In June 2014, the MOLDX program (which has its own website, here) published several guidance documents for labs submitting new-test dossiers and publications for coverage decisions.
In addition, the MOLDX program published an innovative draft LCD (DL35368) providing coverage for the MDxHealth test ConfirmMDX. ConfirmDX helps rules out the need for repeat biopsies in cases of potential prostate cancer.
Links and more after the break.
The three new coverage & submission guidance documents have their own webpage, here.
I have also put the PDF bundle of the three guidance documents and the coverage-with-evidence LCD at a cloud archive here. However, note that the documents might be regularly updated on the live MOLDX website.
[Update August 13, 2014]. Finally, I also provide the major MOLDX webpages, new July 2014 guidance documents, MOLDX Q&A, the MOLDX Program Guide, all strung together in one 59 page PDF with a table of contents, updated as of their website on 8/10/2014 - Here.
The Coverage Guidance Documents
In brief, the Palmetto guidance documents include:
- (A) A twelve page PDF, mostly text, but with several elaborate flowcharts, offering a roadmap to their coverage decision process. This is "CTEP," the MolDX Clinical Test Evaluation Process. There are several fast-track lanes, such as when a combination diagnostic is approved with a drug in an FDA trial, or when a diagnostic is strongly endorsed by a major national association. Absent those two fast track pathways, a test enters a detailed dossier review based on the three-step EGAPP process (analytical validity, clinical validity, clinical utility.)
- (B) A detailed table that provides guidelines for evidence and data, such as by reference external sources such as Clinical and Laboratory Standards Institute (CLSI) guidelines.
- (C) A detailed data submission checklist, with 31 checkboxes in 10 categories. (19 of the checkboxes are in the analytical validity subsection).
A Molecular Test Covered, Conditioned on Evidence Development
In brief, the draft LCD DL35368 (CMS website here, my cloud archive here) provides coverage of the ConfirmMDX test. The LCD first describes the test and then provides "coverage with data development" (very similar to coverage with evidence development or similar controlled entry programs) for the test.
ConfirmMDX addresses patients with the dilemma that they have abnormal lab findings but a direct prostate biopsy was initially negative. Per reported data, 40% of such patients come to a repeat biopsy, but in early experience, cited in the LCD, only 4% of patients require this when the ConfirmMDX test is inserted in the care pathway.
MOLDX appears to be covering the test for patients actually enrolled in a new trial, PASCUAL, and also for similar patients who are not literally enrolled in the trial, as long as they are treated by PASCUAL-accredited providers and managed under clinical follow up similarly to the trial participants. (Another way of saying this - the federal Medicare coverage is not conditional on the patient's decision to consent or not, to the company's trial enrollment.)
Palmetto Releases Two Additional MOLDX LCDs
Palmetto also released two additional MOLDX LCD's the week of June 23. One provides coverage for the Biotheranostics breast cancer prognostic test, BCI (Breast Cancer Index; LCD here) and one provides coverage for the AssureRx gene panel test that is predictive of response and non response for several dozen drugs in psychiatry illness (GeneSight; LCD here.)