AMP Policy Memo to Hill
(January 5, 2015)
In December 2014, the "21st Century Cures" workgroup (21CC) of the House Ways and Means Committee issued a multfaceted request for comments on the FDA's potential regulation of LDTs. AMP responded with a 14 page public letter to 21CC, online here. AMP concludes that there is an urgent need to reform the FDA regulation of molecular IVD test kits and an equal need to address adverse Medicare coverage and reimbursement policies. AMP supports modernizing the CLIA program for review of advanced molecular diagnostic procedures.
AMP White Paper: The Perfect Storm
(January 8, 2015)
Aligned with its conclusions presented to 21CC, AMP released a 16 page white paper (here), and press release here, on the "perfect storm" of regulatory and reimbursement challenges to molecular diagnostics. Authors span membership of the AMP's Clinical Practice, Professional Relations, and Economic Affairs committees.
AMP Weighs in on FDA LDT Proposals
(February 2, 2015)
Last fall, the FDA released its extensive guidance on a wide ranging plan to regulate laboratory-developed tests. The AMP's 23-page response, at the end of the three month comment period, is online here (press release, here.)
AMP Position Statement on Direct to Consumer Genetic Testing
(February 10, 2015)
In November 2013, a flurry of news reports informed us that FDA wanted 23andMe to immediate stop its DNA testing service (e.g. Bloomberg here, November 25, 2013; FDA letter online here.) Test offerings were stopped, by December 6, 2013 (here). By summer 2014, there were reports that 23andMe was actively submitting review data to the FDA (here). In February 2015, a couple weeks after this AMP position statement, FDA approved a first DTC genetic test from 23andMe (here).
With a two-page position statement and a press release (here and here), AMP softened its 2007 position that all genetic testing should be available only through a physician. AMP notes that DTC genetic testing represents an ongoing "paradigm shift," and "appear[s] to be a permanent sector of the healthcare environment." AMP segregates genetic testing into four areas, (1) clinically meaningful, (2) business interest [sale of supplements, books, etc, by the laboratory], (3) ancestry testing, and (4) novelty testing [e.g. why you taste foods differently]. AMP supports limited DTC clinically meaningful (e.g., clinically relevant) genetic testing without a physician prescription, subject to seven conditions. AMP is neutral on "ancestry" and "novelty" testing, since it does not involve health information and AMP is a health/medical organization. However, AMP opposes genetic testing that is both clinically non-meaningful and used to "sell additional products and services" unless, at the least, they "clearly identify the lack of data" for the additional tangible-product sales.
Letter to House 21st Century Cures Committee re Draft Legislation
(February 10, 2015)
This House workgroup released a lengthy "potpourri" grab-bag of legislative options (here), some of which involve CMS, coverage with evidence development, LCDs, FDA...for the 6-page AMP comment, see here.
Webinar on Pricing/MicroCosting of Genomic Procedures (Next Gen Sequencing)
(February 13, 2015)
In the July 2014 Medicare CLFS public meeting, AMP proposed some novel costing approaches to price next gen sequencing procedures. CMS did not accept them as crosswalk pricing (CMS is allowing its contractors to gapfill the NGS CPT codes for CY2015). AMP is continuing to develop its concepts, with a webinar presented on February 13, 2015. Video and PDF are available online (here, here). AMP notes that two expert consulting groups, Tynan Consulting and Boston Healthcare Associates, have assisted in the project.
Launch Process for Revised CAP/AMP/IASLC Guidelines in Lung Cancer Genomics
In a joint position statement, the College of American Pathologists, AMP, and the International Association for the Study of Lung Cancer announced it was undertaking revised guidelines for EGFR and ALK Inhibitor testing in lung cancer tissue (new 2015 press release here, existing guideline webpage here, .) The current guideline, from April 2013, is available at Journal of Molecular Diagnostics (here; Lindeman et al.).
AMP notes the revised guideline has been started, but will take 18 months to complete. It will cover ALK testing by IHC, ALK-EGFR resistance, additional genes such as ERB-B2, RET, RO1, MET, and NTRK-1, as well as a position on next-generation gene panel testing and the use of rebiopsy for updated genomic information and blood- or circulating-tumor-cell based genetic testing. In late January 2015, the Medicare MolDX program announced a draft position that would endorse limited coverage (in narrow circumstances) for NGS gene panels in lung cancer patients as long as chemotherapy outcome data collection was collected in a database (here).
A single zip file with 8 early-2015 AMP online documents is in the cloud, here (click small down-arrow to download).