In brief: Noridian provides guidance, Lifeway Mobility gets PE boost, Medicaid gets new director

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 should DME suppliers address the situation with Medicare beneficiaries who are in the first 90-days adherence metric in the PAP and RAD Local Coverage Determinations (LCDs)? 
Response: During the Public Health Emergency (PHE), CMS has instructed the DME 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 should DME suppliers do if a beneficiary wishes to return their Philips Respironics product that is impacted by the voluntary recall? 
Response: Suppliers are reminded that the CMS Supplier Standards (42 CFR 424.57) 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 continue PAP, RAD or 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 a DME supplier continues to bill for PAP, 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 the DME supplier stop billing for rental? Is it a break in service that they simply pickup when the new equipment is provided? 
Response: Yes, the DME supplier 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. CMS defines 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.