Because less than five percent of those who could benefit from a cochlear implant either do not take advantage of the device or fall outside of the criteria for coverage, I am constantly seeking articles about coverage.

Donna Sorkin, the Executive Director of the American Cochlear Implant Alliance (ACIAlliance.org) recently did an online presentation about the changes in the criteria for adults covered by Medicare.

By dogged persistence and seven years of work and cooperation with surgeons, audiologists, and medical centers, as well as public input (including from one of the best known cochlear implant recipients, Lou Ferrigno) eventually and happily CMS, the administration arm of Medicare, broadened the criteria.

The American Cochlear Implant Alliance, founded in 2011, has a very diverse involvement with hearing loss and cochlear implants as you will learn in this interview. From information to rehabilitation, you will find it all at ACIAlliance.org

Thank you Donna Sorkin for your advocacy and for taking the time to talk to us.

Transcript

Voiceover:

Cochlear Implant Basic is a site for candidates and their families and friends. If you have been told you qualify for a cochlear implant, these podcast interviews tell how receiving a cochlear implant can be a life changing experience. You will meet recipients who face a hearing loss and that hearing aids could no longer provide comprehension of speech or music. They face growing isolation, inability to socialize or compete in the world of business, the joy of music disappeared. They explain how receiving or cochlear implant changed their lives. Welcome to Cochlear Implant Basics. A reminder, Cochlear Implant Basics is not sponsored by anyone, nor is it offering medical advice. Please consult your own healthcare provider. Good

Richard:

Good afternoon. We have the executive director of the American Cochlear Implant Alliance this afternoon. Would you please tell me your name, the date and where you’re at? What city?

Donna Sorkin:

Thank you first of all Richard for having me on your podcast and helping to expand information about cochlear implants and access. I am Donna Sorkin. I’m the executive director of the American Cochlear Implant Alliance and it is, I believe, the 12th of October.

Richard:

Tell me a little bit about the American Cochlear Implant Alliance. What kind of organization are you and what’s your objective?

Donna Sorkin:

We are actually a nonprofit organization and we’re unique in that we involve people who are involved in cochlear implants in diverse ways. So, we have surgeons, we have audiologists, speech language pathologists, educators, psychologists, social workers, anybody that’s involved in the care of a child or an adult who either has or is going to receive a cochlear implant. And then we also, have a number of adults who have cochlear implants or are interested in cochlear implants such as yourself as well as family members. We have parents of children who either have or exploring cochlear implants and other family members. And then we have military members. We actually offer a membership to anybody who has served or is in the military for free.

Richard:

I’ve noticed from some of your postings and all that you basically also, serve as a political action committee for legislation. What kind of role do you play in that?

Donna Sorkin:

We try to get involved in anything at the state or national level, sometimes local but less frequently that interferes with awareness of or access to cochlear implants. So, some of the activities that we get involved in at the state level, for example are Medicaid and a number of states now are working to increase coverage of cochlear implants for adults. Children are covered in all of the 50 states because of aspects of national legislation, but adults, it’s left up to the states. So, we’re involved in a number of states trying to ensure that adults have access in that way. We’re involved in various aspects of screening for children, for hearing loss, So, passage of loss, and I mean now most recently the CMV virus, which babies can be exposed to if the mother has CMV while she’s pregnant, that can affect the child in different ways.

And one of those ways is hearing loss. So,, we’re trying to encourage states to screen for CMV and that will help the families to know if the child might develop hearing loss later because it’s not always present at birth. So,, we’re working on that. We work also on ensuring that parents have choices about how they want to educate their child, whether they want to use a spoken language approach or if they want to use signing language or both. We really want to ensure that families have access to information and access to communication. At the national level, we’re involved in a whole bunch of different issues, but most recently, and the one that I know you’re interested in is expanding access to cochlear implants for Medicare beneficiaries.

Richard:

That’s exactly right because that’s something I’ve been involved in for the past five or six years to make sure that people who are sitting on the fence can get a cochlear implant if they want one. And that’s been increasingly easier over the past five years in terms of the criteria. Would you do minutes and discuss what the change is? So,, I can have our listeners aware of that.

Donna Sorkin:

So, for some time the criteria for cochlear implants under Medicare has been more stringent than that for the FDA. And many of us when we hit 65 are covered by Medicare. some people are covered still by private insurance and So, those that were using straight Medicare in some instances were unable to get their implant when they were at a level of hearing loss that someone would’ve been eligible when they were younger. We knew that a lot of older adults were very frustrated by watching people who had less residual hearing than they did, but they were eligible for cochlear implants and then they would get one and they were talking on the phone and just negotiating the world. So, for the past seven or eight years, that’s been an important project for us. And changing Medicare criteria is actually very complex and takes a lot of time.

So, it was one of the very first projects that we started as a new organization. We were actually incorporated in 2011 and I came in 2012 and then we really started getting organized with our advocacy and other activities then. So, in 2013 we started a study that was a collaborative effort with CMS, the agency that oversees Medicare. And they allowed us to conduct a study in which Medicare beneficiaries would have hearing characteristics that were similar to those of your younger adults. For those Medicare beneficiaries who were in the study, they would be covered by Medicare. In this instance, if they had just been going in normally without being in the study, they wouldn’t have been covered. So, that was what we did, and we conducted a study, we started out with 10 centers and then expanded it to increase the number of people that were in the study.

These were all centers that did a lot of adults and academic institutions, and I think there were a couple of private center clinics as well. So, the idea was we were going to track how well older adults did with caring characteristics that were more like those that were in effect for younger adults. We wanted to see how they did if they improved, and we wanted to see if they had a greater extent of health issues if they were not as able to withstand the surgery if they had aftereffects because of cochlear implant surgery.

So, all of those things were part of the study. They had some interesting aspects of it. They had a telephone test where they actually tested people before they got their cochlear implant and then after these were tests that were done, words and sentences. So, those of course are easier tests than single words, which some clinics are using. But that was the testing protocol that Medicare wanted us to use. So, that’s what we did. And then a study was done, it was published in one of the JAMA publications, So, a very high level peer reviewed publication and academic journal. And then the results of that from the study were submitted to Medicare. And then we looked at that and then we requested that they open a process which is known as NCD or a national coverage determination that would follow a specific prescribed process that they use and then hopefully result in a change in those criteria for adults. So,, that’s essentially what we did.

Richard:

But it took seven years, which is a lot of perseverance to get through that.

Donna Sorkin:

Yes.

Richard:

Putting it mildly. So, the day when CMS announced the change, you broke out the champagne. Everybody was probably pretty happy that day.

Donna Sorkin:

We definitely did that.

Richard:

Okay. I do have a question right along those lines, if CMS which is Medicare makes a change, do private insurance companies tend to follow with that or they wait until the FDA makes the approval? How does that work?

Donna Sorkin:

So, that’s a really good question and usually that’s the case, but in this particular instance, Medicare is actually following private. The FDA’s criteria have been in effect for quite a long time. And So, with the FDA criteria, they were saying that you could have up to 60% words in sentences and be a candidate. And in probably the guideline because you could… It’s not the same for private insurance. Private insurance, it depends on your particular insurance instrument. It depends on if your clinic goes in and pursues coverage for you, that’s what’s called off label. So, it’s not exactly what the FDA criteria are. And the physician can go in and ask for that coverage for a patient. You can’t do that with Medicare.

Richard:

This is new to me because I was under the impression that the FDA was a 40% [inaudible 00:10:43].

Donna Sorkin:

Was actually at 60. And So, we were asking for FDA. FDA also, says that adults with specific hearing characteristics or eligible for bilateral cochlear implants and there’s also, single-sided [inaudible 00:11:01] criteria for the FDA. Medicare has chosen to remain silent on the issue of bilateral and on SSD. And because they have remained silent, different clinics have different approaches to whether or not they will cover a patient who’s bilateral or someone who has and then providing a second implant. sometimes there are some clinics that will do it. It’s a little risky because as you mentioned earlier, Medicare does not pre-approve. And if they come back and look at what the clinic has done and they don’t exactly agree with their determination, they could have the money pulled. So, it’s a fuzzy area. And what we changed with this NCD was the amount of residual hearing that someone could have and be eligible for a cochlear implant.

And the arguments that we used are the fact that people tend to do better. In fact, if they have more residual hearing, if they haven’t been deaf for a long time, they tend to do better than if they’ve been deaf for quite a number of years. We also, know that there are important quality of life benefits associated with being properly fit with technology, whether it’s hearing aids or cochlear implants, people are going to have those important benefits. And increasingly we’re seeing an association between cognitive health and how someone is fit with technology. If people can hear and engage and go about their life attending book club or going to the theater or talking to their friends, whatever it is, all of that contributes to our cognitive health. And so, that was also, something that the physicians and those who reviewed this determination at CMS, that was part of the consideration. We even took the incredible Hulk in with us and-

Richard:

Lou Ferrigno

Donna Sorkin:

He was great. He was really, really great. So, he just talked about the benefits that he’s derived and the improvement that he has experienced in his hearing, including being able to use the phone, which he hadn’t been able to do in a very long time. So, we had some interesting tools in our kit that we used to convince CMS to make the change. And I think they’re happy that they were able to make this change and provide the opportunity to hear from more older adults. So, I’m very excited about it. It’s been something that I’ve been working out for a long time. So, yes, we did break out the champagne when the rule came in.

Richard:

I’ve interviewed Lou twice for my podcast. I did one interview with him about three or four months after he was activated, and I did one with him in June of this year, almost a year later to discuss the differences of the year makes that how important rehabilitation is to get good results. My fingers are crossed that he goes for a second CI and becomes bilateral because I want to interview him a third time. It’s like we say, sometimes getting people off the fence is the hardest thing. Will this change the criteria for those who are looking for a cochlear implant for single sided deafness? Do you think that’s going to be changing anymore?

Donna Sorkin:

I can’t answer that. I just don’t know. A lot of people are interested in getting a CI for SSD under Medicare. I don’t honestly know clinics that are doing that because it’s not So,mething that’s been discussed at all. I mean, just think how long it took us to get this particular change. Doesn’t mean I don’t think it’s important it older adults should have the same access as younger adults to single sided deafness. I can’t really speak to whether it’s realistic or not and who would go after it. I mean, it’s different entities. We’re not talking about doing it right now. It doesn’t mean we wouldn’t do it.

Richard:

I know the FDA did approve the single sided So, there are a lot of private insurance did start to approve. Yes.

Donna Sorkin:

It depends Richard on which insurance you have coverage for private insurance is actually something that we work on for SSD. I’ve had a number of conversations with one particular large insurer, which I’m not going to reveal here, but I think that they’re going to change. And the argument with them was that they were following the FDA guideline for children who have single-sided deafness, which right now stands at five years of age. So, a child who’s born with deafness on one side right now, if the insurer decides they’re not going to cover because of the FDA guideline, would mean that child couldn’t get their implant for single sided deficits until they were five years old. Of course, by that time it’s too late. The child’s not going to get much benefit from it. And So, what ends up happening is the physician will go to the insurer and go through a set of procedures that they have to try to get the insurance company to go ahead and cover it, even if their policy says they don’t cover or don’t cover till the child’s five.

That is an area we’re working on quite a lot. And we sponsored four papers recently that are on our website. If people go to ACI Alliance.org and then look under the tab called awareness, there’s a section of papers on candidacy. And So, we sponsored these task forces to look at how professionals today in 2022 determine candidacy for adults who have bilateral deafness, deafness on one side or unilateral hearing loss. And then for children, the same two. And So, there’s four papers. Three have been published, the three are up there. The fourth will be published sometimes soon. We are using those papers because they were developed by clinicians from across the care continuum and then published in a scholarly journal in our talking discussions with different insurers. And they have actually been the pediatric ones that have been endorsed by the American Academy of Audiology.

So, that’s huge too, because it says an important society of audiologists says, “Yeah, we agree with this. We’re not necessarily about cochlear implants, we’re about hearing care. We agree with what they’re seeing. We use tools like that.” It’s sort of a unique aspect of how we pursue access to cochlear implants because our mission statement says that we are an organization that addresses access to cochlear implants through research, advocacy, and awareness. And So, we use those three legs of the stool to address the issues of access in different ways. And with the whole issue of the access according to SSD or in the case of Medicare and bilateral, we tend to conduct studies, or we look at studies that have been done or we talk about clinical practice and then we publish research. Studies then are used by insurers and others. Insurers do look at research studies and yet it’s one thing to go in and say, Yeah, I do better with this. But that’s not what they use to change criteria. They want to see published research.

So, that’s a lot of what we do related to the candidacy criteria issue. And we use that also, the state level. The state level kinds of discussions are different, but it’s still something that comes up. For example, right now we’ve been talking in the state of Washington to encourage them to include adults under Medicaid for cochlear implants. It’s an effort that we started maybe eight months ago. We anticipate that in 2023 it will be in the budget, and they will cover adults who may not be working because they can’t hear. And So, their younger adults of working age who need a cochlear implant to hear, to work to negotiate the world. So, that’s another way we use studies like this to encourage, in this case, state government to improve access.

Richard:

You have your work cut out for you.

Donna Sorkin:

Yeah, sometimes we win.

Richard:

Yes, but no, I mentor 24 time zones in all around the world and I have to be very much aware of legal and cultural differences at everywhere. I’m always surprised just within the 50 states, the differences that people have trying to get approval. Because one of the things I’d like to address when I did an interview a long time ago with Dr. Jack Wazen at Silverstein Institute here in Florida, he mentioned the fact that they were trying to get Medicare coverage for simultaneous bilateral cochlear implant surgery. And that spoke to me because I had simultaneous bilateral surgery, but it was covered by private insurance and I did it just before my 65th birthday So, I wouldn’t have to go for Medicare. So, your work was cut out for you to reach out. It made sense to me because it’s one operation. You don’t have to go back to the hospital a second time, but they were obviously not interested without showing a paper of the benefit. The other day when I watched her presentation, Theresa Zoland, what was her role within the ACIA?

Donna Sorkin:

Terry was a very early leader of the organization. She was one of the co-founding chairs of the organization. She has been an audiologist in cochlear implants for over 30 years. She was the director of the Cochlear implant program at University of Michigan before she retired pretty recently. When the organization was started, the co-chairs were Terry and audiologist and Dr. John Niparko, who was a surgeon who started out his work at Johns Hopkins. Dr. Niparko Was actually my surgeon. I have a cochlear implant and he was on the board of every organization I’d ever served. So, I knew him quite well. The two of them were very early leaders. And when I arrived on the scene in 2012, they were both on the board. John was the chair of the board at the time, Terry was the vice chair. It was the priority of the board that we would pursue this.

And So, the two of them and Dr. Craig Beckman, who now is at Washington University in St. Louis, were what’s called the principal investigators. And So, they were the study heads and the three of them went together to meet with CMS and to say, “Would you consider starting a process that would allow Medicare beneficiaries to have access that’s similar to that offered now under the FDA?” So, they said, “Yeah, we’re interested.”

So, that’s how it came about. And there were different tools to do that. But the one that we chose was the coverage with evidence development, which means you conduct a study and then you use that study to submit for coverage. So, they were the ones that led it all the way through. They did it without pay. They just did it in a volunteer capacity. In fact, everyone involved in the study was doing it without compensation.

There were additional testing that was required to be part of the study. And So, the clinics that were part of this had some extra work than they normally would do that wasn’t reimbursed. What was reimbursed was the surgery and the device and the audiology and all of the aspects of cochlear implantation that are normally covered under Medicare for patients that had less hearing. And So, they were saying, yes, as part of this study, we’ll cover for you. So, they had Medicare coverage for the study. So, they led it all the way through. Once the results came in, they analyzed the study, the results, which were phenomenal. You heard Terry speak about them. Most of the people in the study had to be part of the study. They had to have residual hearing above 40%, which is what had been allowed before. So, most of them were sort of mid-forties to 50.

And in terms of the immediate test results, people were improved up to 80, 85, 90%. Many of them almost double their hearing outcomes having been in the study. We’re going to be writing some articles about the study and a number of professional as well as consumer publications. And we did interviews with three of the study participants and just ask them, What’s this meant to you? They were all uniformly So, positive, So, grateful for having had this opportunity to get a cochlear implant when they did and be part of the study. It required more work on their part because they had to come in for more testing, but they didn’t care. They had the opportunity part of it. And So, the other aspect that we did was at each step of the process, there was a sort of public comment aspect of it. And So, we publicized that to the larger community, encouraged people to put comments in.

And when they published the final rule, the draft final rule I should say, we encouraged comments and there were 147 comments that were put in on the draft rule and one hundred forty five of them were positive. There was one that was ambiguous and one that in my mind didn’t make any sense that was negative. And then they went with essentially what the draft had been and finalized that to be the final rule.

So, we put a lot of effort into ensuring that the larger community knew it was going on and participated in the process, both in terms of serving as study sites and then commenting along the way. There was quite a bit of buzz in professional magazines. We also, went to the Adult Consumer Conference, HLAA at one point, and Terry and I in the very early timeframe of the study, we solicited volunteers. So, we talked about the fact this study was going on and encouraged people if they thought they fit the criteria to go to one of the study sites. You had to do this at a study site, you didn’t necessarily have it at you’re close to home site. And So, people had to travel a little bit and get to the site if they wanted to do that. And So, we promoted it So, that the consumer groups could also, know this was going on and encourage their members to be part.

Richard:

This is really fantastic stuff. I really appreciate your time. I have to ask right now, what can you do for my listeners and what can my listeners do for ACIA. I think that’s a very important aspect of what we need to talk about.

Donna Sorkin:

We’d love to have you and be part of the organization. We have probably the most inexpensive due on the planet. That’s $10 if you’re an adult and you want to be part of it. And if that $10 is a financial burden, we’ll waive it. Anybody not to be a member because money’s a problem. We have a lot of great information that we have. Actually, a lot of it’s free. Most of the information on our website, anybody can come on and have.

One of the resources that’s extremely popular is they have a blog on adult rehabilitation that’s in there. There’s, I don’t know, 40 or 45 blog posts. It’s written by a speech language pathologist, Naama Thach, she’s Israeli and she goes back and forth between Israel and the US and she’s one of our wonderful volunteers, So, she writes the blog. So, that’s up there. Somebody can go up and see them. And then we also, look for people to be part of our consumer volunteer network like you are Richard. And then that way we can provide support and information for people who want to do just like what you’re doing. You come on and you keep yourself informed and then you share the information, support others. So, that’s how your listeners could be part. If they would like and they want to just join, they can join. But we’d love to have them as part of our advocacy network as well.

Richard:

Thank you So, much for your time and I know that the listeners are going to get So, much out of this interview and I hope your membership shoots up by 6000% next week.

Donna Sorkin:

Thank you So, much. Really my pleasure to be with you.