MedRhythms, Inc.

The Centers for Medicare and Medicaid Services (CMS) assigned a new, unique Health Care Common Procedure Coding System (HCPCS) code to InTandem under Medicare's Durable Medical Equipment (DME) Benefit category E3200, as the new code, will go into effect on October 1, 2024 InTandem is indicated to improve walking and ambulation in chronic stroke and is intended to be used in the home for the physical rehabilitation of ambulatory adults. PORTLAND, Maine, Aug. 22, 2024 /PRNewswire/ -- MedRhythms, Inc. today announced that the Centers for Medicare and Medicaid Services (CMS) established a new reimbursement code for the company's flagship product, InTandem, the only clinically validated, prescription medical device that delivers rhythmic auditory stimulation (RAS) in the home to improve walking and ambulation in chronic stroke patients. Continue Reading InTandem(R) includes shoe-worn sensors, a headset, and a touchscreen control unit. In its final determination, CMS established a new HCPCS code to describe InTandem: E3200 (gait modulation system, rhythmic auditory stimulation, including restricted therapy software, all components and accessories, prescription only). CMS also determined that InTandem qualified under Medicare's durable medical equipment (DME) benefit category based on InTandem's durability and indication for home use. The CMS decision to issue a new code for InTandem underscores recognition of this significant unmet need in chronic stroke. A consistent barrier for patients with chronic stroke is a lack of access to rehabilitation once they have returned to the home. "As a clinician, I'm far too familiar with the challenges stroke patients face in accessing treatment, particularly in the chronic phase of stroke recovery," said Brian Harris, MedRhythms' Co-Founder and CEO. "The establishment of this HCPCS code offers new hope to chronic stroke patients who are battling walking deficits, and advances MedRhythms mission to bring effective care to patients who need and deserve to have access to it." InTandem delivers individualized, progressive RAS therapy in the home setting, producing gait quality and speed improvements to drive improved health outcomes and reduce the risk of adverse health events common in post-stroke patients. By leveraging wearable, clinical-grade gait sensors and a hardware control unit containing adaptive algorithms and clinically optimized music, InTandem automates the key principles of effective RAS therapy, in combination with best practices for neurorehabilitation interventions: individualization, progression, and challenge. InTandem's unique integration of advanced hardware, software, and best clinical practices enables patients to access this evidence-based intervention independently at home. "InTandem's personalized approach, grounded in the neuroscience of RAS and neuroplasticity, positions InTandem as an effective clinical intervention for chronic stroke patients seeking to improve their walking ability and overall mobility," said Dr. Alexander Pantelyat, Associate Professor of Neurology at the Johns Hopkins University School of Medicine. Jennifer Lavanture, MedRhythms' VP of Business Development and Corporate Strategy, continued: "These CMS decisions are crucial developments in the path to provide access to this groundbreaking treatment to patients. MedRhythms commends CMS for their thoughtful consideration, and we greatly appreciate the time and efforts of the many patients, clinicians, and stakeholders who provided input and support throughout this process." The new code for InTandem will become effective October 1, 2024. InTandem, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2020 and was listed as a Class II medical device in July 2023, is designed to be used by people with chronic stroke gait impairment. Results of a multi-site randomized controlled trial that demonstrated the clinical benefits and safety of InTandem were published in Nature Communications earlier this year. InTandem Indication and Intended Use InTandem is indicated to improve walking and ambulation in chronic stroke, and is intended to be used in the home for the physical rehabilitation of ambulatory adults. For full prescriber information, including important safety information and Instructions for Use (IFU) visit: . About MedRhythms MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music with advanced neuroscience to target neural circuitry. The company is developing a pipeline of products across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease. In 2021, the company partnered with Universal Music Group and raised a Series B financing round led by Morningside Ventures and Advantage Capital. MedRhythms is headquartered in Portland, Maine. For more information, visit . MedRhythms and InTandem are trademarks of MedRhythms, Inc. Forward-Looking Statements THIS MANAGEMENT COMMENTARY CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO THE COMPANY THAT ARE BASED ON INFORMATION AVAILABLE TO US AS OF THE DATE HEREOF. STATEMENTS THAT ARE NOT HISTORICAL FACTS, INCLUDING STATEMENTS ABOUT THE COMPANY'S BELIEFS, DESIGNS, ANTICIPATION, AIMS, GOALS, EXPECTATIONS AND POTENTIAL RESULTS ARE FORWARD-LOOKING STATEMENTS. IN ADDITION, THE WORDS "WILL," "MAY," "BELIEVE," "ANTICIPATE," "INTEND," "ESTIMATE," "EXPECT," "PROJECT," "PLAN," "SHOULD," "COULD," AND SIMILAR EXPRESSIONS, AND THEIR VARIATIONS AND NEGATIVES, AS THEY RELATE TO THE COMPANY OR THE FUTURE PERFORMANCE OF THE COMPANY, ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. SUCH FORWARD LOOKING STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES, ASSUMPTIONS AND OTHER IMPORTANT FACTORS THAT COULD CAUSE THE COMPANY'S ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF RESULTS TO DIFFER MATERIALLY FROM ANY FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY SUCH FORWARD LOOKING STATEMENTS. THIS MANAGEMENT COMMENTARY SPEAKS ONLY AS OF THE DATE HEREOF AND THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO UPDATE THIS COMMENTARY IN THE FUTURE. CONTACT [email protected] SOURCE MedRhythms

At day two of the Digital Therapeutics Alliance's annual conference in Washington, D.C., attendees collaborated on a flow chart describing the industry. During Day 2 of the Digital Therapeutics Alliance's annual conference in Washington, D.C., industry stakeholders addressed the reality of the digital therapeutics market and offered advice to DTx companies looking to be acquired, find revenue streams and contract with health plans.  Here are three takeaways:  Stakeholders expect mergers and acquisitions of digital therapeutics companies to pick up in the fall and say the market is ripe with opportunity, though it might seem down and out. Companies are finding creative ways to create revenue by working with established players like the Department of Veterans Affairs and school systems.  Health plans are in "a sea of opportunity" with digital health — and that's not necessarily a good thing. M&A in digital therapeutics Industry stakeholders expect mergers and acquisitions in the digital therapeutics market to pick up in the second half of 2024.  Omar Manejwala, chief medical officer at DarioHealth, and Susa Monacelli, general manager at Propeller Health/ResMed, said though the DTx market may look slightly down and out after the hardships of the last two years, the time is ripe for companies to make moves in M&A and hire new personnel.  Wayne Janke, senior associate at Arnold & Porter, said their clients have been assessing companies to begin acquisitions in the coming months. “I think there's a lot of activity in the private market, market scanning, that's going on on our end, and we've had a pretty steady flow, like I said earlier, in terms of doing acquisitions,” Monacelli said. “I would not be surprised if (M&A) starts to pick up in the third and fourth quarter, not just for us as a company, but for others as well.” Monacelli said she has noticed a strategic shift for DTx companies that have traditionally focused on DME to build out capabilities to access other channels like direct-to-payer contracting opportunities and direct-to health system relationships.   “First of all, this is a precious moment,” Manejwala said. “I know people have been looking at this as (a hard time for the industry) …  In my view, it's the opposite. These were the kinds of moments that Google was born in, that Amazon was born in. If you look at the charts, this is the time properties are on sale. There's amazing talent that's floating out there. I mean, I think if you wait when things are running high then you're missing the opportunity.”  The experienced panel resoundingly said that the most important aspect of successful M&A is the ability for personnel to work well together. There should also be similarities in business models, goals or priorities.  If looking for an acquisition deal, Monacelli said founders should be proactive in reaching out to executives of companies they think their business would work well with.  Revenue pathways for digital therapeutics As digital therapeutics is still an emerging market, companies are finding creative ways to create revenue, while reimbursement for digital therapeutics as a standalone category remains elusive from the Centers for Medicare and Medicaid Services (CMS) and other national payers.  The three companies represented on the panel – MedRhythms, Floreo and JOGO Health – all had different revenue streams, but a key similarity between them was working within established networks: the Department of Veterans Affairs, school systems and health systems.  Owen McCarthy, CEO and co-founder of MedRhythms, said the company decided to work within the construct of durable medical equipment, which has an established regulatory pathway through the Food and Drug Administration (FDA) and CMS. It has been approved as DME and works with DME suppliers in states for distribution.  MedRhythms has also found the Department of Veterans Affairs to be a partner open to innovations in medical treatment. It has contracted with the VA to offer its products.  McCarthy also advised that breaking into the direct-to-consumer space is not as costly as executives may believe. He said companies could also take the route of using a miscellaneous code with payers in the process to create a unique code for the product.  Siva Nadarajah, president of JOGO Health, said JOGO’s revenue strategy was to become a brick-and-mortar healthcare provider. JOGO partners with established health systems like Mayo Clinic and Mount Sinai who refer their patients to the DTx provider for treatment. Nadarajah said the service industry is profitable. He shared that within 18 months of being stood up, the clinics had generated $1 million. Because of the success the company had with its clinics, Nadarajah said health systems gained interest in licensing the technology to use themselves. Licensing can generate much higher revenues, he said.  Nadarajah advised that DTx companies partner with regional patient advocacy groups to build trust and buy-in with the product. April Marrone, advisor to the FDA’s Total Product Lifecycle Advisory Program, helps medical devices with FDA Breakthrough status achieve successful commercialization. Marrone suggested that DTx companies consider pathways to payment as they develop their regulatory strategy and the level of evidence needed for each pathway. Vijay Ravindran, CEO of Floreo, said the company has tapped into an established market by doing equipment rentals to autism therapy clinics and licensing the product to school systems. Both have helped the company obtain a firm grasp on revenue within the uncertain DTx market.  Collaboration with health plans Health plans are in "a sea of opportunity" with digital health — and that's not necessarily a good thing. Meg Barron, managing director of engagement and outreach at the Peterson Health Technology Institute, says plans are dealing with an overwhelming landscape of digital health products. Most want to get down to brass tacks and find out if a given digital health solution will actually work for them and their members compared to the status quo of care. PHTI’s goal as an independent assessor of digital health technologies is to help stakeholders cut through the noise of the digital health industry and help proven products scale faster.  Monica Frederick, senior vice president of strategic accounts at Freespira, says companies need to fit into the processes of health plans.  When Freespira goes to pitch a health plan, it comes armed with a rigorous implementation plan so the payer can easily see how the therapy could be rolled out across their membership. Frederick says DTx companies have to be ready to do the heavy lifting of implementation.  They also must look at the health plan as a partner. Freespira always comes armed with co-branded marketing materials and works with the health plan to tailor outreach to their members, Frederick noted. Moreover, Frederick said digital therapeutics companies have to understand the risk and responsibility the plans are taking on when they implement a new product. The plan member will look to the plan if something goes wrong with the device, she said, not the DTx company. Cody Midlam, director at Willis Towers Watson's healthcare practice, says plans want to contract with technology vendors that can offer better care to their patients. Employer-sponsored health plans aim to improve the health of their employees, he said, and drive employee retention. Even if implementing a digital therapeutic would increase costs for the plan, it could still be worth it if, for example, the therapy was meeting an unmet need for members.  Midlam said employers are focused on three major health concerns — obesity, oncology and autoimmune conditions. Many employers want to keep the costs of GLP-1s to a minimum and thus prefer products that offer tech wraparound services along with the drugs. Midlam said he thinks there’s opportunities for clinical innovation in oncology and immunology.  He continued saying one of the most important things for a digital therapeutics company to do is plug their solution into the messiness of the healthcare system in a way that does not make operations more difficult.  Shirley Moncada, director of program management at Kaiser Permanente, said DTx companies need to include subject matter experts in their conversations with health plans. When in conversation with a health plan, DTx companies also need to think about how they are increasing the quality of care, how they will implement their solution and how they will bring down overall costs for providers and payers. Companies should also think about how they will support health plans if problems arise with their software.  Jonathan Schremp, director of digital health engagement at Banner Health, explained that the company often looks for solutions in the areas where it has the most claims. He said the company might hold a meeting to discuss the conditions with the highest claims volume in the last month and may look for digital solutions in that area. He also said Banner’s uptake of new solutions depends on the year and the health system's financial margins at that time.  Patients trust their providers first and foremost in their clinical care, Schremp noted, so having a provider recommend the product to the patient is the best way to gain adoption. He also pointed out the discrepancy between physicians’ priorities to “do no harm” and tech’s tendency to “go fast and break things.” DTx companies need to thread that needle, he said.

WEDNESDAY, Jan. 17, 2024 -- The Montreal Cognitive Assessment (MoCA) cutpoints for identifying mild cognitive impairment (MCI) or dementia are inappropriately high in a diverse community setting, yielding a high false-positive rate, according to a study published online Jan. 10 in the Journal of the American Geriatrics Society . Marnina B. Stimmel, Ph.D., from Albert Einstein College of Medicine in New York City, and colleagues examined the utility and discriminative validity of the Spanish and English MoCA versions to identify cognitive impairment among diverse community-dwelling older adults. The analysis included 231 older adults (aged 65 years and older; 43 percent Hispanic and 39 percent Black/African American) with cognitive concerns attending outpatient primary care. The researchers found that neuropsychological assessment identified 90 participants as cognitively normal with subjective cognitive concerns (average MoCA, 19.9), 133 with MCI (average MoCA, 16.6), and eight with dementia (average MoCA, 10.6). The mean English MoCA average was 18.6 versus 16.7 for Spanish. There was a high false-positive rate using the published cutpoint ≤23 for MCI (79 percent). Using the English MoCA, ≤18.5 was identified as the score to identify MCI or dementia (65 percent sensitivity; 77 percent specificity) and ≤16.5 for the Spanish MoCA (64 percent sensitivity; 73 percent specificity). "Lower Spanish and English MoCA cutpoints may improve diagnostic accuracy for identifying cognitive impairment in this group, highlighting the need for the creation and validation of accurate cognitive screeners for ethnoculturally and linguistically diverse older adults," the authors write. One author disclosed ties to MedRhythms. Abstract/Full Text (subscription or payment may be required) Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.