Ann: Clarification of Novitas Timeline, page-5

Well, thats that then:

The responses to comments are here, A59417:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59417&ver=17

The FINAL LCD, L39365 2023, is HERE:

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39365&ver=80

The billing and coding article is here, A59125:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59125&ver=26

Tier 2 Codes Handled?

Novitas has paid out a billion dollars in the last couple years for Tier 2 codes, at least a good part of which, to labs indicted or pled guilty in court. In this billing article, only 2 Tier 2 81408 genes are eligible for coverage, ataxia telangiectasia and neurofibromatosis, and folks requiring either of this two genes will be rare as hen's teeth in the nursing homes of Texas and Florida.

I don't see (by search) a reference to 81493, the CardioDx test I recently wrote about. It doesn't seem to be in Group 1, where it had been. I'll keep looking. It might be dropped for being a "proteomic" test.

BILLING & CODING, A59125, 283 pages.

LCD, L39365, 68 pages.

Response to Comments, A59417, 44 pages.

Large Changes in Content

The increase in LCD content, about 14 to 68 pages or 5X, means that much of the text that is now effective on July 13, 2023, was not prior reviewed by the public or commented on by the public.

My own draft-to-final comparison or redline is in the cloud here.

Not Medically Necessary

This section of the LCD is clipped and pasted below.

Limitations. The following are considered not medically reasonable and necessary:

• A genetic test with unestablished analytical validity, clinical validity, and/or clinical utility.
• Interventions with levels of evidence not identified by ClinGen24, NCCN25, or OncoKB26 as demonstrating actionability in clinical decision making OR interventions that are non-covered per MAC review.
• Genetic testing in patients who do not have either an established diagnosis of cancer or substantiated suspicion of cancer as determined by a clinical evaluation and abnormal results (cancer or suspicious for cancer) from histologic, cytologic, and/or flow cytometric examination. (Except where otherwise specified in the Covered Indications as reasonable and necessary) (See SSA Section 1862(a)(1)(A))
• Genetic testing of asymptomatic patients for the purposes of screening the patient or their relatives. (See SSA Section 1862(a)(1)(A))
• Repetitions of the same genetic test on the same genetic material. (see Medicare NCCI Policy Manual, Chapter 10, Section A Introduction)
• DecisionDx-Melanoma*
• DecisionDx-SCC*
• UroVysion fluorescence in situ hybridization (FISH)*
• Cxbladder Detect*
• Enhanced Cxbladder Detect*
• Cxbladder Monitor*
• Cxbladder Triage*
• Enhanced Cxbladder Triage*
• Cxbladder Resolve*
• Colvera*
• PancreaSeq Genomic Classifier*
• PancraGEN*
• ThyroSeq CRC*