Integrative medicine is morphing from an extension of complementary medicine and/or intrusion into conventional care, into everyday prevention and wellness. Find out how three integrative medicine legal trends can make or break you.
Integrative medicine law is slow to change
The good news is that integrative medicine law hasn’t changed much. From a legal perspective, the fundamental framework of laws remains what it was when I wrote Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives some years ago.
I recently found a powerpoint on complementary medicine regulation from a talk given at the Institute of Medicine, when I served as Director of Legal Programs at the Harvard Medical School Osher Institute and Division for Research and Education on Complementary and Integrative Medical Therapies.
The key legal issues that talk addressed for integrative medicine are:
- licensure and credentialing of complementary and alternative medical providers (and of physicians integrating CAM therapies)
- scope of practice of CAM practitioners
- professional discipline (principally for physicians who practice integrative medicine)
- right of access to treatments (i.e., FDA and FTC legal rules governing who can access drugs, dietary supplements, medical devices, and cosmetics, and under what circumstances)
- third-party reimbursement (healthcare insurance)
- healthcare fraud.
Among these, licensure of healthcare practitioners was a prominent issue, given the questions physicians were having about when or if to refer to CAM providers; the presence of so many unlicensed healthcare practitioners; and the fact that the “Minnesota Model” for non-licensed healthcare providers (in California, embodied in SB 577) had not yet arrived in widespread form.
Notably, unlicensed medical practice is a crime – creating deterrent to practices by many healers, aromatherapists, and others who lack licensure as, say, a chiropractor, acupuncturist, or naturopathic physician.
As well, with the scramble by various professional organizations to achieve licensure, states were looking at the differences between mandatory licensure, and title licensure (in which practice is permitted, but use of title is not, without the professional license).
I also talked about my research into hospital policies governing credentialing, and malpractice liability issues, relating to provision of complementary therapies and inclusion of CAM providers.
The IOM later published a Report on Use of Complementary and Alternative Medicine in the United States–a rich document for integrative medicine physicians and practitioners, including its chapter on legal and ethical issues.
Fee-Splitting, Vicarious Liability, and Negligent Credentialing
Three legal updates are important:
- With multidisciplinary clinical practices or clinics, including quasi-medical settings such as medical spas, laws prohibiting self-referral (Stark), kickbacks, and fee-splitting must be considered in structuring any arrangement. Fee-splitting issues arise again and again with our clients, some of whom are medical doctors and others who are entrepreneurs launching ventures in conjunction with physicians.
- Vicarious liability continues to be important as a source of risk exposure, given the increasing integration among providers. Vicarious liability refers to your liability for someone else’s negligence. You can be vicariously liable, for example, if you have a legal duty to supervise another practitioner (i.e., MD vicariously liable for nurse’s conduct), or, if you have “apparent agency”–i.e., the public believes the practitioner is your agent. This is huge in integrative medicine.
- Negligent credentialing looms larger as telemedicine companies begin offering integrative health solutions. As soon as you take responsibility for vetting practitioners, you can be legally responsible for failing to use due care in your vetting procedures.
Many healthcare lawyers focus on licensure issues but fail to recognize how fee-splitting and anti-kickback laws, vicarious liability, and negligent credentialing can dramatically expand the range of legal issues that must be addressed for the integrative medicine venture to succeed.
Our integrative medicine attorneys and healthcare lawyers track integrative medicine legal developments so we can counsel our clients on their integrative medicine compliance legal obligations. Contact our integrative medicine legal team for laws and updates relevant to your situation.