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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 date of service (DOS) policy for either a clinical laboratory test or the technical component of physician
pathology service is as follows: General Rule: The DOS of the test/service must be the date the specimen was
collected. Variation: If a specimen is collected over a period that spans two calendar days, then the DOS must
be the date the collection ended. Exceptions: The following three exceptions apply to the DOS policy for either
a clinical laboratory test or the technical component of physician pathology service: A. DOS for Tests/Services
Performed on Stored Specimens: In the case of a test/service performed on a stored specimen, if a specimen
was stored for less than or equal to 30 calendar days from the date it was collected, the DOS of the test/service
must be the date the test/service was performed only if: - The test/service is ordered by the patient's physician
at least 14 days following the date of the patient's discharge from the hospital; - The specimen was collected
while the patient was undergoing a hospital surgical procedure; - It would be medically inappropriate to have
collected the sample other than during the hospital procedure for which the patient was admitted; - The results
of the test/service do not guide treatment provided during the hospital stay; and - The test/service was
reasonable and medically necessary for treatment of an illness. If the specimen was stored for more than 30
calendar days before testing, the specimen is considered to have been archived and the DOS of the test/service
must be the date the specimen was obtained from storage. You can find this in the Medicare Claims Processing
Manual Chapter 16 under Laboratory Services, section 40.8, Date of Service (DOS) for Clinical Laboratory
and Pathology Specimens.
The rules also say that certain data elements are required. Any claim with incomplete, missing, or invalid
information for all these elements may be returned as un-processable. You can find this rule in the Medicare
Claims Processing Manual, Chapter 1, Section 80.3.1.
The rules state that when completing the 1500 claim form, providers must enter the correct Place of Service
(POS) code in section 24B. Invalid or incorrect POS codes will be denied and returned to the provider. You
can find this rule at Medicare Claims Processing Manual Ch. 26 Section 10.6.
The rules state for next generation sequencing, below are the Nationally Covered Indications:
1. Somatic (Acquired) Cancer
Effective for services performed on or after March 16, 2018, the Centers for Medicare & Medicaid Services
(CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable
and necessary and covered nationally, when performed in a Clinical Laboratory Improvement Amendments
(CLIA)-certified laboratory, when ordered by a treating physician, and when all of the following requirements
are met:
a. Patient has:
i. either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and
ii. not been previously tested with the same test using NGS for the same cancer genetic content, and
iii. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
b. The diagnostic laboratory test using NGS must have:
i. Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic;
and,
ii. an FDA-approved or -cleared indication for use in that patient's cancer; and,
iii. results provided to the treating physician for management of the patient using a report template to
specify treatment options.
2. Germline (Inherited) Cancer
Effective for services performed on or after January 27, 2020, CMS has determined that NGS as a diagnostic
laboratory test is reasonable and necessary and covered nationally for patients with germline (inherited) cancer,
when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the
following requirements are met:
a. Patient has:
i. ovarian or breast cancer; and,
ii. a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and,
iii. a risk factor for germline (inherited) breast or ovarian cancer; and
iv. not been previously tested with the same germline test using NGS for the same germline genetic
content.
b. The diagnostic laboratory test using NGS must have all of the following:
i. FDA-approval or clearance; and,
ii. results provided to the treating physician for management of the patient using a report template to
specify treatment options.
C. Nationally Non-Covered Indications
1. Somatic (Acquired) Cancer
Effective for services performed on or after March 16, 2018, NGS as a diagnostic laboratory test for patients
with acquired (somatic) cancer are non-covered if the cancer patient does not meet the criteria noted in section
B.1., above.
You can find the Medicare National Coverage Determination (NCD) Next Generation Sequencing (NGS)
90.2
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.