**Notice** : It is not appropriate to bill Medicare for services that are not
covered (as described by this entire LCD) as if they are covered. When billing
for non-covered services, use the appropriate modifier.

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

**History/Background and/or General Information**

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 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 acceptable documentation for a
covered laboratory service. A glucose monitoring laboratory service must be
performed in accordance with laboratory service coverage criteria including
the order and clear use of a laboratory result prior to a similar subsequent
laboratory order to qualify for separate payment under the Medicare laboratory
benefit.

Please note there are some specific relevant Medicare requirements with
respect to glucose monitoring. Medicare Part B may pay for a glucose
monitoring device and related disposable supplies under its 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 Skilled Nursing Facility (SNF) is not
considered a home under this benefit (Section 1861(h) of the Social Security
Act, 42 CFR 410.38). Routine glucose monitoring of diabetics is never covered
in an 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.

**Limitations**

The following are the pertinent laboratory tests for which frequency
limitations will be specified, noting that lipid, thyroid, glycated
hemoglobin/glycated protein, and glucose testing frequencies apply to analytes
from the laboratory National Coverage Determination (NCD) via negotiated
rulemaking:

  * Lipids
  * Thyroid testing
  * Glucose testing
  * Glycated hemoglobin/glycated protein

This LCD imposes frequency limitations. For frequency limitations please refer
to the Utilization Guidelines section below.

**Notice** : Services performed for any given diagnosis must meet all of the
indications and limitations stated in this policy, the general requirements
for medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.
Refer to Billing and Coding: Frequency of Laboratory Tests, A56420, for
applicable CPT codes and diagnosis codes.

The redetermination process may be utilized for consideration of services
performed outside of the reasonable and necessary requirements of this LCD.