With Donald Trump’s victory last November, and a number of regulatory rollbacks made by the young administration, conservatives have the impression that the era of expansive federal regulations was over. With GOP control over Congress and the White House, Republicans finally have the chance to put a stop to what seemed to be a never ending carousel of new Obama regulations.
Yet they may be embracing a new regulatory scheme, courtesy of potential 2020 Democrat frontrunner Senator Elizabeth Warren (D-Mass.).
A recent regulatory proposal advanced by Sen. Warren not only increases red tape but could increase costs for health care consumers, including veterans and Medicaid patients, and is another power grab of the federal government over an area currently well overseen by the states.
The Over the Counter Hearing Aid Act of 2016 pilfers authority over personal sound amplification products (PSAPs) from the states and establishes a one-size-fits-all mandate from Washington, D.C., for all 50 states, regardless whether the state’s current laws are appropriate for the state’s citizens.
The bill conflates two categories of devices: hearing aids and PSAPs. Hearing aids are medical devices. Patients receive hearing aids after meeting with medical professionals who assess their condition and the severity of their hearing loss. A hearing aid is a personalized device to fix hearing loss, and they are treated and regulated as medical devices by the Food and Drug Administration (FDA).
PSAPs are sold over the counter. They are not considered medical devices by the FDA, and they are not subject to the stringent regulations of hearing aids. PSAPs do not treat hearing loss that is at the moderate level or above the moderate level.
States have different laws governing hearing aids, hearing screenings, and PSAPS. In some states, audiologists can prescribe hearing aids, and the requirements for licensing and continuing education for audiologists may be different depending on current state laws. Likewise, the state laws regulating physician assistants are not uniform across all 50 states. But Warren’s bill would disrupt the current state laws.
Contra the congressional Republicans and the Trump administration’s promises to deregulate our federal government to improve health outcomes for patients and respect the principle of federalism for local communities to decide their best course of action, Warren’s bill benefits big corporations, including Bose, located in Sen. Warren’s home state of Massachusetts.
The bill would establish the first over-the-counter hearing aid category and would apply FDA medical device regulations to PSAPs. These PSAP products are already available over the counter; the effect of Warren’s bill would be to create more regulations for these products than at present.
Warren’s bill could also lead to poorer health outcomes.
At present, doctors, audiologists, and physician assistants (depending on the state) work with patients to identify the causes of hearing loss and recommend the best treatment options for the patient. Often, hearing loss may be caused by another serious medical issue, which could go undiagnosed without a medical screening.
Warren’s bill may also have the unintended yet consequential effect of increasing health care costs for veterans and Medicaid patients.
TRICARE, the veterans’ health care plan, covers hearing aids and medical screenings for hearing aids. Of the 3 million hearing aids prescribed in 2013, twenty percent originated from the Department of Veterans Affairs.
It is no surprise that veterans, especially ones who served on active duty, are at high risk for hearing damage. The VA notes that hearing loss is “one of the most common military service-related injuries.” Veterans currently can obtain screenings and hearing aids through their medical plan, but if Warren’s bill became law, veterans could lose coverage of hearing aids and end up paying more out of pocket than under the current status.
Federalizing the laws and regulations governing PSAPs may seem like a good idea on paper. Proponents argue this proposal will lower costs and lead to more innovation, but a closer look reveals that such an effort would end the ability of local state communities to determine what works for their residents.
The proposal would also create poorer health outcomes for some patients and could substantially increase out of pocket expenses for those who can afford it the least, our veterans and Medicaid patients.
With Republican control of the Congress and the White House, this flawed proposal can easily be abandoned.
First published in The Hill in May 2017