local coverage determination (lcd): glucose …

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LOCAL COVERAGE DETERMINATION (LCD): GLUCOSE MONITORS (L33822)

Contractor InformationContractor Name Contract Type Contract Number Jurisdiction State(s)CGS Administrators, LLC DME MAC 17013 - DME MAC Jurisdiction B Illinois

Indiana Kentucky Michigan Minnesota Ohio Wisconsin

CGS Administrators, LLC DME MAC 18003 - DME MAC Jurisdiction C Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi New Mexico North Carolina Oklahoma Puerto Rico South Carolina Tennessee Texas Virgin Islands Virginia West Virginia

Noridian Healthcare Solutions, LLC

DME MAC 16013 - DME MAC Jurisdiction A Connecticut Delaware District of Columbia Maine Maryland Massachusetts New Hampshire New Jersey New York - Entire State Pennsylvania Rhode Island Vermont

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Contractor Name Contract Type Contract Number Jurisdiction State(s)Noridian Healthcare Solutions, LLC

DME MAC 19003 - DME MAC Jurisdiction D Alaska American Samoa Arizona California - Entire State Guam Hawaii Idaho Iowa Kansas Missouri - Entire State Montana Nebraska Nevada North Dakota Northern Mariana Islands Oregon South Dakota Utah Washington Wyoming

LCD InformationDocument InformationLCD ID

L33822

LCD Title

Glucose Monitors

Proposed LCD in Comment Period

N/A

Source Proposed LCD

DL33822

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2020 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2020 American Dental Association. All rights reserved.

Copyright © 2013 - 2020, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also contact us at [email protected].

Original Effective Date

For services performed on or after 10/01/2015

Revision Effective Date

For services performed on or after 07/18/2021

Revision Ending Date

N/A

Retirement Date

N/A

Notice Period Start Date

06/03/2021

Notice Period End Date

07/17/2021

CMS National Coverage Policy

CMS Pub. 100-03, (Medicare National Coverage Determinations Manual), Chapter 1, Section 40.2

CMS Ruling 1682R

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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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.

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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.

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

B. 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,

C. 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)

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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.

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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.

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Summary of Evidence

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 T1DM2-10 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 groups2-4,8,10-12 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,

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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 T1DM17-20 and T2DM21-23 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):

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§ 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

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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 RCTs36,37 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

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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

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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

Analysis of Evidence

(Rationale for Determination)

Certainty of Evidence


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


Overall Certainty of Evidence: Moderate

Conclusion


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.


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.

14

Coding InformationCPT/HCPCS Codes

Group 1 Paragraph:

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS

CG – Policy criteria applied

EY - No physician or other licensed health care provider order for this item or service

KF – Item designated by FDA as Class III device

KS - Glucose monitor supply for diabetic beneficiary not treated by insulin

KX - Requirements specified in the medical policy have been met

HCPCS

EQUIPMENT

Group 1 Codes

Code DescriptionE0607 HOME BLOOD GLUCOSE MONITORE0620 SKIN PIERCING DEVICE FOR COLLECTION OF CAPILLARY BLOOD, LASER, EACHE2100 BLOOD GLUCOSE MONITOR WITH INTEGRATED VOICE SYNTHESIZERE2101 BLOOD GLUCOSE MONITOR WITH INTEGRATED LANCING/BLOOD SAMPLEK0554 RECEIVER (MONITOR), DEDICATED, FOR USE WITH THERAPEUTIC GLUCOSE CONTINUOUS

MONITOR SYSTEMGroup 2 Paragraph:

ACCESSORIES/SUPPLIES

Group 2 Codes:

Code DescriptionA4233 REPLACEMENT BATTERY, ALKALINE (OTHER THAN J CELL), FOR USE WITH MEDICALLY

NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACHA4234 REPLACEMENT BATTERY, ALKALINE, J CELL, FOR USE WITH MEDICALLY NECESSARY HOME

BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACHA4235 REPLACEMENT BATTERY, LITHIUM, FOR USE WITH MEDICALLY NECESSARY HOME BLOOD

GLUCOSE MONITOR OWNED BY PATIENT, EACHA4236 REPLACEMENT BATTERY, SILVER OXIDE, FOR USE WITH MEDICALLY NECESSARY HOME

BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACHA4244 ALCOHOL OR PEROXIDE, PER PINTA4245 ALCOHOL WIPES, PER BOXA4246 BETADINE OR PHISOHEX SOLUTION, PER PINTA4247 BETADINE OR IODINE SWABS/WIPES, PER BOX

15

Code DescriptionA4250 URINE TEST OR REAGENT STRIPS OR TABLETS (100 TABLETS OR STRIPS)A4253 BLOOD GLUCOSE TEST OR REAGENT STRIPS FOR HOME BLOOD GLUCOSE MONITOR, PER 50

STRIPSA4255 PLATFORMS FOR HOME BLOOD GLUCOSE MONITOR, 50 PER BOXA4256 NORMAL, LOW AND HIGH CALIBRATOR SOLUTION / CHIPSA4257 REPLACEMENT LENS SHIELD CARTRIDGE FOR USE WITH LASER SKIN PIERCING DEVICE,

EACHA4258 SPRING-POWERED DEVICE FOR LANCET, EACHA4259 LANCETS, PER BOX OF 100A9275 HOME GLUCOSE DISPOSABLE MONITOR, INCLUDES TEST STRIPSA9276 SENSOR; INVASIVE (E.G., SUBCUTANEOUS), DISPOSABLE, FOR USE WITH INTERSTITIAL

CONTINUOUS GLUCOSE MONITORING SYSTEM, ONE UNIT = 1 DAY SUPPLYA9277 TRANSMITTER; EXTERNAL, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE

MONITORING SYSTEMA9278 RECEIVER (MONITOR); EXTERNAL, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE

MONITORING SYSTEMK0553 SUPPLY ALLOWANCE FOR THERAPEUTIC CONTINUOUS GLUCOSE MONITOR (CGM), INCLUDES

ALL SUPPLIES AND ACCESSORIES, 1 MONTH SUPPLY = 1 UNIT OF SERVICE

General InformationAssociated Information

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.

16

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

Sources of Information

Reserved for future use.

Bibliography

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.

4. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016;388(10057):2254-2263.

5. Heinemann L, Freckmann G, Ehrmann D, et al. Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial. Lancet. 2018;391(10128):1367-1377.

https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

17

6. Lind M, Polonsky W, Hirsch IB, et al. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017;317(4):379-387.

7. Pratley RE, Kanapka LG, Rickels MR, et al. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020;323(23):2397-2406.

8. Ruedy KJ, Parkin CG, Riddlesworth TD, Graham C, Group DS. Continuous Glucose Monitoring in Older Adults With Type 1 and Type 2 Diabetes Using Multiple Daily Injections of Insulin: Results From the DIAMOND Trial. J Diabetes Sci Technol. 2017;11(6):1138-1146.

9. Tumminia A, Crimi S, Sciacca L, et al. Efficacy of real-time continuous glucose monitoring on glycaemic control and glucose variability in type 1 diabetic patients treated with either insulin pumps or multiple insulin injection therapy: a randomized controlled crossover trial. Diabetes Metab Res Rev. 2015;31(1):61-68.

10. van Beers CA, DeVries JH, Kleijer SJ, et al. Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open-label, crossover trial. Lancet Diabetes Endocrinol. 2016;4(11):893-902.

11. Beck RW, Riddlesworth TD, Ruedy K, et al. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017;167(6):365-374.

12. Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017;8(1):55-73.

13. Yaron M, Roitman E, Aharon-Hananel G, et al. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 Diabetes. Diabetes Care. 2019;42(7):1178-1184.

14. Soupal J, Petruzelkova L, Flekac M, et al. Comparison of Different Treatment Modalities for Type 1 Diabetes, Including Sensor-Augmented Insulin Regimens, in 52 Weeks of Follow-Up: A COMISAIR Study. Diabetes Technol Ther. 2016;18(9):532-538.

15. Soupal J, Petruzelkova L, Grunberger G, et al. Glycemic Outcomes in Adults With T1D Are Impacted More by Continuous Glucose Monitoring Than by Insulin Delivery Method: 3 Years of Follow-Up From the COMISAIR Study. Diabetes Care. 2020;43(1):37-43.

16. Paris I, Henry C, Pirard F, Gerard AC, Colin IM. The new FreeStyle libre flash glucose monitoring system improves the glycaemic control in a cohort of people with type 1 diabetes followed in real-life conditions over a period of one year. Endocrinol Diabetes Metab. 2018;1(3):e00023.

17. Langendam M, Luijf YM, Hooft L, Devries JH, Mudde AH, Scholten RJ. Continuous glucose monitoring systems for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2012;1:CD008101.

18. Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011;343:d3805.

18

19. Szypowska A, Ramotowska A, Dzygalo K, Golicki D. Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials. Eur J Endocrinol. 2012;166(4):567-574.

20. Wojciechowski P, Rys P, Lipowska A, Gaweska M, Malecki MT. Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes: systematic review and meta-analysis. Pol Arch Med Wewn. 2011;121(10):333-343.

21. Ida S, Kaneko R, Murata K. Utility of Real-Time and Retrospective Continuous Glucose Monitoring in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. J Diabetes Res. 2019;2019:4684815.

22. Janapala RN, Jayaraj JS, Fathima N, et al. Continuous Glucose Monitoring Versus Self-monitoring of Blood Glucose in Type 2 Diabetes Mellitus: A Systematic Review with Meta-analysis. Cureus. 2019;11(9):e5634.

23. Poolsup N, Suksomboon N, Kyaw AM. Systematic review and meta-analysis of the effectiveness of continuous glucose monitoring (CGM) on glucose control in diabetes. Diabetol Metab Syndr. 2013;5:39.

24. Dicembrini I, Mannucci E, Monami M, Pala L. Impact of technology on glycaemic control in type 2 diabetes: A meta-analysis of randomized trials on continuous glucose monitoring and continuous subcutaneous insulin infusion. Diabetes Obes Metab. 2019;21(12):2619-2625.

25. American Diabetes A. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020;43(Suppl 1):S77-S88.

26. Diabetes Canada. Diabetes Canada 2018 Clinical Practice Guidelines for the prevention and control of Diabetes. Can J Diabetes. (Suppl 1):S1-S325. 2018;42.

27. Handelsman Y, Bloomgarden ZT, Grunberger G, et al. American Association of Clinical Endocrinologists and American College of Endocrinology—Clinical Practice Guidelines for Developing a Diabetes Mellitus Comprehensive Care Plan—2015—Executive Summary. Endocr Pract. 2015;21(4):413-437.

28. LeRoith D, Biessels GJ, Braithwaite SS, et al. Treatment of Diabetes in Older Adults: An Endocrine Society* Clinical Practice Guideline. J Clin Endocrinol Metab. 2019;104(5):1520-1574.

29. Peters AL, Ahmann AJ, Battelino T, et al. Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016;101(11):3922-3937.

30. National Institute for Clinical Excellence (NICE). Type 1 diabetes in adults: diagnosis and management NICE guideline [NG17]. https://www.nice.org.uk/guidance/ng17. Updated July 15, 2016. (Assessed May 1, 2020).

31. U.S. Food & Drug Administration. Afrezza (insulin human) Inhalation Powder. Printed Labeling. May 28, 2015. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000TOC.cfm. Accessed July 13, 2020.

32. Akturk HK, Snell-Bergeon JK, Rewers A, et al. Improved Postprandial Glucose with Inhaled Technosphere Insulin Compared with Insulin Aspart in Patients with Type 1 Diabetes on Multiple Daily Injections: The STAT Study. Diabetes Technol Ther. 2018;20(10):639-647.

https://www.nice.org.uk/guidance/ng17

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000TOC.cfm

19

33. U.S. Food & Drug Administration. Afrezza (insulin human) Inhalation Powder. Approval Letter(s). May 28, 2015. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000TOC.cfm. Accessed July 13, 2020.

34. U.S. Food & Drug Administration. Afrezza (insulin human) Inhalation Powder. REMS. May 28, 2015. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000TOC.cfm. Accessed July 9, 2020.

35. Pittas AG, Westcott GP, Balk EM. Efficacy, safety, and patient acceptability of Technosphere inhaled insulin for people with diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2015;3(11):886-894.

36. Bode BW, McGill JB, Lorber DL, et al. Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial. Diabetes Care. 2015;38(12):2266-2273.

37. Rosenstock J, Franco D, Korpachev V, et al. Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naive Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents. Diabetes Care. 2015;38(12):2274-2281.

38. American Diabetes A. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020;43(Suppl 1):S98-S110.

39. Galderisi A, Cohen N, Calhoun P, et al. Effect of Afrezza on Glucose Dynamics During HCL Treatment. Diabetes Care. 2020;43(9):2146-2152.

40. Raskin P, Heller S, Honka M, et al. Pulmonary function over 2 years in diabetic patients treated with prandial inhaled Technosphere Insulin or usual antidiabetes treatment: a randomized trial. Diabetes Obes Metab. 2012;14(2):163-173.

41. Rave K, Heise T, Heinemann L, Boss AH. Inhaled Technosphere insulin in comparison to subcutaneous regular human insulin: time action profile and variability in subjects with type 2 diabetes. J Diabetes Sci Technol. 2008;2(2):205-212.

42. Seaquist ER, Blonde L, McGill JB, et al. Hypoglycaemia is reduced with use of inhaled Technosphere((R)) Insulin relative to insulin aspart in type 1 diabetes mellitus. Diabet Med. 2020;37(5):752-759.

Revision History Information



20

Revision History Date

Revision History Number

Revision History Explanation Reason(s) for Change

07/18/2021 R8 Revision Effective Date: 07/18/2021 COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY: Removed: Four times or more per day testing with blood glucose monitor as prerequisite for CGM coverage Revised: “injections” to “administrations” for insulin treatment regimen criterion for CGMs Removed: “Medicare-covered” from CSII pump criterion language for CGMs Clarified: Coding verification language for products billed as K0554 SUMMARY OF EVIDENCE: Added: Information related to glucose testing and insulin administration Revised: “5” to “1” minutes for measuring of interstitial fluid glucose content by CGM device ANALYSIS OF EVIDENCE: Added: Information related to glucose testing and insulin administration APPENDICES: Revised: Language of insulin-treated, by removing reference to insulin injections BIBLIOGRAPHY: Added: Section related to glucose testing and insulin administration RELATED LOCAL COVERAGE DOCUMENTS: Added: Response to Comments (A58798)

§ Provider Education/Guidance

§ Reconsideration Request

21




01/01/2020 R7 Revision Effective Date: 01/01/2020 COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY: Removed: Statement to refer to ICD-10 Codes that are Covered section in the LCD-related PA Added: Statement to refer to ICD-10 code list in the LCD-related Policy Article Revised: “physician” to “treating practitioner” Revised: "treating physician" to "treating practitioner" Revised: “month” to “30 days,” as clarification of billing K0553 Revised: Format of HCPCS code references, from code spans to individually-listed HCPCS Revised: Order information as a result of Final Rule 1713 REFILL REQUIREMENTS: Revised: “ordering physician” to “treating practitioner” CODING INFORMATION: Removed: Field titled “Bill Type” Removed: Field titled “Revenue Codes” Removed: Field titled “ICD-10 Codes that Support Medical Necessity” Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity” Removed: Field titled “Additional ICD-10 Information” GENERAL DOCUMENTATION REQUIREMENTS: Revised: Prescriptions (orders) to SWO APPENDICES: Revised: “physician” to “practitioner”02/20/2020: Pursuant to the 21st Century Cures Act , these revisions do not require notice and comment because they are due to non-discretionary coverage updates reflective of CMS FR-1713, HCPCS code changes, and non-substantive corrections (listing individual HCPCS codes instead of a HCPCS code-span).


§ Other

22




01/01/2019 R6 Revision Effective Date:01/01/2019 COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY: Removed: Statement to refer to diagnosis code section below Added: Refer to Covered ICD-10 Codes in the LCD-related Policy Article ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY: Moved: All diagnosis codes to the LCD-related Policy Article diagnosis code section per CMS instruction ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY: Moved: Statement about noncovered diagnosis codes moved to LCD-related Policy Article noncovered diagnosis code section per CMS instruction

§ Other (ICD-10 code relocation per CMS instruction)

01/12/2017 R5 Revision Effective Date: 01/12/2017 COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY: CPT/HCPCS Codes: Revised: Incorporated K0554 into Group 1 Codes and HCPCS code K0553 into Group 2 Codes04/19/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

§ Revisions Due To CPT/HCPCS Code Changes

23




01/12/2017 R4 Revision Effective Date: 01/12/2017 COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY: Removed: Standard Documentation Language Added: New reference language and Directions to Standard Documentation Requirements Revised: Coverage criteria for home blood glucose monitors Added: Documentation requirements for home blood glucose monitors Added: Coverage criteria for continuous glucose monitors and supply allowance Added: Documentation requirements for continuous glucose monitors Added: General Requirements Revised: Refill requirements Added: HCPCS codes for therapeutic CGM (K0554) and supply allowance (K0553) out of sequence to allow early publishing of codes and narratives. (For dates of service on or after 07/01/2017) DOCUMENTATION REQUIREMENTS: Removed: Standard Documentation Language Added: General Documentation Requirements Added: New reference language and directions to Standard Documentation Requirements POLICY SPECIFIC DOCUMENTATION REQUIREMENTS: Removed: Standard Documentation Language Added: Directions to Standard Documentation Requirements Removed: PIM reference under Appendices RELATED LOCAL COVERAGE DOCUMENTS: Added: LCD-related Standard Documentation Requirements article


§ Other (Revisions and updates based on CMS Ruling 1682R )

24




10/01/2016 R3 Revision Effective Date 10/01/2016 COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY: Revised: Standard Documentation language - ACA order requirements – Effective 04/28/16 ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY: Added: New ICD-10 codes Deleted: Non-valid ICD-10 Revised: ICD-10 code descriptions DOCUMENTATION REQUIREMENTS: Revised: Standard documentation language for orders, added New order requirements, and Correct coding instructions; revised Proof of delivery instructions – Effective 04/28/16


§ Revisions Due To ICD-10-CM Code Changes

07/01/2016 R2 Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.

§ Change in Assigned States or Affiliated Contract Numbers

10/01/2015 R1 Revision Effective Date: 10/31/2014 COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY: Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility DOCUMENTATION REQUIREMENTS: Revised: Standard Documentation Language to add who can enter date of delivery date on the POD Added: Instructions for Equipment Retained from a Prior Payer Revised: Repair to beneficiary-owned DMEPOS


Associated DocumentsAttachments

N/A

Related Local Coverage Documents

Article(s)

A52464 - Glucose Monitor - Policy Article

A58798 - Response to Comments: Glucose Monitors – DL33822

A55426 - Standard Documentation Requirements for All Claims Submitted to DME MACs

Related National Coverage Documents

https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=52464&ver=30&LCDId=33822

https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=58798

https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=55426&ver=83&LCDId=33794

25

N/A

Public Version(s)

Updated on 05/26/2021 with effective dates 07/18/2021 - N/A

Updated on 02/14/2020 with effective dates 01/01/2020 - 07/17/2021

Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

KeywordsN/A

26

END OF LOCAL COVERAGE DETERMINATION

Per the Code of Federal Regulations, 42 C.F.R § 426. 325, only those portions of the currently effective Local Coverage Determination (LCD) that are based on section 1862(a)(1)(A) of the Social Security Act, may be challenged through an acceptable complaint as described in 42 C.F.R §

426.400. Also, per 42 C.F.R § 426.325 items that are not reviewable, and therefore cannot be challenged, include the Policy Article. Please note the distinction of the documents when reviewing the materials.

27

LOCAL COVERAGE ARTICLE:

GLUCOSE MONITOR - POLICY ARTICLE (A52464)

Contractor InformationContractor Name Contract Type Contract Number Jurisdiction State(s)CGS Administrators, LLC DME MAC 17013 - DME MAC Jurisdiction B Illinois

Indiana Kentucky Michigan Minnesota Ohio Wisconsin

CGS Administrators, LLC DME MAC 18003 - DME MAC Jurisdiction C Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi New Mexico North Carolina Oklahoma Puerto Rico South Carolina Tennessee Texas Virgin Islands Virginia West Virginia

Noridian Healthcare Solutions, LLC

DME MAC 16013 - DME MAC Jurisdiction A Connecticut Delaware District of Columbia Maine Maryland Massachusetts New Hampshire New Jersey New York - Entire State Pennsylvania Rhode Island Vermont

28

Contractor Name Contract Type Contract Number Jurisdiction State(s)Noridian Healthcare Solutions, LLC

DME MAC 19003 - DME MAC Jurisdiction D Alaska American Samoa Arizona California - Entire State Guam Hawaii Idaho Iowa Kansas Missouri - Entire State Montana Nebraska Nevada North Dakota Northern Mariana Islands Oregon South Dakota Utah Washington Wyoming

Article InformationGeneral InformationArticle ID

A52464

Article Title

Glucose Monitor - Policy Article

Article Type

Article

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2020 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

29

Current Dental Terminology © 2020 American Dental Association. All rights reserved.

Copyright © 2013 - 2020, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also contact us at [email protected].

Original Effective Date

10/01/2015

Revision Effective Date

07/18/2021

Revision Ending Date

N/A

Retirement Date

N/A

Article GuidanceArticle Text:

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES

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. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).

Home blood glucose monitors (BGM) and therapeutic continuous glucose monitors (CGM) are covered under the Durable Medical Equipment benefit [Social Security Act §1861(s)(6)]. In order for a beneficiary’s DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

Effective for claims with dates of service on or after January 12, 2017, Medicare covers therapeutic CGM devices under the DME benefit. CGM devices covered by Medicare are defined in CMS Ruling

mailto:[email protected]

30

1682R as therapeutic CGM. CGM devices that do not meet the definition of a therapeutic CGM as defined in CMS Ruling 1682R will be denied as non-covered (no benefit).

The supply allowance for supplies used with a therapeutic CGM system encompasses all items necessary for the use of the device and includes, but is not limited to: CGM sensor, CGM transmitter, home BGM and related BGM supplies (test strips, lancets, lancing device, calibration solutions) and batteries. Supplies or accessories billed separately will be denied as unbundling.

There is no Medicare benefit for supplies and accessories used with equipment that is not classified as DME. Coverage of a CGM system supply allowance (K0553) is available for those therapeutic CGM systems where the beneficiary uses a receiver classified as DME to display glucose data. In addition, Medicare coverage is available for a CGM system supply allowance if a non-DME device (watch, smartphone, tablet, laptop computer, etc.) is used in conjunction with the durable CGM receiver (K0554). The following are examples of this provision:

1. Medicare coverage of a CGM supply allowance is available where a beneficiary uses a durable CGM receiver to display their glucose data and also transmits that data to a caregiver through a smart phone or other non-DME receiver.

2. Medicare coverage of a CGM system supply allowance is available where a beneficiary uses a durable CGM receiver on some days to review their glucose data but may also use a non-DME device on other days.

If a beneficiary never uses a DME receiver for a therapeutic CGM, the supply allowance is not covered by Medicare.

Smart devices are non-covered by Medicare because they do not meet the definition of DME (i.e., not primarily medical in nature and are useful in the absence of illness). Claims for smart devices must be billed using code A9270 (noncovered item or service).

To be eligible for Medicare reimbursement, all CGM devices billed as K0554 must have received coding verification review by the Pricing, Data Analysis and Coding (PDAC) contractor and be listed on the Product Classification List (PCL) for HCPCS code K0554. Continuous Glucose Monitor systems that are billed as K0554, but that have not been reviewed and listed on the PCL for HCPCS code K0554, will be denied as incorrect coding. Products reviewed by the PDAC which do not meet the requirements for a therapeutic CGM must be coded as A9278 and will be denied as non-covered (no Medicare Benefit). See Coding Guidelines below.

Alcohol or peroxide (codes A4244, A4245), betadine or hexachlorophene (pHisohex) (codes A4246, A4247) are noncovered since these items are not required for the proper functioning of the device.

Urine test reagent strips or tablets (code A4250) are noncovered since they are not used with a glucose monitor.

Reflectance colorimeter devices used for measuring blood glucose levels in clinical settings are not covered as durable medical equipment for use in the home because their need for frequent professional re-calibration makes them unsuitable for home use.

Glucose monitors that are not designed for use in the home must be coded A9270 and will be denied as statutorily noncovered (no benefit category).

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Home blood glucose disposable monitor, including test strips (code A9275) is noncovered because these monitors do not meet the definition of DME.

REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217)

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provides a list of the specified codes, which is periodically updated. The link will be located here once it is available.

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD- related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.

Refer to the LCD-related Standard Documentation Requirements article (A55426), located at the bottom of this Policy Article under the Related Local Coverage Documents section, for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.

For beneficiaries who exceed the usual utilization amounts of BGM testing supplies, there must be sufficient information in the beneficiary’s medical record to determine that:

§ The treating practitioner has had an in-person visit to evaluate the beneficiary’s diabetes control; and,

§ The specific quantities of supplies ordered are reasonable and necessary; and,

§ The beneficiary is actually testing at a frequency that corroborates the quantity of supplies that have been dispensed (e.g., a specific narrative statement that adequately documents the frequency at which the beneficiary is actually testing or a copy of the beneficiary's log).

For the in-person treating practitioner visit that is required as part of the initial provision of a therapeutic CGM, there must be sufficient information in the beneficiary’s medical record to determine that the beneficiary has diabetes mellitus (criterion 1), requires frequent dosing of their insulin (criterion 2) and frequent adjustment of their diabetes treatment regimen (criterion 3). For criterion 3, it is not a mandate that insulin dose adjustments must be made if glucose levels are within the target range as established collaboratively with their treating practitioner and documented in the beneficiary’s medical record.

For the in-person treating practitioner visit that is required as part of the ongoing provision of a therapeutic CGM, there must be sufficient information in the beneficiary’s medical record to

32

determine that the beneficiary continues to adhere to their diabetes treatment regimen and use of the CGM device on a daily basis.

MODIFIERS

KS, KX and CG MODIFIERS:

For blood glucose monitors (codes E0607, E2100, E2101) and related supplies (codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259) and therapeutic CGM devices (code K0554) and supply allowance (code K0553), the following modifiers must be added to the code(s) on every claim submitted:

§ Use modifier KX if the beneficiary is insulin treated; or,

§ Use modifier KS if the beneficiary is non-insulin treated.

The KX modifier must not be used for a beneficiary who is not treated with insulin administrations.

For therapeutic CGM devices (code K0554) and the supply allowance (code K0553) only, the CG modifier must be added to the claim line only if all of the therapeutic CGM coverage criteria (1-5) in the Glucose Monitors Local Coverage Determination are met. If any of the coverage criteria (1-5) for a therapeutic CGM are not met, the CG modifier must not be used.

Devices coded K0553 and K0554 that are classified by the Food & Drug Administration as Class III devices must include the KF modifier.

CODING GUIDELINES

For claims with dates of service from January 12, 2017 through June 30, 2017, a therapeutic CGM must be billed with code E1399 and code A9999 for the supply allowance. Only one (1) month of the supply allowance (one (1) Unit of Service) may be billed to the DME MACs at a time.

For claims with dates of service on or after July 1, 2017, a therapeutic CGM must be billed with code K0554 and code K0553 for the supply allowance. Only one (1) month of the supply allowance (one (1) Unit of Service) may be billed to the DME MACs at a time.

Code K0553 describes a supply allowance used with a therapeutic CGM device. The supply allowance includes all items necessary for the use of the device and includes, but is not limited to: CGM sensor, CGM transmitter, home BGM and related BGM supplies (test strips, lancets, lancing device, calibration solutions) and batteries. K0553 must not be used for supplies used with CGM coded as A9278.

A supplier does not have to deliver supplies used with a therapeutic CGM every month in order to bill code K0553 every month. In order to bill code K0553, the supplier must have previously delivered quantities of supplies that are sufficient to last for one (1) full month, thirty (30) days, following the DOS on the claim. Suppliers must monitor usage of supplies. Billing for code K0553 may continue on a monthly basis as long as sufficient supplies remain to last for one (1) full month, thirty (30) days, as previously described. If there are insufficient supplies to be able to last for one (1) full month, thirty (30) days, additional supplies must be provided before the supply allowance is billed.

No more than 1 unit of service (UOS) of HCPCS code K0553 is billable per thirty (30) days.

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Code K0554 describes a continuous glucose monitor that meets the requirements of the DME benefit as described in CMS Ruling 1682R. CGM devices that meet these requirements are termed “Therapeutic CGM”.

Codes A9276 (SENSOR; INVASIVE (E.G., SUBCUTANEOUS), DISPOSABLE, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM, ONE UNIT = 1 DAY SUPPLY) and A9277 (TRANSMITTER; EXTERNAL, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM) describe the supplies used with a non-therapeutic CGM. Codes A9276 and A9277 are not used to bill for supplies used with code K0554.

Code A9278 (RECEIVER (MONITOR); EXTERNAL, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM) describes any CGM system that fails to meet the DME Benefit requirements as described in CMS Ruling 1682R.

Home blood glucose monitors (code E0607) are devices that measure capillary whole blood for determination of blood glucose levels. Results are displayed on a screen and may be stored in memory on the device for download or viewing at a later time. The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism.

Blood glucose monitors with integrated voice synthesizers (code E2100) are devices that measure capillary whole blood for determination of blood glucose levels. Results are displayed on a screen but are also digitized and converted to sound output. Test results may also be stored in memory on the device for download or viewing at a later time. The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism.

Blood glucose monitors with integrated lancing and/or blood sampling (code E2101) are devices that measure capillary whole blood for determination of blood glucose levels. The lancing device for obtaining the capillary blood sample is integrated into the glucose monitor rather than a separate accessory. Test results may also be stored in memory on the device for download or viewing at a later time. The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism.

Code A4256 describes control solutions containing high, normal, and low concentrations of glucose that can be applied to test strips to check the integrity of the test strips. This code does not describe the strip or chip which is included in a vial of test strips and which calibrates the glucose monitor to that particular vial of test strips.

A laser skin lancing device (code E0620) uses laser technology to pierce the skin in order to obtain capillary blood for use in home blood glucose monitors.

For glucose test strips (code A4253), 1 unit of service = 50 strips. For lancets (code A4259), 1 unit of service = 100 lancets.

Blood glucose test or reagent strips that use a visual reading and are not used in a glucose monitor must be coded A9270 (noncovered item or service). Do not use code A4253 for these items.

With the exception of batteries (see below), suppliers may bill test strips, lancing devices, lancets and other glucose monitor supplies with the initial issue of a glucose monitor.

In the following table, a Column II code is included in the allowance for the corresponding Column I code when provided at the same time.

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Column I Column IIE0607 A4233, A4234, A4235, A4236E2100 A4233, A4234, A4235, A4236E2101 A4233, A4234, A4235, A4236K0553 E0607, E2100, E2101, A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250,

A4253, A4255, A4256, A4257, A4258, A4259Suppliers should contact the PDAC contractor for guidance on the correct coding of items addressed in this policy.

Effective for claims with dates of service on or after 07/01/2017, the only products that may be billed using code K0554 are those that are specified in the PCL on the PDAC contractor web site.

Coding InformationCPT/HCPCS Codes

N/A

ICD-10 Codes that Support Medical Necessity

Group 1 Paragraph:

The presence of an ICD-10 code listed in this section is not sufficient by itself to assure coverage. Refer to the LCD section on “Coverage Indications, Limitations, and/or Medical Necessity” for other coverage criteria and payment information.

Group 1 Codes:

ICD-10 Code

Description

E08.00 Diabetes mellitus due to underlying condition with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC)

E08.01 Diabetes mellitus due to underlying condition with hyperosmolarity with comaE08.10 Diabetes mellitus due to underlying condition with ketoacidosis without comaE08.11 Diabetes mellitus due to underlying condition with ketoacidosis with comaE08.21 Diabetes mellitus due to underlying condition with diabetic nephropathyE08.22 Diabetes mellitus due to underlying condition with diabetic chronic kidney diseaseE08.29 Diabetes mellitus due to underlying condition with other diabetic kidney complicationE08.311 Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edemaE08.319 Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy without macular

edemaE08.3211 Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with

macular edema, right eyeE08.3212 Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with

macular edema, left eyeE08.3213 Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with

macular edema, bilateral

35

ICD-10 Code

Description

E08.3219 Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

E08.3291 Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, right eye

E08.3292 Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, left eye

E08.3293 Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, bilateral

E08.3299 Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye

E08.3311 Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, right eye

E08.3312 Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, left eye

E08.3313 Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

E08.3319 Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

E08.3391 Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, right eye

E08.3392 Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, left eye

E08.3393 Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, bilateral

E08.3399 Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye

E08.3411 Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye

E08.3412 Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, left eye

E08.3413 Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, bilateral

E08.3419 Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

E08.3491 Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, right eye

E08.3492 Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, left eye

E08.3493 Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, bilateral

E08.3499 Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye

36

ICD-10 Code

Description

E08.3511 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, right eye

E08.3512 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, left eye

E08.3513 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, bilateral

E08.3519 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, unspecified eye

E08.3521 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

E08.3522 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

E08.3523 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

E08.3529 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye

E08.3531 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

E08.3532 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

E08.3533 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

E08.3539 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye

E08.3541 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

E08.3542 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

E08.3543 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

E08.3549 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye

E08.3551 Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, right eyeE08.3552 Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, left eyeE08.3553 Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, bilateralE08.3559 Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, unspecified

eyeE08.3591 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular

edema, right eyeE08.3592 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular

edema, left eyeE08.3593 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular

edema, bilateral

37

ICD-10 Code

Description

E08.3599 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, unspecified eye

E08.36 Diabetes mellitus due to underlying condition with diabetic cataractE08.37X1 Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following

treatment, right eyeE08.37X2 Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following

treatment, left eyeE08.37X3 Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following

treatment, bilateralE08.37X9 Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following

treatment, unspecified eyeE08.39 Diabetes mellitus due to underlying condition with other diabetic ophthalmic complicationE08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecifiedE08.41 Diabetes mellitus due to underlying condition with diabetic mononeuropathyE08.42 Diabetes mellitus due to underlying condition with diabetic polyneuropathyE08.43 Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathyE08.44 Diabetes mellitus due to underlying condition with diabetic amyotrophyE08.49 Diabetes mellitus due to underlying condition with other diabetic neurological complicationE08.51 Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy without gangreneE08.52 Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy with gangreneE08.59 Diabetes mellitus due to underlying condition with other circulatory complicationsE08.610 Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathyE08.618 Diabetes mellitus due to underlying condition with other diabetic arthropathyE08.620 Diabetes mellitus due to underlying condition with diabetic dermatitisE08.621 Diabetes mellitus due to underlying condition with foot ulcerE08.622 Diabetes mellitus due to underlying condition with other skin ulcerE08.628 Diabetes mellitus due to underlying condition with other skin complicationsE08.630 Diabetes mellitus due to underlying condition with periodontal diseaseE08.638 Diabetes mellitus due to underlying condition with other oral complicationsE08.641 Diabetes mellitus due to underlying condition with hypoglycemia with comaE08.649 Diabetes mellitus due to underlying condition with hypoglycemia without comaE08.65 Diabetes mellitus due to underlying condition with hyperglycemiaE08.69 Diabetes mellitus due to underlying condition with other specified complicationE08.8 Diabetes mellitus due to underlying condition with unspecified complicationsE08.9 Diabetes mellitus due to underlying condition without complicationsE09.00 Drug or chemical induced diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-

hyperosmolar coma (NKHHC)E09.01 Drug or chemical induced diabetes mellitus with hyperosmolarity with comaE09.10 Drug or chemical induced diabetes mellitus with ketoacidosis without comaE09.11 Drug or chemical induced diabetes mellitus with ketoacidosis with comaE09.21 Drug or chemical induced diabetes mellitus with diabetic nephropathy

38

ICD-10 Code

Description

E09.22 Drug or chemical induced diabetes mellitus with diabetic chronic kidney diseaseE09.29 Drug or chemical induced diabetes mellitus with other diabetic kidney complicationE09.311 Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edemaE09.319 Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy without macular

edemaE09.3211 Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular

edema, right eyeE09.3212 Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular

edema, left eyeE09.3213 Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular

edema, bilateralE09.3219 Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular

edema, unspecified eyeE09.3291 Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without

macular edema, right eyeE09.3292 Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without

macular edema, left eyeE09.3293 Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without

macular edema, bilateralE09.3299 Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without

macular edema, unspecified eyeE09.3311 Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with

macular edema, right eyeE09.3312 Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with

macular edema, left eyeE09.3313 Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with

macular edema, bilateralE09.3319 Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with

macular edema, unspecified eyeE09.3391 Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without

macular edema, right eyeE09.3392 Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without

macular edema, left eyeE09.3393 Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without

macular edema, bilateralE09.3399 Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without

macular edema, unspecified eyeE09.3411 Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with

macular edema, right eyeE09.3412 Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with

macular edema, left eyeE09.3413 Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with

macular edema, bilateral

39

ICD-10 Code

Description

E09.3419 Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

E09.3491 Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye

E09.3492 Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye

E09.3493 Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral

E09.3499 Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye

E09.3511 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

E09.3512 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

E09.3513 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

E09.3519 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

E09.3521 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

E09.3522 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

E09.3523 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

E09.3529 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye

E09.3531 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

E09.3532 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

E09.3533 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

E09.3539 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye

E09.3541 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

E09.3542 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

E09.3543 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

E09.3549 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye

E09.3551 Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, right eye

40

ICD-10 Code

Description

E09.3552 Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, left eyeE09.3553 Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, bilateralE09.3559 Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, unspecified

eyeE09.3591 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular

edema, right eyeE09.3592 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular

edema, left eyeE09.3593 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular

edema, bilateralE09.3599 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular

edema, unspecified eyeE09.36 Drug or chemical induced diabetes mellitus with diabetic cataractE09.37X1 Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment,

right eyeE09.37X2 Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment,

left eyeE09.37X3 Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment,

bilateralE09.37X9 Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment,

unspecified eyeE09.39 Drug or chemical induced diabetes mellitus with other diabetic ophthalmic complicationE09.40 Drug or chemical induced diabetes mellitus with neurological complications with diabetic neuropathy,

unspecifiedE09.41 Drug or chemical induced diabetes mellitus with neurological complications with diabetic

mononeuropathyE09.42 Drug or chemical induced diabetes mellitus with neurological complications with diabetic

polyneuropathyE09.43 Drug or chemical induced diabetes mellitus with neurological complications with diabetic autonomic

(poly)neuropathyE09.44 Drug or chemical induced diabetes mellitus with neurological complications with diabetic amyotrophyE09.49 Drug or chemical induced diabetes mellitus with neurological complications with other diabetic

neurological complicationE09.51 Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy without gangreneE09.52 Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy with gangreneE09.59 Drug or chemical induced diabetes mellitus with other circulatory complicationsE09.610 Drug or chemical induced diabetes mellitus with diabetic neuropathic arthropathyE09.618 Drug or chemical induced diabetes mellitus with other diabetic arthropathyE09.620 Drug or chemical induced diabetes mellitus with diabetic dermatitisE09.621 Drug or chemical induced diabetes mellitus with foot ulcerE09.622 Drug or chemical induced diabetes mellitus with other skin ulcerE09.628 Drug or chemical induced diabetes mellitus with other skin complications

41

ICD-10 Code

Description

E09.630 Drug or chemical induced diabetes mellitus with periodontal diseaseE09.638 Drug or chemical induced diabetes mellitus with other oral complicationsE09.641 Drug or chemical induced diabetes mellitus with hypoglycemia with comaE09.649 Drug or chemical induced diabetes mellitus with hypoglycemia without comaE09.65 Drug or chemical induced diabetes mellitus with hyperglycemiaE09.69 Drug or chemical induced diabetes mellitus with other specified complicationE09.8 Drug or chemical induced diabetes mellitus with unspecified complicationsE09.9 Drug or chemical induced diabetes mellitus without complicationsE10.10 Type 1 diabetes mellitus with ketoacidosis without comaE10.11 Type 1 diabetes mellitus with ketoacidosis with comaE10.21 Type 1 diabetes mellitus with diabetic nephropathyE10.22 Type 1 diabetes mellitus with diabetic chronic kidney diseaseE10.29 Type 1 diabetes mellitus with other diabetic kidney complicationE10.311 Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edemaE10.319 Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edemaE10.3211 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eyeE10.3212 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eyeE10.3213 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateralE10.3219 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema,

unspecified eyeE10.3291 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right

eyeE10.3292 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eyeE10.3293 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateralE10.3299 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema,

unspecified eyeE10.3311 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right

eyeE10.3312 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left

eyeE10.3313 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema,

bilateralE10.3319 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema,

unspecified eyeE10.3391 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema,

right eyeE10.3392 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema,

left eyeE10.3393 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema,

bilateralE10.3399 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema,

unspecified eye

42

ICD-10 Code

Description

E10.3411 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

E10.3412 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eyeE10.3413 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateralE10.3419 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema,

unspecified eyeE10.3491 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right

eyeE10.3492 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left

eyeE10.3493 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema,

bilateralE10.3499 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema,

unspecified eyeE10.3511 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eyeE10.3512 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eyeE10.3513 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateralE10.3519 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eyeE10.3521 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving

the macula, right eyeE10.3522 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving

the macula, left eyeE10.3523 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving

the macula, bilateralE10.3529 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving

the macula, unspecified eyeE10.3531 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not

involving the macula, right eyeE10.3532 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not

involving the macula, left eyeE10.3533 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not

involving the macula, bilateralE10.3539 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not

involving the macula, unspecified eyeE10.3541 Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, right eyeE10.3542 Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, left eyeE10.3543 Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, bilateralE10.3549 Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, unspecified eyeE10.3551 Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, right eye

43

ICD-10 Code

Description

E10.3552 Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, left eyeE10.3553 Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, bilateralE10.3559 Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eyeE10.3591 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eyeE10.3592 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eyeE10.3593 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateralE10.3599 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eyeE10.36 Type 1 diabetes mellitus with diabetic cataractE10.37X1 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, right eyeE10.37X2 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, left eyeE10.37X3 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateralE10.37X9 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eyeE10.39 Type 1 diabetes mellitus with other diabetic ophthalmic complicationE10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecifiedE10.41 Type 1 diabetes mellitus with diabetic mononeuropathyE10.42 Type 1 diabetes mellitus with diabetic polyneuropathyE10.43 Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathyE10.44 Type 1 diabetes mellitus with diabetic amyotrophyE10.49 Type 1 diabetes mellitus with other diabetic neurological complicationE10.51 Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangreneE10.52 Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangreneE10.59 Type 1 diabetes mellitus with other circulatory complicationsE10.610 Type 1 diabetes mellitus with diabetic neuropathic arthropathyE10.618 Type 1 diabetes mellitus with other diabetic arthropathyE10.620 Type 1 diabetes mellitus with diabetic dermatitisE10.621 Type 1 diabetes mellitus with foot ulcerE10.622 Type 1 diabetes mellitus with other skin ulcerE10.628 Type 1 diabetes mellitus with other skin complicationsE10.630 Type 1 diabetes mellitus with periodontal diseaseE10.638 Type 1 diabetes mellitus with other oral complicationsE10.641 Type 1 diabetes mellitus with hypoglycemia with comaE10.649 Type 1 diabetes mellitus with hypoglycemia without comaE10.65 Type 1 diabetes mellitus with hyperglycemiaE10.69 Type 1 diabetes mellitus with other specified complicationE10.8 Type 1 diabetes mellitus with unspecified complicationsE10.9 Type 1 diabetes mellitus without complicationsE11.00 Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma

(NKHHC)E11.01 Type 2 diabetes mellitus with hyperosmolarity with comaE11.21 Type 2 diabetes mellitus with diabetic nephropathyE11.22 Type 2 diabetes mellitus with diabetic chronic kidney disease

44

ICD-10 Code

Description

E11.29 Type 2 diabetes mellitus with other diabetic kidney complicationE11.311 Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edemaE11.319 Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edemaE11.3211 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eyeE11.3212 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eyeE11.3213 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateralE11.3219 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema,

unspecified eyeE11.3291 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right

eyeE11.3292 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eyeE11.3293 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateralE11.3299 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema,

unspecified eyeE11.3311 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right

eyeE11.3312 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left

eyeE11.3313 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema,

bilateralE11.3319 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema,

unspecified eyeE11.3391 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema,

right eyeE11.3392 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema,

left eyeE11.3393 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema,

bilateralE11.3399 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema,

unspecified eyeE11.3411 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right

eyeE11.3412 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eyeE11.3413 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateralE11.3419 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema,

unspecified eyeE11.3491 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right

eyeE11.3492 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left

eyeE11.3493 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema,

bilateral

45

ICD-10 Code

Description

E11.3499 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye

E11.3511 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eyeE11.3512 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eyeE11.3513 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateralE11.3519 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eyeE11.3521 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving

the macula, right eyeE11.3522 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving

the macula, left eyeE11.3523 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving

the macula, bilateralE11.3529 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving

the macula, unspecified eyeE11.3531 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not

involving the macula, right eyeE11.3532 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not

involving the macula, left eyeE11.3533 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not

involving the macula, bilateralE11.3539 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not

involving the macula, unspecified eyeE11.3541 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, right eyeE11.3542 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, left eyeE11.3543 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, bilateralE11.3549 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, unspecified eyeE11.3551 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, right eyeE11.3552 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, left eyeE11.3553 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, bilateralE11.3559 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eyeE11.3591 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eyeE11.3592 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eyeE11.3593 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateralE11.3599 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eyeE11.36 Type 2 diabetes mellitus with diabetic cataractE11.37X1 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eyeE11.37X2 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eyeE11.37X3 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral

46

ICD-10 Code

Description

E11.37X9 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eyeE11.39 Type 2 diabetes mellitus with other diabetic ophthalmic complicationE11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecifiedE11.41 Type 2 diabetes mellitus with diabetic mononeuropathyE11.42 Type 2 diabetes mellitus with diabetic polyneuropathyE11.43 Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathyE11.44 Type 2 diabetes mellitus with diabetic amyotrophyE11.49 Type 2 diabetes mellitus with other diabetic neurological complicationE11.51 Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangreneE11.52 Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangreneE11.59 Type 2 diabetes mellitus with other circulatory complicationsE11.610 Type 2 diabetes mellitus with diabetic neuropathic arthropathyE11.618 Type 2 diabetes mellitus with other diabetic arthropathyE11.620 Type 2 diabetes mellitus with diabetic dermatitisE11.621 Type 2 diabetes mellitus with foot ulcerE11.622 Type 2 diabetes mellitus with other skin ulcerE11.628 Type 2 diabetes mellitus with other skin complicationsE11.630 Type 2 diabetes mellitus with periodontal diseaseE11.638 Type 2 diabetes mellitus with other oral complicationsE11.641 Type 2 diabetes mellitus with hypoglycemia with comaE11.649 Type 2 diabetes mellitus with hypoglycemia without comaE11.65 Type 2 diabetes mellitus with hyperglycemiaE11.69 Type 2 diabetes mellitus with other specified complicationE11.8 Type 2 diabetes mellitus with unspecified complicationsE11.9 Type 2 diabetes mellitus without complicationsE13.00 Other specified diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar

coma (NKHHC)E13.01 Other specified diabetes mellitus with hyperosmolarity with comaE13.10 Other specified diabetes mellitus with ketoacidosis without comaE13.11 Other specified diabetes mellitus with ketoacidosis with comaE13.21 Other specified diabetes mellitus with diabetic nephropathyE13.22 Other specified diabetes mellitus with diabetic chronic kidney diseaseE13.29 Other specified diabetes mellitus with other diabetic kidney complicationE13.311 Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edemaE13.319 Other specified diabetes mellitus with unspecified diabetic retinopathy without macular edemaE13.3211 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema,

right eyeE13.3212 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema,

left eyeE13.3213 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema,

bilateral

47

ICD-10 Code

Description

E13.3219 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

E13.3291 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye

E13.3292 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye

E13.3293 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral

E13.3299 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye

E13.3311 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

E13.3312 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

E13.3313 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

E13.3319 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

E13.3391 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye

E13.3392 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye

E13.3393 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral

E13.3399 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye

E13.3411 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

E13.3412 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

E13.3413 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

E13.3419 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

E13.3491 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye

E13.3492 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye

E13.3493 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral

E13.3499 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye

E13.3511 Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

48

ICD-10 Code

Description

E13.3512 Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eyeE13.3513 Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateralE13.3519 Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified

eyeE13.3521 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment

involving the macula, right eyeE13.3522 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment

involving the macula, left eyeE13.3523 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment

involving the macula, bilateralE13.3529 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment

involving the macula, unspecified eyeE13.3531 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment

not involving the macula, right eyeE13.3532 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment

not involving the macula, left eyeE13.3533 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment

not involving the macula, bilateralE13.3539 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment

not involving the macula, unspecified eyeE13.3541 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, right eyeE13.3542 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, left eyeE13.3543 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, bilateralE13.3549 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal

detachment and rhegmatogenous retinal detachment, unspecified eyeE13.3551 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, right eyeE13.3552 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, left eyeE13.3553 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, bilateralE13.3559 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eyeE13.3591 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, right

eyeE13.3592 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eyeE13.3593 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateralE13.3599 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema,

unspecified eyeE13.36 Other specified diabetes mellitus with diabetic cataractE13.37X1 Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, right eyeE13.37X2 Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, left eyeE13.37X3 Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral

49

ICD-10 Code

Description

E13.37X9 Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye

E13.39 Other specified diabetes mellitus with other diabetic ophthalmic complicationE13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecifiedE13.41 Other specified diabetes mellitus with diabetic mononeuropathyE13.42 Other specified diabetes mellitus with diabetic polyneuropathyE13.43 Other specified diabetes mellitus with diabetic autonomic (poly)neuropathyE13.44 Other specified diabetes mellitus with diabetic amyotrophyE13.49 Other specified diabetes mellitus with other diabetic neurological complicationE13.51 Other specified diabetes mellitus with diabetic peripheral angiopathy without gangreneE13.52 Other specified diabetes mellitus with diabetic peripheral angiopathy with gangreneE13.59 Other specified diabetes mellitus with other circulatory complicationsE13.610 Other specified diabetes mellitus with diabetic neuropathic arthropathyE13.618 Other specified diabetes mellitus with other diabetic arthropathyE13.620 Other specified diabetes mellitus with diabetic dermatitisE13.621 Other specified diabetes mellitus with foot ulcerE13.622 Other specified diabetes mellitus with other skin ulcerE13.628 Other specified diabetes mellitus with other skin complicationsE13.630 Other specified diabetes mellitus with periodontal diseaseE13.638 Other specified diabetes mellitus with other oral complicationsE13.641 Other specified diabetes mellitus with hypoglycemia with comaE13.649 Other specified diabetes mellitus with hypoglycemia without comaE13.65 Other specified diabetes mellitus with hyperglycemiaE13.69 Other specified diabetes mellitus with other specified complicationE13.8 Other specified diabetes mellitus with unspecified complicationsE13.9 Other specified diabetes mellitus without complicationsO24.011 Pre-existing type 1 diabetes mellitus, in pregnancy, first trimesterO24.012 Pre-existing type 1 diabetes mellitus, in pregnancy, second trimesterO24.013 Pre-existing type 1 diabetes mellitus, in pregnancy, third trimesterO24.019 Pre-existing type 1 diabetes mellitus, in pregnancy, unspecified trimesterO24.02 Pre-existing type 1 diabetes mellitus, in childbirthO24.03 Pre-existing type 1 diabetes mellitus, in the puerperiumO24.111 Pre-existing type 2 diabetes mellitus, in pregnancy, first trimesterO24.112 Pre-existing type 2 diabetes mellitus, in pregnancy, second trimesterO24.113 Pre-existing type 2 diabetes mellitus, in pregnancy, third trimesterO24.119 Pre-existing type 2 diabetes mellitus, in pregnancy, unspecified trimesterO24.12 Pre-existing type 2 diabetes mellitus, in childbirthO24.13 Pre-existing type 2 diabetes mellitus, in the puerperiumO24.311 Unspecified pre-existing diabetes mellitus in pregnancy, first trimesterO24.312 Unspecified pre-existing diabetes mellitus in pregnancy, second trimesterO24.313 Unspecified pre-existing diabetes mellitus in pregnancy, third trimester

50

ICD-10 Code

Description

O24.319 Unspecified pre-existing diabetes mellitus in pregnancy, unspecified trimesterO24.32 Unspecified pre-existing diabetes mellitus in childbirthO24.33 Unspecified pre-existing diabetes mellitus in the puerperiumO24.811 Other pre-existing diabetes mellitus in pregnancy, first trimesterO24.812 Other pre-existing diabetes mellitus in pregnancy, second trimesterO24.813 Other pre-existing diabetes mellitus in pregnancy, third trimesterO24.819 Other pre-existing diabetes mellitus in pregnancy, unspecified trimesterO24.82 Other pre-existing diabetes mellitus in childbirthO24.83 Other pre-existing diabetes mellitus in the puerperiumO24.911 Unspecified diabetes mellitus in pregnancy, first trimesterO24.912 Unspecified diabetes mellitus in pregnancy, second trimesterO24.913 Unspecified diabetes mellitus in pregnancy, third trimesterO24.919 Unspecified diabetes mellitus in pregnancy, unspecified trimesterO24.92 Unspecified diabetes mellitus in childbirthO24.93 Unspecified diabetes mellitus in the puerperiumICD-10 Codes that DO NOT Support Medical Necessity

Group 1 Paragraph:

All ICD-10 codes that are specified in the previous section.

Group 1 Codes: N/A

Additional ICD-10 Information

N/A

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

N/A

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

N/A

Revision History Information

51



Revision History Explanation

07/18/2021 R9 Revision Effective Date: 07/18/2021 NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES: Revised: Incorrect coding denial language for products billed using HCPCS that require written coding verification review Removed: Trademark from reference to pHisohex POLICY SPECIFIC DOCUMENTATION REQUIREMENTS: Revised: Criteria references, to align with LCD criteria Added: Clarifying language for criterion 3, frequent insulin adjustment is not a mandate if glucose levels are within target range MODIFIERS: Added: KF modifier instructions for Class III devices Revised: KX modifier language “injections” to “administrations” 06/03/2021: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

01/01/2020 R8 Revision Effective Date: 01/01/2020 NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES: Removed: STATUTORY ORDER REQUIRMENTS section Removed: REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO 42 CFR 410.38(g) section REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217): Added: Section and related information based on Final Rule 1713 MODIFIERS: Revised: Format of HCPCS code references, from code spans to individually-listed HCPCS CODING GUIDELINES: Clarified: Coding guideline related to K0553 billing timeline Revised: Format of HCPCS code references, from code spans to individually-listed HCPCS ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY: Revised: Section header “ICD-10 Codes that are Covered” updated to “ICD-10 Codes that Support Medical Necessity” ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY: Revised: Section header “ICD-10 Codes that are Not Covered” updated to “ICD-10 Codes that DO NOT Support Medical Necessity”02/20/2020: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

52




01/01/2019 R7 Revision Effective Date: 01/01/2019 ICD-10 CODES THAT ARE COVERED: Added: All diagnosis codes formerly listed in the LCD ICD-10 CODES THAT ARE NOT COVERED: Added: Notation excluding all unlisted diagnosis codes from coverage02/21/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

06/07/2018 R6 Revision Effective Date: 06/07/2018 NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES: Added: Allowance for use of smart devices in conjunction with covered DME Added: A9270 coding of smart devices6/21/2018: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.

01/12/2017 R5 Revision Effective Date: 01/12/2017 NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES: Added: Date of inclusion in DME benefit CODING GUIDELINES: Added: Coding information for CGM, based on date of service04/19/2018: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.

01/12/2017 R4 Revision Effective Date: 01/12/2017 NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES: Added: Coverage and benefit category statements about continuous glucose monitors and supply allowance POLICY SPECIFIC DOCUMENTATION REQUIREMENTS: Added: 42 CFR 410.38(g) and modifiers Added: CG modifier use CODING GUIDELINES Added: For dates of service on or after 7/1/17, HCPCS codes for therapeutic CGM (K0554) and supply allowance (K0553) Added: Definitions for continuous glucose monitor and supply allowance Revised: Bundling table to include continuous glucose monitors and supply allowance Added: PDAC coding verification review for CGM systems RELATED LOCAL COVERAGE DOCUMENTS: Added: LCD-related Standard Documentation Requirements Language Article

10/01/2016 R3 Revision Effective Date: 07/01/2016 NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES: Revised Standard Language to add Statutory Prescription (Order) Requirements, revised Face to Face and ACA requirements (Effective 04/28/2016)

53




07/01/2016 R2 Effective July 1, 2016 oversight for DME MAC Articles is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the Articles.

10/01/2015 R1 Revision Effective Date: 10/31/2014 NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES: Removed: “When required by state law” from ACA new prescription requirements Revised: Face-to-Face Requirements for treating practitioner

Associated DocumentsRelated Local Coverage Document(s)

Article(s)

A55426 - Standard Documentation Requirements for All Claims Submitted to DME MACs

LCD(s)

L33822 - Glucose Monitors

Related National Coverage Document(s)

N/A

Statutory Requirements URL(s)

N/A

Rules and Regulations URL(s)

N/A

CMS Manual Explanations URL(s)

N/A

Other URL(s)

N/A

Public Version(s)



Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

KeywordsN/A

https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=55426

https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?lcdid=33822