Standing Up for Survivors in Washington

How amoena has taken action for patients and providers

Over the past year, amoena has invested in the future of the industry so that boutiques, providers, and most important, patients, can thrive.

How?

We launched a federal lobbying initiative aimed at lowering tariffs, improving product classification, and ensuring that mastectomy products are recognized and treated as medical devices.

We have been encouraged by the progress we’ve made so far. Here are important details on how we’re getting it done.

May 2026 – L8031 Adhesive breast forms

Years ago, CMS determined that the HCPCS code L8031 was "not reasonable or necessary" -- that an adhesive form offered no clinical advantage over a standard one. Our reconsideration request challenged that finding, and the DME MACs agreed it warranted a fresh look.

Amoena leadership met directly with the Centers for Medicare & Medicaid Services (CMS), to educate them about the medical necessity of adhesive breast forms for patients with intolerances to bra strap pressure, lymphedema, or chest wall pain after breast surgery.

In response to our reconsideration request, the DME MACs have now proposed removing the “not reasonable or necessary” designation from the L8031 code. Read more

June 2026 – Tariff classification of medical devices

Amoena leaders visited the offices of both Senators from Georgia (where our Kennesaw office is located), as well as several other Congressional members of the House, to advocate for a bipartisan bill amending the tarriff classifications of breast care devices.

That bill was introduced in August by Congresswomen Carol Miller (R-WV) and Terri Sewell (D-AL) and aims to reclassify mastectomy bras as medical devices, rather than regular apparel.
Read more in our press release.

August 2026 – L8035 custom breast prostheses

Amoena management has joined with other breast care manufacturers in an effort to re-engage CMS on L8035, the HCPCS code for custom breast prostheses. Medicare and Medicaid do not currently cover custom breast prostheses, though two states and many private insurers do. The group aims for an outcome similar to the compression garment industry, who helped pass the Lymphedema Treatment Act in 2024.

Leading the way for the future

We look forward with this momentum toward other opportunities for advocacy, always keeping our patients top of mind. These medically necessary breast care products play an important role in post-mastectomy healing, and our continued work will help ensure access and affordability.

With more than 4 million women living after breast cancer across the country, this work will truly create a positive impact.

Photo by Ben Kelsey: