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Will State Action on Biosimilars Thwart Anticipated Savings for Health Care Programs?

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DESCRIPTION

Government and private health-care program payers have been anxiously awaiting the Federal Drug Administration’s (FDA) action on biosimilars. Payers anticipate that the ability to substitute and dispense a biosimilar product in lieu of a more expensive prescribed biologic or specialty drug may save payment programs millions, if not billions, of dollars.

On March 6, 2015, the FDA approved the first biosimilar under the abbreviated approval pathway created by the Affordable Care Act’s amendments to the Public Health Service Act. Despite the lack of FDA guidance on interchangeability, federal and state government entities are attempting to get ahead of the biosimilar curve by establishing biosimilar reimbursement and substitution policies. On March 30, 2015, the Centers for Medicare and Medicaid services (CMS) released guidance addressing Medicare and Medicaid coverage and reimbursement of FDA-approved biosimilar drug products. At the same time, multiple states have enacted, or are considering, legislation that would impose procedural hurdles to the substitution of biosimilars for prescribed reference drug products.

Join Bloomberg BNA and our expert panel of speakers--Theresa C. Carnegie, Joanne S. Hawana and Ellyn L. Sternfield from Mintz, Levin, Cohn, Ferris, Glovsky and Popeo PC, in Washington—as they discuss the state action on biosimilars, potential cost savings for Health Care Programs, the role of the FDA, and the CMS guidance addressing Medicare and Medicaid coverage and reimbursement of FDA-approved biosimilar drug products.

Educational Objectives:
• Discuss the state action on biosimilars
• Explore potential cost savings for health care programs
• Address the role of the Federal Drug Administration’s approval of biosimilar drug products
• Review the Centers for Medicare and Medicaid services guidance addressing Medicare and Medicaid coverage and reimbursement of FDA-approved biosimilar drug products

Who would benefit most from attending this program?
Legal counsel, health care practitioners interested in the legal aspects of the Federal Drug Administration, Affordable Care Act, and the Centers for Medicare and Medicaid services.

SPEAKERS

THERESA C. CARNEGIE, MEMBER OF MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO PC

Theresa C. Carnegie is a member of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo PC, in Washington, DC. Theresa counsels health care clients on a variety of transactional, regulatory, and fraud and abuse matters. Theresa focuses much of her practice on counseling health plans, pharmacy benefit managers, pharmacies, device manufacturers, and distributors on regulatory and compliance matters. Her practice extends to counseling on drug pricing and reimbursement issues, Medicare Advantage and Medicare Part D compliance, and the regulatory requirements under the Affordable Care Act and state health insurance exchanges. She also specializes in representing clients in connection with mergers and acquisitions, joint ventures, strategic affiliations, complex service agreements, provider contracts, network development programs, and general contracting. Theresa advises clients on the structuring and legal, practical, and fraud and abuse implications of these business arrangements and transactions. Theresa also has deep experience assisting private equity firms in connection with their investment in the health care industry and the day-to-day regulatory compliance of their portfolio companies. She is admitted to practice in the District of Columbia and Massachusetts.


JOANNE S. HAWANA, COUNSEL, MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO PC

Joanne S. Hawana is of counsel Mintz, Levin, Cohn, Ferris, Glovsky and Popeo PC, in Washington, DC. Joanne advises clients around the world in the food, drug, and biotechnology industries on issues ranging from prescription drug advertising to state licensing requirements for wholesale distribution. In particular, Joanne counsels clients on the business impact of new US federal and state actions that affect regulated products, such as drugs, foods, and medical devices. Joanne is experienced in US federal drug regulations, including pre-market and post-market requirements, and restrictions on advertising and sampling. Joanne also has counseled clients on state regulation of prescription drug distribution and licensing requirements. She is well versed in advising clients on the regulatory considerations for marketing controlled substances, and track-and-trace systems for prescription drugs. Joanne also has counseled both pharmacies and practitioners on drug compounding regulatory matters. In addition, she has worked with manufacturers and retailers to determine the regulatory status of certain medical devices, laboratory tests, and mobile medical applications. Joanne advises clients on the food safety and labeling requirements for human and animal food. She also provides ongoing counseling on the impact of sweeping changes to the Food Drug Administration’s Food Safety Modernization Act, including upcoming foreign supplier verification requirements, and preventive controls for registered food facilities. She is admitted to practice in the District of Columbia and Maryland.


ELLYN L. STERNFIELD, COUNSEL, MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO PC

Ellyn L. Sternfield is of counsel Mintz, Levin, Cohn, Ferris, Glovsky and Popeo PC, in Washington, DC. Ellyn has more than 30 years of legal experience, with an extensive background in the field of government health care enforcement. Ellyn’s experience enables her to provide valuable insight to clients facing potential state or federal investigations, or who have general compliance concerns. Ellyn currently represents a variety of health care product and service providers in federal and state administrative, civil, and criminal matters around the country. She conducts internal reviews and investigations for clients concerned about potential compliance issues, including compliance investigations having to do with data security and privacy safeguards. Ellyn advises clients on proposed or existing health care business arrangements, especially those involving Medicaid, Medicare, and the 340B Drug Pricing Program. Ellyn drafts compliance plans to help insulate clients from future whistleblower claims or enforcement efforts. Ellyn helps negotiate resolutions of matters brought under federal or state false claims acts. She is admitted to practice in the District of Columbia, Missouri, Oregon, and Utah.