In brief: AAH rallies for bid relief, Philips recalls more vents, Belluscura beats forecasts

WASHINGTON – AAHomecare is calling on providers to contact their members of Congress to sign on as original co-sponsors for draft legislation from by Rep. Markwayne Mullins, R.-Okla., and Paul Tonko, D-N.Y., that would provide reimbursement relief. 

The legislation would apply 90/10 blended reimbursement rates for the 13 product categories that were removed from Round 2021 of Medicare’s competitive bidding program. The rates would apply from Jan. 1, 2022, through Dec. 31, 2023. 

“A strong show of grassroots support at the open of this campaign will raise the visibility of this measure and re-affirm our industry’s passion and commitment to advocate for this legislation to our allies on the Hill,” says the association in a bulletin. 

AAHomecare is asking providers to send a brief, personally drafted e-mail to their representative’s staffer who deals with health care issues containing a couple of sentences about the critical need to align Medicare reimbursement rates with the cost and operational environment the industry faces. Also include: an ask that they serve as an original co-sponsor to the bill. 

Providers can find draft messaging and information about how to contact their legislators here, including details on finding the email for the staffer who handles health care issues, as well a list of legislators who joined a House sign-on letter last November asking CMS to address Medicare reimbursements for HME. 

AAHomecare has also provided a pre-drafted email through its Action Center. 

Philips recalls additional Trilogy vents 

Trilogy 100 and 200 vents were previously recalled in June 2021 

WASHINGTON – Philips Respironics has recalled certain Trilogy Evo ventilators for potential health risks from PE-PUR foam, according to the U.S. Food and Drug Administration. 

The recall affects 215 Trilogy Evo Ventilators (DS211OX11B) and 51 repair kits (KR211X15B, not distributed in the United States). 

“A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material, in the muffler assembly of the affected Trilogy Evo ventilators,” the FDA states “The issue was identified during lab testing of the Trilogy Evo ventilator. The Trilogy Evo ventilators with non-conforming foam were distributed to customers in the United States and Korea. There have been no reported injuries or death to date.” 

The FDA noted that Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam risk. 

Philips Respironics sent an Urgent Medical Device Recall notification to Trilogy Evo ventilator customers on Dec. 21, 2021, and the company sent an updated version to clarify information on cleaning and filters on Jan. 13, 2022. 

The notification requested customers take the following actions: 

• Create awareness of this safety information by forwarding to your organization's personnel. 
• Identify all of the impacted devices purchased by your organization. 
• Do not stop or change patient therapy unless the patient has consulted their health care provider or unless a replacement Trilogy Evo ventilator has been provided. 
• Instruct patients and/or caregivers to closely monitor the bacteria filter for foam debris. Using an inline bacterial filter may help to filter out particles of foam. Additionally, after placement of an inline filter, instruct patients and/or caregivers to be aware of potential changes in breathing circuit resistance and monitor as ventilator performance may change due to increase in resistance of air flow through the device after filter placement. Bacterial filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam. 
• Inspect and clean the patient circuit and accessories per the instructions included with the notification. 

A replacement Trilogy Evo ventilator will be provided by Philips. Once the patient has been transitioned, return the affected Trilogy Evo ventilator to Philips. Your Philips Representative will provide a return authorization and any support needed to facilitate this return. The packing instructions are in Appendix A of the notification. 

For the repair kit for Trilogy Evo muffler assembly, the Dec. 21, 2021, notification letter requested customers take the following actions: 

• Segregate inventory of Repair Kit - Trilogy Evo Muffler Assembly Part Number 1135257, and quarantine any lot between 210414 and 210524. 
• Do not use any quarantined material and contact Philips for return instructions. You will be shipped replacements. 
• Determine if any Trilogy Evo devices have been repaired using Trilogy Evo Muffler Assembly Part Number 1135357 starting 14 April 2021 or later 
• If the lot number used in repair is between 210414 and 210524. Contact Philips for next steps. Philips will replace the device these parts were installed into. 
• If the lot number used in a repair is unknown, assume it is affected and contact Philips for next steps. Philips will replace the device these parts were installed into. 
• If lot number is known and is not an affected lot, no further action is required. 

Certain other Trilogy models are not affected by this most recent recall: Trilogy Evo O2, Trilogy EV300 and Trilogy Evo Universal.  

Belluscura beats forecasts 

LONDON and PLANO, Texas – Belluscura has sold 377 X-PLO2R portable oxygen concentrators since the launch of the device in September 2021, 25% above current consensus forecasts and 150% above initial forecasts for 2021, according to the company’s board of directors. 

“Market reception for the X-PLO2R has been positive and initial demand has been very strong,” said Robert Raulker, CEO. “We are very excited about the upcoming launch of the X-PLO2R and X-PLO2 DX and look to the future with confidence.” 

Belluscura expects to launch the X-PLO2R CX and X-PLO2 DX in the second and third quarters, respectively. 

The company says it has significantly increased inventory levels of key components and other raw materials to pre-empt any potential disruption on production levels due to supply chain challenges. It has also scaled up its manufacturing capability significantly to ensure it can meet increased demand. 

Belluscura expects to release preliminary financial results for 2021 in mid-February. As of Dec. 31, 2021, it retained cash balances of $15.6 million and remained debt free. 

Cherub Medical talks supply chain concerns 

SHAWNEE, Kan. – Cherub Medical Supply hosted Rep. Sharice Davids, D-Kan., on Jan. 24 to discuss the impact of supply chain challenges on its business and patients, according to a release from Davids and MAMES. 

In addition to Sam Cress of Cherub Medical, Nick Hulsing of Reliable Medical Supplies and Rose Schafhauser of MAMES attended the meeting. 

“As a small business caring for medically fragile children in Kansas City, we have faced many issues due to rising costs, semiconductor supply chain shortages, and declining reimbursement,” said Sam Cress, director of operations at Cherub Medical. “We look forward to partnering with Rep. Davids regarding these concerns to champion and protect the families we serve.” 

Davids has been a vocal proponent of the bipartisan CHIPS Act, which would boost domestic manufacturing of semiconductors. The act, which has been passed by Congress, awaits full funding through the U.S. Innovation and Competition Act. 

If funded, the act would provide $52 billion to strengthen domestic semiconductor production, including $2 billion targeted to the research and development of mature node semiconductors, known as legacy chips, which are critical for medical devices, smartphones, cars, computers and more. 

NCPA: Demand ‘sky-high’ for at-home COVID tests 

ALEXANDRIA, Va. –  More than nine in 10 pharmacists are having a difficult time keeping up with the surging demand for at-home COVID-19 tests, according to a new survey by the National Community Pharmacists Association. 

“COVID-19 has caused shortages throughout the economy, but this is acute,” said B. Douglas Hoey, NCPA CEO. “Community pharmacists are the first line of defense against the virus. Testing is a key to getting everyone back at work and back in school, and right now the supply just isn’t there.” 

NCPA recently surveyed roughly 8,000 pharmacy owners and managers and found that 92.7% say they are having a tough time sourcing enough at-home COVID-19 tests to meet demand. 

The demand for tests is sky-high largely because of protocols established by public and private employers, schools and colleges, and even restaurants and bars in some cities that require some patrons to present a negative test. 

“This is much more contagious variant, and while it may be milder than previous strains, it is affecting many more people, and that is driving the demand,” said Hoey. 

Other findings from the survey: 

• Roughly 43% of community pharmacies are performing COVID-19 tests. Among those, more than 26% say they are having a difficult time getting the testing supplies they need. 
• Almost 90% of community pharmacists say the demand for COVID-19 tests is higher than it was last November when the Delta strain was spreading across the country. 

Quipt nearly doubles revenue 

CINCINNATI – Quipt Home Medical reported revenue of $102.4 million for fiscal year 2021, a 41% increase compared to $72.6 million for fiscal year 2020. 

The company experienced organic growth of 10%. 

For the fourth quarter, it reported revenue of $29.1 million compared to $19.7 million for the prior year, a 48% increase; organic growth of 14%, excluding new acquisitions; and adjusted EBITDA of$5.6 million, 19.2% margin. 

“We are extremely proud of breaching the $100 million mark in annual revenue for fiscal year 2021, whilst maintaining an above 20% Adjusted EBITDA margin, a major milestone,” said Hardik Mehta, CFO. “Our continued progress in strategically building scale utilizing the infrastructure we have in place is producing consistent financial results, inclusive of over 77% of our revenue being classified as recurring.” 

Quipt made several acquisitions during the fourth quarter, expanding its footprint to 76 locations in 15 states.  

Coloplast reports growth 

HUMLEBAEK, Denmark – Coloplast saw 6% organic growth in its first quarter ended Dec. 31. Reported revenue in DKK was up by 9% to DKK 5,169 million. Organic growth rates by business area were ostomy care 6%, continence care 5%, interventional urology 5% and wound & skin care 12%. EBIT before special items was DKK 1,649 million, a 7% increase from last year, corresponding to an EBIT margin before special items of 32% against 32% last year. EBIT after special items was DKK 1,615 million, a 5% increase from last year, corresponding to an EBIT margin after special items of 31% (special items were DKK 34 million related to Atos Medical, which Coloplast announced Nov. 8, 2021, it had acquired). 

Save the date: AAHomecare Legislative Conference 

WASHINGTON - AAHomecare will partner with Advocacy Associates to host a virtual Washington Legislative Conference on Sept. 21. The event provides members of the HME community the opportunity to advocate for issues affecting their businesses and patients. “As we enter year three of the public health emergency, our challenges have escalated, but your service and care has not diminished,” said AAHomecare. “In the wake of supply chain issues, microchip shortages, labor shortages and more, you have continued to provide a high level of service on a minimal reimbursement rate. We need you to parlay your story and challenges to your legislators.” Last year’s event resulted in more than 220 meetings in 40 states. More information to come. 

Medtrade veteran promoted 

ATLANTA - Sarah Varner has been promoted to vice president of marketing for Emerald Expositions, which produces the Medtrade shows. During her dozen years at Emerald, Varner distinguished herself as director and senior director of marketing on a variety of shows. “March 2022 will mark 12 years for me at Emerald, and the only brand I’ve had the entire time is Medtrade,” said Varner. “I love the brand because of the people who make up the industry and who they’re ultimately serving—neighbors and family. I’m also excited about the new brands I’ll be working on, because it’s always interesting to learn about new industries that many of us take for granted.” In addition to Medtrade West (April 4-6, 2022, in Phoenix) and Medtrade East (Oct 24-26, 2022, in Atlanta), Varner will have marketing duties for four additional brands: Marine Military Expos, National Pavement Expo, Impressions and International Fastener Expo. 

Numotion to distribute Braze Mobility’s sensors 

BRENTWOOD, Tenn. – Numotion has signed an agreement with Braze Mobility to distribute its blind spot sensors for wheelchairs, which transform any wheelchair into a “smart wheelchair.” The sensors automatically detect obstacles and provide feedback through intuitive lights, sounds and vibrations. “We are thrilled to offer this innovative technology to our ATPs and customers,” said John Pryles, executive vice president of sales, Numotion. “Braze Blind Spot Sensors were designed to increase the overall spatial awareness of the person using the system and can be used to help people perform activities of daily living with their wheelchair – all while improving mobility, access and independence for users.” Braze Mobility’s sensors  have their roots in more than a decade of user-centered research with wheelchair users that has been published in several peer-reviewed journals. 

Sun Medical earns second accreditation 

BIRMINGHAM, Mich. – Sun Medical Equipment and Supply has been awarded CHAP accreditation. “Our dedicated team worked tirelessly to make our new store in Birmingham a great success,” said Greg Jamian, president/CEO for Sun Medical Inc. “While Sun Medical has always been accredited, through AmeriCare, we felt it very important that our new store receive the same accreditation.” The evaluation by CHAP focuses on structure and function, quality of services and products, human and financial resources and long-term viability. Sun Medical, part of AmeriCare Medical Inc., provides a wide variety of home medical equipment products, supplies and services to patients and their families in the Birmingham and Bloomfield surrounding areas. 

CareRx launches Revicare brand, expands offerings 

TORONTO - CareRx Corp., a provider of pharmacy services to senior living communities, will offer an expanded assortment of medical supplies under a new brand, Revicare, including incontinence products, nutritional supplements, wound care products and other general medical supplies. CareRx currently operates a successful incontinence supplies business under the brand ClassMed that predominantly supplies incontinence products to residents living in select seniors living communities. "The launch of Revicare is a natural step following our significant growth that has expanded our reach to close to 100,000 residents across Canada, and is consistent with our strategic focus on seniors care," said Puneet Khanna, chief commercial officer of CareRx. "We believe that our enhanced offering of medical supply products will provide added convenience to our home operator partners and their residents who are already receiving their medications from CareRx." CareRx serves more than 96,000 residents in more than 1,600 senior and other congregate care communities, such as long-term care homes, retirement homes, assisted living facilities and group homes. 

Soleo able to administer VYGART 

FRISCO, Texas – Soleo Health has been selected as a limited distribution partner for VYGART by argenx SE. Effective immediately, Soleo Health is able to manage and administer VYVGART intravenously in the homes of patients or at its ambulatory infusion centers nationwide. “Soleo Health is at the forefront of bringing revolutionary specialty pharmaceuticals to patients nationwide with this new partnership with argenx,” said Drew Walk, Soleo Health CEO. “Our ever-growing limited drug distribution portfolio continues to expand as we are increasingly recognized for our capabilities, particularly within the autoimmune and neurology arenas.” The U.S. Food and Drug Administration approved VYGART on Dec. 17 for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. gMG affects approximately 36,000 to 60,000 people in the U.S., according to the Myasthenia Gravis Foundation of America, but it remains underdiagnosed in patients and its prevalence is likely higher. Soleo Health operates 21 locations throughout the U.S., with national nursing coverage and pharmacy licensure in 50 states, and is accredited by URAC, ACHC with Distinction in Rare Disease and Orphan Drugs, and The Joint Commission. 

Invacare reduces size of board following resignation 

ELYRIA, Ohio – Invacare has announced that Diana Ferguson resigned as a director Jan. 19 from the company’s board of directors. Ferguson’s decision to resign, effectively immediately, is due to her other personal and professional obligations and not due to any disagreement with Invacare, the company stated. Following her resignation, Invacare’s board intends to reduce its size to eight members. Members of the board are now Matthew Monaghan, chairman, as well as president and CEO of the company; C. Martin Harris, M.D.; Stephanie Fehr; Susan Alexander; Petra Danielsohn-Weil; Clifford Nastas; Julie Beck; and Marc Gibeley. 

RemSleep engages investor relations firm, news service 

TAMPA, Fla. – RemSleep Holdings has partnered with Preya Co. and MCAP Mediawire to maximize its communication and exposure with current and potential shareholders, as well as refine and broaden its overall messaging and outreach. The move comes as the company prepares to get its DeltaWave nasal CPAP interface approved by the U.S. Food and Drug Administration and launched to market. “We feel we owe it to our current and future investors to have partnered with a gold star firm to assist us with our investor relations moving forward,” said Tom Wood, CEO of RemSleep. “Maintaining an open line of communication with our shareholders and providing consistent, timely updates will only serve to add value to our company.” Preya Co. is a consulting team with more than 20 years combined experience in OTC, OTCQB/QX, foreign and NASDAQ markets. MCAP Mediawire is a news distributor offering press releases, digital media and financial disclosure services for microcap and exchange listed companies. 

Encore exec earns certification 

LIVINGSTON, Tenn. – Encore Healthcare has announced that its vice president of clinical operations, Carrie Hylton-Proffitt, RRT, has earned certification by the Accreditation Commission for Health Care (ACHC) to provide consulting services. Hylton-Proffitt completed an intensive consultant training program demonstrating competence in ACHC survey preparation, including comprehensive knowledge of standards and processes for pharmacy and DMEPOS. “At Encore Healthcare, we are committed to providing the most comprehensive services for our Nexus software clients,” said Dan Easley, chief strategy officer. “In choosing an ACHC Certified Consultant, our clients can be assured that Encore is well-prepared to assist them throughout the entire accreditation process to successfully achieve and maintain accreditation.” The ACHC Consultant Certification program is designed for consultants who prepare health care providers for ACHC accreditation. The program is instructed by ACHC Clinical Compliance Educators who have extensive experience operating health care organizations, surveying to ACHC standards and leading accreditation workshops. 

AscellaHealth taps three home infusion pharmacies with preferred status 

BERWYN, Pa. – AscellaHealth has announced that Amber Specialty Pharmacy, AcariaHealth and BioMatrix Specialty Pharmacy are preferred partners within its Home Infusion Pharmacy Network. These designations are part of AscellaHealth’s Site of Care Optimization initiative and overall strategies designed to cut costs without compromising quality of care. “By selecting these top pharmacies for preferred status, we are taking an important step toward reducing the cost of specialty biologic medications and encouraging patients to move from higher-cost settings, like big hospitals and institutions, to lower-cost settings, such as physician’s in-office infusion suites or stand-alone infusion centers,” says Dea Belazi, president and CEO, AscellaHealth. “As part of our mission to help our clients better manage the high costs of specialty medication, this initiative exemplifies our efforts to increase care accessibility by encouraging the use of clinically appropriate, lower-cost care settings. The extensive range of these pharmacy sites that are dedicated to infusion therapy creates a better patient experience and improves outcomes.” SOC optimization is particularly helpful for acute therapies, such as intravenous antibiotics or routine therapies for Crohn’s disease or rheumatoid arthritis, which can be safely and easily administered outside of the hospital or physician’s office settings. The goals are to: Improve drug affordability, increase price transparency, reduce disparities in quality of care and safety across care settings, enable care delivery in the highest-quality, lowest-cost care setting, and increase patient convenience for enhanced compliance to therapy. 

Harbor Healthcare announces home infusion deal 

SAN DIEGO – Harbor Healthcare has announced the successful sale of a California-based home infusion pharmacy to a strategic buyer that maintains a nationwide presence in the home infusion space. The acquisition provides the buyer with key access to a competitive market, according to Harbor Healthcare, a boutique investment bank offering a variety of M&A advisory services to middle market health care and pharmacy businesses. "Joining a legacy pharmacy with a management team that brings decades of experience in the space is an exceptional opportunity,” said Michael Cammeyer, managing director of Harbor Healthcare. “With the expanded customer facing team, the newly formed business is in an ideal position to service patients while expanding its geographical footprint. We are excited to watch this pharmacy grow from the synergies created by this investment.” The buyer specializes in intravenous immunoglobin (IVIG), total parenteral nutrition (TPN) and other specialty infusion products.