VALID Act of 2020

American Rescue Plan implementation COVID-19 preparedness products and services Diagnostic test reimbursement and policies H.R. 6102 VALID (Verifying Accurate Leading‐edge IVCT Development) Act of 2020 Proposals related to COVID-19 medical device regulation Proposals related to newborn screening Proposals related to preserving medical supply chain COVID-19 preparedness products and services Diagnostic test reimbursement and policies

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

American Rescue Plan implementation COVID-19 preparedness products and services Diagnostic test reimbursement and policies H.R. 6102 VALID (Verifying Accurate Leading‐edge IVCT Development) Act of 2020 Proposals related to COVID-19 medical device regulation Proposals related to newborn screening Proposals related to preserving medical supply chain

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

American Rescue Plan implementation COVID-19 preparedness products and services Diagnostic test reimbursement and policies H.R. 6102 VALID (Verifying Accurate Leading‐edge IVCT Development) Act of 2020 Proposals related to COVID-19 medical device regulation Proposals related to newborn screening Proposals related to preserving medical supply chain

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

American Rescue Plan implementation COVID-19 preparedness products and services Diagnostic test reimbursement and policies H.R. 6102 VALID (Verifying Accurate Leading‐edge IVCT Development) Act of 2020 Proposals related to COVID-19 medical device regulation Proposals related to newborn screening Proposals related to preserving medical supply chain Proposals related to pandemic preparedness

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

American Rescue Plan implementation COVID-19 preparedness products and services Diagnostic test reimbursement and policies H.R. 6102 VALID (Verifying Accurate Leading‐edge IVCT Development) Act of 2020 Proposals related to COVID-19 medical device regulation Proposals related to newborn screening Proposals related to preserving medical supply chain

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to T cells, COVID testing, pandemic preparedness and immune medicine H.R. 6102 and S. 3404, The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020, all provisions H.R. 5745, COVID-19 Access to Testing and Support for Immune Response Research Act of 2021 S. 3062 Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act, FY2022

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to T cells, COVID testing, and immune medicine. H.R. 6102 and S.3404, The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020, all provisions H.R.5745 - COVID-19 Access to Testing and Support for Immune Response Research Act of 2021

Client expense: $190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to T cells, COVID testing, and immune medicine. H.R. 6102 and S.3404, The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020, all provisions

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

No Surprises Act (H.R. 133) Verifying Accurate Leading-edge IVCT Development Act of 2020 (S.3404, H.R. 6102) Rare Cancer Awareness, Research, and Treatment Act of 2020 (draft, not yet introduced) Government response to COVID-19, including liability reforms and supply chain issues Issues related to the reauthorization of the FDA drug and device user fee programs

Client expense: $130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Public Law 117-2 The American Rescue Plan Act of 2021. Public Law 116-123 Coronavirus Preparedness & Response Supplemental Appropriations Act of 2020. Public Law 116-136 CARES (Coronavirus Act, Relief, and Economic Security) Act. S. 3942 Securing America's Medical Supply Chain Act of 2020. S. 3780 Help Onshore Manufacturing Efficiencies (HOME) for Drugs and Devices Act. H.R. 6102 VALID (Verifying Accurate Leading-edge IVCT Development) Act of 2020. Proposals regarding regulatory policies affected by public health emergencies. Proposals regarding diagnostic and serologic coronavirus testing. Proposals related to the advancement, testing, and detection of Traumatic Brain Injury. Proposals related to preserving the medical supply chain. Proposals related to future pandemic preparedness.

Client expense: $1,020,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

Issues related to T cells, COVID testing, and immune medicine. H.R. 6102 and S.3404, The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020, all provisions

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6102 and S.3404, The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020, all provisions

Client expense: $130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

No Surprises Act (H.R. 133) Verifying Accurate Leading-edge IVCT Development Act of 2020 (S.3404, H.R. 6102) Temporary Reciprocity to Ensure Access to Treatment Act (S.4421, H.R. 8283) Rare Cancer Awareness, Research, and Treatment Act of 2020 (draft, not yet introduced) Government response to COVID-19, including liability reforms and supply chain issues Reauthorization of the FDA drug and device user fee programs Schrems II, government lobbying activities pertaining to data privacy COVID-19 response; White House COVID-19 Response Team's call to private business

Client expense: $190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE, White House Office

The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 (HR 6102/S 3404).

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to diagnostic testing; The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 (HR 6102/S 3404); The Access to TESTs Act (HR 747).

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Public Law 117-2 The American Rescue Plan Act of 2021. Public Law 116-123 Coronavirus Preparedness & Response Supplemental Appropriations Act of 2020. Public Law 116-136 CARES (Coronavirus Act, Relief, and Economic Security) Act. S. 3942 Securing America's Medical Supply Chain Act of 2020. S. 3780 Help Onshore Manufacturing Efficiencies (HOME) for Drugs and Devices Act. H.R. 6102 VALID (Verifying Accurate Leading-edge IVCT Development) Act of 2020. Proposals regarding regulatory policies affected by public health emergencies. Proposals regarding diagnostic and serologic coronavirus testing. Proposals related to the advancement, testing, and detection of Traumatic Brain Injury. Proposals promoting diversity in clinical trials. Proposals to advance policies related to effective pain management. Proposals related to telehealth implementation and remote monitoring. Proposals related to preserving medical supply chain.

Client expense: $840,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H.R.6102: VALID Act of 2020. Education related to COVID-19 testing. Education related to Telehealth during COVID-19.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: HR 6514, Worker Health Coverage Protection Act HR 1425, Patient Protection and Affordable Care Enhancement Act Issues related to regulations for implementing section 1557 of the Affordable Care Act on anti-discrimination HR 6800, Health and Economic Recovery Omnibus Emergency Solutions Act or The HEROES Act Issues related to the Senate HELP Committee initiative on preparing for future pandemics. Regulatory issues related to telehealth Issues related to surprise medical billing, including HR 3630, the No Surprises Act; S 1895, the Lower Health Care Costs Act; S 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019; Issues relating to curbing health care costs; H.R.647 & S. 2080, the Palliative Care and Hospice Education and Training Act; Anti-cancer medication cost-sharing parity respecting H.R. 1409; A national family caregiving strategy respecting S. 1719 and H.R. 1028; Access to medicines respecting FDA implementation of right to try law; Introduction of the S. 3404 & H.R. 6102, Verifying Accurate Leading-edge IVCT Development Act of 2020 or the VALID Act of 2020; H. Res. 282, supporting initiatives to encourage parents and guardians to take measures to prevent sunburns in minors they care for; H.R. 1966 & S 946, the Henrietta Lacks Enhancing Cancer Research Act of 2019, regarding decreasing disparities in access to cancer clinical trials; Additional issues related to reducing health disparities in cancer clinical trials; Issues related to capturing racial and ethnic data demographic data for communities disproportionately affected by coronavirus; H.R. 2222 and S. 1107, the Women and Lung Cancer Research and Preventative Services Act; H.Res. 14 & S.Res. 223, Expressing support for the designation of DIPG Awareness Day H.R. 1730 and S. 741, the Cancer Drug Parity Act; Cannabis research issues, including S. 2032 Cannabidiol and Marihuana Research Expansion Act and S. 2400Expanding Cannabis Research and Information Act ; H.R. 4078 & S. 2424 EARLY Act Reauthorization of 2019 S. 2497, the Dependent Income Exclusion Act; Issues related to HHS regulation of prescription drug prices and costs; H.R. 4439, Creating Hope Reauthorization Act; H.R. 1730 and S. 741, the Cancer Drug Parity Act; H.R. 6556, the Gabriella Miller Kids First Research Act 2.0; H.R. 4439 & S. 4010, the Creating Hope Reauthorization Act; H.R.6666 & S. 4315, the COVID-19 Testing, Reaching, And Contacting Everyone (TRACE) Act, bill related to support needed data collection efforts to begin to contain coronavirus; Issues related to cancer survivorship and transitions of care from oncology treatment back to primary care; Issues related to improving data collection during the COVID-19 pandemic; and H.Res 1125, which expresses support for prioritizing racial and ethnic diversity in clinical trials for therapies, diagnostics in clinical trials for therapies, diagnostics, and vaccines for COVID -19. S 4557, COVID Enrollment Response Act (Sen. Baldwin)

Client expense: $490,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: HR 6514, Worker Health Coverage Protection Act HR 1425, Patient Protection and Affordable Care Enhancement Act Issues related to regulations for implementing section 1557 of the Affordable Care Act on anti-discrimination HR 6800, Health and Economic Recovery Omnibus Emergency Solutions Act or The HEROES Act Issues related to the Senate HELP Committee initiative on preparing for future pandemics. Regulatory issues related to telehealth Issues related to surprise medical billing, including HR 3630, the No Surprises Act; S 1895, the Lower Health Care Costs Act; S 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019; Issues relating to curbing health care costs; H.R.647 & S. 2080, the Palliative Care and Hospice Education and Training Act; Anti-cancer medication cost-sharing parity respecting H.R. 1409; A national family caregiving strategy respecting S. 1719 and H.R. 1028; Access to medicines respecting FDA implementation of right to try law; Introduction of the S. 3404 & H.R. 6102, Verifying Accurate Leading-edge IVCT Development Act of 2020 or the VALID Act of 2020; H. Res. 282, supporting initiatives to encourage parents and guardians to take measures to prevent sunburns in minors they care for; H.R. 1966 & S 946, the Henrietta Lacks Enhancing Cancer Research Act of 2019, regarding decreasing disparities in access to cancer clinical trials; Additional issues related to reducing health disparities in cancer clinical trials; Issues related to capturing racial and ethnic data demographic data for communities disproportionately affected by coronavirus; H.R. 2222 and S. 1107, the Women and Lung Cancer Research and Preventative Services Act; H.Res. 14 & S.Res. 223, Expressing support for the designation of DIPG Awareness Day H.R. 1730 and S. 741, the Cancer Drug Parity Act; Cannabis research issues, including S. 2032 Cannabidiol and Marihuana Research Expansion Act and S. 2400Expanding Cannabis Research and Information Act ; H.R. 4078 & S. 2424 EARLY Act Reauthorization of 2019 S. 2497, the Dependent Income Exclusion Act; Issues related to HHS regulation of prescription drug prices and costs; H.R. 4439, Creating Hope Reauthorization Act; H.R. 1730 and S. 741, the Cancer Drug Parity Act; H.R. 6556, the Gabriella Miller Kids First Research Act 2.0; H.R. 4439 & S. 4010, the Creating Hope Reauthorization Act; H.R.6666 & S. 4315, the COVID-19 Testing, Reaching, And Contacting Everyone (TRACE) Act, bill related to support needed data collection efforts to begin to contain coronavirus; Issues related to cancer survivorship and transitions of care from oncology treatment back to primary care; Issues related to improving data collection during the COVID-19 pandemic; and H.Res 1125, which expresses support for prioritizing racial and ethnic diversity in clinical trials for therapies, diagnostics in clinical trials for therapies, diagnostics, and vaccines for COVID -19. S 4557, COVID Enrollment Response Act (Sen. Baldwin)

Client expense: $490,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office

H.R. 6102 and S.3404; The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020; all provisions

Client expense: $190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Public Law 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020. Public Law 116-136 CARES (Coronavirus Aid, Relief, and Economic Security) Act. S. 3942 Securing Americas Medical Supply Chain Act of 2020. S. 3780 Help Onshore Manufacturing Efficiencies (HOME) for Drugs and Devices Act. H.R. 6102 VALID (Verifying Accurate Leading-edge IVCT Development) Act of 2020. Proposals related to preserving medical supply chain. Proposals regarding regulatory policies affected by public health emergencies. Proposals related to the use of coronavirus testing in CLIA waived settings. Proposals regarding diagnostic and serologic coronavirus testing. Proposals related to the advancement, testing, and detection of Traumatic Brain Injury. Proposals to advance policies related to effective pain management. Proposals related to the expansion of telehealth during the public health emergency.

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

S.734, Internet of Things Cybersecurity Improvement Act of 2019, creates national standards for cybersecurity for products purchased by the federal government; S.142, American Data Dissemination Act of 2019 - creates data privacy rules; S.189, Social Media Privacy Protection and Consumer Rights Act of 2019; draft legislation and HHS proposed rules to create new value base care arrangement safe harbors under Stark and Anti-Kickback Statutes and educate key staff on FDA regulation of device service; S.3404, H.R.6102, the Verifying Accurate Leading-edge IVCT Development Act 2020 - legislation to modernize regulation of lab tests; S. 3548 CARES Act regarding enhanced provider funding and medical device shortage provisions. COVID-19 Testing - PCR molecular, serology testing coverage, payment, and funding; S.4473 and H.R.7956, Critical Medical Infrastructure Right-to-Repair Act of 2020.

Client expense: $1,010,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

S.734, Internet of Things Cybersecurity Improvement Act of 2019, creates national standards for cybersecurity for products purchased by the federal government; S.142, American Data Dissemination Act of 2019 - creates data privacy rules; S.189, Social Media Privacy Protection and Consumer Rights Act of 2019; draft legislation and HHS proposed rules to create new value base care arrangement safe harbors under Stark and Anti-Kickback Statutes and educate key staff on FDA regulation of device service; S.3404, H.R.6102, the Verifying Accurate Leading-edge IVCT Development Act 2020 - legislation to modernize regulation of lab tests; S. 3548 CARES Act regarding enhanced provider funding and medical device shortage provisions. COVID-19 Testing - PCR molecular, serology testing coverage, payment, and funding; S.4473 and H.R.7956, Critical Medical Infrastructure Right-to-Repair Act of 2020.

Client expense: $950,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

Advocacy on health care issues related to genetics and genetic testing, including H.R. 3235 - Access to Genetic Counselor Services Act of 2019; H.R.4393 - Advancing Access to Precision Medicine Act; and S. 3404/HR 6102 - Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6102/S.3404 - The Verifying Accurate, Leading-edge IVCT Development Act; S.1895 - The Lower Health Care Costs Act; H.R.861 - End Surprise Billing Act of 2019. HR 4393- Advancing Access to Precision Medicine Act. HR 6201- Families First Coronavirus Response Act; HR 748 - Coronavirus Aid, Relief, and Economic Security Act

Client expense: $80,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 6102/S.3404 - The Verifying Accurate, Leading-edge IVCT Development Act; S.1895 - The Lower Health Care Costs Act; H.R.861 - End Surprise Billing Act of 2019. HR 4393- Advancing Access to Precision Medicine Act. HR 6201- Families First Coronavirus Response Act; HR 748 - Coronavirus Aid, Relief, and Economic Security Act

Client expense: $80,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Healthcare issues related to clinical laboratories; H.R. 6102/S. 3404, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, provisions relating to FDA oversight of laboratory-developed tests; Federal policy related to implementation of the Families First Coronavirus Response Act, Pub. L. 116-127, provisions relating to coverage of and funding for COVID-19 diagnostic tests; Federal policy related to implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. 116-136, provisions relating to coverage and reimbursement of COVID-19 diagnostic tests and Medicare reimbursement for clinical laboratory tests; Section 307 of H.R. 8406, the Heroes Act, provisions relating to coverage of COVID-19 testing; H.R. 8496, the SPEEDY COVID-19 Test Act, provisions relating to varying Medicare reimbursement for COVID-19 tests based on result delivery time; Federal policy relating to funding COVID-19 surveillance and transmission studies using next generation sequencing, including potential legislation; Federal policy relating to drug development, including potential legislation known as Cures 2.0; Federal policy relating to anti-kickback requirements in Section 8122 of the Support for Patients and Communities Act, Pub. L. 115-271 (18 U.S.C. 220), including potential legislation as part of the Fiscal Year 2021 Commerce-Justice-Science appropriations bill and the Fiscal Year 2021 Labor-HHS appropriations bill; and Federal policy relating to FDA oversight of pharmacogenetic tests, including potential legislation as part of the Fiscal Year 2021 Agriculture-FDA appropriations bill; and Title I of Division BB of the Consolidated Appropriations Act of 2021, Pub. L. 116-260, provisions relating to surprise billing.

Client expense: Not reported · Firm income: $100,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor implementation of H.R. 6201, the Families First Coronavirus Response Act (Public Law 116-127), and provisions related to clinical laboratory testing for COVID-19, including coverage and reimbursement of COVID-19 diagnostic tests Monitor implementation of H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act, the CARES Act, (Public Law 116-136), and provisions related to clinical laboratory testing for COVID-19, including coverage and reimbursement of COVID-19 diagnostic tests, laboratory data collection and reimbursement under PAMA, and laboratory data reporting Federal policy relating to implementation of anti-kickback requirements in Section 8122 of the Support for Patients and Communities Act, Public Law 115-271 H.R. 6102/S. 3404, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, provisions relating to FDA oversight of laboratory-developed tests The Public Readiness and Emergency Preparedness Act (PREP Act) and COVID-19 liability protection for frontline health care providers, including CLIA-licensed laboratories and their personnel H.R. 8496, the SPEEDY COVID-19 Tests Act, relating to varying Medicare reimbursement for COVID-19 tests based on result delivery time Section 307 of H.R. 8406, the Heroes Act, provisions relating to coverage of COVID-19 testing H.R. 133, Consolidated Appropriations Act, 2021 (Public Law 116-260), and provisions related to clinical laboratory testing for COVID-19, and Medicare reimbursement for pathology services

Client expense: $220,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE

The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 (HR 6102/S 3404).

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Policies related to diagnostic testing and diagnostic testing capacity; The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 (HR 6102/S 3404); ), Consolidated Appropriations Act, 2021 (H.R. 133).

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussions regarding the implementation of COVID-19 related emergency legislation (H.R.748, H.R.6102, H.R.6074) regarding the role of AI and machine learning to assist in response and recovery from COVID-19 pandemic. Leveraging analytics in unemployment programs; infection control; telehealth; hospital data reporting requirements.

Client expense: $540,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Small Business Administration (SBA), Social Security Administration (SSA), State, Dept of (DOS), Transportation, Dept of (DOT), U.S. Agency for International Development (USAID), U.S. Coast Guard (USCG), Veterans Affairs, Dept of (VA), Vice President of the U.S., White House Office

Surprise medical billing and access to colon cancer screening provisions within H.R. 133, the Consolidated Appropriations Act 2021; H.R. 6102/S. 3404 - VALID Act; issues related to COVID-19 pandemic response and clinical laboratories

Client expense: $160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.6102: VALID Act of 2020. Education related to COVID-19 testing.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS)

Regulation of laboratory developed tests "Verifying Accurate, Leading-edge IVCT Development (VALID) Act of 2020" - HR 6102/S 3404

Client expense: $210,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

No Surprises Act (H.R. 133) Verifying Accurate Leading-edge IVCT Development Act of 2020 (S.3404, H.R. 6102) Temporary Reciprocity to Ensure Access to Treatment Act (S.4421, H.R. 8283) Rare Cancer Awareness, Research, and Treatment Act of 2020 (draft, not yet introduced) Government response to COVID-19, including liability reforms and supply chain issues

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6102, The Families First Coronavirus Response Act, P.L. 116-227, provisions related to essential worker designation, transportation, and farm stimulus programs. H.R. 748, Coronavirus Aid, Relief, and Economic Security Act, provisions related to farm programs.

Client expense: $281,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: HR 6514, Worker Health Coverage Protection Act HR 1425, Patient Protection and Affordable Care Enhancement Act Issues related to regulations for implementing section 1557 of the Affordable Care Act on anti-discrimination HR 6800, Health and Economic Recovery Omnibus Emergency Solutions Act or The HEROES Act Issues related to the Senate HELP Committee initiative on preparing for future pandemics. Regulatory issues related to telehealth Issues related to surprise medical billing, including HR 3630, the No Surprises Act; S 1895, the Lower Health Care Costs Act; S 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019; Issues relating to curbing health care costs; H.R.647 & S. 2080, the Palliative Care and Hospice Education and Training Act; Anti-cancer medication cost-sharing parity respecting H.R. 1409; A national family caregiving strategy respecting S. 1719 and H.R. 1028; Access to medicines respecting FDA implementation of right to try law; Introduction of the S. 3404 & H.R. 6102, Verifying Accurate Leading-edge IVCT Development Act of 2020 or the VALID Act of 2020; H. Res. 282, supporting initiatives to encourage parents and guardians to take measures to prevent sunburns in minors they care for; H.R. 1966 & S 946, the Henrietta Lacks Enhancing Cancer Research Act of 2019, regarding decreasing disparities in access to cancer clinical trials; Additional issues related to reducing health disparities in cancer clinical trials; Issues related to capturing racial and ethnic data demographic data for communities disproportionately affected by coronavirus; H.R. 2222 and S. 1107, the Women and Lung Cancer Research and Preventative Services Act; H.Res. 14 & S.Res. 223, Expressing support for the designation of DIPG Awareness Day H.R. 1730 and S. 741, the Cancer Drug Parity Act; Cannabis research issues, including S. 2032 Cannabidiol and Marihuana Research Expansion Act and S. 2400Expanding Cannabis Research and Information Act ; H.R. 4078 & S. 2424 EARLY Act Reauthorization of 2019 S. 2497, the Dependent Income Exclusion Act; Issues related to HHS regulation of prescription drug prices and costs; H.R. 4439, Creating Hope Reauthorization Act; H.R. 1730 and S. 741, the Cancer Drug Parity Act; H.R. 6556, the Gabriella Miller Kids First Research Act 2.0; H.R. 4439 & S. 4010, the Creating Hope Reauthorization Act; H.R.6666 & S. 4315, the COVID-19 Testing, Reaching, And Contacting Everyone (TRACE) Act, bill related to support needed data collection efforts to begin to contain coronavirus; Issues related to cancer survivorship and transitions of care from oncology treatment back to primary care; Issues related to improving data collection during the COVID-19 pandemic; and H.Res 1125, which expresses support for prioritizing racial and ethnic diversity in clinical trials for therapies, diagnostics in clinical trials for therapies, diagnostics, and vaccines for COVID -19. S 4557, COVID Enrollment Response Act (Sen. Baldwin)

Client expense: $490,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office

Issues related to lab analysis and review of diagnostics and lab developed tests, including VALID Act of 2020 (H.R. 6102/S. 3404), Eliminating Kickbacks in Recovery Act of 2018, and the 21st Century Cures 2.0 Concept Paper.

Client expense: Not reported · Firm income: $70,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to lab analysis and review of diagnostics and lab developed tests, including the VALID Act of 2020 (H.R. 6102/S. 3404), Eliminating Kickbacks in Recovery Act of 2018, and 21st Century Cures 2.0 Concept Paper.

Client expense: Not reported · Firm income: $70,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.6102 and S.3404, Verifying Accurate Leading-edge IVCT Development Act of 2020, all provisions

Client expense: Not reported · Firm income: Not reported

H.R.6102 and S.3404, Verifying Accurate Leading-edge IVCT Development Act of 2020, all provisions

Client expense: Not reported · Firm income: Not reported

H.R.6102 and S.3404, Verifying Accurate Leading-edge IVCT Development Act of 2020, all provisions

Client expense: Not reported · Firm income: Not reported

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

Healthcare issues related to clinical laboratories; H.R. 6102/S. 3404, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, provisions relating to FDA oversight of laboratory-developed tests; Federal policy related to implementation of the Families First Coronavirus Response Act, Pub. L. 116-127, provisions relating to coverage of and funding for COVID-19 diagnostic tests; Federal policy related to implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. 116-136, provisions relating to coverage and reimbursement of COVID-19 diagnostic tests and Medicare reimbursement for clinical laboratory tests; H.R. 8406, the HEROES Act, provisions in Section 307 relating to coverage of COVID-19 testing H.R. 8496, the SPEEDY COVID-19 Test Act, provisions relating to varying Medicare reimbursement for COVID-19 tests based on result delivery time; Federal policy relating to funding COVID-19 surveillance and transmission studies using next generation sequencing, including potential legislation; Federal policy relating to drug development, including potential legislation known as Cures 2.0; Federal policy relating to anti-kickback requirements in Section 8122 of the Support for Patients and Communities Act, Pub. L. 115-271 (18 U.S.C. 220), including potential legislation as part of the Fiscal Year 2021 Commerce-Justice-Science appropriations bill and the Fiscal Year 2021 Labor-HHS appropriations bill; Federal policy relating to FDA oversight of pharmacogenetic tests, including potential legislation as part of the Fiscal Year 2021 Agriculture-FDA appropriations bill; and H. R. 133, the Consolidated Appropriations Act of 2021, provisions in Title I of Division BB relating to surprise billing.

Client expense: $650,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE