Friday report
From Washington, DC,
- Govexec reports,
- “President Trump created another new category of federal employee on Thursday evening, issuing an executive order to expand the number of political appointees who do not require Senate confirmation and will serve in policy-making or policy-advocating roles.
- ‘While presidents can already tap an uncapped number of appointees to serve in Schedule C positions, Trump noted those individuals serve in more narrow confidential or policy-determining roles. The new positions will therefore fill a gap that currently exists in federal appointments, the White House said.
- “The order is the latest in Trump’s effort to establish a tighter grip on the executive branch and its actions. He has already created Schedule Policy/Career, formerly known as Schedule F, which is similarly defined to Schedule G but reserved for career civil servants. Agencies are in the process of determining who qualifies for conversion to Schedule Policy/Career and those employees will become easier to fire for any reason.”
- Federal News Network tells us,
- “The Postal Service’s new chief executive is defending the agency’s current operating model, at a time when the Trump administration considers challenging its independence.
- “David Steiner, former FedEx board member and Waste Management CEO, began his tenure as postmaster general on Tuesday.
- “Steiner told employees Thursday he supports keeping USPS independent from the executive branch and defended the 10-year reform plan of his predecessor, former Postmaster General Louis DeJoy.
- “Steiner told employees in a video message on Thursday that, “I do not believe that the Postal Service should be privatized, or that it should become an appropriated part of the federal government.”
- “I believe in the current structure of the Postal Service as a self-financing, independent entity of the executive branch,” Steiner said. “My goal for the Postal Service is to meet the financial and service performance expectations of our nation under this structure.”
- The American Hospital Association News informs us,
- “Health Insurance Marketplace insurers will propose a median premium increase of 15% for 2026, according to an analysis of preliminary rate filings published July 18 by the Peterson Center on Healthcare and KFF. It would be the largest hike in premiums since 2018, the report said. Factors cited for the increase include the scheduled expiration of enhanced premium tax credits and impacts from tariffs. The analysis found that the expiring tax credits would increase out-of-pocket premium payments by more than 75% on average, while tariffs could increase the cost of certain drugs, medical equipment and supplies.”
- “Health Insurance Marketplace insurers will propose a median premium increase of 15% for 2026, according to an analysis of preliminary rate filings published July 18 by the Peterson Center on Healthcare and KFF. It would be the largest hike in premiums since 2018, the report said. Factors cited for the increase include the scheduled expiration of enhanced premium tax credits and impacts from tariffs. The analysis found that the expiring tax credits would increase out-of-pocket premium payments by more than 75% on average, while tariffs could increase the cost of certain drugs, medical equipment and supplies.”
- The Centers for Medicare and Medicaid Services shares highlights from its 2025 Quality Conference held earlier this month.
- KFF, writing in Fierce Healthcare, criticizes the No Surprises Act. No law is perfect.
From the Food and Drug Administration front,
- BioPharma Dive reports,
- “The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive.
- “Sarepta last month paused shipments for certain older Duchenne patients following the death from acute liver failure of a second teenager treated with the therapy, called Elevidys. The FDA subsequently began a formal investigation of Elevidys’ liver risks.
- “Reuters first reported news of the FDA’s request. FDA Commissioner Martin Makary told Bloomberg in an interview Friday that his agency is weighing whether to withdraw Elevidys from the market entirely.
- “The news comes on the heels of Sarepta reporting this week the death of a 51-year-old man who received an experimental gene therapy it’s developing for another kind of muscular dystrophy known as limb-girdle. The man died of complications from acute liver failure in June.
- “While the two treatments are constructed differently, they both use the same kind of engineered virus to deliver a replacement gene to the body’s muscles.”
- The New York Times adds,
- In a remarkable public dispute between drugmaker and regulator, the biotech company Sarepta Therapeutics is defying the Food and Drug Administration’s request that it halt distribution of its treatment for a deadly muscle-wasting disease.
- In a news release on Friday evening, the agency said that it requested that the company voluntarily stop all shipments of the therapy, known as Elevidys, citing the deaths of three patients from liver failure who had taken the product or a similar therapy.
- In its own news release later on Friday evening, Sarepta, which is based in Cambridge, Mass., said that it would continue to ship the treatment for patients who do not use wheelchairs. The company said its analysis showed no new safety problems in those patients and that it was committed to patient safety.
- BioPharma Dive points out,
- “A panel of medical experts called for the removal of warning labels on hormone therapy for menopausal women during a meeting convened Thursday by the Food and Drug Administration.
- “Led by FDA Commissioner Martin Makary, the meeting focused on the benefits and risks of menopause hormone therapy, or MHT, which has become a controversial topic due to mixed study data.
- “The panel, which consisted of 12 experts with various medical backgrounds, took a generally positive view of MHT and described situations in which patients experienced severe symptoms could not get access to treatment.”
- Healthexec notes,
- “The U.S. Food and Drug Administration announced a recall of multiple active glucose monitoring units manufactured by Dexcom due to a malfunction in the receivers. The speakers on these devices may fail to alert wearers when blood sugar levels become dangerously high or low. Typically, the monitors emit an alert sound; however, in Dexcom G6, G7, ONE and ONE+ products, reports indicate that the alarms do not always function properly.
- “There have been at least 56 injuries associated with the error, the FDA said. However, no deaths have been reported.”
- Reuters adds,
- “The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK’s (GSK.L) blockbuster shingles vaccine Shingrix, providing patients a more convenient option to receive the shot, the company said on Thursday.”
From the judicial front,
- Healthcare Dive reports,
- “A Texas federal judge has dismissed Humana’s lawsuit against the federal government seeking to improve its Medicare Advantage star ratings, in a significant loss for the insurer.
- “Humana sued the CMS in October 2024 to reverse its quality scores, arguing that the agency acted arbitrarily and capriciously in downgrading the ratings, which are tied to billions of dollars in reimbursement, for 2025.
- “However, District Judge Reed O’Connor ruled on Friday that Humana failed to exhaust administrative remedies before filing its lawsuit. Humana said it is exploring further legal action.”
- Bloomberg Law lets us know,
- “A federal judge refused Friday to remove an order that halted US Health Secretary Robert F. Kennedy Jr. from carrying out mass firings and restructuring across health agencies.
- “The US District Court for the District of Rhode Island disagreed with the Justice Department’s request to lift the order due to pending stays in two other cases that challenge with government’s reduction-in-force. Those cases are McMahon v. New York , regarding layoffs at the Department of Education, and Trump v. AFGE, regarding President Donald Trump’s reorganization of the federal government.” * * *
- “Defendants misguidedly argue that the Supreme Court’s recent grants of stays pending appeals” in those cases mean that the court should immediately reverse its July 1 decision granting plaintiffs’ preliminary injunction, Judge Melissa R. DuBose for the US District Court for the District of Rhode Island said in the order. * * *
- “DuBose rejected the government’s request to stay pending the appeal.”
From the public health and medical research front,
- The Centers for Disease Control and Prevention announced today,
- “COVID-19 activity is increasing in many Southeast, Southern, and West Coast states. Seasonal influenza activity is low, and RSV activity is very low.
- “COVID-19
- “COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among young children 0-4 years old. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in many Southeast, Southern, and West Coast states.
- “Influenza
- “Seasonal influenza activity is low.
- “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
- “RSV
- “RSV activity is very low.
- The University of Minnesota’s CIDRAP tells us,
- “Only 35% to 40% of US pregnant women and parents of young children say they intend to fully vaccinate their child, per survey results from researchers at Emory University and the Centers for Disease Control and Prevention (CDC).
- “For the two surveys, published as a research letter this week in JAMA Network Open, the investigators recruited 174 pregnant women and 1,765 parents from a nationally representative panel in April 2024 to answer questions about their intent to have their child receive all recommended vaccines by 18 months.
- “Many parents in the US choose to delay or refuse vaccines that are recommended for their child from birth to age 18 months,” the study authors wrote. “Research is necessary to understand the value of intervening during pregnancy to proactively support parents with vaccination decisions before the birth of the child, as implementation of such interventions will require substantial engagement of health care professionals and entities outside of the pediatric care setting.”
- Per an NIH news release,
- “Sjögren’s disease is a chronic autoimmune condition affecting up to four million Americans, characterized by symptoms such as dry eyes and mouth, fatigue, and inflammation in various organs. Although it primarily affects women, men tend to face more severe complications. The disease can impact pregnancy outcomes and increase risk for lymphoma. Despite extensive research, its underlying causes remain unclear, and current treatments mainly aim to manage symptoms.
- “Recent NIH-supported research using mouse models sheds new light on Sjögren’s disease, pointing to dysfunction in regulatory T cells and a heightened interferon gamma response as key drivers of disease symptoms. A drug called baricitinib, already approved for conditions such as rheumatoid arthritis, showed promising results in mice by reducing inflammation and restoring gland function. The similarities between mouse and human immune responses suggest that baricitinib could be a viable future treatment for people with Sjögren’s disease, offering hope for more targeted therapies ahead.”
- The Washington Post reports,
- “A baby’s sex may not be up to mere chance.
- “A study published Friday in the journal Science Advances describes the odds of having a boy or girl as akin to flipping a weighted coin, unique to each family. It found evidence that an infant’s birth sex is associated with maternal age and specific genes.
- “The findings challenge assumptions that birth sex is random. They mirror the results of similar studies in Europe that have also found that birth sex does not follow a simple 50-50 distribution.”
From the U.S. healthcare business front,
- The New York Times reports,
- “Prescription drug denials by private insurers in the United States jumped 25 percent from 2016 to 2023, according to a new analysis of more than four billion claims, a practice that has contributed to rising public outrage about the nation’s private health insurance system.
- “The report, compiled for The New York Times by the health analytics company Komodo Health, shows that denial rates rose from 18.3 percent to 22.9 percent. The rejections went up across many major health plans, including the country’s largest private insurer, UnitedHealthcare.” * * *
- “The analysis found that the most common reason for a drug claim to be rejected was that a refill had been requested “too soon,” before the patient was eligible for more medication.”
- “Appropriate prescription drug denials can happen for numerous reasons, and many can be resolved within minutes,” said Greg Lopes, a spokesman for the Pharmacy Care Management Association, a trade group for pharmacy benefit managers.”
- Beckers Payers Issues gives us a look inside the Humana-Mercy partnership “that’s shaping the future of health care.”
- Behavioral Health Business tells us,
- “Lyra Health, a national provider of mental health benefits for employers, has acquired Bend Health with the goal of strengthening its pediatric and neurodiversity capabilities.
- “Lyra’s acquisition of Madison, Wisconsin-based Bend Health was completed July 16. Exact terms of the deal were not disclosed in the press release.
- “The move enables Lyra to utilize Bend Health’s collaborative care model and specialized providers to offer more comprehensive evaluations and virtual intensive outpatient care to its 20 million members.”
- NCQA, writing in LinkedIn, discusses a new look for HEDIS that will arrive on August 1.