provided by all discretionary appropriations bills under current law as of April 30 against the [FRA’s] section 102 interim spending limits. A breach of the section 102 spending limits would require OMB to order a sequestration to bring the current law discretionary appropriations in line with those interim spending limits.”
  • Govexec identifies the federal agencies with the greatest increases and decreases in employee morale in 2023 according to OPM’s 2023 Federal Employee Viewpoint Survey.
  • Fedweek offers a summary of OPM’s current regulatory activities.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Immune-boosting drugs have revolutionized cancer care. Now doctors are experimenting with cutting them off.  
    • “Immunotherapies unleash the immune system on tumors. They have extended the lives of people with melanoma, lung and bladder cancers. They have also been a boon for drugmakers, generating global sales of $44 billion in 2022, according to Leerink Partners analysts. 
    • “But some patients are getting more of the drugs than they need, exposing them to side effects and costs they could avoid without risking their cancer recurring. Preliminary research suggests taking the drugs at a lower dose or for a shorter period could be sufficient, but drugmakers haven’t funded the studies needed to confirm the findings. 
    • “We don’t know when to stop,” said Dr. Jedd Wolchok, an oncologist focused on melanoma at Weill Cornell Medicine in New York. * * *
    • “Recalibrating care toward less treatment is a fraught undertaking. Drug companies won’t fund studies exploring whether patients can do as well with less of their products, doctors said. Some doctors and patients worry about pulling back before exhausting their best chance to beat the disease.
    • “There was this dogma that more is better,” said Dr. Mark Ratain, an oncologist at the University of Chicago. 
    • “He is trying to recruit cancer patients to study whether they could do as well with less of Merck’s Keytruda or Bristol-Myers Squibb’s Opdivo, so-called immune checkpoint inhibitors. After three years, he has found just 60 of the 260 patients he wants, and most medical centers have declined to join the trial. “It was going to be difficult to convince people,” he said.”
  • Beckers Payer Issues interviews Kofi Essel, MD, Elevance Health’s first food as medicine program director. Dr Essel “sat down with Becker’s to discuss how Elevance is building a food as medicine strategy intended to eventually touch and improve the lives of its more than 47 million members nationwide.” Check it out.
  • MedPage Today tells us,
    • “The 988 lifeline routes callers to a network of more than 200 state and local call centers that are financially supported by the Substance Abuse and Mental Health Services Administration (SAMHSA), as well as state and local governments. In its first year, according to a July press release from SAMHSA, the lifeline answered nearly 5 million calls, texts, and chats from people looking for help with suicide, mental health, and substance use-related crises; that’s 2 million more contacts than the lifeline received in the previous 12 months, when it was a 10-digit phone number. (That 10-digit number — 800-273-8255 — is still in operation.)
    • “So far, 1.5 years in, things seem to be going well overall, said Michele Gilbert, MPH, senior policy analyst at the Bipartisan Policy Center in Washington, D.C. “Luckily, the implementation of 988 has seen some real success,” Gilbert said in a phone interview. “A lot of the operations have gone relatively smoothly.”
    • “Debbie Plotnick, MSS, executive vice president for state and federal advocacy for Mental Health America, agreed. “We have seen tremendous increases in the number of people who call, and even more importantly, what has improved dramatically is the wait time to speak to an actual human being,” she told MedPage Today. “Going back a couple of years, it could have been up to, like, 2 minutes, and now it’s within 30 or 40 seconds that you are actually connected to a live human being.”
    • “That decrease in wait time may not sound like a lot, but it’s actually “huge,” Plotnick said. “If you’re at the point where you’re going to hurt yourself and you don’t know if anybody in the world cares, 2 minutes can really feel like an eternity. But now calls are being answered very quickly.” She also praised the lifeline’s addition of text and chat options, as well as special lines for veterans, for Spanish speakers, and for LGBTQ+ callers.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • “The median hospital operating margin rose to 2% in November after holding steady at 1.6% in September and October, but escalating expenses — including rising drug costs — remain a concern as 2023 draws to a close, according to a Dec. 21 report from Syntellis Performance Solutions, which includes data from more than 1,300 hospitals.
    • “U.S. hospitals began the year with a median operating margin of -0.9%, but that figure has steadily increased and looks set to end the year at a healthier level around the 2% mark in December. November was the ninth consecutive month of positive operating margins. 
    • “While the median hospital margin remains far below pre-pandemic levels, it has shown significant progress in recent months as hospitals continue their recovery after more than a year of negative results. 
  • The Wall Street Journal reports,
    • “Drug company Bristol-Myers Squibb struck a $4.1 billion deal to buy  RayzeBio in a bet on a re-emerging cancer drug technology.
    • “RayzeBio develops radiopharmaceutical drugs, which use targeted forms of radiation that are delivered directly to cancer cells. Earlier products using the technology struggled commercially, but further research led to another wave of promising therapies that can attack tumors while limiting damage to surrounding healthy cells.  * * *
    • “Bristol said the RayzeBio deal is slated to close in the first half of 2024.”
  • and
    • AstraZeneca has agreed to buy Gracell Biotechnologies for a transaction value of $1.2 billion, as part of the former’s efforts to grow its cell therapies business.
    • The acquisition will help grow AstraZeneca’s pipeline of cell therapies for potential treatment of cancer and autoimmune diseases.
    • The transaction is expected to close in the first quarter of next year, AstraZeneca said.