This coverage policy provides the following information:

  * defines tests required to register for a unique identifier
  * defines tests required to submit a complete technical assessment (TA) for coverage determination
  * defines the payment rules applied to covered tests that are not reported with specific codes from a code set recognized in 45 CFR 162.1002 (a)(5), and termed "HIPAA compliant code sets" throughout the remainder of this LCD
  * lists specific covered tests that have completed the registration and TA process and meet Medicare's reasonable and necessary criteria for coverage

Tests evaluated through the application process and/or technical assessment
will be reviewed to answer the following questions:

  * Is the test performed in the absence of clinical signs and symptoms of disease?
  * Will the test results provide the clinician with information that will improve patient outcomes and/or change physician care and treatment of the patient?
  * Will the test results confirm a diagnosis or known information?
  * Is the test performed to determine risk for developing a disease or condition?
  * Will risk assessment change management of the patient?
  * Is there a diagnosis specific indication to perform the test?
  * Is the test performed to measure the quality of a process or for Quality Control/Quality Assurance (QC/QA), i.e., a test to ensure a tissue specimen matches the patient?

_Molecular Diagnostic Test (MDT) Policy Specific Definitions_  
  
MDT: Any test that involves the detection or identification of nucleic acid(s)
deoxyribonucleic acid/ribonucleic acid (DNA/RNA), proteins, chromosomes,
enzymes, cancer chemotherapy sensitivity and/or other metabolite(s). The test
may or may not include multiple components. A MDT may consist of a single
mutation analysis/identification, and/or may or may not rely upon an algorithm
or other form of data evaluation/derivation.  
  
Laboratory developed test (LDT): Any test developed by a laboratory developed
without Food and Drug Administration (FDA) approval or clearance.  
  
 _Applicable Tests/Assays_  
  
In addition to the MDT definition, this coverage policy applies to all tests
that meet at least one of the following descriptions:

  * All non-FDA approved/cleared laboratory developed tests (LDT)
  * All modified FDA-approved/cleared kits/tests/assays
  * All tests/assays billed with more than one code from a HIPAA compliant code set to identify the service, including combinations of method-based, serology-based, and anatomic pathology codes
  * All tests that meet the first three bullets and are billed with a Not Otherwise Classified (NOC) code

_Unique Test Identifier Requirement_  
  
Because the available language in the current HIPAA compliant code sets used
to describe the pathology and laboratory categories and the tests included in
those categories are not specific to the actual test results provided, all MDT
services must include an identifier as additional claim documentation. Test
providers must receive an identifier specific to the applicable test and
submit the test assigned identifier with the claim for reimbursement. The
assigned identifier will provide a crosswalk between the test's associated
detail information on file and the submitted claim detail line(s) required to
adjudicate each test's claim. The unique identifier limits the need to submit
the required additional information about the test on each claim.  
  
 _Technology Assessments (TA)_  
  
Molecular Diagnostic Services Program (MolDX) will review all new test/assay
clinical information to determine if a test meets Medicare's reasonable and
necessary requirement. Labs must submit a comprehensive dossier on each new
test/assay prior to claim submission. MolDX will only cover and reimburse
tests that demonstrate analytical and clinical validity, and clinical utility
at a level that meets the Medicare reasonable and necessary requirement.  
  
_Payment Rules_  
  
MolDX will reimburse:

  * approved tests covered for dates of service consistent with the effective date of the coverage determination.

  
_Covered Tests_  
  
 **Please refer to the MolDX  website www.palmettogba.com/MolDX for covered
and excluded tests' specific coding and billing information.**  
  
For additional MolDX Program information, go to the Medicare home page
www.PalmettoGBA.com/MolDX.  
  
MolDX expects laboratory providers to follow test indications published by
the developer.