Current Procedural Terminology

American Medical Association (AMA) Grants Cardio Diagnostics a Dedicated CPT PLA Reimbursement Code for Epi+Gen CHD, an AI-powered Test for Assessing the Probability of a Heart Attack or Coronary Heart Disease Event

Retrieved on: 
Wednesday, January 3, 2024

Primary Prevention of Heart Attacks: The Clinical and Economic Benefits of Epi+Gen CHD

Key Points: 
  • Primary Prevention of Heart Attacks: The Clinical and Economic Benefits of Epi+Gen CHD
    Every year, about 805,000 people in the United States have a heart attack, with someone experiencing a heart attack every 40 seconds.
  • Heart disease is the leading cause of death for both men and women.
  • In peer-reviewed studies, Epi+Gen CHD was more cost-effective and more sensitive for assessing heart attack risk compared to standard lipid-based risk calculators.
  • Cardio Diagnostics continues to lead the way in precision cardiovascular medicine, leveraging the power of AI and epigenetics to help prevent heart attacks.

Gynesonics Announces New Category 1 CPT Code for its Sonata Transcervical RF Ablation Procedure Used to Treat Uterine Fibroids

Retrieved on: 
Tuesday, January 2, 2024

The new code is effective January 1, 2024, and is defined as CPT 58580 Transcervical ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency.

Key Points: 
  • The new code is effective January 1, 2024, and is defined as CPT 58580 Transcervical ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency.
  • Commenting on the new CPT code, Skip Baldino, President and Chief Executive Officer of Gynesonics said, “We are very pleased that the AMA has established a new Category I code that applies to our Sonata® Procedure for the treatment of uterine fibroids.
  • The code is a critical milestone for the broader adoption of the technology to treat uterine fibroids in the United States.
  • Fibroids are treated from inside the uterus, so the Sonata Procedure requires no incisions, no tissue is surgically removed, and the uterus is preserved.

American Medical Association (AMA) Grants Cardio Diagnostics Holdings, Inc.’s AI-Powered Coronary Heart Disease Detection Test, PrecisionCHD, a Dedicated CPT PLA Reimbursement Code

Retrieved on: 
Tuesday, January 2, 2024

Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the American Medical Association (AMA) has assigned a dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analysis (PLA), 0440U, for the company’s AI-driven coronary heart disease (CHD) detection test, PrecisionCHD.

Key Points: 
  • Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the American Medical Association (AMA) has assigned a dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analysis (PLA), 0440U, for the company’s AI-driven coronary heart disease (CHD) detection test, PrecisionCHD.
  • Identifying those with CHD and intervening prior to a heart attack occurring are essential to reducing the unprecedented economic and health burden associated with CHD.
  • “Cardio Diagnostics is committed to ensuring that our solutions are widely accessible and receiving a dedicated CPT PLA code for PrecisionCHD is a critical milestone in our commercialization strategy,” said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics.
  • PrecisionCHD introduces a groundbreaking approach to CHD detection, which creates a new category of scalable and personalized cardiovascular diagnostic tools.

CMS Posts Final Payment Determination for bioAffinity Technologies’ CyPath® Lung Effective January 2024

Retrieved on: 
Thursday, November 30, 2023

bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other lung diseases, today announced that the Centers for Medicare and Medicaid Services (CMS) has made a final determination for payment for CyPath® Lung, a noninvasive test for early-stage lung cancer, for the 2024 calendar year.

Key Points: 
  • bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other lung diseases, today announced that the Centers for Medicare and Medicaid Services (CMS) has made a final determination for payment for CyPath® Lung, a noninvasive test for early-stage lung cancer, for the 2024 calendar year.
  • For the calendar year 2024 Medicare Clinical Lab Fee Schedule, CMS finalized the panel’s recommendation for CyPath® Lung for purposes of payment by Medicare.
  • In November 2023, CMS finalized the 2024 payment determination for CPT 0406U, effective January 1, 2024.
  • “Actionable results from CyPath® Lung may help doctors and their patients determine appropriate next steps for suspected cases of lung cancer,” Ms. Zannes said.

ProPhase Labs Announces Financial Results for the Three Months Ended September 30, 2023

Retrieved on: 
Thursday, November 9, 2023

Garden City, NY, Nov. 09, 2023 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH) (“ProPhase” or the “Company”), a next-generation biotech, genomics, therapeutics and diagnostics company, today reported its financial and operational results for the three and nine months ended September 30, 2023.

Key Points: 
  • Three Months Ended September 30, 2023 as compared to the Three Months Ended September 30, 2022.
  • Net revenue for the three months ended September 30, 2023 was $8.4 million as compared to $24.2 million for the three months ended September 30, 2022.
  • Diagnostic services costs for the three months ended September 30, 2023 were $0.1 million compared to $2.4 million for the three months ended September 30, 2022.
  • Adjusted EBITDA loss for the three months ended September 30, 2023 was $(2.5) million compared to adjusted EBITDA income of $6.3 million for the three months ended September 30, 2023.

Sleepiz AG Lands FDA 510(k) Clearance for Contactless Remote Patient Monitoring Device Measuring Vital Signs

Retrieved on: 
Tuesday, October 10, 2023

MINNEAPOLIS, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Sleepiz , a Zurich-based medical technology company providing contactless bedside patient monitoring, today announces the FDA Class II 510(k) clearance of its Sleepiz One+ device.

Key Points: 
  • MINNEAPOLIS, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Sleepiz , a Zurich-based medical technology company providing contactless bedside patient monitoring, today announces the FDA Class II 510(k) clearance of its Sleepiz One+ device.
  • The FDA clearance opens doors for seamless integration of the Sleepiz One+ device into Remote Patient Monitoring (RPM) and clinical study platforms.
  • In the world of remote patient monitoring, compliance is key, and Sleepiz One+ allows for 16 out of 30 days of measurements for CPT billing purposes.
  • “With this FDA 510(k) clearance, Sleepiz has achieved a critical milestone in the highly regulated medical device market.

Avantect Pancreatic Cancer Test Receives CPT Code and Preliminary Payment Determination from the Centers for Medicare and Medicaid Services

Retrieved on: 
Thursday, September 28, 2023

Effective October 1, 2023, the new CPT code, 0410U, establishes a reimbursement pathway for increased patient access and broader test adoption.

Key Points: 
  • Effective October 1, 2023, the new CPT code, 0410U, establishes a reimbursement pathway for increased patient access and broader test adoption.
  • The Avantect test is intended for patients at high risk for pancreatic cancer, such as those recently diagnosed with Type 2 diabetes or with a family history of pancreatic cancer.
  • In addition, the Centers for Medicare and Medicaid Services (CMS) announced that it has proposed preliminary reimbursement rate determinations for new and revised CPT codes issued by the AMA, including 0410U for the Avantect Pancreatic Cancer Detection Test.
  • Its proprietary epigenomic methods use a standard blood draw to identify pancreatic cancer signals at its earliest stages by measuring levels of the 5-hydroxymethylcytosine (5hmC) in cell-free DNA.

atai Life Sciences Reports Second Quarter 2023 Financial Results and Operational Highlights, and Announces Clinical Data from the Phase 1 Study of DMX-1002 (Ibogaine)

Retrieved on: 
Thursday, August 10, 2023

“Looking ahead to the second half of 2023 and beyond, we believe we are well positioned to continue advancing our key clinical programs.

Key Points: 
  • “Looking ahead to the second half of 2023 and beyond, we believe we are well positioned to continue advancing our key clinical programs.
  • Drug-induced prolongation of the QT interval is a phenomenon that has been, with many but not all drugs, associated with cardiac arrhythmias.
  • The single-blinded Phase 1 study assessed the safety, tolerability and pharmacokinetics of single-ascending doses of DMX-1002 in healthy volunteers.
  • Enrollment has been recently completed and the company expects to report initial clinical data in Q4 2023.

Nine Additional California Counties Choose Qualifacts as their Behavioral Health EHR Vendor of Choice

Retrieved on: 
Tuesday, July 25, 2023

With these recent additions, an impressive total of 17 counties have successfully implemented the Credible EHR Platform.

Key Points: 
  • With these recent additions, an impressive total of 17 counties have successfully implemented the Credible EHR Platform.
  • “We are excited to partner with these California counties, equipping them with the robust capabilities of the Credible platform.
  • For over 25 years, KVPS has provided California's behavioral health market with clear and actionable technical solutions.
  • Working alongside Qualifacts, they bring cutting-edge EHR solutions to California counties.

Cybin Announces the Development of a Scalable Psychedelic Facilitation Training Program, EMBARKCT

Retrieved on: 
Wednesday, July 12, 2023

Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, today announced that it has commenced the development of a streamlined, scalable version of its EMBARK Training Program, known as EMBARKCT.

Key Points: 
  • Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, today announced that it has commenced the development of a streamlined, scalable version of its EMBARK Training Program, known as EMBARKCT.
  • The EMBARK psychedelic facilitator training program was launched in October 2021 and provides facilitators the foundational training needed to provide skillful and ethical care to work with psychedelic therapeutics.
  • EMBARKCT is a streamlined training program designed for individuals with existing knowledge, skills and experience in psychedelic facilitation.
  • “The evolution of the EMBARK Training Program to EMBARKCT enhances our capacity to deliver high quality, scalable facilitator training suitable for a multisite, global clinical trial.