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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 that molecular pathology procedures (Tier1 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) of analytical
validity and clinical utility; AND
- Results of the testing must directly impact treatment or management of the Medicare 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 obtain necessary information for therapeutic decision making; 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.) Exceptions include clinical scenarios
whereby repeat testing of somatically acquired mutations (for example, pre- and post- therapy) may be required
to inform appropriate therapeutic decision-making.

Limitations:

- Any procedures required prior to cell lysis 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.
- The medically necessary interpretation and report of a molecular pathology test, written by a pathologist,
which is above and beyond the report of standard laboratory results may not be reported by Non- physician
practitioners (e.g., PhD, scientists etc.); only physicians are eligible to report this service.
- Testing for quality assurance component of the service is not separately billable.

You can find this information in the Local Coverage Determination (LCD): Molecular Pathology Procedures
(L35000)

If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.

The Plan contract says that the Plan covers items and services in accordance with Medicare rules.