Continuous Glucose Monitors and Insulin Pumps: What Suppliers Need to Know

Effective January 1, 2028, the Centers for Medicare & Medicaid Services (CMS) will implement updated billing and payment policies for Continuous Glucose Monitors (CGMs) and insulin pumps paid for under the Medicare Part B benefit category for durable medical equipment (DME). The changes will impact class II CGMs and insulin pumps included under Round 2028 of the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program (CBP) as well as class III CGMs and insulin pumps used in conjunction with class III CGMs that are excluded from the DMEPOS CBP and are paid for under the DME fee schedule. This fact sheet provides guidance on:

• Transition to payment on a bundled, monthly rental basis
• Billing requirements and procedures
• Options available to Medicare beneficiaries for obtaining CGMs, insulin pumps, and replacement supplies and accessories from suppliers under the new policies
• Grandfathered suppliers

Beneficiary-Owned CGMs and Insulin Pumps 

For items subject to the DMEPOS CBP (i.e., Class II CGMs and insulin infusion pumps, except for insulin infusion pumps used in conjunction with class III CGMs) and owned by the beneficiary as of December 31, 2027, only contract suppliers may furnish the necessary supplies and accessories for such items. Medicare will continue to make separate payment for such supplies and accessories until the equipment reaches its reasonable useful lifetime; is lost, stolen or irreparably damaged; or the beneficiary elects to replace the equipment they own with new, rented equipment. Beneficiaries who own their equipment and want to replace the equipment with new equipment have the option to obtain new rented equipment from a contract supplier at any time. Once the beneficiary replaces the equipment they own with new rented equipment, the equipment will be paid for on a bundled monthly rental basis.

For items not subject to the DMEPOS CBP (i.e., class III CGMs and insulin infusion pumps used in conjunction with class III CGMs) and owned by the beneficiary as of December 31, 2027, a supplier does not have to be a contract supplier to furnish the necessary supplies and accessories for such items. Medicare will continue to make separate payment for such supplies and accessories until the equipment reaches its reasonable useful lifetime; is lost, stolen, or irreparably damaged; or the beneficiary elects to replace the equipment they own with new, rented equipment. Beneficiaries who own their equipment and want to replace the equipment with new equipment have the option to obtain new rented equipment from a supplier at any time. Once the beneficiary replaces the equipment they own with new rented equipment, the equipment will be paid for on a bundled monthly rental basis. Suppliers should append the KF modifier on claims for supplies for class III, non-adjunctive CGM (A4239KF) or class III adjunctive CGM (A4238KF) owned by the beneficiary as of December 31, 2027. Suppliers should use the KF modifier on claims for supplies for an insulin pump owned by the beneficiary as of December 31, 2027, when used in conjunction with a class III CGM (A4227KF).

Healthcare Common Procedure Coding System (HCPCS) Level II codes for the monthly supplies and accessories for beneficiary-owned CGMs and insulin pumps are included in Table A.

Effective January 1, 2028, the fee schedule amounts for supplies and accessories for beneficiary-owned class III CGMs and insulin pumps used in conjunction with class III CGMs will be limited to the national payment amount established for supplies and accessories for beneficiary-owned class II CGMs and insulin pumps under the DMEPOS CBP.

Table A

Billing Scenarios

For items and services under the DMEPOS CBP (Class II CGMs and Insulin Pumps Used in Conjunction with Class II CGMs)

• A beneficiary owns a class II CGM and an insulin pump used in conjunction with such product as of December 31, 2027.
  • For supplies for beneficiary-owned external insulin infusion pump, use code A4227.  
  • For supplies for class II non-adjunctive, non-implanted CGMs, use code A4239.

For items and services excluded from the DMEPOS CBP (class III CGMs and Insulin Pumps Used in Conjunction with class III CGMs)

• A beneficiary owns a class III CGM and an insulin pump used in conjunction with such product as of December 31, 2027.
  • For supplies for beneficiary-owned external insulin pump, use A4227KF.
  • For supplies for class III adjunctive, non-implanted CGMs, use code A4238KF.
  • For supplies for class III non-adjunctive CGMs, use code A4239KF. 

Rented CGMs and Insulin Pumps Subject to the DMEPOS CBP

Effective January 1, 2028, with the exception of CGMs and insulin pumps owned by the beneficiary as of December 31, 2027, all CGMs and insulin pumps will be paid for on a bundled monthly rental basis, with payment for all necessary supplies and accessories included in the monthly rental payment amount, with the exception of insulin, which will continue to be paid for separately. The bundled monthly rental payments are not capped and continue for as long as Part B coverage for the equipment continues. Insulin may be furnished by any enrolled DMEPOS supplier.

• Only a contract supplier under the DMEPOS CBP or a grandfathered supplier can furnish a rented class II CGM or any rented insulin pump (excluding an insulin pump used in conjunction with a class III CGM) beginning January 1, 2028.  
   
• Suppliers that are not awarded a contract under the DMEPOS CBP can elect to become grandfathered suppliers for class II CGMs or insulin pumps (other than an insulin pump used in conjunction with a class III CGM) they are renting only to beneficiaries as of December 31, 2027. The beneficiaries renting the equipment in these cases can elect to continue renting the equipment from the grandfathered supplier. These beneficiaries may elect to switch to a contract supplier at any time.   

HCPCS Level II codes for CGMs, insulin pumps, and supplies and accessories for CGMs and insulin pumps subject to the CBP are included in Table B. Guidance applies to contract suppliers and grandfathered suppliers furnishing rented products.  

Table B  

Billing Scenarios

• A beneficiary begins using equipment for the first time on or after January 1, 2028.
  • Use code E2103, E0784, or both, as applicable.
• A beneficiary is currently renting the equipment as of December 31, 2027, and rental payments have not reached the purchase fee schedule cap for a rented CGM1 or the 13-month cap for an insulin pump2.
  • Use codes E2103, E0784, or both, as applicable.
• A beneficiary owns the equipment and the equipment is replaced by a contract supplier.
  • Use codes E2103, E0784, or both, as applicable.

Rented CGMs and Insulin Pumps Not Subject to the DMEPOS CBP

For items not subject to the DMEPOS CBP, a supplier does not have to be a contract supplier to furnish this equipment.  Class III CGMs and insulin pumps used in conjunction with class III CGMs are excluded from the DMEPOS CBP and can be furnished by any enrolled DMEPOS supplier. As above, beginning January 1, 2028, with the exception of CGMs and insulin pumps owned by the beneficiary as of December 31, 2027, all CGMs and insulin pumps will be paid for on a bundled monthly rental basis, with payment for all necessary supplies and accessories included in the monthly rental payment amount, with the exception of insulin, which will continue to be paid for separately.  The bundled monthly rental payments are not capped and continue for as long as Part B coverage for the equipment continues. Insulin may be furnished by any enrolled DMEPOS supplier.  In cases where a rented insulin pump is used in conjunction with a class III CGM, suppliers should append the KF modifier to the claim (E0784KF) to indicate that the insulin pump is being used in conjunction with a class III CGM and is excluded from the DMEPOS CBP.

Effective January 1, 2028, the fee schedule amounts for class III CGMs and insulin pumps used in conjunction with class III CGMs will be limited to the national payment amount established for class II CGMs and insulin pumps under the DMEPOS CBP.

HCPCS Level II codes for CGMs, insulin pumps, and supplies and accessories for CGMs and insulin pumps not subject to the DMEPOS CBP are included in the Table C.

Table C

Billing Scenarios

• A beneficiary begins using equipment for the first time on or after January 1, 2028.
  • Use code E2102KF, E2103KF, and/or E0784KF, as applicable and only if the CGM is a class III CGM or the insulin pump is used with a class III CGM.
• A beneficiary is currently renting the equipment as of December 31, 2027, and rental payments have not reached the purchase fee schedule cap for a rented CGM3 or the 13-month cap for an insulin pump4.
  • Use codes E2102KF, E2103KF, and/or E0784KF, as applicable and only if the CGM is a class III CGM or the insulin pump is used with a class III CGM.
• A beneficiary owns the equipment and the equipment is replaced by an enrolled DMEPOS supplier.
  • Use codes E2102KF, E2103KF, and/or E0784KF, as applicable and only if the CGM is a class III CGM or the insulin pump is used with a class III CGM.

Billing Frequency

In the case of all rented CGMs and insulin pumps, and supplies and accessories for CGMs and insulin pumps owned by the beneficiary as of December 31, 2027, suppliers may bill in 90-day increments (i.e., up to three rental months in advance or up to three months of supplies and accessories in advance).

Transition period 

Contract suppliers will have six months from the start of Round 2028 (until July 1, 2028) to obtain a written order for patients transitioning to them from non-contract suppliers.  Once the six-month grace period expires, suppliers will be expected to submit the required documentation upon request without exception.

Options Available to Medicare Beneficiaries for Obtaining CGMs, Insulin Pumps, and Replacement Supplies and Accessories on or after January 1, 2028

Table D shows the options for beneficiaries for obtaining CGMs and/or insulin pumps under Medicare Part B, effective January 1, 2028.

Note that the payment amounts are established for each month of items and services but up to three months or 90 days of items and services can be billed for in advance. Also note that while supplies may be packaged in the typical quantity used in a month, suppliers must ensure that all supplies and accessories needed for the entire month must be furnished and cannot let the supplies run out before the end of the month.

Table D

Grandfathered Suppliers⁵

The following information pertains to grandfathered suppliers under the DMEPOS CBP.

Coordination with Noncontract and/or Grandfathered Suppliers for Beneficiary Transitions

When a beneficiary transitions to a contract supplier, any CGM, insulin pump, or both, that is not owned by the beneficiary must be picked up or otherwise returned to the original supplier that owns the equipment. The contract supplier must furnish replacement equipment from its own inventory or contract with other companies for the purchase of items necessary to fill the order as required by DMEPOS Supplier Standard #4 (42 C.F.R. § 424.57(c)(4)). The original supplier and the contract supplier should coordinate the pickup of the old equipment and delivery of the new equipment in a manner suitable to the beneficiary so no break in service occurs. Suppliers should also review the additional notice requirements and related pickup procedures in 42 C.F.R. § 414.408(j)(5) and (6), including requirements that may apply if a beneficiary chooses not to continue receiving the item from a grandfathered supplier or if a supplier chooses not to become a grandfathered supplier.

Suppliers Considering Grandfathered Status

A supplier that is not awarded a DMEPOS CBP contract in Round 2028 for class II CGMs and insulin pumps, also known as a noncontract supplier, can decide to be a grandfathered supplier for Medicare beneficiaries to whom they are currently renting class II CGMs and insulin pumps.

It is important to understand that the only scenario in which grandfathered suppliers can support beneficiaries going into Round 2028 is when beneficiaries have been renting the class II CGM as of December 31, 2027, and have not yet reached the cap on allowed charges for rental of the CGM (cap = purchase fee schedule amount), or beneficiaries have been renting the insulin pump used with a class II CGM for less than 13 months of continuous use as of December 31, 2027. If a noncontract supplier has been furnishing monthly supplies for the CGM or insulin pump for a beneficiary-owned class II CGM or insulin pump, on or before December 31, 2027, the beneficiary must be transitioned to a contract supplier by January 1, 2028, and cannot be served by the noncontract, grandfathered supplier.

A supplier that elects to be a grandfathered supplier must continue to furnish the grandfathered equipment and supplies to all beneficiaries who elect to continue receiving the grandfathered items from that supplier, unless the beneficiary elects to switch to a contract supplier or the item is no longer medically necessary. A grandfathered supplier cannot turn a beneficiary away if the beneficiary chooses to continue receiving the equipment and supplies from the grandfathered supplier.

A noncontract supplier that elects to become a grandfathered supplier must provide a written notification at least 30 business days in advance of the start of Round 2028 to each Original Medicare beneficiary that is currently renting a class II CGM or insulin pump from that supplier. The notification to the beneficiary must meet all the requirements outlined under 42 C.F.R. 414.408(j)(5). This means the written notification must be sent to the beneficiary on or before November 18, 2027. For any new beneficiaries who elect to receive equipment or supplies from November 18 – December 31, 2027, these new beneficiaries are not able to be served by the grandfathered supplier after January 1, 2028, and should be notified as such. No new beneficiaries can be served on or after January 1, 2028, that are not customers of the grandfathered supplier as of November 18, 2027, and also have been properly notified.

Beneficiaries who transition from a Medicare Advantage Plan to Original Medicare on or after January 1, 2028, and are renting equipment from a grandfathered supplier that rents the equipment under both Medicare Advantage and Original Medicare, may elect to continue to rent the equipment from the grandfathered supplier. The grandfathered supplier should notify the beneficiary transitioning from Medicare Advantage to Original Medicare in accordance with 42 C.F.R. 414.408(j)(5) but does not need to provide the notification to this beneficiary 30 business days before the start of Round 2028. Suppliers that choose to be grandfathered suppliers will be paid at the Round 2028 monthly rental single payment amount. Beneficiaries are responsible for the 20 percent coinsurance and any unmet annual deductible.

A grandfathered supplier must accept assignment on all claims for items furnished to Medicare beneficiaries.

When a Beneficiary Transitions from a Grandfathered Supplier to a Contract Supplier

A beneficiary may transition from a grandfathered supplier to a contract supplier at any time, and the contract supplier is required to accept the beneficiary as a customer.  When a beneficiary transitions to a contract supplier, any CGM, insulin pump, or both, must be picked up or otherwise returned to the original supplier that owns the equipment. The contract supplier must furnish replacement equipment from its own inventory or contract with other companies for the purchase of items necessary to fill the order as required by DMEPOS Supplier Standard #4 (42 C.F.R. § 424.57(c)(4)). The original supplier and the contract supplier should coordinate the pickup of the old equipment and delivery of the new equipment in a manner suitable to the beneficiary so no break in service occurs.

Decision Not to be a Grandfathered Supplier and Other Notice Requirements

Suppliers should also review the additional notice requirements and related pickup procedures in 42 C.F.R. § 414.408(j)(5) and (6), including requirements that may apply if a beneficiary chooses not to continue receiving the item from a grandfathered supplier or if a supplier chooses not to become a grandfathered supplier.

Billing by Grandfathered Suppliers

For the items described in Table E, a grandfathered supplier will only bill using HCPCS Level II codes E2103 or E0784. HCPCS Level II codes A4239 and A4227 may not be billed to Medicare by grandfathered suppliers.

Table E

Further, if a beneficiary owns a class II CGM and rents an insulin pump from a grandfathered supplier, a grandfathered supplier cannot bill E2103 or A4239. The grandfathered supplier can bill E0784. A contract supplier is the only appropriate supplier allowed to bill for E2103 or A4239 when the beneficiary owns a class II CGM.

Similarly, if a beneficiary owns an insulin pump and rents a class II CGM from the grandfathered supplier, a grandfathered supplier cannot bill E0784 or A4227. The grandfathered supplier can bill E2103. A contract supplier is the only appropriate supplier allowed to bill for E0784 or A4227 when the beneficiary owns an insulin pump.

A grandfathered supplier cannot switch the beneficiary’s ownership of the class II CGM or insulin pump to rental after December 31, 2027, and must instead notify the beneficiary to transition to a contract supplier to receive monthly supplies and accessories for the owned equipment.

A grandfathered supplier must follow the Physician or Treating Practitioner Authorization Process, which is a special beneficiary safeguard to ensure that beneficiaries have access to specific brands or modes of delivery of competitively bid items in the product category when needed to avoid an adverse medical outcome

Billing may occur for 90-day increments.