2015 |
Title |
Keywords |
Committee |
December 16 |
Analysis of the FDA Report, "The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies" |
CLIA, CMS, FDA, LDPs, LDTs, IVD |
Professional Relations |
November 25 |
Comments to FDA on a Standards-Based Approach to Analytical Performance Evaluation of NGS In Vitro Diagnostic Tests |
FDA, NGS, IVD, LDPs, LDTs |
Professional Relations |
November 25 |
Comments to FDA on the Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants |
FDA, NGS, IVD |
Professional Relations |
November 24 |
Comments to CMS on the Medicare Clincal Diagnostic Laboratory Tests Payment System Proposed Rule |
CMS, PAMA, CDLTs, ADLTs, CPT, CLFS, MACs, LCDs |
Economic Affairs |
November 23 |
Reponse to Palmetto on Proposed MolDX LCD of Chromosome 1p/19q deletion analysis (DL36483) |
CAP, dLCD, CPT, Palmetto, MAC, CMS |
Economic Affairs |
November 20 |
Reponse to WPS on Proposed LCD of Genetic Testing for CYP2C19, CYP2D6, CYP2C9, and VKORC1 (DL36398) |
CAP, dLCD, CPT, MAC, CMS, WPS |
Economic Affairs |
November 17 |
Written Testimony to House E&C Subcommittee Hearing on "Examining the Regulation of Diagnostic Tests and Laboratory Operations" |
LDPs, LDTs, FDA, CMS, CLIA, IVD |
Professional Relations |
October 26 |
Sign-on Letter to Senate HELP and House E&C in support of congressional action to ensure a CLIA moderization approach to LDPs |
LDPs, LDTs, FDA, CMS, CLIA |
Professional Relations |
October 26 |
Comments to FDA, CDC, and NLM on Promoting Semantic Interoperability of Laboratory Data |
FDA, CDC, NLM, EHR, LOINC, SNOMED-CT |
Professional Relations |
October 26 |
Endorsement of Clinical Pharmacogenetics Implementation Consortium (CPIC) initative to standardize pharmacogenetic nomenclature |
CPIC |
Clinical Practice |
August 26 |
Presentation of New Code Crosswalk Recommendations to Advisory Panel on Clinical Diagnostic Laboratory Tests |
CMS, CLFS, PAMA, GSP, CPT, CAP |
Economic Affairs |
August 10 |
Response to Noridian on Proposed LCD of NSCLC, Comprehensive Genomic Profile Testing (DL36194, DL36198) |
CAP, dLCD, CPT, MAC, CMS |
Economic Affairs |
August 10 |
Response to Noridian on Proposed LCD of BRCA1 and BRCA2 Genetic Testing |
CAP, dLCD, CPT, MAC, CMS |
Economic Affairs |
August 10 |
Response to Noridian on Proposed LCD of MolDX: HLA-B*15:02 Genetic Testing (DL36145, DL36149) |
CAP, dLCD, CPT, MAC, CMS |
Economic Affairs |
August 10 |
Response to Noridian on Proposed LCD of MGMT Promoter Methylation Analysis (DL36192, DL36188) |
CAP, dLCD, CPT, MAC, CMS |
Economic Affairs |
August 6 |
Crosswalk Recommendations for the CY2016 Clinical Lab Fee Schedule |
CLFS, CMS, GSP, CPT |
Economic Affairs |
August 4 |
Proposal for Modernization of CLIA Regulations for LDPs |
LDPs, LDTs, FDA, CLIA, CMS |
Professional Relations |
July 22 |
Comments to Palmetto on "Analytic Performance Specifications for Comprehensive Genomic Profiling" (M00118, V1) |
Palmetto, Medicare, CMS, NGS, PFS, CLFS, PFS, CLIA |
Economic Affairs |
July 20 |
Comments to CMS on Preliminary Gapfill Determinations |
CMS, GSP, CPT codes, |
Economic Affairs |
July 16 |
2015 Clinical Lab Fee Schedule Publc Meeting Presentation |
CLFS, GSP, CMS, CPT |
Economic Affairs |
June 22 |
Comments to House Energy and Commerce Committee on Draft Legislation on the Regulation of In Vitro Clinical Tests |
LDPs, LDTs, FDA, CLIA, IVDs |
Professional Relations |
June 19 |
Group Letter to EEOC Opposing Proposed Rule on ADA/GINA and Wellness Programs |
GINA, EEOC, ADA, genetic testing |
Professional Relations |
May 19 |
Comments to House Energy and Commerce Committee on 21st Century Cures Act |
LCD, FDA, Federal travel, CMS, CME |
Professional Relations |
March 20 |
Written Comments to FDA on Regulation of NGS Diagnostic Tests |
NGS, FDA, LDTs, LDPs |
Professional Relations |
February 23 |
Feedback to Senate HELP Committee on Report Titled 'Innovation for Healthier Americans' |
LDTs, LDPs, FDA, NGS |
Professional Relations |
February 20 |
Comments at FDA Workshop on Optimizing Regulatory Oversight of Next Generation Sequencing Diagnostic Tests |
LDPs, LDTs, FDA, NGS |
Professional Relations |
February 10 |
Feedback to House Energy and Commerce Committee on the 21st Century Cures Discussion |
LCD, LDPs, LDTs, PAMA, CTEP |
Professional Relations |
February 10 |
Position Statement on Direct Access Genetic Testing (Direct to Consumer Genetic Testing) |
DTC, genetic testing |
Professional Relations |
January 29 |
Comments to FDA on 'Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) |
FDA, LDTs, LDPs |
Professional Relations |
January 8 |
Molecular Diagnostic Perfect Storm White Paper |
FDA, CLIA, LDTs, CMS, CPT Code, LDPs |
Professional Relations |
January 5 |
Feedback to House Energy and Commerce Committee re: "A Modernized Framework for Innovative Diagnostic Tests." |
LDPs, FDA, LDTs |
Professional Relations |