ADVOCACY

Position Statements & Letters

The AMP advocacy program endeavors to inform and influence public policy affecting molecular pathology. AMP represents its membership to the federal agencies and members of Congress regarding professional and reimbursement issues - reaching out to fellow professional associations, industry and other association partners to accomplish common goals. Position statements, comments, and letters are usually generated by our Professional Relations and Economic Affairs Committees, though our Clinical Practice and Training & Education Committees do advocate in their areas.

We invite you to explore AMP's Position Statements and Communications. For more information, please contact Mary Williams.

2017 Title Keywords Committee
September 11 Comments to CMS on the CY2018 Physician Fee Schedule Proposed Rule CMS, PFS, PAMA, CLFS Economic Affairs
September 11 Follow-up Comments on Reps Bucshon and DeGette Discussion Draft - Diagnostic Accuracy and Innovation Act DAIA, LDPs, LDTs, FDA, CMS, CLIA, IVD Professional Relations
August 17 Comments to CMS on list of 60 CLFS test codes for which CMS received no and/or insufficient data CMS, CLFS, PAMA, CPT, GSP Economic Affairs
August 14 Joint Comments to Noridian on MolDx: Foodborne Gastrointestinal Panels Identified by Mulitplex Nucleic Acid Amplications Tests (DL37368) AGA, ASM, APHL, CAP, IDSA, PASCV, NAATs Economic Affairs
August 14 Joint Comments to Noridian on MolDx: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels (DL37301) ASM, APHL, CAP, IDSA, PASCV Economic Affairs
August 10 Comments to CMS on CLFS CY2018 CMS, GSP, CLFS, CPT Economic Affairs
August 2 AMP-CAP Comments to NGS on Genomic Sequence Analysis Panels in the Treatment of Myelodysplastic Syndromes (DL37078) GSP, CAP, LCD, MDS, AML Economic Affairs
April 7 Comments to Reps. Bucshon and DeGette on Diagnostic Accuracy and Innovation Act draft legislation DAIA, LDPs, LDTs, FDA, CMS, CLIA, IVDS Economic Affairs
March 30 AMP-CAP Comments to Noridian-CGP Melanoma-(DL37111 and DL37109) CAP, CGP, Noridian, Melanoma Economic Affairs
March 30 AMP-CAP Comments to Noridian-CGP Ovarian (DL37101 and DL37103) CAP, CGP, Noridian, Ovarian Economic Affairs
March 30 AMP-CAP Comments to Noridian-CRC (DL37105 and DL37107) CAP, CGP, Noridian, CRC Economic Affairs
March 24 AMP-CAP Comments to WPS on MGMT Promoter Methylation Analysis (DL37001) CAP, LCD, MGMT, MolDx Economic Affairs
March 24 AMP-CAP Comments to WPS on Infectious Disease Moleculat Diagnostic Testing (DL37007) CAP, LCD, Infectious Disease, MolDx Economic Affairs
March 24 AMP-CAP Comments to WPS on Chromosome 1p/19q Deletion Analysis (DL37009) CAP, LCD, MolDx, Chromosome Deletion Analysis Economic Affairs
March 23 AMP-CAP Comments to Palmetto on Comprehensive Genomic Profiling to Guide Treatment in Patients with Metastatic Melanoma (DL37041) CAP, CGP, NGS, Melanoma, Palmetto, MolDx Economic Affairs
March 23 AMP- CAP Comments to Palmetto on Comprehensive Genomic Profiling to Guide Treatment in Patients with Metastic Colorectal Cancer (DL37039) CAP, CGP, NGS, Palmetto, Colorectal Cancer Economic Affairs
March 23 AMP-CAP Comments to Palmetto on Comprehensive Genomic Profiling to Guide Treatment in Patients with Advanced Primary Peritoneal, Fallopian Tube and Ovarian Cancer (DL37045) CAP, NGS, Palmetto, CGP, Ovarian Cancer Economic Affairs
March 7 Joint Letter Opposing H.R. 1313, The Preserving Employee Wellness Programs Act GINA, ADA Professional Relations
February 1 Joint Letter to President Trump on Recent Immigration Executive Order Immigration, executive order Board of Directors
2016 Title Keywords Committee
December 22 AMP and CAP Joint Comments to CGS on Bladder Tumors CGS, dLCD, MAC, CAP Economic Affairs
December 2 Comments to NGS on Genomic Sequence Analysis Panles in the Treatment of Acute Myelogenous Leukemia (DL36926) NGS, GSP, AML, dLCD, MAC, CAP Economic Affairs
December 1 Comments to CGS on APC and MUTYH Gene Testing dLCD (DL36910) CGS, MAC, CAP, dLCD Economic Affairs
December 1 Comments to Noridian on APC and MUTYH Gene Testing dLCD (DL36882) Noridian, CAP, MAC, dCLD Economic Affairs
November 14 Comments to First Coast on dLCD on Noncovered Services (DL33777) CMS, MAC, First Coast, HHV-6 Economic Affairs
October 31 Comments to CMS on CY2017 CLFS Preliminary Determinations CMS, CLFS, GSP, CPT Economic Affairs
October 31 Reconsideration Request to CMS on Final Gapfill Determinations CMS, GSP, CLFS, CPT Economic Affairs
October 14 Joint Letter to CDC Regarding Molecular Testing for Zika Virus ASM, PASCV, Zika, CDC, rRT-PCR Professional Relations
October 13 Comments to FDA on Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product IVD, FDA, Companion Dx Professional Relations
October 6 Comments to FDA on Use of Public Human Genetic Varient Databases to Support Clinical Validity for NGS-based IVDs FDA, NGS, IVD, Database, Clinical Validity Professional Relations
October 6 Comments to FDA on Use of Standards in FDA Regulatory Oversight of NGS IVDs Used for Diagnosing Germline Diseases FDA, NGS, IVD Professional Relations
October 6 Comments to FDA on Retrospective Review of PMA Application Devices FDA, PMA, IVD Professional Relations
September 11 ASM, AMP, APHL, IDSA, and PASCV Comments to FDA on Next Generation Sequencing for Infectious Diseases FDA, NGS, APHL, AMP, IDSA, PASCV Professional Relations
August 12 AMP-CAP Comments to NGS on Molecular Pathology Procedures dLCD (DL35000) CAP, dLCD, MAC Economic Affairs
August 10 Comments to CMS on 2016 Gapfill Preliminary Determinations CMS, CLFS, CPT, GSP Economic Affairs
August 8 AMP-CAP Comments to Cahaba on BRCA1 and BRCA2 Genetic Testing (DL36741) BRCA, CAP, Cahaba, dLCD, MAC Economic Affairs
August 8 AMP-CAP Comments to Noridian on Bladder Tumor Markers dLCD (DL36678) CAP, Noridian, dLCD, MAC Economic Affairs
August 8 Comments to CMS on CY2017 CLFS CMS, CLFS, CPT, GSP Economic Affairs
August 2 Comments to FDA on E18 Genomic Sampling and Management of Genomic Data FDA, IVD, IHC Professional Relations
August 2 Letter of Support for S.2978 - Protect Continuing Physician Education and Patient Care Act Education, CME Professional Relations
July 7 AMP-CAP Comments to Noivats on Biomarkers Overview dLCD - DL35062 CAP, Novitas, dLCD, MAC Economic Affairs
July 7 AMP-CAP Comments to Novitas on Biomarkers for Oncology- DL35396 CAP, Novitas, dLCD, MAC Economic Affairs
July 7 AMP-CAP Comments to Novitas on BRCA1 and BRCA2 Genetic Testing - DL36715 BRCA, CAP, Novitas, dLCD, MAC Economic Affairs
June 3 Comments to FDA on Emergency Use Authorization of Medical Products and Related Authorities EUA, IDSA, LDP, LDT, IVD Professional Relations
April 29 Comments to NYSDOH on Proposed Policy for Risk-based Evaluation of Laboratory Developed Tests NYSDOH, LDP, LDT Professional Relations
April 15 AMP-CAP Comments to Cahaba on dLCD on K-RAS Testing Prior to Treatment of Colorectal Cancer MAC, Cahaba, KRAS, CAP, dLCD Economic Affairs
April 4 AMP-CAP Comments to Noridian on MOLDX: Chromosome 1p/19q Deletion Analysis MAC, Noridian, CAP, dLCD Economic Affairs
March 31 Comments to FDA on the Return of Genetic Test Results FDA, Genetic Test Results Professional Relations
March 28 Comments to FDA on NGS-Based Oncology Panels FDA, NGS, Oncology, LDP Professional Relations
February 19 Comments to CMS on Request for Information Regarding the Awarding and the Administration of MAC Contracts CMS, MAC, LCD, gapfill Economic Affairs
January 28 Sign-on letter opposing EEOC GINA proposed rule GINA, EEOC, Genetic Testing Professional Relations
January 6 AMP Comments on Common Rule NPRM NPRM, ASIP, Biospecimens, Common Rule, HHS Professional Relations
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
2014 Title Keywords Committee
December 17 Group Letter to Palmetto Regarding Concerns with DLCD: Molecular Diagnostic Tests (DL33599) Palmetto, LCD, MOLDX, MDT, MAC, Medicare, CMS, CPT code, CAP Economic Affairs
December 17 Comments to Palmetto Regarding the Classification of CDH1 Genetic Testing (M00087) Palmetto, CDH1, Medicare, CMS, HDGC, MOLDX, LCD Economic Affairs
November 18 Group letter to the FDA asking for a withdrawal of proposed draft guidance seeking to regulate laboratory developed tests (LDTs) LDT, FDA, AMA Professional Relations
September 9 Testimony for Energy and Commerce Hearing on "21st Century Cures: Examining the Regulation of Laboratory Developed Tests" LDT, FDA, LDP, CLIA Professional Relations
September 8 Group Letter to Congress opposing S. 1347 S. 1347, federal employee travel Multiple Organizations
September 2 Comments to the CMS CY2015 Proposed Physician Fee Schedule (PFS) Rule Medicare, CLFS, LCD, Palmetto MolDx Economic Affairs
July 30 Comments to the USPTO on the draft Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena & Natural Products Mayo, Myriad, patent Professional Relations
July 29 Letter to Congress requesting S. 1347 exempt scientific and medical conferences S. 1347, federal employee travel Professional Relations
July 3 Comments on Section 1834A of the Protecting Access to Medicare Act of 2014 PAMA, CMS, CLIA Professional Relations
June 1 Response to the "21st Century Cures: A Call to Action" request for comments FDA, CLIA, LDP, HUGO, CMS, federal employee travel Professional Relations
May 13 Letter to FDA regarding HPV Indications for Use FDA, HPV Professional Relations
March 27 Letter to Sen Harry Reid regarding sweeping changes to the CLFS in SGR patch legislation. CLFS, CMS, CPT, SGR Economic Affairs & Professional Relations
February 18 Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Transfusion and Transplantation FDA, ASHI Professional Relations
January 27 Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, and Other Revisions to Part B for CY 2014, Final Rule (CMS-1600-FC) CMS, PFS, CLFS Economic Affairs
2013 Title Keywords Committee
October 30 Concerns about the Palmetto Molecular Diagnostics (MolDX) Services Program and Medicare coverage as well as their impact on Gap Fill Pricing for Molecular Pathology Procedures CMS, Medicare, MolDX, Palmetto, Noridian, gap fill, Medicare beneficiaries Joint Society
September 6 Comments to the CMS CY2014 Proposed Physician Fee Schedule (PFS) Rule outpatient, OPPS, Medicare Economic Affairs
August 29 Comments to Palmetto on DLCD: Molecular Diagnostic Tests (DL33599) MAC, local coverage determination, MDT, Medicare, CMS, CPT code Economic Affairs
August 29 Comments to Palmetto on DLCD: Lynch Syndrome (DL33779) MAC, local coverage determination, Medicare, CMS, CPT code, cancer screening Economic Affairs
August 23 Group Letter to CMS: Concerns with Physician Fee Schedule Proposed Rule for CY 2014 PFS, diagnostic pathology, patient access Joint Society
August 20 FDA Guidance Cybersecurity in Medical Devices electronic medical records Professional Relations
July 25 Comments to First Coast DLCD: HLA Typing (DL33732) MAC, local coverage determination, Medicare, CMS, CPT code, Human Leukocyte Antigen Economic Affairs
July 25 Comments to First Coast DLCD: Molecular Pathology Procedures (DL33703) MAC, local coverage determination, Medicare, CMS, CPT code, genetic testing Economic Affairs
July 18 Comments to Novitas DLCD: Biomarkers Overview (DL33640 and DL33638) MAC, local coverage determination, Medicare, CMS, CPT code, cytogenetics, CED Economic Affairs
July 15 Comments to WPS DLCD: Molecular Diagnostic Testing (PATH-037)(DL33219) MAC, local coverage determination, MDT, Medicare, CMS, CPT code, genetic testing, cytogenetics Economic Affairs
July 08 Comments to CMS on the 2013 Gap Fill Payment Amounts to the Clinical Lab Fee Schedule Medicare, MAC, reimbursement, molecular pathology codes, CPT code, PFS Economic Affairs
July 08 Comments to FDA on Instruments with Combined Functions molecular diagnostic instruments Professional Relations
July 03 Comments to Presidential Commission - Bioethics of Incidental Findings genetic and genomic testing Professional Relations
April 23 Comments to AHRQ on Genetic Testing genetic testing, cancer, CPT coding Professional Relations
April 9 Comments regarding Health Information Technology Reform Act HR 1309, health IT, meaningful use AMP President
March 1 Comments to FDA on Alternative Approval Pathways drug labels, FDA approval pathway, genetic subpopulations AMP President
March 1 Comments to FDA on Drug Labeling drug labeling, KRAS, companion diagnostics AMP President
January 10 Comments to USTPO on Genetic Diagnostic Testing USTPO, gene patents, genetic testing AMP President
January 10 Comments to USTPO on Genetic Diagnostic Testing USTPO, gene patents, genetic testing
2012 Title Keywords Committee
December 28 Comments to CMS regarding 2013 PFS Final Rule CLFS, CPT Coding, final rule Economic Affairs Committee
September 27 Letter of Support for the Taking Essential Steps for Testing (TEST) Act (PDF) CLIA, proficiency testing, TEST Professional Relations
September 26 Gene Patent Case Appeal gene patents, mayo v prometheus, BRCA1, BRCA2, USPTO AMP President
March 5 Letter of Support for the Health Information Technology Reform Act HR 4066, Health IT, meaningful use AMP President
February 16 Testimony to USPTO on the Impact of Gene Patents on Genetic Testing gene patents, USPTO, testimony, genetic testing AMP President
2011 Title Keywords Committee
November 21 Objection to Proposed NIH Exclusive License (PDF) Patent Application 61/144,501; companion diagnostic; protein expression Joint Society: AMP, CAP, ASCP
October 25 AMP Comments on Proposed Changes to the Common Rule (PDF) DHHS, Common Rule, ANPRM Professional Relations
October 12 AMP Comments Regarding FDA Draft Guidance for "In Vitro Companion Diagnostic Devices" (PDF) FDA, Companion Dx, Companion Diagnostics Professional Relations
September 26 AMP Comments Regarding the NIH Genetic Test Registry (PDF) NIH, GTR, Genetic Test Registry Professional Relations
September 20 AMP Comments Regarding Sustained Funding for GME (PDF) Graduate Medical Education, GME, budget, funding AMP President
August 30 AMP Comments to FDA RUO Guidance (PDF) FDA, RUO, IUO, Guidance Professional Relations
June 23 AMP Comments at FDA Meeting on Next Generation Sequencing (PDF) FDA, NGS, Next Gen, Next Generation Sequencing Professional Relations
May 16 AMP Comments to FDA on Diagnostics in Drug Labels FDA, Companion Dx, Companion Diagnostics, Drug Labeling, Therapeutics Professional Relations
February 28 AMP Comments to FDA Regarding Draft Guidance on Detection of C. difficile (PDF) C. difficile; FDA, Guidance Professional Relations
January 14 Comments to the AHRQ on the Draft Technology Assessment (PDF) AHRQ, Technology Assessment Professional Relations
2009 Title Committee
November Letter to HHS Office for Civil Rights to support amending HIPAA Privacy Rule to implement GINA Professional Relations
  AMP urges federal agencies to implement GINA Professional Relations
  Association for Molecular Pathology (AMP) Proposal for CPT Coding Reform in Molecular Diagnostics Economic Affairs
October AMP reiterates its position on gene patents, direct-to-consumer marketing of genetic testing, and genetic nondiscrimination to the Secretary's Advisory Committee on Genetics, Health & Society (SACGHS) on October 8 Professional Relations
  AMP lobbies for equitable reimbursement - AMP has been vigorously advocating with members of Congress for several months to revise or reject legislation that would eliminate the 14-day waiting period for a wide spectrum of molecular tests - for laboratories that are independent of the hospital where the specimen was collected and not under any arrangements. Economic Affairs
September Comments to CLIAC regarding ensuring laboratory testing quality during a public health emergency: AMP labs during the Spring 2009 H1N1 outbreak Professional Relations
  Comments to NIST Roadmap: "Measurement Science and Measurement Standards to Support Innovation in Healthcare Professional Relations
  Comments to AHRQ Draft Report on LDTs Clinical Practice
August Letter to Dr. Janet Woodcock encourages FDA to always identify a companion diagnostic on drug labeling by the biological description Clinical Practice
June AMP priorities for Comparative Effectiveness Research (CER) Professional Relations
  AMP Principles for Health Care Reform Professional Relations
  Comments to House Science & Technology Committee regarding the immediate and long-term needs for standards development in biotechnology at NIST Clinical Practice
May MEDCAC Comments Economic Affairs
April AMP responds to Genentech Citizen Petition Professional Relations, Clinical Practice
March AMP recommends to the IOM priorities for Stimulus Bill spending on comparative effectiveness research (CER) Professional Relations
February Comments to NHGRI Regarding Long Range Planning   Clinical Practice
  AMP Position on Genetic Ancestry Testing Clinical Practice
  MEDCAC Presentation Economic Affairs
January Comments on ACMG's Technical Standards and Guidelines for Myotonic Dystrophy Type 1 Testing Clinical Practice
  MEDCAC/CMS Letter Economic Affairs

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