In brief: Philips update, vaccine mandate, premium increase

WASHINGTON – The U.S. Food and Drug Administration obtained additional information during an inspection of a Philips’ manufacturing facility that was not previously available to the agency that showed the silicone-based foam used in a singular, similar device marketed outside the U.S. failed one safety test for the release of volatile organic compounds. 

Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 

“The FDA has requested that Philips retain an independent laboratory to perform additional testing to determinate what, if any, potential safety risks may be posed to patients by silicone-based foam,” the agency stated in a press release. “At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product.” 

The FDA initially approved Philips’ plan to repair the polyester-based polyurethane foam in recalled CPAP and BiPAP devices with a different, silicone-based foam, in part, on testing the company provided to the agency in June. 

The FDA has provided the results of its inspection to the company in a Form 483, but it noted that the results do not constitute a final determination whether or not any condition is in violation of the Food, Drug and Cosmetic Act or any of its implementing regulations. 

“We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing,” said Frans van Houten, CEO of Philips. “Until we have concluded these discussions, we are not able to publicly provide further details on these responses. We remain fully committed to supporting the community of patients who rely on the affected devices, and the physicians and customers who are dedicated to meeting patient needs.”  

Since June, Philips and certified testing laboratories have been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks, with support from appropriately qualified third-party experts. The company plans to make more data available in the fourth quarter. 

Separately, Philips has also conducted testing to support the new silicone replacement foam.  

CMS announces increase in premiums 

WASHINGTON – The standard monthly premium for Medicare Part B enrollees will be $170.10 for 2022, an increase of $21.60 from $148.50 in 2021. 

The annual deductible for all Medicare Part B beneficiaries will be $233 in 2022, an increase of $30 from the $203 in 2021. 

The increases are due to: 

Rising prices and utilization across the health care system that drive higher premiums year-over-year alongside anticipated increases in the intensity of care provided. 

Congressional action to significantly lower the increase in the 2021 Medicare Part B premium, which resulted in the $3.00 per beneficiary per month increase in the Medicare Part B premium (that would have ended in 2021) being continued through 2025. 

Additional contingency reserves due to the uncertainty regarding the potential use of the Alzheimer’s drug, Aduhelm, by people with Medicare.  

The Medicare Part A inpatient hospital deductible that beneficiaries pay if admitted to the hospital will be $1,556 in 2022, an increase of $72 from $1,484 in 2021.  

AAHomecare sees increased support for industry advocacy 

WASHINGTON – AAHomecare has created a new Diamond corporate partner class, with 11 leading HME companies joining to signal their support for industry advocacy. 

The Diamond class represents a 25% increase in dues support for AAHomecare’s public policy initiatives over the previous top level, Platinum.  
“The 11 companies in the inaugural Diamond partner class are making an unprecedented investment in advocacy efforts to secure sustainable reimbursements and sensible regulatory policies,” said Tom Ryan, AAHomecare president and CEO. “Their additional financial support, coupled with the expertise and involvement in our policy work that these companies contribute on a continual basis, will underpin our advocacy efforts to address the biggest challenges we face.” 

The inaugural Diamond class comprises AdaptHealth, Apria, Byram Healthcare, Cardinal Health, Lincare, McKesson, Medline, Medtrade, Philips, ResMed and Rotech. 

These companies say they feel a responsibility to step up their contributions at a critical time for the industry. 

“After the past 18 months and dealing with the impact that the pandemic had on the DME industry acting as a second line of defense, we believe strongly that it is more important than ever that we stand united to achieve the best possible care for our patients,” aid Crispin Teufel, CEO of Lincare. “We appreciate the partnership with AAHomecare over the past years to accomplish this goal and look forward to further increasing our support for the industry.” 

“As a market leader for medical supplies and equipment distribution to the HME market, we think McKesson has a responsibility beyond selling medical supplies,” said Jeff Bowman, vice president of HME sales for McKesson. “That responsibility extends to being fully engaged and arm-and-arm with HME providers as they work to address advocacy issues that can have a material impact on the industry.” 

AAHomecare’s full list of partners can be found at aahomecare.org/corporate-partners. For information on becoming a part of AAHomecare’s corporate partner program, contact Mike Nicol at michaeln@aahomecare.org.   
 
Quipt adds repair services through acquisition 

CINCINNATI — Quipt Home Medical has acquired a privately held biomedical services company with operations in the Southeastern United States reporting unaudited trailing 12-month annual revenues of approximately $1.5 million and net income of $225,000. 

Quipt acquired the biomedical services operation for approximately $700,000 in cash, expanding its services to include biomedical repair services for respiratory equipment, including preventative maintenance.  

“We are delighted to enter this segment of the market, a logical fit for us given the growing number of patients and referral partners in our network, as well as the burgeoning amount of equipment deliveries we complete every year,” said Greg Crawford, chairman and CEO. “The opportunity to include annual preventative maintenance and repair services for respiratory equipment is timely and we feel we can penetrate new and existing long term care facilities, hospital systems and other medical facilities with this additional service.” 

The acquisition services a wide range of respiratory products, including ventilators, oxygen devices, CPAP/bilevel devices and more from both the acute and non-acute settings from within the home and hospital environments. 

Other acquisitions by Quipt announced this month include companies in the Midwest and Illinois. 

Quipt announces LOI, increases guidance 

CINCINNATI – Quipt Home Medical has executed a non-binding letter of intent to acquire “an arm’s length” private respiratory company in the Midwestern United States with 15,000 active patients. 

The company reported unaudited trailing 12-month annual revenues of about $13 million, $1.6 million in net income and positive adjusted EBITDA. 

“This acquisition target is very powerful as it services a significant metro hub in the Midwest and after closing, we plan on quickly integrating their business operations and leveraging the company’s payer contracts across our existing Midwest locations,” said Greg Crawford, CEO. “Additionally, we expect to see cross-selling growth from lathering on our clinical ventilation therapy program as an extension to their existing respiratory product mix.” 

Quipt expects the acquisition to be accretive to its adjusted EBITDA and overall profitability, adding $13 million to the top-line and $1.6 million in net income. 

Based on current business, market trends and completed and prospective acquisitions, the company expects run-rate revenue for the end of calendar year 2022 of $180 million to $190 million with $38 million to $43 million in adjusted EBITDA. 

“This considerable increase stems from the ongoing strength of the business, favorable industry dynamics and robust acquisition pipeline,” said Hardik Meta, CFO. “As a reminder, our balance sheet remains very solid with over $30 million in cash and an untapped $20 million credit facility, giving us ample flexibility as we continue on our strategic path.” 

CMS reports decrease in improper payment rates 

WASHINGTON – The improper payment rate for Medicare fee-for-service is 6.27% or $25.74 billion for fiscal year 2020 compared to 7.25% or $28.91 billion for fiscal year 2019, according to CMS. 

The decrease was driven by reductions in the improper payment rates for home health and skilled nursing facility claims, the agency says.  

Home health: There was a $5.90 billion decrease in estimated improper payments from 2016 to 2020 due to corrective actions such as policy clarification and Targeted Probe and Educate (TPE) programs for home health agencies. 

Skilled nursing facilities: There was a $1 billion decrease in estimated improper payments from 2019 to 2020 due to a policy change related to the supporting information for physician certification and recertification for skilled nursing facility services and TPE for skilled nursing facilities. 

CMS says improper payment rates are not necessarily indicative of, or measures of, fraud. Instead, they are payments that did not meet statutory, regulatory, administrative, or other legally applicable requirements and may be overpayments or underpayments. 

Additionally, CMS notes that improper payments do not necessarily represent expenses that should not have occurred.   

Medicaid moms more hesitant on COVID vax 

ASHVILLE, N.C. – New mothers with Medicaid were more apprehensive about receiving the COVID-19 vaccine than those with private insurance, according to a survey from Aeroflow Breastpumps.  

Among women surveyed who did not have access to the vaccine while pregnant or breastfeeding, the majority with Medicaid (64%) reported they would not at all feel comfortable getting vaccinated if it was available to them and nearly half (47%) of those with private insurance said the same. 

"It's important that new mothers feel comfortable with and informed about receiving the COVID-19 vaccine given the proven safety and efficacy in protecting mothers and babies against the virus," said Dr. Jessica Madden, board-certified pediatrician and neonatologist, IBCLC, and medical director of Aeroflow Breastpumps. "Since this study took place in July 2021, various health organizations, including the CDC, American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine, updated their vaccine recommendations for pregnant/breastfeeding women toward the end of summer, asserting that the vaccines are safe and encouraging all pregnant and breastfeeding women to get vaccinated. However, we are still seeing pregnant and breastfeeding women hesitant to receive the vaccine, especially among women of lower socioeconomic status, which is concerning given the higher rates of high-risk pregnancies in those populations." 

Among mothers with Medicaid, 16% received the vaccine while breastfeeding, 39% chose not to receive the vaccine while pregnant or breastfeeding and 44% reported the vaccine was not available to them while pregnant or breastfeeding 

Among all women surveyed who chose not to get the vaccine, there were four main reasons: They're not sure if it's safe for them or the baby (60%); they had concerns about adverse side effects (57%); they don't feel comfortable getting the vaccine in any situation (52%); and they don't know what's in the vaccine (36%). 

Among all women surveyed who received the vaccine, the top three reasons were: They wanted to protect themselves and their baby from getting COVID (84%); they knew they would now be able to pass the COVID antibodies to the baby (68%); and they felt it was a safe vaccine for them and the baby (60%). 

CQRC applauds telehealth proposal 

WASHINGTON – The Council for Quality Respiratory Care has commended lawmakers in the House of Representatives for including an important provision in the newly 21st Century Cures 2.0 Act to permanently extend the home as a site for telehealth for Medicare beneficiaries. The bill would also allow CMS to extend other telehealth flexibilities permanently to increase access to telehealth services. “Given the increasingly important role of home respiratory care in the treatment of Medicare patients before and during the COVID-19 pandemic, as well as the crucial importance of telehealth as a way to increase access to care, we strongly support the efforts to permanently extend Medicare telehealth flexibilities and increase access to these services,” said Crispin Teufel, CQRC Chairman. "If passed, 21st Century Cures 2.0 would go a long way to supporting a sustainable home respiratory therapy infrastructure.” More specifically, the bi-partisan bill, introduced by Reps. Diana DeGette, D-Colo., and Fred Upton, R-Mich., would permanently remove Medicare's geographic and originating site restrictions that require a patient to live in a rural area and be physically in a doctor's office or clinic to use telehealth services, a long-time priority of CQRC. 

AARP, Lowe’s to offer aging-in-place strategies 

WASHINGTON - A new collaboration between AARP and Lowe’s will provide strategies and information to help make living spaces more accessible for everyone and allow older adults to stay in their homes safely and comfortably as they age. “People are living longer and they want to live their best lives at every age,” says Jo Ann Jenkins, AARP CEO. “Ageless homes that work for older adults are good for people of all ages, but most houses weren’t built to support our needs long term. The best way to continue living in the home you love is to make healthy aging improvements today that will benefit you tomorrow.” The collaboration offers information and guidance around home improvement and design techniques to support older adults and family caregivers as they reimagine their homes for the next stage of life. Seventy-seven percent of people 50 and older want to remain in their current homes as they age, according to an AARP survey, but the majority of homes do not have the features needed to support that option. 

OSHA suspends vaccine enforcement 

WASHINGTON - OSHA is suspending enforcement of the COVID-19 vaccine mandate for employers with 100-plus employees. The suspension comes after the U.S. Court of Appeals for the Fifth Circuit fully blocked Biden’s executive order requiring companies with more than 100 workers to mandate vaccination for their employees. The court ordered that OSHA “take no steps to implement or enforce” the vaccine mandate “until further court order.” FMI: COVID-19 Vaccination and Testing ETS | Occupational Safety and Health Administration (osha.gov). 

Drive DeVilbiss, BILT partner on app 

PORT WASHINGTON, N.Y. - Drive DeVilbiss Healthcare is partnering with BILT Incorporated, creator of the BILT app, to make it easier for users to assemble products at home with the help of 3D, step-by-step instructions. "Drive DeVilbiss is excited to be able to bring these easy-to-use instructions to our customers through our partnership with BILT," said Laura Williams, product manager of bathroom safety & commodes. "Recognizing that users may have limited strength or disabilities that leave little room for cumbersome assembly processes, our hope is to make putting products together easier and faster than ever before." The free app allows the assembler to access instructions by searching the database or scanning a QR code with their smartphone or tablet. The app provides a 3D walkthrough with audible step-by-step explanation, image rotation and zoom, and instant replay. It also provides additional information like warnings, cautions, tools required, list of parts and warranty information.  

RESNA, DMERT Group launch ATP pathway 

ARLINGTON, Va. – RESNA and the DMERT Group are partnering on a new career pathway to becoming an ATP. They’ve developed a program that will allow DMERT Level 2 Repair Technician Certificate holders to continue their professional career development by gaining the training and necessary skills to successfully become an ATP. “There is a growing need for DME and complex rehab technology repair technicians, as technologies become more intricate and complex,” RESNA stated. “The DMERT Group’s Level 1 and Level 2 Certificate programs ensure that technicians have a solid understanding of DME and CRT equipment.” The program is expected to be ready for enrollment by the fall of 2022. There will be a general information session at ISS in Pittsburgh in January 2022 and at the RESNA Conference in Arlington, Va., in July 2022. The two organizations are also planning educational sessions and online webinar support throughout the next 12 months to explain this pathway in-depth as the course development progresses. 

Apnimed treatment shows reduction in AHI 

CAMBRIDGE, Mass. – Apnimed, a pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea and related disorders, has announced positive topline results from a proof-of-concept randomized, controlled, double-blind, single-dose, three-period crossover study (protocol APX-001) in patients with OSA evaluating AD504 and AD182. Patients treated with AD504 (atomoxetine plus trazodone) showed a strong trend in the reduction in AHI from placebo, which was the study’s primary endpoint. Additionally, the study’s secondary endpoint was met with a significant reduction of sleep apnea specific hypoxic burden (HB) following treatment with AD504. HB is a measure of the total amount of respiratory event-related hypoxemia and a growing body of evidence supports HB as the most meaningful predictor of adverse cardiovascular outcomes in patients with OSA. A second drug, AD182 (atomoxetine and an orexin antagonist) was also studied and demonstrated a positive trend in the reduction of HB. “We’re pleased with the reduction in HB demonstrated by AD504 in this small, proof-of-concept, Phase 2 study,” said Larry Miller, M.D., CEOof Apnimed. “In our pursuit to deliver breakthrough oral medications to patients with OSA, we are exploring multiple drug combinations and patient subpopulations. This drug combination involving a medication commonly prescribed for sleep problems could particularly benefit OSA patients with disturbed sleep – difficulty initiating and maintaining sleep – which we believe represents an important sub-population of OSA patients.” 

BOC names new officers 

OWINGS MILLS, Md. – The board of directors of the Board of Certification/Accreditation (BOC) has named new officers to its 2022 executive committee. They are: Wayne Rosen, BOCP, BOCO, LPO, CDME, FAAOP, clinical consultant, as chair; Abel Guevara III, MHIM, RHIA, CPHT, CDME, director of reimbursement & privacy officer for Abilitech Medical, as vice chair; William “Bill” Powers, MBA, LFACHE, retired COO of the American Nurses Association and retired officer of the Air Force Medical Service Corp., as secretary; Cameron Stewart, BOCO, BOCP, co-founder of Alcam Medical Orthotics and Prosthetics, as treasurer; Rick Todd, COF, president and managing partner of Collier & Laurence Orthotics & Prosthetics, as member at large; and Bradley “Brad” Watson, BOCO, BOCP, LPO, president of Clarksville Limb + Brace + Rehab, as immediate past chair. “BOC’s executive committee showcases the leadership and commitment of our entire board,” said Rosen. “I am honored to lead this dedicated group in achieving continued success for BOC and for those we serve.” 

InfuSystem lays groundwork for significant contributions to top line 

ROCHESTER HILLS, Mich. – InfuSystem Holdings reported net revenues of $26.6 million for the third quarter of 2021, a 6% increase compared to the same period last year. DME services represented revenue of $10 million, a 5% increase.  “In the third quarter, we made substantial progress in diversifying and extending our business by securing one new business relationship and being selected for an additional new business relationship, which we expect will drive significant growth in 2022 and future years,” said Richard Dilorio, CEO. “The first, involving our Pain Management business, was announced via a press release on Nov. 2, 2021. The second, which we expect to announce in the coming weeks following negotiation and execution of a definitive agreement, relates to our expanding biomedical services business. Both of these new relationships have been in development over the course of the current year and are expected to commence before the end of this fiscal year and are expected to begin making significant contributions to our top line in fiscal year 2022.” InfuSystem announced earlier this month that it has entered into an exclusive three-year pain management agreement with a leading U.S. health care provider with more than 12 million members. Other results from the third quarter: gross profit of $15.3 million, gross margin of 57.4%, a net loss of $400,000 and adjusted EBITDA of $5.5 million. 

Reps push for more care in home 

WASHINGTON – Reps. Henry Cuellar, D-Texas, and James Comer, R-Ky., have introduced the Choose Home Care Act of 2021 to give medically appropriate patients the option to leave the hospital and recover at home rather than being discharged to a skilled nursing facility, the only current option under Medicare. H.R. 5514 would provide a time-limited, cost-effective benefit that combines Medicare-covered skilled nursing and therapy with essential personal care, transportation, meal supports, remote patient monitoring, respite care, telehealth and other services. “By combining this set of extended care services with traditional Medicare home health, seniors can leave the hospital and recover at home with increased patient and family satisfaction and reduced exposure to infectious disease — as well as significant savings to Medicare when compared with institutional costs,” Cuellar and Comer wrote in an op-ed in The Hill. Eligibility would be controlled by use of an assessment process that considers an individual’s place-of-care preferences, their medical conditions and their goals and family caregiver abilities. Sens. Debbie Stabenow, D-Mich., and Todd Young, R-Ind., have introduced a similar bill. 

OIG: Seven drug codes up for price substitutions 

WASHINGTON – Seven drug codes met CMS’s price substitution criteria by exceeding the 5% threshold for two consecutive quarters or three of the previous four quarters, according to an update from the Office of Inspector General. If the OIG finds that the average sales price for a drug exceeded the average manufacturer price by a certain percentage – currently 5% – the Social Security Act directs the secretary of Health and Human Services to substitute the ASP-based payment amount with a lower calculated rate. The OIG is providing the seven drug codes to CMS for its review. It says CMS should review this information to determine whether to pursue price substitutions that would limit excessive payments for Part B drugs. 

NorthShore adds fashion 

GREEN OAKS, Ill. – NorthShore Care Supply has launched a video fashion show called MEGAMAX: Style & Protection. The video provides an exclusive look at the MEGAMAX Color Collection Briefs, absorbent tab-style briefs in new colors, black and tie-dye. “Can adult diapers be considered fashion?” said NorthShore President and Founder Adam Greenberg. “At NorthShore, we like to think so. MEGAMAX offers protection and style. Our customers asked and we listened by offering a glimpse of how people managing incontinence can look and feel confident doing the things they love. For people to feel less stigmatized for needing absorbent products, it is helpful to see adult diapers treated as just another form of underwear.” The MEGAMAX Briefs collection was inspired by customer input. Customers with moderate and heavy to total incontinence reached out to NorthShore asking for a high-absorbency incontinence product to address leaks. They also asked for a product that would keep them dry overnight so they could get the rest they needed.