CYNTHIA BENS

Congressional Personalized Medicine Caucus Genetic Testing and Genomic Sequencing for Rare Diseases S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act S.2761/H.R.5269 Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act Implementation of the Inflation Reduction Act of 2022 Medicare Drug Price Negotiation Provisions Implementation of Rural Health Transformation Program Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model [CMS-5546-P] Global Benchmark for Efficient Drug Pricing (GLOBE) Model [CMS-5545-P] Reclassification of Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments [Docket No. FDA-2025-N-4622] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Genetic Testing and Genomic Sequencing for Rare Diseases S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act S.2761/H.R.5269 Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act Implementation of the Inflation Reduction Act of 2022 Medicare Drug Price Negotiation Provisions Implementation of Rural Health Transformation Program Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model [CMS-5546-P] Global Benchmark for Efficient Drug Pricing (GLOBE) Model [CMS-5545-P] Reclassification of Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments [Docket No. FDA-2025-N-4622] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Genetic Testing and Genomic Sequencing for Rare Diseases S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act S.2761/H.R.5269 Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act Implementation of the Inflation Reduction Act of 2022 Medicare Drug Price Negotiation Provisions Implementation of Rural Health Transformation Program Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model [CMS-5546-P] Global Benchmark for Efficient Drug Pricing (GLOBE) Model [CMS-5545-P] Reclassification of Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments [Docket No. FDA-2025-N-4622] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Genetic Testing and Genomic Sequencing for Rare Diseases S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act S.2761/H.R.5269 Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act Implementation of the Inflation Reduction Act of 2022 Medicare Drug Price Negotiation Provisions Implementation of Rural Health Transformation Program Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model [CMS-5546-P] Global Benchmark for Efficient Drug Pricing (GLOBE) Model [CMS-5545-P] Reclassification of Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments [Docket No. FDA-2025-N-4622] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act House Energy and Commerce Committee Privacy Working Group Request for Information CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program; Draft Guidance for the Medicare Drug Price Negotiation Program: Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Office of Science and Technology Policy Request for Information on the Development of an Artificial Intelligence (AI) Action Plan Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations [FDA-2024-D-4488] Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products [FDA-2024-D-4689] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act House Energy and Commerce Committee Privacy Working Group Request for Information CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program; Draft Guidance for the Medicare Drug Price Negotiation Program: Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Office of Science and Technology Policy Request for Information on the Development of an Artificial Intelligence (AI) Action Plan Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations [FDA-2024-D-4488] Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products [FDA-2024-D-4689] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act House Energy and Commerce Committee Privacy Working Group Request for Information CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program; Draft Guidance for the Medicare Drug Price Negotiation Program: Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Office of Science and Technology Policy Request for Information on the Development of an Artificial Intelligence (AI) Action Plan Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations [FDA-2024-D-4488] Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products [FDA-2024-D-4689] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act House Energy and Commerce Committee Privacy Working Group Request for Information CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program; Draft Guidance for the Medicare Drug Price Negotiation Program: Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Office of Science and Technology Policy Request for Information on the Development of an Artificial Intelligence (AI) Action Plan Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations [FDA-2024-D-4488] Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products [FDA-2024-D-4689] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act House Energy and Commerce Committee Privacy Working Group Request for Information CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program; Draft Guidance for the Medicare Drug Price Negotiation Program: Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Office of Science and Technology Policy Request for Information on the Development of an Artificial Intelligence (AI) Action Plan Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations [FDA-2024-D-4488] Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products [FDA-2024-D-4689] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act House Energy and Commerce Committee Privacy Working Group Request for Information CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program; Draft Guidance for the Medicare Drug Price Negotiation Program: Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Office of Science and Technology Policy Request for Information on the Development of an Artificial Intelligence (AI) Action Plan Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations [FDA-2024-D-4488] Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products [FDA-2024-D-4689] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act House Energy and Commerce Committee Privacy Working Group Request for Information CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program; Draft Guidance for the Medicare Drug Price Negotiation Program: Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Office of Science and Technology Policy Request for Information on the Development of an Artificial Intelligence (AI) Action Plan Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations [FDA-2024-D-4488] Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products [FDA-2024-D-4689] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act House Energy and Commerce Committee Privacy Working Group Request for Information CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program; Draft Guidance for the Medicare Drug Price Negotiation Program: Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Office of Science and Technology Policy Request for Information on the Development of an Artificial Intelligence (AI) Action Plan Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations [FDA-2024-D-4488] Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products [FDA-2024-D-4689] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Genetic Testing and Genomic Sequencing for Rare Diseases H.R. 2471 Right Drug Dose Now Act S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act Implementation of the Inflation Reduction Act of 2022 Medicare Drug Price Negotiation Provisions Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program (CMS-1832-P) Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency (CMS-1834-P) Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Genetic Testing and Genomic Sequencing for Rare Diseases H.R. 2471 Right Drug Dose Now Act S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act Implementation of the Inflation Reduction Act of 2022 Medicare Drug Price Negotiation Provisions Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program (CMS-1832-P) Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency (CMS-1834-P) Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Genetic Testing and Genomic Sequencing for Rare Diseases H.R. 2471 Right Drug Dose Now Act S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act Implementation of the Inflation Reduction Act of 2022 Medicare Drug Price Negotiation Provisions Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program (CMS-1832-P) Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency (CMS-1834-P) Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Genetic Testing and Genomic Sequencing for Rare Diseases H.R. 2471 Right Drug Dose Now Act S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act Implementation of the Inflation Reduction Act of 2022 Medicare Drug Price Negotiation Provisions Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program (CMS-1832-P) Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency (CMS-1834-P) Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Genetic Testing and Genomic Sequencing for Rare Diseases H.R. 2471 Right Drug Dose Now Act S. 832/H.R. 1492 the Ensuring Pathways to Innovative Cures Act H.R. 946 Optimizing Research Progress Hope and New Cures Act H.R. 1672 Maintaining Investments in New Innovation Act Implementation of the Inflation Reduction Act of 2022 Medicare Drug Price Negotiation Provisions Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program (CMS-1832-P) Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes (CMS-1833-P) Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency (CMS-1834-P) Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

FY 2025 Food and Drug Administration Budget Priorities for CDER, CBER and CDRH FY 2025 National Institutes of Health Budget Priorities H.R. 10545 The American Relief Act of 2025

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.0 Initiative Response to House Request for Information American Privacy Rights Act provisions related to personalized medicine Oversight of Laboratory Developed Tests H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 8267 Old Drugs, New Cures Act H.R. 2407 Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027 Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; etc (CMS-1809P) Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) Agency for Healthcare Research and Qualitys (AHRQs) Review Protocol titled: Blood-based Tests for Multiple Cancer Screening: A Systematic Review Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No. FDA-2021-D0789] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.1 Oversight of Laboratory Developed Tests H.R. 3876/S. 2323 Access to Genetic Counselor Services Act H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) FDA Center for Drug Evaluation and Research AI Council Priorities Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.1 Oversight of Laboratory Developed Tests H.R. 3876/S. 2323 Access to Genetic Counselor Services Act H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) FDA Center for Drug Evaluation and Research AI Council Priorities Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.0 Initiative Response to House Request for Information American Privacy Rights Act provisions related to personalized medicine Oversight of Laboratory Developed Tests H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 8267 Old Drugs, New Cures Act H.R. 2407 Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027 Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; etc (CMS-1809P) Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) Agency for Healthcare Research and Qualitys (AHRQs) Review Protocol titled: Blood-based Tests for Multiple Cancer Screening: A Systematic Review Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No. FDA-2021-D0789] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.1 Oversight of Laboratory Developed Tests H.R. 3876/S. 2323 Access to Genetic Counselor Services Act H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) FDA Center for Drug Evaluation and Research AI Council Priorities Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.0 Initiative Response to House Request for Information American Privacy Rights Act provisions related to personalized medicine Oversight of Laboratory Developed Tests H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 8267 Old Drugs, New Cures Act H.R. 2407 Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027 Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; etc (CMS-1809P) Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) Agency for Healthcare Research and Qualitys (AHRQs) Review Protocol titled: Blood-based Tests for Multiple Cancer Screening: A Systematic Review Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No. FDA-2021-D0789] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.0 Initiative Response to House Request for Information American Privacy Rights Act provisions related to personalized medicine Oversight of Laboratory Developed Tests H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 8267 Old Drugs, New Cures Act H.R. 2407 Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027 Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; etc (CMS-1809P) Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) Agency for Healthcare Research and Qualitys (AHRQs) Review Protocol titled: Blood-based Tests for Multiple Cancer Screening: A Systematic Review Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No. FDA-2021-D0789] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.1 Oversight of Laboratory Developed Tests H.R. 3876/S. 2323 Access to Genetic Counselor Services Act H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) FDA Center for Drug Evaluation and Research AI Council Priorities Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.0 Initiative Response to House Request for Information American Privacy Rights Act provisions related to personalized medicine Oversight of Laboratory Developed Tests H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 8267 Old Drugs, New Cures Act H.R. 2407 Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027 Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; etc (CMS-1809P) Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) Agency for Healthcare Research and Qualitys (AHRQs) Review Protocol titled: Blood-based Tests for Multiple Cancer Screening: A Systematic Review Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No. FDA-2021-D0789] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.1 Oversight of Laboratory Developed Tests H.R. 3876/S. 2323 Access to Genetic Counselor Services Act H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) FDA Center for Drug Evaluation and Research AI Council Priorities Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.1 Oversight of Laboratory Developed Tests H.R. 3876/S. 2323 Access to Genetic Counselor Services Act H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) FDA Center for Drug Evaluation and Research AI Council Priorities Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.0 Initiative Response to House Request for Information American Privacy Rights Act provisions related to personalized medicine Oversight of Laboratory Developed Tests H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 8267 Old Drugs, New Cures Act H.R. 2407 Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027 Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; etc (CMS-1809P) Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) Agency for Healthcare Research and Qualitys (AHRQs) Review Protocol titled: Blood-based Tests for Multiple Cancer Screening: A Systematic Review Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No. FDA-2021-D0789] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.0 Initiative Response to House Request for Information American Privacy Rights Act provisions related to personalized medicine Oversight of Laboratory Developed Tests H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 8267 Old Drugs, New Cures Act H.R. 2407 Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027 Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; etc (CMS-1809P) Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) Agency for Healthcare Research and Qualitys (AHRQs) Review Protocol titled: Blood-based Tests for Multiple Cancer Screening: A Systematic Review Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No. FDA-2021-D0789] Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.1 Oversight of Laboratory Developed Tests H.R. 3876/S. 2323 Access to Genetic Counselor Services Act H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) FDA Center for Drug Evaluation and Research AI Council Priorities Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 2144/S. 1450 Access to Genetic Counselors Services Act H.R. 5376 Inflation Reduction Act of 2022 Food and Drug Omnibus Reform Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act S. 2022 Ending the Diagnostic Odyssey Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 6202 the Telehealth Extension Act S. 3593 the Telehealth Extension and Evaluation Act Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 CMMI Oncology Care Model/Oncology Care First

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 Reimbursement for Chimeric antigen receptor T cell therapy in FY 2023 IPPS Proposed Rule

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 and S.4348 FDASLA Act of 2022 H.R. 5376 Inflation Reduction Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Medicare Advantage Request for Information CMS Calendar Year 2023 Physician Fee Schedule Proposed Rule CMS/CMMI Enhancing Oncology Model

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 2144/S. 1450 Access to Genetic Counselors Services Act H.R. 5376 Inflation Reduction Act of 2022 Food and Drug Omnibus Reform Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 and S.4348 FDASLA Act of 2022 H.R. 5376 Inflation Reduction Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Medicare Advantage Request for Information CMS Calendar Year 2023 Physician Fee Schedule Proposed Rule CMS/CMMI Enhancing Oncology Model

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 2144/S. 1450 Access to Genetic Counselors Services Act H.R. 5376 Inflation Reduction Act of 2022 Food and Drug Omnibus Reform Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 2144/S. 1450 Access to Genetic Counselors Services Act H.R. 5376 Inflation Reduction Act of 2022 Food and Drug Omnibus Reform Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act S. 2022 Ending the Diagnostic Odyssey Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 6202 the Telehealth Extension Act S. 3593 the Telehealth Extension and Evaluation Act Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 CMMI Oncology Care Model/Oncology Care First

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 and S.4348 FDASLA Act of 2022 H.R. 5376 Inflation Reduction Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Medicare Advantage Request for Information CMS Calendar Year 2023 Physician Fee Schedule Proposed Rule CMS/CMMI Enhancing Oncology Model

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 Reimbursement for Chimeric antigen receptor T cell therapy in FY 2023 IPPS Proposed Rule

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 and S.4348 FDASLA Act of 2022 H.R. 5376 Inflation Reduction Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Medicare Advantage Request for Information CMS Calendar Year 2023 Physician Fee Schedule Proposed Rule CMS/CMMI Enhancing Oncology Model

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 2144/S. 1450 Access to Genetic Counselors Services Act H.R. 5376 Inflation Reduction Act of 2022 Food and Drug Omnibus Reform Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 Reimbursement for Chimeric antigen receptor T cell therapy in FY 2023 IPPS Proposed Rule

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act S. 2022 Ending the Diagnostic Odyssey Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 6202 the Telehealth Extension Act S. 3593 the Telehealth Extension and Evaluation Act Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 CMMI Oncology Care Model/Oncology Care First

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act S. 2022 Ending the Diagnostic Odyssey Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 6202 the Telehealth Extension Act S. 3593 the Telehealth Extension and Evaluation Act Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 CMMI Oncology Care Model/Oncology Care First

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 Reimbursement for Chimeric antigen receptor T cell therapy in FY 2023 IPPS Proposed Rule

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 2144/S. 1450 Access to Genetic Counselors Services Act H.R. 5376 Inflation Reduction Act of 2022 Food and Drug Omnibus Reform Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 and S.4348 FDASLA Act of 2022 H.R. 5376 Inflation Reduction Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Medicare Advantage Request for Information CMS Calendar Year 2023 Physician Fee Schedule Proposed Rule CMS/CMMI Enhancing Oncology Model

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act S. 2022 Ending the Diagnostic Odyssey Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 6202 the Telehealth Extension Act S. 3593 the Telehealth Extension and Evaluation Act Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 CMMI Oncology Care Model/Oncology Care First

H.R.7667 the Food and Drug Amendments of 2022 S. 4348 the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 FY 2023 Food and Drug Administration Budget Priorities for CDRH, CDER and CBER FY 2023 National Institutes of Health Budget Priorities

H.R.7667 the Food and Drug Amendments of 2022 S. 4348 the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 FY 2023 Food and Drug Administration Budget Priorities for CDRH, CDER and CBER FY 2023 National Institutes of Health Budget Priorities

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 2144/S. 1450 Access to Genetic Counselors Services Act H.R. 5376 Inflation Reduction Act of 2022 Food and Drug Omnibus Reform Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act S. 2022 Ending the Diagnostic Odyssey Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 6202 the Telehealth Extension Act S. 3593 the Telehealth Extension and Evaluation Act Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 CMMI Oncology Care Model/Oncology Care First

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act S. 2022 Ending the Diagnostic Odyssey Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 6202 the Telehealth Extension Act S. 3593 the Telehealth Extension and Evaluation Act Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 CMMI Oncology Care Model/Oncology Care First

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 Reimbursement for Chimeric antigen receptor T cell therapy in FY 2023 IPPS Proposed Rule

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 and S.4348 FDASLA Act of 2022 H.R. 5376 Inflation Reduction Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Medicare Advantage Request for Information CMS Calendar Year 2023 Physician Fee Schedule Proposed Rule CMS/CMMI Enhancing Oncology Model

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 2144/S. 1450 Access to Genetic Counselors Services Act H.R. 5376 Inflation Reduction Act of 2022 Food and Drug Omnibus Reform Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act S. 2022 Ending the Diagnostic Odyssey Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 H.R. 6202 the Telehealth Extension Act S. 3593 the Telehealth Extension and Evaluation Act Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Transitional Coverage of Emerging Technology (TCET) CMS Transmittal 10832 Removal of ICD-10 Not Otherwise Specified (NOS) Codes Under National Coverage Determination (NCD) 90.2 CMMI Oncology Care Model/Oncology Care First

H.R.7667 the Food and Drug Amendments of 2022 S. 4348 the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 FY 2023 Food and Drug Administration Budget Priorities for CDRH, CDER and CBER FY 2023 National Institutes of Health Budget Priorities

H.R.7667 the Food and Drug Amendments of 2022 S. 4348 the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 FY 2023 Food and Drug Administration Budget Priorities for CDRH, CDER and CBER FY 2023 National Institutes of Health Budget Priorities

Congressional Personalized Medicine Caucus H.R. 5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 H.R. 6875 Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 and S.4348 FDASLA Act of 2022 H.R. 5376 Inflation Reduction Act of 2022 Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community CMS Medicare Advantage Request for Information CMS Calendar Year 2023 Physician Fee Schedule Proposed Rule CMS/CMMI Enhancing Oncology Model

Congressional Personalized Medicine Caucus H.R.5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 Draft bill Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 Support for FDA Commissioner Nomination Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community Delay of Clinical Laboratory Fee Schedule Cuts under the Protecting Access to Medicare Act of 2014 CMS Medicare Coverage for Innovative Technology Pathway and Definition of Reasonable and Necessary CMS Most Favored Nations Model CMMI Oncology Care Model/Oncology Care First Local Coverage Determination on Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms

Congressional Personalized Medicine Caucus H.R.5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 Draft bill Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 Support for FDA Commissioner Nomination Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community Delay of Clinical Laboratory Fee Schedule Cuts under the Protecting Access to Medicare Act of 2014 CMS Medicare Coverage for Innovative Technology Pathway and Definition of Reasonable and Necessary CMS Most Favored Nations Model CMMI Oncology Care Model/Oncology Care First Local Coverage Determination on Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms

Congressional Personalized Medicine Caucus H.R.5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 Draft bill Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 Support for FDA Commissioner Nomination Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community Delay of Clinical Laboratory Fee Schedule Cuts under the Protecting Access to Medicare Act of 2014 CMS Medicare Coverage for Innovative Technology Pathway and Definition of Reasonable and Necessary CMS Most Favored Nations Model CMMI Oncology Care Model/Oncology Care First Local Coverage Determination on Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms

Congressional Personalized Medicine Caucus H.R.5989 Precision Medicine Answers for Kids Today Act H.R. 6000 Cures 2.0 Draft bill Right Drug Dose Now Act H.R. 4128/S.2209 The VALID Act of 2021 Support for FDA Commissioner Nomination Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community Delay of Clinical Laboratory Fee Schedule Cuts under the Protecting Access to Medicare Act of 2014 CMS Medicare Coverage for Innovative Technology Pathway and Definition of Reasonable and Necessary CMS Most Favored Nations Model CMMI Oncology Care Model/Oncology Care First Local Coverage Determination on Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms

Congressional Personalized Medicine Caucus Barriers to Genetic Testing for ALS/Congressional ALS Caucus Briefing H.R. 4393 Advancing Access to Precision Medicine Act H.R. 4144 Ending the Diagnostic Odyssey Act Draft bill Personalizing Medications Act Draft bill Rare Cancer Awareness, Research, and Treatment Act Medicare Coverage of Innovative Technology (MCIT)Pathway CMS Coverage for Minimal Residual Disease Testing CMS National Coverage Analysis for Colorectal Cancer Screening using Blood-Based Biomarker Testing CMS Laboratory Date-of-Service Policy Changes in CY 2021 Hospital OPPS Proposed Rule Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Congressional Personalized Medicine Caucus Barriers to Genetic Testing for ALS/Congressional ALS Caucus Briefing H.R. 4393 Advancing Access to Precision Medicine Act H.R. 4144 Ending the Diagnostic Odyssey Act Draft bill Personalizing Medications Act Draft bill Rare Cancer Awareness, Research, and Treatment Act Medicare Coverage of Innovative Technology (MCIT)Pathway CMS Coverage for Minimal Residual Disease Testing CMS National Coverage Analysis for Colorectal Cancer Screening using Blood-Based Biomarker Testing CMS Laboratory Date-of-Service Policy Changes in CY 2021 Hospital OPPS Proposed Rule Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

H.R. 6102/S. 3404 Verifying Accurate Leading-edge IVCT Development (VALID) Act Congressional Personalized Medicine Caucus H.R. 5741 "Strengthening Innovation In Medicare and Medicaid Act" CMS National Coverage Analysis for Blood-Based Screening Tests in Colorectal Cancer CMS Reimbursement Policy for Chimeric Antigen Receptor (CAR) T-cell Therapy FDA Activities on Pharmacogenomic Tests

H.R. 6102/S. 3404 Verifying Accurate Leading-edge IVCT Development (VALID) Act 21st Century Cures 2.0 Concept Paper Congressional Personalized Medicine Caucus CMS Reimbursement Policy for Chimeric Antigen Receptor (CAR) T-cell Therapy

H.R. 6102/S. 3404 Verifying Accurate Leading-edge IVCT Development (VALID) Act Congressional Personalized Medicine Caucus H.R. 5741 "Strengthening Innovation In Medicare and Medicaid Act" CMS National Coverage Analysis for Blood-Based Screening Tests in Colorectal Cancer CMS Reimbursement Policy for Chimeric Antigen Receptor (CAR) T-cell Therapy FDA Activities on Pharmacogenomic Tests

H.R. 6102/S. 3404 Verifying Accurate Leading-edge IVCT Development (VALID) Act 21st Century Cures 2.0 Concept Paper Congressional Personalized Medicine Caucus CMS Reimbursement Policy for Chimeric Antigen Receptor (CAR) T-cell Therapy

H.R. 6102/S. 3404 Verifying Accurate Leading-edge IVCT Development (VALID) Act Congressional Personalized Medicine Caucus H.R. 5741 "Strengthening Innovation In Medicare and Medicaid Act" CMS National Coverage Analysis for Blood-Based Screening Tests in Colorectal Cancer CMS Reimbursement Policy for Chimeric Antigen Receptor (CAR) T-cell Therapy FDA Activities on Pharmacogenomic Tests

Verifying Accurate Leading-edge IVCT Development (VALID) Act House Discussion Draft Patient Centered Outcomes Research Institute Reauthorization Congressional Personalized Medicine Caucus H.R.4393 "Advancing Access to Precision Medicine Act" H.R. 4144 "Ending the Diagnostic Odyssey Act of 2019" H.R.3235 "Access to Genetic Counselor Services Act of 2019" S.2543 "Prescription Drug Pricing Reduction Act of 2019" CMS Potential Revisions to Laboratory Date of Service Policy in CY 2020 Hospital Outpatient Prospective Payment System Rule FDA Center for Devices and Radiological Health List of Patient Preference-Sensitive Priorities FDA Activities on Pharmacogenomic Tests Support for full appointment of Acting FDA Commissioner Ned Sharpless

Verifying Accurate Leading-edge IVCT Development (VALID) Act House Discussion Draft 21st Century Cures 2.0 RFI Patient Centered Outcomes Research Institute Reauthorization Congressional Personalized Medicine Caucus H.R. 4144 "Ending the Diagnostic Odyssey Act of 2019" CMS Proposed Decision Memo Coverage of Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer CMS Oncology Care First Model RFI FDA Activities on Pharmacogenomic Tests Support for FDA Commissioner Nominee Steve Hahn

Verifying Accurate Leading-edge IVCT Development (VALID) Act House Discussion Draft Patient Centered Outcomes Research Institute Reauthorization Congressional Personalized Medicine Caucus H.R.4393 "Advancing Access to Precision Medicine Act" H.R. 4144 "Ending the Diagnostic Odyssey Act of 2019" H.R.3235 "Access to Genetic Counselor Services Act of 2019" S.2543 "Prescription Drug Pricing Reduction Act of 2019" CMS Potential Revisions to Laboratory Date of Service Policy in CY 2020 Hospital Outpatient Prospective Payment System Rule FDA Center for Devices and Radiological Health List of Patient Preference-Sensitive Priorities FDA Activities on Pharmacogenomic Tests Support for full appointment of Acting FDA Commissioner Ned Sharpless

Verifying Accurate Leading-edge IVCT Development (VALID) Act House Discussion Draft Patient Centered Outcomes Research Institute Reauthorization Congressional Personalized Medicine Caucus H.R.4393 "Advancing Access to Precision Medicine Act" H.R. 4144 "Ending the Diagnostic Odyssey Act of 2019" H.R.3235 "Access to Genetic Counselor Services Act of 2019" S.2543 "Prescription Drug Pricing Reduction Act of 2019" CMS Potential Revisions to Laboratory Date of Service Policy in CY 2020 Hospital Outpatient Prospective Payment System Rule FDA Center for Devices and Radiological Health List of Patient Preference-Sensitive Priorities FDA Activities on Pharmacogenomic Tests Support for full appointment of Acting FDA Commissioner Ned Sharpless

Verifying Accurate Leading-edge IVCT Development (VALID) Act House Discussion Draft Patient Centered Outcomes Research Institute Reauthorization Congressional Personalized Medicine Caucus H.R.4393 "Advancing Access to Precision Medicine Act" H.R. 4144 "Ending the Diagnostic Odyssey Act of 2019" H.R.3235 "Access to Genetic Counselor Services Act of 2019" S.2543 "Prescription Drug Pricing Reduction Act of 2019" CMS Potential Revisions to Laboratory Date of Service Policy in CY 2020 Hospital Outpatient Prospective Payment System Rule FDA Center for Devices and Radiological Health List of Patient Preference-Sensitive Priorities FDA Activities on Pharmacogenomic Tests Support for full appointment of Acting FDA Commissioner Ned Sharpless

H.R. 5062 Access to Precision Medicine Advancement Act Diagnostics Accuracy and Innovation Act Regulation of Laboratory Developed Tests Personalized Medicine Caucus CMS National Coverage Determination for Next Generation Sequencing in Advanced Cancer

H.R. 5062 Access to Precision Medicine Advancement Act Diagnostics Accuracy and Innovation Act Regulation of Laboratory Developed Tests Personalized Medicine Caucus National Coverage Determination for Next Generation Sequencing in Advanced Cancer National Coverage Analysis for CAR T-cell Therapy Medicare Hospital Inpatient Prospective Payment System Proposed Rule for FY 2019

H.R. 5062 Access to Precision Medicine Advancement Act Diagnostics Accuracy and Innovation Act Verifying Accurate Leading-edge IVCT Development (VALID)Act of 2018 National Coverage Analysis for CAR T-cell Therapy Long Term Follow-Up After Administration of Human Gene Therapy Products Protecting Access to Medicare Act Implementation Calendar Year 2019 Clinical Laboratory Fee Schedule Preliminary Determinations Medicare Advantage Prior Authorization and Step Therapy for Part B Drugs Advance Notice of Proposed Rulemaking International Pricing Index Model (IPI) for Medicare Part B Drugs Personalized Medicine Caucus

H.R. 5062 Access to Precision Medicine Advancement Act Diagnostics Accuracy and Innovation Act Regulation of Laboratory Developed Tests Personalized Medicine Caucus National Coverage Analysis for CAR T-cell Therapy Protecting Access to Medicare Act Implementation Blueprint to Lower Drug Prices and Out-of-Pocket Costs