OVERSIGHT & COMPLIANCE

Transcription

1 REGISTER BY 9/13/13 AND SAVE $300 2nd Annual OVERSIGHT & COMPLIANCE Navigate State and Federal Requirements, Mitigate Fraud and Abuse Enforcement and Ensure Stakeholder Compliance NOVEMBER 13-14, 2013 HILTON SUITES MAGNIFICENT MILE CHICAGO, IL Excellent conference. I ll bring more of my team with me next year! 2012 Attendee, Ed Stacey, Vice President of Network Operations, CIGNA Pharmacy Management Interactive Discussion Addressing Key Industry Challenges: Privacy Regulations and Protections Medicare Part D Audits Pharmacy and Manufacturer Interactions PBM/Health Plan Collaboration FEATURED SPEAKERS INCLUDE: J. Edward C. Gilmartin, President and Co-Founder, CaptureRx Natalie Pons, Senior Vice President, Assistant General Counsel, CVS Caremark Jeffrey Sinko, Vice President, General Counsel, DaVita Christine Wiehl, Vice President and Chief Compliance Officer, Express Scripts Robert W. Nolan, Vice President, Compliance, Kentucky Spirit Health Plan, Inc. Nancy Radtke, Esq., Senior Vice President, Corporate Services, MedImpact Phil Walls, Chief Clinical and Compliance Officer, mymatrixx Ann Tobin, Chief Compliance Officer, Prime Therapeutics Candy Olson, Associate General Counsel, UnitedHealth Group Deidre Rodriguez, Director, Corporate Privacy Office and Regulatory Oversight, WellPoint, Inc. Media Partners: REGISTER AT FC13130_updated.indd 1 7/29/13 2:10 PM

2 THE ONLY CONFERENCE that invites key stakeholders and industry thought leaders for targeted and insightful discussion around the nuanced legal and compliance challenges involved with managing pharmacy benefits. Network with peers from PBMs and health plans to understand enforcement trends, benchmark to build solid compliance and audit work plans and explore ways to help ensure thorough oversight throughout the benefit management process. Dive into privacy protections and marketing implications Understand focus areas for CMS and OCR audits Look at the latest pharmacy law enforcement Align contracts with manufacturers Ensure compliance in an era of health reform Analyze state laws impacting PMBs Bring your whole team! See who benefited in % 8% Legal 35% 17% 35% Compliance 25% 25% Pharmacy Benefits/Management 17% Privacy 15% Sales 8% Who Should Attend You will benefit from attending this event if you are an executive, senior manager or director overseeing pharmacy benefits in a PBM, health plan, pharmacy or manufacturer with responsibilities or involvement in the following areas: Compliance Audit Legal/Counsel Regulatory Affairs Medicare Pharmacy Services Contracting This conference will also benefit law firms and consultants who supply the industry with assistance in regulatory, compliance and legal challenges. CONFERENCE SPONSORS A Great Place to Meet Your Market! Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating thought leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact Jamie McHugh at or [email protected]. FC13130_updated.indd 2

3 MAIN CONFERENCE Wednesday, November 13, :30 Main Conference Registration 8:30 Chairperson s Welcome and Opening Remarks Ann Tobin, Chief Compliance Officer, Prime Therapeutics Shifts in State and Federal Enforcement 8:40 Implications of the Health Insurance Exchange Marketplace and State Law Trends on Commercial Pharmacy Benefit Management With the deadline to go live to participate in the Exchange marketplace quickly approaching in January 2014, this session addresses what the market will look like and what compliance concerns will arise. Understand how the Exchange marketplace and recent trends in state law impact commercial PBM business Examine compliance implications of industry trends introduced with a new government program and new state law trends, including the potential for false claims and anti-kickback risks Implement new reporting for mandated transparency Samantha Brown, Member, Phoenix Law Group of Feldman Brown Wala Hall & Agenat Suzanne Broderick, Member, Phoenix Law Group of Feldman Brown Wala Hall & Agenat 9:20 OCR Criteria for Investigations and Audits This session provides an update of audit criteria directly from OCR to help companies prepare for potential audit/investigations. Auditing of Covered Entities by Office for Civil Rights Increased scrutiny on Covered Entities and expanded authority over Business Associates Discuss how PBMs may be impacted Deidre Rodriguez, Director, Corporate Privacy Office and Regulatory Oversight, WellPoint, Inc. 10:00 Networking and Refreshment Break CASE STUDY 10:30 Manage CMS Medicare Part D Program Audits In this session, understand what happens during a program audit and what challenges arise. Gain insight into how one company navigated this process to prepare for effective audit facilitation. CMS Program Audit requirements and expectations Plan sponsor requirements and expectations during a CMS Program Audit Maximizing outcomes Discuss how PBMs can support health plans in CMS audits while providing rapid turnaround for CMS documentation and reporting and data requests Understand the plan sponsor oversight requirements for PBMs Nancy Radtke, Esq., Senior Vice President, Corporate Services, MedImpact Healthcare Systems, Inc. Lisa Byerley, Vice President, Regulatory Compliance, MedImpact Healthcare Systems, Inc. 11:10 Pharmacy Benefit Litigation Overview This session provides an overview of recent and pending litigation impacting pharmacy benefits. Update on manufacturer-sponsored coupon/co-payment assistance litigation Update on False Claims Act cases involving Medicare Part D Pharmacy litigation related to network reimbursement Stephanie Trunk, Attorney, Arent Fox LLP 11:50 Federal 340B Drug Program Dynamics and PBM Reporting and Processing Roles This session explores the scope and challenges to properly identify, report and process 340B drug claims for Managed Medicaid Programs. Scope and trends of today s 340B drug programs Federal and State regulations relating to Medicaid and Managed Medicaid POS and Retrospective Reporting Processes and obstacles PBMs roles and solutions for Managed Medicaid Clients J. Edward C. Gilmartin, President and Co-Founder, CaptureRx 12:30 Luncheon 1:30 Deep Dive on Privacy and Security Regulations and Protections EXTENDED SESSION This has been a year of tremendous change to privacy regulations, as HIPAA has been updated and there are increasing demands on companies to protect private information. This extended, interactive session takes a close look at the updated laws and implications for pharmacy benefit management, allowing time for participants to break into groups and discuss practical applications and strategies for complying with these evolving regulations. FC13130_updated.indd 3

4 I. HIPAA Updates Best practices and challenges for implementing rules Finalized amendments of the HIPAA Omnibus Rule Notice of Proposed Rule Making II. Business Associate Alignment with Covered Entities Considerations for both PBMs and health plans Strategies to comply with new regulations for business associates Impact of new rules on business associate agreements III. Processes for new and expanded Bas Plans for September 2014 Marketing Implications Understand how to operationalize new HIPAA rules Evaluate the impact of opt-in requirements for determining the allowable target audience for marketing campaigns Prepare to advise marketing teams on what strategies are permissible Privacy and security requirements around use of mobile devices in marketing and interaction with pharmacies Niels Quist, Privacy Director, OptumRx 3:00 Networking and Refreshment Break Customized Workshops A 3:30 Fundamentals of PBM Compliance in the Health Reform Era This workshop provides an overview of the need-to-know compliance considerations for PBM operations. Whether you ve been in the industry for years or are just getting involved, learn the critical implications of the newest healthcare laws to ensure compliance in your organization. Outline critical changes to Medicare and Medicaid in healthcare reform Discuss strategies for developing an effective compliance plan incorporating the seven elements and complying with Medicare Part D Chapter 9 Align internal roles and responsibilities for a FWA program Compliant billing practices to avoid false claims violations Christine Wiehl, Vice President and Chief Compliance Officer, Express Scripts Jarrod Henshaw, Vice President, Deputy General Counsel, Express Scripts B 3:30 Compliant Oversight and Collaboration Between PBMs and Health Plans In this workshop, identify the most current and sophisticated issues between health plans and PBMs to strengthen relationships and ensure compliance. Join the conversation with experienced executives to understand key challenges and encourage collaboration. Analyze the differences between requirements for health plans and PBMs Align priorities between organizations Understand reporting timelines and accountability for PBMs and plans Look at contractual relationships and assign roles for privacy and compliance responsibilities Kyle Verley, Regulatory Compliance Manager, Prime Therapeutics Renee Treberg, Government Programs Compliance Officer, Prime Therapeutics Robert W. Nolan, Vice President, Compliance, Kentucky Spirit Health Plan, Inc. 5:00 Close of Day One Join us for a Networking, Wine and Cheese Reception after the closing session on Day One DAY TWO Thursday, November 14, :30 Continental Breakfast 8:00 Chairperson s Review of Day One Ann Tobin, Chief Compliance Officer, Prime Therapeutics FC13130_updated.indd 4

5 Process Implementation for Compliant Operations 8:15 Optimize Resources to Build an Efficient Compliance Program Discuss what tools and functions are necessary for a successful compliance program, looking at strategies for optimal organization and adherence to key compliance principles. P A N E L Benchmark with other companies about organizational structure for legal, regulatory and compliance responsibilities Compare focus areas and strategies for justifying budget and resource requests internally Discuss best practices to mitigate newly evolving risk in the health care industry Moderator: Natalie Pons, Senior Vice President, Assistant General Counsel, CVS Caremark Panelists: Ann Tobin, Chief Compliance Officer, Prime Therapeutics Mark Fendler, Chief Operating Officer, General Counsel, MedTrak Services 9:00 Strategies and Risks Implementing Medicare Part D Chapter 18 Look closely at the new Chapter 18 released in late February that provides new guidance for Coverage Determination for Appeals and Grievances and ensure compliance with these updates. Learn how plans and PBMs can work together to implement Chapter 18 Prepare for increased auditing from CMS in this area Understand financial implications for failure to comply with new criteria for higher IREs, as tied to star ratings Michelle Juhanson, Director, Compliance and Quality, PerformRx 9:45 Nuances of State Laws on Transparency and Licensing Enforcing PBM Operations Because of the variable nature of state laws impacting drug benefits, PBMs must take a wide range of regulations into consideration in day-to-day operations. Review the most current requirements and in light of these shifts, understand how to operate compliantly. Licensure requirements state by state Consequences of state reporting laws Phil Walls, Chief Clinical and Compliance Officer, mymatrixx 10:30 Networking and Refreshment Break Effective Stakeholder Oversight of Suppliers and Pharmacies 11:00 Examine Contractual Challenges and Oversight for Network Pharmacy Collaboration Understand concerns and challenges for both the PBM and the network pharmacy in developing contracts and conducting audits. Look at what rights PBMs have to audit network pharmacies and what concerns may arise in this process Negotiate pricing mechanisms with business leaders while ensuring compliance Fraud waste and abuse efforts within the relationship between the PBM and network pharmacy including controlled substance dispensing, training and credentialing Understand shifts in CMS rules around Any Willing Providers Jarrod Henshaw, Vice President, Deputy General Counsel, Express Scripts Bob Weinberg, Vice President, Associate General Counsel, Express Scripts 11:45 Anti-Kickback Statute Compliant Alignment of Contracts with Manufacturers This session looks at the contractual relationship between PBMs and pharmaceutical manufacturers, focusing on government enforcement and discussing strategies for maintaining compliance. Analyze what services can become legally problematic Challenges with rebate agreements and pricing Understand parameters of financial relationships with manufacturers to prevent fraudulent practices Joshua Stein, Senior Vice President and Principal Counsel, OptumRx 12:30 Luncheon 1:45 Key Legal Considerations for Mail-Order Pharmacy Operations This session focuses on the mail-order pharmacy element of many PBMs, detailing the most important legal considerations for compliant operations. Look at the latest enforcement focus areas in pharmacy law to prepare for increased scrutiny Mail parity legislation Focus on DEA controlled substance controls and suspicious order monitoring units Regulations around licensing and dispensing Betsy Ferguson, Senior Vice President, Assistant General Counsel, CVS Caremark Jeffery Sinko, Vice President, General Counsel, DaVita 2:30 Determine Roles and Responsibilities for Compliance in PBM/Health Plan Relationships With the unique relationship between PBMs and health plans, what is the proper role of each organization in ensuring compliance? Hear directly from the health plan perspective on how this relationship can function in an optimal way. Plan preferences for oversight from the PBM Understand what support PBMs can give for health plan audits Collaborate effectively to identify priorities and execute a compliance plan Candy Olson, Associate General Counsel, UnitedHealth Group Shirley Qual, Compliance Officer, UnitedHealth Group 3:15 Close of Conference RE FC13130_updated.indd 5

6 2nd Annual OVERSIGHT & COMPLIANCE Navigate State and Federal Requirements, Mitigate Fraud and Abuse Enforcement and Ensure Stakeholder Compliance Register by 9/13/13 and Save $300! SCAN HERE NOVEMBER 13-14, 2013 HILTON SUITES MAGNIFICENT MILE CHICAGO, IL 4 WAYS TO REGISTER NOW! WEBSITE CBI 600 Unicorn Park Drive Woburn, MA [email protected] PHONE outside the U.S. LIVE CHAT ANY QUESTIONS OR TO REGISTER PLEASE CONTACT SONIA LIMA Phone: Fax: [email protected] PHARMACY BENEFIT AND OVERSIGHT COMPLIANCE CONGRESS REGISTRATION FEE: ADVANTAGE PRICING Standard Standard Rate $1595 $1895 Health Plan Rate $1295 $1595 Register by 9/13/13 and SAVE $300. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.) PLEASE NOTE: All advertised discounts are taken from the final, Standard Rate. TEAM DISCOUNT: Attend this conference FREE if you bring 3 registered colleagues from your organization or external to your organization (enables cross-company teams). All team registrations must be made at the same time to qualify. Please contact for further information. SATISFACTION GUARANTEED: CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable CBI conference of your choice. Please contact for further information. Advanced preparation for CBI conferences is not required. VENUE: Hilton Suites Magnificent Mile 198 East Delaware Place Chicago, IL Phone Reservations: Hotel Direct Line: ACCOMMODATIONS: FC13130 To receive CBI s special discounted hotel rate online or by phone, please go to: Online: Phone reservations: and mention CBI s Pharmacy Benefit and Oversight Compliance Congress BOOK NOW! The Hilton Suites Magnificent Mile is accepting reservations on a space and rate availability basis. Rooms are limited so please book early. All travel arrangements are subject to availability. SUBSTITUTION AND CANCELLATION: Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. Cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $295 administrative charge. No refunds will be made after this date; however, the registration fee less the $295 administrative charge can be credited to another CBI conference if you register within 30 days from the date of this conference to an alternative CBI conference scheduled within the next six months. In case of conference cancellation, CBI s liability is limited to refund of the conference registration fee only. CBI reserves the right to alter this program without prior notice. Please Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made without notice. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or CBI. REGISTER AT FC13130_updated.indd 6