Weekend Update

David Ermer–Congress, FDA, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Senate Executive Calendar informs us that Majority Leader Thune is bringing to the Senate floor nominations that received Committee approval in the same week as OPM Director nominee Scott Kupor (Calendar No. 81).
  • The Wall Street Journal reports,
    • “House Republicans are releasing their plan to cut Medicaid spending, with the program’s defenders in the GOP appearing to win the intraparty clash over how aggressively to change the system that provides health insurance to more than 70 million low-income and disabled people. 
    • “A section-by-section summary of the bill text, which was viewed by The Wall Street Journal, includes some of the changes Republicans have weighed for Medicaid, including work requirements and more frequent eligibility checks. But it doesn’t lower the minimum share the federal government contributes to Medicaid in each state, cap per-person federal spending in the program or other steps some spending hawks sought.” * * *
    • “The bill would require Medicaid recipients to work, volunteer or attend school for 80 hours a month. The requirement would apply to most able-bodied adults through age 64 without dependents and includes exceptions for pregnant women, people with substance-use disorders and others.”
  • Fierce Healthcare tells us,
    • “Senators Shelley Moore Capito, R-W.Va., and Jeanne Shaheen, D-N.H., reintroduced the Access to Prescription Digital Therapeutics (PDT) Act on Thursday to expand access to software-based treatments.
    • “Advocates will bring new economic data from Germany to make the case to Congress, Centers for Medicare & Medicaid Services (CMS) Director Mehmet Oz, M.D., and Department of Health and Human Services Secretary Robert F. Kennedy Jr. to create pathways for coverage of the technologies. 
    • “By leaning into the Make America Healthy Again (MAHA) crowd in Washington, advocates at the American Telemedicine Association’s (ATA’s) lobbying arm think they have an unprecedented chance to pass the bill. 
    • “The Access to PDT Act would create a reimbursement pathway for software that treats medical conditions, like Cognoa’s early autism diagnosis product and Freespira’s panic attack disorder treatment. The category has broadly struggled with uptake because the Medicare program does not have the authority to cover the technologies under its existing benefit categories.”
  • Bloomberg Law reports,
    • “President Donald Trump said he plans to sign an executive order to cut prescription drug prices by mandating that the US pays the same price for drugs as whichever country pays the lowest price in the world.
    • “He said in a social media post that that he would sign the order at 9 am Monday, Washington time. He predicted pharmaceutical prices could drop 30% to 80%. 
    • “Trump’s Truth Social post didn’t detail how the order would work. He also didn’t specify potential limits on the policy, such as if it would apply only to government programs like Medicare or Medicaid, or if the White House sees a way to apply this more broadly.”
    • If true, this would be a policy mistake in the FEHBlog’s opinion. Government price controls usually backfire.
  • Federal News Network reports,
    • “The Office of Personnel Management appears to be walking back the surprise sole-source contract award it made just a week ago for HR information technology services.
    • “On Friday, OPM posted a one-sentence notice on SAM.gov saying that the justification and approval it issued a week earlier, explaining its no-bid award to Workday, was being “canceled in its entirety.”
    • “Spokespeople for OPM and Workday did not immediately respond to inquiries from Federal News Network, and the reasons for canceling the justification document were not immediately clear. Also unclear was whether the government was canceling the $342,200 award entirely, or merely the approval document that allowed the contract to go forward without a competitive bidding process. However, federal contracting experts said the agency would not be able to proceed with the award without a documented justification and approval.”
  • Medical Economic informs us,
    • “Osteoboost Health Inc. announced Wednesday the nationwide release of Osteoboost, the first and only FDA-cleared prescription medical device for low bone density, offering new hope for the more than 50 million Americans affected by osteopenia and osteoporosis.
    • “The wearable device delivers targeted vibration therapy to the spine and hips—areas most vulnerable to osteoporotic fractures. Cleared through the FDA’s De Novo pathway and designated a Breakthrough Device, Osteoboost represents a major innovation in preventative care for bone health.
    • “The longevity conversation is everywhere, but people rarely mention bone health even though it is fundamental to aging with confidence,” said Laura Yecies, CEO of Osteoboost Health. “Osteoboost empowers people to lead longer, stronger, and more active lives.”
    • “Designed for at-home use, the belt-like device requires 30 minutes a day of therapy and can be worn while performing everyday tasks such as walking or cooking.”

From the judicial front,

  • Govexec relates,
    • “Federal agencies cannot take any action to implement its widespread layoff plans across government after a federal judge ruled the Trump administration has likely acted unlawfully in ordering the staffing reductions. 
    • “The pause came in the form of a temporary restraining order and will last at least 14 days, Judge Susan Illston for the U.S. Court for the Northern District of California ruled Friday evening, meaning agencies cannot issue any reduction-in-force notices through May 23. The order came as several agencies, such as the Interior Department, Agriculture and others, were expected to begin implementing large-scale layoffs in the coming days. 
    • “The order prevents agencies from implementing their Agency RIF and Reorganization Plans, previously mandated by the Office of Personnel Management and Office of Management and Budget, and President Trump’s executive order that precipitated them. It applies to OMB and OPM, as well as the departments of Agriculture Commerce, Energy, Health and Human Services, Housing and Urban Development, Interior, Labor, State, Treasury, Transportation and Veterans Affairs. It also applies to AmeriCorps, the Environmental Protection Agency, the General Services Administration, the National Labor Relations Board, the National Science Foundation, the Small Business Administration and the Social Security Administration.”
  • Here is a Dropbox link to the Judge’s opinion, which the Justice Department has appealed to the U.S. Court of Appeals for the Ninth Circuit.

From the public health and medical research front,

  • The New York Times fills us in on the hepatitis A outbreak in Los Angele County, California.
    • “The first signs of the infection can look a lot like a classic stomach bug: fever, fatigue, nausea and a loss of appetite, followed by vomiting and diarrhea. Over time, people who become infected can also experience yellowed skin and eyes, dark urine and pale stools.
    • “One of the challenges to halting a hepatitis A outbreak is that contact tracing can be nearly impossible. The infection can incubate for up to seven weeks before symptoms appear, and a person carrying the virus can spread it for up to two weeks before they feel ill.
    • “In addition, a significant proportion of people who become infected don’t experience major symptoms, said Dr. Edward Jones-Lopez, an infectious disease specialist with Keck Medicine of the University of Southern California, so they do not visit their doctor, who in turn does not run a blood test and report the case.”
  • Per Medscape,
    • “Many of the US children not vaccinated with the measles-mumps-rubella (MMR) vaccine in the past decade were also missing other routine vaccinations after 12 months of age, according to data presented at Pediatric Academic Societies (PAS) 2025 Meeting.
    • “Efforts to increase MMR vaccination should include outreach to families whose children fall behind on vaccines or may have lost contact with primary care,” Sophia R. Newcomer, PhD, MPH, of the University of Montana in Missoula, Montana, and colleagues reported in a poster.
    • “The findings have particular significance in the midst of the current measles outbreaks, which have resulted in three deaths, including two children, in 2025. The Centers for Disease Control and Prevention (CDC) reported 884 total cases in 2025 as of April 25, most of which (93%) are associated with the 11 outbreaks in the country. The cases have spread to 29 states excluding Washington, DC, with 11% of cases involving hospitalization. Most of the cases were in children younger than 5 years (30%) or aged 5-19 years (38%), and 97% of the children were unvaccinated or their vaccination status was unknown.”
  • The Washington Post discusses new alternatives to knee replacement surgery. “Physicians caution that the treatments aren’t permanent fixes, but they may work well for some.”
  • Cardiovascular Business points out,
    • “Tirzepatide is associated with a much lower all-cause mortality rate than semaglutide when patients present with type 2 diabetes, chronic kidney disease (CKD) and heart failure, according to new data presented at SCAI 2025 Scientific Sessions, the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).
    • “Tirzepatide and semaglutide are both popular diabetes drugs being used more and more for weight loss and other benefits.
    • “Tirzepatide is a popular dual GIP/GLP-receptor agonist sold by Eli Lilly and Company under the brand names Zepbound and Mounjaro. It has previously been linked to improved outcomes in patients with sleep apnea and heart failure with preserved ejection fraction. 
    • “Semaglutide, meanwhile, is a GLP-1 receptor agonist sold by Novo Nordisk under the brand names Wegovy and Ozempic. It has been associated with a long list of health benefits, including several associated with improvements in cardiovascular symptoms in patients with and without diabetes.” * * *
    • Tirzepatide is associated with a much lower all-cause mortality rate than semaglutide when patients present with type 2 diabetes, chronic kidney disease (CKD) and heart failure, according to new data presented at SCAI 2025 Scientific Sessions, the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).” * * *
    • “Lead author Adbul Wali Khan, MD, a resident at the University of Missouri Kansas City, presented the group’s findings. Overall, semaglutide was linked to a higher one-year risk of all-cause mortality, acute myocardial infarction, ischemic stroke and hospital readmission than tirzepatide. The rates of hemorrhagic stroke, atrial fibrillation, atrial flutter and cardiac arrest were comparable between the two drugs.
    • “Semaglutide did appear to perform better than tirzepatide in one important way; HbA1c levels were less likely to be under 7% for patients treated with tirzepatide than those treated with semaglutide.” 
  • Medscape considers whether new approaches can turn the tide against U.S. pain problems.

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Omada Health, a virtual chronic care provider, filed to go public Friday, marking the second digital health company making plans for an initial public offering in 2025.
    • “The company has not specified the number of shares to be offered or the price range for the proposed offering.
    • “It intends to list on the Nasdaq Global Market under the ticker symbol “OMDA.”
  • Per Healthcare Dive,
    • “New Insulet CEO Ashley McEvoy set out her priorities for the diabetes technology company on Thursday. 
    • “Insulet is already a standout success story,” McEvoy told investors during her first call after taking on the role, adding that the firm is one of the fastest-growing businesses in medtech. “Now is the time to envision what it will take to expand from a medtech platform with emerging global strength to a durable world leader in diabetes management.” 
    • “McEvoy was named chief executive in late April, with the goal of helping the insulin pump maker prepare for its next phase of growth. Previously, she led Johnson & Johnson’s medtech business unit and has more than 15 years of leadership experience in the medical device sector. 
    • “McEvoy said Insulet sits at the intersection of consumer health and medtech.
    • “I have a deep appreciation for the consumer’s increasing role in healthcare decisions and understanding that is especially relevant to a wearable technology like Omnipod,” McEvoy said.”