A Billing Code Is Not a Product Strategy

The Buyer’s Question

What should we compare besides the billing code or headline product price?

A Documented Distinction: Off-the-Shelf, Custom-Fitted and Custom-Fabricated

Medicare’s coding framework for orthoses separates the item from the service delivered with it. For many prefabricated orthoses—including several types of spinal orthoses—Medicare uses paired codes:

• Off-the-shelf: a prefabricated item that needs only minimal self-adjustment at delivery—an adjustment the patient, a caregiver or the supplier can make.

• Custom-fitted: a prefabricated item that is trimmed, bent, molded or otherwise modified at delivery to fit the individual, by a certified orthotist or a person with specialized training, with documentation supporting that fitting.

• Custom-fabricated: an orthosis individually made for a specific patient.

Depending on how it is fitted, the same prefabricated product may fall under either the off-the-shelf or the custom-fitted code. The difference lies in the service performed and documented at delivery, not in the product alone.

Source: Centers for Medicare & Medicaid Services, Medicare Coverage Database, “Spinal Orthoses: TLSO and LSO – Policy Article” (A52500), revision effective January 23, 2024; reviewed October 29, 2026. Medicare fee-for-service guidance; other payers may apply different policies. cms.gov/medicare-coverage-database

Why a Code Alone Does Not Answer the Purchasing Question

• A code groups products. Items within the same code can differ in design, materials, adjustability, sizing range and manufacturer support.

• A printed code is not a verified classification. For many orthoses, Medicare requires that a product be reviewed by its Pricing, Data Analysis and Coding (PDAC) contractor and listed for the code being billed. A code shown on product literature is the manufacturer’s statement.

• Service and distribution matter. The same product may reach a patient through a clinic fitting, a hospital delivery or a shipment—each with different fitting, education and follow-up.

• Coverage is a separate question. A documented code does not establish that a plan covers the item for a particular patient.

Three Questions to Ask Before a Product or Formulary Decision

1. What service level does this decision assume—off-the-shelf, custom-fitted or custom-fabricated—and how will that service be documented?

2. Which products are actually furnished under the codes we pay for, and is their coding classification verified rather than assumed?

3. How do distribution, fitting and follow-up differ across the vendors and channels that will deliver the product?

How a Scoped Review Helps

In a scoped project, ARCLYFT can map a category’s manufacturers and product families, documented product-to-code relationships, service-level distinctions and distribution considerations, then frame the decisions a formulary or preferred-product approach would need to make. The review informs clinical and contracting decisions; it does not establish therapeutic equivalence, determine coverage or replace individual clinical judgment.

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