Midweek update

COVID-19

Midweek update

David Ermer–AHRQ, CDC, CMS, Congress, COVID-19, FDA, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The Wall Street Journal reports
    • “Congressional leaders struck a cautiously optimistic tone Wednesday on reaching a deal combining tighter border security with aid for Ukraine, as they emerged from meeting with President Biden at the White House.
    • “House Speaker Mike Johnson (R., La.) said the hour-and-20-minute sit down was “productive” while reiterating Republicans’ demand that changing border law was a condition for further funding Kyiv, which is one piece of a stalled $110.5 billion foreign-aid package championed by Biden.”
  • and
    • “The Biden administration on Wednesday finalized requirements to streamline the process for doctors and patients seeking health insurance approval for medical care and treatments.
    • “The rule aims to shorten the timeline for the so-called prior authorization process to as little as 72 hours for many of the tens of millions of people who get their health insurance through Medicare Advantage, Medicaid or an Affordable Care Act health plan by automating some of the processing of the requests.
    • “Plans would also have to share more information with doctors about the status of decisions and information on denials, with a turnaround time of seven calendar days for non-urgent requests.”
  • Here is a link to the CMS fact sheet on the final rule.
    • “Impacted payers must implement certain operational provisions, generally beginning January 1, 2026. In response to public comment on the proposed rule, impacted payers have until compliance dates, generally beginning January 1, 2027, to meet the API development and enhancement requirements in this final rule. The exact compliance dates vary by the type of payer.”
  • STAT News reports that the federal government dismissed its appeal of a D.C. district court decision vacating a Trump Administration rule favoring use of copay accumulators by health plans. “Insurers can still use the copay accumulators when patients use brand drugs that do have generic competition.”
  • MedPage Today tells us,
    • “The FDA cleared an artificial-intelligence (AI)-powered device designed to non-invasively detect skin cancer in the primary care setting, the agency announced on Tuesday.
    • “Developer DermaSensor said the device uses AI-powered spectroscopy technology to non-invasively evaluate cellular and subcellular characteristics of a lesion for any of the three common skin cancers — melanoma, basal cell carcinoma, and squamous cell carcinoma. The wireless, handheld device then provides a result in real time using an FDA-cleared algorithm.”
  • MedTech Dive informs us,
    • “The Food and Drug Administration issued an alert for patients and healthcare providers about the risks associated with an Exactech shoulder replacement device after the company “declined to initiate a voluntary recall.”
    • “FDA officials advised healthcare professionals against implanting Equinoxe Shoulder Systems packaged in defective bags because of a risk of oxidation that can accelerate device wear or failure. The issue could lead to patients needing additional surgery to replace or correct devices.
    • “Exactech recalled other orthopedic devices in 2021 and 2022, initially because of excessive and premature wear of unknown cause, and later because it found a problem with its packaging.”

From the public health and medical research front,

  • Beckers Hospital Review points out 35 states where respiratory illness levels remain high or very high, according to the Centers for Disease Control.
  • The Wall Street Journal lets us know,
    • “Americans are living longer, but spending less time in good health.
    • “The estimated average proportion of life spent in good health declined to 83.6% in 2021, down from 85.8% in 1990, according to an analysis of the latest data from the Institute for Health Metrics and Evaluation’s Global Burden of Disease study, a research effort based at the University of Washington.
    • “The decrease of time spent in good health is partly because medical advances are catching and treating diseases that once would have killed us. But it is also because of the rising prevalence, often among younger people, of conditions such as obesity, diabetes and substance-use disorders.
    • “Declining health takes a deep physical and emotional toll on patients and their caregivers. There are also broad ramifications on society, including rising health costs that eat into household budgets, as well as more people who want to work but can’t.
    • “The period of life spent not healthy is getting larger and larger and the implications of that are enormous,” says Dr. John Rowe, a professor of health policy and aging at Columbia University. “70 is the new 80.”
  • Beckers Hospital Review adds,
    • “The expected increase in new cancer diagnoses this year is record-setting, even as overall cancer mortality is expected to continue its decline, the American Cancer Society said in its latest report.
    • “The report was based on the most recent data on population-based cancer occurrences and outcomes collected by central cancer registries through 2020 and mortality data from the National Center of Health Statistics through 2021.
    • “The projected number of new diagnoses tops 2 million for the first time, with an increase in six out of 10 top cancers. Notably, colorectal cancer new cases have shifted mortality patterns in adults younger than 50 and have moved up from being the fourth leading cause of cancer death to the first in men and second in women.”
  • AHRQ announced the following study result:
    • “Diagnostic errors can result in significant morbidity and mortality. This large cohort study reviewed the health records of 2,428 adult inpatients who were transferred to the intensive care unit (ICU) and/or died in the hospital to estimate frequency, cause, and harms of diagnostic errors. Nearly a quarter (23.0%) of patients in the cohort experienced a diagnostic error, and 6.6% of patients who died had a diagnostic error. Delays in ordering and interpreting tests and problems with clinical assessment were the most common contributing factors resulting in transfer to ICU and/or death.”
  • According to Healio,
    • “Rates of long COVID were similar between groups of people who received Paxlovid and those who do not.
    • “COVID-19 rebound is not linked to an overall risk for long COVID.”
  • Per Beckers Payer Issues,
    • “RSV vaccinations brought more older adults to their primary care offices in the last months of 2023, one factor behind rising medical costs in Medicare Advantage, UnitedHealth Group executives said. 
    • “Andrew Witty, CEO of UnitedHealth Group, told investors on a Jan. 12 call that more visits to primary care providers for RSV vaccines led to increased medical service costs in other areas for the Medicare population. 
    • “To be clear, all of that is good news for healthcare. These are seniors, many of whom had not been to the office in a long time,” Mr. Witty said. “They’ve come back in now, got vaccinated, and physicians have picked up on other things.” 

From the U.S. healthcare business front,

  • Healthcare Dive notes,
    • “Cigna announced a slew of leadership updates on Wednesday, including an expansion of chief financial officer Brian Evanko’s role.
    • “Evanko will continue to hold the CFO position, and he’ll also serve as president and CEO of the company’s Cigna Healthcare division, its benefits business, which includes the U.S. Commercial and U.S. Government segments.”  
  • Per Beckers Payer Issues,
    • “Humana plans to lay off a small portion of its workforce, the Louisville Courier-Journal reported Jan. 16. 
    • “Humana did announce some limited workforce reductions last week,” a Humana spokesperson told Becker’s Jan. 16. “The impacted positions represented a small percentage of our total workforce and were geographically dispersed across multiple locations.”
  • Forbes reports,
    • “Three months ago, venture capital firm General Catalyst announced an unusual move: The creation of an entirely new company that would someday acquire a multi-billion dollar health system that could serve as a proving ground for new technologies.
    • “On Wednesday, that company – the Healthcare Assurance Transformation Corporation, or HATCo – revealed its intended target: Akron, Ohio-based Summa Health, a nonprofit three-hospital system and health insurer.”
  • Medical Economics notes,
    • “This year promises to be a Super Bowl of telehealth, according to plans by the American Telemedicine Association (ATA).
    • “The year 2024 has at least two major factors that could be hugely influential for telehealth, according to the organization and its affiliated ATA Action advocacy nonprofit.
    • “It’s a presidential election year, and it will bring the end of the telehealth flexibilities that Congress enacted by during the COVID-19 pandemic and continued after the end of the public health emergency. Those need to remain in place, said Kyle Zebley, ATA senior vice president for public policy and ATA Action executive director.
    • “With Congress back in session, the clock officially starts counting down,” Zebley said in a news release this month. “It’s time for the administration and our congressional leaders to take permanent action to ensure patients across the country have access to safe, affordable, and effective health care where and when they need it and provide certainty to beneficiaries and our nation’s health care providers. That would be a win-win.”
  • The Brookings Institution offers a report assessing early experience with arbitration under the No Surprises Act.

Friday Factoids

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

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

From Washington, DC

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

From the public health and medical research front,

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

Per the U.S. healthcare business front,

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

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.”  

Midweek Update

David Ermer–CDC, COVID-19, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC

  • Govexec informs us,
    • “A new website has made available a database of anyone serving in a top-ranking position in the federal government, offering new insight that advocates said will boost transparency and better prepare new administrations to transition into power.  
    • “The Office of Personnel Management launched the site to comply with the Periodically Listing Updates to Management (PLUM) Act, which so far includes the names, roles and pay levels of more than 8,000 executives in government.
    • “OPM said that figure will grow to 10,000 as it ensures compliance and updates the list over the coming months. It will include senior leaders at every federal agency, including all 4,000 political appointees, Senior Executive Service members and other top or non-competitively appointed officials. “
  • The Department of Health and Human Services tells us,
    • On Wednesday, January 3, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra met virtually with long-term care facility (LTCF) leaders to express concerns about low vaccination rates among nursing home residents and remind industry leaders of their obligations to offer the COVID-19 vaccine to residents and staff.
    • Today’s conversation was a follow-up call from a previous HHS virtual meeting on December 21 with LTCF leaders to discuss the Centers for Disease Control and Prevention’s (CDC) December 2023 report finding that just 33% of long-term care facility residents were up to date with their COVID-19 vaccinations. The Centers for Medicare & Medicaid Services (CMS) requires all nursing homes to offer COVID-19 vaccines to residents and staff and educate them on their benefits.
  • FedWeek notes,
    • “Fraud against the federal retirement program is continuing, an inspector general report has said, with lack of reporting to OPM on the deaths of beneficiaries the most common means.
    • “These unreported deaths may allow payments to continue because of program vulnerabilities or intentional fraud on the part of bad actors. Sometimes, CSRS or FERS improper payments continue for years and cost tens of thousands of dollars before discovery,” says the IG’s latest summary of its investigative activities.”
  • FEHBlog note — The government needs a better system to keep track of deaths.

From the U.S. public health and medical research front,

  • The New York Times reports,
    • “The holidays have come and gone, and once again Americans are riding a tide of respiratory ailments, including Covid. But so far, this winter’s Covid uptick seems less deadly than last year’s, and much less so than in 2022, when the Omicron surge ground the nation to a halt.
    • “We’re not seeing the signs that would make me think that we’re heading into another severe wave,” said Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. “So far, we’re in relatively good shape.”
    • “Still, * * * just a fraction of the most vulnerable people have received the latest Covid shots, she noted.
    • “It’s not too late,” Dr. Rivers added. “We have not even reached peak yet for Covid, and once you reach peak, you still have to get down the other side.” That leaves plenty of time for the vaccine to provide some protection.”
  • Beckers Hospital Review adds,
    • “COVID-19 and flu admissions continue to climb across the country, with the majority of states now reporting high levels of respiratory virus activity. 
    • “Overall, 31 states reported high levels of respiratory virus activity for the week ending Dec. 23. Included in this total are a growing number of states seeing “very high” activity levels: Alabama, California, Colorado, Georgia, Louisiana, Mississippi, Nevada, New Jersey, New Mexico, North Carolina, South Carolina, Tennessee, Virginia and New York City. Two weeks ago, just five states reported very high levels.” 
  • Medscape notes
    • “While COVID has now claimed more than 1 million lives in the United States alone, these aren’t the only fatalities caused at least in part by the virus. A small but growing number of Americans are surviving acute infections only to succumb months later to the lingering health problems caused by long COVID.
    • “Much of the attention on long COVID has centered on the sometimes debilitating symptoms that strike people with the condition, with no formal diagnostic tests or standard treatments available, and the effect it has on quality of life. But new figures from the US Centers for Disease Control and Prevention (CDC) show that long COVID can also be deadly.
    • “More than 5000 Americans have died from long COVID since the start of the pandemic, according to new estimates from the CDC.”
  • STAT News alerts us,
    • “One in three heart patients live with anxiety, depression, and ongoing stress, according to a 2023 meta-analysis of over 100 studies. But even in the age of 24/7 monitoring via implantable loop recorders and wearables, many patients are without professional support for the mental and emotional social aspects of coping with heart disease.
    • “The technology of cardiology is locked down. People get that. What’s not locked down is the patient experience,” said Sam Sears, professor of health psychology at East Carolina University, and the author of over 200 research studies on psychological interventions for heart health. “The human factors in all this just don’t get addressed as a standard of care.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Cigna is in advanced talks to sell its Medicare business in an about-face for the health-insurance giant, which had been expanding its footprint in the fast-growing sector. 
    • “Cigna, which has been running an auction for the business, known as Medicare Advantage, is now in exclusive talks to sell it to Health Care Service Corp. for between $3 billion and $4 billion, according to people familiar with the matter. 
    • “Should there be a deal, it would mark a major expansion for HCSC, a big nonprofit health insurer that is the parent of Blue Cross Blue Shield plans in five states including Texas and Illinois. HCSC has long been a powerful player in its home states, but the deal would give it a significant Medicare business and far broader reach. Cigna is offering Medicare plans in 29 states for 2024.
  • Drug Channels offers its annual “reality check on U.S. drug pricing.”
  • Per Fierce Healthcare,
    • “Solera Health, a chronic condition management platform for payers and employers, is expanding its platform to include virtual specialty care facilitated by several new clinical partners.
    • “Solera’s HALO Platform is an omni-condition management tool that aims to address high-cost chronic conditions, mostly serving commercial populations. The latest expansion into virtual specialty care furthers the company’s value-based care mission by widening access to specialist docs in a low-cost setting, executives told Fierce Healthcare.
    • “The new capabilities leverage partnerships with two new partners, 9am.health and Vori Health, as well as an existing partner, Oshi Health.
    • “Each partner specializes in addressing high-cost conditions, from obesity and diabetes to musculoskeletal pain to GI conditions. They offer a health coach, nutritionist, peer support and other support services while also coordinating with a patient’s primary or in-person care doc.”
  • Health Payer Intelligence looks at employer-sponsored plan trends for 2024.

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.”

Thursday Miscellany

David Ermer–AHRQ, COVID-19, Electronic health records, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports
    • “The Office of Personnel Management had a busy year, managing to push out plenty of proposed regulations during 2023 that aim to reform federal hiring and improve workforce challenges.
    • “Even more plans and changes appear to lie ahead, though many may come in smaller bites, and require leadership from chief human capital officers (CHCOs) and other workforce experts in government.
    • “We are fundamentally rethinking hiring in government,” OPM Director Kiran Ahuja said during a Dec. 12 CHCO Council meeting. “Our big focus has been on utilizing pooled hiring, where multiple agencies with the same need can take advantage of one hiring action … It is so incredible of a tool that we have at our disposal right now.”
  • Govexec identifies the five agencies that did the most hiring in the fiscal year that ended September 30, 2023, with support from the White House.
  • The U.S. Preventive Services Task Force released for public comments a draft research plan to form a recommendation on medication to reduce breast cancer risk. The public comment deadline is January 31, 2024.
  • HHS’s Agency for Healthcare Research and Quality posted “Social and Structural Determinants of Maternal Morbidity and Mortality: An Evidence Map.” That’s certainly worth a gander.
  • Bloomberg reports,
    • “The US Food and Drug Administration has seized thousands of units of counterfeit Ozempic, Novo Nordisk A/S’s diabetes drug that’s been adapted into a blockbuster weight-loss treatment, and warned against using them.
    • “The regulator advised wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute or sell products labeled with lot number NAR0074 and serial number 430834149057.
    • “The FDA and Novo are testing the seized products and don’t yet have information about the drugs’ identity, quality, or safety.”
  • Kiplinger provides a useful overview of Medicare Part B and D’s income-adjusted premiums for 2024, known as IRMAA. The 2024 IRMAA is calculated based on the taxpayer’s 2022 adjusted gross income. The article explains how to obtain an IRS redetermination of 2024 IRMAA due to a life-changing event, for example.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Covid-19 infections and hospitalizations are rising this holiday season, mostly in people who have had the virus before. 
    • “A newer Omicron subvariant known as JN.1 is the culprit behind almost half of new cases in the U.S. The World Health Organization classified JN.1 as a variant of interest on Dec. 19 and said it was spreading rapidly worldwide. 
    • “The Centers for Disease Control and Prevention said the variant’s speedy spread suggests it is either more transmissible than other circulating variants or better at evading our immune systems. But existing vaccines, treatments and tests still work against it, the CDC said.”
  • Beckers Hospital Review identifies the ten States where COVID hospital admissions are the highest and where COVID hospital admissions are rising the fastest.
  • Fierce Healthcare considers whether GLP-1 patients can stop taking the drug and keep the weight off.
    • “While the current clinical paradigm for GLP-1 treatment requires lifelong medication at the highest dose, Calibrate is exploring whether members can be transitioned off of medication while sustaining their results,” shared a Calibrate spokesperson in a statement with Fierce Healthcare. “Accordingly, Calibrate is the first and only program with a proactive plan to get members off of medication.”
    • “That program, Calibrate says, was designed with evidence-based lifestyle interventions and is a more realistic approach for patients who don’t want to stay on GLP-1s forever. The company pointed to a 2018 study in The Obesity Society that shows 10% weight loss is the average attainable weight patients can realistically attain.
    • “Unlike the STEP 1 trial, where participants regained two-thirds of their prior weight loss after ceasing semaglutide utilization but continuing lifestyle intervention, Calibrate conducted its own analysis of 512 of its members to see if it’s possible to keep the weight off through the Calibrate program by tapering the drug’s usage. Its results showed that 93% sustained greater than 10% weight loss six to 12 months after beginning to taper off GLP-1 drugs.
    • “Calibrate advises speaking with a doctor to determine if GLP-1 tapering is appropriate for them but said it could be advisable at a normal BMI or if a patient plateaus for more than three months at a maximum dose of a GLP-1 medication.”
  • NBC News reports,
    • “Eating fewer carbohydrates can slow weight gain over time. But it’s not enough to just cut back on carbs. 
    • “An analysis of data from nearly 125,000 healthy adults revealed that replacing refined carbs — white bread, white rice or sugary cereals —with whole grain foods and cutting back on animal-based fats and proteins appeared to lessen the amount of weight people gained over a four-year period, according to the report published Wednesday in JAMA Network Open. 
    • “When it comes to a low-carbohydrate diet, quality is paramount,” said the study’s senior author, Dr. Qi Sun, an associate professor in the departments of nutrition and epidemiology at the Harvard T.H. Chan School of Public Health. “The things people need to pay attention to are high-quality carbohydrates.”
  • Health Day lets us know,
    • “Colon cancer screening is a known lifesaver, but the benefit may be even bigger than experts previously assumed
    • “New statistical analysis finds recommended screening cuts the 10-year incidence of the disease from 1% to 0.5%, double that of prior estimates
    • “Mentioning this to patients should boost colon cancer screening rates, researchers hope.”
  • Medscape tells us that cardiologists are not happy with the Lown Institute’s recent report about the overutilization of coronary stents.
    • “Lown “used an extremely liberal definition of overuse,” said Wayne Batchelor, MD, FACC, chair of the Interventional Council at the ACC, noting that overuse covered any stent placed during a nonemergency.
    • “We don’t just do procedures to try to save lives in very acute situations,” he said. “We also do procedures to try to improve symptoms and quality of life,” said Batchelor, director of Interventional Cardiology at the Inova Schar Heart and Vascular Institute in Fairfax, Virginia.
    • “Batchelor said that drawing conclusions from claims data alone in this report is improper because “it’s devoid of all the clinical information that a doctor and patient would want to discuss to make a decision as to whether or not a stent would provide a meaningful benefit to the patient.”
  • and
    • discusses changes to the adult vaccination schedule for 2024.

From the U.S. healthcare business front,

  • Health IT Analytics brings us up to date on the Fast Healthcare Interoperability Resource (FHIR).
    • “Using standardized application programming interface (API) standards, FHIR allows developers to create apps that transcend this document-based environment. Applications can be plugged into a basic EHR operating system and feed information directly into the provider workflow, avoiding pitfalls of document-based exchange, which often requires providers to access data separately.
    • “But FHIR APIs require health IT developers to publish FHIR endpoints in a standardized format, according to a 2022 blog post written by Office of the National Coordinator (ONC) officials. By developing the Lantern tool — which consumes public endpoint data, tests the accessibility of these endpoints, and then reports capability information to a public-facing dashboard — ONC worked with health IT stakeholders to form consensus around a standard format to publish FHIR endpoint lists.
    • “A slew of providers, developers, and vendors have created tools that leverage the data standard. The use cases for the standard are nearly limitless and include some of the major challenges preventing healthcare organizations from increasing patient engagement, developing robust population health management programs, and diving into advanced, intelligent clinical decision support.”

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.”

Holiday Weekend Update

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

The FEHBlog trusts that everyone is enjoying the holiday season

From Washington, DC,

  • Congress is out of town this week.
  • On December 22, 2023, the President signed into law H.R. 2670,
    • “the “National Defense Authorization Act for Fiscal Year 2024,” which authorizes fiscal year 2024 appropriations principally for Department of Defense programs and military construction, Department of Energy national security programs, Department of State, and Intelligence programs; specifies authorities relating to the U.S. Armed Forces; extends the Foreign Intelligence Surveillance Act; and other matters.”
  • Congress convenes for the second session of this 118th Congress in the first full week of January 2024.

From the public health and medical research front,

  • The American Medical Association tells us what doctors wish their patients knew about the current reigning Omicron sub-variant, JN.1.
  • Medscape points out,
    • “Gut bacteria are stronger together when it comes to preventing infectious diseases.
    • “When a large, diverse community of gut bacteria compete with pathogens for nutrients, the pathogens may not have enough fuel to colonize and invade the body, according to a new study in Science.
    • “The more microbes there are, the more different nutrients they’re likely to eat, increasing the chances of nutrient overlap with the pathogen. The greater the overlap, the better the host is protected, the study found.
    • “The nutrients available to the pathogen are limited,” said lead study author Frances Spragge, a researcher in the Department of Biochemistry, University of Oxford, Oxfordshire. “So, its invasion is blocked.”
    • “It makes sense, said Thomas Schmidt, PhD, professor of microbiology and immunology at the University of Michigan, Ann Arbor. (Schmidt was not involved in the study.) “It’s kind of no surprise that competition for resources is what is providing the colonization resistance,” Schmidt said. “But we didn’t have evidence that that was the case.”
    • “The study is among the first to take a systematic approach to addressing competition between pathogens and specific host microbes, Schmidt said. It’s a step toward identifying microbes that could be useful in treating infections.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Bristol Myers Squibb has agreed to acquire Karuna Therapeutics for $14 billion, betting that the biotechnology company’s experimental schizophrenia drug will become a top-selling medicine.
    • “Per deal terms announced Friday [December 22], Bristol Myers will pay $330 a share for Karuna, a roughly 53% premium to its closing price on Dec. 21. Net of the cash that Karuna has on hand, the deal is worth about $12. 7 billion.
    • “The acquisition hands Bristol Myers a closely watched medicine known as “KarXT” that’s currently being reviewed by the Food and Drug Administration as a potential treatment for schizophrenia. The drug is a newer type of medication that doesn’t work like available schizophrenia treatments. It’s already succeeded in three mid- to late-stage trials and, if approved by regulators, could be launched by the end of 2024.
    • “KarXT is also in advanced testing as an adjunctive therapy to existing schizophrenia drugs and as a potential treatment for psychosis in patients with Alzheimer’s disease.
    • “The FDA is expected to make a decision on its use in schizophrenia by Sept. 26 of next year.”