OPOS-Fullpower launches “The First 24/7 Opioid Compliance Solution”

SANTA CRUZ, Calif. and SAN MATEO, Calif., Jan. 2, 2020 /PRNewswire/ — Fullpower® Technologies, “The sleep technology company” and OPOS, “The opioid optimization company”, are announcing a partnership to create “The first 24/7 opioid compliance solution“.  The solution combines Fullpower’s patented contactless biosensing polysomnography grade sleep monitoring and AI platform with OPOS opioid optimization, functional monitoring, and prescriber risk management.

The opioid epidemic has revealed that these powerful pain medications have real risks. The more recent reductions in opioid prescribing have created new obstacles for patients who rely on these important treatments. Physicians are challenged with compliance across a wide range of new opioid prescribing guidelines from the CDC, state medical boards and recent changes in state laws across the country that define a new de facto standard of care for opioid use. The Fullpower OPOS solution ensures that physicians are able to meet the new standard of care and adhere to the guidelines based on information that reflects the 24/7 life experience of the patient non-invasively while protecting privacy and security.

It is estimated that there are 116 million people suffering from chronic pain in the US and as many as 30 million patients receive long term opioid care (IOM, 2011). Chronic opioid therapy and the complexities of polypharmacy affect sleep, daily activities, and quality of life. Through 24/7 functional monitoring, physicians and their patients can gain insight into the efficacy, safety, and risks of long term opioid use to maximize a patient’s quality of life.

“Patients in America deserve safe access to the best medical treatment of their pain while we pursue a cure. OPOS delivers what doctors want and patients need.” – William G Brose, MD, OPOS Chief Medical Officer, a 30-year innovator in chronic pain management and Founder Stanford University Pain Program.

According to Dr. Carl Noe, Professor in the Department of Pain Management and Anesthesiology at UT Southwestern Medical Center, Director of its Division of Pain Management and Medical Director of the Eugene McDermott Center for Pain Management, “This is a game-changer. Optimizing both medication and non-medical tools along a continuum of chronic pain care has always been the holy grail.  This is the realm of truly individualized care for pain patients.”

Justin Kromelow, CEO of OPOS said: “We considered all available PSG-Level technologies as well as big data and AI technology platforms.  These are essential components of a 24/7 compliance system. Fullpower is the clear technology leader.  Only Fullpower demonstrated proven technology at a scale that is able to help us address this large problem and improve many lives today. That is why OPOS partnered with Fullpower.” 

Fullpower CEO, Philippe Kahn said: “Leveraging AI-innovation and Fullpower’s Sleep technology leadership, OPOS and Fullpower are delivering life-changing experiences that help manage one of the most challenging epidemics of the 2020 decade.”

About Fullpower Technologies Inc.
Fullpower Technologies designs, develops and operates a complete platform for hybrid Edge/Cloud AI, algorithms, big data, predictive analytics, together with end-to-end engineering services. The Company’s platform is backed by a patent portfolio of 125+ patents. The Company’s key areas of expertise are non-invasive PSG-level sleep technology as well as general activity quantification. The Company’s markets are in Medical, SmartHome and Wearable Solutions. For more information, visit http://www.fullpower.com. Please contact: BusDev@fullpower.com #AI #opioid #sleep

About OPOS, Inc.
OPOS transforms the legitimate use of opioids into a safer and more effective therapy without abandoning patients that demonstrate long term benefit. OPOS provides opioid prescribers with a complete picture of a patient’s benefits and risks, reducing the burden and liability while increasing regulatory compliance. OPOS extends patient monitoring and management to 24×7, utilizing data from mobile devices, medical sensors and devices and the Internet of Things (IoT).  For more information, visit https://opos.solutions.

Fullpower and Sleeptracker are trademarks of Fullpower Technologies, Inc., registered in the U.S. and other countries.

Fullpower – OPOS Q&A

Q. What problem are you solving?
A: There is an Opioid epidemic and as a result, the legitimate and responsible use of pain management medicine becomes harder to access for pain patients and practitioners. OPOS-Fullpower solutions provide a clear method for the responsible use of opioids in treating pain.

The quality of a person’s life depends on their ability to be functional, productive and independent. For many people, there are no effective surgical or alternative treatments to manage their chronic pain that enables them to have an acceptable quality of life. Chronic opioid therapy as part of a comprehensive pain management treatment plan may be the most effective therapeutic tool for many patients.  Physicians that believe chronic opioid therapy is the best available treatment for their patients are met with a myriad of new complex and confusing opioid prescribing guidelines, regulations and insurance restrictions that create burden, liability and uncertainty (Dowell. 2019).  Our solution ensures that the prescriber is able to meet all of the complex requirements of the guidelines and regulations for each opioid prescription. Our solution takes the guesswork out of compliance.

Q: How does your solution work?
A: By accurately monitoring sleep and activity, the AI models deliver a dashboard that assures that Opioids are used responsibly and legitimately and flag any anomalies. This, in turn, allows the practitioner to confidently issue the next pain medicine prescription.

Q. Who’s your competition and why are you better?
A: Most opioid compliance solutions focus on the abuse and addiction populations.  These solutions include prescription drug monitoring programs, Medication-Assisted Treatment (MAT) programs and addiction based cognitive behavior therapy.  All of these solutions are focused on the 2 million people that suffer from opioid use disorder.  We focus on the 30 million patients that do not have opioid use disorder and receive a benefit from chronic opioid therapy. The competition focuses on what happens between the patient and the prescriber during the 8-minute encounter of an office visit. We know that there is no way a prescriber can collect and analyze information, formulate a treatment plan and document all of the considerations of the prescribing guidelines and regulations.  We monitor patients 24/7 and present all of the information in a single document to the prescriber.  Instead of lengthy narratives, the prescriber is presented with a comprehensive background and analysis of patient function, performance and opioid benefits and risks to document their compliance and inform their decision making.

Q: What is “compliance” and why does it matter?
A: For prescribers, compliance is adherence to federal, state and medical board guidelines and regulations that define the standard of care for the safe, effective and appropriate use of opioids. For patients, compliance is adherence to the treatment plan prescribed by the physician where opioids may be one of several therapeutics or modalities. This is important because this creates a solution for legitimately prescribing and benefiting from the responsible use of opioids.

Q: What about privacy?
A: In the OPOS-Fullpower solution, all patient information is managed according to state and federal regulations that govern medical records. All patient information is considered Protected Health Information (PHI) with federal privacy protections afforded by Title II of HIPAA (Health Insurance Portability and Accountability Act) and Subtitle D of The HITECH (Health Information Technology for Economic and Clinical Health) Act. The HIPAA Privacy Rule establishes national standards to protect individuals’ medical records and other personal health information.

Q: What about security?
A: Security is managed and enforced using industry-standard and widely accepted healthcare information best practices.  Fullpower and OPOS meet and exceed security protections required by HIPAA and HITECH. The companies are committed to continuously assessing data security controls through risk assessment and maintain a risk management program to address any vulnerabilities that are identified.

Q: What happens when a pain patient is not compliant, how do they manage their pain?
A: Treatment goals are individualized between a physician and patient based on the specific needs, conditions and desired clinical and functional outcomes.  The prescribing physician makes the determination on the level of unique and functional benefit a patient is receiving from chronic opioid therapy (COT) with consideration of the many risk factors and potential harms that may be associated with COT.  There are many legitimate reasons that a patient may be out of compliance.  Ultimately, it is up to the physician and the patient to revise the treatment plan to more closely align with treatment outcomes and patient circumstances.

Q: I have chronic pain, how do I sign up?
A: Call OPOS at 1-833-694-9500 to learn if your provider is offering the solution to their patients, or go to https://opos.solutions/learnmore.  If your provider is not currently providing the solution to their patients, we can reach out to them and educate them on the benefits we can bring to their organization and patients.

Q: How much does it cost and who pays for it?
A: For most patients, there is no cost for using the solution.  For provider organizations, the platform has the capability to generate additional net practice income based on patient demographics. 

Q: What do I need to qualify?
A: Our solution should be used with all patients currently receiving chronic opioid therapy (COT).  For patients not yet on COT,  patients should be enrolled when they receive their first continuous 30-day opioid prescription and the prescriber intends to continue opioids for at least 3 months. In cases where state law or insurance companies require prescriptions of less than 30 days, patients should be enrolled once the prescriber is committing to a COT treatment plan.

Q: Can you fix the problem with all the people overdosing on the streets?
A: The opioid epidemic is a complex multifaceted problem. Our approach is to focus on the legitimate use of opioids among patients that demonstrate a benefit and functional gain where there may be no effective alternative treatments.  Illicit opioid use, characterized by abuse and addiction, requires a very specialized set of skills and tools.  Through compliance monitoring, we identify risk factors associated with addiction and abuse so the physician may make appropriate clinical and resource decisions for the patient prior to any significant negative outcomes. We rely on abuse and addiction providers to continue their work in assisting patients using illicit drugs.

Q: How is the OPOS /Fullpower collaboration defined?
A: OPOS is focused on sales and marketing in the medical industry, Fullpower develops and operates the AI-powered platform.

Q: Why is PSG-level sleep monitoring essential?
A: There are several reasons:

  1. Sleep is ⅓ of people’s lives and with accurate PSG-level monitoring tools and the Fullpower AI Analytics, sleep is a reliable signpost for responsible pain management.
  2. Because chronic opioid therapy has been associated with reduced sleep efficiency and increased risk of sleep-disordered breathing, the American Academy of Sleep Medicine issued a position statement to inform healthcare providers that they should be aware of the effects of chronic opioid therapy on sleep architecture, e.g., respiratory depression, increasing the risk of sleep-disordered breathing (Lu, 2019). In addition, the complex relationship between opioids, sleep, and daytime function can also contribute to fatigue and disturbed sleep. The CDC Guideline for Prescribing Opioids for Chronic Pain describes that opioid therapy can decrease respiratory drive with a high percentage of patients on long-term opioid therapy reporting to have an abnormal apnea-hypopnea index, as well as worsen central sleep apnea in obstructive sleep apnea patients and cause further desaturation in obstructive sleep apnea patients not on continuous positive airway pressure (CPAP). The American Sleep Apnea Association estimates that 80% of sleep-related breathing disorders are undiagnosed.  Our use of PSG-level sleep monitoring provides important information to be considered by physicians and patients in assessing the potential dangers of chronic opioid therapy and pursuing appropriate sleep-based breathing disorder diagnostic testing and follow up to ensure patient safety. 

Q. If I’m a new patient describe how you monitor my sleep? What does the patient need to do?
A: The new patient installs the sleep sensor underneath the mattress, between the boxspring and mattress,  and connects it to their WiFi network using the smartphone app and an electrical outlet.  If a patient has a disability, home installation is a service option.  To date, over 100,000 monitors have been installed by the end-user. Once the sleep sensor is installed, it is set and forget.  The cloud AI monitors the device remotely to ensure it is always working properly and can take action ranging from self-repair to notifying the patient that the sensor is unplugged or WiFi is not operating properly.

Q. Is PSG-Level home-monitoring of sleep powered by AI predictive analytics your “secret sauce”?
A: Yes, in many ways. This is a critical factor because subtle changes in sleep are predictors of other physiological emotional conditions or changes in conditions. Historically, PSG-level sleep monitoring has been the greatest challenge to achieving true 24/7 monitoring. The Fullpower Sleeptracker technology platform is the first AI-powered platform to deliver in-home PSG-level sleep monitoring. While studies have shown that chronic opioid therapy increases the risk of sleep disorders, prior to this solution, other approaches have failed to be used consistently by users (Yi, 2019). Wearables have poor battery life and cause skin irritation when worn 24/7. Mattress top sleep sensors contribute to an uncomfortable layered sleeping environment and have data gap issues as users lose contact with the mattress top sensor. Sonar based systems have to be properly placed each time the user goes to sleep. All of these technologies have gaps in their data. Using our contactless biosensors, we are able to capture accurate, high-quality data every night.  AI is used to examine sleep data and detect changes in user sleep characteristics over time.  This is a critical factor because subtle changes in sleep are predictors of other physiological and emotional conditions or changes in conditions.

Q. Do you have an example of how a doctor can tell that a patient is at risk for opioid addiction by monitoring sleep?
A: Risk of addiction and abuse are established by an initial assessment completed by the patient. If a patient has a risk of addiction and abuse, chronic opioid therapy should not be pursued. By monitoring sleep, we have the ability to identify changes and events that only occur during sleep and are usually unobserved (Rosen, 2019).  The majority of these events contribute to the mortality risk of the patient if they remain unaddressed.   Examples of these include undiagnosed sleep breathing disorders that are characterized by the occurrence of cessation in airflow in the absence of the usual corresponding respiratory effort or opioid-induced reductions in airway muscle activation. These disorders may exist independent of opioid use, be caused by opioids or excess opioid dosage, or result from polypharmacy. It is estimated that 80% of patients on chronic opioid therapy may exhibit undiagnosed sleep-based breathing disorders. Undiagnosed sleep-based breathing disorders are a large risk, and represent an unmanaged liability, for both patients and prescribers.

In addition to identifying the potential of additional mortality risk, monitoring sleep can also be used to identify opioid withdrawal during sleep.  Many patients may complain of increased pain during the night causing them to wake up. A typical response from a compassionate physician may be to increase the opioid dosage to enable uninterrupted sleep. While this may appear to solve the problem in the short term, what the system is observing is a combination of hyperalgesia and opioid withdrawal (Schuh-Hofer, 2013).  Rather than increasing dosage, this patient may be a candidate for reducing the opioid dosage to reduce the symptoms of withdrawal and hyperalgesia. Studies have shown that as little one night of sleep deprivation promotes hyperalgesia.  Because of the individual and unique nature of sleep cycles, these examples could only be observed by looking at the changes in a patient’s sleep patterns over time. There may be many weeks or months of symptom development prior to the patient experiencing a wakeup from withdraws and hyperalgesia.  Without this information and explanation, a clinician would not be able to manage the underlying mechanism amplifying the pain which before now, has only been observable in limited small scale studies because of the complexities associated with accurate longitudinal sleep monitoring.

References:

American Sleep Apnea Association, https://www.sleepapnea.org/learn/sleep-apnea-information-clinicians/, last accessed December 31, 2019.

Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1external icon

Dowell M.D., M.P.H., Deborah, Haegerich, Ph.D., Tamara, and Chou, M.D., Roger,  “No Shortcuts to Safer Opioid Prescribing”, N Engl J Med 2019; 380:2285-2287, DOI: 10.1056/NEJMp1904190

Errata. Vol. 65, No. RR-1. MMWR Morb Mortal Wkly Rep 2016;65:295. DOI: http://dx.doi.org/10.15585/mmwr.mm6511a6external icon

Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from: https://www.ncbi.nlm.nih.gov/books/NBK91497/ doi: 10.17226/13172

Lu, Brandon & Budhiraja, Rohit & Parthasarathy, Sairam. (2005). Sedating medications and undiagnosed obstructive sleep apnea: Physician determinants and patient consequences. Journal of clinical sleep medicine: JCSM: official publication of the American Academy of Sleep Medicine. 1. 367-71.

Nicholson, Kate M., Hoffman, Diane E., Kollas, Chad D., “Overzealous use of the CDC’s opioid prescribing guideline is harming pain patients.” Statnews, December 6, 2018, https://www.statnews.com/2018/12/06/overzealous-use-cdc-opioid-prescribing-guideline/, last accessed December 31, 2019

Rosen IM, Aurora RN, Kirsch DB, Carden KA, Malhotra RK, Ramar K, Abbasi-Feinberg F, Kristo DA, Martin JL, Olson EJ, Rosen CL, Rowley JA, Shelgikar AV; American Academy of Sleep Medicine Board of Directors. Chronic opioid therapy and sleep: an American Academy of Sleep Medicine position statement. J Clin Sleep Med. 2019;15(11):1671–1673.

Schuh-Hofer S, et al., “One night of total sleep deprivation promotes a state of generalized hyperalgesia: a surrogate pain model to study the relationship of insomnia and pain.”, Pain. 2013 Sep;154(9):1613-21. doi: 10.1016/j.pain.2013.04.046. Epub 2013 May 11.

Yi, Yangtian; Sossenheimer, Philip; Rai, Victoria; El Jurdi, Katia; Rubin, David,” Using Wearable Devices to Predict Length of Stay For IBD Patients After Bowel Surgery”, The American Journal of Gastroenterology: December 2019 – Volume 114 – Issue – p S29 doi: 10.14309/01.ajg.0000613408.68111.f3

Weiner  SG, Baker  O, Poon  SJ,  et al.  The effect of opioid prescribing guidelines on prescriptions by emergency physicians in Ohio.  Ann Emerg Med. 2017;70(6):799-808.e1.

Contacts:
Gary Bird (for Fullpower Technologies Inc)
831.401.3175
Fullpower@43pr.com

Justin Kromelow
OPOS
press@opos.solutions  

SOURCE Fullpower Technologies Inc.

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