Welcome to Trends and Developments Impacting the Hearing Healthcare - - PowerPoint PPT Presentation

IHS Organizers

Esther Waldman Membership Specialist

Welcome to

Trends and Developments Impacting the Hearing Healthcare Industry

Presenters:

Gary Rosenblum, President, Oticon, Inc.

Fran Vincent Director of Marketing and Membership

This presentation is sponsored by

Doug Beck, AuD, Executive Director

• f Academic Sciences, Oticon, Inc.

Housekeeping

• This presentation is being recorded
• CE credit is available! Visit ihsinfo.org for details
• Note taking handouts are available at ihsinfo.org on the

webinar page. Feel free to download now!

Housekeeping

Today’s presentation is sponsored by Oticon, Inc. and represents their view on industry trends and changes. The content of this webinar has been developed especially for you by Oticon, Inc., and may not necessarily reflect IHS’ policy and stand on hearing healthcare issues.

Trends and Developments Impacting the Hearing Healthcare Industry

Contents

5

Part 1: Medicare Part 2: OTC Update Part 3: Telemedicine Part 4: Questions

Medicare

6

How many people (USA, 2019) have Medicare?

• Currently, 59.9 million

beneficiaries — 18% of the U.S. population — enrolled in Medicare.

• Enrollment anticipated at 79

million by 2030.

• 10,000 people per day turn 65

and are therefore eligible for Medicare

https://www.medicareadvocacy.org/wp- content/uploads/2018/05/Medicare-Fact-Sheet.pdf

Does Medicare cover hearing aids?

8

Medicare has two options for members

9

Original Medicare (US Government Plan): (63%) is a fee-for-service health plan that has TWO parts:

• Part A is Hospital Insurance
• Part B is Medical/Doctor Insurance
• Hearing Aids are not covered under Original or FFS Medicare

Medicare Advantage (MA): (37%)

• Parts A and B are both covered under MA
• MA covers health care services like:

Vision, Dental, Health Clubs, Chiropractor, Hearing Health Care

Medicare Advantage (MA)

10

• MA is Medicare in the private sector.
• The US government sub-contracts to the private sector, the government pays “per

member, per month (PMPM)” to manage Medicare members.

• MA plans bundle ancillary benefits - vision, gym memberships, dental, hearing, etc.

directly into their plans, thus no need for a supplement (Medi-Gap) plan.

• When you enroll into a Medicare Advantage policy, you get your benefits from the

plan, not Medicare. You use the MA plan’s network of providers and pay co-pays.

Medicare Advantage Enrollment Growth

11

2019 -22,600,000 Members 11.6% Y/Y Growth, 36.7% Total Medicare Enrollment

5 10 15 20 25

• Jan. 2015
• Jan. 2016
• Jan. 2017
• Jan. 2018
• Jan. 2019

TOTAL ENROLLMENT

Medicare Advantage Plans with Hearing Care Benefits

2015 47% 2017 65% 2018 73%

Medicare Advantage Membership by Plan

73% have HA Benefit 74% of HA users are New Users

Hearing healthcare benefit companies (TPA’s) contract with Medicare Advantage plans to offer HA benefit

• Tru Hearing – BC/BS plans, Humana, SCAN
• HCS - Anthem, Anthem Amerigroup, CareMore, Aetna, Cigna
• EPIC/United Hearing – United Health Care
• Amplifon Hearing Health Care – Cigna
• HUSA – Anthem, AARP, Kaiser, Well Care

List of Hearing Healthcare Third Party Administrators and their corresponding plans:

14

Medicare Advantage Impact

• 22M total members enrolled in Medicare Advantage
• 73% with a hearing care/hearing aid benefit
• Therefore 16,060,000 MA members have access to a HC benefit
• Benefits range from “free” to member to $2500 benefit toward HA purchase
• Utilization of about 1% = 160,000 members accessing care, or 320,000 HA’s in

2018 Must be on MC plan provider panel to have access to MA members

15

Three bills submitted to Congress for review could mean further changes

• H.R.1393 - To amend title XVIII of the Social Security Act to provide for

coverage of dental, vision, and hearing care under the Medicare program

• Sponsor: Rep. Doggett, Lloyd [D-TX-35] | Cosponsor statistics: 8 current -

includes 0 original

• H.R.1518 - To amend title XVIII of the Social Security Act to remove the

exclusion of Medicare coverage for hearing aids and examinations therefor, and for other purposes.

• Sponsor: Rep. Dingell, Debbie [D-MI-12] | Cosponsor statistics: 7 current -

includes 7 original

• H.R.576 - Seniors Have Eyes, Ears, and Teeth Act
• Sponsor: Rep. Roybal-Allard, Lucille [D-CA-40] (Introduced 01/15/2019)

16

Implications for us…

If Fee-for-service Medicare covers hearing aids…

• What will the reimbursement rate be?
• Will it still allow me to be profitable?
• Will patients be able to top up?
• Will it be featured as a DME or a specialty product?
• Will hearing aids fall under a competitive bidding?
• Will OTC hearing aids be covered by Medicare?
• Why does Medicare need to cover HAs if OTC is now a reality?

HIA will be monitoring these issues closely and will be sharing our opinions!

17

OTC Overview

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Defining “Over-the-Counter”

• Patients purchase products over the counter or “off the

shelf” with no interaction with an HCP

• FDA regulates via defined regulatory approval process

to ensure patient safety and efficacy

• Assumes patient can self-diagnose, select and self-fit

19

OTC Hearing Aids: 2015 – 2019 Developments

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June 2016 NASEM produces 12 recommendations for hearing aids, including OTC October 2015 PCAST recommends OTC November 2016 Senators propose OTC bill December 2016 FDA commits to "considering" OTC device March 2017 OTC Hearing Aid Act of 2017 introduced in Senate and House April 2017 FTC workshop assessing consumer protection July 2017 Legislation passes House August 2017 Legislation passes Senate President Trump signs bill into law October 2018 Bose receives approval for self-fitting HI

PCAST = President’s Council on Science and Technology NASEM= National Academies of Science Engineering and Medicine

2019 Nov release of Draft Guidelines

Likely timing for approval of final guidelines…

21

June, 2020

Penetration by severity of hearing loss:

22

Profound (6%)

Moderate (28%) Mild (67%)

70%

wear hearing aids

50%

wear hearing aids

10%

wear hearing aids

23

3 reasons why OTC concerns may be

• ver-stated

In Switzerland,

where OTC has been available for years, the majority of consumers prefer to go to specialty retailers.

24

3 reasons why OTC concerns may be

• ver-stated

In Japan,

OTC hearing aids are readily available, yet penetration is at 15% vs. 30% in the US; & satisfaction is at 40% vs. 90% in the U.S.

25

3 reasons why OTC concerns may be

• ver-stated

OTC Readers

has had a negligible impact on consumer demand for prescription lenses and eye-care professionals.

26

Recent Developments:

Recommendation for OTC safety and effectiveness sent to FDA from AAA, ADA, ASHA, IHS, and HIA (July ’18)

Recommendations to FDA: Focus on Safety and Efficacy

• Establish product requirements (gain limits, SPL limits, etc.)
• Define out of the box labeling appropriate for OTC, (intended use, medical

device language)

• Define inside-the-box labeling appropriate for OTC medical devices (lack of

benefit should trigger need for HCP)

• Define name category easily comprehensible by consumers (“self-fit OTC”

to distinguish between OTC and HCP; should require 510k)

• Adequate provisions for consumer protections, in coordination with FTC

(strong return and refund policies, claims should be verified)

27

28

Recent Developments:

Bose receives Class II approval to market a self-fitting hearing aid (October ’18)

De Novo Process:

• The De Novo process provides a pathway to classify novel medical devices

for general controls1 alone, or general and special controls2.

• Provide reasonable assurance of safety and effectiveness for the intended

use, but for which there is no legally marketed predicate device.

• De Novo classification is a risk-based classification process and it is

confidential.

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1. General Controls basic provisions by which FDA regulates products 2. Special Controls are regulatory requirements for Class II devices

30

Recent Developments:

July 24, 2018 FDA letter to hearing aid manufacturers stating OTC does not exist until the regulations are finalized, so don’t advertise OTC

FDA Letter highlights:

• “The OTC hearing aid category, as defined by FDARA section 709, does

not exist until the effective date of a published final regulation”

• “Until that time, no products that are claimed to address hearing loss are,
• r can claim to be, OTC hearing aids within the meaning of FDARA

section 709”

31

32

Recent Developments:

HIA Meeting with FDA on the topic of DTC hearing aids

HIA / FDA Meeting highlights:

• FDA stated does not view this behavior as currently illegal, as long as

certain criteria are met.

• FDA says if the product says “DTC” instead of “OTC,” FDA considers the

sale lawful, without any review of the DTC hearing aids.

• FDA says it is permissible to sell DTC if the hearing aids are promoted as

DTC, conform to the labeling requirements and remaining conditions of sale and are sold to patients 18 years or older.

• FDA believes hearing aids are NOT OTC but can be sold DTC.

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Demant Position on OTC Hearing Aids

34

• Demant has no intention to manufacture, market, sell, or license OTC

hearing instruments in the United States at this time

• OTC hearing aids exist today – even though they are not legally marketed

as such – and have not increased the penetration of hearing aid usage among hearing loss patients

• The high level of patient satisfaction in the US (83%) is a result of the

existing medical model where a medical professional (audiologist or Hearing Instrument Specialist) treats patients with hearing loss with a medical device (hearing instrument). Demant has supported this model in the past and will continue to do so

• Evidence shows that patients are unwilling to pay a high out of pocket

amount for OTC hearing aids (<$300); medical professionals should keep this in mind when deciding to carry these devices in the future

Tele-Practice

35

36

Background: Types of Telemedicine

• Live Video – Face to Face
• Store and Forward

US Congress Defines Telemedicine in Distinct Categories

• Remote Patient Monitoring
• Mobile Health

37

The challenge in our Industry and your

• pportunity

Demant Solution Challenges

Workforce Issues ”Dark Offices” Inexperienced/Unmotivated Providers Consumer Inconvenience Inefficient/Static Scheduling Industry Disruptors in Product/Service Lack of Graduates Entering Profession Synchronous TeleAudiology – Demant Diagnostics Demant Live Face-to-Face

• Solves Challenges related to

location

• Solves Challenges related to

staffing

• Reduces Patient Visits

38

A shortfall in the number of audiologists is predicted to occur in the not-so-distant future. If we do not address this impending crisis, any gaps in care will be filled by alternatives outside the profession.”

Why now?

The Crisis Coming in Audiology. Barry Freeman, Audiology Today Nov/Dec 2009

Current challenge in meeting needs

Like MDs, there will be shortage of hearing care providers in near future

39

40

Face to Face

Test/Diagnosis Counselling/Selling Fitting Rehab./Self Adjustment Service & Support

Remotely Assisted

Remote Test/Diagnosis Rehab./Self Adjustment Remote Service & Support Remote Counselling and Fitting

Remotely Unassisted

Online Purchase Self Fitting Rehab./Self Adjustment Self Test/Diagnosis Realize HL Screening

INFO

Web Self/Call Center Service & Support

Patient Journey

41

Demant Diagnostic: Interacoustics

• PC based Clinical Audiometer
• Counseling Screens
• Video Otoscope
• Circumaural Headphones
• Insert Phones
• Bone Conductor
• Room Noise Monitor

Live Face to Face

Interacoustics System in Portugal

42

• Person-to-person between remote audiologists

and clinics with a Virtual Waiting Room software

• setup. Prototype stage.
• Implemented in 4 clinics and with 3 field

dispensers.

• National roll-out when Interacoustics delivers

that: ‒ Measures background noise ‒ Allows remote audiologist to be heard in the sound booth and consultation rooms

43

Oticon RemoteCare

RemoteCare functionality is leading the way in the VA

Future/RoadMap Today

Available for iPhone and iPad

• Important for veterans as they

can have iPads

• Long process getting VA IT

security clearance. Now

• btained!

Demant Diagnostics – Make Oticon the Preferred Provider in the VA through Ease of Use First successful demonstration through VA firewall on meeting with VA leadership on April 24!

From an informal survey of patients and providers...

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Question Yes No

Were you aware that today's appointment would be via Telehealth? 11 123 Were you seen on time for your appointment? 120 14 Did you SEE the Telehealth provider Clearly? 134 Did you HEAR the Telehealth provider Clearly? 133 1 Were your needs fully met through the Telehealth appointment today? 133 1 Would you be willing to schedule future Telehealth appointments? 132 2

45

Thank You

Questions

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Contact Gary Rosenblum: gary@oticon.com Contact Doug Beck: doug.beck@Oticon.com

For more info on obtaining a CE credit for this webinar, visit www.ihsinfo.org

Thank you for attending!