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Legislative Progress
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Verified Innovative Testing in American Laboratories Act of 2020 or the VITAL Act of 2020 This bill expressly shifts the regulation of laboratory-developed testing procedures from the Food and Drug Administration (FDA) to the Centers for Medicare & Medicaid Services (CMS). Under current law, the FDA regulates the safety and effectiveness, as well as quality of design and manufacture, of laboratory-developed tests, while the CMS regulates clinical laboratories and testing processes. Historically, the FDA has exercised enforcement discretion and not enforced certain statutory and regulatory requirements with respect to these tests. The CMS must hold a public meeting to solicit recommendations to update existing regulations related to clinical laboratories, and the Department of Health and Human Services must report specified information to Congress, including an assessment of the availability and use of laboratory-developed testing procedures during the COVID-19 (i.e., coronavirus disease 2019) response.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (5)
2021 · first_quarter · Health Issues
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
HR 6578 Public Health Workforce Loan Repayment Act Cures 20.0 HR 1868 - to prevent across-the-board direct spending cuts and other purposes HR 1319 - American Rescue Plan Act Paul Coverdell Forensic Science Grant Program The Diagnostic Accuracy & Information Act Independent Advisory Payment Boaqrds S3512 - VITAL Act of 2020 - Verified Innovation Testing in American Laboratories Act of 2020 The Health Workforce Resilience Act Conrad State 30 and Physician Access Reauthorization Act CLIA Waiver HR8337 - Continuing Appropriations Act, 2021 and Other Extensions Act
Client expense: $137,521 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Medical/Disease Research/Clinical Labs
Legislation to regulate in vitro clinical diagnostic tests, including the Verifying Accurate, Leading-edge IVCT Development (VALID) Act (H.R.6102; S.3404); and the Verified Innovative Testing in American Laboratories (VITAL) Act (S.3512); Coronavirus relief and stimulus legislation as it relates to clinical laboratories and medical practices; coronavirus testing and vaccine supply chain issues.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2020 · fourth_quarter · Health Issues
Paul Coverdell Forensic Science Grant Program The Diagnostic Accuracy & Information Act Independent Advisory Payment Boards S3512, VITAL Act of 2020 - Verified Innovative Testing in American Laboratories Act of 2020 Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) Coronavirus Aid, Relief, and Economic Securities (CARES) Act The Health Workforce Resilience Act "Conrad State 30 and Physician Access Reauthorization Act Clia Waiver HR8337 - Continuing Appropriations Act, 2021 and Other Extensions Act
Client expense: $183,583 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 6102/S. 3404, Verifying Accurate Leading-Edge IVCT Development (VALID) Act Coverage S.3512, Verified Innovative Testing in American Laboratories (VITAL) Act Laboratory test supply shortages
Client expense: Not reported · Firm income: $37,500
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Paul Coverdell Forensic Science Grant Program The Diagnostic Accuracy & Information Act Independent Advisory Payment Boards S3512, VITAL Act of 2020 - Verified Innovative Testing in American Laboratories Act of 2020 Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) Coronavirus Aid, Relief, and Economic Securities (CARES) Act The Health Workforce Resilience Act "Conrad State 30 and Physician Access Reauthorization Act Clia Waiver
Client expense: $134,437 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Medical/Disease Research/Clinical Labs
H.R. 6102/S. 3404, Verifying Accurate Leading-Edge IVCT Development (VALID) Act Coverage S.3512, Verified Innovative Testing in American Laboratories (VITAL) Act Laboratory test supply shortages
Client expense: Not reported · Firm income: $37,500
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Support for immune-driven biotechnologies platforms. VALID Act of 2020 (H.R. 6102/S. 3404), VITAL Act of 2020 (S. 3512), Eliminating Kickbacks in Recovery Act of 2018, 21st Century Cures Act.
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Medicare/Medicaid
Support for immune-driven biotechnologies platforms. VALID Act of 2020 (H.R. 6102/S. 3404), VITAL Act of 2020 (S. 3512), Eliminating Kickbacks in Recovery Act of 2018, 21st Century Cures Act.
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Medical/Disease Research/Clinical Labs
Appropriations for CDC initiative to establish pediatric reference intervals for clinical diagnostic testing; prospective legislation to regulate in vitro clinical diagnostic tests, including the Verifying Accurate, Leading-edge IVCT Development (VALID) Act (H.R.6102; S.3404); and the Verified Innovative Testing in American Laboratories (VITAL) Act (S.3512); Coronavirus relief and stimulus legislation as it relates to clinical laboratories and medical practices; coronavirus testing supply chain issues.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2020 · second_quarter · Health Issues
Support for immune-driven biotechnologies platforms. VALID Act of 2020 (H.R.6102/S.3404) VITAL Act of 2020 (S.3512), Eliminating Kickbacks in Recovery Act of 2018, 21st Century Cures Act.
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · second_quarter · Medicare/Medicaid
Support for immune-driven biotechnologies platforms. VALID Act of 2020 (H.R.6102/S.3404) VITAL Act of 2020 (S.3512), Eliminating Kickbacks in Recovery Act of 2018, 21st Century Cures Act.
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · second_quarter · Health Issues
Paul Coverdell Forensic Science Grant Program The Diagnostic Accuracy & Information Act Independent Advisory Payment Boards S3512, VITAL Act of 2020 - Verified Innovative Testing in American Laboratories Act of 2020 Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) Coronavirus Aid, Relief, and Economic Securities (CARES) Act The Health Workforce Resilience Act "Conrad State 30 and Physician Access Reauthorization Act Clia Waiver
Client expense: $195,130 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Medical/Disease Research/Clinical Labs
H.R. 6102/S. 3404, Verifying Accurate Leading-Edge IVCT Development (VALID) Act Coverage S.3512, Verified Innovative Testing in American Laboratories (VITAL) Act Laboratory test supply shortages
Client expense: Not reported · Firm income: $37,500
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Medical/Disease Research/Clinical Labs
Appropriations to CDC for harmonization of diagnostic laboratory test results; Appropriations for CDC initiative to establish pediatric reference intervals for clinical diagnostic testing; proposed legislation to establish clinical laboratory workforce development initiatives under the Public Health Service Act and other potential legislative vehicles; prospective legislation to regulate in vitro clinical diagnostic tests, including the Verifying Accurate, Leading-edge IVCT Development (VALID) Act (H.R.6102; S.3404); and the Verified Innovative Testing in American Laboratories (VITAL) Act (S.3512); Coronavirus relief and stimulus legislation as it relates to clinical laboratories and medical practices; coronavirus testing supply chain issues.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2020 · first_quarter · Medical/Disease Research/Clinical Labs
Appropriations to CDC for harmonization of diagnostic laboratory test results; Appropriations for CDC initiative to establish pediatric reference intervals for clinical diagnostic testing; proposed legislation to establish clinical laboratory workforce development initiatives under the Public Health Service Act and other potential legislative vehicles; prospective legislation to regulate in vitro clinical diagnostic tests, including the Verifying Accurate, Leading-edge IVCT Development (VALID) Act (H.R.6102; S.3404); and the Verified Innovative Testing in American Laboratories (VITAL) Act (S.3512).
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Medical/Disease Research/Clinical Labs
H.R. 6102/S. 3404, Verifying Accurate Leading-Edge IVCT Development (VALID) Act Coverage S.3512, Verified Innovative Testing in American Laboratories (VITAL) Act
Client expense: Not reported · Firm income: $37,500
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Medical/Disease Research/Clinical Labs
On February 28, 2020 AACC wrote to the Food and Drug Administration requesting that the agency permit laboratories develop laboratory developed tests to detect COVID-19 without having to obtain an Emergency Use Authorization from the agency. On March 25, 2020 AACC wrote to the Department of Health and Human Services requesting that pathologists and related staff be permitted to work offside during the COVID-19 pandemic under their existing CLIA lab certificate. On March 27, 2020 AACC endorsed S.3512, the Verified Innovative Testing in American Laboratories (VITAL) Act, which would codify federal regulation of laboratory developed tests under the Clinical Laboratory Improvement Amendment regulations overseen by the Centers for Medicare and Medicaid Services.
Client expense: $70,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE