From Washington, DC,

• BioPharma Dive tells us,
  • Novo Nordisk’s top executive vowed to reopen price negotiations with insurers covering the company’s obesity and diabetes drugs at a congressional hearing on Tuesday in which lawmakers pressed Novo to lower the cost of the fast-selling medicines.
  • At the hearing, Novo CEO Lars Fruergaard Jørgensen said the company would consider new talks with insurers about the list prices of Wegovy and Ozempic if they follow through on a pledge to keep the medicines on their formularies. Novo has claimed that insurers have previously pulled coverage of its other medicines — such as insulins — once the company lowered list prices, because it resulted in less revenue for payers afterwards.
  • “If it works in a way where patients get access to a more affordable medicine, and we have certainty that it actually happens and not like when we lowered prices in prior rounds — that less people got access to our medicine — we will be positive towards it,” Jørgensen said.” * * *
  • [Senate HELP Committee Chair Bernie] Sanders [I VT] came to the hearing with, what he claimed, is a commitment from Cigna [Express Scripts], UnitedHealth Group [/ Optum Rx] and CVS Health [/ Caremark] to commit to covering the two drugs even if lower list prices lead to lower rebates. The initiative for doing so was the difference in list and after-rebate prices for Wegovy and Ozempic in the U.S. compared to other countries.”
    
• Here is a link to the Federal Trade Commission’s public administrative complaint against Express Scripts, Caremark, and Optum Rx over insulin rebates.

• Per Healthcare Dive,
  • “The chair of the powerful Senate Finance Committee is pressing hospitals on their compliance with federal emergency care law amid mounting reports that patients who need lifesaving abortions are being turned away.
  • “Sen. Ron Wyden, D-Ore., sent letters to eight hospitals in states with abortion restrictions on Monday, asking about policies and procedures they have in place around the Emergency Medical Treatment and Active Labor Act, or EMTALA.
  • “Wyden also asked for a list of personnel involved in deciding when terminating a pregnancy is the appropriate course of treatment, and what legal and human resource support is offered to them by the hospital.”

• CMS has created a website for its new civil monetary penalty program applicable to Section 111 reporting that will take effect on October 5, 2024, and will hold a compliance webinar on October 15, 2024, at 1 pm ET.

• Per HHS press releases,
  • “Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), announced actions to increase the supply of mpox vaccine, supporting the U.S. Government commitment to make over a million combined doses of mpox vaccines available to the global mpox response. This is the largest international donation of the JYNNEOS mpox vaccine to date, which just received regulatory approval from WHO last week.”
• and
  • “Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced nearly $75 million to support health care services in rural America. Funding will launch new opioid treatment and recovery services in rural communities, strengthen maternal health care in the South, and help rural hospitals stay open. HRSA Administrator Carole Johnson attended an event yesterday in Wilson, North Carolina, where she discussed the impact of this investment in rural health care.” * * *
  • “For a list of the awards, visit: https://www.hrsa.gov/about/news/fy24-rural-award-announcements“

• Bloomberg reports,
  • “The Biden administration issued a final rule Tuesday designed to address suspicious billing for durable medical equipment that may have cost the Medicare program more than $2 billion.
  • “The problem involving urinary catheters has disproportionately affected accountable care organizations, the groups of doctors, clinicians, and hospitals that provide coordinated care for beneficiaries in traditional Medicare. 
  • “After detecting the spike in billing in early 2023, the Centers for Medicare & Medicaid Services stopped payment on almost all of the claims and began an investigation.
  • “They found the activity “was attributed to a small group of durable medical equipment supply companies,” and “determined that the beneficiaries did not receive catheters and were not billed directly, physicians did not order these supplies, and supplies were not needed,” said a CMS fact sheet. Since then, the top 15 billers of suspicious catheter claims have had their Medicare enrollment revoked.
  • “The CMS rule (RIN 0938-AV20) excludes payments involving certain billing codes for durable medical equipment from calculations used to assess an ACO’s financial performance in 2023.”

From the public health and medical research front,

• BioPharma Dive tells us
  • “Obesity drug startup Metsera on Tuesday reported its first clinical data since launching in April with $290 million in venture funding. The data come from a Phase 1 trial of a drug, MET-097, that’s designed to have longer-lasting effects than injectable GLP-1 therapies like Novo Nordisk’s Wegovy. The results show that a weekly administration of the highest dose tested stimulated weight loss of 7.5% over 36 days, “matching, or potentially exceeding,” currently marketed and investigational anti-obesity medications, Metsera chief medical officer Steve Marso said in a statement. Metsera claimed the findings are supportive of once-monthly dosing and will start mid-stage trials in the fourth quarter, with results expected next year.” 

• Per a National Institutes of Health press release,
  • “Cancer incidence trends in 2021 largely returned to what they were before the COVID-19 pandemic, according to a study by researchers at the National Institutes of Health (NIH). However, there was little evidence of a rebound in incidence that would account for the decline in diagnoses in 2020, when screening and other medical care was disrupted. One exception was breast cancer, where the researchers did see an uptick in diagnoses of advanced-stage disease in 2021. The study appears Sept. 24, 2024, in the Journal of the National Cancer Institute.
  • “A previous study showed that new cancer diagnoses fell abruptly in early 2020, as did the volume of pathology reports, suggesting that many cancers were not being diagnosed in a timely manner. To determine whether these missed diagnoses were caught in 2021, possibly as more advanced cancers, researchers from NIH’s National Cancer Institute (NCI) compared observed cancer incidence rates for 2021 with those expected from pre-pandemic trends using data from NCI’s Surveillance, Epidemiology, and End Results Program.”
  • “A full recovery in cancer incidence should appear as an increase over pre-pandemic levels (also known as a rebound) to account for the missed diagnoses. The researchers looked at cancer overall, as well as five major cancer types that vary in how they are typically detected: through screening (female breast and prostate cancer), due to symptoms (lung and bronchus and pancreatic cancer), or incidentally during other medical procedures (thyroid cancer).
  • “Cancer incidence rates overall and for most specific cancers approached pre-pandemic levels, with no significant rebound to account for the 2020 decline. However, in addition to an uptick in new diagnoses of advanced breast cancer in 2021, the data also provided some evidence of an increase in diagnoses of advanced pancreatic cancer. Also, new diagnoses of thyroid cancers in 2021 were still below pre-pandemic levels.
  • “The researchers concluded that 2021 was a transition year that was still affected by new variants and new waves of COVID-19 cases, which continued to impact medical care. They said the findings highlight the need for ongoing monitoring to understand the long-term impacts of the pandemic on cancer diagnoses and outcomes.”

• CNN reports,
  • “The US government plans to make more at-home Covid-19 tests available for free this month as the country heads into respiratory virus season with high levels of the coronavirus already circulating.
  • “Each household will be able to order another round of four free at-home test kits starting at the end of September at COVIDTests.gov.
  • “More than 900 million test kits have been delivered directly to US residents through the COVIDTests.gov program, according to the US Department of Health and Human Services.
  • “COVID-19 testing can help you know if you have COVID-19 so you can decide what to do next, like getting treatment to reduce your risk of severe illness and taking steps to lower your chances of spreading the virus to others,” the agency said.
  • “This next set of tests – the program’s seventh round of distribution – will be able to detect currently circulating variants and can be used as people prepare for year-end holiday gatherings.”

• The Washington Post reports that “Doctors and patients struggle with starting and stopping GLP-1 medications with little guidance.”

• Per Fierce Pharma,
  • “The FDA is having second thoughts about the broad labels it has granted PD-1 inhibitors in newly diagnosed stomach cancer, questioning whether restrictions should be placed on products from Bristol Myers Squibb and Merck & Co. plus a stomach cancer hopeful from BeiGene.
  • “In a briefing document prepared for an Oncologic Drugs Advisory Committee meeting slated for Thursday, the FDA suggested that PD-1 inhibitors may not be suitable for certain patients with HER2-negative gastric cancer who have low PD-L1 expression, even though these immunotherapies have shown life-extension benefits in broad study populations.”

From the U.S. healthcare business front,

• The American Hospital Association News reports,
  • “An EY report prepared for the AHA shows that tax-exempt hospitals and health systems delivered $10 in benefits to their communities for every dollar’s worth of federal tax exemption in 2020, the most recent year for which comprehensive data is available. It represents an increase from $9 in benefits from the prior year despite efforts in battling the COVID-19 pandemic.”  

• Per Business Insurance,
  • “Prudential Financial is re-entering the U.S. stop-loss insurance market, targeting employers with at least 100 employees, offering coverage for medical, prescription drug, dental, vision, and short-term disability claims, BenefitsPro reports. Prudential aims to leverage its experience under the leadership of Jessica Gillespie, who is head of Prudential’s group insurance products. The stop-loss market has seen significant price hikes, with some competitors dissatisfied with their financial outcomes.”
• and
  • “Health insurance companies are increasingly covering prescriptions written by pharmacists as states expand pharmacists’ prescribing authority through “test to treat” legislation, Forbes reports. This shift aims to improve access to medications amid a shortage of primary care physicians. Major insurers like Cigna and Blue Cross and Blue Shield of Illinois are adapting their coverage policies accordingly.”

• The New York Times reports
  • “Every day, patients send hundreds of thousands of messages to their doctors through MyChart, a communications platform that is nearly ubiquitous in U.S. hospitals.
  • “They describe their pain and divulge their symptoms — the texture of their rashes, the color of their stool — trusting the doctor on the other end to advise them. 
  • “But increasingly, the responses to those messages are not written by the doctor — at least, not entirely. About 15,000 doctors and assistants at more than 150 health systems are using a new artificial intelligence feature in MyChart to draft replies to such messages.
  • “Many patients receiving those replies have no idea that they were written with the help of artificial intelligence. In interviews, officials at several health systems using MyChart’s tool acknowledged that they do not disclose that the messages contain A.I.-generated content.
  • “The trend troubles some experts who worry that doctors may not be vigilant enough to catch potentially dangerous errors in medically significant messages drafted by A.I.”