- Simplicity is a virtue.
From Washington, DC,
- Today’s Federal Register included an OPM system of records notice greenlighting
- “OPM/Central-15, Health Benefits Claims and Cost Records.’’ The system of records contains health benefits service use and cost [a/k/a claims] data about enrollees and their family members, who are or have been covered under the FEHB [or PSHB] Program.”
- The OPM Director explained in a recent “Secrets of OPM” blog post
- “OPM will scramble, or pseudonymize, the member ID information using a state-of-the-art cryptographic hashing process, replacing the Member ID with a random set of numbers and characters that is divorced from the real identity of the plan participant. That scrambled dataset will be then used by OPM’s analysts to uncover anomalies that are the classic indicators of fraud, while the stripped, encrypted data from the OIG will remain in a secure, separate environment, encrypted at rest and protected with our IT security best practices. Importantly, the data set that OPM analysts will use cannot be mapped back to any plan participant.”
- The Federal Register notice (91 Fed. Reg. at 37,441) contradicts the Director as follows:
- “Pseudonymization is employed as a privacy-enhancing safeguard; however, records remain subject to the Privacy Act because OPM retains the ability to re-identify records for authorized operational purposes. OPM will apply pseudonymization wherever practicable, and routine disclosures ordinarily will be made using pseudonymized records unless identifiable information is reasonably necessary to accomplish an authorized purpose.“
- What’s more, Federal Register notice states (id. at 37,439),
- “This modified system is effective upon publication in the Federal Register, with the exception of the routine uses, which become effective July 23, 2026.”
- The Federal Register notice is open for public comment until July 23, 2026.
- The American Hospital Association News reports,
- “A bipartisan group of senators June 18 urged the Centers for Medicare & Medicaid Services to improve implementation of the Rural Health Transformation Program. In a letter, led by Sens. Michael Bennet, D-Colo., co-chair of the Senate Rural Health Caucus, and Susan Collins, R-Maine, lawmakers expressed concerns that the current structure and guidance for implementing the RHTP could “unintentionally disadvantage” many rural hospitals the program was intended for.
- “CMS’s recent clarification that states may use provider payment funding for workforce recruitment and retention, infrastructure investments, technical assistance, systems development for alternative payment model participation, and support for non-clinical roles is a step in the right direction,” the senators wrote. “These flexibilities recognize many of the practical challenges rural providers face and are important steps toward helping hospitals and clinics remain viable. We believe that implementation can be improved further by lifting the cap on infrastructure and capital improvements for rural facilities, as many need significant improvement and equipment upgrades. We also believe that clarifying the permissibility of direct payments to providers is crucial.”
- Beckers Payer Issues relates,
- “The White House Council of Economic Advisers addressed the possibility of banning antisteering practices, which prohibit insurers from guiding patients to lower-cost providers, in payer-provider contracting. Its conclusion: Prices and premiums could drop.
- “Along with broader antisteering issues, the memo tackles all-or-nothing contracting, which demands insurers accept all of a system’s hospitals and affiliated physicians — or none at all.
- “These contracting strategies have been in the spotlight. On June 16, Columbus-based OhioHealth reached an agreement with the Justice Department and the state’s attorney general to end a civil lawsuit that alleged the system used anticompetitive contract provisions to raise costs for patients and employers. Under the agreement, the system did not admit any wrongdoing nor face penalties. In March, the Justice Department filed a similar lawsuit targeting New York City-based NewYork-Presbyterian.”
From the Food and Drug Administration front,
- STAT News tells us,
- “For many years, generic drugs have accounted for roughly 90% of the prescriptions doled out to Americans thanks to their lower cost. Yet reliable supplies have been an issue due to inconsistent quality — more than 60% of the generic shortages have been attributed to quality concerns, according to the Food and Drug Administration. Numerous manufacturers, many based in India, have been cited for violating manufacturing protocols that led to product recalls and, sometimes, bans on sending drugs to the U.S.
- “But Kevin Schulman, a professor and deputy director of the Clinical Excellence Research Center at the Stanford University School of Medicine, believes a solution is within reach. Schulman — who has also worked with an independent lab called Valisure that found impurities in some widely used medicines — argues the FDA should encourage testing by independent, accredited laboratories.” * * *
- “The cost of testing is cheap. You run sample testing on, say, 10 out of 600,000 bottles and it’s maybe $6 bucks each. … It’s ridiculous that we’re not doing it already.”
- Oncology News Central reports,
- “The U.S. Food and Drug Administration (FDA) has fully approved afamitresgene autoleucel (afami-cel; Tecelra) and expanded its indication to include patients aged 12 years and older with unresectable or metastatic synovial sarcoma whose disease has progressed after chemotherapy. Eligible patients must be positive for HLA-A*02:01, -A*02:02, -A*02:03, or -A*02:06 and have tumors that express the MAGE-A4 antigen.
- “US WorldMeds, the maker of afami-cel, announced the approval of the MAGE-A4-directed genetically modified autologous T-cell immunotherapy in a June 22 news release. The company noted that the conversion and expansion of the drug’s accelerated approval in 2024 also marks the first engineered T-cell therapy approved for children as young as age 12 years with a solid tumor.”
- Beckers Hospital Review relates,
- “Inventia Healthcare Limited is recalling 11,460 bottles of Chlorthalidone Tablets USP, 25 mg, a blood pressure medication distributed nationwide after the product failed dissolution specifications.
- “The recall was initiated June 5 and was classified as a Class II recall by the FDA on June 22, according to a June 22 enforcement report. The recall affects 100-tablet and 1,000-tablet bottles from two lots with expiration dates of April 2027.
- “Chlorthalidone is a diuretic used to treat high blood pressure and can also reduce swelling related to heart, kidney, or liver disease. Failed dissolution specifications mean the tablets may not dissolve properly in the body, potentially affecting how the drug’s active ingredients are absorbed.
- “Inventia Healthcare Limited manufactured the product. Rising Pharma Holdings distributed it in the U.S.”
From the judicial front,
- The Wall Street Journal reports,
- “The Justice Department on Tuesday unveiled charges against around 450 defendants for alleged healthcare fraud totaling over $6.5 billion as part of the Trump administration’s stepped-up antifraud efforts.
- “The announcement includes charges against 90 medical professionals and targets a range of alleged healthcare fraud schemes, such as wound care and opioid distribution. It also includes what officials said is a record number of Medicaid fraud defendants, with nearly 300 people accused of submitting over $500 million in false Medicaid claims.
- “Federal officials said the operation spanned 57 federal court districts and 41 states and territories, involving 46 state Medicaid Fraud Control Units in what they described as the department’s largest coordinated antifraud effort to date. They added that authorities seized more than $127 million in cash, luxury vehicles, jewelry and other assets. * * *
- “As part of Tuesday’s announcement, the Justice Department also unveiled a series of new data-sharing agreements across the federal government that officials said will significantly expand their access to fraud-related data.
- “Among them are memorandums of understanding with the Federal Trade Commission, giving prosecutors access to consumer-complaint data relevant to telemarketing and telemedicine scams. Officials announced an agreement with the Department of Homeland Security, providing travel information that can help identify providers billing for services while they are physically outside their clinics.
- “The Justice Department also announced an agreement with the Centers for Medicare and Medicaid Services that gives prosecutors access to CMS’s fraud-detection system, which uses machine learning to identify suspicious billing by healthcare providers. Officials said the tool is already helping investigators spot potential fraud faster and send cases to specialized teams that analyze emerging fraud trends.”
- Bloomberg Law relates,
- “Enanta Pharmaceuticals Inc. failed to convince the Federal Circuit to revive a patent it claims Pfizer Inc. infringed with its blockbuster Covid-19 antiviral drug Paxlovid.
- “Enanta’s US Patent No. 11,358,953 was properly canceled and Enanta’s related infringement suit was properly nixed ahead of a trial, the US Court of Appeals for the Federal Circuit said.”
- Here is a link to the Court’s opinion.
From the public health and medical / Rx research front
- Health Day reports,
- “Middle-aged women have the highest levels of problematic alcohol use, a new national survey shows, yet they may be the least aware that drinking can increase breast cancer risk.
- “Researchers questioned 2,200 women, 18 and older, about their drinking habits and mental health, as well as their knowledge and beliefs about alcohol and breast cancer.
- “The results revealed a striking paradox: Middle-aged women reported the highest levels of problematic drinking while also showing the lowest awareness of its link to breast cancer.
- “Research consistently shows that breast cancer risk increases as alcohol consumption increases, meaning there does not appear to be a completely ‘safe’ level of alcohol use when it comes to cancer risk,” said Dipali Rinker, research assistant professor at the University of Houston.”
- The University of Minnesota’s CIDRAP informs us,
- “A new study suggests that the 2025-26 COVID-19 vaccine helps protect against serious illness by reducing the risk of hospitalization and emergency department/urgent care (ED/UC) visits, adding protection for a population with significant existing immunity from previous infections and vaccinations.
- “The study, published today in JAMA Network Open, found that adults who received the updated vaccine were about 50% less likely to require ED/UC treatment for COVID and 55% less likely to be hospitalized than those who did not receive the vaccine.”
- MedPage Today relates,
- “Guidelines recommend antibiotics, intranasal corticosteroid sprays, and saline rinses for individual episodes of acute rhinosinusitis, with endoscopic sinus surgery as a possible treatment if the condition recurs multiple times a year.
- “Endoscopic sinus surgery improved quality of life related to recurrent acute rhinosinusitis compared with conservative medical therapy alone in a small randomized trial.
- “The trial was limited by premature termination, resulting in imprecise effect sizes.”
- The New York Times tells us,
- “Psychiatry has a long history of treating mental illness with drugs that were developed for entirely different purposes.
- “Take depression medications: The first antidepressant was initially designed for tuberculosis. One of the newest treatments, ketamine, started as an anesthetic. Now, scientists are investigating whether anti-inflammatory drugs might benefit some patients. A medication for rheumatoid arthritis was the focus of a small studypublished last month, building on decades of research examining a connection between inflammation and depression.
- “Roughly 25 percent of people with depression have elevated levels of inflammatory proteins in their blood, and the inflammation seems to develop before the depression does. In studies where people were given a substance to stimulate inflammation, participants experienced feelings of depression and anxiety shortly after.
- “People with high inflammation are less likely to benefit from traditional antidepressants. “I don’t think that this is likely important for everyone with depression,” said Dr. David Goldsmith, an associate professor of psychiatry and behavioral sciences at the Emory University School of Medicine. But inflammation “may help explain why a lot of individuals don’t respond to first-line treatments for depression, like S.S.R.I.s,” he said.”
From the U.S. healthcare business and artificial intelligence front,
- Modern Healthcare reports,
- “Digital health company Cadence has raised $100 million in a Series C round to scale its artificial intelligence-enhanced remote monitoring platform for patients with chronic illnesses.
- “The company also announced Tuesday it is partnering with Durham, North Carolina-based Duke Health — which participated in the funding round — and Arlington-headquartered Texas Health Resources to monitor patients at home.
- “The funding announcement comes amid scaled-up interest in remote patient monitoring — and increasing scrutiny of the care-delivery model by insurers and regulators.
- “Cadence partners with health systems to remotely monitor the vitals of patients with hypertension, diabetes, heart disease and other chronic conditions. Its nurses have access to electronic health records and can adjust patient medications if necessary.”
- Fierce Healthcare relates,
- “With employers seeking new solutions to address rising healthcare costs, Health Care Service Corporation is rolling out its Edge health plans, a new alternative option aimed at simplifying the member experience.
- “Edge is supported by a proprietary plan design called Easify, with the goal of making the coverage easier for members to understand and use. Members pay a simple copay, and will not have a deductible or coinsurance for care that’s in-network. The plans also includes a broad, PPO network.
- “The goal, the insurer said in an announcement, is to help connect members with high-quality and cost-effective care. Members are provided digital tools and personalized supports that are designed to explain options clearly and help them find appropriate care.
- “In addition, Edge plans offer incentives to members who select high-quality providers, according to the announcement.”
- and
- “Elevance Health is making strides toward a simpler and more streamlined clinical review process through its Health OS platform.
- “Health OS is a secure data platform the insurer built to unify data from key sources, such as electronic health records, labs and health information exchanges, to support faster clinical decisions without the need for greater administrative effort from providers.
- “It also connects with other data systems, such as Epic’s Payer Platform, to collate necessary data. Elevance was the first to lean on Epic’s tool to address inpatient concurrent care reviews, which occur when a patient is admitted for one condition, such as treatment for pneumonia, and then develop a concurrent issue, such as sepsis.
- “These types of reviews have traditionally required manual documentation, which can lead to delays, incomplete information or additional administrative effort.”
- Healthcare Dive tells us,
- “New Jersey nonprofit health systems Hackensack Meridian Health and Hunterdon Health are considering a merger, as regional hospitals continue to explore partnerships to keep up with larger, better-resourced competitors.
- “HMH and Hunterdon have signed a letter of intent to merge after the boards of both systems voted to move forward, according to a press release on Monday.
- “Still, the letter of intent is nonbinding and doesn’t represent a final deal. No immediate changes are planned at HMH or Hunterdon as the pair work toward a definitive agreement, the press release said.”
- Beckers Hospital Review informs us,
- “The Lown Institute published its 2026 Lown Hospitals Index “Honor Roll” June 23, spotlighting the top hospitals for social responsibility in every state.
- “To compile the list, the nonpartisan healthcare think tank assessed 2,718 acute care hospitals, 900 critical access hospitals and 331 health systems nationwide across more than 50 metrics related to health equity, value of care and patient outcomes. Lown used publicly available data from CMS and the IRS, among other sources, for its analysis. Learn more about the methodology here.
- “Overall, 123 acute care hospitals, 37 critical access hospitals and 11 health systems earned a spot on the Lown Index Honor Roll.”
- Drug Channels offers it “annual look at pharmacist salaries and employment.”
- “As we predicted, the situation was grim for retail pharmacists. Employment in retail outpatient pharmacies fell by 8,200 positions in 2025, following a drop of 11,700 positions over 2023 and 2024 combined.
- “Meanwhile, pharmacist employment at hospitals grew by 3,000 positions, after hospitals added more than 11,000 pharmacist jobs in 2023 and 2024. Nearly half of all pharmacists now work outside a traditional retail setting.
- “Overall pharmacist salaries averaged $140,920, but varied widely across practice settings. Salary growth in many settings, however, did not keep pace with overall inflation.”
- STAT News points out,
- “Doctors using OpenEvidence will soon be able to upload an image of an electrocardiogram to get an algorithmic prediction of whether a patient has structural heart disease.
- “Called EchoNext, the artificial intelligence model was developed by researchers at New York-Presbyterian Hospital and Columbia University and is being commercialized by a spinout called Pathway Labs. The company this month received a sweeping Food and Drug Administration clearance for the technology that can sniff out six forms of structural heart disease — including conditions where blood doesn’t flow properly through the organ owing to blocked or leaky valves and where the chambers of the heart don’t pump blood as well as they should — from EKG.
- “In addition to marketing it to hospitals, Pathway will take the novel step of licensing the technology to OpenEvidence, a medical evidence search engine that’s used by hundreds of thousands of clinicians.
- “We don’t want FDA-approved AI tools siloed in the ivory tower of academic medical centers, which historically have been the only places with the infrastructure to put them in front of physicians and patients,” Travis Zack, the chief medical officer of OpenEvidence, told STAT by email. “Instead, we envision a different model: The minute these AI biomarkers are approved, every doctor in the country has access to them through a trusted information platform.”
