In brief: AAH reports numerous updates, Golden Technologies makes masks for Geisinger

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Friday, March 27, 2020

WASHINGTON – CMS recently updated its COVID-19 FAQ to include coverage for home oxygen for patients diagnosed with the disease.

The agency is currently reviewing the NCDs and LCDs to determine if there are other regulatory barriers that can be removed during this emergency and will provide an update soon, AAHomecare reports.

Other developments, according to the association:

·      Performant Recovery, the DMEPOS RAC, is following CMS’s COVID-19 emergency guidance and holding off on new audits. Starting March 18, the RAC will not be sending any new ADR letters for 30 days. Performant will also work with providers on previous requests, granting them extensions if they’re having difficulties gathering/submitting documentation. The RAC suggests contacting the customer service line at 866-201-0580.

·      The U.S. Food and Drug Administration is allowing vent manufacturers to add product lines or alternative sites to increase production, as well as easing the review process for modifications. The agency is also allowing hospitals to use vents that were intended to be used in other environments and is providing recommendations on other devices that can be used in the place of vents, such as CPAP devices. Finally, the FDA is extending the shelf life of vents to increase capacity.

·      The Trump Administration has invoked the Defense Production Act, which could be leveraged to require vent manufacturers to prioritize government contracts; require manufacturers to make more face masks and other goods, offering loans/promises to buy; and establish a pool of industry execs from leading companies who could be called into government service in the interest of national defense.

AAHomecare has also developed a COVID-19 Resources Page as a home for government and industry resources/updates to help HME providers stay informed.

Ventec partners with GM to ramp up production

BOTELL, Wash. – Ventec Life Systems is collaborating with GM to increase production of its respiratory care products to support the growing fight against the coronavirus pandemic.

Ventec will leverage GM’s logistics, purchasing and manufacturing expertise to build more of its VOCSN multi-function ventilators.

“With GM’s help, Ventec will increase ventilator production,” said Chris Kiple, CEO. “By tapping their expertise, GM is enabling us to get more ventilators to more hospitals much faster. This partnership will help save lives.”

Ventec and GM are partnering in cooperation with StopTheSpread.org, an organization coordinating the private sector response to COVID-19.

“As this virus continues to endanger the lives of countless Americans, StopTheSpread.org is working to unite the business community around a common threat to our economy and way of the life,” the organization stated. “We know the strength of this effort relies on urgent coordination between the public and private sectors to get through this crisis.”

ResMed ramps up production

SAN DIEGO – ResMed is looking to double or triple its output of ventilators and increase more than tenfold its production of masks, says CEO Mick Farrell.

“As a global leader in respiratory medicine, ResMed stands with the world in the face of the latest coronavirus disease COVID-19 and is ready to help mitigate its effects, helping people breathe while their immune system fights the virus,” he said in a March 23 statement. “More than 7,500 Resmedians are working in over 140 countries for this purpose. We are working with governments, health authorities, hospitals, physicians and patients worldwide to assess their needs and to deliver the ventilation therapy that is essential to treat the respiratory complications of COVID-19.”

ResMed is also taking precautions like instituting a work-from-home policy for all employees who can do so, social distancing, and ensuring safe manufacturing practices and top-level hygiene procedures at its manufacturing, service and distribution centers.

Farrell also thanked front-line clinical workers—many thousands of respiratory therapists, nurses, pulmonary and critical care medicine physicians, as well as hospital and clinical staff who set up vents and masks for patients.

“You are the superheroes of this crisis and we salute you,” he said.

Invacare shares mixed impact from coronavirus pandemic

ELYRIA, Ohio – Invacare provided a business update on March 23, saying demand for respiratory products and beds has increased dramatically but demand for mobility and seating products has slowed.

“While demand of our respiratory products and beds continues to spike, we have experienced a reduction in the momentum of our mobility and seating product line over the past few weeks,” said Matt Monaghan, chairman, president and CEO. “This has been caused by a shift in priorities of our institutional customers, as well as new restrictions on onsite commercial interactions at hospitals and long-term care facilities, all of which is reducing our sales force’s access to, and personal contacts with, our customers.”

Invacare has been deemed an essential business as defined by the U.S. Department of Homeland Security and all of its global manufacturing facilities are operational.

The company says it’s doing all it can to increase production of respiratory products and beds, including working with local and federal agencies to expedite the process of securing necessary materials.

“Invacare is uniquely positioned to be part of the solution combatting this global pandemic as we offer essential healthcare products for those impacted by this virus,” Monaghan said.

For mobility and seating, Invacare believes it will be some time before “normal customer engagement and clinical fittings occur as clinical care areas focus on acute priorities related to this pandemic,” Monaghan said.

“We remain committed to continuing to grow our mobility product pipeline and launch new, innovative products that will help drive profitable growth over the long-term,” he said.

Invacare says it is taking actions to ensure it has the appropriate resources allocated to those business units that are experiencing increased demand, while taking steps to mitigate negative financial and operational impacts of COVID-19.

“As of March 20, we are pleased with our consolidated business performance to-date with first quarter results expected to be in line with previous guidance, including flat year-over-year sales and free ash flow similar to 1Q19,” Monaghan said.

NC board paves path to increase RTs

CHARLOTTE, N.C. – The North Carolina Respiratory Care Board has implemented waivers reducing the licensing time for respiratory therapists from 30 days to two days, according to the ACMESA. Doing so will allow the state to increase the number of RTs available as the state and nation grapple with the coronavirus outbreak. “In an effort to expedite licensing for respiratory therapists in this time of heightened need, we are sending digital copies of the application packet out to all applicants,” wrote Dr. William Croft, executive director of the board. The NCRCB has sent out packets by hard copy and by email, with the two-day process working only with the emailed version. The mailed version will take a week.

AOPA monitoring ‘essential’ businesses

ALEXANDRIA, Va. – The American Orthotic & Prosthetic Association has stated that O&P facilities will continue to be exempt from state and municipal orders restricting or closing non-essential business until further notice. AOPA has reviewed the orders and found language that deems healthcare facilities as essential. This exemption applies to both patients and employees. AOPA will alert its members if additional restrictions are implemented that affect the operation of O&P businesses.

DarioHealth appoints new CMO, VP

NEW YORK – DarioHealth has appointed Omar Manejwala to the newly created position of Chief Medical Officer. As CMO, Manejwala will lead clinical delivery and quality and support to product and sales teams. Prior to joining DarioHealth, he was CMO for Catasys, a firm specializing in the blend of human engagement with technology. DarioHealth has also named Barbara Stark as senior vice present and head of managed markets. Stark has more than 35 years of experience and most recently worked at One Homecare Solutions.

TBO maintaining operations

MODESTO, Calif. – Tactical Back Office, a firm offering remote personnel services for processing HME orders, has continued operations throughout the coronavirus outbreak, resulting in little disruption for its clients, while keeping employees and clients safe. The company currently provides remote personnel to HME companies nationally.

Golden Technologies to make masks for Geisinger

OLD FORGE, Pa. – Golden Technologies, better known as a manufacturer of power mobility devices, has begun sewing cloth face masks to donate to Geisinger Health System. “Concerned about the availability of medical supplies in our area and around the country, we identified a way t use the exceptional skills of our employees in our power lift chair division and the capabilities within our manufacturing facility to quickly produce disposable face masks four our local healthcare providers,” said CEO Rich Golden.

Bedard partners to create, donate masks

LEWISTON, Maine – Bedard Pharmacy & Medical Supplies has teamed with a local manufacturer, Allen Manufacturing, to begin manufacturing and distributing cloth face masks. Anyone bringing unused N95 masks can trade those toward the cloth masks, which provider expects have available in its locations by March 27.The N95 masks will be distributed to front-line medical professionals including at area hospitals. The cloth masks will be available free to the elderly and other high-risk populations, and available for purchase for $5 with proceeds going toward expanding the PPE supply chain locally.

Caire ups production of 02 equipment

BALL GROUND, Ga. – Caire has added production shifts, extended work hours and is expanding production lines at its facilities in Ball Ground, Ga., Buffalo, N.Y., and Chengdu, China, to meet the increased demand for oxygen equipment due to the coronavirus pandemic. “As the Covid-19 virus has spread in recent weeks, we have seen a dramatic increase in demand for stationary oxygen from our customers globally—particularly from those who are providing emergency aid in pandemic hot zones,” said the company.

DarioHealth receives nod of approval

NEW YORK – DarioHealth’s Diabetes Management System has been endorsed by the U.K.-based ORCHA as being safe and suitable for children. ORCHA, a global health app evaluation adviser, said Dario’s app is especially useful for helping parents monitor their child’s information. The organization has also included Dario Health on its of coronavirus apps. "The ongoing COVID-19 pandemic has made it difficult for millions of patients worldwide with chronic disease to access healthcare though conventional channels,” said Erez Raphael, CEO of DarioHealth. “This recognition from ORCHA further validates the use of our platform technology for remote patient monitoring for chronic care management, especially in these challenging times.

OxyGo continues to operate

ORLANDO, Fla. – OxyGo and its affiliates Applied Home Healthcare Equipment and SuperFlash Compress Gas Equipment have been deemed essential businesses and will continue to operate as critical infrastructure of health care and public health as identified by the U.S. Department of Homeland Security. The company says all of its locations are complying with all CDC, WHO and federal, state and local government mandates. All of its products are disinfected, and employees are observing required hygiene practices and social distancing. OxyGo is also asking vendors to prioritize OxyGo purchase orders and shipments so it can continue to serve those with respiratory disease during the crisis.