Happy Flag Day!

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, No Surprises Act, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal confirms,
    • “The federal government plans to redo this year’s quality ratings of private Medicare plans, a move that will deliver hundreds of millions in additional bonus payments to insurers next year.
    • “The decision by the Centers for Medicare and Medicaid Services was announced late Thursday, after The Wall Street Journal reported the agency’s plans. It comes in the wake of two court rulings that faulted the agency’s ratings, in cases filed by insurers SCAN Health Plan and Elevance Health.
    • “The agency said it would recalculate all of the 2024 quality ratings, but only apply the results if a plan’s ratings go up under the new methodology. If a plan’s ratings go down, the change won’t be implemented, CMS said in a guidance document.”
  • STAT News reports,
    • “Novo Nordisk CEO Lars Fruergaard Jørgensen will testify before the Senate after Sen. Bernie Sanders threatened to subpoena the company over its pricing of the popular diabetes drug Ozempic and the obesity drug Wegovy, the Senate health committee announced Friday.
    • “The agreement is a finale to a farcical public back-and-forth over apparent difficulties between the Senate health committee and Novo in scheduling a hearing. Sanders’ team claimed that Novo was uncooperative with his requests, but the company said they had told the senator’s team that the company was willing to testify.”
  • The American Hospital Association News lets us know,
    • “The Departments of Health and Human Services, Labor and the Treasury today announced a 120-day extension for parties impacted by the cyberattack on Change Healthcare to open disputes under the No Surprises Act independent dispute resolution process. Parties have until Oct. 12 to file disputes and must attest that their ability to open a dispute was impacted by the incident, the Centers for Medicare & Medicaid Services said. The departments published an attestation that parties must submit along with the standard IDR form during the extension period. The AHA previously advocated for the departments to create the extension.”
  • Bloomberg News adds,
    • “Medical providers continue to beat out insurers in most surprise billing arbitration disputes, often pocketing awards of at least double the in-network rate for a given service, according to new federal agency data.
    • “Providers were the prevailing party in about 82% of payment determinations made in No Surprises Act arbitration in the second half of 2023, according to a data report released Thursday by the Centers for Medicare and Medicaid Services. A total of 125,478 disputes resulted in award decisions in that period, the report showed, a 50% increase from the first half of 2023.”
  • Per a Department of Health and Human Services press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced notices of funding opportunities aimed at improving behavioral health for racial and ethnic minorities, and other underserved populations, providing training and technical assistance to programs serving these populations, and integrating primary and behavioral health care. The funding totals $31.4 million and supports the Biden-Harris Administration’s efforts to address the mental health and overdose crises, two key pillars of the President’s Unity Agenda for the nation, as well as continuing efforts to advance heath equity and address the consistent and disproportionate impact of HIV on racial and ethnic minorities.  
    • “These grant programs additionally support HHS’ Overdose Prevention Strategy, the HHS Roadmap for Behavioral Health Integration, and SAMHSA’s strategic priorities: preventing substance use and overdose; enhancing access to suicide prevention and mental health services; promoting resilience and emotional health for children, youth, and families; integrating behavioral and physical health care; and strengthening the behavioral health workforce. ”   
  • The Labor Department’s Assistant Secretary for Employee Benefit Security, Lisa Gomez, writes in her blog about “avoiding elder financial abuse.”

From the public health and medical research front,

  • The Centers for Disease Control tells us today,
    • “Summary
      • “Seasonal influenza, COVID-19, and RSV activity is low nationally.
    • “COVID-19
      • “Most key indicators are showing low levels of activity nationally. However, COVID-19 test positivity has increased to 5.4% from 4.6% in the previous week. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 34 states and territories, declining or likely declining in 1 state or territory, and are stable or uncertain in 14 states and territories, based on CDC modeled estimates of epidemic growth. An increasing proportion of the variants that cause COVID-19 are projected to be KP.3 and LB.1 (CDC COVID Data Tracker: Variant Proportions).
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • Radiology Business informs us,
    • “Gen X is experiencing larger cancer incidence increases than generations before it, according to a new analysis published Monday in JAMA Network Open.
    • “Increases among this group (born between 1965 to 1980) are “substantial” when compared to the baby boomers who came before them (1936 to 1960). For instance, Gen X Hispanic women have seen a nearly 35% increase in cancer incidence while Latino men have recorded a 14% uptick.
    • “The findings are based on an analysis of data from 3.8 million individuals with invasive cancer.”
    • “The substantial increases we identified in Generation X versus both the baby boomers and their proxy parents surprised us,” lead author Philip S. Rosenberg, PhD, principal investigator at the National Cancer Institute, wrote June 10. “Numerous preventable causes of cancer have been identified. Cancer control initiatives have led to substantial declines in tobacco consumption. Screening is well accepted for precancerous lesions of the colon, rectum, cervix, uterus and breast. However, other suspected carcinogenic exposures are increasing.”
    • “For the study, Rosenberg and the NCI’s Adalberto Miranda-Filho, PhD, gathered data from the institute’s Surveillance, Epidemiology and End Results (SEER) Program spanning 1992-2018. They used a tool called the age-period-cohort model to project cancer incidence among the varying generations.”
  • Health Day notes,
    • “The death rate for type 1 diabetes has fallen 25% over the past few decades, and there are more seniors than ever with the illness
    • “Uncontrolled blood sugar was the prime driver behind poor outcomes with type 1.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Lilly’s Weight-Loss Drug Is a Huge Hit. Its CEO Wants to Replace It ASAP.
    • “Dave Ricks is pushing his scientists to find an even more potent anti-obesity treatment. ‘Lilly’s got a lead, and we plan to exploit that lead.’”
  • Beckers Hospital Review explains how “Kaiser Permanente’s phone and video visit rates remain significantly higher than pre-pandemic levels.” Check it out.
  • mHealth Intelligence relates,
    • “Most Americans said they would be willing to participate in hospital-at-home programs to return home sooner, according to a new survey.
    • “The survey, conducted by remote patient monitoring (RPM) technology developer Vivalink, polled 1,025 United States adults over 40.
    • “An overwhelming majority of US adults are likely to participate in a hospital-at-home monitoring program to get back home more quickly, with 39.15 percent saying they are very likely and 45.27 percent saying they are somewhat likely to participate in these programs. Only 15.58 percent said they are not likely to participate in a hospital-at-home program to return home sooner.”
  • Per BioPharma Dive,
    • “AbbVie is securing its place in an emerging gastrointestinal disease drug field, paying China-based FutureGen Biopharmaceutical $150 million in immediate and near-term fees for rights to an antibody drug targeting TL1A, a molecule linked to heightened immune responses in inflammatory bowel disease.
    • “The Illinois-based drugmaker is following rivals like Merck, Roche, Teva and Sanofi, which have piled billions of dollars into acquisitions to gain ownership of TL1A-targeting drugs.
    • “Per terms of the deal announced Thursday, AbbVie will gain global rights to the drug, called FG-M701, and will be responsible for its development, manufacturing and commercialization. FutureGen could receive up to $1.56 billion in additional fees based on hitting development, regulatory and sales milestones.”
  • and
    • “The failure of a Pfizer medicine for Duchenne muscular dystrophy adds new uncertainty around the effectiveness of gene therapy for the muscle-wasting condition, days before the Food and Drug Administration is expected to decide on expanding use of a similar treatment from Sarepta Therapeutics.
    • “On Wednesday, Pfizer said the treatment missed its mark in a definitive Phase 3 study of boys between 4 and 7 years of age with Duchenne. Pfizer didn’t disclose specifics, but said the therapy didn’t lead to a significant difference versus placebo on a measure of motor function, or on key secondary measures such as timed tests for how quickly study participants could stand or walk. The results will be presented at future medical and patient advocacy meetings.”
    • “The study’s failure makes it much less likely there will soon be a second gene therapy option for people with Duchenne, a progressive and deadly condition with no cure and limited treatment options. Pfizer had previously expected to file for a regulatory approval of its medicine if study results were positive. Now the company says it is “evaluating appropriate next steps” for the program. Multiple Wall Street analysts expect Pfizer to discontinue research.
    • “The results are “a discouraging blow to our community, particularly devastating to those who participated in the study,” said Parent Project Muscular Dystrophy, a patient advocacy group, in a statement.”