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

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

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

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

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

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

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

For the items addressed in this LCD, the "reasonable and necessary" criteria,
based on Social Security Act  1862(a)(1)(A) provisions, are defined by the
following coverage indications, limitations and/or medical necessity.  
  
HOME BLOOD GLUCOSE MONITORS (BGM)  
  
To be eligible for coverage of home blood glucose monitors and related
accessories and supplies, the beneficiary must meet both of the following
basic criteria (1)-(2):

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

  2. The beneficiary's treating practitioner has concluded that the beneficiary (or the beneficiary's caregiver) has sufficient training using the particular device prescribed as evidenced by providing a prescription for the appropriate supplies and frequency of blood glucose testing.

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

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

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

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

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

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

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

The quantity of test strips (code A4253) and lancets (code A4259) that are
covered depends on the usual medical needs of the beneficiary and whether or
not the beneficiary is being treated with insulin, regardless of their
diagnostic classification as having Type 1 or Type 2 diabetes mellitus.
Coverage of testing supplies is based on the following guidelines:  
  
Usual Utilization

For a beneficiary who is not currently being treated with insulin
administrations, up to 100 test strips and up to 100 lancets every 3 months
are covered if the basic coverage criteria (1)-(2) (above) are met.

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

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

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

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

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

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

If neither basic coverage criterion (1) or (2) is met, all testing supplies
will be denied as not reasonable and necessary. If quantities of test strips
or lancets that exceed the utilization guidelines are provided and criteria
(a)-(c) are not met, the amount in excess will be denied as not reasonable and
necessary.  
  
CONTINUOUS GLUCOSE MONITORS (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.

Refer to the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES and CODING
GUIDELINES sections in the LCD-related Policy Article for additional
information regarding classification of CGMs as DME.

To be eligible for coverage of a CGM and related supplies, the beneficiary
must meet all of the following initial coverage criteria (1)-(5):

  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's treating practitioner has concluded that the beneficiary (or beneficiary's caregiver) has sufficient training using the CGM prescribed as evidenced by providing a prescription; and, 

  3. The CGM is prescribed in accordance with its FDA indications for use; and, 

  4. The beneficiary for whom a CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:

  5.     1. The beneficiary is insulin-treated; or, 

    2. The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following (see the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section of the LCD-related Policy Article (A52464)):

      * Recurrent (more than one) level 2 hypoglycemic events (glucose <54mg/dL (3.0mmol/L)) that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or, 

      * A history of one level 3 hypoglycemic event (glucose <54mg/dL (3.0mmol/L)) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia

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

CGM Continued Coverage

Every six (6) months following the initial prescription of the CGM, the
treating practitioner conducts an in-person or Medicare-approved telehealth
visit with the beneficiary to document adherence to their CGM regimen and
diabetes treatment plan.

When a CGM (code E2102 or E2103) is covered, the related supply allowance
(code A4238 or A4239) is also covered. Supplies (code A4238) for an adjunctive
CGM integrated into an external insulin infusion pump are covered when the
beneficiary meets both the CGM coverage criteria and the coverage criteria for
an external insulin infusion pump. Refer to the External Infusion Pumps LCD
(L33794) for additional information regarding billing a CGM receiver
incorporated into an insulin infusion pump.

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

The supply allowance (code A4238 or A4239) is a monthly allowance that may be
billed up to a maximum of three (3) units of service (UOS) per ninety (90)
days at a time. Billing more than three (3) UOS per ninety (90) days of code
A4238 or A4239 will be denied as not reasonable and necessary. Refer to the
CODING GUIDELINES section in the LCD-related Policy Article for additional
billing instructions.

Non-adjunctive CGM devices replace standard home BGMs (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 a non-adjunctive
CGM device (code E2103) and associated supply allowance (code A4239), will be
denied.

Adjunctive CGM devices do not replace a standard home BGM. The supply
allowance for an adjunctive CGM (A4238) encompasses all items necessary for
the use of the device and includes but is not limited to, CGM sensors and
transmitters. Code A4238 does not include a home BGM and related BGM testing
supplies. These items may be billed separately, in addition to code A4238.
Refer to the CODING GUIDELINES section in the LCD-related Policy Article for
additional information.

All CGM devices billed to Medicare using HCPCS code E2103 must be reviewed for
correct coding by the Pricing, Data Analysis and Coding (PDAC) contractor and
be listed on the Product Classification List (PCL). Effective July 1, 2022,
all CGMs billed to Medicare using HCPCS code E2102 must be reviewed for
correct coding by the PDAC contractor and be listed on the PCL. If a CGM
system is billed using HCPCS code E2102 or E2103 but the CGM system is not on
the PCL for that particular HCPCS code, then the claim will be denied as
incorrect coding. Refer to the CODING GUIDELINES section in the LCD-related
Policy Article for additional information.  
  
GENERAL

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

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

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

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

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are
required to maintain POD documentation in their files. Proof of delivery
documentation must be made available to the Medicare contractor upon request.
All services that do not have appropriate proof of delivery from the supplier
shall be denied as not reasonable and necessary.  
  
REFILL REQUIREMENTS  
  
For DMEPOS items and supplies provided on a recurring basis, billing must be
based on prospective, not retrospective use. For DMEPOS products that are
supplied as refills to the original order, suppliers must contact the
beneficiary, and document an affirmative response, 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 expected to end,
and to confirm any changes or modifications to the order. Contact with the
beneficiary or designee regarding refills must take place no sooner than 30
calendar days prior to the expected end of the current supply. For delivery of
refills, the supplier must deliver the DMEPOS product no sooner than 10
calendar days prior to the expected end of the current supply. 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 and
document an affirmative response, prior to dispensing a new supply of items.
Suppliers must not deliver refills without a refill request and an affirmative
response 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 A4238 or A4239. The supply allowance
(code A4238 or A4239) is a monthly allowance that may be billed to the DME
MACs up to a maximum of three (3) units of service (UOS) and no more than a
ninety (90) day supply may be dispensed to the beneficiary at a time. Refer to
the CODING GUIDELINES section in the LCD-related Policy Article for additional
billing instructions.