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Aggregate Spend Reporting & Proactive Strategies to Sunshine Act

Even with the postponed CMS release on the Sunshine Act Collection details, companies must prepare their organizations to comply with to the tough factors that Act calls for while ensuring minimal business interruptions. Aggregate spend, transparency and compliance professionals should see this date push as an outstanding opportunity to better prepare for the impeding change. Lack of cooperation across organizations and limited understanding of the requirements for accurate and compliant aggregate spend reporting are two big factors limiting organizational readiness. Without a strategy or proper improvements to a current plan in place, organizations are exposed to costly fines up to $1 million per submission due to non compliance as well as risks to the reputation.With the right action plan and focus along with internal support, wise companies will be better prepared for the impeding changes.

Turning 'Theory' into 'Practice'?

This program will combine an overview of the ingredients required to implement a successful aggregate spend program that will be compliant to requirements within the impending Sunshine Act along with the skills required to implement this approach.  

Who should attend?

Senior and strategic leader representatives from pharmaceutical, biotechnology and medical device with responsibilities in: Aggregate spend, Corporate finance, Regulatory compliance, State reporting, Transparency and Disclosure, Internal audit, Legal/ Legal affairs/Inhouse, Counsel Business, Analytics and Development, Finance Regulatory/ Government/Medical affairs, Ethics Sales and Marketing, IT, Commercial and Clinical Operations, Medical Affairs

Key areas to be covered in the programme and documentation

Conducting Spend Discovery and Planning ·Discover, track and profile data across the organization in relation to Aggregate Spend ·Design clearly defined program governance ·Examine how to win senior leadership support and sponsorship ·Understand cross department implications for aggregate spend planning ·Identify the organization’s current and future gaps in regards to Sunshine act ·Determine approach to customer master and software solutions ·Identify critical tasks for executives, managers and team leaders ·Build a road map for implementation and integration Case Study: What could I be missing as it relates to data capture?  

Enabling and Understanding Business and Information Architectures ·Create definitions of “Healthcare Professionals” and “Healthcare Organizations” ·Identify spend nomenclature and mapping of purposes and natures ·Determine essential date requirements vs. best practice/ nice-to-have fields ·Identify critical and key data management/quality concerns  

Identifying Required Business Process Changes (and Documenting Them!) ·Interpret regulatory guideline impacts to business processes ·Ensure processes and solutions can evolve with the shifting environment ·Document internal processes, procedures, workflows and structures to ensure a successful implementation ·Assess key capabilities needed to execute core tasks and ability to comply with proposed changes ·Balance organization hindrances with aggregate spend optimization  

Developing Communications & Training Plans ·Understand where to focus spend awareness education and attitudes likely to be encountered ·Educate physicians and external parties on pending Sunshine Act requirements and what directions the organization will be taking ·Coordinate internal transparency and disclosure initiatives across the organization ·Determine training and communication plan for impacted third-party suppliers ·Define organizational and department-level training requirements ·Develop tactical plans for training and change management communications Case Study: Developing a Change Management Plan  

Managing a Steady-State Aggregate Spend Program ·Ensure complete and clean aggregate spend report submissions ·Document development, functional and technical system capabilities ·Create Alerts and Proactive monitoring ·Establish controls to support compliance objectives ·Establish spend certification requirements ·Document quality assurance methods  

Auditing and Monitoring For Data Integrity ·Create approaches for monitoring aggregate spend data ·Identify techniques for source system audits and reconciliation ·Build and evaluate valuable formal compliance audits and scorecards ·Ensure internal audit team awareness to federal and state requirements Case Study:Data Integrity Analysis  

Planning for the Future of Aggregate Spend ·Evaluate potential enhancements to your HCP customer master ·Determine approaches to capture clinical and research data ·Capture HCO data beyond “Teaching Hospitals” ·Develop potential HCP dispute resolution processes ·Develop an approach to capturing global spend ·Continue to identify ways to generate business value from aggregate spend Case Study:Develop Your 2013-2015 Plan

Benefits to you

• Ensure your organization understand regulatory compliance laws while addressing the challenges to aggregate spend

• Understand where to plan-out and implement solutions that best meets the business needs Recognize practical and proactive strategies for improving in current Aggregate Spend Reporting and transparency compliance programs  

• Improve and build upon current processes to streamline and sustain data tracking, collection and internal auditing that will comply with anticipated Federal and current state requirements  

• Establish compliant protocol for dealing with sensitive third party data

• Initiates an understandable and compliant focused relationship between related stakeholders

• Establish cross-functional readiness though effective communications an training

Companies already benefiting include:

Duration of Course

2 Day Course

Course details

TBA, 2013

For more information about this course and upcoming course dates, please contact Emily Jones at emilyj@marcusevansch.com or call 312.540.3000 ext 6714

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Further information

UK Enquiries: +44 (0) 203 002 3057
or dzingim@marcusevansuk.com

Non-UK Enquiries: +420 (0)2 5570 7246
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Testimonials

"This course will allow my company to develop its existing strategies to a much greater and hopefully profitable level."

Managing Director, Tarmac