Policy and Medicine

Emerging Issues in Food and Drug Law: A National Conference for Lawyers, Policy-Makers, and Corporate Leaders

The University of Maryland Francis King Carey School of Law’s Law & Health Care Program and Student Health Law Organization and the School of Pharmacy’s Center for Drugs and Public Policy, in collaboration with the Washington, DC law firm, Arnold & Porter LLP, recently announced a conference to be held this April. 

Entitled, “Emerging Issues in Food and Drug Law: Implementation of FDASIA,” this day long, free conference, will cover a number of important topics in the food and drug law world, with a particular focus on the recently enacted Food and Drug Administration Safety and Innovation Act (FDASIA), which we wrote about this past summer.  The conference will be held at Arnold & Porter’s Washington, DC office on Wednesday, April 17, 2013. 

Click here to register 

The timing of this conference will be just over nine months after the enactment of FDASIA and follows the more recent spotlight on FDA involvement in drug shortages and its regulation of pharmacy compounding.  More recently, FDA announced its FDASIA timeline.  The day-long conference includes panels on the following topics: 

• Innovative Drug Approval
• Medical Device Regulatory Improvements
• The User Fee Acts: Updates on Implementation; and
• Hot Topics Panel (e.g., drug shortages, compounding) 

A number of important FDA officials and legal stakeholders in the FDA world including: 

• Keynote Speaker Leslie Kux, JD, Assistant Commissioner for Policy, FDA
• Representatives from FDA’s Center for Drug Evaluation and Research (CDER), including Patric Frey, MPP, Office of Planning and Analysis
• A Representative from the Center for Devices and Radiological Health (CDRH)
• Ryan Hohman, JD, MPA Managing Director, Friends of Cancer Research
• Lunch Keynote Speaker Laura R. Broch, PhD, RN, Director, Human Research Protections Office, U.S. Army Medical Research and Materiel Command
• Elizabeth Jungman, JD, MPH, Senior Health Policy Advisory, U.S. Senate HELP Committee  

About the Sponsors 

The UM Carey School of Law is a national leader in health law, and our conferences are integral tools in expanding practical knowledge on important health law topics and encouraging scholarship on cutting-edge issues.  The Law and Health Care Program combines education and research on emerging medical, health policy and legal matters, addressing health law issues from both legal and interdisciplinary perspectives.  The Law School’s nationally-recognized Journal of Health Care Law & Policy serves as a forum for interdisciplinary discussion of leading issues in health law, medicine, and health policy.  The UM Carey School of Law also boasts strong inteprofessional collaboration with the UM School of Pharmacy and its Center for Drugs and Public Policy.  

For decades, Arnold & Porter LLP's FDA and Healthcare practice has been a leader in helping pharmaceutical, biotechnology, medical device, and diagnostic companies, as well as other healthcare entities, respond to complex regulatory and compliance challenges in the US and Europe.  The firm assists clients in routine counseling matters, resolving their issues and concerns and supporting key business operations, as well as in the most complex crises-all with an eye on their long-term business and product goals.   

Morning refreshments and working lunch will be provided.  There is no fee to attend this conference, but registration is required.  The event will conclude with a networking reception to be held at Arnold & Porter.

Healthcare Innovation and Progress in a Sunshine Era: Establishing Principles for 21st Century Collaboration

The Healthcare Leadership Council a coalition of chief executives from all disciplines within American healthcare, is hosting a moderated panel discussion on Healthcare Innovation and Progress in a Sunshine Era: Establishing Principles for 21st Century Collaboration.  

The purpose of this briefing is to educate Congressional staff and others on the value of principled collaboration, introduce NDHI’s Principles Statement, share initial reactions to the final Sunshine provisions and highlight the potential relationship between federal regulations and future medical innovation.   

The program includes the following panelists: 

• David Caraway, MD, PhD, St. Mary’s Medical Center
• Guy Chisolm, PhD, Director, Innovation Management and Conflict of Interest Program, Cleveland Clinic
• Ryan M. Hohman, JD, MPA, Managing Director, Policy & Public Affairs, Friends of Cancer Research
• Mary R. Grealy, President of the Healthcare Leadership Council, will moderate the briefing.   

Date: Monday, March 11

Time: 12pm Noon

Location: U.S. Capitol Visitor Center (Room HVC 201) 

National Disclosure Summit Offers First Full Conference on Physician Payment Sunshine Act Final Rule

Now that CMS has issued the finalized regulations implementing the Physician Payment Sunshine Act—Section 6002 of the Affordable Care Act—lawyers, stakeholders, and other interested parties are scrambling to analyze and interpret the 287-page final rule.  While attorneys and stakeholders scramble through the pages, interested stakeholders can attend the 5th Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies. 

The summit is being held in Washington, DC, between February 19 – 21, 2013.  The three-day agenda is packed with expert panels from the industry and government.  

The Summit will offer pharmaceutical and medical device professionals the first opportunity to assess the Final Rule with the help of senior government regulators, as well as an array of industry experts and leading consultants who have been in the vanguard of building and implementing aggregate spend solutions.  The Summit will also provide a comprehensive update of the rapidly evolving transparency requirements now taking shape across the globe and offer timely advice on creating a global aggregate spend and disclosure program.   

In-house experts will share their experience on a wide array of emerging best practices ranging from project management to building scalability and sustainability. Panels of in-house and outside experts will weigh in on key topics such as drug sample compliance, R&D and clinical trials compliance, Fair Market Value, and advanced operational issues. 

HCEA Summit Features Physician Payment Sunshine and Transparency Talks

On January 24, 2013, the Healthcare Convention & Exhibitors Association (HCEA) will hold its annual Marketing Summit, at the Sheraton Inner Harbor Hotel in Baltimore, Maryland.  The HCEA Summit is a one-day, intense learning forum that focuses on high-level, current topics in the healthcare convention marketing industry.   

In the opening general session, Doug Amann, Pfizer Global Commercial Operations, Vice President, Customer Engagement, will discuss changes in the healthcare industry and perspective on how to become a leader within one’s own organization.  Following this session, there will be several breakout sessions on the following topics: 

• Managing Change: Regulatory and Compliance
  Moderators: Diane Benson, CTSM, Global Events Manager, GE Healthcare, and Kathy Clarke, Managing Partner, SageRock Advisors, LLC
  • Sunshine Act
  • Corporate integrity agreements
  • Transparency initiatives 
• Managing Change: Organizational
  Moderators: Christine Farmer, Director, Marketing Operations, Sanofi, and Sean Feehan, GWF Associates, LLC
  • Mergers and acquisitions
  • Budget challenges
  • Reliance on agencies
• Managing Change: Environmental Challenges
  Moderators: Laine Mann, Global Congress Lead, Pfizer, and Mike Ryan, Global Sales Manager, Association for Research in Vision and Ophthalmology
  • Patent cliff
  • Technology
  • Global perspective on meetings 

In the afternoon, there will be an Expert Panel Discussion: Exploring Dynamics Between Healthcare Brand Management, Sales and Conventions.
Panelist:  Roger May, Senior Director of US Marketing, Siemens Health Services
Moderator:  Christine DiDomenico, MBA, Assistant Director, Marketing Education and Conventions, Purdue Pharma L.P.  

The afternoon plenary session will bring the perceptions of the role of conventions in the marketing mix by product marketing managers from both pharma and device points of view.  They will answer:  

• What is the role of conventions?
• What do they expect from convention management?
• What defines success for them when evaluating conventions, and what metrics do they think are important to measure the effectiveness of face-to-face marketing?

Following this session will be another panel entitled, “The Art of Benchmarking and the Science of Measuring Value: Using Benchmarks to Demonstrate Value of Your Events.”  Presenters include: 

• Ann Marie Bermudez, Senior Manager, Convention and Association Relations, Daiichi Sankyo, Inc.
• Don Schmid MBA, Manager, Conventions & Corporate Branding, Hospira Worldwide, Inc.
• Marc Goldberg, CME, Partner, marketech360
• Ian Sequeira, Executive Vice President, Exhibit Surveys, Inc.
• Moderator: Frank Skinner, Executive Director, HCEA 

If you ask ten people how they define value, cost and return on investment, you’ll likely get ten different answers.  Every company has different objectives and definitions for things like how they define cost, how they define leads, and how they define the value of things like brand awareness, ROI and pre-event promotion.  Likewise, people use these kinds of benchmarks in completely different ways, some strategically and some not.  HCEA has embarked on the groundbreaking mission to identify the common ground with how major healthcare exhibitors benchmark their success and how they use this information for their strategic planning and program improvement.   

This unique session features the results of a new HCEA survey on how healthcare exhibitors define ROI, costs and success, which will enable attendees to compare and contrast the results with their own programs. Additionally the survey results will be accompanied by a panel of experts who will share the best ways to showcase your metrics and benchmarks so that you can get the most out of your strategic planning and communicating the most critical findings within your own data. 

The final panel of the day will include Thomas Sullivan, author and editor of this blog, where he will discuss the “Sunshine Rules – What’s Important to Know Now” 

Completion of the final rule for the Physician Payments Sunshine Act, part of the Patient Protection and Affordable Care Act (PPACA), has been sent to the White House for final review.  If the rule is released in advance of the Summit, we will discuss the rule and its impact on medical meetings.   If it is not released, we will discuss the proposed rule and share insights on the process for finalizing the rule, and what to expect based on stakeholder comments and feedback from Centers for Medicare & Medicaid Services.

Scope Summit Features Physician Payment Sunshine Session

Cambridge Healthcare Institute recently announced its Fourth Annual SCOPE Summit 2013 (Summit for Clinical Ops Executives), being held February 5-7, 2013 in Miami, Florida. 

The program brings together eight conferences under the SCOPE umbrella, which creates an opportunity for idea sharing and cross-pollination amongst clinical operations professionals from different groups.  Despite a shared exhibit floor where the community can share ideas, each conference remains autonomous and goes deeply into its own set of issues with its expert faculty.  Each conference will feature best practice case studies and interactive discussions relevant to clinical operations experts as well as those new to the field. 

SCOPE 2013 coverage includes the following programs: 

Pre-Conference Events  

• Optimizing the Grant Payments Process
• Clinical Trial Monitoring and Compliance 
• Impact of Affordable Care Act and the Sunshine Act (including Thomas Sullivan, author of this blog)
• Apply SharePoint to ClinOps Challenges
• Improving Study Start-up
• Tools to Detect Drug-Induced Adverse Events 

Main Programs - February 5-6, 2013 

• Electronic Data in Clinical Trials
  
• Global Site Selection, Feasibility Assessment, Operations and Site Management
  
• Implementing and Managing Strategic Alliances
  
• Post-Marketing Studies as a Tool for Safety, Outcomes and Comparative Effectiveness Research 

February 6-7, 2013

Integrating and Leveraging Clinical Trial Operations Data

Patient Recruitment and Retention in Studies and Registries

Clinical Trial Forecasting, Budgeting, and Project Management

Managing Post-Marketing Studies and Registries

 

Visit www.scopesummit.com for detailed program information.  Readers of our blog are entitled to a $200 discount on a commercial registration and $100 discount on an academic registration!   

To register go to https://chidb.com/register/2013/scope/reg.asp, enter registration code RPSCOP to receive your discount or call Cambridge Healthtech Institute directly at 781-972-5400 and ask for Registration.  Be sure to mention your priority code: RPSCOP- in order to receive your discount. 

We look forward to seeing you in Miami.

CBI 14th Annual Forum on Off-Label Guidelines

In light of the new guidance from the Food and Drug Administration (FDA) and numerous high profile court cases, it is necessary for companies to continue to stay current with new regulatory requirements in regards to field-based team interactions with prescribers and off-label information.  CBI’s 14^th Annual Forum on Off-Label Guidelines, October 11-12, 2012 at the Doubletree Hotel Center City in Philadelphia, PA, convenes the industry’s leading pharmaceutical, biotech and medical device executives to discuss regulatory guidance, field force oversight, promotional review and more. 

Industry must continue to revaluate and update their internal standard operating procedures (SOPs) to ensure all medical and promotional information complies with current off-label regulations.  This interactive forum provides a platform for industry peers to review and discuss best practices regarding compliance and legal oversight as well as an opportunity to discuss industry benchmarks, activities and practical guidelines for off- label information. 

• Discuss implications of the FDA Guidance released in December of 2011
• Understand the current regulatory environment for off-label information
• Learn from industry experts how companies are monitoring interactions between field force teams and prescribers
• Define what constitutes as solicited vs. unsolicited information
• Review influential court cases as well as recent OPDP warning letters regarding off-label allegations

The two day workshop will include a number of important panels and esteemed speakers who will address the trends and challenges companies face in the current regulatory environment with respect to off-label promotion.  Below is a summary of some of the panels.

Understand the Current Environment for Off-Label and Misbranding Compliance

The current environment for off-label information continues to evolve as enforcement focus moves away from obvious off-label promotion outside of an approved therapeutic indication, to misbranding by overstating efficacy or minimization of risk information.  While biopharmaceutical and device companies continue to adjust their internal compliance activities to prevent “the same old violations”, many questions and clarifications remain unanswered on what is compliant practice versus what is considered misbranding or off-label promotion.  During this session, hear from a former government prosecutor who now represents whistleblowers in misbranding and off-label promotion qui tam cases.

• Hear what whistleblowers are saying about their company’s conduct
• Review the current trends in the type off-label allegations cited by OPDP
• Understand the evolving nature of misbranding off-label allegations
• Discuss the future of off-label in the face of the new FDA Guidance and Federal Review Notice
• An Update on Recent OPDP Warning Letters, Notice of Violation (NOV) and FDA’s Bad Ad Program

In 2012, FDA’s Office of Prescription Drug Promotion (OPDP) has asked for “voluntary” compliance to prevent common violations including omission and minimization of risk information, misleading claims of efficacy, promotion of unapproved uses and misleading superiority claims.  While this request is certainly a heads up to the industry, and promotional activities by industry appear to be improving, there are still activities and materials which are of concern to OPDP.  Surveillance activities have been augmented by the introduction of the Bad Ad program and the reporting of in-person promotional violations may be increasing.  In this session, review OPDP Warning Letters and NOVs to better understand what language and information constitute as off-label information.

Off-Label Legislation — Identify and Address Risk for Executives and Individuals

The government has begun aggressively assessing personal liability against individuals within corporations, in addition to levying civil and criminal assessments against corporations for off-label promotion violations.  While some of the governmental actions have been against individuals directly responsible for the decision-makers, in other instances, the government has opted to proceed against individuals not directly responsible, rather, through the individuals’ standing within the organization.  Under the so-called Park Doctrine, or Responsible Corporate Officer Doctrine, corporate officers are held responsible based solely upon his or her position and responsibility, and without evidence of specific wrong-doing.  With an increase in enforcement actions against individuals, companies are examining what steps they can take to protect their employees and management team.  This session examines what actions the government has taken against individuals, describes the legal theories government is utilizing and reviews precautions that companies can take to prevent individual liability, improve compliance programs and revise policies to prevent violations.  

• Review recent enforcement actions against individuals and the underlying alleged activity
• Learn which actions have been successful and which have failed    
• Review recent enforcement actions against individuals and the underlying alleged activity
• Learn which actions have been successful and which have failed
• Understand the legal theories the government is employing, including the origins of the Park Doctrine and how it is being applied
• Acquire key takeaways to improve internal compliance activities

Federal Prosecutors’ Discussion: Recent Trends in State and Federal Enforcement — Evaluate Recent Complaints, Investigations and Settlements with Federal Prosecutors

In addition to the federal government False Claim Act, several states have created False Claim Act statues with qui tam provisions.  Off-label promotion continues to be the major factor in the majority of settlements — whether it be a misbranding issue, overstating of benefits or another violation.  Previous cases have shown that adhering to FDA guidelines is not enough.  To ensure compliance, pharma must be aware of both FDA and individual state restrictions.  During this discussion, hear directly from the prosecutors on their areas of focus, insight into current trends in off-label cases and recommendations to lessen the risk of off-label promotion.

• Hear recommendation from the government on how to monitor and prevent off-label promotion
• Identify top priorities for enforcement
• Discuss and evaluate False Claim Act Statues across federal government and individual states
• Understand the Benefits of Proper Off-Label Compliance Training and Monitoring Field-Based Sales Operations

Many companies see communication and interactions between field-based sales teams and prescribers as a major concern for off-label promotion and risk to the organization.  The FDA has tried to create more concrete restrictions with the new guidance, but most in the industry remain unclear on what is legal and illegal information exchange.  And with the rise of the social media platform, communications are now far reaching, with the potential for unintended consequences. 

In this changing environment, both small and large companies alike must monitor field-based sales and company-wide communications to ensure that they are adhering to FDA, state and DOJ guidelines.  It is through a corporate training and monitoring program where compliance and legal teams can ensure that all communications remain compliant.  Yet the extent of monitoring, particularly with respect to social media, is a concern and challenge.  In this session, explore common risk areas for compliance in field-based operations as well as the importance of training, tracking and monitoring these activities to illustrate and actively obey compliance efforts.

 

• Learn how to effectively track communications between field-based teams and physicians
• Discover the positive impact of a concrete, internal set of compliance regulations
• Establish ways to prevent the relay of off-label information from sales to prescribers
• Learn tips for creation of an internal social media policy that addresses appropriate and inappropriate communication    
• Uncover the benefits of cross-company training on what is and is not off-label communication
• Essential Elements of Compliant Scientific Exchange under New FDA Guidance

In its Federal Register Notice, the FDA notes that it was particularly interested in reviewing the public’s response to a group of thirteen questions based on the legality of scientific exchange.  As a result, the distinction between scientific exchange and promotion for industry remains unclear under the new guidance.  This uncertainty creates a barrier as the pharmaceutical and medical device industries encourage scientific exchange to ensure patients receive the most appropriate treatment.  During this session, explore the elements that allow for compliant scientific exchange to ensure that patients continue to benefit from therapy innovation and appropriate uses of currently available therapies in this informative session.

• Discuss elements of appropriate and inappropriate scientific exchange
• Relate these elements to the FDA’s recent request for public response answering the thirteen questions related to scientific exchange
• Define the distinctions between scientific exchange and promotion
• Understand the difference between communications concerning the use of unapproved products versus new uses of approved products
• The Importance of Monitoring Target Lists and Compensation Plans for Field-Based Sales Operations — Lessons Learned from Recent Litigation

Recent litigation trends indicate that the government is increasing its focus on sales target lists, compensation plans and sales goals related to off-label compliance.  Industry guidance recommends that companies examine whether the current company policies, procedures and practices encourage improper promotional practices.  In this session, review recent government settlements, understand what the government sees as red flags and discuss better industry practices.

 

• Analyze recent industry guidance regarding target lists, sales goals and compensation plans
• Discuss red flags in compensation plans, target lists and sales goals that should be monitored
• Discuss better industry practices to mitigate risk of off-label promotion related to target lists, sales goals and compensation plans
• Effectively Manage and Improve Compliant Interaction Between Field-Based Sales and MSLs

 

Many companies see communication and interaction between field-based sales teams and Medical Science Liaisons as a major risk to the organization.  In response to government claims that MSL teams have been misused to promote off-label, many companies have put a firewall between their medical affairs and commercial operations in an attempt to demonstrate a clear independence of MSL teams from commercial influence.  By doing this, companies have successfully lowered their risk; however, these critical functions now rarely communicate, creating a barrier for appropriate and valuable knowledge exchange and effectively blocking a successful transition of products from development to commercialization.

 There is significant benefit in finding a compliant method of communication between sales and MSLs but requires ongoing effective management and comprehensive training to mitigate potential risk.  Such a dynamic model takes time and effort, but if done correctly and compliantly can result in great gain to the organization. In this session, learn about the benefits of effectively managing communication between field-based sales and MSLs as they carry out their respective roles in interactions with prescribers.

• Discuss appropriate distinctions between promotion and scientific exchange to ensure understanding of a compliant internal  and external communication processes
• Discuss the benefits and potential pitfalls of joint training sessions with MSLs and sales representatives that address the purpose of each function, how to communicate appropriately in the field and how to respond compliantly to unsolicited requests for off-label information
• Learn how to manage communication between MSL teams and their commercial colleagues to minimize risk and maximize value to the organization
   
• Case Study: The Changing Role of MSLs in the Current Compliance Environment — What it Means for Medical Affairs Departments

 

As a result of new FDA guidance, company reorganization and shrinking budgets; new questions regarding how to communicate on- and off-label information continues to be discussed in detail for MSL departments.  New questions about what communications, both on-label and off-label, fall under the umbrella of complaint MSL interactions continue to arise.  Seven pharmaceutical companies recently filed a Citizen Petition asking for information on appropriate communication on how truthful, non-misleading information that is not included in product labeling can be communicated.  As MSLs are usually at the forefront of this type of communication and respond to unsolicited requests; companies must define the proper interface between field sales and MSLs within an organization.  During this session, learn about the changing environment of MSL departments and what constitutes as compliant interactions according to the federal government.

Case Study The Importance of Off-Label Compliance Training for Field-Based Operations — Effective Methods and Training Activities

In order to best protect from off-label compliance risks, it is essential for companies to first have an effective and efficient internal training program in place.  With continually changing regulations, including the new guidance, it is important to check that your training practices are up to date and adhere to FDA and DOJ guidelines.  Corporate training programs are the foundation for ensuring compliant interactions between field-based teams and prescribers, and where compliance teams can ensure that all team members are adequately trained and properly informed.  Proper off-label compliance trainings help establish clear-cut lines between compliant and illegal activities, while defining what constitutes as off-label interactions during internal and external communications.  Evolving technologies such as social media, smart phones, iPads only increase compliance risks as they increase the mobility of field-based teams, creating further need for compliance trainings.  

Promotional Review Committee’s Role in Evolving Compliance Environment

In the current environment, is there value in having a member of the compliance department as a voting member of your promotional review committee?  It’s been almost ten years since the Department of Health and Human Services published OIG Compliance Program Guidance for Pharmaceutical Manufacturers.  In that time, the compliance function has become a more prominent part of company life.  Is wide spread acceptance as full voting members on promotional review committees the next step? 

The meeting promises to be educational and provide practical information for life science companies.

 

 

Diabetes Innovation 2012 Conference: Offers Futuristic View on Innovation

The diabetes epidemic demands a powerful response from leaders in the diabetes community, nationally and globally.  To this end, for the first time in its 114 year history, Joslin Diabetes Center, an affiliate of Harvard Medical School will convene all stakeholders for a groundbreaking, immersive activity over 3 days in September called Diabetes Innovation 2012.  

Joslin is an independent, nonprofit institution affiliated with Harvard Medical School.  Their mission is to prevent, treat and cure diabetes, and to help envision a world free of diabetes and its complications.   

The conference will take place from September 23-25, 2012 at the Hyatt Crystal City in Arlington, VA.  Those who register before August 23 save $100, and also get an additional $300 off the regular registration fee!   

You can register online at www.diabetesinnovation.org.  Use promo3VIP in the ‘special code’ box when prompted to save $300! Also on the website you will find hotel information.  A block of discounted rooms has been reserved for delegates.  Questions can be directed to manager Nancy Felsheim at 617-309-5878 or nancy.felsheim@joslin.harvard.edu.    

Diabetes Innovation 2012  

This conference will act as a powerful catalyst for ideas, partnerships and collaborations. It will provoke thought, innovation and action that address the cost, productivity and quality-of-life impact of diabetes on our society by bringing together all stakeholders:  payers, purchasers, providers, industry, government, research, patients, consumers, technologists, developers, and funders.   

“Simply put, we MUST forge new approaches and dramatically increase our sense of urgency to address diabetes head-on.  Despite all of our collective efforts, we are not keeping up with the global threats presented by obesity and diabetes,” says John L. Brooks III, CEO, Joslin Diabetes Center. “To effectively make a real difference, we need to convene, apply our collective energies, and work together, to truly create innovative policies and programs that will involve all stakeholders and that will make a real difference.  This world-wide pandemic will not be solved until all of us use our combined resources, commitment, determination, and passion to map out an aggressive and meaningful path forward.” 

Diabetes Innovation 2012 will provide a powerful foundation for sustained for advancement in all facets of diabetes prevention, treatment and payment reforms including social media and gaming, translational research breakthroughs, food sourcing, distribution to mobile patient technologies and everything in between.   

“Diabetes is the seventh leading cause of death in the U.S.  We need more preventive programs that help improve individuals’ health and sustain behavior change.  When consumers make better choices about diet, exercise and smoking, potentially disastrous outcomes like diabetes and heart disease can be avoided” said Donald M. Berwick, MD, former CMS Administrator and former President and CEO, Institute for Healthcare Improvement and Diabetes Innovation 2012 Senior Advisor. “We need to ‘innovate’ processes, tools and incentives towards prevention for consumers and all stakeholders.” 

Diabetes Innovation 2012 features leaders and innovators from all sectors, and will include innovations in prevention, delivery and adherence as well as innovations in process and policy.  Among over 80 faculty, and hundreds of audience members, from industry and the payer, provider and purchaser community and academia, leaders from many of the most important government agencies (AHRQ, PCORI, NIH, CDC, FDA, CMS, CMMI) will be on hand to encourage open dialogue and collaboration to speed system improvements. 

Support for the activity is provided by Sanofi US.  According to Dennis Urbaniak, Vice President, Head of U.S. Diabetes, Sanofi US, “At Sanofi , we know innovation is the key to fostering accelerated improvements. We are pleased to provide opportunities that stimulate innovation not only in products, but also in other solutions, as evidenced by our Data Design Diabetes Innovation Challenge. We’re committed to supporting Joslin Diabetes Center’s important initiative to convene all stakeholders onto common ground, to move forward as collaborators, and not as individual constituencies.” 

 “Our very successful pilot of this convening event that we held in Washington DC last July, convinced us that there is a tremendous amount of interest and enthusiasm for expanding  this program to a three day program so we can engage as many participants and encompass as many ideas and inputs as possible,” according to Brooks. “If you really want to shape the future direction of diabetes, covering the entire spectrum of care, education, technology, prevention as well as the landscape of diabetes complications, comorbidities, and related health conditions, you should sign up now so your voice can be heard.” 

To sponsor, exhibit or register for Diabetes Innovation 2012, visit www. diabetesinnovation.org

 

CBI 6th Annual Forum on Sunshine and Aggregate Spend

On August 14-16, 2012, CBI will be hosting its 6^th 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.

To register for the conference

The National Dialogue for Healthcare Innovation: The State and Future of Physician-Industry Collaborations

 
The National Dialogue for Healthcare Innovation (NDHI) recently announced its inaugural event: the NDHI Summit on Physician-Industry Collaboration.  This summit, the first-of-its-kind, will include a cross-disciplinary dialogue on the issue of collaboration between physicians, industry, and other stakeholders in the U.S. healthcare ecosystem that drives innovation for the benefit of patients.  We previously wrote about NDHI last year and provided an update as well. 

NDHI was formed by the Healthcare Leadership Council, a coalition of chief executives representing all sectors of American healthcare, as an interactive forum where leaders from across the healthcare industry can work toward consensus on the most important issues affecting healthcare innovation, and ultimately, patient care. 

During the summit, one of the programs, entitled “The State and Future of Physician-Industry Collaborations: Spreading Some Sunshine on the Outlook for Innovative Patient Care,” will focus on the Physician Payment Sunshine Act.  This session will be held on June 13, 2012 from Noon – 1:00 p.m. in the Cannon Caucus Room at the House of Representatives, in Washington, D.C.  To attend, email auherek@hlc.org. 

While the Affordable Care Act (ACA) included “sunshine” provisions to ensure transparency and public disclosure, the dialogue on what’s best for patients continues.  This discussion will focus on how to ensure principled collaboration that serves the public interest and furthers the discovery of new cures, treatments, and medical technologies.  This panel will generate discussing surrounding the following questions:   

Is collaboration between physician and industry vital to innovation?

• What is the impact on patients and medical innovation if government goes too far in restricting or discouraging collaboration?
• How do we ensure a balance?

Confirmed Speakers Include:

• William Silverman, DO, Family Practice Physician & former Trustee, American Osteopathic Association
• Phyllis Greenberger, President and CEO, Society for Women's Health Research
• Mary Grealy, President, Healthcare Leadership Council
• Dr. Richard Murray, Vice President of External Medical & Scientific Affairs, Merck & Co.
• Dr. David Charles, Chief Medical Officer, Vanderbilt University Clinical Neurosciences Institute 

 

CBI 10th Annual Forum on Educational Grants

As pharmaceutical companies continue to change their granting policies and procedures to stay focused on quality improvement initiatives, many CME stakeholders want to know how these changing models are impacting patient care, physician behavior and stakeholder relationships.  What is the effect of these funding models on partnerships between supporters and providers?  These issues are particularly prominent in light of the Sunshine Act and other government requirements affecting public reporting and quality measures. 

Early next fall, CBI will be hosting its 10^th Annual Forum on Educational Grants.  The title of this year’s event is “Ensure Compliant Funding & Evaluate Quality Improvement for Medical Education Programs.  The program, which will be held in Philadelphia, Pennsylvania, on September 11-12, 2012, is led by CME experts from supporter and provider organizations.  The annual event will discuss the challenges surrounding commercial support for medical education programs and provides a forum to discuss how to overcome those challenges and maintain compliance in the funding of outcomes-driven educational programs.  Some of the distinguished speakers include:

 

-          Thomas Sullivan, President, Rockpointe  

-          Jan Price, Director, Medical Education and Investigational Studies, U.S. Medical Affairs, Bayer HealthCare  

-          John Ruggiero Ph.D., MPA, CCMEP, Group Manager, Oncology, Genentech

-          Frank Skopowski, Senior Director, Global Academic and Professional Affairs – Grant Operations, Merck & Co., Inc.

-          Emily A. Miles CCMEP, Publications and Grants Associate, U.S. Medical Communications, Actelion Pharmaceuticals

-          Laura Muttini RPh, MBA, CCMEP, Associate Director, Proprietary Products Division – U.S. Grant Management Department, Abbott Laboratories  

Topics include:

• Examination of transparency measures and compliant reporting of grant funding under the Physician Payment Sunshine Act
• Evaluation of the changing CME environment and granting policies
• The integration of FDA-mandated REMS and continuing education initiatives
• How to monitor and audit CME programs through needs assessment
• The grant submission and review process
• Outcomes measurement and reporting 

Below are some of the topics and panels in greater detail.

CME and Sunshine

 

With the implementation of the Sunshine Act in January 2012, many pharma companies are increasingly concerned about how the new public reporting guidelines will ultimately affect CME.  The guidelines released by CMS are rather vague, using broad terminology such as “applicable manufacturer” and “covered recipient.”  If a CME organization receives an educational grant from an applicable manufacturer and uses any portion of the payment toward a covered recipient (i.e. physician or teaching hospital), the manufacturer is responsible for reporting that payment.  What are the pros and cons of this regulation, how are pharma companies dealing with the uncertainties

surrounding this law and how does the regulation affect both supporters and providers?

 

-          How should supporters and providers navigate and interpret the guidance?

-          What do the ambiguous terms actually mean?

-          What resources are being used to meet government requirements?

-          How will healthcare reform affect funding for CME?

-          What other quality measures is the federal government looking at?

 

CME and REMS

 

For the first time ever, the FDA issued a REMS around long-acting and extended release opioids that required certified continuing education as part of its plan. While considered by many to be a positive move, this presented many challenges for the manufacturers and CE community alike. This session provides an update on the opioid REMS and also evaluates the potential role of certified CE in support of other REMS programs.

 

-          Review lessons to be learned from the Industry Working Group (IWG) on meeting FDA’s expectations for certified CE in support of opioid REMS

-          Explore how to align goals of REMS with educational needs

-           Identify if, when and how certified CE can be integrated into any REMS program

 

How to Promote CME to Government, Public

 

As CME activities continue to receive scrutiny from the government and other stakeholders, how can companies justify their CME budget?  If these educational initiatives are accomplishing positive results, how can this information be made known?  How can the perceived improvement outcomes be disseminated?  This panel describes how to raise the profile of CME impact with the public and the government, discusses how to advocate for CME internally and explains best practices for extending the life of important medical information through publication.

 

-          Discuss the process of getting material published and identifying appropriate journals for your data

-          Get outcomes data in front of government agencies and the general public

-          Make use of outcomes data to validate CME spend inside pharma
 

Industry’s Role in Outcomes

 

As pharma works to take a bigger role in moving outcomes forward, how can pharma companies help to move providers up the outcomes continuum by requesting them to submit grant requests for high level educational outcomes?  How can there be more consistent and open communication between providers and supporters?  This panel discussion brings together representatives from Pfizer, GSK, Abbott and Astellas to discuss pharma’s elevated role in outcomes measurement and to address the changing granting models.