Friday, August 31, 2018

House Messages CMS: Asks CMS to Address Panel Unbundling

›
Each year, annual budgets prepared at House and Senate come with something called "report language" which describes something of t...

MolDx Releases Set of New LCDs

›
A Genomeweb article on August 30, 2018, notes that MolDx has released a draft LCD favorable to the Veracyte test Envisia, for pulmonary fibr...
Thursday, August 30, 2018

Very Brief Blog: The Swing to FDA Approval: FMI Discontinues F1 Test for CDx Test

›
I may not be the first one to hear it but I heard today:  Foundation Medicine is officially turning off the production line on its F1 test. ...
Wednesday, August 29, 2018

Very Brief Blog: MolDx Analysis of Evidence "Quality, Strength, and Weight"

›
The 21st Century Cures Act requires LCDs to provide rationales for their decisions and a summary of evidence considered .   For an overview...

Very Brief Blog: New Medical Director at CMS MolDx Program - Dr Paul Gerrard

›
The Medicare special contractor program for genomic tests, MolDx , has a new interim medical director, Dr. Paul Gerrard.   Labs who work wit...
Wednesday, August 22, 2018

My Short Deck on LCD/NCD and Combination Diagnostics: For NextGenDx Conference in DC

›
This week is the 1000-person NextGenerationDx conference in Washington, here . This afternoon I have the chance to present a concise 15-mi...
Monday, August 20, 2018

Two New Research Studies Propose Updated Approaches to Medicare Dx LCDs

›
Classically, a new diagnostic test is created and its developer produces a series of studies showing it is clinically valid and has strong c...
Saturday, August 18, 2018

Two Precision Medicine-Related Conferences in Nashvillle, September/October 2018

›
Two precision medicine related conferences in Nashville in September and October 2018. The first is sponsored by the "Precision Medic...

Foundation Medicine's Final SEC Report: Medicare Policy as a Chutes and Ladders Game

›
On August 9, 2018, Foundation Medicine (FMI) filed its SEC 10-Q  [MAY NOT WORK; SEE CLOUD COPY INFRA] for the quarter ending June 30. And on...
Friday, August 17, 2018

Brief Blog: CAP Keeps Legislative LCD Reform Alive

›
In its July 31, 2018, open access government affairs bulletin STATLINE, College of American Pathologists notes that its legislation to impro...
Thursday, August 16, 2018

FDALawBlog posts FDA's 59-page Diagnostics Legislation for Reform of Itself

›
Update 2019/07.   This blog leads to the 59 page FDA comments on DAIA in 8/2018.  See a July 2019 blog that leads to 18 page HHS comments o...
Wednesday, August 15, 2018

Very Brief Blog: Legislation Would Cover Know-Error DNA Biopsy Provenance Test; Not Covered by MACs

›
In a brief tidbit, the MolDx program does not cover the Know Error Test, a DNA test that confirms the provenance (origin) of biopsy specimen...

President's 2019 Budget Proposes Cutting USPSTF Budget

›
I ran across the President's 2019 Proposed Budget for AHRQ, which includes a discussion of the sub-budget for U.S. Preventive Services T...

MolDx Program Drops "Coverage with Data Development" From Its Handbook

›
National CED Coverage with Evidence Development (CED) is a form of gated entry for new technologies into the healthcare payment system.*  ...
Thursday, August 9, 2018

California MD-PhD Becomes Head of Diagnostics at FDA: Tim Stenzel

›
Amidst a significant reorganization of the Center for Devices and Radiologic Health (CDRH), Tim Stenzel MD PhD becomes head of the Office of...