Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Federal News Network reports
    • “Federal retirement processing times are slowing down. During June, it took the Office of Personnel Management an average of 108 days to process a retirement claim, according to the agency’s latest data release. Processing times for digital-only applications averaged 96 days. That’s a full 30 days longer than the previous month’s average. But at the same time, OPM’s retirement claim inventory in June was the lowest it’s been all year, coming in at just under 34,000 pending applications. OPM received close to 9,000 new claims last month and processed nearly 13,000.(June 2026 retirement processing statistics – Office of Personnel Management)
  • FEHBlog observation: It’s hardly surprising that a slow down occurred during last month’s big processing system change.
  • Federal News Network adds
    • “There’s room for improvement in the Office of Personnel Management’s efforts to prevent improper retirement payments. OPM’s use of manual processes and delays in payment suspensions are hampering the ability to mitigate improper retirement payments. A recent report from OPM’s inspector general office recommends that the agency tighten its timeline and transition to digital tools to help identify and prevent overpayments or underpayments to federal retirees. Officials in OPM’s retirement services division say discussions are ongoing to automate various surveys and projects associated with improper payment prevention.(Evaluation of OPM Retirement Services’ efforts to identify and prevent improper payments – OPM Office of Inspector General)”
  • The American Hospital Asssociation News relates,
    • “The Health Resources and Services Administration has announced new funding available to healthcare providers in rural areas through the Small Health Care Provider Quality Improvement Program. Up to 20 grantees may be awarded up to $250,000 each to providers, such as critical access hospitals, rural health clinics or networks of small rural providers, to build programs that collect and use clinical data and evidence-based approaches to improve healthcare quality, particularly focused on improving chronic disease outcomes. The grant also is intended to be used to strengthen the skills and collaboration of the billing and coding staff in coordination with the front-line clinical staff. Applications must be submitted by Aug. 6, 2026.”
  • Fierce Healthcare informs us,
    • “Participants in the ACO REACH program generated nearly $1 billion in savings in 2024, according to new performance data from the Trump administration.
    • “The Centers for Medicare & Medicaid Services released its latest look at program performance on Thursday, which found $988.3 million in net savings for the federal government from the accountable care program. Gross savings, before accounting for benchmark discounts and shared savings arrangements, were $2.5 billion, according to the report.
    • “Net shared savings payments to the ACOs totaled $1.5 billion, for a shared savings rate of 4.2%.
    • Most of the 115 ACOs participating in REACH for 2024 earned shared savings, according to the report. Just 19 ACOs, or 17%, posted a net loss, while 96 organizations, or 83%, earned savings.
    • The participating ACOs also generally maintained high performance on quality, CMS said, with 49 organizations qualifying for the high performance pool that allows them to earn additional financial benefits. This pool was first offered for the 2023 program year, CMS said.
    • The ACO REACH model is set to conclude at the end of 2026, and the Center for Medicare and Medicaid Innovation will transition to a new model called Long-Term Enhanced ACO Design (LEAD) beginning on Jan. 1.

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration July 10 released a proposed rule that would modernize drug establishment registration requirements, with implications for pharmaceutical manufacturers and health systems that depend on a stable medication supply chain. The proposal would create a streamlined registration process for distributed manufacturing operations that use a “hub-and-spoke” model, allowing qualifying networks to register as a single establishment rather than registering each manufacturing unit separately.
    • “The rule would also clarify registration and drug listing requirements for certain foreign manufacturers, including facilities that produce active pharmaceutical ingredients destined for the U.S. market through intermediary facilities. FDA officials said the change would improve visibility into upstream supply chains and strengthen the agency’s ability to identify and respond to potential safety and quality concerns.”
  • Fierce Pharma informs us,
    • “The increasingly more popular combination of Padcev and Keytruda has expanded its bladder cancer territory once again.
    • “Thanks to an FDA nod on July 10, Padcev and Keytruda have become the first muscle-invasive bladder cancer (MIBC) treatment that does not require considerations over the patient’s eligibility for cisplatin-based chemotherapy. 
    • “The latest go-ahead allows the combo as neoadjuvant treatment before surgery, followed as adjuvant treatment after surgical removal of the bladder in MIBC, building on a previous perioperative indication that was limited to cisplatin-ineligible patients. 
    • “The inclusive MIBC label adds to the Padcev-Keytruda combo’s well-established profile in metastatic bladder cancer. It arrives more than a month earlier than the FDA’s target decision date of Aug. 17 under an already accelerated priority review timeline. “
  • and
    • “The third time is not the charm for Hengrui Pharma and Elevar Therapeutics’ star-crossed combination of camrelizumab and rivoceranib at the FDA.
    • “U.S. regulators have declined to approve the anti-PD-1/VEGFR combo for a third time as a first-line treatment for liver cancer, Hengrui and Elevar’s parent company, HLB Group, said in separate announcements Friday.
    • “The problem, again, is manufacturing. Only this time, the complete response letter (CRL) stemmed from deficiencies the FDA had identified in April at the plant producing rivoceranib, also known as apatinib, unlike the previous two rejections, which centered on Hengrui’s camrelizumab facility, according to the Chinese pharma. The rivoceranib manufacturer had passed an inspection by EU authorities in 2025, it noted.
    • “Still, three CRLs do not necessarily mean three strikes and you’re out for Hengrui and Elevar.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of July 10, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “COVID-19 activity is low and stable nationally but is beginning to increase from low in a few areas of the country.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV), a respiratory virus that can cause illnesses such as croup, is elevated nationally. Rhinovirus/enterovirus (RV/EV), which often cause cold-like respiratory illness, are also elevated nationally but is going down. Whooping cough (pertussis) is still circulating.”
  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) confirmed 61 new US measles cases today and 2,231 for the year, as Virginia has become the country’s latest hot spot.
    • “Last year the CDC recorded 2,289 infections for the entire year, so the nation is just 58 cases short of that as we pass the midpoint of the year. The 2025 total was the most since 1991, and the United States is now on track to lose its measles elimination status that it gained in 2000.
    • “All but 13 of this year’s cases were locally acquired, with the rest related to travel outside the country. Of the total, 20% of infections are in children age 5 and under, and 70% involve kids and young adults to age 19. Six percent of patients have been hospitalized, compared with 11% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status. 
    • “No measles deaths have been reported this year, compared with three in 2025.”
  • The American Hospital Association News relates,
    • “The Centers for Disease Control and Prevention has reported 843 cases of cyclosporiasis across 31 states, with 86 people hospitalized. State health departments are reporting higher case numbers than the CDC, which works to confirm the cases reported to it. Michigan has announced that it is investigating 1,562 cases, with 44 people hospitalized. No deaths have been reported, and investigators haven’t identified a source.”
  • The New York Times adds,
    • “How to Stay Safe From the Severe Stomach Bug That’s Going Around
      • “Cyclospora, a parasite that causes intestinal illness, is sickening many people across the United States. Health experts have tips for avoiding infection.”
      • “Past cyclospora outbreaks in the United States have mainly been linked to fresh produce, including raspberries, basil, cilantro, fruit mixes, snow peas, snap peas, lettuce and salad mixes. They have been caused by both imported and domestic fruits and vegetables and those prepared at home and in restaurants, said Donald Schaffner, chair of the food science department at Rutgers University.
      • “Because the cause of the recent infections is unknown, the best way to prevent illness is to follow standard hygiene and food safety practices, said Dr. Adam Ressler, an infectious disease physician with Michigan Medicine.
      • Always wash your hands with soap and water after using the bathroom and before preparing food, Dr. Moore said. Alcohol-based hand sanitizers do not kill cyclospora, he said, but soap and water does.
      • “Rinsing fruits and vegetables with water is always a good practice, Dr. Moore said. Some cyclospora may still cling to contaminated produce after rinsing, but it will reduce their numbers and in turn can reduce your risk of getting sick or make the illness less severe, he said.
      • “Cleaning produce with vinegar or other solutions is generally no more effective than doing so with running water, Dr. Schaffner said.”
  • Cardiovascular Business tells us,
    • “Data on the potential relationship between cannabis use and cardiovascular disease (CVD) remain mixed. Some studies have linked cannabis to an increased risk of heart attack and ischemic stroke, for example, but the current evidence is far from consistent. 
    • “With cannabis legalization skyrocketing in the United States, the team behind a new analysis in Trends in Cardiovascular Medicine hoped to explore the latest evidence and provide a fresh look at this important topic.[1]
    • “Compared with respiratory or psychiatric outcomes, the cardiovascular consequences of cannabis remain poorly established,” wrote first author Ahmed K. Mahmoud, MD, a cardiovascular health researcher with Mayo Clinic, and colleagues. “This highlights the urgent need for prospective studies and clinical trials to more clearly define cardiovascular risk.”
  • The University of Minnesota’s CIDRAP informs us,
    • “A new study finds that the antiviral drug Paxlovid can safely be used by children aged 6 and older.
    • “The study, published recently in Pediatrics, found Paxlovid, which combines the drugs nirmatrelvir and ritonavir, is safe for children who weigh at least 44 pounds who have mild to moderate COVID-19 but are at risk of developing severe disease.
    • “Paxlovid is approved by the US Food and Drug Administration in children at least 12 years old who weigh at least 88 pounds.
    • “The study included 75 children 6 to 17 years old who received at least one dose of Paxlovid. One group received a lower dose and the other a higher dose. 
    • “Researchers found that both doses were safe and well-tolerated, with no serious adverse events. In 90% of participants in both groups, blood concentrations of the drug reached levels that have been shown to have antiviral effects in adults.”
  • BioPharma Dive points out,
    • “An experimental drug GSK licensed from Hansoh Pharma has succeeded in a late-stage study in China, boosting the outlook for a therapy the British pharmaceutical company has already advanced into a series of large global trials. 
    • “GSK said Friday that the antibody-drug conjugate risvutatug rezetecan, or ris-rez, improved survival in people with advanced or relapsed small cell lung cancer when compared to standard treatment, meeting the trial’s main objective. The company didn’t provide specifics, but said that the drug was associated with “statistically significant and clinically meaningful improvements” in survival compared to that typical treatment, the chemotherapy topotecan. Riz-rez also produced “consistent benefits” across secondary study measures, including delaying tumor progression, according to GSK.” 

From the U.S. / worldwide healthcare business front,

  • The Wall Street Journal reports,
    • “Asset-management firm Apollo Global Management APO  agreed to buy a minority stake in Bayer’s BAYN  long-acting reversible contraceptives business for €3 billion, or $3.43 billion, the companies said.
    • “German pharmaceutical company Bayer said it secured €3 billion in equity capital, as part of an agreement with Apollo for its managed funds and affiliates to obtain a minority stake in a new entity. The newly established entity will hold Bayer’s long-acting reversible contraceptives business.
    • “Bayer will retain a majority stake in and full operational control over the business, it said.
    • “The long-acting contraceptives business focuses on methods that prevent pregnancy for a long period of time, such as the intrauterine device, according to Bayer’s website.”
  • Modern Healthcare relates,
    • “Health systems and insurers are trying to minimize poorly executed handoffs between post-acute facilities and home care providers that are costing them millions of dollars in hospital readmissions.
    • “CenterWell, Optum and Banner Health are using a combination of technology, staffing and their own post-acute operations to ensure patients receive timely and consistent care as they transition from skilled nursing facilities to home following a hospital stay.” 
  • Fierce Pharma tells us,
    • “The launch of Eli Lilly’s Foundayo remains “muted,” with weekly prescriptions flat over the last five weeks, analysts from Jefferies said in a July 10 note. The analysis is based on data collected by IQVIA.
    • “In the 13th week of Foundayo’s launch, IQVIA reported 19,550 prescriptions, down for the third straight week after peaking at Week 10 with 21,648 prescriptions. The figure also comes in significantly shy of the Week 13 launch of Novo’s Wegovy pill (more than 105K scripts) and Lilly’s injected obesity treatment Zepbound (59K), but ahead of Novo’s injected Wegovy (13K).
    • “Meanwhile, weekly scripts for Wegovy pill ticked slightly upward sequentially to about 153K, although they still lag behind the drug’s peak of more than 161K.
    • “Jefferies points out that CVS was the last of the big three PBMs to provide coverage of Foundayo, starting on June 1. By contrast, Wegovy had full coverage at the first week of its launch.
    • “While Jefferies’ $71 million quarterly sales projection for Foundayo sits significantly below Wall Street consensus of $130 million, the team still believes that the Lilly med can reach the consensus revenue estimate of $1.2 billion for 2026.”
  • Kaufmann Hall informs us,
    • “Most U.S. adults who use social media engage with health-related content, including sharing health information, according to a study published last month in JAMA. This includes joining online health communities and sharing personal or general health information, with more than one in five adults making health decisions based on what they see online. However, many adults also doubt the accuracy of health information on social platforms. This suggests a public health problem: social media has become a major health information channel, but one built for engagement rather than reliability. This comes as healthcare organizations explore “influencer engagement” as a way to introduce credible information into spaces where patients already are, and where trust is being shaped.”

Notable Death

  • The Wall Street Journal reports,
    • “For decades, oncologists blamed cancers of the mouth and throat on excessive use of tobacco or alcohol. It was typically an old man’s disease.
    • “Starting in the 1980s, they were shocked to see more of these so-called oropharyngeal cancers in people—often young or middle-aged men—who had little or no history of drinking or smoking. A few oncologists suggested those might be caused by the human papillomavirus, or HPV, just as cervical and some other cancers are. But most scoffed at that idea.
    • “In the late 1990s, Maura Gillison, a doctoral student at Johns Hopkins University who was then in her early 30s and little known in the field, sought to resolve the debate. She competed with other researchers for access to scarce tissue samples from human tumors and led a team analyzing them for clues. That work led to a 2000 article in the Journal of the National Cancer Institute demonstrating that HPV-related cases were very different from those related to tobacco or alcohol—and less deadly.”
    • “Gillison, who died June 21 at the age of 61, built on that work with more studies, describing how HPV-related cancers required different treatment—typically less aggressive than the intensive chemotherapy and radiation applied to many non-HPV cancers. These findings saved lives and spared patients from needless treatments and side effects, cancer specialists say.”
  • RIP

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