American Journal of Law & Medicine

A way out of the maze: federal agency preemption of state licensing and regulation of complementary and alternative medicine practitioners.

I. INTRODUCTION

In recent years, complementary and alternative medicine ("CAM") has grown in both popularity and economic import across all segments of society and is now an established presence in the lives of millions of Americans.(1) It has generated its own field of adherents, practitioners, opponents, lobbyists and counter-lobbyists, case law, and regulations. On one side of the CAM equation stand the advocates of CAM: its practitioners and satisfied patients. On the other stand its detractors: its dissatisfied patients, groups within the established or mainstream medical community, and historically, the American Medical Association ("AMA").(2) In the aggregate, the two sides engage in large scale scientific and philosophical battles over how best to treat or address the health care needs of patients. On a smaller scale, individuals on each side are essentially lobbying to protect their professions and their jobs. The struggle between the two warring camps fills volumes of medical, legal and popular scholarship. However, it is not the point of this Note to address the validity of the debate between CAM and mainstream medicine.

This Note shall attempt to examine the complex battleground of regulation and professional licensure which separates the two factions, and will propose a peace treaty. Part II of this Note provides an overview of CAM and the licensing maze currently in place for CAM providers. Part II also discusses the state's power to regulate under the Police Power and the emergence of CAM as part of the national healthcare debate. Part III of this Note outlines the subversive tendency of lobbying captivity in regulation and the special lobbying issues confronting CAM regulation. Part IV recommends federal regulatory preemption of existing state licensing regimes and urges the National Center for Complementary and Alternative Medicine (NCCAM) to adopt a regulatory function. Part IV also outlines the mechanism of federal regulatory preemption based on the model of the Cigarette Labeling Act. Part IV further focuses on the capacity of the NCCAM to step into a regulatory role, and discusses potential counterarguments.

This Note argues that the current regime of individual state licensing schemes to control access to CAM is unworkable, and that the only way out of the maze of regulations is through federal regulatory preemption with the NCCAM taking on a regulatory agency function.

II. HISTORICAL BACKGROUND AND OVERVIEW

A. DEFINING COMPLEMENTARY AND ALTERNATIVE MEDICINE

CAM is best defined negatively. It is broadly defined as those treatments and healthcare practices "not presently considered an integral part of conventional medicine."(3) The "complementary" portion of CAM denotes therapy used to supplement or augment traditional or mainstream medicine.(4) The "alternative" component denotes therapy used instead of traditional or mainstream medicine.(5) CAM comprises a vast number of treatments, theories, systems, methods and ideologies that depart from traditional medicine in a number of ways.(6) Central to the concept of traditional or allopathic medicine is its attempt to diagnose and treat conditions and symptoms based on evidence and scientifically researched, proven curative methods.(7) CAM, on the other hand, embraces concepts of wholeness, energy, balance, spirituality, lifestyle, biology, sociology and a host of other notions, which together constitute wellness or which individually or in combination with allopathic and other medicine may be used to cure or correct disease.(8) CAM is, therefore, very inclusive and very difficult to classify. The National Institutes of Health ("NIH") has created the NCCAM, which has undertaken a classification scheme for CAM treatments.(9) Despite efforts to classify and categorize CAM practices, the nature and scope of alternative treatments often depend on a patient's perceived (non-quantifiable, non-scientific) improvement in his or her state of well-being, making it inherently difficult to regulate or license.(10) This difficulty has resulted in a crazy quilt of inadequate regulatory regimes which differ in every state.(11)

It is difficult to conceive of one overarching and comprehensive regulatory scheme for CAM, much less to expect a single modality of regulation to arise out of 50 individual state regulatory schemes.(12) Part of the confusion underlying the problem is that while some of the more popular CAM techniques are strictly regulated,(13) others seem difficult to regulate to any practical degree.(14) This is not to say that states (and the District of Columbia) have not tried.(15)

B. REGULATION AND LICENSING REGIMES

1. The Nature of Licensing

The range and nature of CAM treatments reveals the daunting task faced by state regulators of complementary and alternative care providers.(16) By contrast and by design, traditional medical practitioners, M.D.s, are governed by a rigid and difficult qualification and licensing regime in every state.(17) Doctors have been both constrained and protected by such licensure for over 200 years in this country.(18) The possession of a medical license not only ensures that a physician has met certain minimum qualifications, but also permits him to exchange his medical services for money within the borders of the licensing state,(19) Licensure creates a distinction, which some view as arbitrary or artificial, between professional and non-professional occupations.(20) Those who are licensed are professionals, while those who are not are tradesmen.(21)

In the medical profession, the distinction between licensed skilled professionals, and unlicensed tradesmen has not always been sharply based on technical training and qualification.(22) Occupational licensing has been on the increase for some time,(23) and while it may once have served mainly to distinguish skill levels within the medical profession, one if its main purposes today is to protect current practitioners from uncontrolled entry of others into the competitive market.(24) Because only relatively few CAM practices are defined as the practice of medicine,(25) the CAM competition faced by licensed doctors comes mainly from other health care professionals, rather than from other doctors.(26) Within the ranks of these other professionals, however, the pressure to use occupational licensing as a barrier to competition is very high.(27) The protective economic pressure which organized professional groups can exert is very hard to counter unless there is a competing professional group.(28) This exclusive competitive pressure has the unfortunate side effect of driving up prices, which is felt acutely in the healthcare sector.(29) Moreover, the abuse of professional licensure within the healthcare community has the effect of chilling innovation and restricting the mobility of skilled workers.(30)

Those possessing and controlling licensure have the power to shut out competition and to monopolize professional markets.(31) This raises the stakes for both traditional doctors and CAM providers who are often competing for patients and for limited healthcare dollars, and who each perceive a threat from the other side.(32)

2. Existing Licensure Regimes

There are three broad categories of professional licensure used with respect to healthcare providers: mandatory licensure, title licensure (certification) and registration.(33) Mandatory licensure is the most stringent regulatory regime and carries the strongest penalties for violation.(34) Under a mandatory licensure regime, only those who are licensed may engage in the licensed activity and violators (unlicensed practitioners) may face criminal as well as civil penalties.(35) The most important of these violations, for the purposes of CAM providers, are state statutes that punish the practice of medicine without a license.(36) The second means of state regulation is title licensure or certification, whereby only one possessing a license may use a professional title to describe his or her qualifications, while non-licensed practitioners may perform the same service provided they do not use the licensed title.(37) The third, and least stringent, means of licensure is registration.(38) Under a registration licensure scheme, providers need only register their personal information and qualifications with a state agency, which is empowered to investigate complaints against such registered practitioners.(39) There is usually no accompanying threshold of qualifications imposed by the agency, which serves mainly as a channel for complaints.(40)

3. The Faulty Model of Massage Therapy and Licensing Reform

CAM providers in practice face this variety of state licensing schemes, depending not only on the nature of the care delivered, but also on the legal culture of the regulating state. The same practice may face mandatory licensure requirements in one state, as for massage therapists in Alabama,(41) title certification requirements in another, as for massage therapists in Washington,(42) and registration requirements in a third, as for those same massage therapists when they work in Texas.(43) Further adding to the confusion surrounding CAM licensure, a state may choose not to place regulatory restrictions on a given CAM practice, such as massage therapy in Kansas.(44)

Proposed solutions to the occupational licensure problem have called for a reform to the medicinal paradigm underlying the existing system,(45) or emphasizing title certification and registration over mandatory licensure. …

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