Structuring a Compensation Framework for Clinical Research

Mitigating Fraud and Abuse Risks for Healthcare Providers, Navigating FMV in Clinical Research Budgeting, Lessons From Recent Enforcement

A live 90-minute CLE webinar with interactive Q&A


Wednesday, May 24, 2017
1:00pm-2:30pm EDT, 10:00am-11:30am PDT

Early Registration Discount Deadline, Friday, April 28, 2017


This CLE webinar will review the status of, and recent developments in, the laws implicated by clinical research relationships, and provide guidance to healthcare counsel to create a framework for smart research funding and compensation planning.

Description

Funding and budgeting for clinical research may implicate a number of state and Federal laws. Given recent changes to the enforcement environment, counsel involved with clinical research operations should have an understanding of and framework for evaluating the implications of financing and compensation decisions for research. Various providers and research sponsors, including hospitals, academic medical centers, physicians and pharmaceutical and medical device companies, have had to pay a steep price to resolve issues and allegations related to improper payments in the context of clinical research.

Listen as our authoritative panel of healthcare attorneys examines the healthcare providers’ role in clinical research and recent trends in compensation and enforcement. The panel will discuss what puts providers at risk and will offer guidance on creating a framework for compensation that complies with federal laws.

Outline

  1. Physicians and clinical research activity
  2. Areas of risk
    1. Stark Law
    2. AKS
    3. Inducements
  3. Best practices for creating a framework for compensation
    1. Factors to consider
      1. Sponsor needs and goals
      2. Investigator needs and goals
      3. Regulatory enforcement environment
    2. Role of fair market value in clinical research budgeting

Benefits

Discussion topics will include specific legal risks and strategies for mitigating those risks, including:

  • How the flow of clinical research dollars from sponsors to providers may or may not implicate Federal and state laws, such as anti-kickback laws, self-referral laws, tax exemption requirements for not-for-profit entities, and the Foreign Corrupt Practices Act for parties engaged in international research activities.
  • Lessons learned from recent enforcement actions, including the importance of (and factors that determine) reasonable, fair market value research compensation.
  • Real world examples, tips and strategies for creating a long term and sustainable regulatory compliance and risk mitigation framework for clients involved in clinical research.

Faculty

Andrea M. Ferrari, JD, MPH, Director
HealthCare Appraisers, Delray Beach, Fla.

Ms. Ferrari focuses on physician payments related to hospital physician alignment and efficiency improvement strategies, valuation of services provided by physician hospital organizations, payments for services provided in connection with clinical research/clinical trial agreements, payments for physician supervision of midlevel practitioners, and health practitioner recruitment and support arrangements. She has provided counsel and representation to various types of clients in the healthcare industry, including hospitals, physicians and physician groups, and pharmaceutical and medical device vendors, distributors and manufacturers.

Additional faculty to be announced.


Live Webinar

Live Webinar $247.00

Includes Early Discount Savings of $50.00 (through 04/28/17)

Add a colleague on the same connection in the same room for only $97.00 in the shopping cart or by calling customer service.

This webinar is eligible for at least 1.5 general CLE credits.

CLE credits are not available for PR.

*In KS, OH, PA, for more than 1 attendee on the connection you must contact Strafford CLE via email or call 1-800-926-7926 ext. 35 prior to the program for special instructions.


Recordings

CLE On-Demand - Streaming Video

Includes recorded streaming video of full program plus PDF handouts.

On-demand is the only recorded format recognized for CLE credits in DE, IN, KS, LA, MS, NC, OH, OK, SC, TN, VA, WI.

AK, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN*, KS, KY, LA, ME, MN, MO, MT, NC, ND, NH**, NJ, NM, NV, NY, OH*, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY (Note: Some states restrict CLE eligibility based on the age of a program. Refer to our state CLE Map for additional information.)

*Only available for attorneys admitted for more than two years. For OH CLE credits, only programs recorded within the current calendar year are eligible - contact the CLE department for verification.

**NH attendees must self-determine if a program is eligible for credit and self-report their attendance.

CLE On-Demand Video $247.00
Available 48 hours after the live event

Includes Early Discount Savings of $50.00 (through 04/28/17)

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Recorded Event

Includes full event recording plus handouts (available after live webinar).

Strafford is an approved provider and self-study CLE credit is available in most states.

AK, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KY, ME, MN, MO, MT, ND, NJ, NM, NY, OR, PA, TN, TX, UT, VT, WA, WV, WY (Note: Some states restrict CLE eligibility based on the age of a program. Refer to our state CLE Map for additional information.)

Strafford will process CLE credit for one person on each recording.

Additional copies of a recording can be purchased at a discount. Please call Strafford Customer Service toll-free at 1-800-926-7926 ext 10 or email customerservice@straffordpub.com to place your order.

Recorded Webinar Download $247.00
Available 48 hours after the live event

Includes Early Discount Savings of $50.00 (through 04/28/17)

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Recorded Audio Download (MP3) $247.00
Available 24 hours after the live event

Includes Early Discount Savings of $50.00 (through 04/28/17)

How does this work?

DVD (Slide Presentation with Audio) $247.00 plus $9.45 S&H
Available ten business days after the live event

Includes Early Discount Savings of $50.00 (through 04/28/17)

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Registration Plus Recorded Event

Best value!

Live Webinar & Webinar Download $344.00

Includes Special Savings of $250.00 (through 04/28/17)

Live Webinar & Audio Download $344.00

Includes Special Savings of $250.00 (through 04/28/17)

Live Webinar & DVD $344.00 plus $9.45 S&H

Includes Special Savings of $250.00 (through 04/28/17)


Webinar

Strafford webinars offer several options for participation: online viewing of speaker-controlled PowerPoint presentations with audio via computer speakers or via phone; or audio only via telephone (download speaker handouts prior to the program).  Please note that our webinars do not feature videos of the presenters.

Early Registration
Discount Deadline
April 28, 2017
(4 days)

or call 1-800-926-7926

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CLE Credits By State

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Customer Reviews

The webinar was clearly presented and organized. It was a good mixture of the law and practice.

David N. Crapo

Gibbons

The speakers were well prepared and were able to explain the information in a clear and concise manner.

Ayala Schwartz

Columbia University Clinical Trials Office

Very concise - provided what was needed, yet also included many examples, thoughts and ideas.

Ron Keith

Skilled Care

The speakers included a significant number of best practices, which are critical to application of the law.

Deirdre J. Kamber

Fitzpatrick Lentz & Bubba

I liked the topic and the tools provided in the handouts.

Mildred Johnson

Texas Tech University Health Sciences Center

or call 1-800-926-7926

Health Law Advisory Board

Lowell C. Brown

Partner

Arent Fox

Jennifer L. Evans

Shareholder

Polsinelli

Ryan S. Johnson

Shareholder

Fredrikson & Byron

Gina M. Kastel

Partner

Faegre Baker Daniels

Karen S. Lovitch

Member

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo

David A. Manko

Partner

Rivkin Radler

John J. Miles

Principal

Ober Kaler

C. Elizabeth O'Keeffe

Counsel

Wyatt, Tarrant & Combs

J. Peter Rich

Partner

McDermott Will & Emery

Donald H. Romano

Of Counsel

Foley & Lardner

Judith A. Waltz

Partner

Foley & Lardner

John R. Washlick

Shareholder

Buchanan Ingersoll & Rooney

Jesse A. Witten

Partner

Drinker Biddle & Reath

or call 1-800-926-7926

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