Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021 or the CONNECT for Health Act of 2021 This bill expands coverage of telehealth services under Medicare. Among other provisions, the bill allows the Centers for Medicare & Medicaid Services (CMS) to waive certain restrictions, such as restrictions on the types of technology that may be used; permanently removes geographic restrictions on originating sites (i.e., the location of the beneficiary) and allows the home of the beneficiary to serve as the originating site for all services; permanently allows federally qualified health centers and rural health clinics to serve as the distant site (i.e., the location of the health care practitioner); and allows the CMS to generally waive coverage restrictions during any public health emergency. Additionally, the CMS must report on the effects of expanded telehealth services during the COVID-19 public health emergency, including with respect to the utilization, quality, and outcomes of services. The Center for Medicare and Medicaid Innovation may also test alternative payment models relating to expanded telehealth services.
Sponsored bills
Modernizing Therapeutic Equivalence Rating Determination Act This bill requires the Food and Drug Administration (FDA) to provide a therapeutic equivalence rating for certain new drug applications if the applicant requests such a rating. Upon request in the application, the FDA must provide such a rating for a new drug application that relies on information from studies not conducted by the applicant and that the applicant does not have a right to reference or use (commonly referred to as a 505(b)(2) application). The FDA must provide the rating no later than 30 days after the application's approval. (A drug is a therapeutic equivalent of another if they produce the same clinical effect and have the same safety profile. Typically, for certain generic drugs, the FDA rates the therapeutic equivalence of that generic drug to another drug, such as the brand name version. Currently, an applicant seeking approval of a drug through a 505(b)(2) application typically only receives an equivalence rating by requesting one from the FDA in a separate petition.)
Gabriella Miller Kids First Research Act 2.0 This bill modifies funding for a pediatric disease research initiative within the National Institutes of Health (NIH). Currently, this initiative receives funding through FY2023 from the 10-Year Pediatric Research Initiative Fund. This bill directs certain penalties assessed by the Securities and Exchange Commission against pharmaceutical companies for specified violations to that fund. In making allocations from the fund, the NIH must prioritize pediatric research that does not duplicate existing research activities.
USTR Inspector General Act of 2021 This bill requires the President to appoint an Inspector General of the Office of the U.S. Trade Representative (USTR). Among other responsibilities, the Inspector General shall (1) conduct and supervise audits and investigations relating to the programs and operations of the USTR, (2) recommend policies for preventing and detecting fraud and abuse in those programs, and (3) provide a means for keeping the USTR and Congress informed about problems and deficiencies in those programs and operations.
Constitutional Concealed Carry Reciprocity Act of 2021 This bill allows a qualified individual to carry a concealed handgun into or possess a concealed handgun in another state that allows its residents to carry concealed firearms. A qualified individual must (1) be eligible to possess, transport, or receive a firearm under federal law; (2) carry a valid photo identification document; and (3) carry a valid state-issued concealed carry permit, or be eligible to carry a concealed firearm in his or her state of residence.
Simplifying the Generic Drug Application Process Act This bill removes a requirement for a generic drug maker to, in some instances, petition the Food and Drug Administration (FDA) before seeking market approval for a generic drug. Currently, if an applicant wishes to submit an abbreviated application (i.e., the type of application typically used to get market approval for a generic drug) for a drug that has a different dosage form or strength from an already-approved drug, the applicant must first petition the FDA for permission to submit the application. Under this bill, an applicant is no longer required to petition the FDA for permission in these instances.
This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product. Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval. Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.
Veterans Burn Pits Exposure Recognition Act of 2021 This bill requires the Department of Veterans Affairs (VA) to concede, for the purposes of health care benefits and wartime disability compensation, that a veteran was exposed to certain toxic substances, chemicals, and hazards from burn pits if such veteran served on active duty in a covered location during a specified time frame (unless there is affirmative evidence to establish that the veteran was not exposed during such service). A burn pit is an area used for burning solid waste in open air without equipment. Specifically, the bill covers the following locations and corresponding time periods: Iraq between August 2, 1990, and February 28, 1991, as well as from March 19, 2003, until burn pits are no longer used in this location; Southwest Asia (including Kuwait, Saudi Arabia, Oman, and Qatar) from August 2, 1990, until burn pits are no longer used in these locations; and Afghanistan, Syria, Jordan, Egypt, Lebanon, Yemen, and Djibouti from September 11, 2001, until burn pits are no longer used in these locations. Under the bill, if an exposed veteran submits insufficient evidence to establish a service-connection for purposes of disability compensation, the VA shall provide a medical examination and request a medical opinion regarding a causal link between the disability and a toxin, chemical, or hazard.
Sustainable Shark Fisheries and Trade Act of 20 21 This bill addresses the conservation and management of sharks. The bill prohibits the importation into the United States of shark products from a nation that does not have measures to provide for the conservation and management of sharks and measures to prohibit shark finning (the removal of a shark's fins, including the tail, and discarding the remainder of the shark at sea) that are comparable to those of the United States. The bill includes exceptions to this prohibition for law enforcement, subsistence purposes, education, conservation, or scientific research. The Department of Commerce must certify nations with protections for sharks that are comparable to those of the United States. Commerce must revise its regulations to include rays and skates as species that are subject to the Seafood Import Monitoring Program. (The Seafood Import Monitoring Program has data reporting and recordkeeping requirements for imported fish or fish products entering U.S. commerce.)
Protect America's Paper for Recycling Act This bill modifies the tax credit for producing electricity from renewable resources to revise the definition of municipal solid waste . The bill specifies that municipal solid waste does not include paper that is commonly recycled and that has been segregated from other solid waste, or solid waste that is collected as part of a system that does not provide for the separate collection of paper that is commonly recycled from residential solid waste. The bill includes exceptions for incidental and residual waste. In the case of a facility that produces electricity both from municipal solid waste and other solid waste that is not a qualified energy resource (1) the facility is a qualified facility if it otherwise meets the requirements for qualified facilities, and (2) the credit only applies to the portion of the electricity produced from municipal solid waste.