FDA and Healthcare

Nicole Liffrig Molife is counsel in the firm’s Washington, DC office and a member of the FDA and healthcare practice group. Her practice focuses on healthcare regulatory law and healthcare transactions. Ms. Liffrig Molife provides legal advice to a diverse set of healthcare clients, including early-stage and established pharmaceutical and medical device manufacturers, management companies, long-term care and senior living providers, hospitals and academic medical centers, outpatient diagnostic imaging centers, ambulatory surgery centers, dialysis companies, industry trade associations, and professional societies on regulatory compliance and business transactions.

Ms. Liffrig Molife’s regulatory practice focuses on compliance with physician self-referral laws, anti-kickback laws, and federal tax-exemption laws, regulatory and legislative initiatives affecting the healthcare industry, Medicare and Medicaid regulations and policies, enrollment standards, reassignment and purchased diagnostic test rules, and federal and state pharmaceutical laws. Her transactional practice focuses on advising clients on the regulatory, structuring and business considerations in healthcare business transactions and contractual arrangements.

Her representation for clients include:

• advising clients on product launch strategies and assisted clients with obtaining coding, coverage and payment for their products and services;
• providing clients with strategic legal counseling on various business transactions and contractual arrangements for compliance with the Stark Law, the Federal Anti-Kickback Statute, and other federal and state fraud and abuse laws;
• analyzing, drafting and negotiating business deals and arrangements, including joint venture arrangements, distribution agreements, management agreements, discount and rebate agreements, consulting agreements, and professional services and employment agreements; and  
• conducting regulatory due diligence reviews and risk assessment of healthcare companies and acting as healthcare regulatory counsel to investors, buyers, and sellers in major acquisitions and financings.

Ms. Liffrig Molife’s practice includes a focus on the diagnostic industry.  She has represented trade associations, imaging and remote monitoring providers, independent diagnostic testing facilities, and device manufacturers in connection with business transactions and regulatory matters. 

Ms. Liffrig Molife writes and speaks frequently on a variety of healthcare transaction and regulatory topics, including compliance with the Stark Law, contract negotiation and due diligence strategies, and Medicare coverage and reimbursement matters.

Prior to joining Arnold & Porter LLP, Ms. Liffrig Molife was an associate with the healthcare practice at Arent Fox LLP in Washington, DC, and with the healthcare transaction practice at Foley & Lardner in Chicago, IL, where she handled healthcare transactions for hospital systems, long-term care providers, and other healthcare companies.