Verifying Accurate Leading-edge IVCT Development Act of 2021 or the VALID Act of 2021 This bill requires the Food and Drug Administration (FDA) to regulate in vitro clinical tests (IVCTs). Currently, the FDA and the Centers for Medicare & Medicaid Services have authority to regulate in vitro diagnostic devices. The bill defines IVCTs, which includes in vitro diagnostic devices, as tests intended for the collection, preparation, analysis, or in vitro clinical examination of specimens from the human body to provide information about a disease, condition, or treatment. An IVCT may not be introduced into interstate commerce unless it has received FDA premarket approval or is covered by certain exemptions, such as an exemption for a test that (1) was developed and introduced before this bill's enactment and meets certain requirements, (2) is a low-risk test, (3) is solely for public health surveillance, (4) is covered by a technology certification issued under this bill, or (5) has received a humanitarian exemption or emergency use authorization. The FDA may grant upon application a technology certification. Generally, such a certification covers a group of tests that use a single technology and may be evaluated using a representative test. While such a certification is valid, a qualifying IVCT that falls within the scope of the certification shall be cleared for interstate commerce. The bill also imposes various requirements related to IVCTs, including those related to quality control, labeling, and reporting adverse events. The FDA shall have various enforcement authority, including authority to order the recall of an IVCT with a reasonable probability of causing serious adverse health consequences.
Allergy Testing Access Act of 2021 This bill requires equal coverage of two types of allergy tests under Medicaid and Medicare. Specifically, in vitro specific IgE tests (blood tests) and percutaneous tests (skin tests) must be treated equally with respect to (1) medical necessity or other coverage requirements, (2) frequency limits, and (3) allergen unit limits.
Expanding Health Care Options for Early Retirees Act This bill establishes a Medicare buy-in option for certain qualifying first responders. Specifically, the bill allows first responders aged 50 to 64 to enroll in Medicare if they are retired or otherwise separated from service due to a disability. The Centers for Medicare & Medicaid Services (CMS) must determine enrollment periods and set premiums for the buy-in option established under the bill, in accordance with specified requirements. The CMS must also award grants to states and nonprofit organizations for outreach and enrollment activities relating to the buy-in option.
Therapeutic Fraud Prevention Act of 20 21 This bill prohibits commercial conversion therapy, which is a practice or treatment designed to change a person's sexual orientation or gender identity or otherwise change behaviors, thoughts, or expressions related to gender or sexual attraction. This prohibition does not apply to treatment that assists an individual undergoing a gender transition or facilitates identity exploration and development.
Medication Access and Training Expansion Act of 2021 or the MATE Act of 2021 This bill requires health care providers, as a condition of receiving or renewing a registration to prescribe potentially addictive drugs, to complete a one-time training on managing patients with substance use disorders. In addition, the Department of Health and Human Services must award grants to health professional associations and education programs for integrating substance use disorder training into relevant curricula.
Verifying Accurate Leading-edge IVCT Development Act of 2021 or the VALID Act of 2021 This bill requires the Food and Drug Administration (FDA) to regulate in vitro clinical tests (IVCTs). Currently, the FDA and the Centers for Medicare & Medicaid Services have authority to regulate in vitro diagnostic devices. The bill defines IVCTs, which includes in vitro diagnostic devices, as tests intended for the collection, preparation, analysis, or in vitro clinical examination of specimens from the human body to provide information about a disease, condition, or treatment. An IVCT may not be introduced into interstate commerce unless it has received FDA premarket approval or is covered by certain exemptions, such as an exemption for a test that (1) was developed and introduced before this bill's enactment and meets certain requirements, (2) is a low-risk test, (3) is solely for public health surveillance, (4) is covered by a technology certification issued under this bill, or (5) has received a humanitarian exemption or emergency use authorization. The FDA may grant upon application a technology certification. Generally, such a certification covers a group of tests that use a single technology and may be evaluated using a representative test. While such a certification is valid, a qualifying IVCT that falls within the scope of the certification shall be cleared for interstate commerce. The bill also imposes various requirements related to IVCTs, including those related to quality control, labeling, and reporting adverse events. The FDA shall have various enforcement authority, including authority to order the recall of an IVCT with a reasonable probability of causing serious adverse health consequences.
Prevent All Soring Tactics Act of 2021 or the PAST Act of 2021 This bill addresses the practice of soring horses. The soring of horses includes various actions taken on horses' limbs to produce higher gaits that may cause pain, distress, inflammation, or lameness. Specifically, the bill expands soring regulation and enforcement at horse shows, exhibitions, sales, and auctions, including by establishing a new system for inspecting horses for soring. In addition, the bill increases penalties for violations.
Highway Formula Modernization Act of 2021 This bill requires the Department of Transportation (DOT) to study the methods and data used to apportion certain federal-aid highway funding and develop recommendations for a new apportionment method. DOT must consult with state departments of transportation and representatives of local governments on the study and recommendations.
Therapeutic Fraud Prevention Act of 20 21 This bill prohibits commercial conversion therapy, which is a practice or treatment designed to change a person's sexual orientation or gender identity or otherwise change behaviors, thoughts, or expressions related to gender or sexual attraction. This prohibition does not apply to treatment that assists an individual undergoing a gender transition or facilitates identity exploration and development.
Minor League Baseball Relief Act This bill establishes a program for the relief of certain minor league baseball clubs and independent professional baseball clubs that experienced large business losses. The bill provides funding for the Small Business Administration to make grants to such clubs that experienced decreases in gross revenue in 2020 of at least 75%, as measured against revenues in 2019 (or, if revenues were negatively affected by a natural disaster or weather disruption in 2019, by the average of revenues over the prior three-year period). The source of funding for the grants shall be funds appropriated under enacted COVID-19 relief legislation that have not been obligated and are no longer being used to carry out activities authorized under those laws. Grant amounts provided to any club may not exceed $10 million.
Preparing and Retaining Education Professionals Act of 2021 or the PREP Act of 2021 This bill reauthorizes and revises certain grant programs to address shortages of teachers and school leaders (e.g., principals) in elementary and secondary schools, including shortages in rural areas and related to specific positions (e.g., special education and English language instruction). First, the bill makes permanent and otherwise revises the Teacher Quality Partnership program (which provides grants to improve the quality of teachers and enhance professional development activities). In particular, the bill revises the program to (1) expand the purpose of grants to include the recruitment of well-prepared individuals, including individuals from underrepresented populations, into the teacher and school leadership force; (2) include training and professional development opportunities for school leaders; and (3) establish a grant program to address workforce shortages or increase workforce diversity. Next, the bill makes permanent and otherwise revises the Augustus F. Hawkins Centers of Excellence program (which provides grants to establish teacher preparation programs at minority-serving institutions). Further, the bill allows grants to be used for school leader preparation programs. Additionally, the bill aligns activities within teacher preparation programs at predominantly Black institutions, Native American-serving institutions, and other minority-serving institutions with certain changes made to the Teacher Quality Partnership program. The bill permanently reauthorizes the Minority Science and Engineering Improvement program (which provides grants to improve science and engineering education at predominantly minority institutions).
Responsibly and Equitably Change How Auto-charging Rates Get Evaluated Act or the RECHARGE Act This bill requires states to consider measures to promote greater electrification of the transportation sector, including the review of utility rates for charging electric vehicles.
