In-House Survey Results
In February 2012, the ABA Health Law Section Litigation and Risk Management Interest Group developed a survey to send to all Health Law Section In-House Counsel members. The In-House Counsel Sub-Interest Group, which is currently affiliated with the Healthcare Facility Operations Interest Group, collaborated on the content of that survey.
Over 50 in-house counsel, from a variety of healthcare sectors, responded to questions regarding key risk mitigation and litigation issues facing in-house counsel in today’s challenging environment. In addition, several participants provided candid feedback for outside counsel. The results are provided here, for your information.
|This edition of eSource is brought to you by the Healthcare Litigation & Risk Management Interest Group. |
OIG Advisory Opinion 12-06: Insightful Guidance from the OIG For Structuring Company Model Arrangements
By Carey Kalmowitz, Abby Pendleton and Kathryn Hickner-Cruz, The Health Law Partners, PC, Southfield, MI
On June 1, 2012, the Department of Health and Human Services Office of Inspector General (“OIG”) issued its Advisory Opinion No. 12-06, which provides long-awaited guidance to the healthcare industry regarding the legal permissibility of an anesthesia delivery service model commonly referred to as the “company model.” Insofar as Advisory Opinion No. 12-06 is the initial OIG guidance that specifically focuses on such an arrangement and determines that the factual paradigms presented implicate risks under the federal anti-kickback statute (the “AKS”) (Section 1128B(b) of the Social Security Act), this Advisory Opinion understandably is capturing broad attention within the medical and legal communities.
Roadblock to Payment & Delivery Reform:
the Program Integrity Laws
By Cybil G. Roehrenbeck, American Medical Association, Washington, DC
A clarion call resounds from Washington, DC and beyond: stakeholders must find innovative ways to improve the quality and reduce the cost of healthcare. Physicians and other providers are answering this call by leading new efforts to promote care coordination, incentivize value, and define positive outcomes. However, stakeholders that seek to lead and participate in this transformation of care delivery may encounter legal barriers that inhibit their work. In particular, federal and state laws governing program integrity are a barrier to fundamental delivery reform that must be addressed.
New FDA Rule Clarifies, Broadens Power to Disqualify Clinical Investigators
By Steven W. Postal, MedStar Health Research Institute at MedStar Washington Hospital Center, Washington, DC
On April 30, 2012, the Food and Drug Administration (“FDA”) published a Final Rule (the “Rule”) clarifying and broadening its power to disqualify, via a Commissioner’s decision, clinical investigators (“Investigators”) who submit false information pertaining to clinical studies or that otherwise fail to abide by FDA regulations. The Rule went into effect on May 30, 2012. Although hard to quantify, clinical research impropriety and fraud has gained more press recently; this Rule closely follows the widely publicized case of alleged research misconduct and alleged fraud of Dr. Anil Potti, Investigator at Duke University.
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Healthcare Litigation & Risk Management Interest Group
The Healthcare Litigation and Risk Management Interest Group examines areas in healthcare related litigation and the continuum of liability control..
The IG is led by Chair John H. "Jay" McEniry IV, MediStat, Foley, AL and Vice Chairs Rebecca Avitia, Bannerman & Johnson, P.A., Albuquerque, NM; Lisa Estrada, Arent Fox LLP, Washington, DC; Gary Keilty, Huron Consulting Group, Washington, DC and Michael K. Loucks, Skadden, Arps, Slate, Meagher & Flom LLP, Boston, MA.
If you would like to join the Interest Group, continue by clicking the following link: Health Law Section IG Sign-up Form.
ABA eSource Editorial Board
The ABA Health eSource Editorial Board is led by Editor, Marla Durben Hirsch, Potomac, MD; Chair Adrienne Dresevic, The Health Law Partners, PC, Southfield, MI and editorial board members Claire Castles, Jones Day, Los Angeles, CA; Michael E. Clark, Duane Morris LLP, Houston, TX; Conrad Meyer, Chaffe McCall, LLP, New Orleans, LA; Robert T. Rhoad, Crowell & Moring LLP, Washington, DC and Jennifer Tsao, Hernandez Schaedel & Associates LLP, Pasadena, CA.
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|The opinions expressed are those of the authors and shall not be construed to represent the policies or positions of the ABA or the ABA Health Law Section.|
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