In brief: RemSleep milestone, Medtrade ‘surge’ 

TAMPA, Fla. – RemSleep has successfully passed testing protocol for 510K clearance of its DeltaWave CPAP mask, including cytotoxity and MLA tests, which were the subject of past issues requiring retesting. The company now expects submit for 510k clearance with the U.S. Food and Drug Administration before the end of September. "This is a substantial and critical milestone for RemSleep and the DeltaWave mask,” said CEO Tom Wood. “It has taken significantly longer to get to this point than we had ever envisioned due to the unforeseen delays and administration issues, but in the end, the successful results demonstrate what we have confidently stated and believed from the start: The DeltaWave mask, and the materials used in the manufacture of the mask, are safe.” RemSleep, which also makes a CPAP device called ResPlus, says it continues to reach out to distributors and channel partners for DeltaWave’s eventual launch. The company says it will apply lessons learned to its next generation of masks. “While this has been a tough learning curve, we expect to be able to employ the knowledge gained to move our next generation masks through the clearance process and into the market significantly faster and with less expense,” Wood said. 

Price substitution policy works, OIG says 

WASHINGTON – Medicare and its enrollees have saved $73.4 million since 2013, because of CMS’s price substitution policy for Part B covered drugs, according to an August issue brief from the Office of Inspector General. They could have realized an additional $889,000 in savings in 2021, if CMS expanded the price-substitution criteria, the OIG says. When Congress established average sales prices (ASPs) as the basis for reimbursement for Medicare Part B drugs, it also provided a mechanism for monitoring market prices and limiting potentially excessive payment amounts. The Social Security Act mandates that the OIG compare ASPs with average manufacturer prices (AMPs), and if the OIG finds that the ASP for a drug exceeds the AMP by 5%, the act directs the secretary of Health and Human Services to substitute the ASP-based payment amount with a lower calculated rate. CMS makes this substitution only if the ASP for a drug exceeds the AMP by 5% in the two previous consecutive quarters or three of the previous four quarters. The issue brief is one in a series of annual reports— produced since CMS implemented the price-substitution policy in 2013—that quantifies the savings to Medicare and its beneficiaries that result from CMS’s price-substitution policy. 

NCART update: Awareness Week turnout, new supplier member 

WASHINGTON – National CRT Awareness Week Aug. 14-18 saw more than 120 organizations and hundreds of individuals share stories, write articles, post videos, hold webinars and create new resources for advocacy, according to NCART. “The week accomplished exactly what we set out to do, which was develop a better understanding of complex rehab technology, the people who use it, how it’s prescribed and provided, and why access is so important,” the organization stated in a bulletin. “Even though CRT Awareness Week has come to an end, advocacy work to protect CRT will continue throughout the rest of the year. Stay tuned for other ways to get involved and to be active advocate for CRT.” NCART also plans a Virtual Congressional Fly-In on Sept. 13…HCH Medical has joined NCART as a supplier member, the organization has announced. HCH Medical serves the complex rehab community in Tennessee. 

Medtrade sees ‘surge’ 

DALLAS – Medtrade says it has seen a “surge” in first-time and returning exhibitors. Recent exhibitors that have signed up for the show include Contour Products of Charlotte, N.C.; Philips of Amsterdam; EZ Access of Auburn, Wash.; Modus Direct of Sarasota, Fla.; and Cleanwaste Medical of Oceanside, Calif. “Contour Products is set to unveil a range of groundbreaking products, designed to enrich patient lives, but also to empower HME stores in generating increased cash revenue—thus mitigating the impact of reduced insurance reimbursements,” said Kathy Davis, medical sales manager, Contour Products. “Setting these products apart is the extensive reach of our national TV advertising. These products are consumer-tested, ensuring that HME stores can tap into a wider customer base, which drives more foot traffic and sales.” Medtrade takes place March 26-28 at the Kay Bailey Hutchinson Convention Center in Dallas.