Automating Compliance Monitoring of Patient Programs
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The document discusses the increasing scrutiny of patient services programs within the pharmaceutical industry amid legal challenges and government investigations. It outlines the importance of automating compliance monitoring to mitigate risks associated with patient assistance programs, thereby ensuring adherence to regulations. Several compliance initiatives and analytics-driven monitoring strategies are proposed to enhance oversight of these programs and address potential risks.
Automating Compliance Monitoring of Patient Programs
- 1. Automating Compliance Monitoring of Patient Programs in Light of Recent Government Scrutiny February 28, 2018
- 2. Disclaimer PROPRIETARY & CONFIDENTIAL | 2 The views expressed and ideas presented in this session are those of the speakers and are not necessarily shared by the presenters’ employers. Any examples provided are hypotheticals and should not be attributed to any individual company.
- 3. Introductions Manny Tzavlakis Managing Partner Helio Health Group Chapman Richardson Global Head of Data Consumerization Sanofi SPEAKERS PROPRIETARY & CONFIDENTIAL | 3
- 4. Agenda PROPRIETARY & CONFIDENTIAL | 4 Patient Services Compliance Landscape Patient Services Monitoring – Automation Potential Use Cases / Scenarios
- 6. Industry Landscape INCREASED SCRUTINY OF PATIENT SERVICES PROGRAMS PROPRIETARY & CONFIDENTIAL | 6 Patient Services Program Financial Support Benefits Education Pharmaceutical companies have created patient services programs to aid patients in the use of their products by providing support and reimbursement services. Pharmaceutical and biopharmaceutical manufacturers have begun receiving more attention, legal scrutiny and activity from government and other entities regarding various components of their patient support services programs. Due to the changing landscape in the healthcare reform act as well as the increased number of specialty pharmaceuticals, this new attention and focus on compliance is becoming an increasing risk that companies are beginning to address.
- 7. Industry Landscape INCREASED SCRUTINY OF PATIENT SERVICES PROGRAMS PROPRIETARY & CONFIDENTIAL | 7 While there are many business and process considerations in creating and executing patient services programs, if not managed or executed correctly, these programs can increase companies’ risk in various areas for litigation and investigations. Various government investigations have caused companies to examine aspects of their patient services programs for compliance and risk mitigation Warner Chilcott Agrees to Plead Guilty to Felony Health Care Fraud Scheme and Pay $125 Million to Resolve Criminal Liability and False Claims Act Allegations Aegerion Agrees to Plead Guilty to Submission of False Claims to Federal Health Care Programs and Pay more than $35 Million to Resolve Criminal and Civil Liabilities. Office of Inspector General 2014 Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs Addressed Trend of PAPs Establishing Specific Disease Funds Limited to Subset of Available Products Government Accountability Office Report States that Coupon Programs for Privately Insured Patients Could Impact Medicare Part B Drug Spending DOJ Led by the US Attorney’s Office of Massachusetts Has Issued At Least Ten Subpoenas Related to Charitable PAPs Founder and Owner of Insys Therapeutics Inc., Arrested and Charged with Conspiracy to Profit by Using Bribes and Fraud for Illegal Distribution of Cancer Pain Medication
- 8. Industry Landscape INCREASED SCRUTINY OF PATIENT SERVICES PROGRAMS PROPRIETARY & CONFIDENTIAL | 8 Recent settlements with the OIG, which saw United Therapeutics pay $210 million to resolve kickback claims for contributions to copay assistance charities, have resulted in companies entering into Corporate Integrity Agreements (“CIAs”) providing the industry with a first glimpse on how federal agencies plan to monitor companies on their Patient Services programs. The agreements shine light and guidance into a key area of focus - Patient Assistance Programs (”PAPs”) - where companies can potentially influence charities on who or where to allocate support for patients in need of drug funding. Patient Assistance Programs StandardizingCriteria andControlsfor Donations EmphasisonPolicies& Procedures(Budget, Communications,etc.) Establish Clear Roles & Responsibilities Live & Automated Monitoring of Interactions “Specifically, OIG seems focused on patient charities with narrowly defined diseases that allow companies with relevant products to sidestep the independence required to avoid anti-kickback violations”
- 9. Industry Landscape INCREASED SCRUTINY OF PATIENT SERVICES PROGRAMS “Sales staff passed around intricate spreadsheets, with thousands of rows each, on potential patients, including details such as birthdates and information about symptoms, doctor, and hospital.” “Nurses reported directly to sales, and the pressure to lock in and keep customers was often heaped on them because they had the most access.” PROPERTY OF HELIO HEALTH GROUP. ALL RIGHTS RESERVED | PROPRIETARY & CONFIDENTIAL | 9
- 10. Potential Risk Areas PROPRIETARY & CONFIDENTIAL | 10 ALONG THE PATIENT JOURNEY – EXAMPLE Example Patient Experience: Each company provides different patient support services based on the specific product. Some companies internally manage various components of patient support services while other outsource all services or portions to HUBs or Specialty Pharmacies.
- 11. Patient Services Monitoring – Automation
- 12. Compliance Monitoring: Patient Services MITIGATING RISK WHILE SUPPORTING EXECUTION PROPRIETARY & CONFIDENTIAL | 12 Increasing scrutiny of the relationship between industry and patients highlight the importance of ensuring patient service programs are not only compliant with existing regulations but also mitigating any perceived risks. The following are examples of compliance initiatives that support patient service activities: Establish compliance controls to mitigate risk through processes and documentation of activities Institute field monitoring: in-person and digital Implement firewalls between sales activities and case management Create advanced compliance programs utilizing analytics and automated digital audits
- 13. Compliance Monitoring: Patient Services The implementation of an analytics engine can produce real-time results when monitoring your patient services program. Discovered outcomes are addressed and identified best practices identified will be applied to business intelligence for future activities. ARCHITECTURE & METHODOLOGY IDENTIFY & PREPARE DATA SETS • Gather relevant data • Normalize, aggregate and bridge data to obtain insights from full range of information • Identify key measures to utilize in analysis DATA ANALYSIS • Establish comparative criteria and measures for analysis • Develop algorithms to evaluate data • Score risk areas and organize risks by priority • Anticipate future risk from historical contexts and trends CREATE VISUALIZATIONS • Develop supporting visualizations to provide valuable insights • Develop full view to understand scale of identified risks REMEDIATION • Develop strategic plan to mitigate identified and potential risks • Determine gaps, weigh key attributes and identify areas of improvement to prevent future occurrences PROPRIETARY & CONFIDENTIAL | 13 ENGINE
- 14. Compliance Monitoring: Patient Services IDENTIFY & PREPARE DATASETS CRM Patient Consent Data Patient Support Territory Alignment CRM Call Notes Data CRM Materials Provided Attachments from Call Notes Approved Materials for Product ListPatientID Patient SupportID ProductID ProductNDC The key to gathering insightful information is to prepare accurate data. By gathering relevant datasets and normalizing the information, a biopharma can optimize analytic capabilities. The key to this model is to bridge datasets to extract the full range of intelligence for patient services and compliance teams to evaluate. 50 55 60 65 70 75 80 85 65 75 85 95 105 115 HCPRx's Details (Field Nurse) Normalize datasets to define risk constraints PROPRIETARY & CONFIDENTIAL | 14
- 15. $- $5 $10 $15 $20 $25 $30 2012 2013 2014 2015 2016 PAPPaymentAmounts x100,000 0 2 4 6 8 10 12 14 2012 2013 2014 2015 2016 PAPPayments Compliance Monitoring: Patient Services DATA ANALYSIS Next step is to establish risk criteria and measures to analyze the datasets against. Based on these measures, algorithms can be developed to dissect the data and provide the required compliance monitoring metrics. Algorithms can be run as often as the data is updated to provide up-to-date, real- time results. A data engine will also weigh these attributes with historical context to measure how likely future violations will occur. Key stakeholders can then decide next best actions and allocate the proper resources to minimize those prospects. The goal is to continuously refine the engine to consistently provide value to each company’s Compliance program. Data Sets Create & Apply Algorithms & Perform Analysis Summary PROPRIETARY & CONFIDENTIAL | 15 y = 36667x + 90000 R² = 0.222 $- $1 $2 $3 $4 $5 2012 2013 2014 2015 2016 AveragePAPPaymentAmount x100,000
- 16. Compliance Monitoring: Patient Services VISUALIZATIONS Visual dashboards will provide the supporting details to help our clients understand where areas of risk are occurring and the story behind these areas. Helio strives to give our clients the full view of the landscape before assessing next steps. PROPRIETARY & CONFIDENTIAL | 16
- 17. Compliance Monitoring: Patient Services LIVE MONITORING AND ADDITIONAL AUDIT FUNCTIONALITY A Patient Services team or its delegates (vendors) should create and document live monitoring or other assessments and audits of its various groups and employees. This functionality allows all qualitative and quantitative analyses to be completed and compiled in the same tool. Additionally, and engine will summarize the data and create visualizations of the outcomes of these audits / monitoring activities for additional usage or presentations. The inputs of these audits / monitors or reviews can be updated and changed at any time by managers of the tool. Examples of usage of these can be patient advocate speaker program monitors, patient support services team ride-a-longs, hub audits, etc. PROPRIETARY & CONFIDENTIAL | 17
- 18. Compliance Monitoring: Patient Services REMEDIATION Based on the results of the data analysis, a biopharma should look for summaries of identified risk areas and group them by category. Risk summary will indicate issues with high priority and suggest actionable recommendations for remediating identified risks as next steps. The key is to develop strategic plans to mitigate risks and to prevent them from happening in the future. PROPRIETARY & CONFIDENTIAL | 18
- 19. Patient Use Cases / Scenarios
- 20. Compliance Monitoring: Patient Services Patient Consent Patient & HCP Interactions Patient Communication Patient Materials POTENTIAL COMPONENTS & DATA SOURCES PROPRIETARY & CONFIDENTIAL | 20 The following are some high level areas that has various components that can be monitored to address various risks. Additionally, from a Patient Services standpoint, this may include monitory services provided by HUB providers or internal services, based upon who is conducting the activity. Prior Authorizations / Appeals Patient Adherence Patient Data Usage & Sharing Patient Assistance Programs (PAPs)
- 21. Use Cases / Scenarios PATIENT CONSENT PROPRIETARY & CONFIDENTIAL | 21 Potential Insights Questions to Answer Key Data Sources Example Metrics Were any patients contacted by Patient Services Support Team (Internal / HUB / SP) 1. without consent? 2. prior to receiving patient consent? 3. or during lapse in consent (when restarting a drug or expired consent form)? Are inactive patients at risk of patient consent lapse (data violations)? • HUB or Internal CRM Patient Consent Dates • CRM Call Notes & Details • CRM Patient IDs • Comparison of patients enrolled in patient services program to list of patients agreeing to consent • Comparison of patient enrollment dates to patient consent dates • Comparison of CRM call note dates for Patient Services team members to patient consent dates • Comparison of consent end and restart dates within CRM call note details • Comparison of patient consent end dates to product shipment dates • Potential HIPAA Violations
- 22. Use Cases / Scenarios PATIENT & HCP INTERACTIONS – ANALYSES ON CALL LOGS PROPRIETARY & CONFIDENTIAL | 22 Potential Insights Questions to Answer Key Data Sources Example Metrics Are there any patients or HCP activity outliers in the Patient Support Services call activity logs? Examples: 1. Are injection education nurses conducting more than one training per patient? 2. Are there any reimbursement specialists spending too much time on a specific territory / HCP? 3. Are patients responding to field nurse follow- up calls? • Patient Support Services Territory Information • CRM Call Notes • HUB Call Notes • SP Call Notes • HCP information (CRM) including patient scripts • Total number of patient injections vs number of patients; highlight instances totaling more than allowable per patient (by product) • Total calls by reimbursement specialist vs total number of prescriptions; Highlight outliers for total calls vs prescriptions • Total calls for field nurses (answered calls vs messages left and returned by patient); compare percentages of answered • Effectiveness of Patient Services Team activities and interactions with HCPs and Patients • Potential ANTI-KICKBACK issues
- 23. Use Cases / Scenarios PATIENT & HCP INTERACTIONS – ANALYSES ON POST-INTERACTION SURVEYS PROPRIETARY & CONFIDENTIAL | 23 Potential Insights Questions to Answer Key Data Sources Example Metrics Did the patient or HCP indicate any negative behaviors/interactions with Patient Support Services in follow-up surveys: Examples: 1. Did the field nurse provide fair and balanced medical advice? 2. Did the reimbursement specialist provide information on diagnostic/medical codes for prior authorizations? • Post-Interaction Survey Results • Number of instances where patient or HCP indicated a field nurse mentioned competitor products • Number of instances where patient support services provided diagnostic codes to an HCP while filling out diagnostic codes • Potential instances where a rep or patient support team member mentioned off-label indications to a patient or HCP • Direct feedback from HCPs and patients on the quality of interactions with Patient Support Services • Effectiveness of Patient Services Team activities and interactions with HCPs and Patients • Potential ANTI-KICKBACK issues • Potential Off-Label interactions
- 24. Use Cases / Scenarios PATIENT COMMUNICATION PROPRIETARY & CONFIDENTIAL | 24 Potential Insights Questions to Answer Key Data Sources Example Metrics Are Patient Support Services / HUBs communicating the following when working with patients or HCPS: 1. Providing safety vs. efficacy in fair and balanced statements 2. Utilizing approved "scripts" 3. Answering questions utilizing approved FAQs verbiage Confirming that they are not: 1. Providing medical advice to patient 2. Discussion off-label indications or answering off-label questions • Call Notes & Details • Voice Recordings of Patient Calls • ICD-9 / 10 Codes • Call Script Language • FAQ Language • Voice monitoring of calls with Support Services for off-label, medical advice, script adherence, fair & balanced utilizing key terms based on product, scripts, label, etc. • Patient support services call note monitoring for support services for off-label, medical advice, script adherence, fair & balanced utilizing key terms based on product, scripts, label, etc. • Off-label messaging • Compliance with company policies / procedures • Provision of medical advice
- 25. Use Cases / Scenarios ADVERSE EVENTS PROPRIETARY & CONFIDENTIAL | 25 Potential Insights Questions to Answer Key Data Sources Example Metrics • Are adverse events mentioned on calls properly documented, addressed and reported by HUB, Patient Services support or Specialty Pharmacies? • Voice recordings • CRM Call Notes • AE Reports • Voice Analytics and call note monitoring for key adverse events terms • Comparison identified adverse events to adverse events reporting system • Potential identification of adverse events that have not been reported or have not been reported accurately • Compliance with company policies / procedures
- 26. Use Cases / Scenarios PRIOR AUTHORIZATIONS / APPEALS PROPRIETARY & CONFIDENTIAL | 26 Potential Insights Questions to Answer Key Data Sources Example Metrics • Are company employees / delegates (reimbursement specialists, sales reps, etc.) aiding in filling out, completing, or submitting prior authorization forms or appeals • Are those individuals coaching HCPs and / or the HCP staff on language for prior authorizations or appeals (diagnoses)? • Call Notes • ICD 9 / 10 Codes • Voice Recordings • Pas / Appeals • Hand-writing analysis via machine learning (if prior authorization / appeals are available) • Monitoring ICD 9 / 10 code data • Reviewing sales reps and reimbursement specialist call notes • Voice analytics and call monitoring for key terms • Potential for False Claims
- 27. Use Cases / Scenarios OFF-LABEL PROPRIETARY & CONFIDENTIAL | 27 Potential Insights Questions to Answer Key Data Sources Example Metrics • Is the Patient Services support team providing support to off- label patients? • ICD-9 / 10 Codes • HUB Data • Free Product / Copayment Data • Review co-payment & free product information for prescribed for off-label indications • Potential for Off Label mentions
- 28. Use Cases / Scenarios PATIENT ASSISTANCE PROGRAMS (PAPS) PROPRIETARY & CONFIDENTIAL | 28 Potential Insights Questions to Answer Key Data Sources Example Metrics 1. Are government insured patients receiving product from PAPs (i.e. Co- Pay Support and Free Product)? 2. Are ineligible patients receiving access to co-payment or free drug program support from PAPs? • HUB • CRM (Insurance Information, Co- payment information, free product information) • Comparison of patient insurance information against patients currently enrolled in PAPs • Comparison of patient insurance information, tax return, income, diagnosis info, etc. against approved eligibility criteria for PAPs (specific to company and product) • Anti-kickback government insured employees receiving PAPs • Ineligible patients receiving PAPs
- 29. Contact Us Manny Tzavlakis Managing Partner (201) 966-9656 mtzavlakis@heliohealthgroup.com PROPERTY OF HELIO HEALTH GROUP. ALL RIGHTS RESERVED | PROPRIETARY & CONFIDENTIAL | 29 https://www.surveymonkey.com/r/HelioPSSurvey