From Washington, DC

• Roll Call reports,
  • “If and when the next government shutdown rolls around, the laundry list of consequences will now include a pay freeze for U.S. senators.
  • “On a voice vote, the Senate passed a resolution from Sen. John Kennedy, R-La., that requires the Senate secretary to withhold compensation for the duration of a shutdown.
  • “The change in Senate rules is set to take effect on the date of the 2026 midterm elections to comply with the 27th Amendment to the Constitution, which prohibits a change in congressional salaries from being enacted until after an intervening election.
  • “The speedy passage, which followed a 99-0 procedural vote Wednesday, underscored a growing frustration among lawmakers with the frequency of partial shutdowns.”

• The American Hospital Association relates,
  • “The Centers for Medicare & Medicaid Services has released details on downloading its upcoming fiscal year 2025 Program for Evaluating Payment Patterns Electronic Report, or PEPPER, for critical access hospitals. The report, set to release this month, summarizes provider-specific Medicare data statistics for areas often associated with improper Medicare payments due to billing, diagnosis related group coding and/or admission necessity issues. CMS said the report would be available through its PEPPER Portal to authorized officials, access managers and users with the staff end user business function in the CMS Identity and Access Management System. A guide and FAQ on accessing the PEPPER are also available for users.”
    
• Tammy Flanagan, writing in Govexec, advises federal and postal employees that “Waiting to retire could be worth thousands of dollars.”
  • “Before you rush out the door, consider how a few more years of service can permanently boost your FERS annuity and Social Security benefits.”

• Fierce Healthcare informs us,
  • “A new ad campaign takes aim at the “misaligned incentives” in the No Surprises Act arbitration process, arguing they “create a ‘fox guarding the hen house’ dynamic.”
  • “The seven-figure campaign from the Coalition Against Surprise Medical Billing, called “Judge Fox,” features a court battle between a pair of chickens and a pair of foxes. The chickens confer and say that a “reasonable judge” would not allow these foxes to freely set prices for medical bills.
  • “Then the judge also turns out to be a fox, meant to illustrate that private equity firms that own providers that purportedly flood the dispute resolution system may also operate the independent entities meant to mitigate these disputes.
  • “The coalition said in a press release that the campaign comes “amid mounting evidence that some private equity-backed providers and IDR middlemen are relentlessly abusing the IDR process to maximize their own profits at Americans’ expense.”

From the Food and Drug Administration front,

• Bloomberg Law reports,
  • “A lawyer is leading the FDA for the first time, after President Donald Trump‘s selection Tuesday of Kyle Diamantas to serve as acting commissioner after Marty Makary resigned.
  • “The promotion of Diamantas to acting FDA commissioner also marks the second time in history someone leading the agency’s food oversight has been put in charge, a move that comes as the Trump administration advances a range of food policy changes aligned with the “Make America Healthy Again” movement.”

• Fierce Pharma relates,
  • “BeOne Medicines has entered the BCL-2 arena, securing an FDA green light for Beqalzi that carves out a unique piece of territory ahead of a potential broader clash with market leader Venclexta.
  • “The FDA has granted an accelerated approval to BeOne’s Beqalzi (sonrotoclax) for the treatment of patients with relapsed or refractory mantle cell lymphoma after at least two prior lines of therapy, including a BTK inhibitor, the company said Wednesday.
  • “The go-ahead makes Beqalzi the first BCL-2 inhibitor specifically approved for MCL in the U.S., as AbbVie and Roche’s first-to-market Venclexta has only been used off-label for this type of blood cancer.”
• and
  • “Taiho Pharmaceutical nabbed an expanded FDA approval for its Inqovi, which can now be taken alongside AbbVie and Roche’s Venclexa (venetoclax) to treat newly diagnosed acute myeloid leukemia in patients who are 75 and older and ineligible for intensive induction therapy. 
  • “The therapy is the first all-oral combination treatment regimen cleared for this specific patient population and represents an alternative to standard-of-care parenteral hypomethylating agent-based regimens, which require frequent visits to the clinic. With a more convenient offering that can potentially reduce the overall treatment burden associated with receiving the standard-of-care at hospitals or infusion centers, Taiho figures that its approach can make a “meaningful impact for patients and caregivers,” chief medical officer Harold Keer, M.D., Ph.D. pointed out in a company release.” 

• BioPharma Dive tells us,
  • “An experimental Duchenne muscular dystrophy gene therapy from Regenxbio has met its main objective in a pivotal trial, positioning the company to seek an accelerated regulatory clearance in the U.S.
  • “Three months after treatment with Regenxbio’s therapy, RGX-202, 28 of the 30 study participants receiving muscle biopsies produced at least 10% of normal levels of a diminutive protein, “microdystrophin,” believed to help Duchenne patients. That result hit the trial’s main goal and passed a key threshold needed to support an approval. Nine volunteers with at least one year of follow-up also demonstrated statistically significant improvements, from the study’s start, on multiple tests of motor function.
  • “Regenxbio did report two serious adverse events among treatment recipients — one case of heart inflammation and another of asymptomatic liver injury. Both were “easily managed and resolved within weeks” without further incident, and the average levels of liver inflammation markers in those who got RGX-202 didn’t surpass the “upper limit of normal.” Still, company shares fell by more than 35% as the safety findings “muddy the update,” wrote Leerink Partners’ analyst Mani Foroohar.”

From the judicial front,

• Per Justice Department news releases,
  • “A federal jury in the Southern District of Florida convicted the founder and owner of HealthSplash yesterday for his role in operating a platform that generated false doctors’ orders and prescriptions to defraud Medicare and other federal health care benefit programs out of more than $1 billion.” * * *
  • “According to court documents and evidence presented at trial, Brett Blackman, 42, of Johnson County, Kansas, and his co-conspirators aggressively targeted hundreds of thousands of Medicare beneficiaries to get them to accept medically unnecessary orthotic braces and other items. They then arranged for purported telemedicine doctors to sign bogus prescription orders for these items, so that their co-conspirators could bill Medicare for them. All told, Blackman and his co-conspirators billed Medicare and other federal health care benefit programs over $1 billion for this unnecessary equipment.
  • “Blackman owned, controlled, and was the CEO of HealthSplash, which acquired Power Mobility Doctor Rx, LLC (DMERx) in September 2017. DMERx was an internet-based platform that generated false and fraudulent doctors’ orders for durable medical equipment (DME) and prescriptions for other items. As part of the scheme, Blackman and his co-conspirators connected pharmacies, DME suppliers, and marketers with telemedicine companies that would accept illegal kickbacks and bribes in exchange for signed doctors’ orders created using the DMERx platform. Blackman and his co-conspirators took a cut for themselves in exchange for the referrals.”
• and
  • “Takeda Pharmaceuticals, U.S.A. Inc. has agreed to pay $13,670,921 to resolve allegations that it knowingly caused the submission of false claims to Medicare and other federal health care programs by paying kickbacks to healthcare providers to induce prescriptions of Trintellix, an antidepressant medication that Takeda marketed and sold to treat major depressive disorder.”
  • “The Department of Justice is committed to vigorously pursuing violations of the False Claims Act arising from illegal kickbacks,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “Such conduct can erode the trust that patients place in their healthcare providers and lead to higher drug costs for American taxpayers.”

From the public health and medical / Rx research front,

• The Washington Post reports,
  • “Health officials in the United States and around the world are assessing and managing potential exposures linked to the hantavirus outbreak on an expedition ship. Some of the American passengers on the ship are quarantining in Nebraska and Georgia. Others returned home earlier.” * * *
  • “David Fitter, the Centers for Disease Control and Prevention official leading the response, told reporters Thursday during a media briefingthat 41 people across the U.S. are under monitoring, but there are no cases.
  • “The people being monitored for symptoms fall into three groups. The first are the 18 passengers who were recently flown back to the United States from the Canary Islands and are being monitored in special facilities in Nebraska and Georgia. The second group comprises passengers who had already left the ship and returned home before the outbreak was identified. 
  • “In the third group are people who may have been exposed during flights with a known and symptomatic patient. That patient was the wife of the Dutch man, the first known patient to became sick, who died April 11 on board the ship. She left the ship and flew to Johannesburg, where she died on April 26.”

• Per a National Institutes of Health news release,
  • “A scientific team funded by the National Institutes of Health (NIH) has isolated and mapped in detail the first comprehensive group of human antibodies targeting the measles virus. The findings reveal previously unknown details about how the human immune system fights measles and identify specific antibodies capable of reducing the virus to undetectable levels in an animal model. The research could serve as the foundation for development of a measles treatment.
  • “Measles cases have recently increased in the United States and worldwide. More than 470,000 measles cases were reported globally in 2024, and at least 72 outbreaks have been recorded in the United States since January 2025. While effective prevention in the form of vaccination is available, no safe and effective therapies have received regulatory approval in the United States. This leaves people who cannot safely receive the vaccine – the immunocompromised, pregnant women, and infants too young to be vaccinated – with a lack of medical options.
  • “With measles cases increasing, we urgently need effective therapeutics to protect the most vulnerable,” said Jeffrey K. Taubenberger, M.D., Ph.D., acting director of NIH’s National Institute of Allergy and Infectious Diseases. “This research gives us a clear picture for the first time of the most promising targets for antibody-based medicines that could protect or treat people for whom measles vaccination is not an option.”

• Medscape tells us,
  • “Two new studies have identified risk factors that may be associated with the increasing incidence of colorectal cancer (CRC) among younger Americans.
  • “The majority of cases are sporadic, suggesting modifiable, nongenetic factors may play an important role,” said Mohamed Eldesouki, MD, internal medicine resident at New York Medical College at Saint Michael’s Medical Center in Newark, New Jersey, at Digestive Disease Week (DDW) 2026.
  • “In the first study, Eldesouki and colleagues identified a distinct phenotype, based on multiple factors, associated with an elevated risk in people aged 18-49 years. In addition, they found that inflammatory bowel disease, family history of CRC, severe obesity, and obesity were independent predictors that increased the risk for early-onset vs late-onset CRC more than twofold.
  • In the second study, a history of oral antibiotic exposure was associated with an increased risk for colorectal adenomas, especially among people with a greater or longer history of using these agents.”
    
• Med Page Today informs us,
  • “Dementia with Lewy bodies — a disease characterized by faster progression and greater functional decline than Alzheimer’s disease — was confirmed as a predominantly late-onset dementia with incidence rising sharply with age, a systematic review and meta-analysis showed.
  • “Across 12 population-based studies, the pooled incidence was 46.85 per 100,000 person-years (95% CI 23.78-92.30) for people ages 65 and older, and the pooled prevalence was 352.26 per 100,000 population (95% CI 112.25-1,099.79), reported Daniele Urso, MD, MPH, of the University of Bari Aldo Moro in Italy, and co-authors in JAMANeurologyopens in a new tab or window.
  • “In people younger than 65, the pooled incidence was 0.34 per 100,000 person-years (95% CI 0.14-0.83) and the prevalence was 2.52 per 100,000 population (95% CI 1.43-4.44).”

• Health Day points out,
  • “Women entering menopause are twice as likely to have lower heart health scores than those still having regular periods, a new study says.
  • “Perimenopausal women are more likely to have high cholesterol and blood sugar levels, researchers reported today in the Journal of the American Heart Association.
  • “These problems likely are fueled by varying estrogen levels, which can negatively affect cholesterol, insulin resistance, blood pressure and weight, researchers said.
  • “But diet also plays a powerful role, with women’s healthy nutrition scores declining as they begin and then enter menopause, the study found.
  • “Mid-life women should think of the perimenopausal period as a ‘window of opportunity.’ They should be proactive and not wait until they reach menopause to start checking their blood pressure, cholesterol and blood sugar levels,” said senior researcher Dr. Garima Arora, an professor of medicine at the University of Alabama at Birmingham.”
• and
  • “Abdominal obesity (AO) is associated with a higher prevalence and greater severity of menopausal symptoms, according to a study published online May 5 in Menopause.” * * *
  • “Educating women early about healthy lifestyle interventions to prevent midlife weight gain is key to improving mental and physical well-being during a tumultuous time frame,” Monica Christmas, M.D., associate medical director for The Menopause Society, said in a statement.”

From the U.S. healthcare business front,

• Modern Healthcare reports,
  • “Companies such as UnitedHealth Group, CVS Health, Cigna and Centene recorded strong first quarters.
  • “Earnings reports suggest chronically high medical costs may be subsiding.
  • “Insurers outperformed Wall Street expectations and upgraded earnings guidances, driving share prices higher.
  • “Seasonal factors, a shift toward higher-deductible plans and incomplete claims data cloud insights into cost trends.”
• and
  • “UnitedHealth Group division Optum Rx has rolled out a new pharmacy benefit manager model the company describes as transparent.
  • “Optum Rx, first in PBM market share, will phase out practices tying revenue to drug prices and shift toward fees.
  • “The company is attempting to respond to criticisms from its customers, the public and policymakers about how PBMs operate.
  • “Chief rivals CVS Caremark and Express Scripts previously announced similar changes.”
  • * * * “The fact that we’re having this discussion shows progress,” said Robert Andrews, CEO of the Health Transformation Alliance, a coalition of large employers that lobbies Congress.”
    
• The Wall Street Journal relates,
  • “Much of the public debate over cancer blood tests has focused on early detection products like the Galleri test from a company called Grail, which promises to screen healthy people for more than 50 types of cancer. 
  • “While these tests capture headlines and Super Bowl ads, the more proven opportunity for investors has been in a less glamorous market: checking for cancer recurrence.
  • For a patient who has just had a tumor surgically removed, the critical question is whether every cancer cell is gone. Many oncologists now use blood tests to answer that question months before a traditional scan could. 
  • “Natera NTRA, based in Austin, Texas, holds a near-monopoly in this market, known as minimal residual disease (MRD) testing. Its stock has roughly quadrupled over three years. The company is now valued at about $31 billion, making it the dominant player in what may be a new era of blood-based cancer testing. It has even surpassed Illumina, the sequencing giant on whose technology much of the industry depends. Revenue has grown from roughly $1 billion in 2023 to $2.3 billion last year and is projected by analysts on FactSet to reach $2.77 billion this year.”
• and
  • “Merck KGaA lifted its full-year sales and earnings guidance, causing its shares to rise 8.2% in European midday trading.
  • “The company now forecasts net sales of 20.4 billion to 21.4 billion euros and organic sales growth of up to 3%.
  • “Merck cited strong momentum in its life-sciences unit and greater resilience in its healthcare division for the improved outlook.”
• and
  • “State laws restricting private-equity involvement in the medical sector have taken their first scalps, as authorities signal an aggressive approach to enforcement.
  • “Last year, lawmakers in California and Oregon passed measures to prevent corporate healthcare investors from encroaching on medical care, part of a broad backlash against private equity’s role in the sector.
  • “The new laws started to bite last week. In California, Attorney General Rob Bonta unveiled the first settlement for violating the new law, penalizing Aspen Dental Management, which is backed by asset managers Leonard Green & Partners and Ares Management.
  • “Just a day earlier, Oregon hospital operator PeaceHealth scrapped plans to bring in an out-of-state medical-staffing company after a federal judge said the move looked like an end-run around the state’s strictest-in-the-nation ban on corporate medicine.”

• Beckers Hospital Review tells us,
  • “Becker’s has compiled a list of the hospitals with a CMS 5-star rating for cleanliness.
  • “CMS’ Patient survey (HCAHPS)-Hospital database listed hospital ratings based on the Hospital Consumer Assessment of Healthcare Providers and Systems surveys. This is a national, standardized survey of hospital patients about their experience during a recent inpatient hospital stay. The surveys were completed between July 1, 2024, and June 30, 2025. The data was updated May 13. 
  • “In 2025, 374 hospitals had a five-star cleanliness rating and Wisconsin had the most highly rated hospitals for cleanliness at 30.
  • “This year, 22 more hospitals made it to 5-star ratings, and Texas had the hospitals recognized for cleanliness with 36.”
  • The article includes the list.
• and
  • Americans are unlikely to see generic versions of semaglutide — the active ingredient in Novo Nordisk’s Ozempic and Wegovy — until at least the end of 2031, according to a May 13 NBC News report.
  • Novo Nordisk first applied for a U.S. patent on semaglutide in 2006. While standard drug patents last 20 years, patent extensions and secondary patents have delayed generic competition in the U.S., experts told NBC News.
• and
  • “Lentocilin, a penicillin G benzathine product, is back in stock and available to hospitals, clinics and pharmacies nationwide on Cost Plus Drugs’ marketplace.
  • “The restock comes as healthcare organizations continue managing supply disruptions affecting penicillin G benzathine products across the market, according to a May 11 company news release.
  • “Penicillin G benzathine is the only recommended treatment for syphilis during pregnancy and for preventing congenital syphilis — a condition whose national diagnosis rate has risen 203% over five years, according to an alert from the New Mexico Department of Health. The branded equivalent, Bicillin L-A, has been in shortage since 2023 and was further disrupted by a Pfizer recall in July 2025 due to particulates in prefilled syringes.” 

• MedTech Dive points out,
  • “Johnson & Johnson has launched a new iteration of its Shockwave coronary intravascular lithotripsy catheter that is designed to make it easier for physicians to treat complex calcified lesions and restore blood flow in the arteries.
  • “Called Shockwave C2 Aero, the improvements in the fifth-generation platform are intended to allow clinicians to use the catheter in a broader range of cases. 
  • “The device is available in the U.S. and Japan and will be introduced in Europe and Canada in the coming months, J&J said Tuesday.”

• Beckers Payer Issues discusses “How AI is turning UnitedHealth, CVS and Elevance into software companies.”