Policy Areas

Access and Affordability of Healthcare

Access to Affordable, High-Quality Healthcare Coverage and Services

• ACMG-ASHG-NSGC Joint Response to Supreme Court Decision to Overrule Roe v Wade (2022)
• ACMG Calls on Courts to Stop Texas Abortion Law (2021)
• ACMG Responds to Court Decision on Ohio Law Criminalizing Physicians for Providing Healthcare Services Requested by Their Patients (2021)
• Insuring patient access and affordability for treatments for rare and ultrarare diseases: a policy statement of the ACMG (2018) 
• Considerations in healthcare reform for patients and families with genetic diseases: a statement of the American College of Medical Genetics and Genomics (2018) 
• CMSS Letter to US Senate and House of Representatives (2017)

Coverage and Reimbursement

Reimbursement of Genetics Professional Services

• ACMG Letter to Congress Supporting Reimbursement of Genetic Counseling Services (2021)
• Understanding the Details: ACMG’s Position on the Access to Genetic Counselor Services Act (2021)
• ACMG Letter to Congress on HR 3235 (2020)
• ACMG Recommends Recognition of Board-Certified Clinical Laboratory Professionals as Qualified Healthcare Professionals (2019)

Value of a Diagnosis

• Developing a Value Framework for Genetic Diagnosis: A Systematic Review of Outcomes Hierarchies and Measurement Approaches (2012) 

Centers for Medicare & Medicaid Services (CMS) and National Coverage Determinations (NCDs)

• ACMG Response to CMS Proposed Rule for Changes to the CY 2021 Physician Fee Schedule and Other Payment Policies (2020)
• ACMG Asks CMS to Reconsider Final Payment Determination for New PALB2 CPT Code 81307 (2020)
• CMS Releases Final Coverage Policy Decision for NGS-Based Germline Testing for Patients with Cancer (2020)
• ACMG Comments on CMS Proposed Coverage Policy for NGS-Based Germline Tests for Cancer (2019)
• ACMG submits comments to CMS in support of coverage of NGS-based testing for Medicare beneficiaries with cancer (2019)
• ACMG Signs Letter Urging CMS to Retain Coverage of NGS-based Test for Hereditary Cancers (2019)
• ACMG Comments on CMS's Gapfill Preliminary Determinations for Whole Genome Sequencing (2018)
• ACMG Signs Letter Regarding proposed changes to Medicare E/M Services (2018) 
• ACMG Comments to CMS on Proposed NCD for Coverage of NGS for Medicare Beneficiaries with Advanced Cancer (CAG-00450N) (2018)
• ACMG Economics Committee Advocates for Restored Reimbursement of Cytogenetic Tests – Fall 2016 Medical Geneticist, pg. 10  (2016)
• CMS Expands List of Covered ICD-10 Codes for Cytogenetic Testing: Medicare Transmittal 1708: Change Request 9751, Coding Revisions to NCDs  (2016)
  • National Government Services, Inc. Adds ICD-10 Cytogenetic Testing Codes (2018) 
• CMS Adds New Specialty Code for Medical genetics and Genomics (2018)

Local Coverage Determinations (LCDs) and Medicare Administrative Contractors (MACs)

• ACMG Sends Letter to CMS Regarding the Palmetto Molecular Diagnostics (MolDX) Services Program and Its Extension to Other MACs (2013)
• ACMG Sends Comments to Palmetto GBA Regarding Cytogenetic Microarray Coverage Under Medicare (2013)

• ACMG Joins the PPMNE Coalition in Support of the Medical Nutrition Equity Act  (2021)
• ACMG Joins the PPMNE Coalition in Support of the Medical Nutrition Equity Act  (2019)
• ACMG Efforts Lead AMA Resolution 122 to Support Coverage of Medical Food Products  (2016)
• AMA Resolution 122 – Health Coverage for Nutritional Products for Inborn Errors of Metabolism D-185.982 (2016)
• ACMG Signs Letter Expressing Support for the Proposed Medical Nutrition Equity Act (S. 1194/H.R. 2587)   (2018)
  • S. 1194: Medical Nutrition Equity Act of 2017 is Introduced in the U.S. Senate (2017)
  • H.R. 2587 Medical Nutrition Equity Act of 2017 is Introduced in the U.S. House of Representative (2017)
• For Additional Information on Medical Foods for Inborn Errors of Metabolism, See Historical Perspective Presented to the ACHDNC  (2016)

Educating Lawmakers about Medical Genetics and Genomics

• ACMG-ASHG Joint Briefing on Capitol Hill - The Undiagnosed Diseases Network (UDN) (2019)

Genetic Testing

Laboratory Developed Tests (LDTs)

• ACMG/AACC/AMP/APC Joint Webinar on The Regulatory Landscape of Laboratory Developed Testing Procedures (2021)
• ACMG Comments on the Verifying Accurate, Leading-edge IVCT Development (VALID) Act of 2020 (2020)
• ACMG Joins AACC and AMP on Letter Supporting HHS Statement Clarifying Regulatory Process for LDTs (2020)
• Congress Introduces S 3404 & HR 6102, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act of 2020 (2020)
• Congress Introduces S 3512, the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020 (2020)
• Congress Releases the Verifying Accurate, Leading-edge IVCT Development (VALID) Act Discussion Draft (2018)
• ACMG Signs Letter Describing Concerns about the DAIA Draft (2018)
• Regulation of Laboratory Developed Tests (2015-2014)
• ACMG Position on LDTs (2015)
  • ACMG’s Proposed Approach for Oversight of LDTs for Inherited Conditions (2013)
• ACMG Signs Letter Requesting Withdrawal of FDA’s Draft Guidance Titled “Framework for Regulatory Oversight of Laboratory Developed Tests”(2014)
  • ACMG Sends Comments to FDA Expressing Concerns About Draft Guidance on FDA Notification and Medical Device Reporting for LDTs  (2015)
  • ACMG Sends Comments to FDA Expressing Concerns About Draft Guidance on FDA’s Proposed Regulatory Oversight of LDTs (2015)
  • FDA Announces Withdrawal of Both LDT Draft Guidances Posted in 2014  (2017)
• ACMG Signs Letter Expressing Support of CLIA Modernization for the Oversight of LDTs (2015)
  • ACMG/AMP Webinar on Impending Actions on Laboratory Developed Tests (2016)
  • ACMG/AMP/ISDA Participates in Congressional Briefing on Laboratory Developed Tests (2016)

Next-Generation Sequencing (NGS) Tests

• ACMG Provides Prepared Statement On Oversight of NGS-Based Tests at FDA Public Meeting (2016)
  • FDA Finalizes Guidance on Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics (2018)
  • FDA Finalizes Guidance on Considerations for Design, Development, and Analytical Validation of NGS-Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases (2018) 

Direct-to-Consumer (DTC) Tests

• ACMG Revised Position Statement on Direct-to-Consumer Genetic Testing (2015)
• ACMG Responds to FDA’s Approval for DTC Testing for Three BRCA Gene Mutations (2018) 

Intellectual Property

• ACMG Joins Organizations in Sending Letter to Biden Administration Concerning Patent Eligibility Reform (2021)
• ACMG and ASHG Presidents Ask Congress to Protect Existing Policies that Prevent Patenting of Genetic Information (2019)
• ACMG Signs Letter to Protect Section 101 of the Patent Act and Prevent Patenting of Genes (2019)
• Points to Consider in Preparing License Agreements for Patented Genetic Tests (2004)
• Position Statement on Gene Patents & Accessibility of Gene Testing (1999, reaffirmed 2005)
  • ACMG Lauds Federal Court Ruling of Gene Patents as Invalid  (2010)
  • ACMG Applauds Supreme Court Decision on Gene Patents (2013)

Genomic Data Sharing

• ACMG Calls on Labs to Share Variant Classification Data in Response to Wall Street Journal Article (2020)
• ACMG Position Statement on Laboratory and Clinical Genomic Data Sharing (2017)

Patient Access to Genetic and Genomic Data

• ACMG Comments on ONC Information Blocking Rule Compliance Dates (2021)
• ACMG Statement on the interface of genomic information with the electronic health record (2020)

PGx Testing

• ACMG Letter Supporting the Right Drug Dose Now Act (2022)

Medical Genetics Workforce

• CMSS Sign-On Letter to President Trump and US House of Representatives (2017)
• Congress Asks the Government Accountability Office to Assess the Medical Genetics Workforce (2018) 

Newborn Screening

Newborn Screening Saves Lives Act

• ACMG Joins Others in Urging the HHS Secretary to Reinstate the Advisory Committee on Heritable Disorders in Newborns and Children (2019)

Residual Newborn Screening Dried Blood Spots

• Position Statement on Importance of Residual Newborn Screening Dried Blood Spots (2009)
• Response to the Proposed Rule Making to Revise the Common Rule (2016)

Newborn Carrier Screening

• ACMG position statement on prenatal/preconception expanded carrier screening (2013)
• Joint Statement on Expanded Carrier Screening in Reproductive Medicine (2015) 

Prenatal Screening and Diagnosis

Noninvasive Prenatal Screening (NIPS)

• ACMG Responds to NYT Article Regarding Noninvasive Prenatal Screening (2022)
• ACMG Sends Letter of Support for the Expanded Genetic Screening Act (2021)
• ACMG Sends Letter of Support for Accurate Education for Prenatal Screenings Act (H.R. 3441) (2015)
  • H.R. 3441: Accurate Education for Prenatal Screenings Act (2015)
  • House Energy and Commerce Committee Hearing Memo on H.R. 3441 (2015)
  • ACMG Testimony of Anthony Gregg, M.D., FACMG on H.R. 3441 (2015)
• ACMG Updates Position Statement on Noninvasive Prenatal Screening for Fetal Aneuploidy  (2016) 

Privacy and Protection of Genetic Information

Employer Wellness Programs

• ACMG Position Statement on Points to Consider in Preventing Unfair Discrimination Based on Genetic Disease Risk (2001, reaffirmed 2005) 
• ACMG Sends Comments on the U.S. Equal Employment Opportunity Commission’s (EEOC) Proposed Rule for Title II of GINA (2016)
  • EEOC's Proposed Changes to the Americans with Disabilities Act Regarding Wellness Program (2015)
• ACMG Signs Letter Expressing Concerns About the Use of Genetic Information Included in the Proposed Preserving Employee Wellness Programs Act (H.R.1313) (2017)
  • H.R. 1313: Preserving Employee Wellness Programs Act (2017)

State Legislation

• Oregon House Bill 2619 - Support (2021)
• Montana House Bill 217 - Support with Amendments (2021)
• Maryland House Bill 299 - Support with Amendments (2021)
• Maryland Senate Bill 34 - Support with Amendments (2021)
• Arizona House Bill 2815 - Support with Amendments (2021)
• Rhode Island House Bill 5147 - Support with Amendments (2021)
• Rhode Island Senate Bill 111 - Support with Amendments (2021)
• New York Assembly Bill 2151 - Support with Amendments (2021)