HCPCS

Helius Medical Technologies, Inc. Secures HCPCS Codes for Portable Neuromodulation Stimulator (PoNS®) Mouthpiece and Controller

Retrieved on: 
Monday, March 4, 2024

NEWTOWN, Pa., March 04, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced that the Centers for Medicare & Medicaid Services (“CMS”) has assigned Healthcare Common Procedure Coding System (“HCPCS”) Level II codes A4593, “Neuromodulation stimulator system, adjunct to rehabilitation therapy regime” to describe the PoNS controller and A4594, “Neuromodulation stimulator system, adjunct to rehabilitation therapy regime, mouthpiece each” to describe the PoNS mouthpiece. The new HCPCS codes will be effective April 1, 2024.

Key Points: 
  • The new HCPCS codes will be effective April 1, 2024.
  • “PoNS Therapy® is life-changing for people who suffer gait impairment due to MS and we’re pleased that CMS understood the benefits of this innovative treatment by establishing HCPCS codes for both the PoNS mouthpiece and controller.
  • This marks a critical reimbursement and access milestone and provides Helius the ability to begin negotiating reimbursement with third-party payers using these unique HCPCS codes.
  • In Canada, PoNS is authorized to treat balance impairment due to MS, stroke and mild-to-moderate traumatic brain injury.

Lifeward announces the Centers for Medicare & Medicaid Services (“CMS”) is deferring its final decision on the payment rate for personal exoskeletons so that more recent claims information on the current, more advanced ReWalk Personal Exoskeleton may be c

Retrieved on: 
Friday, March 1, 2024

MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, March 01, 2024 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (DBA Lifeward™), (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global market leader delivering life-changing solutions to revolutionize what is possible in rehabilitation, recovery, and the pursuit of life’s passions in the face of physical limitation or disability, today announced that in CMS’ February 29th HCPCS decision memorandum the pricing decision for personal exoskeletons is deferred to obtain more information about current exoskeleton pricing. CMS accepted that “between the original 2020 HCPCS application and the present, the previous model [of the ReWalk Exoskeleton] has been discontinued in favor of the current model that incorporates additional, clinically significant functionality,” and the agency is open to gaining more information about pricing of the current exoskeleton model.

Key Points: 
  • CMS issues these HCPCS decision memorandums twice per year, so it is anticipated that a pricing decision would be made in the next cycle, if not earlier.
  • As of February 2024, a total of 35 ReWalk Personal Exoskeleton systems have been delivered to Medicare beneficiaries and will continue to be processed accordingly.
  • “We set a goal many years ago to help individuals with spinal cord injury achieve broader access to technologies which enable them to walk again.
  • To learn more about the Lifeward mission and product portfolio, please visit GoLifeward.com .

TriSalus Life Sciences Receives Approval from the World Health Organization and the American Medical Association’s Adopted Name Council for “Nelitolimod” as the Nonproprietary Drug Name for SD-101

Retrieved on: 
Thursday, March 7, 2024

“The WHO INN and USAN approval of nelitolimod is an important milestone in the continued progress we are making with our nelitolimod program,” said Mary Szela, Chief Executive Officer and President of TriSalus.

Key Points: 
  • “The WHO INN and USAN approval of nelitolimod is an important milestone in the continued progress we are making with our nelitolimod program,” said Mary Szela, Chief Executive Officer and President of TriSalus.
  • This approach has the potential to enable more durable responses by patients to other immunotherapeutics, thereby facilitating better patient outcomes.
  • Information on nelitolimod will be posted on the USAN website ( www.ama-assn.org/go/usan ) and will be published in the Chemical Abstracts Service and in the U.S. Pharmacopeia.
  • Going forward, TriSalus will use the name in publications and public statements, at conferences and other forums, and in corporate-related materials.

Axena Health Announces New HCPCS Code Supporting Coverage for the Leva Pelvic Health System

Retrieved on: 
Monday, March 4, 2024

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, welcomes the Centers for Medicare & Medicaid Services’ (CMS) new Healthcare Common Procedure Coding System (HCPCS) Level II code for the Leva® Pelvic Health System.

Key Points: 
  • Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, welcomes the Centers for Medicare & Medicaid Services’ (CMS) new Healthcare Common Procedure Coding System (HCPCS) Level II code for the Leva® Pelvic Health System.
  • The Leva System’s new HCPCS Level II code simplifies access for patients, eliminating barriers that can delay coverage through their insurance plan.
  • The Leva System’s HCPCS code along with its previously established pharmacy code, make either channel an option to increase access through insurance.
  • And this new code is a huge step towards making the Leva System available to all women who need symptom relief.”

CMS Posts Final Medicare DMEPOS Fee Schedule Rate for the MyoPro®

Retrieved on: 
Friday, March 1, 2024

The final average fee schedule rates for the two Healthcare Common Procedures System (HCPCS) codes describing the MyoPro, L8701, our Motion W device, and L8702, our Motion G device, are $33,480.90 and $65,871.74, respectively, and can be found here beginning on page 67.

Key Points: 
  • The final average fee schedule rates for the two Healthcare Common Procedures System (HCPCS) codes describing the MyoPro, L8701, our Motion W device, and L8702, our Motion G device, are $33,480.90 and $65,871.74, respectively, and can be found here beginning on page 67.
  • On January 1, 2024, the MyoPro was officially classified in the brace benefit category, which enables reimbursement on a lump sum basis.
  • “This is an important milestone for qualified Medicare Part B beneficiaries with long-term muscular weakness or partial paralysis, and for Myomo as a company.
  • We extend thanks to the personnel at CMS for their efforts and for appreciating the benefits that powered braces such as the MyoPro can provide to Medicare Part B beneficiaries. "

TriSalus Life Sciences Announces Real-World Data Demonstrating the Ability of TriNav® to Successfully Treat Patients with Higher Disease Burden and to Improve Delivery of Therapeutics to Liver Tumors

Retrieved on: 
Thursday, February 29, 2024

Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden.

Key Points: 
  • Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden.
  • In a matched cohort comparison, TriNav patients had fewer 30-day inpatient visits post-procedure than non-TriNav patients.
  • TriNav TARE patients with liver metastases had fewer clinical complications post-procedure vs. non-TriNav patients in a matched cohort comparison.
  • “This large sample size study underscores the particular benefits of the TriNav device compared to standard drug delivery systems.”

Amniowrap2™ Product Launch Leads Year of Highlights for BioStem Technologies

Retrieved on: 
Tuesday, January 30, 2024

POMPANO BEACH, Fla., Jan. 30, 2024 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived allografts for advanced wound care, today highlights its 2023 accomplishments and provides a business update.

Key Points: 
  • BioStem Technologies CEO, Jason Matuszewski, said, “2023 was a year of tremendous growth, progress and achievement for BioStem.
  • This growth is primarily attributed to the successful launch of Amniowrap2™, our innovative placental-derived allograft product designed to address a broad spectrum of wound applications.
  • BioStem Technologies appointed a proven life science sales leader, Mr. Shawn McCarrey, as Chief Commercial Officer.
  • BioStem will host a conference call and webcast to discuss fourth quarter and full year 2023 financial results in March 2024.

CorMedix Inc. Announces Commercial and Reimbursement Updates

Retrieved on: 
Tuesday, January 30, 2024

As such, CorMedix is entitled to submit an application for a Transitional Drug Add-On Payment (TDAPA) which currently allows for five years of additional payment reimbursement to outpatient providers.

Key Points: 
  • As such, CorMedix is entitled to submit an application for a Transitional Drug Add-On Payment (TDAPA) which currently allows for five years of additional payment reimbursement to outpatient providers.
  • CorMedix submitted its TDAPA application on January 26th after receiving the CMS notification, and CMS has subsequently confirmed receipt.
  • CorMedix previously applied for and received a New Technology Add-On Payment (NTAP) from CMS for inpatient reimbursement of DefenCath.
  • I look forward to providing additional commercial updates in the upcoming months as CorMedix brings this important novel drug product to market.”

Verrica Pharmaceuticals Receives Permanent J-Code (J7354) for YCANTH™ from Centers for Medicare and Medicaid Services

Retrieved on: 
Monday, January 29, 2024

Under the Healthcare Common Procedure Coding System (HCPCS) process, the J-Code for YCANTH™ will become fully published April 1, 2024.

Key Points: 
  • Under the Healthcare Common Procedure Coding System (HCPCS) process, the J-Code for YCANTH™ will become fully published April 1, 2024.
  • J-codes help determine how managed care organizations reimburse medical providers for products and services.
  • Inaccurately reporting medical services can cause insurance complications and make it harder to get rebates.
  • Using a standardized code reduces the risk of billing errors and allows companies to receive pass-through payments through government-sponsored healthcare plans.1

KATE FARMS PEDIATRIC BLENDED MEALS NOW AVAILABLE

Retrieved on: 
Wednesday, January 24, 2024

"Kate Farms listened," said Dr. Debora Duro, Program Director of Pediatric Gastroenterology, Hepatology and Nutrition at Broward Health. "We--clinicians, parents and caregivers—have been asking for whole food variety, convenience and smart packaging, and Kate Farms delivered. A new package that easily connects to common tube feeding devices is truly innovative, and the kid-friendly design will make the little ones smile too."

Key Points: 
  • SANTA BARBARA, Calif., Jan. 23, 2024 /PRNewswire/ -- Kate Farms ® the #1 prescribed plant-based brand, launched its first Pediatric Blended Meals innovation, bringing to market the first plant-based, organic, whole-food blended meals designed for ease and convenience.
  • Kate Farms Pediatric Blended Meals are designed for children ages one to 13 to help support their healthy growth and development and can be used for both tube and oral feeding.
  • Kate Farms Pediatric Blended Meals have no common allergens, and do not contain any artificial sweeteners, flavors, colors, or preservatives.
  • Kate Farms Pediatric Blended Meals are eligible for insurance coverage under HCPCS code B4149.