Alan M. Kirschenbaum
For more than 20 years, Alan M. Kirschenbaum has advised pharmaceutical and medical device companies on the marketing and promotion of their products. He specializes in the intersection of laws that govern these activities, including health care fraud and abuse laws, FDA restrictions on promotion, government pricing and price reporting requirements, and state drug and device marketing laws.
In the area of promotion and marketing, Mr. Kirschenbaum helps clients design marketing programs within the bounds of the health care fraud and abuse laws, FDA restrictions on promotion, and state marketing prohibitions. He helps clients build their in-house compliance capabilities by developing policies and procedures, providing training, and conducting internal audits. He assists with drafting and reviewing agreements among partners throughout the distribution and payment chains, including manufacturers, distributors, providers, pharmacy benefit managers, health plans, and other entities. He also advises clients on transparency reporting at the state and federal level.
Mr. Kirschenbaum's work in government pricing includes advising companies on requirements for price reporting to the federal and state governments, meeting requirements for government discount and rebate programs, and contracting with the federal government. As part of this work, Mr. Kirschenbaum negotiates with the Centers for Medicare & Medicaid Services, the Department of Veterans Affairs, and other federal and state government agencies on behalf of clients.
Mr. Kirschenbaum frequently writes articles and gives lectures on developments in drug and device promotion and marketing law. Before entering private practice in 1990, Mr. Kirschenbaum served as a law clerk for Judge Theodore R. Newman of the District of Columbia Court of Appeals.
Promotion and Marketing
• Helps companies design compliant marketing programs and sales practices.
• Develops sales and marketing compliance policies and procedures.
• Conducts internal compliance audits and investigations.
• Drafts and reviews agreements among manufacturers, distributors, providers, PBMs, GPOs, and other entities in the distribution and payment chains.
• Conducts training for sales, legal, and management personnel.
• Advises clients on federal and state transparency reporting requirements.
Government Pricing and Contracting
• Helps companies comply with government price reporting and discounting requirements, including the Medicaid Drug Rebate Program, reporting of ASP and NFAMP, 340B Program pricing limitations, and price reporting to Texas and other states.
• Provides counsel on FSS and other federal contracting issues.
• Helps clients develop policies, procedures, and training for government pricing compliance.
D.C. Bar Health Law Section, former member of its Steering Committee
American Health Lawyers Association
Articles / Publications
see more articles
Application of Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices,
January 5, 2014
Summary of CMS Final Rule on Transparency Reporting,
February 12, 2013
CMS proposed ACA rule - 2-4-2012,
CMS Proposed Rule on Reporting of Payments or Transfers of Value and Physician Ownership or Investment Interests,
December 22, 2011
Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing,
ACI - Prescription Drug Pricing, June 23-24, 2014
Final AMP Rule Forecast
ACI Prescription Drug Pricing Conference, February 26 - 27, 2013
Analyzing CMs/FDA Interplay in Government Payor Pricing and Reimbursement: Interpreting the Intent Behind the Inclusion of FDA Regulatory terminology in the AMP Draft Rule and understanding Its Repercussions
see more blog entries
340B Orphan Drug Exclusion Saga Continues; Court Says PhRMA Must Start Over,
August 27, 2014
Final Rule on Branded Rx Drug Fee Treats All NDAs the Same, but IRS Might Consider a Special Rule for Pre-Hatch-Waxman Paper NDAs,
August 24, 2014
Drug and Device Manufacturers Should Take Note of OIG Special Fraud Alert on Laboratory Payments,
June 25, 2014
Phase 2 Sunshine Reporting Information Released By CMS,
May 23, 2014
OIG To Focus on a Number of Prescription Drug Issues in FY 2014,
February 12, 2014