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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 screening tests are excluded from coverage. The only exceptions are for the following
services:
1. screening mammography,
2. colorectal cancer screening tests,
3. screening pelvic exams,
4. prostate cancer screening tests,
5. glaucoma screening exams,
6. ultrasound screening for abdominal aortic aneurysms (AAA),
7. cardiovascular disease screening tests,
8. diabetes screening tests, and
9. screening electrocardiograms, and
10. certain other testing recommended by the United States Preventive Services Task Force and approved by
the Centers for Medicare and Medicaid Service.
You can find this rule at 42 CFR Section 411.15(a)(1) and 42 CFR Section 410.64.
Medicare coverage for screening of those individuals with a family history of certain disease is covered only
for a limited number of services as listed in the Section 280 - Preventative and Screening Services of the IOM
100-02, Medicare Benefit Policy Manual, Chapter 15.
Tests performed without relationship to treatment or diagnosis of a patient with no findings or history for a
specific illness, symptom, complaint or injury unless set exclusion are so noted in Title 42 CFR, Section
411.15(a)(1).
Local Medicare coverage of such biomarkers must be predicated upon three fundamental principles:
First, there must be an underlying performance of acceptable, high-quality analytical validity for all such
laboratory testing. As a result, the laboratory shall have available upon request: - Analytical and clinical validation reports for Clinical Laboratory Improvement Amendments (CLIA),
including the test description, intended use, and indications for testing.
- If applicable, all formal, written minutes and correspondences (including any Q & A and supporting
documentation) with the New York State Department of Health (NYSDOH) or the US Food and Drug
Administration (FDA).
- Most recent inspection results (including recommendations) or scheduled inspection(s) from CLIA, College
of American Pathologists (CAP), or NYSDOH, as applicable.
Second, there must be an appreciation of evidence-in-transition where new biomarkers should be brought online
in harmonization with their proven clinical validity/utility (CVU). Although analytical validity is an
equally important metric, it remains more outside of a payer's purview to conduct such detailed evaluations.
Therefore, in the absence of a standard CVU referee process (e.g., although FDA labeling of biomarkers can be
a helpful adjunct, it may not always be relevant), the key imperative is for medical necessity to be reflected by
the clear articulation of a particular biomarker niche.
Third, there must be a recognized decision impact of such biomarkers by the clinical community. In other
words, there must be acceptance/uptake of specific testing into patient management. It should be taken into
account that to reach the medical necessity threshold, such acceptance should be based on the strongest
evidence available, ideally from along the spectrum of high-quality masked, randomized controlled clinical
trials, and much less preferably from lower levels of evidence, which are predicated upon expert opinion only
without primary study data. You can find this information in the Local Coverage Determination (LCD):
Biomarkers Overview (L35062).
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.