Simplicity is a Virtue.

From Washington, DC,

• Per a U.S. Office of Personnel Management news release,
  • “The US Office of Personnel Management (OPM) today proposed a rule to eliminate the federal government’s time-in-grade requirement, an outdated rule that forces many General Schedule federal employees to wait 52 weeks before becoming eligible for promotion.
  • “The proposed rule would shift federal advancement away from time served and toward merit, performance, skills, and demonstrated readiness for higher-level work. Employees would still be required to meet OPM qualification standards and any additional job-related agency requirements.
  • “Federal employees should be rewarded for what they can do, not how long they have waited,” OPM Director Scott Kupor said. “This proposed rule strengthens merit, gives managers more flexibility to recognize high performers, and helps agencies move talented people into mission-critical roles faster.” * * *
  • “Read the proposed rule here“

• The OPM Director, writing his Secrets of OPM blog in Linked In, discusses the proposed rule that would require federal employees to sign a non-disclosure agreement.
  • “Every well-functioning organization, whether it’s a startup, Fortune 500 company, nonprofit, law firm, university, or government agency, depends on the ability to have candid internal discussions about strategy, policy, personnel, operations, and decision-making.
  • “There’s a reason this principle is embedded throughout federal law. Under the Freedom of Information Act (FOIA), pre-decisional deliberations are generally protected from disclosure because organizations work better when people can debate ideas openly and honestly before a final decision is made. If every brainstorming session, disagreement, or draft proposal is instantly leaked into public view, people stop speaking candidly. Collaboration suffers. Decision-making suffers. Organizations become slower, more political, and less effective.
  • “Put differently: you cannot run a functional organization if employees believe internal deliberations will immediately be broadcast outside the organization.
  • “And contrary to some headlines, this proposal does not eliminate whistleblower protections. If someone witnesses illegal conduct, fraud, abuse, or misconduct, longstanding whistleblower laws remain fully intact. Protected disclosures are protected disclosures.”
• The public comment deadline for this proposed rule is June 26, 2026.

• Per a Justice Department news release,
  • “Today, the Civil Division announced reforms to accelerate the review of False Claims Act whistleblower complaints alleging fraud against federally funded, state-administered benefits programs. These reforms will empower the Department to move quickly on meritorious qui tam cases, maximize finite enforcement resources, and focus on dismantling sophisticated fraud schemes that exploit taxpayer-funded programs.” * * *
  • “The Civil Division will now prioritize qui tam complaints alleging fraud against public benefits programs by performing its initial review within 60 to 120 days. At the conclusion of that review, the Department will decide whether to:
    • “Permit the relator to proceed with the action and to assume primary responsibility for litigating it, subject to the government’s ongoing supervision and ultimate control of the matter;
    • “Conclude the allegations warrant further government investigation; or,
    • “Determine the qui tam should be dismissed under 31 U.S.C. §3730(c)(2)(A) because the allegations lack adequate specificity or are legally deficient.”

From the Food and Drug Administration front,

• Fierce Pharma reports,
  • “Outlook Therapeutics has notched a win in its uphill battle to commercialize an ophthalmic version of Roche’s Avastin (bevacizumab) in the U.S., with the FDA now agreeing that the drug has demonstrated its effectiveness as a treatment for wet age-related macular degeneration. 
  • “The FDA’s change of heart comes after it granted an appeal of Outlook’s formal dispute resolution (FDR) request, which the company initiated last month following its third rejection of Lytenava (ONS-5010).
  • “As a result of the proceedings, the FDA’s Office of New Drugs (OND) concluded that clinical trial results, coupled with natural history and other mechanistic and pharmacodynamic data, were enough to establish “substantial evidence of effectiveness” for the drug, Outlook explained in a Tuesday release.” * * *
  • “The decision stipulates that Outlook can resubmit its biologics license application for Lynteva, which will be given an FDA decision date that should fall within 60 days of receipt of resubmission.
  • “Outlook expects to file the resubmission next month, it said.” 

• Fierce BioTech relates,
  • “The FDA has delayed a decision on the approval of AstraZeneca’s camizestrant, deferring its ruling to review analyses filed after an advisory committee voted against the breast cancer prospect.
  • “AstraZeneca filed for FDA approval of the oral SERD based on a phase 3 switching study. Patients in the Serena-6 trial received an aromatase inhibitor and a CDK4/6 inhibitor. After detecting an ESR1 mutation, investigators swapped the aromatase inhibitor for camizestrant. AstraZeneca linked switching to its oral SERD to a 56% jump in progression-free survival.
  • “However, the FDA raised questions about the study design, and its advisory committee voted six to three that AstraZeneca failed to show camizestrant provides a clinically meaningful benefit. The vote was a blow to AstraZeneca’s hopes of winning approval, although the FDA can go against advisory committees.
  • “After the setback, AstraZeneca provided additional analyses requested by the FDA. The analyses include data on circulating tumor DNA clearance linked to longer-term efficacy outcomes, which AstraZeneca will share next week at the American Society of Clinical Oncology annual meeting. The FDA has pushed back its ruling on whether to approve camizestrant while it reviews the analyses.” 

• MedTech Dive tells us,
  • “Insulet is recalling 7 million insulin patch pumps due to a manufacturing issue where devices may have a small tear in the tubing just above the skin.
  • “The problem can cause insulin to leak outside of the body, with the potential for people to not receive enough medication. For people with diabetes, this can lead to serious complications associated with high blood sugar, such as diabetic ketoacidosis, a medical emergency caused by a severe lack of insulin.
  • “Insulet said in a Tuesday notice that it has received 24 reports of serious adverse events, including hospitalization and diabetic ketoacidosis. The company has not reported any deaths related to the recall.”

From the public health and medical / Rx research front,

• The American Hospital Association News reports,
  • “The American Cancer Society released updated colorectal cancer screening guidelines May 27 that include the addition of a blood-based screening test to be taken in a doctor’s office. The blood test, which detects tumor DNA in the blood, is only recommended for individuals who decline or do not complete preferred screening tests. The organization said a colonoscopy remains the primary recommendation for screening. The blood test has been found to be less effective in detecting advanced precancerous lesions and stage I cancers, according to the ACS. In addition, the organization announced guidelines for using stool-based tests by Cologuard and ColoSense. The ACS reaffirmed that individuals at average risk for colorectal cancer begin screening at age 45.”
    
• MedPage Today relates,
  • “In advanced heart failure, cardiac remuscularization with BioVAT was associated with an increase in the target heart wall thickness, left ventricular ejection fraction, and quality of life in a small early-stage study.
  • “BioVAT consists of thin patches of engineered cardiac muscle that can be surgically attached to the outside of the ventricle where cardiomyocytes have been lost.
  • “Questions of efficacy and potential electrical dysfunction require longer-term follow-up and further clinical investigation.”

• Health Day tells us,
  • “The college years are prime time for the emergence of mental illnesses involving psychosis, according to a new study.
  • “However, almost 60% of college students who seek mental health care after a psychotic episode do not get the recommended treatment, researchers recently reported in the journal Social Psychiatry and Psychiatric Epidemiology.
  • “Going without even one of the recommended three components of treatment — counseling, therapy and medication — could have consequences, researchers warned.
  • “Early intervention and access to services such as therapy and medication in this population are important because it improves outcomes related to overall quality of life, school involvement, employment, symptom severity and relapse rate,” lead author Clara Godoy-Henderson said in a news release. She’s a graduate student in health services and policy research at the Boston University School of Public Health.
  • “It’s estimated that about 3% of Americans are affected by psychosis, a condition in which individuals lose touch with reality and may experience delusions or hallucinations, researchers said in background notes.”

• BioPharma Dive informs us,
  • “Kailera said Wednesday its triple-acting obesity shot spurred double-digit weight loss in a short Phase 1 dosing trial conducted in China by partner Hengrui Pharmaceuticals, with investigators reporting that enrollees lost up to 16% of their body weight over 12 weeks.
  • “The data compare favorably to early-stage data reported by Zepbound maker Eli Lilly with its so-called “triple-G” agonist drug, which hadn’t reached 10% at the 12-week time point, wrote T.D. Cowen analyst Yaron Werber. Kailera is readying its own Phase 1 trial outside China, which will have data in 2027, while Hengrui is advancing the drug into Phase 2 in China.
  • “Data from the triple-G drug, called KAI-4729, follows positive mid-stage data for Kailera and Hengrui’s dual-acting Zepbound competitor, which has already entered a Phase 3 study. The rapid advancement of Kailera’s pipeline licensed from Hengrui has driven investor enthusiasm for the company and allowed it to enter the publicly traded markets with one of biotech’s largest-ever initial public offerings.”
• and
  • “Apogee Therapeutics is set to begin Phase 3 studies of an eczema treatment designed to compete with the mega-blockbuster medicine Dupixent after another round of successful Phase 2 testing.
  • “The late-stage research will kick off in the second half of this year, Apogee said Wednesday. It will include three placebo-controlled trials with about 400 patients each, with one study evaluating the medicine in combination with topical corticosteroids. Patients will be followed for a year after an initial 16-week induction period.
  • “Apogee released the plans as it shared the latest positive Phase 2 results and announced as much as $1.3 billion in financing from a collaboration with Blackstone Life Sciences. Apogee says it now won’t need any future equity financing.”

From the U.S. healthcare business front,

• The New York Times reports,
  • “On a sunny Wednesday morning last month, dozens of preschoolers filed into a Compleat Kidz autism clinic in Concord, N.C. One wore light-up sneakers. Another had a Spider-Man lunchbox. They settled into tiny green cubicles, each accompanied by a staff member, and started their work.
  • “A decade ago, this Charlotte suburb had no clinics providing therapy to children with autism. Now it has 12. Inside this one, children buzzed with activity as they worked long sessions with therapists. One 6-year-old girl, exhausted after hours of therapy, fell fast asleep in her therapist’s lap.
  • “Soon, a supervisor, Stephen Schroeder, intervened.
  • “How long?” Mr. Schroeder asked Courtney Evans, the therapist.
  • “I set the timer for 7. We’re almost done,” Ms. Evans said. A couple of minutes later, she nudged the child awake. The girl cried.
  • “At Compleat Kid, a fast-growing chain of autism clinics based in North Carolina, the policy is firm: Naps cannot be longer than seven minutes before children are awakened to resume therapy. The company says this is necessary to prevent fraud since clinics can be paid only when children are awake and getting services. But it also allows the clinic to bill insurers or Medicaid for more hours.
  • “Across the United States, where treatment for autistic children was once fairly rare, thousands of clinics have sprung up, turning a once obscure therapy into a multibillion-dollar industry. The growth has been fueled by rising autism diagnoses, state insurance mandates and a federal requirement that Medicaid cover the therapy. Private equity investors have rushed into the business, buying up chains and opening new clinics.”

• Beckers Payer Issues relates,
  • “Member satisfaction with commercial health plans has held nearly flat for a third consecutive year, even as rising premiums and deductibles continue to strain the member-plan relationship, according to J.D. Power’s 2026 U.S. Commercial Member Health Plan Study.
  • “J.D. Power published its annual ranking of the top commercial health plan in each region on May 27. Now in its 20th year, the study measures satisfaction among members of 148 health plans in 22 regions based on eight dimensions including trust, digital channels, claims resolution and cost. This year’s results are based on responses from 37,768 commercial members surveyed from September 2025 through March 2026.
  • “The study rates health plans on a 1,000-point scale. The average satisfaction score for commercial plans in 2026 is 562, down one point from 2025 and three points from 2024. 
  • “More than half of surveyed members saw their monthly premium rise this year, a shift the study linked to a 116-point drop in satisfaction. Another 34% faced higher annual deductibles, contributing to an 111-point decline. Claims resolution emerged as one of the clearest opportunities for plans to differentiate. Members who rated their claims experience as excellent scored 734 on satisfaction, compared to 404 among those who described it as good, just okay, or poor.”
• and
  • “Health plans that aren’t built around provider networks will be allowed on the ACA individual marketplace beginning in 2028, marking a structural change to a system that has operated exclusively on network-based models since the ACA launched more than a decade ago.
  • “For Sidecar Health, an insurer that sells employer-sponsored plans without provider networks, the change opens a market it has long wanted to enter. The company administers benefits for hundreds of employer clients, ranging from companies with 51 to 60,000 covered lives across 25 industries in 48 states.
  • “The individual population and individual people and families — they’re a critical piece of our mission,” Sidecar CEO Patrick Quigley told Becker’s. “Today we only serve employers. What this does is open the door for us to serve even more people, and an audience that is frankly often left behind.”
  • “Sidecar’s model sets fixed benefit amounts based on average local prices rather than contracting with providers. Its members pay at the point of care using a company-issued Visa card and keep half the savings when a provider charges less than the benefit amount. The company says that in 2025, fewer than 1% of claims were clinically denied.”

• Fierce Healthcare tells us,
  • “GoodRx announced Wednesday the launch of GoodRx Companion, a subscription program that offers access to virtual healthcare services and prescription medications at discounted prices.
  • “Through the $14.99 monthly GoodRx Companion subscription, users can access free and low-cost generic medications, online care visits and additional healthcare services. The company says the new subscription advances its strategy by adding broader offerings alongside its weight loss, erectile dysfunction and hair loss programs.
  • “More than 200 generic medications are free through the telehealth platform, with “hundreds more” for less than $10 across pharmacies nationwide, according to the company. Telehealth visits are $19 through GoodRx Companion to address common health conditions, such as influenza, urinary tract infections (UTIs) and more.”
• and
  • “Humana’s CenterWell Pharmacy has invested $83 million in its latest distribution center, opening in Florida.
  • “The company announced Wednesday that the new facility will build out the company’s prescription delivery infrastructure in the state, offering an easier and more coordinated experience for members and CenterWell patients.
  • “In addition to home delivery options for Humana members, the 162,000-square-foot facility in Orlando will also offer payer-agnostic services such as direct-to-consumer and direct-to-employer partnerships, which are growing in popularity as prescription costs rise.
  • “The facility can process up to 64,000 prescriptions each day, and will employ 165 people, Humana said.”

• Healio informs us,
  • The number of U.S. dialysis facilities closing has risen since 2018, particularly smaller, rural and Midwest facilities, according to study data published in American Journal of Kidney Diseases. * * *
  • “The annual opening-to-closure ratios decreased from 8.9 in 2018 to 0.8 in 2024.
  • “More research is needed to determine whether closures impact patient outcomes.”

• Per a KFF news release,
  • “Drew Altman, Founding President and CEO of KFF, Announces Retirement Plans; Board Appoints Larry Levitt and Mollyann Brodie as Next Leadership Team.”
• Best wishes in retirement, Mr. Altman.