LEEDer Group Inc.
8508 North West 66th St.
Miami, Florida 33166 USA

Phone Toll-free: 866.814.0192
Fax Toll-free: 866.818.0373
E-mail Address: orders at LEEDerGroup.com

2010-05 Glucose Monitors and Supplies; Physician Letter

May 20, 2010

Glucose Monitors and Supplies Physician Letter

Dear Physician,

Glucose monitor supplies have consistently been one of the highest sources of errors in medical reviews performed by the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) and the Comprehensive Error Rate Testing (CERT) contractor. It is your responsibility as the ordering physician to determine and document the medical necessity for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) items. The following information is intended to provide you with guidance on Medicare’s coverage and documentation requirements for glucose monitors and testing supplies.

COVERAGE
Glucose monitors and related supplies are covered for patients with diabetes (ICD-9 Codes 249.00 – 250.93) if they or their caregiver can be trained to use the prescribed device appropriately.

The Glucose Monitors Local Coverage Determinations (LCDs) of the DME MACs define the quantity of test strips and lancets that are covered, if the basic criterion above is met.

Treatment regimen Basic coverage
Test strips and lancets Average testing
Insulin treated 100 per month 3x per day
Non-insulin treated 100 per 3 months 1x per day

Additional quantities of test strips can be considered for coverage if they are deemed medically necessary – see following section.

Coverage is also provided for a lancing device, calibration solution, and replacement batteries.

MEDICAL NECESSITY DOCUMENTATION
CMS expects that physician records will reflect the care provided to the patient including, but not limited to, evidence of the medical necessity for the prescribed frequency of testing. (Physicians are not required to fill out additional forms from suppliers or to provide additional information to suppliers unless specifically requested of the supplier by the DME MAC).

There are several critical issues to address in the patient’s medical record related to medical necessity for glucose testing supplies:

Basic coverage criteria for the glucose monitor and any related supplies; and,
If ordering quantities of test strips and lancets that exceed the quantities specified in the LCD:
Justification for testing frequency; and,
Evidence of the patient’s use of the testing supplies.
To satisfy the requirements for the basic coverage criteria, the patient’s medical record should provide information about the following elements:

Diagnosis
Treatment regimen (insulin treated versus non-insulin treated)
Education of the patient or caregiver on the use of the glucose monitor
To support coverage for quantities of supplies that exceed the limits specified in the LCD, there must be:

Documentation by the physician in the patient’s medical record of the necessity for the higher frequency of testing. This may include some of the following elements:
Names, dosages, and timing of administration of medications used to treat the diabetes;
Frequency and severity of symptoms related to hyperglycemia and/or hypoglycemia;
Review of beneficiary-maintained log of glucose testing values;
Changes in the patient’s treatment regimen as a result of glucose testing results review;
Dosage adjustments that the patient should make on their own based on self-testing results;
Laboratory tests indicating level of glycemic control (e.g., hemoglobin A1C);
Other therapeutic interventions and results.

Not every patient medical record will contain all of these elements; however, there must be enough information in the patient’s medical record to support the medical necessity for the quantity of item(s) ordered and dispensed.

Documentation by the beneficiary of the actual frequency of testing.
Logs of self-testing values including the date, time, and results
Information about medication dosage adjustments related to the results is also helpful.
ORDERS
There must be a written order for all testing supplies. The written order must contain the following elements:

Item(s) to be dispensed;
Frequency of testing (“as needed” is not acceptable);
Physician’s signature;
Signature date;
Start date of order – only required if start date is different than signature date.
A new order for diabetic testing supplies is required only if there is a change in the frequency of testing, a change in supplier, or a new treating physician.

Physicians should inspect these written confirmations carefully. Suppliers must not add unrelated items to the detailed written order, whether requested by the beneficiary or not, in the absence of a dispensing order from the physician for that item.

This article is only intended to be a general summary. It is not intended to take the place of the written law, regulations, national or local coverage determinations. The LCD for Glucose Monitors can be found in the Medicare Coverage Database on the CMS web site at& (search “Glucose Monitors”).

Sincerely,

Paul J. Hughes, M.D.
Medical Director, DME MAC, Jurisdiction A
NHIC, Corp.

Robert D. Hoover, Jr., MD, MPH, FACP
Medical Director, DME MAC, Jurisdiction C
CIGNA Government Services

Adrian M. Oleck, M.D.
Medical Director, DME MAC, Jurisdiction B
National Government Services Richard W. Whitten, MD, MBA, FACP
Medical Director, DME MAC, Jurisdiction D
Noridian Administrative Services