Item 1. Business
ITEM 1. BUSINESS
Spine Injury Solutions Inc. was incorporated under the laws of Delaware on March 4, 1998. We changed our name from Spine Pain Management Inc. to Spine Injury Solutions, Inc. on October 1, 2015.
We are actively pursuing a merger or similar transaction with a private company where it becomes the controlling company. We find this to be the best course of action for our stockholders. Further, we have been in negotiations with a certain third-party candidate since December 2021. We are presently negotiating terms of a proposed share exchange agreement with the candidate, under which its shareholders would exchange their shares for shares of our stock. Although we do not presently have a binding agreement with this company or its shareholders, it is possible that a definitive agreement for the proposed transaction could be agreed to and consummated in the imminent future. There is no assurance that such transaction will be completed, or if completed, that the terms will be favorable to us.
From 2009 to 2018, we operated as a technology, marketing, billing, and collection company facilitating diagnostic services for patients who have sustained spine injuries resulting from traumatic accidents. We delivered turnkey solutions to spine surgeons, orthopedic surgeons and other healthcare providers for necessary and appropriate treatment of musculo-skeletal spine injuries resulting from automobile and work-related accidents. Through our affiliate system, we facilitated spine surgeons, orthopedic surgeons and other healthcare providers to provide reasonable, necessary, and appropriate treatments to patients with musculo-skeletal spine injuries. We assisted the centers that provide the spine diagnostic injections and treatment and paid the doctors a fee for the medical procedures they performed. After a patient was billed for the procedures performed by the affiliated doctor, we took control of the patients’ unpaid bill and oversee collection. In most instances, the patient was a plaintiff in an accident case, where the patient was represented by an attorney. Typically, the defendant (and/or the insurance company of the defendant) in the accident case would pay the patient’s bill upon settlement or final judgment of the accident case. The payment to us was made through the attorney of the patient. In most cases, it was required that we agree to the settlement price and the patient must sign off on the settlement. Once we were paid, the patient’s attorney would receive payment for his or her legal fee.
During the fourth quarter of 2018, the decision was made to discontinue our involvement in future medical procedures due to our cash position, and we have not been involved in any procedures since then, including in 2021 or 2020. Presently, we continue to have no plans to do so in the future. However, we continue to actively pursue the collection of previously funded procedures. Without additional funding, there is no guarantee that we can continue as a going concern.
We own a device and process by which a video recording system known as the Quad Video Halo (“QVH”) is used to record medical procedures. The QVH system can simultaneously capture views and machine images, thus providing a record of internal and external views of a recorded procedure. The QVH system has been refined and improved over the years. The first- and second-generation systems required post-procedure file transfers, synchronizing and editing. This involved considerable software and time for a videographer to produce a complete video. The latest generation of the QVH referred to as NextGen 2.0 completely eliminates all of the issues associated with prior QVH approaches. The new varifocal lens cameras allow ceiling placement which eliminates the impact of room clutter and fluoroscope movement. The system server automatically synchronizes and renders the final videos, thus eliminating all backend processing.
We lease QVH units to customers who pay us monthly lease payments. Presently, the majority of our total revenues are derived from these lease payments. Our wholly-owned subsidiary, Quad Video Halo, Inc. holds certain company assets affiliated with the QVH units.
Billing and Operations
From 2009 to 2018, we worked with independent medical contractors who would perform the medical services for patients and bill a fixed fee for the services. We funded certain spine injury diagnostic centers where we work with healthcare providers as independent contractors to perform medical services for patients (however, we discontinued our involvement in future medical procedures during the fourth quarter of 2018—see above). We paid the healthcare providers for medical services performed. The patients were billed based on Current Procedural Terminology (“CPT”) codes for the medical procedure performed. CPT codes are numbers assigned to every task and service a medical practitioner may provide to a patient including medical, surgical and diagnostic services. CPT codes are developed, maintained and copyrighted by the American Medical Association. Patients were billed at the normal billing amount, based on national averages, for a particular CPT code procedure. We would take control of the patients’ unpaid bills.
The clinic facilities where our spine injury diagnostic centers operated were owned or leased by a medical affiliate or third party. We had no ownership interest in these clinic facilities, nor did we have any responsibilities towards building or operating the clinic facilities.
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Governmental Regulation
All of the medical diagnostic procedures offered at the clinics were performed by independent medical contractors, who were subject to regulation by a number of governmental entities at the federal, state, and local levels. We were and are subject to laws and regulations relating to business corporations in general.
HIPAA Administrative Simplification Provisions — Patient Privacy and Security
The Health Insurance Portability and Accountability Act of 1996, commonly known as “HIPAA,” requires the adoption of standards for the exchange of health information in an effort to encourage overall administrative simplification and to enhance the effectiveness and efficiency of the healthcare industry. Pursuant to HIPAA, the Secretary of the Department of Health and Human Services has issued final rules concerning the privacy and security of health information, the establishment of standard transactions and code sets, and the adoption of a unique employer identifier and a national provider identifier. Noncompliance with the administrative simplification provisions can result in civil monetary penalties up to $100 per violation as well as criminal penalties that include fines and imprisonment. The Department of Health and Human Services Office of Civil Rights is charged with implementing and enforcing the privacy standards, while the Centers for Medicare and Medicaid Services are responsible for implementing and enforcing the security standards, the transactions and code sets standards, and the other HIPAA administrative simplification provisions.
The HIPAA requirements only apply to “covered entities,” such as health plans, healthcare clearinghouses, and healthcare providers, which transmit any health information in electronic form. Our business is likely considered a “covered entity” under HIPAA.
Of the HIPAA requirements, the privacy standards and the security standards have the most significant impact on our business operations. The privacy standards require covered entities to implement certain procedures to govern the use and disclosure of protected health information and to safeguard such information from inappropriate access, use, or disclosure. Protected health information includes individually identifiable health information, such as an individual’s medical records, transmitted or maintained in any format, including paper and electronic records. The privacy standards establish the different levels of individual permission that are required before a covered entity may use or disclose an individual’s protected health information and establish new rights for the individual with respect to his or her protected health information.
The final security rule establishes security standards that apply to covered entities. The security standards are designed to protect health information against reasonably anticipated threats or hazards to the security or integrity of the information, and to protect the information against unauthorized use or disclosure. The security standards establish a national standard for protecting the security and integrity of medical records when they are kept in electronic form.
The administrative simplification provisions of HIPAA require the use of uniform electronic data transmission standards for healthcare claims and payment transactions submitted or received electronically. We believe that we are in substantial compliance with the transaction and code set standards. The transaction standards require us to use standard code sets when we transmit health information in connection with certain transactions, including health claims, health payments and remittance advices.
In addition, the Secretary of the Department of Health and Human Services issued a final rule that requires each healthcare provider to adopt a standard unique health identifier, the National Provider Identifier (“NPI”). The NPI will identify healthcare providers in the electronic transactions for which the Secretary has already adopted standards (the “standard transactions”). These transactions include claims, eligibility inquiries and responses, claim status inquiries and responses, referrals, and remittance advices. All health plans and all healthcare clearinghouses must accept and use NPIs in standard transactions.
Other Privacy and Confidentiality Laws
In addition to the HIPAA requirements described above, numerous other state and federal laws regulate the privacy of an individual’s health information. These laws specify how an individual’s health information may be used internally, the persons to whom health information may be disclosed, and the conditions under which such uses and disclosures may occur. Many states have requirements relating to an individual’s right to access his or her own medical records, as well as requirements relating to the use and content of consent or authorization forms. Also, because of employers’ economic interests in paying medical bills for injured employees and in the timing of the injured employees’ return to work, many states have enacted special confidentiality laws relating to disclosures of medical information in workers’ compensation claims. These laws limit employer access to such information. Many states have also passed laws that regulate the notification process to individuals when a security breach involving an individual’s personally identifiable information, such as social security number or date of birth, occurs. To the extent that state law affords greater protection of an individual’s health information than that provided under HIPAA, the state law will control.
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We anticipate that there will be more regulation in the areas of privacy and confidentiality, particularly with respect to medical information. We regularly monitor the privacy and confidentiality requirements that relate to our business, and we anticipate that we may have to modify our operating practices and procedures in order to comply with these requirements.
Competition
Presently, the majority of our total revenues are derived from leasing QVH units. Although we believe the QVH system is unique in the healthcare industry, there may be low barriers to entry in this market, and the addition of new competitors may occur relatively quickly. If competition within our industry intensifies, our ability to maintain or increase our revenue growth, price flexibility and control over medical costs, trends, and marketing expenses, may be compromised.
Employees
We currently have one paid part-time employee (our CFO, John Bergeron), plus one collection consultant and one QVH consultant at our corporate headquarters. We do not presently pay our President and CEO, William Donovan, M.D., any compensation. We expect to continue to use independent contractors, consultants, attorneys and accountants as necessary, to complement services rendered by our employees.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.