Friday Factoid

COVID-19

Friday Factoid

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

From Washington, DC

  • Govexec informs us,
    • “Federal agencies will have to speed up their presidential transition preparations and ensure they are prepared for extended periods without a known electoral winner under a new law introduced on Friday by a bipartisan pair of senators. 
    • “The Agency Preparation for Transitions Act, put forward by Sens. Gary Peters, D-Mich., and Susan Collins, R-Maine, aims to provide greater resources to career employees at federal agencies tasked with preparing potential future administrations. Agencies already face a slew of requirements in drafting materials and answering questions from campaign transition teams, but the new measure looks to speed up some of the established timelines for those interactions and boost communication between the White House and agency transition teams.”
  • The Department of Health and Human Services announced
    • “On December 7, the Biden-Harris Administration announced new actions to promote competition in health care, including increasing transparency in the Medicare Advantage (MA) insurance market and strengthening MA programmatic data. Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is continuing momentum in this area by releasing a Request for Information (RFI) to solicit feedback from the public on how best to enhance MA data capabilities and increase public transparency. Transparency is especially important now that MA has grown to over 50% of Medicare enrollment, and the government is expected to pay MA health insurance companies over $7 trillion over the next decade. The information solicited by this RFI will support efforts for MA plans to best meet the needs of people with Medicare, for people with Medicare to have timely access to care, to ensure that MA plans appropriately use taxpayer funds, and for the market to have healthy competition. * * *
    • The MA Data RFI can be accessed on the Federal Register’s webpage at https://www.federalregister.gov/public-inspection/current.  Comments are due on May 29, 2024.
  • MedTech Dive reports,
    • “Absolutions Med has received breakthrough designation for an abdominal wall closure device that is intended to reduce the risk of hernia. 
    • “The Food and Drug Administration designation, which Absolutions disclosed Wednesday, covers a device designed to distribute suture tension over a large area of tissue.
    • “Absolutions began testing the device, Rebuild Bioabsorbable, in cancer patients undergoing abdominal surgeries in 2022, and the company began a study in a broader population in March 2023.”
  • The Centers for Medicare and Medicaid Services made available the latest version of the Section 111 reporting user guide for group health plans and the slides from a recent webinar on the new Section 111 civil monetary penalties program that kicks in on October 11, 2024.
  • The Society Human Resource Management points out that
    • “The Department of Labor has issued guidance on emergency savings accounts linked to retirement savings plans, a new benefit available this year under a provision of the Secure 2.0 Act of 2022.
    • “Secure 2.0 amended the Employee Retirement Income Security Act (ERISA) to authorize the establishment of pension-linked emergency savings accounts (PLESAs), which are short-term savings accounts established and maintained as part of an individual’s retirement savings plan, such as a 401(k) plan. The provision creating PLESAs, Section 127, took effect on Jan. 1.
    • “The DOL guidance comes in the form of 20 frequently asked questions.”

From the public health and medical research front,

  • STAT News reports,
    • “A historic new study out of Scotland shows the real-world impact of vaccines against the human papillomavirus: The country has detected no cases of cervical cancer in women born between 1988-1996 who were fully vaccinated against HPV between the ages of 12 and 13.
    • “Many previous studies have shown that HPV vaccines are extremely effective in preventing cervical cancer. But the study, published on Monday in the Journal of the National Cancer Institute, is the first to monitor a national cohort of women over such a long time period and find no occurrence of cervical cancer.
    • “The study is super exciting. It shows that the vaccine is extremely effective,” said Kathleen Schmeler, a professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, who was not involved in the research. “It’s obviously early. We’re just starting to see the first data of the impact of the vaccine because it takes so long from the time of the vaccine to the effects.”
    • “The results underscore the importance of working to increase uptake of the HPV vaccine in the U.S., said Schmeler. Scotland, for example, introduced routine immunization in schools in 2008, and close to 90% of students in their fourth year of secondary school (equivalent to 10th grade in the U.S.) in the 2022-2023 school year had received at least one dose of the vaccine. In the U.S., where HPV vaccines are not administered in school, uptake among adolescents ages 13 to 17 is a little over 60%.
    • “The study also points to how crucial the timing of vaccination is. “The girls that didn’t develop any cancer were vaccinated before becoming sexually active,” said Schlemer. “So we should not wait to vaccinate folks and really do it, for the guidelines, prior to becoming sexually active.”
  • The Centers for Disease Control tells us,
    • “A new CDC study has found that more recent COVID-19 hospitalizations among adults experienced fewer severe outcomes than during earlier parts of the COVID-19 pandemic, and that the proportion of severe hospital outcomes from COVID-19 became more similar to adults hospitalized with flu. Most recently, when COVID-19 Omicron variants predominated, hospitalized flu and COVID-19 patients had similar levels of intensive care unit (ICU) admissions and use of supplemental oxygen, respiratory support, and invasive mechanical ventilation. Even the risk of death as an outcome became more similar across the two diseases, with the exception of among people 18 to 49 years, who continued to experience higher in-hospital deaths from COVID-19. This study underscores the fact that both diseases have the potential to be dangerous and that both warrant the compliance with CDC prevention and treatment recommendations.
    • “The study, published in Open Forum Infectious Diseases, analyzed a subset of adult hospitalizations with COVID-19 or flu that were recorded in one surveillance system to compare clinical outcomes and other characteristics between the two groups. People who were hospitalized with COVID-19 were additionally sorted into groups depending on the predominant COVID-19 variant circulating at the time. The most recent COVID-19 Omicron BA.5-predominant period was compared to flu outcomes during the 2021-2022 season.”
  • MedPage Today offers a transcript of an interview with Dr. Paul Paul Offit, MD, on “the history of the MMR vaccine and the lasting legacy of COVID.”
  • Precision Vaccinations lets us know,
    • “In 2023, the U.S. Food and Drug Administration (FDA) approved one respiratory syncytial virus (RSV) vaccine and an updated monoclonal antibody therapy to prevent respiratory disease in very young children.
    • “Given these were new options, health officials did not know which product pregnant women would prefer during the 2023-2024 RSV season.
    • “According to new data published by the U.S. Centers for Disease Control and Prevention (CDC) on January 23, 2024, the winner has been Beyfortus™ (Nirsevimab).”
  • The JAMA Open Network explains,
    • Question  What are the long-term trends in breast cancer incidence among women aged 20 to 49 years?
    • Findings  In this population-based, cross-sectional study using data from Surveillance, Epidemiology, and End Results, age-standardized, age-cohort–adjusted, and age-period–adjusted breast cancer incidence rates increased over the past 20 years among different races in different age groups. Incidence rates for estrogen receptor (ER)-positive, stage I, and stage IV tumors increased, while rates decreased for ER-negative, stage II, and stage III tumors.
    • Meaning  These results suggest that understanding factors driving differential trends in incidence rates for different age groups by race and ER-positive status should provide insights into breast cancer prevention in young women.

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Nonprofit hospital operating margins soared last year, increasing 20% January to November 2023 as compared to the same period in 2022, according to Kaufman Hall’s “National Hospital Flash Report,” published Jan. 9. 
    • “Operating EBITDA jumped 15% year over year in November and was up 9% for the first 11 months of the year compared to 2022.
    • “Hospitals with 500-plus beds also did particularly well. On average their operating margin was up 59.3% year over year for November, and operating EBITDA margin was : up 20.5%, according to Kaufman Hall.”
  • and
    • Boston-based Tufts Medicine reported a $171 million operating loss in the fiscal year ending Sept. 30, a 57% improvement on the $399 million loss it posted in the previous year, according to financial documents published Jan. 26. 
    • Year over year, revenue increased 14.4% to $2.6 billion while expenses grew by 3.8% to $2.8 billion. Under expenses, salaries and wages increased 6.4% to $1.3 billion and employee benefits were up 6% to $260.5 million.
    • After accounting for the performance of its investment portfolio and other nonoperating items, Tufts ended the 12-month period with an overall gain of $1.6 million, a significant improvement on the $530.4 million net loss recorded in the prior year. 
  • Per Healthcare Dive,
    • “Healthcare bankruptcies spiked in 2023 to the highest level in the past five years, according to a report released Thursday by healthcare restructuring advisory firm Gibbins Advisors.
    • “The analysis included Chapter 11 bankruptcies for companies with liabilities of at least $10 million. Gibbins Advisors found 79 such bankruptcies last year — more than three times the level seen in 2021.
    • “The number of filings dropped from the third to the fourth quarter, but total case volume could remain high in 2024 as the market continues to be “very challenging” for providers, said Tyler Brasher, a director at Gibbins Advisors, in a statement.”
  • Mercer Consulting shared its views on managing prescription drug benefits.

 

Thursday Miscellany

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

From Washington DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

The FEHBlog is back!!

David Ermer–CDC, CMS, COVID-19, HSA, Medical / Rx research, OPM, U.S. Healthcare–

On Friday, the FEHBlog flew from Austin to Washington, DC, having left his briefcase at home. As a result he did not have his laptop or his FEHBlog log in information over the weekend. He is back in action today.

From Washington, DC,

  • The White House issued a fact sheet about new actions taken by the White House Task Force on Reproductive Healthcare Access which is marking the 51st Anniversary of Roe v. Wade. Of note to the FEHB Program, the Fact Sheet discusses
    • “Strengthen[ing] Contraception Access and Affordability for Women with Private Health Insurance. The Administration is committed to ensuring that women have access to contraception—an essential component of reproductive health care that has only become more important in the wake of the Supreme Court’s decision to overturn Roe v. Wade—and reducing barriers that women face in accessing contraception prescribed by their provider. The Departments of the Treasury, Labor, and Health and Human Services (HHS) are issuing new guidance [ACA FAQ 64] to clarify standards and support expanded coverage of a broader range of FDA-approved contraceptives at no cost under the Affordable Care Act. This action builds on the progress already made by the Affordable Care Act to expand access to affordable contraception for millions of women nationwide.
    • “In addition, the Office of Personnel Management will strengthen access to contraception for federal workers, retirees, and family members by issuing guidance to insurers participating in the Federal Employee Health Benefits Program that incorporates the Departments’ guidance. OPM will also newly require insurers that participate in the Federal Employee Health Benefits Program to take additional steps to educate enrollees about their contraception benefits.”
  • You may recall that OPM issued comprehensive guidance for carriers on contraceptive coverage in Carrier Letter No. 2022-17 back in the summer of 2022.
  • The FEHBlog was surprised that new ACA FAQ 64 does not announce a decision on whether group health plans are required to cover the new over-the-counter female contraceptive Opill which is not yet reached pharmacy shelves. The FEHBlog expects that the regulators will requires that group health plans cover Opill with no cost sharing when purchased at a network pharmacy.
  • In related news, the HHS and Centers for Medicare and Medicaid Services announced:
    • “launch[ing] a series of actions to educate the public about their rights to emergency medical care and to help support efforts of hospitals to meet their obligations under the Emergency Medical Treatment and Labor Act (EMTALA). As part of this comprehensive plan, the Department will:
      • “Publish new informational resources on CMS’s website to help individuals understand their rights under EMTALA and the process for submitting a complaint if they are denied emergency medical care;
      • “Partner with hospital and provider associations to disseminate training materials on providers’ obligations under EMTALA; 
      • “Convene hospital and provider associations to discuss best practices and challenges in ensuring compliance with EMTALA; and
      • “Establish a dedicated team of HHS experts who will increase the Department’s capacity to support hospitals in complying with federal requirements under EMTALA.”
  • In sum, HHS Secretary Xavier Becerra also sent a “letter to Medicare plans, health insurance issuers, and State Medicaid and CHIP programs about upholding their [contraceptive coverage] bligations under federal law.
    • Secretary Becerra wrote: ‘From day one, the Biden-Harris Administration has made clear that women should have access to the healthcare they need, including contraception and other family planning services. I’m writing to reaffirm that access to reproductive healthcare is a core priority of the U.S. Department of Health and Human Services.’”
  • American Hospital News tells us,
    • “A Department of Veterans Affairs policy that provides free emergency suicide prevention care has helped nearly 50,000 veterans and former service members in its first year, the VA announced last week. The policy allows the agency to provide, pay for or reimburse for eligible individuals’ emergency suicide care, transportation costs and follow-up care at any VA or non-VA facility for up to 30 days of inpatient care and 90 days of outpatient care.”
  • CMS issued its latest top ten Section 111 reporting issues for group health plans.
  • Fierce Healthcare informs us,
    • “Truveta, the real-world data analysis company backed by dozens of health systems and other life sciences groups, won a multi-million-dollar contract from the Centers for Disease Control and Prevention (CDC) to assist with the agency’s research into maternal health, pediatric care and respiratory viruses, including COVID-19.
    • “The company will let the CDC tap into its collection of more than 100 million patients’ deidentified, normalized electronic health record data.
    • “The Bellevue, Washington-based collective receives the information from its 30 health system members, which include major providers like Providence, Trinity Health and Tenet Healthcare. Together, the members provide over 18% of the country’s daily clinical care.”

From the public health and medical research front,

  • U.S. New and World Report lets us know,
    • “Coronavirus hospital admissions last week decreased for the first time in more than two months, according to data from the Centers for Disease Control and Prevention. Though the number remains elevated, weekly hospitalizations fell by nearly 10% week over week.
    • “More than 32,800 new COVID-19 hospital admissions were reported over the week ending Jan. 13, and over 27,800 Americans on average each day were considered currently hospitalized due to the disease during the same time frame, according to CDC data.
    • “Despite test positivity (percentage of tests conducted that were positive), emergency department visits, and hospitalizations remaining elevated nationally, COVID-19 rates have stabilized, or in some instances decreased,” the CDC said in a post on Friday.”
  • The CDC’s Fluview from last Friday notes,
    • “Seasonal influenza activity remains elevated in most parts of the country.
    • “After several weeks of increases in key flu indicators through the end of 2023, two weeks of decreasing or stable trends nationally have 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 baseline nationally since November and is above baseline in all 10 HHS regions.
    • “The number of weekly flu hospital admissions has decreased slightly for two consecutive weeks.”
  • Medpage Today points out,
    • “Several recent measles outbreaks have public health officials concerned — and are drawing attention to rising childhood vaccine exemptions and renewing calls for increased measles awareness.
    • “Philadelphia’s health department confirmed nine casesof the illness as of Tuesday, which spread at local health facilities and a daycare. At least three of the infections were in unvaccinated children, according to ABC News.
    • “As of January 12, two counties in Washington state noted “3 lab-confirmed and 3 [epidemiologically]-linked measles cases have been identified among unvaccinated adults.” Delaware identified 20-30 people who were exposed to measles at the Nemours Children’s Hospital a few days earlier. * * *
    • “Katelyn Jetelina, MPH, PhD, epidemiologist and author of the “Your Local Epidemiologist” newsletter, calls the recent measles outbreaks a potential symptom of “collective amnesia” in a recent newsletter, writing, “As generations age, the memory of mid-20th-century diseases like measles fade. … Some don’t know why this disease is bad or if this vaccine is safe. This is understandable.”
  • The FEHBlog subscribes to the Your Local Epidemiologist on Substack and he finds it to be worth the money.
  • NBC News reports,
    • “After decades of good news in the fight against cervical cancer — marked by decades of steady declines in cases and deaths — a new report suggests that some women are being left behind. * * *
    • “Among women in their 30s and early 40s, incidence has been edging upward. Diagnosis of cervical cancer among women ages 30 to 44 rose almost 2% a year from 2012 to 2019.
    • “We need to make sure we are not forgetting about that generation that was a little too old for HPV vaccination,” said Jennifer Spencer, an assistant professor at the Dell Medical School at University of Texas-Austin who studies population health.
    • “Fortunately, the cancers found in 30- and 40-something women were mostly early, curable tumors, said Ahmedin Jemal, senior author of the new report and the cancer society’s senior vice president for surveillance and health equity science. About 13,800 American women are diagnosed with cervical cancer each year and 4,360 die from the disease.”

From the U.S. healthcare business front,

  • Cigna issued a report on the top healthcare trends of 2024.
  • Kaiser Health News calls our attention to the following Modern Healthcare story
    • “Blue Cross Blue Shield insurers have become the first carriers to cover multimillion-dollar new gene therapies for sickle cell disease, and other insurers and Medicaid agencies are moving to follow suit. Blue Cross’ Synergie Medication Collective has inked risk-sharing agreements with drugmaker BlueBird Bio to offer its $3.1 million Lyfgenia gene therapy treatment for sickle cell disease to some self-insured employers, as well as competitor Vertex Pharmaceuticals’ $2.2 million Casgevy treatment.”
  • Per Fierce Healthcare,
    • “UnitedHealthcare is rolling out a new resource hub that seeks to make it easier for members to use wellness offerings while also easing the financial burden on employers.
    • “The UHC Hub features more than 20 different options, including wellbeing programs that target healthy living and more complex care management. Its network is built to make it easier for employers to find and purchase solutions and to make it simpler for consumers to engage.
    • “It’s not a secret that employers are feeling increasingly overwhelmed with the wide array of vendor options available to them. Samantha Baker, chief consumer officer for UnitedHealthcare’s commercial business, told Fierce Healthcare in an email that this is a pain point that comes up frequently in conversations with plan sponsors. * * *
    • “UnitedHealthcare said in an announcement that the hub builds on existing advocacy programs that it offers to clients, which help members in finding in-network providers, during a hospital discharge or in reviewing treatment and medication options.” 
  • Per Healthcare Dive,
    • “Intermountain-owned Saltzer Health said it will shut down if it cannot find a buyer by March 29, citing financial and economic challenges.
    • “The physician group said it’s in active negotiations with healthcare companies over the sale of some operations, and is “optimistic that a sale can be achieved,” according to a Thursday news release. 
    • “The health group, which is owned by Salt Lake City-based Intermountain Health, employs 450 people and serves approximately 100,000 annual patients across 11 Treasure Valley locations, according to a company spokesperson.”
  • BioPharma Dive explains why “With two biotech buyouts, schizophrenia drugs appear back on pharma’s radar. Deal documents suggest others besides Bristol Myers and AbbVie may be looking.”

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Politico reports,
    • “The House cleared a stopgap spending bill on Thursday afternoon that officially keeps federal agencies funded through early March, sending the measure to President Joe Biden’s desk. * * *
    • “With parts of the government now funded through March 1 and March 8, leading appropriators have a tremendous amount of work to do in just a matter of weeks. ***
    • “Haggling over the broader spending bills can’t begin in earnest, however, until leading appropriators lock down a deal on funding totals for all 12 of them. It’s a critical next step that has consumed the last couple weeks for Senate Appropriations Committee Chair Patty Murray (D-Wash.) and her House counterpart, Chair Kay Granger (R-Texas).”
  • The American Hospital News informs us,
    • “The Departments of Health and Human Services, Labor, and the Treasury will reopen the public comment period for their proposed rule to improve the No Surprises Act independent dispute resolution process for 14 days beginning Jan. 22 to provide additional time for interested parties to comment.”
  • The Center for Medicare and Medicaid Services announced the Innovation in Behavioral Health (IBH) Model.
    • IBH is focused on improving quality of care and behavioral and physical health outcomes for Medicaid and Medicare populations with moderate to severe mental health conditions and substance use disorder (SUD). Medicare and Medicaid populations experience disproportionately high rates of mental health conditions and/or substance use disorders (SUD), and as a result are more likely to experience poor health outcomes and experiences, like frequent visits to the emergency department and hospitalizations, or premature death. 
    • The IBH Model seeks to bridge the gap between behavioral and physical health; practice participants under the IBH Model will screen and assess patients for select health conditions, as well as mental health conditions and/or SUD, in community-based behavioral health practices. IBH is a state-based model, led by state Medicaid Agencies, with a goal of aligning payment between Medicaid and Medicare for integrated services.
    • CMS will release a Notice of Funding Opportunity (NOFO) in Spring 2024, and up to eight states will be selected to participate. The model will launch in Fall 2024 and run for eight years.
  • The Department of Health and Human Services also issued a fact sheet about steps taken over the last year to expand access to behavioral health by integrating behavioral health with primary care and other physical health and community settings.
  • The U.S. Preventive Services Task Force posted a draft research plan concerning “BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing” for public comment. The public comment deadline is February 14, 2024.

From the public health and medical research front

  • The Kaiser Family Foundation discusses the two healthcare cost crises facing our country.
    • “The cost of health care isn’t a single problem, it’s a multi-dimensional one. That’s one reason we often talk past each other about healthcare costs; we’re talking about different problems. There’s national health spending, consumer out-of-pocket costs, federal health spending (mostly for Medicare and Medicaid), state health spending (mostly Medicaid), employer premiums, and the cost problem currently in vogue—getting better “value” for the health care dollar. Like a Venn diagram with sets that don’t always overlap, each of these are different challenges that often have different and sometimes conflicting solutions. We work on all of these dimensions of health care costs at KFF, but two health cost problems stand out as legitimate health policy crises: Affordability, especially for people who are sick and need a lot of healthcare, and national health spending (the subject of the CMS annual report).”
  • STAT News reports,
    • Mental health care in the United States is in crisis. As the need for care surges — a longstanding trend exacerbated by the Covid-19 pandemic — the demand for therapists far outstrips the supply. In national surveys, more than one in five U.S. adults suffer from mental illness, yet almost half of those in need report receiving no care. People struggling with mental health challenges often spend months on a wait list despite needing immediate care. Others simply can’t afford it. And getting care is even harder for people living in rural areas and people of color. * * *
    • In the face of these issues, there’s growing interest in the use of lay counselors. One scientific journal recently announced a call for papers for a special issue on the subject. In its executive summary for a recent population health summit, the APA [American Psychological Association] declared that the “exclusive reliance on trained mental health care providers when there are severe gaps in support for training of a mental health workforce has left millions untreated.” A number of recent research articles suggest addressing the gap by innovating on the traditional model of mental health treatment, including where and how it is provided and who provides it.
    • Lynn Bufka, associate chief of practice transformation and quality at the APA, believes that an expanded approach to providing mental health care is essential to meet the current need. “We clearly cannot meet the need for mental health services in this country with the existing workforce,” she said. “We’re going have to consider those kinds of models and options in order to get to where we need to be in this country.”
  • STAT New also delves into whether recent scientific findings may lead to a test for long Covid.
    • “Long Covid has long eluded scientists looking for its cause. Not knowing what triggers its persistent and distressing symptoms makes the condition challenging to treat; it’s hard to even say definitively who has it. New research published Thursday in Science has identified proteins present in the blood of people with long Covid that could point the way to a much-needed diagnostic test and possibly to future therapeutic targets.
    • “Scientists at the University of Zurich discovered high levels of proteins involved in the complement system — an important part of the immune system bridging innate and adaptive responses — that were disrupted in people with long Covid symptoms, but not in those who got better after the initial Covid-19 infection or in those who had recovered from long Covid symptoms after six months. The team also found damaged red blood cells and platelets as well as signs of harm to the endothelial cells that line blood vessels.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Drugmakers kicked off 2024 by raising the list prices for Ozempic, Mounjaro and dozens of other widely used medicines. Companies including the maker of Ozempic, and Eli Lilly , which sells Mounjaro, raised list prices on 775 brand-name drugs during the first half of January, according to an analysis for The Wall Street Journal by 46brooklyn Research, a nonprofit drug-pricing analytics group. 
    • “The drugmakers raised prices of their medicines by a median 4.5%, though the prices of some drugs rose by around 10% or higher, according to the research group. The median increase is higher than the rate of inflation, which ticked up to 3.4% in December. * * *
    • “Among the notable increases: The price for Ozempic, a diabetes treatment that many people are taking to lose weight, went up by 3.5% to nearly $970 for a month’s supply. Mounjaro, a diabetes drug in the same class that is also widely used for weight loss, climbed 4.5% to almost $1,070 a month.”
  • Healthcare Dive identifies “Top healthcare trends in 2024; Here’s what industry experts see coming down the pike for hospitals, insurers and digital health companies this year.” The article summarizes Healthcare Dive’s 2024 trend reports from the past few weeks.
  • Healthcare Dive also informs us,
    • “Humana is the latest victim of elevated medical costs in the fourth quarter. The health insurer on Thursday lowered its 2023 profit outlook after members utilized more healthcare than expected as the year drew to a close.
    • “Humana now expects $26.09 in adjusted earnings per share for full-year 2023, according to a financial filing. That’s down from its prior guidance of at least $28.25.
    • “Humana also lowered its expectations for growth in the lucrative Medicare Advantage program. The insurer now expects to increase MA membership 1.8% this year. Previously, Humana said it would outstrip expected industry growth of 6% to 8%.”
  • CVS Health posted a report highlighting opportunities for the future of community pharmacies.

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.