340B Drug Pricing Program

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-inc… Read More

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 hundreds… 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 provide… 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

Medicare / Medicaid

Flanagan & Testoni LLP offers clients more than thirty years of experience working with the complex statutes and regulations governing Medicare and Medicaid programs. We advise and represent a large range of providers, from large hospital systems… Read More


The Medicare and Medicaid programs sometimes refuse to pay a health care provider’s claims or seek to recoup payment. Drawing on three-plus decades of health care regulatory experience, Flanagan & Testoni LLP advises providers on the proper ste… Read More

Medicare / Medicaid Compliance

Medicare and Medicaid regulations are extensive and constantly changing. The government accepts no excuses for failing to know and comply with the myriad rules of government health care programs. Michael Flanagan and Maureen Testoni have spent more t… Read More

Medicare / Medicaid Fraud and Abuse

An accusation of Medicare or Medicaid fraud and abuse can saddle a provider with substantial distractions and fines, and could even result in criminal penalties. Even a rumor that the government is considering such an accusation can keep a provider a… Read More

HIPAA Compliance

Health care providers must be constantly vigilant in maintaining compliance with the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the relatively new enforcement provisions added to HIPAA by the H… Read More

Regulatory Transactional Work

As the health care industry has grown, so have the number and complexity of health care regulatory transactions — acquisitions, sales, expansions and financings, for example. Mike Flanagan has represented health care clients in every facet of these… Read More

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