Promising Pathway Act This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable. The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations. During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis. The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties. A provisionally approved drug must be labeled as such. If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded. The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective. Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.
Stronger Communities through Better Transit Act This bill requires the Department of Transportation to establish a grant program to support operating projects for public transportation (e.g., service expansion) and related capital improvements, particularly in underserved communities and areas of persistent poverty.
Pediatricians Accelerate Childhood Therapies Act of 2021 or the PACT Act of 2021 This bill requires the National Institutes of Health (NIH) to make awards to support early-career pediatric researchers. It also provides statutory authority for the Trans-NIH Pediatric Research Consortium to coordinate pediatric research across national health research institutions.
Physical Therapist Workforce and Patient Access Act of 2021 This bill makes physical therapists eligible for the National Health Service Corps Loan Repayment Program. This program assists primary care, mental health, and dental providers in repaying eligible student loans in exchange for working in areas with shortages of such providers.
Katherine's Law for Lung Cancer Early Detection and Survival Act of 2021 This bill requires private health insurance plans to cover, without cost sharing, screenings for the detection of lung cancer for certain high-risk individuals.
Accountable Care in Rural America Act This bill requires the Centers for Medicare & Medicaid Services (CMS) to exclude certain components from a methodology used under the Medicare Shared Savings Program. The program enables accountable care organizations (ACOs) to receive payments for savings stemming from care coordination and management. Specifically, the bill requires the CMS to exclude an ACO's assigned Medicare fee-for-service beneficiaries from certain regional adjustments to the ACO's benchmark for savings determinations, and to otherwise ensure that an ACO is not in a less favorable financial position due to its share of assigned beneficiaries in the region.
Nullifying Opportunities for Variants to Infect and Decimate Act or the NOVID Act This bill establishes the Pandemic Preparedness and Response Program to coordinate and carry out the U.S. government's global health response to COVID-19, its variants, and other pathogens with pandemic potential. As part of the program, the bill requires, within 30 days, the development of a comprehensive strategy to end the COVID-19 pandemic. The strategy must outline efforts to increase COVID-19 vaccinations worldwide, including through the immediate release of the COVID-19 vaccine doses that the United States committed to sending abroad. The bill also requires a long-term strategy for the program to prevent future pandemics.
Better Utilizing Infrastructure for Lasting Development of Veterans Businesses Act of 2021 or the BUILD Veterans Businesses Act of 2021 This bill requires a specified percentage of certain Federal-aid highway and public transportation funds to be expended through veteran-owned small businesses.
Medical Nutrition Equity Act of 2021 This bill expands coverage under Medicare, Medicaid, other specified federal health care programs, and private health insurance to include foods, vitamins, and individual amino acids that are medically necessary for the management of certain digestive and metabolic disorders and conditions.
Parity Implementation Assistance Act This bill provides grants to assist states with the implementation of the federal mental health parity requirements. States receiving the grants must request and review from private health insurance plans their required comparative analysis of nonquantitative treatment limitations (NQTLs) with respect to mental health or substance use disorder benefits. (NQTLs are limitations on the scope or duration of benefits for treatment, such as preauthorization requirements.)
State-Based Universal Health Care Act of 20 21 This bill establishes the option for states, or groups of states, to apply to waive certain federal health insurance requirements and provide residents with health insurance benefits plans through a state-administered program. Such programs must cover 95% of the residents in the state within five years and plan benefits must be at least as comprehensive and affordable as the coverage under the equivalent federal program. State programs are supported with funds from the federal programs the state programs replace, which may include Medicare, Medicaid, the Children's Health Insurance Program, the Federal Employee Health Benefits program, certain federal tax credits, and premium-assistance funds, among others. The bill requires the Department of Health and Human Services to appoint an Independent Assessment Panel for Comprehensive Care to review and recommend whether to approve state applications. Each approved state program must be independently reviewed every five years to evaluate changes in health benefits access, quality, and coverage, including whether the state has met the 95% coverage requirement. The federal government must pay all health insurance costs for American Indians and Alaska Natives who enroll in a plan through a state insurance program.
This joint resolution recognizes and affirms the sovereign and unilateral authority of states to defend themselves against invasion.
