Michael Elkins

Health law guidance on varied matters

Mike Elkins advises a variety of clients in the health care industry, including multiple types of pharmacies, drug and device distributors, physicians, and other individual and corporate health care service providers. Mike handles matters such as:

• State and federal regulatory compliance
• Licensing and contracting
• Administrative litigation
• Representation before state licensing boards
• Government relations
• Veterinary pharmacy

Mike’s philosophy has always been that there are no shortcuts in life, but you should always try to peek around the corner. He brings this same philosophy to his work, offering clients practical advice and creative solutions.

• Drafts comprehensive analysis of state and federal laws and regulations specific to health care clients’ operations, on an array of regulatory compliance issues affecting single providers to multinational corporations.
• Provides risk assessment and recommendations to pharmacies, drug and device wholesale distributors, third-party logistics providers and reverse distributors, in matters including licensing and permitting, controlled substances, reporting obligations, shipping and drug destruction.
• Provides risk assessment and recommendations to pharmacies engaged in mail order, shared services, central fill, remote operations, telepharmacy, automated dispensing, and sterile and non-sterile compounding.
• Advises health care entities attempting to leverage new and existing technology to improve patient care, including automated pharmacy systems and telehealth.
• Engages in the defense of administrative complaints issued by state licensing boards, including investigation and discovery, drafting responses, negotiations and representation at hearings.
• Prepares legislative and regulatory analysis concerning the effects of proposed and amended laws and regulations, including submission of public comments on behalf of clients to offer crucial industry perspective and practical implications.

• Successfully convinced the Florida Board of Pharmacy to grant a non-resident pharmacy’s Petition for Rule Variance, allowing the pharmacy to utilize an automated pharmacy system, located at an inpatient hospice facility, for limited dispensing to patients under hospice care in their homes.
• Obtained dismissal of state board of pharmacy administrative complaint alleging improper referrals by a pharmacy benefits manager.
• Assisted pharmacies with submission of public comments on multiple state board of pharmacy proposed rulemakings, in matters such as compounding for veterinary office use, drug donation, shared services and central fill.
• Prepared significant revisions and additions to proposed physician employment agreements, providing necessary protections to parties on both sides and narrowing the potential for controversy.
• Created customized patient services agreement for concierge medical practice, ensuring appropriate disclosures, payment structure and safeguards with respect to patients concurrently enrolled in Medicare.