COVID Defense Act This bill rescinds specified defense appropriations and authorizes funding for manufacturing and delivering COVID-19 vaccines internationally.
Improving Access to Home Dialysis Act of 2021 This bill provides for Medicare coverage of staff-assisted home dialysis services for certain individuals with end-stage renal disease (ESRD). Specifically, the bill provides for coverage of services for ESRD individuals who are either initiating peritoneal or home hemodialysis or receiving home dialysis and are unable to self-dialyze due to illness, injury, caregiver issues, or other temporary circumstances. The Centers for Medicare & Medicaid Services must develop a payment system for such services. The bill also requires the development of a patient-centered decision tool that includes home dialysis as an option, as well as a report on racial disparities with respect to the use of staff-assisted home dialysis services.
National Security Reforms and Accountability Act This bill limits presidential authorities related to, and increases congressional oversight of, introducing U.S. armed forces into hostilities, arms transactions, and national emergencies. The bill makes various changes to the War Powers Resolution, which provides procedures for Congress and the President to participate in decisions to send U.S. forces into hostilities. These changes include requiring specific statutory authorization for, and revising congressional procedures to approve or disapprove of, the introduction of U.S. forces into hostilities. The bill also prohibits the use of federal funds for any activity of U.S. forces that lacks the required authorization. The President must also seek congressional approval before entering, renewing, or extending an arms sale or related transaction if the transaction exceeds specified dollar thresholds. This does not apply to transactions with NATO and its member countries, Australia, Japan, South Korea, Israel, New Zealand, or Taiwan. The bill also prohibits transfers of defense articles and services to countries that commit genocide or otherwise violate international humanitarian law. The bill restricts presidential authorities related to national emergencies, including by limiting the period of a declared emergency to 30 days unless Congress authorizes an extension. The bill also establishes procedures for approving or disapproving an extension, requires the President to provide more detailed reports to Congress about national emergencies, and sets out specific provisions for terminating an emergency.
This bill requires the Department of Defense (DOD) to conduct outreach to build awareness among former members of the Armed Forces of the process established for the review of discharge characterizations related to sexual orientation (i.e., on the basis of Don't Ask, Don't Tell or a similar policy). DOD must also provide for specified relief for former members of the Armed Forces who were impacted by the discharge characterizations and ensure that DOD oral historians review related facts and receive testimony from affected individuals.
Veteran Families Health Services Act of 2021 This bill addresses fertility treatments, counseling, and other health-related programs for veterans and members of the Armed Forces. Specifically, the bill requires the Department of Defense (DOD) and the Department of Veterans Affairs (VA) to provide fertility treatments and counseling to covered veterans and active duty service members or a spouse, partner, or gestational surrogate of such veteran or service member. A covered veteran or service member is a former or current member of the Armed Forces who has an infertility condition, unless it is demonstrable that the individual was completely infertile prior to serving in the Armed Forces. In the case of in vitro fertilization treatment, DOD and the VA may not furnish more than three completed cycles or six attempted cycles, whichever occurs first. DOD must establish procedures related to gamete retrieval and storage. Additionally, DOD must provide service members with the opportunity to cryopreserve and store their gametes prior to deployment to a combat zone or a hazardous duty assignment. DOD and the VA must share best practices and facilitate referrals for the furnishing of fertility treatment and counseling to eligible individuals. Fertility counseling and treatment are included within authorized VA medical services. The VA may pay the adoption expenses (for up to three adoptions) for a covered member who is enrolled in the VA health care system. The VA must facilitate specified reproduction and infertility research conducted collaboratively by DOD and the Department of Health and Human Services.
Debt Ceiling Reform Act This bill authorizes the Secretary of the Treasury to increase the public debt limit. Under current law, the debt limit restricts the amount of funds that the Department of the Treasury may borrow to fund the federal government.
COBRA Subsidy Extension for Workers and Families Act This bill extends temporary health insurance premium assistance for enrollees in the COBRA (Consolidated Omnibus Budget Reconciliation Act) continuation coverage program. Currently, COBRA premiums are fully subsidized through September 30, 2021, and the bill extends the subsidy through September 30, 2022. The bill also provides for expedited review of denials of eligibility for such assistance.
Rock Creek National Park Act of 2021 This bill redesignates Rock Creek Park in the District of Columbia as Rock Creek National Park.
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission to sue in court or institute administrative proceedings to enforce this prohibition. 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 changed, modified, or reformulated 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 engages in a hard switch or a soft switch . A hard switch occurs when, after receiving notice of an application for Food and Drug Administration (FDA) approval to market a generic (or biosimilar) version of the reference drug, the manufacturer markets a follow-on product and (1) the FDA withdraws approval of the reference drug at the manufacturer's request, or (2) the manufacturer announces the withdrawal or discontinuance of the reference drug or destroys the drug's inventory in a manner that impedes generic competitors. Furthermore, the bill presumes that a soft switch occurred if a reference drug manufacturer (1) markets a follow-on product, and (2) takes actions that disadvantage the reference drug relative to that follow-on product in a way that impedes competition from a generic drug. A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.
Preserve Access to Affordable Generics and Biosimilars Act This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar. An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations. The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.
