The Study
Precision Medicine-Based Complex Case Management Research Study
Pharmacogenomic testing and case management for members with complex chronic disease.
Study Lead
Dr. Kimberly Jinnett
The Center for Workforce Health and Performance (CWHP), led by Dr. Kimberly Jinnett, will study the outcomes of employee populations after medical genomics are facilitated, case managed, and applied in high-risk, highly complex plan members. This study will focus on clinical and cost reduction outcomes of medical genomics in employee populations. The entire medical genomic process will be facilitated by Rx-Precision.
Introduction
The Cost of Non-optimized Prescriptions
Most prescription drugs are “one size fits all,” but they don’t work the same way for everyone. Therefore, it’s difficult to predict who will benefit from a medication, who will not respond at all, and who will experience negative side effects. This is especially true for high-cost, high-risk patients with complex chronic disease and polypharmacy.
These “non-optimized” medications result in an estimated $528 billion in annual healthcare costs and $200 billion in unnecessary and inappropriate prescription drug utilization1
Adverse drug reactions, often caused by non-optimized medications are the fourth leading cause of death and account for 7% of all hospital admissions and 20% of readmissions2, 3
Furthermore, many important classes of drugs are effective in only 25-60 percent of the patient population4
Pharmacogenomics is Underutilized
Low physician awareness, knowledge and interpretation
Lack of access to laboratory services
A Lack of time and resources to educate patients
Lack of time or resources to educate patients
PGx-Guided Care™
A NEW PHARMACOGENOMICS CARE DELIVERY MODEL
Identifies high-risk, high-cost patients who will clinically benefit from PGx testing and guides them and their physician through the entire testing and medication optimization process
Study Objective
The objective of this industry-sponsored study is to measure the clinical, financial and implementation outcomes of a turnkey Pharmacogenomics intervention designed specifically for payors. The intervention Identifies high-risk, high-cost employees and health plan members with complex chronic disease who have a medical necessity for a PGx test and guides them and their physician through the entire testing and medication optimization process.
Material and Methods
Inclusion Criteria
A minimum of 2,000 high-risk, high cost members with a medical necessity for a PGx intervention will be identified via claims data.
Test Selection and Tracking
Members opting-in will be matched to the optimal PGx panel and be supported through a clinical genomic case management process and paired with a genetic counselor.
Member Enrollment
Members meeting the research criteria will receive education about the study and given the option to opt-in.
Genetic Counseling and CDS
The member’s physician will be provided with tools, education, and peer-to-peer clinical decision support to implement treatment changes securely and immediately.
Study Endpoints
Clinical Outcomes
Each study participant will provide baseline pre-intervention clinical data relevant to their current clinical condition. This data will be studied against post-interventional data at intervals of 3, 6 and 12 months to show the effectiveness of the intervention on improving clinical outcomes.
Example Clinical Data Include:
Blood Pressure
Glucose and A1c
BMI
Waist/Hip Measurement
Symptoms Related to Diagnosis
Claims and Cost Outcomes
Medical and pharmaceutical claims data including but not limited to utilization, prevalence of services, dosages, claims patterns and costs will be studied pre and post intervention to evaluate the effectiveness of the intervention in reducing claims costs. Claims data will be studied in both the participant group as well as the control group that qualified for the intervention but opted-out. Controls will be in place to ensure data reported is accurate and accounts for outliers and regression.
Process Outcomes
Once the intervention is complete, each study participant, their physician and their employer or health plan will be offered the opportunity to answer brief questionnaires gathering their experience with the intervention, care coordination process and value of the intervention.
Example Clinical Data Include:
Member Participants: QOL, Care Satisfaction, Stress, Absenteeism, Presenteeism, Productivity
Physician Experience: Care Coordination, Integrating New Technology, Quality of Care
Health Plan Experience: Cost Concerns, Implementation via Plan & Providers, Care Coordination
Our Partners
Co-founded by Mayo Clinic. Have the most comprehensive, cost-effective PGx test on the market.
Backed by JP Morgan. Delivers genetic counseling to patients and CDS to healthcare providers.
Leading microbiome and RNA sequencing company with the highest resolution of a person’s gut microbiome.
Study Sponsors
Employers
Medicare Advantage Health Plans
Managed Medicaid Plans
Commercial Health Plans
Third-Party Administrators
Payor Benefits
Independently-validated Data
Independently-validated data around a new option for helping high-risk members get better clinical outcomes
Full Study Results
Full study results including all clinical, process and claims outcomes
Lower Costs
Potentially lower pharmacy and medical costs for your highest-risk, complex patients
Member Impact Analysis
Pharmacogenomic impact analysis of your entire member population
Improve Employee Productivity
Potentially improved employee absenteeism, presenteeism and productivity
Billed as a Medical Claim
Because we contract with payors as a healthcare provider, PGx-Guided Care™ can be billed to your claims fund as a medical claim (the same way an MRI is billed).
Cost to Participate
The fees will be used to fund the research staff and process, clinical genomic case management process, telemedicine genetic specialists for participants and peer-to-peer clinical decision support for physicians, PGx testing and analysis and reporting and publishing of the research once the study has concluded. For reference this fee is approximately 50%-90% of Medicare reimbursement for only the PGx test and analysis.
Let’s Get Started
Testimonials
Professional Response
“With this advanced genetic test, you can finally take your life back. Free of pain and free of the adverse side effects from medications that aren’t right for you. You can finally feel like you. No more hassle to take four, six or eight pills a day. Now you have the ability to know what will work and what won’t work with your body. No more guesswork is involved. You’re not a science experiment and you shouldn’t have to feel that way.”
Cindy Reed, R.N., PhD
Physician Response
“A.P. is a 41 year old woman with cutaneous lupus, hypertension, diabetes, and chronic pain. She has made great progress with lifestyle changes, but continues to depend on 13 prescription medications to control her symptoms. Your test fortunately revealed that most of the medications she is taking work well with her genetics. She did learn that her body requires higher doses of 2 of her chronic medications to be most effective. She also learned that one of the medications her rheumatologist has suggested for her lupus would NOT be metabolized safely by her body, so she has deferred starting it. She feels empowered by these results to stay consistent with the lifestyle modifications that she knows reduce her inflammation.”
Julia Buchkina, MDCindy Reed, R.N., PhD
Member Response
“Thank you so much for calling me. I am so happy my insurance covers this test! I didn’t even know a test like this existed. I have been having a lot of trouble with my psych meds and this will be helpful. Wow! This is really great news!”
Anonymous Health Plan Member
Read More
For Payors
A turnkey pharmacogenomics risk management and medication optimization platform for employers, health plans, third-party administrators and other payors
Improving Clinical Outcomes
Read more about the people behind it all.
The Science
Numerous clinical studies have documented that PGx testing leads to improved clinical outcomes and significant costs savings in the right patient populations.
1. Annals of Pharamcotherapy, 2018. Vol. 52(9) 829-837
2. Lazarou J, Pomeranz BH, Corey PN. JAMA . 1998 Apr 15;279(15):1200-5.
3. Foster, A.J., Murff, H.J., Peterson, J.F. et al. (2003). Ann Intern Med, 2003 Feb 4; 138(3)
4. Spear BB, Health-Chiozzi M, Hu J: Clinical Applications of Pharmacogenetics. Trends Mol. Med. 7, 201-204 (2001)
5. Sudia, Jason, “Exploring Barriers to the Adoption of Pharmacogenomic Technology in the Clinical Setting by Clinical Healthcare Providers” (2016) 138(3).
6. J. Med Econ. 2016;19(3): 213-28 Epub Nov 11, 2015.
7. Plos ONE 12(2): e0170905. https://doi.org10.1371/journal.pone.170905.
8. Sudia, Jason, “Exploring Barriers to the Adoption of Pharmacogenomic Technology in the Clinical Setting by Clinical Healthcare Providers” (2016) 138(3).
Copyright 2019 © Rx-Precision, Inc. All rights reserved.
Rx-Precision, Inc.
2945 Townsgate Rd.
Suite #200
Westlake Village, CA 91361
The Study
Precision Medicine-Based Complex Case Management Research Study
Pharmacogenomic testing and case management for members with complex chronic disease.
Study Lead
Dr. Kimberly Jinnett
The Center for Workforce Health and Performance (CWHP), led by Dr. Kimberly Jinnett, will study the outcomes of employee populations after medical genomics are facilitated, case managed, and applied in high-risk, highly complex plan members. This study will focus on clinical and cost reduction outcomes of medical genomics in employee populations. The entire medical genomic process will be facilitated by Rx-Precision.
Introduction
The Cost of Non-optimized Prescriptions
Most prescription drugs are “one size fits all,” but they don’t work the same way for everyone. Therefore, it’s difficult to predict who will benefit from a medication, who will not respond at all, and who will experience negative side effects. This is especially true for high-cost, high-risk patients with complex chronic disease and polypharmacy.
These “non-optimized” medications result in an estimated $528 billion in annual healthcare costs and $200 billion in unnecessary and inappropriate prescription drug utilization1
Adverse drug reactions, often caused by non-optimized medications are the fourth leading cause of death and account for 7% of all hospital admissions and 20% of readmissions2, 3
Furthermore, many important classes of drugs are effective in only 25-60 percent of the patient population4
Pharmacogenomics is Underutilized
Low physician awareness, knowledge and interpretation
Lack of access to laboratory services
A Lack of time and resources to educate patients
Lack of time or resources to educate patients
A NEW APPROACH
PGx-Guided Care™
Identifies high-risk, high-cost patients who will clinically benefit from PGx testing and guides them and their physician through the entire testing and medication optimization process
Study Objective
The objective of this industry-sponsored study is to measure the clinical, financial and implementation outcomes of a turnkey Pharmacogenomics intervention designed specifically for payors. The intervention Identifies high-risk, high-cost employees and health plan members with complex chronic disease who have a medical necessity for a PGx test and guides them and their physician through the entire testing and medication optimization process.
Material and Methods
Inclusion Criteria
A minimum of 2,000 high-risk, high cost members with a medical necessity for a PGx intervention will be identified via claims data.
Test Selection and Tracking
Members opting-in will be matched to the optimal PGx panel and be supported through a clinical genomic case management process and paired with a genetic counselor.
Member Enrollment
Members meeting the research criteria will receive education about the study and given the option to opt-in.
Genetic Counseling and CDS
The member’s physician will be provided with tools, education, and peer-to-peer clinical decision support to implement treatment changes securely and immediately.
Study Endpoints
Clinical Outcomes
Each study participant will provide baseline pre-intervention clinical data relevant to their current clinical condition. This data will be studied against post-interventional data at intervals of 3, 6 and 12 months to show the effectiveness of the intervention on improving clinical outcomes.
Example Clinical Data Include:
Blood Pressure
Glucose and A1c
BMI
Waist/Hip Measurement
Symptoms Related to Diagnosis
Process Outcomes
Once the intervention is complete, each study participant, their physician and their employer or health plan will be offered the opportunity to answer brief questionnaires gathering their experience with the intervention, care coordination process and value of the intervention.
Example Clinical Data Include:
Member Participants: QOL, Care Satisfaction, Stress, Absenteeism, Presenteeism, Productivity
Physician Experience: Care Coordination, Integrating New Technology, Quality of Care
Health Plan Experience: Cost Concerns, Implementation via Plan & Providers, Care Coordination
Claims and Cost Outcomes
Medical and pharmaceutical claims data including but not limited to utilization, prevalence of services, dosages, claims patterns and costs will be studied pre and post intervention to evaluate the effectiveness of the intervention in reducing claims costs. Claims data will be studied in both the participant group as well as the control group that qualified for the intervention but opted-out. Controls will be in place to ensure data reported is accurate and accounts for outliers and regression.
Our Partners
Co-founded by Mayo Clinic. Have the most comprehensive, cost-effective PGx test on the market.
Backed by JP Morgan. Delivers genetic counseling to patients and CDS to healthcare providers.
Leading microbiome and RNA sequencing company with the highest resolution of a person’s gut microbiome.
Study Sponsors
Employers
Medicare Advantage Health Plans
Managed Medicaid Plans
Commercial Health Plans
Third-Party Administrators
Payor Benefits
Independently-validated data
Independently-validated data around a new option for helping high-risk members get better clinical outcomes
Full Study Results
Full study results including all clinical, process and claims outcomes
Lower Costs
Potentially lower pharmacy and medical costs
Member Impact Analysis
Pharmacogenomic impact analysis of your entire member population
Improve Employee Productivity
Potentially improved employee absenteeism, presenteeism and productivity
Billed as a Medical Claim
Because we contract with payors as a healthcare provider, PGx-Guided Care™ can be billed to your claims fund as a medical claim (the same way an MRI is billed).
Cost to Participate
The fees will be used to fund the research staff and process, clinical genomic case management process, telemedicine genetic specialists for participants and peer-to-peer clinical decision support for physicians, PGx testing and analysis and reporting and publishing of the research once the study has concluded. For reference this fee is approximately 50%-90% of Medicare reimbursement for only the PGx test and analysis.
Let’s Get Started
Testimonials
Professional Response
“With this advanced genetic test, you can finally take your life back. Free of pain and free of the adverse side effects from medications that aren’t right for you. You can finally feel like you. No more hassle to take four, six or eight pills a day. Now you have the ability to know what will work and what won’t work with your body. No more guesswork is involved. You’re not a science experiment and you shouldn’t have to feel that way.”
Cindy Reed, R.N., PhD
Physician Response
“A.P. is a 41 year old woman with cutaneous lupus, hypertension, diabetes, and chronic pain. She has made great progress with lifestyle changes, but continues to depend on 13 prescription medications to control her symptoms. Your test fortunately revealed that most of the medications she is taking work well with her genetics. She did learn that her body requires higher doses of 2 of her chronic medications to be most effective. She also learned that one of the medications her rheumatologist has suggested for her lupus would NOT be metabolized safely by her body, so she has deferred starting it. She feels empowered by these results to stay consistent with the lifestyle modifications that she knows reduce her inflammation.”
Julia Buchkina, MDCindy Reed, R.N., PhD
Member Response
“Thank you so much for calling me. I am so happy my insurance covers this test! I didn’t even know a test like this existed. I have been having a lot of trouble with my psych meds and this will be helpful. Wow! This is really great news!”
Anonymous Health Plan Member
Read More
For Payors
A turnkey pharmacogenomics risk management and medication optimization platform for employers, health plans, third-party administrators and other payors
Improving Clinical Outcomes
Read more about the people behind it all.
The Science
Numerous clinical studies have documented that PGx testing leads to improved clinical outcomes and significant costs savings in the right patient populations.
1. Annals of Pharamcotherapy, 2018. Vol. 52(9) 829-837
2. Lazarou J, Pomeranz BH, Corey PN. JAMA . 1998 Apr 15;279(15):1200-5.
3. Foster, A.J., Murff, H.J., Peterson, J.F. et al. (2003). Ann Intern Med, 2003 Feb 4; 138(3)
4. Spear BB, Health-Chiozzi M, Hu J: Clinical Applications of Pharmacogenetics. Trends Mol. Med. 7, 201-204 (2001)
5. Sudia, Jason, “Exploring Barriers to the Adoption of Pharmacogenomic Technology in the Clinical Setting by Clinical Healthcare Providers” (2016) 138(3).
6. J. Med Econ. 2016;19(3): 213-28 Epub Nov 11, 2015.
7. Plos ONE 12(2): e0170905. https://doi.org10.1371/journal.pone.170905.
8. Sudia, Jason, “Exploring Barriers to the Adoption of Pharmacogenomic Technology in the Clinical Setting by Clinical Healthcare Providers” (2016) 138(3).
Copyright 2019 © Rx-Precision, Inc. All rights reserved.
Rx-Precision, Inc.
2945 Townsgate Rd.
Suite #200
Westlake Village, CA 91361
Oren is an innovator and technologist with deep experience in healthcare, big data and analytics. He has over 20 years’ experience as an entrepreneur and startup leader. Oren has had proven success in leading the creation of new products, businesses and venture-backed portfolios both as an entrepreneur and in partnership with Fortune 500 / Global 1000 companies. Oren is passionate about building transformative solutions and highly effective teams. He has expertise in artificial intelligence, deep learning, and data science across financial services, healthcare, and industrial sectors. Oren’s recent experience includes being Co-Founder and President of Pivotus Ventures, a new breed of enterprise software company focused in the banking industry that recently sold to Kony. Previously he was General Partner and Chief Strategy and Technology officer at FDC, a venture fund and startup foundry based in Orange County, CA. At FDC Oren ran incubation and oversaw technology and strategy across a portfolio of over 20 new ventures created at FDC.
Dr. Martin Kohn is an expert in health data analytics, health policy and healthcare management. He is an experienced physician, clinical informaticist, and health policy analyst. He was most recently Chief Medical Scientist at Sentrian, which creates predictive analytic systems integrating home monitoring with longitudinal health data for patients with complex chronic diseases. Sentrian identifies patients who are likely to need hospitalization days before they become seriously ill to provide time to intervene and avoid hospitalization. Previously, he was the Chief Medical Scientist for Care Delivery Systems in IBM Research developing analytic tools for healthcare, including the use of the Watson supercomputer.
Roni has more 20 years of industry healthcare technology experience in roles as CTO, CIO and CISO at Health Systems, Pharmaceutical, Biotechnology, Payer, Academic, City/State Government and Medical device companies.
As Chief Financial Officer, Shital is responsible for all of the company’s financial functions including accounting, audit, treasury, corporate finance and investor relations. Shital also leads human resource and legal activities. Her career spans more than 15 years of varied experience in financial management, business leadership and corporate strategy for software companies. Prior to joining Rx-Precision, Shital held previous CFO and Management positions at Pivotus Ventures, Maana and Microsoft. Shital earned a Bachelors of Speech Communication from California State University of Fullerton.
As COO, Joshua designed, built and manages our case management operations which includes member enrollment, testing and all activities between the lab, member, genetic counselors and treating physicians.
Jake has owned and operated family medicine, integrated health, and behavioral health clinics where he saw first hand how clinical solutions and advancements based on precision medicine can change the way we treat disease.
Dean is a healthcare industry veteran and digital health pioneer with more than twenty years of hands-on digital health experience as a startup Founder, CEO, Chief Commercial Officer and VP of Sales. Dean also has experience as a Partner and Advisor for venture capital firms and startup incubators, accelerators and growth foundries.
Dr. Bleyl is board-certified in medical genetics with a doctorate degree in human genetics and background experience spanning clinical care, academic research and oversight of clinical services across an integrated health system. Prior to this role, he directed the Clinical Genetics Institute (CGI) for Intermountain Healthcare, where he oversaw provision of genetic services, implementation of genetic testing stewardship and development of a system-wide infrastructure for storage and use of genomic data. Dr. Bleyl maintains an academic affiliation with the University of Utah, where his clinical practice focuses on cardiovascular genetics.
Guru is driven to develop and apply deep technology innovations to solve the big challenges, especially in health and education. He is known for his work on Microbiome Analytics, IBM Watson AI, Smarter Cities, Services Innovation, Mobile Computing, and Distributed Systems.
Tyler Koep, PhD is a Medical Affairs Specialist at OneOme specializing in clinical research and data analytics. Tyler received his PhD from Mayo Graduate School with a focus in Biomedical Sciences in 2014 and completed a post-doctoral fellowship at the University of Minnesota in 2017. Dr. Koep has numerous publications within the field of epidemiology and public health and provides expertise in designing and executing clinical research studies. Further, Dr. Koep offers subject matter expertise across the field of pharmacogenomics, including scientific foundations of drug metabolism, cost-effectiveness of pharmacogenomic testing, and chronic disease applications
