The following checklist of CAM and integrative medicine legal issues offers an efficient and sensible way to work through the different areas of potential legal challenge.
The checklist addresses the question: what are the kinds of legal issues that someone can expect to face as an individual clinician, hospital, or other organization providing services involving complementary and alternative medical (CAM) therapies such as massage therapy, acupuncture and traditional oriental medicine, nutritional therapy, recommendations involving herbs, naturopathy, homeopathy, energy healing, and chiropractic, or developing medical spa services that integrate some of these CAM therapies?
A Summary Checklist of Legal Issues in Complementary, Alternative, & Integrative Medicine
1. Business Structure
a. Ownership structure
b. Anti-kickback and self-referral prohibitions
c. Prohibition on corporate practice of medicine
2. Clinical Practice Structure
a. Licensure and scope of practice
b. Credentialing providers
c. Supervision/quality assurance
d. FDA issues/dietary supplements and medical devices
e. Professional discipline
g. Advertising and claims
h. Privacy and confidentiality/HIPPA
i. Medical records/documentation
3. Billing and Coding
a. Fraud and abuse
Within each arena a number of sub-issues can be organized into checklists as well. For example, within 2.f. (Malpractice), one has to think about subtopics such as: (i) standard of care/evidence of safety and efficacy; (ii) informed consent/assumption of risk; (iii) scope of practice/duty to refer; (iv) vicarious liability/referrals; (v) professional liability insurance; and (vi) other risk management tools.
Organizing the issues in this way helps ensure that no small details are overlooked. The ideal goal is that clinical practice involving CAM therapies be made clinically responsible, ethically appropriate, and legally defensible.
The checklist aims to guide efforts to work through most situations, with the caveat that the list does not constitute legal advice or opinion. It is important when planning a particular project to consult an attorney for legal advice or opinion specific to that enterprise or activity.
Detailed information on many of these topics can be found elsewhere on this site, such as the table on sources of malpractice liability, the posts on legal and ethical issues in integrative mental healthcare, related ethical issues, advertising on the Web, credentialing CAM providers and hospital policy involving dietary supplements, or in the books, articles and list of legal and regulatory resources.