Healthcare & Health Industry Wire — Week of November 10, 2026: CVS splits in two, the first factor XIa stroke drug, and $5.45 billion cut from hospital drug payments
This week's U.S. healthcare scan covers CVS Health's breakup into two companies, the first factor XIa inhibitor approved for stroke prevention, a class-wide vision warning on GLP-1 drugs, Medicare's 2027 payment rules and $10 billion in rural awards, and two hospital deals that moved.
Coverage window: November 3 – November 10, 2026
This edition covers U.S. healthcare developments published or completed between November 3 and November 10, 2026.
The Food and Drug Administration (FDA) approved the first drug in a new class of blood thinners, for people who have already had a stroke. It added a vision warning to every GLP-1 weight-loss and diabetes drug on the market. CVS Health said it will break itself in two. Medicare finished its 2027 payment rules in one week, including one that cuts about $5.45 billion from what hospitals are paid for drugs in 2027. And hospitals wrote off $132 billion last year while their technology budgets grew.
1. Health-tech funding and products
Hospitals wrote off $132 billion while their technology budgets grew
Status: Kodiak Solutions published the analysis on November 4. The window's coverage of it ran November 9.
Hospitals lost an estimated $132 billion in 2025 to bad debt and final claim denials, roughly 10% of net revenue. Write-offs rose nearly 18% from 2024. 1
The estimate comes from Kodiak Solutions, a revenue cycle analytics company, and covers all 6,100 registered U.S. hospitals. The hospitals running Kodiak's software accounted for $52 billion of it. 1
Two rates have held flat for three years. Bad debt sits near 7% of net revenue, and final denials near 3%. 1
The dollars grow anyway, because individual denials are larger and total hospital revenue is higher. A stable rate on a rising base is still a rising loss. 1
Technology budgets moved the other way. Forrester put hospital spending on technology at $69 billion for 2026, up 7.6%, and Kodiak cites that figure in its own analysis. 1
Revenue cycle work has been the busiest corner of that spending, especially artificial intelligence (AI) agents aimed at prior authorization, the insurer approval a hospital needs before some tests and procedures. 1
Kodiak's researchers wrote that providers may not be separating the technology needed to run a revenue cycle from the capability needed to improve its results. 1
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The AI scribe that raised $340 million cut 18% of its staff
Status: Heidi Health told employees on November 6. The cuts take effect over the following weeks.
Heidi Health, a Melbourne company whose software writes up clinical notes from a patient visit, cut 18% of its global workforce. The company had 600 employees, so 108 people are affected. 2
Two co-founders, Waleed Mussa and Yu Liu, resigned the day before. 2
The timing is what makes it notable. In September the company closed a $100 million Series C and secured $240 million in nondilutive financing from General Catalyst's Customer Value Fund, $340 million in all, at a $900 million valuation. 2
Chief executive Thomas Kelly told staff that the company had not been putting its investment into the right teams and markets. Heidi said it would bring research and development under a single roadmap and give its newer product businesses their own teams. 2
"To those who are affected, I'm truly sorry for the impact this will have on you, your families and your teammates," Kelly said. 2
For a practice buying a documentation tool, the question this raises is contractual rather than technical. Clinical notes belong in the medical record, and a vendor that trims support staff and consolidates products is a vendor whose roadmap changed after the contract was signed. 2
Zipline raises $1.5 billion to build more delivery drones
Status: The company announced the round on November 9.
Zipline raised $1.5 billion at a $21.5 billion post-money valuation. Paradigm, WCM Investment Management and Layer Global led the round, with Valor Equity Partners, Fidelity, Tiger Global, Salesforce Ventures, Uber, ARK Invest and J.P. Morgan participating. 3
The San Francisco company will spend it on U.S. manufacturing and hiring. 3
Healthcare is where Zipline's public contracts sit. Its drones carry blood, vaccines and medical supplies to health facilities, and deliver prescriptions to patients' homes. 3
The largest commitments are outside the United States. Côte d'Ivoire signed an eight-year agreement this year to grow from one distribution hub in Daloa to 10, covering 2,200 health facilities and 12 million people. Rwanda signed a nationwide expansion. Both followed a 2025 award of up to $150 million from the U.S. State Department across five African countries. 3
Domestic work runs through health systems. Cleveland Clinic launched home prescription delivery with Zipline this year, within five miles of its Beachwood, Ohio campus, with tracking through the MyChart patient portal. Mayo Clinic uses it for patients in hospital-at-home programs in Jacksonville, Florida and Rochester, Minnesota. 3
Funding and deal briefs
Status: Three announcements between November 3 and November 5.
- nPhase, $30 million Series D, November 3. Viking Global Investors led the round, the company's first equity raise since 2017. nPhase sells an AI-native platform that pulls trial data from sites, laboratories, patients and sensors into one place, checks it as it arrives, and drafts statistical programming. Its agents flag discrepancies, and the company says human experts keep decision authority. Chief executive Scott Climes said the money goes to expanding those agent capabilities. 4
- Ellipsis Health acquires Kouper Health, November 5. Ellipsis sells Sage, a voice agent that reads vocal biomarkers for anxiety and depression and handles follow-up calls and texts. Kouper builds the plumbing that puts such an agent inside a health system, including electronic health record integrations and a longitudinal map of a patient's care across emergency, inpatient and urgent care. Terms were not disclosed. 5
2. Pharma and device FDA news
The first factor XIa inhibitor, for a second stroke
Status: The FDA approved Sunharbo on November 9. The label carries no launch price.
Sunharbo (asundexian) 50 mg tablets is the first factor XIa inhibitor approved in the United States. It is given with antiplatelet therapy to reduce the risk of stroke in adults who have recently had a mild-to-moderate non-cardioembolic ischemic stroke, or a high-risk transient ischemic attack (TIA, often called a mini-stroke). 6
The terms in that indication decide who qualifies. Non-cardioembolic means the clot did not travel from the heart, which rules out the atrial fibrillation patients who take blood thinners long term. A TIA produces stroke symptoms that resolve. 6
Factor XIa is the activated form of a clotting protein. The drug slows clot formation, and Bayer sells it. 6
The evidence comes from OCEANIC-STROKE, a randomized, double-blind, placebo-controlled phase 3 trial that enrolled 12,327 adults. Participants entered within 72 hours of symptoms, with a stroke severity score of 15 or lower, and everyone received antiplatelet therapy. 6
Sunharbo cut the risk of ischemic stroke by 26% compared with placebo over a median 14.2 months of treatment. 6
Bleeding is the trade-off every stroke-prevention drug is judged on. The overall rate of major bleeding was similar between the two groups, and it was higher with Sunharbo in patients older than 75 and during the first 90 days. Gastrointestinal bleeding was more common on the drug. 6
The label sets boundaries worth knowing. Sunharbo should be stopped at least 24 hours before elective surgery or an invasive procedure, and for at least 24 hours after thrombolysis, the clot-dissolving treatment given in acute stroke. It is not recommended in moderate or severe liver impairment, and combining it with medicines such as carbamazepine can reduce its effect. 6
Diarrhea was the most frequent adverse reaction, reported in 3% or more of treated patients. The agency granted Fast Track and Priority Review designations and approved the drug for Bayer HealthCare Pharmaceuticals of Whippany, New Jersey. 6
"Stroke is a leading cause of disability and death in the United States, and survivors are at risk of having another stroke," said Hylton V. Joffe, director of the FDA office that reviews cardiology and hematology drugs. 6
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Every GLP-1 drug now carries a vision warning
Status: The FDA issued the drug safety communication on November 9. Labeling changes follow from manufacturers.
The agency is requiring every maker of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) to add a warning about non-arteritic anterior ischemic optic neuropathy (NAION) to the Warnings and Precautions section of its label. NAION is a rare condition that causes sudden, painless loss of vision in one eye, and the loss can be permanent. 7
The requirement covers the whole class: semaglutide (Ozempic, Rybelsus, Wegovy), tirzepatide (Mounjaro, Zepbound), liraglutide (Victoza, Saxenda), dulaglutide (Trulicity), orforglipron (Foundayo, approved in 2026) and the older fixed-dose combinations. 7
The evidence is a meta-analysis of 126 randomized trials covering 134,253 patients and 288,879 person-years of exposure. FDA identified 15 probable NAION events: 10 in patients on a GLP-1 RA, five on placebo, and none on other glucose-lowering drugs. 7
That works out to 6.4 cases per 100,000 person-years on a GLP-1 RA against 3.8 on a comparator. In the general population over age 50, published estimates run from 2.3 to 10.2 cases per 100,000 people per year. 7
A second analysis points the same way and shows how hard the comparison is. In FDA's Sentinel database, adults with type 2 diabetes starting a GLP-1 RA had 30 to 32 NAION events per 100,000 person-years. Users of sodium-glucose cotransporter-2 (SGLT-2) inhibitors, another diabetes drug class, had 31, and users of dipeptidyl peptidase-4 (DPP-4) inhibitors had 26. 7
The risk against SGLT-2 inhibitors was not statistically significant. Against DPP-4 inhibitors it was, with a hazard ratio of 1.43. 7
Animal data turned up no mechanism by which these drugs would raise the risk. Cases have been reported for every marketed GLP-1 RA. 7
FDA told clinicians to refer a suspected case to an ophthalmologist promptly and to consider stopping the drug unless the benefit clearly outweighs the risk. Patients who have already had NAION are told to discuss with their prescriber whether to continue. 7
A dual-targeted drug for head and neck cancer, given under the skin
Status: The FDA granted accelerated approval on November 5.
Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech) won accelerated approval for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed after platinum-based chemotherapy and an anti-PD-(L)1 antibody. 8
The indication excludes patients whose cancer is oropharyngeal and linked to human papillomavirus (HPV), a distinction the trial population was screened for. 8
It is the first dual-targeted therapy approved in this setting, hitting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) at once. Both are proteins that drive tumor growth. 9
Efficacy rests on OrigAMI-4, an open-label trial with 102 patients in its primary efficacy group. The overall response rate was 42%, and 56% of the patients who responded were still responding at six months. 8
Patients receive it as a weight-based subcutaneous injection every three weeks, rather than an intravenous infusion. 8
The label warns of hypersensitivity and administration-related reactions, interstitial lung disease and pneumonitis, skin reactions, eye toxicity and harm to a fetus. Accelerated approval requires confirmatory trials. 8
The review ran under Project Orbis, the agency's program for reviewing cancer drugs alongside other countries' regulators. This time those were Brazil's ANVISA, Health Canada, Israel's Ministry of Health and Singapore's Health Sciences Authority. 8
Device briefs: four new device types and a robotics paper
Status: These FDA actions are dated November 5 and 6. Two company announcements rest on decisions from late October.
- Four device types classified in three days. The FDA published final orders placing the digital cervical cytology slide imaging system with an AI algorithm (91 FR 69687), prognostic assessment software for mild cognitive impairment (91 FR 69690) and a wearable vibration device for orthopedic use (91 FR 69692) into class II with special controls. A fourth, the external mechanical stimulator for relief of congestion, followed on November 6 (91 FR 70007). Class II is the middle tier of device risk. Each order means the next maker of that kind of product can file a 510(k) premarket notification against a published set of expectations. 10111213
- A robotics discussion paper, open for comment until January 5, 2027. The FDA's device center published a paper on how to weigh benefit and risk for robotic devices that act with some autonomy or are driven remotely by an operator. The paper asks for terminology, risk mitigations and the specific questions reviewers should ask. The agency states it is discussion material and sets out no regulatory expectations. 14
- PulseAI, AI arrhythmia analysis for wearables, announced November 5. The Belfast company said the FDA cleared a model that reads electrocardiogram recordings from consumer wearables. The agency's index gives the decision date as October 27, 2026, under K254226. In a 296-person prospective study published in Heart Rhythm, the algorithm found atrial fibrillation at higher sensitivity and produced 92% fewer inconclusive readings than the Apple Watch's own algorithm. 15
- Cepheid, Xpert Hemorrhagic Fever Panel, announced November 3. Cepheid, a Danaher operating company, said the FDA cleared the panel. The agency's index shows the decision dated October 30, 2026, under K262971. 16
3. Insurance and policy
CVS Health will break itself in two
Status: The company announced the separation on November 4. It aims to complete it in the first half of 2028.
CVS Health plans to separate into two independent, publicly traded companies. A healthcare solutions company holds Aetna, CVS Caremark, CVS Specialty, Oak Street Health and Signify Health, and keeps the name CVS Health for now. A pharmacy company holds about 9,000 retail pharmacies, the mail pharmacy, MinuteClinic including its virtual care arm, and the Health100 technology services business, and will be called CVS Pharmacy. 17
The separation is intended to be tax-free to the company and its shareholders, and both companies are expected to carry investment-grade ratings. 17
David Joyner, now chairman and chief executive of CVS Health, will run the healthcare solutions company. Prem Shah, group president, becomes chief executive of CVS Pharmacy. 17
The board reached the decision through a strategic review. "From a position of strength, and a focus on the long term, we plan to create two focused companies to improve consumer engagement, affordability, and care coordination," Joyner said. 17
The company reported third-quarter results the same morning: $2.2 billion in profit on $108.4 billion in revenue. Shares rose 3% before the market opened. 18
Until the separation closes, CVS Health operates as one company, so Aetna's 2027 Medicare Advantage and marketplace plans sit under the same ownership they did last week. The structural question for employers and brokers is what happens to contracts that span both halves, such as a Caremark pharmacy benefit contract paired with CVS retail network access. That answer arrives with the separation agreement. 18
Medicare cut hospital drug payments by $5.45 billion and repriced same-day visits
Status: The Centers for Medicare & Medicaid Services (CMS) published two final rules on November 4. Both take effect January 1, 2027.
Start with the 340B Drug Pricing Program, which requires drugmakers to sell at a discount to eligible hospitals and clinics. CMS surveyed hospitals and found they buy 340B drugs for substantially less than the average sales price. The final rule moves Medicare's payment closer to that acquisition cost. 19
CMS estimates the change saves people with Original Medicare $1.1 billion in drug costs and taxpayers $4.35 billion in 2027, about $5.45 billion in total. A beneficiary who receives a qualifying drug in a hospital outpatient department saves an average of $900 that year. 19
Hospitals collect the difference between the discounted price they pay and the rate Medicare pays them. That margin is what shrinks, and the money moves to beneficiaries and to the program. 19
Imaging gets the same treatment. Scans without contrast done at off-campus, hospital-owned clinics will be paid at the lower physician fee schedule rate instead of the hospital outpatient rate. That covers bone density scans, X-rays, ultrasounds, CT scans and MRIs, and CMS estimates $260 million in savings in 2027 and more than $9 billion through 2036. 19
Where surgery happens keeps moving outward. CMS continued phasing out its inpatient-only list and added several hundred procedures to the list that ambulatory surgical centers may perform. The agency says the shift often lowers what patients owe. 19
One payment change touches ordinary office visits. When an office visit and a minor procedure happen on the same day, CMS will cut payment for the lower-cost of the two services by 20%. 20
The physician fee schedule rule also closes a payment loophole the agency values at $2.38 billion over ten years, and it sets the end date for a quality reporting program. The traditional Merit-based Incentive Payment System (MIPS) reporting option sunsets with the 2031 performance year, giving clinicians through 2030 to move to MIPS Value Pathways or an advanced alternative payment model. CMS says the value pathways already cover about 98% of clinicians. 20
Accountable care organizations get a new lever on patient costs. Starting April 1, 2027, an approved accountable care organization (ACO), a group of clinicians jointly responsible for a set of patients' quality and spending, may reduce or eliminate Part B cost sharing for many services its assigned patients receive. 20
The track record behind that incentive: in 2024, 75% of the 476 ACOs in the Shared Savings Program earned shared savings totaling $4.1 billion, producing about $2.5 billion in net savings against spending benchmarks. CMS says the program has saved money for eight consecutive years. 20
The outpatient rule adds prior authorization to eight more botulinum toxin injection codes, after hospital outpatient claims for those codes rose 42.8% from 2017 to 2024 while overall outpatient volume fell 8.3%. CMS also let hospital accrediting organizations check certain emergency department requirements during routine surveys. 19
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Ten billion more rural dollars, divided by state
Status: CMS announced the second-year awards on November 9.
CMS awarded $10 billion to all 50 states for the second year of the Rural Health Transformation Program (RHTP), bringing total awards under the program to $20 billion of the $50 billion set aside. The five-year program was created by the Working Families Tax Cuts Act. 21
This year's state awards run from $142.3 million for New Jersey to $282.0 million for Texas. 21
The amounts partly reflect how far each state has got with its own plan. CMS reviewed annual reports from all 50 states and weighed progress on policies including the Presidential Fitness Test and continuing medical education on nutrition. 21
"Rural Americans have life expectancies three years shorter than their urban peers," CMS Administrator Mehmet Oz said in the announcement. 21
Policy briefs
Status: Two more rules on November 5.
- Drug price negotiation, made permanent. A final rule codifies the Medicare Drug Price Negotiation Program for prices taking effect in 2029. By February 1, 2027, CMS will select up to 20 more drugs for the fourth negotiation cycle, from Part D and Part B, and pick drugs for renegotiation. The rule also sets a price floor for certain small biotech drugs in 2029 and 2030, and requires Part D plans to carry selected drugs on formulary. 22
- A proposed rollback of provider conditions of participation. The CARE proposed rule reviews the Conditions of Participation for all 21 provider and supplier types, the rules a facility must meet to bill Medicare and Medicaid. CMS estimates it would save $320 million and return 3.26 million hours of staff time. It would drop obstetric staff training and obstetric quality reporting requirements that were due to take effect January 1, 2027, end COVID-19 vaccine education and documentation duties in long-term care, stop routine respiratory illness data reporting outside a declared emergency, and remove the requirement that patient care areas have access to outside windows or doors. 23
4. Hospital M&A
CommonSpirit hands three North Dakota hospitals to Altru
Status: The definitive agreement was signed November 4. Closing is expected in early 2027.
Chicago-based CommonSpirit Health agreed to transfer three North Dakota hospitals to Altru Health System of Grand Forks: CHI St. Alexius Health in Bismarck, CHI St. Alexius Health Turtle Lake and CHI St. Alexius Health Garrison. 24
The two systems signed a nonbinding letter of intent in January, so this week's agreement converts a year of talks into a transaction. 24
The Benedictine Sisters of Annunciation Monastery will keep their sponsorship of CHI St. Alexius Health, and the hospitals keep their Catholic identity under Altru. Patient care and daily operations stay as they are through an orderly transition. 24
This is the second time the two organizations have done this. Altru bought CHI St. Alexius Health Devils Lake, a 25-bed critical access hospital, from CommonSpirit on March 1. A critical access hospital is the federal designation for a small rural hospital. 24
"Through our work together over the years, we've developed tremendous confidence in Altru's commitment to high-quality, compassionate care," said Tim Bricker, president of CommonSpirit's Central Region. 24
Terms were not disclosed. For patients in Bismarck, Turtle Lake and Garrison, the visible change is a new parent organization and a transition plan, with the Catholic sponsorship unchanged. 24
A rival bid lifts the Surgery Partners price to $25 a share
Status: Surgery Partners announced the amended agreement on November 9. The deal still needs a shareholder vote and regulatory approval.
Surgery Partners and HealthSpan Partners, the acquisition vehicle of Bon Secours Mercy Health, raised the cash price to $25.00 a share from $23.50. The enterprise value, which includes debt, now reaches about $6.0 billion. 25
The increase answers a competing offer. An unnamed third party proposed buying the company on November 3 and raised its bid to $28.00 a share on November 8. 25
A special committee of independent directors judged the higher bid inferior. Its stated reasons were that the rival offer would take materially longer to close or might fail, that its regulatory path was riskier, and that it carried fewer contractual protections. 25
Anyone holding shares past March 1, 2027 while the deal is still pending gets paid for the wait. A ticking fee accrues at 10% a year on the $25, up to $1.61 a share if the merger closes at its outside date of October 23, 2027, for a maximum of $26.61. 25
Bain Capital, which owns about 39% of the company, will roll its shares into equity in the acquiring entity instead of taking cash, and its voting agreement stays in place. 25
Chief executive Eric Evans called the result "exceptional value for our stockholders, along with regulatory certainty and a closing expected in the near term." The deal is still targeted to close in the first quarter of 2027. 25
This channel covered the original $5.7 billion agreement in its October 27 edition. What changed this week is the price, the existence of a bidder willing to pay more, and the board's decision to take certainty over the highest number. 25
5. Patient health tip
Sudden vision loss in one eye is a reason to call the same day
Status: This tip follows the FDA's November 9 labeling change for GLP-1 drugs.
If you take a GLP-1 drug, the new warning covers a symptom most people have never heard of. NAION is a blockage of blood flow to the front of the optic nerve. It shows up as vision that goes dim or dark in one eye, often noticed on waking, and it does not hurt. 7
Four symptoms the agency lists: sudden painless loss of vision in one eye, missing patches of vision such as blind spots or tunnel vision, distorted color, and a blurry or hazy patch at the center of what you see. 7
Call your prescriber right away and ask for an eye exam, ideally the same day. Tell the ophthalmologist which GLP-1 drug you take and when you started it. 7
Keep taking the drug until you have spoken to your prescriber. The agency's instruction to clinicians is to weigh the benefit of treatment against the risk, and that is a conversation to have with your prescriber. 7
Some people carry more risk. The agency names smoking, diabetes, high blood pressure, sleep apnea, anemia and kidney disease. If NAION has already hit one eye, the other is at higher risk, so any change in its vision deserves the same call. 7
The odds are small, and worth keeping in proportion. In FDA's pooled trial data the rate was 6.4 cases per 100,000 person-years on these drugs. The reason to know the symptom is that NAION has no treatment that restores lost vision, and the loss can be permanent. 7
Your pill bottle insert may lag the label change by months. The warning now lives in the labeling for the whole class, so a pharmacist or prescriber can confirm it before your next refill. 7
References
- 1Hospitals write off $132B as AI fails to move the needle with finances
healthcaredive.com
- 2Heidi Health announces 18% reduction of global workforce
mobihealthnews.com
- 3Zipline raises $1.5B at $21.5B for autonomous drone delivery
mobihealthnews.com
- 4nPhase raises $30M for clinical data platform
mobihealthnews.com
- 5Ellipsis Health acquires Kouper Health
mobihealthnews.com
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- 18CVS reveals plans to split into two companies
fiercehealthcare.com
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- 24CommonSpirit signs definitive agreement to sell 3 North Dakota hospitals
beckershospitalreview.com
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