UF takes seriously the obligation to protect Restricted Data. Failure to protect Restricted Data impacts UF's reputation, liability and finances. This introductory course explains the do's and don'ts of using Restricted Data on computers and what to do in the event of a Restricted Data exposure. Attendees will learn when to use encryption and proper methods for disposal of Restricted Data.  Specific safeguards for portable media, email, personally managed computers and other uses of Restricted Data are taught. Important contacts and other resources are presented.

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Research Administration and Compliance

RAC800 Research Billing Crash Course

Friday, May 4, 10 a.m. to 12 noon, HPNP Building, Room G110
Wednesday, May 9, 10 a.m. to 12 noon, HPNP Building, Room G110
Friday, June 1, 10 a.m. to 12 noon, HPNP Building, Room G110
Thursday, June 7, 10 a.m. to 12 noon, HPNP Building, Room G110
Friday, July 13, 10 a.m. to 12 noon, HPNP Building, Room G110
Thursday, July 19, 10 a.m. to 12 noon, HPNP Building, Room G110
Wednesday, August 1, 10 a.m. to 12 noon, HPNP Building, Room G110
Tuesday, August 7, 10 a.m. to 12 noon, HPNP Building, Room G110
Instructor: Edythe Zettler

This course will provide an introduction to the essential aspects of Clinical Research Billing Compliance and what everyone needs to know. We will explore the national research climate, Medicare’s clinical trial policy, the role of the Research Administration and Compliance Office (RAC), UF Policy & Standards and available resources that will guide you through the RAC process. If you work as an investigator, administrator, coordinator, coding or billing specialist, or have a role that involves any clinical research activity, this course applies to you. In addition, this course is a prerequisite for all other RAC course offerings.

Learning Objectives to As a result of participation in this activity, participants should be able to:

• Identify two main areas of UF HSC research billing risk.
• Explain why clinical research billing compliance should be a priority.
• Understand the responsibilities of Study Teams regarding research billing compliance.

CEU Contact Hours: 2
CME Credit: The University of Florida College of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. 
CME Accreditation: The University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CME Disclosure: In accordance with University of Florida and ACCME requirements, no one in a position to control content has any financial relationship(s) to disclose.

RAC801 To Bill or Not to Bill

Monday, May 7, 10 a.m. to 12 noon, HPNP Building, Room G110
Thursday, May 10, 10 a.m. to 12 noon, HPNP Building, Room G110
Monday, June 4, 10 a.m. to 12 noon, HPNP Building, Room G110
Tuesday, June 12, 10 a.m. to 12 noon, HPNP Building, Room G110
Monday, July 16, 10 a.m. to 12 noon, HPNP Building, Room G110
Friday, July 20, 10 a.m. to 12 noon, HPNP Building, Room G110
Friday, August 3, 10 a.m. to 12 noon, HPNP Building, Room G110
Wednesday, August 8, 10 a.m. to 12 noon, HPNP Building, Room G110
Instructor: Edythe Zettler

Does your study qualify for Medicare/third party payer reimbursement? Not sure? This course will help you understand the reimbursement policy for clinical research studies and Category A & B devices. What items/services can be billed to Medicare/third party payer and how to appropriately code these claims will also be discussed. Course attendees will practice using the Medicare Coverage Analysis Worksheet to determine if a clinical research study qualifies for coverage. If you work as an investigator, administrator, coordinator, coding or billing specialist, or have a role that involves ordering any protocol-required clinical services that are intended to be billed to patients/third party payers, this course is for you! Please note that completion of the “Research Billing Crash Course” (RAC800) is required prior to attending this workshop.

Learning Objectives to As a result of participation in this activity, participants should be able to:

• Understand what items and services are covered under Medicare Clinical Research and Device Policy.
• Review several study examples and perform a Medicare Coverage Analysis for each.
• Assign correct Medicare codes to covered research items/services.

CEU Contact Hours: 2
CME Credit: The University of Florida College of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 Credits™.  Physicians should only claim credit commensurate with the extent of their participation in the activity. 
CME Accreditation: The University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CME Disclosure: In accordance with University of Florida and ACCME requirements, no one in a position to control content has any financial relationship(s) to disclose.

RAC802 Service Provider Communication

Tuesday, May 8, 10 a.m. to 12 noon, HPNP Building, Room G110
Friday, May 11, 10 a.m. to 12 noon, HPNP Building, Room G110
Tuesday, June 5, 10 a.m. to 12 noon, HPNP Building, Room G110
Wednesday, June 13, 10 a.m. to 12 noon, HPNP Building, Room G110
Tuesday, July 17, 3 to 5 p.m., HPNP Building, Room G108
Monday, July 23, 10 a.m. to 12 noon, HPNP Building, Room G110
Monday, August 6, 10 a.m. to 12 noon, HPNP Building, Room G110
Friday, August 10, 10 a.m. to 12 noon, HPNP Building, Room G110
Instructor: Edythe Zettler

This course will provide rationale for effectively communicating clinical research information with Shands/UF service providers, billing personnel and the Research Administration and Compliance Office (RAC). Course attendees will participate in the completion of select sections of the Study Registration Form. If you work as an investigator, administrator, coordinator, coding or billing specialist, or have a role that requires any technical/professional clinical services, this course is for you! Please note that completion of the “Research Billing Crash Course” (RAC800) and “To Bill or Not to Bill” (RAC801) are required prior to attending this workshop.

Learning Objectives to As a result of participation in this activity, participants should be able to:

• Describe the “R99” & Confirmation of Services process.
• Identify who the Service Providers are at Shands UF Health Science Center, along with appropriate billing entities.
• Discuss the different tools that are used to communicate to Service Providers in order to avoid billing errors.

CEU Contact hours: 2
CME Credit: The University of Florida College of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. 
CME Accreditation: The University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CME Disclosure: In accordance with University of Florida and ACCME requirements, no one in a position to control content has any financial relationship(s) to disclose.

RAC803 Building a Detailed Budget

Monday, May 14, 10 a.m. to 12 noon, HPNP Building, Room G110
Friday, June 15, 10 a.m. to 12 noon, HPNP Building, Room G110
Tuesday, July 24, 10 a.m. to 12 noon, HPNP Building, Room G110
Monday, August 13, 10 a.m. to 12 noon, HPNP Building, Room G110
Instructor: Sharon Hiemenz

This course will provide rationale for preparing a detailed budget and outline costs to consider for each budget category. The budget’s impact on other key documents will also be discussed. Course attendees will participate in the preparation of a Detailed Budget. If you work as an investigator, administrator, coordinator, coding or billing specialist, or have a role that involves a study that requires any budget building or sponsor negotiations, this course is for you! Please note that completion of the “Research Billing Crash Course” (RAC800) and “To Bill or Not to Bill” (RAC801) are required prior to attending this workshop.

RAC804 Navigating the RAC Web Site

Wednesday, May 16, 10 a.m. to 12 noon, Health Science Center, C3-013
Monday, June 18, 10 a.m. to 12 noon, Health Science Center, C3-013
Wednesday, July 25, 10 a.m. to 12 noon, Health Science Center, C3-013
Tuesday, August 14, 10 a.m. to 12 noon, Health Science Center, C3-013
Instructor: Edythe Zettler

The Clinical Trials Compliance (CTC) Website contains resources, tools, required forms and procedures necessary to conduct compliant clinical research. This course will provide an overview of the website’s content with lots of helpful time-saving tips! Course attendees will participate in interactive seek-and-find activities. If you work as an investigator, administrator, coordinator, coding or billing specialist, or have a role that involves any clinical research activity, you may benefit by becoming proficient with navigating the website. Please note that completion of the “Research Billing Crash Course” (RAC800) is required prior to attending this workshop.

RAC805 Tracking Research Services

Friday, May 18, 10 a.m. to 12 noon, HPNP Building, Room G110
Wednesday, June 20, 10 a.m. to 12 noon, HPNP Building, Room G110
Friday, July 27, 10 a.m. to 12 noon, HPNP Building, Room G110
Wednesday, August 15, 10 a.m. to 12 noon, HPNP Building, Room G110
Instructor: Edythe Zettler

This course will provide rationale for tracking sponsor-funded clinical services and identify data that needs to be tracked. Factors to consider before developing a tracking system as well as a variety of tracking options will also be discussed. Course attendees will participate in the completion of a Participant Service Tracking Log.  If you work as an investigator, administrator, coordinator, coding or billing specialist, or have a role that involves ordering and/or processing payment for sponsor-funded clinical services, this course is for you! Please note that completion of the “Research Billing Crash Course” (RAC800) and “To Bill or Not to Bill” (RAC801) are required prior to attending this workshop.

Learning Objectives - As a result of participation in this activity, participants should be able to:

• Explain the compliance rationale for tracking sponsor-funded services.
• Explain how tracking can save time & money, while reducing billing errors.
• Complete a tracking template.

CEU Contact hours: 2
CME Credit: The University of Florida College of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 Credits™.  Physicians should only claim credit commensurate with the extent of their participation in the activity. 
CME Accreditation: The University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CME Disclosure: In accordance with University of Florida and ACCME requirements, no one in a position to control content has any financial relationship(s) to disclose.

RAC806 Study Registration/Initiation

Tuesday, May 29, 10 a.m. to 12 noon, Health Science Center, C3-013
Monday, June 25, 10 a.m. to 12 noon, Health Science Center, C3-013
Monday, July 30, 10 a.m. to 12 noon, Health Science Center, C3-013
Friday, August 17, 10 a.m. to 12 noon, Health Science Center, C3-013
Instructor: Edythe Zettler

This course will provide rationale for submitting a Study Registration & Initiation Packet to the Research Administration and Compliance Office (RAC). Course attendees will participate in the completion of the Study Registration & Initiation Checklist and associated forms using information from a mock study. As a result of participation in this activity, participants should be able to:

• Explain the purpose of the RAC Study Registration & Initiation Packet
• Find the various forms used in the RAC packets via the RAC website
• Complete a Study Registration & Initiation Packet
  

RAC807 Billing for Device Studies

Wednesday, May 30, 10 a.m. to 12 noon, HPNP Building, Room G110
Tuesday, June 26, 10 a.m. to 12 noon, HPNP Building, Room G110
Tuesday, July 31, 10 a.m. to 12 noon, HPNP Building, Room G110
Monday, August 20, 10 a.m. to 12 noon, HPNP Building, Room G110
Instructor: Edythe Zettler

Does your device study require local Medicare pre-approval before enrolling patients? If you are not sure, your device study could have increased billing compliance risks with financial repercussions. This course will help you understand what types of device studies require Medicare pre-approval and the reimbursement policy for Category A & B devices approved by FDA under the Investigational Devices Exemption (IDE) rules. We will also discuss what items/services can be billed to Medicare/third party payers on pre-approved studies and how to appropriately code these claims. In addition, the Shands Hospital requirements for procuring and/or storing research devices will be covered. If you work as an investigator, administrator, coordinator, or coding or billing specialist for device studies, or have a role that involves ordering any protocol-required clinical services for device studies, this course is for you! 

As a result of participation in this activity, participants should be able to:

• Understand what types of device studies require Medicare pre-approval.
• Describe the process to follow to obtain Medicare pre-approval.
• Discuss the Shands requirements for research device procurement and storage. 
• Understand when to use the Device Listserv.
• Assign correct Medicare codes to covered items/services on pre-approved device studies.

RAC810 HSC Research Billing Risks
Course available through e-learning

This training module presents very basic information about Federal, State, and University of Florida rules and regulations that affect Health Science Center Research Billing policy and procedures. This training is required on a biannual basis for all faculty and staff in the University of Florida Health Science Center who conduct research involving human subjects and services.

CME Accreditation: The University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Credit: Online Session - The University of Florida College of Medicine designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CME credit availability begins 03/16/11. The term of approval is for two years from this date.
Credits are provided to physicians who complete the online module and successfully pass the associated quiz with at least an 80% score.  A quiz will be available at the conclusion of the program.

Limited Live Sessions - The University of Florida College of Medicine designates this live activity material for a maximum of 1.5 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure: In accordance with University of Florida and ACCME requirements, no one in a position to control content has any financial relationship(s) to disclose.

Learning Objectives: As a result of participation in this activity, participants should be able to:

• Identify two main areas of fiscal/billing risk for HSC clinical research studies.
• Explain the importance of reconciling Informed Consents with Contractual fiscal terms.
• Describe the processes that have been put into place to reduce risk at UF.

Target Audience: Primary care physicians, specialty physicians, pharmacists, physician assistants, nurses, billing personnel and study coordinators.

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UF Privacy Office

PRV800 HIPAA and Privacy General Awareness
Course available through e-learning

This training module is required for all members of the workforce* in UF’s medical components and their affiliated entities, whether they have access to health information or not. It presents very basic information about federal (HIPAA) and state information privacy and security regulations.

*The workforce includes faculty, resident/fellows, staff, students, volunteers, and third parties under the direct control of UF, both temporary and permanent, whether paid or not.

NOTE: If you are involved in human subject research, you should complete HIPAA & Privacy to Research (PRV801) in place of this module.

• If you complete this general module, you will also have to complete HIPAA & Privacy to Research.
• If you have recently completed HIPAA & Privacy to Research, do not register for this general module.

PRV801 HIPAA and Privacy – Research
Course available through e-learning

This training module presents very basic information about federal (HIPAA) and state information privacy and security regulations, and the impact of these regulations on human subject research at the University of Florida. It is required for all members of the workforce* in UF’s medical components and their affiliated entities who are involved in human subject research.

*The workforce includes faculty, resident/fellows, staff, students, volunteers, and third parties under the direct control of UF, both temporary and permanent, whether paid or not.

To conduct human subject research at UF or to use the Institutional Review Board (IRB) as a Privacy Board for research review, all principal investigators, co-principals, sub-investigators, research coordinators, and staff with access to research-related health information must complete this training module before research documents are submitted.

PRV803 FERPA for Faculty
Course available through e-learning

Designed specifically for UF faculty, this course will provide a very brief and basic overview of FERPA and other student privacy rules. Throughout this course, the following topics will be covered:

• Key privacy issues related to student records
• Core elements of state and federal education privacy laws
• Commonly used terms related to education records and privacy
• When to ask an expert for advice or help with a student record issue or question

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