May 2020

COVID-19: Highlights of Responses—Clinical, Economic, Regulatory

The pandemic caused by COVID-19 (brought on by the severe acute respiratory syndrome coronavirus, SARS-COV-2), has now touched every continent, save Antartica. The World Health Organization (WHO) is now estimating the global death toll will reach 400,000 by mid-June, with no end in sight. Hopes for an early vaccine were bolstered by recent positive findings from clinical trials, but the trials must be allowed to run full course and the data must be thoroughly analyzed before we have the evidence to move forward. Things are moving at a rapid pace in multiple spheres. Here’s a quick recap of what we’ve seen happening—both clinically and in the world of business.

Distinct Coagulopathy and Cloth Face Masks

Researchers, both public and private, are seeking to understand how the virus infects the human body and why it is so devastating to some. What seems clear is that, for some, it can be far more than the respiratory syndrome initially identified. In a new review published in the Journal of Clinical Medicine, Marchandot and colleagues in France discuss the distinct coagulopathy that appears to affect some individuals and the disproportionately worse outcomes they suffer as a result. The authors conclude: The relationship between COVID-19 and thrombogenesis seems deeply intricate, complex, and still little understood. And call for research to further explore whether the COVID-19 related coagulopathy is new or is part of the well-known sepsis-induced pattern.

Data show that nearly 81% of those who report COVID-19 symptoms are classified as mild cases that are treated at home. However, rapid spread has been seen from symptomatic, pre-symptomatic, and asymptomatic individuals, making testing ever more important and reaffirming the need for face masks to reduce droplet transmission. The Centers for Disease Control and Prevention continues to recommend the wearing of cloth face masks in public settings where other social distancing measures are difficult to maintain (eg, grocery stores and pharmacies), especially in areas of significant community-based transmission.

Business Community Stepping Up

Numerous businesses are stepping up to support essential workers. Let us know what YOU’RE doing so we can let others know as well.

ADDG Provides SelectFlex Insoles to Genentech Employees, Donates to Global Giving

Alliance Design & Development Group (ADDG), Matawan, NJ, co-creator of SelectFlex, commercially available adjustable arch insoles, became an ergonomic vendor for Roche subsidiary Genentech. Genentech is a developer of medicines for serious diseases, including a new treatment for severe COVID-19 pneumonia that was recently approved for clinical trial by the US Food & Drug Administration. As a vendor, ADDG’s SelectFlex insoles are now among the health and safety offerings in Genentech’s employee Ergo Room, which means ADDG is supporting the efforts of a biotechnology company on the forefront of fighting coronavirus. ADDG is also donating 10% of all SelectFlex sales to the Global Giving Coronavirus Relief Fund.

Allard Offers 5% List Price Reduction on AFOs Amid Covid-19 Pandemic

Allard USA, Rockaway, NJ, announced it has reduced list prices on all Allard AFOs by 5% immediately, effective through year-end 2020. The basis for the decision is twofold. First, to help practitioners reduce the number of face-to-face visits by fitting patients with a customizable carbon fiber AFO versus the requirements of fitting a patient with a traditional plastic AFO, said Dennis Williams, Allard USA CEO. Second, to help practitioners financially amid the COVID-19 pandemic. “We care about our O&P community and want to help our orthotists be successful; reducing their cost is one way we can give back,” said Kelly Millard, Allard USA Director of Sales.

DJO Offers 6-Month Free Access to TJA Outpatient Risk Assessment Tool

DJO, a subsidiary of Colfax Corp., Austin, TX, announced that its OaraScore patient risk assessment algorithm will be available with a 6-month free trial for all new users. This offer is being made available to support the resumption of elective orthopedic procedures (which were suspended due to COVID-19), help surgeons qualify patients for outpatient total joint arthroplasty (TJA), and make patient safety a priority. The software tool is a validated, multidisciplinary algorithm that provides medical professionals with the information needed to predict which patients are most medically appropriate to discharge home the same day or the next morning.

Össur Donates Nasal Swabs for COVID-19 Testing

In the face of a nasal swab shortage in Iceland, prosthetic and orthotic manufacturer Össur, Reykjavik, Iceland, was contacted by a local biopharmaceutical company, deCODE Genetics, about the possibility of manufacturing swabs for use in COVID-19 testing. While Össur manufactures swabs for in-house use, they are not of the same quality as those that should preferably be used for the requested purpose, according to several news reports. However, the company had 20,000 nasal swabs in stock that were produced by an outside vendor and donated those. The donated swabs were tested extensively at National University Hospital and by deCODE Genetics before being put into use.

Paceline Assists in the Manufacture of Surgical Masks

Paceline, Matthews, NC, a provider of medical products and solutions for casting, fabrication, prosthetics, orthotics, and more, recently purchased machines specifically to produce ear loop fabric for surgical masks as a means to join the fight against COVID-19. “With our years of knowledge in the medical fabrics industry, we reached out to the nation’s largest surgical mask manufacturer to see if we could lend them support,” said Paceline President and CEO, Joe Davant. “We found they had a tremendous need for ear loop fabric….” According to Davant, 100% of the fabric made on the new machines will be going to surgical mask manufacturers. The company is open to expanding capacity should additional manufacturers need assistance as well.

SkinIntegra Donates to Hospitals; Offers Free Samples to Healthcare Facilities

Healthcare professionals on the frontlines of the COVID-19 pandemic are subject to frequent hand washings with disinfecting soap, which is harsh on hands and can cause cracks, potentially leading to infections. To this end, SkinIntegra, Huntington Beach, CA, has donated over 2,000 samples of its Rapid Crack Repair Cream to hospitals in California, Arizona, New York, and Pennsylvania.

The company said it is committed to protecting healthcare workers and has set up a website to handle requests. The donation size provides skincare protection for 1 worker, with 2 daily applications, for 1 month. Hospitals, healthcare facilities, diabetes and wound care centers, and skilled nursing care facilities can apply for product donations at skinintegra.com/pages/donations.

Medicare Providers Impacted by COVID-19 Granted Stimulus Money

On April 10, the Centers for Medicare and Medicaid Services (CMS) began directly depositing grants to Medicare facilities and providers impacted by COVID-19, based on eligible providers’ 2019 Medicare payments. The funds, totaling $30 million, were part of the $100 billion distribution established through the Coronavirus Aid, Relief, and Economic Security (CARES) Act Provider Relief Fund. As the funds are grants, they do not need to be paid back. Providers who were allocated a payment were required to sign an attestation confirming receipt of the funds and agree to the terms and conditions within 45 days of payment.

A second round of direct deposits totaling $20 million, also part of this aid package, were distributed beginning April 24, based on 2018 patient net revenue. However, durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers were not included in this round of funding, according to AAHomecare. Instead, DMEPOS suppliers could apply for payments from this funding stream through the General Distribution Portal.

To access information regarding the CARES Act, visit www.hhs.gov/coronavirus/cares-act-provider-relief-fund/index.html. To access the CARES Act General Distribution FAQs, visit www.hhs.gov/sites/default/files/provider-relief-fund-general-distribution-faqs.pdf.

Telehealth OK to Certify for Diabetic Shoes; Face-to-Face Encounter for Shoe Selection, Fitting

According to the American Orthotic & Prosthetic Association (AOPA), the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have confirmed that physicians who are certifying the medical need for diabetic shoes may use telehealth to fulfill face-to-face encounter requirements during the COVID-19 Public Health Emergency (PHE). However, suppliers of diabetic shoes will still be required to perform an in-person evaluation at the time of shoe selection and an in-person fitting of the shoes at delivery.

On April 6, 2020 the Centers for Medicare and Medicaid Services (CMS) released an Interim Final Rule with Comment Period (IFC) that indicated for claims with dates of service on or after March 1, 2020, policy-based “requirements for face-to-face or in-person encounter for evaluations, assessments, certifications, or other implied face-to-face services would not apply during the COVID-19 PHE.” Additional guidance was provided on the IFC by the DME MACs on May 7, 2020, in a joint educational article. The DME MAC article indicated that while the IFC provided significant relief from policy-based face-to-face visit requirements, a subsequent CMS IFC that was issued on May 8, 2020, reiterated the statutory requirement to establish and document the medical necessity for Medicare-covered services.

The DME MAC joint article indicated that the IFC-based waiver of face-to-face encounter requirements only applies to policy-based requirements and not to face-to-face encounter requirements that are memorialized elsewhere, specifically those that are part of the Durable DMEPOS [Durable Medical Equipment, Prosthetics, Orthotics and Supplies] Quality Standards or Social Security Act.

To access the DME MAC guidance article on the CMS IFC, visit www.cgsmedicare.com/jc/pubs/news/2020/05/cope17144.html.

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