L11520-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Glucose Monitors (L11520)

Contractor Information

Contractor Name CGS Administrators, LLC

Contractor Number 18003

Contractor Type

DME MAC

Jurisdiction

J - G

LCD Information

Document Information

LCD ID Number L11520

LCD Title Glucose Monitors

Contractor's Determination Number GLUC

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. 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. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi North Carolina New Mexico Oklahoma Puerto Rico South Carolina Tennessee Texas Virginia Virgin Islands West Virginia

Oversight Region Region IV

DME Region LCD Covers Jurisdiction C

Original Determination Effective Date

For services performed on or after 10/01/1993 Original Determination Ending Date

Revision Effective Date

For services performed on or after 11/01/2012

Revision Ending Date

CMS National Coverage Policy

CMS Pub. 100-3, (Medicare National Coverage Determinations Manual), Chapter 1, Section 40.2 Indications and Limitations of Coverage and/or Medical Necessity

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

For an item to be covered by Medicare, a detailed written order (DWO) must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed DWO, the item will be denied as not reasonable and necessary.

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):

The beneficiary has diabetes (ICD-9 codes 249.00-250.93); and

The beneficiary’s physician 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 (E2100, E2101) are covered when the basic coverage criteria (1)-(2) are met and the treating physician 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 physician certifies that the beneficiary has an impairment of manual dexterity severe enough to require the use of this special monitoring system. Coverage of E2101 for beneficiaries with manual dexterity impairments is not dependent upon a visual impairment.

If an E2100 or E2101 glucose monitor 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 (A4259), blood glucose test reagent strips (A4253), glucose control solutions (A4256) and spring powered devices for lancets (A4258) are covered for beneficiaries for whom the glucose monitor is covered.

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

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

The quantity of test strips (A4253) and lancets (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 injections, 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 injections, 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 injections, 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 injections, 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. The treating physician has seen the beneficiary, evaluated their diabetes control within 6 months prior to ordering quantities of strips and lancets that exceed the utilization guidelines and has documented in the beneficiary's medical record the specific reason for the additional materials for that particular beneficiary; and,

c. If refills of quantities of supplies that exceed the utilization guidelines are dispensed, there must be documentation in the physician's records (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) that the beneficiary is actually testing at a frequency that corroborates the quantity of supplies that have been dispensed. If the beneficiary is regularly using quantities of supplies that exceed the utilization guidelines, new documentation must be present at least every six months.

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.

REFILL REQUIREMENTS

For Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products (A4233-A4236, A4253, A4256, A4258 and A4259) 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. (CMS Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-8, Chapter 5, Section 5.2.6).

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 ordering physicians that any changed or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a three (3)-month quantity at a time.

Coding Information

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 policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

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 policy 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 policy should be assumed to apply equally to all Revenue Codes.

CPT/HCPCS Codes

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

HCPCS MODIFIERS

EY - No physician or other licensed health care provider order for this item or service KS - Glucose monitor supply for diabetic beneficiary not treated by insulin

KX - Specific required documentation on file

EQUIPMENT

E0607 HOME BLOOD GLUCOSE MONITOR

E0620 SKIN PIERCING DEVICE FOR COLLECTION OF CAPILLARY BLOOD, LASER, EACH E2100 BLOOD GLUCOSE MONITOR WITH INTEGRATED VOICE SYNTHESIZER

E2101 BLOOD GLUCOSE MONITOR WITH INTEGRATED LANCING/BLOOD SAMPLE

ACCESSORIES/SUPPLIES

A4233 REPLACEMENT BATTERY, ALKALINE (OTHER THAN J CELL), FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH

A4234 REPLACEMENT BATTERY, ALKALINE, J CELL, FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH

A4235 REPLACEMENT BATTERY, LITHIUM, FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH

A4236 REPLACEMENT BATTERY, SILVER OXIDE, FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH

A4244 ALCOHOL OR PEROXIDE, PER PINT A4245 ALCOHOL WIPES, PER BOX

A4246 BETADINE OR PHISOHEX SOLUTION, PER PINT A4247 BETADINE OR IODINE SWABS/WIPES, PER BOX

A4250 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 STRIPS A4255 PLATFORMS FOR HOME BLOOD GLUCOSE MONITOR, 50 PER BOX

A4256 NORMAL, LOW AND HIGH CALIBRATOR SOLUTION / CHIPS

A4257 REPLACEMENT LENS SHIELD CARTRIDGE FOR USE WITH LASER SKIN PIERCING DEVICE, EACH A4258 SPRING-POWERED DEVICE FOR LANCET, EACH

A4259 LANCETS, PER BOX OF 100

A9275 HOME GLUCOSE DISPOSABLE MONITOR, INCLUDES TEST STRIPS

A9276 SENSOR; INVASIVE (E.G. SUBCUTANEOUS), DISPOSABLE, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM, ONE UNIT = 1 DAY SUPPLY

A9277 TRANSMITTER; EXTERNAL, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM

A9278 RECEIVER (MONITOR); EXTERNAL, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM

ICD-9 Codes that Support Medical Necessity

The presence of an ICD-9 code listed in this section is not sufficient by itself to assure coverage. Refer to the section on “Indications and Limitations of Coverage and/or Medical Necessity” for other coverage criteria and payment information.

249.00 - 249.91 opens SECONDARY DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, NOT STATED

AS UNCONTROLLED, OR UNSPECIFIED - SECONDARY DIABETES MELLITUS WITH

UNSPECIFIED COMPLICATION, UNCONTROLLED

250.1 - 250.93 opens DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, TYPE II OR UNSPECIFIED

TYPE, NOT STATED AS UNCONTROLLED - DIABETES WITH UNSPECIFIED COMPLICATION,

TYPE I [JUVENILE TYPE], UNCONTROLLED

Diagnoses that Support Medical Necessity

All diagnoses that are specified in the preceding section. ICD-9 Codes that DO NOT Support Medical Necessity

All ICD-9 codes that are not specified in the previous section.

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

All diagnoses that are not specified in the previous section.

General Information

Documentations 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 physician'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.

PRESCRIPTION (ORDER) REQUIREMENTS

GENERAL (PIM 5.2.1)

All items billed to Medicare require a prescription. An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items dispensed and/or billed that do not meet these prescription requirements and those below must be submitted with an EY modifier added to each affected HCPCS code.

DISPENSING ORDERS (PIM 5.2.2)

Equipment and supplies may be delivered upon receipt of a dispensing order except for those items that require a written order prior to delivery. A dispensing order may be verbal or written. The supplier must keep a record of the dispensing order on file. It must contain:

• Description of the item

• Beneficiary's name

• Prescribing Physician's name

• Date of the order and the start date, if the start date is different from the date of the order

• Physician signature (if a written order) or supplier signature (if verbal order)

For the "Date of the order" described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

The dispensing order must be available upon request.

For items that are provided based on a dispensing order, the supplier must obtain a detailed written order before submitting a claim.

DETAILED WRITTEN ORDERS (PIM 5.2.3)

A detailed written order (DWO) is required before billing. Someone other than the ordering physician may produce the DWO. However, the ordering physician must review the content and sign and date the document. It must contain:

• Beneficiary's name

• Physician's name

• Date of the order and the start date, if start date is different from the date of the order

• Detailed description of the item(s) (see below for specific requirements for selected items)

• Physician signature and signature date

For items provided on a periodic basis, including drugs, the written order must include:

• Item(s) to be dispensed

• Dosage or concentration, if applicable

• Route of Administration

• Frequency of use/testing frequency, for test strips and lancets

• Duration of infusion, if applicable

• Quantity to be dispensed

• Number of refills

For the "Date of the order" described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

For blood glucose monitor supplies provided on a periodic basis, not all 7 of the above elements are required. See POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section for the specific elements required for the detailed written orders for diabetic testing supplies.

Frequency of use information on orders must contain detailed instructions for use and specific amounts to be dispensed. Reimbursement shall be based on the specific utilization amount only. Orders that only state "PRN" or "as needed" utilization estimates for replacement frequency, use, or consumption are not acceptable. (PIM 5.9)

The detailed description in the written order may be either a narrative description or a brand name/model number.

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

The DWO must be available upon request.

A prescription is not considered as part of the medical record. Medical information intended to demonstrate compliance with coverage criteria may be included on the prescription but must be corroborated by information contained in the medical record.

MEDICAL RECORD INFORMATION

GENERAL (PIM 5.7 -5.9)

The Indications and Limitations of Coverage and/or Medical Necessity section of this LCD contains numerous reasonable and necessary (R&N) requirements. The Nonmedical Necessity Coverage and Payment Rules section of the related Policy Article contains numerous non-reasonable and necessary, benefit category and statutory requirements that must be met in order for payment to be justified. Suppliers are reminded that:

• Supplier-produced records, even if signed by the ordering physician, and attestation letters (e.g. letters of medical necessity) are deemed not to be part of a medical record for Medicare payment purposes.

• Templates and forms, including CMS Certificates of Medical Necessity, are subject to corroboration with information in the medical record.

Information contained directly in the contemporaneous medical record is the source required to justify payment except as noted elsewhere for prescriptions and CMNs. The medical record is not limited to physician's office records but may include records from hospitals, nursing facilities, home health agencies, other healthcare professionals, etc. (not all-inclusive). Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for the purpose of determining that an item is reasonable and necessary.

CONTINUED USE

Continued use describes the ongoing utilization of supplies or a rental item by a beneficiary.

Suppliers are responsible for monitoring utilization of DMEPOS rental items and supplies. No monitoring of purchased items or capped rental items that have converted to a purchase is required. Suppliers must discontinue billing Medicare when rental items or ongoing supply items are no longer being used by the beneficiary.

Beneficiary medical records or supplier records may be used to confirm that a DMEPOS item continues to be used by the beneficiary. Any of the following may serve as documentation that an item submitted for reimbursement continues to be used by the beneficiary:

1. Timely documentation in the beneficiary's medical record showing usage of the item, related option/accessories and supplies

2. Supplier records documenting the request for refill/replacement of supplies in compliance with the Refill Documentation Requirements (This is deemed to be sufficient to document continued use for the base item, as well)

3. Supplier records documenting beneficiary confirmation of continued use of a rental item

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in this policy.

CONTINUED MEDICAL NEED

For all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered; therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. For purchased items, initial months of a rental item or for initial months of ongoing supplies or drugs, information justifying reimbursement will come from this initial time period. Entries in the beneficiary's medical record must have been created prior to, or at the time of, the initial DOS to establish whether the initial reimbursement was justified based upon the applicable coverage policy.

For ongoing supplies and rental DME items, in addition to information described above that justifies the initial provision of the item(s) and/or supplies, there must be information in the beneficiary's medical record to support that the item continues to be used by the beneficiary and remains reasonable and necessary. Information used to justify continued medical need must be timely for the DOS under review. Any of the following may serve as documentation justifying continued medical need:

A recent order by the treating physician for refills A recent change in prescription

A properly completed CMN or DIF with an appropriate length of need specified Timely documentation in the beneficiary's medical record showing usage of the item

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in the policy.

REFILL DOCUMENTATION (PIM 5.2.5-6)

A routine refill prescription is not needed. A new prescription is needed when:

• There is a change of supplier

• There is a change in the item(s), frequency of use, or amount prescribed

• There is a change in the length of need or a previously established length of need expires

• State law requires a prescription renewal

For items that the beneficiary obtains in-person at a retail store, the signed delivery slip or a copy of the itemized sales receipt is sufficient documentation of a request for refill.

For items that are delivered to the beneficiary, documentation of a request for refill must be either a written document received from the beneficiary or a contemporaneous written record of a phone conversation/contact between the supplier and beneficiary. The refill request must occur and be documented before shipment. A retrospective attestation statement by the supplier or beneficiary is not sufficient. The refill record must include:

• Beneficiary's name or authorized representative if different than the beneficiary

• A description of each item that is being requested

• Date of refill request

• Information documenting that the beneficiary’s remaining supply is approaching exhaustion by the expected delivery date

• For consumable supplies i.e., those that are used up (e.g., ostomy or urological supplies, surgical dressings, etc.) - The Supplier should assess the quantity of each item that the beneficiary still has remaining, to document that the amount remaining will be nearly exhausted on or about the supply anniversary date.

• For non-consumable supplies i.e., those more durable items that are not used up but may need periodic replacement (e.g., PAP and RAD supplies) - The supplier should assess whether the supplies remain functional, providing replacement (a refill) only when the supply item(s) is no longer able to function. Document the functional condition of the item(s) being refilled in sufficient detail to demonstrate the cause of the dysfunction that necessitates replacement (refill).

This information must be kept on file and be available upon request.

PROOF OF DELIVERY (PIM 4.26, 5.8)

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. For medical review purposes, POD serves to assist in determining correct coding and billing information for claims submitted for Medicare reimbursement. Regardless of the method of delivery, the contractor must be able to determine from delivery documentation that the supplier properly coded the item(s), that the item(s) delivered are the same item(s) submitted for Medicare reimbursement and that the item(s) are intended for, and received by, a specific Medicare beneficiary.

Suppliers, their employees, or anyone else having a financial interest in the delivery of the item are prohibited from signing and accepting an item on behalf of a beneficiary (i.e., acting as a designee on behalf of the beneficiary). The signature and date the beneficiary or designee accepted delivery must be legible.

For the purpose of the delivery methods noted below, designee is defined as any person who can sign and accept the delivery of DMEPOS on behalf of the beneficiary.

Proof of delivery documentation must be available to the Medicare contractor on request. All services that do not have appropriate proof of delivery from the supplier will be denied and overpayments will be requested. Suppliers who consistently fail to provide documentation to support their services may be referred to the OIG for imposition of Civil Monetary Penalties or other administrative sanctions.

Suppliers are required to maintain POD documentation in their files. For glucose monitors and supplies, there are two methods of delivery:

1. Delivery directly to the beneficiary or authorized representative

2. Delivery via shipping or delivery service

Method 1—Direct Delivery to the Beneficiary by the Supplier

Suppliers may deliver directly to the beneficiary or the designee. In this case, POD to a beneficiary must be a signed and dated delivery slip. The POD record must include:

• Beneficiary's name

• Delivery address

• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

• Quantity delivered

• Date delivered

• Beneficiary (or designee) signature and date of signature

The date of signature on the delivery slip must be the date that the DMEPOS item was received by the beneficiary or designee. In instances where the supplies are delivered directly by the supplier, the date the beneficiary received the DMEPOS item must be the date of service on the claim.

Method 2—Delivery via Shipping or Delivery Service Directly to a Beneficiary

If the supplier utilizes a shipping service or mail order, the POD documentation must be a complete record tracking the item(s) from the DMEPOS supplier to the beneficiary. An example of acceptable proof of delivery would include both the supplier's own detailed shipping invoice and the delivery service's tracking information. The supplier's record must be linked to the delivery service record by some clear method like the delivery service's package identification number or supplier's invoice number for the package sent to the beneficiary. The POD record must include:

• Beneficiary's name

• Delivery address

• Delivery service's package identification number, supplier invoice number or alternative method that links the supplier's delivery documents with the delivery service's records.

• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

• Quantity delivered

• Date delivered

• Evidence of delivery

If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of service on the claim.

Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a POD. This type of POD record must contain the information specified above.

REPAIR/REPLACEMENT (BPM Ch 15, §100.2)

A new Certificate of Medical Necessity (CMN) and/or physician’s order is not needed for repairs.

The supplier must maintain detailed records describing the need for and nature of all repairs including a detailed explanation of the justification for any component or part replaced as well as the labor time.

A physician’s order and/or new Certificate of Medical Necessity (CMN), when required, is needed to reaffirm the medical necessity of the item for replacement of an item.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

The ICD-9 diagnosis code describing the condition that necessitates glucose testing must be included on each claim for the monitor, accessories and supplies.

If the beneficiary is being treated with insulin injections, the KX modifier must be added to the code for the monitor and each related supply on every claim submitted. The KX modifier must not be used for a beneficiary who is not treated with insulin injections.

If the beneficiary is not being treated with insulin injections, the KS modifier must be added to the code for the monitor and each related supply on every claim submitted.

Documentation of the training requirement specified in basic coverage criterion 2 in the Indications and Limitations of Coverage and/or Medical Necessity section is deemed to have been met by evidence of the treating physician providing the beneficiary with a prescription for the appropriate monitor, testing supplies and frequency of blood glucose testing.

Additional documentation requirements apply to:

• A beneficiary who is not insulin-treated (KS modifier present) and whose prescribed frequency of testing is more often than once per day; or,

• A beneficiary who is insulin-treated (KX modifier present) and whose prescribed frequency of testing is more often than three times per day.

Additional documentation in the medical record must demonstrate that the basic coverage criteria (1) – (2) described in the Indications and Limitations of Coverage and/or Medical Necessity section of this LCD have been met and that the additional criteria (a) – (c) for high utilization have been met, including the evaluation of the beneficiary’s glucose control necessitating quantities of test strips and lancets that exceed the usual utilization guidelines (criterion b). This information does not have to be submitted with the claim but must be available upon request.

The medical necessity for E2100 or E2101 in a beneficiary with impaired visual acuity must be documented by a narrative statement from the physician that must include the beneficiary’s specific numerical visual acuity (e.g., 20/400) and that this result represents "best corrected" vision. This information does not have to be sent in with the claim but must be substantiated in the beneficiary’s medical record and available upon request.

Similarly, claims for E2101 for beneficiaries with impaired manual dexterity must be documented by a narrative statement from the physician that includes an explanation of the beneficiary’s medical condition necessitating the monitor with special features. This information does not have to be sent in with the claim, but must be available request.

Suppliers are not prohibited from creating data collection forms in order to gather medical necessity information; however, the DME MAC or DME PSC/ZPIC will not rely solely on those forms to prove the medical necessity of services provided. Suppliers must not attribute any self-generated forms or data collection requests to the Medicare Program, CMS, or the DME MAC or DME PSC/ZPIC. Physicians are not required to fill out additional forms from suppliers or to provide additional forms to suppliers or to provide additional information to suppliers unless specifically requested by the supplier per the DME MAC or DME PSC/ZPIC.

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

Appendices PIM citations above denote references to CMS Program Integrity Manual, Internet Only Manual 100-8

Insulin-treated means that the beneficiary is receiving insulin injections to treat their diabetes. 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 physician.

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 Indications and Limitations of Coverage and/or Medical Necessity.

Sources of Information and Basis for Decision

Reserved for future use. Advisory Committee Meeting Notes

Start Date of Comment Period 04/16/1993

End Date of Comment Period 05/31/1993

Start Date of Notice Period 08/01/1993

Revision History Number 015

Revision History Explanation Revision Effective Date: 11/01/2012 (December Publication) INDICATIONS AND LIMITATIONS OF COVERAGE:

Clerical Correction: Re-inserted documentation requirement for high utilization beneficiaries inadvertently omitted from 11/01/2012 publication

DOCUMENTATION REQUIREMENTS:

Added: Consumable and non-consumable supplies to Refill documentation

Deleted: Method 3 under Proof of Delivery (Delivery to nursing facility) since this does not apply to DME

Clerical Correction: Re-inserted documentation requirement for high utilization beneficiaries inadvertently omitted from 11/01/2012 publication

Clerical Correction: Consolidated redundant written order requirements in Policy Specific Documentation Requirements

Revision Effective Date: 11/01/2012 INDICATIONS AND LIMITATIONS OF COVERAGE:

Revised: Format and layout of basic coverage and high utilization criteria Revised: Order requirements language to specify a “detailed written order” Revised: Word “Patient” to “Beneficiary”

Clarified: Coverage of laser lancing devices and lens shield cartridges DOCUMENTATION REQUIREMENTS:

(Note: The effective date above is not applicable to this section. These revised and added requirements are existing Medicare requirements which are now included in the LCD for easy reference)

Revised: Prescription requirements

Added: Documentation of beneficiary training

Revision Effective Date: 07/01/2012

This LCD revision was rescinded prior to the 7/1/2012 effective date

08/05/2011 - The Jurisdiction C contractor adopted a new business name. This LCD revision only includes the change from CIGNA Government Services to CGS Administrators, LLC. No coverage information was included in this revision and no provider action is needed regarding this revision.

Revision Effective Date: 08/02/2011 INDICATIONS AND LIMITATIONS OF COVERAGE:

Revised: Refills information DOCUMENTATION REQUIREMENTS:

Added: Refills documentation information

Revision Effective Date: 02/04/2011 INDICATIONS AND LIMITATIONS OF COVERAGE:

Revised: Preamble language

Deleted: Least costly alternative language for codes E2100 and E2101 Deleted: Least costly alternative language for codes E0620 and A4257

08/08/2009 - This policy was updated by the ICD-9 2009-2010 Annual Update. Revision Effective Date: 10/1/2008

INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: Delivery timeframe for shipping of refills ICD-9 CODES that SUPPORT MEDICAL NECESSITY:

Added: 249.00 – 249.91 ICD-9 diagnosis codes

Revision Effective Date: 03/01/2008

In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC CIGNA Government Services (18003) LCD L11517 from DME PSC TrustSolutions (77012) LCD L11517.

Revision Effective Date: 01/01/2008 HCPCS CODES:

Added: A9276-A9278

Revision Effective Date: 06/01/2007

In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

Revision Effective Date: 01/01/2007

Clarified Revision History entry for 07/01/2005 INDICATIONS AND LIMITATIONS OF COVERAGE:

Clarification of claims processing contractor – DME MAC

Printed on 1/26/2013. Page 12 of 14

Clarified visual acuity criteria for E2100 and E2101

Removed paragraph addressing the renewal order from the treating physician

Revision Effective Date: 03/01/2006

In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TrustSolutions (77012) from DMERC Palmetto GBA (00885)

Revision Effective Date: 01/01/2006 HCPCS CODES AND MODIFIERS:

Added: A4233, A4234, A4235, A4236, A9275

Deleted: A4254

Revision Effective Date: 07/01/2005 LMRP converted to LCD and Policy Article DOCUMENTATION REQUIREMENTS:

Eliminated certain required elements from order

Eliminated requirement for a routine order every 12 months

Revision Effective Date: 04/01/2003 LMRP name changed to Glucose Monitors HCPCS CODES AND MODIFIERS:

Added: EY

INDICATIONS ANDLIMITATIONS OF COVERAGE:

Adds standard language concerning coverage of items without an order DOCUMENTATION REQUIREMENTS:

Adds standard language concerning use of EY modifier for items without an order

The revision dates listed below are the dates the revisions were published and not necessarily the effective dates for the revisions.

10/01/2002 – Revised definitions of order renewal and order refill. Clarified that coverage of E2101 for beneficiaries with manual dexterity impairments is not dependent on visual impairment. Emphasized that suppliers have an obligation to monitor a beneficiary’s utilization of supplies and dispense supplies accordingly. Stated specific elements required for orders. Clarified the DMERC position on the use of data collection forms. Removed bundling table.

04/01/2002 – Added new HCPCS codes E0620, E2100, E2101 and A4257. Added definition of E0620 (skin piercing device for collection of capillary blood, laser, each). Deleted E0609 and crosswalk to E2100 and E2101. Added coverage and payment rules for E2101. Updated ICD-9 code range for diabetes mellitus. Replaced ZX with KX modifier. Changed timeframe for new prescription from every 6 months to every 12 months. Applied least costly alternative authority to E0620 and A4257.

03/01/1999 – Updated Coverage and Payment Rules section adding reasonable and necessary language and criteria (f) regarding utilization.

12/01/1998 – Added definitions for renewal order and A4256. Updated coverage and payment rules allowing coverage for non-insulin treated diabetics. Added KS modifier for non-insulin treated diabetics. Updated utilization guidelines for test strips/lancets for insulin and non-insulin treated diabetics.

12/01/1997 – Code XX003 (platforms) changed to A4255. Updated coding guidelines removing effective date for A4254 & A4258 and added bundling table.

10/01/1996 – Changed codes: K0267 to A4254 and K0131 to A4258. Deleted code XX002 (test strips, per 25). Added effective dates for A4254 & A4258.

10/01/1995 – Added code K0267 (replacement battery for monitor). Added utilization guidelines for test strips/lancets to the Coverage and Payment Rules section.

07/01/1995 – Added ZX modifier. Added definition for insulin-treated diabetic. Moved Indications information to Coverage and Payment Rules section. Removed criteria 2) concerning documentation in the Coverage and Payment Rules section. Updated coding guidelines for number of services for A4259 from "per 50" to "per 100." Updated coding guidelines for XX002 to exclude claim submission to DMERC; instructed suppliers to use A4253 instead. Updated Documentation section adding information regarding use of ZX modifier and utilization guidelines for test strips/lancets.

12/01/1993 – Added code XX002 (test strips, per 25). Included utilization guidelines in the Coverage and Payment Rules section for XX002. HAO corrected to HA0 in Documentation section.

Reason for Change Narrative Change Typographical Correction