From Washington, DC,

• Govexec informs us,
  • “President Donald Trump on Friday repealed two late-issued Biden regulations and will likely revoke more in the coming weeks. 
  • “The Congressional Review Act enables Congress and the president, if they are in agreement, to overturn by simple majority regulations that were promulgated during the 60 Senate session days or 60 legislative House days before a session of Congress adjourns, whichever is earlier. In this case, Trump and congressional Republicans can use the CRA to override rules finalized on or after Aug. 16, 2024. 
  • “The resolutions, both of which Congress approved with some Democratic support, would:
  • S.J. Res 11, revoke a September Bureau of Ocean Energy Management rule that required oil and gas companies working on the Outer Continental Shelf to submit a report identifying potential archaeological resources on the sea floor that could be affected by such development. 
  • “H.J. Res 35, repeal a November EPA rule specifying requirements under the Methane Emissions Reduction Program, through which the agency charges oil and gas companies for methane and other greenhouse gas emissions if they surpass certain thresholds. 
  • Six other measures to block late Biden rules have been approved in either the House or Senate, including resolutions targeting EPA emission standards for rubber tire manufacturing (H.J. Res 61), IRS reporting requirements for digital asset sales (S.J. Res 3 / H.J. Res 25) and Energy Department conservation standards for consumer gas-fired instantaneous water heaters (H.J. Res 20). 
  • “In total, 57 CRA resolutions have been introduced, according to a tracker from the Center for Progressive Reform. The resolutions’ most frequent target is rules from the EPA.” 

• The American Hospital Association (AHA) News tells us,
  • “The Food and Drug Administration has identified a Class I recall of Medtronic Neurovascular 027 Compatible Pipeline Vantage Embolization Devices due to reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall during and after procedures.”

• Per MedTech Dive,
  • “Monogram Technologies received Food and Drug Administration 510(k) clearance for its mBôS TKA System for total knee replacements and will now work toward commercializing the system, the Austin, Texas-based company said Monday.
  • “Monogram aims initially to place the robot with surgeons who are key opinion leaders in strategic geographies as it establishes clinical experience and demonstrates the platform in real-world settings. It plans to integrate recent upgrades to the robot’s cutting system and other enhancements into the cleared mBôs device over the coming months.”

From the judicial front,

• Per FiercePharma,
  • “Previously at the epicenter of the U.S. opioid crisis, Purdue Pharma is looking to reenter the public lexicon as a new public benefit company. After a prior bankruptcy settlement was nixed by the Supreme Court, the drugmaker has come back with a new plan that would deliver more than $7.4 billion to its creditors.
  • “The company hopes to emerge from the Chapter 11 bankruptcy process it entered in 2019 with a new reorganization plan, filed Wednesday with the U.S. Bankruptcy Court for the Southern District of New York. The plan lays out more than $7.4 billion in payments to compensate opioid victims and “abate the opioid crisis,” Purdue said in a press release.
  • “That $7.4 billion sum includes available company cash and payments by the Sacklers, the billionaire family who helmed the company until 2019.” * * *
  • “The plan is subject to confirmation by the bankruptcy court, which is expected to hold a hearing in May. After a potential court approval, Purdue would solicit votes to finalize the plan.”

From the public health and medical research front,

• STAT News reports,
  • “The expanding measles outbreak that has spread from West Texas into New Mexico and Oklahoma could take a year to contain, a public health leader in the area where the outbreak started warned on Tuesday.
  • “Katherine Wells, director of public health for the city of Lubbock, said the outbreak is still growing, with capacity to transmit both locally and further afield through spread to pockets of unvaccinated individuals. Though the response teams have been stressing the importance of vaccination, uptake of vaccines “has definitely been a struggle,” Wells said.”
  • “This is going to be a large outbreak. And we are still on the side where we are increasing the number of cases, both because we’re still seeing spread and also because we have increased testing capacity, so more people are getting tested,” Wells said during a press conference organized by the Big Cities Health Coalition, a forum for leaders of metropolitan health departments. 
  • “I’m really thinking this is going to be a year-long in order to get through this entire outbreak,” she said.”

• AHA News relates,
  • The U.S. birth rate fell 2% in 2023 to about 3.6 million, according to final data released March 18 by the Centers for Disease Control and Prevention. The cesarean delivery rate increased 1% in 2023 to 32.3%. The preterm birth rate was 10.41%, essentially unchanged from 2022. Medicaid was the source of payment for 41.5% of births, a slight increase from 2022 (41.3%).
    
• Health Day adds,
  • “Young American women are greeting the prospect of pregnancy with a decided “meh,” driving down U.S. fertility rates, a U.S. Centers for Disease Control and Prevention (CDC) study says.
  • “The actual number of U.S. births declined by 14% between 1990 and 2023, and the fertility rate went down by 23%, according to a paper in the CDC’s National Vital Statistics Reports.
  • “This drop in fertility occurred mainly among women younger than 30, statistics show.
  • “Women under 30 accounted for 7 in 10 births (70%) in 1990. But by 2023, this age group accounted for less than half of U.S. births (49%).
  • “The sharp drop in births among young women overwhelmed a slight increase in birth rates among women 30 and older, researchers reported.
  • “In summary, the decline in fertility rates over the past few decades results from declining rates among females younger than 30 that are offset somewhat by smaller increases in rates among older women,” the research team led by senior researcher Brady Hamilton of the CDC’s Division of Vital Statistics concluded.”

• The Washington Post reports,
  • “Pollen seasons are not the same across the United States. Now, a report released Tuesday by the nonprofit Asthma and Allergy Foundation of America shows where allergy sufferers had it the worst last year.
  • “About a quarter of U.S. adults suffer from seasonal allergies — many experiencing itchy and watery eyes, a scratchy throat and an ever-running nose. Pollen exposure is now lasting longer and intensifying nationwide, data shows, as warmer temperatures take over more of the year. But for some areas, the changes are more dramatic.
  • “The report ranks the top 100 largest U.S. cities by how challenging they were for allergy sufferers to live in last year. These “allergy capitals” are based not only on pollen counts, but also on the use of over-the-counter medication and the number of allergy physicians in the area.”

• MedPage Today points out,
  • “The simple addition of a deadline to a mailed invitation for fecal immunochemical test (FIT) colorectal cancer (CRC) screening resulted in improved return rates, the randomized TEMPO trial showed.
  • “Across eight study arms, the highest return rate was seen with a 2-week deadline without a problem-solving planning tool, with 68% of usable FIT kits returned by 3 months compared with 66% in the control group (no deadline and no planning tool), reported Kathryn Robb, PhD, of the University of Glasgow in Scotland, and colleagues in The Lancet.”

• Per BioPharma Dive,
  • “Prime Medicine will test its gene editing technology as treatment for a rare liver and lung disorder, revealing on Tuesday plans for a research program in alpha-1 antitrypsin deficiency. 
  • “The company, which is developing “prime editing” as a way to flexibly edit genes without cutting through both strands of DNA, expects to ask regulators next year for permission to begin human testing of the new treatment. 
  • “The program in alpha-1 antitrypsin deficiency, or AATD, is the first new target Prime has picked since significantly paring back its research plans last September. As with other developers of genetic medicines, Prime has faced investor scrutiny on the pace and cost of its research.:

From the U.S. healthcare business front,

• Fierce Healthcare reports,
  • “Cigna has officially sealed the deal on the $3.3 billion sale of its Medicare business to Health Care Service Corporation.
  • “HCSC acquired Cigna’s Medicare Advantage, Part D, supplemental benefits and CareAllies units as part of the deal.
  • “While it will no longer operate the Medicare unit directly, Cigna said it will continue to provide pharmacy benefit management and other services through its Evernorth division, as part of an agreement with HCSC.”

• Healthcare Dive lets us know,
  • “Optum Rx is moving to eliminate prior authorizations on dozens of drugs, the UnitedHealth-owned pharmacy benefit manager said Wednesday, paring back a key pain point for physicians and patients at a time of widespread discontent with middlemen in the healthcare industry.
  • “Starting May 1, Optum Rx will eliminate reauthorizations — when drugs already being used by a patient need to be reapproved by their plan — for roughly 80 drugs. The program will cut up to 25% of all reauthorizations, or 10% of prior authorizations overall, the PBM said.
  • ‘The drugs included treat high cholesterol, lung disease, multiple sclerosis, migraines and more. Optum Rx said it plans to apply the policy to additional drugs in the future.”

• The Wall Street Journal reports,
  • “Today was supposed to mark the beginning of the end for cheaper, knockoff versions of hot weight-loss drugs. The Food and Drug Administration wants bulk production of the copycats to stop—starting Wednesday for pharmacy-prepared versions of Zepbound and later in the spring for knockoffs of Ozempic and Wegovy.
  • “But telehealth companies and pharmacies that have fueled wide use of copycats have other plans.
  • “Telehealth platform Hims & Hers Health says it will keep offering pharmacy-made, or compounded, versions of Ozempic and Wegovy tweaked to individual prescriptions. And some of the pharmacies making the GLP-1 drug copycats will continue, according to people familiar with the industry.
  • “The firms are seeking to take advantage of current law, which allows compounding pharmacies to make special, individualized versions of drugs that aren’t available commercially. Telehealth firms and pharmacies instead intend to sell versions of the obesity drugs tailored for specific patients whose doctors say they need a different dosage than one of the original drugs or a version with extra vitamins added. 
  • “A lot of these patients won’t be able to afford switching over to a brand-name medication,” said Dr. Taylor Kantor, a co-founder of Ivim Health, a telehealth platform offering obesity drugs. “We’re trying to make sure those patients aren’t left in the dust.”

• MedTech Dive tells us,
  • Orthopedic device companies gathered last week in San Diego to demonstrate their latest innovations and discuss industry trends at the American Academy of Orthopaedic Surgeons’ annual meeting.
  • Robotic surgery systems remained a focus at the event, with Stryker showcasing the newest version of its Mako surgical robot and Johnson & Johnson displaying a feature that was cleared for its Velys robot last year, allowing it to be used for partial knee replacements. 
  • Company executives also discussed economic trends, expecting procedure volumes and hospital equipment purchases to remain steady despite financial pressures.
  • [The article includes] four takeaways from the event

• Fierce Healthcare notes,
  • “Instacart is rolling out multiple features it says will make it easier for users to make healthy choices, headlined by its artificial-intelligence-powered Smart Shop.
  • “The tool seeks to make grocery shopping through the platform more “intuitive,” according to an announcement from the company, while leveraging AI and machine learning to personalize the experience. Users can select from 14 dietary preference options, including gluten-free, low-calorie or pescatarian, to tailor their shopping.
  • “For example, take an individual looking for foods low in carbohydrates. There are many food options that are naturally low-carb, which can make recommendations difficult. Through the AI tech, Smart Shop is able to filter these options and delineate the difference between items that are deliberately chosen to be low in carbs.”