INTRODUCTION: Coronaviruses (“COV”) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (“MERS-COV”) and Severe Acute Respiratory Syndrome (“SARS-COV”). The novel coronavirus (“SARS-COV-2" or “COVID-19”) is a new strain that has not been previously identified in humans.
Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.
INTENDED USE:To detect and/or diagnose COVID-19, Global 7 Diagnostics utilizes a LDT Saliva COVID-19 RT-PCR Test (the “Test”). The Test has not been FDA cleared or approved. The Test is limited to United States laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), 42 U.S.C. §263a, to perform moderate complexity tests, and in United States laboratories certified under CLIA to perform high complexity tests, by clinical laboratory personnel who have received specific training on the use of the Test. As with any complex clinical laboratory test, there is a nominal possibility of failure or error in analysis. Extensive measures are taken to avoid these errors.
Positive results are indicative of the presence of SARS-COV-2 nucleic acid; clinical correlation with patient history and other diagnostic information are necessary to determine patient infection status. A patient obtaining a positive result should seek physician consultation immediately. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-COV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
By engaging our services, you acknowledge and agree to assume the risk of these limitations.
I understand the above statements. I had the opportunity to ask questions and have had them answered.
I consent to the collection and testing of my blood for the purpose of the service noted above (“SERVICE” I release the testing laboratory (“LABORATORY”), its affiliates, assignees or inheritors, including healthcare promoters from all liability, directly and indirectly, intentionally or by mistake or misplacement, arising from the collection and testing of my blood for the purpose stated herein. I acknowledge the results for the SERVICE can be affected by multiple factors and do not constitute medical advice or a diagnosis. I am informed that a diagnosis is only made by a physician or clinician in conjunction with a physical examination and medical history. I authorize the LABORATORY to release copies of my laboratory results and data to healthcare providers, including biotech companies, for the purpose of continuing and coordinating my plan of treatment, quality assurance, regulatory or accreditation purposes. I hereby assign to the LABORATORY the medical benefits to which I am entitled from my health insurance plan(s) or service(s) provider. I understand that some of the providers or entities associated with the SERVICE or LABORATORY may not be in my health plan’s network (“NON-PARTICIPATING PROVIDERS” The LABORATORY is authorized to release all information required for insurance claims and to permit reproduction of this authorization for use in place of the original assignment. I consent to a transfer of insurance benefits to all entities involved in this test. I consent to the release to third parties the results and data of my SERVICE (without my name being used) and to the use of the results and data in clinical and research studies and reports including but not limited to product development, product correlations, and validation. In compliance with National Codes and Industry Standards, my referring physician has disclosed to me at the time of referral (A) his, her or its affiliation with the LABORATORY, and (B) that he, she or it will receive, directly or indirectly, remuneration for referring me. I certify that I was informed of effective alternative resources at the time of my decision-making and that it is my option to use one of the alternative resources. I was further informed that if I selected to use an alternative resource, neither my physician nor his or her staff would treat me differently if I choose an alternative provider or entity. I understand the referring physician does not know if the provider is in or out of network or of the fees the referring provider charges. I have read and fully understand this Disclosure Notice. Therefore, I acknowledge I received such disclosure and notice, and I agree to accept such referral if offered. The patient acknowledges that SARS-CoV-2 (Covid-19) is Pandemic. In the interest of advancing research and testing; the patient hereby waives personal, estate, and inheritor’s rights to sue for illness and wrongful death in the event of inaccurate testing for SARS-CoV-2 (COVID-19).
YOU MAY BE ENTITLED TO GOVERNMENT REIMBURSEMENT BUT WE CANNOT GUARANTEE THAT PLEASE READ CAREFULLY, THERE IS NO CO-PAY WITH ANY INSURANCE PROVIDER, IF YOU FORGOT YOUR INSURANCE INFORMATION PLEASE BRING THE INSURANCE CARD TO THE TEST SITE.
YOU MAY BE ABLE TO RECEIVE GOVERNMENT REIMBURSEMENT FOR CORONAVIRUS RELATED CHARGES MAKE SURE TO SAVE ANY RECORDS RELATED TO TESTING, BUT WE CANNOT GUARANTEE THIS. IF YOU ARE UNINSURED YOU CONSENT TO BE ENROLLED IN THE COVID19 HRSA UNINSURED TRUST PROGRAM TO COVER RELATED COSTS* citation of H.R.6201 — 116th Congress (2019-2020)
(Sec. 6001) This section requires private health insurance to cover testing for COVID-19 without imposing cost-sharing (e.g., deductibles, coinsurance, or copayments) for the duration of the public health emergency declared on January 31, 2020. This coverage includes the cost of administering such approved tests and related visits to health care providers.
(Sec. 6002) This section requires Medicare to cover, without cost-sharing, visits to health care providers that relate to COVID-19 testing during the public health emergency.
(Sec. 6003) Medicare Advantage (MA) plans must also cover COVID-19 testing and related visits without cost-sharing during the public health emergency. MA plans are also prohibited from instituting prior authorization or other utilization management requirements with respect to coverage of such services.
(Sec. 6004) Additionally, COVID-19 testing and related visits must be covered without cost-sharing under the Children’s Health Insurance Program (CHIP) and Medicaid during the public health emergency.
(Sec. 6006) During the emergency period, the Department of Defense (i.e., TRICARE) and the Department of Veterans Affairs are also prohibited from requiring cost-sharing for COVID-19 testing and related visits. Additionally, individuals in civil service (i.e., all appointive positions in the executive, judicial, and legislative branches, excluding the uniformed services) who are enrolled in a health benefits plan shall not be subject to cost-sharing requirements for such services.
State Medicaid programs may also cover COVID-19 testing and related visits for uninsured individuals during this period. The section applies a 100% Federal Medical Assistance Percentage (FMAP) to such coverage.
Being tested also includes analysis of symptoms assessed in this required form, a medical visit, and genetic sampling. I agree to this a COVID-19 test and all recommended ancillary tests for the diagnosis of respiratory illnesses including SARS-CoV-2 (COVID-19) as deemed medically necessary.
YOU MAY BE ABLE TO RECEIVE GOVERNMENT REIMBURSEMENT FOR CORONAVIRUS RELATED CHARGES MAKE SURE TO SAVE ANY RECORDS RELATED TO TESTING, BUT WE CANNOT GUARANTEE THIS. IF YOU ARE UNINSURED YOU CONSENT TO BE ENROLLED IN THE COVID19 HRSA UNINSURED TRUST PROGRAM TO COVER RELATED COSTS*