Compliance with the provisions in this LCD may be monitored and addressed
through post payment data analysis and subsequent medical review audits.  
  
 **History/Background and/or General Information**

Molecular pathology procedures have broad clinical and research applications.
The following examples of applications may not be relevant to a beneficiary or
may not meet a benefit category and/or reasonable and necessary threshold for
coverage. Such examples include Genetic Testing and Genetic Counseling (when
applicable) for:

  * Disease Risk,
  * Carrier Screening,
  * Hereditary Cancer Syndromes,
  * Gene Expression Profiling for certain cancers,
  * Prenatal Diagnostic testing, and
  * Diagnosis and Monitoring Non-Cancer Indications 

For guidelines regarding laboratory services, please refer to 42 CFR part 493
- Laboratory Requirements.

For guidelines regarding orders for clinical laboratory services, please refer
to 42 CFR 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and
other diagnostic tests: Conditions.

For guidelines regarding orders for diagnostic tests, please refer to CMS IOM
Publication 100-02, _Medicare Benefit Policy Manual_ , Chapter 15, Section
80.6 Requirements for Ordering and Following Orders for Diagnostic Tests.

Many applications of the molecular pathology procedures are not covered
services given lack of benefit category (preventive service) and/or failure to
reach the reasonable and necessary threshold for coverage (based on quality of
clinical evidence and strength of recommendation). Furthermore, payment of
claims in the past (based on stacking codes) or in the future (based on the
new code series) is not a statement of coverage since the service was not
audited for compliance with program requirements and documentation supporting
the reasonable and necessary testing for the beneficiary. Certain molecular
pathology procedures may be subject to prepayment medical review (records
requested) and paid claims must be supportable, if selected, for post payment
audit. Molecular pathology tests for diseases or conditions that manifest
severe signs or symptoms in newborns and in early childhood or that result in
early death (e.g., Canavan disease) could be subject to automatic denials
since these tests are not usually relevant to a beneficiary.

**Covered Indications**

Molecular pathology procedures (Tier 1 and Tier 2) may be eligible for
coverage when **ALL** of the following criteria are met:

  * Alternative laboratory or clinical tests to definitively diagnose the disorder/identify the condition are unavailable or results are clearly equivocal; AND
  * Availability of a clinically valid test, based on published peer reviewed medical literature; AND 
  * Testing assay(s) are Food and Drug Administration (FDA) approved/cleared or if LDT (lab developed test) or LDT protocol or FDA modified test(s) the laboratory documentation should support assay(s) analytical validity and clinical utility; AND 
  * Results of the testing must directly impact treatment or management of the beneficiary; AND 
  * For testing panels, including but not limited to, multiple genes or multiple conditions, and in cases where a tiered approach/method is clinically available, testing would be covered ONLY for the number of genes or test that are reasonable and necessary to establish a diagnosis; AND 
  * Individual has not previously received genetic testing for the disease/condition. (In general, diagnostic genetic testing for a disease should be performed once in a lifetime.)

**Limitations  
  
** The following are considered not medically reasonable and necessary:

  1. Any procedures required prior to cell lysis (e.g., microdissection) should be reported separately and utilization must be clearly supported based on the application and clinical utility. Such claims may be subject to prepayment medical review. 
  2. For testing for quality assurance please refer to NCCI Policy Manual for Medicare Services, Chapter 10, Pathology/Laboratory Services.
  3. Screening services such as pre-symptomatic genetic tests and services used to detect an undiagnosed disease or disease predisposition are not a benefit and are not covered. Similarly, the costs of tests/examinations that assess the risk of a condition unless the risk assessment clearly and directly effects the management of the patient may not be reimbursed.
  4. A specific genetic test may only be performed once in a lifetime per beneficiary for inherited conditions; however, when medically reasonable and necessary, genetic testing may be done on acquired conditions such as malignancies (including separate malignancies developing at different times) as they are treated and are being followed, in order to assess response or other relevant clinical criteria. Likewise, there are situations where medical record and literature documentation are able to demonstrate that serial testing can be reasonably predicted to provide additional clinically useful information. When the record documents that this information, such as confirmed significant response to current therapy, is likely to assist in modifying treatment, serial testing can be considered reasonable and necessary and eligible for coverage.