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.

2022 Position Statements and Letters

Date Title Keywords Committee
June 13 UPDATED: Sign-on Letter Expressing Concern About the VALID Act of 2022 in the Discussion Draft of the FDASLA Act VALID, LDPs, FDASLA Professional Relations
May 27 AMP, APHL, and CAP Response to Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs) – DL38227 (First Coast) and DL38229 (Novitas) GIP NAATs, DL38227, DL38229 Economic Affairs
May 22 AMP Comments on the Discussion Draft of the FDASLA Act and in Particular, Subtitle C of Title VIII Which Includes VALID Act of 2022 VALID, LDPs, FDASLA Professional Relations
May 6 UPDATED: Stakeholder Sign-on Letter Requesting Congress Consider the VALID Act Separately from the Medical Device User Fee Agreement (MDUFA) V Legislative Process VALID, LDPs, MDUFA Professional Relations
April 27 AMP Response to Recent FDA Safety Communication on NIPS Testing NIPS, FDA Professional Relations

April 6

 Sign-on Letter Expressing Concern RE: CMS Transmittal 10832 from June 2, 2021, regarding the National Coverage Determination (NCD) for Next Generation Sequencing (NGS) (90.2) CMS, NGS NCD, NOS ICD-10 Economic Affairs

April 1

 Sign-on Letter Urging Congressional Action to Approve Additional Resources for the Nation’s COVID-19 Response COVID-19, CLC Professional Relations
March 26 AMP and CAP Response to NGS Proposed Coverage Policy for Multiplex Gastrointestinal Pathogen Panel (GPP) Tests for Acute Gastroenteritis (AGE) (DL39226) NGS, GPP, AGE, DL39226 Economic Affairs
March 24 Sign-on Letter to Support the Reducing Hereditary Cancer Act (H.R. 4110/S.B. 3656) HR 4110, SB 3656, Hereditary Cancer Economic Affairs
March 4 AMP and CAP Response to Draft Noridian Coverage Policy MolDX: Plasma-Based Genomic Profiling in Solid Tumors (JE) DL39230 and (JF) DL39232 Noridian, DL39230, DL39232 Economic Affairs
February 23 Stakeholder Sign-on Letter Requesting Congress Consider the VALID Act Separately from the Medical Device User Fee Agreement (MDUFA) V Legislative Process VALID, LDPs, MDUFA Professional Relations
February 4 AMP Comments on the Draft Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics (PREVENT Pandemics) Act PREVENT Pandemics Act, COVID-19 Professional Relations
February 4 Stakeholder Sign-on Letter to Support S. 3534, the Tracking Pathogens Act Tracking Pathogens Act, COVID-19 Professional Relations

2021 Position Statements and Letters

Date Title Keywords Committee
December 31 AMP Response to Cures 2.0 Legislative Text Cures 2.0 Professional Relations, Economic Affairs
December 3 UPDATED: AMP Position Statement on Variant Data Sharing Variant Data Sharing Professional Relations
November 30 Sign-On Letter Requesting Congress to Delay the 2022 Medicare CLFS Cuts and Private Payer Data Reporting Period by One Year PAMA, sign-on, CLFS Economic Affairs
November 15 AMP Comments on the Diagnosis Proposals Presented at the ICD-10 Coordination and Maintenance Committee Meeting on September 13-14, 2021: Q85.89 (Other hamartoma syndromes) for Phosphatase and Tensin Homolog (PTEN) Hamartoma Tumor Syndrome ICD-10, Q85.89, PTEN Economic Affairs
November 11 AMP and CAP Response to Proposed National Government Services Coverage Policy: Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms (DL37810) LCD, NGS, DL37810 Economic Affairs
November 2 Sign-on Letter Requesting the Clinical Laboratory Improvement Advisory Committee (CLIAC) Discuss the Modernization of the CLIA Regulations for Laboratory Developed Tests (LDTs/LDPs) CLIAC, CLIA, LDPs Professional Relations
November 1 AMP Comments on the NIH and FDA’s RFI on “Critical resource gaps and opportunities to support NGS test development, validation, and data interpretation, including the use oftechnologies such as artificial intelligence (AI)/machine learning (ML)” NIH, FDA, AI, ML, NGS Professional Relations
October 15 AMP Comments on Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” (CMS-3372-P2) CMS, MCIT Economic Affairs
September 13 AMP Comments on the Calendar Year (CY) 2022 Medicare Physician Fee Schedule Proposed Rule (CMS-1751-P) CMS, PFS Economic Affairs
September 11 AMP and CAP Response to Proposed Coverage Policy for Genetic Testing for Cardiovascular Disease DL39084 (First Coast) and DL39082 (Novitas) dLCD, First Coast, Novitas Economic Affairs
September 8 Sign On Letter in Support for the Verified Innovative Testing in American Laboratories (VITAL) Act VITAL Act, LDPs, IVDs Professional Relations
September 7 AMP Comments in Response to the United States Patent and Trademark Office’s (USPTO) Request for Public Input in a Patent Eligibility Jurisprudence Study (PTO-P-2021-0032) gene patents, Section 101, USPTO Professional Relations
August 17 Cancer Leadership Coalition Sign-On Letter Advocating for COVID-19 Vaccine Requirements for Healthcare Workers COVID-19, vaccine, CLC Professional Relations
July 29 AMP Position Statement on Variant Data Sharing Variant Data Sharing Professional Relations
July 23 AMP and CAP Response to Proposed Coverage Policy for Pharmacogenomics Testing DL39073 (First Coast) and DL39063 (Novitas) dLCD, Pharmacogenomics, First Coast, Novitas Economic Affairs
July 16 AMP Comments on Cures 2.0 Discussion Draft Cures 2.0 Professional Relations and Economic Affairs
July 15 AMP and CAP Response to Proposed Coverage Policy for NGS Respiratory Pathogen Panel Testing (DL39027) NGS, Coverage, Respiratory Pathogen Panel Economic Affairs
July 3 AMP and CAP Response to Proposed Coverage Policy for MolDX: Next-Generation Sequencing Lab-Developed Tests for Inherited Cancer Syndrome - CGS Administrators (DL39017), Noridian (JE) (DL38972) and (JF) (DL38974), Palmetto (JJ) and (JM) (DL38966), Wisconsin Physicians Service (J5) and (J8) (DL39040) MolDX, Coverage, Inherited Cancer Syndrome Economic Affairs
July 2 AMP, CAP, and AGA Response to Proposed Coverage Policy for MolDX: Multiplex Nucleic Acid Amplification Test (NAAT) Panels for Infectious Disease Testing - CGS Administrators, LLC (DL39038), Noridian Healthcare Solutions (DL39001), (DL39003), Palmetto GBA (DL38988), Wisconsin Physicians Service Insurance Corporation (DL39044) MolDX, Coverage, Infectious Disease Economic Affairs
June 24 AMP Response to S. 1873, the Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 (MCSA) MCSA, screening, CMS Economic Affairs
June 8 Coalition Letter to Biden Administration on Patent-Eligibility Section 101, Gene patents Professional Relations
May 10 AMP Restates Support for HHS’ Statement on the Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests FDA, LDPs, COVID-19 Professional Relations
April 28 Stakeholder Sign-on Letter Supporting Increasing Budget for Advanced Molecular Detection (AMD) program at CDC in the Fiscal Year 2022 (Senate Version) CDC, COVID-19, AMD Professional Relations
April 28 Stakeholder Sign-on Letter Supporting Increasing Budget for Advanced Molecular Detection (AMD) program at CDC in the Fiscal Year 2022 (House Version) CDC, COVID-19, AMD Professional Relations
April 26 AMP Response to H.R. 1946, the Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 (MCSA) MCSA, screening, CMS Economic Affairs
April 19 AMP Response to the Center for Medicare & Medicaid Services (CMS) Transmittal 10624 from March 23, 2021 CMS, NCD, NGS, ICD-10 Economic Affairs
April 16 AMP Comments on Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” (CMS3372-IFC) CMS, MCIT, Coverage Economic Affairs
March 15 AMP Response to Accelerating Innovation in Diagnostic Testing for Lyme Disease RFI RFI, Lyme disease Professional Relations
February 24 AMP and CAP Response to Proposed Coverage Policy for Respiratory Pathogen Panel Testing DL38918 (First Coast) and DL38916 (Novitas) Coverage, MolDX, CMS Economic Affairs
February 11 Group Sign-on Letter Endorsing the Tracking COVID-19 Variants Act (Senate) COVID-19, variants, pandemic Professional Relations
February 11 Group Sign-on Letter Endorsing the Tracking COVID-19 Variants Act (House) COVID-19, variants, pandemic Professional Relations
January 29 AMP Response to the CMS Modernization Section of the Cures 2.0 Concept Paper Cures 2.0, Coverage, CMS Professional Relations and Economic Affairs
January 20 AMP Reconsideration Request to CMS for CLFS Final Determinations CMS, CLFS Economic Affairs

2020 Position Statements and Letters

Date Title Keywords Committee
December 31 AMP Comments on CMS Ruling No: CMS-2020-1-R2 – CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing COVID-19, CMS, Reimbursement, Coverage Economic Affairs
December 2 Joint Letter to Biden Transition Team Regarding Laboratory Testing Supply Chain Issues COVID-19, Supply Chain, Public Health Professional Relations
November 15 AMP Comments on Proposed Decision Memo for Screening for Colorectal Cancer Blood-Based Biomarker Tests (CAG-00454N) NCD, Coverage, CMS, Screening Economic Affairs
November 7 AMP and CAP Comments on MolDX’s proposed coverage policy for Minimal Residual Disease Testing for Cancer MolDx, MRD, Coverage, CMS Economic Affairs
November 2 AMP Comments on CMS' Third Interim Final Rule on COVID-19 Public Health Emergency CMS, COVID-19, pandemic Economic Affairs
November 2 AMP Comments on Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary CMS, FDA, LDP, Coverage Economic Affairs
October 21 Laboratory Stakeholder Letter on CLFS Crosswalk Recommendations for SARS-CoV-2 Testing CMS, CLFS, CPT, COVID-19, pandemic Economic Affairs
October 21 AMP Comments on CY2021 CLFS Preliminary Determinations CMS, CLFS, CPT, COVID-19 Economic Affairs
October 19 AMP Comments on Verifying Accurate, Leading-edge IVCT Development (VALID) Act Pandemic, COVID-19, LDPs, IVD, VITAL, FDA, CMS, CLIA Professional Relations
October 6 Laboratory Stakeholder Letter to Coronavirus Taskforce Regarding Testing Supplies and Tranparency Pandemic, COVID-19, Coronavirus Professional Relations
October 5 AMP Comments to CY2021 Payment Policies Under the Physician Fee Schedule PAMA, G0452, NCD, CLFS, CMS Economic Affairs
October 5 AMP Comments to CY2021 Medicare Program Hospital Outpatient Prospective Payment Program MAAA, CLFS, DOS, CMS Economic Affairs
September 23 AACC, ACMG, AMP Joint Letter of Support for HHS Statement LDP, LDT, pandemic, COVID-19, HHS, FDA, CMS, CLIA Professional Relations
September 21 AMP Response to HHS RFI on Surge Capacity COVID-19, pandemic, supply chain Professional Relations
September 13 Stakeholder Letter to CMS Regarding National Correct Coding Initiative and COVID-19 Clinical Diagnostic Laboratory Testing NCCI, pandemic, COVID-19, coding, CPT, CMS Economic Affairs
September 10 Letter to HHS Regarding Coverage and Reimbursement of COVID-19 Laboratory Developed Testing Procedures LDPs, pandemic, COVID-19, coverage CMS Economic Affairs
September 7 Stakeholder Letter to CMS Regarding COVID-19 Diagnostic Code 87635 CLFS, pandemic, COVID-19, pricing, CPT, CMS Economic Affairs
September 4 AMP Advocates for Inclusion of Laboratory Staff Working to Provide SARSCoV-2 Testing as Part of the Phase 1a Group for Vaccine COVID-19, pandemic, vaccine Professional Relations
September 2 Society Sign-on Letter to Support Chairwoman Johnson's Call for an NASEM Study on Systemic Racism in Academia NASEM, diversity, academia Professional Relations
August 28 AMP Response to FDA–2020–N–1046 for Use of Codeine Containing Analgesics in Children Under 12 Years of Age Subsequent to CYP2D6 Genetic Testing FDA, PGx, CYP2D6 Professional Relations
August 24 Response to CLIAC Request for Information Concerning Personnel and the Retention of Next Generation Sequencing Data in Clinical and Public Health Laboratories CLIAC, NGS, Data Professional Relations
August 11 Society Sign-on Letter Regarding COVID-19 Testing Prioritization Guidelines Update COVID-19, pandemic, supply issues Professional Relations
July 10 Society Sign-on Letter Requesting Renewal of Public Health Emergency (PHE) COVID-19, pandemic, PHE Professional Relations
July 8 Sign-on Letter from Laboratory Community Regarding COVID-19 Testing Supply Chain Issues COVID-19, pandemic, diagnostic testing Professional Relations
June 26 AMP Comments in Response to Chairman Alexander's Whitepaper "Preparing for the Next Pandemic" COVID-19, pandemic, diagnostic testing Professional Relations
June 25 Laboratory Stakeholder Letter Regarding NCCI Policy Manual 2020 Updates NCCI edits, CLFS, diagnostic testing Economic Affairs
June 22 AMP Pricing Recommendations for the Diagnostic Testing Codes at the Annual CMS Clinical Laboratory Fee Schedule Meeting pricing, CLFS, diagnostic testing Economic Affairs
June 12 Joint Comments on MolDX: Phenotypic Biomarker Detection in Circulating Tumor Cells DL38584 LCD, MolDX, Circulating Tumor Cells Economic Affairs
June 12 Joint Comments on MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer DL38586 LCD, MolDX, Bladder Cancer Economic Affairs
June 12 Joint Comments on MolDX: Liquid Biopsies for Solid Organ Transplantation DL38582 LCD, MolDX, Liquid Biopsy Economic Affairs
May 29 AMP Recommendations on Public Health Emergency Sections of the Cures 2.0 Concept Paper Cures 2.0, Coverage, COVID-19, PHE Professional Relations
May 4 AMP Response to the FDA Citizen Petition on Behalf of the Coalition to Preserve Access to Pharmacogenomics (PGx) FDA, PGx, Citizen Petition Professional Relations
April 29 AMP-CAP Sign-on Letter Requesting Immediate National Coverage for Multiplex PCR Respiratory Viral Panel (RVP) Tests COVID-19, CMS, PCR RVP, sign-on Economics Affairs
April 22 AMP Sign-on Letter Requesting Hazard Pay for Laboratory Professionals during COVID-19 Pandemic COVID-19, Hazard Pay, sign-on Professional Relations
April 20 Multi-Society Sign-on Letter to Support Congressional Resolution to Denounce Anti-Asian Discrimination as Related to COVID-19 COVID-19, sign-on Professional Relations
February 26 AMP Response to Creation of Personalized Medicine Caucus Personalized Medicine Caucus Professional Relations

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