MEDICAL DEVICES

Bills and resolutions

Abortion: revise regulations banning mailing or receiving of drugs, instruments, equipment, and educational materials relative to medication abortions (see S. 951), S1663 [11MR] (see H.R. 2029), H1147 [11MR]

Centers for Medicare & Medicaid Services: clarify that fully implanted active middle ear hearing devices are prosthetics and are not subject to Medicare hearing aid coverage exclusion (see S. 983), S1704 [12MR] (see H.R. 1921), H1037 [6MR]

Dept. of Defense: carry out pilot program to provide certain Armed Forces members with continuous glucose monitoring technology (see H.R. 3750), H2504 [5JN]

——— establish pilot program to facilitate development of certain traumatic brain injury diagnostics for members of Armed Forces (see H.R. 6823), H6023 [17DE]

Dept. of HHS: award grants to increase early detection of and intervention for uterine fibroids (see S. 2531), S4904 [30JY] (see H.R. 4392), H3314 [15JY]

——— carry out program to facilitate and coordinate efforts between U.S. and Israel to expand and enhance collaboration on development and delivery of health care products and services (see H.R. 4473), H3367 [16JY]

——— 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. 675), H385 [23JA]

——— 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. 141), S226 [16JA] (see H.R. 4977), H3698 [15AU]

——— modernize clinical trials and remove barriers for participation in clinical trials (see H.R. 3521), H2198 [20MY]

——— provide certain adjustments to Medicare payment for durable medical equipment included in DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics and Supplies) Competitive Bidding Program (see S. 2951), S6874 [30SE] (see H.R. 2005), H1066 [10MR]

——— require pharmaceutical and device manufacturers to publicly disclose covered payments made to patient advocacy organizations (see S. 2710), S6320 [4SE]

——— study and report to Congress on use of home cardiorespiratory monitors for infants (see H.R. 2168), H1162 [14MR]

Dept. of Veterans Affairs: improve provision of prosthetic and rehabilitative items and services (see S. 2981), S6980 [7OC]

——— include adaptive prostheses and terminal devices for sports and other recreational activities in medical services furnished to eligible veterans (see S. 3138), S7962 [6NO] (see H.R. 1971), H1064 [10MR]

——— include licensed hearing aid specialists under Veterans Community Care Program (see H.R. 3088), H1773 [30AP]

——— offer annual preventative health evaluations to veterans with spinal cord injuries or disorders and increase access to assistive technologies (see H.R. 6835), H6113 [18DE]

Disabled: provide certain copyright exceptions for repair of powered mobility assistance device and require manufacturers to make documentation and repair information available to repair providers and consumers (see H.R. 5039), H3710 [26AU]

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 H.R. 1563), H835 [25FE]

FDA: amend approval of combination products consisting of generic drug and device (see H.R. 5158), H3861 [4SE]

——— establish electronic format for medical device recall notifications (see S. 3421), S8623 [10DE] (see H.R. 6594), H5560 [10DE]

——— establish nonvisual accessibility standards for certain devices with digital interfaces (see H.R. 5605), H4501 [26SE]

——— exempt non-invasive diagnostic devices from regulation as devices (see H.R. 88), H31 [3JA]

——— expand types of devices for which required labeling may be made available solely by electronic means (see H.R. 1539), H767 [24FE]

——— provide marketing reciprocity to certain drugs, biological products, and medical devices authorized to be lawfully marketed abroad (see S. 3081), S7849 [30OC] (see H.R. 1632), H878 [26FE]

——— require manufacturers of covered devices to disclose to patients all patient-specific data recorded or transmitted by devices and accessible to manufacturers (see H.R. 6117), H4770 [18NO]

——— 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. 2372), H1301 [26MR]

Health: reduce patient cost-sharing for prescription drug inhaler products used to treat breathing disorders such as asthma and chronic obstructive pulmonary disease (see S. 2756), S6537 [10SE] (see H.R. 5278), H4237 [10SE]

Insurance: require coverage of hearing devices and systems in certain private health insurance plans (see S. 3400), S8576 [9DE] (see H.R. 4606), H3552 [22JY]

Medicare: clarify payment rules for manual wheelchairs under part B (see S. 247), S371 [24JA] (see H.R. 1703), H915 [27FE]

——— ensure prompt coverage of breakthrough devices (see S. 1717), S2862 [12MY] (see H.R. 5343), H4309 [15SE]

——— establish pilot program for testing use of predictive risk-scoring algorithm to provide oversight of payments for durable medical equipment and clinical diagnostic laboratory tests (see S. 2066), S3389 [12JN] (see H.R. 3996), H2820 [12JN]

——— facilitate patient access to certain pediatric technologies (see S. 249), S371 [24JA] (see H.R. 1931), H1037 [6MR]

——— improve access to new medical technologies by ensuring breakthrough devices are eligible for conditional approval under New Technology Add-On Payment (NTAP) Program (see H.R. 4441), H3366 [16JY]

——— improve payment method and increase beneficiary access to oxygen and oxygen related equipment, supplies, and services (see S. 1406), S2560 [10AP] (see H.R. 2902), H1599 [10AP]

——— permanently extend certain in-home cardiopulmonary rehabilitation flexibilities established in response to coronavirus (see S. 248), S371 [24JA] (see H.R. 783), H403 [28JA]

——— 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 S. 2329), S4456 [17JY] (see H.R. 4475), H3472 [17JY]

——— provide coverage for certain fall prevention items (see S. 2831), S6695 [17SE] (see H.R. 5554), H4493 [23SE]

——— provide coverage of contraceptive items and services with no cost-sharing (see S. 3560), S8920 [18DE]

——— provide coverage of dental, vision, and hearing care (see S. 939), S1663 [11MR] (see H.R. 2045), H1148 [11MR]

——— provide coverage of external infusion pumps and non-self-administrable home infusion drugs (see H.R. 4993), H3702 [19AU]

——— provide coverage of portable ultrasound transportation and set up services (see S. 1168), S1905 [27MR] (see H.R. 2477), H1337 [27MR]

——— 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. 1785), H943 [3MR]

NIH: take certain steps to increase clinical trial diversity (see S. 3564), S8920 [18DE] (see H.R. 6867), H6114 [18DE]

Presidents of the U.S.: authorize to enter into trade agreements for reciprocal elimination of duties or other import restrictions relative to medical goods to contribute to national security and public health of U.S. (see S. 998), S1704 [12MR] (see H.R. 2213), H1170 [18MR]

Roads and highways: improve access to automated external defibrillators at interstate transportation facilities (see H.R. 5897), H4565 [31OC]

Taxation: establish refundable credit for expenses incurred for mobility devices (see H.R. 2320), H1272 [25MR]

——— expand eligible educators who receive educator expense deduction for certain nonathletic supplies to include interscholastic sports administrators and coaches (see S. 1982), S3255 [5JN]

——— provide rules for determining tax-exempt status of organizations that manufacture and distribute drugs and medical devices to meet public health needs (see S. 3325), S8483 [3DE]

Remarks in Senate

Medicare: provide coverage of dental, vision, and hearing care (S. 939), S1657, S1658 [11MR]

——— provide coverage of dental, vision, and hearing care (S. 939), unanimous-consent request, S1658 [11MR]

Texts of

S. 3421, Medical Device Recall Improvement Act, S8625 [10DE]