Diabetic Rules and Limits
Rules and Limits Having trouble finding the Diabetic Supplies you need or finding a supplier that will accept Medicare Assignment? Better Living Now is here to help you. We carry all your supplies and we work with you towards providing your supplies under Medicare assignment through our Preferred Program. If you are covered under Medicare, many of your medically necessary supplies and related products may be covered! To get started enroll today or print out an Diabetic Supplies Order Form, bring it to your doctor and mail your or fax your order to us. It is that easy! How The Program Works
Diabetic Supplies Allowable Amounts
Allowable Amounts Better Living Now has developed preferred product relationships with industry leading manufacturers in an effort to bring you the highest quality products available that will be 100% covered by your insurance/Medicare plan with no additional out-of-pocket expense to you. Contact us for more information Diabetic Supplies Allowable Amounts - Effective 08/02/2011
Product Description Allowable Amount
Non Insulin Dependant
Allowable Amount
Insulin Dependant
E0607
HOME BLOOD GLUCOSE MONITOR
1 per 5 years 1 per 5 years
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
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
N/C* N/C*
A4245
ALCOHOL WIPES, PER BOX
N/C* N/C*
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)
N/C* N/C*
A4253
BLOOD GLUCOSE TEST OR REAGENT STRIPS FOR HOME BLOOD GLUCOSE MONITOR, PER 50 STRIPS
100 per 3 months 100 per month (up to 3 month supply)
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
1 per 6 months 1 per 6 months
A4259
LANCETS, PER BOX OF 100
100 per 3 months 100 per month (up to 3 month supply)
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
A927
RECEIVER (MONITOR); EXTERNAL, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM
Notes *Please inquire about our low discounted prices Monthly allowable amounts do not represent a benefit limit. The actual quantity needed by a particular member may be more or less than the amount listed, depending on the individual member's medical condition. Members ordering over the allowable amount must have appropriate medical justification, including a one-month log of all blood glucose readings. ICD-9 Codes that Support Medical Necessity
Product Description Allowable Amount
Non Insulin Dependant
Allowable Amount
Insulin Dependant
249.00 - 249.91
SECONDARY DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, NOT STATED AS UNCONTROLLED, OR UNSPECIFIED - SECONDARY DIABETES MELLITUS WITH UNSPECIFIED COMPLICATION, UNCONTROLLED
250.00 - 250.93
DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED - DIABETES WITH UNSPECIFIED COMPLICATION, TYPE I [JUVENILE TYPE], UNCONTROLLED
Notes 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. 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.
Diabetic Supplies Guidelines
General Information For more information on local coverage determination
Local Coverage Determination (LCD) for Diabetic Supplies
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 written signed and dated order 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 order, 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 patient must meet all of the following basic criteria: 1. The patient has diabetes (ICD-9 codes 249.00-250.93) which is being treated by a physician; and 2. The glucose monitor and related accessories and supplies have been ordered by the physician who is treating the patient's diabetes and the treating physician maintains records reflecting the care provided including, but not limited to, evidence that the prescribed frequency of testing is reasonable and necessary; and 3. The patient (or the patient's caregiver) has successfully completed training or is scheduled to begin training in the use of the monitor, test strips, and lancing devices; and 4. The patient (or the patient's caregiver) is capable of using the test results to assure the patient's appropriate glycemic control; and 5. The device is designed for home use. For all glucose monitors and related accessories and supplies, if the basic coverage criteria (1)-(5) are not met, the items 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)-(5) are met and the treating physician certifies that the patient 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)-(5) are met and the treating physician certifies that the patient has an impairment of manual dexterity severe enough to require the use of this special monitoring system. Coverage of E2101 for patients 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)-(5) 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), spring powered devices for lancets (A4258), and replacement lens shield cartridge (A4257) for use with laser skin piercing device are covered for patients 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), lancets (A4259), and replacement lens shield cartridges (A4257) that are covered depends on the usual medical needs of the diabetic patient according to the following guidelines: For a patient who is not currently being treated with insulin injections, up to 100 test strips and up to 100 lancets or one lens shield cartridge every 3 months are covered if criteria (a)-(c) are met: For a patient who is currently being treated with insulin injections, up to 100 test strips and up to 100 lancets or one lens shield cartridge every month are covered if criteria (a)-(c) are met: For a patient who is not currently being treated with insulin injections, more than 100 test strips and more than 100 lancets or one lens shield cartridge every 3 months are covered if criteria (a)-(f) are met: For a patient who is currently being treated with insulin injections, more than 100 test strips and more than 100 lancets or one lens shield cartridge every month are covered if criteria (a)-(f) are met: a. Coverage criteria (1)-(5) listed above for a glucose monitor are met. b. The supplier of the test strips and lancets, or lens shield cartridge maintains in its records the order from the treating physician. c. The beneficiary has nearly exhausted the supply of test strips and lancets, or useful life of one lens shield cartridge previously dispensed. d. The treating physician has ordered a frequency of testing that exceeds the utilization guidelines and has documented in the patient's medical record the specific reason for the additional materials for that particular patient. e. The treating physician has seen the patient and has evaluated their diabetes control within 6 months prior to ordering quantities of strips and lancets, or lens shield cartridges that exceed the utilization guidelines. f. 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 patient is actually testing or a copy of the beneficiary's log) or in the supplier's records (e.g., a copy of the beneficiary's log) that the patient is actually testing at a frequency that corroborates the quantity of supplies that have been dispensed. If the patient is regularly using quantities of supplies that exceed the utilization guidelines, new documentation must be present at least every six months. If criteria (a)-(c) are not met, all testing supplies will be denied as not reasonable and necessary. If quantities of test strips, lancets or lens shield cartridges that exceed the utilization guidelines are provided and criteria (d)-(f) are not met, the amount in excess will be denied as not reasonable and necessary. For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products (A4233-A4236, A4253, A4256, A4258 and A5259) 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/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.
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 patient's medical records will reflect the need for the care provided. The patient'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. 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 billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code. The order for home blood glucose monitors and/or diabetic testing supplies must include all of the following elements: 1. All item(s) to be dispensed; 2. For test strips, the specific frequency of testing; 3. The treating physician's signature; 4. The date of the treating physician's signature; 5. A start date of the order - only required if the start date is different than the signature date. An order that only states "as needed" will result in those items being denied as not reasonable and necessary.
Refills
A routine refill prescription is not needed. A new prescription is needed when: • There is a change of supplier • There is a change in treating physician • 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 periodic prescription renewal For items that the patient obtains in person at a retail store, the signed delivery slip or copy of 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 • Quantity of each item that the beneficiary still has remaining This information must be kept on file and be available upon request. 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 patient 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 patient who is not treated with insulin injections. If the patient 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. Additional documentation requirements apply to: 1) a diabetic patient who is not insulin-treated (KS modifier present) and whose prescribed frequency of testing is more often than once per day, or 2) a diabetic patient who is insulin-treated (KX modifier present) and whose prescribed frequency of testing is more often than three times per day. When refills for quantities of supplies that exceed the utilization guidelines are dispensed, the documentation as described in criteria (d)-(f) in the Indications and Limitations of Coverage and/or Medical Necessity section must be available upon request. The medical necessity for E2100 or E2101 in a patient with impaired visual acuity must be documented by a narrative statement from the physician that must include the patient'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 patient’s medical record and available upon request. Similarly, claims for E2101 for patients with impaired manual dexterity must be documented by a narrative statement from the physician that includes an explanation of the patient'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 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. 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. Refer to the Supplier Manual for more information on documentation requirements.
For more information on local coverage determination
Local Coverage Determination (LCD) for Diabetic Supplies

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