Demonstration project on coverage by Department of Veterans Affairs of over-the-counter hearing aids

(a)

Establishment of demonstration project

Beginning not later than one year after the date of the enactment of this Act, the Secretary of Veterans Affairs (in this section referred to as the Secretary) shall commence a project (in this section referred to as the demonstration project) to demonstrate and evaluate the fiscal impact of covering FDA-cleared, over-the-counter hearing aids under section 1707(b) of title 38, United States Code, in the same or similar manner as coverage is provided for prescription hearing aids under such section. (b)

Duration

The Secretary shall carry out the demonstration project for a period of two years. (c)

Eligible participants

A veteran is eligible to participate in the demonstration project if— (1)the veteran is enrolled in the system of annual patient enrollment established and operated under section 1705(a) of title 38, United States Code; (2)an audiologist determines, through a clinical evaluation of the veteran, that— (A) furnishing an over-the-counter hearing aid to the veteran for mild-to-moderate hearing loss is medically necessary; and (B)the veteran has no red flag conditions or contraindications for over-the-counter hearing aid use, as specified by the Food and Drug Administration; and (3)the veteran has access to a mobile phone device and mobile data or Wi-Fi, or any successor technology, to operate over-the-counter hearing aid functionality. (d)

Locations

The Secretary shall carry out the demonstration project at not fewer than two medical facilities of the Department of Veterans Affairs selected by the Secretary across different Veterans Integrated Services Networks and that have a demonstrated ability to reduce access barriers and provide services to a diverse veteran population in both rural and urban settings and surrounding areas. (e)

Project design

(1)

In general

The Secretary shall design the demonstration project to demonstrate the effectiveness of FDA-cleared, over-the-counter hearing aids compared to professionally fitted prescription hearing aids by an audiologist according to the audiological best practices of the Department of Veterans of Affairs, including the fiscal impact on the Department of providing permanent coverage of over-the-counter hearing aids under section 1707(b) of title 38, United States Code. (2)

Design elements

(A)

In general

The Secretary shall ensure the demonstration project includes the following study groups: (i)An FDA-cleared, over the counter hearing aid group. (ii)An audiologist-fitted prescription hearing aid group. (B)

Participants

The Secretary shall allocate an approximately equal number of participants in the demonstration project to each group specified in subparagraph (A). (f)

Measurement of benefits

To the maximum extent possible, in carrying out the demonstration project, the Secretary shall measure both self-reported benefits and speech recognition in noise among a diverse veteran population and evaluate the fiscal impact over a two-year follow-up period of permanent coverage of over-the-counter hearing aids under section 1707(b) of title 38, United States Code, for the FDA-cleared, over-the-counter hearing aids found under the demonstration project to be most beneficial. (g)

Consultation

In conducting the demonstration project, the Secretary shall consult with organizations that represent consumers with mild-to-moderate hearing loss and other stakeholder organizations. (h)

Reports

(1)

Interim report

Not later than one year after the commencement of the demonstration project, the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report that describes the progress and preliminary findings from the demonstration project. (2)

Final report

(A)

In general

Not later than 180 days after the last day of the demonstration project and after solicitation and consideration of formal written input on the project from organizations specified under subsection (g), the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a final report on the project. (B)

Elements

The report required under subparagraph (A) shall include an evaluation of the fiscal impact on the Department of Veterans Affairs of providing permanent coverage of over-the-counter hearing aids under section 1707(b) of title 38, United States Code, and such other findings and recommendations as the Secretary determines appropriate. (i)

FDA-Cleared, over-the-Counter hearing aid defined

In this section, the term FDA-cleared, over-the-counter hearing aid means a device— (1) cleared by the Food and Drug Administration; (2) fully regulated by the Food and Drug Administration under section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(q)); and (3) that contains features that allow personalization through technology, such as hearing tests, software, and smart phone applications.

Comptroller General study and report on veterans hearing aid benefits

(a)

Study

The Comptroller General of the United States shall conduct a study on the furnishing to veterans with mild-to-moderate hearing loss under section 1707(b) of title 38, United States Code, of assistance for hearing aids and related examinations. (b)

Elements

The study required under subsection (a)— (1)shall include an examination of— (A)the number of individuals in the United States with mild-to-moderate hearing loss who need hearing aids; (B)the medical coverage of such individuals relating to obtaining hearing aids; and (C)the effectiveness of such medical coverage in meeting such need; and (2)may include an examination of contract design for purchasing hearing aid devices. (c)

Report

(1)

In general

Not later than 18 months after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report on the study conducted under subsection (a). (2)

Recommendations

The report required under paragraph (1) shall include such recommendations on changes to programs and benefits of the Department of Veterans Affairs, including the establishment of new programs and benefits, as would meet the needs of veterans with mild-to-moderate hearing loss.