Rep. Doris O. Matsui

Diverse and Equitable Participation in Clinical Trials Act or the DEPICT Act This bill requires applications for an investigational use exemption of a new drug or medical device to include information about the demographic diversity of the clinical trial population and addresses related issues. (Generally, a developer of a new drug or device may seek an investigational use exemption to facilitate clinical investigations, as part of the process to obtain approval to sell that drug or device.) Specifically, the Food and Drug Administration (FDA) must issue regulations to require applications for such exemptions to include certain information, including (1) demographic data disaggregated by subgroup, where such data is available, about the expected or potential patient population; (2) the applicant's enrollment targets for the clinical trials involved, disaggregated by age group, sex, race, and ethnicity; (3) a diversity plan for how the applicant will meet these targets; and (4) what is known about the patient population, such as comorbidities. The regulations must also require certain applicant reports to the FDA to address issues related to demographic diversity in clinical trials and product safety and effectiveness for demographic subgroups. The bill also authorizes the FDA to, in certain instances, require additional studies or surveillance after a drug or device has been approved if the clinical trials used in the application process did not meet the demographic enrollment targets.

Restore Veterans' Compensation Act of 2022 This bill eliminates the recoupment of separation pay, special separation benefits, and voluntary separation incentive payments from members of the Armed Forces who subsequently receive disability compensation from the Department of Veterans Affairs. In addition, the bill limits recoupment of such pay from service members who subsequently receive military retired or retainer pay.

Early Childhood Mental Health Support Act This bill requires the Department of Health and Human Services (HHS) to identify and review evidence-based interventions, best practices, curricula, and staff trainings in Head Start programs that improve the behavioral health of children and support staff wellness. HHS must (1) award grants to participating Head Start agencies to implement the interventions, and (2) evaluate the implementation of the interventions. The bill also permits HHS to fund five best practice centers in universities to prepare future Head Start agencies and staff to deliver the interventions.

Heating and Cooling Relief Act This bill provides additional energy assistance to households, including heating and cooling assistance. Specifically, the bill reauthorizes through FY2031 and revises the Low Income Home Energy Assistance Program. Under the existing program, the Department of Health and Human Services (HHS) may award grants to states for assisting low-income households that pay a high proportion of their income for home energy. To be eligible under the existing program, households must have incomes which do not exceed the greater of an amount equal to 150% of the poverty level for their state or an amount equal to 60% of the state median income. The bill expands eligibility to households with incomes which do not exceed the greater of an amount equal to 250% of the poverty line as defined in the Community Services Block Grant Act or an amount equal to 80% of the state median income. In addition, the bill expands eligibility to households with a monthly energy burden of 3% or more per year. It also requires states to establish procedures to protect households receiving assistance under the program from energy shutoffs and certain late fees. In addition, the bill requires HHS and the Department of Energy to jointly carry out a program that awards grants to states and local governments for developing and implementing interagency plans to reduce energy burdens for eligible households with high home energy use. The plans must promote the reduction of energy from fossil fuels.

Leading Infrastructure For Tomorrow’s America Act or the LIFT America Act This bill establishes several programs and incentives to modernize the nation's communications, drinking water, energy, transportation, health care, and other related infrastructure. For example, the bill provides incentives to make broadband internet more accessible and affordable. It also establishes grants to implement next generation 9-1-1 services. In addition, it supports drinking water programs, including the drinking water state revolving fund program. Further, it provides grants to treat perfluoroalkyl or polyfluoroalkyl substances (commonly referred to as PFAS) in drinking water and to replace lead service lines. The bill establishes a variety of programs to support clean energy infrastructure and address climate change, including efforts to (1) modernize the electric grid and make it more resilient, efficient, and secure; (2) increase energy efficiency in buildings; and (3) support renewable energy infrastructure. Further, it provides incentives for vehicle infrastructure, such as incentives to develop infrastructure for electric vehicles and grants to reduce air pollution at ports by electrifying port infrastructure. Additionally, the bill establishes grants and programs for health care infrastructure, including by providing support for the Centers for Disease Control and Prevention, laboratories, and state, local, tribal, and territorial health departments. Finally, the bill reauthorizes grant programs to remediate brownfield sites (i.e., sites contaminated with hazardous substances) through FY2026.

Climate Risk and Emergency Support In Livable Inclusive and Equitable Neighborhoods and Communities Everywhere Act or the Climate RESILIENCE Act This bill makes changes to the Robert T. Stafford Disaster Relief and Emergency Assistance Act to take into account climate change. The bill includes extreme temperature events, such as heat waves or freezes, within the scope of the act and defines resilience for purposes of disaster assistance and mitigation efforts. Federal and state preparedness and mitigation assistance may be used for reducing the impacts of extreme temperatures and improving air quality and mitigating against wildfire smoke.. The bill authorizes implementing predisaster hazard mitigation measures that will be cost-effective and equitable long-term and provide enhanced protection to the community. The Federal Emergency Management Agency (FEMA) must (1) provide technical assistance to underserved and disadvantaged communities for such measures; and (2) provide guidance to implement the latest published editions of relevant consensus-based codes, specifications, and standards that incorporate the latest hazard-resistant designs. The bill includes within the hazard mitigation program requirements the abatement of lead, mold, mildew, radon, asthma, and allergen triggers, or other pollutants and hazardous materials directly caused by a major disaster or emergency. FEMA must report to Congress regarding challenges posed by FEMA requirements for determining the cost-effectiveness of mitigation activities and how such requirements may disproportionately burden underserved or disadvantaged communities.

PrEP Access and Coverage Act This bill requires private health insurance plans to cover prescription drugs that prevent HIV, including related screenings, diagnostic procedures, administrative fees, and clinical follow-ups, without any cost-sharing obligation for the plan holder. Further, insurance plans must not impose any preauthorization requirement for this coverage. These coverage requirements also apply to public health insurance programs, including Medicare, Medicaid, and the Children's Health Insurance Program. Additionally, the bill prohibits denying, limiting, or qualifying coverage or increasing premiums for disability insurance, long-term care insurance, or life insurance policies based on an individual taking medication for HIV prevention. The bill further requires the Department of Health and Human Services to award grants to states, or directly to eligible local organizations, to provide uninsured individuals and underinsured individuals access to prescription drugs and related services that prevent HIV. The Centers for Disease Control and Prevention also must develop a public awareness campaign that focuses efforts in communities with a high need for HIV prevention treatment.

Western Wildfire Support Act of 2021 This bill establishes activities to address wildfires. The bill requires the Department of Agriculture (USDA) and the Department of the Interior to establish spatial fire management plans before the end of FY2024. The bill establishes accounts in the Treasury for addressing wildfires, a program to train and certify citizens who wish to be able to volunteer to assist USDA or Interior during a wildland fire incident, a program to award grants to eligible states or units of local government to acquire slip-on tank and pump units for a surge capacity of resources for fire suppression, the Theodore Roosevelt Genius Prize for the management of wildfire-related invasive species, and the Management of Wildfire-Related Invasive Species Technology Advisory Board. The bill also requires the Department of Defense (DOD) to reimburse a state or federal agency for the costs of wildfire suppression as a result of a fire caused by DOD activity, requires the Joint Fire Science Program to work with unmanned aircraft test ranges to carry out research and development of unmanned aircraft system fire applications, requires federal and state disaster preparedness programs to include postdisaster assistance, and authorizes the Federal Emergency Management Agency to provide funding to a state agency to establish and operate a website to provide information relating to postfire recovery funding and resources to a community or an individual impacted by a wildland fire.

SNAP Provisions to Lower Undue Struggle Act of 2021 or the SNAP PLUS Act of 2021 This bill expands the Supplemental Nutrition Assistance Program (SNAP) to permit the use of SNAP benefits to purchase prepared foods fit for immediate consumption and hot foods.

Cures 2.0 Act This bill addresses pandemic preparedness and public health issues, caregiver and patient engagement, drug development, insurance coverage, and biomedical research. The Department of Health and Human Services (HHS) must undertake research and other activities concerning COVID-19 and develop a strategy for future pandemics and declared emergencies. Additionally, the bill specifies actions to combat antimicrobial resistance. HHS may award grants for caregiver training. The bill also addresses diversity in clinical trials, collecting patient experience data during clinical trials, and coverage for care related to participation in specified clinical trials. The bill modifies the timeframe and requires additional guidance relating to expedited approval of certain breakthrough drugs, devices, or products. It also establishes two intercenter institutes within the Food and Drug Administration (FDA) focused on particular diseases that meet specified criteria. The bill also addresses (1) coverage in Medicare, Medicaid, and the Children's Health Insurance Program for telehealth, genetic and genomic testing, and other services; (2) electronic prescribing standards for Medicare drug benefits; and (3) access to Medicare and Medicaid claims data by certain registries. Furthermore, the bill prohibits the use of geographic tracking or biometrics in Medicaid electronic visit verification systems. The bill establishes the Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health to accelerate biomedical research and innovation through grants, contracts, cash prizes, and other means. The FDA may work with ARPA-H to expedite the development of medical products through specified activities.