Medical Coverage Policy [Glucose MonitoringContinuous

Coverage Summary

This policy covers continuous (long-term) and short-term (intermittent, up to 72 hours) glucose monitoring for Blue Cross & Blue Shield of Rhode Island members. Status: CURRENT. Subject: Continuous and Short-term (Intermittent) Glucose Monitoring (CGM/FGM).

Therapeutic CGM is defined as a device that provides information that can be used to make diabetes treatment decisions (for example changing diet or insulin dosage) based solely on the CGM readings and is intended to replace information from blood glucose monitors. Non-therapeutic CGM are adjunctive devices that complement, but do not replace, blood glucose monitors and are not intended for treatment decisions without confirmatory fingerstick.

Insulin-treated is defined as members who are receiving insulin injections to treat their diabetes (oral medications do not qualify as insulin-treated).

Effective date: 2017-01-01. Last review: 2020-03-24. Note: Medicare coverage follows CMS Ruling 1682R — only CGMs that meet the CMS definition of therapeutic CGM are covered by Medicare; non-therapeutic CGMs are non-covered.

Thresholds / Quick Facts

Short-term monitoring durationMinimum of 72 hours required for ambulatory CGM CPT codes 95249/95250/95251

Test strips/lancets - non-insulin treatedUp to 100 test strips (A4253) and up to 100 lancets (A4259) every 3 months

Test strips/lancets - insulin treatedUp to 300 test strips (A4253) and up to 300 lancets (A4259) every 3 months

Coverage Determinations and Criteria

Therapeutic vs Non-therapeutic CGM Coverage

Coverage depends on whether a CGM meets the CMS definition of “therapeutic” (can be used to make diabetes treatment decisions without confirmatory fingerstick):

Therapeutic CGM devices (provide information sufficient to make diabetes treatment decisions without confirmatory fingerstick) are covered for BlueCHiP for Medicare and Commercial products.
Therapeutic CGMs are defined per CMS Ruling 1682R and Medicare coverage policy.
Non-therapeutic CGM devices (adjunctive devices intended to complement, not replace, blood glucose monitors) are not covered.
Non-therapeutic CGMs that do not meet CMS therapeutic definition will be denied as non-covered.

Implantable CGM Devices

Coverage determination for implantable CGM devices:

Coding (HCPCS / CPT / Other)

Covered HCPCS / CPT for BlueCHiP for MedicareHCPCS|CPT|mixedCovered

K0553	Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service
K0554	Receiver (monitor), dedicated, for use with therapeutic continuous glucose monitor system
95249	Ambulatory continuous glucose monitoring via subcutaneous sensor for a minimum of 72 hours; patient-provided equipment; sensor placement; hook-up, calibration, patient training, and printout
95250	Ambulatory continuous glucose monitoring via subcutaneous sensor for a minimum of 72 hours; sensor placement, hook-up, calibration, patient training, removal of sensor, and printout
95251	Ambulatory continuous glucose monitoring via subcutaneous sensor for a minimum of 72 hours; interpretation and report
S1030	Continuous non-invasive glucose monitoring device, purchase
S1031	Continuous non-invasive glucose monitoring device, rental, including sensor; sensor replacement, and download to monitor

Covered HCPCS / CPT for Commercial ProductsHCPCS|CPT|mixedCovered

A9276	Sensor; invasive (e.g., subcutaneous) disposable, for use with interstitial continuous glucose monitoring system, 1 unit = 1 day supply
A9277	Transmitter; external, for use with interstitial continuous glucose monitoring system
A9278	Receiver (monitor); external, for use with interstitial continuous glucose monitoring system
K0553	Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service
K0554	Receiver (monitor), dedicated, for use with therapeutic continuous glucose monitor system
S1030	Continuous non-invasive glucose monitoring device, purchase
S1031	Continuous non-invasive glucose monitoring device, rental, including sensor; sensor replacement, and download to monitor

Not Covered / Not Medically Necessary CodesHCPCS|CPT|mixedNot Covered

A9275	Home blood glucose disposable monitor; including test strips (not covered as DME)
A9270	Glucose monitors not designed for home use (must be coded A9270 and will be denied as statutorily not covered)
A9276	Classified by Medicare as non-therapeutic for Medicare claims (see note); BCBSRI notes A9276/A9277/A9278 are not correct codes for therapeutic devices under Medicare
A9277	Transmitter; external, for use with interstitial continuous glucose monitoring system (not covered by Medicare if non-therapeutic)
A9278	Receiver (monitor); external, for use with interstitial continuous glucose monitoring system (not covered by Medicare if non-therapeutic)
0446T	Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and training patient (not covered/medically necessary)
0448T	Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation (not covered/medically necessary)
0447T	Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision (refer to Related Policy Removal of Non-Covered Implantable Devices)

Test Strips and Lancets (Quantity Limits per CMS MUEs)HCPCSCovered

A4253	Test strips for self-testing of blood glucose
A4259	Lancets for blood glucose testing

Billing, Documentation, and Audit Actions

Billing Rule

Use correct HCPCS for therapeutic CGMs (Medicare)

For BlueCHiP for Medicare, therapeutic CGM devices and supplies must be billed with HCPCS K0554 (receiver) and K0553 (supply allowance). Filing claims using A9276–A9278 for devices that meet the Medicare therapeutic definition is incorrect and will be denied.

Affected codes: K0553
Affected codes: K0554
Incorrectly used codes that will be denied: A9276, A9277, A9278
Denial consequence: Claims filed with A9276–A9278 for therapeutic devices will be denied

Billing Rule

PDAC / Pricing and Coding verification

Devices and supplies billed under K0554/K0553 must be reviewed and listed by PDAC to be considered covered. Continuous glucose monitor systems not listed on the PDAC Product Classification List for HCPCS K0554 will not be covered.

Background and Evidence

Background: CGM measures interstitial glucose automatically and frequently to show glucose trends; devices can be used intermittently (short-term monitoring up to 72 hours) or continuously (long-term). Devices vary in design (real-time rtCGM and intermittently viewed/flash glucose monitors) and in capability — some are approved as adjuncts while others are intended to replace fingerstick self-monitoring.

CMS/Medicare distinction: Medicare covers CGM devices only when they meet the CMS definition of therapeutic CGM (can be used to make treatment decisions without confirmatory fingerstick) per CMS Ruling 1682R; adjunctive (non-therapeutic) CGMs are not covered.

Regulatory and evidence context: Multiple CGM systems have received FDA approval (examples include Dexcom G4/G5/G6, FreeStyle Libre, Guardian Connect, Eversense) and randomized trials and systematic reviews (for example DIAMOND, GOLD, CONCEPTT and several meta-analyses) have demonstrated CGM effectiveness in improving glycemic control in type 1 diabetes and in pregnancy.

Evidence / References

FDA approvals referencedMultiple device approvals cited including Dexcom G4/G5/G6, FreeStyle Libre, Guardian Connect, Eversense with indicated ages and device-specific intended uses

Guideline / Trials citedRandomized trials and systematic reviews cited (e.g., DIAMOND, GOLD, CONCEPTT) and multiple systematic reviews/meta-analyses supporting CGM effectiveness

Medicare Determinations

name	number	type	effective date
CMS Ruling 1682R	1682R	NCD	2017-01-12

Key Definitions

Therapeutic CGM: A CGM that provides information sufficient to make diabetes treatment decisions, such as changing diet or insulin dosage, based solely on CGM readings and intended to replace blood glucose monitor information; Medicare covers therapeutic CGMs under the DME benefit when the CMS definition is met.

Non-therapeutic CGM: A CGM intended to complement, not replace, blood glucose monitors and not intended for making diabetes treatment decisions without confirmatory fingerstick; such devices are classified as non-covered under Medicare.

Insulin-treated: Member is receiving insulin injections to treat their diabetes; oral diabetes medications do not qualify a member as insulin-treated.

Revision History

2017-01-12policy_date

Effective for claims on or after January 12, 2017, Medicare covers therapeutic CGM devices under the DME benefit per CMS Ruling 1682R; CGMs that do not meet the therapeutic definition will be denied as non-covered.

2017-01-01policy_date

Policy effective date: 2017-01-01.

2020-03-24policy_dateLatest

Policy last updated: 2020-03-24.