The FDA and CMS in Conjunction with Leading HealthcareStakeholders Tackle Challenges of Drug Pricing &Reimbursement of Specialty Drugs

Niall Brennan,

Acting Director, Office of Enterprise Management, CMS will discuss the

analysis and crucial insights gained from this data, and what next

steps may follow.

Tamara Syrek-Jensen, Acting Director, Coverage & Analysis Group Office

of Clinical Standards and Quality, Centers for Medicare & Medicaid

Services (CMS) in Medicare's Part B and Part D groups will review

priorities for 2015, including the evolution of coverage with evidence

development and potential hot topics for coverage review.

Karen Ignagni, President and CEO, America's Health Insurance Plans

will give a talk on "Pricing and Reimbursement - The Tipping Point in

the Future of Healthcare".

For more information about The FDA/CMS Summit for Payers, please visit:www.FDACMSSummitforPayers.com

About The FDA/CMS Summit for Payers

The FDA/CMS Summit for Payers will focus on how businesses can better

interact with government to remain compliant, adaptive, and successful. At The FDA/CMS

Summit for Payers, the leading players in the healthcare ecosystem will

tackle this hotly contested issue, and begin the critical dialogue

leading to harmonizing individual interests for the benefit of patients.

The FDA/CMS Summit for Payers will be held in conjunction with 10th

Annual FDA/CMS Summit for Biopharmaceutical Executives, December 11-12,

2014 at The Fairmont Hotel, Washington D.C.

Program highlights include:

The high-price and extraordinary demand for Gilead'sSovaldi, a new

hepatitis C drug that sells for $1,000 a pill, or $84,000for a

typical course of treatment, has prompted calls frominsurers and

other health care stakeholders for action on specialtydrug pricing.

The meeting will focus on relevant legislation, regulation, and

accompanying guidelines, and will be composed of policy makers from FDA

and CMS together with payers, providers and pharmaceutical

manufacturers. How to maintain a pipeline

of novel and effective new treatments for patients without feeding

healthcare cost inflation is challenging the industry.

Industry leaders Chris Garabedian, Sarepta; David Beier, Bay City

Capital; John McHutchison, Gilead; and Mark McClellan, Health Care

Innovation and Value Initiative, Brookings Institution, will debate

the contours of an effective public policy response.

Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA

will review the FDA's priorities for 2015.

The Centers for Medicare & Medicaid Services' (CMS) release of

physician-level payment data is bringing unprecedented transparency to

the federal government's largest health care program.

NEW YORK--(BUSINESS WIRE)--The continued rise in healthcare costs in the United States hasplaced

drug pricing under increased payer scrutiny. Each stakeholder will discuss and share theirperspective

on how businesses and government can work together.