On August 14-16, 2012, CBI will be hosting its 6th Annual Forum on Sunshine and Aggregate Spend: Stay Ahead of the Curve to Ensure Transparency Readiness.
The complexities surrounding the collection of healthcare provider (HCP) spend data continue to challenge aggregate spend teams across the industry. Though still awaiting specific guidelines from CMS, compliance professionals and their transparency reporting peers must press forward to meet federal and state requirements. Best practices are emerging and CBI’s Annual Aggregate Spend Forum has served as the meeting place to share those efforts and successes since 2007.
The two-day conference will include a number of panels and discussions about Sunshine, transparency, and aggregate spend. These panels will be led by esteemed experts from the healthcare industry. Below is a summary of some of the panels.
Niall Brennan, who has been leading the effort at the Centers for Medicare and Medicaid Services (CMS) to write the final Sunshine regulations, will lead this brief update. This will be followed by a “Congressional Perspective on the Progress of the Implementation of Sunshine” given by a senior health policy advisor for the Senate Special Committee on Aging. There will also be sessions on:
- The Physician Role in manufacturers’ Sunshine and Transparency Initiatives;
- State Update from Vermont
- Unpacking the FDA Federal Prescription Drug Sample Transparency Regulations
Several of the sessions will include case studies; exploring common questions regarding reporting across affiliates and to learn how some companies are currently handling Sunshine and transparency requirements.
There will also be a session on keeping up with transparency legislation trends and requirements outside the United States. Similar healthcare provider (HCP) spend transparency requirements are emerging throughout Europe and other parts of the world. Participants will gain a basic understanding of current and pending provisions in different regions, as well as considerations for how these laws and regulations may impact Sunshine and state spend collection and reporting efforts in the U.S. Discussion will focus on France, The Netherlands, Slovakia, Japan, Australia and other countries. The panel will also explore the new International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.
The Fundamentals of Sunshine Compliance and Aggregate Spend Solutions
For those new to the aggregate spend team or compliance function, or for those who need a refresher, this “back to basics” course explores both the state and federal laws and requirements related to HCP spend transparency and foundational knowledge around the key components of an aggregate spend solution. Key Questions to Be Addressed:
- What are the requirements outlined in the Physician Payments Sunshine Act and how did we get to the federal regulations we’re at today?
- What states have similar transparency and reporting requirements?
- What parts of my organization are involved in Sunshine compliance and reporting?
- What are the basic components to an aggregate spend solution?
The workshop will explore the State and Federal Transparency and Disclosure Laws Related to HCP Spend Collection and Reporting. Panelists will analyze the federal Sunshine provisions passed in Section 6002 of PPACA; discuss the key requirements proposed by CMS in its draft regulations. Participants will:
- Discover which internal business units need to be involved
- Explore which external partners have spend data that must be reported
- · Enact training and communication programs that ensure awareness and outline responsibilities
Aggregate Spend Systems, Processes and Data
With the implementation of the Sunshine Act quickly approaching, many life sciences organizations have addressed the fundamental challenges of identifying, capturing and reporting spend activities. For the purposes of this workshop, attendees take a step back and discuss ways in which organizations can leverage these new systems, processes and data to support aggregate spend compliance and other requirements. The specific topics to be addressed include reengineering processes to meet additional business needs and testing data sets for potential compliance risks.
Key Questions to Be Addressed:
- What additional value can be extracted from the actual processes developed for aggregate spend compliance?
- How can the information from the processes be leveraged for improvements in other areas of the business?
- What procedures can be developed to determine whether aggregate spend systems and people are performing as expected?
- How could potential compliance risks be identified prior to Sunshine reporting?
Update from the National Trade Associations on Regulations Development
A number of trade associations submitted comments to CMS regarding its proposed rule on behalf of their member companies, including all of the major life sciences trade associations. Examples of some common topics included requests that the Agency provide more clarity around various definitions and concerns regarding potential mischaracterizations if the information is not put in appropriate context. In this panel discussion, hear about the continuing efforts and dialogue the trade associations engage in with the government as the industry moves towards implementation.
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