Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021 or the BENEFIT Act of 2021 This bill requires the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs. After a new drug application has been approved, the FDA's public statement about how it used patient experience data shall include a description of how such data was considered in the risk-benefit assessment framework.
Rep. Darren Soto
Sponsored bills
This resolution recognizes and expresses support for efforts to promote democracy and human rights in Cuba.
End Double Taxation of Successful Consumer Claims Act This bill allows a deduction from gross income (above-the-line deduction) for attorney fees and court costs in connection with a claim of a consumer protection violation.
Securities Clarity Act This bill excludes an investment contract asset as being considered a security, including for disclosure and registration purposes. An investment contract asset as defined by the bill is a tangible or intangible asset sold pursuant to an investment contract that is not otherwise considered a security.
Pathways to Health Careers Act This bill provides funding for, reauthorizes through FY2026, and makes a variety of changes to certain grants administered by the Department of Health and Human Services that provide education and training to low-income individuals for health care occupations, including by establishing a new competitive grant for projects designed to train low-income individuals in allied health professions.
Veterans Entrepreneurship Act of 2021 This bill requires the Small Business Administration to carry out a pilot program assessing the feasibility and advisability of making grants to eligible veterans to start or acquire a small business concern, a franchise business enterprise, or any other appropriate category of business enterprise. Eligible veterans are those veterans or members of the Armed Forces who (1) are currently retiring or separating from the Armed Forces or have been honorably discharged from active duty, (2) have completed a specified minimum period of active duty, and (3) are entitled to certain educational assistance programs. Grant recipients must complete an entrepreneurship readiness program and prepare a business plan, and they may use grant funds for purposes such as purchasing goods or services, funding a project that is directed toward economic development objectives, and acquiring a business enterprise.
Processing Revival and Intrastate Meat Exemption Act or the PRIME Act This bill expands the exemption of custom slaughtering of animals from federal inspection requirements. Under current law, the exemption applies if the meat is slaughtered for personal, household, guest, and employee uses. The bill expands the exemption to include meat that is slaughtered and prepared at a custom slaughter facility in accordance with the laws of the state where the facility is located; and prepared exclusively for distribution to household consumers in the state or restaurants, hotels, boarding houses, grocery stores, or other establishments in the state that either prepare meals served directly to consumers or offer meat and food products for sale directly to consumers in the state. The bill does not preempt any state law concerning (1) the slaughter of animals or the preparation of carcasses, parts thereof, meat and meat food products at a custom slaughter facility; or (2) the sale of meat or meat food products.
Protecting Seniors Through Immunization Act of 2021 This bill specifies that certain deductible, coinsurance, initial coverage limit, and cost-sharing requirements that apply under the Medicare prescription drug benefit shall not apply with respect to vaccines that are recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention. The Centers for Medicare & Medicaid Services must provide to Medicare beneficiaries specified information regarding (1) coverage of vaccines for seniors, and (2) access to recommended vaccines without cost-sharing.
Data to Save Moms Act This bill expands data collection and research on maternal morbidity and mortality among minority populations. Specifically, the bill adds requirements to a program within the Centers for Disease Control and Prevention (CDC) that supports maternal mortality review committees. To the extent practicable, the committees must use the most up-to-date indicators of severe maternal morbidity; review deaths caused by suicide, overdose, or other behavioral health conditions attributed to or aggravated by pregnancy or childbirth; and consult with representatives of communities about nonclinical factors that may contribute to adverse maternal outcomes. The CDC may also award grants to committees to increase their engagement with local communities, such as by bringing on community representatives as committee members. Additionally, the Centers for Medicare & Medicaid Services and the Agency for Healthcare Research and Quality must consult with diverse stakeholders to review maternal health data collection processes and quality measures and make recommendations to improve them. The Indian Health Service and the Department of Health and Human Services must also arrange for studies on adverse maternal health outcomes among tribal and minority populations, respectively.
Technical Reset to Advance the Instruction of Nurses Act or the TRAIN Act This bill modifies the methodology and application of Medicare Advantage nursing and allied health education payments for hospitals. Specifically, for 2010-2019, the bill eliminates the annual cap on total payments and excludes any resulting increase from factoring into calculations for graduate medical education payments for such hospitals. (The Centers for Medicare & Medicaid Services recently issued guidance providing for the recalculation and correction of certain payments to account for the annual payment cap.)