Update: Coverage of home blood glucose monitors

Effective Oct. 1, 2015, home blood glucose monitors with special features (procedure codes E2100 and E2101) are covered when basic coverage criteria are met and the treating physician certifies that the member has a severe visual impairment requiring use of this special monitoring system. We consider severe visual impairment to be a visual acuity of 20/200 or worse in both eyes when corrected.

Code E2101 is also covered for those with impairment of manual dexterity when the basic coverage criteria are met and the treating physician certifies that the member has an impairment of manual dexterity severe enough to require the use of this special monitoring system. Coverage of E2101 for beneficiaries with manual dexterity impairments isn’t dependent upon a visual impairment.

The quantity of test strips (A4253) and lancets (A4259) that are covered depends on the usual medical needs of the member and whether or not the member is being treated with insulin, regardless of his or her diagnostic classification as having Type 1 or Type 2 diabetes mellitus. Coverage of testing supplies is based on the following guidelines**:

• Usual utilization
• For a member who isn’t currently being treated with insulin injections, up to 100 test strips and up to 100 lancets every three months are covered if the basic coverage criteria are met.
• For a member who is currently being treated with insulin injections, up to 300 test strips and up to 300 lancets every three months are covered if basic coverage criteria are met.
• High utilization
• For a member who isn’t currently being treated with insulin injections, more than 100 test strips and more than 100 lancets every three months are covered if criteria a–c below are met.
• For a member who is currently being treated with insulin injections, more than 300 test strips and more than 300 lancets every three months are covered if criteria a-c below are met.

1. Basic coverage criteria for all home glucose monitors and related accessories and supplies are met and each of the following:
• The member has diabetes.
• The member’s physician has concluded that the member or the member’s caregiver has sufficient training using the particular device prescribed as evidenced by providing a prescription for the appropriate supplies and frequency of blood glucose testing.
2. The treating physician has seen the member, evaluated his or her diabetes control within six months before ordering quantities of strips and lancets that exceed the utilization guidelines and has documented in the member’s medical record the specific reason for the additional materials for that particular member.
3. If refills of quantities of supplies that exceed the utilization guidelines are dispensed, there must be documentation in the physician’s records (for example, a specific narrative statement that adequately documents the frequency at which the member is actually testing or a copy of the member’s log) that the member is actually testing at a frequency that corroborates the quantity of supplies that have been dispensed. If the member is regularly using quantities of supplies that exceed the utilization guidelines, new documentation must be present at least every six months.

If neither basic coverage criterion is met, all testing supplies will be denied as not reasonable and necessary. If quantities of test strips or lancets that exceed the utilization guidelines are provided and criteria a–c aren’t met, the amount in excess will be denied as not reasonable and necessary.

Refill requirements

For DMEPOS provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products A4233-A4236, A4253, A4256, A4258 and A4259 that are supplied as refills to the original order, suppliers must contact the member before dispensing the refill and not automatically ship on a predetermined basis, even if authorized by the members.

This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion and to confirm any changes or modifications to the order.

Contact with the member or designee regarding refills must take place no sooner than 14 calendar days before the delivery and shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days before the end of usage for the current product. This is regardless of which delivery method is utilized. (CMS Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-08, Chapter 5, Section 5.2.6.)

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the member, caregiver or designee before dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a member. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a member’s expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the ordering physicians that any changed or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a three-month quantity at a time.

For all glucose monitors and related accessories and supplies, if the basic coverage criteria aren’t met, the items will be denied as not reasonable and necessary**.

**These guidelines don’t apply to MESSA.