HCPCS

Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights

Retrieved on: 
木曜日, 5月 9, 2024
FDA, CMS, Risk, SARS-CoV-2, Food, Webcast, U.S. FDA, Administration, Research and development, Pre-exposure prophylaxis, COVID-19, Patient, Immunodeficiency, Medicine, Medicare, Clinical trial, HCPCS, Vaccine

“The recent months have been incredibly productive for Invivyd.

Key Points: 
  • “The recent months have been incredibly productive for Invivyd.
  • At the beginning of April, Invivyd announced that PEMGARDA is available for purchase in the U.S. through a network of authorized specialty distributors.
  • The company will begin reporting PEMGARDA net product revenue with its second quarter 2024 financial results.
  • First Quarter 2024 Financial Results:
    Cash Position: Cash and cash equivalents were $189.4 million as of March 31, 2024.

CorMedix Inc. Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
木曜日, 5月 9, 2024
FDA, Sale, CMS, ESRD, Investment, Drug, Risk, Research, TPN, Patient, Nutritional science, Eastern Time Zone, Marketing, HCPCS, Pharmaceutical industry

BERKELEY HEIGHTS, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the first quarter ended March 31, 2024 and provided an update on its business.

Key Points: 
  • BERKELEY HEIGHTS, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the first quarter ended March 31, 2024 and provided an update on its business.
  • The TDAPA program currently provides for five years of additional payment reimbursement beyond the ESRD bundled rate to outpatient providers.
  • Operating expenses in the first quarter 2024 were $15.9 million, compared with $11.0 million in the first quarter of 2023, an increase of approximately 44%.
  • The management team of CorMedix will host a conference call and webcast today, May 9, 2024, at 8:30am Eastern Time, to discuss recent corporate developments and financial results.

Helius Medical Technologies, Inc. Announces Preliminary CMS Payment Determination of Reimbursement for Portable Neuromodulation Stimulator (PoNS®)

Retrieved on: 
月曜日, 5月 6, 2024
HSDT, CMS, Stroke, Pons, Public, Medicare, Helios, HCPCS, Health insurance

NEWTOWN, Pa., May 06, 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) posted proposed Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment rates for the PoNS Controller and Mouthpiece to be discussed at the bi-annual Healthcare Common Procedure Coding System (HCPCS) Public Meeting, scheduled for May 29, 2024.

Key Points: 
  • For the PoNS Mouthpiece (HCPCS code A4594), CMS based pricing on the cash pay price of $4,500, resulting in a total capped payment of $3,075.53.
  • For the PoNS Controller (HCPCS Code A4593), CMS preliminarily set pricing by mapping reimbursement to existing code E0745, (Neuromuscular stimulator, electronic shock unit), resulting in a total capped fee of $1,206.53.
  • “CMS’s preliminary determination of reimbursement for both the PoNS Controller and Mouthpiece is a significant win for Helius,” stated Helius’ President and Chief Executive Officer, Dane Andreeff.
  • The Company cannot provide any assurance that these rates will be finalized and adopted in their current amounts, or at all.

CorMedix Inc. Announces U.S. Inpatient Commercial Availability of DefenCath® (Taurolidine and Heparin)

Retrieved on: 
月曜日, 4月 15, 2024
FDA, CMS, Risk, Safety, CLS, Heparin, Food, Kidney failure, HD, Incidence, Patient, Medicare, Taurolidine, CVC, HCPCS, Medical device

We are proud to provide an option for adult patients who face the risk of CRBSIs.

Key Points: 
  • We are proud to provide an option for adult patients who face the risk of CRBSIs.
  • We look forward to expanding the availability of DefenCath to the outpatient setting later this year.”
    The commencement of U.S. outpatient commercialization of DefenCath is planned for July 1, 2024.
  • If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.
  • To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch .

Invivyd Receives Healthcare Common Procedure Coding System (HCPCS) Reimbursement Codes from the U.S. Centers for Medicare & Medicaid Services (CMS) Covering PEMGARDA™

Retrieved on: 
月曜日, 4月 15, 2024
Momentum, Vaccination, CMS, Risk, Safety, SARS-CoV-2, Food, Health care, Pre-exposure prophylaxis, Patient, COVID-19, Immunodeficiency, Medicare, Interim, HCPCS, Pharmaceutical industry

In addition, CMS issued a product specific M code (M0224) covering the administration of PEMGARDA.

Key Points: 
  • In addition, CMS issued a product specific M code (M0224) covering the administration of PEMGARDA.
  • Both HCPCS codes are effective retroactively to March 22, 2024, the date of emergency use authorization (EUA) for PEMGARDA.
  • HCPCS is a group of standardized codes that represent medical procedures, supplies, products, and services.
  • For additional information about PEMGARDA, please see the full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning.

Axena Health receives two additional positive insurance coverage decisions for Leva

Retrieved on: 
木曜日, 4月 11, 2024
Medical Devices, Women, FDA, Health Technology, Health Insurance, Biotechnology, Health, Consumer, Pharmaceutical, UI, Urinary incontinence, Woman, BCBS, Food, Cigna, The Institute, Leva, MD, Highmark, Life, Pelvic floor, Female, Pelvic organ prolapse, Privacy, Incontinence, Overactive bladder, Storey, MBA, FACOG, Food and Drug Administration, HCPCS, Nursing

Both positive coverage decisions became effective on April 1, 2024.

Key Points: 
  • Both positive coverage decisions became effective on April 1, 2024.
  • “Axena Health is focused on providing evidence-based solutions through both formal clinical trials with world-class academic institutions and published real-world evidence.
  • “Two more positive coverage decisions for the Leva System means more women can access effective, first-line treatment for UI.
  • Highmark BCBS and BCBS of ND have joined Cigna in demonstrating their clear commitment to women’s health.

Kalogon Unveils Orbiter Med: A Medicare-Approved Custom Wheelchair Cushion for Pressure Management and Postural Support

Retrieved on: 
木曜日, 4月 11, 2024
Women, Seniors, Men, Software, Artificial Intelligence, Medical Devices, Internet, Hardware, Consumer, Consumer Electronics, Technology, Physical Therapy, Medical Supplies, General Health, Health, Apps, Applications, Health Technology, Health Insurance, Wheelchair, CMS, Risk, Safety, Heart, Machine learning, Insurance, APM, Spacecraft, Patient, Mobility, Medicare, HCPCS, Communications satellite

For the first time, Orbiter Med combines Kalogon’s groundbreaking Advanced Pressure Management (APM) system with the individualized postural support of a custom cushion reimbursable by insurance.

Key Points: 
  • For the first time, Orbiter Med combines Kalogon’s groundbreaking Advanced Pressure Management (APM) system with the individualized postural support of a custom cushion reimbursable by insurance.
  • However, people who use wheelchairs have had to compromise by choosing to focus on either structural support or skin integrity.
  • Orbiter Med is custom fabricated based on each patient’s unique seating and positioning requirements - needs that can’t sufficiently be satisfied by a prefabricated seating system.
  • Orbiter Med is a fully customized system that blends the best technology in pressure management with tailored stability and postural support specific to a patient’s needs."

Natural Cycles Receives HCPCS Level II Code from Centers for Medicare & Medicaid Services (CMS) for its birth control app

Retrieved on: 
水曜日, 4月 17, 2024
FDA, CMS, HCPCS, Pregnancy, Food, De novo, Hormone, Natural Cycles, Insurance, Thermoregulation, Medicare, Temperature, Medical device

NEW YORK, April 17, 2024 /PRNewswire/ -- Natural Cycles, a leading women's digital health company and maker of the world's first birth control app, announced the Centers for Medicare & Medicaid Services ("CMS") established a new HCPCS (Healthcare Common Procedure Coding System) Level II code to identify Natural Cycles. The Natural Cycles code, A9293, became effective on April 1, 2024.

Key Points: 
  • The code will be used to facilitate the processing of health insurance claims by insurers, helping Natural Cycles users get reimbursed for their non-hormonal birth control method
    NEW YORK, April 17, 2024 /PRNewswire/ -- Natural Cycles, a leading women's digital health company and maker of the world's first birth control app, announced the Centers for Medicare & Medicaid Services ("CMS") established a new HCPCS (Healthcare Common Procedure Coding System) Level II code to identify Natural Cycles.
  • The HCPCS level II code makes it easier for insurers to cover a subscription to the Natural Cycles birth control app.
  • The Natural Cycles app, which received the Food and Drug Administration's (FDA's) De Novo clearance in 2018, is used to prevent pregnancy naturally without hormones.
  • The HCPCS level II code will ensure Natural Cycles is described consistently across the healthcare industry, making it easier for insurers to cover a subscription to the FDA Cleared Natural Cycles birth control app.

Lifeward CEO Issues Open Letter to Shareholders on Progress to Finalize Exoskeleton Medicare Payment Rate

Retrieved on: 
月曜日, 4月 1, 2024
HCPCS, Durable medical equipment, Disability, Freedom, Face, Robotics, DBA, Macs, Medicare, CMS, SCI, Rehabilitation

MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, April 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 issued an open letter from Larry Jasinski, Chief Executive Officer, to shareholders discussing the Company’s progress with the Centers for Medicare & Medicaid Services (“CMS”) to establish a payment rate for ReWalk Personal Exoskeletons. The full letter is published below:

Key Points: 
  • As a result of the deferral, the payment rate is not included in CMS’ April 2024 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (“DMEPOS”) fee schedule of Medicare payment rates that are effective April 1.
  • Our active engagement with CMS is ongoing and we work to establish the payment rate as soon as possible.
  • Until a payment rate for exoskeletons is added to the DMEPOS schedule, the Medicare Administrative Contractors (“MACs”) still have authority to approve and pay claims on a case-by-case basis with discretion to set the payment rate.
  • Lifeward intends to submit an additional 60-75 additional Medicare claims by the end of 2024 to accelerate its momentum in expanding access for qualified Medicare beneficiaries.

Helius Medical Technologies, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
木曜日, 3月 28, 2024
Research, HCPCS, Gait, Patient, Operating cost, Stroke, Sale, Acquisition, HSDT, Andreyev, Social services, ATM, Pons, Medicare, FDA, CMS, PTAP, Food, Video game

NEWTOWN, Pa., March 28, 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 results for the quarter and full year ended December 31, 2023.

Key Points: 
  • Gross profit for the fourth quarter of 2023 was $44 thousand, compared to gross profit of $132 thousand in the fourth quarter of 2022.
  • Operating loss for the fourth quarter of 2023 decreased to a loss of $2.2 million, compared to an operating loss of $2.7 million in the fourth quarter of 2022.
  • Net loss was $1.0 million for the fourth quarter of 2023, compared to a net loss of $4.9 million in the fourth quarter of 2022.
  • The basic and diluted net loss per share for the fourth quarter 2023 was $1.47, compared to net loss per share of $8.66 in the fourth quarter 2022.