The latest in digital therapeutics features a new device that uses Ai to scan a patient’s sinuses and create an acoustic vibration, delivered through a headband, to reduce nasal congestion.

AI is being touted as the biggest new thing since the printing press, a technology that can clear up healthcare’s administrative headaches and improve clinical outcomes. But can it also help cure a stuffy nose?

Digital health company SoundHealth has announced De Novo authorization from the U.S. Food and Drug Administration for SONU, a digital therapeutic device that uses AI-enhanced “acoustic vibrational energy” to relieve nasal pressure. The San Francisco-based company can now market  the device to consumers aged 22 and older.

“Acoustic vibration associated with humming has been shown to decrease symptoms of nasal congestion, possibly through modulation of autonomic inputs to the nasal mucosa or through nitric oxide activity, which may in turn exert a decongestant and anti-inflammatory effect on the nasal passages,” the company said in its press release.

According to a 2021 Harris On Demand survey, roughly one of every four Americans suffers from nasal congestion on a daily basis, and 85% of those with chronic nasal congestion say it impacts their daily activities. Aside from the discomfort of a stuffy nose, nasal congestion can also lead to sleep problems, headaches, coughing, and a sore throat.

The device may interest healthcare providers who, wary of the addictive nature and side-effects of nasal sprays and drugs, have been looking for alternatives to traditional medication-based treatments, including digital therapeutics.

The SONU device combines innovative new technology with an ages-old therapy.

“It's based on the really old understanding that when we hum or sing or whistle, our sinuses open, and we also feel very relaxed,” Jacob Johnson, MD, president of San Francisco Audiology, an ENT specialist with the San Francisco Otolaryngology Medical Group, and an associate clinical professor at the University of California, San Francisco, said in the SoundHealth press release.

“The vibration relaxes the sympathetic and parasympathetic parts of our autonomic nervous system,” he continued. “It opens our sinuses with resonance [and] improves the flow of mucus in the nose and promotes ciliary action. …It's a very good alternative to the other options of medications, allergy management, surgery and office procedures.”

According to the company, the SONU device includes a headband and smartphone app that scans the user’s sinuses to create a digital map, then calculates the user’s “optimal resonant frequencies.” The user then puts on the headband, which “delivers frequencies tailored to the patient based on the app’s calculations.”

But don’t feel bad for nasal sprays. If they lose their appeal for defeating stuffy noses, they may find a new use, such as in treating Alzheimer’s.

Richardville was a CIO for more than 30 years at health systems including Intermountain, Atrium and ProMedica.

Craig Richardville, MBA, CHCIO, Intermountain Health’s award-winning Chief Information and Analytics Officer, has left the health system to pursure other opportunities in healthcare.

Richardville announced Tuesday night on LinkedIn that “it was the right time to find the next challenge."

“These are exciting times for all of us in healthcare IT,” he wrote in his social media post. “I want to thank the many partners who work in this space that are so valuable to the successes we've had but mostly to the people, the caregivers who commit and contribute to the mission each and every day.”

Richardville was a familiar presence on social media and at innovation conferences and a strong supporter of digital health innovation.

Craig Richardville.

He joined Intermountain as its Chief Digital and Information Officer in 2022, after more than three years as SVP and Chief Digital and Information Officer at Denver-based SCL Health (which merged with Intermountain). Prior to that, he’d been CIO and chief analytics officer at Atrium Health in North Carolina for more than 20 years and vice president of information services at ProMedica for 11 years. His many honors include the 2015 John E. Gall Jr. National CIO of the Year Award, from HIMSS and CHIME; the 2021 National CIO of the Year Healthcare ORBIE Award, the 2020 Colorado CIO of the Year Award, and the 2017 Carolinas CIO of the Year Award.

Richardville had a busy tenure at Intermountain, and listed several accomplishments on his social media post, including consolidating nine EHR platforms across the enterprise into one Epic platform; helping the health system develop and launch several AI programs; developing digital health programs to improve patient care; transitioning the health system’s Microsoft and Google cloud environments into one Microsoft Azure platform; and transitioning multiple ETP systems into one with Workday.

[Also read: Intermountain Health adds AI, Interoperability to CDS Platform.]

Richardville took part in a HealthLeaders Healthcare Workforce of the Future forum in 2022, shortly after joining Intermountain. During that roundtable he spoke of the challenges of keeping a talented workforce together and his pride in developing staff who could move on to bigger roles.

"I've got 12 CIOs or CDOs in the industry that used to work for me, and I'm just privileged that those people have grown," he said. "It's really [about saying] 'I'll give you the challenge, I'll grow your résumé, I'll make you more valuable to the market, and if I'm able to keep you I'll just continue that. But if there are other opportunities somewhere else, I'm here to help you capture those as well so you can fulfill your life goals.'"

He was also a familiar presence at innovation events like ViVE. At last year’s conference in Nashville, he spoke of the collaborative nature of healthcare innovation at a time when health systems and hospitals were struggling to be competitive.

"I might see something really interesting and tell (another healthcare executive) about it, or someone will tell me, 'You should check this company out,'" he said. "It's the chance to meet up and talk with people."

He also signed on this past March to support the Match IT Act of 2024, a bill now before Congress that would create a federal definition of ‘patient match rate’ that providers would address as they would a clinical quality measurement.

“[T]his legislation will address our nation’s current inability to consistently and accurately identify patients to their health records,” he said in a press release. “Improved standardization of patient demographic data will lead to more accurate patient matching, which in turn will produce advances in patient safety, more complete information for clinical care, and cost savings from reducing the need for repeated medical care, among other benefits.”

The proposed Physician Fee Schedule includes, among other things, Medicare coverage for care management using telehealth and digital health tools, as well as coverage for some digital therapeutics devices used in behavioral health treatment

Healthcare providers will have more opportunities to receive Medicare reimbursements for digital health and virtual care programs under the Centers for Medicare & Medicaid Services’ proposed 2025 Medicare Physician Fee Schedule.

In what is roundly considered a positive step forward for healthcare innovation, CMS is showing support for care management programs that embrace new technologies and strategies to meet patients where they are, rather than paying providers to entice them into the doctor’s office or hospital.

Advance Primary Care Management Codes

Perhaps most surprising to analysts is CMS’ efforts to incorporate virtual care into primary care to push the healthcare industry toward value-based care. CMS is proposing three new “Advanced Primary Care Management” HCPCS codes that focus on interactions with patients at the time and place of their choosing.

In a blog post, Carrie Nixon and Kaitlin O’Connor of Nixon Gwilt Law say the new codes are not based on time spent with a patient, but focus on specific activities by clinicians and using technology to address patient needs.

“The Advanced Primary Care Management (or APCM) HCPCS codes bundle elements of the existing Chronic Care Management (CCM) and Principal Care Management (PCM) codes set with Communications Technology-Based Services (CTBS) codes for virtual check-ins, remote evaluation of images, e-visits, and interprofessional consults to create what CMS refers to as an “enhanced care management” bundle,” they wrote. “Unlike CCM and PCM services, the APCM codes are not time-based – meaning, care management services that do not meet the 20 or 30-minute requirements for CCM or PCM would be billable under APCM.”

Nixon and O’Connor also noted that CMS is expanding the rule to allow non-physician care providers, such as nurse practitioners and physician assistants, to order and bill for those services, as long as any practitioner who bills for those services “Intends to be responsible for the patient’s primary care and is the continuing focal point for all needed healthcare services.”

The three new codes are:

• GPCM1: Advanced primary care management services provided by clinical staff and directed by a physician or other qualified health care professional who is responsible for all primary care and serves as the continuing focal point for all needed health care services, per calendar month. Approximate reimbursement is $10 per patient per month.
• GPCM2: Advanced primary care management services for a patient with multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, which place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, provided by clinical staff and directed by a physician or other qualified health care professional who is responsible for all primary care and serves as the continuing focal point for all needed health care services, per calendar month, with the elements included in GPCM1, as appropriate. Approximate reimbursement is $50 per patient per month.
• GPCM3: Advanced primary care management services for a patient that is a Qualified Medicare Beneficiary with multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, which place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, provided by clinical staff and directed by a physician or other qualified health care professional who is responsible for all primary care and serves as the continuing focal point for all needed health care services, per calendar month, with the elements included in GPCM1, as appropriate. Approximate reimbursement is $110 per patient per month.

Telehealth Flexibilities

In other news, CMS is proposing to continue a Medicare waiver through 2025 that enables providers to bill for telehealth services delivered from their homes while using their practice location for billing purposes.

More than 100 healthcare organizations had lobbied CMS to continue that waiver or even make it permanent, saying it reduces stress and burnout and enables clinicians to design virtual care programs that are more flexible to their lifestyles and that don’t need costly and complex on-site telehealth centers.

Separately, CMS did not create any new CPT codes for telehealth services that duplicate existing telehealth-eligible services covered by Medicare. The Alliance for Connected Care praised that decision, saying, “We believe that telehealth is a modality for providing health care, it is not a different service.

Digital Therapeutics Coverage

Also, the proposed 2025 PFS is showing some love for the digital therapeutics sector, with reimbursement for some behavioral health treatments that use FDA-approved devices. Specifically, the proposed rules offer reimbursement for the first 20 minutes, and then for an additional 20 minutes, of treatment using a “digital mental health treatment” (DMHT) device.

The new codes are:

• GMBT1 (Supply of digital mental health treatment device and initial education and onboarding, per course of treatment that augments a behavioral therapy plan). CMS is proposing contractor pricing for GMBT1 and seeking comments on which national pricing methodologies may be considered, including crosswalks. 
• GMBT2 (First 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the digital mental health treatment (DMHT). CMS proposes a direct crosswalk to CPT code 98980 (RTM first 20 minutes), that is assigned a work RVU of .62 and has a 2024 National Payment Amount of $50.60 (non-facility) and $30.29 (facility). 
• GMBT3 (Each additional 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the digital mental health treatment (DMHT). CMS proposes a crosswalk to CPT code 98981 (RTM each additional 20 minutes), that is assigned a work RVU of .61 and has a 2024 National Payment Amount of $39.95 (non-facility) and $29.96 (facility). 

In an e-mail, the Digital Therapeutic Alliance hailed the proposal as “the first acknowledgement of a pathway for reimbursement for a certain sector of digital therapeutic interventions,” and said they set “a precedent for Medicare coding, coverage, and reimbursement that can be applied to additional therapeutic categories.”

According to Nixon and O’Connor, DMHT devices, also known as digital CBT devices, “refer to software devices cleared by [FDA] that are intended to treat or alleviate a mental health condition, in conjunction with ongoing behavioral healthcare treatment under a behavioral health treatment plan of care, by generating and delivering a mental health treatment intervention that has a demonstrable positive therapeutic impact on a patient’s health.”  

One issue with the proposed rule, Nixon and O’Connor say, is the language used to define what devices will be covered. Because it requires only that the software meet the FDA’s definition of a device but doesn’t specifically state that a device be FDA-cleared, the rule could disqualify and device that is subject to FDA enforcement discretion or exempt from FDA pre-market clearance.

Clearing Up Coding for FQHCs and RHCs

The proposed 2025 PFS didn’t offer any good news for federally qualified health centers (FQHCs) or rural health centers (RHCs), which have been lobbying for increased use of and reimbursement for telehealth and digital health services for years. In the proposed rule, CMS is eliminating HCPCS G0511, under which FQHCs could bill for remote physiological monitoring and remote therapeutic monitoring services, and telling FQHCs and RHCs to bill under existing CPT codes for care management (including the proposed APCM codes).

The change is designed to clear up reported confusion over what services could be billed under HCPCS G0511, but Nixon and O’Connor noted that it could mean less reimbursements for FQHCs and RHCs.

Other Proposals

Finally, the proposed 2025 PFS includes the following:

• Permanent coverage of two-way, real-time, audio-only telehealth services, such as the telephone, “for any telehealth service furnished to a beneficiary in their home if the distant site physician or practitioner is technically capable of using an interactive telecommunications system but the patient is not capable of, or does not consent to, the use of video technology.” This would enable providers to expand treatment services in rural and remote areas where broadband is limited, as well as for patients who can’t access audio-video telemedicine.
• Reimbursement for audio-only telehealth services for periodic assessment of patients undergoing substance abuse disorder (SUD) treatment when video is not available.
• Reimbursement for audio-only telehealth services used in initial intake for SUD patients seeking methadone treatment when video is not available.
• Extending the definition of “direct supervision” to include access by audio-video telemedicine, rather than requiring everyone to be in the same room. CMS is also proposing to add audio-visual telemedicine access to a permanent definition of direct supervision.
• Coverage for remote supervision (such as telehealth) of physical therapists and occupational therapists over PT assistants and OT assistants as permitted by state laws. This would open the door to more telehealth therapy services.
• A continuation of the policy to “allow teaching physicians to have a virtual presence for purposes of billing for services furnished involving residents in all teaching settings, but only in clinical instances when the service is furnished virtually (for example, a three-way telehealth visit, with the patient, resident, and teaching physician all parties in separate locations) through December 31, 2025.”

CMS will accept public comments on the proposed 2025 PFS through September 9.

The OrganOx replicates conditions inside the human body to keep livers viable during the journey from the donor to the recipient.

New technology is helping healthcare organizations improve transplants by preserving the organ during its journey from the donor to the recipient.

One such innovation is the OrganOx, a portable “pump” now being used by Intermountain Health for liver transplants. Officials say the technology, which has been used in more than 35 liver transplants since December 2023, could save hundreds of lives and improve the quality of life for thousands of people.

“This is potentially life-changing for the thousands of patients on the national waiting list for a liver transplant, and the more than a thousand patients a year who die waiting for a liver to become available,” Richard Gilroy, MD, a transplant hepatologist and Intermountain Health’s liver transplant medical director, said in a recent press release from the Utah-based health system. “Because of this technology we are able to use livers from donors that would previously not even have been considered for donation.”

The OrganOx includes a pump that functions as the heart and an oxygenator that functions as the lungs. When a human liver is placed inside the device, they combine to function as a human body would, keeping the liver oxygenated and maintained at normal body temperature until it can be transplanted.  

[Also read: Can ECMO Help Rural Hospitals Save More Lives?]

“This technology allows the donor liver to remain viable for longer periods of time, extending the time from organ removal to transplant from just hours to more than one day, and potentially travel longer distances between donor and recipient sites,” Jean Botha, MD, the medical director of Intermountain Health’s abdominal transplant program as well as Intermountain Primary Children’s Hospital’s pediatric transplant program, said in the press release. “The device also enables real-time assessment of liver function and quality, which may help to increase the pool of suitable organs for transplantation.”

The OrganOx is one of several devices and platforms developed over the past few years to improve transplants. Some aim to preserve organs longer outside the body, while others are using data analysis tech technology, including AI, to match donors faster and more efficiently with those in need of new organs.

The technology aims to improve clinical outcomes for the estimated 10,000 organ transplants performed each year and improve chances for the estimated 10,000 people on the waiting list for a new organ. According to experts, 17 people die each day on a waiting list, and a new name is added to a waiting list every 10 minutes. With livers in particular, it’s estimated that more than 2,000 are discarded each year because they don’t survive the typical process of cold preservation or are damaged by oxygen deprivation.

The strategy does come with some controversy. The process of keeping organs alive outside the donor’s body is called a normothermic regional perfusion, or an NRP transplant. When a device like the OrganOx is used, the process is called normothermic machine perfusion, or NMP. A recent NPR story shed light on the debate, highlighted by the American Journal of Bioethics, over whether the process keeps the body technically alive and blurs the definition of death.

In an e-mail to HealthLeaders, Botha said both NRP and NMP are saving lives.

“Actually, the two modalities are not in competition with each other but rather complimentary,” he wrote. “NRP is our preferred modality for all DCD (Donation after Circulatory Death) donors, in addition to increasing the utilization of DCD organs (livers and kidneys), it improves the outcomes of both.”

According to Botha, recent research comparing NMP to the traditional method of cold storage on a hypothetical cohort of 432 patients found that NMP allowed 54 additional successful transplants and saved hundreds of additional lives through the availability of more liver grafts and a reduction in waitlist mortality.  This also improved the quality of life for liver transplant recipients.

Intermountain has done more than 1,000 liver transplants--including living-related, deceased donor, and split implantation--since launching its liver transplant program in 1986. Officials say the program has grown threefold since its launch, making it the third fastest-growing liver transplant program in the country.

Botha says the OrganOx is currently kept at Intermountain Medical Center in Murray, Utah, though it’s portable enough to be deployed from the donor’s operating room table to nearby transplant centers. The company is now putting a similar device through trials for kidney perfusion.