340B Program Counseling

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The 340B program — or 340B drug pricing program — refers to a federal public health law that requires certain pharmaceutical manufacturers to sell their drugs at a discount to specific health providers that have a proven record of serving low-income populations, including hospitals, community health centers, and others. By offering some relief from the high cost of pharmaceuticals, 340B discounts play a critical role in allowing these safety net providers to maintain and expand critical health services in their communities.

Attorney Maureen Testoni is a national expert on all aspects of the 340B program, having spent almost 7 years at 340B Health, the national trade association representing 340B hospitals. Maureen most recently served as the Senior Vice President and General Counsel at 340B Health, where she oversaw the Legal, Policy, and Government Affairs Division, which worked to influence law and policy regarding the 340B program. She regularly counseled health systems regarding 340B implementation, compliance, audits and appeals, as well as federal policy guidance. She is also a frequent speaker at national conferences on topics relating to the 340B program and the Medicaid Drug Rebate Program.

Maureen can assist you with 340B compliance, outlook, policy, strategy and advocacy. She also has expertise with pharmaceutical pricing and the Medicaid drug rebate program.

For advice and help with the 340B program or drug pricing issues, please contact Flanagan & Testoni LLP.

Audits and Appeals

The Health Resources and Services Administration (HRSA) began auditing 340B program providers in 2012, and since 2013 over half of hospitals audited had findings that required repayment. Maureen Testoni has counseled health systems regarding hund… Read More

Compliance and Contracts

The 340B program has multiple vague requirements, and their interpretation has significantly changed over time. Knowing that over half of audited hospitals have findings requiring repayment, it is clear that 340B compliance is a key issue for provi… Read More

Policy and Advocacy

The best way to ensure a favorable regulatory environment is to engage the process, including influencing legislation being considered by Congress, commenting on regulations and guidances promulgated by executive agencies, and advocating for the amel… Read More

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