
From Washington, DC,
- Today, the Supreme Court held a conference of its justices at which the Court decided next steps with the Kennedy v. Braidwood Management case heard last Monday.
- Bloomberg Law reports that following the conference,
- “The Supreme Court ordered more briefing after arguments in a dispute over Obamacare’s preventative services mandate, which requires insurers to cover certain treatments like cancer screenings free of charge.
- “In an order on Friday, the justices asked the parties to address whether the health secretary has the power to appoint the members of the US Preventive Services Task Force, which recommends services that should be covered under the Affordable Care Act.
- “The court wants to know “whether Congress has ‘by Law’ vested” the secretary with this authority.” * * *
- “Additional briefs are due May 5. It’s rare but not unheard of for the court to request more briefing after a case has been argued.
- “This occasionally occurs on issues that come up during argument if they weren’t initially briefed by the parties.”
- FEHBlog note — That’s exactly what happened in the Braidwood Management case.
- STAT News tells us,
- “The federal health department is not creating a new registry of Americans with autism, a Department of Health and Human Services official said in a written statement Thursday. Instead, the official said, HHS will launch a $50 million research effort to understand the causes of autism spectrum disorder and improve treatments.
- “The announcement arrives two days after National Institutes of Health Director Jay Bhattacharya announced the intent to create such a registry at an all staff meeting, kicking off a firestorm of panic and confusion among autism self-advocates and the broader research community. Much of the fear centered around Bhattacharya’s remarks that the government would pull health data from private sources, such as electronic health records maintained by health care providers, pharmacy data, insurance claims and even wearables like smart watches and fitness trackers.”
- Science Soft Healthcare predicts that “”By the end of 2026, 25–30% of all medical visits in the United States will be conducted via telemedicine. Although the adoption rate of telemedicine has been low in 2024, it will grow considerably with regulatory support from the US Congress.”
- “In 2023, telemedicine usage in mental health was over three times higher than in other medical specialties, according to Epic Research. We believe that the resilient demand for telemedicine in mental health indicates that the technology is here to stay.”
- The American Hospital Association News informs us,
- “The Food and Drug Administration published a notice from Amneal Pharmaceutical that said the company is recalling two lots of its Ropivacaine Hydrochloride Injection 500mg/100mL Infusion bags due to the products potentially containing inert polypropylene fibers. As of April 18, Amneal Pharmaceuticals said it received no reports of adverse events or injuries related to the recall. The recalled IV bags were distributed nationwide to wholesalers and distributors from April 23-Nov. 8, 2024.”
In other judicial news,
- STAT News reports,
- “Novo Nordisk has notched a major legal win against compounding pharmacies that make copies of its diabetes and obesity drug semaglutide, sold under the brand names Ozempic and Wegovy.
- “A federal judge on Thursday ruled against a compounding trade group’s request for a preliminary injunction that would have prevented the Food and Drug Administration from taking action against its members for making copies of semaglutide.
- “Compounding pharmacies are legally allowed to make versions of branded treatments if the drugs are deemed to be in shortage by the FDA. For the two years when Ozempic and Wegovy were recently in shortage, compounders rushed to make copies to meet the enormous demand for weight loss treatments. But when semaglutide was ultimately taken off the FDA’s shortage list in February, the compounding trade group, called the Outsourcing Facilities Association, quickly sued the agency, arguing that there were still in actuality shortages of the branded treatments.”
From the public health and medical research front,
- The Centers for Disease Control and Prevention announced today:
- “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
- “COVID-19
- “COVID-19 activity continues to decline nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
- “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
- “Influenza
- “Seasonal influenza activity continues to decline.
- “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
- “RSV
- “RSV activity continues to decline in most areas of the country.
- “Vaccination
- “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults.
- “Other Respiratory Illnesses
- “Mycoplasma pneumoniae
- Respiratory infections caused by the bacteria Mycoplasma pneumoniae have increased in some areas of the United States over the last few weeks as indicated by emergency department visits and test positivity. M. pneumoniae infections are generally mild but can sometimes be severe, causing what’s known as “walking pneumonia.” Most people will recover without medicine, but some need antibiotics to get better. Learn more: About Mycoplasma pneumoniae Infection | M. pneumoniae | CDC.
- “Pertussis
- “Reported cases of whooping cough (pertussis) continue to be elevated nationwide but preliminary case reports have been trending downward for the past several months. Whooping cough is very contagious and can spread easily from person to person. Babies younger than 1 year old are at highest risk of severe disease and complications. The best way to prevent complications from whooping cough is to get vaccinated. Learn more: About Whooping Cough | Whooping Cough | CDC.“
- “Mycoplasma pneumoniae
- The University of Minnesota’s CIDRAP adds,
- “Flu activity continues to ebb nationwide, with rates of influenza-like illness (ILI) dropping further last week, but flu-related deaths in children climbed to 204, up 6 from the previous week, the Centers for Disease Control and Prevention (CDC) said in its weekly update today.”
- The AHA News lets us know,
- “There have been 884 confirmed cases of measles nationwide so far this year, with cases reported by 29 states, according to the latest data from the Centers for Disease Control and Prevention. There have been 11 outbreaks, and 93% of confirmed cases (820 of 884) are outbreak-associated. The vaccination status of 97% of all cases is classified as “unvaccinated or unknown.”
- “The CDC April 24 released a report that said increasing national and local measles, mumps and rubella vaccination coverage is essential to preventing measles cases and outbreaks. The report also said that cases this year are the second highest in 25 years. A JAMA study also released April 24 found that measles could become endemic again within another 25 years if current childhood vaccination rates remain the same.”
- The University of Minnesota’s CIDRAP drills down on these measles statistics.
- Eating Well reports,
- “A recall on a popular brand of apple juice sold in 28 states was just announced, according to the Food and Drug Administration. This is due to a potential contamination with patulin, a mycotoxin that can cause internal organ damage when consumed in excess. Approximately 173,616 bottles are affected by this recall.
- “The product impacted is Martinelli Apple Juice sold in its signature clear, round glass bottles with a white metal screw top lid. The recalled 10-ounce apple juice bottles were sold in 4-packs, contain a UPC of “0 41244 04102 2” and have a best-by date of December 5, 2026. They were sold at retail locations in the following states: Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia and Wisconsin.
- “This recall was just classified as a Class II recall, meaning that drinking this apple juice can “cause temporary or medically reversible adverse health consequences,” per the FDA.
- Healio points out,
- An estimated 24,499 people visited the ED for adverse events related to semaglutide in the 2 years after its approval for weight loss, according to a study published in Annals of Internal Medicine.
- The most common symptoms included nausea, vomiting and diarrhea, which had been previously documented in clinical trials. However, researchers also discovered that 16% of ED visits involved hypoglycemia.
- “What I see in clinical practice is that some patients end up in the ED due to these severe symptoms from semaglutide, and it is not recognized in the ED,” Pieter Cohen, MD, associate professor of medicine at Harvard Medical School and internist at Cambridge Health Alliance, told Healio. “It is really important to make sure we are asking our patients about the use of semaglutide when they have these symptoms, particularly since use is so prevalent these days.”
From the U.S. healthcare business front,
- Healthcare Dive reports,
- “Centene beat Wall Street expectations for earnings and revenue in the first quarter thanks to significant membership increases, especially in Affordable Care Act and Medicare prescription drug plans, according to results released Friday.
- “Citing the strong enrollment, the St. Louis-based payer raised its revenue guidance and reiterated its earnings guidance for 2025.
- “However, Centene signaled medical costs may also be increasing, raising the outlook for its full-year medical loss ratio — a marker of spending on patient care. Centene’s stock fell 7% in Friday morning trade following the results.”
- Per BioPharma Dive,
- “Gilead Sciences on Thursday reported $6.7 billion in revenue in the first quarter, missing consensus Wall Street estimates as its cancer drug sales fell short of analyst expectations.
- “Gilead’s oncology portfolio generated $758 million in sales over the first three months of the year, down about 4% compared to the same period in 2024. Slower-than-expected sales of Gilead’s breast cancer drug Trodelvy were the main culprit, though the company also blamed lower demand for a decline in cancer cell therapy revenue.
- “Gilead’s HIV drug business, though, helped offset those losses, garnering $4.6 billion and climbing 6% year over year. The company expects further growth in the future, as by June 19 the Food and Drug Administration could significantly expand use of lenacapavir, a twice-yearly injectable medicine proven in testing to prevent HIV infections.
- Beckers Payer Issues provides 101 things to know about Blue Cross Blue Shield.
- Beckers Hospital Review offers a list of the 25 most expensive hospital drugs.
- Fierce Healthcare tells us,
- “HCA Healthcare reaffirmed its 2025 guidance following an opening quarter of solid care demand and better-than-expected earnings.
- “The country’s largest for-profit health system announced Friday morning $1.61 billion of net income attributable to the company ($6.45 per diluted share) and revenues of $18.32 billion for the first quarter. Both are improvements over the prior year’s $1.59 billion ($5.93 per diluted share) and $17.34 billion.
- “Adjusted EBITDA for the quarter was $3.73 billion, also up from $3.35 billion in the first quarter of 2024.”
- Per Fierce Pharma,
- “With the potential for pharmaceutical import tariffs spurring a rush of life sciences investments in the U.S., AbbVie is joining the trend with plans to spend billions in the country over the next decade.
- “AbbVie aims to invest $10 billion in the U.S. through 2035 to support its current growth plans and expand into new areas like obesity, the Chicago drugmaker’s CEO, Rob Michael, said on a call with analysts Friday.
- “AbbVie’s executives did not go into the fine details of the domestic investment plan on the call, though the company’s CFO Scott Reents noted that a portion of the sum will be earmarked to build four new U.S. production facilities devoted to active pharmaceutical ingredients (API), drug product, peptides and devices.”
- and
- “After unveiling a new drug substance facility in North Carolina in December, Amgen is doubling down on expanding its U.S. production presence with plans for a major upgrade at its plant in central Ohio.
- “The new project represents the latest in a string of pharma investments in the U.S. as the Trump administration threatens to clamp down on the industry with sector-specific import tariffs.
- “Amgen is plugging $900 million into an expansion of its biomanufacturing facility in New Albany, Ohio, the company said Friday. The project is expected to bring the total number of Amgen jobs in the state to 750 and increase the company’s overall investment in Ohio to more than $1.4 billion.”