National Coverage Determination

ACLA warns proposed Medicare criteria will ‘impede’ access to genetic oncology testing
By Nick Paul Taylor
The American Clinical Laboratory Association (ACLA) has warned that draft Medicare coverage criteria “will impede patient access to appropriate genetic testing for oncology.”
October 6, 2023
Lab Test Tube Dna Blood Social
Natera’s Prospera Lung transplant assay approved for Medicare coverage
By LabPulse.com staff writers
The test will be covered under the Medicare Local Coverage Determination for Molecular Testing for Solid Organ Allograft Rejection for use in the surveillance setting in lung transplant patients.
August 17, 2023
Lung 3 D Social
CareDx lands Medicare coverage for heart transplant surveillance testing
By Nick Paul Taylor
The testing service, branded HeartCare, features AlloMap Heart and AlloSure Heart, both of which have individual Medicare coverage.
August 9, 2023
Cardiac Heart Eeg Social
CDC coronavirus test comes to labs | A closer look at payment policy | CRISPR drives diagnostics
By Emily Hayes
Dear LabPulse Member,
February 10, 2020
CMS broadens coverage for NGS tests in breast, ovarian cancers
By LabPulse.com staff writers
In a decision memo issued January 27, CMS announced that it will be covering NGS tests that are cleared or approved by the U.S. Food and Drug Administration (FDA) for some patients. The agency explained that its coverage determination applies to patients who have breast or ovarian cancer, as long as the patient has a risk factor or clinical indication for germline (inherited) breast or ovarian cancer and has not been previously tested with the same test for the same germline genetic content.
January 26, 2020
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Biennial stool screening on the table | Frightful discourse on genomic tests | Medicare opens wallet for sequencing | NIPT crackdown
By Emily Hayes
Dear LabPulse Member,
November 4, 2019
CMS plans broader coverage for NGS in breast, ovarian cancer
By Emily Hayes
The agency's review and terms and conditions on the matter were published on October 29 in a proposed national coverage determination (NCD). The agency advised coverage for next-generation sequencing with physician-ordered companion diagnostic tests approved or cleared by the U.S. Food and Drug Administration (FDA) and performed in a CLIA-certified lab. Patients must meet a range of conditions, according to CMS. They must have ovarian or breast cancer, have clinical indications for testing for hereditary cancer, and have never received a prior NGS test. Results will be provided to the treating physician.
October 29, 2019
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CMS opens review of NGS testing for hereditary cancer
By Brian Casey
CMS announced that it has begun a national coverage analysis (NCA) of next-generation sequencing for Medicare beneficiaries with advanced cancer. The NCA announcement triggers a 30-day comment period that will expire on May 29. The agency expects to issue a proposed decision memo on the topic by October 2019, with completion of the review in January 2020.
April 28, 2019
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