A Fresh FDA, A Changed CMS
President Obama has brought with him a new administration. There also are new federal reform laws that affect the operations of the FDA and the Center for Medicare and Medicaid Services (CMS). There is a review of the new 510(k) process, for example. There also is a newly reorganized CMS that will include an Office of Innovation and a new Office of Consumer Information and Insurance Oversight (OCIIO). These changes have a profound effect on the commercialization of new devices in the U.S. This webinar will discuss some of these new reforms.

Presenters

Lynn Shapiro Snyder, Senior Member, Epstein Becker & Green
Marcia Nusgart, President, Nusgart Consulting
Benjamin Martin, Senior Associate, Epstein Becker & Green

The Comparative Effectiveness Effect
The U.S. Government is moving forward, through the Agency for Healthcare Research and Quality (AHRQ) and Centers for Medicare and Medicaid Services (CMS) to support, conduct, prioritize, disseminate and assess comparative effectiveness research of therapies, including those that involve medical devices. AHRQ and CMS, for example, have recently been assessing the comparative effectiveness of surgery versus different types of radiation therapy, versus "watchful waiting" for patients with prostate cancer. This is a new challenge to the commercialization of products in the U.S. This webinar will discuss what comparative effectiveness is, what agencies and payers are active in this area and how this topic affects the commercialization of medical devices in the U.S. going forward.

Presenters

Lynn Shapiro Snyder, Moderator, Senior Member, Epstein Becker & Green
Marcia Nusgart, President, Nusgart Consulting
Jason Caron, Senior Associate, Epstein Becker & Green
Moderator: Barry Bogage, Executive Director of the Maryland/Israel Development Center

LYNN SHAPIRO SNYDER is a Senior Member of Epstein, Becker & Green in the Health Care and Life Sciences and Litigation Practices in the firm's Washington, DC office, and she is Strategic Counsel with EBG Advisors, Inc. Ms. Snyder has over 30 years of experience advising clients about federal, state and international health law issues, including Medicare, Medicaid, TRICARE, compliance, and managed care issues. Her clients include health care providers, payers, pharmaceutical/device manufacturers and those companies and financial services firms that support the health care industry. She is a frequent speaker and publishes extensively.

In August 2002, Modern Healthcare magazine named Ms. Snyder as one of the "100 Most Powerful People in Healthcare" in its inaugural list. In April 2005, Modern Healthcare magazine named Ms. Snyder as one of the "Top 25 Women in Healthcare." In the May 2006 issue of Nightingale's Healthcare News, Ms. Snyder was named one of the "Outstanding Fraud & Compliance Lawyers for 2006." Beginning in 2006, Ms. Snyder has been listed in the specialty of Health Care Law in The Best Lawyers in America. Ms. Snyder was listed as one of the "Top 50 Women Lawyers in Washington, DC" in 2008 according to Super Lawyers. Also in 2007, Ms. Snyder was presented with the 2007 Women to Watch Award by Jewish Women International. Chambers USA - 2008 named Lynn Snyder as a Leader in the Health Care & Life Sciences field. She has also been quoted in The New York Times and other leading publications.

Marcia Nusgart, R.Ph. is the president of Nusgart Consulting, LLC and the Executive Director of the Coalitions and Alliance that operate under the aegis of Nusgart Consulting, LLC. She is an industry leader in providing comprehensive strategies to medical device and pharmaceutical manufacturers regarding coding, coverage and reimbursement issues under Medicare and Medicaid. Her accomplishments range from advocating successfully, in her coalition capacity, for the Centers for Medicaid and Medicare Services (CMS) to modernize the HCPCS coding process to make it more timely, transparent and understandable for manufacturers; to, in her consulting role, obtaining new HCPCS codes along with appropriate coverage and payment for manufacturers' products.

She is highly regarded in the home care industry through her numerous published articles and is a highly sought after speaker, appearing at various conferences such as the Symposium on Advancement in Wound Care Conferences, MEDTRADE shows, Rehabilitation Engineering and Assistive Technology Society of North America meetings, and the Wound Ostomy Continence Nurses Society annual meetings.

ROBERT E. WANERMAN is Senior Counsel in the Health Care and Life Sciences Practice in Epstein Becker & Green's Washington, DC office. His practice concentrates on reimbursement, regulatory, and compliance matters affecting health care manufacturers, service providers, and investors in health care organizations. He has extensive experience counseling clients in matters arising under the Medicare and Medicaid programs, the False Claims Act, clinical research rules, grant administration rules, the Anti-Kickback and Stark laws, HIPAA, and EMTALA.

JASON B. CARON is an Associate in the Health Care and Life Sciences Practice in Epstein Becker & Green's Washington, DC office and he is an Advisor with EBG Advisors, Inc. Mr. Caron represents a variety of health care and life science entities including hospitals and health systems, pharmaceutical and medical device manufacturers, distributors, pharmacies, home health agencies, hospices, dialysis providers, clinical laboratories, medical transportation providers, ambulatory surgery centers and professional services organizations. Mr. Caron also advises investors and other financial institutions that invest in or support the health care and life science industries.

BENJAMIN S. MARTIN is a Senior Associate in the Health Care and Life Sciences Practice in the Epstein Becker & Green's Washington, DC office, where he practices in the Pharmaceutical Industry Health Regulatory Group. Mr. Martin provides regulatory counseling and litigation support on a wide range of issues affecting pharmaceutical and medical device manufacturers. Before joining EBG, Mr. Martin was an associate in the pharmaceutical and medical device practice group of a large Washington, DC law firm. Prior to that, he was a law clerk for the Honorable Phyllis A. Kravitch, United States Court of Appeals for the Eleventh Circuit.

BARRY BOGAGE is Executive Director of the Maryland/Israel Development Center (MIDC), a non-profit organization that promotes trade and investment between Maryland and Israeli companies and research institutions. The MIDC is a partnership between the Maryland Department of Business and Economic Development, Israel's Ministry of Industry and Trade and The ASSOCIATED: Jewish Community Federation of Baltimore.

Mr. Bogage is an international business development professional with 25 years experience developing and executing strategies to identify, cultivate and close new business opportunities. He has been the executive director of the MIDC since its inception in 1992. His responsibilities include targeted trade development to assist Maryland and Israeli companies expand through international trade and technology joint ventures. Prior to joining the MIDC, Mr. Bogage was the Director of Business Development for Welsh Development International, the North American arm of the Welsh Development Agency of Great Britain. In this capacity, Mr. Bogage marketed the Principality of Wales as a European location for American manufacturers.

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