Enrollment and Licensing for CGM and Insulin Pump Suppliers

Continuous glucose monitors and insulin pumps are among the fastest-moving lines in DME, and most of the volume ships by mail. That makes CGM and pump suppliers the companies most exposed to Round 2028 of Medicare competitive bidding, to the payment changes that come with it, and to state licensing in every state where patients live.

How are CGMs and insulin pumps treated in Round 2028?

"Class II continuous glucose monitors (CGMs) and insulin pumps" is one of seven Round 2028 product categories, bid in a single nationwide remote item delivery area. From CBIC's published materials:

• Lead item: A4239, the monthly supply allowance for a Class II CGM owned by the beneficiary. Bid limit: $273.28.
• Other items in the category: E2103 (monthly rental of a Class II CGM and all supplies), E0784 (monthly rental of an insulin pump not used with a Class III CGM, with supplies) and A4227 (monthly supplies for a beneficiary-owned pump not used with a Class III CGM).
• Contracts CMS plans to award: 10, possibly more for small suppliers or demand.
• Bidder registration opens December 1, 2026; the bid window runs January 5 to March 10, 2027 (target dates); contracts start January 1, 2028.

Class III CGMs, and insulin pumps used with Class III CGMs, are excluded from competitive bidding and stay on the fee schedule. Items covered under Medicare Part D are not part of the program at all.

What changes in Medicare payment on January 1, 2028?

CMS's fact sheet "Continuous Glucose Monitors and Insulin Pumps: What Suppliers Need to Know" says Medicare will pay for these items on a bundled, monthly rental basis starting January 1, 2028. Key points:

• For Class II CGMs and pumps a beneficiary already owns on December 31, 2027, only contract suppliers may furnish the supplies and accessories. Medicare keeps paying separately for those supplies until the equipment reaches its reasonable useful lifetime, is lost, stolen or irreparably damaged, or the beneficiary switches to new rented equipment.
• Code A4227 (supplies for a patient-owned insulin pump, per month) replaces A4224 and A4225 for Medicare.
• For Class III CGMs and pumps used with them, a supplier does not need a contract to furnish supplies for owned equipment, but the KF modifier applies and payment is capped at the Class II amount.
• Payment can be monthly or in 90-day installments, and a supplier must ship more if a patient runs out before the period ends (CBIC, Lead Item Bidding and Pricing).

Do current patients stay with you if you are not awarded a contract?

It depends on whether they rent or own. CBIC's FAQs say a non-contract supplier renting a Class II CGM or insulin pump when contracts start may elect to be a grandfathered supplier for those patients, and must then keep serving any of them who want to stay; grandfathering does not apply once 13 months of pump rental have been paid and title transfers. For CGM supplies, there is no grandfathering: beneficiaries "will need to obtain these supplies from a DMEPOS CBP contract supplier." The six-month period starting January 1, 2028 is a grace period for contract suppliers to collect written orders, not for non-contract suppliers to keep billing.

Do physician offices and hospitals need contracts for these items?

For insulin pumps, not always. Physicians, treating practitioners and hospitals can furnish competitively bid insulin infusion pumps to their own patients without a contract under 42 CFR 414.404. CBIC says the exceptions do not apply to CGMs or CGM supplies. A DME company owned by a physician gets no exemption. See when a physician practice supplies DME.

Which state licensing rules matter most for CGM and pump suppliers?

A remote supplier needs a license, permit or registration in each state that requires one for these products, and for Round 2028 every one of them must be current in PECOS by the close of the bid window. Some state rules work in your favor and some do not:

• Florida does not require an HME license for a location that supplies only "diabetic monitors and disposable supplies, e.g., diabetic, ostomy, urological and wound care supplies" (Fla. Admin. Code 59A-25.002(2)). The exemption names those items; it does not mention insulin pumps, so confirm with the agency before relying on it for pumps. See Florida.
• Oklahoma requires DME suppliers to keep an Oklahoma office or, if enrolled in Medicare or Medicaid, an accredited facility within 100 miles of each Oklahoma patient, but its DME licensing Act exempts suppliers of insulin infusion pumps and related supplies (59 Okla. Stat. 375.1 to 375.5). See Oklahoma.
• California registers out-of-state home medical device retailers that supply prescription devices, at $280 a year as of July 23, 2026. See California.
• North Carolina's device permit covers anyone, in or out of the state, who dispenses or delivers prescription devices to users there. See North Carolina.
• Alabama exempts a mail order company that ships only by carrier, but not one supplying respiratory or oxygen equipment that way. See Alabama.

The enrollment contractors' DMEPOS licensure database lists requirements by product category; CMS calls it "a guide only" and stresses its Notes section. Our state index shows what we have verified from state law.

Are pharmacies treated differently for CGMs?

In competitive bidding, no: CBIC says accreditation exemptions do not apply, and all pharmacies must be accredited for every item in the category to bid. In commercial and Medicare Advantage plans, sometimes yes. Blue Cross Blue Shield of Michigan's April 2026 FAQ says its Medicare Advantage members must get CGM products from a participating network pharmacy for dates of service on or after October 1, 2024, with stated exceptions, while its commercial members with both medical and pharmacy coverage can use either a DME supplier or a network pharmacy. Plan rules like these decide which channel gets paid, so check each plan. See DMEPOS enrollment for pharmacies.

What should a CGM or pump supplier have done before the bid window closes?

1. Confirm your accreditation names CGMs and insulin pumps and their supplies, for every location you would bid.
2. Map every state that requires a license for these products, including the exemptions above, and apply where needed.
3. Report every new license to your enrollment contractor so PECOS shows it before the close of the window.
4. Register in Connexion between December 1, 2026 and February 1, 2027.
5. Arrange the $100,000 bid surety bond and a business credit report dated within 90 days before the bid window opens.

How do we help diabetes supply companies?

We prepare state license applications for your owner or officer to sign, put each license into PECOS through an 855S change of information, and track renewals so none lapses during a contract. The Remote Delivery Licensing Package is $4,995 for 10 states; the Nationwide Licensing Package is $9,995; single states are $699 ($899 in California, Florida, Georgia and Alabama); renewal tracking is $299 per license, per year. You pay state fees directly. We do not sell bonds or equipment, and no one can promise a contract. A $149 Readiness Review is the right first step. See the licensing deadline for the details CMS checks.