Frequently Asked Questions:
What Happens if the results of the Test are POSITIVE?
Your results will be provided to your Prescribing Physician who will review the results with you and determine what, if anything, needs to be done to address any positive findings of Obstructive Sleep Apnea. Numerous therapies, lifestyle changes and surgical procedures are available to address the condition typically based upon severity, physician and patient preference and other factors.
The most typical therapy for Sleep Apnea is Continuous Positive Airway Pressure (CPAP) which involves a special beside machine, and mask interface to force air into your airway to prevent it from narrowing or closing. Additional Therapies include Oral Appliances, weight loss, cessation of smoking and drinking and if mild enough, sleep position aids to prevent you from sleeping on your back Only CPAP has the ability to electronically monitor your utilization, which depending upon your circumstances, may be needed to satisfy your medical examiner that you are being effectively and consistently treated.
Typically you will be granted a window of time to initiate the treatment with a temporary medical certificate and to satisfy the requirements specified by the Medical Examiner.
If CPAP therapy is recommended, the equipment is provided regionally by companies referred to as Durable Medical Equipment companies and needs to be obtained directly from one of them or several online vendors. 1st Line Medical, Inc. does not provide any DME services.
Are these results of the Home (Unattended) Study considered valid?
The WatchPAT platform is FDA cleared and recognized as medically valid by every insurer and medical association, including the Centers for Medicare Services. It is supported by the most significant body of medical literature of any Unattended Sleep Study platform. The accuracy (more formally referred to as the Sensitivity and Specificity) of identifying the Respiratory Events associated with OSA as compared to In-Lab Polysomnography has been proven to be medically valid. The WatchPAT is limited to it's proper indication only for the condition of Obstructive Sleep Apnea, and does not provide any insight into other Sleep Syndromes that may be present in your case which if suspected are appropriate for an Attended Sleep Study in a formal Lab environment. The majority of patients undergoing a Sleep Study however are being tested for the most prevalent Sleep Syndrome, which is Obstructive Sleep Apnea. The WatchPAT enables a very realistic, convenient, readily available and cost effective alternative to formal Sleep Labs for those seeking to diagnose Obstructive Sleep Apnea.
What if the results are NEGATIVE?
If you are found to NOT have Sleep Apnea, the Prescribing Physician and the Medical Examiner will want a copy of the Sleep Study to document the finding. As the WatchPAT is used in the privacy and convenience of your own home, it is important to be able to identify that you were actually the person participating in the study to eliminate any concern of potential fraud by having someone else use the system. To facilitate this, the WatchPAT has a unique Chain of Custody capability that can be utilized initially, or upon a repeat study if the first if found to be negative. This Chain of Custody Capability includes a positive ID bracelet (similar to a hospital ID bracelet) that must be put upon the test individual by an authority figure that testifies in writing to the placement of the Bracelet in a manner in which it cannot be removed (without cutting). The Bracelet must be in place and connected to the test device in order for it to activate. The tether connection is of such short length that it would be impossible to connect a test device and the bracelet to get it to function.
If you or your physician suspects you have Sleep Apnea, you most likely do, and thus we typically reserve the chain of custody function for a second study as it requires the extra step of having your physician, one of their staff members or a Notary Public confirm the placement of the Chain of Custody bracelet prior to use, thus slowing down the process. If you feel strongly that you do not have Sleep Apnea and would like to incorporate the Chain of Custody confirmation at the outset, we will gladly accommodate that. There is no extra charge for the second night study for a negative finding or for the Chain of Custody capability in either case.
How is the service provided?
Simply complete the Prescription order form on our website and have your physician or Medical Examiner (if they're willing - not all are) authorize it with their information and signature. Fax or Scan and eMail this completed form to the numbers/eMail on the bottom of the form. You may then go online to order the service or contact our Customer Service department at 866-720-8080, 9-6 ET, Monday- Friday. We will review the service coordinate delivery of the system to you at your desired time and location. The system is provided via UPS and a Return Label is provided. Round Trip Standard shipping rates are applicable according to Zone and desired Priority from our facility in the Northeast US. A Credit Card is required for payment as well as securing a deposit on the equipment to ensure timely use. No deposit fees are charged as long as the equipment is returned to us within the allocated timeframe that is mutually agreed upon during service coordination for testing, typically two days. Upon receipt the results are confirmed adequate for interpretation and reviewed by a Board Certified Sleep Physician licensed in the State in which you live. The results are then forwarded to the Prescribing Physician for review with you.
What if the study does not work?
The WatchPAT is an extremely robust system and VERY easy to use, so failures are rare. If there is a failure and it is determined to be a a result of the testing device, we will repeat the study at no cost (including the same level of shipping). If the study fails due to a non-compliance issue with the patient or inability to follow the instructions, we will repeat the study one time for a fee of $100.00 (+ S/H). If the study fails and you do not wish to repeat the study, or if the second study also fails at no fault of the equipment, we will reimburse half the initial testing fee (not including S/H).
Is the service covered by Insurance/ do we take insurance?
Reference the provided Insurance Policy. The service may be covered under your Medical Insurance Benefits provided there are no exclusions or limitations and that your plan covers out of network benefits. The restrictions to prompt service as well as the chain of custody prohibits us from submitting claims to insurers for the service, but we encourage you to do so and have provided links to some of the major insurer links to provide Member Claim Submission Forms. You can contact the Member Services department of your insurer, if you have one, to inquire into coverage for Diagnostic Medical Services under CPT code 95800.
Your results will be provided to your Prescribing Physician who will review the results with you and determine what, if anything, needs to be done to address any positive findings of Obstructive Sleep Apnea. Numerous therapies, lifestyle changes and surgical procedures are available to address the condition typically based upon severity, physician and patient preference and other factors.
The most typical therapy for Sleep Apnea is Continuous Positive Airway Pressure (CPAP) which involves a special beside machine, and mask interface to force air into your airway to prevent it from narrowing or closing. Additional Therapies include Oral Appliances, weight loss, cessation of smoking and drinking and if mild enough, sleep position aids to prevent you from sleeping on your back Only CPAP has the ability to electronically monitor your utilization, which depending upon your circumstances, may be needed to satisfy your medical examiner that you are being effectively and consistently treated.
Typically you will be granted a window of time to initiate the treatment with a temporary medical certificate and to satisfy the requirements specified by the Medical Examiner.
If CPAP therapy is recommended, the equipment is provided regionally by companies referred to as Durable Medical Equipment companies and needs to be obtained directly from one of them or several online vendors. 1st Line Medical, Inc. does not provide any DME services.
Are these results of the Home (Unattended) Study considered valid?
The WatchPAT platform is FDA cleared and recognized as medically valid by every insurer and medical association, including the Centers for Medicare Services. It is supported by the most significant body of medical literature of any Unattended Sleep Study platform. The accuracy (more formally referred to as the Sensitivity and Specificity) of identifying the Respiratory Events associated with OSA as compared to In-Lab Polysomnography has been proven to be medically valid. The WatchPAT is limited to it's proper indication only for the condition of Obstructive Sleep Apnea, and does not provide any insight into other Sleep Syndromes that may be present in your case which if suspected are appropriate for an Attended Sleep Study in a formal Lab environment. The majority of patients undergoing a Sleep Study however are being tested for the most prevalent Sleep Syndrome, which is Obstructive Sleep Apnea. The WatchPAT enables a very realistic, convenient, readily available and cost effective alternative to formal Sleep Labs for those seeking to diagnose Obstructive Sleep Apnea.
What if the results are NEGATIVE?
If you are found to NOT have Sleep Apnea, the Prescribing Physician and the Medical Examiner will want a copy of the Sleep Study to document the finding. As the WatchPAT is used in the privacy and convenience of your own home, it is important to be able to identify that you were actually the person participating in the study to eliminate any concern of potential fraud by having someone else use the system. To facilitate this, the WatchPAT has a unique Chain of Custody capability that can be utilized initially, or upon a repeat study if the first if found to be negative. This Chain of Custody Capability includes a positive ID bracelet (similar to a hospital ID bracelet) that must be put upon the test individual by an authority figure that testifies in writing to the placement of the Bracelet in a manner in which it cannot be removed (without cutting). The Bracelet must be in place and connected to the test device in order for it to activate. The tether connection is of such short length that it would be impossible to connect a test device and the bracelet to get it to function.
If you or your physician suspects you have Sleep Apnea, you most likely do, and thus we typically reserve the chain of custody function for a second study as it requires the extra step of having your physician, one of their staff members or a Notary Public confirm the placement of the Chain of Custody bracelet prior to use, thus slowing down the process. If you feel strongly that you do not have Sleep Apnea and would like to incorporate the Chain of Custody confirmation at the outset, we will gladly accommodate that. There is no extra charge for the second night study for a negative finding or for the Chain of Custody capability in either case.
How is the service provided?
Simply complete the Prescription order form on our website and have your physician or Medical Examiner (if they're willing - not all are) authorize it with their information and signature. Fax or Scan and eMail this completed form to the numbers/eMail on the bottom of the form. You may then go online to order the service or contact our Customer Service department at 866-720-8080, 9-6 ET, Monday- Friday. We will review the service coordinate delivery of the system to you at your desired time and location. The system is provided via UPS and a Return Label is provided. Round Trip Standard shipping rates are applicable according to Zone and desired Priority from our facility in the Northeast US. A Credit Card is required for payment as well as securing a deposit on the equipment to ensure timely use. No deposit fees are charged as long as the equipment is returned to us within the allocated timeframe that is mutually agreed upon during service coordination for testing, typically two days. Upon receipt the results are confirmed adequate for interpretation and reviewed by a Board Certified Sleep Physician licensed in the State in which you live. The results are then forwarded to the Prescribing Physician for review with you.
What if the study does not work?
The WatchPAT is an extremely robust system and VERY easy to use, so failures are rare. If there is a failure and it is determined to be a a result of the testing device, we will repeat the study at no cost (including the same level of shipping). If the study fails due to a non-compliance issue with the patient or inability to follow the instructions, we will repeat the study one time for a fee of $100.00 (+ S/H). If the study fails and you do not wish to repeat the study, or if the second study also fails at no fault of the equipment, we will reimburse half the initial testing fee (not including S/H).
Is the service covered by Insurance/ do we take insurance?
Reference the provided Insurance Policy. The service may be covered under your Medical Insurance Benefits provided there are no exclusions or limitations and that your plan covers out of network benefits. The restrictions to prompt service as well as the chain of custody prohibits us from submitting claims to insurers for the service, but we encourage you to do so and have provided links to some of the major insurer links to provide Member Claim Submission Forms. You can contact the Member Services department of your insurer, if you have one, to inquire into coverage for Diagnostic Medical Services under CPT code 95800.