Rep. Grace F. Napolitano

Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act This bill requires activities to increase diversity in clinical trials. It also expands reporting by laboratories that test for and diagnose COVID-19 and requires a study on data collection and data sharing during public health emergencies. Specifically, the Food and Drug Administration (FDA) must issue guidance on decentralized clinical trials to promote meaningful demographic and geographic diversity in patient engagement, enrollment, and participation. Decentralized clinical trials include those executed through telemedicine or other digital technologies to allow for the remote collection and assessment of clinical trial data. The FDA may also work with foreign regulators to harmonize international regulations governing decentralized clinical trials and the use of digital health technology. In addition, the Department of Health and Human Services (HHS) may support community education, outreach, and recruitment activities for clinical trials of treatments for conditions that disproportionately impact populations underrepresented in clinical trials. The bill also specifies that drug or device manufacturers may provide, subject to some limits, free digital health technologies and other remuneration to patients in approved clinical trials without violating laws that address fraud and abuse in federal programs. Furthermore, laboratories that test for and diagnose COVID-19 must report additional demographic data, including information about social determinants of health. HHS must also contract with the National Academy of Medicine to study and propose a design for an interoperable platform to facilitate data sharing during public health emergencies.

Twenty-First Century Dams Act This bill addresses dam infrastructure and safety. First, the bill provides resources for programs related to state dam safety, the rehabilitation of high hazard potential dams, and the inspection of dams. In particular, the bill reauthorizes through FY2026 the National Dam Safety Program. In addition, the bill reauthorizes through FY2026 a program related to the rehabilitation of structural measures and a program related to water infrastructure. Next, the bill allows a new tax credit for maintaining and enhancing hydroelectric dams that is equal to 30% of the basis of any qualified dam safety, environmental, and grid resilience enhancement property placed in service in a taxable year. It also allows a 30% credit for qualified obsolete river obstruction removal expenditures for demolishing and removing certain nonpowered or hydroelectric dams. The bill directs the Department of the Army to establish a program to carry out dam removal projects. Further, the bill establishes the Dam Removal Council to (1) coordinate with participating federal agencies to annually notify all known dam owners of the availability of dam removal funding and provide guidance on the existing programs of participating agencies; (2) evaluate and submit to Army recommendations for dam removal projects, technical assistance programs, and funding allocations; and (3) develop a dam removal strategy. The bill requires certain dam assessments, including a joint assessment by the U.S. Geological Survey and the Department of Energy. The bill also authorizes specified federal agencies to undertake certain activities related to federal dam infrastructure.

Bringing Enhanced Treatments and Therapies to ESRD Recipients Kidney Care Act or the BETTER Kidney Care Act This bill requires the Centers for Medicare & Medicaid Services (CMS) to establish a demonstration program for Medicare beneficiaries with end-stage renal disease (ESRD). Under the program, renal dialysis facilities, kidney disease specialists, physician practices, and other health care practitioners may form an organization that partners with certain health care entities to provide integrated care to beneficiaries with ESRD. Such care must include all covered Medicare benefits as well as transition services for transplantations, palliative care, and hospice. Each organization must have a minimum number or percentage of participating beneficiaries (350 or 60% of beneficiaries served at the organization's facilities) and must also comply with certain fiscal, governance, and quality of care requirements. Additionally, the Government Accountability Office must study certain data that is reported to the CMS regarding pediatric dialysis care, as well as the effects of race-based corrections to a specified kidney function test on referrals of ESRD patients for transplant evaluations.

9/11 Responder and Survivor Health Funding Correction Act This bill increases funding for and otherwise modifies a federal program that provides medical monitoring and treatment to responders and survivors who suffer from health conditions related to the September 11, 2001, attacks on the World Trade Center. Among the changes, the bill allows certain health care providers other than physicians to determine whether an individual's health condition is related to the attacks, and it establishes a research program to study the impacts of the attacks on health and educational outcomes of individuals who were 21 years of age or younger when the attacks occurred.

Children's Mental Health Infrastructure Act of 2021 This bill provides funding through FY2026 to the Health Resources and Services Administration for grants to improve the capacity of children's hospitals to provide pediatric behavioral health services, including by modernizing sites of care and enhancing telehealth capabilities.

Helping Kids Cope Act of 2021 This bill provides funding through FY2026 to the Health Resources and Services Administration (HRSA) for grants to enhance access to and provider training in pediatric behavioral health care. Specifically, HRSA must award grants to pediatricians, children's hospitals, and other providers to support pediatric behavioral health integration and coordination within communities. Grant-funded activities may include hiring community navigators to assist families in accessing appropriate services, incorporating behavioral health services in pediatric practices, and delivering services via telehealth. In addition, HRSA must award grants to children's hospitals to expand training for providers in the pediatric behavioral health workforce.

Central American Women and Children Protection Act of 2021 This bill temporarily authorizes the Department of State to enter into bilateral compacts with the governments of El Salvador, Guatemala, and Honduras to strengthen criminal justice systems, social supports, and other means to protect women and children from domestic and gender-based violence. At least 15 days before entering a compact, the State Department must submit to Congress a copy of the proposed agreement and related materials. Authority to enter a compact terminates on September 30, 2023, and a compact may last no more than six years. To support the objectives outlined in a compact, the State Department may provide assistance to international organizations, civil society, or other private entities for programs and activities to prevent and respond to domestic and gender-based violence in a compact country. The bill bars the provision of assistance to the government of a compact country as direct budgetary support. The State Department may suspend or terminate the assistance if a compact country or entity receiving the assistance engaged in conduct contrary to U.S. national security interests or inconsistent with the objectives of the compact. The State Department must notify Congress at least 15 days before suspending or terminating assistance. The bill also requires the State Department to annually report on progress made under each compact, including its effect on reported violence against women and children and other domestic and gender-based violence indicators.

Medical Device Nonvisual Accessibility Act of 2021 This bill requires certain medical devices with a digital interface to meet nonvisual accessibility standards established by the Food and Drug Administration (FDA). Specifically, the FDA must establish regulations to require a Class II or Class III medical device with a digital interface to provide a blind or low-vision user access to the same services and information, and generally the same ease of use, as provided to a user who is not low-vision or blind. (The FDA classifies medical devices in three classes. Class I devices are low-risk, Class II devices are moderate-risk, and Class III devices are high-risk.) A Class II or Class III medical device that does not meet the nonvisual accessibility standards established under this bill may not be sold.

Acupuncture for Our Seniors Act of 2021 This bill provides for Medicare coverage of acupuncturist services.

Domestic Workers Bill of Rights Act This bill provides rights and protections for domestic workers (e.g., housekeepers, nannies, caretakers, personal assistants, and chauffeurs), including pay and leave rights, and health and safety protections. Specifically, the bill repeals the exemption of domestic live-in employees from certain minimum wage and maximum hour requirements. Employers must provide written notice of termination and provide at least 30 days of lodging and two weeks of severance pay to terminated live-in employees. Live-in employees also must be provided with reasonable access to telephone and internet service during their employment. The bill requires employers to provide domestic workers with a written agreement covering wages, sick leave, benefits, and other matters. Further, domestic workers may request and be granted changes to work schedules due to personal events. The bill also provides domestic workers with certain privacy rights, extends to domestic workers protections against discrimination in employment, and increases the federal medical assistance percentage (FMAP) for certain Medicaid-funded medical services provided by domestic workers. The Department of Labor must (1) award grants for a domestic worker national hotline for reporting emergencies, training on hazards facing domestic workers, and workforce investment activities for domestic workers; and (2) establish a Domestic Worker Wage and Standards Board to investigate standards in the domestic workers industry. Labor must publish online a document that describes the rights and protections for domestic workers under this bill.