HSA / FSA / Health Insurance + FDA Information

Eczema Pajamas Clos-up Fabric Image

Soothems eczema treatment sleepwear is made from environmentally sustainable, high performance raw materials: TENCEL™ with Chitosan, TANBOOCEL® (viscose made from bamboo), and Creora® latex-free spandex and Zinc Oxide for treating atopic dermatitis/eczema with either dry or for wet wrapping therapy, and in combination with a healthcare professional or doctor's recommendation for special eczema treatment bathes like apple cider vinegar and colloidal oatmeal bath, or to cover topical special eczema creams, lotions or emollients and National Eczema Association approved moisturizers.

Soothems eczema sleepwear is registered with the FDA as a Class 1 Medical Device and could be eligible for medical insurance and Health Savings (HSA) account claims. Please visit our health insurance section or check with your individual health insurance provider and your subscriber's /member's benefit plan to determine eligibility.


Medical Insurance Information
Soothems are eligible, but cannot guarantee health insurance payment coverage, or that your HSA/FSA debit card will be accepted by our credit card processor as part of your Soothems purchase. You must refer to your subscriber's/member's contract benefits to determine if Soothems eczema clothing, that is registered with the FDA as a Class 1, Medical Device, are covered under your subscriber’s/member's benefit plan.

Please note that just because a service, procedure, device, or equipment that has been issued a CPT or HCPCS code and is approved by the FDA does not mean that the service procedure, device, or equipment is covered by your insurance. Each policy is different.

If this is a contingency requirement for your purchasing Soothems eczema clothing, please check with your individual health insurance provider prior to making a purchase.

Your insurance provider may require prior authorization or supporting documentation in order to process and cover a claim for the requested Soothems therapy. A patient-specific letter of necessity will help to explain the patient’s needs and the physician’s rationale and clinical decision in recommending Soothems. It may be helpful for the recommending physician to briefly describe dry or wet wrapping as a highly effective therapy used in the treatment of atopic eczema, and that it can involve the use of a cream, lotion, or emollient under Soothems which is acting as retention bandaging and that Soothems are made from special fibers that keep the skin hydrated and moist, control bacteria growth and help reduce skin inflammation thereby relieving itching.

The link below has a sample letter of medical necessity that can be customized by the medical care provider based on patient medical history and demographic information. Please note that some payers may have specific forms that must be completed to process payments or to document medical history.


HRA, HSA or Health Care FSA
Soothems.com is enabled to accept payment from most major health insurance companies HRA, HSA or Health Care FSA credit cards allowing you to reimburse yourself for medical expenses under Section 213(d) of the tax code as a federal income tax deduction. If your HRA, HSA, FSA card is declined at check-out please contact the issuing card company with questions. Other than providing the information above like the CPT / HCPCS code number and the FDA registration information, we are sorry, Soothems cannot help with the resolution of the payer’s decision, it is a matter between you and your subscriber’s /member’s benefit plan and the payer.


Federal Drug Administration Information
Soothems garments and our TEWLTect smart fabric are registered with the Federal Drug Administration as a Class 1, Medical Device, exempt status in the Durable Medical Equipment (DME) category 880.5075. Soothems FDA Registration Number is 3013841561and the Soothems, LLC FDA owner operator number is 10055549. Our physical address is Soothems, LLC; 15650 17th Avenue N; Plymouth; MN; 55447. 


Soothems CPT / HCPCS code is A4467
The CPT (or Current Procedural Terminology) or HCPCS (Healthcare Common Procedure Coding System) is a medical code that is used to report medical, surgical, and diagnostic procedures and services to entities such as physicians, health insurance companies and accreditation organizations. A4467 is a valid 2019 CPT/HCPCS code for "belt, strap, sleeve, garment, or covering, any type" category for which Soothems has been classified under.