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In brief: Spiro Health grows, FDA warns, AAH comments

In brief: Spiro Health grows, FDA warns, AAH comments

SANDWICH, Mass. - Spiro Health has acquired Absolute Respiratory Care in Johnston, R.I., further cementing its presence in New England and the Northeast. 

Absolute Respiratory Care offers a full range of home medical equipment and supplies with a focus on sleep services. Through wireless monitoring, the provider has created a touchless telehealth model for sleep therapy. 

“Absolute Respiratory Care is excited to join with the team at Spiro Health,” said Jayne Matoian, president of Absolute Respiratory Care. “We look forward to collaborating on best practices, maintaining continued growth, and driving industry leading clinical outcomes. We know that this integration will ensure we can continue to deliver excellent patient care, especially as we continue to scale.”   

Spiro Health has operations in eight states and the District of Columbia. 

In October, Spiro Health acquired Burlington, Vt.-based The Medical Store. 

FDA on oxygen concentrators: Don’t try them at home without scripts 

WASHINGTON – The U.S. Food and Drug Administration warned consumers not to use oxygen concentrators in their homes unless prescribed by a health care provider in a consumer update posted to its website on Oct. 30 as the number of cases of COVID-19 spikes across the country. 

The agency says giving yourself oxygen without talking to a doctor first may do more harm than good. 

“You may end up taking too much or too little oxygen,” it says. “Deciding to use an oxygen concentrator without a prescription can lead to serious health problems, such as oxygen toxicity. It can also lead to a delay in receiving treatment for serious conditions like COVID-19.” 

The FDA also warns consumers that, as with any device, there is always a risk of an inaccurate reading with pulse oximeters used to monitor oxygen levels. 

The agency advises consumers to contact a health care provider if they are concerned about a reading. 

“And do not rely on a pulse oximeter,” it says. 

AAHomecare comments on product innovation 

WASHINGTON – CMS needs to move away from the gap-fill methodology and develop an alternative payment system, AAHomecare urges in comments to a recent proposed rule on innovation and technology

The association says a new payment system would ensure appropriate payment and access, should a device receive approval under the proposed “Medicare Coverage of Innovative Technology” (MCIT). 

CMS has proposed MCIT as a streamlined pathway for “FDA-designated breakthrough medical devices” to get Medicare coverage. The agency’s rule also proposes codifying the definition of “reasonable and necessary” that will be used under the MCIT and other coverage determinations, such as NCDs and LCDs. 

AAH’s other points include: 

The association disagrees that a product must be within a benefit category to be eligible under MCIT. This restriction seems at odds, it says, with the intent to open coverage to innovative technology which, often by definition, will not fit in an established benefit category. 

It believes the agency should consider including digital therapeutics, which currently don’t have a benefit category, under the existing benefit category of DME. 

It supports the agency’s proposal to codify the current Program Integrity Manual definition of “reasonable and necessary” with some modifications. 

It supports the addition of commercial plan coverage language, as long as the agency is transparent about the evidence it uses to determine that individuals covered under commercial plans are clinically different from Medicare beneficiaries. 

It requests CMS to abandon its restrictive interpretation of the “in-the-home” language in Section 1861 of the Social Security Act for coverage of DME to improve beneficiary access for rehab and assistive technology. 

Viemed sees double-digit growth in core biz 

LAFAYETTE, La. – Viemed Healthcare reported total revenues of $33.4 million for the third quarter of 2020, including $8.6 million in product sales and services related to the ongoing COVID-19 pandemic. 

Revenues attributable to the company’s core business were $24.9 million for the quarter, a 22% increase compared to the same quarter in 2019. 

“This year has challenged the health care system in an unprecedented manner with the ongoing respiratory pandemic creating a strain on the acute-care facilities around the country,” said Casey Hoyt, CEO. “We all look forward to a day where the pandemic is behind us, and until then, we will continue to serve as a resource, while delivering value to our shareholders.” 

Viemed reported adjusted EBITDA of $7.7 million and an all-time high cash balance of $32.4 million. 

Total revenues for the nine months ended Sept. 30, 2020, were $100.1 million and revenues attributable to the core business were $70.8 million. 

Numotion expands Upstate New York presence 

BRENTWOOD, Tenn. - Numotion has opened a location in Buffalo, N.Y., its fourth in the upstate area and its fifth in the state. The new location builds on Numotion’s acquisition of Syracuse-based Monroe Wheelchair in February. “Building upon our acquisition of Monroe Wheelchair earlier this year, we are excited to open our fourth location in the upstate region and fifth location overall in the State of New York,” said Gary Gilberti, executive vice president, East Division, for Numotion. “Numotion remains committed to expanding our physical presence and our national network of experienced assistive technology professionals to reach more individuals in need of mobility and independence solutions.” The new location will be staffed by an assistive technology professional, and additional dedicated service and support teams. Numotion currently has locations in the state in Rochester, Syracuse, Albany and New York. 

Medtrade offers education on timely topics 

ATLANTA – The Medtrade Virtual Conference last week explored CMS’s decision to remove 13 product categories from Round 2021 of the competitive bidding program. The conference, which took place online Nov. 4-5, featured more than 25 educational sessions that are still available on-demand, including “CMS Competitive Bidding Announcement and Legislative Update: Where Do We Go From Here?” A pass is $79. “It’s not uncommon to pay more than that for just one webinar, so the $79 is an excellent deal,” said Sarah Varner, senior marketing director. “And as you might expect, the Medtrade Virtual Conference will feature several COVID-specific sessions.” COVID-specific sessions included a “COVID-19 Ask The Experts Panel” with Cara Bachenheimer, Andrea Stark, Kim Brummett, and Laura Williard; and “Audit and Compliance in the Post-Pandemic Era” with Wayne van Halem and Kelly Grahovac.

Ventec Life Systems honors RTs 

BOTHELL, Wash. – Ventec Life Systems recently donated $10,000 to a COVID-19 RT Fund created by the American Association of Respiratory Care’s board of directors. The fund sends financial assistance to the surviving families of licensed respiratory therapists who have died while caring for patients with COVID-19. Ventec Life Systems made the donation during National Respiratory Care Week, Oct. 26-31. “Respiratory Care Week shines a light on the vital role respiratory therapists play, and the COVID-19 pandemic illustrates the bravery and commitment of RTs each and every day,” said Chris Kiple, CEO of Ventec Life Systems. “We are proud to honor the sacrifice of those who dedicated their lives to this profession and in doing so saved countless lives.” Through the fund, the AARC grants $500 to the family of each licensed RT who contracted COVID-19 while working and then died from complications of the disease. It will also donate two commemorative blocks in the AARC Virtual Museum, one for the RT’s family and one for the RT’s employer. To date, the AARC has been able to assist 21 families. More than 1,000 health care workers have now died as a result of caring for patients with COVID-19, according to the Centers for Disease Control and Prevention. 

Soleo Health expands relationship with AscellaHealth 

FRISCO, Texas – Soleo Health has been selected by AscellaHealth as a tier-one preferred provider for the care and management of its members requiring intravenous immunoglobin therapies (IVIG), as well as subcutaneous immunoglobin therapies (SCIG). Soleo Health is one of only two preferred providers of immunoglobin therapy for AscellaHealth, a national specialty pharmacy benefit manager, serving commercial, Medicare and Medicaid markets. AscellaHealth manages care for thousands of members with immunodeficiencies and autoimmune disorders and Soleo Health now provides clinical support to members in need of IVIG and SCIG therapies. Soleo Health brings to the table its Therapeutic Care Management Centers staffed with a specially trained, local and national interdisciplinary IG-focused team. Previously, in July, Soleo Health became one of four exclusive providers for AscellaHealth in the care and management of its hemophilia members. 

CTF names new leaders 

VENICE, Fla. – The Clinician Task Force has announced new leadership for 2021-23, including Dr. Cara Masselink as executive director. Masselink replaces Cathy Carver, PT, ATP/SMS. She will serve a two-year term. The CTF also welcomes Nicole LaBerge, PT, ATP, to the executive board. She replaces Lorri Bernhardt, PT, MPT, ATP. Masselink, who has been active in the CTF for a few years, recently led a clinical subgroup for the ITEM Coalition providing clinical input for an NCD recommendation to CMS for coverage of power seat elevation and power standing. She is currently on the faculty in the occupational program at Western Michigan University in Kalamazoo, Mich. LaBerge is currently a Level III senior physical therapist and ATP at Hennepin Healthcare in Minneapolis. She has been a practicing neurological PT for 15-plus years and an ATP for 13-plus years. Both Carver and Bernhardt will remain active members of the CTF. 

VGM Insurance marks 30 years in business 

WATERLOO, Iowa – VGM Insurance Services, a division of VGM Group, is celebrating 30 years providing specialty insurance programs for a variety of niche industries. “We’re excited to celebrate such an important milestone,” said Mike Mallaro, VGM’s CEO. “VGM Group as a whole has experienced significant growth over the past three decades, and VGM Insurance has been essential to that progress.” Over the last five years, VGM Insurance has seen tremendous growth – it has made strategic acquisitions and diversified from servicing primarily HME providers to many other allied health care classes, in addition to businesses in the golf and hospitality industries. Its portfolio of coverage has also grown to include general and professional liability, property, workers’ compensation, excess liability, business auto, cyber liability, employment practices liability and more. 

ACHC offers distinction in telehealth 

CARY, N.C. – The Accreditation Commission for Health Care has launched its Distinction in Telehealth for health care providers in collaboration with Health Recovery Solutions, a national provider of telehealth and remote patient monitoring solutions. As the focus on telehealth expands, providers are turning to digital telehealth options as safe, efficient and cost-effective alternatives to traditional in-person visits, especially during the COVID-19 pandemic, ACHC says. “Telehealth is dramatically changing the way we view health care,” said Matt Hughes, director of business development for ACHC. “ACHC and HRS share a commitment to promoting comprehensive advancements in telehealth throughout the industry. This will open new avenues for providers, giving them more opportunities to ensure continuity of care and minimize risk.” ACHC and HRS based standards for the distinction on telehealth clinical guidelines of the American Telemedicine Association. ACHC clinical experts collaborated with Patty Upham, vice president of clinical services at HRS, and Beth O’Leary, a physician assistant affiliated with University of North Carolina Health Care, to develop the standards. The distinction is available for organizations offering services in ambulatory care, behavioral health, home health, hospice, private duty and renal dialysis. 

Option Care Health ‘rises to challenge’ 

BANNOCKBURN, Ill. – Option Care Health reported net revenue of $781.6 million for the third quarter of 2020, an increase of 27% over the same quarter in 2019. Gross profit was $174.2 million or 22.3% of net revenue, an increase of 26%. Adjusted EBITDA was $59.2 million, an increase of 70%. “The third quarter was very productive for Option Care Health as we continue to serve patients relying on us for critical infusion therapies while also laying the foundation for sustained organic growth,” said CEO John Rademacher. “Despite a very challenging operating environment, the team continues to rise to the challenge and reinforce the reliability and dedication of the Option Care team.” The COIVD-19 pandemic continues to have an impact on operations, although referrals increased relative to the second quarter, with referrals for chronic patients showing the largest improvement, say company execs. 

NHIA urges caution on policy changes 

ALEXANDRIA, Va. – The National Home Infusion Association says it’s encouraged by CMS’s acknowledgement that broader access to home infusion services is necessary, but it urges the agency to use caution with any proposed changes to coverage policies. In a recently published proposed rule, CMS proposes expanding the classification of external infusion pumps. “While CMS appears to recognize the need to expand access to home infusion, including for patients suffering from rare diseases, this approach fails to truly modernize the Part B benefit and adds confusion for physicians, providers and beneficiaries relying on these services,” said NHIA President & CEO Connie Sullivan, BSPharm. “We look forward to providing comments on this and other approaches to expanding coverage for home infusion.” Under the proposal, CMS would clarify that, in those circumstances in which an individual is unable to self-administer certain drugs, such drugs can be covered as a supply necessary for the effective use of an external infusion pump under the DME benefit, and that both the pump and the associated supplies can be covered under the DME benefit if reasonable and necessary, but only if the associated home infusion therapy services are also furnished and covered by Medicare. Despite the intent of the proposal, NHIA has concerns that this approach will jeopardize coverage for life-saving therapies for the thousands of beneficiaries relying on existing coverage of home infusion drugs under Medicare Parts B and D. The association believes CMS’s proposed policy changes will have far-reaching impacts and is concerned that the agency is under-estimating the unintended consequences of this proposed policy. 

NHIA announces virtual event for 2021 

ALEXANDRIA, Va. – The National Home Infusion Association will hold its 2021 Annual Conference virtually, April 19-22. “During the public health emergency (PHE), home and specialty infusion services are more critical than ever,” said Jennifer Charron, COO. “Nothing replaces in-person interaction, but we are confident the NHIA team can provide the same high-quality education and opportunities for engagement that attendees expect from the annual conference.” Registration for the 2021 Annual Conference is now open. For more information and registration, visit

CareCentrix offers home health report 

HARTFORD, Conn. - CareCentrix has published a report, “Health-at-Home 2020: The New Standard of Care Delivery,” that offers a deep dive into current attitudes about home health care and demonstrates why the trend toward care at home is in the best of interest of payers and patients. The report also includes perspectives from providers and policymakers who look at growing opportunities in home health care. Report highlights include: 95% of payers agree treatment at home is often more cost effective in the long term than treatment in a facility; 95% says supportive care and coaching at home can extend the reach of the primary care provider; and 48% have already expanded home health care options. To order the report: 


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