Glucose Monitor - Policy Article

**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 (BGMs) and continuous glucose monitors (CGMs) are
covered under the Durable Medical Equipment (DME) 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 (LCD) 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 began coverage of therapeutic (non-adjunctive) CGM devices under the
DME benefit. CGM devices covered by Medicare were defined in CMS Ruling 1682R
as therapeutic (non-adjunctive) CGMs.

A non-adjunctive CGM can be used to make treatment decisions without the need
for a stand-alone BGM to confirm testing results. An adjunctive CGM requires
the user verify their glucose levels or trends displayed on a CGM with a BGM
prior to making treatment decisions. On February 28, 2022, CMS determined that
both non-adjunctive and adjunctive CGMs may be classified as DME. CGM devices
that solely display results on a smartphone and do not have a stand-alone
receiver or integration into an insulin infusion pump do not meet the
definition of DME and will be denied as non-covered (no benefit).

The supply allowance for supplies used with a CGM system (A4238, A4239)
encompasses all items necessary for the use of the device and includes but is
not limited to, CGM sensors and transmitters. For non-adjunctive CGMs, the
supply allowance (A4239) also includes a home BGM and related supplies (test
strips, lancets, lancing device, calibration solution, and batteries), if
necessary. Supplies or accessories billed separately will be denied as
unbundling.

For adjunctive CGMs, the supply allowance (A4238) encompasses all items
necessary for the use of the device and includes but is not limited to, CGM
sensors and transmitters. Separate billing of CGM sensors and transmitters
will be denied as unbundling. Code A4238 does not include a home BGM (HCPCS
codes E0607, E2100, E2101) and related BGM testing supplies (HCPCS codes
A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255,
A4256, A4257, A4258, A4259). These items may be billed separately, in addition
to code A4238.  

Coverage of a CGM system supply allowance (code A4238 or A4239) is available
for CGM systems when the beneficiary uses a stand-alone receiver or insulin
infusion pump 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 (code E2102 or E2103). The following are examples of
this provision:

  1. Medicare coverage of a CGM supply allowance is available when 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 when a beneficiary uses a durable CGM receiver on some days to review their glucose data but uses a non-DME device on other days.

If a beneficiary never uses a DME receiver or insulin infusion pump to display
CGM glucose data, 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
(non-covered item or service).

To be eligible for Medicare reimbursement, all CGM devices billed as E2103
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 E2103. Effective July 1, 2022, all CGMs billed to
Medicare using HCPCS code E2102 must have received coding verification review
by the PDAC contractor and be listed on the PCL for HCPCS code E2102. If a CGM
system is billed using HCPCS E2102 or E2103 but the CGM system is not on the
PCL for the particular HCPCS code, then the claim will be denied as incorrect
coding. Products reviewed by the PDAC which do not meet the DME benefit
category requirements must be coded as A9276, A9277, A9278, or A9279 and will
be denied as non-covered (no Medicare Benefit). See the CODING GUIDELINES
section below.

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

Urine test reagent strips or tablets (code A4250) are non-covered 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 non-covered (no benefit category).

Home blood glucose disposable monitors, including test strips (code A9275) are
non-covered 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 provide a list of the specified codes, which is periodically updated.
The required Face-to-Face Encounter and Written Order Prior to Delivery List
is available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).  

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 or Medicare-approved telehealth 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 or Medicare-approved telehealth treating practitioner visit
that is required as part of the initial provision of a CGM, there must be
sufficient information in the beneficiary's medical record to determine that
the beneficiary has diabetes mellitus (criterion 1), the beneficiary (or the
beneficiary's caregiver) has received appropriate training in the use of the
device as evidenced by a prescription (criterion 2), the CGM is being
prescribed in accordance with FDA indications for use (criterion 3), and the
CGM is being prescribed to improve glycemic control for a beneficiary who is
insulin treated or has a history of problematic hypoglycemia (criterion 4).

For criterion 4B, the treating practitioner's medical record must document the
beneficiary has a history of problematic hypoglycemia consistent with one of
the following pathways to coverage:

  1. **Beneficiaries with non-insulin treated diabetes and a history of recurrent (more than one) level 2 hypoglycemic events**
  2.     1. The treating practitioner must document at least one of the following in the medical record for each event: 
      1. The glucose values for the qualifying event(s) **(glucose <54mg/dL (3.0mmol/L))**; or,
      2. Classification of the hypoglycemic episode(s) as level 2 event(s); or,
      3. Incorporate a copy of the beneficiary's BGM testing log into the medical record reflecting the specific qualifying events **(glucose <54mg/dL (3.0mmol/L))**; and,
    2. Documentation of more than one previous medication adjustment and/or modification to the treatment plan (such as raising A1c targets) prior to the most recent level two event.

  2. **Beneficiaries with non-insulin treated diabetes and a history of at least one level 3 hypoglycemic event**
    1. The treating practitioner must document at least one of the following in the medical record: 
      1. The glucose value for the qualifying event **(glucose <54mg/dL (3.0mmol/L))**; or,
      2. Classification of the hypoglycemic episode as level 3 event; or,
      3. Incorporate a copy of the beneficiary's BGM testing log into the medical record reflecting the specific qualifying event **(glucose <54mg/dL (3.0mmol/L))**; and,
    2. An indication in the medical record that the beneficiary required third party assistance for treatment.

For the in-person or Medicare-approved telehealth treating practitioner visit
that is required as part of the ongoing provision of a CGM, there must be
sufficient information in the beneficiary's medical record to determine that
the beneficiary continues to adhere to their diabetes treatment regimen and
use of the CGM device.  
  
**MODIFIERS**

CG, KF, KS and KX 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 CGM devices (code E2102 or E2103) and
supply allowance (code A4238 or A4239), 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 exclusively treated
with oral hypoglycemic agents.

For initial coverage of non-adjunctive CGM devices (code E2103) and the supply
allowance (code A4239) the CG modifier must be added to the claim line only if
all of the CGM coverage criteria (1)-(5) in the Glucose Monitors LCD are met.
For continued coverage of non-adjunctive CGM devices (code E2103) and the
supply allowance (code A4239) the CG modifier must be added to the claim line
only if the continued coverage criterion in the Glucose Monitors LCD is met.
If any of the coverage criteria are not met, the CG modifier must not be used.

The CG modifier must be added to the claim line for an adjunctive CGM (E2102)
incorporated into an insulin infusion pump and supply allowance (code A4238)
only if all of the initial CGM coverage criteria (1)-(5) in the Glucose
Monitors LCD and the coverage criteria for an insulin infusion pump as
outlined in the External Infusion Pumps LCD (L33794) are met. For continued
coverage of adjunctive CGM devices incorporated into an insulin infusion pump
(code E2102) and the supply allowance (code A4238), the CG modifier must be
added to the claim line only if the continued coverage criteria in the Glucose
Monitors LCD and the External Infusion Pumps LCD are met. If any of the
coverage criteria are not met, the CG modifier must not be used.

CGMs (E2102 and E2103) and related supplies (A4238 and A4239) which are
classified by the Food & Drug Administration as Class III devices must include
the KF modifier.

**CODING GUIDELINES**

For claims with dates of service on or after July 1, 2017, through December
31, 2022, a non-adjunctive CGM must be billed with code K0554 and code K0553
for the supply allowance. For claims with dates of service on or after January
1, 2023, a non-adjunctive CGM must be billed with code E2103 and code A4239
for the supply allowance. Code E2103 or K0554 describes a non-adjunctive CGM
that meets the requirements of the DME benefit.

For claims with dates of service on or before March 31, 2022, adjunctive CGMs
which meet the definition of DME must be billed with code E1399. For claims
with dates of service on or after April 1, 2022, adjunctive CGMs which meet
the definition of DME must be billed with code E2102. There are currently no
stand-alone adjunctive CGMs on the United States (US) market which meet the
definition of DME (as described under the NON-MEDICAL NECESSITY COVERAGE AND
PAYMENT RULES section). However, there are adjunctive CGMs incorporated into
an insulin infusion pump on the US market which may meet the definition of
DME. Refer to the External Infusion Pumps LCD (L33794) for additional
information on billing a CGM receiver incorporated into an insulin infusion
pump.

For claims with dates of service on or before March 31, 2022, adjunctive CGM
disposable supplies which fall under the DME benefit (as described under the
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section) must be billed with
code A9999 (MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE SPECIFIED)
for the supply allowance. When submitting a claim for A9999, suppliers must
enter "adjunctive" in loop 2300 (claim note) and/or 2400 (line note), segment
NTE02 (NTE01=ADD) of the ANSI X12N, version 5010A1 professional electronic
claim format or in Item 19 of the paper claim form, so that the items can be
identified as adjunctive CGM supplies and accessories when processing the
claim.

For claims with dates of service on or after April 1, 2022, adjunctive CGM
disposable supplies which fall under the DME benefit (as described under the
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section) must be billed with
code A4238 for the supply allowance.

The CGM supply allowance includes all items necessary for the use of the
device and includes, but is not limited to, CGM sensors and transmitters. For
non-adjunctive CGMs, the supply allowance (A4239) also includes a home BGM and
related supplies (test strips, lancets, lancing device, calibration solution,
and batteries), if necessary. Supplies used with a non-covered CGM are
considered non-covered (no Medicare benefit) and must not be billed using
HCPCS code A4238 or A4239.

A supplier does not have to deliver supplies used with a CGM every month in
order to bill code A4238 or A4239 every month. In order to bill code A4238 or
A4239, 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
A4238 or A4239 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.

Up to a maximum of three (3) months, ninety (90) days of the supply allowance
may be billed for code A4238 or A4239 to the DME MAC at a time and suppliers
may not dispense more than a ninety (90) day supply.

For dates of service prior to April 1, 2022, and dates of service on or after
January 1, 2023, 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 NON-
DURABLE MEDICAL EQUIPMENT INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM)
describe the supplies used with a CGM that does not meet the definition of
DME. Codes A9276 and A9277 are not used to bill for supplies used with a non-
adjunctive CGM (E2103) or for adjunctive CGM supplies furnished in conjunction
with an insulin infusion pump used as a CGM receiver.

For dates of service prior to April 1, 2022, and dates of service on or after
January 1, 2023, code A9278 (RECEIVER (MONITOR); EXTERNAL, FOR USE WITH NON-
DURABLE MEDICAL EQUIPMENT INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM)
describes any CGM system that fails to meet the DME Benefit requirements as
described under the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section.

For dates of service between April 1, 2022, through December 31, 2022, code
A9279 (MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY TYPE,
INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE
CLASSIFIED) is used to describe any CGM system and/or related supplies that
fail to meet the DME benefit requirement as described under the NON-MEDICAL
NECESSITY COVERAGE AND PAYMENT RULES section.

Home BGMs (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.  
  
BGMs 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.  
  
BGMs 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 (non-covered 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.

Column I | Column II  
---|---  
E0607 | A4233, A4234, A4235, A4236  
E2100 | A4233, A4234, A4235, A4236  
E2101 | A4233, A4234, A4235, A4236  
E2103 | E0607, E2100, E2101, A4233, A4234, A4235, A4236, A4244, A4245, A4246,
A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259  
  
Suppliers should contact the PDAC contractor for guidance on the correct
coding of items addressed in this policy.