Healthcare Common Procedure Coding System

BioStem Technologies Awarded Q Code for VENDAJE AC® Line from Centers for Medicare and Medicaid Services

Retrieved on: 
Wednesday, November 8, 2023

(OTC:BSEM), a leading regenerative medicine company focused on the development, manufacture and commercialization of placental-derived biologics for advanced wound care, today announced that the Centers for Medicare and Medicaid Services (CMS) has published a new Q code, Q4279 for VENDAJE AC® pursuant to its application for Healthcare Common Procedure Coding System (HCPCS) “Q” codes.

Key Points: 
  • (OTC:BSEM), a leading regenerative medicine company focused on the development, manufacture and commercialization of placental-derived biologics for advanced wound care, today announced that the Centers for Medicare and Medicaid Services (CMS) has published a new Q code, Q4279 for VENDAJE AC® pursuant to its application for Healthcare Common Procedure Coding System (HCPCS) “Q” codes.
  • The HCPCS code assigned for VENDAJE AC® will be effective January 1st, 2024.
  • VENDAJE AC is a human connective tissue matrix comprised of dehydrated amniotic/chorionic tissue processed using BioStem’s proprietary BioREtain® process.
  • "Securing the CMS Q code for our VENDAJE AC® tissue allograft marks yet another win for BioStem Technologies and ensures broader access to another top-tier wound care product within our portfolio,” said Biostem Technologies CEO Jason Matuszewski.

ReWalk Robotics to Discuss Medicare’s Preliminary Payment Determination for ReWalk Personal Exoskeleton

Retrieved on: 
Tuesday, November 7, 2023

MARLBOROUGH, Mass., and BERLIN, and YOKNEAM ILLIT, Israel, Nov. 07, 2023 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or the “Company”), a leading provider of innovative technologies that enable mobility and wellness in rehabilitation and daily life for individuals with neurological conditions, today announced that that it has scheduled a conference call for Wednesday, November 8, 2023 at 8:30 a.m. EST, to discuss Medicare’s preliminary payment determination for the ReWalk Personal Exoskeleton.

Key Points: 
  • MARLBOROUGH, Mass., and BERLIN, and YOKNEAM ILLIT, Israel, Nov. 07, 2023 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or the “Company”), a leading provider of innovative technologies that enable mobility and wellness in rehabilitation and daily life for individuals with neurological conditions, today announced that that it has scheduled a conference call for Wednesday, November 8, 2023 at 8:30 a.m. EST, to discuss Medicare’s preliminary payment determination for the ReWalk Personal Exoskeleton.
  • On Friday, November 3, the Centers for Medicare & Medicaid Services (“CMS”) released an agenda for the upcoming Healthcare Common Procedure Coding System (“HCPCS”) meeting on November 29, 2023, which includes an item to discuss the Medicare payment determination for the ReWalk Personal Prosthetic Exoskeleton system and provides a preliminary payment determination of $94,617.
  • Larry Jasinski, Chief Executive Officer, Jeannine Lynch, Vice President of Market Access and Strategy, and Mike Lawless, Chief Financial Officer, will host a conference call at 8:30 a.m. EST to discuss the potential impact of this announcement.
  • To access the call, analysts and investors may utilize the following:

Myomo Reports Third Quarter 2023 Financial Results Featuring Record Product Revenue and Authorizations

Retrieved on: 
Tuesday, November 7, 2023

Excluding guaranteed minimum payment revenue from the China JV company, product revenue was $5.0 million, up 27% compared with the third quarter of 2022.

Key Points: 
  • Excluding guaranteed minimum payment revenue from the China JV company, product revenue was $5.0 million, up 27% compared with the third quarter of 2022.
  • Myomo recognized revenue on 119 MyoPro units in the third quarter of 2023, up 37% over the same quarter a year ago.
  • Gross margin for the third quarter of 2023 was 68.7%, compared with 66.5% for the third quarter of 2022.
  • Operating expenses for the third quarter of 2023 were $5.5 million, an increase of 1% over the third quarter of 2022.

In Historic Move, Medicare Proposes Preliminary Reimbursement Level for ReWalk Personal Exoskeleton

Retrieved on: 
Monday, November 6, 2023

MARLBOROUGH, Mass. and BERLIN and YOKNEAM ILLIT, Israel, Nov. 06, 2023 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or the “Company”), a leading provider of innovative technologies that enable mobility and wellness in rehabilitation and daily life for individuals with neurological conditions, today announced that the Centers for Medicare & Medicaid Services (“CMS”) has included the ReWalk Personal Prosthetic Exoskeleton system in the agenda for the upcoming Healthcare Common Procedure Coding System (“HCPCS”) meeting on November 29, 2023 and provided a preliminary payment determination of $94,617.

Key Points: 
  • Preliminary payment determination of $94,617 does not yet factor in currently available ReWalk system with Breakthrough Device Designation.
  • CMS welcomes additional pricing materials at upcoming HCPCS meeting to reflect subsequent advancements in technology and pricing since ReWalk’s 2020 application.
  • In applying this formula to the code describing the ReWalk Personal Exoskeleton, CMS relied on average prices from 2020 market transactions, which CMS determined to be $125,500, and resulted in preliminary Medicare pricing of $94,617.
  • A final payment determination is expected in early 2024 with an April 1, 2024 effective date.

BioXcel Therapeutics Receives Permanent J-Code for IGALMI™ (dexmedetomidine) Sublingual Film from Centers for Medicare & Medicaid Services

Retrieved on: 
Monday, October 30, 2023

NEW HAVEN, Conn., Oct. 30, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that the Centers for Medicare & Medicaid Services (CMS) has issued a permanent and product-specific J-Code for IGALMI™ (dexmedetomidine) sublingual film, which is approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults1,2. Under the Healthcare Common Procedure Coding System (HCPCS) process, the IGALMI J-Code J1105 will become effective January 1, 2024.

Key Points: 
  • Under the Healthcare Common Procedure Coding System (HCPCS) process, the IGALMI J-Code J1105 will become effective January 1, 2024.
  • J-codes are permanent codes used by healthcare providers, commercial insurance plans, and government payers to help standardize the reimbursement process.
  • Compared to a miscellaneous or unlisted product code, a J-code simplifies claims submission, which in turn streamlines the billing and reimbursement process.
  • “Ultimately, we believe this commercial milestone will facilitate additional patient access to this important therapeutic option for the treatment of bipolar disorder- or schizophrenia-associated agitation.”

CMS Posts Proposed Medicare DMEPOS Fee Schedule Rate for the MyoPro® for Review at the Upcoming HCPCS Public Meeting

Retrieved on: 
Monday, November 6, 2023

CMS has proposed fee schedule rates for the two HCPCS codes describing the MyoPro, L8701, which is our Motion W device, and L8702, which is our Motion G device, of $31,745.42 and $62,457.28, respectively.

Key Points: 
  • CMS has proposed fee schedule rates for the two HCPCS codes describing the MyoPro, L8701, which is our Motion W device, and L8702, which is our Motion G device, of $31,745.42 and $62,457.28, respectively.
  • “We’re pleased to see the process moving forward to determine a national fee schedule rate from CMS for the MyoPro,” stated Paul R. Gudonis, Myomo’s Chairman and CEO.
  • “This is an important milestone for the Company and an important step in facilitating access to the MyoPro for qualified Medicare Part B beneficiaries with long-term muscular weakness or partial paralysis.”
    The preliminary payment determinations published by CMS for discussion at the public meeting are only proposed fee schedule rates.
  • The Company cannot provide any assurance that these rates will be finalized and published in their current amounts, or at all.

Eagle Pharmaceuticals Granted Unique J-Code and Pass-Through Status for BARHEMSYS® from CMS

Retrieved on: 
Monday, October 23, 2023

WOODCLIFF LAKE, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that Centers for Medicare & Medicaid Services (“CMS”) has established a unique, product-specific billing code and granted transitional pass-through payment status for Barhemsys (amisulpride) injection. The new Healthcare Common Procedure Coding System (“HCPCS”) Level II code (“J-code”) is J-0184 “Injection, amisulpride, per 1 mg” and will be effective on January 1, 2024, replacing the C-code (C-9153), which will be discontinued. Beginning October 1, 2023, Barhemsys became eligible for separate reimbursement outside of the surgical bundled payment in both the ambulatory surgery center (“ASC”) and hospital outpatient department (“HOPD”) care settings.

Key Points: 
  • -- J-code is effective January 1, 2024, and transitional pass-through status became effective October 1, 2023, facilitating patient access --
    WOODCLIFF LAKE, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that Centers for Medicare & Medicaid Services (“CMS”) has established a unique, product-specific billing code and granted transitional pass-through payment status for Barhemsys (amisulpride) injection.
  • Beginning October 1, 2023, Barhemsys became eligible for separate reimbursement outside of the surgical bundled payment in both the ambulatory surgery center (“ASC”) and hospital outpatient department (“HOPD”) care settings.
  • “Receiving pass-through status, as well as a J-code, is an ideal combination that will facilitate patient access to this important therapeutic,” stated Scott Tarriff, President and Chief Executive Officer of Eagle.
  • The granting of pass-through status helps streamline the reimbursement process and facilitates patient access to Barhemsys.

AAOS Comments on Proposed Medicare Payment Policy Changes for 2024

Retrieved on: 
Monday, September 18, 2023

WASHINGTON, Sept. 18, 2023 /PRNewswire/ -- The American Association of Orthopaedic Surgeons (AAOS) issued formal comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed payment policy changes in the Medicare program for Calendar Year (CY) 2024.

Key Points: 
  • WASHINGTON, Sept. 18, 2023 /PRNewswire/ -- The American Association of Orthopaedic Surgeons (AAOS) issued formal comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed payment policy changes in the Medicare program for Calendar Year (CY) 2024.
  • The AAOS' concerns center around ongoing cuts to physician reimbursement, as the CY 2024 Medicare Physician Fee Schedule (MPFS) proposed rule includes a $32.75 conversion factor, which is a $1.14 (almost 3.26%) decrease from the $33.89 conversion factor for 2023.
  • "AAOS is committed to helping create an equitable healthcare system for patients and physicians," said AAOS President Kevin J. Bozic, MD, MBA, FAAOS.
  • "Therefore, we urge CMS to support a statutory fix that provides an annual inflationary update for physicians, akin to all other providers covered by the Medicare payment system.

NanoVibronix Responds to CMS’ Determination for PainShield

Retrieved on: 
Tuesday, August 29, 2023

NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today provided a response to the recently published payment determination by the Centers for Medicare & Medicaid Services (“CMS”) regarding the company’s PainShield device.

Key Points: 
  • NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today provided a response to the recently published payment determination by the Centers for Medicare & Medicaid Services (“CMS”) regarding the company’s PainShield device.
  • As a result of CMS’ determination, PainShield is not reimbursable under Medicare and Medicaid at this time.
  • Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., said, “We are working to fully understand the implications of CMS’ HCPCS summaries and payment determiniations as it relates to PainShield.
  • We remain steadfast in our commitment to fully commercializing PainShield and getting it into the hands of those that could benefit from its use.”

AppliedVR and National Cancer Institute Collaborate on Research Evaluating Virtual Reality for Reducing Anxiety in Primary Brain Tumor Patients During Imaging Services

Retrieved on: 
Thursday, July 20, 2023

LOS ANGELES, July 20, 2023 /PRNewswire/ -- AppliedVR, an immersive therapeutics (ITx) pioneer advancing a novel approach to medicine, today announced interim analysis results of a phase 2 clinical trial study performed in collaboration with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). The phase 2 clinical trial explored whether virtual reality (VR) could be an intervention for primary brain tumor (PBT) patients who experience distress and anxiety prior to their clinical evaluations. The study is part of an ongoing collaboration agreement between AppliedVR and the NCI and is led by the Neuro-Oncology Branch (NOB), Center for Cancer Research (CCR), NCI. The patient population of the study is comprised of patients who are actively enrolled in NOB's Natural History Study.

Key Points: 
  • The phase 2 clinical trial explored whether virtual reality (VR) could be an intervention for primary brain tumor (PBT) patients who experience distress and anxiety prior to their clinical evaluations.
  • The study is part of an ongoing collaboration agreement between AppliedVR and the NCI and is led by the Neuro-Oncology Branch (NOB), Center for Cancer Research (CCR), NCI.
  • The patient population of the study is comprised of patients who are actively enrolled in NOB's Natural History Study .
  • In the future, the two organizations may continue to work together to expand and deepen research that evaluates how immersive therapeutics can help serve cancer patients.