What genomic tests/panels/NGS are actually reimbursed and by whom?

Discussion in 'Laboratory/Diagnostic Sales - Managed Care and Rei' started by anonymous, Jul 23, 2015 at 10:32 PM.

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  1. anonymous

    anonymous Guest

    It seems like all these tests are generic and generally get a NO answer from payers. is that everyone's experience? Among private payers, who is reimbursing for this genomic stuff, like the NGS panels? All they can do really, is send you to a clinical trial, maybe. It's not like any treatment is going to change today because of them, correct? Is it all out of pocket?
     

  2. anonymous

    anonymous Guest

    Only Medicare and Workers comp pay these, and they do that because they are unorganized and stupid. Where the technology exists now, these tests have no clinical value and doctors who routinely order them are jeopardizing their in-network status with insurers. I know a physician that ordered one for all of his Medicare patients and received a warning letter from Medicare.
     
  3. anonymous

    anonymous Guest

    Its difficult to understand what you are referring to in terms of NGS. NGS is a technology and not specific to any one specialty or disease. NGS is used with hereditary cancers, prenatal genetics, personalized (somatic) oncology disease and many other genetic issues across a broad list of specialities.

    Ideally, they most common places you see them in the medical community today is prenatal genetics, hereditary cancers and somatic cancers.

    Both Hereditary and somatic cancers have a great deal of utilization for NGS panels. The issue or concern is around the bioinformatics that are used to determine the actionable clinical information. In terms of hereditary cancers, you are able to do more genes, lower costs and faster work flow to incorporate more at-risk patients/suspected genes. This can come with significant or marginal clinical utilization.

    In terms of prenatal genetics, there are some places the technology is utilized, but a large portion is still supposed to be done on genotyping. However, for faster TAT and lower costs some companies are doing biologic blinding. Some labs use NGS platforms blind everything except the areas of interest...essentially making this a genotype test but done on NGS technology. This is definitely actionable, but to be done as full sequencing isn't clinical accepted...yet.

    Finally, somatic cancers and personalized medicines are very common for NGS. There a great deal of information that can be used or clinical utilization and useful ancillary data. Again its usefulness and actionability come down more to the bioinformatics that company developed and less on the technology used. (Anyone can use NGS and new labs are popping up everyday, NGS is more cost effective and many come with generic information to utilize but is lacking true clinical insight.)

    As for reimbursement typically they reimburse for the guideline mutations of genes. Examples would be EGFR/ALK/ROS1/KRAS etc (for Lung), KRAS/NRAS/BRAF, (CRC), BRAF, KIT etc (For Melanoma)..there are many more examples across many disease states.

    There are other situations and guidelines, but these can be done by PCR or NGS. Some can't be done by NGS (and be reimbursed) b/c the FDA approval (medication, treatment) designates the mutation done by a specific technology. Ideally, the reimbursement revolves around the mutations that have FDA approved therapies or Lack of Response/Resistance evidence. There are ever emerging mutations and as the data proves new mutations and clinical data the reimbursement will follow, but outside the founded FDA approved therapies or resistance mutations there won't be any additional reimbursement.

    Hopefully this gets to the meat of what you are looking to address, but this arena is ever expanded. The most successful labs will be those that utilizing the best bioinformatics for clinical purposes and those companies that leverage their insurance coverages.
     
  4. anonymous

    anonymous Guest


    This obviously proves you have no idea what your talking about. NGS panels provide great insight to FDA approved therapy (based on the results) resistance patterns, contraindications companion diagnostics for biologics, etc. There are some panels that are more for "research" purposes but it really comes down to the bioinformatics the lab uses to provide information. Yes, clinical trial eligibility is one thing that can be provided but not all these tests are science projects. Many provide additional info and avoid reflex cascades many of us face in an oncology setting. Your comment above either proves A) you don't know what you're talking about and/or B) You are part of a big box lab and have no idea how to sell clinically.