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.” 

PHOENIX - While labor is the No. 1 cost center for HME providers, it’s also the No. 1 thing they can control, says John Skoro, president of Xmed Oxygen and Medical Equipment. Here’s what Skoro, who will be co-hosting a session on how to leverage technology to automate referral processes, had to say about mitigating costs with e-prescribing. HME News: Why is it so important for HME providers to play an active role in “selling” technology to automate referral processes and e-prescribe? John Skoro: We might say, “Hey, it only takes my customer service person six to seven minutes to do an order,” but the reality is it might take them 30 minutes between doing the order, going back to the fax machine, sending it out, getting an email, reading it over, and resending it again. Whereas e-prescribing lets you do that order correctly—upfront—and takes the complexity out of all the different types of requirements. The end result is that our customer service personnel could do three to four times as many orders than they could without using the technology. HME: What’s a good tip for talking with referral sources about how to use this technology?  Skoro: It's about saying, “I'm going to save you time for something you are not getting paid for,” and who wouldn't want that? The second challenge is, “How do I do this, this looks really complicated,” and you have to be able to say, “We're here with you every step of the way.” HME News: If attendees walk away with one thing from your session, what should that be?  Skoro: We all benefit from strength in numbers. Even if I lose a relationship with a referral source, the next guy benefits if he's using similar technology, because I already trained that particular health system, and that's good for everybody.

SAN DIEGO – ResMed says a draft technology assessment that shows published studies mostly do not support that CPAP therapy affects long-term clinical health outcomes bypasses “a generation of data in real-world evidence.” The company submitted comments on the 155-page assessment, presenting peer-reviewed and published data that show CPAP therapy improves quality of life, reduces health care costs and even reduces mortality. The data show a reduction in the incidences of heart attacks, a reduction in hypertension and a reduction in the incidences of solid cell cancer tumors, says CEO Mick Farrell. “These data prove that in partnership with our physician and provider colleagues in the market, we are saving lives and saving money for the health care system through our medical technology,” Farrell during a conference call to discuss the company’s most recent financial results. CMS requested that the Agency for Healthcare Research and Quality evaluate the evidence on the improvement of long-term clinical health outcomes with CPAP treatment, as well as the validity of criteria used as surrogate outcomes, and seek comments. Farrell also highlighted recent decisions by the health ministries in France, Germany and Japan to reimburse for digital health to treat OSA and recently published draft guidelines from the National Institute of Clinical Effectiveness (NICE) in the U.K. recommending that CPAP therapy, along with telemonitoring, is the frontline treatment option for patients with mild OSA. “That would be an expansion of coverage in the U.K. and also an expansion of the use of digital health technology in that market,” he said. It’s this kind of real-world evidence that needs to be incorporated into the assessment, says David Pendarvis, chief administrative officer and global general counsel. “We believe AHRQ is taking a very narrow perspective on looking at the clinical literature, looking only at randomized controlled trials done under certain very careful criteria,” he said. “While traditionally that has been the hallmark of the gold standard of trials, we think, particularly in this industry, you’ve got a massive amount of real-world evidence and a lot of other longitudinal trials that clearly demonstrates benefits. All of that evidence ought to be used to come to a conclusion.” Farrell pointed out that there are randomized controlled trials, or RCTs, that show CPAP therapy does affect outcomes, but they weren’t included in the assessment. “So, if you’re just looking at RCTs even, you need to include some of those RCTs which were very positive,” he said, “and the AHRQ just looked at some neutral RCTs and said, well, neutral means no benefit. There’s all these other proponents of evidence and RCTs that are positive.” Farrell continued: “We are optimistic that the final report, when issued, will reflect the preponderance of real-world evidence and broader RCTs showing both the clinical and economic benefits of treating sleep apnea with positive airway pressure.”

We’ve been doing a lot of talking here at HME News about the Philips recall. In fact, I’m pretty sure that’s all anyone’s been talking about in the industry, on webinars, on state association calls, to me.Forget COVID. "This is going to be far worse,” is a common refrain.It’s not hard to understand why, even as we don’t yet fully know how far the ripple effect will spread. While the immediate concerns have focused on just getting information to communicating with patients to worrying about the existing supply chain issues, longer range are billing concerns and blowback from insurers and the general public.I suspect many providers will also see a small percentage of patients who may have already been on the fence about using CPAP use the recall as an excuse to “throw away the device,” as one panelist said on a June 18 webcast hosted by the American Academy of Sleep Medicine, which drew so much interest not everyone who wanted to could join in.In speaking with CPAP providers, the reactions range from furious (“I am so angry with Philips right now it is probably best I do not express my opinions” from one provider) to sympathetic (“This type of a recall is fairly unprecedented for our industry so I’m patient,” said another).At any rate, the recall is certainly keeping us hopping here at HME News. Unfortunately, I suspect it's also causing a lot of sleepness nights out there, too.

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. 

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. 

YARMOUTH, Maine – Obstructive sleep apnea is often under recognized 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. 

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.

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.  

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.

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.

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 said on Friday that it planned to provide additional perspective on the guidance this week. 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.  

YARMOUTH, Maine – Manufacturers like ResMed and 3B Medical are ramping up production to meet increased demand due to a voluntary recall of millions of Philips CPAP devices, but their efforts are complicated by supply chain and other challenges. “Yes, we’re ramping up production as quickly as possible, while working closely with our global supplier network to navigate the well-known global supply chain challenges impacting this and other industries,” said Jayme Rubenstein, a ResMed spokesperson.  Following the announcement of the recall on June 14, ResMed told customers to place all orders for CPAP and APAP devices for the month by June 18. The company expects to start taking new orders on, or soon after, July 1. Due to supply chain challenges, ResMed says it is prioritizing orders with “highest-acuity needs,” Rubenstein says. “Our top priority is patients’ safety and wellbeing,” he said. 3B Medical says it is working with its factory to guarantee a higher number of CPAP devices – “a large multiplier over what we’re currently getting from them,” says Katherine Royster, vice president of sales and marketing. “We are surging manufacturing and relying on air freight for the next two months to raise stocking levels to meet demand,” she said. Following the announcement of the recall, 3B also paused sales and implemented a “priority allocation” program, whereby the company is negotiating strategic agreements with customers to “protect the availability of CPAP devices” based on their historical purchasing levels, Royster says.  “We’re really looking at identifying strategic partners who are looking at a relationship with us for the long-term,” she said. “The day the recall happened, we got thousands of orders from brokers and third parties. We put everything on hold so we could investigate every account. We didn’t want anyone buying everything and flipping it at a profit.” Fisher & Paykel Healthcare says it has seen an increase in demand for its CPAP devices, but due to supply chain challenges, “we are currently unable to increase production rates significantly,” says Subbarao Potharaju, director of marketing for homecare. “We appreciate this is a difficult situation for our customers and will update our field sales teams if the position improves,” he said.  In many ways, the timing of the Philips recall couldn’t be worse. Combine supply chain challenges with the pent-up demand for CPAP therapy from the COVID-19 pandemic, and all manufacturers are strained. “It’s a perfect storm,” Royster said. “At the end of the day, it’s all about taking care of the patients and the industry as a whole, as we navigate through this.”