October 16, 2025      Applications      306

Regulatory recognition removes key barrier to adoption; expands patient access and supports broader clinical use of additive manufacturing in orthotics and prosthetics

Thanks to an HP-backed initiative, 3D printing is now officially recognized as a reimbursable fabrication method for prosthetic devices in the United States, following a regulatory update from the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) and the Pricing Data Analysis and Coding (PDAC). The change marks a major shift for the orthotics and prosthetics (O&P) industry, removing a longstanding reimbursement barrier and formally legitimizing additive manufacturing across the full O&P spectrum.
The decision builds on a 2024 milestone in which 3D printing was approved for orthotic device reimbursement. With this latest update, clinicians and providers can now offer 3D printed prosthetics under Medicare coverage, improving clinic economics, increasing prescribing confidence, and enabling broader access to personalized care for amputees.

“This decision changes everything. It means clinicians can confidently prescribe 3D printed prosthetics, insurers can cover them, and patients can access care that’s faster, more affordable, and personalized to their needs,” said François Minec, Vice President and Global Head of Sales and Business Development at HP Additive Manufacturing Solutions.

The recognition follows efforts led by a consortium launched by HP to advance digital manufacturing in healthcare. The group includes clinicians, engineers, and industry stakeholders focused on integrating 3D printing into clinical workflows and generating the evidence needed to support reimbursement.

HP has reported recent momentum in the sector, including its work with The Limb Kind Foundation to deliver custom pediatric prosthetics to children in Kenya and Sri Lanka within two days, and a milestone at VA Puget Sound where 3D printed transtibial sockets were produced in-house for U.S. veterans.

With regulatory alignment now in place, industry observers expect additive manufacturing to play an increasingly important role in scaling customized, cost-effective solutions across the prosthetics field.







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