Gordon Glantz is a freelance medical writer.
It is unclear what former Supreme Court Justice Felix Frankfurter meant when he said: “All our work, our whole life is a matter of semantics, because words are the tools with which we work, the material out of which laws are made, out of which the Constitution was written. Everything depends on our understanding of them.”
It comes down to how words are heard, then interpreted.
For the hearing impaired, both hearing and interpretation seemingly form an unholy alliance when it comes to Medicare coverage of, or affordable alternatives to, hearing aids.
Based on what could be tricky wordplay, hearing aids do not fall under the definition of a durable medical device, which Medicare.gov describes as the following:
* Durable (long-lasting)
* Used for a medical reason
* Not usually useful to someone who isn’t sick or injured
* Used in your home
* Has an expected lifetime of at least three years
This equipment must be “medically necessary” and something “that your doctor prescribes for use in your home.”
Examples include blood sugar monitors and test strips for diabetics, canes and crutches for the immobile, and oxygen equipment for those with compromised breathing capacity. And, since 1986, so are cochlear implants, which involves a surgical procedure for the “severe-to-profound” nerve deafness.
But when it comes to hearing aids, the swelling number of people with age-related hearing loss is left in the dark.
And in silence.
At the time of the 1935 Social Security Act, seniors accounted for 7.8 percent of the population, according to the Social Security Administration, and many did not live long enough to feel the full effect of sensorineural hearing loss (which occurs in 23% of the population over 65 years old).
As of 2014, seniors accounted for 14.5 percent of the U.S. population. Add in that life expectancy rises more than three decades longer than in 1935, and age-related hearing loss becomes a reality.
And the original Section 1862(a) of the Social Security Act, which excluded coverage of hearing aids–and eyeglasses–appears to be nothing less than an outdated law.
Aside from a small exception of Medicare Advantage plans that may cover hearing aids, which has existed since the 1970s, it is dependent upon Congress to make the sweeping changes needed.
Despite the 2015 bills introduced by Reps. Debbie Dingell (D-Mich.) and Matt Cartwright (D-Pa.) to pave the way for Medicare coverage of hearing aids, it is an issue that is both powerful and problematic for a system subject to the threat of flux under a new president.
In terms of flat-out fairness, one must consider that more than half of the 50 million Americans 65 and older, who paid a total of $606 million into Medicare in 2015, are not reaping the benefits of coverage for a hearing aid.
Meanwhile, not only was coverage of cochlear implants expanded in 2005 to include more potential patients, so are accessories (microphones, batteries, etc.) and other additional coverages (intra-surgical monitoring).
According to an article by Fan-Gang Zeng, PhD, professor and director at the Center for Hearing Research, University of California Irvine, in the September issue of The Hearing Journal http://bit.ly/2cHnMhl: “The Office of Health Technology Assessment (OHTA) and Centers for Medicare and Medicaid Services (CMS) guidelines relied heavily on peer-reviewed publications; to a lesser extent, on data submitted by the manufacturers to the Food & Drug Administration (FDA) and on professional society position statements; and the least extent, on expert opinions.”
Zeng also cited “regulatory differences” as contributing factors to the coverage disparity. The cochlear implant is a Class-III medical device that requires FDA approval, while the majority of hearing aids are regulated as low-risk Class-I devices and are marketed, typically, without the FDA’s blessing.
The cochlear implant, as a Class-III medical device, has to be proven both safe and effective through comprehensive and expensive clinical trials to obtain FDA approval. Most hearing aids are regulated as a low-risk Class-I device and generally exempt from FDA review and clearance before marketing. Bone conduction hearing aids and tinnitus maskers are regulated as Class-II devices and may gain FDA clearance before marketing by simply demonstrating their equivalence to an existing product without conducting any clinical trials. While the exemption or clearance regulation has shortened the time to market for hearing aids, the lack of prospective randomized controlled clinical trials to demonstrate its health benefits prevents Medicare coverage of these devices.
“Ultimately, achieving Medicare coverage of hearing aids and determining criteria and extent of coverage will depend on the willingness and ability of hearing aid manufacturers to quantify the health benefits of hearing aids, which would be directly compared to other covered medical devices,” wrote Zeng.
He also cited a lack of an “organic” relationship between audiologists and physicians, who generally have little to do with the ordering and fitting of hearing aids, as a stark contrast to the role of audiologists in pre- and post-surgical evaluation for cochlear implants.
This allows for the landscape wherein CMS can draw distinctions between what does or does not receive coverage.
A POLITICAL FOOTBALL
One of the major concerns after the recent election of President Donald Trump was what would happen to Medicare, particularly with the House and Senate both under Republican control. In other words, what will the prospect of privatization mean for seniors and others such as low-income Americans reliant on government assistance that accounts for up to 15 percent of the federal budget, a number sticking in the craw of conservatives?
On Nov. 7, 2016, the day before Trump was elected, Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) announced that they will introduce the Over-the-Counter Hearing Aid Act of 2016, with the primary aim of providing quality-of-life relief to the estimated 30 million Americans who experience age-related hearing loss.
According to Grassley’s statement on his website, only about 14 percent of those with hearing loss use assistive hearing technology, i.e., hearing aids, with the primary reason of not using one being cost. The average price tag for a hearing aid is in the range of $2,400 and an estimated 80 percent of people with age-related hearing loss need them for both ears.
“Millions of people in Massachusetts and across the country experience hearing loss as they get older, but they are unable to get the hearing aids they need because of high costs and complicated regulations,” Warren, a vocal opponent of Trump, was quoted as saying. “This bipartisan bill is a simple fix that will make hearing aids easier to access and, unlike in the current marketplace, will make it easier for consumers to shop for the best value.”
The Over-the-Counter Hearing Aid Act-buoyed by recommendations from former President Barrack Obama’s Council of Advisors on Science and Technology (PCAST) and the National Academies of Sciences, Engineering, and Medicine-would allow hearing aids intended to be used by adults to compensate for mild to moderate hearing impairment to be sold over the counter.
“I hear from Iowans about the high cost of hearing aids, and I understand the concern,” Grassley was quoted as saying. “If you can buy non-prescription reading glasses over the counter, it makes sense that you should be able to buy basic, safe hearing aids, too. The goal is that by making more products more easily available to consumers, competition will increase and lead to lower costs. More consumer choice and convenience are what we want to accomplish with this legislation. This won’t affect those who need professional expertise to be fitted for hearing aids or have hearing aids implanted. The over-the-counter option is for those who would benefit from a simpler device.”
MONEY SOLVES THE MYSTERY
There seemingly stood a significantly better chance of finally shedding light on the mystery of why hearing aids are not covered by Medicare but cochlear implants–at an average of $24,000 each–began receiving coverage as early as 1986, and the coverage was extended to children in 1992.
The many underlying reasons why hearing aids are cost-prohibitive and generally not insured, while cochlear implants are covered, will either come to light or fall further into a dark abyss–perhaps for the long haul under the Trump administration.
As is almost always the case, it seems to be a simple bread-crumb trail of dollar signs. Follow the money, and the answer–or answers–may be there.
It is more a matter of if those answers are acceptable.
At present, just 19 states require health insurance to cover hearing aids, but mainly for children. The only three states mandating coverage for adults are New Hampshire, Rhode Island, and Arkansas.
In the rest of America, the cost of the exam that may result in the diagnosis of needing a hearing aid is covered. The hearing aid itself? The patient is on his or her own. Even if you are covered by a plan with some cursory coverage, that level of coverage is, at best, supplemental and likely not enough to support binaural hearing aids and the average price of two hearing aids is in the range of $5,000.
Why? Deemed elective, insurance companies have a convenient out and can avoid emotive arguments about quality-of-life issues. Insurance companies make their living on unlikely risks, and hearing loss–particularly age-related at a time when people are living longer–is anything but unlikely.
So, while the costs of a cochlear implant is significantly higher, it is a less likely outcome for the majority of Americans, as an estimated 50 percent of those over 75 will have the type of hearing loss requiring hearing aids that generally need to be replaced on average every three to five years.
From a business model, this is not feasible. Medicare should, theoretically, pick up the ball that some would think insurance companies fumble in the name of the bottom line. Yet, that does not happen. Instead, Medicare/Medicaid and the insurance companies have developed a long tradition of following the lead of the other to remain fiscally sound.
Frustratingly for many, the Affordable Care Act–Obamacare –only provided a vague window with a “rehabilitative medical devices” option, leaving open an interpretation that could vary from state to state.
A given state’s “benchmark plan,” the second lowest priced plan available within a state health insurance exchange, typically does not consider hearing aids to be essential medical devices, as laid out in the original 1965 Medicare/Medicaid amendments to the 1935 Social Security Act.
In 1965, seniors were the demographic most likely to be impoverished, and estimations indicated just half had insurance.
That was a lot of ground to be made up, and it was left up to CMS to make determinations as to what constituted a “significant disability,” leading to coverage of devices such as iron lungs.
In the ensuing decades, as the population has aged, the Centers for Disease Control and Prevention placed the hard-to-pin-down number of those with hearing loss in the range of 37 million. While other organizations have different estimations, all agree on one undeniable fact–hearing loss, if considered a disability, would rank as the number one disability in the country.
It is, literally, the sound of silence for those with age-related hearing loss.