Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1862(a)(7).  This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

CMS Medicare Benefit Policy Manual, Chapter 15, Section 80.1 and 80.6, and Section 1833 and 1861 of the Social Security Act provide for payment of clinical laboratory services under Medicare Part B, when in keeping with the requirements under Section 80.6 for ordering and following orders for diagnostic tests.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

Blood glucose determination may be done using whole blood, serum or plasma. It may be sampled by capillary puncture, as in the fingerstick method, or by vein puncture or arterial sampling. Meter assay of whole blood acquired through a finger stick using a device approved for home monitoring allows a patient to have access to blood glucose values on a digital display in a minute or less and has become a standard of care for control of blood glucose, even in the inpatient setting.

Routine glucose monitoring of diabetics is never covered in a SNF, whether the beneficiary is in a covered Part A stay or not. Glucose monitoring may only be covered when it meets all the conditions of a covered laboratory service including use by the physician in modifying the patient's treatment.

Medicare pays for a blood glucose test only when the service meets all of the conditions of payment for a test payable under the clinical laboratory fee schedule including that the test must be ordered by the physician who is treating the beneficiary and the physician must use the results in the management of the beneficiary’s specific medical condition. For payment to be made for a blood glucose test under Medicare Part B, a physician must certify that each test is medically necessary and that a standing order for many tests over a time period is not sufficient documentation.

Repeated performance of finger-stick blood glucose tests to maintain standing orders for insulin injection or oral hypoglycemic agents does not meet the criteria for Part B payment in a SNF. Payment for nursing care glucose monitoring is encompassed under Medicare Part A and other payment methods. If the patient is in a skilled nursing facility, routine glucose monitoring (including any tests which are not promptly reported) is a part of routine personal care and is not a separately billed procedure (PM AB-00-108, December 2000).

The home glucose monitoring device is on the list of instruments that can be administered by providers registered under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), including providers registered with only a certificate of waiver. However, Medicare Part B may only pay for a glucose monitoring device and related disposable supplies under the durable medical equipment benefit if the equipment is used in the home or in an institution that is used as a home. A hospital or SNF is not considered a home under the SSA, Sect. 1861 (h).

Blood glucose values are often necessary for the management of patients with diabetes mellitus, where hyperglycemia and hypoglycemia are often present. They are also critical in the determination of control of blood glucose levels in the patient with impaired fasting glucose, the patient with insulin resistance syndrome and/or carbohydrate intolerance (excessive rise in glucose following ingestion of glucose or glucose sources of food), in the patient with a hypoglycemia disorder such as insulinoma, and in patients with a catabolic or malnourished state. In addition to those conditions already listed, glucose testing may be medically necessary in patients with tuberculosis, unexplained chronic or recurrent infections, alcoholism, coronary artery disease (especially in women), or unexplained skin conditions (including pruritis, local skin infections, ulceration and gangrene without an established cause).

Many medical conditions may be a consequence of a sustained elevated or depressed glucose level. These include comas, seizures or epilepsy, confusion, abnormal hunger, abnormal weight loss or gain, and loss of sensation. Evaluation of glucose may also be indicated in patients on medications known to affect carbohydrate metabolism.

The frequency of monitoring of blood glucose values should be determined by the physician on an individual basis while considering and documenting any of the following factors that affect glycemic control:

• Variations and degree of glycemic control as documented by hemoglobin A1C levels
• Treatment with insulin versus oral agents
• Frequency of symptoms of hypoglycemia
• Frequency of prior adjustments in therapy
• Motivation/ability for self-care and the presence of limitations such as language barriers and mental illness
• Presence of diabetic complications

Patients who have exhibited long-term control of blood glucose levels as evidenced by normal (per reference laboratory range) or steady A1C levels over a 6 month period, minimal or no changes in diabetic therapy, OR no complications of diabetes mellitus (to include retinopathy, neuropathy, or diabetic renal or vascular complications) do not require frequent blood glucose monitoring.

CMS Transmittal 80, Change Request 5743 of January 11, 2008, in keeping with the Medicare Benefit Policy Manual, Chapter 15, 80.1, states "Clinical laboratory services must be ordered and used promptly by the physician who is treating the beneficiary as described in 42 CFR 410.32(a), or by a qualified non physician practitioner, as described in 42 CFR 410.31(a)(3).

Sections 42 CFR 410.32 and 411.15 specify that for a laboratory service to be reasonable and necessary, it must not only be ordered by the physician but the ordering physician must also use the result in the management of the beneficiary's specific medical problem. Implicitly, the laboratory result must be reported to the physician promptly in order for the physician to use the result and instruct continuation or modification of patient care; this includes the physician's order for another laboratory service. Compliance program guidance for laboratory services sets forth conditions under which a physician's order for a repeat laboratory service can qualify as an order for another covered laboratory service. A standing order is not usually acceptable documentation for a covered laboratory service.

Any laboratory study ordered on a continuing basis without a cutoff time frame and without documentation in the medical record supporting that any previously ordered study was evaluated, will be considered a standing order and therefore, not reimbursable. Examples of acceptable time frames are as follows: daily times 3 days, BID times 2 days, weekly FBS times 2 weeks.

It should be noted that this policy does not prohibit a nursing home's Medical Director from authorizing services or procedures in emergency situations in a manner consistent with the Medical Director's obligations under state or federal law. In such instances, however, there must be documentation as to why the circumstances warrant intervention into the attending physician's role of caring for the patient.

As stated above, for a laboratory test to be covered, the result must be reported to the physician promptly in order for the physician to use the result and instruct continuation or modification of patient care. The following are time frames for use in reporting the results of blood glucose testing “promptly” to the physician.

Effective January 1, 2005, the Medicare law expanded coverage to diabetic screening services. Some forms of blood glucose testing covered under this national coverage determination may be covered for screening purposes subject to specified frequencies. See 42 CFR 410.18 and section 90, chapter 18, of the Claims Processing Manual, for a full description of this screening benefit.

Reporting Abnormal Blood Glucose Results

When reporting the abnormal values listed below, the time frame in which the blood glucose result must be reported to the physician is dictated by that result.

When blood glucose values are 60-90 mg/dl or 160-299 mg/dl (high), the physician must be notified of the results within 12 hours.

When blood glucose values are below 60 mg/dl (low) or over 300 mg/dl (high), the physician must be notified of the results immediately.

The above timeframes are appropriate for most patients. Depending on patient history and circumstances, shorter time frames may be clinically warranted.

When reporting an abnormal blood glucose value to the physician, the previous two or more results, as appropriate, should also be provided for trending purposes.

Documentation must delineate when the result was obtained, time of physician contact, and the resultant management of the beneficiary’s specific medical condition based on the glucose value(s) and report, by the physician.

Reporting Blood Glucose Results within Normal Limits

In the absence of abnormal blood glucose results, the condition of the patient dictates the time frame for physician notification. The physician should be provided with a trending report consisting of the appropriate number of blood glucose values based on the frequency of monitoring.

Patient Category Timeframes for reporting to physician

Category A:

Blood glucose results must be reported to the physician within 12 hours for patients who have documented:

1. unstable diabetes mellitus with or without unstable glucose levels and are at risk for alterations in glucose levels, OR

2. fingerstick glucose monitoring performed at least two (2) times per day.

Category B:

Blood glucose results must be reported to the physician within 24 hours for patients who have documented:

1. diabetes mellitus which is not completely stable and are at some risk for alterations in glucose levels, although with less probability and/or lower magnitude of fluctuations, OR

2. fingerstick glucose monitoring performed less than two (2) times per day.

Documentation for either category must delineate when the result was obtained, time of physician contact, and the resultant management of the beneficiary’s specific medical condition based on the glucose value(s) and report, by the physician.

In addition, all other criteria for coverage as delineated in this LCD and Medicare regulations must be satisfied.

Limitations

Blood glucose measurements without prompt physician notification as outlined above are not covered as diagnostic laboratory tests.

It is the provider's responsibility to select codes carried out to the highest level of specificity and selected from the ICD-9-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.

ICD-9 codes that support Medical Necessity are per the NCD for Blood Glucose Testing (190.20) which can be accessed at:

http://www.cms.hhs.gov/mcd/index_section.asp?ncd_sections=40 

or via the CMS Coverage Center at:

http://www.cms.hhs.gov/center/coverage.asp