Rep. Yvette D. Clarke

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.

Accelerating Access to Critical Therapies for ALS Act This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions. The Department of Health and Human Services (HHS) shall award grants to eligible entities for scientific research utilizing data from expanded access to investigational ALS treatments for individuals who are not otherwise eligible for clinical trials.  The Food and Drug Administration (FDA) shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other rare neurodegenerative diseases. HHS shall also establish the Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the FDA, and at least one eligible entity (generally, an institution of higher education or a nonprofit organization). The partnership shall support the development and regulatory review of drugs that address ALS and other rare neurodegenerative diseases. The FDA shall publish on its website a five-year action plan for fostering the development of drugs that improve or extend the lives of people living with rare neurodegenerative diseases. The Government Accountability Office must report to Congress about the grants provided under this bill, including an analysis of the impact of such grants on research and development of treatments for ALS.

Future Generations Protection Act This bill prohibits (1) the emission of any greenhouse gas in any quantity from a new electric utility steam generating unit (i.e., certain power plants); (2) hydraulic fracturing on all onshore and offshore land in the United States; and (3) exports of domestically produced crude oil and natural gas, with specified exceptions.

African American History Act This bill authorizes the National Museum of African American History and Culture to carry out educational programs and related activities. Such activities include developing and making available accurate, relevant, and accessible resources to promote the understanding of African American history; and expanding the collection acquisition and collection access processes, including conservation and digitization. The museum may also develop and maintain on its website content designated for educators, students, and families to improve their awareness and understanding of African American history.

Protecting Our Democracy Act This bill addresses issues involving (1) abuses of presidential power; (2) checks and balances, accountability, and transparency; and (3) election integrity and security. Specifically, regarding abuses of presidential power, the bill requires the Department of Justice (DOJ) and the President to submit to Congress specified materials relating to certain pardons, prohibits presidential self-pardons, suspends the statute of limitations for federal offenses committed by a sitting President or Vice President, prohibits the acceptance of foreign or domestic emoluments, and sets forth provisions regarding Office of Government Ethics and Office of Special Counsel jurisdiction and enforcement authority. To address checks and balances, accountability, and transparency, the bill authorizes specified actions to enforce congressional subpoenas, imposes limits on presidential declarations of emergencies, requires DOJ to maintain a log of specified communications between it and the White House, requires cause for removal of inspectors general, increases whistleblower protections, and requires a candidate for President or Vice President to provide copies of tax returns for the 10 most recent taxable years to the Federal Election Commission. To address election integrity and security, the bill requires federal campaign reporting of foreign contacts, makes various changes to requirements concerning foreign donations to political campaigns and candidates and foreign contributions to online electioneering communications, prohibits distribution of materially deceptive audio or visual media prior to an election (i.e., deepfakes), and establishes a program to support states and localities transition to ranked choice voting systems.

Humane Cosmetics Act of 2021 This bill generally prohibits animal testing in the evaluation of cosmetic products, and it prohibits the sale or transport of cosmetics developed using animal testing, subject to civil penalties. These prohibitions begin one year after enactment. The bill specifies exceptions to these prohibitions, including if such animal testing (1) is conducted outside the United States to comply with a foreign regulatory authority; (2) is pursuant to a specified finding that there are no nonanimal alternatives to test the safety of a potentially dangerous cosmetic product or ingredient; (3) is of a product or ingredient for a drug or device subject to regulation by the Food and Drug Administration (FDA); or (4) is required for a noncosmetic purpose pursuant to a state, federal, or foreign regulatory authority. Further, no animal-testing evidence may be used to establish the safety of a cosmetic product or ingredient that is regulated by the FDA after the effective date of this bill, subject to limited exceptions.

Sickle Cell Disease Comprehensive Care Act This bill establishes and provides funds for a demonstration project for state Medicaid programs to improve outpatient care for individuals with sickle cell disease, with a focus on young adults and pregnant women. The Centers for Medicare & Medicaid Services must award planning grants to at least 10 states and must select between 5 and 10 states to participate in the project. Participating states must provide specified services and support for individuals with sickle cell disease, including multidisciplinary care teams, appropriate treatments, mental health services, and specialist services. The bill provides a 100% Federal Medical Assistance Percentage (i.e., federal matching rate) for services provided through the project.

Telehealth Extension Act of 2021 This bill expands and otherwise modifies coverage of telehealth services under Medicare. Specifically, the bill permanently (1) removes geographic restrictions on originating sites (i.e., the location of the beneficiary), (2) allows the home of the beneficiary to serve as the originating site for all services, and (3) allows federally qualified health centers and rural health clinics to serve as the distant site (i.e., the location of the health care practitioner). The bill also extends any Medicare telehealth flexibilities that were granted during the COVID-19 public health emergency until two years after the emergency ends and generally allows such flexibilities to be granted during any public health emergency. In addition, the bill (1) allows for Medicare payment of outpatient critical access hospital services consisting of telehealth behavioral therapy until two years after the COVID-19 public health emergency ends; and (2) after the emergency ends, conditions payment for certain high-cost laboratory tests and durable medical equipment that are ordered via telehealth on at least one in-person visit during the preceding six-month period.

Stillbirth Health Improvement and Education for Autumn Act of 2021 or the SHINE for Autumn Act of 2021 This bill authorizes grants and establishes other programs to improve data collection on stillbirths. Specifically, the Department of Health and Human Services (HHS) may award grants for surveillance and data collection on stillbirths, and HHS must issue guidelines for health departments and vital statistics units concerning the collection of stillbirth data. HHS must also develop educational awareness materials about stillbirths and make them publicly available. Furthermore, HHS must implement a fellowship program to provide training in perinatal autopsy pathology and otherwise support research on stillbirths and fetal autopsies. The bill also requires HHS to issue a report with educational guidelines on stillbirths and stillbirth risk factors.

Maddy summaryHRES 845 is a procedural resolution passed by the U.S. House of Representatives to remove Representative Lauren Boebert (Colorado) from two standing committees: the Committee on the Budget and the Committee on Natural Resources. The resolution directly affects Boebert's committee assignments, which are part of her official duties as a House member. It does not change laws or policies but alters her participation in specific legislative committees. This action was taken under House rules requiring members to "reflect creditably on the House," though the resolution itself only addresses committee membership. The resolution was submitted by multiple House members and referred to the Committee on Ethics.