Practice Area Overview

Health Care

Health care law encompasses the myriad legal and regulatory requirements that apply to providers of health care products and services, from individual health care practitioners to non-physician health care providers, major pharmaceutical manufacturers, and medical device companies.

Our attorneys represent individual physician and non-physician health care professionals, pharmaceutical manufacturers, medical device manufacturers, vendors of health care information, and a nationwide professional association of non-physician health care practitioners in matters such as:

Medicare and Medicaid coverage and reimbursement
Protection of private health information under the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Compliance with FDA and Department of Health and Human Services regulations protecting human subjects who participate in clinical trials
Compliance with federal laws and regulations prohibiting health care fraud and abuse
Compliance with the Drug Enforcement Administration (DEA) requirements for the manufacture and distribution of controlled substances and listed chemicals
Government oversight of clinical investigators assisting in the development of new drugs and devices

Focus on the Anti-kickback Statute

The federal anti-kickback statute significantly restricts the marketing of pharmaceutical products. We assist our clients in anti-kickback compliance. We evaluate marketing practices for compliance with the anti-kickback statute and its many safe harbors and other exceptions.