Larri represents pharmaceutical manufacturers of both pioneer and generic drugs, wholesale distributors of prescription drugs and devices, and physician practices and practice management companies with a focus on medical and radiation oncology. She services as outside regulatory counsel to patient advocacy organizations operating co-payment assistance programs open to individuals covered by Medicare Part B and Medicare Part D.

Larri regularly provides counseling and advice to her pharmaceutical clients and other interested parties on:

• Prescription drug pricing and government price reporting, including AWP and WAC reporting to the compendia, ASP reporting to Medicare, AMP and Best Price reporting to Medicaid, ceiling and sub-ceiling price reporting to support the Public Health Service 340B program, and non-FAMP and FCP reporting to FA/FSS
• Medicare coverage, coding, and payment issues

She assists pharmaceutical and device manufacturers and distributors with:

• Fraud and abuse risk assessments associated with the sales and marketing of prescription drugs and devices
• Compliance program development, monitoring, auditing, and training, particularly in the drug and device arena
• Tracking state law developments relating to price reporting, reporting of advertising and marketing costs, registering of clinical trials and reporting of trial results, limitations on prescription data-mining, and licensing or other oversight of field sales representatives
• Contracting and other interactions with wholesalers, managed care organizations, pharmacy benefits managers, Medicare and Medicare Part D plans, and patient assistance foundations
• Privacy issues that arise in sales and marketing and in the clinical trial context

She also helps physician practices with:

• Regulatory questions tied to billing requirements
• Fraud and abuse risk assessments under federal and state anti-kickback laws, state fee splitting and corporate practice laws, and federal and state physician self-referral laws
• Compliance with HIPAA privacy and security regulations

Larri has been engaged to:

• Assist manufacturers and providers with the investigation and resolution of compliance complaints
• Defend drug manufacturers against federal and state actions alleging fraudulent pricing
• Defend manufacturers facing False Claims Actions based on theories of fraud against the FDA
• Assist with the development of legislative and executive lobbying strategies and to draft comments on drug pricing issues and on reimbursement issues that impact physicians and/or drug and device manufacturers

Prior to attending law school and joining Arent Fox, Larri worked at a Fortune 100 chemical manufacturer where she managed industrial hygiene functions at the corporate level. She was responsible for regulatory tracking, program development, and compliance auditing and she served as the company’s representative to various trade associations. The most significant project Larri handled during her tenure involved the development and implementation of a comprehensive health surveillance system operated by facility-based occupational health nurse practitioners at 15 manufacturing plants.

Larri is an active member of the American Health Lawyers Association and the American Bar Association's Health Law Section.

An active writer and speaker, Larri serves as a member of the editorial board for BNA’s Pharmaceutical Law & Industry.

Larri is the author of a book chapter focused on compliance issues in a key pharmaceutical market:

• “Controlling Fraud, Waste, and Abuse in the Medicare Part D Program,” Health Care Fraud and Abuse: Practical Perspectives, 3d ed., edited by Linda A. Baumann, published by the ABA Health Law Section and BNA

Larri has spoken frequently on drug pricing and fraud and abuse compliance. On December 7-8, 2009, she co-chaired the ACI Conference on Managing Legal Risks and Avoiding Conflicts of Interest in Medical Affairs and she will participate in a panel discussion on Continuing Medical Education and Related Grant Challenges during the conference.

Her speeches in recent years include:

• ACI’s 4th Annual Rx Drug Pricing Boot Camp
  “Medicaid Rebate Terminology and the AMP Litigation”
  New York, NY
  November 12-13, 2009
• CBI Webinar
  “Buying and Selling in the Drug Rebate Program”
  November 10, 2009
• ExPharma’s Pharmaceutical Pricing and Reimbursement Conference
  “Key Litigation and Legislation that Will Affect How the Industry Determines Prices"
  Bridgewater, NJ
  July 16-17, 2009
• CBI Medicaid Rebate Conference
  “The Pharmacists Fight to Preserve Generic Margins: NACDS et. al v. CMS”
  Orlando, FL
  May 19-20, 2009
• ExPharma’s Marketing and Salesforce Effectiveness Under the Revised PhRMA Code
  “Reconciling the Voluntary PhRMA Code with Mandatory State Laws to Ensure Compliant Sales and Marketing Efforts”
  Philadelphia, PA
  March 23-24, 2009
• ACI’s 7th Annual Advanced Forum on Government Regulation of Prescription Drug Pricing (conference chair)
  “Mastering the Mechanics and Operational Challenges Associated with the Final DRA Rule” (co-presented with Tim Nugent)
  New York, NY
  March 11-12, 2009
• CBI’s 10th Annual Patient Assistance Programs Conference
  “Supporting Patients with Out-of-Pocket Expenses for Part D through Charitable Foundations”
  Baltimore, MD
  March 10, 2009
• HDMA Distribution Management Conference & Technology Expo
  “Update on Reimbursement: AMP and Its Alternatives”
  Baltimore, MD
  March 6, 2009
• CBI Webinar
  “Unprecedented Regulation of Pharmaceutical Detailers in the District of Columbia: New Licensing and Recordkeeping Requirements Every Pharmaceutical Company Should Know”
  February 25, 2009

Larri has served as chair of the Governing Board of Legal Counsel for the Elderly in Washington, DC. She was elected to Order of the Coif and is a member of Phi Beta Kappa.

After long-being suburbanites, Larri and her husband are enjoying city life in their “new” Capitol Hill home that was built in 1893 and is three blocks from historic Eastern Market. In her free time, Larri enjoys entertaining, attending theater, traveling, and being a grandmother to a young teen who, unfortunately, lives too far away in North Dakota. Aside from North Dakota, recent travel has taken Larri and her husband to Barcelona and Northern Spain.