A Silent Regulatory Shift Now Hitting the HME Sector
For decades, many HME importers relied on a broad interpretation of HTSUS 9817.00.96, the duty‑free provision for articles “specially designed or adapted” for persons with disabilities. The Federal Circuit’s decision in Sigvaris, Inc. v. United States, 899 F.3d 1308 (Fed. Cir. 2018), narrowed that standard significantly and is now driving a CBP enforcement shift across disability equipment tariffs and accessibility products.
CBP has begun applying the Sigvaris ruling to multiple categories, including ramps, mobility devices, and stairlift imports. The emerging pattern is clear: products must demonstrate objective, disability‑specific engineering to qualify for duty‑free eligibility under HTSUS 9817.00.96.
Why This Matters for HME Importers and Mobility Manufacturers
Under the Sigvaris standard, a product qualifies for 9817 only if it is:
- engineered for a specific class of disabled individuals, and
- not designed for the general population.
This creates sector‑wide consequences for:
- mobility scooters and powered mobility equipment
- walkers and rollators
- lift chairs and adjustable beds
- bath safety equipment and accessibility products
- ramps and general accessibility devices
Many of these mobility and accessibility products were never engineered to meet the narrower Sigvaris criteria, yet have historically been entered under HTSUS 9817.00.96. As CBP tightens tariff classification and enforcement, HME importers face a growing risk of unexpected tariff exposure.
Retroactive Duty Exposure and Compliance Risk
Federal Circuit decisions apply retroactively, and CBP cannot waive statutory requirements through past non‑enforcement. In practical terms, this means:
- past 9817 claims that fail Sigvaris may be deemed invalid
- CBP may assess retroactive duties for the prior five years
- interest applies under 19 U.S.C. § 1505
- negligence penalties may apply under 19 U.S.C. § 1592
This combination of retroactive duties, interest, and potential penalties represents a significant trade compliance risk for HME importers and mobility equipment manufacturers who have relied on broad disability‑related tariff exemptions.
Avalon Stairlifts’ Position
Avalon Stairlifts imports only parts — not complete lifts — and classifies them under HTSUS 8431, a heading not affected by the Sigvaris ruling or the current CBP crackdown on HTSUS 9817.00.96. Our focus is on transparency and regulatory integrity, and on helping dealers and partners understand how Federal Circuit decisions and CBP rulings are reshaping medical equipment import compliance.
We encourage HME importers, distributors, and manufacturers to review:
- their current tariff classifications and HTS codes
- their engineering documentation supporting “specially designed or adapted” claims
- their historical use of HTSUS 9817.00.96
- their exposure to retroactive duties and tariff reclassification
Related Coverage
For additional reporting on the Federal Circuit ruling and its impact on mobility equipment imports, see the recent coverage from THIIS Magazine: