Medical Devices

Section 2(a)(1)(C) adds a new subparagraph (Q) to 1862(a)(1) providing transitional coverage for breakthrough devices under Medicare, and Section 2(a)(2) defines 'breakthrough device' and 'transitional coverage period'. This creates a new Medicare coverage pathway for qualifying devices, directly benefiting medical device manufacturers.

Section 5(a)(3)(A) requires providing information to relevant stakeholders including industry, tissue establishments, academic health centers, biomedical consortia, research organizations, and patients; Section 5(a)(3)(B) requires conducting workshops and educational sessions for such stakeholders to support regulatory predictability and scientific advancement. This benefits medical device manufacturers involved in human cell and tissue products by improving regulatory clarity and access to info

Section 2 amends the Social Security Act to establish separate HCPCS codes for ultralightweight manual wheelchairs with titanium or carbon fiber bases, allowing suppliers to charge beneficiaries the difference between Medicare payment and actual charge, which benefits manufacturers of such wheelchairs.

Section 2 amends 38 U.S.C. § 1701(6)(F)(i) to include adaptive prostheses and terminal devices for sports/recreational activities in medical services furnished to veterans, directly benefiting manufacturers of such devices.

Section 2(a)(1) authorizes purchase or development of a cloud-based IT system for inventory management of expendable and nonexpendable items for Veterans Health Administration, which would increase demand for medical devices and supplies tracked by the system.

Section 2(a)(2) adds coverage for Alzheimer's disease and related dementias early detection screening tests, which include genomic sequencing blood tests, single-analyte tests, multiplex panel tests, whole genome sequencing, protein expression, etc. These are medical devices that would be reimbursed by Medicare, creating a market expansion for manufacturers of such diagnostic tests.

Section 2(a)(2)(A)(iii) inserts 'lung cancer biomarker testing' as a covered service under Medicaid, which will increase demand for diagnostic tests and related medical devices used in biomarker testing.

Section 2(a)(2)(B) adds coverage for lung cancer biomarker testing under Medicare, which will increase demand for diagnostic tests and related medical devices used to detect biomarkers in tissue, blood, or bodily fluids.

Section 2(a) amends Social Security Act to provide Medicare coverage for external infusion pumps and associated home infusion drugs, directly benefiting medical device manufacturers that produce such pumps.

Section 2(a)(1)(B) adds coverage for multi-cancer early detection screening tests under Medicare, which are defined as genomic sequencing blood tests or comparable biological material tests (Section 2(a)(2)(nnn)(1)(B)(i)-(ii)). This creates a new reimbursable diagnostic test category, benefiting medical device manufacturers that develop and sell such tests (e.g., Guardant Health, Exact Sciences).

Section 2(d)(2)(A) requires grantees to purchase trauma kits meeting performance standards, creating a market for medical device manufacturers that produce tourniquets, bandages, gloves, scissors, instructional materials, and containers.

Section 2(a) establishes a Prosthetic and Rehabilitative Items and Services Formulary and requires the Secretary to enter into contracts to support availability of items and services included in the Formulary (subsection (d)). This directly benefits medical device manufacturers that produce prosthetic and rehabilitative items by increasing demand through VA contracts and ensuring availability across VA facilities.

Section 2 amends 38 U.S.C. § 1701(6)(F)(i) to include adaptive prostheses and terminal devices for sports/recreational activities in VA medical services, directly benefiting manufacturers of such devices.

Section 2(d)(1)-(E) directs the VA to provide annual preventative health evaluations that include assessment of prosthetic equipment and assistive technology, such as spinal cord neuromodulation technology, powered exoskeletons, speech generating devices, and implantable spinal cord stimulation systems. This creates demand for medical devices used by veterans with spinal cord injuries, benefiting manufacturers.

Section 2(f) defines HBOT as therapy with a medical device approved by the FDA or issued an investigational device exemption by the FDA. This provision supports the use of FDA-cleared hyperbaric chambers, directly benefiting medical device manufacturers that produce such equipment.

Section 2(c) defines fertility treatment to include assisted reproductive technology and laboratory services, which will increase utilization of medical devices used in IVF and related procedures.

Section 2(a)(1)(C)(iii)(I) allows VA to furnish dentures and dental appliances, increasing procurement of dental appliances, benefiting medical device manufacturers.

Section 3(a)(2) defines peripheral artery disease screening tests to include noninvasive physiologic studies (ankle-brachial index) and arterial duplex scans, which are medical devices, and Section 3(c) establishes Medicare payment for these tests, creating a market for device manufacturers.

Section 2(a) explicitly includes 'medical devices' among the health care items or services for which Medicare Advantage and prescription drug plans must reimburse the VA. This provision ensures payment for medical devices used in veteran care, directly benefiting medical device manufacturers by securing reimbursement channels through the VA for devices provided to veterans in Medicare Advantage plans.

Section 5 amends laboratory quality and surveillance provisions to include development of new screening tests and performance evaluation services, which benefits medical device manufacturers involved in diagnostic test development.

Section 2(b)(5)(C) includes a blood pressure monitor in the newborn supply kit definition, creating demand for medical devices.

Section 2(b) includes 'necessary wound care supplies, including wound care dressings (inclusive of primary and secondary dressings), gauze, and bandage retainers,' which are medical devices, benefiting manufacturers.

Medical devices that incorporate biotechnology (e.g., diagnostics, biosensors, implantable devices) would benefit from the initiative's focus on product commercialization, regulatory streamlining, and R&D support (Sections 3(c)(5), 4(b)(3)(E), 4(b)(3)(F), 6(5), 6(6)). The bill aims to reduce regulatory burdens and accelerate commercialization of biotechnology-produced products.

The bill funds the purchase of forensic equipment, including supplies, reagents, consumables, and validation expenses for genetic genealogy techniques (Section 3063(d)(1)). This benefits medical device manufacturers that produce DNA sequencing equipment, laboratory instruments, and related consumables used in forensic analysis (e.g., Thermo Fisher Scientific, Illumina, Agilent).

Title VI includes $445,808,000 from medical device user fees authorized by 21 U.S.C. 379j, credited to the FDA account and available until expended, supporting medical device review activities.

Section 3(b)(1) includes 'Screening procedures, including advanced gynecological imaging, including payment for such procedures,' which would increase demand for medical imaging devices used in uterine fibroid detection.

Title VI, Defense Health Program allocates $354,821,000 for procurement, which includes medical devices and equipment, directly benefiting medical device manufacturers.

Section 2(f) defines HBOT as therapy provided via a medical device approved by FDA or with an investigational device exemption, directly benefiting manufacturers of hyperbaric chambers and related equipment.

Section 2(l)(3) defines 'treatment' to include therapeutic devices, and Section 2(c)(1) funds designing and testing novel or integrative treatments for mTBI, which could include medical devices used in neurorehabilitation.

Expansion of mammography programs (Section 2) increases utilization of mammography equipment, benefiting medical device manufacturers.

Section 2(a)(1)-(2) and Section 3(a) reference 'drugs and devices' for emergency opioid overdose treatment, including devices like naloxone auto-injectors, thereby creating demand for medical device manufacturers.

Section 1(b)(1)(E) adds 'and evidence-based practices to identify and address concussion' to subsection (b), which may increase demand for diagnostic and monitoring devices used in concussion assessment.

Section 3(e)(2) defines non-covered reproductive health care to include assisted reproductive technology procedures such as ovarian stimulation, egg retrieval, sperm processing, intrauterine insemination, and in vitro fertilization, which rely on medical devices and equipment, thereby benefiting manufacturers.

Section 2(b) requires naloxone or similar medication to be available on Coast Guard installations and operational environments, implying procurement and distribution of medical delivery devices (e.g., auto-injectors, nasal spray devices).

Section 113 allows grant funds to facilitate access to products used to prevent overdose deaths by detecting substances like fentanyl and xylazine test strips, which are medical devices, expanding their use and market.

Section 2(a)(1)(B) adds the definition of 'nonclinical test' to sections 312.3, 314.3, 315.2, and 601.31 of title 21 CFR, which includes medical device regulations, potentially reducing testing burdens for device manufacturers.

Section 2(b)(1)(C) provides technical implementation guidance to ensure nucleic acid synthesis screening is effective and secure, which aids medical device manufacturers involved in diagnostics and nucleic acid-based testing.

Section 2(c)(9) and Section 3(c) involve oversight of safe patient handling and mobility technology, including requiring access to such technology in medical facilities and emergency settings, which could drive demand for medical devices used in fall prevention and patient handling.

Section 2(b)(3) includes 'other therapies designed to promote or enhance activities of daily living,' which can encompass medical devices, benefiting manufacturers.

The presumption of service connection for diseases such as cancer, cardiovascular disease, and respiratory conditions may increase demand for diagnostic and therapeutic medical devices used in treating these conditions, benefiting medical device manufacturers.

Division B, Title VI funds the FDA's Center for Devices and Radiological Health ($894,063,000) and includes medical device user fees ($478,166,000), directly supporting the medical device industry through regulatory science and approval processes.

Section 2(b)(1) mentions vans equipped with full diagnostic and treatment dental equipment, which will drive demand for dental medical devices.

Section 749E(c)(1)(B) references integrating AI tools into clinical support and decision-making processes, which often involves AI-enabled medical devices, thus benefiting manufacturers through increased training and potential adoption.