The milestone that will drive the healthcare industry forward is the approval of additive manufacturing as an appropriate fabrication method for prosthetic devices in the US.
This means that the technology is recognized as a reimbursable method for prosthetic fabrication, removing a critical barrier that has slowed adoption of digital manufacturing in healthcare and improving clinic economics.
With this official approval from the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) and the Pricing Data Analysis & Coding (PDAC), clinicians will have confidence to prescribe 3D-printed prosthetics at scale.
This will also open new opportunities for faster, more personalized, and affordable patient care and broaden access to care for amputees across the country.
The Local Coverage Determination (LCD) for lower limb prostheses has been updated:
“Prosthetic devices (such as sockets, inserts, and applicable additions [e.g., lightweight material]) that are custom fabricated for the individual beneficiary are not solely restricted to standard methods of fabrication (e.g., wet lamination and prepreg composite) and can include alternative fabrication methods (e.g., additive manufacturing). Correct coding of custom fabricated items includes compliance with the HCPCS long description of the individual HCPCS code, along with any other published coding guidelines.”
This milestone was supported by a consortium launched by HP to accelerate adoption of digital manufacturing in orthotics and prosthetics. By bringing together prosthetists, engineers, and industry leaders, the consortium coordinated efforts to align clinical practice with technological innovation and generate the evidence to support progress in the field.
In the meantime, the reimbursement status in Europe is still unclear and is often assessed on a case-by-case basis across countries.
Read more: Business | Current state of public policies that help patients benefit from 3D printed implants
“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, VP & Global Head of Sales and Business Development, HP Additive Manufacturing Solutions.
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