Sorry, the government doesn’t pay for your therapy app

There is now a bipartisan movement to change this, but it comes at a time when many companies are competing for survival. Their plight is a predicament for regulators who must balance the need and cost of new treatments, especially when evidence that treatments work is limited and health care costs are skyrocketing. It highlights that we are facing

member of parliament Mike Thompson (California Democrat) said it was important to advance digital therapy experiments. “In the modern world we live in, it’s imperative to provide alternative ways to access care,” Thompson said. Kevin Hahn (Republican, Oklahoma) is leading the effort in the House. Gene Shaheen (DN.H.) and Shelly Moore Capito (RW.Va.) is presenting a companion bill to the Senate.

“Prescription digital therapies can help treat a range of ailments, including substance use disorders and mental health problems, but it is deplorable that many who need them today do not have access,” Shaheen said. said.

As things stand, “more insurers are blocking device reimbursement, and more patients are effectively unable to receive proper treatment and support,” Capito said. She sees this technology as a way to better assist patients with conditions such as substance use disorders in rural and other hard-to-reach areas.

Their efforts came too late for Pear Therapeutics. The Boston-based company appears to be on the cutting edge of healthcare, touting interest from major providers and state governments for its smartphone-and-addiction treatment product as of January. looked like

It all came crashing down last month when Pia filed for bankruptcy and announced it would sell its assets, an FDA-approved online app to help opioid and other drug addicts.

“Peer’s bankruptcy filing is a direct result of Congress’ failure to pass the bill,” said Kevin Brennan, a former Peer lobbyist and aide to a Connecticut congressman. Rosa DeLaurothe ranking of Democrats on the Appropriations Committee.

If Congress doesn’t act, “patients will be denied the next generation of innovative care, and it will be especially problematic for people in underserved communities,” Brennan said. added Mr.

Other companies in the industry have made similar claims.

Will Robinson, policy director at BigHealth, which makes drugs for insomnia and anxiety, said, “Frankly, it’s very hard to realize how far the U.S. is falling behind other countries on these products. I think it’s important for the Robinson noted that Germany and France are accelerating reimbursement for digital treatments.

A CMS spokesperson, who spoke on condition of anonymity about Politico’s review of the digital therapeutics, said that after reviewing Pear’s products, they are “durable medical devices, prosthetics, orthotics and consumables. ,” the agency said. declined to report for this reason.

Even if the software is covered, it is not guaranteed.

A spokesperson said CMS may consider whether the app fits into another category. Even if the agency decides they have, Medicare beneficiaries must determine whether it is “reasonable and necessary” before paying.

Cost may also be a barrier to government reimbursement, as Pia’s app adds about $300 to a typical 12-week treatment protocol for opioid use disorder, according to one analysis. Pair did not respond to a request for comment.

There is some evidence that the protocol is cost-effective, but it may not convince insurance companies.

Critics say the companies behind these innovative treatments may have taken a flawed approach in building an entirely new category of drugs.

“As a digital therapeutics company, you have to go to the FDA, go to the insurance companies, and then actually get people to use your digital therapeutics to make money,” said Keith Figlioli of investment firm LRV Health Ventures. rice field. “There is so much friction involved in getting a company off the ground.”

video games, breathing exercises, etc.

Obtaining FDA clearance is one thing; proving that a product is cost-effective.

Some people want to see more data.

“We shouldn’t start changing healthcare systems and payments based on evidence that doesn’t exist yet,” said John Taurus, director of the Digital Psychiatry Division at Beth Israel Deaconess Medical Center in Boston. “I don’t think I’ve ever seen anything as solid evidence as this.”

But some argue that insurance companies could benefit if these new treatments prove cost-saving.

In contrast to industrial products such as tablets, software can be built once and expanded relatively cheaply.

The field of digital therapeutics aims to harness the utility of smartphones to enhance the effectiveness of traditional cognitive-behavioral therapy, a coping skill for fighting disease.

The category is not clearly defined, but the FDA is believed to have approved 30 digital therapeutics.

Akili Interactive creates the video game EndeavorRX to help ADHD sufferers learn how to focus, multitask and ignore distractions.

Additionally, AppliedVR’s virtual reality chronic pain treatment EaseVRx teaches breathing techniques and more to reduce back pain.

In addition to its addiction apps, Pear Therapeutics has created Somryst, an insomnia product that offers lessons to help people train their brains to rest. It is marketed as a “long-term treatment” to replace “Band-Aid” sleeping pills.

Given the limitations of existing drug therapies, the companies argue that there are good reasons to promote this innovation. Mental illness and substance use disorders are prime targets.

The number of suicides, which fell in 2019 and 2020, has largely returned in 2021, returning to 48,344 in 2018, the highest in U.S. history (although the rate is still below the Great Depression).

Meanwhile, lethal drug overdoses have reached peak levels and are on the rise. That number will reach 107,622 in 2021, up 15% from 2000, according to the latest CDC figures.

When announcing the agency’s approval, FDA official Christopher M. Loftus touted EaseVRx as “a treatment option for pain relief without the opioids at the root of America’s overdose epidemic.”

Proponents of these new treatments believe that if insurance companies pay for them, they will not only be more effective than traditional treatments, but their ease of use will also allow them to expand their reach. claims to have sex.

“There was a belief that once we had the FDA’s clearance, we would be reimbursed after that,” said Jenna Karl, chief medical officer at Big Health.

Karl’s company has long been skeptical of this approach, focusing instead on building robust data proving that interventions work.

That strategy paid off. Scotland’s National Health Service offers both of its apps for free. In the US, Big Health struck a deal with his CVS Health to make their products available to employers and plan sponsors through pharmacy benefits manager Caremark.

wheels of bureaucracy

Despite the FDA’s approval of digital therapeutic products, the lack of a definition of what a digital therapeutic product is has hampered the development of CMS.

The agency does not have a benefit category for software that is a digital therapeutic or medical device, and Congress needs to approve a new reimbursement category.

Rachel Goodman, partner at law firm Foley & Lardner, said, “This is just one example of how the law is not quite keeping up with the state of innovation.”

bicameral systembipartisan Access to Prescription Digital Therapies We define them as any FDA cleared or approved device, product, Internet application, or other technology that “primarily uses software.”

Shaheen told POLITICO that he is excited about the bill’s potential and believes it will save money.

In the meantime, the companies are coordinating their efforts.

A trade group led by the Consumer Technology Association has developed a draft standard that aims to clear up confusion and facilitate adoption by giving more structure to evidence generation.

Proponents hope that getting the device into the hands of lawmakers will help. Jennifer Mathieu, senior vice president of professional and government affairs at the Managed Care Pharmacy Academy, said her group plans to host a demo day for staff, lawmakers and senators.

Bail Wright, a psychologist and senior director of healthcare innovation at the American Psychological Association, said some companies are giving away their products effectively.

Some have tried workarounds. AppliedVR has received FDA clearance for its back pain program RelieVRx as a combination software and medical device (CMS reimbursement category).

This spring, CMS approved the coding, allowing Medicare to reimburse the cost.

AppliedVR has also successfully signed a deal with the Department of Veterans Affairs.

Some companies, like Pear, are doing the hard work of signing up with individual Medicaid programs.

At least that wasn’t enough for Pear.

“This is a real problem in healthcare,” says René Quashie, vice president of digital health at the Consumer Technology Association. “If we develop an innovative solution, how will it be adopted by clinicians, how will it be covered and paid for? think.”

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