Tuesday Report

FDA

Tuesday Report

David Ermer–CDC, CMS, FDA, Medical / Rx research, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • OPM and FedSmith report on yesterday’s swearing in ceremony for OPM’s new director Scott Kupor.
    • “I am honored by the Senate’s confirmation and grateful to President Trump for entrusting me with this opportunity to serve,” Director Kupor said. “The federal workforce is the backbone of our government’s ability to deliver for the American people. My commitment is to empower these dedicated public servants with the tools, systems, and leadership they deserve, building a high-performing, accountable, and mission-driven workforce that upholds the trust of every taxpayer.
    • “I will prioritize President Trumpʼs America-first agenda by focusing on a smart stewardship of taxpayer resources, fostering a workplace culture that rewards innovation and performance, and ensuring federal agencies are equipped to serve Americans with efficiency and integrity,” Kupor continued. “Throughout my career, I have worked to champion organizational excellence. As Director of OPM, I will apply these experiences to modernize how the federal government attracts, develops, and retains top talent.”
  • Federal News Network reports,
    • “The Trump administration is continuing to keep the details of agencies’ reorganization and staff reduction plans out of the public eye, according to court documents the government’s lawyers filed on Monday.
    • “U.S. District Court Judge Susan Illston last week ordered the Trump administration to submit a list of the 40 reduction-in-force actions across 17 agencies that government officials told the Supreme Court are ready for implementation. Illston’s order comes after the Supreme Court allowed agencies to move forward with agency RIF and reorganization plans (ARRPs) on July 8.
    • “In its response this week to Illston’s order, the government refused to disclose details about agencies’ planned staffing reductions and opted not to submit a court-ordered list of dozens of expected RIFs. Instead, the government’s lawyers said the information is “privileged” and argued that there is “no lawful basis” for Illston to order the disclosure of a list.
    • ‘Rather than turning over a list of agencies’ planned RIFs, the government’s lawyers said they plan to file a motion to dismiss the case within the next week.”
  • Bloomberg Law reports,
    • “President Donald Trump said that he was likely to impose tariffs on pharmaceuticals as soon as the end of the month and that levies on semiconductors could come soon as well, suggesting that those import taxes could hit alongside broad “reciprocal” rates set for implementation on Aug. 1.
    • “Probably at the end of the month, and we’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build, and then we’re going to make it a very high tariff,” Trump told reporters Tuesday as he returned to Washington after attending an artificial intelligence summit in Pittsburgh.” * * *
    • “Trump on Tuesday predicted that he could strike “two or three” trade deals with countries before implementing his so-called reciprocal tariffs before they are implemented on Aug. 1, saying that an agreement with India was among the most likely.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.1 This action reflects the Agency’s growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations, and corner stores. While 7-OH occurs naturally in trace amounts in kratom, the Agency’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots, which may be dangerous. 
    • “7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods. Additionally, there are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH. Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use.”

From the CMS front,

  • Fierce Healthcare tells us,
    • The Centers for Medicare & Medicaid Services’ [CMS] annual pay rate proposal for outpatient and ambulatory surgical centers (ASCs) includes a step toward site-neutral payments, a broader list of services eligible for outpatient reimbursement, updates to hospital price transparency rules and several quality rating methodology updates.
    • “We are advancing our mission to protect Medicare and its beneficiaries, fight fraud and empower patients with access to the latest innovations, all while holding providers accountable and ensuring taxpayer dollars are spent wisely,” CMS Administrator Mehmet Oz, M.D., said in a Tuesday afternoon release. “These reforms expand options and enforce the transparency Americans deserve to ensure they receive high-quality care without hidden costs.”
    • The Calendar Year 2026 Outpatient Prospective Payment System (OPPS) and ASC Payment Systems proposed rule is headlined by a 2.4% proposed payment rate increase for hospitals that meet applicable requirements for quality reporting. It reflects a projected 3.2% hospital market basket increase and a required productivity adjustment of 0.8 percentage points, and is estimated to increase OPPS expenditures approximately $8.1 billion over 2025’s estimated payments.
  • Following up on yesterday’s post, Fierce Healthcare points out,
    • “The Centers for Medicare & Medicaid Services released the proposed physician fee schedule on Monday evening, which would set the conversion factor, or the amount that Medicare pays per work relative value unit, at $33.42, an increase of 3.62% over the 2025 rate of $32.35.
    • “That increase accounts for a 2.5% payment adjustment required by the Big Beautiful Bill Act, and a bump of 0.55% to account for changes to some RVUs, per a fact sheet on the rule.
    • “The agency also said it intends to set the conversion rate in qualifying alternative payment models at $33.59, an increase of 3.83%.”
  • CMS also announced today,
    • “The Centers for Medicare & Medicaid Services (CMS) announced today that 33 states, plus the District of Columbia and Puerto Rico, will participate in the Cell and Gene Therapy (CGT) Access Model, a bold new approach to delivering cutting-edge treatments for people on Medicaid living with sickle cell disease. Participating states represent approximately 84% of Medicaid beneficiaries with the condition, significantly expanding access to transformative care.” * * *
    • “The following states and territories are participating in the CGT Access Model: Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Illinois, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, and Wisconsin, as well as the District of Columbia and Puerto Rico.
    • “To learn more about the Cell and Gene Therapy Access Model, visit:  www.cms.gov/priorities/innovation/innovation-models/cgt.

From the public health and medical research front,

  • Health Day lets us know,
    • “Cancer deaths linked to obesity more than tripled in the U.S. during the past two decades, a new study says.
    • “Deaths linked to the 13 types of obesity-related cancer rose to 13.5 deaths per million from 3.7 deaths per million between 1999 and 2020, researchers reported Sunday at the Endocrine Society’s annual meeting in San Francisco.
    • “Obesity is a significant risk factor for multiple cancers, contributing to significant mortality,” said lead researcher Dr. Faizan Ahmed of Hackensack Meridian Jersey Shore University Medical Center in Neptune City, N.J.
    • “This research underscores the need for targeted public health strategies such as early screening and improved access to care, especially in high-risk rural and underserved areas,” Ahmed added in a news release.”
  • MedPage Today warns us that “Two separate manufacturers of needle mushrooms and cremini mushrooms recalled their products for potential Listeria monocytogenes contamination.
  • The American Hospital Association News relates,
    • “A Health Affairs study on the decline of obstetric services in rural and urban hospitals nationwide from 2010-2022 found that seven states had at least 25% of their hospitals report they are no longer providing obstetric services. Additionally, by 2022, more than two-thirds of rural hospitals in eight states were without obstetric services.
    • “In five states, 25% or more of their urban hospitals no longer reported providing obstetric services by 2022, but this was more pronounced in rural areas, with a total of 12 states experiencing 25% or more losses of obstetric services in rural hospitals. The study examined AHA survey data as well as information from the Centers for Medicare & Medicaid Services Provider of Services files.”
  • The July 15, 2025, issue of NIH Research Matters covers the following topics: “Lung cancer in never-smokers | CAR T cells | Measuring aging from brain images.”
  • The Washington Post interviews “a gastroenterologist, here’s what she eats in a day to boost her gut health. Studies have shown that a high-fiber diet can also lower the risk of heart disease and cancer and improve longevity.”
  • The Wall Street Journal calls attention to the fact that “a growing number of female scientists, entrepreneurs and influencers are edging into a space long dominated by men [, the study of human longevity]. Their study of hormones and ovaries could unlock the key to a longer life for everyone.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Teladoc Health is launching an employee assistance program as the virtual care giant looks to boost its mental healthcare offerings. 
    • “The program, called Wellbound, includes online therapy through its direct-to-consumer mental healthcare unit BetterHelp, as well as additional psychiatry and medication management services provided through Teladoc, the telehealth vendor said Tuesday.
    • “The EAP will also be able to connect users to Teladoc’s other services, like primary care and chronic condition management programs.”
  • Beckers Payer Issues lets us know,
    • “EmblemHealth is enlisting AI agents to help keep members cool this summer. 
    • “Extreme heat is a silent killer, said Dan Knecht, MD, EmblemHealth’s chief medical officer. In New York City, where EmblemHealth is based, more than 500 people die from extreme heat each year. 
    • “This summer, EmblemHealth launched its weather resilience program, designed to find members at risk of heat-related illness, and provide them with information and resources. 
    • “The health plan uses data about members’ age, chronic conditions and other factors, combined with public data from New York City’s heat vulnerability index, to identify members at risk. Then AI voice agents are used to contact members, providing information about heat safety, cooling centers and other resources. 
    • “The program has reached over 2,600 members as of July 8.” 
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • “ICER today released a Final Evidence Report assessing the comparative clinical effectiveness and value of for the treatment of tolebrutinib (Sanofi) for the treatment of secondary progressive multiple sclerosis (SPMS).” * * *
    • “Tolebrutinib has not yet been approved by the FDA, and the manufacturer has not announced a US price if approved. 
    • “Consistent with ICER’s process, because there is no firm estimate yet of a potential launch price for the treatment, the panel did not take a vote on the treatment’s long-term value for money. 
    • “ICER has calculated a health benefit price benchmark (HBPB) to be between $3,250 and $5,900 per year.”

Monday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, Obesity, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • Federal News Network informs us,
    • “Top Republicans on the House Education and Workforce Committee are pushing for an investigation into the long-standing workers’ compensation program for federal employees, saying the program is particularly “susceptible to waste, fraud and abuse.”
    • “In a letter to the Government Accountability Office on Monday, Committee Chairman Tim Walberg (R-Mich.) and Rep. Ryan Mackenzie (R-Pa.), chairman of the workforce protections subcommittee, requested a further examination into areas for reforms of the Federal Employees’ Compensation Act (FECA) program, which provides benefits to federal employees who get injured or become ill from work.
    • “In their letter, the GOP committee leaders argued that the program is “overly generous” to federal employees. The FECA program, which dates back to 1916, hasn’t seen any major updates in over 50 years.” * * *
    • “This year, bipartisan lawmakers have also been attempting to reform the FECA program through the “Improving Access to Workers’ Compensation for Injured Federal Workers Act.” If enacted, the legislation would revise FECA to allow physician assistants and nurse practitioners to treat federal employees in workers’ compensation cases — something that is currently prohibited by law.”
  • Per a Centers for Medicare and Medicaid Services news release,
  • Beckers Hospital Review shares highlights from the proposed rule.
  • Bloomberg Law reports,
    • “The US Department of Health and Human Services officially laid off employees on Monday, following an order from the Supreme Court on July 8 that allowed its restructuring plans to proceed, according to emails viewed by Bloomberg. 
    • “Many employees who were supposed to be released during the agency’s first round of 10,000 layoffs in April have been in limbo as the effort made its way through the court system and was paused by federal judges. The reorganization, in addition to cutting staff, was supposed to consolidate the department’s 28 divisions into 15 and cut regional offices from 10 to five.” 
  • KFF issued an analysis of the Competitiveness of Medicare Advantage Markets.
    • “The average beneficiary has access to 34 Medicare Advantage plans with prescription drug coverage in 2025, double the number available in 2018. However, recent analysis suggests that Medicare Advantage markets are highly concentrated, with only a few firms accounting for the lion’s share of enrollment.
    • “Among other key takeaways, the new analysis finds that nine in ten (90%) Medicare beneficiaries lived in a county where at least half of all Medicare Advantage enrollees were in plans sponsored by one or two insurers in 2024. Medicare Advantage markets were more concentrated in rural counties than in urban counties. Among insurers, UnitedHealthcare  or Humana had the highest enrollment in two-thirds of counties in 2024.”
  • and an analysis of the 988 Suicide & Crisis Lifeline Data on the Third Anniversary of the National Hotline.
    • “The 988 service has received 16.5 million contacts since its launch in July 2022, including 11.1 million calls, 2.9 million texts, and 2.4 million chats. Monthly contact volume has steadily increased, consistently surpassing 500,000 contacts per month over the past year and approaching or exceeding 600,000 per month since early 2025—more than double the contacts recorded just before launch (277,000 in June 2022).
    • “Most states now answer 80% or more of 988 calls in-state, a significant improvement compared to before 988’s launch. In-state answer rates in May 2025 ranged from 58% in Arkansas to 99% in Rhode Island. Calls not answered in-state are redirected to national backup centers, where counselors may be less familiar with local resources. 
    • “The overall number of suicide deaths remained stable from 2022 to 2023 (49,476 to 49,316), according to the latest data available from the CDC. Provisional CDC data suggest this stabilization may have continued into 2024 (48,796). It is too soon to fully determine the impact of 988.” 
  • The American Hospital Association (AHA) News tells us,
    • The AHA today responded to a Department of Health and Human Services request for information regarding lawful regulation and innovation to promote better health. The AHA said it agreed with HHS’ stance that reducing unnecessary administrative burden could foster improved health, and highlighted recommendations on deregulation opportunities relevant for hospitals and health systems to address chronic disease. The AHA made initial recommendations that included reducing administrative and coverage barriers to care, advancing the sustainable adoption of technology and innovation, facilitating whole-person care and sustaining the health care workforce. The AHA also shared a comprehensive list of 100 ways to free hospitals from burdensome administrative requirements and highlighted a report of programs across all 50 states to demonstrate the critical work hospitals do daily to combat chronic illness.

From the Food and Drug Administration (FDA) front,

  • From an FDA news release,
    • “Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice. It is the fourth color derived from natural sources approved by the FDA for use in foods in the last two months.”
    • * * * In addition to approving a new color additive, the FDA also announced today that it had sent a letter to manufacturers encouraging them to accelerate the phase-out of FD&C Red No. 3 in foods, including dietary supplements, sooner than the January 15, 2027, required deadline. This earlier phase-out was another of the series of measures introduced by Secretary Kennedy in April. * * *
    • “On Friday, July 11, Consumer Brands—a national trade association for manufacturers of consumer-packaged goods—announced their voluntary commitment to encourage the makers of America’s food and beverage products to remove certified Food, Drug & Cosmetic (FD&C) colors from products served in schools nationwide by the start of the 2026–2027 school year.”
  • Fierce Pharma notes,
    • “The use of SGLT2 inhibitors has been a game-changer in the treatment of heart failure (HF). Now, another drug class has reached the market that could further alter the HF landscape.
    • “The FDA has expanded the label of Bayer’s Kerendia, a nonsteroidal selective mineralocorticoid receptor antagonist (MRA), to include treatment of patients with two types of heart failure. Kerendia can now be used by HF patients with either preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF).
    • “The U.S. regulator originally approved Kerendia four years ago to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with type 2 diabetes.
    • The new nod allows Kerendia to be given to HF patients who do not have CKD linked to type 2 diabetes.

From the judicial front,

  • Federal News Network tells us,
    • “The Supreme Court is allowing President Donald Trump to put his plan to dismantle the Education Department back on track — and to go through with laying off nearly 1,400 employees.
    • “With the three liberal justices in dissent, the court on Monday paused an order from U.S. District Judge Myong Joun in Boston, who issued a preliminary injunction reversing the layoffs and calling into question the broader plan. The layoffs “will likely cripple the department,” Joun wrote. A federal appeals court refused to put the order on hold while the administration appealed.
    • “The high court action enables the administration to resume work on winding down the department, one of Trump’s biggest campaign promises.”
  • The AHA News points out,
    • “The U.S. District Court for the Eastern District of Texas July 11 vacated a rule issued by the previous administration that would have banned medical bills from appearing on credit reports and prohibited lenders from using medical information in lending decisions. U.S. District Judge Sean Jordan said in the order that the rule exceeded the authority of the Consumer Financial Protection Bureau and violates the Fair Credit Reporting Act.”
  • and
    • “The U.S. District Court for the Eastern District of Missouri July 11 granted a motion by the state to dismiss claims by AbbVie that the state’s 340B contract pharmacy law is invalid and should not be enforced. The Missouri law prohibits drug companies from denying hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. The court found that AbbVie lacked standing to bring action against the state where the injuries alleged in its complaint were attributable to the federal 340B statute — not the state law.”

From the public health and medical research front,

  • GoodRx offers insights into signs of colon cancer.
    • “Changes in stool shape or blood in stool may suggest colon cancer. But most people with colon cancer do not have symptoms.
    • “Screening for colon cancer is important whether or not you have changes in your stool. Talk with your provider about when and how you should get screened.
    • “In its early stages, colon cancer is preventable and treatable. This is why early detection through regular screening or at the first sign of symptoms is important.”
  • The American Medical News tells us what doctors wish their patients knew about “water warts.”
    • “Molluscum contagiosum, more commonly known as “water warts,” is a highly contagious skin infection caused by a poxvirus. While the condition is generally harmless, its persistent and sometimes unsightly lesions can cause anxiety and confusion for families. Becoming familiar with the signs, symptoms and best practices for preventing the spread of this surprisingly common viral skin infection is key.”
  • Per the AHA News,
    • “To help hospitals across the country improve sepsis care, the Centers for Disease Control and Prevention created the Hospital Sepsis Program Core Elements, consisting of seven strategies designed to enhance early detection and treatment. The AHA’s Living Learning Network recently visited Ochsner Health, a system at the forefront of implementing this framework, highlighting how leadership, systemwide coordination and team-based practices are improving sepsis outcomes. LEARN MORE” 
  • BioPharma Dive reports,
    • “A new kind of sleeplessness medicine developed by Takeda met its goals in late-stage testing, positioning the company to capitalize on what Wall Street analysts believe could be a multibillion-dollar market opportunity.
    • “The drug, formerly known as TAK-861 but now called oveporexton, was evaluated in two Phase 3 studies in a main type of narcolepsy. According to Takeda, oveporexton hit every main and secondary trial endpoint, helping improve patient-reported scores on measures of wakefulness, excessive daytime sleepiness, muscle weakness, and other symptoms after 12 weeks of treatment.”
  • and
    • “An experimental drug being developed by AstraZeneca significantly reduced blood pressure versus placebo in a Phase 3 study of people with either uncontrolled or treatment-resistant hypertension, the pharmaceutical firm said Monday.
    • “The reduction in mean seated systolic blood pressure associated with AstraZeneca’s drug was clinically meaningful, the company added. Called baxdrostat, the drug also met all of the study’s secondary endpoints and was “generally well tolerated.”
    • “AstraZeneca plans to share the trial data with health authorities around the world and will present detailed study findings at the European Society of Cardiology Congress next month.”
  • The Washington Post reports,
    • “Nearly a fifth of U.S. adults previously deemed “overweight” would be categorized as “obese” under a 2024 obesity classification framework, according to a new study published in Annals of Internal Medicine.
    • “Using the recent obesity framework, 18.8 percent of the adults who had previously been categorized as “overweight” now fit under the “obese” category, researchers said.
    • “Last year, the European Association for the Study of Obesity (EASO) released the framework, which incorporates fat mass’s effects on health in addition to body mass index (BMI).
    • “In the Annals of Internal Medicine study, researchers applied the framework to a representative sample of 44,030 U.S. adults ages 18 to 79, testing how the distribution of obesity compared with a traditional measure that uses BMI only.”
  • STAT New explains “how an elite rehab center is using GLP-1s to ‘obliterate’ all kinds of cravings.”
    • “In recent months, doctors at Caron Treatment Centers, an elite nonprofit rehab facility, have begun prescribing semaglutide to patients not to address obesity or diabetes but to help treat the addictions that brought them here in the first place.” * * *
    • “Caron is, without a doubt, in uncharted territory. While the medications show significant promise as addiction treatments, only a handful of clinical trials are underway to measure their ability to reduce substance use. Several are unlikely to publish results within the next two years.” 
    • “At this idyllic facility 70 miles outside Philadelphia, however, [Steve] Klein and two fellow doctors are bypassing the speculation and the slow-moving scientific enterprise. No program has so openly and aggressively touted GLP-1s as a means of treating substance use disorder. And while their operation is backed by limited clinical data, their own eyes are giving them more confidence day by day.” 
  • STAT News adds,
    • When anti-vaccine activists and others argue that the immunizations used to protect children from infectious diseases are risky, they often point to aluminum salts, a product added to many childhood vaccines to increase their effectiveness.
    • A new large study from Denmark directly counters those claims. After mining the vaccination and medical records of more than 1.2 million children over a 24-year period, researchers could see no evidence that exposure to aluminum in vaccines led to a statistically significant increase in a child’s risk of developing any of a wide variety of conditions that can be diagnosed in childhood, including asthma and autism.

From the U.S. healthcare business front,

  • MedTech Dive reports,
    • “Waters has agreed to combine with BD’s biosciences and diagnostic solutions business in a deal valued at about $17.5 billion, the companies said Monday. The combined company will continue to operate under the Waters name and retain its listing on the New York Stock Exchange.
    • “The BD business will be spun off generally tax-free to BD shareholders and simultaneously merged with a subsidiary of Waters, through a structure known as a Reverse Morris Trust. Waters CEO Udit Batra will lead the new entity, and Waters’ headquarters will remain in Milford, Massachusetts.
    • “The transaction doubles Waters’ total addressable market to about $40 billion, with an annual growth rate of 5% to 7%, according to the statement. Waters shares fell more than 11% to $313.66 in early NYSE trading on Monday, while BD shares were down about 1% at $174.12.”
  • and
    • “Zimmer Biomet said Monday that it plans to buy Monogram Technologies, an orthopedics company with a robot for knee replacement procedures, for about $177 million.
    • “Monogram’s mBôS robot received Food and Drug Administration clearance in March for total knee replacement surgeries. The system uses CT scans and AI navigation for orthopedic procedures.
    • “Monogram’s robot will be sold with Zimmer implants in early 2027, the companies said in the announcement. They expect the merger to close later this year, if approved by regulators and Monogram’s shareholders.” 
  • HR Dive informs us,
    • “Most U.S. employers are expected to maintain their salary budgets for 2026, with increases remaining flat at 3.5%, matching actual increases for 2025, according to a July 8 report from WTW, a global advisory firm.
    • “In a survey of more than 1,500 U.S. organizations, 3 in 5 said their salary budgets changed in the last pay cycle. While 53% reported no change in their anticipated and actual pay budgets for 2025, 31% projected lower salary increase budgets than last year.
    • “While top-line budgets are generally holding steady, the real shift is happening beneath the surface,” Brittany Innes, director of rewards data intelligence for WTW, said in a news release. “Organizations are being more deliberate about how they allocate pay, where they focus investment and what outcomes they expect to drive. Employers are no longer simply reacting to economic signals; they’re reimagining how to best support broader business goals despite uncertainty.”

Thursday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, SCOTUS, SDOH, U.S. Healthcare–

From Washington, DC,

  • On July 2, 2025, the U.S. Office of Personnel Management’s Inspector General issued a Flash Report titled “OPM’s Postal Service Health Benefits Program: Critical Resource Issues,” which Govexec discusses here. The FEHBlog believes and has repeatedly stated that the eligibility program for FEHB and PSHB could be vastly improved if OPM used the widely adopted HIPAA 820 Electronic Enrollment Roster Transaction. The HIPAA 820 transaction would allow carriers to promptly and systematically identify situations where no, or an incorrect, premium payments.
  • The American Hospital Association News reports,
    • Senior leaders from the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, along with White House representatives, visited pharmaceutical company Phlow Corp.’s new production system that manufactures key starting materials, active pharmaceutical ingredients and finished dose forms for 15 medicines used in the U.S. health system. Phlow laboratories and manufacturing facilities are located in the Mid-Atlantic, keeping the complete manufacturing cycle contained in one region. HHS-ASPR and Phlow have collaborated since May 2020 to bring pharmaceutical supply chains into the U.S. and reduce dependency on foreign countries. China and India, for example, account for more than 70% of APIs and KSMs imported to the United States. 
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today unveiled its groundbreaking Functional Repair of Neocortical Tissue (FRONT) program, a transformative initiative to restore brain function and position the U.S. as the global leader in brain repair technology. The FRONT program aligns directly with the priorities set by President Trump and Secretary Robert F. Kennedy, Jr., demonstrating a strong commitment to innovation, public health, and the economic well-being of the American people.
    • “Millions of Americans are living with the damage caused by strokes and traumatic brain injuries. Current treatments are not enough. ARPA-H hopes to deploy regenerative medicine to transform the treatment of neurological diseases and relieve the suffering,” said HHS Deputy Secretary Jim O’Neill.
    • ‘The neocortex, the largest part of the brain, is critical for sensory perception, motor control, and decision-making. Damage to this area—due to conditions like stroke, traumatic injury, or neurodegeneration, such as Alzheimer’s disease—has long led to irreversible damage, leaving individuals dependent on costly therapies or caregivers. The FRONT program aims to change that, using cutting-edge neurodevelopmental principles and stem cell technology to regenerate brain tissue and restore lost functions.”
  • The Brown & Brown actuarial consulting firm helpfully summarizes here the employee benefit provisions of the One Big Beautiful Act.
  • CMS announced resources and flexibilities to address the public health emergency in the State of Texas.

From the judicial front,

  • Govexec reports,
    • “The federal judge who temporarily blocked the Trump administration from implementing mass layoffs before the Supreme Court intervened has suggested she still plans to litigate the legality of individual agency workforce reduction plans. 
    • “The high court this week struck down the injunction that impacted most major agencies, allowing the administration to move forward with widespread RIFs. New layoff notices have not gone out since that decision on Tuesday, but they are expected imminently at several agencies. The court made clear, however, that its ruling applied only to the overall finding of President Trump’s capacity to order staffing cuts and not to the legality of individual agency RIF plans. 
    • “The content of those individual plans “thus remains squarely at issue in this case,” California-based U.S. District Judge Susan Illston, whose original decision led to the RIF pause, said in a new order Wednesday evening.” * * *
    • “Attorneys for the Trump administration previously noted it had 40 RIF actions underway at 17 agencies that were paused by Illston’s injunction. The federal employee unions, local governments and non-profit organizations that originally brought the lawsuit issued an “urgent request” following the Supreme Court decision asking the administration to submit those plans to the court for a decision on their legality. Illston ordered the administration to reply to that request by Monday and suggested she agreed the plans should be submitted for examination. 
    • “The administration previously argued it could not release them because they were predecisional and subject to executive privilege, but the judge on Wednesday suggested that final decisions on the RIFs must have been made if her injunction had paused them from taking effect. She added the court was “not inclined” to allow for significant redactions.” 
    • Here is a Dropbox link to the Court’s order.
  • The New York Times adds,
    • “A federal judge on Thursday blocked the Trump administration from enforcing a contentious executive order ending birthright citizenship after certifying a lawsuit as a class action, effectively the only way he could impose such a far-reaching limit after a Supreme Court ruling last month.
    • “Ruling from the bench, Judge Joseph N. Laplante of the U.S. District Court for the District of New Hampshire said his decision applied nationwide to babies who would have been subject to the executive order, which included the children of undocumented parents and those born to academics in the United States on student visas, on or after Feb. 20.
    • “The Trump administration has fought to challenge the longstanding law, laid out in the Constitution, that people born in the United States are automatically citizens, regardless of their parents’ immigration status. Judge Laplante’s order reignites a legal standoff that has been underway since the beginning of President Trump’s second term.
    • “The judge, an appointee of President George W. Bush, issued a written order formalizing the ruling on Thursday morning. He also paused his order for seven days, allowing time for an appeal.”

From the Food and Drug Administration front

  • BioPharma Dive lets us know,
    • The Food and Drug Administration on Thursday granted full approval for Moderna’s COVID-19 vaccine Spikevax in children aged 6 months through 11 years who are at an increased risk for COVID disease.
    • The shot was previously available for these individuals under emergency use authorization. The company said it expects to have an updated version of its shot available in time for the 2025-2026 respiratory disease season.
    • In May, Health and Human Services Secretary Robert F. Kennedy Jr. announced that COVID vaccines would no longer be recommended for healthy children and pregnant people. The Centers for Disease Control and Prevention currently recommends shared clinical decision-making for healthy children.

From the public health and medical research front,

  • The American Journal of Managed Care tells us,
    • “Ovarian cancer mortality rates have declined, but disparities exist across age, race, and geographic regions, with older women and non-Hispanic White women having the highest rates.
    • “Despite treatment advances, late-stage diagnosis remains a barrier due to the lack of routine screening, resulting in low survival rates for advanced-stage ovarian cancer.
    • “Geographic disparities show the Northeast with the highest mortality rates, while both metropolitan and non-metropolitan areas experienced declines, with metropolitan areas showing a steeper decline.
    • “The study’s limitations include the absence of individual-level data on lifestyle factors, tumor histology, and treatment protocols, hindering causal conclusions.”
  • Radiology Business points out,
    • “Shared decision-making visits significantly boost patients’ adherence to low-dose CT lung cancer screening, according to new research published Wednesday. 
    • “Numerous studies have explored poor uptake of LDCT, with rates as low as 18% among eligible individuals.
    • “Researchers with the American College of Radiology’s Neiman Policy Institute recently explored whether “shared decision-making” visits—required by Medicare as part of CT referrals—can boost screening adherence. They found a clear correlation, with imaging rates nearly 27% higher than those who did not meet with their primary care provider to discuss their risks and benefits of lung cancer screening, according to the study results, published in Chest. 
    • “Shared decision-making is more than just a billing requirement—it’s a valuable opportunity to engage patients in informed, personalized discussions about screening,” study author Farouk Dako, MD, MPH, associate professor of radiology, with the Perelman School of Medicine in Philadelphia, said in a July 9 announcement from the Policy Institute. “There is an opportunity to leverage this new evidence in national campaigns to raise awareness of lung screening and the importance of prioritizing SDM in routine clinical care to improve early detection and outcomes for one of the deadliest forms of cancer.” 
  • Gen Edge relates,
    • Scientists have produced the first detailed characterization of the changes that weight loss (WL) causes in human adipose tissue (AT) by analyzing hundreds of thousands of cells from morbidly obese individuals undergoing weight loss surgery. They found a range of positive effects, including clearing out damaged, aging cells and increased metabolism of harmful fats.
    • The team, headed by William R Scott, PhD, at the MRC Laboratory of Medical Sciences and at Imperial College London, analyzed gene expression in more than 170,000 cells that made up the fat tissue samples from 70 people. They generated a high-resolution single-nucleus and spatial atlas of human AT in people with extreme obesity undergoing therapeutic weight loss and in healthy lean counterparts. The investigators suggest that their findings could help scientists better understand how weight loss leads to health improvements at a molecular level, which in the future could help to inform the development of therapies for diseases such as type 2 diabetes.
    • “We’ve known for a long time that weight loss is one of the best ways to treat the complications of obesity, such as diabetes, but we haven’t fully understood why,” Scott said. “This study provides a detailed map of what may actually be driving some of these health benefits at a tissue and cellular level.”
    • “Scott and colleagues reported on the study in Nature, in a paper titled “Selective remodeling of the adipose niche in obesity and weight loss,” in which they stated, “This rich representation of human AT biology and pathophysiology offers a valuable resource for mechanistic and therapeutic exploration.”
  • The New York Times considers “Just How Harmful Is Vaping? More Evidence Is Emerging. A new study that found high levels of heavy metals in popular nicotine vapes adds to concerns about the products.”
  • Per Fierce Pharma,
    • “Pfizer and Astellas are underlining the benefits of Xtandi as part of a combination therapy for certain patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with an overall survival win.
    • “The new data come from the companies’ phase 3 Embark study, which in 2023 led to the FDA approval of Xtandi in patients with nmHSPC with biochemical recurrence (BCR) at high risk of metastasis.
    • “In the trial, Xtandi was studied as a single agent and in combination with leuprolide against placebo and leuprolide. For the trial’s primary endpoint, the Xtandi combo delivered a statistically significant improvement in metastasis-free survival compared with placebo and leuprolide.
    • “At the time, the trial’s overall survival data were mature.
    • “Now, Xtandi plus leuprolide has proved it can, in fact, extend the lives of these patients, demonstrating a “statistically significant and clinically meaningful improvement” in overall survival, Pfizer announced in a July 10 press release.”

From the U.S. healthcare business front,

  • The WTW consulting firm discusses how to strategically manage health and wellness costs in 2025.
  • Healthcare Dive reports,
    • “UnitedHealth has tapped longtime insurance executive Mike Cotton to lead its Medicaid business, filling a role that has stood empty since the company reshuffled its executive team earlier this year, the company confirmed to Healthcare Dive.
    • “Meanwhile, Bobby Hunter, who leads the healthcare juggernaut’s Medicare division, is stepping up as CEO of government programs, with oversight of both Medicare and Medicaid.”
  • Fierce Healthcare notes,
    • “Health Care Service Corporation is launching the HealthSpring brand for its Medicare products after closing the deal to acquire Cigna’s Medicare plans.
    • “Plans under the HealthSpring label were included in the deal, and HCSC said in an announcement that it refreshed the brand identity for a national rollout. The insurer will offer its first plans under the HealthSpring umbrella later this year, pending needed regulatory approvals.”
  • Fierce Biotech informs us,
    • “AbbVie is paying Ichnos Glenmark Innovation (IGI) $700 million upfront for a next-generation rival to Johnson & Johnson’s Tecvayli, positioning the Big Pharma to advance a new option for multiple myeloma patients.
    • “The deal gives AbbVie rights to ISB 2001, a trispecific antibody that targets CD38, BCMA and CD3. J&J’s Tecvayli, Pfizer’s Elrexfio and Regeneron’s Lynozyfic hit BCMA and CD3. Adding CD38 to the mix could boost binding to tumor cells with low expression of BCMA and stop cancers from becoming resistant by downregulating the antigens.
    • “AbbVie has placed a high price on that potential, coughing up $700 million for a phase 1 candidate and offering up to $1.225 billion in development regulatory, and commercial milestones. In return, IGI has granted AbbVie rights to the trispecific across North America, Europe, Japan and Greater China.”

Midweek Report

David Ermer–CDC, Congress, FDA, Medical / Rx research, Mental health care, OPM, SDOH, U.S. Healthcare–

From Washington, DC,

  • At 6:45 pm ET, the Senate confirmed by a 49-46 vote the President’s nomination of Scott Kupor to be Office of Personnel Management Director for a four-year term. The confirmation vote followed a 51-46 vote in favor of Mr. Kupor to close debate on his nomination. (Link to Govexec story) Congratulations and best wishes, Mr. Kupor.
  • Govexec tells us,
    • “President Donald Trump’s candidate to lead the Centers for Disease Control and Prevention advanced out of a Senate committee Wednesday following a party-line vote, moving her one step closer to confirmation.
    • “Susan Monarez’s nomination now goes to the floor, where she will likely secure the backing needed to officially take on the role of CDC director after garnering support from Republicans across the political spectrum during the committee’s 12-11 vote.
    • “Senate Majority Leader John Thune, R-S.D., will be in charge of scheduling that vote, though if it isn’t held during the next few weeks, Monarez will have to wait until after the chamber’s August recess.”
  • BioPharma Dive informs us,
    • “President Donald Trump is planning to introduce tariffs of 50% on copper imports and levies “at a very, very high rate, like 200%” on pharmaceutical products, he said at a cabinet meeting Tuesday.
    • “Trump indicated official announcements of the tariffs would come “very soon” but did not elaborate on an exact timeline. He did say, however, that the U.S. would give pharmaceutical importers at least a year to shift their strategies before the implementation of the levies.” * * *
    • “In a note to clients, Leerink Partners David Risinger wrote how the planned grace period is a “positive” for the sector, which has for years built up production capacity in countries like Ireland, Switzerland and the Netherlands. Many generic medicines and drug ingredients, meanwhile, are sourced from India and China.”

From the Food and Drug Administration front,

  • BioPharma Dive relates,
    • “The Food and Drug Administration has approved a modified dosing schedule for Eli Lilly’s Alzheimer’s disease drug Kisunla, permitting a smaller first dose and a more gradual increase that in clinical trials, reduced dangerous episodes of brain swelling, the company said Tuesday.
    • “That side effect, called ARIA, has made physicians reluctant to prescribe the drug and resulted in its use being blocked in some countries. The new dosing protocol will “aid healthcare professionals in evaluating appropriate treatment options for their patients,” said Brandy Matthews, Lilly’s vice president for Alzheimer’s medical affairs, in a statement.
    • “Approved in 2024, Kisunla was the third drug cleared by the FDA to slow Alzheimer’s progression by targeting toxic plaques of a protein called amyloid beta. Despite its potency, sales were only a modest $21 million in the first quarter of 2025.”
  • Mobihealth News points out,
    • “Mendaera, a robotics company, announced it has been granted FDA 510(k) clearance for Focalist, a handheld robotic system, which aims to combine handheld robotics with real-time imaging to enable clinicians to place needles with precision. 
    • “Mendaera said the system integrates robotics, ultrasound imaging and advanced software to make medical procedures more accessible. 
    • “Among Focalist’s features are touchscreen targeting, robotic needle positioning and continuous needle depth tracking, enabling a reproducible procedure experience.
    • “While needle placement is used for a variety of procedures and in a broad range of clinical settings, the initial focus of the system will be in urology. Full commercialization is expected in 2026.”
  • Per Fierce BioTech,
    • “The FDA has cleared its first cuffless blood pressure monitor that will be available over-the-counter, with the Hilo wristband developed by Aktiia. 
    • “According to the Swiss company, the wearable’s optical sensors can capture continuous blood pressure readings similar to the traditional inflated cuff with monthly calibrations, and they have demonstrated accuracy across a variety of skin tones—as well as while the user is sitting, standing or lying down. 
    • “The system previously obtained a CE Mark approval in Europe, and Aktiia said its newly 510(k)-cleared product will reach the U.S. sometime in 2026. The Hilo bracelet has also been given go-aheads in Canada, Australia and Saudi Arabia, and more than 120,000 have already been sold, the company said.
    • “This is not just a regulatory win: it’s the start of a paradigm shift in hypertension management,” Aktiia’s co-founder and chief technology officer, Josep Sola, said in a statement. “With FDA’s OTC clearance, we are breaking down the barriers that have kept cuffless blood pressure monitoring out of the hands of millions.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The US Centers for Disease Control and Prevention (CDC) today reported 21 more measles cases from the past week, pushing the year’s total above a record set in 2019 for the most cases since the disease was eliminated in the United States in 2000.
    • “So far this year, 1,288 cases have been reported from 39 states, and 88% have been part of 27 outbreaks. Among confirmed cases, 92% occurred in people who are unvaccinated or have unknown vaccination status. 
    • “Measles isn’t just striking young children and their school-age peers: about one-third of cases have been reported in those ages 20 and older. The measles surge was initially fueled by a large outbreak in West Texas that began in January, but smaller outbreaks have now been reported from multiple states, along with numerous infections in unvaccinated people who traveled abroad.
    • ‘Measles activity has increased globally, including in North America, where the virus is spreading in communities with large numbers of unvaccinated people—including Mennonite communities linked to large outbreaks in the United States, Canada, and Mexico. Canada has reported 3,703 measles cases this year, the most since it eliminated the disease in 1998.”
  • and
    • “A study of more than 70,000 US pregnancies suggests a commonly used antibiotic for urinary tract infections (UTIs) may be tied to increased risk of congenital malformations when taken during the first trimester of pregnancy.
    • “The study, published today in JAMA Network Open, found that exposure to trimethoprim-sulfamethoxazole (TMP-SMX) during the first trimester was associated with increased risk of any malformation, severe cardiac and other cardiac malformations, and cleft lip and palate compared with beta-lactam antibiotics. No increased risk of congenital malformations was observed with nitrofurantoin, which is also commonly used to treat UTIs.
    • “The study partly substantiates the concerns of the American College of Obstetricians and Gynecologists (ACOG), which has suggested that TMP-SMX and nitrofurantoin be avoided during the first trimester when possible because of uncertainty about the risk of congenital malformations, though studies to date have produced mixed results. Despite the ACOG recommendation, the two antibiotics still account for more than half of first-trimester UTI prescriptions, according to the study authors.” 
  • STAT News adds,
    • “When several countries endorsed the notion of some high-risk people taking the antibiotic doxycycline after unprotected sex to lower their chances of contracting a sexually transmitted disease, as the U.S. did last year, there was a theoretical concern the shift could drive antibiotic resistance in some bacterial infections.
    • “That risk no longer appears to be theoretical.
    • “In a newly published letter in the New England Journal of Medicine, researchers reported a steep rise in resistance to tetracycline — the antibiotic class to which doxycycline belongs — in gonorrhea isolates collected from across the country since results of the studies investigating the use of so-called doxy PEP were made public. PEP is short for post-exposure prophylaxis. 
    • “An earlier report out of the University of Washington showed a similar trend in the Pacific Northwest, as well as a rise in tetracycline resistance in other bacteria carried by people who took doxy PEP, specifically Staphylococcus aureus and group A Streptococcus.”
  • and
    • About 1 in 3 young people who are 12 to 17 years old have prediabetes, new national data show, putting them at risk not just for type 2 diabetes but also for heart disease and stroke. Developing chronic diseases early in life also heightens their chances for worse outcomes from these conditions. 
    • Experts said the data reflect a concerning rise in obesity among teens but also noted that not all teens with prediabetes will progress to diabetes.
    • “The new report from the Centers for Disease Control and Prevention relied on the long-running National Health and Nutrition Examination Survey, which asked adolescents if they’d ever been diagnosed with diabetes and analyzed results of their fasting blood glucose or hemoglobin A1c tests. Its conclusion: In 2023, an estimated 8.4 million adolescents, or 32.7% of 12- to 17-year-olds, had prediabetes.”
  • Health Day lets us know,
    • “Three-quarters of stomach cancer cases could be prevented if doctors eradicate infection by a common type of bacteria, a new study says.
    • “The bacteria, Helicobacter pylori, is linked to 76% of future stomach cancer cases, researchers reported July 7 in the journal Nature Medicine.
    • “Most stomach cancers “are caused by chronic infection with H. pylori and can be prevented by treatment of the infection with a combination of antibiotics and proton pump inhibitors,” wrote the research team led by Jin Young Park, a scientist with the International Agency for Research on Cancer in Lyon, France.” * * *
    • “About 30,300 new cases of stomach cancer will occur in the U.S. this year, and about 10,780 people will die from this type of cancer, according to the American Cancer Society. Most cases occur in seniors.” * * *
    • “In the USA, there are currently no national guidelines or formal recommendations for gastric cancer prevention, although gastric cancer disproportionately affects Asian Americans, Hispanic Americans, African Americans and American Indian-Alaska Native individuals, and an increasing trend in young individuals (age <50 years) has been observed between 2016 and 2022, most notably in women,” researchers wrote.
    • “While H. pylori infections can be easily treated, researchers said it would be best if a vaccine for the bacteria is developed.
    • “Currently, only one H. pylori vaccine has passed phase 3 of a clinical trial,” researchers noted. “More investment in future vaccine trials focusing on pediatric populations should be made, clarifying the mechanisms of vaccine-associated immunoprotection.”
  • and
    • “Uterine cancer incidence and mortality rates are projected to increase significantly through 2050, according to a study published online July 1 in Cancer Epidemiology, Biomarkers & Prevention.
    • “Jason D. Wright, M.D., from the Columbia University College of Physicians and Surgeons in New York City, and colleagues developed a natural history model for uterine cancer to project trends through 2050.
    • “The researchers reported that uterine cancer is projected to increase in incidence and mortality through 2050. Black women will experience a disproportionate rise in incidence compared with White women between 2020 and 2050 (86.9 and 74.2 per 100,000, respectively), as well as a rise in mortality (27.9 and 11.2 per 100,000, respectively). For nonendometrioid tumors, White women will experience only a slight increase, while Black women will experience a substantial increase (10.8 and 36.3 per 100,000, respectively). Hypothetical screening and intervention methods were most effective when introduced at age 55 years with declines in cancer incidence that lasted up to 15 years in White women and up to 16 years in Black women.”
  • and
    • A healthy plant-based diet might protect people from inflammatory bowel diseases, a new study says.
    • People noshing healthy plant-based foods had a 14% lower risk of Crohn’s disease and an 8% lower risk of ulcerative colitis, researchers found.
    • On the other hand, an unhealthy diet containing more animal fats and vegetable oils was associated with a 15% increased risk of Crohn’s disease, results show.
    • “Our research indicates that a healthy plant-based diet may protect against inflammatory bowel disease, with its anti-inflammatory properties playing a key role,” senior researcher Dr. Zhe Shen of the Zhejiang University School of Medicine in China said in a news release.
  • The New York Times reports,
    • “Few practices in mental health are debated more than the long-term use of antidepressant medications, which are prescribed to roughly one in nine adults in the United States, according to data from the Centers for Disease Control and Prevention.
    • “A reassessment began in 2019, when two British researchers published a study that found that 56 percent of patients suffered from withdrawal symptoms when they stopped antidepressant medications and that 46 percent of those described their symptoms as severe.
    • “The findings made headlines in Britain and had a powerful ripple effect, forcing changes to psychiatric training and prescribing guidelines. And they fed a growing grass-roots movement calling to rein in the prescription of psychotropic drugs that has, in recent months, gained new influence in the United States with the rise of Robert F. Kennedy Jr. as health secretary.
    • “A new study, published on Wednesday in the journal JAMA Psychiatry, makes the case that these warnings were overblown. The authors of the new paper found that a week after quitting antidepressants, patients reported symptoms like dizziness, nausea and vertigo, but that they remained, on average, “below the threshold for clinically significant” withdrawal.”
  • Per MedPage Today,
    • “About half of teen vapers said they had tried to quit in the past year, and about a third wanted to try quitting in the next 6 months.
    • “The most common nicotine cessation tools used in these attempts were apps.
    • “No nicotine replacement therapy is approved for youth, but the American Academy of Pediatrics recommends considering off-label use for some adolescents.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Merck will buy Verona Pharma for roughly $10 billion, adding Ohtuvayre to its cardiopulmonary pipeline and portfolio.
    • “The acquisition helps Merck prepare for the loss of patent exclusivity for Keytruda in 2028.
    • “Verona shareholders will receive $107 per share, a 23% premium to Tuesday’s closing price.”
  • Healthcare Dive notes,
    • “Health insurers are steadily expanding their control over the U.S. primary care market — especially in areas with a lot of seniors eligible for Medicare Advantage plans, according to new research.
    • “In 2023, payer-operated practices accounted for 4.2% of the national Medicare primary care market by service volume, up from 0.8% in 2016, the study published in Health Affairs Scholar found. It’s the first concrete estimate of insurer ownership of physician practices nationwide and suggests that vertical consolidation is being driven by the potential for profits in nudging MA members to owned clinics, researchers said.
    • “The paper could also intensify the microscope on UnitedHealth as lawmakers and regulators scrutinize the healthcare behemoth’s outsized control over the industry. UnitedHealth-owned Optum was the largest operator of primary care clinics of all the insurers included in the analysis, holding more than 2.7% of market share nationally and more than 35% in several large counties.”
  • Per Beckers Health IT,
    • “A recent survey from the American Medical Association found that 66% of medical providers used AI in some capacity in the past year. That represented a dramatic 78% increase from the prior year.  
    • “Usage is only going up, but many providers remain skeptical about AI. Resistance to change is understandable—particularly when AI-focused headlines often seem better described as “clickbait” than substantive. However, practices that dismiss the idea of AI-enabled workflows are missing out on valuable opportunities to measurably boost efficiency, increase patient satisfaction, and reduce costs.  
    • “When applied strategically, AI can make a real impact in day-to-day practice operations and throughout the patient journey. So, how should a practice best determine where to focus efforts when it comes to AI enablement? 
    • “First and foremost, AI adoption should be thoughtful, not frenzied,” says Dr. Sanjeev Kumar, Ph.D., chief data and analytics officer at NextGen Healthcare and a globally recognized AI expert. “An AI-driven tool should always address real need and make life easier for the humans using it.” 
  • Fierce Healthcare adds,
    • “Nabla is integrating its AI medical scribe with Navina’s AI-enabled copilot to provide doctors with an AI layer that supports clinical workflows.
    • “The aim is to deliver real-time support through the full clinical encounter, according to the companies.
    • “The integration combines Navina’s clinician copilot with Nabla’s in-visit ambient documentation, reconciling historical patient records with live patient dialogue to help improve patient outcomes and financial performance.” 
  • Per Beckers Clinical Leadership,
    • “Columbus-based Ohio State University Wexner Medical Center and James Comprehensive Cancer Center researchers found about 1% to 2% of all inpatient hospitalizations resulted in patients discharging against medical advice — and these patients led to more than $800 million in annual associated healthcare costs.
    • “The study, published June 26 in Journal of the American College of Surgeons, used the data from 1,768,752 surgical patients between 2016 and 2020 in the Nationwide Readmissions Database. All patients underwent major surgeries in various medical specialties. Researchers evaluated trends in DAMA incidence, postoperative outcomes, risk factors for DAMA and 30-day healthcare expenditures.”

Tuesday report

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

From Washington, DC,

  • The FEHBlog watched the closing of today’s Senate session. He learned that late tomorrow morning the Senate will vote to invoke cloture on the nomination of Scott Kupor to be OPM Director for a four-year term and if cloture is invoked the Senate will vote to confirm Mr. Kupor’s nomination tomorrow afternoon.
  • Govexec tells us,
    • “President Trump on Monday extended his administration’s hiring freeze of all federal civilian positions for another three months, leaving in place the moratorium into the start of fiscal 2026.
    • “The freeze, which the president initially ordered on Jan. 20, the day he took office, prevents the hiring of civilian employees at federal agencies for either vacancies or new positions. The initial executive order was set to run through April 20 and was subsequently extended until July 15.
    • “As with previous orders, the freeze exempts positions related to immigration enforcement, national security or public safety, as well as the components of the Executive Office of the President. The order also reiterated that roles will be filled to protect the “provision of Social Security, Medicare, or veterans’ benefits.” Despite the carveouts, the Defense Department continues to operate under a partial hiring freeze of its own for civilian personnel.” 
  • Per MedTech Dive,
    • “Boston Scientific said Monday it gained Food and Drug Administration approval for use of its Farapulse pulsed field ablation system in people with persistent atrial fibrillation, broadening the pool of patients eligible for the treatment.
    • “Farapulse has become a significant growth driver for Boston Scientific as physicians embrace the technology for its potential safety benefits over traditional cardiac ablation methods to treat AFib, an irregular heartbeat that increases stroke risk.
    • “The label expansion, for both the Farawave and Farawave Nav PFA catheters, was backed by evidence from the first phase of the Advantage AF clinical trial, which met its primary safety and effectiveness goals.”
  • Cardiovascular Business adds,
    • “Boston Scientific has received an expanded approval from the U.S. Food and Drug Administration (FDA) for its Farapulse Pulsed Field Ablation (PFA) System. More U.S. heart patients are now eligible to be treated with the technology than ever before.
    • “The Farapulse PFA system first gained FDA approval to treat patients with symptomatic, paroxysmal atrial fibrillation (AFib) back in January 2024. This new approval covers patients with symptomatic, persistent AFib that is resistant to drug treatment. 
    • “Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AFib treatment with safe and effective ablation technologies,” Brad Sutton, MD, chief medical officer of AFib solutions for Boston Scientific, said in a statement. “We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation.”

From the judicial front,

  • The Wall Street Journal reports,
    • “The Supreme Court on Tuesday lifted a halt on President Trump’s plan to shrink the federal workforce, clearing the way for potential mass layoffs. 
    • “In February, Trump issued an executive order aimed at drastically reducing the government’s workforce “by eliminating waste, bloat, and insularity.” The order directed heads of agencies to work with the Department of Government Efficiency on hiring decisions and developing plans for layoffs. In May, a federal judge in San Francisco blocked it from taking effect
    • “The high court, in an unsigned order on Tuesday, said it had based its decision on the legality of Trump’s executive order, and didn’t rule on whether any reorganization plans broke the law.  
    • “The Government is likely to succeed on its argument that the Executive Order and Memorandum are lawful,” the court said. 
    • “Justice Ketanji Brown Jackson dissented, accusing the court of greenlighting legally dubious actions.” * * *
    • “Justice Sonia Sotomayor on Tuesday wrote separately to concur with the court’s decision to lift the halt, noting that the plans themselves weren’t before the high court. She said the district court could still consider the legality of the layoff plans.”
       
  • Fedweek adds,
    • OPM said “hundreds of thousands” of federal employees accepted deferred resignation offers while confirming that “tens of thousands” are facing layoffs in pending RIFs.
    • OPM made that statement in the first—although not exact—accounting of the government-wide impact of those offers, and touted a reduction in the federal employee count on its FedScope site to just under 2.29 million through March, down by some 23,000 from last September.
    • “In addition, hundreds of thousands more workers will drop off the rolls in October 2025, when workers depart the federal government as part of the Deferred Resignation Program; and tens of thousands of employees who have received reduction-in-force or termination notices remain on government payrolls due to court orders that the administration is now challenging,” the OPM said prior to Tuesday’s SCOTUS decision siding with the White House.
  • Per Fierce Healthcare,
    • “Southwest Airlines is buckling up to join in on a long-running legal battle surrounding an alleged price-fixing scheme involving generic medicines in the U.S.
    • “In a 730-page lawsuit filed in federal court in Pennsylvania, the airline targets dozens of drugmakers and argues the companies “deprived the public” of the benefits of cheaper generic drugs by fixing the price of their meds since at least 2009. Among the generic defendants named are Teva Pharmaceutical Industries, Sandoz, Dr. Reddy’s Laboratories, Lupin and Apotex.
    • “The scheme cost Southwest, a large employer that self-funds its employee health plans, “hundreds of millions of dollars” and caused “substantial injury” to its business, the company claims in the recently unsealed lawsuit.” * * *
    • “American Airlines and Target are among other large employers that have sued the group of generic drugmakers. The companies filed a joint lawsuit in the same court back in April 2024, Bloomberg Law reported at the time. 
    • “The issue is also playing out in pending multi-district litigation grouping more than 20 separate lawsuits that date back to 2016. A handful of drugmakers, including Sandoz, Apotex, and Sun Pharma, have so far agreed to multi-million dollar settlements to resolve their end of the claims.” * * *
    • “Southwest, for its part, cited the federal government’s prosecution efforts in its own case. At least seven companies have admitted to criminal wrongdoing, according to the Department of Justice, and have agreed to fork over hundreds of millions of dollars in fines, civil penalties and restitution.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention July 7 announced it is streamlining H5N1 bird flu updates with its routine influenza data given the low public health risk and lack of person-to-person spread. Data on the number of people monitored and tested for bird flu will be reported monthly.
    • “Bird flu detection data in animals will no longer be reported on the CDC website; instead, it will be publicly available on the U.S. Department of Agriculture website.”
  • and
    • “A study published July 7 by JAMA found children’s health has significantly worsened from 2007 to 2023. Researchers studied changes in child mortality; chronic physical, developmental and mental health conditions; obesity; sleep health; early puberty; limitations in activity; and physical and emotional symptoms. Researchers said the findings highlight the need to identify root causes for the decline in health.”
  • Beckers Clinical Leadership lets us know eight things to know about the JAMA report on children’s health.
  • STAT News reports,
    • “Female hearts are different from male hearts, down to their cell populations and up to the thickness of their walls, making cardiovascular care far from one-size-fits-all. There’s a growing appreciation that heart attack symptoms occur on a spectrum. Women may not have the classic crushing chest pain that men do; they may feel a subtler, wider discomfort that can delay care. 
    • “There’s another potentially deadly, dramatic difference. Men are much more likely than women to suffer sudden cardiac arrest, but when female athletes do collapse on the playing field from sudden cardiac arrest, they are less likely than male athletes to be resuscitated right away, despite coaches, trainers, or teammates watching on the sidelines. That’s a disparity women share outside sports events with people of color, whose chances of receiving life-saving help from bystanders are even lower. 
    • “Across disciplines, scientists are arguing for the importance of studying sex differences throughout biomedical research. Sports medicine researchers are also bringing new attention to women, from young competitors in the spotlight to older amateurs trying to stay active.” “
  • Beckers Hospital Review points out,
    • “Mississippi had the highest mortality rate across all cancer types between 2018 and 2022, according to data published by the American Cancer Society. 
    • “The American Cancer Society used data from the North American Association of Central Cancer Registries to calculate mortality rates per 100,000 people for each state and each cancer type.
    • “Read the states with the highest cancer incidence, by type, here.”
  • and
    • “A commonly prescribed medication used to counteract lung cancer therapy side effects could be minimizing a cancer treatment’s efficacy, according to research from Los Angeles-based Keck Medicine of USC. 
    • “To evaluate how baseline steroid use can affect immune checkpoint inhibitor therapy, researchers analyzed clinical outcomes of 277 patients with non-small cell lung cancer. Corticosteroids, a frequently prescribed steroid to treat side effects common to this type of lung cancer, was associated with worse outcomes, the study found. 
    • “Among 88 patients at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., and 189 at the University of Southern California in Los Angeles who received immune checkpoint inhibitor therapy, 21 were taking steroids at the start of ICI therapy. Compared to those not taking corticosteroids, these patients experienced a higher number of negative effects. 
    • “The study, published July 7 in Cancer Research Communications, found a worse overall response rate and shorter overall survival and progression-free survival rates among lung cancer patients taking the steroid concurrent with ICI therapy. 
    • “Additionally, higher doses of corticosteroids severely affected ICI therapy and patient outcomes more than small or medium doses.”
  • Per Health Day,
    • “Some women have expressed concerns about the risk of breast cancer associated with using hormone therapy to treat symptoms of menopause like hot flashes and night sweats, and now, new research suggests that one type of hormone therapy might increase your risk if you’re younger than 55.
    • “Women in this age group who were treated with estrogen plus progestin were more likely to develop breast cancer than those not on hormone therapy, researchers report in The Lancet Oncology.
    • “On the other hand, women younger than 55 given estrogen alone, without progesterone, had a lower risk of breast cancer, results show.
    • “Hormone therapy can greatly improve the quality of life for women experiencing severe menopausal symptoms or those who have had surgeries that affect their hormone levels,” lead author Katie O’Brien, an epidemiologist with the National Institute of Environmental Health Sciences, said in a news release.”
  • Per BioPharma Dive,
    • “Biotech and pharma companies are searching for ways to “hijack” the cell’s waste disposal systems in hopes of making more effective drugs.”
  • and
    • “Glucotrack, which is developing a glucose monitor that is implanted through a minimally invasive surgery, said the small study met safety and performance goals.”

From the U.S. healthcare business front,

  • Risk and Insurance reports,
    • “Medical stop loss claims are undergoing significant shifts as cancer diagnoses remain dominant across all deductible levels while million-dollar claims have doubled in frequency over four years, driven by expensive treatments and rising disease prevalence among younger populations, according to analysis by QBE.” * * *
    • “View the full report here.”
  • Check out Adam J. Fein who writes in Drug Channels,
    • “The 2025 launch of biosimilars to Johnson & Johnson’s Stelara (ustekinumab) marks another turning point in pharmacy benefit dynamics. But unlike the chaotic rollout of Humira biosimilars, pharmacy benefit managers (PBMs) came prepared.
    • “Private label strategies, aggressive pricing, and exclusive formulary deals have transformed what might have been a slow-crawling biosimilar introduction into a full-on pricing war. As with Humira, the reality of biosimilar economics is far messier—and more revealing—than the policy narratives suggest.
    • “In this post, I examine how the major PBMs—and some of the smaller ones—are handling Stelara biosimilars, what’s changed since the Humira experience, and why their strategies reflect the growing dominance of private-label rebating schemes.”
  • Beckers Hospital Review calls attention to “18 health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2025, and considers the state of virtual nursing
    • “Virtual nursing has continued to expand since bursting onto the scene a few years ago. But has the care model lived up to its promise?
    • “Health system leaders told Becker’s that virtual nursing still has room to grow but has had positive benefits for the industry thus far.
    • “While virtual nursing has proven effective at boosting patient outcomes and satisfaction, its broader adoption faces significant barriers: high implementation costs, complex regulatory policies and the challenge of integrating new hospital workflows,” said Zafar Chaudry, MD, senior vice president and chief digital, AI and information officer of Seattle Children’s.”
  • Per Fierce Healthcare,
    • “Nearly all states saw declines in the number of acute care hospitals offering obstetric services between 2010 through 2022, with seven states seeing a quarter or more of their hospitals dropping obstetric care, according to new analysis.
    • “The shutdowns were spread across urban and rural hospitals alike, but more pronounced in the latter. Twelve states lost obstetric services among a quarter or more of their hospitals, and by 2022, there were eight states in which more than two-thirds of all rural hospitals did not offer obstetric care, researchers found.” * * *
    • “Rural hospital obstetrics closures exceeded more than 40% in Pennsylvania (46.2%), South Carolina (46.2%), West Virginia (42.9%) and Florida (40%) between 2010 and 2022. Urban hospital closure percentages were less pronounced among individual states, with Rhode Island (28.6%), Oklahoma (27.6%) and Hawaii (25%) leading the way.
    • “Three states—Delaware, Utah and Vermont—had no hospital obstetric service losses during the study window, as opposed to the seven (Iowa; Oklahoma; Pennsylvania; Rhode Island; South Carolina; Washington, D.C.; and West Virginia) that saw cuts among a quarter or more of their hospitals. Rural-urban divides were also spotted within individual states, such as New Hampshire, where 36.4% of rural hospitals lost obstetrics as opposed to zero urban hospitals.
    • “Access to obstetric care is a key determinant of health outcomes among mothers and infants, the researchers wrote. The study’s findings could be a resource for policymakers and others to craft targeted, state-level interventions addressing access disparity.”
  • and
    • “Humana’s senior-focused primary care unit is set to acquire The Villages Health, which provides care to the large Florida-based retirement community.
    • “The Villages Health filed for bankruptcy last week as it seeks to undergo a strategic restructuring designed to “preserve the business’s day-to-day operations and further enhance patient care.” Humana’s CenterWell has entered a “stalking horse” agreement to buy TVH’s assets, according to an announcement.
    • “Finalizing the sale will require a court order after an auction process that accepts additional bids. As it navigates the sale and bankruptcy proceedings, The Villages Health said it will continue to operate as normal, with the goal of averting disruptions to patient care.
    • “As CenterWell is payer-agnostic, current TVH patients are “expected” to be able to maintain the relationship with their existing providers, according to the release.”

Monday update

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The FEHBlog noticed today that the Speaker of the House of Representatives has declared this week to be a District work week for members of the House. As a result, the previously scheduled House Committee meetings have been cancelled or postponed.
  • Fierce Healthcare reports,
    • “Congress has made permanent a pandemic-era telehealth provision for millions of Americans with high-deductible health plans.
    • “In its massive tax package signed into law on July 4, Congress included a last-minute provision to allow employer-sponsored health plans to offer covered telehealth services before employees meet their deductibles.
    • “Under high deductible health plans, patients typically have to pay out of pocket for healthcare services until they meet their deductible, with an exception for preventive care services. 
    • “Now, employers will be able to offer digital healthcare services to their employees for little to no out-of-pocket cost. The telehealth safe harbor policy also allows employers to waive copays for digital health. 
    • “Congress extended the tax provision multiple times throughout the COVID-19 pandemic to allow commercially insured patients the option to receive care from anywhere. The policy was allowed to lapse at the end of 2024 when it did not make it into the end-of-year healthcare package. 
    • “The telehealth safe harbor policy in reconciliation applies to all plan years beginning after December 31, 2024.”
  • MedPage Today tells us,
    • With the CDC director’s chair still empty, HHS Secretary Robert F. Kennedy Jr. endorsed recommendations made months ago by former members of the Advisory Committee on Immunization Practices (ACIP) to expand access to respiratory syncytial virus (RSV) vaccination, as well as to add a new option for meningococcal vaccination. * * *
    • “A notice this [past] week appeared on the CDC’s website, which details the recommendations from the April ACIP meeting: “With no current CDC Director and pending confirmation of a new CDC Director this recommendation was adopted by the HHS Secretary on June 25, 2025, and is now an official recommendation of the CDC.”
    • The new RSV recommendation calls for a single dose of vaccine for adults age 50 to 59 years who are at increased risk of severe RSV disease. 
    • “The CDC also endorsed the previous ACIP members’ recommendation that GSK’s pentavalent Neisseria meningitidis (groups A, B, C, W, and Y) vaccine (Penmenvy) may be used when both the MenACWY and MenB vaccine are indicated at the same visit. That recommendation applies to healthy people ages 16 to 23 years “when shared clinical decision-making favors administration of MenB vaccine.” The recommendation also covers people age 10 years or older “who are at increased risk for meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia).” Committee members also voted to include the shot in the Vaccines for Children program.”
  • The Washington Post informs us,
    • “The Department of Veterans Affairs said Monday [July 7] that it will no longer be forced to conduct a large reduction in workforce, unlike several other federal agencies that were forced to make mass layoffs because of the Trump administration’s U.S. DOGE Service.
    • “In a news release, VA said that it was on pace to reduce its total staff by nearly 30,000 employees by the end of this fiscal year, a push that the department said eliminates the need for a “large-scale reduction-in-force.” The announcement marks a significant reversal for the Trump administration, which had planned for months to cut VA by roughly 83,000 employees, according to plans revealed in an internal memo circulated to agency staffers in March.” 
  • MedTech Dive lets us know,
    • “The U.S. plans to charge up to 70% tariffs on imports from some countries starting Aug. 1 as President Donald Trump’s 90-day pause on his country-specific reciprocal duties nears its expiration date.
    • “Starting Monday at noon EST, the U.S. will send letters detailing tariff rates for specific trading partners that have yet to reach a tariff deal with the Trump administration before the pause ends July 9, the president said Sunday. Trump told reporters Friday that the rates would range between 10% and 70%.
    • “The U.S. is specifically focused on “18 important trading relationships,” Treasury Secretary Scott Bessent said on CNN’s “State of the Union” Sunday. He also indicated that countries that do not reach deals in the next few days will return to the tariff rate Trump first outlined as part of the president’s global reciprocal tariff announcement April 2.
    • “President Trump’s going to be sending letters to some of our trading partners, saying that, if you don’t move things along, then, on August 1, you will boomerang back to your April 2 tariff level,” Bessent said.”
  • The American Hospital Association (AHA) News relates,
    • The National Institutes of Health July 3 announced that all NIH-funded research published in scientific journals must be made publicly accessible immediately upon release, accelerating a policy originally set to begin in December. Previously, many NIH-funded studies in journals were password-protected and not widely available to nonsubscribers.

From the judicial front,

  • Healthcare Dive reports,
    • “Six medical groups and a pregnant physician have sued Health and Human Services Secretary Robert F. Kennedy Jr. and his principal deputies over changes made to federal COVID-19 vaccine recommendations.
    • Filed Monday, the lawsuit argues that Kennedy’s directive, which removed guidelines recommending COVID vaccination for pregnant people and healthy children, is unlawful and “a pressing public health emergency that demands immediate legal action and correction.”
    • “The Directive is but one example of the Secretary’s agenda to dismantle the longstanding, Congressionally-authorized, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans,” the suit states.
    • “Plaintiffs include the American Academy of Pediatrics, the American Public Health Association, the Infectious Diseases Society of America and several other groups.”
    • The case is captioned American Academy of Pediatrics v. Kennedy, Case No. 1:25-cv-11916 (D. Mass.).

From the public health and medical research front,

  • Last Wednesday, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced, 
    • “Kraft Heinz Foods Company, a Newberry, S.C., establishment, is recalling approximately 367,812 pounds of fully cooked turkey bacon products that may be adulterated with Listeria monocytogenes (Lm). The turkey bacon was produced from April 24, 2025, through June 11, 2025. The following products are subject to recall [view labels]:
      • “12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548601” printed on the packaging under the barcode,”use by” dates ranging “18 JUL 2025” to “02 AUG 2025,” and lot code “RS40.”
      • “36-oz. packages containing three 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548748” printed on the packaging under the barcode, “use by” dates ranging “23 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
      • “48-oz. packages containing four 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and UPC “071871548793” printed on the packaging under the barcode and “use by” dates ranging “18 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
    • “The products subject to recall bear the USDA mark of inspection on the front of the label. These items were shipped to retail locations nationwide and some were exported to the British Virgin Islands and Hong Kong.” * * *
    • “FSIS is concerned that some products may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.”
  • Per Axios.
    • “It’s not food, it’s not chewing tobacco and it’s not gum — though it might look like it when you see it — but it is becoming America’s new addictive obsession.
    • “Sales of Zyn nicotine pouches are soaring, prompting the tobacco company that makes them to scramble to boost U.S. production to meet demand.” * * *
    • “Threat level: The product is addictive because nicotine is addictive.
      • “But it does not cause cancer since it doesn’t contain tobacco, whose harmful chemicals are carcinogenic. As a result, advocates say nicotine pouches can serve as a safer alternative to smoking.
      • “Philip Morris International U.S. CEO Stacey Kennedy argued that nicotine is “misunderstood” and contains “cognitive benefits.”
      • “You have to be able to separate out the misconceptions of what causes harm — and nicotine is probably one of the most misunderstood compounds, because many people believe that nicotine is responsible for smoking-related disease, and it’s not,” Kennedy said in an interview.
    • Yes, but: Tobacco industry watchdogs say products that contain nicotine, such as pouches and e-cigarettes, can serve as a gateway to smoking, especially for teens.
  • Per MedPage Today,
    • “Parent nudges and clinician feedback/audits boosted HPV vaccination uptake and completion.
    • “Adolescents with the most economic disadvantage, rural kids, and Black children saw the least benefit.
    • “More research is needed to tailor interventions to improve HPV vaccine uptake and completion for these groups.”
  • The American Medical Association lets us know what doctors wish their patients knew about hyperthyroidism.
  • Consumer Reports, writing in the Washington Post, points out “What to eat to protect your aging muscles. The foods you choose are as important as exercise for getting and staying strong.”
  • BioPharma Dive informs us,
    • After a delay due to “resource constraints,” the Food and Drug Administration on Monday [July 7] approved Kalvista Pharmaceuticals’ pill Ekterly to treat swelling attacks in people with the rare disorder hereditary angioedema.
    • Ekterly is the first oral drug to treat hereditary angioedema, or HAE, attacks, competing with shots like Firazyr from Takeda and Ruconest from Pharming. Analysts have estimated Ekterly, Kalvista’s first marketed drug, could bring in $600 million a year in U.S. sales at its peak.
    • The FDA delayed the decision beyond its June 17 deadline, Kalvista said, because of a “heavy workload and limited resources.” While Kalvista awaited its decision, the FDA granted approval to another HAE drug, CSL’s Andembry, a preventive shot that won’t compete directly with Ekterly.
  • STAT News reports,
    • “Apogee Therapeutics said Monday [July 7] that its experimental antibody treatment alleviated the signs and symptoms of atopic dermatitis, a common inflammatory skin condition, far more than a placebo — achieving the efficacy goals of a mid-stage clinical trial.
    • “In a side-by-side comparison, the Apogee drug, called APG777, showed similar skin-clearance rates compared to two antibody treatments already on the market: Sanofi and Regeneron’s Dupixent and Ebglyss from Eli Lilly. 
    • “APG777 was designed to be injected quarterly or twice-yearly, which, if proven in later clinical trials, would make it more convenient than the twice-monthly and monthly injections required for its competitors.” 
  • and
    • “Cogent Biosciences said Monday that its experimental drug reduced the symptoms of a chronic immune disorder called indolent systemic mastocytosis. The results mean the drug achieved the goals of a Phase 3 study, but a comparison to a rival treatment from Blueprint Medicines remains muddled. 
    • “In its study, Cogent’s drug, called bezuclastinib, showed a 24-point improvement in a patient-reported symptoms score, compared to a 15-point improvement for participants given a placebo. The nine-point difference was statistically significant. 
    • “Indolent systemic mastocytosis is the most common form of an immune system disorder that causes allergic-like skin reactions, gastrointestinal and neurological symptoms, fatigue, and generalized pain.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Molina Healthcare warned higher medical costs will hit earnings this year, adding to Wall Street worries.
    • “New legislation will shrink the number of insured, especially Medicaid, creating uncertainty for insurers.
    • “Insurers are seeing that rising mental-healthcare use and costly drugs, like weight-loss medications, increase spending.”
  • Per MedPage Today, “Obesity Drug Prices Are Dropping, but Getting a Steady Supply Remains a Challenge — Insurance coverage remains inconsistent.”
  • Beckers Hospital Review lets us know,
    • “A new study suggests that the introduction of a real-time prescription benefit tool did not lead to meaningful changes in prescription spending or medication use among Medicare Advantage beneficiaries during its first year of implementation. 
    • “The analysis, published in JAMA Network Open, examined more than 2.8 million beneficiaries and compared patients treated with access to the tool to those without it. The tool, integrated into EHRs in 2019, helps provide clinicians with real-time cost and coverage information at the point of prescribing. 
    • “Despite hopes that the tool would lower out-of-pocket costs and increase prescription adherence by guiding prescribers toward lower cost alternatives, the study found no significant difference in total prescription spending, out-of-pocket costs or number of prescription fills between the two groups.” 

Weekend update

David Ermer–Congress, FDA, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • On July 4, the President signed into law H.R. 1, the budget reconciliation act. The law’s one FEHB provision creating the FEHB Protection Act of 2025 begins on page 766 of the new law.
  • The Senate Executive Calendar for July 7, 2025, includes a Unanimous Consent Agreement that reads as follows:
    • Ordered, That at 5:30 p.m. on Tuesday, July 8, 2025, notwithstanding Rule XXII, the cloture motions filed on the following nominations ripen:
    • Preston Griffith, of Virginia, to be Under Secretary of Energy;
    • Bryan Bedford, of Indiana, to be Administrator of the Federal Aviation Administration for the term of five years;
    • Scott Kupor, of California, to be Director of the Office of Personnel Management for a term of four years; and
    • William Briggs, of Texas, to be Deputy Administrator of the Small Business Administration. (July 1, 3, 2025.).
  • Odds are that Mr. Kupor will be sworn in as OPM Director later this week.

From the judicial front,

  • Bloomberg Law reports,
    • “Among the federal appeals courts, the Fourth Circuit was the biggest loser at the US Supreme Court this term.
    • “The Richmond, Virginia-based court had the second-highest number of its rulings reviewed by the justices and they reversed everyone.
    • “The data suggests attorneys have been testing the waters to see if the liberal-leaning court could counterbalance the conservative Fifth Circuit on the right as a preferred venue for progressive causes. A 100% reversal rate at the Supreme Court, however, may make litigants rethink that strategy in certain cases.”

From the public health and medical research front,

  • The Hill reported on July 3,
    • “The Food and Drug Administration (FDA) upgraded a blueberry recall this week to the highest risk level amid concerns of contamination. 
    • “The FDA raised the recall of 400 boxes that weigh 30 pounds to Class I.
    • “The blueberry recall, which took place June 9, was initiated after Alma Pak International LLC of Alma, Ga. received a positive result of listeria monocytogenes during routine testing, according to the FDA. 
    • “FDA’s Class I classification is a “situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” 
    • “The firm shipped the blueberries to one customer in North Carolina. The number of the recall is H-0204-2025.” 
  • The Wall Street Journal informs us,
    • “Ticks! They’re summer’s most unwelcome guests and are lurking everywhere: on golf courses and hiking trails, in backyard gardens and even in city parks. 
    • “And this year appears to be especially bad: Emergency-department visits for tick bites are the highest since 2019, according to the Centers for Disease Control and Prevention tick-bite data tracker.
    • “The tick index run by Fordham University’s Louis Calder Center is currently at nine out of 10. “If you’re thinking of taking a hike, consider going to a movie instead,” the website says.” * * *
    • Use a tick key—it’s a small, cheap tool you can buy in lots of places—or fine-tipped tweezers and grasp the tick as close to the skin’s surface as possible. (In a pinch you could use a credit card.) Pull with a steady, even pressure and try not to twist or jerk the tick. You need to remove the whole tick, not just break off part of it. Also, don’t try to use a match or solvent.
    • If you find one tick, make sure to do a thorough tick check on the rest of your body. Look behind your knees, under your arms, behind your ears and around your crotch.
  • Medscape discusses “Intermittent Fasting and Type 2 Diabetes: When to Recommend and When to Avoid This Eating Plan.”

Thursday report

David Ermer–Congress, FDA, Government Contracting, Medical / Rx research, U.S. Healthcare–

Note to readers: There will be no Friday report this week due to the Fourth of July holiday. Happy Independence Day!

From Washington, DC

  • The Wall Street Journal reports,
    • “The House narrowly passed Republicans’ sprawling tax-and-spending bill, delivering a major second-term victory for President Trump and again demonstrating his power to keep GOP lawmakers in line. 
    • “The 218-214 vote Thursday sends the measure to Trump’s desk, ahead of the July 4 target he set for Congress to finish the legislation that cuts taxes, boosts border security and lowers social safety-net spending. Trump and GOP leaders muscled the bill through the House after an all-night session, despite many lawmakers’ misgivings about the version the Senate passed 51-50 earlier this week.
    • “Two Republicans—Thomas Massie of Kentucky and Brian Fitzpatrick of Pennsylvania—voted with all Democrats against the “one big, beautiful bill.” The vote followed a long day of negotiations with conservative and moderate holdouts, as Trump and Speaker Mike Johnson (R., La.) eventually swayed enough members to prevail.
    • “We’ve had spirited debates, we’ve had months of deliberations, and now we are finally ready to fulfill our promise to the American people,” Johnson said.”
  • The Akin Gump law firm offers a summary of the key tax and healthcare provisions of the One Big Beautiful bill.
  • Govexec tells us,
    • “A postal advocacy group is asking the U.S. Postal Service to pause a planned July 13 increase in the price of stamps until after the new postmaster general begins his tenure. 
    • “Keep US Posted, a nonprofit advocacy group that represents consumers, nonprofits and newspapers, among other entities, in a July 3 letter backed a freeze on mailing rates until Waste Management CEO and FedEx board member David Steiner takes the helm of USPS, which is slated for the day after stamps increase to 78 cents. 
    • “We believe it is counterproductive for another postage surge to take place immediately before you undertake leadership of the Postal Service, as it will deprive you of the ability to thoroughly assess, and potentially rectify, one of the most destructive policies in [former Postmaster General Louis] DeJoy’s Delivering for America plan,” wrote former Rep. Kevin Yoder, R-Kan., the executive director of Keep US Posted.” 
  • Bloomberg Law informs us,
    • “The Department of Labor’s federal contractor watchdog will resume action on complaints under regulations prohibiting bias against veterans and disabled workers. 
    • ‘Labor Secretary Lori Chavez-DeRemer lifted a hold on the Office of Federal Contract Compliance Programs’ enforcement work that had been in place since January, the agency said Wednesday. 
    • “The agency’s enforcement of Section 503 of the Rehabilitation Act and the Vietnam Veterans Readjustment Act were paused after President Donald Trump rescinded the decades-old executive order that gave the agency authority to police and audit race and sex bias at companies that do business with the government. 
    • “Enforcement of Section 503 and VEVRAA regulations was not upended by the Trump order since those OFCCP duties were statutorily established.
    • “Chavez-DeRemer said Section 503 and VEVRAA complaints that were held up during the period of abeyance will resume processing immediately and complaints filed during the pause will move forward normally.”
  • Per MedPage Today,
    • The FDA cleared an artificial intelligence (AI)-powered wristband (Felix NeuroAI) to treat upper-limb functional limitations in adults with essential tremor, device maker Fasikl announcedopens in a new tab or window.
    • The noninvasive, wearable peripheral nerve stimulator connects to a cloud-based AI platform and incorporates patient recordings to continuously adjust settings, allowing therapy to be personalized.
    • Essential tremor is one of the most common types of movement disorders, affecting approximately 7 million people in the U.S.

From the public health and medical research front,

  • Health Day warns,
    • “Tens of thousands of people suffer needless heart attacks and strokes every year because they aren’t taking cholesterol-lowering drugs, a new study says.
    • “More than 39,000 deaths, nearly 100,000 non-fatal heart attacks and up to 65,000 strokes in the U.S. could be prevented if people eligible for statins and other cholesterol-lowering drugs were taking them, researchers reported June 30 in the Journal of General Internal Medicine.
    • “Nearly half of Americans (47%) who’ve never had a heart attack or stroke are eligible to take statins under U.S. guidelines, researchers found.
    • But fewer than a quarter (23%) of them have been prescribed the life-saving drugs, results show.
    • “A substantial number of heart attack or stroke survivors also aren’t taking the drugs, even though all are eligible for them under U.S. guidelines, researchers said.
    • “These results add to a growing body of evidence that there are important shortcomings in the quality of care for common and costly chronic diseases such as high cholesterol, and that addressing those shortcomings would yield major public health benefits,” lead researcher Dr. Caleb Alexander, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, said in a news release.”
  • The New York Times reports,
    • “Screening can be a powerful weapon against cancer, helping catch some tumors months, or even years, before a person would feel sick enough to see a doctor.
    • “There are many different types of cancer, but the U.S. Preventive Services Task Force, a group of independent medical experts, only recommends regular screening for four types: lung, breast, colorectal and cervical. For this quartet, the task force has found that regular screening can save lives without exposing too many people to false alarms, additional testing or unnecessary treatments.
    • “Screening is on the front lines of reducing deaths from cancer,” said Robert Smith, an epidemiologist at the American Cancer Society.” * * *
    • “For some cancer types like skin, oral and bladder, there’s not enough evidence to recommend one way or another. In other cases — like ovarian, pancreatic, testicular, and thyroid cancers — the task force has found that screening people without symptoms can lead to too many false positives and complications without reducing people’s risk of death.
    • “For that reason, the task force recommends against screening older men for prostate cancer but says that men ages 55 to 69 should talk with their doctor to discuss the harms and benefits. Most prostate cancers grow so slowly that they would never be an issue, Dr. Reid said. While screening can find these tumors, it risks a cascade of unnecessary treatments and complications, such as rectal bleeding and impotence.
    • “Sometimes, the treatment is worse than having the cancer,” Dr. Reid said.”
  • and
    • “Drinking is harmful to your health at any age. But as you get older, the risks become greater — even with the same amount of drinks.
    • “Alcohol affects “virtually every organ system in the body,” including the muscles and blood vessels, digestive system, heart and brain, said Sara Jo Nixon, the director of the Center for Addiction Research & Education at the University of Florida. “It particularly impacts older adults, because there’s already some decline or impact in those areas.”
    • “There’s a whole different set” of health risk factors for older drinkers, said Paul Sacco, a professor of social work at the University of Maryland, Baltimore who studies substance use and aging. People might not realize that the drinks they used to tolerate well are now affecting their brains and bodies differently, he said.” * * *
    • “Drinking alcohol can increase the risk of developing chronic conditions like dementia, diabetes, cancer, hypertension and heart disease. But it can also worsen outcomes for the majority of older adults already living with chronic disease, said Aryn Phillips, an assistant professor of health policy and administration at the University of Illinois Chicago who studies alcohol and aging. * * *
    • “If you’re not currently drinking, don’t start,” Dr. Phillips said. And if you do drink, be honest with your doctor about your consumption, and do it in a safe environment, knowing that your tolerance may not be what it used to be, she added.
    • “The answer doesn’t have to be abstinence,” Dr. Nixon said. But healthy aging “probably does not include multiple drinks a day for most people.”
  • Gastroenterology Advisor lets us know, “Development of gallstones and metabolic disorders, including obesity, metabolic dysfunction-associated steatotic liver disease (MASLD), diabetes, and hypertension, are related, according to study results published in Journal of Digestive Diseases.”
    • “The study authors noted, “[W]e revealed a significant increase in the prevalence of gallstone disease in the United States over the past years, which was potentially linked to a rising occurrence of metabolic disorders.” However, they concluded, “Further studies are necessary to evaluate the causal relationship and the underlying mechanisms involved in these conditions.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • The [One Big Beautiful] bill reduces the power of states to boost Medicaid payments to hospitals. 
    • States have increasingly imposed taxes on hospitals to trigger Medicaid matching funds from the federal government. Hospitals would typically balk at such levies, but in this case hospitals typically get back more money than they pay out in the form of higher payment rates.
    • The megabill reduces the maximum tax rate from 6% of hospitals’ net patient revenue to 3.5% in the 40 states that have expanded Medicaid under the Affordable Care Act. Nonexpansion states will have their state “provider taxes” frozen in place at the time the bill is signed.
  • This is excerpted from a Journal article about corporate winners and losers from enactment of the One Big Beautiful bill.
  • The Journal also discusses “what Trump’s Megabill means for you. How parents, retirees, tipped workers, Medicaid recipients and more will be affected.”
  • Per Beckers Hospital Review,
    • “Hospital and health system margins have stabilized for the moment, but a variety of factors could change that in coming months.
    • “Data from Strata Decision Technology, which gathers information monthly from more than 1,600 hospitals, found health system operating margins were around 1% for the fifth consecutive month in May while hospital margins grew by less than 1%. Hospitals in the West and Midwest reported slight margin declines while hospitals in the South reported 3.6 percentage points gained in average margins; hospitals in the Northeast reported 1.3 percentage point gains.
    • “Hospital size matters as well. Hospitals with 300-499 beds reported average margin increase of 2.6 percentage points while larger hospitals of 500 beds or more reported a 2.6 percentage point average margin decrease in May. The average margin for hospitals with less than 25 beds dropped 3.3 percentage points.
    • “Gross hospital revenue grew consistently as well, but gains were offset by increased expenses. Overall expenses were up nationwide year over year, driven by higher drug costs. Average total drug expenses increased 8.7% over the last year. Month over month, drug expenses jumped 0.7% while other non-labor expenses decreased slightly.”
  • and
    • lists the 18 hospital and emergency department closures in 2025 about which Beckers has reported. Most recently,
      • “St. Louis-based St. Luke’s Des Peres Hospital, a 143-bed acute care facility, will close on Aug. 1 due to low utilization and increased financial pressures.
      • “Stilwell (Okla.) Memorial Hospital and its clinic shuttered, ABC affiliate KTUL reported June 21. An employee told the news outlet the hospital will close June 27 and the clinic will shut down 30 days later.”

Midweek report

David Ermer–CDC, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Republican leaders kept pressing the gas pedal Wednesday to get their “one big, beautiful bill” passed by this weekend, even while hundreds of billions of dollars in crucial decisions are being negotiated, key senators are holding out, and some House lawmakers are crying foul.
    • “President Trump wants the legislation on his desk by July 4, and Republicans hope the megabill’s perceived inevitability overcomes any momentary implausibility. Senators aim to start votes as soon as Friday on the legislation, which would cut taxes, reduce spending on Medicaid and nutrition assistance, and boost spending on border security and national defense. The House could send the bill to Trump early next week. 
    • “For now, there aren’t enough votes for a bill that isn’t finished yet. 
    • “It is this mysterious process of trying to be able to move specific ideas through 53 other people and trying to be able to get ideas and opinions,” said Sen. James Lankford (R., Okla.). “And where do people land? It’s a moving target.”
    • “Senators aren’t quite ready to vote, and they expect to change the legislation in the days ahead. Several senators, including Josh Hawley (R., Mo.) and Dan Sullivan (R., Alaska), said they want to be able to review the whole bill before taking the first procedural step—a vote to open debate. 
    • “Our guys are all going to keep advocating for what they want, till the final minute, till we pass it,” said Sen. John Hoeven (R., N.D.) “That’s how it works.” 
  • and
    • “Health Secretary Robert F. Kennedy Jr.’s new panel of vaccine advisers will re-evaluate the recommended schedule for vaccines for children and teenagers, including for measles and hepatitis B, its new chairman said Wednesday.
    • “The new slate of advisers met for the first time Wednesday in Atlanta, kicking off a two-day meeting with an agenda partially set by political appointees. Meanwhile, on Capitol Hill, the nominee to lead the Centers for Disease Control and Prevention, Susan Monarez, told senators she believes vaccines save lives and there is no causal link between vaccines and autism.” * * *
    • “Monarez, if confirmed, would have the power to decide whether or not to adopt ACIP recommendations. Asked if she agreed with Kennedy’s decision to remove all members of the previous committee, Monarez responded “that the secretary had to make a decision related to ensuring that the ACIP could be supportive of restoring public trust in decision-making.”
    • “The vaccine advisory panel is set Thursday to hear a presentation on thimerosal, a preservative that antivaccine activists have often blamed for autism, from Lyn Redwood, a nurse practitioner who is president emerita of Children’s Health Defense, an antivaccine nonprofit previously helmed by Kennedy. Antivaccine activists have long claimed that thimerosal causes autism. Rates of the disorder have continued to climb even after thimerosal was removed from most vaccines in the early 2000s.”
  • Beckers Health IT tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. says he wants every American using a wearable health device within four years, Politico reported June 24.
    • “Speaking during a June 24 hearing of the House Energy and Commerce Health Subcommittee, Mr. Kennedy said the department is preparing “one of the biggest advertising campaigns in HHS history” to promote wearable technology.
    • “The devices are central to Mr. Kennedy’s “Make America Healthy Again” initiative. He told lawmakers that wearables give people a way to “take control of their own health.”
  • Govexec fills us in on what happened at yesterday’s House Oversight and Government Reform Subcommittee on Government Operations hearing titled “The Route Forward for the U.S. Postal Service: A View from Stakeholders.”
  • The American Hospital Association News informs us,
    • “The Administration for Strategic Preparedness and Response June 25 announced it conducted an exercise transporting simulated patients with high-consequence infectious diseases in a new portable biocontainment unit from Toronto to U.S. hospitals in the northeast and southeast. The hospitals are all Regional Emerging Special Pathogen Treatment Centers for highly infectious diseases. ASPR said the biocontainment unit is the first domestic resource for isolating and transporting patients with high-consequence infectious diseases, such as Ebola, across long distances to RESPTCs. The unit can be transported by air or by ground.”
  • CMS called attention to its Medicare website explaining how to get medical assistance in a disaster or emergency.

From the state and local government front,

  • Politico lets us know,
    • New York City Mayor Eric Adams announced [June 22] he will not move forward with a contentious effort to cut costs by shifting retired city workers to a Medicare Advantage plan, bringing a sudden end to a four-year saga.
    • “We have heard concerns from retirees about these potential changes at numerous older adult town halls and public events, and our administration remains focused on ensuring that New York City remains an affordable place to live,” Adams said in a statement Friday.
    • Just two days earlier, the state Court of Appeals ruled in City Hall’s favor in a lawsuit over the Medicare Advantage transition, handing Adams a rare win in the long legal battle to implement a plan he inherited from former Mayor Bill de Blasio.

From the Food and Drug Administration front,

  • STAT News reports,
    • Outgoing Food and Drug Administration regulator Jacqueline Corrigan-Curay acknowledged to staff [June 24] that much is still in flux at the agency, weeks before she retires.
    • “We are leaner and therefore we have to find ways to be efficient and do things in new ways,” she told staff, according to a recording of a town hall meeting obtained by STAT. 
    • She did not say who will be the next leader of the Center for Drug Evaluation and Research once she retires next month. Her retirement is the latest in a series of departures of senior officials at the FDA, who have either chosen to take early retirements, left for other jobs, or been forced out by political appointees.
    • “CDER has filled one leadership position, though. At the meeting, Corrigan-Curay introduced staff to the new deputy director of CDER, Mike Davis. Davis, a psychiatrist and pharmacologist, was most recently chief medical officer at the Usona Institute, a nonprofit organization developing psychedelic drugs for the treatment of depression and PTSD. He previously spent six years at the FDA as a clinical team leader in the psychiatry division.” 
  • Per BioPharma Dive,
    • “The Food and Drug Administration is investigating two deaths among [over 900] patients treated with Sarepta Therapeutics’ gene therapy Elevidys for Duchenne muscular dystrophy. Both patients died this year of acute liver failure after receiving Elevidys, with the second case reported earlier this month. The FDA said their deaths appear to be related to treatment and that it will evaluate “the need for further regulatory action.”
  • Per MedPage Today,
    • “The FDA said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.
    • “Myocarditis, a type of heart inflammation that is usually mild, emerged as a complication after the first shots became widely available in 2021. Prescribing information from both Pfizer and Moderna already advises doctors about the issue.
    • “In April, the FDA sent letters to both drugmakers asking them to update and expand the warnings to add more detail about the problem and to cover a larger group of patients. While the FDA can mandate label changes, the process is often more of a negotiation with companies.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “A study published June 25 by the Journal of the American Heart Association found that heart disease death rates fell 66% from 1970 to 2022. Deaths from heart attacks decreased 89% in that time span. The study attributed the declines to advancements in intervention and prevention efforts. Meanwhile, deaths from other types of heart disease, including arrhythmia, heart failure and hypertensive heart disease, increased by 81% during the same period. The study said the rising prevalence of obesity, diabetes, hypertension and physical inactivity have contributed to those causes.”
  • Cardiovascular Business adds,
    • “A team of surgeons with Baylor St. Luke’s Medical Center in Houston has made history, performing what is believed to be the first fully robotic heart transplant in the United States. 
    • “The procedure occurred in March 2025. Kenneth K. Liao, MD, PhD, chief of cardiothoracic transplantation and circulatory support at Baylor College of Medicine and chief of cardiothoracic transplantation and mechanical circulatory support at Baylor St. Luke’s Medical Center, and colleagues completed the transplant using an advanced Da Vinci surgical system. 
    • “The patient’s chest did not need to be opened all for the procedure—everything was done through small incisions.
    • “Opening the chest and spreading the breastbone can affect wound healing and delay rehabilitation and prolong the patient’s recovery, especially in heart transplant patients who take immunosuppressants,” Liao explained in a statement. “With the robotic approach, we preserve the integrity of the chest wall, which reduces the risk of infection and helps with early mobility, respiratory function and overall recovery.”
    • “The patient in question was a 45-year-old male who had been hospitalized with advanced heart failure for four months. He was discharged after being observed in the hospital for a month. There have been no complications.”
  • Per Medscape,
    • “The investigational non-peptide small-molecule oral GLP-1 agonist orforglipron significantly reduced A1c over 40 weeks in adults with early type 2 diabetes, according to the results of ACHIEVE-1 sponsored by Eli Lilly. 
    • “In the trial, orforglipron reduced A1c to the 6.5% range and produced clinically meaningful weight loss with a safety profile similar to that of other GLP-1 drugs. ACHIEVE-1 is the first of seven phase 3 studies of the safety and efficacy of the drug in over 6000 patients with type 2 diabetes and obesity,
    • “Orforglipron and other similar non-peptide small molecules “have the potential to be widely accepted as a much earlier therapy for type 2 diabetes,” Julio Rosenstock, MD, senior scientific advisor for Velocity Clinical Research and clinical professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said at a press briefing here at the American Diabetes Association (ADA) 85th Scientific Sessions. The findings were simultaneously published in the New England Journal of Medicine.”
  • STAT New relates,
    • “A study tracking nearly 250,000 Swedish people using ADHD medication for 14 years found that these treatments can reduce risks of traffic crashes, injuries, and criminal behavior — and that conclusion remained true even as more girls, women, and adult men received a diagnosis.
    • “I wish we had access to this kind of data for the U.S.,” said Ryan Sultan, who was not part of the study and is a psychiatrist and professor at Columbia University Irving Medical Center where he specializes in ADHD. “Being able to follow them from birth means that their data is really, really powerful.”
    • “The study arrives as providers in the United States contend with twin realities: ADHD medication prescriptions are skyrocketing — largely thanks to telehealthand diminishing stigma — while medication shortages are imperiling people’s access to these critical treatments. Scientists are also learning more about how the condition interacts with other variables, such as how menstrual periods can affect symptoms and treatment. 
    • “We’re in a moment in U.S. society where … everyone and their grandmother are asking whether they have ADHD or not,” said Sultan. “It’s really interesting to be thinking about, when we’re expanding [access], who are we actually expanding it to, and who are we actually treating?”
  • Medical Economics points out,
    • “According to Dexcom’s 2025 State of Type 2 Report, most U.S. physicians now consider continuous glucose monitoring (CGM) one of the most impactful interventions for managing type 2 diabetes, surpassing even medications and lifestyle counseling in future importance.
    • “The findings are based on a national survey of 310 adults with type 2 diabetes and 111 U.S. health care professionals (HCPs), including primary care physicians, nurse educators and diabetes specialists.
    • “CGM adoption remains relatively low among patients — just 16% of U.S. adults with type 2 diabetes currently use the technology — but satisfaction among users is high. The vast majority report improved quality of life, reduced stress and better engagement with their glucose data. Physicians, meanwhile, see CGM as a key solution to longstanding pain points, including poor adherence, low health literacy and difficulty tracking glucose fluctuations outside clinic visits.
    • “The report highlights a disconnect between CGM’s perceived value and its real-world accessibility. Most patients cite cost or insurance coverage as the top reason for not trying it. Most physicians say they lack the tools to educate patients on its benefits. And nearly three-quarters of people with type 2 diabetes say they need better understanding of how diabetes technology can help them manage their condition.”
  • Per the American Journal of Managed Care,
    • The use of pre-exposure prophylaxis (PrEP) for prevention of HIV has helped to curb the spread of the virus nationally. Knowing how much PrEP is needed in certain areas can help to more specifically target vulnerable populations who need it more.
    • A model was developed that could estimate the need for PrEP, according to a study published in Annals of Epidemiology. Public health authorities can use this information to monitor progress and establish resource allocation.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “U.S. households, businesses and governments will spend $8.6 trillion on healthcare in 2033, when the sector will comprise just over one-fifth of gross domestic product, according to a federal report issued Wednesday.
    • “The Centers for Medicare and Medicaid Services Office of the Actuary attributes its forecast to factors such as a rapidly aging population and high demand for healthcare. The independent CMS division published its analysis in the journal Health Affairs.
    • “National health expenditures will increase 5.8% a year on average from 2024 to 2033, the actuaries predict. The healthcare spending trend is expected to continue outpacing economic growth, which the office projects will average 4.3% annually over the coming decade.”
  • Fierce Healthcare adds,
    • “In an uncertain policy and macroeconomic environment, healthcare finance leaders are concerned about what the future holds, a new report showed.
    • “Analysts at Deloitte surveyed 64 finance leaders, split evenly between executives from health systems and insurers, to capture what they view as the biggest challenges and opportunities coming down the pike. Most (84%) of those surveyed said they are worried about business conditions given the cloudy policy outlook, economic concerns and potential disruptions from tariffs and the supply chain.
    • “Over the past several years, workforce challenges, cost reductions and cybersecurity have all been top concerns for finance leaders in healthcare. However, this year’s survey found external factors taking on a much greater role.”
    • “Internal concerns like workforce challenges, cost reduction, and cybersecurity—once top priorities for healthcare chief financial officers in our previous surveys—seem to have become less urgent amid rising external factors, according to survey respondents,” the researchers said.”
  • Per a press release,
    • “Optum is accelerating the adoption of artificial intelligence (AI) for health care technology companies, providers and payers with the launch of the Optum AI Marketplace. The new marketplace is the only health care-specific AI digital platform of its kind, built by health care developers to simplify AI integration across clinical and administrative systems.
    • “Many emerging health care organizations want to modernize their systems but don’t have the time, resources, or infrastructure to build AI solutions on their own. The new marketplace addresses these gaps by offering a centralized, health care-specific ecosystem of curated solutions and APIs that are ready to implement, helping organizations streamline operations, reduce integration costs, and scale AI adoption.
    • “Optum brings decades of health care expertise and advanced data infrastructure to the AI Marketplace. This foundation ensures the platform is built for real-world health care needs and supports faster, more effective AI and API implementation. With more than 1.4 billion API transactions each year, the marketplace powers real-time insights and seamless integrations across the health care landscape.” * * *
    • Discover more at Optum AI Marketplace.
  • Per Beckers Hospital Review,
    • Overall demand for healthcare services is poised to continue its significant growth across various service lines over the next decade, with outpatient care expected to experience the highest growth rate and inpatient services seeing more moderate increases, according to Sg2’s 2025 Impact of Change Forecast published in June.
    • Sg2’s forecasting model integrates a broad range of factors, including national data, institutional data, and market trends. National population changes, epidemiological shifts, economic influences, policy developments and advances in technology were considered in the projections.
    • Sg2 used data from the HCUP National Inpatient Sample and CMS Limited Data Sets, alongside its own analysis of healthcare usage trends.
  • Per Beckers Payer Issues,
    • “Medicare Advantage enrollees experience longer hospital stays before being discharged to post-acute care settings compared to individuals enrolled in traditional Medicare, according to a June 2025 analysis by NORC at the University of Chicago.
    • “The analysis was commissioned by the Coalition to Strengthen America’s Healthcare, a group of more than 5,000 hospitals, businesses and hospital associations that includes the AHA and FAH. 
    • “The researchers found that while hospital discharges overall declined over the five-year study period, discharges to post-acute settings increased for MA enrollees and decreased slightly for traditional Medicare enrollees. At the same time, MA enrollees had longer hospital stays prior to post-acute discharge, with the gap widening over time.
    • “While the data is age-adjusted, the study did not control for clinical or demographic differences that could affect length of stay or discharge destination. Future research is recommended using tools like HCC risk scores and claims-based frailty index to better isolate coverage-related effects.”

Tuesday report

David Ermer–ACA, AHRQ, CMS, Congress, FDA, Medical / Rx research, NIH, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump is urging Republicans to get their “one big, beautiful bill” to his desk by July 4. That’s just a week from Friday, and lawmakers still face a series of hurdles and headaches on issues ranging from artificial intelligence to deficit spending to rural hospitals.
    • “Senate GOP leaders are revising their version in advance of potential votes later this week, searching for a mix that can garner a majority in the chamber, which is divided 53-47. Anything that gets through the Senate must pass the House, which is divided 220-212 in Republicans’ favor; any subsequent House changes would require another Senate vote. Lawmakers are scheduled to leave Washington for a recess next week but signaled they were prepared to stay to finish the bill.”
  • The American Hospital Association News tells us,
    • “Secretary of Health and Human Services Robert F. Kennedy Jr. today appeared before the House Energy and Commerce Subcommittee on Health for a hearing to testify on the HHS fiscal year 2026 budget proposal, which requests $94.7 billion.”  
  • Modern Healthcare informs us,
    • Prescription drug middlemen should end the complicated system of drug rebates before the government steps in to change it, Medicare and Medicaid chief Mehmet Oz said Tuesday.
    • The remarks signal the Trump administration may revive attempts to eliminate the payments drugmakers send to pharmacy benefit managers after prescriptions are filled. In his first term in 2019, President Donald Trump considered regulations that would have eliminated that system, but officials abandoned them before they went into effect.
    • “There’s a possibility that we have a window now where the three big PBMs might actually consider doing away with the rebate-slash-kickback system,” Oz told a meeting hosted by Transparency-Rx, a coalition of smaller PBMs committed to more open pricing. The three largest companies in the industry, CVS Health Corp., UnitedHealth Group and Cigna Group, handle about 80% of US prescriptions.” * * *
    • “Oz met with large insurers about separate issues on Monday. The insurers voluntarily committed to reduce the use of preapprovals for medical care, and Oz said that there could be an opportunity for insurers to take similar voluntary action to change how they pay for medicines.”
  • Healthcare Dive also discusses the CMS Administrator’s presentation at this meeting with a focus on drug price transparency.
  • Federal News Network lets us know,
    • “Rep. Robert Garcia was elected the top Democrat on the powerful House Oversight Committee on Tuesday, charting a new direction for the party’s opposition to congressional Republicans and President Donald Trump’s administration.
    • “Garcia, of California, won the job overwhelmingly in a closed-door vote of the House Democratic caucus. He beat out Rep. Stephen Lynch of Massachusetts, 150-63.”
  • Fierce Healthcare summarizes the public comments submitted in response to the May 13, 2025, CMS and National Coordinator of Health IT RFI “on how to ease data exchange among the healthcare ecosystem for patients, providers, payers, vendors and value-based care organizations.”
  • Fierce Healthcare also points out,
    • “While major provider organizations welcomed insurers’ pledge earlier this week to reform prior authorization, these groups withheld praise without yet seeing the efforts bear fruit.
    • “Bobby Mukkamala, M.D., president of the American Medical Association, said in a statement that patients and physicians both will need to see the promises made yield significant results to ease the headaches around prior auth.
    • “Mukkamala said that many of the elements of Monday’s pledge echo a 2018 consensus statement from major payer and provider organizations, such as reducing the number of required prior authorizations, preserving the continuity of care for the patient and expanding automation.
    • “He said the AMA will “closely monitor” the rollout of the prior authorization changes and continue to work with regulators and legislators on this issue.”
  • The U.S. Preventive Services Task Force today gave a Grade B to “screening women of reproductive age, including those who are pregnant and postpartum for intimate partner violence.” The USPSTF also “concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for caregiver abuse and neglect in older or vulnerable adults [Grade I]. Both grades are consistent with the conclusions that the USPSTF reached in 2018 following a similar analysis.
  • MedPage Today adds,
    • “Expanding eligibility criteria for lung cancer screening to include 20-year smoking history without requiring a certain number of pack-years yielded a relative 28% increase in the number recommended for screening.
    • “The number of lung cancers identified would have increased by a relative 17%.
    • “The increase in detection was particularly seen among women and Black persons, groups with under-detection by current criteria.”
  • Per PR Newswire,
    • “More than 1.3 million women in the U.S. enter menopause every year. Menopause affects every woman—but not every woman gets the care, clarity, and support she deserves. A new national program, “Menopause for All,” intends to change that and will launch in Baltimore, MD and Washington, D.C., on June 28th and 29th, respectively.
    • “The National Menopause Foundation, a leading patient advocacy organization dedicated to empowering women with the knowledge and resources they need to navigate menopause through igniting community and harnessing science, has teamed up with Perry, a pioneering digital health platform transforming perimenopause care through expert-led community support, evidence-based education, and training of health care professionals. Together, they believe menopause care should be local, personal, and accessible.
    • From trusted medical professionals and wellness experts to culturally sensitive support groups, the Menopause for All program will help women and their families connect with resources in their own local communities—because navigating menopause shouldn’t be done alone or in the dark.
    • Menopause for All events are free and open to the public, but space is limited. On Saturday, June 28, 2025, the event will be held at Enoch Pratt Free Library, 400 Cathedral Street in Baltimore, MD from 1:30-4:30 p.m. On Sunday, June 29, 2025, the event will be held at the Hill Center at the Old Navy Hospital, 921 Pennsylvania Avenue, SE Washington, D.C., from 2:30-5:30 p.m.
    • “Our expert-led sessions will provide women with practical, scientifically-backed guidance and real solutions ensuring every woman has the care and support she deserves,” added Claire Gill, founder and President of NMF. “We’re grateful to our presenting sponsor [and FEHB, PSHB and FEDVIP carrier] Government Employees Health Association (G.E.H.A) and supporting sponsor Clearblue for their commitment to advancing women’s midlife health.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “The FDA has blessed AstraZeneca and Daiichi Sankyo’s Datroway to treat patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). The accelerated nod—which could hinge upon verification of clinical benefit in a confirmatory trial—applies to patients who have received prior EFGR-related treatment and platinum-based chemotherapy.
    • “The label expansion comes five months after Datroway secured its first FDA nod, for patients with previously treated metastatic, HR-positive, HER2-negative breast cancer. With the nod, Datroway becomes the first TROP2-directed therapy in the U.S. for NSCLC.
    • “Addressing disease progression in patients with advanced EGFR-mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options available,” Jacob Sands, M.D., of the Dana-Farber Cancer Institute and an investigator in two trials that paved the way for the latest approval, said in a June 23 press release.”
  • STAT News relates,
    • “A sutureless device for peripheral nerve repair could be available on the market in the coming months.
    • “The Food and Drug Administration has authorized a polymer-based device developed by medical technology company Tissium. The authorization, announced Tuesday, will give physicians a new method for treating peripheral nerve injuries.
    • “This approval is really a game-changer for patients with peripheral nerve injuries,” said Jeffrey Karp, a Tissium co-founder who developed the device’s technology. “For the first time, surgeons now have a sutureless, bio-inspired option that can really simplify the procedure while improving outcomes.”
  • Per Cardiovascular Business,
    • “The U.S. Food and Drug Administration (FDA) has announced an expansion of an earlier Medtronic recall, now issuing a new Class 1 recall for Medline Industries’ procedure kits that contain Medtronic aortic root cannulas. The recalls indicate that there may be excess material in the male luer, which could potentially lead to serious adverse events, including procedure delays, neurological deficits, strokes, or even death.”
  • Per Health Exec,
    • “In what is being referred to as a recall, the U.S. Food and Drug Administration (FDA) released a notice on behalf of GE HealthCare for a line of its Carestations due to a risk the ventilation systems may not work properly. Despite the serious risk of death or injury caused by inadequate respiration, the problem has been isolated and can be fixed with updated use instructions. 
    • “Although no devices have been removed from care settings, this recall has been designated a Class I by the FDA, reserved for the most serious issues. Luckily, no injuries or deaths have been reported. 
    • “The systems are typically used to aid with anesthesia in patients of all ages. They can be found in many hospitals and surgery centers across the country.” 

From the public health and medical research front,

  • MedPage Today tells us,
    • “Over the last two decades, U.S. neonatal mortality has generally declined, though not all leading causes of death followed this trend.
    • “There were 283,696 neonatal deaths from perinatal complications, with the top leading causes being disorders related to short gestation and low birth weight; maternal complications of pregnancy; and complications of placenta, cord, and membranes.
    • “Mortality due to slow fetal growth and fetal malnutrition increased annually, and mortality from maternal complications and bacterial sepsis of the newborn remained stable.”
  • Per Endocrinology Advisor,
    • “Individuals with celiac disease or thyroid disease have a significantly increased risk of developing type 1 diabetes (T1D), according to study findings published in Diabetes, Obesity and Metabolism.”
  • Per Pulmonology Advisor,
    • “Obstructive sleep apnea (OSA) is highly prevalent in those age 50 years and older, but manifests differently by race/ethnicity and sex, with the most rapid-eye-movement (REM) sleep respiratory events in Black women and the highest oxygen saturation (SpO2) levels in Mexican American women. These were among study findings published in the Annals of the American Thoracic Society.”
  • BioPharma Dive lets us know,
    • “A targeted lung cancer drug from Nuvalent led to tumor responses in about half of people who previously received at least one therapy like it, and 44% of those who had received at least two similar medicines, according to results from a clinical trial the company shared Tuesday.
    • “The study of Nuvalent’s drug, zidesamtinib, involves people whose metastatic non-small lung cancer has alterations in the gene ROS1. In addition to past treatment with so-called tyrosine kinase inhibitors, some participants had also received chemotherapy beforehand. Nuvalent will use the data to support a U.S. approval application for these “pre-treated” patients, which it expects to complete in the third quarter.
    • ‘Nuvalent is also studying zidesamtinib in ROS1-positive lung cancer patients who haven’t yet been treated and is discussing with the Food and Drug Administration the possibility of a “line-agnostic expansion” for the drug. A similar medicine from Nuvation Bio was approved this month for patients regardless of whether they’d previously been given a tyrosine kinase inhibitor.”
  • Per Healio,
    • “COPD mortality rates varied across North Carolina, often correlating with access to care and other risk factors, according to a pair of posters presented at the American Thoracic Society International Conference.
    • “What we’re looking at is your risk of COPD mortality based on your ZIP code,” Alexa M. Zajecka, MD, a first-year pulmonary critical care fellow at East Carolina University Medical Center, told Healio.”
    • “The researchers noted that although COPD is a leading cause of mortality and that North Carolina has one of the highest COPD-related death rates in the United States, there has been little research into its spatial clustering at the local level.” 
  • Gen Edge reports,
    • Amyotrophic lateral sclerosis (ALS) remains one of the most devastating and biologically elusive neurodegenerative diseases. Despite decades of research, its underlying mechanisms are still not fully understood. The condition presents a complex and highly variable interplay of genetic mutations, environmental factors, and cellular dysfunctions that differ widely across patients. This heterogeneity has slowed the development of effective diagnostics and therapeutics, leaving researchers to chase a moving target across a fragmented molecular landscape.
    • Yet much of ALS research still relies on static models—snapshots of a disease in motion. The condition unfolds dynamically, impacting multiple neural and non-neural cell types in real time. Capturing that progression requires lifelike systems that can replicate ALS as it unfolds in the human body. Without that, critical windows for intervention may remain hidden in plain sight.
    • “In a new study published in Cell Stem Cell titled, “An organ-chip model of sporadic ALS using iPSC-derived spinal cord motor neurons and an integrated blood-brain-like barrier,” researchers at Cedars-Sinai have developed a dynamic ALS model using patient-derived stem cells. This system may help uncover both the causes of ALS and new therapeutic targets.”
  • Per an NIH Intramural Research Program release,
    • It seems like every news report touting the health benefits of a daily glass of wine is soon followed by another that claims consuming any amount of alcohol harms health. While the jury is still out on this issue for younger individuals, a recent IRP study suggests that alcohol consumption may accelerate the typical age-related erosion of the cardiovascular system

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “It is becoming more difficult for insured and uninsured Americans to access affordable healthcare services, according to a new report from S&P Global Ratings.
    • “The United States spends more on healthcare services than any other country by any metric, according to the report. As of 2023, an individual could expect average out-of-pocket annual healthcare costs to run them an average of $6,159 annually and ancillary costs to account for approximately 6% of their average annual income before taxes.
    • “Efforts to rein in healthcare spending thus far have been mixed, and recent cost pressures could cause costs to climb further still, according to the report. Should headwinds continue, providers may be forced to make tough choices about what services they offer and where.”
  • and
    • “Ascension CEO Joseph Impicciche will retire at the end of the year, the nonprofit health system announced Tuesday.
    • “The health system’s board of directors has appointed President Eduardo Conrado to succeed Impicciche, effective Jan. 1, 2026.
    • “Ascension said it has been preparing for Impicciche’s departure for some time, adding the executive will be “actively engaged” in Conrado’s transition.”
  • Per BioPharma Dive,
    • “Perceptive Xontogeny Venture Funds and venBio Partners are contributing up to $40 million to a spinout of genetic medicine maker Lexeo Therapeutics to that will aim to advance drugs for heart conditions.
    • “The new biotech will focus on RNA-based medicines for genetically mediated cardiac conditions using a non-viral delivery method, according to a Tuesday announcement from Lexeo.
    • “Under the agreement, Lexeo will hold double-digit percentage equity in the new company, and could receive future milestone payments, royalties and opt-in rights to its programs.”
  • MedCity News informs us,
    • “Cohere Health, a clinical intelligence company, launched a new solution called Review Assist, which speeds up medical necessity reviews for health plans, the company announced on Monday.
    • “Boston-based Cohere Health provides AI-powered prior authorization solutions to help improve the relationship between payers and providers. The new tool is meant to help health plan clinical staff with prior authorization reviews, which are often extremely burdensome, according to the company. The typical process requires reviewers to analyze hundreds of pages of clinical records in order to determine if a patient procedure is medically necessary.
    • “Review Assist operates within existing utilization management workflows. It uses Cohere’s AI and large language models to analyze unstructured and structured clinical data and provide actionable insights for reviewers, as well as links to its source for this information. In addition, it has an AI chatbot that can answer questions for the reviewer and find additional insights.”
  • and describes Cigna Healthcare’s six new digital tools to improve the customer experience.
  • Per Beckers Health IT,
    • “Amazon One Medical and Edison, N.J.-based Hackensack Meridian Health continue to open clinics across New Jersey to expand access to primary care.
    • “The two organizations joined forces in 2023 to co-open the offices and make Hackensack a specialty care referral partner of Amazon One Medical.
    • “We hope to have 20 or maybe even more of these types of centers,” Hackensack CEO Robert Garrett said at a ribbon-cutting of the latest clinic June 17 covered by NJBiz. “It’s so well-needed. We’re going to be looking at different locations throughout the state of New Jersey in terms of where we think there’s a need for greater access to care.”
  • Modern Healthcare reports,
    • Current Health cofounder Chris McGhee has reacquired the at-home care company from Best Buy Co.
    • Financial details of the transaction were not disclosed.
    • “McGhee is returning as Current’s CEO. Former Chief Technology Officer Stewart Whiting and other former team members are also returning, according to a Tuesday announcement on the company’s website.”