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Wednesday, July 1, 2026

Vertex OKd for Expanded Use of CASGEVY® for Ages 2 Years and Older With Sickle Cell

 - First and only approved genetic therapy to treat children as young as 2 years for both severe sickle cell disease and transfusion-dependent beta thalassemia -

- Approximately 5,500 additional children in the U.S. are now eligible for this established one-time therapy, expanding upon the prior FDA approval in people 12 years and older -

- Regulatory review for label expansion underway in the Kingdom of Saudi Arabia and United Kingdom -

https://news.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-approval-expanded-use-casgevyr-treatment

US Sees 10 Million Barrels Via Hormuz Sapping Iran Oil Leverage

 Commercial shipping through the Strait of Hormuz has surged over the past few weeks, with American military support helping boost oil flows to more than 10 million barrels per day, a US official said.

The increase since President Donald Trump signed an interim peace agreement with Iran represents a big jump in traffic since the war paralyzed flows. That has caught Tehran off guard, underscoring its now-limited ability to halt traffic through the corridor and helping spark recent attacks around the strait, said the official, who requested anonymity to describe internal thinking.

The Islamic Republic seized leverage by choking off the strait during the conflict, encouraging Trump to embrace a ceasefire and negotiations as dwindling crude reserves and surging energy prices made the war politically untenable. The regime has continued to insist that it will keep some control over maritime traffic, even signaling some ships may ultimately have to pay transit fees.

Even before the truce, the US took actions to weaken Tehran's control of the strait. Layers of defensive military support coordinated by US Central Command — including air power and naval forces — have given shippers greater confidence to move oil through the southern portion of the waterway closer to Oman, the official said.

The 10 million figure is broadly in line with shipping data previously reported by Bloomberg.

Navigation in the strait is hanging over indirect talks this week involving US negotiators Steve Witkoff and Jared Kushner in Qatar, where the fate of Iran's nuclear capabilities and its ability to control traffic through Hormuz are central issues.

According to the official, the US is pressing Iran to comply with the maritime provisions of the memorandum of understanding and establish a long-term agreement guaranteeing open commercial transit. The memo provides for toll-free traffic during the 60-day negotiating period and leaves its status beyond that up for discussion. Trump and US Secretary of State Marco Rubio have said that neither tolls nor maritime service fees would be unacceptable in a final deal.

Iran has not publicly accepted the US's demands for the strait.

Iran breached the US measures last week with a drone attack on a Singapore-flagged container ship. The incident set off a wave of retaliatory strikes that put the two countries' truce on shaky ground.

Trump's decision to call off more strikes and let negotiations proceed was the latest sign that he's unwilling to risk more economic pain stemming from the war. The US leader has said he doesn't want to be remembered as Herbert Hoover, who was president during the 1929 stock market crash that triggered the Great Depression.

Analysts have warned that those economic and political considerations could embolden Iran to draw out the talks, potentially sapping Trump's capability to force Tehran into key concessions. Restoring traffic through Hormuz represents a return to the status quo prior to the US and Israel launching the war, rather than a new breakthrough.

Still, the administration sees last week's attacks as evidence that Tehran is attempting to reassert control over the strait after realizing its ability to paralyze traffic is limited, according to the official.

Iran's limited capacity to monitor traffic far from its coastline has hampered its awareness of activity in the southern transit corridor, leading to a relatively late realization of the extent of the region's oil flows, the official said.

Before the war, the Strait of Hormuz handled about a fifth of the world's oil and liquefied natural gas supplies, with roughly 20 million barrels of crude and fuel flowing on average per day. With at least 10 million now getting through daily, combined with 5 million via alternative routes, flows are approaching normal levels.

Even so, getting Iran to back off its desire to control the strait won't be easy. Iranian chief negotiator Mohammed Bagher Ghalibaf on Tuesday told state television that sovereignty over the corridor belongs to Iran and Oman. While Oman's top diplomat has said plans for Hormuz don't entail the imposition of "transit fees," the country has told European officials some charges may be necessary, Bloomberg reported.

Shippers, oil industry officials and other stakeholders have warned that any tolls — or fees masquerading as them — are an unacceptable violation of international law that would set a dangerous precedent, potentially encouraging charges in other waterways.

Vessels continued sailing through the strait after the tit-for-tat attacks, a sign of increased confidence in the US posture and Iran's limited reach. The sustained traffic may have also been driven by expectations Iran would avoid attacks that have catastrophic, ecological consequences, the US official said.

Last week's strike on the cargo ship, for instance, damaged its bridge but caused no casualties, allowing the vessel to sail on.

https://finance.yahoo.com/energy/articles/us-sees-10-million-barrels-162440474.html

Micron, GM in semiconductor supply deal for vehicles

 Micron Technology Inc. and General Motors Company signed a strategic supply agreement for memory and storage platforms used for vehicle production, the two companies said in a press release on Wednesday.

Micron said that this deal will be supported by its ongoing investments to expand supply for the auto industry in the United States, including a $2 billion investment to modernize its manufacturing plant in Manassas, Virginia.

"As demand for memory and storage continues to grow, we are investing to extend supply availability, expand capacity and align more closely with our customers to improve supply predictability across the automotive ecosystem," Micron CEO Sanjay Mehrotra commented.

https://breakingthenews.net/Article/Micron-GM-ink-semiconductor-supply-deal-for-vehicles/66612650

CMS seeks new powers to remove ‘problematic’ Medicare providers

 CMS wants to raise Medicare home health payments by 2.4% in 2027 while arming itself with sweeping new authority to remove “problematic” and noncompliant providers — and recoup their payments — across the entire Medicare program.

The CY 2027 Home Health Prospective Payment System proposed rule, issued July 1, pairs a $420 million payment increase for home health agencies with a program integrity package the agency estimates would save about $82 million a year. The proposal would reverse the 1.3% cut CMS finalized for 2026, driven largely by the agency declining to impose a new permanent behavioral adjustment this year.

The enrollment provisions — though housed in a home health rule — would reach every Medicare provider and supplier type, hospitals included.

“These proposals would give CMS stronger tools to protect Medicare beneficiaries and taxpayer dollars from fraud, waste and abuse,” CMS Administrator Mehmet Oz, MD, said in a news release. “The Trump Administration is committed to ensuring only qualified providers and suppliers participate in Medicare while preserving access to high-quality care for patients across the country.”

Eight things to know: 

1. CMS wants broader authority to revoke Medicare enrollment. CMS is proposing several new grounds for denying or revoking Medicare enrollment, including when a provider or supplier is deemed to present a high risk of fraud, waste and abuse because it operates in an area with an excessive concentration of providers or suppliers. The agency also proposes denying or revoking enrollment for providers convicted within the past 10 years of misdemeanors related to sexual assault or financial misconduct.

2. CMS could recover more money from noncompliant providers. The agency proposes making all Medicare enrollment revocations retroactive to the date a provider fell out of compliance, allowing it to recover payments already made rather than only those made after a revocation notice. The change would prevent noncompliant providers from retaining Medicare payments they were not entitled to receive, according to CMS. 

3. The proposal includes a 2.4% payment increase for home health agencies. CMS estimates Medicare payments to home health agencies would increase by about 2.4%, or $420 million, in 2027. The update reflects a proposed 2.1% payment increase and a 0.3% adjustment related to fixed-dollar loss payments.

4. A temporary 3% pay cut would continue. CMS is proposing another temporary 3% reduction to the national standardized payment rate as it continues recouping retrospective overpayments tied to implementation of the Patient-Driven Groupings Model. The agency is not proposing an additional permanent payment adjustment for 2027 after determining more recent utilization changes may reflect factors beyond the payment model itself.

5. CMS wants to expand access to palliative care at home. The agency emphasized that skilled palliative care services can already be provided under the Medicare home health benefit for eligible patients with serious illnesses. CMS also plans to issue additional guidance after publication of the final rule to encourage broader use of community-based palliative care before patients qualify for hospice.

6. Home health quality data could be reported months sooner. CMS proposes shortening the Outcome and Assessment Information Set submission deadline from 4.5 months to 45 days. The agency estimates the change would make publicly reported home health quality information available up to three months sooner.

7. Home health agencies would see additional payment model updates. CMS also proposes recalibrating Patient-Driven Groupings Model case-mix weights, updating low utilization payment adjustment thresholds, revising comorbidity adjustment subgroups and updating outlier payment policies for 2027.

8. The rule includes several other Medicare policy changes. Additional proposals would expand Medicare coverage for certain home infusion pumps and drugs beginning in 2027, revise home health quality reporting requirements, seek public input on a home health-specific wage index and require durable medical equipment suppliers participating in the competitive bidding program to report the country of origin for certain products.

Click here to access the 269-page proposed rule.

https://www.beckershospitalreview.com/finance/cms-seeks-new-powers-to-remove-problematic-medicare-providers-8-things-to-know/

Ipsen's M&A team strikes again, adding Memo in $700m deal

 In its second acquisition of the week, Ipsen will take control of Memo Therapeutics and a first-in-class drug for BK polyomavirus, which can cause serious complications in some transplant patients.

The French pharma group will pay €200 million ($228 million) to shareholders in the Swiss biotech on the closing of the deal, which is due in the third quarter of this year, and another €500 million or so if the antibody – called potravitug – meets development, regulatory approval, and sales-based targets.

The new acquisition comes as the ink is barely dry on Ipsen's larger $1.75 billion play for US cancer biotech Kartos Therapeutics, which was announced on Monday and included an upfront payment of $450 million. That was the latest in a string of pipeline-building deals for Ipsen in the last couple of years across its core therapeutic categories of oncology, neurology, and rare diseases.

The Memo deal falls into the latter camp as, while the BK polyomavirus is common, it usually remains inactive in the body and only causes problems in people with a weakened immune system, including kidney transplant recipients taking anti-rejection medications.

Around a third of kidney transplant patients will show high levels of the virus in the blood within the first year of their procedure, placing them at risk of BK polyomavirus-associated nephropathy (BKPyVAN), which can lead to transplant failure.

Potravitug, which targets a capsid protein (VP1) in the virus, is in the phase 2, placebo-controlled SAFE KIDNEY II trial in kidney transplant recipients, which has already revealed that the antibody can achieve dramatic reductions in BK polyomavirus levels in the blood and histological improvements in BKPyVAN, a condition with no approved treatments.

Around a quarter (24.4%) of potravitug-treated patients saw their viral levels reduce to undetectable levels after treatment, compared to 13% of the placebo group, while a 100-fold fall was seen in 40.3% and 24.7% of patients, respectively, at 38 weeks.

Buoyed by the encouraging results, Memo is planning to start a phase 3 trial – SAFE KIDNEY III – later this year.

BKPyVAN is a significant clinical challenge in kidney transplant recipients, according to Darshana Dadhania of Weill Cornell Medicine, medical director of the Kidney and Pancreas Transplant Programme and assistant director of the Immunogenetics and Histocompatibility Lab.

"With no approved targeted treatment, clinicians are forced to reduce immunosuppressive therapy, which increases the risk of graft rejection and graft loss," she said. "Given the frequency and serious consequences of BK virus reactivation, there remains an urgent need for effective therapy that avoids this trade-off."

Over 100,000 kidney transplants are performed each year worldwide, including more than 28,000 in the US, with approximately 90,000 patients on the waiting list.

https://pharmaphorum.com/news/ipsens-ma-team-strikes-again-adding-memo-700m-deal

US shares Trump Accounts investment lineup

 The United States Department of the Treasury unveiled on Wednesday the investment lineup for Trump Accounts.

"At launch, all contributions to Trump Accounts will be invested in the State Street SPDR Portfolio S&P 500 ETF (SPYM), a low-cost exchange-traded fund (ETF) that tracks the performance of the S&P 500 Index," the Treasury detailed.

Additional low-cost index ETFs also include BlackRock Inc.'s iShares Core S&P 500 ETF (IVV) and iShares Core S&P total US Stock Market ETF (ITOT), as well as Vanguard Total Stock Market ETF (VTI) and State Street SPDR Portfolio S&P 1500 Composite Stock Market ETF (SPTM). The Treasury has yet to share when investment election functionality will become available.

https://breakingthenews.net/Article/US-shares-Trump-Accounts-investment-lineup/66615624

'AP: Trump Administration Suspends Funding for New York's Medicaid Fraud Unit'

 The Trump administration on Tuesday said it would freeze federal funding for New York's Medicaid Fraud Control Unit (MFCU), a state agency responsible for investigating and prosecuting fraud in the safety-net government healthcare program.

In a letter sent to New York officials, HHS Inspector General Thomas March Bell accused the state of not securing enough criminal indictments and convictions and said millions of dollars in funding would be suspended through at least Sept. 30.

The move is the second suspension of a state Medicaid fraud unit this year by the Republican Trump administration, and part of a barrage of anti-fraud actions it has aggressively promoted in the healthcare sector. They have included the creation of a new task force, targeted investigations, funding deferrals, and demands for revalidation of healthcare providers that have touched all states but focused largely on Democratic ones.

The pulled funding also comes after the administration admitted a glaring error in figures meant to help justify a fraud probe into New York's Medicaid program earlier this year, a mistake critics said revealed a Trumpian tendency to attack first and verify the facts later.

New York Attorney General Letitia James, a Democrat, immediately vowed to fight Tuesday's funding freeze.

"During my time as Attorney General, my office has recovered over $627 million for Medicaid and was recognized by this very administration for leading the nation in anti-fraud efforts," she wrote. "We are considering all legal options to stop this outrageous action."

Letter Accuses New York of Low Performance

Bell's letter to James and New York MFCU Director Amy Held argues that the unit is moving too slowly on cases and amassing too few indictments and convictions for wrongdoing in the Medicaid system. It notes that compared to four similarly-sized units in other states, it secured the lowest number of criminal fraud convictions between 2023 and 2025.

The letter acknowledges that one reason the state has fewer criminal convictions than other states is that it made a deliberate choice to focus on "high-impact, complex fraud cases" rather than smaller-scale individual cases, but says that tradeoff didn't produce sufficient results.

"Enough is enough," Bell wrote. "The New York MFCU has failed to comply with the terms and conditions of its MFCU grant award."

Bell said in the letter that the funding suspension could be lifted before Sept. 30 if New York takes corrective action, "showing it has remediated concerns that formed the basis for this suspension." He said if the state doesn't fix the problems, the freeze will continue.

New York Officials Dispute the Trump Administration's Claims

New York's attorney general's office said in a statement that it has "long been recognized as a national leader in effectively investigating and prosecuting Medicaid fraud schemes," including by the HHS inspector general's office. A 2025 report from the office notes that New York is one of four states that made up half the total civil recoveries in that year.

A spokesperson for the attorney general's office said most of the unit's criminal convictions focus on company owners, executives, and corporations that would return large amounts to Medicaid.

"Under the leadership of Governor Kathy Hochul, New York State has taken concrete steps to root out waste, fraud, and abuse in Medicaid," said New York health department spokesperson Cadence Acquaviva. "We look forward to the day when these disingenuous attacks end."

The funding cutoff follows a similar move in Hawaii. In early June, Bell told Hawaii officials that Medicaid fraud funding would be cut off there, saying that it had a 3-year stretch without a Medicaid fraud indictment or conviction.

Joan Alker, executive director and co-founder of Georgetown University's Center for Children and Families, said there's an irony in the federal government cutting off money intended for prosecuting fraud when its stated goal is to do just that.

"If you want to fight fraud, don't take away money from states' fraud control units," she said. "I chalk this up to more political theater to distract voters from historic Medicaid cuts before the midterms."

The Department of Justice named the MFCUs in both Hawaii and New York as prosecutorial partners in a news release about a national Medicaid fraud takedown last week.

Move Follows Months of Federal Warnings and Deferrals

For months, the Trump administration has contended that states -- especially some Democratic-led ones -- have been lax about fraud in social safety-net programs, including Medicaid.

It has demanded at least five states, four of them governed by Democrats, share information about how they identify, prevent, and address Medicaid fraud.

The federal government has also withheld some Medicaid funding from Minnesota and California over fraud concerns. Minnesota Gov. Tim Walz, a Democrat who was Kamala Harris' 2024 running mate, accused Trump of making cuts because of retribution.

The fraud-busting efforts have also targeted Medicare programs. Mehmet Oz, MD, MBA, who leads CMS, announced a 6-month moratorium on new enrollments for providers of hospice and home care nationally.

https://www.medpagetoday.com/publichealthpolicy/medicaid/122019