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Newborn Screening Saves Lives Reauthorization Act of 2021
Legislative Progress
Introduced
February 22, 2021
Latest Action
February 22, 2021
Primary Sponsor
Margaret Wood HassanDemocratic(NH)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 5,357 other S bills in the 117th — cohort avg 38d
Newborn Screening Saves Lives Reauthorization Act of 2021 This bill reauthorizes through FY2026 and revises several programs and activities relating to newborn screening for certain conditions and genetic, endocrine, and metabolic diseases. Among its changes, the bill reauthorizes and makes mandatory the Hunter Kelly Research Program at the National Institutes of Health, and national surveillance activities conducted by the Centers for Disease Control and Prevention. The bill also aligns statutory requirements for research on non-identified newborn blood spots with federal regulations governing research on human subjects. These blood spots are collected as part of newborn screening programs, and some states make them available for biomedical and public health research. Under current regulations, research on non-identified bio-specimens such as blood spots is not considered to be research on human subjects, to which additional protections apply.
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Filing registrants (25)
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 · first_quarter · Health Issues
Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care; H.R.482/S.350, Newborn Screening Saves Lives Act Reauthorization; H.R.7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R.2617, the Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
FY23 Labor, Health and Human Services, and Education Appropriations Bill: Pediatric Subspecialty Loan Repayment Program, Firearm Injury and Mortality Prevention Research, Pediatric Mental Health Care Access Program, Emergency Medical Services for Children, National Center for Birth Defects and Developmental Disabilities, Global Immunization, Sudden Unexpected Infant Death and Sudden Death in Childhood, Vaccine Injury Compensation Program, VACCINES Act, Antimicrobial Resistance, Maternal and Child Health, School Based Health Centers COVID-19 Supplemental Appropriations H.R.482 / S.350 - Newborn Screening Saves Lives Reauthorization Act FY23 National Defense Authorization Act and Halting Reductions to Military Medical Personnel Defense Health Agency - Autism Care Demonstration H.R.5551 - Improving the Health of Children Act H.R.2347 / S.2691 - Strengthening the Vaccines for Children Program Act of 2021 Childrens Literacy Initiative on Military Bases (CLIMB) Act of 2022 - H.R. 8208 Advancing FASD Research, Services and Prevention Act - S. 2238 / H.R. 4151 Banning Electronic Stimulation Devices - FDA User Fee Bills (H.R. 7667/S. 4348) MIECHV - The Jackie Walorski Maternal and Child Home Visiting Reauthorization Act (H.R. 8876) SSI Savings Penalty Elimination Act (S. 4102) Data on Interactions and Accountability for Law Enforcement with Individuals with Disabilities Act (S. 5107) Augmentative and Alternative Communication Centers to Establish National Training Act (S.2) Equitable Community Access to Pharmacist Services Act (H.R. 7213) Banning electric shock devices Kids Online Safety Act (S. 3663) Children and Teens Online Privacy Protection Act (S. 3663) Privacy and design protections for children and adolescents online Rulemaking Petition on Engagement Optimizing Digital Design Practices Used on Minors Pediatric Subspecialty Loan Repayment Program Implementation (Health Resources and Services Administration) Pediatric Research Priorities at Advanced Research Projects Agency for Health Tobacco Policy Priorities (Flavored products, premarket review, product perception studies) FY 2023 Appropriations for Centers for Disease Control and Prevention Office on Smoking and Health Mainstreaming Addiction Treatment Act (H.R. 1384/S. 445) FY 2023 Funding for National Institutes of Health Accuracy of Pulse Oximetry in Children of Color Gun Violence Prevention Research Funding Child passenger safety (H.R. 5736) Appropriations for the Indian Health Service Maternal, Infant, and Early Childhood Home Visiting Program (including Jackie Walorski MIECHV Reauthorization Act of 2022 (H.R. 8876)) Infant sleep product safety (S. 1259, H.R. 3182) Lead exposure prevention Food safety Paid family and medical leave Regulation of high-powered magnet sets Climate change, Inflation Reduction Act Vehicle Emissions Standards Button battery ingestions (H.R. 5313, S. 3278) Early childhood education Access to genetic sequencing Child product safety and injury prevention Furniture tip-overs (S. 441, H.R. 1314) Child Abuse Prevention and Treatment Act reauthorization, CAPTA Reauthorization Act of 2021 CAPTA Plans of safe care grants Family First Prevention Services Act implementation (House, Senate, ACF) Issues related to the COVID-19 pandemic and providing supports for the child welfare community (House, Senate, and ACF) CAPTA Fatalities Prevention and Response (House, Senate, and HHS) Title IV-B Reauthorization Ensuring Medicaid continuity for Children in Foster Care Act (S. 2689/H.R. 5414) Congregate care reform Mental health supports for foster youth/former foster youth Indian Child Welfare Act & Title IV-B (H.R. 8954) Mercury and Air Toxics Standards, ozone and particulate matter NAAQS, EPA greenhouse gas regulation Appropriations - global child and youth-focused global health subaccounts at USAID (Vulnerable Children, Maternal and Child Health, Nutrition) Global Child Thrive Act Implementation Strengthening Efforts to End Violence Against Children Act Reach Every Mother and Child Act International Children with Disabilities Protection Act Standards in ORR Custody Licensure of ORR Shelters Public Charge Child Nutrition Reauthorization/WIC SNAP Mental Health for Children H.R. 6, DREAM Act Medical Nutrition Equity Act Donor Human Milk Lift the Bar Act CARE for Families Act HR 3107 WIC Act Breastfeeding Peer Counseling Program Public Health Preparedness and Response Research for Pregnant and Lactating Women Funding for Pediatric Device Consortia Funding for Emergency Medical Services for Children Program Funding for HRSA Pediatric Mental Health Care Access Program PUMP Act DEMAND Act Dietary Guidelines Child Poverty Coronavirus Response Legislation Child Poverty Reduction Act Suicide Prevention Child Nutrition Waivers School Meal Standards WIC Food Packages Universal School Meals Equality Act Mental Health Services for Students Act Youth Mental Health and Suicide Prevention Act Child Tax Credit Supporting Childrens Mental Health Care Access Act Infant Formula Shortage White House Conference on Hunger, Nutrition, and Health Mental Health Reform Reauthorization Act Restoring Hope for Mental Health and Well-Being Act Gender Affirming Care Safety of Pediatricians and Childrens Hospitals Emergency Vacating of Aircraft Cabin (EVAC) Act Same Day Billing Restrictions in Mental Health Senate Finance Committee Mental Health Discussion Drafts 12-Month Continuous Eligibility for Children in Medicaid/CHIP Easy Enrollment in Health Care Act of 2021 (Senate) Accelerating Kids Access to Care Act (H.R. 3089/S. 1544) Connect for Health Act of 2021 Medicaid Payment Parity H.R. 2347, Strengthening the Vaccines for Children Program Act HR 1025, the Kids Access to Primary Care Act S. 1833 The Ensuring Access to Primary Care for Women and Children Act of 2021 Medicaid Maintenance of Effort (MOE) Protections Comprehensive Access to Robust Insurance Now Guaranteed (CARING) for Kids Act (H.R.66) H.R. 1791 Childrens Health Insurance Program Permanency (CHIPP) Act Stabilize Medicaid and CHIP Coverage Act (H.R. 1738) Permanent CHIP Funding Extension Permanent Extension of Express Lane Eligibility Option Medicaid Reentry Act Medicaid Funding for the Territories HR 3089/S 1544 The Accelerating KidsAccess to Care Act (AKACA) Expanding Medicaid HCBS Services for Children Access to Care in Medicaid/CHIP Maternal Health H.R. 4996 Helping Moms Act H.R.4995 - Maternal Health Quality Improvement Act of 2020 Postpartum Medicaid Extension and Maternal Health Improvements Closing the Medicaid Coverage Gap Adult Medicaid Vaccine Access Increased Funding for Childrens Hospitals Graduate Medical Education COVID-19 Response (House, Senate, HHS, CMS) Medicaid/CHIP Eligibility Redeterminations post PHE Medicaid Unwinding Payment for COVID-19 Vaccine Counseling Coding Changes for COVID-19 Counseling Payment
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Advocated in favor of robust appropriations funding for the National Institutes of Health, the Food and Drug Administration, the Health Resources and Services Administration, and the Centers for Disease Control and Prevention. Advocated for greater appropriations for the National Center for Advancing Translational Sciences (NCATS) Advocated for greater appropriations for the National Institutes of Health. Advocated for appropriations for HHS, NIH, and FDA to implement the ACT for ALS. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the end-of-year omnibus legislation. Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Advocated for passage of FDA and clinical trial reforms within an end-of-year bill, including accelerated approval reforms, clinical trial diversity advancements, the RARE Act, reauthorization of the Orphan Product Grants Program, and more.
Client expense: $220,000 · Firm income: Not reported
2022 · fourth_quarter · Health Issues
Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for robust funding of the national newborn screening program. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, Centers for Disease Control and Prevention, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Advocated for the swift funding and implementation of the ACT for ALS Act (S.1813 and H.R.3537). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. Advocated for increased funding of home and community-based services (HCBS). Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the end-of-year omnibus package. Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Supported greater appropriations for Consumer Assistance Programs Advocated for the passage of the RARE Act (S. 4185) as part of the end-of-year omnibus package. Supported passage of the Ending the Diagnostic Odyssey Act Advocated for the passage of the Accelerating Kids Access to Care Act Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Support the passage of the Precision Medicine for Children Act Advocated for the passage of the HCBS Access Act Supported the passage of the Stop the Wait Act (S. 3575 / H.R. 6583) Advocated for the Access to Genetic Counselors Act Provided recommendations to the Department of Health and Human Services on the implementation of section 1557 of the Affordable Care Act. Applauded the Department of Health and Human Services in their closing of the family glitch within the Affordable Care Act. Advocated to the Centers for Medicare and Medicaid Services on Medicaid access and the COVID-19 public health emergency Called for passage of the Preserving Patient Access to Home Infusion Act (S. 2652/H.R. 5067) Provided comments to CMS on ensuring equity in accessing health care. Provided comments to the Department of Health and Human Services on how best to streamline eligibility and enrollment within the Medicaid and CHIP programs. Called for recipients of the Deferred Action for Childhood Arrivals program to access Federal health programs and offerings. Provided comments to the CMS on the implementation of the No Surprises Act. Called for greater funding of the National Center for Advancing Translational Sciences (NCATS) Called for the passage of the Medicare Orthotic & Prosthetic Patient-Centered Care Act Provided comments to CMS on National Directory of Healthcare Providers and Services
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
| Democratic |
| MA |
| Jack Reed | Democratic | RI |
| Jeanne Shaheen | Democratic | NH |
| Lisa Murkowski | Republican | AK |
| Mark Kelly | Democratic | AZ |
| Robert P. Casey, Jr. | Democratic | PA |
| Roger F. Wicker | Republican | MS |
| Ron Wyden | Democratic | OR |
| Sherrod Brown | Democratic | OH |
| Susan M. Collins | Republican | ME |
| Tammy Baldwin | Democratic | WI |
Client expense: $200,000 · Firm income: Not reported
Government targets: Administration for Children & Families (ACF), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Indian Health Service, Justice, Dept of (DOJ), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, U.S. Agency for International Development (USAID), White House Office
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
Client expense: $220,000 · 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), Labor, Dept of (DOL), Natl Council on Disability, Natl Institutes of Health (NIH), SENATE, Treasury, Dept of
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 · Medical/Disease Research/Clinical Labs
H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 869: RESEARCH INVESTMENT TO SPARK THE ECONOMY (RISE) ACT OF 2021; ALL PROVISIONS H.R. 3932: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS H.R. 5030: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS H.R. 5566: FINDING ORPHAN-DISEASE REMEDIES WITH ANTIFUNGAL RESEARCH AND DEVELOPMENT (FORWARD) ACT OF 2021; ALL PROVISIONS H.R. 6000: CURES 2.0 ACT; ALL PROVISIONS S. 289: RESEARCH INVESTMENT TO SPARK THE ECONOMY (RISE) ACT OF 2021; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 2076: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS S. 2706: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS S. 3799: PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING THE 2023 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR HHS AND RELATED AGENCIES, FDA AND RELATED AGENCIES, CDC AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 3932: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS H.R. 4040: ADVANCING TELEHEALTH BEYOND COVID-19 ACT OF 2022; ALL PROVISIONS H.R. 5030: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS H.R. 5566: FINDING ORPHAN-DISEASE REMEDIES WITH ANTIFUNGAL RESEARCH AND DEVELOPMENT (FORWARD) ACT OF 2021; ALL PROVISIONS H.R. 5801: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 6000: CURES 2.0 ACT; ALL PROVISIONS H.R. 9303: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2022; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 942: NO JUNK PLANS ACT; ALL PROVISIONS S. 2076: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS S. 2706: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS S. 3799: PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING ACE KIDS 2.0; ALL PROVISIONS
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
HR 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS OF THE BILL (HR 2617) P.L. 117-328: CONSOLIDATED APPROPRIATIONS ACT, 2023: PROVISIONS RELATED TO SECTIONS 3107, 3202, 3210, 3601-3607, 3629 S 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING FEDERAL DRUG ADMINISTRATION AND EUROPEAN MEDICINES AGENCY DRUG APPROVAL GENERAL DISCUSSIONS REGARDING ANTI-KICKBACK SAFE HARBOR FOR PATIENT TRAVEL COSTS GENERAL DISCUSSIONS REGARDING BUDGET RIDERS, ORPHAN DRUG ACT TAX CREDIT, AND VETERANS BENEFITS ADMINISTRATION
Client expense: $420,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care; H.R.482/S.350, Newborn Screening Saves Lives Act Reauthorization; H.R.7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R.2617, the Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
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
H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 1730/S. 670- Speeding Therapy Access Today Act H.R. 1946, S. 1873. Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 5030/ S. 2706 DIVERSE Trials Act HR 5376, Inflation Reduction Act reconciliation bill; Medicare price negotiation provision and Part D redesign; Preventative healthcare services and screenings; Issues related to preventative services and screenings for underrepresented communities H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 Accelerating Access for Patients Act; H.R.7667 - Food and Drug Amendments of 2022; S. 1548, H.R. 3085/H.R. 7845. ENACT Act of 2021 S.4348 - FDASLA Act of 2022; General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases; general issues related to pharmacy benefit managers (PBMs); general issues related to insurance coverage of specialty treatments Issues related to clinical trial diversity COVID-19; COVID-19 vaccine and therapy development Climate, sustainability, and environment; Sustainability & Zero Carbon; Items related to environmental sustainability (including eliminating GHG emissions from pMDIs) and our Ambition Zero Carbon efforts. E-Labeling EVUSHELD Issues related to repeal of the Medicaid AMP Cap. Issues related to drug pricing, IRA Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees;
Client expense: $1,170,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Newborn Screening Saves Lives Act Reauthorization, H.R. 482, S 350. FY 2022 and FY 2023 CDC Appropriations for state newborn screening technical assistance and related Senate appropriations. H.R. 1692, S 250, Fairness in Orphan Drug Exclusivity Act.
Client expense: $190,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Maternal and child health including Medicaid postpartum coverage provisions, public health, maternal therapeutics, vaccination, and other health-related bills. Black Maternal Health Momnibus Act of 2021 (H.R. 959/S. 346), Mothers and Offspring Mortality and Morbidity Awareness Act or the MOMMA'S Act (S. 411), Rural Maternal and Obstetric Modernization of Services Act or the Rural MOMS Act (H.R. 769), Newborn Screening Saving Lives Reauthorization Act of 2021 (H.R. 482/S. 350), Maternal Immunization Enhancement Act, Maternal Immunization Coverage Act, The Strengthening the Vaccines for Children Program Act (H.R. 2347), Improving Social Determinants of Health Act of 2021 (H.R. 379/S.104), the Public Health Infrastructure Saves Lives Act (S. 674), the Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers Act of 2021 (H.R. 1550), Data Mapping to Save Moms Act of 2021 (H.R. 1218/S. 198), The Taskforce Recommending Improvements for Unaddressed Mental Perinatal and Postpartum Health (TRIUMPH for New Moms Act of 2021) for New Mothers Act (H.R. 4217/ S. 2779), Stillbirth Health Improvement and Education for Autumn Act of 2021 or SHINE for Autumn Act (H.R. 5487), Improving the Health of Children Act (H.R. 5551), Lead Poisoning Prevention Act of 2021 (H.R. 5552), Early Hearing Detection and Intervention Act of 2021 (H.R. 5561), Maternal and Child Health Stillbirth Prevention Act (H.R. 7011), Ensuring Lasting Smiles Act (H.R. 1916/S. 754), Into the Light for Maternal Mental Health and Substance Use Disorders Act (H.R. 7073/S.3824), Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R. 7666), PUMP for Nursing Mothers Act (H.R. 3110/S. 1658, PREVENT Pandemics Act of 2022 (S. 3799),the BABES Enhancement Act (H.R. 8695/S.4880), the Healthy Meals, Healthy Kids Act of 2022 (H.R. 8450), the Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022 (H.R. 8876), and Advancing Safe Medications for Moms and Babies Act of 2022 (H.R. 9487).
Client expense: $60,000 · 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), Natl Institutes of Health (NIH), SENATE
2022 · fourth_quarter · Health Issues
Health Insurance Coverage (general); Health Equity (general); Breastfeeding (general); Assisted Reproductive Technology (general); Substance Use Disorder (general); Gynecologic Cancer (general); Reproductive Health (general); Intimate Partner Violence (general); Gun Violence (general); Immunization (general); Breast Cancer (general); Medical Liability Reform (general); Health IT (general); Patient-Physician Relationship (general); Child Welfare (general); Maternal Mortality and Morbidity (general); Graduate Medical Education (general); Contraception (general); Abortion (general); Indian Health (general); Teaching Health Centers Graduate Medical Education (general); Community Health Centers (general); National Health Service Corps (general); Health care workforce (general; Sexually Transmitted Infections (general); Access and Provision of Medication for Opioid Use Disorder (HHS); Research in Pregnant and Breastfeeding Women (general); Health Care Reform (general); Title X Family Planning Program (general); Womens Preventive Services (general); Administrative Burden (general); COVID-19 Response (general); COVID-19 Vaccines (general); Pandemic Preparedness (general); Risk Evaluation and Mitigation Strategies (general); Data Collection (general); Health Insurance and Portability and Accountability Act (general); Social Determinants of Health (General); Maternal Mental Health (general); Online misinformation (general); EMTALA (general); Father Engagement (general); Care for Individuals with Disabilities (general); H.R. 3755/S. 1975, Womens Health Protection Act; implementation of P.L. 115-320, Improving Access to Maternity Care Act; implementation of Maternal Health Quality Improvement Act contained in P.L. 117-103; H.R. 959/ S. 346, Black Maternal Health Momnibus Act; H.R. 1065/S. 1486, Pregnant Workers Fairness Act; H.R. 1350/ S.408, Supporting Best Practices for Healthy Moms Act; H.R. 3407/S. 411, MOMMAs Act; implementation of P.L. 117-2, the American Rescue Plan Act of 2021; H.R. 2007/S. 2444, Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021; H.R. 3110/S. 1658, PUMP for Nursing Mothers Act; H.R. 2903/S.1515, CONNECT for Health Act; H.R. 3671/S.1958, Doctors of Community (DOC) Act; Implementation of P.L. 114-255, the 21st Century Cures Act; Implementation of the No Surprises Act contained in P.L. 116-260; H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act; H.R. 804/S. 248, FAMILY Act; H.R. 5/S. 393, Equality Act; Implementation of P.L. 117-168, Inflation Reduction Act of 2022; H.R. 5218, Collaborate in an Orderly and Cohesive Manner Act; H.R. 5239/ S. 2941, Good Samaritan Health Professionals Act of 2021; H.R. 7073/S.3824, Into the Light for MMH and SUD Act of 2022; H.R.5487/S.3972, SHINE for Autumn Act of 2021; Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV) (general); H.R.7011/S.3797, Maternal and Child Health Stillbirth Prevention Act of 2022; H.R. 2234/S. 1021, Equal Access to Abortion Coverage (EACH) Act; S. 4467, Protecting Access to Medication Abortion Act; S.Res.664, A resolution expressing opposition to the criminalization of essential healthcare, including the full range of sexual and reproductive healthcare such as abortion, gender-affirming care, and contraceptive care, and disapproving of the criminalization of pregnancy outcomes; H.Res.589, Expressing the sense of the House of Representatives that policies governing access to medication abortion care in the United States should be equitable and based on science; H.R. 7894/S. 4347, Affordability is Access Act; H.R. 6005/S. 3223, Access to Birth Control Act; H.R. 7845, NIH Clinical Trial Diversity Act of 2022; H.R. 4217/S. 2779, TRIUMPH for New Moms Act of 2021; H.R. 7974, Endometriosis CARE Act of 2022; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Safety and efficacy of noninvasive prenatal screening tests (FDA/CMS); COVID-19 public health emergency unwinding (general); Implementation of the Maternal Health Quality Improvement Act and Rural MOMS Act included in P.L. 117-103; Implementation of P.L. 117-103, Consolidated Appropriations Act, 2022;; health care provider conscience protections (general);; H.R. 9247, Abortion Care Awareness Act; H.R. 9220, Informing New Factors and Options for Reproductive Care Act; H.R. 8834, EQUIP Act; S. 4688, Reproductive Freedom for All Act; S. 4748, Protecting National Access to Reproductive Care Act; H.R. 4040, Advancing Telehealth Beyond COVID-19 Act of 2021; Reproductive health care workforce (general); S.4467, Protecting Access to Medication Abortion Act; S.4723, Let Doctors Provide Reproductive Health Care Act; H.R. 8373, Right to Contraception Act; S.4764, Reproductive Health Care Accessibility Act; H.R. 9487, Advancing Safe Medications for Moms and Babies Act of 2022; H.R. 9602, Maternal Health Pandemic Response Act of 2022; Reauthorization of P.L. 115-328, PREEMIE Reauthorization Act of 2018; H.R. __, Improving Access to Prenatal Telehealth Care Act of 2022; H.R. 9689, Know Your Body Act; S.5276, Right to Build Families Act of 2022; S.5227/H.R.8452, Reproductive Health Travel Fund Act of 2022; H.R. 6216/S. 3389, Sickle Cell Disease Comprehensive Care Act
Client expense: $120,000 · 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), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2022 · fourth_quarter · Health Issues
Advocacy on health care issues related to genetics and genetic testing, including H.R. 482 / S. 350, Newborn Screening Saves Lives Reauthorization Act; H.R. 1439; the Expanded Genetic Screening Act; H.R. 2144 / S. 1450, to provide for expanded coverage of services furnished by genetic counselors under Medicare Part B; S. 1666, the Verified Innovative Testing in American Laboratories Act (VITAL Act) of 2021; H.R. 4128/S. 2209, the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) of 2021; S.4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives, including H.R. 1629/S.250, the Fairness in Orphan Drug Exclusivity Act; drug pricing proposals, including H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act and H.R. 19/S.2164, Lower Costs, More Cures Act of 2021; access to rare disease and gene therapy drugs; education and awareness of genetic rare bone disorders; FDA approvals of drugs designed to treat rare diseases, including gene therapies; and regulatory reforms generally, including but not limited to S. 3799, the PREVENT Pandemics Act, H.R. 6000, CURES 2.0, H.R. 6963, the Accelerated Approval Integrity Act of 2022, H.R. 6996, the Accelerating Access for Patients Act; H.R. 7667, Food and Drug Amendments of 2022, and S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. Issues pertaining to newborn screening and gene panel screening, including provisions of H.R. 482/S.350 , the Newborn Screening Saves Lives Reauthorization Act of 2021. Policies contained in and amendments offered to S.Con.Res.5, setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030; and policies contained in and amendments offered to P.L. 117-2, the American Rescue Plan Act of 2021; P.L. 117-169, Inflation Reduction Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Potential legislation implementing value based purchasing for pharmaceuticals (HR 7389); Possible provisions related to Drug Pricing Legislation that affect biological products' development, approval, accelerated approval, and marketing, including deliberations associated with the Reauthorization of the Prescription Drug User Fee Act ( HR 7667) (S 4348), or the continuing resolution(Further Extendjnf Government Funding Act P.L. 117-70. Possible drug pricing legislation included in any budget reconciliation legislation ( no specific number). Reauthorization of the Newborn Screening Saves Lives Act (HR 482, S 350.) Consolidated Appropriations Act, 2033. ( PL 117-328).
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
Client expense: $780,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R.2617 - Consolidated Appropriations Act, 2023; Provisions Related to Healthcare H.R.7634 - Protecting Health Care for All Patients Act of 2022; All provisions of the bill H.R.8641 - Orphan Drug COVID-19 Mitigation Act of 2022; All provisions of the bill S.350 - Newborn Screening Saves Lives Reauthorization Act of 2021; All provisions of the bill Issues related to rare disease Issues related to patient access treatments
Client expense: $180,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Congressional passage of the CAROL Act (H.R. 1193/S. 1133) and the Newborn Screening Saves Lives Reauthorization Act of 2021 (H.R. 482/S. 350), continued and expanded federal funding for research into cardiovascular diseases and treatments
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
S. 1357 and H.R. 3773, The Pediatricians Accelerate Childhood Therapies (PACT) Act of 2021 S. 346 and H.R. 959, Black Maternal Health Momnibus Act of 2021 The PREEMIE Act Reauthorization (not yet introduced) CHGME Reauthorization (not yet introduced) S. 2741, Reducing Obesity in Youth Act of 2021 S. 350, The Newborn Screening Saves Lives Reauthorization Act of 2021 S.4747, Investing in Kids Mental Health Now Act of 2022 H.R. 9487, the Advancing Safe Medications for Moms and Babies Act The inclusion of mental health provisions in omnibus (which became Consolidated Appropriations Act, 2023, (P.L.117-328)) H.R.4943, Childrens Mental Health Infrastructure Act of 2021 H.R.4944, Helping Kids Cope Act of 2021 S. 4271, Campus Suicide Prevention Grants, language from the bipartisan Garrett Lee Smith Memorial Act Reauthorization S. 4170, Community Mental Health Services Block Grant, as included in the Mental Health Reform Act of 2022 S. 4472, Health Care Capacity for Pediatric Behavioral Health Act S. 1841 and H.R. 721, Mental Health Services for Students Act H.R. 6411, Veteran Peer Specialist Act included in the House-passed bipartisan STRONG Veterans Act of 2022 S. 467 and H.R. 1324, Effective Suicide Screening and Assessment in the Emergency Department Act
Client expense: $159,386 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 1730, S. 670 - STAT Act; H.R. 482, S. 350 - Newborn Screening Save Lives Reauthorization Act; Cures 2.0; PDUFA; ARPA-H; Telehealth; Covid-relief; Appropriations; S. 373, H.R. 4472 - Better Empowerment Now to Enhance Framework to Improve Treatments (BENEFIT) Act; H.R. 2144, S. 1450 - Access to Genetic Counselor Services Act; H.R. 5989 - Precision Medicine Answers for Kids Today Act (PMAKTA); VALID Act.
Client expense: $20,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for robust funding of the national newborn screening program. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, Centers for Disease Control and Prevention, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Advocated for the swift funding and implementation of the ACT for ALS Act (S.1813 and H.R.3537). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. Advocated for closure of the Medicaid coverage gap and the permanence of the Advanced Premium Tax Credits as part of the Build Back Better Act. Advocated for a robust paid medical leave program. Advocated for increased funding of home and community-based services (HCBS). Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the FDA user fee reauthorizations Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Supported greater appropriations for Consumer Assistance Programs Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Commented on fixing the ACA Family Glitch to the Treasury Department Supported reforms to the HCPCS coding system. Supported passage of the Ending the Diagnostic Odyssey Act Advocated for the passage of the Accelerating Kids Access to Care Act Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Support the passage of the Precision Medicine for Children Act Advocated for the passage of the HCBS Access Act Supported the passage of the Stop the Wait Act (S. 3575 / H.R. 6583) Provided comments to Congress on portions of the Inflation Reduction Act, including the Medicare out-of-pocket cap and smoothing mechanisms. Joined coalition comments on the CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies Proposed Rule. Provided policy suggestions to CMS on the annual Notice of Benefit and Payment Parameters. Advocated for greater coverage of seat elevation systems and standing wheelchairs within the Medicare program. Advocated for the Access to Genetic Counselors Act
Client expense: $200,000 · 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), Labor, Dept of (DOL), Natl Council on Disability, Natl Institutes of Health (NIH), SENATE, Treasury, Dept of
2022 · third_quarter · Medical/Disease Research/Clinical Labs
Advocated in favor of robust appropriations funding for the National Institutes of Health, the Food and Drug Administration, the Health Resources and Services Administration, and the Centers for Disease Control and Prevention. Advocated for greater appropriations for the National Center for Advancing Translational Sciences (NCATS) Advocated for greater appropriations for the National Institutes of Health. Advocated for appropriations for HHS, NIH, and FDA to implement the ACT for ALS. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the FDA user fee reauthorizations Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Advocated for passage of FDA and clinical trial reforms within an end-of-year bill, including accelerated approval reforms, clinical trial diversity advancements, the RARE Act, reauthorization of the Orphan Product Grants Program, and more.
Client expense: $200,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2022 · third_quarter · Health Issues
H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;
Client expense: $930,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
2022 · third_quarter · Health Issues
FY23 Labor, Health and Human Services, and Education Appropriations Bill: Pediatric Subspecialty Loan Repayment Program, Firearm Injury and Mortality Prevention Research, Pediatric Mental Health Care Access Program, Emergency Medical Services for Children, National Center for Birth Defects and Developmental Disabilities, Global Immunization, Sudden Unexpected Infant Death and Sudden Death in Childhood, Vaccine Injury Compensation Program, VACCINES Act, Antimicrobial Resistance, Maternal and Child Health, School Based Health Centers Child passenger safety (H.R. 5736) Appropriations for the Indian Health Service Maternal, Infant, and Early Childhood Home Visiting Program (including Jackie Walorski MIECHV Reauthorization Act of 2022 (H.R. 8876)) Infant sleep product safety (S. 1259, H.R. 3182) Lead exposure prevention Food safety Paid family and medical leave Climate Change Reduction Act Button battery ingestions (H.R. 5313, S. 3278) Early Childhood education Child product safety and injury prevention Furniture tip-overs (S. 441, H.R. 1314) Child Abuse Prevention and Treatment Act reauthorization, CAPTA Reauthorization Act of 2021 CAPTA Plans of safe care grants Family First Prevention Services Act implementation Issues related to the COVID-19 pandemic and providing supports for the child welfare community CAPTA Fatalities Prevention and Response Title IV-B Reauthorization Ensuring Medicaid continuity for Children in Foster Care Act (S. 2689/H.R. 5414) Congregate care reform Mental health supports for foster youth/former foster youth Indian Child Welfare Act & Title IV-B (H.R. 8954) Regulation of high-powered magnet sets Vehicle emissions standards Access to genetic sequencing 12-Month Continuous Eligibility for Children in Medicaid/CHIP Easy Enrollment in Health Care Act of 2021 Provider Relief Fund Reporting Requirements Accelerating Kids Access to Care Act (H.R. 3089/S. 1544) Connect for Health Act of 2021 Medicaid Payment Parity Standards in CBP Custody Standards in ICE Family Detention Standards in ORR Custody Licensure of ORR Shelters Emergency Intake Sites Public Charge Child Nutrition Reauthorization/WIC SNAP Mental Health for Children H.R. 6, DREAM Act Family Separation and Detention Medical Nutrition Equity Act Lift the Bar Act Donor Human Milk CARE for Families Act HR 3107 WIC Act Keep Families Together Act Breastfeeding Peer Counseling Program Public Health Preparedness and Response Research for Pregnant and Lactating Women Funding for Pediatric Device Consortia Funding for Emergency Medical Services for Children Program Funding for HRSA Pediatric Mental Health Care Access Program PUMP Act DEMAND Act Dietary Guidelines Child Poverty Coronavirus Response Legislation Asylum Child Poverty Reduction Act Suicide Prevention Child Nutrition Waivers Universal School Meals Equality Act Mental Health Services for Students Act Youth Mental Health and Suicide Prevention Act Child Tax Credit Comprehensive Mental Health in Schools Pilot Program Supporting Childrens Mental Health Care Access Act Protect Infants from Formula Shortages Act Infant Formula Shortage White House Conference on Hunger, Nutrition, and Health Restoring Hope for Mental Health and Well-Being Act Mental Health Reform Reauthorization Act Safety of Pediatricians and Childrens Hospitals Gender Affirming Care FY23 Labor, Health and Human Services, and Education Appropriations Bill: Pediatric Subspecialty Loan Repayment Program, Firearm Injury and Mortality Prevention Research, Pediatric Mental Health Care Access Program, Emergency Medical Services for Children, National Center for Birth Defects and Developmental Disabilities, Global Immunization, Sudden Unexpected Infant Death and Sudden Death in Childhood, Vaccine Injury Compensation Program, VACCINES Act, Antimicrobial Resistance, Maternal and Child Health, School Based Health Centers COVID-19 Supplemental Appropriations H.R.482 / S.350 - Newborn Screening Saves Lives Reauthorization Act H.R.5551 - Improving the Health of Children Act H.R.2347 / S.2691 - Strengthening the Vaccines for Children Program Act of 2021 Childrens Literacy Initiative on Military Bases (CLIMB) Act of 2022 - H.R. 8208 Advancing FASD Research, Services and Prevention Act - S. 2238 / H.R. 4151 Banning Electronic Stimulation Devices - FDA User Fee Bills (H.R. 7667/S. 4348) Defense Health Agency - Autism Care Demonstration SSI Savings Penalty Elimination Act (S. 4102) FY23 National Defense Authorization Act and Halting Reductions to Military Medical Personnel Kids Online Safety Act (S. 3663) Children and Teens Online Privacy Protection Act (S. 1628) Pediatric Subspecialty Loan Repayment Program Implementation Eunice Kennedy Shriver National Institute of Child Health and Human Development FY 2023 Funding Census Bureau FY 2023 Funding Accelerating Kids Access to Care Act (H.R. 3089/S. 1544) Conrad State 30 and Physician Access Reauthorization Act (H.R. 3541/S. 1810) Clinical Trial Coverage Act (H.R. 8546) American Data Privacy and Protection Act (H.R. 8152) Department of Health and Human Services Office of Adolescent Health Fiscal Year (FY) 2023 Funding Medical Marijuana and Cannabidiol Research Expansion Act (H.R. 8454) Mainstreaming Addiction Treatment Act (H.R. 1384/S. 445) E-Cigarette and Tobacco Product Regulation (FDA) FY 2024 Funding for Adolescent Sexual and Reproductive Health Programs (White House Office of Management and Budget) Strengthening Efforts to End Violence Against Children Act International Children with Disabilities Protection Act Reach Every Mother and Child Act Appropriations - global child and youth-focused global health subaccounts at USAID (Vulnerable Children, Maternal and Child Health, Nutrition) Global Child Thrive Act Implementation
Client expense: $290,000 · Firm income: Not reported
Government targets: Administration for Children & Families (ACF), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Indian Health Service, Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), White House Office
2022 · third_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. 4217/S. 2779, Taskforce Recommending Improvements for Unaddressed Mental Perinatal & Postpartum Health (TRIUMPH) for New Moms Act H.R. 5376, Inflation Reduction Act - 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. 5585, Advanced Research Projects Agency-Health (ARPA-H) Act 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 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
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 · third_quarter · Health Issues
Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care; H.R. 482/S.350, Newborn Screening Saves Lives Act Reauthorization; H.R. 7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 3932: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISION H.R. 4040: ADVANCING TELEHEALTH BEYOND COVID-19 ACT OF 2022; ALL PROVISIONS H.R. 5030: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS P.L. 117-169: (H.R. 5376) INFLATION REDUCTION ACT OF 2022; PROVISIONS RELATING TO MEDICAID COVERAGE GAP, PART D OUT OF POCKET COSTS, AND EXTENDING THE ENHANCED PREMIUM TAX CREDITS H.R. 5566: FINDING ORPHAN-DISEASE REMEDIES WITH ANTIFUNGAL RESEARCH AND DEVELOPMENT (FORWARD) ACT OF 2021; ALL PROVISIONS H.R. 5801: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 6000: CURES 2.0 ACT; ALL PROVISIONS H.R. 6833: AFFORDABLE INSULIN NOW ACT; PROVISIONS RELATING TO FDA USER FEE REAUTHORIZATION S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 942: NO JUNK PLANS ACT; ALL PROVISIONS S. 2076: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS S. 2706: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING ACE KIDS 2.0; ALL PROVISIONS
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medical/Disease Research/Clinical Labs
H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 869: RESEARCH INVESTMENT TO SPARK THE ECONOMY (RISE) ACT OF 2021; ALL PROVISIONS H.R. 3932: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS H.R. 5030: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS P.L. 117-169: (H.R. 5376) INFLATION REDUCTION ACT OF 2022; PROVISIONS RELATING TO MEDICAID COVERAGE GAP, PART D OUT OF POCKET COSTS, AND EXTENDING THE ENHANCED PREMIUM TAX CREDITS H.R. 5566: FINDING ORPHAN-DISEASE REMEDIES WITH ANTIFUNGAL RESEARCH AND DEVELOPMENT (FORWARD) ACT OF 2021; ALL PROVISIONS H.R. 6000: CURES 2.0 ACT; ALL PROVISIONS H.R. 6833: AFFORDABLE INSULIN NOW ACT; PROVISIONS RELATING TO FDA USER FEE REAUTHORIZATION S. 289: RESEARCH INVESTMENT TO SPARK THE ECONOMY (RISE) ACT OF 2021; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 2076: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS S. 2706: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING THE 2023 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR HHS AND RELATED AGENCIES, FDA AND RELATED AGENCIES, CDC AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Maternal and child health including Medicaid postpartum coverage provisions, public health, maternal therapeutics, vaccination, and other health-related bills. Black Maternal Health Momnibus Act of 2021 (H.R. 959/S. 346), Mothers and Offspring Mortality and Morbidity Awareness Act or the MOMMA'S Act (S. 411), Rural Maternal and Obstetric Modernization of Services Act or the Rural MOMS Act (H.R. 769), Newborn Screening Saving Lives Reauthorization Act of 2021 (H.R. 482/S. 350), Maternal Immunization Enhancement Act, Maternal Immunization Coverage Act, The Strengthening the Vaccines for Children Program Act (H.R. 2347), Improving Social Determinants of Health Act of 2021 (H.R. 379/S.104), the Public Health Infrastructure Saves Lives Act (S. 674), the Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers Act of 2021 (H.R. 1550), Maternal Health Quality Improvement Act of 2021 (H.R. 4787/S. 1675), Data Mapping to Save Moms Act of 2021 (H.R. 1218/S. 198), The Taskforce Recommending Improvements for Unaddressed Mental Perinatal and Postpartum Health (TRIUMPH for New Moms Act of 2021) for New Mothers Act (H.R. 4217/ S. 2779), Stillbirth Health Improvement and Education for Autumn Act of 2021 or SHINE for Autumn Act (H.R. 5487), Improving the Health of Children Act (H.R. 5551), Lead Poisoning Prevention Act of 2021 (H.R. 5552), Early Hearing Detection and Intervention Act of 2021 (H.R. 5561), Maternal and Child Health Stillbirth Prevention Act (H.R. 7011), Ensuring Lasting Smiles Act (H.R. 1916/S. 754), Into the Light for Maternal Mental Health and Substance Use Disorders Act (H.R. 7073/S.3824), Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R. 7666), PUMP for Nursing Mothers Act (H.R. 3110/S. 1658, PREVENT Pandemics Act of 2022 (S. 3799),Cures 2.0 Act of 2022 (H.R. 6000),the BABES Enhancement Act (H.R. 8695/S.4880), the Healthy Meals, Healthy Kids Act of 2022 (H.R. 8450), and the Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022 (H.R. 8876).
Client expense: $60,000 · 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), Natl Institutes of Health (NIH), SENATE
2022 · third_quarter · Health Issues
HR 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS OF THE BILL HR 7667: FOOD AND DRUG AMENDMENTS OF 2022; PROVISIONS RELATED TO TITLE V, SECTIONS 703 AND 804 S 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS OF THE BILL S 4348: FOOD AND DRUG ADMINISTRATION SAFETY AND LANDMARK ADVANCEMENTS ACT OF 2022 (FDASLA ACT); PROVISIONS RELATED TO SECTION 506 GENERAL DISCUSSIONS REGARDING RARE DISEASES AND VETERANS BENEFITS ADMINISTRATIONS
Client expense: $170,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;
Client expense: $910,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
2022 · third_quarter · Health Issues
Alpine Group will represent CAE USA, Inc. to Congress and the Administration on the issues of emergency response & recovery, defense, healthcare, pandemic preparedness H.R. 482/S. 350, the Newborn Screening Saves Lives Reauthorization Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE
2022 · third_quarter · Health Issues
Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Newborn Screening Saves Lives Act Reauthorization, H.R. 482, S 350. FY 2022 and FY 2023 CDC Appropriations for state newborn screening technical assistance and related Senate appropriations. H.R. 1692, S 250, Fairness in Orphan Drug Exclusivity Act.
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Congressional passage of the CAROL Act (H.R. 1193/S. 1133) and the Newborn Screening Saves Lives Reauthorization Act of 2021 (H.R. 482/S. 350), continued and expanded federal funding for research into cardiovascular diseases and treatments
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Budget/Appropriations
1. S. 246 / H.R. 851 - Future Advancement of Academic Nursing (FAAN) Act 2. H.R. 7961 - Safety from Violence for Healthcare Employees (SAVE) Act 3. S. 1512 / H.R. 2903 - CONNECT for Health Act of 2021 4. S. 3018 / H.R. 3173 - Improving Seniors' Timely Access to Care Act of 2021 5. S. 4182 / H.R. 1195 - Workplace Violence Prevention for Healthcare and Social Service Workers 6. S. 1133 / H.R. 1193 - Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act 7. S. 350 / H.R. 482 - Newborn Screening Saves Lives Reauthorization Act of 2021 8. The Title VIII Nursing Workforce Reauthorization Act
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;
Client expense: $1,580,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Health Insurance Coverage (general); Health Equity (general); Breastfeeding (general); Assisted Reproductive Technology (general); Substance Use Disorder (general); Gynecologic Cancer (general); Reproductive Health (general); Intimate Partner Violence (general); Gun Violence (general); Immunization (general); Breast Cancer (general); Medical Liability Reform (general); Health IT (general); Patient-Physician Relationship (general); Child Welfare (general); Maternal Mortality and Morbidity (general); Graduate Medical Education (general); Contraception (general); Abortion (general); Indian Health (general); Teaching Health Centers Graduate Medical Education (general); Community Health Centers (general); National Health Service Corps (general); Health care workforce (general); Title VII Health Workforce Programs (general); Title VIII Health Workforce Programs (general); Sexuality Education (general); Sexually Transmitted Infections (general); Access and Provision of Medication-based Opioid Use Disorder Treatment (HHS); Research in Pregnant and Breastfeeding Women (general); Health Care Reform (general); Title X Family Planning Program (general); Womens Preventive Services (general); Administrative Burden (general); COVID-19 Response (general); COVID-19 Vaccines (general); Pandemic Preparedness (general); Risk Evaluation and Mitigation Strategies (general); Data Collection (general); Social Determinants of Health (General); Maternal Mental Health (general); Online misinformation (general); EMTALA (general); H.R. 3755/S. 1975, Womens Health Protection Act; implementation of P.L. 115-320, Improving Access to Maternity Care Act; implementation of Maternal Health Quality Improvement Act contained in P.L. 117-103; H.R. 959/ S. 346, Black Maternal Health Momnibus Act; implementation of P.L. 116-123, the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020; implementation of P.L. 116-127, the Families First Coronavirus Response Act; implementation of P.L. 116-136, the Coronavirus Aid, Relief, and Economic Security Act; implementation of P.L. 116-139, Paycheck Protection Program and Health Care Enhancement Act; H.R. 1065/S. 1486, Pregnant Workers Fairness Act; implementation of P.L. 117-105, Lorna Breen Health Care Provider Protection Act H.R. 1350/ S.408, Supporting Best Practices for Healthy Moms Act; H.R. 3407/S. 411, MOMMAs Act; implementation of P.L. 117-2, the American Rescue Plan Act of 2021; H.R. 2007/S. 2444, Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021; H.R. 3110/S. 1658, PUMP for Nursing Mothers Act; H.R. 2903/S.1515, CONNECT for Health Act; H.R. 3671/S.1958, Doctors of Community (DOC) Act; Implementation of P.L. 114-255, the 21st Century Cures Act; Implementation of the No Surprises Act contained in P.L. 116-260H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act; H.R. 804/S. 248, FAMILY Act; H.R. 5/S. 393, Equality Act; H.R. 4151/S. 2238, FASD Respect Act; Advanced Research Projects Agency for Health (ARPA-H); H.R. 5376, Build Back Better Act, H.R. 5376, Inflation Reduction Act of 2022; H.R. 5218, Collaborate in an Orderly and Cohesive Manner Act; H.R. 5239/ S. 2941, Good Samaritan Health Professionals Act of 2021; H.R. 7073/S.3824, Into the Light for MMH and SUD Act of 2022; H.R.5487/S.3972, SHINE for Autumn Act of 2021; Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV) (general); Disclosure of Ingredients in Menstrual Products (general); H.R.7011/S.3797, Maternal and Child Health Stillbirth Prevention Act of 2022; H.R. 2234/S. 1021, Equal Access to Abortion Coverage (EACH) Act; S. 4467, Protecting Access to Medication Abortion Act; S.Res.664, A resolution expressing opposition to the criminalization of essential healthcare, including the full range of sexual and reproductive healthcare such as abortion, gender-affirming care, and contraceptive care, and disapproving of the criminalization of pregnancy outcomes; H.Res.589, Expressing the sense of the House of Representatives that policies governing access to medication abortion care in the United States should be equitable and based on science; H.R. 7894/S. 4347, Affordability is Access Act (AAA); H.R. 6005/S. 3223, Access to Birth Control Act; H.R. 7845, NIH Clinical Trial Diversity Act of 2022; H.R. 4217/S. 2779, TRIUMPH for New Moms Act of 2021; H.R. 7974, Endometriosis CARE Act of 2022; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; H.R. 8185/S. 4440 Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; H.R. 7617/S. 309, Preventive Care Awareness Act of 2022; Safety and efficacy of noninvasive prenatal screening tests (FDA/CMS); COVID-19 public health emergency unwinding (general); ; Implementation of the Maternal Health Quality Improvement Act and Rural MOMS Act included in P.L. 117-103; Implementation of P.L. 117-103, Consolidated Appropriations Act, 2022;; health care provider conscience protections (general); Access to prenatal telehealth services (general) ; H.R. ____, Abortion Care Awareness Act; Consent for use of human reproductive material in assisted reproductive technology or intrauterine insemination (general); H.R. ____, Informing New Factors and Options for Reproductive Care Act; H.R. 8834, EQUIP Act; S. 4688, Reproductive Freedom for All Act; S. 4748, Protecting National Access to Reproductive Care Act; H.R. 4040, Advancing Telehealth Beyond COVID-19 Act of 2021; Reproductive health care workforce (general); S.4467, Protecting Access to Medication Abortion Act; S.4723, Let Doctors Provide Reproductive Health Care Act; H.R. 8373, Right to Contraception Act; S.4764, Reproductive Health Care Accessibility Act
Client expense: $110,000 · 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), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2022 · third_quarter · Health Issues
H.R.5376 - Inflation Reduction Act of 2022; Healthcare provisions of the bill H.R.7634 - Protecting Health Care for All Patients Act of 2022; All provisions of the bill H.R.7667 - Food and Drug Amendments of 2022; All provisions of the bill S.350 - Newborn Screening Saves Lives Reauthorization Act of 2021; All provisions of the bill S.4348 - FDASLA Act of 2022; All provisions of the bill Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023; healthcare provisions of the bill Issues related to rare disease Issues related to patient access treatments Issues related to newborn screening Issues related to Prescription Drug User Fee Program Reauthorization
Client expense: $230,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
Advocacy on health care issues related to genetics and genetic testing, including H.R. 482 / S. 350, Newborn Screening Saves Lives Reauthorization Act; H.R. 1439; the Expanded Genetic Screening Act; H.R. 2144 / S. 1450, to provide for expanded coverage of services furnished by genetic counselors under Medicare Part B; S. 1666, the Verified Innovative Testing in American Laboratories Act (VITAL Act) of 2021; H.R. 4128/S. 2209, the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) of 2021; S.4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Issues related to simulation, training, and workforce development; H.R. 482/S. 350, the Newborn Screening Saves Lives Reauthorization Act; Issues related to patient safety telesimulation programs
Client expense: $130,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_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)
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 · third_quarter · Health Issues
Potential legislation implementing value based purchasing for pharmaceuticals (HR 7389); Possible provisions related to Drug Pricing Legislation that affect biological products' development, approval, accelerated approval, and marketing, including deliberations associated with the Reauthorization of the Prescription Drug User Fee Act ( HR 7667) (S 4348), or the continuing resolution(Further Extendjnf Government Funding Act P.L. 117-70. Possible drug pricing legislation included in any budget reconciliation legislation ( no specific number). Reauthorization of the Newborn Screening Saves Lives Act (HR 482, S 350.)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
H.R. 1730, S. 670 - STAT Act; H.R. 482, S. 350 - Newborn Screening Save Lives Reauthorization Act; Cures 2.0; PDUFA; ARPA-H; Telehealth; Covid-relief; Appropriations; S. 373, H.R. 4472 - Better Empowerment Now to Enhance Framework to Improve Treatments (BENEFIT) Act; H.R. 2144, S. 1450 - Access to Genetic Counselor Services Act; H.R. 5989 - Precision Medicine Answers for Kids Today Act (PMAKTA); VALID Act.
Client expense: $20,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
S. 1357 and H.R. 3773, The Pediatricians Accelerate Childhood Therapies (PACT) Act of 2021 H.R. 8876 Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022 S. 346 and H.R. 959, Black Maternal Health Momnibus Act of 2021 The PREEMIE Act Reauthorization (not yet introduced) S.2741, Reducing Obesity in Youth Act of 2021 S. 350, The Newborn Screening Saves Lives Reauthorization Act of 2021 The inclusion of mental health provisions in potential End of Year Package: H.R.4943, Childrens Mental Health Infrastructure Act of 2021 H.R.4944, Helping Kids Cope Act of 2021 S.4472, Health Care Capacity for Pediatric Mental Health Act Other key provisions such as school health, workforce, etc.
Client expense: $145,718 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives, including H.R. 1629/S.250, the Fairness in Orphan Drug Exclusivity Act; drug pricing proposals, including H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act and H.R. 19/S.2164, Lower Costs, More Cures Act of 2021; access to rare disease and gene therapy drugs; education and awareness of genetic rare bone disorders; FDA approvals of drugs designed to treat rare diseases, including gene therapies; and regulatory reforms generally, including but not limited to S. 3799, the PREVENT Pandemics Act, H.R. 6000, CURES 2.0, H.R. 6963, the Accelerated Approval Integrity Act of 2022, H.R. 6996, the Accelerating Access for Patients Act; H.R. 7667, Food and Drug Amendments of 2022, and S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. Issues pertaining to newborn screening and gene panel screening, including provisions of H.R. 482/S.350 , the Newborn Screening Saves Lives Reauthorization Act of 2021. Policies contained in and amendments offered to S.Con.Res.5, setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030; and policies contained in and amendments offered to P.L. 117-2, the American Rescue Plan Act of 2021; P.L. 117-169, Inflation Reduction Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Medical/Disease Research/Clinical Labs
AACC initiated grassroots campaigns and met with congressional staff in opposition to including the Verifying Accurate Leading-edge IVCT Development (VALID) Act in either the Medical Device User Fees package or a continuing resolution to fund the federal government through 2022. AACC joined with other healthcare groups in urging key Senators to support the passage of S.350, the Newborn Screening Saves Lives Reauthorization Act, which would extend for another five years federal newborn screening programs.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
Congressional passage of the CAROL Act (H.R. 1193/S. 1133) and the Newborn Screening Saves Lives Reauthorization Act of 2021 (H.R. 482/S. 350), continued and expanded federal funding for research into cardiovascular diseases and treatments
Client expense: Not reported · Firm income: $47,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Medical/Disease Research/Clinical Labs
Advocated in favor of robust appropriations funding for the National Institutes of Health, the Food and Drug Administration, the Health Resources and Services Administration, and the Centers for Disease Control and Prevention. Advocated for greater appropriations for the National Center for Advancing Translational Sciences (NCATS) Advocated for greater appropriations for the National Institutes of Health. Advocated for appropriations for HHS, NIH, and FDA to implement the ACT for ALS. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the FDA user fee reauthorizations Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000)
Client expense: $200,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE