MEDICAL DEVICES

Bills and resolutions

Assistive Technology Act: reauthorize (see S. 1835), S3476 [13JN]

CDC: include certain respiratory protective devices as covered countermeasures for purposes of targeted liability protections for pandemic and epidemic products and security countermeasures (see H.R. 4982), H8729 [5NO]

Dept. of HHS: award grants to health care organizations to promote student access to defibrillation in elementary and secondary schools (see H.R. 4989), H8729 [5NO]

——— require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers (see H.R. 2064), H3067 [3AP]

Dept. of Veterans Affairs: adopt and implement a standard identification protocol for use in tracking and procurement of biological implants (see H.R. 547), H600 [15JA]

FDA: allow continued processing of medical device applications and associated user fees during a lapse in appropriations (see H.R. 1362), H2232 [26FE]

——— amend liability under State and local requirements relative to certain medical devices by allowing legal recourse by victims of unsafe devices (see H.R. 2669), H3726 [10MY]

——— clarify types of patents on safe and effective drug list, require list of applicable exclusivities for listed drugs, update patent sponsor requirements, and reform patent list guidelines (see S. 1617), S3059 [22MY] (see H.R. 1503), H2366 [5MR]

——— provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad (see S. 2161), S4947 [18JY]

——— 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. 818), H1242 [28JA]

——— require physicians and physicians’ offices to be treated as covered device users required to report on certain adverse events involving medical devices (see H.R. 2915), H4118 [22MY]

Health: authorize a pilot program to develop, expand, and enhance the commercialization of biomedical products (see H.R. 5357), H9347 [6DE]

Insurance: ensure common medications, devices, and screenings used to treat chronic conditions are covered without out-of-pocket costs (see H.R. 4457), H7900 [24SE]

——— require coverage of hearing devices and systems in certain private health insurance plans (see H.R. 5485), H12210 [18DE]

Medical Device Sterilization Challenge: establish (see H.R. 3044), H4180 [30MY]

Medicare: delay reduction of durable medical equipment payment reimbursement rates and update budget neutrality requirement for oxygen (see H.R. 2771), H3841 [15MY]

——— establish a payment adjustment to improve access to innovative medical devices to individuals with end-stage renal disease (see S. 2751), S6300 [30OC] (see H.R. 2710), H3788 [14MY]

——— exclude complex rehabilitative manual wheelchairs from competitive acquisition program (see S. 1223), S2485 [29AP] (see H.R. 2293), H3263 [12AP]

——— exclude ventilators from competitive acquisition programs for a certain period of time (see H.R. 4945), H8717 [31OC]

——— increase awareness, expand preventative services, and improve care for individuals with end stage renal disease (see H.R. 3912), H7241 [23JY]

——— 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. 5262), H9175 [22NO]

——— provide coverage for wigs as durable medical equipment (see S. 2633), S5896 [17OC] (see H.R. 3332), H4916 [19JN]

——— provide coverage of certain lymphedema compression treatment items as items of durable medical equipment (see S. 518), S1383 [14FE] (see H.R. 1948), H2915 [28MR]

——— provide coverage of dental, vision, and hearing care (see H.R. 1393), H2270 [27FE]

——— provide for demonstration project to evaluate the fiscal impact of covering low vision devices as durable medical equipment (see H.R. 4129), H7480 [30JY]

Taxation: exempt certain emergency medical devices from the excise tax on medical devices (see H.R. 1290), H2032 [14FE]

——— extend certain expiring provisions of the Internal Revenue Code and provide disaster tax relief (see S. 617), S1593 [28FE] (see H.R. 3301), H4770 [18JN]

——— repeal excise tax on medical devices (see S. 692), S1733 [7MR] (see H.R. 2207), H3252 [10AP]

U.S. Access Board: develop a minimum nonvisual access standard for home use medical devices, exercise equipment, and home appliances (see H.R. 3929), H7376 [24JY]

Letters

Extend certain expiring provisions of the Internal Revenue Code and provide disaster tax relief: several organizations, S1598 [28FE]

Remarks in House

FDA: clarify types of patents on safe and effective drug list, require list of applicable exclusivities for listed drugs, update patent sponsor requirements, and reform patent list guidelines (H.R. 1503), H3486–H3488 [8MY], H4401 [11JN]

Masimo Corp.: anniversary, E529 [2MY]

Medicare: 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 (H.R. 5262), H9210 [3DE]

——— provide coverage of certain lymphedema compression treatment items as items of durable medical equipment (H.R. 1948), H2907 [28MR], E366 [28MR]

National Inventors Hall of Fame (organization): tribute to inductees, E519 [1MY]

Taxation: repeal excise tax on medical devices, H5931, H5962, H5964 [17JY], H7253 [24JY], H9125 [21NO]

——— repeal excise tax on medical devices (H.R. 2207), H8842, H8843 [14NO], H9270 [5DE], H10039–H10041 [11DE]

Remarks in Senate

Social Security: provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under certain programs, S1888 [14MR]

Taxation: extend certain expiring provisions of the Internal Revenue Code and provide disaster tax relief (S. 617), S1597–S1599, S1605 [28FE], S1633 [4MR], S2400 [11AP], S2905 [16MY]

——— repeal excise tax on medical devices, S6913 [10DE]

Reports filed

Orange Book Transparency Act: Committee on Energy and Commerce (House) (H.R. 1503) (H. Rept. 116–47), H3438 [2MY]

Texts of

H.R. 1503, Orange Book Transparency Act, H3486 [8MY]