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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 Covered Indications: 
 
1. GERMLINE (HEREDITARY) MUTATIONS 
 
Medicare considers genetic testing medically necessary to establish a molecular diagnosis of an inheritable 
disease when all of the following criteria are met: 
 
    The beneficiary must display clinical features of an associated disease, but noting that coverage of molecular 
testing for carrier status or family studies is considered screening and is statutorily excluded from coverage; 
and 
    The result of the test will directly impact the treatment being delivered to the beneficiary; and 
    A definitive diagnosis remains uncertain after history, physical examination, pedigree analysis, genetic 
counseling, and completion of conventional diagnostic studies. 
 
Note: The following two germline hereditary mutation tests will be considered medically reasonable and 
necessary when performed for evaluation of venous thromboembolism. Refer to ICD-10 Code Group 3 in the 
related Local Coverage Article: Billing and Coding: Biomarkers Overview A56541. 
 
    Factor II (F2 gene) 
    Factor V (F5 gene) 
 * While not required for payment, NCCN Guidelines recommend referral to a cancer genetics professional with 
expertise and experience in cancer genetics prior to genetic testing and after genetic testing. Examples of 
cancer genetics professionals with expertise and experience in cancer genetics include: an American Board of 
Medical Genetics or American Board of Genetic Counseling certified or board eligible Clinical Geneticist, 
Medical Geneticist or Genetic Counselor not employed by a commercial genetic testing laboratory (excludes 
individuals employed by or contracted with a laboratory that is part of an Integrated Health System which 
routinely delivers health care services beyond just the laboratory test itself as these individuals are also 
considered independent); medical oncologist, obstetrician-gynecologist or other physician trained in medical 
cancer genetics, a genetic nurse credentialed as either a Genetic Clinical Nurse or an Advanced Practice Nurse 
in Genetics by either the Genetic Nursing Credentialing Commission (GNCC) or the American Nurses 
Credentialing Center (ANCC) who is not employed by a commercial genetic testing laboratory (excludes 
individuals employed by or contracted with a laboratory that is part of an Integrated Health System which 
routinely delivers health care services beyond just the laboratory test itself as these individuals are also 
considered independent). 
 
2. SOMATIC MUTATIONS, ONCOLOGY: 
 
    Please Refer to LCD L35396, Biomarkers for Oncology. 
 
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. You can find this 
information in Medicare's Local Coverage Determination (LCD): Biomarkers Overview (L35062). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.