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Verifying Accurate Leading-edge IVCT Development Act of 2021 or the VALID Act of 2021 This bill requires the Food and Drug Administration (FDA) to regulate in vitro clinical tests (IVCTs). Currently, the FDA and the Centers for Medicare & Medicaid Services have authority to regulate in vitro diagnostic devices. The bill defines IVCTs, which includes in vitro diagnostic devices, as tests intended for the collection, preparation, analysis, or in vitro clinical examination of specimens from the human body to provide information about a disease, condition, or treatment. An IVCT may not be introduced into interstate commerce unless it has received FDA premarket approval or is covered by certain exemptions, such as an exemption for a test that (1) was developed and introduced before this bill's enactment and meets certain requirements, (2) is a low-risk test, (3) is solely for public health surveillance, (4) is covered by a technology certification issued under this bill, or (5) has received a humanitarian exemption or emergency use authorization. The FDA may grant upon application a technology certification. Generally, such a certification covers a group of tests that use a single technology and may be evaluated using a representative test. While such a certification is valid, a qualifying IVCT that falls within the scope of the certification shall be cleared for interstate commerce. The bill also imposes various requirements related to IVCTs, including those related to quality control, labeling, and reporting adverse events. The FDA shall have various enforcement authority, including authority to order the recall of an IVCT with a reasonable probability of causing serious adverse health consequences.
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Filing registrants (76)
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
2023 · third_quarter · Health Issues
Drug pricing and access. Implementation of Inflation Reduction Act of 2022. Biosimilars. Pandemic and All-Hazards Preparedness Act (PAHPA). H.R.23639/S.2209 - VALID Act.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, White House Office
2023 · second_quarter · Health Issues
Drug pricing and access. Implementation of Inflation Reduction Act of 2022. Biosimilars. Pandemic and All-Hazards Preparedness Act (PAHPA). H.R.4128/S.2209 - VALID Act.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, White House Office
2023 · first_quarter · Health Issues
- Issues Related to Data Privacy and Security - Diagnostic and medical device regulatory reforms, including the Verifying Accurate Leading-edge IVCT Development Act of 2021 (S.2209,H.R.4128) and the Verifying Accurate Leading-edge IVCT Development Act of 2022 as included in the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (S.4348) and the Consolidated Appropriations Act, 2023 (P.L. 117-328) - Cancer Moonshot
Client expense: $100,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Medicare/Medicaid
Medicare access to diagnostic services. Medicare and Medicaid issues. FDA User Fee. H.R.4128/S.2209 - Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Health Issues
Drug pricing and access. Implementation of Inflation Reduction Act of 2022. Biosimilars. Pandemic and All-Hazards Preparedness Act (PAHPA). H.R.4128/S.2209 - VALID Act.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, White House Office
2023 · first_quarter · Health Issues
Issues related to MDUFA implementation Issues related to H.R. 7667, Food and Drug Amendments of 2022 Issues related to S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act Issues relating to FDA Covid-19 Response Issues relating to the medical product supply chain Issues relating to S. 3799, PREVENT Pandemics Act Issues related to CURES 2.0 Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to the Valid Act of 2021 - H.R. 4128/S.2209 Issues related to cyber security including H.R. 7084/ S. 3983, PATCH Act
Client expense: $300,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2023 · first_quarter · Medical/Disease Research/Clinical Labs
VALID Act of 2021 (H.R.4128/S.2209; Provisions that negatively impact Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory businesses; re-introduced in Spring of 2023 as H.R.2639
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 5376, the Inflation Reduction Act H.R. 4521, America COMPETES Act S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 510K reform, imaging policy, medical device user fee reauthorization and all related policies, mobile medical apps, device regulation, Innovation, service, radiopharmaceuticals, coverage decisions, cybersecurity
Client expense: Not reported · Firm income: $80,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 5376, the Inflation Reduction Act S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 companion diagnostics, testing, innovation, surprise billing implementation
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Medical/Disease Research/Clinical Labs
HR 4128/S 2209 Verifying Accurate Leading-Edge IVCT Development (VALID) Act Coverage S.4348 - FDASLA Act of 2022
Client expense: Not reported · Firm income: $17,500
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Medical/Disease Research/Clinical Labs
HR 4128/S 2209 Verifying Accurate Leading-Edge IVCT Development (VALID) Act Coverage S.4348 - FDASLA Act of 2022 FDA Draft Guidance on ctDNA
Client expense: Not reported · Firm income: $90,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Medical/Disease Research/Clinical Labs
HR 4128/S 2209 Verifying Accurate Leading-Edge IVCT Development (VALID) Act Coverage S 1666, Verified Innovative Testing in American Laboratories (VITAL) Act S.4348 - FDASLA Act of 2022
Client expense: Not reported · Firm income: $63,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
VALID Act (HR 4128/S.2209); Issues related to proposals on reauthorization of the FDA drug and device user fee programs (S.4348/H.R.7667), (H.R. 6833); Issues related to data privacy and security House legislation (H.R. 8152).
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Access and reimbursement to advanced genomic testing for cancer; Providing an appropriate regulatory model for advanced genomic cancer testing;The VALID Act (HR 4128 and S 2209). Increasing overall access to and diversity of clinical trials. Advancing acceptance of Real World Data and Real World Evidence.
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
S. 253, Cannabidiol and Marihuana Research Expansion Act, all provisions H.R. 6087, Improving Access to Workers Compensation for Injured Federal Workers Act of 2022, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5030, Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, all provisions H.R. 1384, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions S. 445, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions H.R. 2067, Medication Access and Training Expansion (MATE) Act of 2021, all provisions S. 2235, Medication Access and Training Expansion (MATE) Act of 2021, all provisions H.R. 6072, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services S. 509, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services H.R. 379, Improving Social Determinants of Health Act of 2021, all provisions S. 104, Improving Social Determinants of Health Act of 2021, all provisions S. 3799, Prepare for and Respond to Existing Viruses, Emerging New Threats, and (PREVENT) Pandemics Act, all provisions H.R. 8, Bipartisan Background Checks Act of 2021, all provisions H.R. 1446, Enhanced Background Checks Act of 2021, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 2163, Safe Step Act, all provisions S. 464, Safe Step Act, all provisions H.R. 666, Anti-Racism in Public Health Act of 2021, all provisions S. 162, Anti-Racism in Public Health Act of 2021, all provisions H.R. 5248, Temporary Responders for Immediate Aid in Grave Emergencies (TRIAGE) Act of 2021, all provisions H.R. 6311, Comprehensive Addiction Resources Emergency Act of 2021, all provisions S. 3418, Comprehensive Addiction Resources Emergency Act of 2021, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 3735, Parity Implementation Assistance Act, all provisions H.R. 7232, 9-8-8 and Parity Assistance Act of 2022, all provisions H.R. 7116, 9-8-8 Implementation Act of 2022, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions S. 4090, Dietary Supplement Listing Act of 2022, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act, all provisions S. 610, Dr. Lorna Breen Health Care Provider Protection Act, all provisions H.R. 3753, Parity Implementation Assistance Act, all provisions S. 1962, Parity Implementation Assistance Act, all provisions S. 3904, Healthcare Cybersecurity Act of 2022, all provisions H.R. 4128, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions H.R. 6000, Cures 2.0 Act, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions H.R. 8152, To provide consumers with foundational data privacy rights, create strong oversight mechanisms, and establish meaningful enforcement, all provisions H.R. 2377, Federal Extreme Risk Protection Order Act of 2022, all provisions H.R. 7910, Protecting Our Kids Act, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions H.R. 7667, Food and Drug Amendments of 2022, all provisions H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022, all provisions H.R. 2503, Social Determinants Accelerator Act of 2021, all provisions S. 3039, Social Determinants Accelerator Act of 2021, all provisions H.R. 7192, Diagnostic Device Advisory Committee Act, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5218, Collaborate in an Orderly and Cohesive Manner Act, all provisions H.R. 7845, NIH Clinical Trial Diversity Act of 2022, all provisions H.R. 708, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions H.R. 4480, Telehealth Coverage and Payment Parity Act, all provisions H.R. 7573, Telehealth Extension and Evaluation Act, all provisions S. 3593, Telehealth Extension and Evaluation Act, all provisions H.R. 5541, Primary and Virtual Care Affordability Act, all provisions H.R. 1306, National Coronavirus Commission Act of 2021, all provisions S. 412, National Coronavirus Commission Act of 2021, all provisions H.R. 1843, COVID-19 Hate Crimes Act, all provisions S. 937, COVID-19 Hate Crimes Act, all provisions H.R. 3778, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions S. 1976, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions H.R. 6904, Patients Before Profits Act of 2022, all provisions H.R. 7053, Hospital Inpatient Services Modernization Act, all provisions S. 3792, Hospital Inpatient Services Modernization Act, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 5224, Preventing Overdoses and Saving Lives Act of 2021, all provisions H.R. 6279, Opioid Treatment Access Act of 2022, all provisions H.R. 7234, Summer Barrow Prevention, Treatment, and Recovery Act, all provisions H.R. 3352, Midwives for MOMS Act of 2021, all provisions H.R. 847, Promoting Digital Privacy Technologies Act, all provisions S. 224, Promoting Digital Privacy Technologies Act, all provisions H.R. 3771, South Asian Heart Health Awareness and Research Act of 2021, all provisions H.R. 7559, Prescription Information Modernization Act of 2022, all provisions H.R. 8289, Banning Misleading Drug Ads Act of 2022, all provisions H.R. 3614, Menstrual Equity For All Act of 2021, all provisions No Surprises Act/implementation Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions 21st Century Cures Act/implementation Maternal mortality Maternal health and inequities/FY 2023 funding Prior Authorization AMA Recovery Plan for Americas Physicians/telehealth/prior authorization/physician burnout/scope Section 2527(b) of the U.S. Innovation and Competition Act (USICA)/Open Access Language Retired Physician Re-entry COVID-19 telehealth flexibilities COVID-19/Vaccine distribution/Vaccines in physician offices Physician burnout and suicide COVID-19/Health Equity/vaccines COVID-19 response/testing/misinformation/therapeutics/Paxlovid Public Health Emergency COVID-19 Health Equity/Men who have sex with men/3-month blood donation use deferral Health Equity/Federally qualified health centers and clinical trials Womens Reproductive Health Medication Abortion Access Diabetes Provider Relief Fund/COVID-19 Electronic Health Records (EHR) Certification Data Privacy Hunger, Nutrition, and Health Digital Health/AI/Digital Therapeutics Monkeypox/testing/vaccination
Client expense: $4,550,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), President of the U.S., SENATE, Vice President of the U.S., White House Office
2022 · fourth_quarter · Health Issues
VALID Act (HR 4128/S.2209); General Issues related to data privacy and security.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R.8295/S.4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2023, Laboratory infrastructure; Mental Health initiatives H.R.4128/S.2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, generally S.4348, Food and Drug Administration Safety and Landmark Advancements Act, Lab Develop Testing issues Public Law 117-328, Consolidated Appropriations Act, FY2023, Laboratory infrastructure; Diagnostic Laboratory Testing issues Monitor the following: H.R.7667, Food and Drug Amendments Act, Lab Develop Testing issues Mental Health initiatives Center for Excellence in Improving Diagnosis legislation 340B generally P.L.117-2, American Rescue Plan Act of 2021, Hospital and healthcare funding eligibility related issues Surprise Billing Health Care Transparency Prescription Drug Cost Disproportionate Share Hospital (DSH) Coronavirus, Hospital and Healthcare Telehealth initiatives H.R.6000, CURES 2.0, Health services delivery; and Research and development issues ARPA-H Proposal Public Law 117-169, Inflation Reduction Act of 2022, Implementation issues
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Antimicrobial resistance research, infectious disease product R&D regulatory science, unnecessary regulatory burdens placed on medical research; laboratory developed tests; comparative effectiveness research; support for evidence-based decision making; point-of-care diagnostic tests; and organ transplant policies to allow HIV+ to HIV+ organ transplants, Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR Act-S. 2076/H.R. 3932), Verifying Accurate Leading Edge IVCT Development (S. 2209/HR. 4128), PREVENT Pandemics Act
Client expense: $166,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE
2022 · fourth_quarter · Health Issues
Infectious diseases (generally, no specific legislation); antimicrobial (generally, no specific legislation); hospital-acquired infections (generally, no specific legislation); immunizations (generally, no specific legislation); pandemic influenza (generally, no specific legislation); public health security and bio-defense (generally, no specific legislation); global infectious diseases (generally, no specific legislation); biomedical research (generally, no specific legislation); President's Emergency Plan for AIDS Relief (PEPFAR) (generally, no specific legislation); Lyme diseases and other infectious diseases issues (generally, no specific legislation); Ryan White Care Act (generally, no specific legislation); Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act (PASTEUR);HIV Epidemic Loan Repayment Program (HELP) Act(H.R. 2295) Verifying Accurate Leading Edge IVCT Development (VALID Act HR 3128/S.2209), Infectious diseases and bio-preparedness health professionals loan repayment issues, BIO Preparedness Workforce Act (S.3244/H.R.5602), Monkeypox outbreak and response (generally, no specific information), PHE Outbreak Activation Act (not-yet introduced), PREVENT Pandemics Act
Client expense: $166,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE
2022 · second_quarter · Medical/Disease Research/Clinical Labs
2023 appropriations requests for NIH for T cell research in COVID19 and other disease areas; HR4128 and S2209 The VALID Act. Provisions related to first of a kind assays
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Medical/Disease Research/Clinical Labs
HR2471 Appropriations for NIH for T cell research in COVID19 and other disease areas; HR4128 and S2209 The VALID Act. Provisions related to first of a kind assays
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
-Support provisions of Cures 2.0 legislation (HR 6000) -Support provisions of VALID Act (HR 4128/S 2209) -Support FDASLA (S 4348) -Support ARPA-H legislation -Oppose limiting telehealth lab orders
Client expense: $480,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Legislation and policies relating to: Adoption of recommendations of the National Academy of Medicine report, The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention H.R. 66, Comprehensive Access to Robust Insurance Now Guaranteed for Kids (CARING for Kids) Act H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 485, Stronger Child Abuse Prevention and Treatment Act H.R. 550, Immunization Infrastructure Modernization Act of 2021 H.R. 909/S. 484, Moms Matter Act H.R. 959/S. 346, Black Maternal Health Momnibus Act of 2021 H.R. 1065/S. 1486, Pregnant Workers Fairness Act H.R. 1324/S/ 467, Effective Suicide Screening and Assessment in the Emergency Department Act of 2021 H.R. 1390, Childrens Health Insurance Program Pandemic Enhancement and Relief (CHIPPER) Act H.R. 1620, Violence Against Women Act Reauthorization Act of 2021 H.R. 1791, Childrens Health Insurance Program Permanency (CHIPP) Act H.R. 2094/S. 1301, Promoting Physical Activity for Americans Act H.R. 2347/S. 2691, Strengthening the Vaccines for Children Program Act of 2021 H.R. 3173/S. 3018, Improving Seniors Timely Access to Care Act of 2021 H.R. 3182, Safe Sleep for Babies Act of 2021 H.R. 3407/S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act H.R. 3655, Vaccine Injury Compensation Modernization Act of 2021 H.R. 4128/S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 H.R. 4217/S. 2779, Taskforce Recommending Improvements for Unaddressed Mental Perinatal & Postpartum Health (TRIUMPH) for New Moms Act Implementation of the Inflation Reduction Act (P.L. 117-169) provisions related to health equity and mental and behavioral health for patients and health care providers H.R. 5487/S. 3972, Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2021 H.R. 7076, Supporting Childrens Mental Health Care Access Act of 2022 H.R. 7236, Strengthen Kids Mental Health Now Act of 2022 H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022 H.R. 7780, Mental Health Matters Act H.R. 8296, Womens Health Protection Act of 2022 H.R. 8391, Continuity in Necessary Evaluative Crisis Treatment (CONNECT) Act of 2022 H.R. 8450, Healthy Meals, Healthy Kids Act H.R. 8812/S. 5212, Improving Care and Access to Nurses (I CAN) Act H.R. 8817/S. 4844, National Nursing Workforce Centers Act H.R. 9260, Stop Online Suicide Assistance Forums Act S. 104/H.R. 379, Improving Social Determinants of Health Act of 2021 S. 248/H.R. 804, Family and Medical Insurance Leave (FAMILY) Act S. 499/H.R. 369, Improving Health Insurance Affordability Act of 2021 S. 674, Public Health Infrastructure Saves Lives Act S. 844/H.R. 3109, PHIT Act of 2021 S. 1259, Safe Cribs Act S. 1275/H.R. 2119, Family Violence Prevention and Services Improvement Act of 2021 S. 1658/H.R. 3110, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act S. 1675/H.R. 4387, Maternal Health Quality Improvement Act S. 2069/H.R. 4323, Excellence in Mental Health and Addiction Treatment Act S. 3479/H.R. 8151, Building a Sustainable Workforce for Healthy Communities Act S. 3623, Violence Against Women Act Reauthorization Act of 2022 S. 3799, Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) S. 4170, Mental Health Reform Reauthorization Act of 2022 S. 4472, Health Care Capacity for Pediatric Mental Health Act of 2022
Client expense: Not reported · Firm income: $24,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
H.R. 4128/S. 2209: Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021; all provisions H.R. 6000: Cures 2.0 Act; discussions related to genomics, sequencing, the applications for sequencing including in rare disease and related reimbursement, CDC surveillance funding and National Institutes of Health funding H.R.7667: Food and Drug Amendments of 2022; discussions related to genomics, sequencing, the applications for sequencing including in rare disease and related reimbursement H.R. 8295/S. 4659: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023; discussions related to genomics, sequencing, the applications for sequencing including in rare disease and related reimbursement, CDC surveillance funding and National Institutes of Health funding S. 2022: Ending the Diagnostic Odyssey Act of 2021; all provisions S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics (PREVENT Pandemics) Act; all provisions S. 4348: Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022; discussions related to genomics, sequencing, the applications for sequencing including in rare disease and related reimbursement, CDC surveillance funding and National Institutes of Health funding Public Law No: 117-180: Making continuing appropriations for fiscal year 2023, and for other purposes (H.R. 6833); discussions related to genomics, sequencing, the applications for sequencing including in rare disease and related reimbursement, CDC surveillance funding and National Institutes of Health funding Public Law No: 117-328 (H.R. 2617): Consolidated Appropriations Act, 2023; discussions related to genomics, sequencing, the applications for sequencing including in rare disease and related reimbursement, CDC surveillance funding and National Institutes of Health funding
Client expense: $1,300,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 4128/S. 2209, The Verifying Leading-edge IVCT Development Act of 2021.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 4128/S. 2209, The Verifying Leading-edge IVCT Development Act of 2021.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Ensuring access to advanced genomic testing for cancer; Providing an appropriate regulatory model for advanced genomic cancer testing, The VALID Act HR 4128 and S 2209; Use of real-world evidence in clinical trials and FDA review. White House Cancer Moonshot Initiative; HR 2617 Consolidated Appropriations Act of 2023
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
VALID Act of 2021 (H.R. 4128/S. 2209) Provisions related to the regulation of laboratory-developed tests (LDTs) in academic clinical laboratories FDASLA Act of 2022 (S. 4348) Provisions related to the regulation of laboratory-developed tests (LDTs) in academic clinical laboratories
Client expense: $120,000 · Firm income: Not reported
Government targets: SENATE
2022 · fourth_quarter · Health Issues
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
Client expense: $38,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Sickle cell disease/trait issues Hematology/oncology treatment issues Hematology/oncology drug research and approval issues General hematology public health and research issues Emergency funding for COVID therapeutics Research Investment to Spark the Economy (RISE) Act (H.R. 869/S. 289) Open access policy for peer reviewed research journals Issues impacting blood supply shortages/safety Issues related to convalescent plasma Issues impacting delivery of bone marrow, peripheral blood, and cord blood Issues related to implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136) Issues related to health equity/disproportionate impact of COVID-19 on minority populations COVID-19 vaccination policies/prioritization Clinical trials regulations and coverage Issues related to diversity, equity, and inclusion (DEI) in hematology research, practice, and training Cures 2.0 Act (H.R. 6000) Advanced Research Projects Agency for Health (ARPA-H) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706 / H.R. 5030) Meaningful Access to Federal Health Plan Claims Data Act (H.R. 5394) Health Equity and Accountability Act (H.R. 7585) Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 4128/S. 2209) Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348)
Client expense: $30,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), President of the U.S., SENATE
2022 · fourth_quarter · Health Issues
Resident Physician Shortage Reduction Act (H.R. 2256/S. 834) Healthcare Workforce Resilience Act (H.R. 2255/S. 1024) Implementation of the Patient Protection and Affordable Care Act (P.L. 111-148) Hematology/oncology drug research and approval issues Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144) Clinical trials regulations and coverage Issues impacting coverage for hematologic diseases and conditions Issues related to CAR-T/cellular and gene therapies Issues impacting opioid access/use for patients with hematologic disease and disorders Issues impacting blood supply shortages/safety Issues related to convalescent plasma Issues related to health equity/disproportionate impact of COVID-19 on minority populations Issues related to diversity, equity, and inclusion (DEI) in hematology research, practice, and training Cures 2.0 Act (H.R. 6000) Implementation of No Surprises Act (P.L. 116-260) Cancer Patient Equity Act of 2021 (H.R.5377) HELP Copays Act (H.R. 5801) Cancer Drug Parity Act of 2021 (H.R. 4385 / S. 3080) Sickle cell disease/trait issues Sickle Cell Disease Comprehensive Care Act (H.R. 6216 / S.3389) Impact of climate change on health Resolution expressing support for healthcare personnel and condemning assaults on healthcare personnel as the U.S. healthcare system faces unprecedented staffing shortages and increased workplace-related stressors (H.Res. 909) Sickle Cell Care Expansion Act (H.R. 7177/S.4425) Women's Health Protection Act (S. 1975/ H.R. 3755/S. 4132) Newborn Screening Saves Lives Reauthorization Act (H.R. 482/S. 350) Prior authorization Improving Seniors Timely Access to Care Act (H.R. 3173/S. 3018) Health Equity and Accountability Act (H.R. 7585) Issues related to maternal health care and abortion access Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 4128/S. 2209) Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348) Affordability of employer coverage for family members/"family glitch Sickle Cell Disease Treatment Centers Act of 2022 (S. 4866/ H.R. 8855) Advancing Telehealth Beyond COVID Act (H.R. 4040) Resolution supporting the designation of September 2022 as "Sickle Cell Disease Awareness Month" (H.Res.1330/S.Res.868) Let Doctors Provide Reproductive Health Care Act (S. 4723/H.R. 8650) FY2023 Consolidated Appropriations Act (H.R. 2617)
Client expense: $30,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Natl Institutes of Health (NIH), SENATE
2022 · fourth_quarter · Health Issues
Issues related to public research universities and the hospitals they operate. VALID Act of 2021 (H.R. 4128/S. 2209); Telehealth waivers for Medicare payments
Client expense: $178,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Natl Science Foundation (NSF), Office of Science & Technology Policy (OSTP), SENATE
2022 · fourth_quarter · Health Issues
VALID Act of 2021 (HR 4128/S.2209); Issues related to proposals on reauthorization of the FDA drug and device user fee programs within Omnibus Bill (H.R. 2617 ); Issues related to data privacy and security House legislation (H.R. 8152).
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Access and reimbursement to advanced genomic testing for cancer; Providing an appropriate regulatory model for advanced genomic cancer testing; The VALID Act (HR 4128 and S 2209) and Omnibus legislation (H.R. 2617). Increasing overall access to and diversity of clinical trials. Advancing acceptance of Real World Data and Real World Evidence.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issue: Educate Congress and the administration on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Draft Graduate Medical Education Reform Act Issue: Support increased funding for the National Health Service Corps, Teaching Health Center GME, and National Disaster Medical Service (NDMS) demonstration pilot. Support increased Medicare support for Graduate Medical Education/physician training. Issues: Educate Congress and the administration about the role of academic medicine in the provision of mental and behavioral health care, including initiatives to respond to the opioid epidemic. Support measures to expand access to mental health care and substance use disorder treatment, including funding for training on substance use disorders, pain management, and safe prescribing practices, enhance enforcement of mental health parity laws, increased financial support for integrated behavioral health models. Support the provision of additional Medicare-supported graduate medical education slots for psychiatry and psychiatry sub-specialties. P.L. 117-328, Consolidated Appropriations Act, 2023 Support the provision of 200 additional Medicare-supported graduate medical education (GME) positions. Support the extension of COVID-related telehealth flexibilities. Support elimination or delay of Statutory Pay-As-You-Go (PAYGO) Medicare sequester and eliminating or reducing scheduled cuts to the Physician Fee Schedule. Support one-year of continuous Medicaid coverage for children. Support extension of postpartum Medicaid and CHIP coverage for 12 months. H.R. 1384/ S.445, Mainstreaming Addiction Treatment (MAT) Act of 2021 P.L. 117-328, Consolidated Appropriations Act, 2023, Division FF Issue: Support suspension of waiver requirement for certain providers to prescribe buprenorphine. H.R. 2067, Medication Access and Training Expansion (MATE) Act of 2021 P.L. 117-328, Consolidated Appropriations Act, 2023, Division FF Issue: Oppose legislative mandates dictating medical education curriculum on pain management and addiction. H.R. 7236, Strengthen Kids Mental Health Now Act/ S. 2727 Investing in Kids Mental Health Now Act Issue: Support increasing Medicaid reimbursement rates for pediatric mental health services through a 100% federal match. P.L. 116-22, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 Issues: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. Issue: Educate Congress on how the 340B Drug Pricing Program helps safety-net providers to fulfill their missions and care for patients and communities. Support measures to preserve and strengthen the 340B Drug Pricing Program and oppose efforts to reduce the scope of the program, including restrictions on covered entities use of contract pharmacy to distribute covered drugs. H.R. 4390, Preserving Rules Ordered for the Entities Covered Through 340B Act of 2021 (PROTECT 340B Act) Issue: Support measures to prevent pharmacy benefit managers and commercial insurers from discriminating against 340B covered entities. H.R. 3203/S. 773 Issue: Support policy to allow 340B DSH hospitals to remain eligible to participate in the program throughout the current public health emergency even if their DSH adjustment falls below the current threshold due to changes in payer mix as a result of the COVID-19 pandemic. Issue: Oppose insurance plans that do not meet Affordable Care Act requirements. Issue: Support increased interoperability and exchange of electronic health information and delayed enforcement of information blocking rule until comprehensive guidance is issued. Issue: Support the ongoing refinement of the two new mandatory alternative payment models, the Radiation Oncology Model and End-stage Renal Disease Treatment Choices Model, to better incentivize high-quality care for all patients. H.R. 4128/ S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 P.L. 117-328, Consolidated Appropriations Act, 2023 Issue: Educate Congress on development of Laboratory Developed Tests at academic medical centers and oppose policies that would increase burdensome regulations and negatively impact patients access to care by allowing Food and Drug Administration regulation of the development of Laboratory Developed Tests at academic medical centers. S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 H.R. 7667, Food and Drug Amendments of 2022 (FDA22) P.L. 117-328, Consolidated Appropriations Act, 2023 Issue: Support promotion of data sharing and clinical trials results reporting. Support increased clinical trials diversity. Issue: Development of Enhanced Primary Care Pilot Act proposal H.R. 2503 / S. 3039, Social Determinants Accelerator Act of 2021 Issue: Support grants to address social determinants of health H.R. 7585 / S. 4486, Health Equity and Accountability Act Issue: Support programs to improve health equity and address social determinants of health. Issue: Support incentives to encourage the inclusion of implicit bias training in medical education and residency training. Issue: Support congressional investment in the Centers for Medicare and Medicaid Innovation (CMMI) models to reduce maternal mortality and improve maternal health. Issue: Support maternal health initiatives to expand coverage during the postpartum period and expand demonstration project grants. H.R. 959, Black Maternal Health Momnibus Act of 2021 S. 1695 / H.R. 4387, Maternal Health Quality Improvement Act S. 1491/ H.R. 769, Rural MOMs Act H.R. 4387, Maternal Health Quality Improvement Act of 2021 H.R. 925 / S. 347, Data to Save Moms Act Issue: Support legislative efforts to improve maternal health and reduce rates of maternal mortality, including the Momnibus. Support legislative initiatives to improve data collection to improve maternal health equity. P.L. 117-159, Bipartisan Safer Communities Act Issue: Support policies to promote firearm safety, universal background checks, violence prevention programs, extreme risk protection orders, child access safety laws, reinstating assault weapons ban, data infrastructure, hospital based and community violence intervention programs, and programs to address mental and behavioral health impact of gun violence. Issue: Support funding for Community Violence Interventions / Hospital Based Violence Intervention Programs P.L. 117-105, Dr. Lorna Breen Health Care Provider Protection Act Issue: Support grants directed at improving clinician burnout and well-being. Issue: Provide feedback on implementation of the Provider Relief Fund. Support extension for use of PRF funds. Issue: Support improvements to the Medicare Accelerated and Advance Payment Programs, including delaying recoupment of MAAP loans. Issue: Support extension of public health emergency declaration. Issue: Provide feedback on COVID-19 and pandemic response. Provide feedback on monkeypox response including testing. S. 3799, PREVENT Pandemics Act P.L. 117-328, Consolidated Appropriations Act, 2023, Division FF Issue: Provide feedback on pandemic preparedness legislation, urge inclusion of provisions to support academic medical centers preparedness activities. Issue: Support establishment of regional pandemic response centers, stronger linkages between public health and academic medicine, and the role of medical students and academic medical centers in administering COVID vaccines. Issue: Support efforts of academic medical centers to respond to public health threats such as monkeypox and COVID-19. Urge establishment and implementation of robust national testing strategy; functional, redundant, and transparent supply chain; improved federal coordination; investments in public health and health care human and other resources; data modernization initiatives; and other actions to improve current and future pandemic response. H.R. 708, S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act Issue: Support for a temporary uniform licensing standard for all practitioners in all states throughout the COVID-19 public health emergency S. 674 Public Health Infrastructure Saves Lives Act Issue: Support investments in core public health infrastructure. Issue: Support ensuring patients are put first, that conscience protections align with medical professionalism standards, and oppose interference in the patient-physician relationship. Issue: Support increased interoperability and exchange of electronic health information. Support delay of enforcement beyond April 2021. H.R. 6000, Cures 2.0 Act Issue: Provide feedback on provisions related to public health, patients and caregivers, FDA, CMS, and research, and ARPA-H. Issue: Promote strategies to strengthen the health, public health, and research workforces. H.R. 3671, Doctors of Community Act Issue: Discuss authorization of the Teaching Health Center Graduate Medical Education program. H.R. 8131, Increasing Competition for Medical Residency Act Issue: Educate Congress on the medical education and training continuum, the annual residency Match, and the role of the National Resident Matching Program (NRMP) in medical education and residency. Issue: Provide guidance on the implementation of the No Surprises Act. Issue: Provide feedback on proposed modifications to the HIPAA privacy rule. H.R. 5035 / S. 2982, Child Suicide Prevention and Lethal Means Safety Act Issue: Support legislation to provide grants to improve suicide prevention and lethal means safety. Issue: Inform Congress and Administration about medical education on caring for older adults, nutrition, climate change, stigma around addiction, reproductive health, and accelerated medical education training programs. Issue: Provide feedback on efforts of the academic medicine community to address climate change and decarbonization. Issue: Support efforts of teaching hospitals to promote patient safety and high-quality care. H.R. 7152/ S.3534, The Tracking Pathogens Act P.L. 117-328, Consolidated Appropriations Act, 2023, Division FF Issue: Support expansion of CDC activities related to genomic sequencing of pathogens. Issue: Support reignition of Cancer Moonshot. H.R. 7961, Safety from Violence for Healthcare Employees (SAVE) Act Issue: Support statutory protections against violence and intimidation for health care workers and provide grants for hospital programs aimed at preventing violence in health care settings. P.L. 117-263, James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 Issue: Support a one year pause in military medical billet reductions in the Military Health System.
Client expense: $876,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Vice President of the U.S., White House Office
2022 · fourth_quarter · Health Issues
Support increased funding for the USPSTF and H.R. 9310, Preventative Services Early Action Act. Monitor S. 2209/H.R. 4128 VALID Act and FY 23 Labor-HHS appropriations.
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
Healthcare issues related to clinical laboratories; H.R. 8188/S. 4449, the Saving Access to Laboratory Services Act (SALSA), provisions relating to reform of Medicare reimbursement for clinical laboratory services under Section 216 of the Protecting Access to Medicare Act, Pub. L. 113-93; H.R. 4128/S. 2209, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, included as Subtitle C of Title VIII of S. 4348, the FDA Safety and Landmark Advancements Act (FDASLA), provisions relating to FDA oversight of laboratory-developed tests; H.R. 4040, the Advancing Telehealth Beyond COVID-19 Act, H.R. 6202, the Telehealth Extension Act, and H.R. 7573/S. 3593, the Telehealth Extension and Evaluation Act, provisions relating to extension of Medicare coverage of telehealth services and limitations on payment for certain laboratory tests; H.R. 8152, the American Data Privacy and Protection Act (ADPPA), provisions relating to data privacy; S. 3799, the PREVENT Pandemics Act, provisions relating to demographic data reporting obligations for laboratories; 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; Federal policy relating to the National Correct Coding Initiative and manual instructions inconsistent with American Medical Association guidelines for Current Procedural Terminology (CPT) coding; and Federal policy relating to availability of Current Procedural Terminology (CPT) codes.
Client expense: Not reported · Firm income: $110,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R.2617, Consolidated Appropriations Act, 2023, provisions related to health care services H.R.4128/S.2209, the VALID Act, issues related to regulation of laboratory developed tests at academic clinical labs H.R.7961, the Safety from Violence for Healthcare Employees (SAVE) Act of 2022 Legislative proposals to improve access to behavioral health and pediatric behavioral health services Issues related to the expansion of telehealth services. Issues related to the regulation of clinical decision support tools. Issues related to national preparedness for future pandemic threats. Transplant issues related to reforms of the OPTN and OPO performance.
Client expense: $30,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to third party servicing of medical devices Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of COVID-19 diagnostic tests Issues related to the Valid Act of 2021 - H.R. 4128/S. 2209 Issues related to Health Equity Issues related to the PASTEUR Act of 2021 - S. 2076/HR 3932 Issues related to COVID-19 Clinical Testing & Testing Supplies Issues related to Public Health Emergency Preparedness Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act Issues related to COVID-19 Clinical Testing and Testing Supplies Issues related to consumer and health data privacy Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act Issues related to H.R. 7667, Food and Drug Amendments of 2022 Issues related to S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Issues related to S. 4386, A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan. Issues related to S. 3799, PREVENT Pandemics Act Issues related to S. 3700 Prevent Pandemics Act Issues related to H.R. 2617 Consolidated Appropriations Act Issues related to H.R. 6833 Continuing Appropriations and Ukraine Supplemental Appropriations Act Issues related to S. 4349 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices. Issues related to H.R. 7676 Emerging Signals Modernization Act of 2022 Issues related to cyber security including H.R. 7084/S. 3983, PATCH Act and S. 4336 Strengthening Cybersecurity for Medical Devices Act
Client expense: $750,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2022 · fourth_quarter · Health Issues
Discussions related to genomics, sequencing and the applications for sequencing including in rare disease and related reimbursement; Issues to related to Biotechnology and Biosecurity best practices; S. 3819, Advanced Research Project Authority for Health (ARPA-H) Act; Issues related to the White House Cancer Moonshot initiative; H.R. 7007, COVID Supplemental Appropriations Act, 2022; S. 3799, PREVENT Pandemics Act; H.R. 791/S. 236, Tracking COVID-19 Variants Act; S.3534/H.R.7152, Tracking Pathogens Act; Issues related to reauthorization of FDA user fee bills (H.R. 7667, Food and Drug Amendments of 2022; S. 4348 Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)), including H.R. 4281/S. 2209, VALID Act H. Rpt. 107-443, Explanatory Statement accompanying Division H - Departments of Labor, Health and Human Services, and Education, and related Agencies Appropriations Act, 2023 - related to whole genome sequencing
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
S. 2209 - VALID Act: Provisions related to the regulation of laboratory developed tests. Issues related to additional residency positions and Graduate Medical Education. Issues related to the extension of telehealth flexibilities. H.R. 5721 - Veterans Affairs Infrastructure Powers Exceptional Research Act (VIPER Act): Provisions related to research affiliations between VA medical centers and partner organizations.
Client expense: $50,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to prescription drug pricing, particularly as it relates to insulin S. 4446, Modernizing the Accelerated Approval Pathway Act of 2022 H.R. 6963, Accelerated Approval Integrity Act of 2022 H.R. 4128/S. 2209, VALID Act of 2021
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Budget/Appropriations
Reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, COVID-19 test coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); regulation and oversight of clinical laboratories, including laboratory developed test services; commercial laboratory surge capacity issues for response to COVID-19 pandemic/epidemic/public health crises, access to clinical laboratory services via telehealth clinical visits. Saving Access to Laboratory Services Act H.R. 8188/S. 4449, VALID Act H.R. 4128/S. 2209, Telehealth Extension and Evaluation Act S. 3593, PREVENT Pandemics Act S. 3799, Consolidated Appropriations Act, 2023, P.L 117-328.
Client expense: $1,319,853 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, COVID-19 test coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); regulation and oversight of clinical laboratories, including laboratory developed test services; commercial laboratory surge capacity issues for response to COVID-19 pandemic/epidemic/public health crises, access to clinical laboratory services via telehealth clinical visits. Saving Access to Laboratory Services Act H.R. 8188/S. 4449, VALID Act H.R. 4128/S. 2209, Telehealth Extension and Evaluation Act S. 3593, PREVENT Pandemics Act S. 3799, Consolidated Appropriations Act, 2023, P.L 117-328.
Client expense: $1,319,853 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Health Issues
Reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, COVID-19 test coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); regulation and oversight of clinical laboratories, including laboratory developed test services; commercial laboratory surge capacity issues for response to COVID-19 pandemic/epidemic/public health crises, access to clinical laboratory services via telehealth clinical visits. Saving Access to Laboratory Services Act H.R. 8188/S. 4449, VALID Act H.R. 4128/S. 2209, Telehealth Extension and Evaluation Act S. 3593, PREVENT Pandemics Act S. 3799, Consolidated Appropriations Act, 2023, P.L 117-328.
Client expense: $1,319,853 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Disaster Planning/Emergencies
Reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, new test coding and pricing, COVID-19 test coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); regulation and oversight of clinical laboratories, including laboratory developed test services; commercial laboratory surge capacity issues for response to COVID-19 pandemic/epidemic/public health crises. Saving Access to Laboratory Services Act H.R. 8188/S. 4449, VALID Act H.R. 4128/S. 2209, PREVENT Pandemics Act S. 3799, Consolidated Appropriations Act, 2023, P.L 117-328.
Client expense: $1,319,853 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Medicare/Medicaid
Reimbursement and coverage issues for and related to clinical laboratory services, including the Medicare clinical laboratory fee schedule, physician fee schedule, new test coding and pricing, COVID-19 test coverage and reimbursement, and implementation of the Protecting Access to Medicare Act (P.L. 113-93); regulation and oversight of clinical laboratories, including laboratory developed test services; commercial laboratory surge capacity issues for response to COVID-19 pandemic/epidemic/public health crises, access to clinical laboratory services via telehealth clinical visits. Saving Access to Laboratory Services Act H.R. 8188/S. 4449, VALID Act H.R. 4128/S. 2209, Telehealth Extension and Evaluation Act S. 3593, PREVENT Pandemics Act S. 3799, Consolidated Appropriations Act, 2023, P.L 117-328.
Client expense: $1,319,853 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Health Issues
Support HR 1946, S. 1873 Medicare coverage of multi-cancer early detection screening tests Support removing barriers to colorectal cancer screening S. 2149 the Colorectal Cancer Detection Act HR. 2209 HR S.4128 Medical Device User Fee Act reauthorization HR.4128/S.2209 Verifying Accurate Leading-edge IVCT Development Act of 2021 S. 958/H.R. 5141, the Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to drug pricing, pharmacies, provider status, biosimilars, and DIR fees; H.R. 7213- Equitable Community Access to Pharmacist Services Act; H.R. 7053- The Hospital Inpatient Services Modernization Act(HR 7053/S 3792); Issues related to the Medical Device User Fee Amendments reauthorization, VALID Act (H.R. 4128/ S. 2209). Saving Access to Laboratory Services Act (SALSA) (HR 8188/S 4449); Improving Seniors Timely Access to Care Act of 2021 (HR 3173/S 3018); Issues related to Medicare provider cuts; Issues related to glucose monitors.
Client expense: $410,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Issues related to medical device sterilization Issues related to medical technology regulation Issues related to pandemic preparedness and coronavirus response Issues related to medical device supply chains and supply chain resiliency H.R.4128, VALID Act of 2021 S.2209, VALID Act of 2021
Client expense: $480,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE