YARMOUTH, Maine – Three weeks after Philips issued a voluntary recall for certain mechanical ventilators, including its popular Trilogy 100 and 200, providers say they're still waiting for guidance on how to move forward.  “Right now, we’re in wait-and-see mode,” said Chris Burgess, vice president of clinical services for Med Emporium in Virginia. “We haven’t been given guidance. We’ll roll out a corrective action, as soon as we get details. I hope it’s something that our clinicians can do.” The recall, issued June 14, states that potential health risks have been identified related to the polyester-based polyurethane sound abatement foam component in these devices. The risks include that the foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and that it may off-gas certain chemicals. As a temporary measure, Philips is directing providers to put a bacteria filter on the outlet side of the ventilator, says provider Roxanne Vennard. “We’re doing that and just waiting for the next directions, and we’ll go from there,” said Vennard, president of Ascent Respiratory Care in Colorado. For patients using affected ventilators, the recall advises they not stop or alter their prescribed therapy until they have talked to their physicians, but there’s still mass confusion out there, says Burgess. “Right now, we are taking calls from everyone – patients, providers, health care systems, case managers,” he said. “We’ve had issues where patients have gone to the hospital and are being told they can’t use Trilogies because it’s a recalled device, but we’re not sure biomed departments should be making those calls.” Complicating matters further, providers are hearing from some referral sources that they’d prefer not to have their patients set up on affected Trilogy devices. That puts providers in a pinch when lead times for some ventilators are now up to three or four weeks, says Vennard. “We do carry a couple of other options, but from a patient perspective, ventilators are not really one size fits all,” she said. “Some people can’t tolerate (certain devices), and we need to find a different option.”

WASHINGTON – It’s not a permanent fix, but stakeholders say it’s a great sign that, about a month after taking the reins, CMS Administrator Chiquita Brooks-LaSure agreed to extend a suspension of scheduled Medicare cuts to accessories for complex rehab manual wheelchairs. CMS announced on June 23 that it would extend an 18-month pause on applying competitive bidding pricing to these accessories for an additional 90 days, until Oct. 1. “We have seen some decisions (since Brooks-LaSure took office) and we had a pretty big decision (on the 23rd),” said Seth Johnson, senior vice president of government affairs for Pride Mobility Products and Quantum Rehab. Stakeholders had been in a holding pattern on various initiatives – including permanently exempting accessories for complex rehab manual wheelchairs from bid pricing – while Brooks-LaSure’s nomination stalled due to a dispute in Congress over Medicaid waivers. She was finally confirmed on May 25. The extension is “reason to celebrate,” says NCART’s Don Clayback, and a reason to “show appreciation” to CMS, as well as the industry’s champions in Congress who signed and sent a letter to Brooks-LaSure on June 21 asking her to stop the cuts.  “Our road has not ended yet and we really need to push this to the conclusion, but we want to take this time to thank all the people and organizations that have been pushing for this,” said Clayback, executive director. The 90-day extension gives CMS and Brooks-LaSure more time to figure out how they can permanently exempt accessories for complex rehab manual wheelchairs from bid pricing, Clayback says. “The idea is to give CMS another 90 days to do their due diligence to make the appropriate policy decision, like they have for accessories for complex rehab power wheelchairs,” he said. “We will be staying in close contact with CMS in these next 90 days.” Stakeholders will continue to fight for a permanent fix, including during a scheduled National CRT Awareness Week on Sept. 20 and a virtual lobbying day on Sept. 21. “Those are very well timed,” Johnson said.

SPOKANE, Wash. – With scattered power outages and ACs operating at maximum capacity, HME providers in the Pacific Northwest were working overtime to make sure staff, particularly delivery techs, stayed cool and hydrated, and patients were taken care of. “We’re making sure people are staying hydrated,” said Brandon Whitney, an ATP and customer service team lead for Inland Medical and Rehab in Spokane, Wash. “The delivery technicians are on the road all day long and we have to plan around that.” A heat dome settled over the region last week, sending temperatures soaring over 100 degrees, including 117 degrees in Salem, Ore., 108 in Seattle and 111 in Spokane, Washington, according to national news reports. The region typically sees average temperatures of 68 to 73 degrees at this time of year. “It’s flat-out miserable,” said Erik Mickelson, CEO of Howard’s Medical, which has locations in Yakima and Sunnyside. “All of our vehicles and buildings are air conditioned. We just don’t go out outside.” For provider Joel Gallion flexibility was key as he sought to manage Bellevue Healthcare’s more than 12 locations in Washington, Oregon and western Idaho. “Two of our locations got too hot and we ended up closing early on Monday,” said Gallion, president. “For our technicians, we provide ice, coolers, Gatorade and water, and pushed to get as much done as early (in the day) as possible.” While extreme heat can be a concern for respiratory patients, providers say they fielded few crisis calls. “We had a few areas lose power, so we did have to do some urgent tank deliveries,” said Gallion. “Beyond that, more than anything, it was just a bit of contingency planning.” Something providers did get quite a few calls about: Oxygen concentrators don’t work well above 95 degrees, causing them to send out alerts, says Mickelson. “When the oxygen purity on a concentrator drops below 90% it will beep at you and say it’s not working but it is still working,” he said. “We tell them to take the concentrator to a colder place (like a senior center).” With little relief in the forecast – temperatures are expected to drop this week in many areas but remain well above average – providers say they try to keep it in perspective. “I’ll take high heat over wildfires any day,” said Mickelson. “That’s what’s next.”

THEODORE, Ala. – Supreme Medical Fulfillment has launched a new online ordering portal with real-time inventory to help its provider customers better respond to everything from the COVID-19 pandemic to supply chain challenges. “Some portals will say a product is available or that it’s in stock,” said Colton Mason, senior vice president. “We found providers didn’t want to know that; they wanted to know if we had six or 60. Now when they’re placing orders in our portal, they can see that in real time.” Supreme Medical piloted real-time inventory with large customers at the end of last year and made it available to all customers in June. When oxygen concentrators were scarce in early 2021 due to the pandemic, Supreme Medical’s provider customers leveraged real-time inventory to buy 1,000 oxygen concentrators in the first few months of the year, Mason says. “A category like oxygen – most providers purchase those direct from the manufacturer at scale, so it hasn’t been a core business of ours in the past,” he said. “But some of our manufacturer partners had availability and the main concern of providers was, ‘We need concentrators; people have to breathe.’” Supreme Medical’s provider customers have also been leveraging real-time inventory when supply chain challenges create significant back orders for a certain product, Mason says. “We don’t just carry one line, we carry eight,” he said. “If one line goes on back order, we will up our stock in the other seven lines. We’ve found that providers are very open to a different line if one isn’t available. They just want the product.” At its foundation, real-time inventory allows providers to act fast and that, not price, is the new currency in the industry, Mason says.“We made the decision at the tail end of last year to change our messaging to focus on a service area of 13 states in the Southeast where we can get packages to porches and stores in one to two days,” he said. “Price used to be top of mind because of competitive bidding, but now it’s speed.” 

WASHINGTON – Noridian Healthcare Solutions has posted FAQs for Jurisdictions A and D on the impact of the Philips recall on coverage and billing for Medicare beneficiaries, AAHomecare has reported. Among the questions in the FAQ: How shouldDMEsuppliers address the situation with Medicare beneficiaries who are in the first 90-days adherence metric in thePAPandRADLocal Coverage Determinations (LCDs)? Response:During the Public Health Emergency (PHE),CMShas instructed theDME MACs to not enforce clinical indications of coverage for the types of respiratory devices involved in the voluntary recall. Services must still be reasonable and necessary. Once a beneficiary gets the new replacement equipment, do they have to restart the 90-day adherence trial? Or do they just pick it up where they left off? Response:The beneficiary has the option to restart the 90-day adherence trial or they may resume meeting the adherence metric where they left off. The supplier should notate their records if the recall impacted the beneficiary’s adherence timeline. What shouldDMEsuppliers do if a beneficiary wishes to return their Philips Respironics product that is impacted by the voluntary recall? Response:Suppliers are reminded that theCMSSupplier Standards (42CFR424.57) apply to this situation, specifically Standard #15 – [Suppliers]Must accept returns from beneficiaries of substandard (less than full quality for the particular item or unsuitable items, inappropriate for the beneficiary at the time it was fitted and rented or sold). If beneficiaries choose not to continuePAP,RADor ventilator use until their equipment has been replaced, how does that affect the supplier as far as Medicare standards? Are they required to provide temporary replacement equipment? Response:If aDMEsupplier continues to bill forPAP,RAD, or ventilators, they are required to provide the equipment for which they’re billing. If a beneficiary chooses to wait for new equipment, does theDMEsupplier stop billing for rental? Is it a break in service that they simply pickup when the new equipment is provided? Response:Yes, theDMEsupplier must stop billing, and resumption of billing would occur with the next unbilled rental month. There is no break in service because the requirements for a new capped rental billing are not met.CMSdefines a 60-plus consecutive day interruption as a period including two full rental months plus whatever days are remaining in the rental month during which the need ends. In addition to the timing requirement, there must also be a change in medical necessity, defined as a resolution of the condition that created the first period of medical necessity and the subsequent development of a second event that creates a new period of medical necessity. In the voluntary recall situation, there is no change in medical necessity as a result of the recall; therefore, there is no break in service and no new capped rental. AAHomecare plans to provide additional perspective on the guidance. Philips announced the recall of certain Bi-Level CPAP, CPAP and mechanical ventilator devices on June 14 to address identified potential health risks related to the polyester-based polyurethan sound abatement foam component in these devices. FDA publishes Safety Communication for Philips recall WASHINGTON – The Food and Drug Administration has issued a Safety Communication regarding the Philips recall of certain respiratory devices. According to a bulletin from AAHomecare, the communication summarizes major issues and considerations related to the recall, and encourages patients using BiPAP and CPAP machines to discuss treatment options and alternatives with their healthcare providers, including “Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.” The FDA notes that it is working with Philips to evaluate the issue, the scope of the recall and appropriate mitigation strategies. The agency is also analyzing medical device reports related to the affected devices over the period of 2009-21 for reports that could be related to this issue. The communication includes a link to the Medwatch Reporting Form where individuals can report problems with their devices directly to the FDA. Additionally, the communication urges patients to register their devices with Philips’ website. AAHomecare said it will continue to work with respiratory stakeholders, clinical groups, government entities and their contractors, and major payers to help expedite replacement equipment and continue high-quality care for patients who continue to use their devices in the near term. AAHomecare engages medical directors on recall WASHINGTON - AAHomecare has reached out to the DME MAC medical directors to address the challenges HME providers and patients face due to the Philips recall. In a letter to the four directors, the association requests that the DME MACs continue to reimburse for equipment and supplies affected by the recall for patients who continue to use them, as well as implement a temporary suspension of time-specific adherence rules to allow patients time to have devices repaired or replaced.   “AAHomecare members and the DME community are committed to supporting the broad cohort of patients who depend on high-quality respiratory equipment and related services, and we look forward to working with you to ensure a high standard of care for these individuals under the current challenging conditions,” AAHomecare states in the letter. Philips on June 14 announced a voluntary recall of certain Bi-Level CPAP, CPAP and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in these devices.  Lifeway Mobility gets PE boost HARTFORD, Conn. – Lifeway Mobility has received a “significant” investment from Cressey & Company, a health care focused private equity firm. “Welcoming Cressey & Company is especially exciting and gratifying for me,” said Tim Burfield, Lifeway’s chairman. “We’ve built two other leading companies with Bryan Cressey and his team over many years. They are outstanding partners and true healthcare innovators.” Lifeway is a provider of home accessibility and safety solutions, including stairlifts, wheelchair ramps and lifts, transfer aids and bath safety products. It currently serves customers in fourteen states. Lifeway’s plans for the investment include continuing organic growth in its current locations and acquiring outstanding providers to create regional hubs throughout the country. Earlier this year it invested in the assets of Pennsylvania-based Accessible Home Automations, LLC, doing business as StairBusters.com, and Los Angeles-based Gamburd. “We’re building the leading accessibility company by collaborating with health care providers, payers and managers; launching unique consumer outreach campaigns; investing in successful regional providers and recruiting leading industry talent,” added Paul Bergantino, Lifeway’s president. “Cressey & Company’s resources, health care expertise and extensive relationships will be instrumental to our success.” Terms of the transaction were not disclosed. NCPA participates in roundtable conversation with HHS Secretary ALEXANDRIA, Va. – B. Douglas Hoey, the CEO of the National Community Pharmacists Association, participated in a roundtable discussion with Health and Human Services Secretary Xavier Becerra and leaders of several other provider organizations to discuss the expanding role of community pharmacies in health care. Hoey discussed four priorities for independent pharmacists: Eliminating retroactive price concessions, known as pharmacy DIR fees, which are imposed on pharmacies by pharmacy benefit managers and have increased by 91,500% in recent years, according to CMS. Making permanent the emergency COVID-19 authorizations allowing pharmacists in every state to administer tests and vaccinations under Medicare and Medicaid. Maximizing Medicare Part D reporting requirements on pharmacy performance standards. Developing Medicare Part D plan guidance for medical-at-home pharmacy services, so long-term care pharmacy can deliver the same type of in-home services that they currently deliver to nursing home patients. “We are grateful to Sec. Becerra for reaching out and starting a dialogue,” said Hoey. “As a member of Congress and as California’s Attorney General, he was responsive to our members’ concerns, and we are pleased he is bringing the same openness to HHS. America’s 21,000 independent pharmacies have distinguished themselves during the COVID emergency as a crucial part of the national health care infrastructure. We look forward to working with Sec. Becerra and the administration to strengthen community pharmacy.” Hart Medical Equipment expands into Ohio FINDLAY, Ohio – Hart Medical Equipment has merged with Northwest Ohio Medical Equipment (NOME), a division of Blanchard Valley Health System (BVHS), in partnership with Wood County Hospital and The Bellevue Hospital. “This is a well-planned merger that reflects Hart’s vision to expand its health system partnerships and focus on continuity of care, reduced readmissions, and long-term patient outcomes,” said Allen Hunt, president of Hart Medical Equipment. During the pandemic, Hart implemented innovative technologies to meet challenges, namely TeleHart, its telehealth platform for educating customers remotely on CPAP/BiPAP, oxygen, glucometers and nebulizers. It now looks forward to expanding the platform throughout its Ohio partner health systems. “As a unique durable medical equipment provider with a specialized focus serving health care systems, Hart Medical Equipment is excited to expand its robust services and distinctive value by merging with NOME," said Bart Buxton, PhD, chair of Hart's board of directors and president and CEO of McLaren Health Management Group. The merger was effective July 1. NOME will rebrand as Hart Medical Equipment. CMS names Medicaid administrator WASHINGTON – CMS has named Daniel Tsai as Deputy Administrator and Director of Center for Medicaid and CHIP Services, effective July 6. Tsai will lead the Center’s efforts to address disparities in health equity and serving the needs of the record 80 million children, pregnant people, parents, seniors, and individuals with disabilities. “As someone who has successfully led a state Medicaid program to focus on value-based care for its recipients, Dan brings invaluable experience to CMS,” said CMS Administrator Chiquita Brooks-LaSure. “The COVID-19 pandemic has made clear what a lifeline Medicaid and CHIP are for families and individuals across the country.” Tsai previously served as the assistant secretary for MassHealth and Medicaid Director.Medtrade West 2022: Call for presentations PHOENIX – The call for presentations for Medtrade West 2022 is now open. Show organizers seek submissions on topics for business operations, managed care payers, legal, retail, executive leadership and planning, and sales and marketing by solo presenters, panel discussions and collaborative teams. Deadline for submissions is July 30.InfuSystem implements stock repurchase program ROCHESTER HILLS, Mich. – The board of directors of InfuSystem Holdings has approved a stock repurchase program allowing the company to purchase up to $20 million in stocks through June 30, 2024. “This authorization will replace the prior authorization which expired on Dec. 31, 2020, and will provide us with an additional capital allocation option to enhance shareholder value,” said Richard Dilorio, CEO. “Additionally, the stock repurchase program emphasizes the confidence that management has in the company’s solid operations, strength of our balance sheet and the outlook for strong growth in 2022 and beyond.” InfuSystem’s top priority for using the capital remains making strategic investments that position the company for sustainable growth, but it also provides the company with the flexibility to be “opportunistic” in repurchasing shares when valuations become attractive, Dilorio says. Fairview HME changes name HIBBING, Minn. – Fairview Home Medical Equipment, formerly known as HealthLine Medical Supply, has changed its name to M Health Fairview Home Medical Equipment. The company has also moved to a new location within the Mesabi Mall, according to Hometown Focus, that provide easier showroom access through an entrance on the West/back side of the building. M Health provides a variety of equipment and supplies, including POCs, CPAP devices, breast pumps and compression garments. In addition to Hibbing, it has locations in Burnsville, Edina, Maplewood, St. Paul, Woodbury, and Wyoming, Minn. InfuSystem enters lymphedema market ROCHESTER HILLS, Mich. – InfuSystem Holdings has entered into a joint agreement with Bio Compression Systems to add lymphedema therapy to its Integrated Therapy Service (ITS) platform. As part of the new relationship, InfuSystem’s solutions will include providing pneumatic compression devices with calibrated and non-calibrated gradient pressure, garments and certified technicians for proper fitting of the compression system. InfuSystem was recently designated as a Community Health Accreditation Partner (CHAP) to provide pneumatic compression devices for the lymphedema market. “We are excited to announce our fourth therapy with the addition of lymphedema to our ITS platform, joining our existing therapies - oncology, pain management and wound care,” said Richard DiIorio, CEO of InfuSystem. “With our recent CHAP accreditation, we expect to begin onboarding new customers and treating patients in the next 60 days, with a significant revenue contribution from our new Lymphedema therapy in 2022 to 2023.” InfuSystem also provides DME to support the ITS platform and to win incremental business from its direct payer clients. The DME segment is comprised of direct payer rentals, pump and consumable sales, and biomedical services and repair. InfuSystem also operates Centers of Excellence in Michigan, Kansas, California, Massachusetts, Texas and Ontario, Canada. AHA releases statement on OSA and cardiovascular disease YARMOUTH, Maine – Obstructive sleep apnea is often underrecognized and understated in cardiovascular practice, despite its high prevalence in patients with heart diseases and the vulnerability of cardiac patients to OSA-related stressors and adverse cardiovascular outcomes, according to a new scientific statement from the American Heart Association. “We recommend screening for OSA in patients with resistant/poorly controlled hypertension, pulmonary hypertension, and recurrent atrial fibrillation after either cardioversion or ablation,” the statement says. OSA prevalence is as high as 40% to 80% in patients with hypertension, atrial fibrillation and stroke, the association believes. The statement, which was published in Circulation, says all patients with OSA should be considered for treatment, including behavioral modifications and weight loss, as indicated. It says CPAP therapy should be offered to patients with severe OSA and oral appliances can be considered for patients with mild- to moderate OSA who are CPAP-intolerant. Rehab Medical names new CFO INDIANAPOLIS – Rehab Medical has named Olga Chaikouskaya as its new CFO to oversee its financial operations. Chaikouskaya has more than 20 years of overall financial experience in diverse industries, including manufacturing, retail and nonprofit organizations. She will lead Rehab Medical through a rapid growth stage, during which it has increased revenue 30% in 2018, 2019 and 2020. “This opportunity to positively impact lives, both internally and externally, is something that really resonated with me,” she said. “I look forward to improving the efficiency and innovation with Rehab Medical in its effort to become the national leader in custom advanced medical equipment.” Prior to joining Rehab Medical, Chaikouskaya was CFO of Stratosphere Quality, a provider of quality assurance services. There, she was responsible for managing all financial aspects of the company in North America and led the company to being named an Inc. 5000 company for five consecutive years. Belluscura nears distribution LONDON – Belluscura has signed its first U.S. distribution agreement for its X-PLO2R portable oxygen concentrator portfolio. The company has issued its first purchase order, with delivery expected in the third quarter, according to reports. The X-PLO2R is a lightweight POC cleared by the U.S. Food and Drug Administration designed to replace larger, metal oxygen tanks and heavier devices. Belluscura began trading on the Alternative Investment Market (AIM) on the London Stock Exchange earlier this year. It also raised 17.5 million pounds supported by new and existing investors. BOC seeks outstanding individuals OWINGS MILLS, Md. – The Board of Certification/Accreditation (BOC) seeks nominations for the Jim Newberry Award for Extraordinary Service. The award, which recognizes outstanding individuals who demonstrate extraordinary service to BOC, is presented in honor and remembrance of longtime practitioner, BOC board member and leader James Newberry, Jr., BOCP, BOCO, BOCD, who passed away in 2016. “We are pleased to continue Jim’s legacy by recognizing exemplary professionals who have demonstrated their commitment to BOC through volunteerism, advocacy, board service and other service to the organization,” said L. Bradley Watson, BOCO, BOCP, LPO, chair of BOC’s board. Nominees might include, but are not limited to, former BOC board members, BOC volunteers, vendors and consultants. To review the award requirements and nominate a colleague for the award, visit the Jim Newberry Award for Extraordinary Service page on BOC’s website. BOC will accept nominations until Sept. 3. ABC Health Care hosts congressional staff RICHMOND, Va. – ABC Health Care hosted a meeting on June 23 with the staff of Rep. Donald McEachin, D-Va., a member of the Energy and Commerce Committee. During the meeting, the group discussed concerns with access to and reimbursement for home medical equipment. “A member of Rep McEachin’s staff was very engaged in the conversation, noting she had family who used oxygen, CPAP and hospital beds,” according to a press release from VGM and ACMESA. “She dealt with her own issues accessing quality services and products.” Attendees of the meeting included Sam Clay of AdaptHealth, John Gallagher of VGM, and Matt Russel and Stephanie Harris of ABC Health Care.

FINDLAY, Ohio – Hart Medical Equipment has merged with Northwest Ohio Medical Equipment (NOME), a division of Blanchard Valley Health System (BVHS), in partnership with Wood County Hospital and The Bellevue Hospital. “This is a well-planned merger that reflects Hart’s vision to expand its health system partnerships and focus on continuity of care, reduced readmissions and long-term patient outcomes,” said Allen Hunt, president of Hart Medical Equipment. During the pandemic, Hart implemented innovative technologies to meet challenges, namely TeleHart, its telehealth platform for educating customers remotely on CPAP/BiPAP, oxygen, glucometers and nebulizers. It now looks forward to expanding the platform throughout its Ohio partner health systems. “As a unique durable medical equipment provider with a specialized focus serving health care systems, Hart Medical Equipment is excited to expand its robust services and distinctive value by merging with NOME," said Bart Buxton, PhD, chair of Hart's board of directors and president and CEO of McLaren Health Management Group. The merger was effective July 1. NOME will rebrand as Hart Medical Equipment.

WASHINGTON – CMS has named Daniel Tsai as Deputy Administrator and Director of Center for Medicaid and CHIP Services, effective July 6. Tsai will lead the Center’s efforts to address disparities in health equity and serving the needs of the record 80 million children, pregnant people, parents, seniors, and individuals with disabilities. “As someone who has successfully led a state Medicaid program to focus on value-based care for its recipients, Dan brings invaluable experience to CMS,” said CMS Administrator Chiquita Brooks-LaSure. “The COVID-19 pandemic has made clear what a lifeline Medicaid and CHIP are for families and individuals across the country.” Tsai previously served as the assistant secretary for MassHealth and Medicaid Director.

HARTFORD, Conn. – Lifeway Mobility has received a “significant” investment from Cressey & Company, a health care focused private equity firm. “Welcoming Cressey & Company is especially exciting and gratifying for me,” said Tim Burfield, Lifeway’s chairman. “We’ve built two other leading companies with Bryan Cressey and his team over many years. They are outstanding partners and true healthcare innovators.” Lifeway is a provider of home accessibility and safety solutions, including stairlifts, wheelchair ramps and lifts, transfer aids and bath safety products. It currently serves customers in fourteen states. Lifeway’s plans for the investment include continuing organic growth in its current locations and acquiring outstanding providers to create regional hubs throughout the country. Earlier this year it invested in the assets of Pennsylvania-based Accessible Home Automations, LLC, doing business as StairBusters.com, and Los Angeles-based Gamburd. “We’re building the leading accessibility company by collaborating with health care providers, payers and managers; launching unique consumer outreach campaigns; investing in successful regional providers and recruiting leading industry talent,” added Paul Bergantino, Lifeway’s president. “Cressey & Company’s resources, health care expertise and extensive relationships will be instrumental to our success.” Terms of the transaction were not disclosed. 

WASHINGTON – The Food and Drug Administration has issued a Safety Communication regarding the Philips recall of certain respiratory devices. According to a bulletin from AAHomecare, the communication summarizes major issues and considerations related to the recall, and encourages patients using BiPAP and CPAP machines to discuss treatment options and alternatives with their healthcare providers, including “Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.” The FDA notes that it is working with Philips to evaluate the issue, the scope of the recall and appropriate mitigation strategies. The agency is also analyzing medical device reports related to the affected devices over the period of 2009-21 for reports that could be related to this issue. The communication includes a link to the Medwatch Reporting Form where individuals can report problems with their devices directly to the FDA. Additionally, the communication urges patients to register their devices with Philips’ website. AAHomecare said it will continue to work with respiratory stakeholders, clinical groups, government entities and their contractors, and major payers to help expedite replacement equipment and continue high-quality care for patients who continue to use their devices in the near term. Earlier this week, the association sent a letter to the DME medical director to outline challenges providers face due to the recall. 

PHOENIX – The call for presentations for Medtrade West 2022 is now open. Show organizers seek submissions on topics for business operations, managed care payers, legal, retail, executive leadership and planning, and sales and marketing by solo presenters, panel discussions and collaborative teams. Deadline for submissions is July 30. Submit your presentation here. 

ROCHESTER HILLS, Mich. – The board of directors of InfuSystem Holdings has approved a stock repurchase program allowing the company to purchase up to $20 million in stocks through June 30, 2024. “This authorization will replace the prior authorization which expired on Dec. 31, 2020, and will provide us with an additional capital allocation option to enhance shareholder value,” said Richard Dilorio, CEO. “Additionally, the stock repurchase program emphasizes the confidence that management has in the company’s solid operations, strength of our balance sheet and the outlook for strong growth in 2022 and beyond.” InfuSystem’s top priority for using the capital remains making strategic investments that position the company for sustainable growth, but it also provides the company with the flexibility to be “opportunistic” in repurchasing shares when valuations become attractive, Dilorio says.

WASHINGTON - AAHomecare has reached out to the DME MAC medical directors to address the challenges HME providers and patients face due to the Philips recall. In a letter to the four directors, the association requests that the DME MACs continue to reimburse for equipment and supplies affected by the recall for patients who continue to use them, as well as implement a temporary suspension of time-specific adherence rules to allow patients time to have devices repaired or replaced.   “AAHomecare members and the DME community are committed to supporting the broad cohort of patients who depend on high-quality respiratory equipment and related services, and we look forward to working with you to ensure a high standard of care for these individuals under the current challenging conditions,” AAHomecare states in the letter. Philips on June 14 announced a voluntary recall of certain Bi-Level CPAP, CPAP and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in these devices.

ALEXANDRIA, Va. – B. Douglas Hoey, the CEO of the National Community Pharmacists Association, participated in a roundtable discussion with Health and Human Services Secretary Xavier Becerra and leaders of several other provider organizations to discuss the expanding role of community pharmacies in health care. Hoey discussed four priorities for independent pharmacists: Eliminating retroactive price concessions, known as pharmacy DIR fees, which are imposed on pharmacies by pharmacy benefit managers and have increased by 91,500% in recent years, according to CMS. Making permanent the emergency COVID-19 authorizations allowing pharmacists in every state to administer tests and vaccinations under Medicare and Medicaid.Maximizing Medicare Part D reporting requirements on pharmacy performance standards. Developing Medicare Part D plan guidance for medical-at-home pharmacy services, so long-term care pharmacy can deliver the same type of in-home services that they currently deliver to nursing home patients. “We are grateful to Sec. Becerra for reaching out and starting a dialogue,” said Hoey. “As a member of Congress and as California’s Attorney General, he was responsive to our members’ concerns, and we are pleased he is bringing the same openness to HHS. America’s 21,000 independent pharmacies have distinguished themselves during the COVID emergency as a crucial part of the national health care infrastructure. We look forward to working with Sec. Becerra and the administration to strengthen community pharmacy.”

WASHINGTON – The payer relations team at AAHomecare is working with state and regional associations to pick off attempts by managed care organizations and other insurers to decrease reimbursement for HME. Stakeholders have a number of bills working their way through state legislatures to protect reimbursement for DME at 100% of the state Medicaid fee schedules. One of those states: New York, where A.5368 is scheduled to go before the Rules Committee before heading to the floor for a vote. A companion bill, S.5118, is also eligible for a vote. “MCOs shouldn’t be able to use some of these crazy reductions, up to 50% off the state Medicaid fee schedule,” said David Chandler, senior director of payer relations for AAHomecare. “We’re cautiously optimistic.” Similar legislation has also been introduced in Texas. A newer threat targeting a specific product category has also popped up in Louisiana. Chandler in May testified before the House Insurance Committee in Baton Rouge to support a bill that would prevent managed care organizations and other payers from setting reimbursement caps for ventilators. The bill has now passed the state’s House and Senate. “There’s this trend developing where the NIV benefit appears to be under siege by payers, particularly commercial payers, and this would be a dangerous precedent that you could cap items that CMS classifies as requiring frequent and substantial servicing,” he said. “We want to make sure this is stopped to protect access to care.”

YARMOUTH, Maine – So-called “Right to Repair” bills in a number of states are raising awareness of the DMERT Group’s certification program for repair technicians. The bills seek to give consumers the right to purchase parts from manufacturers and repair their own products, providing an important talking point for stakeholders on the role providers and their repair techs play in making sure equipment is working properly and safely. “The bills so far have been broad, but if they go to the assistive technology side and if the state asks us, ‘What designations do you have,’ currently we don’t have one (that’s required),” said Matt Macpherson, chairman of the board of directors of DMERT Group. “DMERT Group is the first actual certification, but other than that there’s nothing differentiating repair techs. That puts us in a vulnerable position.” DMERT Group offers Level 1 certification for basic medical equipment like walkers and manual wheelchairs, Level 2 certification for complex rehab wheelchairs and basic seating, and Level 3 certification for training and exam auditing. DMERT Group has seen an increase in the number of providers seeking to get their repair techs certified in response to the bills, among other reasons, but other providers may still wait until it’s a requirement, Macpherson says. “We don’t want the industry to have to have a stick - requirements and litigation issues – but some employers are stick-minded,” he said. “So, we’re trying to offer as many carrots as possible, like leverage to get more accounts, help with liability risk and better resources toward becoming an ATP.’” Another carrot: fewer costs and improved outcomes with certified repair techs, says Greg Packer, who sits on the board of DMERT Group and who is president of U.S. Rehab. U.S. Rehab is collecting evidence of this in its Functional Mobility Assessment tool. “You need a highly skilled technician to perform repairs or you will have problems over time,” he said. “We’ll combat this.”

AUSTIN, Texas – 2020 was a big year for Chris Yule: He led the sale of Travis Medical to National Seating & Mobility, and he became the new president of NCART.  Here’s what Yule had to say about taking his passion for complex rehab to a more national stage and how leveraging technology will lead to better services and outcomes. HME News: What about your industry experience makes you well suited to be president of NCART? Chris Yule: In 2003, I was involved in founding the Texas Rehab Provider Council. We did that to form a stakeholder group to have a voice with Texas legislators. Through this organization, we were able to pass one of the first state laws requiring that an ATP be present for an assessment for equipment and be present to make sure the equipment fulfills the client’s needs and meets expectations. From treasurer to president, I held all the offices in that organization over the years. While we had a state focus, NCART is more of a global initiative.   HME: What do you hope to accomplish as president?  Yule: From a global standpoint, our goals include growing the organization’s membership by 20%, securing a permanent exemption for manual wheelchair accessories from competitive bidding and funding seat elevation. At the state level, our initiatives will involve looking forward in preparation for 2022 state budget shortfalls as a result of COVID. We have to be prepared as an industry to make sure that the needs of individuals with disabilities can be met by the provision of CRT. It will be important to get all the manufacturers, providers and payers all on the same team. We have to position outcomes as a valuable tool and determine how CRT is more than just a piece of equipment – it is truly a cost saver that can support the home and community-based care movement. We are part of the solution to the home care marketplace shift. HME: How do you see the complex rehab industry advancing in the next two, five, 10 years? Yule: As we move to the future, the complex rehab industry will see a more connected process, from data diagnosis to delivery. Technology is really going to take over, making it possible to do much more virtually using a smartphone or tablet. We’ll be able to tie into payers’ member information and we’ll see a shorter transactional cycle times at the end of the day. Overall, we are going to see better services, more accountability and better outcomes.

GREEN OAKS, Ill. – NorthShore Care Supply took one of the last steps in its years-long transition from provider to supplier when it named Sandra DiVito as vice president of B2B sales and development. “We’ve really been transitioning from a provider to a supplier over the last five years and the addition of Sandra DiVito and a soon-to-be growing sales team is going to be one of the last pieces of that transition,” said Adam Greenberg, president and founder of NorthShore Care Supply.  DiVito will be responsible for establishing the company’s B2B sales function, growing revenue and driving partner relationships. One of DiVito’s primary focuses out of the gate: building out NorthShore’s distributor network in the United States and Canada. “We're also exploring distributor relationships in the U.K., Europe and Australia,” she said. “There is tremendous interest from DME/HME, assisted living and specialty pharmacy channels, which are the highest priority at this time.” NorthShore will offer a drop-ship model, as well as options for providers to stock products locally. The company will also offer guidance on which products will be most aligned with a provider’s customer base.  “Our headquarters and distribution center is centrally located in the Chicago suburbs and we have invested millions in robots and other automation to very efficiently fulfill thousands of drop-ship orders per day,” said DiVito. Additionally, NorthShore has partnered with FedEx for same-day shipments, including Sundays, to meet growing demand.  “We see incontinence supplies growing more than 15% in the home care market over the next three years due to the aging population of baby boomers, the strong move toward home care as a preferred option for families and the push by families for higher performing, better protecting absorbent products,” said Greenberg.

WASHINGTON – A group of about 40 providers and manufacturers participated in a call in May to discuss whether there’s enough interest to form a Breast Pump Policy Coalition that could tackle a host of issues related to the product category. “We’re still in the discovery phase,” said Ryan Bullock, COO of Aeroflow and co-chair of the coalition, which AAHomecare is spearheading. “We’ve sent out a follow-up survey to gauge their ongoing interest and willingness to participate, and from there, we will determine if we make this an official coalition.” Among some of the key concerns identified on the call: consistent coverage policies among payers. Although breast pumps have been covered since the Affordable Care Act was passed in 2010, many payers are still adapting their medical coverage guidelines for the coverage of pumps and associated re-supplies, says Bullock. Eliminating sales tax on the pumps is another area of focus, he said. “Depending on the state, some specifically call out breast pumps (as being taxable),” said Bullock. “We are not able to collect that when billing insurance, nor collect it from the patient. We take that out of what we are being reimbursed to cover that.” The coalition is also interested in developing a white paper, in collaboration with breast pump manufacturers, on the clinical benefits of breast feeding, Bullock said.“We want to continue showing its benefits and the need for the mom to have that breast pump as part of her journey,” he said.

NEW YORK – Customers of The CPAP Shop can now get a home sleep test and prescription through Sleep Care Online’s SimpleRx and Complete Care solutions.  This new capability is the result of a new partnership between The CPAP Shop, an online retailer of sleep equipment, and Sleep Care Online, a national telemedicine services provider for self-pay patients with sleep disorders. “The SimpleRx corrected an issue we’ve seen during our 16 years, which is customers saying, ‘I don’t have a prescription, but I’ve been on CPAP for a long time’ or ‘I’ve moved’ or ‘I don’t have insurance’ or ‘My health care provider has gone out of business,’” said Anthony Zadnick, CEO of Agile Medical, the parent company of The CPAP Shop.  For $79.99, patients can renew their prescription for CPAP therapy with a board-certified, licensed physician after a 15-minute telehealth visit, sometimes in 24 hours or less. Those who haven’t been previously diagnosed with OSA or aren’t currently being treated with PAP therapy, don’t qualify for SimpleRx. However, those patients can purchase a Complete Care package from Sleep Care Online that bundles a home sleep apnea test, two telehealth consultations with a board-certified sleep physician and a prescription. “Anyone who is in HST or understands how to set up a project like this knows there’s a lot of steps to finalizing it, but the pandemic has accelerated that by at least three to five years,” said Zadnick. As telehealth becomes more accessible and consumers’ comfort level with the process increases, Zadnick sees the space growing exponentially, “from the top of the funnel, which is the testing piece, all the way down through sleep coaching and continuing with care on sleep and health issues.” “We’re looking to potentially increase testing on insomnia and other sleep-related issues, and we have a doctor network through Sleep Care Online that we can offer other services,” he said. 

With the COVID-19 pandemic on the wane in many parts of the country, mobility manufacturers are rolling ahead with expectations of a brighter outlook for sales and distribution. Scooter and wheelchair specialists say demand for products stayed strong during the pandemic, but that complications from lockdowns, restrictions and a stressedhealthcare system took a toll on orders and logistics. Now that restrictions are easing and society is opening up, the mobility industry is breathing a sigh of relief, said Doug Francis, president and CEO of St. Petersburg, Fla.-based Lifestyle Mobility Aids.  “In March 2020 there was, for the first time, a real contraction of business in our industry,” he said.“This slowdown only caused a build-up of demand that is now beginning to release as more of the country begins opening up. I believe we will see elevated levels of demand for mobility products through the summer as people want to begin traveling again.” Growing demand spans all mobility categories, including wheelchairs, walkers, rollators, canes, crutches and knee walkers, Francis said. To be sure, the past year “was a difficult and challenging time from a sales standpoint,” added Jay Brislin, vice president of Exeter, Pa.-based Quantum Rehab. “We focused on working with our providers and adapting to the current environment to still ensure we were taking care of our customers and end users and supporting them at the highest level.” Demand is high and continues to grow as the country reopens, Brislin said.  “In many cases, backlogs have occurred for people needing equipment and we are now seeing these individuals schedule appointments to get that equipment,” he said. “Growth is happening in all categories, especially with many of the retail product lines. During the pandemic, many people had needs for items such as a scooter or travel mobility device but did not pursue those purchases during the shutdown. Now all that is starting to change.” Surging demand for power mobility has companies like Dallas-based Interstate Batteries jump-starting their distribution to providers, said David Tibbals, sales development manager of national accounts. “Power mobility dealers that have local battery suppliers who can deliver same day or next day have the advantage to grow their customer base and retain existing customers,” he said.“Just as with your car when the battery fails, a replacement is needed immediately, not in days or weeks.Power wheelchair users depend on their batteries to maintain their mobility and quality of life.Providers who have a local supplier delivering quality batteries can get their customers up and running faster than the competition.” ZOOMing forward With so much emphasis over the past 18 months on telehealth, curbside service and other mitigation methods, the mobility industry is trying to determine what customer service will look like in the pandemic aftermath. Mobility suppliers sound confident that a “new normal” will be in place well after the COVID threat officially ends. “No question about it that this past year has brought about the advancement of these ‘safer’ technologies and procedures,” said John Wright, executive vice president of sales management and business development for Torrance, Calif.-based Shoprider Mobility Products. “The ZOOM format for evaluations may become a reality as face-to-face evaluations are phased out if the governing bodies will allow it.” Ryan Zarb, vice president of customer and technical servicefor Nashville-based National Seating & Mobility, adds that remote evaluations, telehealth and no- or low-contact delivery models “have streamlined the client experience and positioned us to provide a better level of service in a post-COVID world. Technology-driven care is not only here to stay, but must continue to evolve to further enhance safety, convenience and efficiency for our clients.” Tech conundrum Scooters and wheelchairs are a technology rich category, with advancements constantly in the pipeline for future development, Yet Francis says payer bureaucracy can stifle the introduction of new technology with insufficient reimbursement. “New technologies are surfacing constantly in the mobility sector, but in the US, unfortunately there’s a hyper focus on billing codes and coverage,” he said.“If the reimbursement rate doesn’t support the new technology, those technologies can struggle to gain momentum and acceptance.” Even so, Francis says there are “numerous breakthrough products” the public wants to purchase even though they aren’t covered. “To get consumers excited about these new products and technologies, we need to focus on marketing to them in an upbeat and positive way,” he said. Darren Lowman, chief supply chain officerfor NSM, contends the key to the success and advancement of new technology in the power wheelchair and scooter market comes down to access and affordability. “Technology in early stages will drive cost and most reimbursement models take time to digest and accept responsibility for those costs,” he said. “Power adjustable seat height is an example of this – seat elevation has been available for years, but we’re just starting to see payer funding for this, and Medicare funding is still not in place.” Quantum and Pride have forged ahead with new developments and “we continue to push the envelope with products the CRT community has been asking for,” Brislin said. “These innovations cut across all aspects of our business, including power lift recliners, scooters and power wheelchairs.Both Pride and Quantum are investing in digital tools for our providers that will improve their ordering and searching capabilities and increase their productivity while in the field with patients.”