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.
Legislative Advocacy
OFW Law attorneys often represent health care clients before Congress, federal agencies, and state legislatures.
