Simplicity is a virtue.

From Washington, DC,

• Per a House of Representatives news release,
  • “Health care providers that deliver high-quality, cost-effective care to American patients will be able to operate more efficiently thanks to bipartisan legislation approved by the U.S. House of Representatives. The Health Care Efficiency Through Flexibility Act (H.R. 5347), introduced by Ways and Means Health Subcommittee Chairman Vern Buchanan (FL-16) and fellow Committee member Representative Jimmy Panetta (CA-19), recognizes the benefits Accountable Care Organizations (ACOs) provide to patients in the way of value-based care, but also that current reporting processes required by the Centers for Medicare & Medicaid Services (CMS) are onerous and costly. As more ACOs deploy sophisticated electronic health records (EHRs) to streamline data reporting to CMS, the legislation provides ACOs with certainty and flexibility to help make the transition to digital quality measure reporting successful.” * * *
  • “Read a fact sheet on the bill here.
  • “The bill passed the Committee with a vote of 43-0.
  • “The bill was approved by the U.S. House of Representatives with unanimous consent.”

• Bloomberg Government adds,
  • “Senators’ search for affordability wins to boast about on the campaign trail is leading back to capping the cost of insulin at $35 in the private insurance market and for the uninsured.
  • “The proposal is modeled on a similar measure Democrats included in their 2022 tax-and-healthcare law designed to curb costs for the diabetes drug in the federal health insurance program for seniors. 
  • “This time, the private-market insulin cap is being pushed by Sen. Susan Collins (R-Maine), who is facing a tough reelection battle this fall. She said last week that she added two more co-sponsors to her bill. 
  • ‘Fourteen Republican senators are now signed on, including Sens. Dave McCormick(R-Pa.), Tommy Tuberville (R-Ala.), Lisa Murkowski (R-Alaska), Jim Banks (R-Ind.), Chuck Grassley (R-Iowa), and Cindy Hyde-Smith (R-Miss.), as well as 12 Democrats.
  • ‘The measure, which previously earned the support of seven Republicans the last time a version of the idea was considered, could serve as a rare bipartisan triumph for lawmakers in what’s been a divisive Congress. 
  • “Every day we’re gaining momentum,” said Collins of her growing number of supporters on the bill. “There’s a hole here that we want to plug, and that is for people on employer plans and people who are uninsured.”

• KFF reports,
  • “A new KFF analysis finds that 3.8 million Medicare beneficiaries met the criteria to be eligible for the new Medicare GLP-1 Bridge, based on claims data from 2023.
  • “The temporary 18-month program, launching on July 1 and running through December 2027, will provide coverage of three GLP-1s (Wegovy, Zepbound, and Foundayo) used for weight reduction and weight management to eligible beneficiaries who are enrolled in Medicare Part D.
  • “The total cost to the federal government of the program will depend in part on what share of eligible beneficiaries participate, how quickly they take up coverage, and how many prescriptions each participating beneficiary fills during the 18-month period.” * * *
  • “The clinical criteria for determining a Part D enrollee’s eligibility for Bridge include having a BMI of 35 or more; or having a BMI of 27 or more along with certain comorbid conditions. In addition, eligibility is limited to Part D enrollees who don’t have conditions treated by GLP-1 drugs that are currently covered under Part D, such as type 2 diabetes, and who have not filled a GLP-1 prescription in their Part D plan in 2026.”

• Healthcare Dive relates,
  • “Enrollment in Affordable Care Act health plans declined by nearly 3 million people this year as policy turbulence continues to roil the exchanges, according to federal data released Friday. 
  • “About 19.2 million people were enrolled in ACA marketplace plans in February, down about 13% from the same time in 2025. 
  • “The Trump administration attributed the decline to efforts to prevent improper and fraudulent enrollment. But more generous financial assistance for ACA plans also expired at the end of last year, pushing more Americans to drop their plans due to rising costs, experts say.” 

• Per a U.S. Office of Personnel Management news release,
  • “The US Office of Personnel Management (OPM) today finalized a rule strengthening the federal government’s ability to address serious misconduct and ensure federal employees continue to meet high standards of integrity throughout their careers. 
  • “The rule advances President Trump’s efforts to build a high-performing federal workforce that serves the American people with professionalism, integrity, and accountability. By modernizing federal suitability regulations, the rule provides agencies and OPM with additional tools to address serious misconduct, protect public trust in government, and support a more consistent approach to accountability across the federal workforce. 
  • “For too long, the federal government has had stronger tools to prevent someone with serious misconduct from entering public service than to address the same misconduct once that individual is already employed,” OPM Director Scott Kupor said. “This rule closes that gap, strengthens accountability, and helps ensure the federal workforce continues to earn the trust of the American people.” * * *
  • “Read the final rule here.” 

• Federal News Network adds,
  • “The Office of Personnel Management is giving many employees in its healthcare and insurance division another chance to accept voluntary incentives and leave their jobs, ahead of their busy season.
  • “OPM told employees in its healthcare and insurance (H&I) division on Monday that most of them will have another shot at opting into the deferred resignation program. Employees who apply and are accepted by OPM will go on paid administrative leave for six months before separating from the agency.
  • “Most of OPM’s healthcare and insurance division employees will also be eligible for early retirement. Federal employees are eligible for early retirement if they have 20 years of service at age 50, or 25 years of service at any age. Eligible employees are allowed to voluntarily retire and earn an immediate annuity.
  • “Eligible employees have until 5 p.m. Eastern on July 13 to accept the DRP or Voluntary Early Retirement Authority (VERA) offers. OPM employees approved for the DRP program will go on paid administrative leave starting Aug. 31, 2026, and will officially separate from the agency on March 1, 2027.”

• Fierce Healthcare tells us,
  • “The Health Resources and Services Administration highlighted on Monday $140 million in newly opened grant funding opportunities focused on rural health priorities like substance use treatment, workforce development and telehealth. 
  • “Applications for the slew of grants opened over the last few weeks and are set to close throughout July. 
  • “HRSA and its administrator Tom Engels, who promoted the funding opportunities during a Monday event at an Iowa critical access hospital, said the programs build on the administration’s priorities of addressing opioid addiction as well as rural healthcare sustainability, the latter of which includes the ongoing $50 billion Rural Health Transformation Program.”
• and
  • “The Trump administration unveiled new efforts to strengthen oversight of the Trusted Exchange Framework and Common Agreement (TEFCA), including hiring a federal IT contractor to provide audit, review and compliance support.
  • “TEFCA is the government-backed health data-sharing initiative that allows patients, providers and payers to share health records. It was mandated by the 21st Century Cures Act back in 2016 and went live in December 2023.” * * *
  • “Alliance Global Tech Inc., a company specializing in federal IT services including cybersecurity, cloud solutions and data analytics, was awarded a five-year contract to provide TEFCA audit, review and compliance support for HHS, according to a new USASpending.gov listing. USASpending.gov is an official open data source of federal spending information, including information about federal awards such as contracts, grants and loans.
  • “The five-year contract is worth up to $5.62 million, structured as a one-year baseline, around $1.28 million, with annual renewal options through June 2031.”

No Surprises Act news

• STAT News reports,
  • “For the past 40 years, it’s been illegal in the U.S. for emergency departments to turn away patients because of an inability to pay. But that only applies to hospitals that contract with Medicare. Houston-based Nutex Health, which runs the hospital Behounek visited, has opted not to at most of its hospitals, so it’s not bound by that law. Nutex claims it complies voluntarily, screening every patient to ensure they’re not dying before demanding payment. But some patients say they were never screened. 
  • “In this way, Nutex is able to have the best of both worlds: It charges emergency department prices while avoiding the responsibilities that usually come with being an ER; namely, taking all comers. It’s just one way Nutex has enriched itself and its investors through exploiting loopholes in laws meant to protect patients. In recent years, that’s meant funneling most of its bills through a surprise billing ban’s arbitration process, even though it’s meant to be a last resort. It’s been a gold mine, quadrupling its revenue. 
  • “There is a growing for-profit business model that is exploiting the benefits and higher revenue that comes with providing emergency care without taking on the risks or obligations of being an emergency department,” said Amber Sabbatini, an associate professor of emergency medicine at the University of Washington. Nutex is one of several companies running microhospitals and freestanding emergency departments, although many are run as satellites of traditional hospitals. They tend to open in wealthier areas where people are likely to have insurance.
  • “The federal arbitration process set up under the No Surprises Act has been a stunning success for providers. Not only are they winning in over 80% of cases, they’re securing payments that are three to nine times in-network rates. The program, known as independent dispute resolution, has also been slammed with far more disputes than federal officials had expected. Because of that, it cost at least $5 billion between 2022 and 2024 alone, potentially wiping out the savings Congress expected it to generate. 
  • “For Nutex, this arbitration process has generated eye-popping returns. In less than a year, the company more than tripled its revenue and profit soared nearly twelvefold. The numbers are so dramatic, in fact, that some investors view the money-making strategy as a house of cards. Several are suing Nutex over what they say is an unsustainable reliance on arbitration wins and a precarious alignment with HaloMD, a middleman whose tactics are the subject of multiple lawsuits.”

From the Food and Drug Administration front,

• The American Hospital Association News reports,
  • “The Food and Drug Administration has identified a Class I recall of North American Rescue first aid kits containing TRUE METRIX Blood Glucose Monitoring Systems by Trividia, which have also been recalled. The FDA said the Trividia recall is due to an issue with an E-5 error code. Trividia has reported 114 serious injuries and one death associated with its recall. The FDA notice said that North American Rescue has not reported any serious injuries or deaths associated with its issue as of March 27.” 
    
• Fierce Pharma relates,
  • “The FDA has accepted two Abbreviated New Drug Applications from generics powerhouse Sandoz for its copycat versions of Eli Lilly’s tirzepatide.The applications are for generic versions of Mounjaro and Zepbound, which help treat patients with type 2 diabetes and obesity, respectively. If Sandoz wins the approvals, the company believes it could launch “one of the first generic tirzepatide products” in the U.S., according to a June 29 release.The company noted that it developed its generic tirzepatide in-house.” 
• and
  • “Viridian Therapeutics has scored FDA approval for Lumvoa to treat thyroid eye disease (TED), triggering competition with Amgen’s blockbuster Tepezza, the only other medicine on the market for the eye-bulging autoimmune condition.
  • “The FDA nod applies to adults with active or chronic TED, making it the first approved therapy in its anti-insulin-like growth Factor 1 receptor (IGF-1R) class to carry labeling that includes data in both active and chronic TED, the company pointed out.
  • “In addition to this advantage, Viridian hopes to count on a convenience edge over Amgen’s IGF-1R Tepezza.”

• BioPharma Dive tells us,
  • “On Friday, [June 26] Replimune said that the Food and Drug Administration has accepted the resubmission for its cancer drug RP1, with a decision expected by Aug. 2 and an advisory committee set to convene in July to discuss the twice-rejected application. The latest move is another signal of the changing attitude of the FDA, which was accused of moving the goal post or providing conflicting feedback to companies, leading to delayed or rejected applications under the now-exited leaders Marty Makary and Vinay Prasad. Multiple other companies that faced hurdles under the prior leadership are now gaining new chances for their applications.

• MedTech Dive informs us,
  • “Edwards Lifesciences on Friday received Food and Drug Administration clearance for the Ecliptis left atrial appendage exclusion system, an entry in the FDA’s 510(k) database shows.
  • “The implantable clip is intended to close the left atrial appendage, or LAA, a small pouch-like structure in the heart’s left atrium, to prevent blood clots from forming that can lead to stroke.
  • “The Edwards device is positioned to compete directly with AtriCure’s AtriClip platform and Medtronic’s Penditure system, BTIG analyst Marie Thibault told clients in a note Monday. Boston Scientific and Abbott sell LAA occlusion devices that are implanted in minimally invasive procedures.”

• Per a FDA news release,
  • “Today, the U.S. Food and Drug Administration announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain.
  • “The FDA launched the PreCheck Pilot Program on February 1, 2026, in response to Executive Order 14293 signed by President Trump in May 2025 and following a public meeting on challenges and opportunities to facilitate domestic manufacturing. The pilot program is intended to support the development of new U.S. pharmaceutical manufacturing facilities by encouraging earlier FDA engagement and providing a more predictable regulatory pathway for companies that plan to manufacture drugs for the U.S. market, helping support greater access to critical medicines for Americans.” * * *
  • “For more information visit the FDA PreCheck Pilot Program webpage.”

From the judicial front,

• Federal News Network reports,
  • “The Supreme Court on Monday dramatically expanded presidential power, upholding President Donald Trump’s firings of the heads of independent federal agencies with one important exception: the Federal Reserve.
  • “The justices allowed Fed governor Lisa Cook to stay in her job while she fights the Republican president’s effort to fire her over allegations of mortgage fraud, which she has denied.
  • ‘But other than at the nation’s central bank, with its role of setting interest rates, the court held that presidents have free rein to fire agency heads at will, despite federal laws that require a cause for such dismissals and a 91-year-old decision that had limited executive authority.
  • “With the six conservative justices in the majority, the nine-member court jettisoned its unanimous [1932] decision in Humphrey’s Executor that had limited when presidents can fire agencies’ board members — in part to try to ensure decision-making free of political influence.
  • “We hold that such protection from removal is contrary to the separation of powers enshrined in the Constitution,” Chief Justice John Roberts wrote for the court.”

From the public health and medical / Rx research front,

• MedPage Today reports,
  • “Getting a COVID and flu shot on the same day was not associated with an increased risk of adverse events, according to a target trial emulation using electronic health data from the VA.
  • “Compared with influenza vaccination alone, coadministration of COVID and influenza vaccines was not associated with an increased risk for any of the three composite outcomes of serious or life-threatening, clinically significant, or less severe or self-limiting adverse events, reported Ziyad Al-Aly, MD, of Washington University in St. Louis, and colleagues in the Annals of Internal Medicineopens in a new tab or window.
  • “Of the 46 individual adverse events assessed, two less severe or self-limiting adverse events had “nominal statistical significance” with coadministration — a slightly higher risk of syncope (risk ratio [RR] 1.09, 95% CI 1.02-1.17) and a slightly lower risk for tinnitus (RR 0.95, 95% CI 0.92-0.99) — but no risks were statistically significant after correcting for multiple comparisons.
  • “Even in today’s world, where people have been exposed to multiple prior COVID-19 vaccines and their immune systems have been shaped by at least one COVID-19 infection, vaccines have a reassuring record of safety,” Al-Aly told MedPage Today. “We looked at 46 different outcomes — literally leaving no stone unturned — and we came up empty-handed.”
• and
  • “Lung cancer screening criteria based on the duration of smoking appeared to be a better option for determining individuals at highest risk for lung cancer in an observational study.
  • “Compared with USPSTF recommendations, criteria based on the minimum number of years smoked (20, 30, or 40 years) identified more individuals most expected to benefit from screening.
  • “A threshold of at least 40 years of smoking was also more effective than the USPSTF in excluding people least expected to benefit from screening.”

• Health Day relates,
  • “Brain imaging could help doctors use magnetic stimulation to better treat depression.
  • “Brain imaging helps find specific targets for stimulation.
  • “People treated using brain imaging had lower symptoms and better response rates.
• and
  • “Women with preeclampsia have increased risk of developing hypertension and chronic kidney disease (CKD) later in life, according to a study published online May 19 in BJOG: An International Journal of Obstetrics and Gynaecology.” * * *
  • “The most surprising finding was how clearly the amount of protein in the urine during preeclampsia was linked to the risk of later high blood pressure and chronic kidney disease,” Dr. Vestergaard said in a statement. “Women with moderate to severe protein excretion had a higher risk of both conditions compared with women with low or no protein excretion.”
    
• MedTech Dive informs us,
  • ‘Johnson & Johnson said last week that it has started pivotal development of a Shockwave Medical device for treating calcified carotid arteries.
  • “J&J designed the investigational device, called SkyRunner, to repurpose Shockwave’s intravascular lithotripsy technology for breaking up calcium in the carotid artery.
  • “A physician in Michigan recently treated the first patient in the investigational device exemption clinical program for SkyRunner.”

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

• Fierce Healthcare reports,
  • “As drug costs and spending continue to rise, the demand for solutions opens the door to closer collaboration between payers and manufacturers.
  • “Brian Evanko, president and chief operating officer for the Cigna Group, and Miguel Fernández Alcalde, president of EMD Serono, spoke at a keynote session at AHIP 2026 earlier this month, discussing the delicate balance between promoting innovation and ensuring affordability.
  • “The two companies are longtime partners and most recently worked alongside one another on the cost of fertility treatments. Evernorth operates Freedom Fertility, the largest provider of fertility specialty pharmacy services in the U.S., while EMD Serono is a leader in fertility on the manufacturer side.
  • “Evanko said the partnership deepened last year, when both worked with the Trump administration to drive down the cost of certain fertility treatments. Patients can sign up for Trump Rx and find treatments at a cash-pay price of between $1,000 and $1,500, depending on the number of doses in a course of treatment, he said.”
• and
  • “AI startup Doctronic is partnering with Simple HealthKit, an at-home health screening platform, to offer consumers end-to-end diagnostic screening integrated with virtual clinical care.” * * *
  • “Simple HealthKit offers at-home screening kits directly to consumers through its website and retail partners and also works with health plans, providers and public health programs.
  • “Through this partnership [with Doctronic], we are initially focused on the conditions where we can deliver the greatest immediate impact across our national health plan and retail partnerships, with plans to expand across our broader portfolio over time. Our vision is to make high-quality healthcare accessible for all,” Simple HealthKit co-founder and CEO Sheena Menezes, Ph.D., told Fierce Healthcare.
  • “Doctronic touts that it’s the first AI system legally authorized to practice medicine in the U.S. The startup offers a free personal AI doctor via chatbot to help navigate symptoms and answer medical questions and can connect users with a licensed physician through a virtual visit. Doctronic, available in all 50 states, is being tested by the state of Utah to refill prescriptions as part of a pilot program.”

• Beckers Hospital Review relates,
  • “Provider compensation continued to rise in 2025, but a new survey suggests health systems may be nearing the limits of what they can sustainably support.
  • “According to the “AMGA 2026 Medical Group Compensation and Productivity Survey,” overall clinical compensation increased 4.3% in 2025. The survey includes data from 451 medical groups and health systems representing nearly 188,000 providers across more than 190 specialties.
  • ‘The increase comes as reimbursement growth remains largely stagnant, creating a widening gap between provider pay and collections.
  • “Over the past several years, provider compensation has increased, but approximately half of the increases have been supported by ongoing growth in wRVU production,” Fred Horton, president of American Medical Group Association Consulting, said in a June 24 news release shared with Becker’s. “In a marketplace with stagnant reimbursement, this is necessary to afford the increases in total cash compensation, but it is not sustainable. At some point productivity will top out, and providers are already adjusting their FTE and seeking alternative work arrangements in response to increased workloads.”
  • “Primary care compensation increased 3.7% in 2025, while medical specialties saw a 4.3% increase and surgical specialties experienced a 3.2% increase. Compensation for radiology, anesthesiology and pathology providers grew 5.7%, the highest increase among specialty categories tracked by the survey.”

• Fierce Pharma tells us,
  • “Likely thanks to the Juneteenth federal holiday, prescriptions for both Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo were lower compared with their highest. For the week ended on June 19, Foundayo logged 20,594 total scripts, down from 21,648 the prior week, according to IQVIA data cited by Jefferies. 
  • “For oral Wegovy, the numbers were about 152,000 for the June 19 week, a roughly 9,500 (5.9%) decrease from the prior week. 
  • As Jefferies’ analysts noted, most GLP-1 scripts were down or rather flat in their weekly comparisons. Injectable Wegovy added about 1,000 (0.3%) scripts, landing at 315,000. Mounjaro essentially saw no change, at 804,000.
  • Lilly has previously noted that it takes time to build awareness for Foundayo as a new brand, whereas Novo benefits from familiarity with the Wegovy moniker.” 

• The Wall Street Journal informs us,
  • “Ipsen IPN said it agreed to buy Kartos Therapeutics in a deal valued at up to $1.75 billion that seeks to strengthen the French drugmaker’s pipeline of cancer medicines.
  • “Through the acquisition, Ipsen adds a late-stage drug candidate for myelofibrosis–a rare blood cancer–to expand its portfolio in oncology, it said Monday. Ipsen is paying $450 million upfront to take over Kartos, with additional payments of up to $1.3 billion subject to regulatory and sales targets.
  • “The deal builds on Ipsen’s acquisition of oncology specialist ImCheck Therapeutics for up to 1 billion euros ($1.14 billion) last year after Somatuline, the company’s top-selling medicine, faced generic competition in recent years.
  • “Redwood City, Calif.-based Kartos is a privately held pharmaceutical company that was founded after the licensing from Amgen of an experimental cancer drug. It is developing the drug, navtemadlin, as an add-on therapy to the standard-of-care treatment for patients with myelofibrosis.”

• BioPharma Dive points out,
  • Royalty management company Zymeworks is buying Theravance Biopharma, announcing Monday a $929 million deal that gives it partial rights to Theravance’s COPD drug Yupelri, along with payouts due from its co-development of Trelegy with GSK and an antibiotic for hospital-acquired infections.
  • Per deal terms, Zymeworks will pay $17 a share, along with a second potential payout should Zymeworks license or sell a drug called ampreloxetine that Theravance has developed for a type of low blood pressure. Zymeworks is partially financing the deal by borrowing $350 million from Omers Life Sciences, which will be paid off with Yupelri’s cash flow.
  • Theravance initiated a strategic review of its business in 2024, which accelerated earlier this year when ampreloxetine missed the primary goal of a Phase 3 trial in nervous-system driven low blood pressure in people with the rare disease multiple system atrophy. In a statement, independent Board Chair Susannah Gray said “this transaction achieves the greatest value for Theravance Biopharma shareholders.”

• OptumRx, writing in LinkedIn, discusses the “Top 5 ways Optum Rx is putting AI into action.”