No Carolina / NY / Florida
Ph: 561.316.3330

No Carolina | NY | Florida

Royal Biologics Reports Cryo-Cord™, Amnio-Maxx™, Amnio-Maxx™ Lite and Derm-Maxx™ Receive High-Tier Reimbursement in the Hospital Outpatient Departments and Reimbursement in the Physician Office to Treat Chronic Non-Healing Wounds

Editor: What To Know

  • “We are very pleased with the decision by CMS to reassign Cryo-Cord™, Amnio-Maxx™, Amnio-Maxx™ Lite and Derm-Maxx™ to the high-cost category for skin substitutes in the hospital outpatient setting while also providing for reimbursement in the physician office.
  • With this new payment designation, hospital outpatient departments and affiliated wound care centers may now be able to receive a higher reimbursement when treating Medicare beneficiaries for chronic non-healing wounds with Cryo-Cord, Amnio-Maxx, Amnio-Maxx, Lite and Derm-Maxx.
  •  “More importantly, this new reimbursement will, for the first time, allow physicians to treat chronic non-healing wounds with a viable umbilical cord graft outside of the operating room setting, which will significantly reduce the costs to our healthcare systems.

Royal Biologics, an Autologous and Live Cellular solutions-focused company, announced today that beginning Jan. 1, 2021, Cryo-Cord™ Placental Allograft, Amnio-Maxx™ Placental Allograft, Amnio-Maxx™ Lite Placental Allograft and Derm-Maxx™ Dermal Allograft will be placed in the high-tier reimbursement category for skin substitutes under the Center for Medicare and Medicaid (CMS) Hospital Outpatient Prospective Payment System.

With this new payment designation, hospital outpatient departments and affiliated wound care centers may now be able to receive a higher reimbursement when treating Medicare beneficiaries for chronic non-healing wounds with Cryo-Cord, Amnio-Maxx, Amnio-Maxx, Lite and Derm-Maxx. Additionally, physicians treating Medicare beneficiaries in their office may be able to receive reimbursement to cover the cost associate with these products.

In Transmittal 10541, January 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS), issued Dec. 31, 2020, by CMS to its Medicare Administrative Contractors, CMS announced that they were reassigning Cryo-Cord™, Amnio-Maxx™, Amnio-Maxx™ Lite and Derm-Maxx™ from the low-cost skin substitute group to the high-cost skin substitute group.

“We are very pleased with the decision by CMS to reassign Cryo-Cord™, Amnio-Maxx™, Amnio-Maxx™ Lite and Derm-Maxx™ to the high-cost category for skin substitutes in the hospital outpatient setting while also providing for reimbursement in the physician office.  This higher Medicare reimbursement rate is more in line with actual costs wound care centers incur when treating non-healing wounds,” said Ryan Paul, Vice President of Royal Biologics Wound Care. “More importantly, this new reimbursement will, for the first time, allow physicians to treat chronic non-healing wounds with a viable umbilical cord graft outside of the operating room setting, which will significantly reduce the costs to our healthcare systems.”

Cryo-Cord™ is a non-DMSO cryopreserved human placental umbilical cord allograft. The proprietary non-DMSO cryoprotectant helps to retain the natural properties of placental tissue including nutrient-rich growth factors, cytokines, endogenous cells and Wharton’s Jelly. It is used to treat chronic non-healing wounds including but not limited to diabetic foot, venous leg, arterial and pressure ulcers. Studies have shown that essential components of placental tissue support wound healing functions, including providing an extracellular matrix and a protective barrier to infection.

Amnio-Maxx™ and Amnio-Maxx™ Lite are dehydrated and sterilized human placental membrane grafts derived from the amniotic layer. Amnio-Maxx™ is a dual-layer membrane and Amnio-Maxx™ Lite is a single layer membrane. They are both used as a scaffold for treating chronic non-healing wounds including but not limited to diabetic foot, venous leg, arterial and pressure ulcers.

Derm-Maxx™ is a dermal matrix allograft that is produced using a process that reduces native nucleic acids, cells and other antigenic material while preserving the collagen matrix with vascular channels.  The extracellular matrix supports cellular infiltration, attachment and proliferation. The unique processing technique preserves the collagen and elastic tissue fibers while maintaining the open channels through which cells can migrate, proliferate and form new blood vessels.  Derm-Maxx™ is intended for support, protection, reinforcement and/or covering during integumentary applications.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Recent News

CV Societies Propel Plans Forward for a New Board of Cardiovascular Medicine

“The open comment period is the time for cardiovascular physicians, allies in other medical specialties, patients, and others to make their voices heard on why an independent CV Board is the best path for cardiologists to stay up-to-date on best practices and evidence-based care, ensuring patients receive the best possible care,” said Jeffrey Kuvin, MD, president of the proposed Board’s new Board of Directors. “The field of cardiovascular medicine has evolved dramatically over the past few decades; now is the right time to develop an independent cardiovascular Board.”

Hyundai Bioscience Announces Clinical Development Plan for Niclosamide-based Metabolic Anticancer Drug Targeting P53 Mutation Cancer

Sang-ki Oh, CEO of Hyundai Bioscience, stated, "Niclosamide-based metabolic anticancer drug candidate will be the first P53-targeting anticancer treatment that selectively kills p53 mutated cancer cells," and added, "Through our subsidiary ADM Korea, we plan to conduct clinical trials targeting cancer patients with intractable cancer caused by p53 mutations, which will be the first step of clinical development on niclosamide-based anticancer agent pipeline."

Sedana Medical Completes Patient Recruitment for INSPiRE-ICU 1 Clinical Trial in the US

Peter Sackey further elaborated: "Once the 30-day follow-up of all patients is complete, we will enter into an intense phase of final monitoring, data cleaning and transfer to our statistician team for analysis. In parallel, the long-term outcomes at 3 and 6 months will be collected centrally by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. With this parallel approach, we expect topline results in the autumn of this year and a swift regulatory submission in Q1, 2025".

Health / Lifestyle

Articles of Interest

Stay Connected

spot_img

About Medical Device News Magazine

About Medical Device News Magazine. A digital publication founded in 2008 located in the United States. The publication is one of the industry’s leading sources of medical device and biotech industry updates. Medical Device News Magazine is easily accessible 24/7/365 and is a fast 1, 2, 3 easy read! Our purpose is...

By using this website you agree to accept Medical Device News Magazine Privacy Policy