Simplicity is a virtue

From Washington, DC,

• Benefits Link calls to our attention:
  • “Text of IRS Rev. Proc. 2026-24: 2027 Inflation Adjusted Amounts for Health Savings Accounts (HSAs) and Maximum Amount for Excepted Benefit Health Reimbursement Arrangements (HRAs) (PDF)
  • “For calendar year 2027, the annual limitation on deductions under section 223(b)(2)(A) for an individual with self-only coverage under a high deductible health plan [which thereby entitles the enrollee to contribute to a health savings account] is $4,500. For calendar year 2027, the annual limitation on deductions under Section 223(b)(2)(B)for an individual with family coverage under a high deductible health plan is $9,000.
  • “For calendar year 2027, a DPCSA [Direct Primary Care Service Arrangement] is not treated as a health plan with respect to an otherwise eligible individual if the aggregate monthly fees for all DPCSAs with respect to the individual do not exceed $150 or, if the individual is covered by a DPCSA that covers more than one individual, $300.
  • “For calendar year 2027, a ‘high deductible health plan’ is defined under section 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,750 for self-only coverage or $3,500 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $8,700 for self-only coverage or $17,400 for family coverage.
  • “For plan years beginning in 2027, the maximum amount that may be made newly available for the plan year for an excepted benefit HRA under Section 54.9831-1(c)(3)(viii) is $2,250.” 

• Healthcare Dive shares industry reactions to yesterday’s final rule on the No Surprises Act Independent Dispute Resolution process.
  • “No Surprises has largely been successful in that goal, preventing millions of Americans from being hit with unexpected out-of-network charges. But the law came with an unintended consequence, creating a multi-billion dollar industry enabling doctors to get paid significantly more than they normally would for providing care.
  • “This rule is a missed opportunity to restore the balance that Congress intended — a balance that has been badly warped by activist courts and predatory provider interests,” James Gelfand, the CEO of the ERISA Industry Committee, which lobbies on benefits issues for large employers, said in a statement.
  • “Payers and providers have been at odds over independent dispute resolution, or IDR. Each side has long complained that the process unfairly benefits the other.
  • “But over the past few years, data has emerged suggesting that doctors and medical groups are raking in the dough from IDR — filing snowballing disputes, winning an exceptional share of awards and garnering massive payouts.”

• Per a Department of Health and Human Services news release,
  • “U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today announced a series of major initiatives to strengthen the nation’s response to Lyme disease and other tick-borne illnesses. HHS actions include a multi-million-dollar pilot program focused on tick control, up to $2.5 million in innovation challenges, funding for NIH researchers to combat Alpha-gal syndrome, and a public-private collaboration to help patients connect with experienced providers.
  • “Secretary Kennedy delivered these announcements during a press conference in New Hampshire — one of the states hardest hit by Lyme disease — after convening a roundtable with state lawmakers and Lyme disease advocates as part of his “Take Back Your Health” tour.”

• The American Hospital Association reports,
  • The Centers for Medicare & Medicaid Services May 28 issued a final rule making changes to the Increasing Organ Transplant Access Model beginning July 1. IOTA is a six-year mandatory model for certain kidney transplant hospitals that began July 1, 2025. CMS finalized its proposal to raise the low-volume threshold from 11 kidney transplants performed annually during each of the baseline years to 15. The agency also finalized its proposal to include Medicare Advantage beneficiaries in the calculation of upside and downside risk payments. Although CMS considered lowering the maximum upside risk payment to $10,000 per transplant, it will remain $15,000 due to comments in opposition submitted by the AHA and other stakeholders. In addition, CMS adopted requirements for notifying patients of changes in waitlist status; however, in response to many concerns raised by the AHA and other commenters, it did not finalize its proposals regarding notifications of declined organ offers. Finally, in a modification of its original proposal, CMS adopted an updated risk adjustment methodology for performance on the model’s one quality measure that is consistent with the widely used Scientific Registry of Transplant Recipients framework.

• Fierce Healthcare relates,
  • “Elevance Health has earned a reprieve from potential federal sanctions on its Medicare Advantage plans.
  • “The Centers for Medicare & Medicaid Services sent a letter (PDF) to the company Friday, saying that it has completed key steps to remedy the agency’s concerns. CMS was set to suspend enrollment in Elevance’s MA plans on March 31 if the insurer did not comply.” * * *
  • In Friday’s letter, CMS said the Elevance has completed initial data submissions through the designated channels, and sent a wire transfer for overpayments based on “all auditable estimates” in the case. How much money that amounts to was not disclosed.
  • But despite the good news, the company is not out of the water yet. CMS said it must complete further steps by June 30 to avoid sanctions, as well as tie up any loose ends from previous steps in the process by July 31.
  • Sanctions would be implemented on July 1 if new steps are not met, or on Aug. 1 if these incomplete processes are not resolved, CMS said.

From the Food and Drug Administration front,

• Cardiovascular Business reports,
  • The U.S. Food and Drug Administration (FDA) is once again warning the public about a safety concern with Johnson & Johnson MedTech’s line of Impella heart pumps. 
  • This latest alert was put in place after the company learned that certain Impella CP sets with SmartAssist “do not meet design specifications” and could experience a low purge pressure event. 
  • “Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support,” according to the FDA’s advisory. “Loss of support may lead to an acute change in care when the pump is exchanged, hypotension, end organ hypoperfusion, and risk of death if not promptly corrected.”
  • One patient died as a result of this issue.

• Fierce Pharma relates,
  • “With a pediatric approval in hand for Afrezza, MannKind believes that it finally has the boost it needs to make an impact in the market after struggling for more than a decade with the inhaled insulin powder.
  • “On Friday, the FDA signed off on an expansion for Afrezza to treat adolescents and children ages 6 and older with Type 1 or Type 2 diabetes. The drug must be used alongside basal insulin in patients with Type 1 disease, according to a May 29 press release. 
  • “The nod comes 12 years after the U.S. regulator cleared Afrezza as a fast-acting, before-meal option for adults with diabetes.”
• and
  • “Johnson & Johnson has bolstered the psoriatic arthritis (PsA) nod for its IL-23 inhibitor Tremfya in the U.S., picking up an FDA expansion that covers the med’s ability to thwart the progression of structural joint damage in adults with active disease. 
  • “Patients with active PsA can start to suffer joint damage as early as 6 months after the onset of their condition, reinforcing the need for a treatment like Tremfya that can provide daily symptom relief and protection from structural joint damage over the long term, Philip Mease, M.D., of the Swedish Medical Center and University of Washington School of Medicine in Seattle, said in a J&J press release.” 

• The Wall Street Journal tells us,
  • “Replimune Group REPL said Friday it has reached an agreement with the Food and Drug Administration on a path to resubmit its application for its experimental treatment for advanced melanoma.
  • “It wasn’t immediately clear whether Replimune would submit new clinical data or additional analyses of existing trial results to help secure approval.
  • “The company plans to resubmit the application in the coming days, the company said.”

From the public health and medical / Rx research front,

• The Centers for Disease Control and Prevention announced today,
  • “As of May 29, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
  • “RSV activity started later than usual in most parts of the United States, but illnesses are not more severe than recent years. Activity has peaked in most regions of the country.
  • “COVID-19 activity is low in most areas of the country.
  • “Seasonal influenza activity is low.”

• The University of Minnesota’s CIDRAP reports,
  • “The Centers for Disease Control and Prevention (CDC) today confirmed 31 new measles cases in a nationwide outbreak that has now reached 1,983 infections, as experts describe sometimes-serious symptoms that can warrant hospital stays, including brain inflammation and pneumonia. 
  • “All but nine of the US infections are locally acquired, with the rest related to international travel. The total for all of last year was 2,288 confirmed cases.” * * *
  • “According to the CDC measles map, South Carolina has recorded the most cases so far this year, at 669, but its outbreak is now over. Utah is next, with 484 cases—although the Utah health department lists 476,just two more than last week. The state recorded eight new cases the previous week and 10 the week before, for a three-week total of 20.
  • “Texas has 182 cases, and Florida 139, four of them new, according to the CDC map.
  • “Fortunately, the outbreak in our region does appear to be slowing,” said Andrew Pavia, MD, chief of pediatric infectious diseases at the University of Utah. He was part of a media briefing this week sponsored by the Infectious Diseases Society of America (IDSA).”

• The Wall Street Journal relates,
  • “Trump administration officials are asking states to ensure 24/7 monitoring for [over a dozen] Americans exposed to hantavirus to allow home isolation.
  • “Federal officials require states to issue quarantine orders if people fail to comply, with health officials checking symptoms twice daily.
  • “The World Health Organization recommended a 42-day quarantine for high-risk exposure to the Andes strain of hantavirus.”

• MedPage Today tells us,
  • “Alzheimer’s pathology appeared as early as midlife and correlated with poorer cognitive performance in a cohort study.
  • “Blood biomarkers identified Alzheimer’s pathology in 6% of middle-age adults.
  • “Baseline pathology predicted steeper 5-year declines in verbal memory and processing speed.”
• and
  • “Strong preclinical evidence suggested PCSK9 inhibitors may overcome immunotherapy resistance by preventing tumor cells from evading the immune system.
  • “In patients with lung cancer, melanoma, or kidney cancer, use of PCSK9 inhibitors, in addition to immunotherapy, was associated with better survival in this matched-cohort study.
  • “The survival benefit was independent of cardiovascular outcomes, suggesting an alternative biological pathway.”
• and
  • “Enhanced, abbreviated MRI (AMRI) outperformed ultrasonography (US) as a screen for early liver cancer in high-risk patients with cirrhosis, according to a single-center, randomized clinical trial.
  • “Overall, AMRI yielded significantly more early-to-advanced stage cancer among 759 patients: the per-patient detection rate in Barcelona-Clinic Liver Cancer (BCLC) stage 0, A, B, or C hepatocellular carcinoma (HCC) was significantly greater in those randomized to screening with hepatobiliary-phase image AMRI (HBP-AMRI) using gadoxetic acid than in those screened with US, at 8.5% versus 3.1% (P=0.002).”

• tctMd informs us
  • “The likelihood that patients with hypertension will stop taking their prescribed blood pressure-lowering medications varies by drug regimen, a meta-analysis of short-term clinical trials suggests.
  • “Combination therapies—particularly angiotensin II receptor blockers (ARBs) paired with calcium channel blockers (CCBs)—generally were better tolerated than monotherapies, researchers reported today in JAMA, and some meds even had discontinuation rates lower than seen with placebo.
  • ‘High blood pressure is notoriously undertreated, something that’s often attributed to the  perceived tolerability, or lack thereof, of antihypertensive drugs. 
  • “Fear of adverse events remains a major reason for undertreatment of high blood pressure, the leading modifiable risk factor for death and cardiovascular disease worldwide. For years, we have assumed that more blood pressure-lowering treatment equates to worse tolerability, and hence most patients are started and remain on single drug monotherapy,” Nelson Wang, MD, PhD (University of New South Wales, Sydney, Australia), told TCTMD in an email.”

• The Journal of American Managed Care informs us that “Endometriosis Surgery Becomes More Complex With Older Age Despite Plateauing Severity, Study Finds.”

From the American Society of Clinical Oncology conference front,

• BioPharma Dive reports,
  • “A regimen combining Bristol Myers Squibb’s experimental mutliple myeloma drug mezigdomide with standard therapies delayed disease progression or death about 10 months longer than typical care alone, according to Phase 3 data unveiled Friday at the American Society of Clinical Oncology meeting.
  • “Trial enrollees who got mezigdomide along with Amgen’s Kyprolis and a steroid were 52% less likely to have progressed or died during the trial period compared with people receiving only those two other therapies. Study recruits in the “SUCCESSOR-2” trial had already seen their disease advance after at least one treatment line. Many had previously received two or more therapies.
  • “Mezigdomide is one of two protein-degrading drugs Bristol Myers has already submitted to U.S. regulators and hopes to position as successors to its popular multiple myeloma therapies Revlimid and Pomalyst. The treatment lanscape has become more competitive, though, with the emergence in recent years of cell therapies and bispecific antibodies that are becoming part of early-stage treatment.”
• and
  • “Merck & Co. has said many new products will be needed to absorb the coming financial impact when its blockbuster cancer medicine Keytruda loses patent protection. One, discovered by China-based Kelun-Biotech and licensed to Merck a few years ago, has now come to the forefront.
  • “Dubbed sacituzumab tirumotecan, or sac-TMT, the therapy is part of a class of “antibody-drug conjugates” drugmakers see as potentially supplanting traditional chemotherapy in many cancers. Merck has been so encouraged by the clinical results it’s seen so far that it’s put the drug into a sprawling Phase 3 program consisting of 17 studies in a range of tumor types.
  • “Sac-TMT “could be one of our cornerstone ADCs, and that’s why you see our conviction in all of these trials,” said Shweta Jain, who oversees Merck’s oncology assets, in an interview with BioPharma Dive.”
    
• STAT News adds,
  • “Investors have never really been excited about Pfizer’s Lorbrena, a targeted drug that is the successor to the company’s earlier targeted drug, Xalkori, to treat non-small cell lung cancer that is caused by any of a number of genetic alterations to the gene including ALK and ROS1. For patients, it has been a breakthrough.”
  • “Lorbrena was approved as second- or third-line treatment in 2018, and then as first-line treatment in 2021. Its main benefit over Xalkori is that Lorbrena can penetrate the brain. Non-small cell lung cancer often metastasizes there, but the large size of the earlier molecule meant that patients would have their disease controlled throughout their body, except inside their heads.
  • “Two years ago at ASCO, Pfizer presented data showing that five years out, Lorbrena reduced disease progression by 81% in patients with altered versions of the ALK gene. Today, researchers presented data that are even more remarkable. At seven years, patients had a 55% likelihood of being alive without disease progression, compared to 3% for those who were taking Xalkori. In an interview, Jeff Legos, Pfizer’s chief oncology officer, said that this appeared to be the longest progression-free survival ever reported in metastatic or advanced non-small cell lung cancer.
  • ‘ALK+ non-small cell lung cancer accounts for less than 5% of cases of disease. But in those patients, about a third will develop brain metastases within two years. Lorbrena reduced those metastases by 91% compared to Xalkori.” 

From the U.S. healthcare business and artificial intelligence front,

• The Wall Street Journal reports,
  • “UnitedHealth UNH Group plans to stop requiring doctors to get approvals for an array of pediatric procedures, tests and services, further cutting back on a process that has long been detested by physicians and patients.
  • “UnitedHealth, parent of the biggest U.S. health insurer, on Friday said that the changes will eliminate roughly two-thirds of prior-authorization requirements for members under the age of 18 by the end of the year.
  • “UnitedHealthcare said it will stop requiring signoffs for many diagnostic services, routine surgical procedures and specialty care services across pediatric subspecialties such as cardiology, neurology, pulmonology and orthopedics.
  • “The insurer will additionally introduce authorization waivers for certain procedures performed at pediatric hospitals.
  • “UnitedHealthcare said it is conducting a rigorous and data-driven review of all pediatric prior authorization requirements in order to determine which services can be safely removed.”

• Beckers Payer Issues informs us,
  • “The forces reshaping health plans over the next several years are converging fast. Across the industry, executives and clinical leaders point to three trends that will define which organizations will thrive: the rapid maturation of AI from pilot projects into core operational workflows, the intensifying pressure to make healthcare genuinely affordable, and the rising tide of consumer expectations for transparency, simplicity and personalized care. 
  • “Becker’s asked 16 health plan executives which trend they think will most influence health plans over the next few years.”
  • You can read the exec’s thoughts in the article.

• Beckers Hospital Review ranks 66 health systems by long term debt.
  • “Long-term debt continues to weigh on health system balance sheets, even as many reported improved operating margins in 2025. Some systems have been actively deleveraging through hospital divestitures, debt refinancings and operational improvements, while others have taken “on new debt to fund capital projects, acquisitions and EHR investments.
  • Highly leveraged systems are looking to sell hospitals, facilities or business lines to reduce leverage and secure long-term sustainability, while systems with stronger balance sheets are using the dislocation to pursue growth through M&A.”

• Healthcare Dive points out,
  • “The Coalition for Health AI released a series of governance resources this week that aim to help health systems safely roll out artificial intelligence tools. 
  • “The playbooks, developed through community workshops and work groups that included more than 150 clinicians and health AI leaders, provide examples and guidance on implenting AI, including resources on setting up AI policies, managing third party developers and assessing risks. 
  • “The goal is to provide a standardized, but flexible framework that health systems can use to deploy AI tools, regardless of their size or available resources, CHAI said.”