In brief: Philips pauses remediation, lymphedema bill passes, AAH comments on CGMs

AMSTERDAM – Philips has temporarily paused its remediation program for its Trilogy 100/200 ventilators while it investigates a limited number of complaints on remediated units. 

“We anticipate a several week delay from our initial four- to six-week timeline in providing remediated devices back to our customers,” the company stated in a Nov. 7 update. “Remediating these devices in a timely manner is our top priority. In order to keep remediation progressing once our investigation is complete, please continue to return product that is currently not in use.” 

The U.S. Food and Drug Administration then announced on Nov. 17 that it had informed Philips that the Trilogy 100/200 vents that have been reworked as part of a June 2021 recall have two potential issues: 

The new silicone sound abatement foam, installed to replace the polyester-based polyurethane (PE-PUR) foam, may potentially separate from the plastic backing and could impact the performance of the device by potentially blocking the air inlet and thus lowering the inspiratory pressure. If the air pressure is significantly impacted, the device could issue a ventilator alarm. 

Trace amounts of particulate matter have been found in the air pathway of some reworked ventilators. Particulate samples were sent to a third-party lab for evaluation. Preliminary results show PE-PUR and environmental debris in some samples, and only environmental debris in others. 

The FDA has requested additional information from Philips to better understand the cause of the issues and to provide informed recommendations to patients, caregivers and health care professionals. 

Once remediation resumes, the company points customers to its “Trilogy remediation step-by-step guide.” 

Philips announced in June that it had begun remediating affected Trilogy 100/200 devices at its service centers. 

Lymphedema bill passes House 

WASHINGTON – The U.S. House of Representatives has passed the Lymphedema Treatment Act 402-13 in another step toward the bill becoming law. 

H.R. 3630, introduced by Rep. Jan Schakowsky, D-Ill., would require Medicare to pay for compression garments, bandages and supplies to reduce lymphedema-related swelling and prevent recurrence. 

“It’s unacceptable that Medicare does not cover the cost of compression garments for seniors dealing with lymphedema,” stated the chairman of the Energy and Commerce Committee, Rep. Frank Pallone, D-N.J., and the chairwoman of the Health Subcommittee, Rep. Anna G. Eshoo, D-Calif., in response to the vote. “The Lymphedema Treatment Act will close this unintended gap in coverage that prevents beneficiaries from accessing medically necessary, prescribed compression garments.  We’re grateful to members for working together to advance this bipartisan bill and will continue to work hard to see it signed into law.”  

A similar bill in the Senate, S. 1315, introduced by Sens. Maria Cantwell, D-Wash., and Chuck Grassley, R-Iowa, currently has 74 co-sponsors. 

For more information on the Lymphedema Treatment Act, go to: https://lymphedematreatmentact.org/. 

Invacare names Purtill president, CEO 

ELYRIA, Ohio – Invacare's board of directors has named Geoffrey Purtill president and CEO, roles he has served on an interim basis since Aug. 28. 

“The board determined that Geoff is the right steward of the company as it undergoes significant transformation and embarks on a new chapter,” said Michael Merriman, Jr., non-executive chairman of the board. “Notably, Geoff and the leadership team have already acted decisively by discontinuing respiratory products and repositioning the business and resources around our core categories of Lifestyle and Mobility & Seating, which are anticipated to drive profitable growth. The board looks forward to partnering with Geoff as we continue to take decisive action to improve our financial performance and enhance shareholder value.” 

Previously, Purtill served as the senior vice president and general manager, EMEA and APAC, since December 2021 and vice president, Global Strategy, and general manager, Asia Pacific, since September 2021. Previously, he served for 11 years as the company's vice president and general manager, Asia Pacific region. 

Prior to joining Invacare, Purtill held various sales, category management and supply chain leadership roles at Johnson & Johnson and Nestle. 

Read a Q&A with Purtill that appeared in HME News in September, following his appointment as interim president and CEO. 

Read a story about Invacare’s decision to exit the respiratory market. 

AAH responds to proposed LCD for CGMs 

WASHINGTON – AAHomecare strongly supported CMS’s proposed local coverage determination for continuous glucose monitors in recent submitted comments. The proposed LCD would, among other things, remove the requirement for multiple administration of insulin and frequent self-adjustments, and allow for telehealth visits in place of in-person visits. The association, however, has concerns about the ability of DMEPOS providers to collect documentation from prescriber medical records that’s as detailed as the proposed criteria appear to require. It provided specific recommendations on crafting more realistic documentation requirements, including limiting them to level 2 or level 3 hypoglycemic events, as appropriate. The association also recommends that CMS implement the LCD before the end of the public health emergency.  

VGM hosts state leaders 

WATERLOO, Iowa – VGM Government Relations hosted the leaders of state and regional HME associations at its headquarters here last week. Leaders discussed their priorities for 2023, as well as how to improve their associations. Also part of the meeting: a conference call with Tangita Daramola, CMS’s competitive acquisition ombudsman, and John Hannigan, CMS regional administrator, as well as representatives from regional offices. Each leader was given a few minutes to introduce themselves and discuss the concerns of their members. Another topic of discussion was the need for reimbursement relief to be included in end-of-year legislation. The industry has an active bill in the House of Representatives, H.R. 6641, which would extend a 90/10 blended reimbursement rate that’s currently in place for competitive bidding items in competitive bidding areas. 

‘A big, big day’ at Pride, Quantum 

DURYEA, Pa. – Pride Mobility and Quantum Rehab held an open house at the company’s new world headquarters in Duryea, Pa., on Oct. 21. Guests from the community, vendors, suppliers, company brand ambassadors and employees gathered in the two-story cafeteria of the newly renovated facility to enjoy a delicious meal and watch as Scott Meuser, CEO and chairman, performed the ribbon cutting ceremony. “It’s the first time the Pride and Quantum team in Pennsylvania has been under one roof, in 30 years, so it’s a big, big day for us,” Meuser said. “I’m just happy we have a home that is worthy of our employees.” The headquarters is situated on 48 acres and features a 400,000-square-foot corporate office in Duryea, Pa., and a 100,000-square-foot distribution center in Old Forge, Pa. It’s also accessible, featuring accessible parking, automatic doors, wide corridors and height adjustable desks. 

RESNA announces dates, location for annual conference 

ARLINGTON, Va. – RESNA has announced that its annual conference will take place July 24-26 at the New Orleans Marriott. The event, which has the theme “Move to the BeAT of Innovation,” will feature two and a half days of education, networking, product demos, scientific paper platforms, student competitions and roundtables. Registration for the event will open in February. Listen to a full announcement with RESNA President Carmen DiGiovine here. 

Carter joins VGM to head up new CPAP program 

WATERLOO, Iowa – John Carter has joined VGM & Associates as the vice president of sleep and respiratory compliance services. In his new role, Carter, a respiratory therapist with more than 25 years of experience in the HME industry, will focus on creating and implementing a new CPAP compliance program that will soon be offered through VGM. “I am looking forward to being on the ground floor of a program that offers a service to DME providers to stay patient-focused and offers patients the opportunity to get the most out of their sleep therapy,” said Carter. Previously, Carter was vice president of network development, contracting and sleep services for VGM Homelink, where he was responsible for the contracting and management of provider accounts and network development, as well as contracting and pricing with third-party payers. “John’s recent experience and knowledge in managing patients is something that will bring incredible value to our team and program at VGM & Associates,” stated Barry Thwaits, vice president, business development, for VGM & Associates. 

Medtronic launches more effective infusion set 

DUBLIN – Medtronic has announced the U.S. launch of its Extended infusion set, which it says is the first and only infusion set labelled for up to seven-day wear. An infusion set is tubing that delivers insulin from a pump to the body and typically requires a set change every two to three days. "When patients first begin using a pump, doctors and other health care providers reinforce the need to change their infusion set every two to three days to limit the risk of infection and other safety concerns,” said Dr. Robert Vigersky, chief medical officer, Medtronic Diabetes. “For many people, this means scheduling life around infusion set changes, which may not be at the most convenient times ― turning around as you are headed out the door when you suddenly remember to change your infusion set or adding a few minutes to a tired child's bedtime routine with an infusion set change. With the Medtronic Extended infusion set, these life interruptions are reduced with an innovation that doubles the wear." The Medtronic Extended infusion set uses advanced materials that help reduce insulin preservative loss and maintain insulin flow and stability to double the wear time of a set. It leverages proprietary technology like a new tubing connector that improves the physical and chemical stability of insulin and the reliability of infusion site performance, as well as reduces the risk of infusion set occlusion. Medtronic says use of the Extended infusion set is also estimated to result in annual cost savings of insulin of up to 25% due to a reduced number of set and reservoir changes that result in unrecoverable insulin, as well as plastic waste reduction of up to 50%. The Medtronic Extended infusion set is now available exclusively for users on the MiniMed 600 and 700 series pumps. 

Medtrade refreshes logo 

ATLANTA – Medtrade officials have debuted a new logo to set the tone for its first unified event next year. Medtrade will take place one time in 2023, on March 28-30 at the Kay Bailey Hutchinson Convention Center in Dallas. “Our mission is to stage events that unite the HME industry, and having one annual event will bring together buyers, sellers, and educators under one roof for the ultimate product and information sourcing event,” said Sarah Varner, vice president of Marketing, Emerald. “Now is the perfect time to refresh the logo and embrace this new era.” Previously, Medtrade took place both in the spring and the fall. Show organizers believe the new three-day show will be well received and will be time well spent. “Switching to one show per year was motivated by feedback from attendees and exhibitors,” said York Schwab, show director. “Moving the show to Dallas is part of the same equation. Dallas is centrally located with reasonably-priced lodging, exhibitor-friendly rules, first-rate transportation, great restaurants and lots of non-stop flights arriving from countless cities.” 

BOC announces new board 

OWINGS MILLS, Md. – The board of directors at the Board of Certification/Accreditation (BOC) has announced the 2023 Executive Committee. The recently elected officers are:  

• Chair (incumbent): Wayne R. Rosen, BOCP, BOCO, LPO, CDME, FAAOP, clinical consultant 
• Vice-chair: Cameron Stewart, BOCO, BOCP, co-founder, Alcam Medical Orthotics and Prosthetics in Riverside, Calif. 
• Secretary: Abel Guevara III, DHA(c), MHIM, RHIA, CPHT, CDME, vice president of revenue cycle & market access, Abilitech Medical, Inc. in Eden Prairie, Minn. 
• Treasurer: Daniel Griffis III, PharmD, pharmacist, Pharmacare of Georgia, Inc. in Brunswick, Ga. 
• Member at large (incumbent): Rick Todd, COF, president and managing partner, Collier & Laurence Orthotics & Prosthetics in Sacramento, Calif. 
• Immediate past chair (incumbent): Bradley “Brad” Watson, BOCO, BOCP, LPO, regional manager, Clarksville Limb + Brace + Rehab in Clarksville, Tenn. 

“BOC is grateful for the passionate, dedicated professionals serving on our board of directors,” said Wayne R. Rosen, BOCP, BOCO, LPO, CDME, FAAOP, board chair. “Their decades of experience and sound leadership support BOC’s continued growth and ensure our credential-holders are backed by professionals who are truly committed to their success.” 

BOC’s board of directors also highlighted the dedication of board member Justina “Justi” Appel, PhD, BOCO, BOCP, FAAOP, who will complete her term of service on Dec. 31, 2022, and congratulates Cameron Stewart, BOCO, BOCP, on his election to a second four-year term on the board. 

Supplemental benefits on the rise for Medicare Advantage 

WASHINGTON – Supplemental benefit offerings in Medicare Advantage, including in-home support services, caregiver support, home-based palliative care and therapeutic massage, increased for the upcoming year, according to a new brief commission by Better Medicare Alliance and prepared by the actuarial consulting firm Milliman. Overall, the number of Medicare Advantage plans to offer at least one of the five recently expanded supplemental benefits jumped 35% from 2022 to 2023, with the largest increase seen among in-home support services, which is now offered across 794 plans in 42 states. “This research shows just some of the ways Medicare Advantage delivers the whole-person care seniors expect and deserve,” said Mary Beth Donahue, president and CEO of the Better Medicare Alliance. “As seniors contend with rising household costs, their ability to access more benefits that are built into the affordable cost of their Medicare Advantage plan is welcome news.” CMS in 2018 reinterpreted “primarily health-related benefits” to include expanded supplemental benefits. Read the full brief here.