Centers for Medicare & Medicaid Services

Aspira Women’s Health Supports Centers for Medicare & Medicaid Services (CMS) Proposed Rule to Crosswalk Medicare Reimbursement Rate for OvaWatch

Retrieved on: 
Thursday, November 9, 2023

AUSTIN, Texas, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or “the Company”) (Nasdaq: AWH), a bio-analytical company focused on the development and commercialization of women’s health diagnostic tools for gynecologic diseases, today announced that during the 2024 Clinical Laboratory Fee Schedule (CLFS) rate setting process, the Centers for Medicare & Medicaid Services (CMS) has proposed to crosswalk the fee paid to the company for OvaWatch to the fee paid historically for Ova1. If finalized later this month (as was preliminarily approved in September), Aspira would be reimbursed at a rate of $897 for all OvaWatch and Ova1 tests processed for Medicare patients meeting applicable coverage requirements beginning in January 2024. The public comment period ended on October 27.

Key Points: 
  • If finalized later this month (as was preliminarily approved in September), Aspira would be reimbursed at a rate of $897 for all OvaWatch and Ova1 tests processed for Medicare patients meeting applicable coverage requirements beginning in January 2024.
  • “Crosswalking” refers to a process for setting the Medicare reimbursement rate for a new laboratory test by assigning the new code the same rate as a comparable existing test.
  • Aspira supports the proposal to crosswalk OvaWatch to Ova1 and believes it is appropriate given the similarity of pre-analytical, analytical, and post-analytical characteristics of the two assays.
  • “We are one step closer to achieving our mission of ensuring this ground-breaking technology is available to all women when they are facing an ovarian cancer diagnosis.”

Arch Therapeutics Provides Year End Operational Update

Retrieved on: 
Thursday, November 9, 2023

FRAMINGHAM, Mass., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), a marketer and developer of novel self-assembling wound care and biosurgical products, today provided a year-end operational update, including key performance metrics related to the ongoing commercialization activities for the Company’s first product, AC5® Advanced Wound System (“AC5”).

Key Points: 
  • FRAMINGHAM, Mass., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), a marketer and developer of novel self-assembling wound care and biosurgical products, today provided a year-end operational update, including key performance metrics related to the ongoing commercialization activities for the Company’s first product, AC5® Advanced Wound System (“AC5”).
  • A more detailed summary of key milestones and achievements from the fiscal year ended September 30, 2023 is provided below.
  • At SAWC Spring 2023, Arch introduced the theme “Experience the Difference” to highlight AC5’s technology, application, wound coverage, and efficacy.
  • AC5 is a synthetic self-assembling wound care product that provides clinicians with multi-modal support and utility across all phases of wound healing.

CMS exec to present keynote at RISE's upcoming CMS Bid Boot Camp

Retrieved on: 
Thursday, November 9, 2023

JACKSONVILLE, Fla. , Nov. 9, 2023 /PRNewswire/ -- Michael de la Guardia, VBID model co-lead, CMS Center for Medicare and Medicaid Innovation, will be the keynote speaker at RISE's CMS Bid Boot Camp, the only conference in the market dedicated to covering the entire bid process from start to finish.

Key Points: 
  • JACKSONVILLE, Fla. , Nov. 9, 2023 /PRNewswire/ -- Michael de la Guardia, VBID model co-lead, CMS Center for Medicare and Medicaid Innovation, will be the keynote speaker at RISE's CMS Bid Boot Camp , the only conference in the market dedicated to covering the entire bid process from start to finish.
  • He'll also discuss the reporting requirements for the model as well as future plans for the VBID hospice benefit component.
  • The CMS Bid Boot Camp brings together product managers, actuaries, and other CMS bid stakeholders to explore timelines, critical steps, and strategies to optimize their CMS bid.
  • The CMS Bid Boot Camp will take place January 22-23, 2024, at The Sawgrass Marriott Golf Resort & Spa, Jacksonville, Fla. Click here for the complete list of speakers, preconference workshops, the agenda, and how to register for the program.

For second time this year, Methodist Le Bonheur Healthcare adult hospitals rated safest in region

Retrieved on: 
Wednesday, November 8, 2023

MEMPHIS, Tenn., Nov. 8, 2023 /PRNewswire/ -- When it comes to patient care in the Mid-South, Methodist Le Bonheur Healthcare continues to deliver the safest in the region, according to fall 2023 ratings by national watchdog The Leapfrog Group. Every Methodist Le Bonheur adult hospital received the highest rating possible – an "A".

Key Points: 
  • Every Methodist Le Bonheur adult hospital received the highest rating possible – an "A".
  • According to national Centers for Medicare and Medicaid Services (CMS) measures, Methodist Le Bonheur has the highest regional ratings for overall hospital quality.
  • To view Methodist Le Bonheur Healthcare's full grade details and see rates of other health systems, visit HospitalSafetyGrade.org .
  • For more updates from Methodist Le Bonheur Healthcare, follow us on Twitter , Facebook and LinkedIn .

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.

AAHKS Grants Force Therapeutics the 2023 Industry Innovation Award

Retrieved on: 
Wednesday, November 8, 2023

NEW YORK, Nov. 8, 2023 /PRNewswire/ -- On Friday, November 3, Force Therapeutics was presented the Industry Innovation Award by the American Association of Hip and Knee Surgeons (AAHKS) at the AAHKS Annual Meeting in Dallas, Texas.

Key Points: 
  • NEW YORK, Nov. 8, 2023 /PRNewswire/ -- On Friday, November 3, Force Therapeutics was presented the Industry Innovation Award by the American Association of Hip and Knee Surgeons (AAHKS) at the AAHKS Annual Meeting in Dallas, Texas.
  • The Industry Innovation Award is a competitive product award for companies demonstrating cutting-edge innovation in the field of orthopedic hip and knee arthroplasty.
  • "AAHKS is truly excited to grant the Industry Innovation Award to Force Therapeutics for its addition of Remote Therapeutic Monitoring (RTM) to its digital care platform.
  • Force Therapeutics' award-winning product is the addition of RTM to the Force Therapeutics digital care platform, which satisfies U.S. Food and Drug Administration (FDA) requirements as Software as a Medical Device (SaMD).

VentureMed Receives Transitional Pass-through Payment (TPT) for FLEX Vessel Prep™ System

Retrieved on: 
Wednesday, November 8, 2023

The pass-through payment provides outpatient facilities with an incremental Medicare payment for procedures in which FLEX VP is utilized.

Key Points: 
  • The pass-through payment provides outpatient facilities with an incremental Medicare payment for procedures in which FLEX VP is utilized.
  • "CMS approval of a TPT for VentureMed's FLEX Device is monumental and will provide access of this novel technology to many deserving patients.
  • This new C-code supports access for our FLEX Vessel Prep System for hospitals and Ambulatory Service Center (ASC's)," said Denis Harrington, VentureMed's President and CEO."
  • This approval was granted in part based on FLEX Vessel Prep meeting CMS criteria for substantial clinical improvement over the existing standard of care.

Ocular Therapeutix™ Provides Third Quarter 2023 Financial Results and Corporate Update

Retrieved on: 
Tuesday, November 7, 2023

BEDFORD, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today reported financial results for the third quarter ended September 30, 2023, and provided updates on its ophthalmology pipeline.

Key Points: 
  • “We made significant progress at Ocular Therapeutix in the third quarter,” said Antony Mattessich, President and CEO.
  • The Company also recorded gains and losses from debt extinguishment, net, of $14.2 million in the third quarter of 2023.
  • Non-cash charges for stock-based compensation and depreciation and amortization were $5.4 million in the third quarter of 2023 versus $4.7 million for the comparable quarter in 2022.
  • Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 4:30 pm Eastern Time to review the Company's financial results and provide a general business update.

Sight Sciences Reports Third Quarter 2023 Financial Results and Withdraws Guidance for Full Year 2023

Retrieved on: 
Tuesday, November 7, 2023

Generated third quarter 2023 total revenue of $20.0 million, an increase of 7% compared to the same period in the prior year.

Key Points: 
  • Generated third quarter 2023 total revenue of $20.0 million, an increase of 7% compared to the same period in the prior year.
  • Achieved total gross margin of 86.6% in the third quarter of 2023 compared to 84.3% in the same period in the prior year.
  • On October 26, 2023, WPS Government Health Administrators (“WPS”), a Medicare Administrative Contractor (“MAC”), published an LCD with an effective date of December 24, 2023.
  • Sight Sciences' management team will host a conference call today, November 7, 2023, beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

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: