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 Noridian website for specific coding and billing
information for services addressed in MolDX . **  
  
**Other tests/assays may be addressed by separate Noridian policy. In
addition,  the CPT codes listed under Group 1 are addressed in the MolDX**
**program. If a test is not linked below under Related Local Coverage
Documents, it may be addressed under separate Noridian policy or it has not
been approved for coverage as it has either not been vetted by the MolDX** 
**contractor or has been found to be considered statutorily excluded.**  
  
For additional MolDX Program information, go to the Noridian Medicare home
page at noridianmedicare.com and select MolDX under the Policies Tab.  
  
MolDX expects laboratory providers to follow test indications published by
the developer.