More and more Blue Cross Blue Shield insurers are agreeing to pay patients for prescription digital therapy, paving the way for broader coverage among carriers and kick-starting an industry. emerging.
According to an analysis provided to Modern Healthcare by PalmHealthco, a company that helps digital therapy companies commercialize their services, at least 17 Blues plans now offer at least one therapy. Digital prescription like a pharmacy or standard medical benefit for some members.
Prescription digital treatments are software applications that must be prescribed by a clinician. Unlike over-the-counter digital health services, health insurers have been slow to pay for these tools due to concerns about liability, lack of clinical evidence, and slow regulatory approval. Food and Drug Administration.
Highmark Health announced last month that it will cover eight prescription digital therapies for 6 million commercial subscribers in four states. Pittsburgh-based Integrated Health Systems was the first insurer to cover group prescription digital therapies. STAT first reported Highmark’s coverage decision.
Akili Interactive CEO Eddie Martucci wrote in an email. Akili Interactive has received FDA approval for the video game EndeavorRX, which is advertised as a treatment for children with attention deficit hyperactivity disorder.
“Family of kids with [attention-deficit/hyperactivity disorder] and adults with ADHD are struggling and need more options,” says Martucci. “Hopefully we will see a larger and faster shift as Highmark has shown the path to a formal policy.”
In the same month as Highmark’s decision, North Carolina’s Blue Cross and Blue Shield added Pear Therapeutics’ prescription digital health service for substance abuse disorders as an option for self-employed insurance. According to PalmHealthco, other Blues insurers will pay for prescription digital therapies in Florida, Illinois, Kansas, Minnesota, Montana, Nebraska, New Jersey, New Mexico, Oklahoma, Texas and Washington.
“I am a big believer in optimism. This is a new therapeutic approach,” said Dr. Matt Fickie, senior medical director of Highmark Health. “We have durable medical equipment, surgery, medicine, radiation therapy, implantable equipment. This is in the same league as me. If you’re in this business and you want to try to give people the best early treatment possible, this is where you need to be.”
The path to coverage
The FDA has approved 10 prescription digital health tools, including three from Pear Therapeutics. Medicaid plans in Massachusetts and Oklahoma took the lead and rolled out Pear Therapeutics’ digital substance abuse services to enrollees this year.
In April, the Centers for Medicare and Medicaid Services paved the way for commercial coverage of FDA-approved digital products by introducing billing codes for “prescription digital behavioral therapy.” ,” making it easier for private health plans to process payments for these services.
CEO Corey McCann said fifteen Blues service providers have added Pear Therapeutics products to their commercial product portfolio. The company’s tools will also be covered by SelectHealth of Salt Lake City-based Intermountain Healthcare and Oakland, California-based Kaiser Permanente.
Evidence-based studies of the clinical effectiveness of Pear’s Therapeutics tools targeting opioid use disorders, chronic insomnia, and stimulant use disorders have forced health insurers have to pay for its products, McCann said.
“We’re on a coverage-bending point of view,” he said. “Many payers make financial gains by restricting access to patient care to almost anything, including prescription digital therapies. You just overcome those objections with real-world data.”
“Pear Therapeutics’ clinical studies have led Blue Cross and Blue Shield of North Carolina to add abuse services,” said Laura Moran, lead manager of commercial formulary and use management at the insurance company. substance as an optional covered benefit for self-insured employers this year. She said the nonprofit will work with its pharmacy benefits manager, Prime Therapeutics, to measure inpatient hospital stays, healthcare costs and home involvement. offers related to the tools of Pear Therapeutics. She said Blue Cross and Blue Shield of North Carolina have not yet decided whether to make their findings public.
“It’s a new frontier,” Moran said. “I bet as real-world demand and evidence continue to grow, other schemes could change their course.”
Blue Cross and Blue Shield of North Carolina added prescription digital services to their portfolio on October 1, so it’s too early to reveal how many employers cover these products. Pear Therapeutics products for their workers, Moran said. The insurer’s behavioral health team is notifying employers of the new benefit, and the company’s customer service staff are trained to answer patient questions about Pear Therapeutics, she said.
Highmark Health has also updated its operations to accommodate prescription digital therapy. Fickie said the company will work with any FDA-approved digital tool to generate real-time data on patient costs and outcomes if its provider branch is able to test the services. service in a clinical setting.
As a result, the company has committed to “substantial monitoring” of how data is stored and how they are accessed by third-party developers. For example, licensed psychologists, clinical social workers and licensed professional counselors can do so, he says.
“The idea is to try to put this out there as a therapeutic modality so that people can get care,” says Fickie. “Access to pure psychiatrists is more difficult. So if you get past all the different mid-level professionals in the ranks of behavioral health, then you might have a much better chance of achieving that goal.”
Why The Blues?
Fickie says Blue Cross and Blue Shield plans can adopt these tools more quickly because they share coverage decisions.
At the same time, Blues plans tend to be more autonomous than larger, for-profit insurers, which allows them to make decisions tailored to the local market, said Antonio Ciaccia, Director said executive director of drug price research firm 46brooklyn Research and president of consulting firm 3 Axis Advisors. . Blues companies may also face more innovation pressure than their larger competitors, he said.
Many for-profit insurers have vertically integrated by purchasing providers. Ciaccia said the Blues’ plans often steer clear of this strategy, which is to their detriment. Because the Blues’ main value proposition is their large hospital network, he said, they may be hesitant to buy suppliers and upset their clinical partners.
The lack of proof that these digital tools have long-term benefits is the biggest hurdle that vendors face insuring, says Ciaccia. Elevance Health, formerly known as Anthem, and Aetna by CVS Health have issued policies concluding that these tools have not proven their worth. Elevance Health and Aetna did not respond to requests for interviews.
“It is difficult to define the formulation range of these products,” said Alex Kilgore, life sciences analyst at Xcenda, a consulting arm of the pharmaceutical wholesaler AmerisourceBergen. “But there has been a lot of momentum with the Highmark decision and the state’s Medicaid policies. We are seeing more digital therapies covered for reimbursement.”
FDA approval plays a large role in the increasing acceptance of these therapies. An Xcenda survey of executives overseeing health plans, integrated distribution networks, and pharmacy benefit managers found that 64% are more likely to pay for digital therapies. digital prescription if they meet FDA requirements and have sufficient clinical evidence.
Kilgore said the FDA could improve communication with digital therapy companies to make the review process more transparent. “A third of payers said they were very familiar with the FDA regulatory approval process, a third said they were somewhat familiar and a third not at all,” he said.
Prescription digital tools also face more skepticism than over-the-counter digital health services. For example, Cigna’s Evernorth and Aetna curated a list of covered digital health tools available to members. Neither digital health catalog includes prescription claim tools. Cigna and Aetna did not respond to requests for interviews.
With the lack of evidence, companies advise the federal government on health IT policy, said Aaron Miri, co-chair of the federal Health Information Technology Advisory Committee, an expert panel that advises the federal government on health IT policy. Insurers may be concerned about an uncertain regulatory environment for prescription treatment.
“If I prescribe you drug X and something happens to you, we understand well,” said Miri, senior vice president and chief digital officer at Coral Gables, Florida-based Baptist Health. that. “If I prescribe application Y, and it is said to have the same results and it does not, where is the liability? Is the doctor at fault? Is the app maker at fault? Is the hospital system at fault? That’s a big question mark.”
Michael Pace, CEO and founder of PalmHealthco, expresses surprise that insurers don’t take the risk of denying FDA-approved prescription digital therapies but will cover Unapproved digital therapies. These underrated tools could actually expose insurers to greater liability, he said.
“I would hate to be an executive at a paying organization that funded their members to use something that wasn’t approved by the FDA and didn’t include something that was approved by the agency, if at all. something bad happens related to that unauthorized therapy,” he said.
Not everyone agrees that FDA approval is the gold standard for patient care or necessary to succeed in the marketplace.
“The rules of engagement are pretty simple,” says McCann. “If you want to treat a disease, then you need to go through the FDA approval process. If you want to tackle something that’s geared toward better health and wellness, such as weight loss, that’s not something the FDA has any purpose in mind.”
Big Health has included digital therapy for insomnia and anxiety in Evernorth’s digital health portfolio. The fact that it’s not considered a prescription therapy doesn’t matter, said Arun Gupta, CEO and Executive Chairman of Big Health.
Big Health is engaging in conversations with the FDA and keeping potential regulatory pathways open, Gupta said. “We have an evidence-based treatment backed by science,” he said. “The most important thing is that these programs need to be evidence-based and effective, and they need to be distributed to the majority of the population.”
