In brief: MedPAC finds no change in health outcomes, CMS suspends CERT reviews

WASHINGTON - Medicare spending for diabetes testing supplies decreased by 88% between 2010-2017, according to a new report from the Medicare Payment Advisory Commission, but health outcomes have remained stable.

Since the national mail-order program was implemented in 2013, the use of diabetes testing supplies is down overall, but retail sales of supplies is up, says the report, “Examining Impacts of the National Mail-Order Program on Medicare Service Utilization and Beneficiary Health Outcomes.”

MedPAC found that health outcomes have stayed the same for diabetics and insulin users, and rates of hospitalization emergency room visits and mortality have stayed the same for those users since the program began.

The national mail-order program is on hold indefinitely.

AAH launches survey to assess business costs related to pandemic

WASHINGTON - In response to a request from CMS, AAHomecare is conducting a survey of HME providers and manufacturer/distributors to assess increased company costs and supply disruptions related to the COVID-19 pandemic. The association and other industry stakeholders believe CMS should delay the Medicare bidding program by at least one year due to the market disruption. The deadline for the survey is Tuesday, April 21. All survey information remains confidential.

Click here to take the provider survey.

Click here to take the manufacturer/distributor survey.

AAH releases reimbursement tool

WASHINGTON - AAHomecare has developed a tool to help providers analyze the estimated 75/25 blended rates for non-rural, non-competitive bid areas during the public health emergency.

The tool allows providers to choose their state in the dropdown menu, filter by product and find the estimated rate.

The blended rates are effective March 6, but CMS has not published the rates yet.

In the interim, the DME MACs will reimburse providers at the 100% adjusted rate and will refund them when their claims systems are updated.

The CARES Act recently passed by Congress and signed by the president extends the 50/50 blended rate to rural areas and establishes the 75/25 rate for non-rural, non-bid areas—both for the duration of the coronavirus pandemic.

AAHomecare offers relief fund calculator

WASHINGTON - Providers can calculate their relief fund payments using a calculator posted on AAHomecare's COVID-19 resources page. The Department of Health and Human Services is in the process of dispersing $30 billion to Medicare fee-for-service providers to help offset the costs and revenue loss during this public health emergency. The payment amount will be based on a company's payments from Medicare FFS in CY2019. Payments will be made to the Automated Clearing House account on file with UnitedHealth Group or CMS. The payments will be from Optum Bank and will have the description “HHSPAYMENT.” For providers that usually receive payments by check, they should be receiving a relief fund check in the coming weeks. Although many have already received the relief fund payments, there are still many who have not. AAHomecare has received word that payment distribution may take up to two weeks.

CMS adds CERT to reviews that are suspended

WASHINGTON - CMS will pause its CERT program, and will not send documentation request letters to or conduct phone calls with providers until further notice, according to AAHomecare. An original statement from the agency on March 30 stated MAC, SMRC and RAC reviews would be suspended during the public health emergency. The DME MACs also announced during a webinar last week that they would release all pending TPE reviews and would pay those claims, AAHomecare reports. Providers that have completed a TPE round prior to the emergency and have a scheduled session may move forward with the session or reschedule it, the association says.

GEMCO adapts, donates protective wound dressing

HUDSON, Ohio - GEMCO Medical has provided an adaptation guide for its GEMCORE360º Silicone Lite Foam Wound Dressing to help provide a layer of facial protection to health care workers wearing personal protective equipment for long periods of time. The manufacturer is also donating 8,000 pieces with adaptation guides to University Hospitals and the Cleveland Clinic. “In our conversations with University Hospitals and the Cleveland Clinic, both hospital systems voiced the need for this type of interface,” said Paul Tracy, president of GEMCO Medical and its parent GEMCORE. “We are incredibly grateful to all the health care workers under these extraordinary circumstances, and as an essential business, we will continue to explore ways we can help during this pandemic.”

FODAC steps up with PPE

TUCKER, Ga. - Friends of Disabled Adults and Children is providing personal protective equipment and other medical supplies to medical centers and hospitals in Georgia. The nonprofit addresses shortages of critically needed medical supplies for health care facilities throughout Georgia, in addition to its main mission of providing DME to people with disabilities. “FODAC has a long history of quick response to large disaster situations, and COVID-19 is certainly a national disaster,” said Chris Brand, president and CEO of FODAC. “We are proud to support the medical community as they courageously continue their work on the frontlines of this global pandemic.” FODAC has also offered to serve as a warehouse distribution site for donations of critical supplies.

Insulet extends financial assistance to 'Podders'

ACTON, Mass. - Insulet, maker of the OmniPod system, has expanded its U.S. financial assistance program for current customers who have been negatively impacted by COVID-19. Upon meeting certain financial criteria, those customers may receive up to a six-month supply (60 pods). “Our coronavirus response plan is guided by our fundamental principles of protecting the health and safety of our employees, preserving the well-being of the communities in which we live and work, and ensuring that customers have continued access to our life-sustaining medical therapy,” said Shacey Petrovic, president and CEO. “Our Podders are part of our community.”

3B Medical receives FDA approval for emergency use of certain devices

WINTER HAVEN, Fla. - 3B Medical has received Emergency Use Authorization from the U.S. Food and Drug Administration for its High-Flow H80 System and its Luna BPAP ST non-invasive respiratory devices for use in the U.S. during the COVID-19 pandemic. “I am pleased that 3B Medical will be able to join the manufacturing industry's collective surge in production capacity to meet global shortages across the board for all therapeutic devices used to treat COVID-19 patients,” said Dr. Jose Llana, vice president of sales.

Invacare sees increase in demand for respiratory

ELYRIA, Ohio - Invacare continues to see high demand globally for its respiratory products, beds and therapeutic support surfaces, which it says are vital in the fight against the coronavirus pandemic, the company said in a business update on April 14. The company is working to increase capacity to produce these products and resolve global supply chain challenges compounded by the effects of the pandemic. “As a result, there are practical limits to the extent we can increase output,” said Matthew Monaghan, chairman, president and CEO. “And we are taking steps to offset cost increases from pandemic-related supply chain disruptions.” Invacare is experiencing a global decline in quotes for mobility and seating products, and expects a decline in orders. It expects, however, for demand to rebound once COVID-19 related priority care and public health policies are relaxed. Invacare expects to report unaudited and preliminary net sales of about $218 million for the first quarter of 2020, a 2.2% decrease compared to the same period in 2019. Preliminary results for the quarter were largely ahead of the influence of the coronavirus, and reflect growth in respiratory and mobility and seating products offset by a decline in lifestyle products.

Philips gets approval for new vent under emergency use authorization

AMSTERDAM - Royal Philips has introduced a ventilator, the Philips Respironics E30 ventilator, designed for large scale production. The vent can be used invasively or non-invasively, offering flexibility to adapt to treatment needs of patients with COVID-19, the company says. “The Philips Respironics E30 ventilator can deliver a range of treatment options, and we will quickly scale its production to 15,000 units per week in April,” said Frans van Houten, CEO of Royal Philips. On April 8, the U.S. Food and Drug Administration authorized the device for use in the U.S. during the COVID-19 public health emergency through its Emergency Use Authorization (EUA) process. Philips is working with the relevant regulatory authorities to also distribute the device globally. The company has started the production of the Philips Respironics E30 ventilator in its New Kensington site in western Pennsylvania, targeting a production of 15,000 per week in April. Philips, which previously announced plans to double the production of its hospital vents for May 2020 and achieve a four-fold increase by the third quarter, has invested several tens of millions of dollars in additional tools and molds, final assembly lines and test facilities, and has hired extra manufacturing employees and changed to 24/7 shifts.

AdaptHealth bolsters IT capabilities

PLYMOUTH MEETING, Pa. - AdaptHealth has appointed Andy Palan as its first chief technology officer. He brings more than 15 years of senior-level health care technology experience, including CVS Health, where he was head of technology strategy, architecture and innovation, and CTO. Throughout his career, Palan has helped create and deploy scalable IT solutions that address critical business needs in the front and back office, sales and marketing, finance and acquisitions. Those solutions include mobile app development and adoption, business transformation initiatives and technology integrations. At AdaptHealth, Palan will be responsible for the company's enterprise-wide IT platform and spearhead the development of digital-first technology solutions that drive operational improvements, enhance efficiencies, heighten customer experience and support M&A.

FODAC takes 'Run Walk 'n' Roll' virtual

TUCKER, Ga. - Friends of Disabled Adults and Children is reformatting its 20th Annual Run Walk 'n' Roll into a virtual event. The event, one of FODAC's main fundraisers, will call on participants to run, walk or roll at a place of their choosing, away from crowds, on May 9. “COVID-19 has forced all of us to adjust our lives while we attempt to slow the spread of the virus and spare a health care system that is already stretched thin,” said Chris Brand, president and CEO of FODAC. “Changing our annual Run Walk 'n' Roll to a virtual event allows our supporters to help our mission, while giving them a needed break from their household routines.” FODAC aims to raise $20,000 through the event, with 100% of funds raised earmarked toward providing HME at little or no cost to people with disabilities. Donations are tax deductible. FMI: fodac.org/run.

AdvaMed highlights role of NIV in COVID-19 treatment

WASHINGTON - Non-invasive ventilators are a good option for less severe cases of COVID-19-related respiratory problems, according to a series of white papers, published evidence and cases studies from China and Italy. “This could be a game changer in the race to get as many ventilators in the hospitals as we possibly can,” said Scott Whitaker, president and CEO of AdvaMed. “A large majority of COVID patients could benefit from these respiratory devices, easing pressure on our critical care system in hospitals and offering another lifesaving option for tens of thousands of people suffering from respiratory problems.” As governments and health administrations around the world respond to the global spike in demand for ventilators, many have now issued guidance documents on the use of bilevel or BiPAP devices that deliver NIV in patients with confirmed or suspected COVID-19. A survey of AdvaMed ventilator manufacturers recently found its member companies could produce, on average, 60,000 NIV devices per week by the middle of the second quarter. This estimate represents an increase from approximately 14,000 per week manufactured presently, due in large part to the less complex design of the non-invasive construct. AdvaMed is a trade association with more than 400 members.

Masimo releases SafetyNet to help combat COVID-19

IRVINE, Calif. - Masimo has announced the full market release of its SafetyNet patient management solution designed to help clinicians care for patients remotely in hospital settings and non-traditional settings. The company has successfully piloted the technology at institutions like University Hospitals in Cleveland, and St. Luke's University Health Network in Pennsylvania and New Jersey. Masimo and University Hospitals will hold a webinar on April 15 to discuss SafetyNet and the hospital's experience using the technology, including best practices and protocols. SafetyNet uses a tetherless, wearable single-patient use SET sensor to monitor a patient's blood oxygen saturation and respiration rate, as well as pulse rate, perfusion index and PVi. It combines Masimo SET Measure-through Motion and Low Perfusion pulse oximetry with a cloud-based remote data capture and surveillance platform accessible from a patient's Android or iOS smartphone or smart device.

Short takes: RESNA, Lofta

RESNA'S testing company, Prometric, has extended the closure of its testing center in the U.S. and Canada through April 30. All displaced test takers will be notified of cancellations by email and be given instructions for re-scheduling…Lofta, a virtual sleep wellness company based in San Diego, is offering same-day delivery for home sleep testing kits, CPAP devices and supplies in the San Diego area, and is working to offer it in other major cities. "As more individuals are diagnosed with the coronavirus, our ability to provide products and services will become increasingly paramount and Lofta can make a real difference due to our virtual and rapid delivery model,” said CEO Jay Levitt.