Simplicity is a virtue.

From Washington, DC,

• Fedweek reports,
  • “Although it is only mid-July, time is running short for Congress to act on bills to fund federal agencies after the September 30 end of the current fiscal year, as well as on the annual must-pass defense authorization bill.
  • “While schedules are subject to change, after next week Congress is scheduled to be in session only four weeks in September until the week after the November elections. Of the dozen regular appropriations bills, the House has passed just [three] and the Senate none.
  • “Typically, in such a scenario Congress would extend current funding levels until sometime in November or even December to buy more time. However, the record-setting shutdown of last fall and the DHS-only shutdown of earlier this year have shown that both Congress and the White House are willing to allow funding to lapse in pursuit of budgetary and program goals.”
    
• Healthcare Dive relates,
  • “Physicians billing Medicare would see a pay dip next year as part of a sweeping reimbursement rule that also aims to increase provider participation in accountable care organizations and overhaul quality reporting.” * * *
  • “Provider groups slammed the proposal, arguing that the payment cut would destabilize physician practices and limit investment in primary care.
  • “The updates “fall well short of what it actually costs our members to deliver care,” said Dr. Jerry Penso, president and CEO of the American Medical Group Association.”

• Fierce Healthcare adds,
  • “New legislation introduced in the House by leaders of both parties’ doctors caucuses takes a crack at providers’ long-requested overhaul of annual physician payment adjustments.
  • “The Patients First Act (PDF of bill text) would eschew the year-to-year reimbursement formula established under 2015’s Medicare Access and CHIP Reauthorization Act (MACRA) to instead tie physician reimbursement to an inflationary measure. The formula would take the Medicare Economic Index and subtract one percentage point. The approach answers years of alarm from physicians and medical groups that the costs of running a practice have grown far faster than reimbursement.
  • “We often talk about expanding access to high-quality care, but without meaningful Medicare reimbursement reform, that mission becomes nearly impossible to achieve,” Rep. John Joyce, M.D., R-Pennsylvania, one of the bill’s cosponsors, said in a statement. “Putting patients ahead of politics, we worked together to develop this comprehensive legislation to address a system that has for far too long undermined patient access to affordable, physician driven care within their communities.” * * *
  • “Jerry Penso, M.D., president and CEO of The American Medical Group Association (AMGA), said the trade group was particularly encouraged by the inflation-tied pay updates and formal rulemaking requirement for mandatory models.  “We appreciate this physician-led policymaking process, as these members of Congress know firsthand how federal policies impact medical practices,” Penso said.”

• Roll Call lets us know,
  • “A bipartisan pair of House members is introducing legislation aimed at treating millions of Americans of a deadly-but-curable liver disease, the culmination of a yearslong push from public health advocates.
  • “The bill, sponsored by Reps. Mariannette Miller-Meeks, R-Iowa and Diana DeGette, D-Colo., would create a national hepatitis C elimination program to expand testing and treatment especially for people least likely to access it, including those who are incarcerated, uninsured, low-income, or receiving care through the Indian Health Service.
  • “The legislation would also direct the federal government to enter into five-year subscription agreements with at least one drug manufacturer to purchase unlimited hepatitis C treatments at a fixed price. That could make a big difference in expanding access to the drug, which can cost tens of thousands of dollars per course of treatment.
  • “Hepatitis C is beatable. We have the tools to eliminate it, and this bill puts them within reach of the Americans who need them most,” Miller-Meeks said in a statement.”

• STAT News tells us,
  • “Medicare regulators on Tuesday proposed to ban vendors from providing remote patient monitoring services on behalf of doctors, a major policy change for a rapidly growing care model that’s been the subject of increasing scrutiny.
  • “Medicare has covered remote patient monitoring since 2018, and payments ballooned to over $500 million in 2024. The proposed change follows widespread concern from the health department’s watchdog, academics, and insurers that the current remote monitoring system is paying for low-value services. If finalized, the rule would impact a large percentage of remote monitoring care as it’s delivered today.”
  • “The update comes as the Trump administration moves to rein in fraud and wasteful spending in the Medicare program. The Centers for Medicare and Medicaid Services also recently launched an alternative model to pay for digital health services. 
  • “Currently, health systems and other primary care providers are allowed to bill when they use a vendor to help patients manage conditions using data collected at home. In one common use case, a vendor’s clinical staff can keep tabs on a patient’s home blood pressure readings and provide guidance to help get a patient’s hypertension under control. If needed, the patient can be referred back to their doctor. 
  • “The proposed change, included in a draft fee schedule from CMS, would require the remote monitoring services to be performed by clinical staff employed by the health care provider billing Medicare.”  

• Fierce Healthcare adds,
  • “The Centers for Medicare and Medicaid Services has joined lawmakers who have questioned the role of the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT) in government healthcare.
  • “Tuesday’s Calendar Year 2027 Physician Fee Schedule proposed rule included, among other policy proposals, a call for public comment “on a number of areas regarding the influence of the CPT coding system and AMA process on physician payment policy as part of the Secretarial priority to Make America Healthy Again.” * * *
  • “CMS asked the public to describe any evidence of “harms or challenges associated with AMA’s monopoly over CPT-4 licenses,” and whether the development of new codes is based on identified medical necessity. The agency also asked for input on any potential alternatives to the AMA’s standards and processes, and floated the Internal Classification of Diseases, 10th Revision (ICD-10) procedure code as an option worth considering.”

• Per the American Hospital Association News,
  • “The AHA July 15 responded to a request for information from the Centers for Medicare & Medicaid Services on the Affordable Care Act’s Essential Health Benefits framework, which creates the guardrails for defining comprehensive insurance coverage. The AHA supported updating the EHBs to reflect a changing healthcare landscape but cautioned CMS against changes to the EHBs that would dilute coverage, noting that affordability cannot be measured by premiums alone and that adequate coverage is essential for true affordability.”
• and
  • “The Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and the Department of Health and Human Services July 15 released a request for information on topics regarding Clinical Laboratory Improvement Amendments of 1988 regulations. Topics include breath testing, laboratory processes and procedures, emergency preparedness, biosafety and biosecurity, cybersecurity and specialty testing areas. The agencies will accept comments through Sept. 14.”

• Per a U.S. Office of Personnel Management news release,
  • “The US Office of Personnel Management (OPM) today announced the launch of the Guide to Processing Personnel Actions (GPPA) Navigator, a new digital tool that modernizes how federal Human Resources (HR) professionals access and apply personnel action guidance.
  • “The GPPA Navigator transforms decades of document-based guidance into an intuitive, searchable digital experience, giving more than 40,000 federal Human Resources specialists across government faster access to the codes, authorities, and policy guidance needed to process personnel actions accurately and consistently.
  • “The launch coincides with OPM’s comprehensive review and modernization of the Guide to Processing Personnel Actions, which streamlined content, removed outdated material, and incorporated recent policy updates to better serve today’s federal workforce.”

From the Food and Drug Administration front,

• Fierce BioTech reports,
  • “After pausing a controversial policy to publicly release drug rejection letters in April, the FDA today confirmed that the pause has been lifted and that more documents will be coming down the line.
  • “A spokesperson for the Department of Health and Human Services told Fierce last week that the policy to release complete response letters (CRLs) in real-time had been temporarily suspendedin April, the first time the pause was confirmed. Mere days later, the agency dropped a new batch of 14 CRLs, raising questions about the policy’s status.
  • “FDA will continue to proactively publish appropriately redacted CRLs, building on the batch released on July 10,” the spokesperson told Fierce today.”

• Reuters relates,
  • “The U.S. FDA has approved Celcuity’s (CELC.O) drug for an advanced form ​of breast cancer, the regulator said on Tuesday, making it the ‌company’s first product to gain market entry.
  • “The Food and Drug Administration’s approval was based on ​late-stage data showing the drug, gedatolisib, branded as Revtorpyk, when combined with ​Pfizer’s (PFE.N) Ibrance and fulvestrant, reduced the risk of disease progression or ⁠death by 76% compared with fulvestrant alone.”

From the U.S. public health and medical / Rx research front,

• STAT News reports,
  • “Sen. Lindsey Graham’s death Saturday at age 71 following an aortic dissection has focused attention on the life-threatening condition. Details about his diagnosis and treatment are not available while a final death certificate is pending, but experts agree on both how serious it is and how suddenly it erupts after a long prelude.” * * *
  • “Echocardiograms and CT scans offer a picture of blood vessel health, with guidelines based on vessel width dictating when surveillance should begin. Surgery can correct the problem, but it’s a major, high-risk operation to replace the weakened aorta with a graft. Another option is a minimally invasive repair that threads a stent into the artery to close the torn vessel lining. 
  • The challenge is determining who might benefit.
  • That’s where AI might help, Cardiologist Eric Topol, who is also director of the Scripps Research Translational Institute, said, something scientists are exploring. 
  • “We are terribly weak at predicting who is going to progress from a widened aorta into a dissection, unfortunately. Where AI could make a huge contribution is to help pinpoint the people at risk because we waste a lot of imaging, putting people through all these MRIs and CTs and echoes on a frequent basis and only a very small proportion of those actually go ahead and have a dissection,” he told STAT. “Our ability to discriminate is very weak. And we need help.” 
    
• Cardiovascular Business adds,
  • High cholesterol and other modifiable risk factors are responsible for a vast majority of deaths from ischemic heart disease (IHD) in the United States, according to a new analysis published in JAMA Cardiology. There has been progress in recent decades, researchers noted, but there is still a lot of work to do. 
  • “U.S. IHD mortality declined between 1980 and 2010 due to improved prevention and treatment,” wrote first author Catherine P. Benziger, MD, a cardiologist with Essentia Health, and colleagues. “Since 2010, this trend has slowed or reversed in most states due to plateaus in risk factor improvements, shifting risk factor exposures and fewer treatment advances.”
  • To learn more about the current state of this trend, Benziger et al. reviewed data from the Global Burden of Disease Study 2023. Overall, the group found that there were 473,000 IHD-related deaths in the United States in 2023. This is a significant improvement in many ways; IHD mortality was down 58.7% from 1990 to 2023 and down 19% from 2010 to 2023. However, the team’s research also identified a number of statistics that show just how much more work there is still to do when it comes to combatting these modifiable risks.
  • “One key takeaway from this analysis is the fact that modifiable risks were responsible for 88.7% of deaths from IHD. The encouraging news is that 127,000 fewer IHD deaths were linked to modifiable risk factors in 2023 than in 1990—and that comes at a time where the U.S. population has increased and grown older. Tobacco use, lead exposure and air pollution were all associated with a significantly lower number of IHD deaths in 2023, highlighting progress the country has made over the years. 
  • “The less encouraging news is the fact that some metabolic risks are on the rise, including high body mass index (BMI) and high fasting plasma glucose.”
  • “Current guidelines recommend screening at age 35 years and sooner if overweight or obesity is present, yet less than half of eligible U.S. adults report glucose testing, potentially due to issues including healthcare access, clinician guideline familiarity or patient care-seeking practices,” the authors wrote. “Glycemic and blood pressure control among U.S. patients with diabetes declined from the late 2000s onwards after a decade of progress in the late 1990s to early 2000s.”
     
• The New York Times notes,
  • According to a New York Times analysis of provisional mortality data from the Centers for Disease Control and Prevention, the [illegal] drug death rate in Arizona last year overtook West Virginia’s for the first time since the proliferation of prescription painkillers in the late 1990s. Arizona and New Mexico now have the highest rate of drug deaths in the contiguous United States.
  • The rising drug deaths in the Southwest are in sharp contrast to the large-scale decline that has returned the U.S. drug death rate to its pre-Covid level. The reasons for this decline are still a matter of debate. 

• CNN relates
  • “A yearly physical is the standard preventive measure for adults, but many Gen Z patients are forgoing regular doctor appointments.
  • “More than 1 in 4 young adults don’t have a primary care provider, according to a recent national survey by the Ohio State University Wexner Medical Center.
  • “For Gen Zers who do have a physician, most skip scheduled checkups or don’t schedule them: Only 47% of 18- to 29-year-olds said they have had an annual wellness visit in the past year, according to the survey findings, released June 29.” * * *
  • “An annual visit isn’t just about today’s health — it helps identify future risks, keeps preventive care on schedule and gives you a trusted clinician who knows your medical history and can help navigate health concerns, be they physical health or mental health concerns, as they arise,” said CNN wellness contributor Dr. Leana Wen, an emergency physician and clinical associate professor at George Washington University, in an email to CNN. Wen was not involved in the study.”

• MedPage Today tells us,
  • “CDC survey data showed a 27% decline in healthcare-associated infections in U.S. hospitals from 2015 to 2023.
  • “The drop was driven primarily by declines in C. difficile infections, central catheter-associated bloodstream infections, and catheter-associated urinary tract infections.
  • “Meanwhile, the researchers said there was still room for improvement regarding surgical-site infections and infections not associated with devices or procedures.”
• and
  • “Very high levels of plasma phosphorylated tau 217 (p-tau217), a marker of amyloid burden in the brain, predicted future risk of cognitive impairment among older adults who were initially unimpaired, a multicohort study suggested.
  • “Using different plasma assays and definitions of cognitive impairment across six cohorts, a “consistent pattern” emerged: those with very high p-tau217 had an estimated 38% risk of cognitive impairment over 5 years and an estimated 78% risk over 10 years, reported Rachel Buckley, PhD, of Mass General Brigham in Boston, at the Alzheimer’s Association International Conferenceopens in a new tab or window. The findings were published simultaneously in JAMAopens in a new tab or window.
  • “P-tau217 provided predictive information beyond amyloid PET, suggesting it may capture aspects of Alzheimer’s disease biology not explained by amyloid plaques alone, Buckley said.”

• Reuters points out,
  • “Potential signs of frailty in older adults taking Eli Lilly’s GLP-1 obesity drug Zepbound may signal relatively high risks for adverse outcomes, according to a large study that underscores concerns about how best to monitor seniors as U.S. Medicare expands access to GLP-1 therapies.
  • “In general, frailty-associated conditions ‌such as malnutrition, dehydration and loss of muscle mass and strength developed only rarely and the results should not discourage appropriate use of Zepbound, known chemically as tirzepatide, ‌or Novo Nordisk’s GLP-1 drug Wegovy, also known as semaglutide, in older adults, the study’s researchers said. Instead, they encouraged closer follow-up of older patients taking the medicines.”

• KFF Health News informs us,
  • “Thousands of Americans who undergo a common knee surgery might be making their problems worse rather than better.
  • “Researchers who followed patients for 10 years after they received either the actual procedure, arthroscopic knee surgery to trim degenerative cartilage tears, or merely “sham surgery” — a skin incision — for knee pain, found that the surgery provided little or no benefit and was, in fact, associated with accelerated osteoarthritis and higher rates of reoperation. That generally meant a total knee replacement.
  • “I don’t know how I would defend this procedure at all,” said one of the study’s authors, Teppo Järvinen, an orthopedist and the head of the Finnish Centre for Evidence-Based Orthopaedics. “What has been shown dramatically is that patients who have this procedure have more pain — they do worse. All the scores pointed in the same direction.”
  • “Järvinen said the Finnish study, published in April in the New England Journal of Medicine, was the first to show the surgery left many patients worse off. Though the study was small, the results were compelling, he said, because his team picked the patients “most likely to benefit.”
  • “The study does not apply to cartilage tears incurred from an acute pain-causing injury. It included subjects middle-aged or older who were experiencing knee pain and whose MRIs showed cartilage tears.”

• Health Day adds,
  • “About 5 million Americans are thought to be using an opioid painkiller to ease their chronic pain. 
  • “A new study suggests that the safest route to reducing use of the powerful drugs is best left up to the patient.
  • “For patients, I think the data are reassuring that if opioids are tapered the right way, meaning a patient-centered approach, people can significantly reduce their opioid doses without having increased pain long term,” said study lead author Beth Darnall. She’s a professor of anesthesiology, perioperative and pain medicine at Stanford University in California.
  • “The study was published recently in the Annals of Internal Medicine and involved more than 500 adult patients.” * * *  
  • “The findings are in line with current U.S. Centers for Disease Control and Prevention (CDC) guidelines, which support a patient-driven approach to tapering off opioids for chronic pain.”
  • “The study does not apply to people who have developed an addiction to the powerful painkillers.”

• Radiology Business lets us know,
  • “New PET imaging findings could help explain why some patients continue to experience lingering side effects from long COVID. 
  • “The analysis, which is published in eBioMedicine, indicates that individuals who have been diagnosed with the disease display significantly decreased dopamine neuron integrity on brain scans. Experts believe this could have something to do with why many continue to struggle with fatigue and lack of focus and motivation. 
  • “Our findings provide compelling evidence that long COVID involves the loss of dopamine-releasing neurons,” said study author Jeffrey Meyer, MD, PhD, senior scientist at the Brain Health Imaging Center in Toronto. “This kind of injury is well known to produce symptoms like lack of motivation and motor slowing, and may contribute to memory difficulties in other neurological conditions. Our results suggest a similar process is occurring in long COVID.” 

• Genetic Engineering and Biotechnology News notes,
  • “An international team of scientists report that they have successfully mapped the cells and genes that regulate bone formation and loss and discovered the critical role that blood vessel cells play in bone health. By combining genomic sequencing with data from half a million individuals, the research team identified hundreds of previously unknown genes that govern bone health and revealed cells surrounding blood vessels as one of the drivers of bone repair.
  • “The study “Multiscale analysis and functional validation of the cellular and genetic determinants of skeletal disease” is published in Nature Genetics. The team says its findings fundamentally enhance our understanding of skeletal disease. It is hoped the discovery will enable the development of new therapies to rebuild lost bone, offering hope to almost half of all individuals over 50 living with rare and common skeletal conditions such as osteoporosis, osteoarthritis and osteogenesis imperfecta, as well as those with rare bone disorders and cancers that spread to bone.
  • “Most people don’t realize that bones are constantly changing; the human body replaces its skeleton every 10 years or so,” said Peter Croucher, PhD, professor at the Garvan Institute of Medical Research in Australia. “This is a hugely important process, but until now we’ve had a limited understanding of the cells and mechanisms that control this turnover of bone. “Most of the drugs now available focus only on halting bone disease, rather than rebuilding lost bone, which is really important for reversing damage.”
    
• Per STAT News,
  • “In a new study published in Science Translational Medicine on Wednesday, researchers say they have uncovered how Epstein-Barr virus launches immune responses that lead to the inflammation and nervous system damage seen in people with multiple sclerosis. 
  • “It’s very nice now to be able to understand more about the underlying mechanisms of how EBV likely causes MS,” said lead author Kjetil Bjornevik, an assistant professor of epidemiology and nutrition at the Harvard T.H. Chan School of Public Health. The findings, researchers hope, could help with the development of EBV vaccines or antiviral medications that could prevent or manage MS symptoms without the major side effects of commonly used immunosuppressants. 

• Per Fierce Pharma,
  • “Merck & Co.’s almighty Keytruda has become the first PD-1 inhibitor to show a benefit as a single agent for the front-line treatment of a subtype of endometrial cancer.
  • “Keytruda significantly improved progression-free survival over platinum-based chemotherapy in patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer. The patients had either received no systemic chemotherapy or experienced recurrence more than six months after completing prior adjuvant therapy.
  • “On its other dual primary endpoint, the Keynote-C93 trial also recorded an immature trend toward improvement in overall survival at the interim analysis. The trial is ongoing, with plans to evaluate the endpoint in the future. 
  • “The positive readout sets Keytruda up to be a new chemo-free option in first-line dMMR endometrial cancer, Brian Slomovitz, M.D., from Mount Sinai Medical Center and the study’s principal investigator, noted in a July 15 release. Merck now plans to share the results with regulatory authorities.”

From the U.S. healthcare business front,

• Healthcare Dive reports,
  • “Elevance Health is shrinking its Medicaid business, worried about future profits in the beleaguered safety-net insurance program.
  • “The insurer is leaving Washington, D.C.’s Medicaid market this summer, and plans to exit additional Medicaid markets over the next 18 months, executives said during a call to discuss Elevance’s second quarter financial results Wednesday morning.
  • “It’s the latest example of insurers exiting underperforming markets to try to recoup margins after a difficult few years.” * * *
  • “Elevance largely delivered in the second quarter, outperforming Wall Street’s revenue and earnings expectations and boosting its 2026 earnings guidance on the strength of the results.
  • “Elevance brought in $1.5 billion in net income in the quarter, down more than 16% year over year, on operating revenue of $49.8 billion, up 1% year over year. Revenue rose thanks to Elevance hiking premiums in its health insurance plans and higher sales from Carelon.”

• The Wall Street Journal relates,
  • “Johnson & Johnson raised its 2026 sales forecast to a range of $100.8 billion to $101.4 billion, up from its prior projection.
  • “The company increased its full-year adjusted earnings guidance to between $11.60 and $11.75 a share.
  • “Second-quarter sales rose 6.6% to $25.31 billion, driven by growth in both the pharmaceutical and medical device businesses.”
• and
  • “Boehringer Ingelheim reported first-half net sales of 15.8 billion euros, up 16% when adjusted for currency changes.
  • “Sales of the company’s top-selling diabetes drug, Jardiance, rose to 5.7 billion euros from 4.3 billion euros in the year-earlier period.
  • “Boehringer Ingelheim is gearing up to file for U.S. approval of survodutide, its new obesity medicine.”
• and
  • “Eli Lilly is losing to rival Novo Nordisk in the weight-loss pill market, capturing only about 11% of prescription volume for new pills.
  • “Doctors say patients prefer Novo Nordisk’s Wegovy pill over Lilly’s Foundayo because study data shows it leads to greater average weight loss.
  • “Lilly’s launch was also slowed by the time it took to secure reimbursement coverage from major pharmacy-benefit managers.”

• Beckers Hospital Review tells us,
  • “Registered nurses in California earn the highest median pay in the country, while nurses in Alabama earn the least, according to data released May 15 by the Bureau of Labor Statistics.
  • [Included in the article] are the median hourly and annual wages for registered nurses in all 50 states and Washington, D.C., based on May 2025 data from the BLS Occupational Employment and Wage Statistics program, listed in descending order by annual wage. Nationally, registered nurses earned an annual median wage of $97,550, according to the BLS.

• MedTech Dive offers an interview with “Jorge Garces, who joined Abbott to oversee scientific strategy for cancer diagnostics after it acquired Exact Sciences, discusses the future of the field, about Abbott’s cancer diagnostics vision: ‘There’s always a hunger to make these tests better.”

• Fierce Healthcare informs us,
  • “Judi Health is continuing on its rebranding journey and announced on Wednesday that its pharmacy benefit management arm will now operate as Judi Rx.
  • “Previously known as Capital Rx, Judi’s PBM has operated on a transparent model for nearly a decade. Demand for new and alternative options in this market has grown as healthcare costs escalate, and Judi’s combined PBM and pharmacy benefit administrator clientele has grown to include more than 50 million lives across Medicare, Medicaid and commercial.
  • “In a June study backed by Judi, Employee Benefit News found that most organizations switching to a transparent PBM jumped ship from one of the legacy “Big Three” companies that have historically dominated this space.
  • “Alongside the Capital Rx rebrand, Judi announced that it will launch Judi Care, which represents its medical, dental and vision solutions, along with Judi Cloud, which allows for the licensure of its proprietary technology.”