Natalie C. Oehlers

How Natalie Helps Clients

Natalie focuses her practice on counseling clients on matters including product development, pre-approval and post-approval sale and marketing, compliance with state or federal regulation, and various reimbursement determinations. Natalie is experienced and confident working on matters involving a variety of state and federal agencies including the Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), Federal Trade Commission (FTC), United States Department of Agriculture (USDA), and the Centers for Disease Control and Prevention (CDC). Key examples of Natalie’s experience include:

• Risk analysis of the marketing and other promotional materials of drugs, medical devices, foods, and dietary supplements to ensure compliance with federal and state law, and other applicable regulations.
• Creation and counseling on CMS or private payer reimbursement strategies ranging from initial reimbursement coding determinations to after-market rebate requirements.
• Responding to several types of FDA enforcement activities and requesting an appeal or hearing, where applicable, on the client's behalf.
• Petitioning FDA to ensure the safety and effectiveness of drug products on the market.
• Assisting clients in maximizing their product portfolio by obtaining additional indications for use for their respective drug products or medical devices.
• Performing due diligence for drug product and medical device investment opportunities.
• Risk analysis of business models and activities to maintain compliance with federal laws such as the Anti-Kickback Statute, the Stark Law and other fraud and abuse laws.

What Clients Can Expect

Natalie values the relationships she has with her clients and strives to provide the best representation, services and resources pertaining to the issue at hand. She has found that direct one-on-one communication with clients allows them to make the most informed business decisions and helps establish a trusted relationship between both parties.

Overall, clients can expect Natalie to produce the most comprehensive strategy that will maximum the outcome they wish to achieve.

Outside the Office

When not in the office, Natalie enjoys settling in to watch her favorite show while knitting the perfect cozy scarf for winter. She also spends her time creating photo albums for her nieces and nephews to give to them when they turn 18.

Proof Points

• Assisted in the development of Families Living in Poverty (FLIP) funded by Ohio Medicaid in which the entire team was awarded the Scholarship in Teaching Award from CWRU School of Medicine 2019-2020.
• Interned for The Honorable Sherrod Brown, U.S. Senator