Since the 1990s there has been a dramatic increase in prescription drug abuse in the U.S. Nonmedical use of prescription drugs is now the nation's second leading cause of accidental death . The Centers for Disease Control and Prevention now classifies prescription drug abuse as a national epidemic . Sadly, this epidemic is having an increasingly disproportionate impact on our Medicaid population. A 2010 study of commercially insured and Medicaid insured beneficiaries found that the prevalence of opioid abuse in the Medicaid population was 10 times higher than in the commercially insured population, and that opioid abusers in the Medicaid population incurred nearly seven times the annual health care costs (i.e., $13,658 versus $1,830) as non-abusers in the Medicaid population .
Medi-Cal, the California Medicaid program, currently insures 7 million people. This insured population is expected to grow by 850,000 in 2013 and by 680,000 in 2014 due to the impact of the Affordable Care Act (ACA) . Consequently, Medi-Cal spending from the California general fund is expected to grow by 460% (from $339 million to $1.9 billion) in 2014 .
The prescription drug abuse epidemic has led to increased regulatory scrutiny at both the federal and state level. Today, forty states have operational prescription drug monitoring programs (PMP). Eight of the remaining ten states are in the process of operationalizing a PMP. The other two have PMP legislation pending. The majority of PMPs, however, employ a patient-centric model for combatting the problem, with a primary goal being to identify and treat persons addicted to prescription drugs . Most have been unsuccessful . Only three focus on prescribers and proactively provide education about prescription drug abuse.
WHY CALIFORNIA LCHPs?
We have introduced SafeUseNow℠ to multiple commercial health plans, and without exception they acknowledge that our prescriber-centric approach and risk scoring methodology are both innovative and comprehensive. Most commercial health plans take a patient-centric approach to combatting prescription drug abuse, an approach that is not working by most accounts. Although one innovative health plan has adopted SafeUseNow℠, the primary obstacle to its adoption by other commercial health plans is a requirement for 12+ months of outcomes demonstrating program efficacy, specifically cost savings. Such outcomes permit health plans to minimize the investment risk of implementing our program and ensure a positive return on investment.
We have also introduced SafeUseNow℠ to several LCHPs in California. LCHPs are the primary sponsor of Medi-Cal services in California, and have fewer dollars to invest in programs like SafeUseNow℠ as compared to their commercial health plan cousins. However, like the commercial plans, LCHPs require a ROI for their investment in health care programs.
With a significantly higher rate of prescription drug abuse in the Medi-Cal population, LCHPs stand to benefit most from a reduction in prescription drug abuse, both in terms of improved patient care and reduction in the utilization of pharmacy, medical, and rehabilitation services.
We propose to configure a one-year SafeUseNow℠ program for four LCHPs in California. The program will utilize our existing risk scoring methodology (with no modification), produce and deliver customized risk reports to up to 150 prescribers per LCHP who score in the 98th percentile of prescription drug abuse risk in their county, include a one-to-one telephonic intervention for up to 75 of each group of 150 prescribers, and provide access to a SafeUseNow℠ program web portal so that LCHP staff can monitor prescriber, patient, and pharmacy risk.
We propose to offer the program to the four largest California LCHPs which, according to June 2012 Medi-Cal enrollment figures, are:
- Los Angeles Care (995,128)
- Inland Empire Health Plan (500,133)
- CalOptima (391,643)
- Partnership (201,692)
- CalViva Health (190,067)
A fifth LCHP is listed in the event one of the top four chooses not to participate.
SafeUseNow℠ is a novel, prescriber-centric solution to combat prescription drug abuse. Using LCHP claims data, advanced analytics, and a patent pending risk identification model our solution will enable LCHPs to identify combinations of prescribers, patients, and pharmacies whose behaviors contribute to prescription drug abuse. Because prescribers are the primary source of prescription drugs, efforts to reduce prescription drug abuse must begin with them, and must accomplish three objectives:
- Identify those whose prescribing behaviors may contribute to prescription drug abuse, and stratify them by risk severity;
- Engage prescribers in an educational program designed to improve appropriate prescription drug prescribing and encourage patient care coordination; and
- Monitor prescribing patterns to detect changes in behavior and measure overall program effectiveness.
SafeUseNow℠ recently completed the intervention phase of a multi-year pilot program for a commercial health plan. Preliminary (i.e., 90-day post intervention) outcomes show that prescribers who received a SafeUseNow℠ intervention experienced a statistically significant reduction in their PSI Score™, a composite measure of network prescription drug abuse risk. The patients of these prescribers, too, experienced a statistically significant reduction in both the number of monthly opioid prescription claims, and the monthly morphine equivalent milligrams taken.
The PSI Score™ is calculated using a weighted combination of multiple risk factors [8,9]. The risk factors are computed using behavioral health care data from prescription drug claims processed by the LCHP. Updated scores for Medi-Cal prescribers, patients, and pharmacies will be computed monthly. By aggregating scores for sub-populations of prescribers, demographic and geographic trends can be identified. Individual and aggregate trend data can be used to analyze changes in prescribing behavior over time.
Ranking and stratifying by PSI Score™ and its component risk factors enables the creation of a risk assessment report tailored to each prescriber’s risk factors and risk severity. Moreover, PSI Score™ results that are rapidly trending toward increased risk identify prescribers who can be prioritized, enabling an LCHP to conduct a more intensive one-to-one intervention as appropriate.
SafeUseNow℠ staff will provide all services for risk scoring, analysis, and report production.
Develop and Mail Risk Report
Prescriber educational materials are designed to effectively engage and educate prescribers about risk-class appropriate strategies to minimize prescription drug abuse and promote safe prescribing practices and patient safety.
Using Social Learning theory [10,11] as a framework for customizing interactions with prescribers, our intervention program optimizes responsiveness and behavior change among the largest possible number of prescribers. The program tailors messages to address prescriber’s risk behaviors and encourage the adoption of safe use prescribing practices. Learning modules related to each risk factor present guidelines regarding safe use prescribing practices, such as showing prescribers how to conduct assessments, create patient agreements, and manage difficult patient interactions to reduce risk of addiction and diversion.
When the PSI Score™ model identifies a prescriber as potentially engaging in multiple risk behaviors, a prioritization algorithm determines the appropriate sequence to bring each behavior to the prescriber’s attention to maximize engagement and rapidly reduce any risk the prescriber’s behavior may pose to patients.
SafeUseNow℠ staff will provide all content production and processing services. An external mail vendor will be used to print labeling for the physician educational materials. Materials will be shipped to each prescriber via USPS Certified Mail Electronic Return Receipt service.
One-to-One Consultation with Prescribers
SafeUseNow℠ clinicians will provide 20-minute, one-to-one telephonic consultations for up to 75 prescribers in each LCHP network. During the outcomes measurement phase of the project this will allow SafeUseNow℠ to evaluate the relative effectiveness of delivering a risk report to a prescriber with (n ≤ 75) and without (n ≤ 75) a one-to-one intervention.
SafeUseNow℠ staff will provide all prescriber intervention and consultation services.
Web Portal and Risk Monitoring
In order to promote engagement and adoption, we will design, develop, and deploy an open source web portal for the four LCHPs. The toolset for this portion of the project includes:
- Node.js / Express
- Twitter Bootstrap
Additionally, we will design and publish the specification for a REST API (i.e., Representational State Transfer Application Programming Interface) to the SafeUseNow℠ scoring database. The API will permit each LCHP to develop a custom web interface to the SafeUseNow℠ scoring database using the API and the open source code for the default web portal. The primary function of the web portal is to provide each LCHP the means to monitor program information for the prescribers, patients, and pharmacies within their county or counties. Appropriate measures will be taken to ensure that each LCHP may access data only for the prescribers, patients, and pharmacies in their network.
One feature, for example, enables the LCHP to review a list of patients who were recently prescribed a controlled drug or a relevant concomitant drug by multiple prescribers in the past 30 days, or who received prescriptions from multiple pharmacies. Similarly, prescribers can check the prescription history of individual patients presenting for drug therapy before writing a prescription. The information will enable prescribers to take additional precautions, and permit an LCHP to lock patients into receiving future prescriptions from only one prescriber and/or one pharmacy.
SafeUseNow℠ also provides the means to measure behavior change over time, and identifies prescribers who are unresponsive to the program so that they can then be triaged to other risk management functions within the LCHP.
SafeUseNow℠ staff will provide all web portal programming services. SafeUseNow℠ information technology infrastructure and client-facing services (e.g., the Web portal) will be contracted to an external HIPAA 2.0-compliant data center partner.
The following project structure was designed, developed, and deployed in a pilot program for a large commercial health plan. We propose to adapt that successful project structure for use in this project. Table 1 lists each project phase and a narrative to describe the key objectives of each phase.
Table 1: SafeUseNow℠ Program Phases and Objectives
Acquire Data: Acquire, validate, and stage LCHP data required to use the PSI Score℠ model.
Risk Score Network: Use PSI Score™ model to score LCHP network.
Research, Catalog, and Configure Program Content: Research, document, evaluate, and finalize selection of all Medicaid-specific acceptable use prescribing guidelines; configure SafeUseNow℠ intervention materials: Welcome Letter, Prescriber Packet, Risk Factor Worksheet, Educational Materials, and LCHP Pharmacist Training Guide; conduct stakeholder review meeting.
Project Planning Meeting: Review program materials, work flow, training protocol; and document management information system requirements.
API Development & Deployment: Design, develop, configure, and deploy the SafeUseNow℠ database API for accessibility by designated LCHP stakeholders.
Data Loading App Development & Deployment: Design, develop, configure, and deploy a LCHP data loading app.
Web Portal Development & Deployment: Design, develop, configure, and deploy web portal for accessibility by designated LCHP stakeholders.
Operational & Outcomes Reports: Configure operational reports to monitor activities and to support outcomes measurement objectives.
Program Support & Logistics: WebEx presentation for all LCHP stakeholders; coordinate final prescriber selection process, generate outbound communications, generate operational reports; hold periodic project team meetings with stakeholder and vendor teams.
Intervention Services: Distribute Welcome Letters, Prescriber Packets to prescribers; conduct one-to-one interventions in each LCHP network; send monthly Patient Safety messages to prescribers; send quarterly letters to prescribers with updated risk scores; measure, monitor, and intervene with relapsed prescribers.
The SafeUseNow℠ project team will consist of the staff listed in Table 2.
Table 2: SafeUseNow℠ Teams and Roles
Patrick J. Burns: President. Overall project leadership.
Technology Services Team
Paul DuBose, PhD: VP Analytics. Risk scoring, outcomes design and analysis, web portal analytics, and general analytical expertise. Project leadership for the Technology Services teams.
Roman Pearah: Senior Consultant. Web portal programming, risk scoring database design, and general scientific programming expertise.
Jason Prull: Analyst II. Risk modeling, data acquisition and processing, and general database analysis expertise.
Britni LaBounty: Analyst II. Risk modeling, data acquisition and processing, and general database analysis expertise.
Intervention Services Team
Lawrence Feinstein, PhD: VP Clinical Programs and Psychologist. Program content configuration, project team planning meeting, and general clinical expertise. Project leadership for the Intervention Services teams.
Mark Mosk, PhD: Clinical Interventionist and Psychologist. Conduct one-on-one interventions with program prescribers.
Ann Wheeler, PharmD: Clinical Interventionist and Pharmacist. Conduct one-on-one interventions with program prescribers.
Suresh Bangara, MD: Medical Director. Consultative partner to Clinical Interventionists on an as-needed basis.
The proposed project requires nominal involvement of LHCP staff for the first four to six weeks of the project, during which time configuration decisions for their program will be made. Thereafter, and for the one year duration of the project, each LCHP should be prepared to allocate 10%-15% of a clinical pharmacist's (i.e., a PharmD) time to field ad-hoc questions from prescribers in their network.
We anticipate the project development/execution schedule shown in Table 3, which uses the project award date as a baseline.
Table 3: SafeUseNow℠ Project Phases and Dates
Project Start: tbd
Configure Program Content: Weeks 1-4
Acquire Data & Score Network: Weeks 5-8
Design Data Loading Application, Web Portal, and API: Weeks 5-8
Review Risk Distribution Result with LCHPs: Weeks 9-10
Develop, Test, & Deploy Data Loading App, Web Portal and API: Weeks 9-40
Produce & Mail Reports: Weeks 11-13
Conduct One-to-One Interventions: Weeks 12-19
Month 1 Score Update: Weeks 15-18
Month 2 Score Update: Weeks 19-22
Month 3 Score Update: Weeks 23-26
Month 4 Score Update: Weeks 27-30
Month 5 Score Update: Weeks 31-34
Month 6 Score Update: Weeks 38-41
Month 7 Score Update: Weeks 42-45
Month 7 Score Update: Weeks 46-49
Month 8 Score Update: Weeks 50-53
Outcomes Assessment: Weeks 45-51
Final Project Results Presentation: Week 52
OPPORTUNITY FOR STATE-WIDE AND NATION-WIDE EXPANSION OF SAFEUSENOW℠
Initial outcomes for the SafeUseNow℠ pilot program currently running for a commercial health plan are encouraging. We are cautiously optimistic that the decreased risk trend will continue during the next nine months. The program includes a follow-up component in which monthly emails or faxes are sent to participating prescribers to maintain their top-of-mind awareness of the program and of the prescription drug abuse epidemic. Over the next 21 months, a series of health economic outcomes analyses will be conducted to assess overall program effectiveness; that is, its impact on prescriber behavior, patient behavior, drug and medical services utilization and costs, and opioid-related mortality.
A Knight News Challenge award would draw significant attention to the prescription drug abuse epidemic, and allow the initial focus on four California LCHPs to pave the way for adoption by the other 10 LCHPs in California. We would welcome an effort to implement SafeUseNow℠ on a coordinated state-wide basis, and would work with the LCHPs to develop a Continuous Quality Improvement (CQI) program to serve the needs of the local community health plans as well as the State Department of Healthcare Services.
Such momentum could result in interest by commercial and other public sector health plans in other states. Such interest could lead to recognition of the SafeUseNow℠ program as a national best practice for reducing prescription drug abuse risk and cost.
 Drug Deaths Now Outnumber Traffic Fatalities in U.S., Data Show. September 17, 2011. Lisa Girion, Scott Glover and Doug Smith, Los Angeles Times. Link
 Office of National Drug Control Policy (ONDCP) Web Site Home Page. September 15, 2013. Link
 Cost and Comorbidities Associated with Opioid Abuse in Managed Care and Medicaid Patients in the United States: A Comparison of Two Recently Published Studies. Ghate SR, et al. J Pain Palliat Care Pharmacother. 2010 Sep;24(3):251-8. Link
 Medi-Cal Facts and Figures: A Program Transforms, 2013. California Healthcare Foundation. 2013 May;1. Link
 Medi-Cal Facts and Figures: A Program Transforms, 2013. California Healthcare Foundation. 2013 May;54. Link
 State Prescription Drug Monitoring Programs. Questions & Answers 2011. November 1, 2011. Link
 Prescription Drug Abuse: What is Being Done to Address This New Drug Epidemic? Manchikanti, L., Testimony before the Subcommittee on Criminal Justice, Drug Policy and Human Resources. Pain Physician, 2006. 9(4): p. 287-321. Link
 Rank-ordering Physicians by Opioid Abuse and Diversion Risk. DuBose, P. et al. Poster presented at the 2011 Annual Meeting of the College on Problems of Drug Dependence (CPDD). Hollywood, FL. Link
 External Validation of the Potential Concern Index Model Based on Individual Prescribing Patterns. DuBose, P. et al. Poster presented at the 2013 Annual Meeting of the College on Problems of Drug Dependence (CPDD). San Diego, CA. Link
 Social Learning Theory. Bandura, A. (1977). Englewood Cliffs, NJ: Prentice-Hall.
 Cognitive-behavior Modification: An Integrative Approach. Meichenbaum, D. (1977). New York:Plenum.
 SafeUseNow℠ Program: Abuse, Misuse, Addiction & Diversion (AMA&D) Economic Impact Model. Model. Developed using SAMHSA Drug Abuse Warning Network (DAWN) data. DuBose, P. et al (2013). Link
Follow-up Question Responses
Q1: Who is working on the project? Who are your partners?
A1: Our project team includes the following company staff, many of whom have actively contributed to our national prescription drug abuse research project (2009-2010) and the design, development, and deployment of the SafeUseNow℠ program (2011-2013). Our project team lead is Patrick J. Burns, President. Our technical team includes Paul DuBose, Ph.D., Vice President Analytics; Roman Pearah, Senior Consultant; Jason Prull, Consultant II; Britni LaBounty, Consultant II. Our intervention team includes Lawrence Feinstein, Ph.D., Vice President Clinical Programs and a Psychologist; Mark Mosk, Ph.D., Psychologist; Ann Wheeler, PharmD, Pharmacist, and Suresh Bangara, MD Medical Director. We propose to engage Abnology, or an entity with equal or greater capabilities, to provide HIPAA 2.0-compliant and LCHP security-compliant information technology hosting services.
Q2: How do you know there is demand for this project?
A2: First, we have three SafeUseNow℠ program clients: (1) a 3-year pilot program with Horizon Blue Cross Blue Shield of New Jersey; (2) a Health Economics & Outcomes Research (HEOR) study with a global pharmaceutical pain drug manufacturer that uses the SafeUseNow℠ risk score engine; and (3) a Prescriber Risk assessment study for a second global pharmaceutical pain drug manufacturer.
Second, this year we have presented the SafeUseNow℠ program at multiple conferences (e.g., Academy for Managed Care Pharmacy, College for Problems on Drug Dependence, National Association of Drug Diversion Investigators, Pharmaceutical Management Science Association, and the National Association of Controlled Substance Authorities) leading to requests for program capabilities presentations by 30+ commercial health plans, local community health plans, pharmacy benefit managers (PBM), pharmaceutical manufacturers, pharmaceutical supply chain distributors, health data services firms and venture capital funds, and their Medical Directors and/or Directors of Pharmacy Services have universally stated their belief that SafeUseNow℠ is more comprehensive and sophisticated than any other methods they currently use or know of, and that they have high confidence SafeUseNow℠ can reduce risk and improve safety among their patient populations. The challenge they face is to present evidence to their Chief Financial Officers that an investment in the SafeUseNow℠ program will result in a positive financial ROI (return on investment).
Third, as a result of the aforementioned business development activities, we recently delivered two SafeUseNow℠ pilot program proposals to: (1) a LCHP in Maryland, and (2) a LCHP in California, and in both cases current discussions are focused on the importance of a positive ROI in the Horizon pilot program.
Q3: How is your project different from what already exists?
A3: Current strategies tend to be patient-centric and are informed by volumetric information (e.g., intervene with patients who have more than 4 oxycodone prescriptions in the last 120 days), and expect the problem to resolve simply by giving prescribers access to transactional pharmacy data through a state-run prescription monitoring program (PMP). These strategies unsophisticatedly assume that prescribers (1) have time to seek and sift through raw data, (2) are proficient at deducing risk, and (3) have the skills, time, and willingness to manage difficult high risk patients; further, such strategies ignore the reality that prescriber behavior itself is an important component of prescription drug abuse risk.
The SafeUseNow℠ strategy is prescriber-centric and is informed by an advanced analytical model that uses behavioral and demographic data for pharmacies, patients, and all treating prescribers to rigorously estimate total network risk. A comprehensive, individualized, and highly actionable risk assessment report is delivered to each prescriber that lists their high risk patients, the prescriber’s own top risk behaviors, and the risk behaviors of other prescribers providing services to their patients which allows for coordination of care across the provider network, and these materials are reviewed during a 20-minute one-to-one consultation with a SafeUseNow℠ clinician, followed by 6 monthly Patient Safety communications designed to reinforce the training messages and keep prescription drug abuse a top-of-mind topic for prescribers.
Q4: How will the data or information you use or create be made open?
A4: With the exception of the SafeUseNow℠ risk scoring engine, which is proprietary intellectual property, we propose to make the tools and resources described below in A5 available to all U.S.-based LCHPs. LCHPs may use these tools and resources to identify, perhaps for the first time, prescriber-patient-pharmacy combinations in their local community that present the greatest risk to patient safety and health, allowing for the development and delivery of risk-appropriate interventions to specifically combat prescription drug abuse.
We will also make available to the LCHPs our proprietary cost model, developed using SAMHSA’s DAWN data and peer reviewed sources of prescription drug abuse cost statistics, to evaluate their cost exposure for this problem in aggregate, and potential cost savings from implementing the SafeUseNow℠ program. As successive LCHPs implement the program, the accuracy of the cost model will be improved, and program outcomes data will be made available to not-yet-participating plans to be used as benchmarks to assess the severity of the problem and cost exposure in their patient population, and the expected ROI of implementation.
Q5: What will you make or do in this project?
A5: First, we will develop an automated data loading/validation application to permit LCHPs to independently upload to SafeUseNow℠ the data required to compute risk scores for prescribers in their network. Second, we will develop an application programming interface (API) to the SafeUseNow℠ engine so that LCHPs can customize built-in SafeUseNow℠ system reports. Third, we will provide open source access to our Web Analytics Portal, an on-line, secure method for interacting with SafeUseNow℠ program information. Fourth, we will provide access to our library of prescriber intervention materials, which are customized using information stored in the SafeUseNow℠ system.
Q6: How can others learn from/build on what you do?
A6: Initially, participating LCHPs will come to understand the true capabilities of the PSI Score™ model and the logic of adopting a prescriber-centric strategy for mitigating prescription drug abuse risk, and how SafeUseNow℠ optimally and efficiently uses limited budget resources to deliver risk-appropriate interventions designed to reduce prescription drug abuse.
Through access to the SafeUseNow℠ open source tools and collaboration with Principled Strategies’ clinical and analytics research specialists, LCHPs will be able to participate in ongoing outcomes evaluation research to improve the effectiveness of the SafeUseNow℠ intervention for their own populations, and will be able to pool data from disparate patient and prescriber populations (different geographic locations, socio-economic and cultural influences, medical and psychiatric conditions) to develop new intervention innovations and match them to prescriber and patient segments for maximal impact.
LHCPs will also be able to integrate the SafeUseNow℠ risk assessment information into internal systems that monitor patient clinical indicators and identify those who require case management intervention; however, because the SafeUseNow℠ risk identification technology also focuses on prescribers, LHCPs will have the ability to identify and notify prescribers who need to engage in active care coordination to improve patient safety. This will prompt many LHCPs to create care coordination protocols (e.g., information exchange, communication of care plans, protocols for treatment team leadership) where currently none exist, and disseminate these protocols among their provider networks.
Q7: How much do you think it will cost?
A7: The budget for this project is $650K. If the project reduces misuse, abuse, addiction and diversion costs by 2%, the resulting savings will be more than 13x the Knight News investment (see Figure 6).
Q8: How would you use News Challenge funds?
A8: The cost breakdown for this project is illustrated in Figure 7.