MEDICAL DEVICES

Bills and resolutions

Biomedical Advanced Research and Development Authority: establish program to develop medical countermeasures for viral threats with pandemic potential (see S. 2093), S2185 [21JN] (see H.R. 3832), H2741 [5JN]

Center for Biomedical Innovation and Development: establish (see S. 1441), S1533 [4MY]

Contraceptives: preempt State bans on prescription, provision, or use of drug, biological product, or device for contraception if approved, licensed, cleared, or otherwise authorized for human use by FDA for contraception (see H.R. 3471), H2452 [18MY]

Crime: exempt possession, sale, or purchase of fentanyl drug testing equipment from punishment under Federal drug paraphernalia laws (see H.R. 3563), H2498 [22MY]

Defense Production Act: enhance authorities to strengthen production of medical supplies and equipment during public health emergencies and appoint civilian personnel to provide oversight of such authorities (see H.R. 1166), H873 [24FE]

——— ensure supply of certain medical articles essential to national defense (see H.R. 555), H427 [26JA]

Dept. of Agriculture: expand medical expense deduction for elderly and disabled persons under Supplemental Nutrition Assistance Program (see S. 2432), S3459 [20JY] (see H.R. 4815), H3888 [20JY]

Dept. of HHS: authorize certain contracts and cooperative agreements with clinical laboratories for purposes of delivery of medical products to Strategic National Stockpile (see H.R. 3840), H2761 [6JN]

——— award grants to develop and implement comprehensive program to promote student access to defibrillation in elementary and secondary schools (see S. 1024), S1052 [29MR] (see H.R. 2370), H1640 [29MR]

——— delegate primary responsibility for maintaining Strategic National Stockpile to Assistant Secretary for Preparedness and Response (see H.R. 3837), H2761 [6JN]

——— eliminate coronavirus vaccine and mask requirement in Head Start programs (see H.R. 794), H677 [2FE]

——— ensure expenses relating to acquisition or use of devices to detect fentanyl, xylazine, and other emerging adulterant substances, including test strips are allowable expenses under certain grant programs (see S. 2976), S4759 [28SE] (see H.R. 5801), H4854 [28SE]

——— enter partnerships with eligible domestic manufacturers to ensure availability of qualified personal protective equipment to prepare for and respond to national health or other emergencies (see H.R. 170), H104 [9JA]

——— establish automated supply-chain tracking application that provides near real-time insight into amount of critical medical and health supplies available in Strategic National Stockpile (see H.R. 3577), H2499 [22MY]

——— identify and address barriers to coverage of remote physiologic devices under State Medicaid programs to improve maternal and child health outcomes for pregnant and postpartum women (see S. 712), S714 [8MR]

——— mitigate drug shortages and provide incentives for manufacturing of active pharmaceutical ingredients, excipients, medical devices, pharmaceuticals, and personal protective equipment (see H.R. 2707), H1885 [19AP]

——— prohibit use of Federal funds to enforce rule on coronavirus vaccine and mask requirements for Head Start programs (see H.R. 1019), H838 [14FE]

——— prohibit use of Federal funds to purchase, procure, or distribute pipes or cylindrical objects intended to be used to smoke or inhale illegal scheduled substances (see S. 1520), S1602 [10MY]

——— provide certain adjustments to Medicare payment for durable medical equipment included in DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics and Supplies) Competitive Bidding Program (see H.R. 5555), H4406 [19SE]

——— provide for clarity relative to duration of contracts for procurement of supplies for Strategic National Stockpile (see H.R. 4458), H3166 [3JY]

——— provide funding for trained school personnel to administer drugs and devices for emergency treatment of known or suspected opioid overdose (see S. 2946), S4720 [27SE] (see H.R. 3065), H2125 [2MY]

——— provide urgent acquisition and deployment authority for purposes of replenishing U.S. stockpiles (see S. 2055), S2145 [20JN]

——— report on interoperability of medical devices (see H.R. 1557), H1279 [10MR]

——— require persons who undertake federally funded research and development of biomedical product or service to enter into reasonable pricing agreements (see H.R. 3093), H2134 [5MY]

——— specify duration of contracts, grants, cooperative agreements, or other transactions awarded or entered into with Biomedical Advanced Research and Development Authority (see H.R. 4459), H3166 [3JY]

Dept. of Veterans Affairs: offer annual preventative health evaluations to veterans with spinal cord injuries or disorders and increase access to assistive technologies (see H.R. 6373), H5728 [13NO]

Depts. of HHS and State: formulate strategy to secure support from foreign countries, multilateral organizations, and others to facilitate development and commercialization of qualified pandemic or epidemic products (see H.R. 1305), H1048 [1MR]

Diseases and disorders: prohibit use of Federal funds to propose, establish, implement, or enforce any requirement that individuals wear masks or other face coverings, or be vaccinated, to prevent spread of coronavirus (see H.R. 74), H100 [9JA]

——— prohibit use of Federal funds to purchase at-home tests for coronavirus imported from certain foreign entities (see S. 3454), S5852 [7DE] (see S. 3454), H6739 [7DE]

Drugs: clarify possession, sale, purchase, importation, exportation, or transportation of drug testing equipment that tests for presence of fentanyl or xylazine is not unlawful (see S. 2569), S3753 [27JY]

——— ensure that States do not prohibit individuals from obtaining, possessing, distributing, or using life-saving drug testing technologies (see S. 2484), S3522 [25JY]

FAA: include medications and medical equipment for emergency treatment of known or suspected opioid overdose in aircraft emergency medical kits (see H.R. 3616), H2546 [23MY]

——— issue regulations concerning accommodations for powered wheelchairs (see S. 1459), S1534 [4MY] (see H.R. 3082), H2133 [5MY]

——— require air carriers and foreign air carriers to provide on publicly available website information on requirements for on-board wheelchairs (see H.R. 4446), H3159 [30JN]

FDA: amend device shortage notifications (see H.R. 3807), H2740 [5JN]

——— establish electronic format for medical device recall notifications (see S. 2907), S4654 [21SE] (see H.R. 5662), H4456 [21SE]

——— exempt non-invasive diagnostic devices from regulation as devices (see H.R. 71), H100 [9JA]

——— expand types of devices for which required labeling may be made available solely by electronic means (see H.R. 3723), H2638 [25MY]

——— provide marketing reciprocity to certain drugs, biological products, and medical devices authorized to be lawfully marketed abroad (see S. 1712), S1744 [18MY] (see H.R. 3532), H2455 [18MY]

——— require medical device manufacturers to provide notification of design or cleaning instruction changes and safety warnings issued in foreign countries about design and cleaning (see H.R. 1090), H853 [17FE]

——— treat certain tests for tuberculosis as breakthrough devices eligible for expedited development and priority review and require tests for active and latent tuberculosis during donor screening and testing (see H.R. 6705), H6814 [11DE]

GAO: submit report on CDC public health mitigation messaging and guidance (see S. 1166), S1134 [17AP] (see H.R. 2647), H1759 [17AP]

Insurance: require coverage of hearing devices and systems in certain private health insurance plans (see S. 1135), S1090 [30MR] (see H.R. 2439), H1691 [30MR]

Israel: authorize funding for bilateral cooperative program with Israel for development of health technologies (see H.R. 4076), H2884 [13JN]

Medicare: permanently extend certain in-home cardiopulmonary rehabilitation flexibilities established in response to coronavirus (see S. 3021), S4948 [4OC] (see H.R. 1406), H1148 [7MR]

——— protect beneficiaries with limb loss and other orthopedic conditions by providing access to safe and effective orthotic and prosthetic care and reduce fraud, waste, and abuse relative to orthotics and prosthetics (see H.R. 4315), H3140 [23JN]

——— provide coverage and payment for certain tests and assistive telehealth consultations (see H.R. 207), H105 [9JA]

——— provide coverage for wigs as durable medical equipment (see S. 1922), S2050 [12JN] (see H.R. 4034), H2808 [12JN]

——— provide coverage of certain technologies and medical devices (see H.R. 5388), H4262 [12SE]

——— provide coverage of dental, vision, and hearing care (see H.R. 33), H98 [9JA]

——— provide coverage of external infusion pumps and non-self-administrable home infusion drugs (see H.R. 5397), H4262 [12SE]

——— provide coverage of hearing and vision care (see H.R. 1326), H1049 [1MR]

——— provide for coverage of monitoring devices to detect and alarm when venous needle dislodgement occurs during home dialysis for hemodialysis patients (see H.R. 3118), H2135 [5MY]

——— provide for payment rates for durable medical equipment (see S. 1294), S1381 [26AP]

——— require in-person appointment prior to ordering high-cost durable medical equipment or laboratory testing, extend certain emergency waivers, and expand access to telehealth services (see H.R. 1746), H1408 [23MR]

National Commission on the COVID–19 Pandemic: establish (see H.R. 3066), H2125 [2MY]

NIH: take certain steps to increase clinical trial diversity (see S. 1701), S1743 [18MY] (see H.R. 3503), H2454 [18MY]

Patient-Centered Outcomes Research Institute: prepare and release report on home cardiorespiratory monitors for infants (see H.R. 5458), H4343 [14SE]

Presidents of the U.S.: authorize to enter into trade agreements for reciprocal elimination of duties or other import restrictions with respect to medical goods to contribute to national security and public health of U.S. (see S. 2115), S2222 [22JN] (see H.R. 4307), H3109 [22JN]

Senate: prohibit imposition of vaccination, testing, and masking requirements relative to coronavirus for Senate Pages (see S. Res. 332), S4270 [7SE]

——— prohibit imposition of vaccination requirements relative to coronavirus for Senate Pages (see S. Res. 336), S4389 [12SE]

Social Security: clarify manufacturer transparency reporting requirements for certain transfers used for educational purposes (see H.R. 4402), H3157 [30JN]

Taxation: expand eligible educators who receive educator expense deduction for certain nonathletic supplies to include interscholastic sports administrators and coaches (see H.R. 3351), H2347 [15MY]

Remarks in House

Dept. of Defense: prohibit funding to enforce coronavirus mask mandates, H4627 [27SE]

Dept. of HHS: award grants to develop and implement comprehensive program to promote student access to defibrillation in elementary and secondary schools (H.R. 2370), H2042 [26AP]

——— funding for States to build or maintain their own medical stockpile through reductions in Strategic National Stockpile funding, H5784 [14NO]

Dept. of Homeland Security: prohibit funding to implement coronavirus mask mandate for employees, H4689 [27SE]

Dept. of the Interior, environment, and related agencies: prohibit funding to enforce coronavirus mask mandates, H5343 [2NO]

Dept. of Transportation: prohibit funding to enforce coronavirus mask mandates, H5512 [7NO]

Dept. of Veterans Affairs: prohibit funding to enforce coronavirus mask mandates, H4002 [26JY]

Energy and water development: prohibit funding to enforce coronavirus mask mandates, H5137 [26OC]

Science, Depts. of Justice and Commerce, and related agencies: prohibit funding to enforce coronavirus mask mandates, H5839, H5840 [14NO]

TSA: prohibit funding to implement coronavirus vaccine and mask mandate for travelers passing through checkpoints, H4683 [27SE]

White Cane Awareness Day: observance, E973 [13OC]

Remarks in Senate

Dept. of Transportation: prohibit funding to enforce coronavirus mask mandates, S5163 [25OC]

Senate: prohibit imposition of vaccination, testing, and masking requirements relative to coronavirus for Senate Pages (S. Res. 332), S4248–S4252 [7SE]

——— prohibit imposition of vaccination, testing, and masking requirements relative to coronavirus for Senate Pages (S. Res. 332), unanimous-consent request, S4251 [7SE]

——— prohibit imposition of vaccination requirements relative to coronavirus for Senate Pages (S. Res. 336), S4369–S4372 [12SE], S4572–S4575 [19SE], S5943–S5946 [13DE]

——— prohibit imposition of vaccination requirements relative to coronavirus for Senate Pages (S. Res. 336), unanimous-consent request, S4371 [12SE], S4574 [19SE], S5944, S5945 [13DE]

Texts of

S. 1294, Competitive Bidding Relief Act, S1385 [26AP]

S. 2907, Medical Device Recall Improvement Act, S4658 [21SE]

S. Res. 332, prohibit imposition of vaccination, testing, and masking requirements relative to coronavirus for Senate Pages, S4272 [7SE]

S. Res. 336, prohibit imposition of vaccination requirements relative to coronavirus for Senate Pages, S4391 [12SE]