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.

2019 Position Statements and Letters

Date	Title	Keywords	Committee
October 16	Letter of Support for the Laboratory Access for Beneficiaries (LAB) Act (H.R. 3584)	CMS, PAMA, CLFS	Economic Affairs
September 27	Comments on the CY 2020 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS-1717-P)	CMS, OPPS, DOS	Economic Affairs
September 9	Group Stakeholder Letter in Support of the Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107)	CMS, Prior-Authorization, HR 3107	Economic Affairs
September 4	Best Practices for Clinical Pharmacogenomic Testing	PGx, FDA, CPIC	Professional Relations
August 11	Joint Comments on First Coast Proposed Local Coverage Determination: Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs)	First Coast, dLCD, NAATs, GIP	Economic Affairs
August 11	Joint Comments on Novitas Proposed Local Coverage Determination: Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs) (DL38229)	Novitas, dLCD, NAATs, GIP	Economic Affairs
July 25	Updated List of Signers: Coalition Letter Opposing Draft Legislation of Section 101 of the Patent Act	Gene Patents, ACLU, Patent Reform	Professional Relations
June 20	Joint Comments on MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies (DL38047)	LCD, CAP, NGS, MolDX	Economic Affairs
June 20	Joint Comments on MolDX: Next-Generation Sequencing for Solid Tumors (DL38045)	LCD, CAP, NGS, MolDX	Economic Affairs
June 10	AMP Position Statement: Consumer Genomic Testing – June 2019	Genomic testing	Professional Relations
June 3	Coalition Letter Opposing Draft Legislation of Section 101 of the Patent Act	Gene Patents, ACLU, Patent Reform	Professional Relations
May 29	Comments on the Reconsideration of the National Coverage Determination on Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer	CMS, NGS NCD, MAC, germline testing	Economic Affairs
May 20	Group Stakeholder Letter Requesting Comment Period Extension on the Reconsideration of the National Coverage Determination on Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer	CMS, NGS NCD, MAC	Economic Affairs
May 4	Joint Comments on the FDA Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable	FDA, ASIP, Common Rule	Professional Relations
March 18	AMP Comments on the "BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing" Draft Recommendation Statement Published by the US Preventative Services Task Force (USPSTF)	USPSTF, BRCA1, BRCA2, NCCN	Professional Relations
March 17	Stakeholder Sign on Letter to CMS Regarding the Revisions to the National Correct Coding Initiative (NCCI) Policy Manual	CMS, NCCI, PTP edits	Economic Affairs
March 4	AMP Comments on the Revisions to the National Correct Coding Initiative (NCCI) Policy Manual	CMS, NCCI, PTP edits	Economic Affairs
March 1	AMP Comments on the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees	CMS, CLIA	Professional Relations
February 13	AMP Comments on the Draft Discussion of the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2018	VALID, LDPs, LDTs, FDA, CMS, CLIA, IVDs, IVCTs	Professional Relations
February 5	Comments on the FDA Draft Guidance titled "Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeautic Products Guidance for Industry"	FDA, Companion Diagnostics, Oncology	Professional Relations
February 1	Stakeholder Sign on Letter to CMS Regarding National Coverage Determination for Next Generation Sequencing for Medicare Patient with Advanced Cancer	NGS, CMS, FDA, NCD, MAC	Economic Affairs, Professional Relations

2018 Position Statements and Letters

Date	Title	Keywords	Committee
December 28	Request for Reconsideration of CPT codes 81163 and 81165 on the 2019 CLFS	CMS, CLFS, Reconsideration Request, BRCA1, BRCA2	Economic Affairs
October 22	Comments on the Preliminary Determinations for Calender Year 2019 for New and Reconsidered Services on the Clinical Laboratory Fee Schedule	CMS, CLFS, Preliminary Determinations	Economic Affairs
September 10	Comments on the CY2019 Physician Fee Schedule Proposed Rule	PAMA, CMS, CLFS, PFS	Professional Affairs
August 8	Joint Comments on Draft Local Coverage Determination - Biomarker Testing for Prostate Cancer Diagnosis (DL37733)	LCD, MAC, DL37733, Biomarker	Professional Affairs
August 7	Comments on the 2018 Preliminary Gapfill Payment Determinations for CY2019	CMS, CLFS, gapfill, PAMA, GSP	Professional Affairs
August 24	Comments on FDA's technical assessment of the Diagnostic Accuracy and Innovation Act	LDP, LDT, DAIA, CLIA, CMS, FDA, IVD	Professional Affairs
June 25	AMP Crosswalk Recommendations to CMS for New and Reconsidered CPT Codes	CMS, CPT, CLFS	Professional Affairs
June 21	Stakeholder Sign On letter for Laboratory Testing Oversight	LDP, LDT, DAIA, CLIA, CMS, FDA, IVD	Economic Affairs
June 11	Joint Comment Letter on MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels (DL37764)	LCD, MAC, DL37764, ID	Economic Affairs
June 11	Joint Comment Letter on Draft Local Coverage Determination: MolDX: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification Tests (NAATs) (DL37766)	LCD, MAC, DL37766, NAATs, ID	Economic Affairs
June 11	Joint Comment Letter on Draft Local Coverage Determination: MolDX: MDS FISH (DL37772)	LCD, MAC, DL37772, FISH, MDS	Economic Affairs
June 11	Joint Comment Letter on Draft Local Coverage Determination: MolDX: Comprehensive Genomic Profiling to Guide Treatment in Patients with Metastatic Colorectal Cancer (DL37222)	LCD, MAC, DL37222, CGP	Economic Affairs
June 11	Joint Comment Letter on Draft Local Coverage Determination: MolDX: Comprehensive Genomic Profiling to Guide Treatment in Patients with Metastatic Melanoma (DL37220)	LCD, MAC, DL37220, CGP	Economic Affairs
June 11	Joint Comment Letter on MolDX: Comprehensive Genomic Profiling to Guide Treatment in Patients with Advanced Primary Peritoneal, Fallopian tube and Ovarian Cancer (DL37203)	LCD, MAC, DL37203, CGP	Economic Affairs
May 10	Joint Comment Letter on Draft Local Coverage Determination: MolDX: Comprehensive Genomic Profiling to Guide Treatment in Patients with Advanced Primary Peritoneal, Fallopian Tube and Ovarian Cancer (DL37723)	LCD, MAC, DL37723, CGP	Economic Affairs
May 10	Joint Comment Letter on Draft Local Coverage Determination: MolDX: Comprehensive Genomic Profiling to Guide Treatment in Patients with Metastatic Colorectal Cancer (DL37719)	LCD, MAC, DL37719, CGP	Economic Affairs
May 10	Joint Comment Letter on Draft Local Coverage Determination: MolDX: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification Tests (NAATs) (DL37709)	LCD, MAC, DL37709, ID, NAATs	Economic Affairs
May 10	Joint Comment Letter on MolDX: MDS FISH (DL37602)	LCD, MAC, DL37602, FISH	Economic Affairs
May 10	Joint Comment Letter on Draft Local Coverage Determination: MolDX: Comprehensive Genomic Profiling to Guide Treatment in Patients with Metastatic Melanoma (DL37721)	LCD, MAC, MolDX, CGP, NGS, DL37721	Economic Affairs
May 10	Joint Comment Letter on MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels (DL37713)	LCD, MAC, ICD-10	Economic Affairs
April 11	Joint Comments to Proposed LCD for Molecular Pathology Procedures (DL35000)	CAP, LCD, MAC	Economic Affairs
April 11	AMP-CAP Comments to Local Coverage Determination Regarding Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases (DL37606).	CAP, LCD, MAC, NGS, MDS, MPN, AML, CPT, ICD-10	Economic Affairs
April 11	AMP Comments to Local Coverage Determination Regarding Administrative Multianalyte Assays with Algorithmic Analyses (MAAA) and Proprietary Laboratory Analyses (PLA) Services (DL37600).	MAAA, PLA, CPT, MAC, LCD	Economic Affairs
March 28	AMP and CAP Comments to MolDX: Guardant360 Plasma-Based Comprehensive Genomic Profiling in Non-Small Cell Lung Cancer (NSCLC) (DL37671)	LCD, NSCLC, CPT, MAC	Economic Affairs
March 23	AMP Comments to North Carolina Medicaid and NC Health Choice Program coverage of genetic testing for susceptibility to breast and ovarian cancer	North Carolina, FORCE, NothingPink, BRCA, Medicaid	Professional Relations
March 19	AMP Comments to Docket No. FDA-2017-N-6356, Investigational In Vitro Diagnostics Used in Clinical Investigations of Therapeutic Products; Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards	FDA, LDP, IVD, CLIA, CMS, IDE, NIH	Professional Relations
March 12	AMP Comments to Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA); CMS-3326-NC	CMS, CLIA, RFI	Professional Relations
January 25	Request for Information on Promoting Healthcare Choice and Competition Across the United States	CMS, NGS, MolDx, MAC, NCA, PAMA, LCD	Economic Affairs
January 17	Comments to CMS for Proposed Decision Memorandum on Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG #00450N)	NGS, CMS, NCA, FDA, F1CDx, IVD, NCD, LDP	Economic Affairs

2017 Position Statements and Letters

Date	Title	Keywords	Committee
November 27	Comments to MolDx for Local Coverage Determination Regarding Genetic Testing for Lynch Syndrome (DL35024)	MolDx, LCD, Palmetto, CAP	Economic Affairs
November 27	Comments to MolDx on Palmetto's Proposed Coverage Policy for Circulating Tumor Cell Marker Assays (DL35071)	MolDx, Palmetto, LCD, CAP, cfDNA	Economic Affairs
October 24	Comments to NAM on the Return of Individual-Specific Research Results Generated in Research Laboratories	NAM, ASIP, CLIA	Economic Affairs
October 23	Comments to CMS on the CY2018 for Preliminary Determinations	CMS, PAMA, CLFS, CPT	Economic Affairs
October 23	Comments to CMS on the CY2018 for New Private Payor-Based CLFS Payment System	CMS, PFS, PAMA, CLFS	Economic Affairs
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 Molecular 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 Position Statements and Letters

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 Position Statements and Letters

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 Position Statements and Letters

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 Position Statements and Letters

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: 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	Proposal to address CPT coding for Genomic Sequencing Procedures	CPT code, GSPs, AMA	Economic Affairs
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 Position Statements and Letters

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 Position Statements and Letters

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

2010 Position Statements and Letters

2010	Title	Committee
October	Letter to FDA Expressing Concerns Over Potential Medical Device Registration Requirement	Multi-Association Coalition
September	Letter to FDA Encouraging Continued Dialogue re: LDTs	Multi-Association Coalition
July	Comments to NIH regarding the Genetic Test Registry	Professional Relations
	Comments to FDA regarding oversight of laboratory developed tests	Professional Relations
June	Comments to SACGHS regarding the draft report on Genetics Education and Training	Professional Relations
	Comments to FDA regarding regulation of cytogenetic arrays	Arrays Working Group
	Comments to FDA CDRH Council regarding barriers to market for molecular diagnostic tests	Professional Relations
	Comments to SACGHS regarding Whole Genome Sequencing	Clinical Practice Committee
February	Comments to the SACGHS to finalize gene patent report and recommendations as presented in October 2009	Professional Relations
	Comments to AHRQ on the draft Technology Assessment, "Systematic Reviews on Selected Pharmacogenetic Tests for Cancer Treatmen	Professional Relations
January	AMP's position on the oversight of laboratory developed tests (LDTs) released and discussed with FDA	Professional Relations
	AMP presents to MEDCAC regarding pharmacogenomic testing	Professional Relations

2009 Position Statements and Letters

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

2008 Position Statements and Letters

2008	Title	Committee
November	Gene Patents and the Exclusive Licensing of Genetic Discoveries	Professional Relations
September	Comments to CMS regarding MUEs	Economic Affairs
	Comments to CMS regarding PGx Testing of Warfarin Response	Economic Affairs
July	Suggestions to the SACGHS regarding New Priorities	Professional Relations
April	Comments to FDA regarding Guidance on PGx Data Submissions	Clinical Practice
	Comments to FDA regarding Guidance on Definitions for PGx and Sample Coding Categories	Clinical Practice
	Comments to NIGMS regarding barriers to PGx research	Clinical Practice
March	Comments to EMEA regarding Guidance on Definitions for PGx and Sample Coding Categories	Clinical Practice

2007 Position Statements and Letters

2007	Title	Committee
December	Comments to NCI regarding Best Practices for Biospecimens	Clinical Practice
	Comments to the SACGHS Task Force Draft Report Regarding Oversight of Genetic Testing	Professional Relations
June	AMP Position regarding Direct Access Genetic Testing (Direct to Consumer Genetic Testing)	Professional Relations
March	Response to FDA regarding IVDMIA Draft Guidance document	Professional Relations
February	Comments to CLIAC regarding introducing a Genetics Specialty to the CLIA regulations	Professional Relations

2006 & Earlier Position Statement and Letters

2006 & Earlier	Title	Committee
2006	Comments to CMS regarding Equivalent Quality Control (May 2006)	Professional Relations
2005	LabCorp v. Metabolite brief (Dec 2005)	Professional Relations
	Comments to FDA regarding drug safety information (Dec. 2005)	Professional Relations
	AMP Letter of Support for S.306, the Genetic Nondiscrimination Act (Feb. 2005)	Professional Relations

Position Statements & Letters

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