Helius opposes Medicare, Medicaid coverage amounts for PoNS device
US decisions will limit reimbursement for device's mouthpiece to $3K
Helius Medical Technologies is opposing new decisions from the U.S. Centers for Medicare & Medicaid Services (CMS) that stipulate how much of the cost of its PoNS device — a neurostimulator designed to improve mobility in people with multiple sclerosis (MS) — will be covered by these public health insurance programs in the U.S. moving forward.
CMS indicated that starting in 2025, Medicare or Medicaid will reimburse a lump sum of just less than $3,000 for the mouthpiece portion of PoNS. The organization deferred a decision on what it will cover for the other component of PoNS — its controller — until its next payment cycle, but reimbursement has been preliminarily set at slightly more than $500.
Helius believes that this coverage level isn’t fair, and that it will limit access to the technology for MS patients who would benefit from it. The company has indicated plans to engage with CMS to obtain a better reimbursement scheme before the changes go into effect. According to information from the National MS Society provided last year, the list price of the PoNS system is $25,700. With an instant rebate, the cash price is $14,500.
“We strongly disagree with CMS’ methods, rationale, pricing and deferral for determining the payment rates for both the PoNS mouthpiece and the PoNS controller,” Dane Andreeff, president and CEO of Helius, said in a company press release.
According to Andreeff, “Helius has spent millions of dollars in R&D to develop technology that the [U.S. Food and Drug Administration] designated a breakthrough device.” The PoNS device was approved in the U.S. in 2021 for use by MS patients.
“We are hopeful that we will be able to finalize fair reimbursement for the PoNS mouthpiece and controller with CMS in the near future,” Andreeff said.
Veterans Affairs has agreed to pay over $30K in total costs
PoNS, or the Portable Neuromodulation Stimulator, is a medical device approved in the U.S. as a short-term treatment for mild or moderate mobility problems in MS patients, ages 22 and older. It’s prescribed alongside a supervised physical rehabilitation program.
The device consists of a mouthpiece placed on the tongue and a controller worn around the neck, which together deliver mild electrical signals intended to stimulate the brain via two major nerves in the tongue. Ultimately, that stimulation is expected to help strengthen neural circuits related to performing physical tasks, thereby boosting the benefits of physical therapy.
PoNS earned the accreditation it needed to be covered by Medicare and Medicaid — the U.S. public insurance programs for elderly and low-income people — from CMS last year.
Once it is determined that a device can be covered, CMS decides how much will be reimbursed based on factors such as market price and value, as well as the cost of comparable technologies.
When the PoNS device first hit the market, Helius offered it at a temporarily subsidized price to aid patient access while it worked on securing reimbursement agreements with insurance carriers. Although that pricing was discontinued earlier this year, as Helius began making negotiations with insurers, CMS still used that value to make its reimbursement decision.
According to Andreeff, that means that the value set by CMS “does not reflect current market pricing,” and is significantly below the reimbursement values that the company has contracted with other major payers, including the U.S. Department of Veteran’s Affairs, known as the VA.
In May, Helius announced it had secured its first third-party reimbursement agreement for PoNS. Under that negotiation, the payer agreed to cover $16,554 for the controller and $7,347 for the mouthpiece — a 7% rebate from the device’s list price. The VA also agreed to pay $23,843 for the PoNS device and $7,344 for the mouthpiece.
Andreeff indicated that the company plans to approach CMS, prior to its pricing decision taking effect, to ask the organization to “more appropriately use the market pricing established through negotiations with the VA and an insurance carrier.”
Pricing for PoNS controller linked to TENS device
For the controller device, CMS has indicated that pricing is more complex, and that it thus needs more time to evaluate the issue. While a final pricing decision won’t be made until the next payment cycle, the organization published a preliminary reimbursement rate of $519.80.
That’s based on the organization’s view that the device is similar to a different stimulation technology called transcutaneous electrical nerve stimulation, or TENS. Designed to deliver electrical stimuli to the skin, TENS is sometimes used to manage MS symptoms such as pain and bladder issues.
“CMS has pivoted to improperly find the PoNS controller to be comparable to a TENS device,” Andreeff said.
We remain hopeful that CMS will properly set pricing for the PoNS controller.
A public meeting will be held in November to discuss this preliminary decision on the controller pricing.
“We will again present the differences between the PoNS controller [and] other devices, this time the TENS devices, in the upcoming public meeting,” Andreeff said. “We remain hopeful that CMS will properly set pricing for the PoNS controller.”
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