Diabetes Tests, Programs and Supplies
Customize your policy alerts
Sign up for Aetna Policy 0070 alerts
Get alerted when Policy 0070 changes without checking for updates manually.
Monitor payer policy activity
Defines medical necessity, coverage, limitations, and coding for diabetes-related tests, self-care programs, continuous glucose monitoring, supplies, and related devices for members with diabetes.
No material clinical or coverage changes in this revision.
Coverage Criteria and Medical Necessity
Diabetes Self-Care Programs (Medical Necessity)
Covered when ALL of the following are met
Program must meet all listed elements to be considered medically necessary.
Continuous Glucose Monitoring - Short-term diagnostic use
Covered when ANY of the following diagnostic indications are present and duration is 72 hours to 1 week (max 2 periods per 12 months)
Documentation should support unresponsiveness to conventional insulin adjustment and number of monitoring periods.
Used when conventional SMBG has not identified/control these patterns.
Appropriate when clinical features suggest congenital or persistent hypoglycemia; document symptoms and indication.
Continuous Glucose Monitoring - Long-term therapeutic use
Covered when ALL of the following are met
Continued coverage requires demonstrated improved glycemic control or decreased hypoglycemia while using CGM, or prescriber assessment of adherence every 6 months.
Experimental/Investigational determinations
Not covered (considered experimental/investigational) for these indications
These indications lack sufficient evidence of clinical benefit per policy.
Special DME: Blood glucose monitors for visual impairment or manual dexterity
Covered when ANY of the following are met
Device provided as DME when criteria for legal blindness are met.
Physician recommendation and documentation required.
Alternate Site Blood Glucose Monitors
Covered when ANY of the following are met
Physician recommendation must document reason for alternate site testing.
Document prior use and reason for alternate-site necessity.
Device/procedure coverage contingent on selection criteria
Coverage of specific CGM procedures, implantable sensors, and supplies is contingent on meeting selection criteria referenced in the policy.
Providers must supply documentation linking billed code to selection criteria and clinical indication.
Diagnosis-based coverage logic
ICD-10 diagnoses guide coverage when selection criteria are met; some diagnoses are explicitly not covered for listed CPB indications.
Type 2 diabetes codes are considered investigational for persons not using intensive insulin regimens unless selection criteria met.
Claims with these principal diagnoses may be denied for listed CPB indications.
Adult type 1 diabetes — supported use
Evidence-supported coverage focus
Assess individual readiness and provide education/support prior to prescribing CGM.
Type 2 diabetes — conditional/limited evidence
Limited or conditional coverage
Consider patient selection, ability to act on CGM data, and adherence.
Children, adolescents, and pregnancy — insufficient evidence
Subgroups with insufficient evidence
Technology assessments recommend further study before broad use in these subgroups.
Professional/diagnostic CGM use
Diagnostic/professional use
Diagnostic yield examples include detection rates of 46–62.5% in small series; clinical significance of reduced duration of asymptomatic hypoglycemia is uncertain.
Clinical uses supported by cited evidence
Evidence-based clinical applications described in the document include:
Studies are often small and short-duration; long-term outcome impact not established.
Users showed high satisfaction; caution when making insulin dosing decisions due to occasional >20–30% deviations.
Data are limited by small sample sizes; useful as adjunctive monitoring tool.
Threshold-suspend devices (eg, MiniMed 530G) have demonstrated reduced nocturnal hypoglycemia in RCTs.
Continuous glucose monitoring in neonates
Evidence summary and uncertainty
UpToDate reviews cite reliability but state clinical significance of readings is uncertain.
Artificial pancreas / threshold-suspend systems
Summarized clinical trial evidence
ASPIRE/Bergenstal randomized trial demonstrated these reductions without increasing A1C.
Device labeling and approval referenced in background.
GlucoWatch Biographer
Device accuracy and outcome data
Randomized trials did not demonstrate improved glycemic control or reduced severe hypoglycemia in children when GlucoWatch was added.
Device considered to supplement, not replace fingerstick testing.
Alternate-site blood glucose monitoring
Accuracy and practical concerns
No evidence that alternate-site testing improves compliance over fingertip testing.
Home A1C and PDA-based monitoring
Outcome evidence
Home A1C testing unlikely to improve outcomes; office/lab testing allows provider interpretation.
Use may aid self-management but outcome benefit unproven.
Infrared foot thermometry for ulcer prevention
Evidence for home temperature monitoring in high-risk patients
Studies enrolled high-risk categories (risk 2 or 3).
TempTouch device protocol used in trials.
Lavery and Armstrong trials reported lower ulcer incidence with thermometry-guided action.
Guideline authors caution interpreting results and recommend standard screening first.
General coverage stance for reviewed devices
Covered when evidence demonstrates clinical effectiveness and impact on management or outcomes; otherwise investigational or research-use devices are not covered.
Follow established guidelines (ADA/IWGDF); adjunct devices require evidence of added benefit.
Coverage contingent on documented clinical justification and evidence of effectiveness.
Implantable CGM evidence and regulatory status
Evidence summary and regulatory findings for implantable CGM systems:
Post-approval studies and documentation of indication are recommended when seeking coverage.
FreeStyle Libre (flash glucose monitoring) evidence
Evidence summary for the FreeStyle Libre flash glucose monitoring system:
Caution when using readings for insulin dosing due to some >20–30% deviations.
Remote glucose monitoring / telemonitoring
Evidence for remote glucose monitoring:
Coverage decisions for remote monitoring accessories should consider current evidence and demonstrated clinical benefit.
Supply coverage: usual and high utilization criteria
Covered quantities and criteria for supplies
These are the baseline covered quantities.
All three criteria (a)-(c) must be met for high utilization coverage.
Aetna considers several items to be noncovered convenience items or not medically necessary when billed under medical coverage. Examples explicitly identified include the I-Port Injection Port and hypoglycemic wristband alarms (e.g., Sleep Sentry). Combination devices that pair a home glucose monitor with unrelated functions (for example, blood pressure or cholesterol analyzers or cellular telephones) are also considered convenience items and not separately reimbursed. In addition, cellular-enabled features that merely allow wireless transmission of glucose results are treated as integral to the meter and not separately reimbursable.
The policy lists specific ICD-10 diagnostic codes that are not covered for the indications addressed in this bulletin: E16.9 (Disorder of pancreatic internal secretion, unspecified) and neonatal hypoglycemia codes P70.3–P70.4. Claims with these principal diagnoses for the CPB-listed indications may be denied.
The evidence base indicates that continuous glucose monitoring (CGM) has limited durable clinical benefit in unselected individuals. Large/longer-term studies (for example MITRE) and technology-assessment reviews concluded that CGM did not produce sustained HbA1c improvement or meet technology-evaluation criteria when applied to unselected insulin-requiring populations. Device benefit appears to be greatest in selected populations (e.g., nonpregnant adults with type 1 diabetes on intensive insulin regimens).
Use of CGM in acutely ill inpatients and routine neonatal diagnostic use is not supported by sufficient evidence. Interstitial sensors lose accuracy over time and have a lag (typically ~6–10 minutes), and UpToDate reviews note that although CGM can be reliable and tolerable in neonates, the clinical significance of low interstitial glucose readings and appropriate treatment thresholds remain unclear; therefore routine inpatient or neonatal reliance on CGM outside research settings is premature.
GlucoWatch labeling and assessments caution that the device is less accurate than fingerstick testing and is intended to supplement, not replace, SMBG. The manufacturer/FDA labeling states users should never make insulin-dosing decisions based solely on GlucoWatch readings and must verify GlucoWatch values with fingerstick measurements; calibration with a fingerstick is required each time the device is worn.
The Scout DS skin autofluorescence system is described in the policy as a research-use device. The document states there is insufficient evidence that the Scout DS can replace standard diagnostic testing and notes the device is currently used for research purposes only.
Cellular activation therapy (also called pulsatile intravenous insulin therapy or PIVIT) is listed as lacking evidence of clinical effectiveness. The policy states there is a lack of evidence supporting CAT for treatment of diabetes and considers it unsupported.
The early validation data cited for the FreeStyle Libre included a very small sample of healthy volunteers (n = 8) in one referenced study. The policy notes this small sample size and absence of diabetic participants as a limitation and indicates larger studies in diabetic populations are needed to confirm findings.
The policy identifies multiple devices and software considered experimental or investigational and not medically necessary in routine care. Examples include Lasette laser blood glucose monitor, devices for measurement of glycated serum proteins (fructosamine), the PreDx risk score, the Biostator artificial pancreas, the GlucoWatch Biographer, home A1C monitors, mobile diabetes self‑management applications, PDA‑based monitors, infrared thermometry devices (e.g., TempTouch) for routine ulcer prevention, skin autofluorescence AGE measurement systems (e.g., Scout DS), remote monitoring attachments/accessories (e.g., Dexcom SHARE or MiniMed Connect), and cellular activation therapy.
Fructosamine (glycated serum protein) testing is noted as having unestablished clinical utility; the ADA does not consider it equivalent to HbA1c and randomized data have not demonstrated benefit. Measurement of GAD‑65 antibodies can be useful to distinguish type 1/LADA from type 2 in ambiguous cases, but its value for population screening is unproven because effective prevention strategies are lacking; routine coverage for screening indications is therefore limited.
Earlier‑generation CGM systems evaluated in randomized trials and technology assessments did not produce durable HbA1c improvement when used broadly in unselected insulin‑requiring individuals. The policy therefore considers use of such earlier CGMs in unselected populations to be not medically necessary absent documented selection criteria that identify patients likely to benefit.
The document reiterates that routine inpatient CGM use is not supported by sufficient evidence. Sensor durability, accuracy drift, and response lag are cited limitations; CGM use in acutely ill hospitalized patients should be considered investigational or limited to research settings until further evidence becomes available.
Home A1C monitors and the GlucoWatch Biographer lack prospective trial evidence demonstrating improved clinical outcomes. The policy states GlucoWatch does not eliminate the need for fingerstick testing and randomized trials did not show improved glycemic control with its addition; overall evidence is insufficient to support routine coverage.
There is insufficient evidence that home infrared thermometry, skin autofluorescence AGE measurement devices, and remote monitoring accessories (for example Dexcom SHARE or MiniMed Connect) consistently improve clinical outcomes. The policy describes these technologies as having limited or uncertain benefit and treats them as investigational or not medically necessary absent stronger evidence or documented clinical need.
The policy again states that cellular activation therapy is unsupported due to inadequate evidence of clinical effectiveness and therefore is considered not medically necessary.
When the policy's selection and medical‑necessity criteria are met, a range of CPT and HCPCS codes for CGM services, implantable sensors, and supplies are covered. Examples include 95249, 95250, 95251 for ambulatory short‑term CGM; 0446T–0448T and G0308–G0309 for implantable sensor insertion/removal; and supply/device codes such as A9276–A9278, A4239, and E2103. Coverage of these codes is contingent on documentation that selection criteria in the policy are satisfied.
Coding: CPT, HCPCS, and ICD-10 Guidance
| 0403T | Preventive behavior change, intensive program of prevention of diabetes |
| 82947 | Glucose; quantitative, blood (except reagent strip) |
| 82948 | Glucose; blood, reagent strip |
| 82950 | Glucose; post glucose dose (includes glucose) |
| 82962 | Glucose, blood by glucose monitoring device(s) cleared by the FDA specifically for home use |
| 83036 | Hemoglobin; glycosylated (A1C) |
| 83037 | Glycosylated (A1C) by device cleared by FDA for home use |
| 95249 | Ambulatory continuous glucose monitoring for minimum of 72 hours; patient-provided equipment... |
| 95250 | Ambulatory continuous glucose monitoring for minimum of 72 hours; sensor placement, hook-up... |
| 95251 | Analysis, interpretation and report for ambulatory CGM |
| A4206 | Syringe with needle, sterile 1 cc or less |
| A4253 | Blood glucose test or reagent strips for home blood glucose monitor, per 50 strips |
| E0607 | Home blood glucose monitor |
| E2101 | Blood glucose monitor with integrated lancing/blood sample |
| S9140 | Diabetic management program, follow-up visit to non-MD provider |
| S1034 | Artificial pancreas device system |
| E10.10 - E10.9 | Type 1 diabetes mellitus |
| E11.00 - E11.9 | Type 2 diabetes mellitus |
| G25.82 | Stiff-man syndrome |
| 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 of recording. |
| 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 of recording. |
| 95251 | Analysis, interpretation and report. |
| 0446T | Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training. |
| 0447T | Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision. |
| 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. |
| A4239 | Supply allowance for non-adjunctive, non-implanted continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service. |
| 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. |
| E2103 | Non-adjunctive, non-implanted continuous glucose monitor or receiver. |
| G0308 | Creation of subcutaneous pocket with insertion of 180 day implantable interstitial glucose sensor, including system activation and patient training. |
| G0309 | Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new 180 day implantable sensor, including system activation. |
| S1030 | Continuous noninvasive glucose monitoring device, purchase. |
| S1031 | Continuous noninvasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor. |
| S1034 | Artificial pancreas device system (e.g., low glucose suspend [LGS] feature) including continuous glucose monitor, blood glucose device, insulin pump and computer algorithm that communicates with all of the devices. |
| S1035 | Sensor; invasive, for use with artificial pancreas device system. |
| E08.00 - E13.9 | Diabetes mellitus (ICD-10 range listed where selection criteria are met). |
| E10.10 - E10.9 | Type 1 diabetes mellitus (ICD-10 range) |
| E11.00 - E11.9 | Type 2 diabetes mellitus (ICD-10 range) — note: considered experimental and investigational for persons not using intensive insulin regimens per document. |
| E74.00 - E74.09 | Glycogen storage diseases (ICD-10 range) |
| E16.9 | Disorder of pancreatic internal secretion, unspecified — listed as ICD-10 codes not covered for indications in the CPB. |
| P70.3 - P70.4 | Iatrogenic and other neonatal hypoglycemia — listed as not covered for indications in the CPB. |
| FDA PMA device | MiniMed 530G System (threshold suspend artificial pancreas device system) — PMA referenced |
| FDA 510(k) | GlucoWatch Biographer — 510(k) cleared device (historical) |
| FDA 510(k) | ReliOn NewTek (Express Blood Glucose Monitoring System) — 510(k) cleared |
| FDA 510(k) | TempTouch infrared thermometer — 510(k) clearance March 2005 |
Provider Actions: Authorization, Documentation, and Billing
Prior authorization for CGM and implantable sensors
Certain CGM and implantable sensor CPT/HCPCS codes are covered only when the policy's selection/medical necessity criteria are met; claims for these codes should be supported by documentation that the member meets the CPB selection criteria prior to billing.
Procedure/device codes requiring criteria
Specific procedure and durable device codes for implantable sensors and CGM systems require that the policy’s selection criteria be met; when billing these procedure/device codes, providers must ensure the medical record documents the applicable selection criteria.
Prior authorization likely for defined populations
Technology assessments and guidelines emphasize limiting CGM use to populations with demonstrated benefit (for example, non-pregnant adults with type 1 diabetes using multiple daily injections or pump therapy); when prescribing CGM for these populations, document indications and education/training provided.
- ADA and technology assessments support CGM for adults with type 1 diabetes on intensive insulin regimens and recommend assessing readiness and providing robust education.
- Document that the member is in a population supported by evidence (e.g., adult type 1 diabetes on ≥3 daily injections or pump).
Inpatient CGM use
Use of CGM in inpatient or acutely ill settings is not supported by sufficient evidence; inpatient CGM use should be considered investigational or limited to research settings unless and until further studies establish clinical benefit.
- The ADA (2007) and systematic reviews note lack of data for acutely ill inpatients; providers should avoid routine inpatient CGM outside research.
PMA device noted — prior authorization not specified
The MiniMed 530G System is FDA-approved (PMA) as a threshold-suspend artificial pancreas device system; the CPB does not specify payer prior authorization rules for PMA devices, so providers should follow applicable plan-level requirements.
- MiniMed 530G is FDA PMA-approved for threshold suspend functionality; plan-specific prior authorization policies are not detailed in this excerpt.
Prior authorization for implantable CGM and accessories
Implantable CGM systems and remote monitoring accessories may be considered investigational or have limited evidence of outcome benefit; such devices may require prior authorization and supporting clinical justification when requested for coverage.
- Eversense implantable CGM has FDA approval but clinical outcome benefits are limited; remote accessories (e.g., Dexcom SHARE) lack demonstrated outcome improvements and may be denied.
- Providers should be prepared to supply evidence of clinical need when requesting coverage for implantable CGM or remote monitoring accessories.
Prior authorization for implantable CGM
Use of implantable CGM requires documentation of the device indication and that insertion/removal was performed as an outpatient procedure; providers should submit the outpatient procedure notes and clinical rationale when requesting coverage.
- Eversense involves outpatient implantation and FDA reviewed insertion/removal procedure safety; document procedure details and device indication in the medical record.
- Include clinical study or FDA approval rationale if coverage is requested for implantable CGM.
Prior authorization / documentation requirements for high utilization
Quarterly usual supplies are limited (non-insulin users up to 100 strips/lancets; insulin users up to 300 strips/lancets); dispensing quantities above these thresholds require physician documentation meeting the CPB’s three required criteria.
- For quantities above usual utilization, physician must document: (a) training/prescription for device and testing frequency; (b) evaluation of diabetes control within 6 months with rationale; (c) evidence that member is testing at the frequency that corroborates dispensed quantities, with updates at least every 6 months.
Prior authorization may be required per plan provisions
Plan provisions govern coverage administration; providers should follow the member’s specific plan rules because prior authorization requirements may apply at the plan level even if not specified in the CPB.
- Clinical Policy Bulletins are partial descriptions of plan benefits and do not replace plan documents; check member plan rules for prior authorization requirements.
Step requirements for long-term CGM
Long-term CGM coverage is limited to adults (≥18 years) using intensive insulin regimens (multiple [≥3] daily injections or insulin pump therapy); CGM for persons with type 2 diabetes not using intensive regimens is considered experimental/investigational.
- Document that the member is ≥18 years and using an intensive insulin regimen (≥3 daily injections or pump) when requesting long-term CGM coverage.
- Type 2 diabetes patients not on intensive regimens are not covered for long-term CGM per CPB.
Therapy sequencing considerations
When CGM is integrated with insulin pump therapies (sensor-augmented systems), these are incremental to care and require structured training and monitoring; document the training and follow-up plan when initiating combined therapies.
- Combined pump/CGM systems require patient education and monitoring; document readiness and training per ADA and technology assessment recommendations.
Consider sequencing insulin delivery changes
Initiation of pump therapy can confound assessment of CGM benefit; when both are started, document the sequencing rationale and clinical justification to support coverage decisions.
- Trials combining pump initiation with CGM make it difficult to attribute benefit; provide rationale if therapies are initiated concurrently.
Professional CGM for diagnostic evaluation
Short-term professional CGM may be used diagnostically to detect unrecognized hypoglycemia (often nocturnal) when conventional SMBG is insufficient; document the diagnostic indication and limit duration to 72 hours–1 week, with no more than two monitoring periods per 12 months.
- Document specific diagnostic indication (e.g., hypoglycemia unawareness, recurrent symptomatic hypoglycemia) and the planned monitoring duration (72 hours to 1 week).
- CPB limits short-term professional CGM to a maximum of 2 periods within 12 months.
No explicit step therapy requirements specified
This excerpt does not specify any formal step therapy mandates; providers should note that no explicit step therapy requirements are stated in the CPB text.
- Although no explicit step therapy mandates are listed, usual utilization thresholds and selection criteria functionally guide coverage decisions.
Step through standard care first
Before authorizing novel monitoring devices for foot ulcer prevention or other adjunctive technologies, consider standard care first (annual foot exam, 10-g monofilament screening) and document attempts at conventional management.
- Standard screening and preventive care (10-g monofilament, annual exam) should be documented prior to using adjunctive devices.
- Document prior outpatient or self-monitoring strategies and rationale for advancing to device-based monitoring.
Step therapy
The CPB does not state explicit step therapy mandates for CGM or related devices; providers should follow the selection criteria and documentation requirements outlined in the policy when requesting coverage.
- No formal step therapy sequence is imposed by the CPB; clinical indications, device-specific criteria, and documentation guide coverage.
Utilization thresholds as step
Usual utilization thresholds (100 strips/lancets per 3 months for non-insulin users; 300 per 3 months for insulin users) act as baseline coverage quantities; quantities above these thresholds require the CPB’s documented justification (physician training confirmation, recent evaluation, corroborating testing logs).
- Use the CPB’s three documentation criteria to support higher quarterly supply requests: prescription/training, evaluation within 6 months, and testing log or narrative.
- Ongoing excess utilization requires updated documentation at least every 6 months.
Documentation for diabetes self-care programs
Providers must order diabetes self-care education programs and include a physician-signed statement that the service is needed; programs must be delivered by recognized healthcare professionals and designed to educate about medically necessary diabetes self-care.
- Ensure the medical record contains the physician order and signed statement of medical necessity for the self-care program.
- Document that the program personnel are recognized healthcare professionals (physician, RD, RN, pharmacist).
Documentation for short-term CGM
Short-term CGM requests must document the diagnostic indication (e.g., hypoglycemia unawareness, repeated daily hypo/hyperglycemia, nesidioblastosis/PHHI) and specify monitoring duration (72 hours–1 week) with a limit of two periods per 12 months.
- Include documentation of symptoms and prior conventional testing that was insufficient to characterize hypoglycemia.
- Specify intended monitoring duration (72 hours to 1 week) and prior short-term CGM use within the past 12 months.
Documentation for long-term CGM
Long-term CGM therapeutic use requires documentation that the patient is an adult (≥18 years) using an intensive insulin regimen (≥3 daily injections or insulin pump) and either is not meeting glycemic targets or is experiencing hypoglycemia; continued use requires evidence of benefit or prescriber assessment of adherence every six months.
- Document age, insulin regimen details (≥3 injections/day or pump), current glycemic control, and history of hypoglycemia or hypoglycemia unawareness.
- For ongoing coverage, document either improved glycemic control or decreased hypoglycemia, or record prescriber adherence assessment at least every 6 months.
Coding and documentation crosswalk
Use of specific CPT/HCPCS codes for CGM procedures, supplies, implantable sensors, and accessories should be supported by meeting the CPB selection criteria; ensure the claim documentation crosswalks the billed codes to the applicable selection criteria.
Document patient readiness and training
Assess and document patient readiness, education, training, and adherence when prescribing CGM; evidence of individualized training and follow-up supports medical necessity.
- Document that robust diabetes education and support were provided and that the patient’s ability to use and adhere to CGM was assessed.
- Record follow-up plans and adherence assessments in the medical record.
Recommended supporting data
When submitting CGM clinical data to support coverage (short-term or long-term), include paired sensor readings with capillary blood glucose values, monitoring durations (e.g., 72-hour or 14-day), and event counts such as hypoglycemic episodes or time-in-range summaries.
- Provide sensor logs paired with SMBG calibration checks and summaries of hypoglycemic events or time-in-range metrics.
- Include duration of monitoring and summary interpretation to justify changes in management.
Calibration/documentation requirement (device labeling)
Follow device labeling for calibration and documentation requirements (for example, GlucoWatch labeling requires fingerstick calibration each time the device is worn); include calibration records when relevant.
- For devices that require calibration, document fingerstick calibration readings and dates in the medical record.
- Note device-specific limitations (e.g., GlucoWatch cannot be used alone for insulin-dosing decisions).
Supporting clinical evidence documentation
For wound-temperature monitoring and implantable CGM, providers should document supporting clinical evidence such as measured reliability, sensor lifespan, sensitivity/specificity, and clinical justification to demonstrate medical necessity.
- Include study results or device performance metrics (e.g., sensor life span, MARD, sensitivity/specificity) when requesting coverage for investigational devices.
- Document potential procedure-related adverse events and outpatient procedure notes for implantable sensors.
Procedure and device documentation
Document procedural details and device safety for implantable CGM insertions/removals; include outpatient procedure notes, informed consent, and any device-related adverse event monitoring in the medical record.
- Record insertion/removal operative notes, device lot/serial numbers, and post-procedure follow-up.
- Document counseling on device risks (infection, bleeding, skin reactions) as noted in FDA review.
Required physician documentation for >usual supply quantities
When requesting quantities of supplies exceeding usual utilization limits, the physician must document (a) training/prescription for device and testing frequency, (b) evaluation of diabetes control within 6 months prior to the order with rationale, and (c) evidence that the member is testing at a frequency that corroborates dispensed quantities; renew this documentation at least every six months for ongoing excess utilization.
- Maintain a testing log or narrative that demonstrates actual testing frequency.
- Keep documentation of the physician’s recent evaluation and explicit reason for additional supplies in the medical record.
Providers are responsible for medical advice and plan verification
Providers are responsible for medical advice and treatment; the CPB is a partial description of plan benefits and not a contract — verify member plan benefits and prior authorization rules before ordering devices or services.
- Check the member’s plan documents for coverage specifics, prior authorization requirements, and whether supplies are covered under pharmacy or medical benefits.
Non-covered/convenience items may be denied
Items listed as non-covered or convenience features (for example, I-Port, hypoglycemic wristband alarms, and cellular-enabled wireless attachments) risk denial if billed to medical coverage or when plan excludes them; verify coverage pathway (medical vs pharmacy) and plan exclusions before ordering.
- Aetna does not cover wireless transmission attachments or provides no additional reimbursement for integrated wireless features considered convenience.
- Confirm whether a device is considered a convenience item or excluded by the member’s plan prior to billing.
Coding-based denial risks
Claims with certain ICD-10 principal diagnoses (for example, E16.9 and P70.3–P70.4) are listed as not covered for the CPB indications and may be denied; ensure appropriate diagnosis coding that aligns with the CPB selection criteria when submitting claims.
- E16.9 (Disorder of pancreatic internal secretion, unspecified [nesidioblastosis]) and P70.3–P70.4 (neonatal hypoglycemia codes) are listed as not covered for CPB indications.
- Use diagnosis codes that match the covered indications (e.g., E10.x, E11.x) and document selection criteria.
Population-specific limits may trigger denial
Evidence is insufficient for broad CGM use in children, adolescents, and pregnant women; use in these populations may not meet technology assessment criteria and could be denied unless strong selection criteria and documentation are provided.
- CTAF and other assessments found conclusive benefit mainly in adults and noted adherence issues in younger populations; document clinical rationale thoroughly if prescribing in these subgroups.
Inpatient use unsupported
Use of CGM and related accessories in the inpatient/acute setting is unsupported by current evidence and may be considered investigational outside research; expect potential denial for inpatient claims for CGM unless part of an approved study.
- ADA and systematic reviews note insufficient inpatient data; document research protocol if device use is part of a study.
Research-use devices
Devices used for research only (for example, Scout DS for AGE measurement) and interventions without demonstrated clinical benefit may not meet coverage criteria; provide clinical evidence if requesting coverage for research-use technologies.
- Scout DS system is currently used for research and is not intended to replace standard diagnostic tests; coverage is unlikely without demonstrated clinical effectiveness.
High utilization documentation requirements
Dispensing quantities of supplies that exceed utilization guidelines without the CPB-required physician documentation (training/prescription, evaluation within 6 months, and testing logs/narrative) may lead to denial of coverage.
- If requesting higher-than-usual quarterly supplies, include the three required documentation elements and ensure records are updated at least every 6 months for ongoing excess use.
Background and Evidence Summary
Background: Continuous glucose monitoring (CGM) is described in the policy for both short‑term diagnostic use and long‑term therapeutic use. Short‑term (professional) CGM is defined as monitoring for 72 hours to 1 week for diagnostic indications such as hypoglycemia unawareness, recurrent daily hypo/hyperglycemia, or evaluation of conditions like nesidioblastosis/PHHI. Long‑term CGM is intended for adults (≥18 years) on intensive insulin regimens (≥3 daily injections or insulin pump therapy) who are not meeting glycemic targets or who experience problematic hypoglycemia; ongoing use requires reassessment and documentation of benefit or adherence.
Implantable CGM systems (for example Eversense/Senseonics) have received regulatory approval for adult use and clinical studies report acceptable accuracy (MARDs in the single digits to low teens) and favorable safety profiles in small prospective trials. However, the policy notes that available studies are limited by sample size and study design, and while accuracy and short‑term safety are supported, evidence that implantable sensors improve long‑term glycemic outcomes remains limited.
FreeStyle Libre (flash glucose monitoring) is described as a factory‑calibrated, intermittently scanned system approved for adult use that can be worn up to 10–14 days without routine SMBG calibration. Accuracy studies reported MARDs generally in the low to mid teens with a large proportion of values in acceptable error grid zones and positive user experience; nonetheless limitations include absence of real‑time alarms and some inaccuracy at low glucose ranges, and longer‑term outcome benefits and adherence remain uncertain.
Remote glucose monitoring / telemonitoring (for example, Dexcom SHARE and other web‑based telemonitoring programs) enable data transmission to caregivers or health systems, but systematic reviews and trials have yielded mixed results. The policy highlights a lack of consistent evidence that remote monitoring improves clinical outcomes or quality of life; as a result, accessory devices that provide remote transmission are generally considered convenience features and are not separately reimbursed in routine care absent clear demonstrated benefit.
Definitions and Key Terms
Policy Dates and Revision History
Policy became effective (Clinical Policy Bulletin No. 0070: Diabetes Tests, Programs and Supplies).
Policy underwent last clinical review (Last Review recorded for the bulletin).
Next scheduled policy review date recorded in the bulletin.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.