Affordable Prescriptions for Patients Act of 2021 This bill prohibits product hopping by drug manufacturers, authorizes the Federal Trade Commission to enforce this prohibition, and imposes limits on patent litigation involving biological products. Generally, product-hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a modified version of the reference drug that shares an indication (what the drug is used for) with the reference drug. The bill presumes product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration (FDA) has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product. A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition. The bill also limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get FDA market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval.
Prescription Pricing for the People Act of 20 21 This bill requires the Federal Trade Commission (FTC) to report about anticompetitive practices and other trends within the pharmaceutical supply chain that may impact the cost of prescription drugs. The FTC also must provide recommendations to increase transparency in the supply chain and prevent anticompetitive practices.
504 Program Level Flexibility Act This bill authorizes the Small Business Administration (SBA), upon a determination that the amount of its commitments to guarantee 504 loans could exceed the authorized limit, to guarantee up to 115% of that limit. Such loans, made through SBA community partners and certified by the SBA, provide long-term, fixed rate financing for major fixed assets that promote business growth and job creation.
Pension and Budget Integrity Act of 20 21 This bill prohibits certain provisions from being counted as an offset to determine budget points of order for legislation in the House of Representatives or the Senate. Specifically, a provision that increases or extends an increase of single-employer pension program premiums payable to the Pension Benefit Guaranty Corporation (PBGC) may not be counted as such an offset. (The PBGC is a federal agency that insures the benefits of private sector, defined benefit pension plans. The PBGC is financed by insurance premiums paid by sponsors of the plans, investment income, assets from pension plans taken over by the PBGC, and recoveries from the companies formerly responsible for the plans.)
Stop Copay Overpay Act This bill prohibits the Department of Defense (DOD) from charging a covered individual (i.e., individuals enrolled under the TRICARE program) a co-payment exceeding a certain rate for an outpatient visit for mental health or behavioral health under the TRICARE program, regardless of whether the visit is furnished by a specialty care provider. Specifically, the co-payment amount may not exceed the amount of a co-payment that would be charged under the TRICARE program for an outpatient visit for primary care services. During the one-year period after this bill is enacted, DOD may not increase the co-payment amount charged to a covered individual for any service (1) furnished by a specialty care provider under the TRICARE program, and (2) that is not mental or behavioral health care.
Affordable EVs for Working Families Act This bill allows an income-based tax credit for the purchase of a previously-owned qualified plug-in electric drive motor vehicle. The credit is limited to 30% of the sales price of such a vehicle. The bill defines previously-owned qualified plug-in electric drive motor vehicle to mean a motor vehicle the model year of which is at least two years earlier than the calendar year in which the vehicle is acquired and that meets certain requirements under the Clean Air Act.
Department of Energy Coastal Research Initiative Act This bill directs the Office of Science of the Department of Energy to carry out a research program to enhance the understanding of coastal ecosystems. In carrying out the program, the office must prioritize efforts to enhance the collection of observational data and shall develop models to analyze the ecological, biogeochemical, hydrological, and physical processes that interact in coastal zones. The office shall establish an integrated system of geographically diverse field research sites in order to improve the quantity and quality of observational data and that encompass the major land-water interfaces of the United States, including the Great Lakes region, the Pacific coast, the Atlantic coast, the Arctic, and the Gulf Coast.
Respond, Innovate, Succeed, and Empower Act of 2021 or the RISE Act of 2021 This bill establishes requirements for institutions of higher education (IHEs) concerning students with disabilities. Specifically, the bill requires IHEs to allow students to use certain documents, such as individualized education programs, to establish their disabilities. In addition, IHEs must make the process for determining the eligibility for accommodations transparent. Finally, IHEs must submit key data related to their undergraduate students with disabilities for inclusion in federal postsecondary institution data collection efforts.
Distillery Revitalization Act This bill requires the Small Business Administration to modify the Restaurant Revitalization Program, established to support food and beverage purveyors in response to COVID-19, to allow certain distilleries to participate in the program. To be program-eligible, a distillery must have at least 33% of revenue from on-site sales. However, certain states limit the percentage of revenue that a distillery may have from on-site sales to less than 33%. For a distillery located in such a state, the bill allows the distillery to use its combined revenue from on-site sales and sales to retailers for on-site sales to reach the 33% threshold.
Provider Relief Fund Deadline Extension Act This bill extends the period during which health care providers may use payments received from the Provider Relief Fund to cover a variety of costs related to COVID-19.
Seniors' Chronic Care Management Improvement Act of 2021 This bill eliminates cost-sharing for chronic care management services under Medicare.
Diversity and Inclusion at the Department of State Act This bill establishes a new position and requires other activities to promote diversity and inclusion in the Department of State. The bill creates the presidentially-appointed position of Chief Diversity and Inclusion Officer in the Office of the Deputy Secretary of State to, among other activities, develop a strategic plan to guide implementation of diversity and inclusion efforts and support State Department personnel from traditionally underrepresented groups. The officer reports directly to the Secretary of State. Additionally, the State Department must establish a Diversity and Inclusion Leadership Council to coordinate applicable strategic plans, initiatives, and policies. The bill also modifies merit selection processes for promotions, performance pay, and related matters to promote diversity and inclusion in the Foreign Service. Specifically, it adds factors (e.g., testimony from peers and subordinates or demonstrated support for diversity and inclusion) that may be considered in recommendations and rankings related to a Foreign Service officer's performance. The State Department must also establish a mentorship program for entry- and mid-level members of the Foreign Service and periodically offer a Senior Executive Service development program to members of the civil service in the top two pay grades. Senior Executive Service members serve as high-level managers within federal agencies. The bill requires the State Department to report on its diversity and inclusion efforts, as well as demographic information about members of boards that make personnel decisions and candidates for the Senior Executive Service.
