• Run For the D.C. Bar Health Law Steering Committee
• Mark Your Calendars
  • End-Of Life Health Care Decision-Making Project
  • Regulation Of Clinical Trials
  • Introduction to Health Law Series
• Part I: Introduction to the U.S. Health Care System
• Part II:Introduction to Medicare
• Part III: Introduction to Medicaid
• Part IV: Compliance Issues
• Part V: Health Care Transactions
• Part VI: Health Care Quality
• Get Involved In Programming
• Community Outreach Call For Volunteers
• Are You A Young Health Law Practitioner?
• Update Your Contact Information
• Email Notices

End-Of-Life Health Care Decision-Making Project
Wednesday, January 9, 2008
12:00 Noon – 2:00 p.m
Bar Conference Center
1250 H Street NW
B-1 Level

Description
Too often, people with serious injuries or illnesses have little or no control over decisions about their medical care because their conditions prevent them from making their wishes known. In these situations, families and close friends are forced to make decisions for a loved one without knowing the person’s preferences. The goal of the D.C. Bar Health Law Section End-of-Life Health Care Decision Making Project is to provide free community workshops on advance directives for senior citizens at senior centers, churches, synagogues, and elsewhere.

Each workshop lasts approximately one (1) hour and involves the presentation of a video (prepared by AARP) on end-of-life health care decision-making issues, a presentation by an attorney on the meaning and content of an advance directive, a presentation by a medical professional regarding the importance of advance health care planning, and the distribution of an advance directive form (approved by the D.C. Hospital Association) . No legal or medical advice is provided.

The intent of the workshops is to spread awareness of the issues and to provide the tools necessary for end-of-life health care decision making. This program will provide training on advance directives and teach attendees’ how to answer questions at the workshops.

This training is free, and lunch will be provided. Attendance is limited – only a few seats remain!

Please call or email Robyn Diaz at (202) 444-3213 to register.

Description
This course will provide an orientation to legal requirements, as well as practical guidance, for lawyers representing clients in the complex and highly regulated field of human clinical trials of investigational drugs and medical devices. Faculty experts will discuss the framework of the current laws and regulations applicable to medical product development. You will learn the steps required to initiate and conduct a clinical trial, to help your clients better navigate the process.

Panelists will provide practical tips and guidance on potential pitfalls and problem areas from the development of the study protocol to informed consent, privacy issues, good clinical practice, quality assurance, clinical trial safety, reporting⁄disclosure obligations and public announcements. The roles, responsibilities, and rights of the various players in clinical trial processes will be clarified.

Our faculty panelists will help you assess potential medical product development options by discussing important differences between the testing of new drugs versus the testing of new medical devices. Faculty also will address the FDA’s highly visible and important role in the review process, significant responsibilities and activities of other federal, state, local, and international entities involved with clinical trial initiation and oversight, rights of clinical trial subjects, and important compliance and enforcement issues.

The class is an ideal introduction to clinical trials for any health law or business attorney. It will be useful for those with clients who are involved directly or indirectly in such trials, in roles such as regulators, sponsor companies, scientific investigators, research facilities, clinical trial participants, insurers, and financial investors.

Program Chair: Stuart Silverman, Office of the Inspector General for the District of Columbia Government
Contact : D.C. Bar CLE Program 202-626-3488
Speakers: Ellen Flannery, Covington & Burling; Catherine Cook, US FDA,;Christina Markus, King & Spalding
CLE Credit: Yes
Cost: Administrative Law and Agency Practice Section $80.00
Health Law Section $80.00
Intellectual Property Law Section $80.00
D.C. Bar Members $90.00
Others $115.00

Part I: Introduction to the U.S. Health Care System (January 24)
This session will provide an overview of the U.S. healthcare system and critical trends that affect U.S. health law, including the growing problem of the uninsured; trends in employer-sponsored health coverage and public sources of health insurance including Medicare and Medicaid; developments in the health care marketplace; health information technology and its implications; public health preparedness; and more. Faculty: H. Guy Collier, McDermott, Will & Emery, LLP; Sara Rosenbaum, Hirsh Professor and Chair, Department of Health Policy, George Washington University Medical Center, School of Public Health and Health Services.

Part II: Introduction to Medicare (January 31)
This session will provide an overview of Medicare. The overview will discuss administration, financing, eligibility, coverage, provider⁄supplier participation, payment methodologies, and more. The session will include basic information on Parts A, B, C and the new Part D (prescription drug program) of the Medicare program, highlighting current issues. Faculty: John F. Lessner, Ober⁄Kaler; Susan A. Turner, Ober⁄Kaler.

Part III: Introduction to Medicaid (February 7)
This session will provide an overview of Medicaid including administration, financing, eligibility, coverage, provider⁄supplier participation, payment methodologies, and current issues. Faculty: Andreas (Andy) G. Schneider, Chief Health Counsel, House Committee on Oversight and Government Reform; Roger A. Schwartz, National Association of Community Health Centers.

Part IV: Compliance Issues and Privacy (February 21)
This session will provide an overview of key health care and fraud and abuse statutes with a specific focus on federal enforcement initiatives. Also, it will deal with confidentiality and privacy compliance issues. Topics to be covered include: HIPAA Administration Simplification and current status of HIPAA rules; electronic data transactions; security; national identifiers; privacy and confidentiality of health information; anti-kickback statute; physician self-referral laws (Stark I and II); the federal False Claims Act; health care enforcement initiatives of the Office of Inspector General and the Department of Justice; Medicaid fraud programs, health care enforcement initiatives and e-Health. Faculty: Jeffrey G. Micklos, senior vice president, Operations and general counsel, Federation of American Hospitals; Barbara H. Ryland, Crowell & Moring, LLP

Part V: Health Care Transactions and Managed Care Contracting (February 28)
This session will provide an overview of the legal issues in health care transactions and a discussion of managed care contracting. It will address key issues in health care transactions and consider uncertainties in transactions due to Stark II regulations. The session also will focus on how key legal issues are addressed in the different managed care relationships with providers, employers and members. Faculty: Cathy Zeman Scheineson, McDermott, Will & Emery; Patricia M. Wagner, Epstein Becker & Green, P.C.

Part VI: Health Care Quality and Patients’ Rights (March 6)
This session will provide an overview of the impact of regulation on health care quality, including professional and institutional licensure. It will consider medical errors, peer review, employer⁄purchaser efforts to improve quality, ERISA preemption and health plan liability, and the right to external and internal appeals. The role of compliance programs in health care quality and use of the False Claims Act for quality-of-care issues will be considered.

Faculty:
Phyllis Borzi, O’Donoghue & O’Donoghue LLP and research professor, GWU School of Public Health and Health Services;
Marie C. Infante, general counsel – Healthcare, Golden Ventures;
Kelly Bagby, Office of the Inspector General, U.S. Department of Health and Human Services

Location:
D.C. Bar Conference Center
1250 H Street, NW (B-1 Level)
(Metro Center)
Washington DC 20005

Contact: D.C. Bar CLE Program 202-626-3488

Speakers:
Andreas Schneider, Committee On Oversight
Roger Schwartz, National Association Community Health
Phyllis Borzi, O’Donoghue & O’Donoghue
Marie Infante, Golden Ventures
Cathy Scheineson, McDermott Will & Emery
Barbara Ryland, CrowellMoring LLP
Susan Turner, Ober Kaler
John Lessner, Ober, Kaler, Grimes & Shriver
Kelly Bagby, Office of Counsel to Inspector General
Patricia M Wagner, Epstein Becker & Green, PC
Jeffrey Micklos, Federation of American Hospitals
Thomas Coons, Ober⁄Kaler
Harry Collier, McDermott Will & Emery

CLE Credit: Yes
Cost:
Health Law Section $240.00
Labor and Employment Law Section $240.00
D.C. Bar Members $250.00
Others $290.00

The committee holds monthly conference calls and other ad hoc meetings as appropriate. Please contact Paul Kim at 410⁄347-7344 or , Patrick Hope at 202⁄261-4541 or Robyn Diaz at 202⁄444-3213 if you are interested in playing an instrumental role in the community outreach activities of the Health Law Section.

An immediate opportunity exists to volunteer with the healthcare decision–making project. Through this project, Health Law section members lead informational workshops about advance healthcare directives for senior citizens at senior centers, churches, synagogues, and elsewhere. Speakers provide copies of the advance directive forms approved for use in the D.C. area, instructions on how to complete the form, and, through use of an interactive video, suggestions about how to raise medical decision–making issues with family members. A number of workshops are scheduled for the end of 2007, and interest on the part of senior centers in hosting these workshops is high. The project needs attorneys who are knowledgeable about advance directives to volunteer to be presenters, and⁄or to answer attendees’ individual questions at the workshops. Please contact one of the community outreach coordinators if you are interested in volunteering.

For information about Health Law Section programs and activities, please visit the Health Law Section web page.

Comments or questions about this newsletter may be addressed to Robyn Diaz.

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