NEWTOWN, Pennsylvania—Helius Medical Technologies, Inc., a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, announced its Portable Neuromodulation Stimulator (PoNS) device has been awarded durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) accreditation by The Compliance Team (TCT), which is authorized by the Centers for Medicare & Medicaid Services (CMS) to accredit all DMEPOS products and services. The accreditation certifies that Helius has established processes that conform to TCT’s Exemplary Provider DMEPOS Quality Standards.
“We are thrilled that PoNS has been awarded DMEPOS accreditation," said Dane Andreeff, Helius president and chief executive officer. "Not only does the certification underscore our commitment to quality and patient care, but it is also a crucial part of our U.S. reimbursement strategy. Organizations that wish to bill Medicare must have accreditation from an approved agency and it’s become a standard with other funding sources as well."
“DMEPOS accreditation has particular relevance under the proposed Transitional Coverage for Emerging Technologies (TCET) legislation," said Andreeff. "If passed as currently proposed, companies with a breakthrough designation could be covered by Medicare for up to four years, allowing time to gather the necessary clinical data to prove the efficacy of their products. PoNS has breakthrough designations in both multiple sclerosis and stroke in the U.S. and this certification establishes that Helius is an Exemplary Provider and our PoNS device has already met and exceeded CMS quality standards."
TCT is a nationally recognized health care accreditation organization that provides comprehensive accreditation and certification services to healthcare providers in all 50 states. TCT’s proprietary accreditation status is known as Exemplary Provider Accreditation and its industry-leading accreditation model features health care’s first comprehensive set of plain language, operations-driven quality standards with expert-led implementation guidance.