More U.S. insurers back nurse‑led TMS, BrainsWay (NASDAQ: BWAY) notes
Filing Impact
Filing Sentiment
Form Type
6-K
Rhea-AI Filing Summary
BrainsWay Ltd. furnished an update highlighting growing U.S. payer support for nurse practitioner‑administered Transcranial Magnetic Stimulation (TMS) therapy, including its Deep TMS™ platform. Optum Behavioral Health revised its TMS policy in late 2025 to let psychiatric mental health nurse practitioners order, supervise, and administer TMS in full‑practice states, covering approximately 34.8 million lives.
BrainsWay notes that other commercial insurers, several Medicare Administrative Contractors, the U.S. Department of Veterans Affairs, and TRICARE West have adopted similar approaches. The company believes broader acceptance of nurse practitioner‑delivered Deep TMS can ease psychiatrist shortages and improve access to non‑drug mental health treatments.
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Key Figures
Lives covered by Optum TMS policy: 34.8 million lives
FDA‑cleared Deep TMS indications: 3 indications
Company founding year: 2003
3 metrics
Lives covered by Optum TMS policy
34.8 million lives
Optum Behavioral Health commercial plans under updated TMS policy
FDA‑cleared Deep TMS indications
3 indications
Major depressive disorder, obsessive‑compulsive disorder, smoking addiction
Company founding year
2003
BrainsWay founded with operations in the U.S. and Israel
Key Terms
Transcranial Magnetic Stimulation (TMS), Deep TMS, Medicare Administrative Contractors (MACs), psychiatric mental health nurse practitioners (PMHNPs), +1 more
5 terms
Transcranial Magnetic Stimulation (TMS) medical
"allow appropriately trained nurse practitioners to administer Transcranial Magnetic Stimulation (TMS) therapy"
A non-invasive medical treatment that uses focused magnetic pulses applied to the scalp to stimulate specific brain regions, often used for depression and other neurological or psychiatric conditions. Think of it as a targeted, external 'tap' that can change how particular brain circuits work without surgery. Investors watch TMS for its impact on medical-device sales, clinic adoption, regulatory approvals and insurance coverage, all of which influence companies’ revenue prospects and valuations.
Deep TMS medical
"including Deep TMS™, when practicing in accordance with applicable regulations"
A non-invasive medical treatment that uses focused magnetic fields to stimulate deeper brain regions through a specialized coil, aiming to change brain activity linked to conditions like depression or obsessive-compulsive disorder. It matters to investors because regulatory approval, clinical evidence, and insurance coverage determine how widely clinics adopt the technology and how much revenue device makers and treatment providers can generate—think of it as a more powerful, targeted ‘wireless signal’ to the brain whose commercial success depends on proven benefits and payor support.
Medicare Administrative Contractors (MACs) regulatory
"multiple other U.S. commercial payers, MACs (including First Coast, National Government Services, and Novitas)"
Medicare Administrative Contractors (MACs) are private companies hired by the government to process Medicare claims, decide whether services and bills meet Medicare rules, and handle payments for providers in defined geographic regions—think of them as regional check-clearing offices for Medicare. Investors care because MACs’ coverage decisions, claim denials, audits and payment practices directly affect health-care providers’ cash flow, reimbursement rates and the commercial prospects for drugs, devices and services that rely on Medicare payment.
psychiatric mental health nurse practitioners (PMHNPs) medical
"permit psychiatric mental health nurse practitioners (PMHNPs) to administer TMS therapy"
Psychiatric mental health nurse practitioners (PMHNPs) are licensed advanced-practice nurses who assess, diagnose and treat mental health conditions, including prescribing medications and providing therapy, often in clinics, hospitals or via telehealth. They matter to investors because they expand access to care and shape demand for medications, digital therapy platforms and staffing services—like adding trained mechanics to a repair network, they speed service, change volumes and influence healthcare revenues and costs.
forward-looking statements regulatory
"This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
FAQ
What did BrainsWay (BWAY) announce about U.S. payer support for TMS?
BrainsWay highlighted a trend of more U.S. payers allowing trained nurse practitioners to administer Transcranial Magnetic Stimulation, including Deep TMS. This shift spans commercial insurers, Medicare Administrative Contractors, the Department of Veterans Affairs, and TRICARE West, potentially broadening access to non‑drug mental health treatments.
How did Optum Behavioral Health’s policy change affect BrainsWay (BWAY) Deep TMS?
Optum Behavioral Health updated its TMS policy in late 2025 to let psychiatric mental health nurse practitioners order, supervise, and administer TMS in full‑practice states. This policy, previously limited to psychiatrists, applies to commercial plans covering approximately 34.8 million lives.
Which other payers now support nurse practitioner‑administered TMS for BrainsWay (BWAY)?
BrainsWay cites multiple U.S. commercial insurers, Medicare Administrative Contractors such as First Coast, National Government Services and Novitas, plus the U.S. Department of Veterans Affairs and TRICARE West. These organizations now permit expanded nurse practitioner roles in delivering TMS, subject to policy and regulatory requirements.
Why does BrainsWay (BWAY) see nurse practitioner‑delivered Deep TMS as important?
BrainsWay believes expanding the pool of qualified clinicians administering Deep TMS may reduce structural barriers to care. The company points to potential benefits like alleviating psychiatrist shortages, shortening wait times, and improving access to clinically proven, non‑pharmacologic treatments for mental health disorders.
What mental health indications are FDA‑cleared for BrainsWay (BWAY) Deep TMS?
BrainsWay states it is the first and only TMS company with three FDA‑cleared indications backed by pivotal studies. These include major depressive disorder, obsessive‑compulsive disorder, and smoking addiction, with additional clinical trials underway in other psychiatric, neurological, and addiction conditions.
What risks and uncertainties does BrainsWay (BWAY) highlight in this update?
BrainsWay includes forward‑looking statements subject to numerous risks, such as financing needs, regulatory approvals, clinical trial progress, reimbursement delays, competitive product development, intellectual property protection, and market acceptance of Deep TMS. These factors could cause actual outcomes to differ materially from expectations.