Brenda Maloney Shafer

Calm, clear and collaborative health law advice

Brenda Maloney Shafer advises a wide variety of health care providers — including pharmacies, pharmacy benefit managers (PBM), drug wholesalers, hospitals, physician groups and long-term care facilities — on regulatory, compliance and transactional matters. A U.S. Army Nurse Corps officer before she became a lawyer, Brenda brings hands-on experience as a health care provider to the counsel she provides on:

• Regulatory compliance, with a focus on pharmacy, nursing, assisted living and long-term care
• 340B drug pricing program compliance
• Licensing issues
• Physician group practice management

Nurturing collaborative professional relationships with regulators across the country and working closely with clients to understand their business needs and risk tolerance, Brenda works nimbly to guide clients toward the legal and business results they seek even in a rapidly changing health care technology and business environment. When the realities of health care delivery outpace the regulations governing them, she focuses on providing practical, operationally feasible recommendations to her clients. In addition to her J.D., Brenda holds a Master of Laws degree (LL.M.) in Health Law. She also is the national chair of the Health & Life Sciences Practice Group.

• Assisting pharmacy clients in complying with pharmacy laws and regulations.
• Advising covered entities and contract pharmacies on 340B program compliance.
• Assisting clients with licensing and regulatory issues related to health care transactions.
• Representing medical professionals before state licensing boards, including physicians, nurses, pharmacists and other health care providers.
• Advising on a variety of nursing issues, including the Nurse Licensure Compact, telenursing, use of nurses in call centers and nursing agency licensure.
• Counseling physician groups on a variety of issues, including general practice management, employee issues, vendor agreements and noncompetition disputes.
• Advising on state assisted living and long-term care compliance matters, including change of ownership and health care licensing opinions.