Monday update
From Washington, DC,
- Per an OPM news release,
- The U.S. Office of Personnel Management (OPM) today issued new government-wide guidance to ensure that performance awards are meaningfully targeted to the highest-performing federal employees. The updated policy directs agencies to strengthen performance management practices, normalize ratings, and reserve the largest awards and bonuses for employees who have demonstrated exceptional contributions to their agencyʼs mission. The guidance also encourages agencies to expand use of non-cash awards, such as time-off and quality step increases, and to recognize real-time accomplishments throughout the year
- Per an HHS news release,
- “Health and Human Services Secretary Robert F. Kennedy, Jr. visited the CDC headquarters in Atlanta today in response to Friday’s tragic gunfire attack that claimed the life of DeKalb County Police Officer David Rose.
- “CDC security led Secretary Kennedy on a tour of the Roybal Campus, pointing out shattered windows across multiple buildings, including the main guard booth. Health and Human Services Deputy Secretary Jim O’Neill and CDC Director Susan Monarez accompanied him on the tour.
- “Secretary Kennedy visited the DeKalb County Police Department, where he met with Police Chief Greg Padrick. Later, he met privately with the widow of Officer David Rose, who courageously gave his life in the line of duty. He offered his deepest condolences and reaffirmed the agency’s commitment to honoring Officer Rose’s bravery, sacrifice, and service to the nation.”
- Per an HHS Office for Civil Rights news release,
- The FAQs support the Centers for Medicare & Medicaid Services’ July 30, 2025 announcement regarding the creation of a patient-centric, digital health care ecosystem that will improve patient outcomes, reduce provider burden, and drive value. Specifically, the HIPAA FAQs address how covered health care providers are permitted to disclose PHI to value-based care arrangements for treatment purposes, and what health information is included in a designated record set and thus subject to the individual’s right to access such information.
- New and Updated FAQs:
New. Does the HIPAA Privacy Rule permit a covered health care provider to disclose protected health information to value-based care arrangements, such as accountable care organizations, for treatment purposes without the individual’s authorization?
Updated. What personal health information do individuals have a right under HIPAA to access from their health care providers and health plans?
From the judicial front,
- It occurred to the FEHBlog this afternoon that we recently passed the August 7 deadline for the parties to submit a joint status report to the federal court considering a challenge to the Biden Administration’s 2024 mental health parity rule amendments.
- It turns out that the status report (Dropbox link) was timely submitted on August 7.
- The parties reported,
- “The Departments continue to consider whether to issue a notice of proposed rulemaking to revise or rescind the 2024 Rule and to determine when it would be appropriate to add a MHPAEA regulatory action to the agencies’ Semiannual Regulatory Agenda.
- “Pursuant to the Court’s May 12, 2025, Minute Order, the parties will file another joint status report on or before November 5, 2025, to report on Defendants’ progress.”
- The most recent semi-annual regulatory report appearing on reginfo.gov is Fall 2024 dated 12/13/2024.
- Fierce Healthcare reports,
- “Hospital and health system groups are skeptical the Trump administration will have enough time to weigh and incorporate providers’ concerns before opening its 340B rebate pilot program up to drugmaker applicants.
- “In a letter sent to the Health Resources and Services Administration (HRSA), which oversees the controversial subsidy program, seven provider associations requested HRSA extend the timeline for stakeholder comments and give itself a broader window to consider public comments.
- “Specifically, the current timeline outlined by HRSA in late July requires comments on the program to be submitted by Sept. 8, and for drugmakers to submit their applications and rebate plans by Sept. 15. Approvals would be made by Oct. 15, and the pilot is slated to begin at the top of the year
- “Instead, the associations have floated a Sept. 15 comment period, an Oct. 20 manufacturer application deadline and a Nov. 3 approval date.
- “With the fundamental changes a rebate model will impose on all 340B stakeholders, it is impossible for the agency to meaningfully consider, in just seven days, all the feedback it will surely receive,” the associations wrote in their letter (PDF). “Moreover, drug companies have spent years developing and preparing for a rebate model, but the agency’s current timeline would give 340B hospitals far less time to prepare.”
From the public health and medical research,
- The American Medical Association lets us know what doctors wish their patients knew about joint injuries and treatment.
- Consumer Reports, writing in the Washington Post, discusses “how to get more out of physical therapy. It can reduce pain, boost strength, get you as healthy as possible for surgery and more.”
- Medscape lets us know what doctors wish their patients knew about “How High-Fiber Diets and Supplements Can Improve Health for Patients With Obesity.”
- Per MedPage Today,
- “Previous research on associations between prediabetes and mortality has produced conflicting results.
- “This study found that prediabetes was statistically significantly associated with mortality only among adults ages 20 to 54 years.
- “Mortality risk in younger adults could be due to metabolic or behavioral risk factors.” * * *
- “Elizabeth Selvin, PhD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, who was not involved in the study, told MedPage Today that the findings were “very consistent with [the 2019 study] demonstrating that prediabetes in older adults is not strongly associated with mortality.”
- “Current definitions of prediabetes are very broad and they capture a lot of people who are not at high risk for poor outcomes, especially in old age,” she said. “In older ages, mild elevations in glucose are extraordinarily common and seem to reflect mild metabolic dysfunction corresponding with aging rather than severe hyperglycemia that leads to diabetes.”
- BioPharma Dive reports,
- “An experimental cancer vaccine fell short of its main objective in a Phase 3 trial in melanoma, causing shares of the shot’s developer, IO Biotech, to fall by double digits on Monday.
- “IO Biotech, however, still believes the vaccine performed well enough to warrant a potential approval consideration from U.S. regulators. The company noted how the study, which compared a regimen of its shot and Merck & Co.’s immunotherapy Keytruda to Keytruda alone, failed by the slimmest of margins. Executives also pointed to other analyses showing potentially stronger benefits among those who hadn’t previously received drugs like Keytruda or aren’t likely to respond to them.
- “It was a very narrow miss, just by a hair,” said Mai-Britt Zocca, IO’s CEO, on a Monday conference call with Wall Street analysts.
- “Called Cylembio, IO’s cancer vaccine consists of engineered peptides that are supposed to provoke an immune response to certain proteins expressed on tumor cells. Those proteins are two of the immune “checkpoints,” PD-L1 and IDO1, long studied by drugmakers.”
- and
- “An experimental Novartis drug has succeeded against a tough-to-treat autoimmune condition, boosting the outlook for a multibillion-dollar acquisition the Swiss pharmaceutical company made last year.
- “According to Novartis, the drug, called ianalumab, met its main goal in two Phase 3 studies in Sjögren’s syndrome, a chronic and progressive immune disease. Novartis didn’t provide specifics, but said Monday that treatment with ianalumab led to statistically significant improvements in disease activity compared to a placebo in each trial, as measured by a widely used index evaluating symptoms. The drug was also “well tolerated” and demonstrated “a favorable safety profile,” the company said in a statement.
- “Novartis will share the findings at an upcoming medical meeting and submit them to global health regulators.”
From the U.S. healthcare business front,
- Fierce Healthcare reports,
- “Kaiser Permanente closed its second quarter of the year with a billion dollars of operating income and a $3.3 billion bottom line—but operating headwinds on the horizon have leadership taking a hard look at the health system’s cost structure and potential efficiencies.
- “The quarter’s performance is a step ahead of last year, when the integrated nonprofit reported $908 million of operating income and $2.1 billion in net income.
- “It’s also a fair jump in the scale of Kaiser’s operations. Consolidated operating revenues and expenses during the most recent quarter were $32.1 billion and $31.1 billion, respectively, up from $29.1 billion and $28.2 billion in the second quarter of 2024. These reflect a 3.2% operating margin in the second quarter of 2025 and a 3.1% operating margin in the second quarter of 2024.
- “Together with the year’s opening quarter, Kaiser now sits at about $63.9 billion of operating revenue and nearly $2 billion of operating income for the first half of the year. Kaiser said its operating income runs highest during the beginning of the year due to the timing of its health plan’s open enrollment”
- Healthcare Dive tells us,
- “Major for-profit hospital chains reported lower-than-expected volumes in second quarter earnings results, causing some to cut back on volume and earnings expectations for the year.
- “Executives at the for-profit hospital chains — HCA Healthcare, Tenet Healthcare, Community Health Systems and Universal Health Services — attributed the volumes to different factors, from lower Medicaid admissions to a decline in consumer confidence, which impacted spending on healthcare services.
- “Softer volumes caused HCA, Tenet and CHS to lower their full-year outlooks for admissions. UHS did not report expectations for volume growth.”
- Here are links to Kaufmann Hall’s June 2025 flash reports on hospitals and physicians, both of which were released today.
- Beckers Hospital Review points out CMS’s 290 five star and 229 one star hospitals.
- “Every year, CMS assigns star ratings to U.S. hospitals based on 46 hospital quality measures, which are divided into five categories: mortality, safety, patient experience, readmission rates, and timely and effective care. Data reporting periods range from July 2020 to December 2024, depending on the measure. The ratings were updated in July and released Aug. 6.” “
- The American Journal of Managed Care informs us,
- “Prescribing semaglutide in routine clinical practice was associated with meaningful—but smaller than seen in clinical trials—improvements in cardiovascular risk factors, along with an unexpected rise in non-drug health care spending, according to a new study published in JAMA Network Open.1
- “Analyzing data from more than 23,500 adult patients across Yale New Haven Health System and Sentara Healthcare, researchers found that patients experienced an average 3.8% reduction in body weight and significant reductions in blood pressure (–1.5 mm Hg for diastolic; –1.1 for systolic), total cholesterol (–12.8 mg/dL), and hemoglobin A1c (HbA1C) at 13 to 24 months following their first semaglutide prescription. However, during the same time period, monthly health care expenditures rose by $80 per patient, not including the cost of semaglutide itself.
- “These findings highlight a disconnect between clinical benefits and short-term cost savings, warranting caution when extrapolating trial-based projections to clinical settings,” the researchers said.”