Positions Fotodigm® to be Issued a CPT Code for Medical Billing
SANTA MONICA, CA, June 20, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – Parallax Health Sciences, Inc. (OTCQB: PRLX) (''Parallax'' or the ''Company''), an outcome-driven connected healthcare company, today announced that the Company is preparing a 510(K) application to be filed with the U.S. Food and Drug Administration (“FDA”). Currently, the FDA regulates only small subsets of mHealth apps, and drug administration.
Dr. David Stark, Parallax Health Sciences, Inc. Chief Regulatory Officer, says, “The rapid growth of mobile health (mHealth) apps has resulted in confusion amongst health care providers and the public about which products rely on evidence-based medicine”. Dr. Stark continued, “obtaining a 510(K) clearance with the FDA is a strong step forward toward differentiating our Fotodigm® technology, while developing trust in the marketplace that it has been reviewed and cleared by the FDA.”
Paul Arena, Parallax Health Sciences, Inc., Chief Executive Officer stated, “Alongside the development of a trusted technology, is the ability for Fotodigm® to obtain Current Procedural Terminology (“CPT”) codes. The CPT codes will allow for a substantial broadening of the medical community for billing for services”. Mr. Arena continued, “With the newly authorized CPT Codes that went into effect in January 2019, the medical community and regulatory agencies have begun the incorporation of digital technologies into mainstream use. This impacts the access to care for patients and dramatically impacts the potential revenue capacity of new medical technologies, especially those targeting the management of Chronic Disease. One of the huge problems of chronic disease management, a $800 billion sector in 2017, has been the ability to generate revenue through medical reimbursement. This is an area of focus for Parallax Care since we can reach a larger audience and achieve our mission of reducing costs, expanding access, and improving outcomes of healthcare.”
“Parallax’s patent portfolio of intellectual property protects our technology and give us the exclusive rights over of Fotodigm® data capture capabilities and our data driven outcomes incorporated within our Parallax Care platform, stated Nathaniel Bradley, Parallax Health Sciences, Inc., Chief Technology Officer. Mr. Bradley added, “Our patented solutions create significant barriers to entry for our competitors and as we continue to create strategic innovations that provide the empowerment of patients, reduces the cost of healthcare delivery, and now increases the revenues that our customers can generate through reimbursements with access to our turn-key Parallax Care platform.”
About CPT Codes
The Current Procedural Terminology (“CPT”) code set is a medical code set maintained by the American Medical Association through the CPT Editorial Panel. The CPT code set (copyright protected by the AMA) describes medical, surgical, and diagnostic services and is designed to communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes. New editions are released each October. The current version is the CPT 2018. It is available in both a standard edition and a professional edition.
CPT coding is similar to ICD-9 and ICD-10 coding, except that it identifies the services rendered, rather than the diagnosis on the claim (ICD-10-CM was created for diagnostic coding- it took the place of Volume 3 of the ICD-9). The ICD code sets also contain procedure codes (ICD-10-PCS codes), but these are only used in the inpatient setting. The CPT is currently identified by the Centers for Medicare and Medicaid Services (CMS) as Level 1 of the Healthcare Common Procedure Coding System.
The American Medical Association (AMA) developed the Current Procedural Terminology (CPT).
FDA 510(K) Clearance
Section 510(K) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(K). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.
About Parallax Health Sciences
Parallax Health Sciences is an advanced technology, outcome-driven telehealth company that allows for cost-effective remote diagnosis, treatment and monitoring of patients through proprietary platforms of integrated products and services. The Company's interoperable novel applications provide patients point-of-care testing and monitoring with information communicated via internet-based mobile phone applications that are agnostic as to operating system and are built on highly sophisticated data analytics. Information is retrieved in real time by physicians that are monitoring patients with chronic diseases or through biometric feedback for health-related behavior modification, and such information can be automatically integrated into electronic patient health records. The Company's products and offerings capitalize upon the digital transformation currently underway in the healthcare industry in order to improve patient compliance, diagnosis and treatment, while supporting healthcare system cost savings and efficiencies. For more information, please visit www.parallaxhealthsciences.com or www.parallaxcare.com.
Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategy, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our Form 10-K and other reports filed with the SEC. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.