PRESENTERS OVERVIEW. Richard Kusserow, SMS CEO/Former HHS IG Jillian Bower, MPA, CRC Vice President
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1 Richard Kusserow, SMS CEO/Former HHS IG Jillian Bower, MPA, CRC Vice President PRESENTERS Richard Kusserow Former HHS Inspector General CEO of Strategic Management Jillian Bower, MPA Vice President of Compliance Resource Center 1 OVERVIEW 1. Introduction 2. Compliance Program Building Block 3. Government Guidance 4. Seven Compliance Program Elements 5. Evidencing Compliance Program Effectiveness Best Practices 8. Questions and Answers 2
2 COMPLIANCE BUILDING BLOCKS CP operating policies Charters Resolutions PDs Code of Conduct Agreements (e.g. BAA) Records management system Policy formatting templates Compliance culture surveys CP knowledge surveys Compliance high risk policies Web-based interactive training Table of penalties CP-legal counsel protocols CP-HRM protocols Performance evaluation forms Confidentiality forms Hotline log tools Hotline posters Complaint tracking tools Training plans Training programs Table of penalties Training effectiveness tools Training evaluation forms Compliance scenario training PowerPoint training tools Board/executive CP briefings Auditing/monitoring tools Employee application forms Investigation guidelines Physician staff privilege forms Sanction screening tools/service CP Auditing/Monitoring Plans 3 HOW TO MAKE THE CP MORE EFFECTIVE CP often built without proper depth and support ( Painting by the Numbers ) Building blocks are activities, solutions, resources, and tools that support the CP All CP elements should be reinforced with building blocks Building blocks can be used to evidence effectiveness Any lack of key building blocks detrimental to CP 4 COMPLIANCE PROGRAM GUIDANCE U.S. Sentencing Guidelines state an effective CP must exercise due diligence to prevent and detect criminal conduct; and promote an organizational culture that encourages ethical conduct and a commitment to compliance with the law. OIG CP guidance to healthcare sectors, first for hospitals and then for other healthcare sectors using same seven elements The term effective stated 19 times in various forms Encourages implementation and use of internal controls to monitor compliance with statutes, regulations and program requirements 5
3 NEW MANDATES CPs are a voluntary for now but the Affordable Care Act makes them mandatory In General [A] provider of medical or other items and services or supplier within a particular industry sector or category shall, as a condition of enrollment establish a compliance program that contains the core elements Establishment of Core Elements. The Secretary, in consultation with the Inspector General of the Department of Health and Human Services, shall establish core elements for a compliance program Required Components of Program Must periodically undertake reassessment of its compliance program to identify changes necessary to reflect changes within the organization and its facilities. 6 NEW MANDATES (cont) ACA mandates CP as condition of participation CMS standards will contain certain core elements CMS mandates will follow the USSC and OIG models A game changers for providers/suppliers Expanding compliance obligations Executive leadership will have to certify their CP Certifications will need to be based upon reasonable evidence 7 SEVEN ELEMENTS OF AN EFFECTIVE CP Designate Compliance Officer & Develop Compliance Infrastructure Investigation & Remediation Policies to Address Sanctioned Parties Written Policies & Procedures Auditing & Monitoring Demonstrate Effectiveness Effective Education and Training System for Disciplinary Action Process to Receive Complaints & Compliance Hotline 8
4 ELEMENT 1: COMPLIANCE PROGRAM INFRASTRUCTURE Designate CO & Develop Compliance Infrastructure Board/Executive CP Charters Board resolutions to empower CO Qualified CP Officer/Staff Spelled out duties & responsibilities CP operation and management Board charters/resolutions Oversight Committee duties CP operation/management P/Ps CO staff PDs Normally CP policies P/Ps must be cross referenced/cited CP records management system 9 ELEMENT 2: WRITTEN GUIDANCE Code of Conduct Written Policies & Procedures Compliance-related policies for operational high risk areas Written guidance understandable Employees must know the duties Code addressing OIG standards ized policy form/formats Cited and cross referenced Policies are CP internal controls Document/record management Address legal/regulatory mandates 10 ELEMENT 3: TRAINING & EDUCATION Effective Education and Training 1-2 hours general CP training Explain the operation of CP Cover applicable laws/regulations Specialized high risk area training Must be effective Compliance training critical Board/Executive training Various training methodologies: (a) web-based interactive, (b) PowerPoint, & (c) scenarios for facilitators Evidence training effectiveness (testing, knowledge surveys) Training plans, policy, evaluation forms, etc. 11
5 ELEMENT 4: COMPLIANCE COMMUNICATION Process to Receive Complaints Hotline operation/management Monitoring/Auditing of Hotline Protect Anonymity/confidentiality Evidence timely action Key P/Ps to support hotline Outsourcing only real option Operator & web reporting Service 24/7 Tools to track complaints Tools to monitor/audit hotline effectiveness Posters, fliers Test vendor periodically Monitoring/Auditing hotline 12 ELEMENT 5: DISCIPLINARY ACTIONS System for Disciplinary Action Disciplinary standards Management obligation for uniform and fair enforcement Protocols between CP and Legal Counsel/HRM Enforcement of Code & Policies Disciplinary policy Table of penalties Supervisor Obligations Compliance as Element of Performance Policy 13 ELEMENT 6: AUDITING & MONITORING Ongoing Monitoring plans Ongoing Auditing Plans Auditing & Monitoring Compliance A/M Plans (CAMP) Audit templates for high risk areas Tools to review risk areas Auditing/Monitoring P/Ps Review plans and tools Risk assessments tools Auditing high risk tools Corrective action tracking tools Reviewing CP effectiveness tools 14
6 ELEMENT 7: INVESTIGATION & REMDIATION Investigation & Remediation Sanction screening, credentialing, employment applications, etc. P/Ps System for sanction screening P/P for resolution of potential hits Investigation P/P Disclosure to outside parties P/P Outsource sanction screening (certification) Employee application templates Policies to meet requirements Internal Investigations protocols On call investigative support CO & Legal Counsel protocols Auditing/Monitoring reviews 15 USING BUILDING BLOCKS TO EVIDENCE EFFECTIVENESS Charters/Resolutions: Empowerment to the CP Compliance Knowledge Survey: Evidence CP understanding Compliance Culture Survey: Evidence change in compliance culture Compliance Training: How many, type, percentage of population Compliance Training Effectiveness: Tests and quiz results Polices: Verify understanding/following Document Management: Documents are cross referenced/up to date Hotline Operation: Log tracking number, type, resolution, trending Compliance Oversight: Minutes, agenda, training of committees 16 USING BUILDING BLOCKS TO EVIDENCE EFFECTIVENESS Sanction Screening: How often, results, follow up, certified reports Code: Evidence of receipt, training, understanding (survey/tests) High Risk Areas: Written audit/review guides(arrangements/billing) Monitoring Plans: Evidence that program managers doing it Ongoing Auditing: Plans to verify monitoring, validate effectiveness Investigations: Protocols, written guidance, resolution results Error Rate Reduction: Benchmarking reduction in error rates Timely Overpayment Disclosure: Evidence reporting 17
7 POLICIES/PROCEDURES = INTERNAL CONTROLS Policy: A statement of guiding principles or courses of action of what action is expected Procedure: Description of how a policy is to be carried out and defines courses of action for Covered Persons to meet obligations When drafted properly, a policy document can be turned into an audit guide to determine whether courses of action are consistent with applicable rules, regulations, laws, and standards. 18 GROWING TREND TO OUTSOURCE COMPLIANCE Growing obligations stretching Compliance Officers Outsourcing work not directly involved in core business activities a major business trend Increasingly, organizations are exploring when and under what circumstances it makes sense to outsource portions of their CP Big considerations are saving time and costs and gaining access to better expertise Outsourcing CP functions has been a long practice, most notably hotlines and sanction-screening Better expertise, relieving pressure, and cost savings 19 MOST OUTSOURCE PARTS OF THEIR CP 1. Compliance and privacy hotlines 2. Sanction screening tools and services 3. Compliance training tools and trainers 4. CP evaluations and assessments 5. P/P and compliance document development 6. CP effectiveness surveys 7. Auditing and monitoring tools and review plans 8. HIPAA Privacy/Security functions 9. CP document management systems 10. Internal audit support 11. Investigations of suspected wrongdoing *Best practice to look for package arrangements for discounts 20
8 COMPLIANCE RESOURCE CENTER (CRC) Provides tools, techniques, content, and support for all 7 elements of CPs Compliance Survey Center: Measures CP effectiveness Policy Resource Center: Policies, forms, charters, PDs, resolutions, agreements, records management tools, Compliance Audit/Monitor Plans (CAMP), etc. Compliance Training Center: Variety of programs/modalities Hotline Service Center: 24/7 operator and web-based services Sanction-Screening Services: Federal/state sanction databases. Can outsource the whole thing 21 COMPLIANCE SURVEY CENTER Surveys cited by OIG as way to benchmark CP Reliable, valuable means to evidence CP effectiveness Benchmark progress Critical to use validated and standardized survey tools Compliance Knowledge Survey database to compare against others Compliance Benchmarking Survey 300,ooo+ in database since 1993 Benchmark with national Health Care Compliance Index Dichotomous and Likert scale survey tool Respondent confidentiality assured Inexpensive with quick results Web-based tools 22 POLICY RESOURCE CENTER Hundreds ready to use, tested and current policies, forms, charters, PDs, resolutions, agreements, records management tools, compliance auditing/monitoring plans (CAMP), etc. Corporate Compliance EMTALA Clinical Research HIPAA/HITECH Privacy/Security Anti-Kickback Statute Committee Charters False Claims Act Cost Reports Human Resources Stark Law/Physician Referrals Billing, Coding, Claims Submission Information Tech. and Security Table of Penalties Records Management Tools Training Plans and Tools Investigation Guidelines Code of Conducts Protocol Documents Position Descriptions Agreements and Forms Resolution Documents Quickly fills gaps in compliance documents Updates on laws, regulations, guidelines, and standards Specialized in healthcare 23
9 COMPLIANCE TRAINING CENTER Three training modalities 1. Interactive online program 2. PowerPoint presentation 3. In-person/facilitated Customized training content to organization needs General compliance program training High-risk area training Test knowledge/understanding through quizzes Report and track employees completion and attestations 24 HOTLINE SERVICE CENTER Reliable confidential communication channel for employees 24/7 telephone & online reporting Portal to view/track reports that are immediately available to the CO Add-on Benefits Policy templates for hotline operations Hotline poster templates Monthly newsletter provides regulatory updates Articles published on subject Highly experienced in healthcare issues Personalized concierge service Inexpensive, flat rate service fee 25 SANCTION SCREENING SERVICES Up-to-date federal and state exclusion databases Immediate sanction check results Streamlines the screening process Evidences checks are completed Experienced in understanding requirements Articles and newsletter keeping abreast of changes TWO OPTIONS In-house sanction checks using vendor screening tool Outsourcing all of it, including resolution of hits 26
10 SUMMATION Building blocks are critical to an effective CP Check for existence of key building blocks Determine if they are doing what they should be doing Are they designed to help evidence CP effectiveness Identify gaps or deficiencies in building blocks Determine best way to fill gaps (in house or through a vendor) Develop corrective action plan and time frames for completion 27 QUESTIONS Jillian Bower, MPA, Compliance Resource Center VP jbower@complianceresource.com (703) Richard Kusserow, Former IG/Strategic Management CEO rkusserow@strategicm.com (703)
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