Glucose Monitors

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

• The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

• The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

• Refer to the Supplier Manual for additional information on documentation requirements.

• Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

HOME BLOOD GLUCOSE MONITORS (BGM)

To be eligible for coverage of home blood glucose monitors and related accessories and supplies, the beneficiary must meet both of the following basic criteria (1) – (2):

1. The beneficiary has diabetes (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses); and

2. The beneficiary’s treating practitioner has concluded that the beneficiary (or the beneficiary’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.

For all glucose monitors and related accessories and supplies, if the basic coverage criteria (1)-(2) are not met, the item(s) will be denied as not reasonable and necessary.

Home blood glucose monitors with special features (HCPCS codes E2100, E2101) are covered when the basic coverage criteria (1)-(2) are met and the treating practitioner certifies that the beneficiary has a severe visual impairment (i.e., best corrected visual acuity of 20/200 or worse in both eyes) requiring use of this special monitoring system.

Code E2101 is also covered for those with impairment of manual dexterity when the basic coverage criteria (1)-(2) are met and the treating practitioner certifies that the beneficiary has an impairment of manual dexterity severe enough to require the use of this special monitoring system. Coverage of code E2101 for beneficiaries with manual dexterity impairments is not dependent upon a visual impairment.

If a glucose monitor (code E2100 or E2101) is provided and basic coverage criteria (1)-(2) plus the additional criteria stated above are not met, it will be denied as not reasonable and necessary.

Lancets (code A4259), blood glucose test reagent strips (code A4253), glucose control solutions (code A4256) and spring powered devices for lancets (code A4258) are covered for beneficiaries for whom the glucose monitor is covered.

More than one spring powered device (code A4258) per 6 months is not reasonable and necessary.

The medical necessity for a laser skin piercing device (code E0620) and related lens shield cartridge (code A4257) has not been established; therefore, claims for code E0620 and/or code A4257 will be denied as not reasonable and necessary.

The quantity of test strips (code A4253) and lancets (code A4259) that are covered depends on the usual medical needs of the beneficiary and whether or not the beneficiary is being treated with insulin, regardless of their 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 beneficiary who is not currently being treated with insulin administrations, up to 100 test strips and up to 100 lancets every 3 months are covered if the basic coverage criteria (1)-(2) (above) are met.

For a beneficiary who is currently being treated with insulin administrations, up to 300 test strips and up to 300 lancets every 3 months are covered if basic coverage criteria (1)-(2) (above) are met.

High Utilization

For a beneficiary who is not currently being treated with insulin administrations, more than 100 test strips and more than 100 lancets every 3 months are covered if criteria (a) – (c) below are met.

For a beneficiary who is currently being treated with insulin administrations, more than 300 test strips and more than 300 lancets every 3 months are covered if criteria (a) – (c) below are met.

1. Basic coverage criteria (1)-(2) listed above for all home glucose monitors and related accessories and supplies are met; and,

2. Within the six (6) months prior to ordering quantities of strips and lancets that exceed the utilization guidelines, the treating practitioner has had an in-person visit with the beneficiary to evaluate their diabetes control and their need for the specific quantity of supplies that exceeds the usual utilization amounts described above; and,

3. Every six (6) months, for continued dispensing of quantities of testing supplies that exceed the usual utilization amounts, the treating practitioner must verify adherence to the high utilization testing regimen.

If neither basic coverage criterion (1) or (2) 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) are not met, the amount in excess will be denied as not reasonable and necessary.

CONTINUOUS GLUCOSE MONITORS (CGM)

CGM devices covered by Medicare under the DME benefit are defined in CMS Ruling 1682R as therapeutic CGMs. Refer to the Non-Medical Necessity Coverage and Payment Rules in the LCD-related Policy Article for additional information.

Therapeutic CGMs and related supplies are covered by Medicare when all of the following coverage criteria (1-5) are met:

1. The beneficiary has diabetes mellitus (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses); and,

2. The beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or a continuous subcutaneous insulin infusion (CSII) pump; and,

3. The beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of BGM or CGM testing results; and,

4. Within six (6) months prior to ordering the CGM, the treating practitioner has an in-person visit with the beneficiary to evaluate their diabetes control and determined that criteria (1-3) above are met; and,

5. Every six (6) months following the initial prescription of the CGM, the treating practitioner has an in-person visit with the beneficiary to assess adherence to their CGM regimen and diabetes treatment plan.

When a therapeutic CGM (code K0554) is covered, the related supply allowance (code K0553) is also covered.

If any of coverage criteria (1-5) are not met, the CGM and related supply allowance will be denied as not reasonable and necessary.

The supply allowance (code K0553) is billed as 1 Unit of Service (UOS) per thirty (30) days. Only one (1) UOS of code K0553 may be billed to the DME MACs at a time. Billing more than 1 UOS per 30 days of code K0553 will be denied as not reasonable and necessary.

Therapeutic CGM devices replace a standard home blood glucose monitor (HCPCS codes E0607, E2100, E2101) and related supplies (HCPCS codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259). Claims for a BGM and related supplies, billed in addition to an approved CGM device (code K0554) and associated supply allowance (code K0553), will be denied. Refer to the Coding Guidelines in the LCD-related Policy Article for additional information.

All therapeutic CGM devices billed to Medicare using HCPCS code K0554 must be reviewed for correct coding by the Pricing, Data Analysis and Coding (PDAC) contractor. Continuous Glucose Monitor systems that are billed using HCPCS code K0554, but that are not listed on the Product Classification List for HCPCS code K0554, will be denied as incorrect coding. Refer to the Coding Guidelines in the LCD-related Policy Article for additional information.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. 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 beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. 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 beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioner that any changed or atypical utilization is warranted.

Regardless of utilization, a supplier must not dispense more than a three (3) - month quantity of BGM testing supplies at a time.

Refill requirements do not apply to code K0553. Only one (1) unit of service of code K0553 may be billed to the DME MACs at a time. Refer to the Coding Guidelines in the LCD-related Policy Article for additional billing instructions.

Standard Blood Glucose Monitoring 4x/Day as Prerequisite for Coverage of Continuous Glucose Monitor

Background

Diabetes mellitus describes diseases of abnormal carbohydrate metabolism characterized by hyperglycemia that are associated with an absolute or relative impairment in insulin secretion, peripheral resistance to the action of insulin, or both. According to the CDC National Diabetes Statistics Report 2020, the estimated prevalence of diabetes in the US for 2018 was 34.2 million people or 10.5%, with 1.5 million Americans being diagnosed with diabetes every year.¹ The percentage of adults with diabetes increases with age, reaching 26.8% (14.3 million) among those aged 65 years or older.¹

CGM devices measure the glucose content of interstitial fluid every 1 to 15 minutes, depending on the device. Interstitial fluid is accessed by a sensor inserted subcutaneously by the patient and changed every 7 to 14 days. A transmitter is attached to the sensor or worn over the sensor and transmits the glucose data to a receiver/smartphone. CGM systems provide visualization of the current glucose value as well as trend analysis, which indicates the direction of changing glucose. This technology can help patients fine-tune diabetic treatment. There are two main types of CGM systems: real time CGM (RT-CGM) and devices that require intermittent scanning, also known as flash continuous glucose monitoring (FGM).

A therapeutic CGM is one that meets the definition of durable medical equipment (DME) and is labeled by the Food & Drug Administration (FDA) for non-adjunctive use (i.e., it can be used to make treatment decisions without the need for a stand-alone home blood glucose monitor to confirm testing results). Therapeutic CGM devices can be either RT-CGM or Flash CGM technology.

The aim of this summary of evidence was to determine if a self-monitoring blood glucose (SMBG) frequency requirement of ≥4x/day prior to initiating CGM is predictive of improved glycemic control, evidenced by a clinically significant improvement in HbA1c or reduction in rate of hypoglycemic events in type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) patients on intensive insulin regimens (multiple daily injections (MDI) ≥ 3/day or continuous subcutaneous infusion insulin (CSII)) compared to a lower frequency of SMBG testing.

Literature Analysis

Randomized Control Trials (RCTs) have demonstrated the efficacy of CGM or FGM use in individuals with T1DM^2-10 and insulin-treated T2DM.^2,8,11-13 Benefits of CGM include reduction in HbA1c,^{3,6,8,9,11,13} decreased time in hypoglycemic range and fewer total hypoglycemic events,^4,5,7,10 and increased time in target glycemic range.^2,8 Additionally, CGM use has been shown to be particularly effective among those with hypoglycemia unawareness and/or frequent episodes of severe hypoglycemia.^4,5,10,12 In the studies that reported baseline SMBG frequencies there were no statistical differences noted between the intervention and control groups^2-4,8,10-12 with the majority of studies reporting mean baseline SMBG frequencies of <4 times per day.^2,3,8,11,12 Of the studies that required a minimum SMBG frequency as an inclusion criteria, there was considerable variability in this requirement (>10 times/week to ≥3 times/day). Notably, no studies required a minimum SMBG frequency of ≥4 times/day.^4,8,10-12 In a pre-specified subgroup analysis of older adults (≥60 years) with T1DM or T2DM, >50% of both the intervention and control group participants reported SMBG frequencies of <4 times/day.⁸ Additionally, glycemic outcomes in CGM users were not stratified based on baseline SMBG frequency in any of the RCTs.

A long term non-randomized study (initial 52-week duration with additional 3-year follow-up) has also demonstrated that CGM provided significant and comparable decrease in HbA1c, glycemic variability, and incidence of hypoglycemia regardless of the insulin delivery system (CSII or MDI) compared to SMBG in patients with T1DM.^14,15 A non-randomized study examining FGM in T1DM with structured therapeutic education was associated with improved HbA1c levels with a moderate increase in mild hypoglycemic events.¹⁶ These studies did not report baseline SMBG frequencies and did not require minimum SMBG frequencies as an inclusion criteria.

Systematic reviews with meta-analyses (SRMAs) attempted to examine the efficacy of CGM use in patients with T1DM^17-20 and T2DM^21-23 compared to SMBG. Several systematic reviews noted variability in observation periods, study populations, intervention type and mechanism of insulin delivery in the studies included, which posed some challenges in aggregating data. All SRMAs that reported on T1DM patients found that CGM use was associated with a significant reduction in HbA1c with mean differences (MD) between -0.25 to -6%. One SRMA noted a significant reduction in the number of hypoglycemic events²⁰ and one noted a reduction in median exposure to hypoglycemia.¹⁸ The remainder of the SRMAs with results on T1DM reported no significant difference in the time spent in hypoglycemia.^17,19 In the T2DM population, CGM was associated with a significant reduction in HbA1c levels;^21-23 however, there was again variation in the presented aggregated data related to hypoglycemia; with one SRMA reporting a shorter time spent with hypoglycemia²¹ and one reporting insufficient data to determine results of this outcome.²⁴ There was no mention in the SRMAs regarding the frequency of SMBG as a requirement for CGM eligibility or outcome data stratification based on the frequency of SMBG at baseline in the CGM intervention groups.

The ADA Clinical Standards state that most patients using intensive insulin regimens should be encouraged to assess glucose levels using SMBG and/or CGM prior to meals and snacks, at bedtime, prior to exercise, when they suspect low blood glucose, after treating low blood glucose until they are normoglycemic, and prior to and while performing critical tasks such as driving.²⁵ No distinction is made in this Clinical Standard between T1DM and T2DM, and there is no discussion regarding the need for a prerequisite frequency of SMBG use prior to the initiation of CGM. Similarly, the CGM use guidelines of the AACE/ACE, the Endocrine Society, Diabetes Canada, and the Chinese Diabetes Society do not set a prerequisite minimum SMBG frequency.^26-29 An outlier is the NICE guidance from the UK that sets a prerequisite SMBG frequency of at least 10 times/day if CGM is to be used to manage hyperglycemia (HbA1c of 9%); however, this recommendation appears to be based on cost; with the authors noting that based on their sensitivity analyses, SMBG 10 or 8 times remained the most cost effective strategy, while CGM was always more effective, but more costly.³⁰

Use of Inhaled Insulin as Substitute for Insulin Injections

Background

The DME MACs received a reconsideration request on 7/24/2020 from MannKind Corporation, manufacturer of Afrezza inhaled insulin, to change the language in the LCD: Glucose Monitors (L33822) to include use of inhaled insulin. MannKind stated that Medicare denials are occurring for patients using CGMs and inhaled insulin as an alternative to injected mealtime insulin. They requested a change in the criteria for CGM to include the following new added language (underlined):

• Has type 1 or type 2 diabetes;
• Currently uses a home blood glucose monitor (BGM) and performs at least four fingersticks per day;
• Takes insulin, either with inhalation, multiple daily injections (MDI) or an insulin pump;
• And has an insulin plan that requires frequent changes based on CGM readings.

Afrezza consists of single-use plastic cartridges filled with a white powder containing insulin (human), which is administered via oral inhalation using the disposable Afrezza Inhaler only. Patients self-administer inhaled insulin using a small dry-powder inhaler which contains a single-use cartridge, available in 4-, 8-, and 12-unit doses of insulin. Rapid-acting inhaled human insulin (Afrezza insulin human inhalation powder) is intended as an alternative to rapid-acting injectable insulin for prandial (mealtime) use by adults with T1DM or T2DM to improve glycemic control. The insulin is inhaled immediately before mealtime, as prescribed and as needed based on blood glucose measurements. Inhaled insulin must be used in combination with injectable long-acting insulin in patients with T1DM and in T2DM patients who require long-acting insulin. Compared with injected rapid-acting insulin, Afrezza has a faster onset of action (12 to 15 minutes) and shorter duration of action (approximately two hours), with a peak effect of 35 to 45 minutes due to rapid absorption from the lungs.^31,32

The FDA approved the New Drug Application (NDA) for Afrezza on June 27, 2014.³³ Afrezza is manufactured and marketed by MannKind; commercial distribution in U.S. pharmacies began in February 2015. Usage, warnings, and contraindications from Afrezza’s product labeling (FDA labeling) are as follows³¹:

• Afrezza is not a substitute for long-acting insulin, and patients with type 1 diabetes must use Afrezza with a long-acting insulin.
• Afrezza is not recommended for the treatment of diabetic ketoacidosis.
• Dosage adjustment may be needed when switching from another insulin to Afrezza.
• Afrezza is not recommended for use by patients who smoke or who have recently stopped smoking.
• Use of Afrezza is associated with a risk of acute bronchospasm in patients with chronic lung disease and has been observed in patients with asthma and COPD. Therefore, its use is contraindicated in patients with chronic lung disease, such as asthma or COPD.
• A detailed medical history, physical examination, and spirometry (FEV1) must be performed in all patients prior to use of Afrezza to identify potential lung disease.
• Afrezza causes a small decline in lung function (FEV1) over time. Pulmonary function should be assessed at baseline, after first six months of therapy, and annually thereafter, even in absence of pulmonary symptoms. In patients with a decline of ≥ 20% in FEV1 from baseline, consider discontinuing Afrezza. More frequent monitoring of pulmonary function in patients with symptoms such as wheezing, bronchospasm, breathing difficulties, or persistent/recurring cough should be considered. If symptoms persist, discontinue Afrezza.

Afrezza Prescribing Information contains a “black box” warning which states “WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE. See full prescribing information for complete boxed warning. Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.” The FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy (REMS), which required implementation of a communication strategy for healthcare providers who may prescribe Afrezza. The goal of the REMS is to mitigate the risk of acute bronchospasm associated with Afrezza by informing healthcare providers that³⁴:

• There is risk of acute bronchospasm associated with Afrezza in patients with chronic lung disease.
• Acute bronchospasm has been observed with Afrezza in patients with asthma and COPD.
• Afrezza is contraindicated in patients with chronic lung disease.
• Patients must be evaluated for lung disease before starting on Afrezza.

Literature Analysis

Literature searches were conducted using the terms “inhaled insulin” and “Afrezza.” English-language studies on human patients published within the last 5 years were retrieved and reviewed, including a systematic review/meta-analysis and three RCTs, summarized here.

A 2015 systematic review and meta-analysis³⁵ included 13 RCTs completed through May 2015 that compared mealtime Afrezza with placebo, oral antidiabetic drugs, or subcutaneous insulin in patients with T1DM or T2DM. Data from 12 trials (n=5,273, aged 18-80 years) were used for the meta-analysis and one four-year follow-up study was reviewed for long-term safety of Afrezza. Study endpoints were changes in HbA1c and body weight; safety outcomes, including severe hypoglycemia and pulmonary toxicity, were also evaluated. It should be noted that only four of the included studies had been published, with published data being used as the primary data source. Data sources for the remaining eight trials were clinicaltrials.gov or regulatory documentation. Two of these unpublished trials were pivotal, phase 3 RCTs^36,37 subsequently published in 2015 that supported FDA approval of Afrezza and are described in more detail below.

In the 12 trials used in the meta-analysis, Afrezza reduced HbA1c by an average of 0.55% (95% CI: 0.34-0.78) from baseline. For patients with T1DM, decrease from baseline HbA1c was greater for subcutaneous insulin. In patients with T2DM who required insulin, there was no significant difference in HBA1c between Afrezza and subcutaneous insulin. For patients with T1DM or T2DM, use of Afrezza was associated with less weight gain than with subcutaneous insulin and fewer episodes of severe hypoglycemia (12% of Afrezza patients versus 19% of subcutaneous insulin patients). The most common reported pulmonary symptom was nonproductive cough, which was reported more frequently in patients taking Afrezza than those taking subcutaneous insulin or oral diabetes drugs (29% versus 4%). Cough was mild, occurred within 10 minutes of inhalation of Afrezza, and was not associated with changes in pulmonary function in studies of shorter duration. In the long-term safety study, 17% of patients reported cough at four-year follow-up. The authors concluded that Afrezza use should be limited to non-smoking adults with diabetes with no pulmonary disease who are unwilling or unable to use injectable insulin.³⁵

Bode et al.³⁶ was a 24-week, open-label, non-inferiority RCT that included adult patients with T1DM on basal insulin randomized to treatment with Afrezza (n=174) or insulin aspart (n=171) at mealtime. Afrezza was found to be noninferior to insulin aspart in reducing HbA1c, but reductions from baseline HbA1c were less with Afrezza (-0.21% vs -0.4%, respectively; 95% CI, 0.02 to 0.36, p). Afrezza was associated with less weight gain and fewer hypoglycemic episodes. Mild cough occurred in 31.6% of Afrezza patients, compared with 2.3% of insulin aspart patients, and led to discontinuation of Afrezza in 5.7%. The authors concluded that Afrezza is an option for mealtime insulin in T1DM in patients who have concerns about hypoglycemia or additional injections.³⁶ A small RCT³² comparing mealtime Afrezza (n=26) with insulin aspart (n=34) published in 2018 reported similar results in patients with T1DM. Patients treated with Afrezza had longer times with in-range glucose with less time spent in hypoglycemic and less weight gain.

Rodenstock et al.³⁷ was a 24-week, double-blind RCT that randomized adult patients with T2DM who were insulin-naïve and inadequately controlled on oral antidiabetic medication to receive Afrezza (n=177) or an inhaled placebo (n=176). Afrezza significantly reduced HbA1c (-0.82 vs -0.42 respectively; 95% CI, -0.57 to -0.23; p<0.0001); 38% of Afrezza patients achieved an HbA1c ≤7% compared with 19% of placebo patients (p=0.0005). Afrezza also effectively controlled postprandial hyperglycemia. Mild dry cough occurred similarly in both groups, suggesting that inactive ingredients in the inhaled powder, not insulin, cause the cough after inhalation. The authors concluded that Afrezza is an effective mealtime alternative to injected insulin in patients with T2DM who are inadequately controlled with oral hypoglycemic agents and resistant to adding injected insulin.³⁷

According to Afrezza FDA product labeling, in the clinical studies used for regulatory approval, 381 patients were 65 years of age or older, with 20 of those aged 75 years or older. No overall differences in safety or effectiveness were observed between patients over 65 and younger patients.³¹

Professional Society Guidelines

Rapid-acting inhaled insulin is recommended as an alternative to rapid-acting insulin analogs when prandial insulin is required for patients with T1DM or T2DM by clinical guidelines. In the American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) Clinical Practice Guidelines for Developing a Diabetes Mellitus Comprehensive Care Plan—2015, it states “When control of postprandial hyperglycemia (T2D) is needed, preference should be given to rapid-acting insulins (the analogs lispro, aspart, and glulisine or inhaled insulin) over regular human insulin because the former have a more rapid onset and offset of action and are associated with less hypoglycemia (Grade B; BEL 2).”²⁷ They also note, “Physiologic insulin regimens, which provide both basal and prandial insulin, should be used for most patients with T1D (Grade A; BEL 1). These regimens involve the use of insulin analogs for most patients with T1D (Grade A; BEL 1) and include the following approaches: Multiple daily injections (MDI), which usually involve 1 to 2 subcutaneous injections daily of basal insulin to control glycemia between meals and overnight, and subcutaneous injections of prandial insulin or inhaled insulin before each meal to control meal-related glycemia (Grade A; BEL 1).”²⁷

In its Standards of Medical Care in Diabetes—2020, the American Diabetes Association (ADA) includes rapid-acting inhaled insulin along with rapid-acting analogs when prandial insulin is required, noting that:

• “Most individuals with type 1 diabetes should use rapid-acting insulin analogs to reduce hypoglycemia risk. Rapid-acting inhaled insulin to be used before meals is now available and may reduce rates of hypoglycemia in patients with type 1 diabetes.”³⁸
• “More recently, two new insulin formulations with enhanced rapid action profiles have been introduced. Inhaled human insulin has a rapid peak and shortened duration of action compared with rapid-acting insulin and may cause less hypoglycemia and weight gain, and faster-acting insulin aspart may reduce prandial excursions better than rapid-acting insulin; further investigation is needed to establish a clear place for these agents in diabetes management.”³⁸

Certainty of Evidence

Standard Blood Glucose Monitoring 4x/Day as Prerequisite for Coverage of Continuous Glucose Monitor
The aim of this analysis was to determine if a SMBG frequency requirement of ≥4x/day prior to initiating CGM predictive of improved glycemic control in patient with T1DM or T2DM intensive insulin regimens (MDI or CSII) compared to a lower frequency of baseline SMBG testing; however, there was no clinical evidence available upon which to address this question.

Overall Certainty of Evidence: Insufficient clinical evidence to determine

Use of Inhaled Insulin as Substitute for Insulin Injections

Overall Certainty of Evidence: Moderate

Conclusion

Standard Blood Glucose Monitoring 4x/Day as Prerequisite for Coverage of Continuous Glucose Monitor

In patients with T1DM or T2DM who are treated with intensive insulin regimens (MDI or CSII), CGM compared with SMBG has been shown to reduce HbA1C, reduce time in hypoglycemia and/ or episodes of hypoglycemia. CGM can be particularly useful for improving safety in patients with nocturnal hypoglycemia, hypoglycemia unawareness, and/or frequent episodes of hypoglycemia. However, there is no evidence to support that frequent SMBG (≥4 times per day) as a prerequisite for initiating CGM use is predictive of improved health outcomes. This is supported by the clinical practice guidelines of the ADA, AACE/ACE, the Endocrine Society, Diabetes Canada and the Chinese Diabetes Society that do not endorse a prerequisite baseline SMBG frequency prior to CGM use. While, the NICE guidance does require a prerequisite SMBG frequency of ≥10 times/day if CGM is used to manage hyperglycemia, this recommendation appears to have been made based on cost. Based on this review, the criteria in the Glucose Monitors LCD (L33822) requiring that a beneficiary has been using a BGM and is performing frequent (four or more times a day) testing as a prerequisite for coverage of a CGM device will be removed.

Use of Inhaled Insulin as Substitute for Insulin Injections

Moderate-quality published evidence, and clinical guidelines, support the use of Afrezza inhaled insulin as an alternative to injected insulin in Medicare patients with T1DM and T2DM diabetes who require mealtime insulin as part of their diabetes management regimen. In addition, inhaled insulin is covered by Medicare Part D, and in use by Medicare patients requiring continuous blood glucose monitoring. Therefore, the Glucose Monitors LCD (L33822) will be updated to allow multiple (three or more) daily administrations of insulin, whether via injections or inhalation.

DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

• SWO

• Medical Record Information (including continued need/use if applicable)

• Correct Coding

• Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.

Appendices

Insulin does not exist in an oral form and therefore beneficiaries taking oral medication to treat their diabetes are not insulin-treated.

A severe visual impairment is defined as a best corrected visual acuity of 20/200 or worse in both eyes.

An order renewal is the act of obtaining an order for an additional period of time beyond that previously ordered by the treating practitioner.

An order refill is the act of replenishing quantities of previously ordered items during the time period in which the current order is valid.

Utilization Guidelines

Refer to Coverage Indications, Limitations and/or Medical Necessity

1. Centers for Disease Control. National Diabetes Statistics Report 2020: Estimates of Diabetes and Its Burden in the United States. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. (Accessed May 1, 2020).
2. Ajjan RA, Abougila K, Bellary S, et al. Sensor and software use for the glycaemic management of insulin-treated type 1 and type 2 diabetes patients. Diab Vasc Dis Res. 2016;13(3):211-219.
3. Beck RW, Riddlesworth T, Ruedy K, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017;317(4):371-378.
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