Sen. Susan M. Collins

Providing Resources for Emergency Preparedness And Resilient Enterprises Act or the PREPARE Act This bill reauthorizes through FY2026 a pre-disaster mitigation program, administered by the Small Business Administration, for disbursing economic injury disaster loans to small businesses for protection of real estate, equipment, inventory, supplies, and materials. The bill also increases the amount for loans to take mitigating actions to protect damaged or destroyed property from possible future disasters.

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receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded.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.

Hizballah in Latin America Accountability Act of 2021 This bill establishes requirements related to activities of Hizballah in Latin America and the Caribbean. Specifically, the President must impose property- and visa-blocking sanctions on foreign persons determined to have knowingly engaged in significant transactions with, or provided material support to, Hizballah in a Latin American or Caribbean country. The Department of the Treasury, in consultation with the Department of State, must report on illicit activities of Hizballah in Latin America and the Caribbean. This report must include (1) an estimate of how much of Hizbollah's budget derives from such activities, (2) an assessment of interagency efforts and progress in countering such activities, and (3) an identification of financial institutions in Latin America and the Caribbean known to be operating on behalf of or with ties to Hizballah. The Department of Homeland Security must seek to improve (1) data sharing among trade transparency units with respect to operations against malign actors among Latin American and Caribbean countries, and (2) cooperation with federal agencies with respect to trade transparency units.

This resolution designates May 9-May 15, 2021, as Doula Week and recognizes the role of doulas in providing maternal health services.

Captive Primate Safety Act This bill limits the trade and possession of nonhuman primates. For example, the bill prohibits most individuals from owning a nonhuman primate as a pet.

Long-Term Care Pharmacy Definition Act of 2021 This bill establishes a statutory definition for long-term care pharmacy under the Medicare prescription drug benefit. Currently, there is no statutory definition. Regulations from the Centers for Medicare & Medicaid Services (CMS) define a long-term care pharmacy as a pharmacy that is owned by or under contract with a long-term care facility to provide prescription drugs to the facility's residents. Additional requirements are set out in CMS guidance relating to the Medicare prescription drug benefit; pharmacies are also subject to regulations and guidance from other agencies (e.g., packaging requirements from the Food and Drug Administration).      The bill defines a long-term care pharmacy as a state-licensed pharmacy that is able to provide enhanced pharmacy and clinical services to individuals who have certain comorbid and medically complex chronic conditions and who reside in skilled nursing facilities, nursing facilities, or any other applicable setting (as determined by the CMS). The term enhanced pharmacy and clinical services includes medication dispensed in special packaging, drug utilization review, and 24-7 availability of medication delivery and on-call pharmacists.

Accelerating Kids' Access to Care Act This bill requires state Medicaid programs to establish a process through which qualifying out-of-state providers may enroll as participating providers without undergoing additional screening requirements. Among other things, a qualifying provider must (1) serve minors, or adults whose condition began as a minor; and (2) have previously been screened for Medicare participation or for participation in the Medicaid program of the state in which the provider is located.

Equity in Neuroscience and Alzheimer's Clinical Trials Act of 2021 or the ENACT Act of 2021 This bill sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimer's disease and related dementias. Specifically, the National Institute on Aging (NIA) must establish and provide technical assistance to Alzheimer's research centers located in areas with higher concentrations of minority groups. These centers must establish diagnostic and treatment clinics designed to serve minority, rural, and other underserved populations; operate clinical trials; and carry out public outreach to encourage members of minority populations to participate in clinical trials and research. Additionally, the NIA must disseminate information to members of minority populations about participating in clinical trials and take other actions to enhance diversity with respect to the Alzheimer's research that it conducts or supports. The bill also directs the NIA to increase diversity among Alzheimer's researchers by encouraging the participation of individuals who are from groups that are underrepresented in clinical, behavioral, and social sciences.

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.)

Medical Nutrition Therapy Act of 2021 This bill expands Medicare coverage of medical nutrition therapy services. Currently, Medicare covers such services for individuals with diabetes or kidney disease under certain circumstances; such services must also be provided by a registered dietitian or nutrition professional pursuant to a physician referral. The bill extends coverage to individuals with other diseases and conditions, including obesity, eating disorders, cancer, and HIV/AIDS; such services may also be referred by a physician assistant, nurse practitioner, clinical nurse specialist, or (for eating disorders) a clinical psychologist.