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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 If the specimen was stored for more than 30 calendar days before testing, the specimen is considered to have been archived and the DOS of the test/service must be the date the specimen was obtained from storage.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 say that Medicare has specific coverage criteria for next generation sequencing:
Indications and Limitations of Coverage: B. 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 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.
D. Other 1. Somatic (Acquired) Cancer Effective for services performed on or after March 16, 2018, Medicare Administrative Contractors (MACs) may determine coverage of NGS as a diagnostic laboratory test for patients with advanced cancer only when the test is performed in a CLIA-certified laboratory, when ordered by a treating physician, and when the patient has: a. either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and, b. not been previously tested with the same test using NGS for the same cancer genetic content, and c. decided to seek further cancer treatment (e.g., therapeutic chemotherapy). 2. Germline (Inherited) Cancer Effective for services performed on or after January 27, 2020, MACs may determine coverage of NGS as a diagnostic laboratory test for patients with germline (inherited) cancer only when the test is performed in a CLIA-certified laboratory, when ordered by a treating physician, when results are provided to the treating physician for management of the patient and when the patient has: a. any cancer diagnosis; and, b. a clinical indication for germline (inherited) testing of hereditary cancers; and, c. a risk factor for germline (inherited) cancer; and, d. not been previously tested with the same germline test using NGS for the same germline genetic content.
You can find these rules in the Medicare National Coverage Determination (NCD) Next Generation Sequencing (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.