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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 
411.15(o). 
 
The rules say Limitations 
 
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. 
 
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. 
 
You can find this information in Medicare's Local Coverage Determination (LCD): Frequency of Laboratory 
Tests (L35099). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.