What happens if I operate without a required DSHS device license?

If you manufacture or distribute medical devices in Texas without the required DSHS license, you may face enforcement actions and administrative penalties under DSHS rules. DSHS laws & rules .

Do I need to renew my accreditation along with my license?

Yes. To bill Medicare, DMEPOS accreditation (unless exempt) must be maintained in addition to any state device license you hold. CMS DMEPOS .

Can I apply for the DSHS device license online?

Yes. DSHS offers online initial and renewal applications for device manufacturer/distributor licenses and opens the renewal window 60 days before expiration. DSHS online licensing .

Is a quality assurance program mandatory?

You must comply with DSHS device rules and applicable federal standards, and Medicare/Medicaid program rules require documented policies and procedures appropriate to DME operations. DSHS rules ; CMS DMEPOS ; TMHP DME handbook .

Do I need an HCSSA license to deliver and set up equipment in a patient’s home?

No. DME supply companies are exempt from HCSSA licensure under Health & Safety Code §142.003(a)(8). This exemption does not remove the need for DSHS device licensing if you manufacture or distribute devices, or for Medicare/Medicaid enrollment requirements if you bill those programs. HSC §142.003 .

DME/HME License Texas

Licensing Requirements

Durable Medical Equipment (DME/HME) License Requirements in Texas — Full checklist of Texas requirements, fees, and steps.
Durable Medical Equipment (DME/HME) License in Arizona
Durable Medical Equipment (DME/HME) License in New Mexico
Durable Medical Equipment (DME/HME) License in Oklahoma
Durable Medical Equipment (DME/HME) Licensing — All States — State-by-state durable medical equipment (dme/hme) licensing overview.

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