Joseph Biden, OTCs, And Medicare Insurance – Starkey’s Take On The Industry

10/22/2021 | Industry News, Patient Resources

Not long ago, Starkey joined together in Washington, D.C. to discuss industry activities, including their new advocacy and advice to hearing professionals.

With the rise of over-the-counter hearing aids, they gave their estimate of what’s going to happen over the next few years and how hearing healthcare clinics can prepare for whatever the outcome is.

It was presented by Brandon Sawalich, the president and CEO of Starkey, and Michael Scholl, Chief Compliance Officer, EVP of Corporate Relations.

They delved into a range of topics, including:

  • President Joseph Biden’s Executive Order – July 9
  • Over-the-counter hearing aids
  • The potential of Medicare coverage for hearing aids
  • Listen Carefully – a new advocacy project launched by Starkey

#1 – President Joseph Biden’s Executive Order

The Secretary of Health and Human Services shall: to promote the wide availability of low-cost hearing aids, not later than 120 days after the date of this order, publish for notice and comment a proposed rule on over-the-counter hearing aids, as called for by section 709 of the FDA Reauthorization Act of 2017 (Public Law 112-52, 131 Stat. 1005).

When the president stood up and made a conversation about hearing aids and competition, the race was on. Following this conversation, there’s been a lot of conversation around hearing aids, which inevitably has led to a spread of misinformation.

The executive order was a great first step, however, it was a very narrow announcement, encouraging HHS to promote the draft of OTC regulation in 120 days.

Starkey’s first immediate response was a letter to President Biden, where they reached out with the two individuals who were responsible for the Executive Order.

Their message was very important, as it’s a general well-being factor. The patient must be informed of the risks involved and the misinformation spread around OTCs.

As a result, they continued to meet and educate Members of Congress about the hearing industry, making them aware of the important factors consumers must know.

So, what has happened since?

As you can see, there are many stages, including tweaks and considerations received. If all stages go ahead, we’re looking at a final rule in effect of OTCs next summer, August 2022.

But what can professionals and the general public do during this time?

So, when that public comment period opens up, hearing healthcare clinics and members of the public can reach out to the FDA, encouraging them to weigh in the options. You can take advantage of this now by submitting a formal comment.

The FDA has to look at all the comments available, as it’s their responsibility, so they will provide an opportunity for everyone to show their opinion.

In truth, Starkey, and others engaged in manufacturing hearing aids and devices, do and will have a voice in the law decision-making process, and those that support consumer safety and protections should absolutely hold influence over those decisions.

#2 – Over-the-Counter Hearing Aids

While any movement in the right direction is always great, Starkey has a few issues with the OTC model:

  • It’s aimed for those with a mild-to-moderate hearing loss – this is very difficult for anyone to identify if they have not had a hearing assessment, which is unlikely in the case of OTCs.
  • There is no awareness of how to protect yourself from overamplification from OTCs.
  • Doesn’t promote seeking professional help from an audiologist.

There is a lot of misinformation online, so many people will be at risk of purchasing hearing aids that are not right for them.

Those who purchase OTCs will most likely be new to hearing aids, so they are in a high-risk category. It’s important that when you are purchasing hearing aids for the first time, you seek help from a medical professional, who can look into your ears and analyze the degree of hearing loss you suffer with.

Without this level of understanding, it can cause serious risks to the individual – including overamplification and further deterioration of their hearing.

So, the question is, what’s next? In the meantime, hearing healthcare clinics and the public can utilize that comment period that will open up in the next coming months.

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#3 – Medicare Coverage Of Hearing Aids

A topic that came up in industry was the expanding of Medicare coverage to dental, vision, and hearing as part of the reconciliation package.

In late July, there was an agreement from Senate leadership and House leadership that they would agree to a $3.5 trillion reconciliation bill.

Essentially, Congress has an opportunity once a year to pass one reconciliation bill – it has to be revenue-neutral.

The conversations that Starkey is having with offices put forward three key factors when considering the expansion of Medicare coverage:

  • Classify hearing aids as prosthetic devices and be exempt from competitive bidding.
  • Give individuals the ability to upgrade (out-of-pocket) to technology that is above what is medically necessary and covered by Medicare.
  • Authorize all licensed hearing healthcare professionals — including physicians, audiologists, and hearing aid specialists licensed under state law — to provide services and treatments to meet the future needs of our growing Medicare population.

As a result, Starkey hosted Senator Klobuchar on campus not long ago, focusing on her understanding of getting Medicare done right. Inevitably, there were some questions from the viewers:

Q1) The bill states that 80% will be paid to audiologists. How transparent is this?

Currently, this is unknown, as it’s up to CMS to understand exactly what this payment structure will be.

Q2) Is anyone doing anything to include hearing instrument specialists in the Medicare bill?

There are a lot of discussions to include HIS in the bill, including personal discussions with ADA who have come together to create another consensus paper on what this needs to be.

#4 – Listen Carefully

To help audiologists and hearing professionals across the US navigate through the struggles in the industry, Starkey created Listen Carefully, which is designed to be a repository for all policy-related activities that may impact the hearing industry.

It will talk about Medicare, over-the-counter, the hearing healthcare model, and will be a place where you, and staff member officials, can go to learn about policies going on.

There will also be an advocacy tool where you can write to policy members.

It’s a source of truth, where you can learn about what’s going on and how to best serve patients.

Do You Need Help With Your Hearing?  

At Audiology and Hearing Aid Associates, we believe these announcements from Starkey are huge.

Since we opened our doors, we’ve always made a big part of our mission to ensure that patients remain informed and up to date. This transpires into ensuring we follow industry updates and attending webinars where possible.

Because whatever happens, we are always prepared, ensuring our patients are at the forefront of everything.

If you need any advice or professional assistance, please contact us at (541) 612-7555.



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Erika Shakespeare CCC-A

Erika Shakespeare, CCC-A, specializes in pediatric and adult diagnostics and amplification. Working with adults to help manage tinnitus and hearing loss since 2002, she is an expert in both of these areas. Additionally, she is a pediatric audiology mentor and educator for pediatric audiologists across the country and is one of the most respected experts on pediatric audiology.

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