Enrollment and Licensing for Urological and Ostomy Suppliers

Most urological and ostomy supplies reach Medicare patients by mail, month after month, from suppliers far from where the patient lives. That pattern is why CMS put all three product lines into Round 2028's nationwide remote item delivery program, and why state licensing in every state you ship to now matters as much as your Medicare enrollment.

How are these supplies split across Round 2028 categories?

Three separate categories, each bid and accredited on its own (CBIC Product Categories and contract award fact sheet):

• Urological supplies. Lead item A4352, bid limit $8.86, 5 contracts planned. Hydrophilic catheters are no longer part of this category.
• Hydrophilic urinary catheters. Lead item A4296, bid limit $8.86, 10 contracts planned. CBIC confirms this is "a distinct product category, separate from other urological supplies." Three new hydrophilic intermittent catheter codes, A4295, A4296 and A4297, took effect January 1, 2026.
• Ostomy supplies. Lead item A4385, bid limit $7.28, 6 contracts planned. Tracheostomy supplies are not included in Round 2028 in any category, and any enrolled supplier may keep furnishing them until they are phased in.

A revised Medicare local coverage determination for urological supplies took effect January 1, 2026, which CBIC addresses in its FAQs because it changes utilization for some codes. A supplier of all three lines bids three competitions, and must be accredited for every lead and non-lead item in each.

What happens to patients you already supply?

CBIC's FAQ is direct: suppliers of "Class II CGM supplies, ostomy supplies, urological supplies, and hydrophilic catheters that are not awarded contracts" cannot keep furnishing them to Medicare patients they served before contracts start. "Medicare beneficiaries will need to obtain these supplies from a DMEPOS CBP contract supplier." There is no grandfathering for supplies. CBIC also says the physician and hospital exceptions in 42 CFR 414.404 do not apply to ostomy or urological supplies.

The six months that begin January 1, 2028 are a grace period for contract suppliers to collect written orders from patients switching to them, not a period in which non-contract suppliers can keep billing. For a supplier whose business is mostly Medicare catheters or ostomy supplies, Round 2028 is a decision about the whole company.

Why does CMS watch catheter suppliers so closely?

CMS laid out its reasons in the February 2026 moratorium notice (CMS-6099-N). It cited a February 2025 Inspector General audit, "Medicare Improperly Paid Suppliers for Intermittent Urinary Catheters," that found noncompliance with refill, proof of delivery and written order requirements and about $35.1 million in improper payments. It also described a scheme CMS found in early 2023 involving 15 DMEPOS companies that had recently changed ownership: beneficiaries did not receive the catheters, physicians did not order them, and they were not needed. CMS stopped payment and revoked all 15 enrollments.

Two rules follow directly from that history. A majority sale within 36 months of a supplier's enrollment now requires the buyer to enroll as a new supplier with new accreditation (42 CFR 424.551). And refill, delivery and order documentation are the first things an auditor reads. For documentation detail, see White Glove Medical Billing on DME documentation requirements.

Which state rules help, and which hurt, a mail-order supplier?

Every state sets its own rules, and supplies-only shippers sometimes fall outside a state's DME license. Examples we have verified:

• Florida does not require an HME license for "locations that supply" only diabetic monitors and "disposable supplies, e.g., diabetic, ostomy, urological and wound care supplies" (Fla. Admin. Code 59A-25.002(2)). See Florida.
• Alabama requires an in-state licensed location for out-of-state providers, but exempts a mail order company that ships only by carrier, unless it supplies respiratory or oxygen equipment that way. See Alabama.
• Pennsylvania has no dedicated HME license, but its Department of Health requires a yearly registration for each place of business that retails devices within the Commonwealth, and its device definition lists "colostomy and ileostomy appliances, bags and supplies" (28 Pa. Code 25.1 and 25.113). See Pennsylvania.
• North Carolina requires every place, in the state or out of it, that delivers medical equipment to users in North Carolina to hold an annual permit. See North Carolina.

Exemptions are narrow and wording matters. CMS's own warning: Colorado exempts suppliers in Medicare's "National Mail Order Program," but that exemption does not carry over to Round 2028's differently named nationwide program. Read the state's text, not a summary. Our post on mail-order DME licensing covers the general rules.

What does Medicare enrollment require for these suppliers?

The same as any DMEPOS supplier, with no shortcuts for supplies-only companies: a compliant physical location open at least 30 hours a week (42 CFR 424.57(c)(7) and (c)(30)); state licenses where required; $300,000 in liability insurance; accreditation that names each product (424.57(c)(22)), renewed at least every 12 months; the $50,000 bond; the CMS-855S with the $750 fee for 2026; and high-risk screening with a site visit and fingerprints for 5 percent owners. Mail-order suppliers also need to keep proof of delivery for every shipment (424.57(c)(12)) and must not call beneficiaries about new items except in the narrow cases allowed by supplier standard 11. See DMEPOS enrollment, step by step.

Did the 2026 moratorium apply to supplies companies?

If they enroll as a "medical supply company" type, yes. The moratorium barred new enrollments of seven medical supply company types from February 27 to August 27, 2026, defining a medical supply company as a business whose principal function is furnishing DMEPOS supplies directly to patients (for example by mail order), providers, or both. It has expired, but CMS can impose another. See the 2026 moratorium.

How do we help urological and ostomy suppliers?

We map which states require a license for the specific supplies you ship, prepare each application for your owner or officer to sign, and report each license so it appears in PECOS before the Round 2028 bid window closes (currently targeted for March 10, 2027). Pricing: $699 per state ($899 in California, Florida, Georgia and Alabama), $4,995 for a 10-state Remote Delivery Licensing Package, $9,995 nationwide, and $1,295 for Medicare enrollment of a first location. You pay every state and CMS fee directly. We do not sell supplies or bonds, and no one can promise a contract. Begin with a $149 Readiness Review.