Compliance Conference

At HCCA’s 2012 Research Compliance Conference, you’ll learn best practices and the latest thinking on: • Implementation of the Sunshine Act provisions...
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At HCCA’s 2012 Research Compliance Conference, you’ll learn best practices and the latest thinking on: • Implementation of the Sunshine Act provisions to the Health Care Reform Package

Research Compliance Conference June 3–6, 2012 | Austin, TX AT&T Executive Education Conference Center

• Handling the updates to the Medicare as Secondary Payer Rules and the effect on research‑related injury • Responding to changes to CMS Clinical Research Policy (replacing the Medicare NCD for Clinical Trials) • And much, much more You’ll hear directly from representatives from NIH, OHRP, ORI, the FDA, the OIG, and the DOJ, and from other industry experts who can provide practical perspectives for how to handle your research compliance risks.

Don’t miss your chance to attend in 2012 Register today and enjoy the flexibility of two conferences for the price of one!

learn more & register at hcca-research-conference.org Platinum Sponsors

Complimentary access to SCCE’s Higher Education Compliance Conference is included with your Research Compliance Conference registration. The parallel schedule gives you the freedom to attend sessions at either conference— two for the price of one.

Program at a Glance Sunday, June 3: Pre-conference 12:00 – 5:30 pm

Registration Open

1:00 – 2:30 pm BREAKOUT SESSIONS PRE-CONFERENCE 1

P1 New Rules for IRBs—What the (A)NPRM Could Mean for Your Institution – Jeffrey P. Braff, Director, Human Research Protections, Kaiser Permanente

2:30 – 3:00 pm

Networking Break

3:00 – 5:00 pm BREAKOUT SESSIONS PRE-CONFERENCE 2

P3 Clinical Research, the Race (and Perils) to Be First with Discovery – Juliann (Juli) Tenney, Institutional Research Compliance and HIPPA Privacy Officer; Director, Institutional Research Compliance Program, The University of North Carolina at Chapel Hill; S. Stanley Young, Assistant Director for Bioinformatics, National Institute of Statistical Sciences

5:00 – 6:30 pm

Welcome Reception

P2 Research Billing Compliance – Ruth Krueger, Regional Director of Corp Compliance, Sanford Health; Eve Sakran, Director Clinical Trials Office, Jackson Health System; Diana Salinas, Corporate Director and Chief Compliance Officer, Jackson Health System P4 Managing Conflicts of Interest in Research in the Face of New Regulatory Requirements – Tracy E. Miller, Senior Member, Health Care Group, Cadwalader Wickersham & Taft; Janis Anfossi, Vice President, Compliance & Privacy, Rush University Medical Center

MONday, June 4: conference

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7:00 am – 5:30 pm

Registration Open

7:00 – 8:15 am

Continental Breakfast (provided)

8:15 – 8:30 am

Opening Remarks

8:30 – 9:30 am

General Session 1: Research Compliance: A Year in Review – Lisa Murtha, Partner, SNR Denton US LLP

9:30 – 10:00 am

Networking Break

10:00 – 11:30 am BREAKOUT SESSIONS

101 Increased Scrutiny on Pharmaceutical and Medical Device R&D Activities: The Impact on Clinical Research Sites – Mary Ann Northrup, Director, Healthcare Life Sciences Disputes, Compliance and Investigations, Navigant Consulting

11:30 am – 12:30 pm

Networking Lunch (provided)

12:30 – 2:00 pm BREAKOUT SESSIONS

201 Clinical Research Enforcement Initiatives and False Claims Act Update – Gary W. Eiland, Partner, King & Spalding LLP

2:00 – 2:30 pm

Networking Break

2:30 – 4:00 pm BREAKOUT SESSIONS

301 Comprehensive Risk Assessments To 302 Clinical Trial Disclosure and the Risk Fuel Research Compliance – Daniel E. Ellis, of Non-Compliance – Barbara Godlew, President, 20/20 Healthcare Advisory Services, President, The FAIRE Company, LLC Ltd.

4:00 – 4:15 pm

Networking Break

4:15 – 5:15 pm

General Session 2: Oversight of Clinical Research – Julie K. Taitsman, Chief Medical Offier, U.S. Department of Health and Human Services, Office of the Inspector General

5:15 – 6:30 pm

Networking Reception

www.hcca-research-conference.org | 888-580-8373

102 Fabrication, Falsification and Plagiarism: Complying with Federal Regulations on Research Misconduct – Randy Mason, Vice President, Research Operations, Institutional Official, Research Integrity Officer, Beth Israel Deaconess Medical Center

103 Your Medical Staff is Conducting Clinical Research. Are you Prepared and Protected? Special Challenges for Community Hospitals – Michael C. Roach, Partner, Meade & Roach, LLP

202 A Successful IRB Model for Handling Noncompliance Cases (Emory’s Experience) – Sarah B. Putney, IRB Director, Emory University

203 Research Compliance Management Project Review & Centralized Research Registration – Kurt Sargent, Manager, Sponsored Projects Administration, Allina Health System; Carmi Anderson, Research Compliance Specialist, Sponsored Projects Administration, Allina Health System 303 The Dynamics of Cooperative Groups Providing Coverage Analysis: How to Utilize the Information and Make it Work for You! – Kelly Willenberg, President, Synergism, LLC; Kati M. Stoermer, Associate Director of Administration, SWOG Group Chairs Office, University of Michigan

Tuesday, June 5: conference 7:30 am – 4:30 pm

Registration Open

7:30 – 8:30 am

Continental Breakfast (provided)

8:30 – 10:00 am

General Session 3: Research Compliance Challenges and Best Practices – Rachel Nosowsky, Principal Counsel, University of California; Angelique Dorsey, Research Compliance Director, MedStar Health; Luanna Putney, Director of Research Compliance, University of California; David Vulcano, AVP & Responsible Executive, Clinical Research, Clinical Services Group, HCA

10:00 – 10:30 am

Networking Break

10:30 am – 12:00 pm BREAKOUT SESSIONS

401 Privacy Complexities in Research Compliance – Marti Arvin, Chief Compliance Officer, UCLA Health System; Mary Thomason, Privacy Compliance Consultant, Intermountain Healthcare

12:00 – 1:00 pm

Networking Lunch (provided)

1:00 – 2:30 pm BREAKOUT SESSIONS

501 Successful FDA Inspections: How to Prevent and Respond to Common FDA Observations in a Form 483 or Warning Letter – Richelle Little, Regulatory Counsel, Western Institutional Review Board; Kara Morgenstern, Associate General Counsel, University of Michigan

2:30 – 2:45 pm

Networking Break

2:45 – 4:00 pm

General Session 4: Behavioral Ethics: Why Good People Do Bad Things – Robert Prentice, Professor of Business Law and Business Ethics in the Business, Government & Society Department, McCombs School of Business, University of Texas

402 Fair Market Value Issues in Financial Arrangements with Research Physicians – Robert A. Wade, Partner, Krieg DeVault LLP

403 Implications of Transparency Reports and Implementation of the PHS Conflict of Interest Regulations – Luanna Putney, Director of Research Compliance, University of California; David Vulcano, AVP & Responsible Executive, Clinical Research, Clinical Services Group, HCA

502 Creating Infrastructure Support for Sponsor-Investigators in Academic Health Centers – Karen Hartman, Operations Manager, Mayo Clinic; Keren Dunn, Manager, Research Compliance and Quality Improvement, Cedars-Sinai Medical Center

503 Effective Financial Research Compliance Management – Kathryn Seifert, Consultant, Ernst & Young; Draco Forte, Director, SNR Denton US LLP

WEdnesday, June 6: Post-Conference 8:00 – 11:30 am

Registration Open

8:00 – 8:30 am

Networking Break (coffee service only)

8:30 – 11:30 am BREAKOUT SESSIONS POST-CONFERENCE

W1 Developing and Implementing a Research Compliance Audit Plan – Jodi Ogden, Executive Director Sponsored Projects Administration, UTHealth, The University of Texas Health Science Center at Houston; Matthew Lester, Managing Director, HuronLife Sciences

11:30 am – 12:30 pm

Lunch (on own)

12:30 – 1:00 pm

CHRC® Exam Check-In

1:00 – 3:00 pm

CHRC® Exam (optional)

(includes 15-min break)

W2 Recent Developments in Clinical Trial Regulation and Oversight – Cynthia Gates, VP Education and Consulting, Western IRB

Top 10 Things to Do in Austin, Texas 1. Completed in 1888, the pink granite Texas State Capitol stands 302 feet high and is 14 feet higher than our nation’s capitol. 2. Relive the pages of Texas history at the Bob Bullock Texas State History Museum. Interactive exhibits, artifacts, an IMAX Theatre and the multi-sensory Texas Spirit Theatre bring the myth, legend and fact of Texas all together under one roof.

6. Visit the Lyndon Baines Johnson Library and Museum to see copious volumes of presidential papers, a scale replica of the Oval Office during his presidency, and a First Lady’s Gallery devoted to the work of Lady Bird Johnson. 7. Swim in the constant 68-degree waters of Barton Springs Pool, an artesian springfed swimming hole in Zilker Park.

3. The University of Texas is home to the Blanton Museum of Art, recognized for its European paintings and modern and contemporary American and Latin American art.

8. Take in all the sights on The University of Texas campus, one of the largest public universities in the nation.

4. Enjoy the spectacle of the Congress Avenue bats, the largest urban bat colony in North America, as 1.5 million Mexican free-tailed bats depart nightly at sunset, April through October, from beneath the bridge.

9. The heart of Austin is found along the Lady Bird Lake Hike and Bike Trail, a 10.1-mile path bordering the lake on its flow through downtown.

5. See the natural beauty of the Texas Hill Country at the Lady Bird Johnson Wildflower Center, where planting areas, wildflower meadows, exhibits and observation tower pay homage to Lady Bird’s devotion to native landscaping and preservation.

10. H  ead to South Congress Avenue to discover eclectic shops, trendy restaurants, unique accommodations and popular music venues.

Visit www.hcca-research-conference.org to learn more. www.hcca-research-conference.org | 888-580-8373 3

Agenda Sunday, June 3: Pre-Conference

Examine the HHS Final Rule on Conflicts of Interest in Research xx

12:00 – 5:30 pm

Explore challenges and approaches to implementing xx

Registration Open 1:00 – 2:30 pm BREAKOUT SESSIONS: Pre-Conference 1

P1 New Rules for IRBs — What the (A)NPRM Could Mean for Your Institution Jeffrey P. Braff, DrPH, CIP, Director, Human Research Protections, Kaiser Permanente

comprehensive conflicts management across the organization

5:00 – 6:30 pm

Welcome Reception

Monday, June 4: Conference 7:00 am – 5:30 pm

Registration Open

This will significantly impact research compliance in your xx organization

7:00 – 8:15 am

This will require a significant “attitude adjustment” on the part xx

Continental Breakfast (provided)

This is a very big deal! xx

8:15 – 8:30 am

of IRBs

P2 Research Billing Compliance Ruth Krueger, MS, RRT, CHC, Director of Corporate Compliance, Sioux Falls Region, Sanford Health; Eve Sakran, Director Clinical Trials Office, Jackson Health System; Diana Salinas, Esq., CHC, Corporate Director and Chief Compliance Officer, Jackson Health System Define risk areas with billing for clinical trial services xx Identify process for integration with research, hospital and xx clinic teams to get it right

Provide audit tools and outcomes from hardwiring research xx billing module in EPIC system

2:30 – 3:00 pm

Networking Break 3:00 – 5:00 pm BREAKOUT SESSIONS: Pre-Conference 2

P3 Clinical Research, the Race (and Perils) to Be First with Discovery Juliann (Juli) Tenney, JD, Institutional Research Compliance and HIPPA Privacy Officer; Director, Institutional Research Compliance Program, The University of North Carolina at Chapel Hill; S. Stanley Young, Ph.D., Assistant Director for Bioinformatics, National Institute of Statistical Sciences A case study (video) of one AMC as depicted by the media (and xx impact)

Scientific analysis for the non-scientist xx Recommendations that can be implemented locally and a xx proposed national solution

P4 Managing Conflicts of Interest in Research in the Face of New Regulatory Requirements Janis Anfossi, JD, MPH, RN, Vice President, Compliance & Privacy, Rush University Medical Center; Tracy E. Miller, Esq., Senior Member, Health Care Group, Cadwalader Wickersham & Taft Learn about the Federal Sunshine Act and its implications for xx research and corporate compliance

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and implementation challenges

www.hcca-research-conference.org | 888-580-8373

Opening Remarks 8:30 – 9:30 am

General Session 1: Research Compliance: A Year in Review Lisa Murtha, Esq., CHC, CHRC, Partner, SNR Denton US LLP

9:30 – 10:00 am

Networking Break 10:00 – 11:30 am BREAKOUT SESSIONS

101 Increased Scrutiny on Pharmaceutical and Medical Device R&D Activities — The Impact on Clinical Research Sites Mary Ann Northrup, MSN, RN, CHRC, CFE, Director, Healthcare Life Sciences Disputes, Compliance and Investigations, Navigant Consulting Recent regulatory requirements for increased transparency xx will affect researchers

Increased government scrutiny on pharmaceutical and xx medical device manufacturers’ R&D activities

Actions research sites can take to mitigate risk xx

102 Fabrication, Falsification and Plagiarism: Complying with Federal Regulations on Research Misconduct Randy Mason, MBA, Vice President, Research Operations, Institutional Official, Research Integrity Officer, Beth Israel Deaconess Medical Center Gain an understanding of the Office of Research Integrity and xx its functions

Learn the key components for handling a misconduct allegation xx Hear actual case examples xx

Agenda 103 Your Medical Staff is Conducting Clinical Research. Are you Prepared and Protected? Special Challenges for Community Hospitals Michael C. Roach, MHSA, JD, CIP, CHRC, Partner, Meade & Roach, LLP Risks faced by community hospitals when unemployed xx medical staff do clinical research

How some hospitals attempt to minimize those risks xx How to get the medical staff to go along xx

11:30 am – 12:30 pm

Networking Lunch (provided) 12:30 – 2:00 pm BREAKOUT SESSIONS

201 Clinical Research Enforcement Initiatives and False Claims Act Update Gary W. Eiland, Partner, King & Spalding LLP Recent changes to the federal False Claims Act, healthcare xx

reform legislation provisions, and related rulemaking initiatives

Selected government enforcement initiatives, investigations, xx and settlements relating to clinical research

Practical strategies for assessing internal compliance and xx minimizing False Claims Act risks

202 A Successful IRB Model for Handling Noncompliance Cases (Emory’s Experience) Sarah B. Putney, JD, IRB Director, Emory University Learn about a successful, streamlined model for IRB handling xx of noncompliance!

Struggling with how to manage noncompliance reviews by xx your IRB? This session is for you.

How your IRB can efficiently, fairly, and confidentially handle xx reports of noncompliance

203 Research Compliance Management Project Review & Centralized Research Registration Kurt Sargent, MBA, CPA, Manager, Sponsored Projects Administration, Allina Health System; Carmi Anderson, Research Compliance Specialist, Sponsored Projects Administration, Allina Health System Conducting a pre-review of research projects for billing xx compliance

Using electronic research management system xx Using a centralized research notification and registration xx process

301 Comprehensive Risk Assessments to Fuel Research Compliance Daniel E. Ellis, CPA, President, 20/20 Healthcare Advisory Services, Ltd. Learn the power of a comprehensive risk assessment when xx optimizing your risk management efforts

This analysis features a wide range of risks: Regulatory xx

agencies, financial requirements, clinical/regulatory risks, etc.

The presentation includes an overall survey of risks plus drill xx downs on key topics

302 Clinical Trial Disclosure and the Risk of Non-Compliance Barbara Godlew, RN, BA, President, The Faire Company, LLC Discuss current and future requirements of FDAAA Section xx 801 and EU

Recognize challenges of regulators, academia, industry in xx clinical trial disclosure Understand impact of noncompliance on the organization xx

303 The Dynamics of Cooperative Groups Providing Coverage Analysis: How to Utilize the Information and Make it Work for You! Kelly Willenburg, MBA, BSN, CHRC, CHC, President, Synergism, LLC; Kati M. Stoermer, MSBA, Associate Director of Administration, SWOG Group Chairs Office, University of Michigan Review rules and understand the complex issues with some xx Cooperative Group studies.

Results from SWOG survey and the needs of members xx participating in research studies

How to make a prepared CA work within your operations and xx how to work it locally

4:00 – 4:15 pm

Networking Break 4:15 – 5:15 pm

General Session 2: Oversight of Clinical Research Julie K. Taitsman, MD, JD, Chief Medical Offier, U.S. Department of Health and Human Services, Office of the Inspector General Data integrity xx Financial integrity xx Human subjects protection xx Conflicts of interest xx

5:15 – 6:30 pm

Networking Reception

2:00 – 2:30 pm

Networking Break 2:30 – 4:00 pm BREAKOUT SESSIONS www.hcca-research-conference.org | 888-580-8373 5

Agenda Tuesday, June 5: Conference 7:30 am – 4:30 pm

Registration Open 7:30 – 8:30 am

12:00 – 1:00 pm

Networking Lunch (provided) 1:00 – 2:30 pm BREAKOUT SESSIONS

8:30 – 10:00 am

501 Successful FDA Inspections: How to Prevent and Respond to Common FDA Observations in a Form 483 or Warning Letter

General Session 3: Research Compliance Challenges and Best Practices

Richelle Little, JD, Regulatory Counsel, Western Institutional Review Board; Kara Morgenstern, JD, MPH, Associate General Counsel, University of Michigan

Continental Breakfast (provided)

Rachel Nosowsky, Principal Counsel, University of California; Angelique Dorsey, JD, CHRC, Research Compliance Director, MedStar Health; Luanna Putney, Ph.D., CHC, CCEP, Director of Research Compliance, University of California; David Vulcano, LCSW, MBA, CIP, RAC, AVP & Responsible Executive, Clinical Research, Clinical Services Group, HCA

10:00 – 10:30 am

Networking Break 10:30 am – 12:00 pm BREAKOUT SESSIONS

401 Privacy Complexities in Research Compliance Marti Arvin, JD, CHC-F, CPC, CCEP-F, CHRC, CHPC, Chief Compliance Officer, UCLA Health System; Mary Thomason, RHIA, CHPS, CISSP, Senior Privacy Compliance Consultant, Intermountain Healthcare Research subjects and privacy: What are the rules? xx Where is your research data or perhaps where isn’t your xx research data

Practical solutions to protect the privacy & security of xx research subjects’ information

402 Fair Market Value Issues in Financial Arrangements with Research Physicians Robert A. Wade, Esq., Partner, Krieg DeVault LLP Fraud and Abuse laws that apply to research compensation xx arrangements

How to construct compliant compensation arrangements with xx research physicians

Recent cases and settlements xx

Identify the top 10 issues that are likely to result in a Warning xx Letter

Discuss strategies for preventing FDA from issuing an FDA xx Form 483 or Warning Letter to you

Know how to respond if you are issued an FDA Form 483 or xx Warning Letter

502 Creating Infrastructure Support for SponsorInvestigators in Academic Health Centers Keren Dunn, CIP, Manager, Research Compliance and Quality Improvement, Cedars-Sinai Medical Center; Karen Hartman, RN, MSN, Operations Manager, Mayo Clinic Presentation of some of the common oversights by sponsorxx investigators

Overview of sponsor-investigator responsibilities under FDA xx regulation

Description of Program to educate sponsor-investigators & xx promote compliance with FDA regulations

503 Effective Financial Research Compliance Management Kathryn Seifert, Consultant, Ernst & Young; Draco Forte, M.Ed., CHRC, Director, SNR Denton US LLP Cover the key elements to financial compliance and managing xx the layers of complexity

Discuss the application of regulatory requirements for a xx successful audit

Discuss opportunities & approaches for ensuring financial xx compliance and assessing current practices

2:30 – 2:45 pm

403 Implications of Transparency Reports and Implementation of the PHS Conflict of Interest Regulations

Networking Break

Luanna Putney, Ph.D., CHC, CCEP, Director of Research Compliance, University of California; David Vulcano, LCSW, MBA, CIP, RAC, AVP & Responsible Executive, Clinical Research, Clinical Services Group, HCA

General Session 4: Behavioral Ethics: Why Good People Do Bad Things

Recall the key provisions and implications of the new xx Transparency (Sunshine) law enacted by the Patient Protection and Affordable Care Act of 2009

Understand the new conflict of interest reporting xx requirements for NIH-funded researchers

Analyze the potential benefits and pitfalls that the above xx laws bring

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www.hcca-research-conference.org | 888-580-8373

2:45 – 4:00 pm

Robert Prentice, Professor of Business Law and Business Ethics in the Business, Government & Society Department, McCombs School of Business, University of Texas Behavioral psychology and ethical behavior xx It’s hard to be the ethical people we want to be xx We are the lying liars who tell lies… to ourselves xx

Agenda Wednesday, June 6: Post-Conference 8:00 – 11:30 am

Exhibitors

Registration Open 8:00 – 8:30 am

Networking Break (coffee service only) 8:30 – 11:30 am Breakout Sessions: Post-Conference (includes 15-minute break)

W1 Developing and Implementing a Research Compliance Audit Plan Jodi S. Ogden, MBA, CRA, Executive Director, Sponsored Projects Administration, UT Health, The University of Texas Health Science Center at Houston; Matthew Lester, MBA, MHA, Managing Director, HuronLife Sciences Establishing baseline based on government areas of focus xx and institutional priorities

Exercise: Identifying and prioritizing research risks xx Case studies for addressing areas of indentified risks and xx control weakness

W2 Recent Developments in Clinical Trial Regulation and Oversight Cynthia Gates, RN, JD, CIP, VP Education and Consulting, Western IRB Hear the latest information about new and proposed changes in xx regulatory oversight

Find out how the changes will affect the conduct of your studies xx Get ideas on processes changes that might help you comply xx with the changes

11:30 am – 12:30 pm

Lunch (on own)

Committed to the Protection of Research Subjects

HCCA would like to thank the 2012 Conference Planning Committee F. Lisa Murtha, Esq., CHC, CHRC, Partner, SNR Denton US LLP Rachel Nosowsky, CHRC, Principal Counsel, University of California David Vulcan0, AVP & Responsible Executive, Clinical Research, Clinical Services Group, HCA

12:30 – 1:00 pm

CHRC® Exam Check-In 1:00 – 3:00 pm

CHRC® Exam (optional)

Exhibit Hall The HCCA Research Compliance Conference and the SCCE Higher Education Compliance Conference have teamed up to provide a combined exhibit hall for your convenience. Discover new products and services provided by companies in the compliance profession. The Internet Café, continental breakfast (Monday and Tuesday only), and networking breaks will be located in the exhibit area throughout the conference. Open hours are listed below.

Exhibit Viewing Hours Sunday, June 3......................... 5:00 – 6:30 pm Monday, June 4................... 7:00 am – 6:30 pm Tuesday, June 5.................. 7:00 am – 2:45 pm

www.hcca-research-conference.org | 888-580-8373 7

Continuing education Credits HCCA is in the process of applying for additional credits. If you do not see information on your specific accreditation, please contact us at 952‑988‑0141 or 888‑580‑8373 as we would like the opportunity to offer it. Visit HCCA’s Research Compliance Conference website, www.hcca-research-conference.org, for up-todate information. ACHE: The Health Care Compliance Association is authorized to award 20 hours of pre-approved Category II (non-ACHE) continuing education credit for this program toward advancement, or recertification in the America College of Healthcare Executives. Participants in this program wishing to have the continuing education hours applied toward Category II credit should indicate on their attendance when submitting application to the American College of Healthcare Executives for advancement or recertification. Compliance Certification Board (CCB): Certified in Healthcare Compliance® (CHC®), Certified Compliance & Ethics Professional® (CCEP®), Certified in Healthcare Research Compliance® (CHRC®), Certified in Healthcare Privacy Compliance (CHPC): For Research Compliance Conference sessions, one clock hour equals 1.2 CCB credit hours. CCB has awarded a maximum of 24.2 CCB Credits for these accreditations in the following subject areas: Application of Management Practices for the Compliance Professional; Application of Personal and Business Ethics in Compliance; Written Compliance Policies and Procedures; Designation of Compliance Officers and Committees; Compliance Training and Education; Communication and Reporting Mechanisms in Compliance; Enforcement of Compliance Standards and Discipline; Auditing and Monitoring for Compliance; Response to Compliance Violations and Corrective Actions; HIPAA Privacy Implementation and/or Complying with Government Regulations.

CLE: The Health Care Compliance Association is a State Bar of California Approved MCLE provider, a Rhode Island Accredited Provider, and a Texas Accredited Sponsor. A maximum of approximately 18.5 clock hours of CLE credit will be available to attendees. The Pennsylvania CLE Board has approved this conference for a maximum of 18.5 CLE Credits. All CLE credits will be awarded based on individual attendance. CPIA: Some portions of this program may meet the requirements for CPIA continuing education. The CPIA Council accepts documentation of continuing education hours when the topics fall within the CPIA Body of Knowledge. If you are unsure about whether a specific session meets these requirements you should consult with PRIM&R. NASBA/CPE: The Health Care Compliance Association is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE sponsors, Sponsor Identification No: 105638. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit and may not accept one-half credits. To verify if your state board of accountancy has adopted one-half credits, please visit our website at www.hcca-info.org/accountancycredits. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite 700, Nashville, TN 37219-2417. Website: www.nasba.org. A recommended maximum of 24.0 credits based on a 50-minute hour will be granted for the entire learning activity. This program addresses topics that are of a current concern in the compliance environment. This is an update, group-live activity. For more information regarding administrative policies such as complaints or refunds, call the HCCA at 888‑580‑8373 or 952‑988‑0141.

CCIP: Some portions of this program may meet the requirements for CIP continuing education. CCIP accepts documentation of continuing education hours when the topics fall within the CIP Body of Knowledge and the education is intended to be beyond initial, basic or fundamental level education. If you are unsure about whether a specific session meets these requirements you should consult with PRIM&R.

Take the CHRC® Certification Exam On-Site When: Wednesday, June 6, 2012 / 1:00–3:00 pm Where: AT&T Conference Center | Austin, TX Cost:

$250 (HCCA Members) / $350 (Non-Members)

You must be pre-registered to sit for the exam. To apply, download the CHRC ® Exam Application from www.hcca-research-conference.org/CEU/ CHRCexamAp_042410.pdf. Questions? E-mail [email protected]. Twenty CCB CEUS are required to sit for the exam. For Research Compliance Conference sessions, one clock hour equals 1.2 CCB/CHRC ® hours. Attending the entire Research Compliance Conference will provide a maximum of 22.2 CEUs to qualify to sit for the exam.

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www.hcca-research-conference.org | 888-580-8373

Nursing Credit: The Health Care Compliance Association is preapproved by the California Board of Registered Nursing: Provider Number CEP 12990, for a maximum of 24.2 contact hour(s). The following states will accept CA Board of Nursing Contact Hours: Alabama, Alaska, Arkansas, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Nebraska, Nevada, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Texas, West Virginia and Wyoming. The following states do not have continuing education requirements: Arizona, Colorado, Connecticut, Georgia, Hawaii, Indiana, Maine, Missouri, Montana, New York, Oklahoma, Pennsylvania, South Dakota, Tennessee, Vermont, Virginia, Washington and Wisconsin. The following states will not accept CA Board of Nursing contact hours: Delaware, Florida, New Jersey and Utah. Massachusetts and Mississippi nurses may submit CA Board of Nursing contact hours to their state board, but approval will depend on review by the board. Please contact the Accreditation Department at [email protected] with any questions you may have. Attendees of the Research Compliance Conference who are seeking credits to fulfill their CCRC Certification through ACRP may request a California RN certificate of participation as well as a copy of the full brochure which in turn may be submitted to ACRP for credits. On the Continuing Education Application, please check the box for RN and clearly indicate that the credits will be used for CCRC Certification. RACC: Attendees seeking CRA credits through the Research Administrators Certification Council (RACC) may request a certificate of attendance from HCCA by completing an Application for Continuing Education and indicating RACC/CRA on the form. A certificate of attendance along with a complete brochure should be submitted to RACC at the end of each individual’s RACC renewal period. The Research Administrators Certification Council (RACC) promotes the concept of voluntary certification by examination for all research and sponsored programs administrators. Certification in research and sponsored programs administration is highly valued and provides formal recognition of basic knowledge in the field. SoCRA: The Society of Clinical Research Associates (SoCRA - www.SoCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers approximately 18 hours* of CE credit. *SoCRA’s requirements for recertification Continuing Education credit are quite general, as they pertain to clinical research regulations, operations and management, and to the therapeutic area of the clinical research in which the candidate participates. We therefore leave it to the candidate to determine whether a course or program would be acceptable for SoCRA’s CE requirement. SoCRA does not “validate” individual training courses/workshops.

Registration

Research Compliance Conference | June 3–6, 2012 | Austin, TX

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www.hcca-research-conference.org | 888-580-8373 9

Registration

Research Compliance Conference | June 3–6, 2012 | Austin, TX

Session Selection

REGISTRATION OPTIONS

Please select to assist in room planning. Select ONE session per time slot.

Early Bird Registration

MON, June 4

TUE, June 5 Breakouts

Post-conference

1:00 – 2:30 pm

10:00 –11:30 am

10:30 am–12:00 pm

8:30 – 11:30 am

Pre-conference 1

Breakouts

P1 P2

101 102 103

Pre-conference 2

401 402 403

12:30 –2:00 pm

3:00 – 5:00 pm

Non-Members................................................................ $749 Membership Renewal & Registration.........................$944 New Membership & Registration................................$849

W1 W2

new members only / dues regularly $295 annually

Pre-Conference Registration 1....................................$100 Pre-Conference Registration 2....................................$100

1:00 –2:30 pm

201 202 203

P3 P4

HCCA/SCCE Members..................................................$649

WED, June 6

Sun, June 3

Post-Conference Registration...................................... FREE

501 502 503

free with full conference registration only

Research Compliance Conference Binder....................$45 available as a pre-sale and for registered conference attendees only Higher Education Compliance Conference Binder..........$45 available as a pre-sale and for registered conference attendees only Exhibit Hall Guest Badge................................................ $50

2:30 –4:00 pm

301 302 303

Contact Information mr.

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Total $



  I’m interested in selecting from SCCE’s Higher Education Compliance Conference. Please send me more information.

By registering for the Research Compliance Conference, you will automatically be registered for SCCE’s Higher Education Compliance Conference at no additional cost.

PAYMENT OPTIONS

dr.

Mail check to: HCCA | 6500 Barrie Road, Suite 250 | Minneapolis, MN 55435 Fax to: 952-988-0146

HCCA Member ID

Invoice me | Purchase Order #

First Name MI Last Name

Check enclosed I authorize HCCA to charge my credit card (choose below) credit card:

American Express

Diners Club

MasterCard

Visa

Credentials (CHC®, CHRC®, CHPC®, etc.)

Title

Credit Card Account Number

Place of Employment

Credit Card Expiration Date

Address

City State

Cardholder’s Name Zip Cardholder’s Signature

Phone

Fax

Email (required for registration confirmation & conference information)

Please fax your completed registration form with payment information to 952-988-0146, or visit www.hcca-research-conference.org to register.

Health Care Compliance Association

6500 Barrie Road, Suite 250, Minneapolis, MN 55435 888-580-8373 (p) / 952-988-0146 (f) www.hcca-info.org / [email protected]

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www.hcca-research-conference.org | 888-580-8373

RC0612

Details Hotel & conference Location AT&T Executive Education Conference Center The University of Texas at Austin 1900 University Avenue, Austin, Texas 78705 A reduced rate of $169.00 for Standard King or Double Queen and $189.00 for Tower View King or Double Queen have been arranged for this program.  These rates are good until Sunday, May 13, 2012. Reservation requests received after this cut-off date or after the group block is filled (whichever comes first) will be accepted at a space and rate availability basis only. Hotel accommodations are not included in your conference registration fee. Identification code for call-in reservations is: SCCHCC0612. Reservations can be made by calling the AT&T Conference Center directly and referring to the SCCE Higher Education or HCCA Research Compliance conference: 877-744-8822 or 512-404-3600. Reservations can also be made directly via the internet at: https://resweb.passkey.com/go/scchcc0612 All Reservations must be guaranteed with a major credit card which will be supplied at time of reservations.  Cancellations will be accepted 24 hours prior to arrival.  Cancellations after this time will result in room rate and applicable taxes being charged to the credit card of file.  The AT&T Conference Center guests rooms offer complimentary high-speed internet access, multi-line phones with data port access, coffee makers, hair dryers, iron and ironing board, oversize safe, and complimentary daily newspaper.  The AT&T Conference Center offers complimentary 1-800 calls from attendee guest rooms.  They also offer 6:00am – 11:00pm room service, restaurants, and complimentary use of the on-site fitness center.

Registration Terms & Conditions: Please make your check payable to HCCA, enclose payment with your registration, and return it to the HCCA office, or fax your credit card payment to 952-988-0146. If your total is miscalculated, HCCA will charge your card the correct amount. All expenses incurred to maintain or improve skills in your profession may be tax deductible, including tuition, travel, lodging, and meals. Please consult your tax advisor (Federal Tax ID # 23-2882664).

Group Discounts: 5 or more: $50 discount for each registrant 10 or more: $100 discount for each registrant Discounts take effect the day a group reaches the discount number of registrants. Please send registration forms together to ensure that the discount is applied. A separate registration form is required for each registrant. Note that discounts will NOT be applied retroactively if more registrants are added at a later date, but new registrants will receive the group discount.

Dress Code: Business casual dress is appropriate. HCCA Is Going Green: Attendees will receive electronic access to the course materials prior to the program as well as an electronic version of the materials at the program. Attendees will not automatically receive the binders. If you would like to purchase the binders for $45, please check “Conference Binders” on the registration form. Attendance Prerequisites: None. Special Needs/Concerns: Prior to your arrival, please call HCCA at 888-580-8373 if you have a special need and require accommodation to participate in the Research Compliance Conference.

Agreements & Acknowledgements: I agree and acknowledge that I am undertaking participation in HCCA events and activities as my own free and intentional act, and I am fully aware that possible physical injury might occur to me as a result of my participation in these events. I give this acknowledgement freely and knowingly and assert that I am, as a result, able to participate in HCCA events, and I do hereby assume responsibility for my own well-being. I agree and acknowledge that HCCA plans to take photographs at the HCCA Research Compliance Conference and reproduce them in HCCA educational, news, or promotional material, whether in print, electronic, or other media, including the HCCA website. By participating in the HCCA Research Compliance Conference, I grant HCCA the right to use my name, photograph, and biography for such purposes.

Cancellations/Substitutions: No refunds will be given for no-shows or cancellations. You may send a substitute or receive a conference credit. If you have questions, please call HCCA at 888580-8373. Additional charges may apply. Cancellation by telephone is NOT valid. Please fax written cancellations to 952-988-0146 or e-mail [email protected].

No audio or video recording of HCCA Conferences is allowed.

hcca-info.org/hccanet

www.hcca-research-conference.org | 888-580-8373 11

6500 Barrie Road, Suite 250 Minneapolis, MN 55435 www.hcca-info.org

Research Compliance Conference June 3–6, 2012 | Austin, TX

AT&T Executive Education Conference Center

Research Compliance Conference June 3–6, 2012 | Austin, TX

Register today and enjoy the flexibility of two conferences for the price of one! Complimentary access to SCCE’s Higher Education Compliance Conference is included with your Research Compliance Conference registration. The parallel schedule gives you the freedom to attend sessions at either conference— two for the price of one.

AT&T Executive Education Conference Center

Register online at www.hcca-research-conference.org