In the back of the local CVS drug store, behind aisles stocked with shampoo, painkillers, soda, and holiday decorations, sits a clinic examination room. The exam room is located next to the pharmacy. The couple of chairs between them do the double duty of seating patients who are waiting to be seen and customers waiting for prescriptions. A small touch screen display outside of the closed door permits those wishing to see the nurse to tap out their name and browse the menu of services that the clinic provides. Services range from pre-summer camp physicals and strep throat tests to diabetes testing and meningitis immunizations. Within fifteen minutes, a patient's name is called, and he or she is ushered into the exam room set up as a smaller-scale physician's examination room. When the exam is completed, the patient will leave the exam room with either a prescription for the pharmacy next door or with an answer to his or her medical problem, all without having to wait in an urgent care clinic, or needing a prescheduled doctor's appointment.
By summer 2009, the Convenient Care Association, a trade group for the retail clinic industry, estimated that 1,200 retail-based health clinics operated in the United States. (1) With such operations in place, any patient who is eighteen months or older (2) can enter a drug store or supermarket that contains a clinic and can be seen and assisted, usually within fifteen minutes of arrival. (3) Each patient of a retail clinic takes part in what critics and proponents alike agree is a major change in the manner in which Americans receive healthcare. (4) Doctors, nurses, politicians, and patients are closely following the spread of retail clinics. These groups hold diverse views on the retail clinics' growth, ranging from deeming the clinics as a solution to the crisis of healthcare coverage, to condemning the clinics as the complete undoing of the doctor-patient relationship in America. (5)
The American public has enjoyed an immense increase in consumer power in every area of commerce. (6) No longer are consumers willing to enter a store and rely completely on the salesman to tell them what products to purchase. As the balance of power shifts from salesman to consumer, so too does the balance shift in the U.S. medical community, with patients increasingly demanding more information and more choices when it comes to their healthcare. The idea that a patient is a retail consumer and healthcare is the product has negative implications within the medical community. The medical community has relied historically on its advanced training and position of power to guide patients in making health-related decisions. (7) To say that a patient could enter into a doctor's office and purchase a strep throat test sounds strange, and yet, as fewer and fewer Americans have access to the traditional primary care provider relationship, shopping becomes a more apt analogy. Accordingly, retail clinics have responded to consumers' demands for convenience, control, and value throughout the United States.
In 2008, spending on healthcare in the United States represented sixteen percent of gross domestic product at $2.3 trillion. (8) As healthcare costs continue to rise, nearly forty-five million Americans remain uninsured and without adequate access to necessary health services. (9) The spread of retail clinics is not a panacea to the healthcare problems facing the United States. It is too early to accurately judge the impact which retail clinics may have on healthcare in the United States, but many groups both for and against, are tracking these clinics' development. Implemented correctly, and controlled appropriately, the increased access to healthcare and preventative focus which retail clinics can provide may help extend healthcare to more Americans when they need it, creating a healthier society. Retail clinics can achieve these goals because of their innovative use of non-physician providers as well as technological and medical innovations. Retail clinic expansion should be guided by targeted legislation meant to ensure patient safety, without destroying the economic advantages which make them successful.
This Note discusses the legal and regulatory issues retail clinics face in conjunction with their rampant expansion within the United States. Section I discusses the historical development of retail clinics as well as the staff composition. Section II analyzes various regulations that have had an effect on both the medical and business aspects of retail clinics. In particular, this Note closely examines the recent amendment to Massachusetts state regulations, which concerns clinic licensure, and the role retail clinics played in crafting the new regulations.
After discussing these regulations, the Note analyzes issues of concern related to retail clinics and recommendations for best approaches to these concerns. Moreover, the discussion focuses on the general opposition to retail clinics from the physician community. In response to the raised opposition, a proposal for specific guidelines as to how retail clinics may address some of the legitimate health concerns these groups express is put forward. Section III recommends regulation seeking to specify physician oversight of the retail clinic staff as well as regulation which ensures sufficient hygiene. The argument is put forward that regulation that simply seeks to make retail clinics economically unviable, such as parking limits, advertising restrictions, and tobacco sales bans should be dismissed. Finally, this Note will discuss the ways in which the development of Electronic Health Records will significantly benefit retail clinics and help to answer some of the major criticism levied against retail clinics.
Historical Clinic Development
Advances in medical testing have led to efficient diagnoses of a range of medical problems which can be safely and easily treated with prescription drugs. (10) Medical issues such as strep throat, influenza, and ear and bladder infections, which are relatively common in the population and comparatively easy to diagnose, can be easily treated before they become exacerbated and require more expensive and involved medical care. Many doctors do not have the time to make appointments on short notice to diagnose these conditions when symptoms first emerge. Appointments cost patients both time and money. Indeed patients incur the medical expenses associated with treatment, but patients also incur costs associated with missing work or school. (11) Doctors must hold open time slots for simple diagnoses or else hold extra hours in order to cope with the demand for such services. It was the realization of these issues which led a doctor to invent the first retail clinics.
In 2000, physician Doug Smith remained at his office after-hours on a Friday night to administer a strep test to an acquaintance's son. The acquaintance was concerned about his sick child and could not find any place that would administer the test over the weekend. (12) This incident inspired Dr. Smith to open QuickMedX, the first so-called convenient care clinic in America and the precursor to modern retail clinics. (13) Dr. Smith, along with his acquaintance, businessman Rick Krieger, set about designing a new way of providing medical care. Answering the demand for ready access to low-cost medical care, Smith began by opening three clinics located in drug stores in the Minneapolis-St. Paul area. (14) Smith, together with his business partner, founded QuickMedX to provide "convenient, fast and inexpensive access to basic healthcare to patients without requiring unreasonable office hours for physicians." (15)
Smith realized that non-physicians, who had prescriptive power, could diagnose and efficiently respond to the demand for such medical services in locations that were more convenient for patients than doctors' offices. (16) With no appointment necessary, QuickMedX allowed a patient to come in for a twenty-minute exam that could allow the patient either to receive treatment or a prescription for medication. (17) From its modest start, QuickMedX grew to become MinuteClinic, which is now wholly owned by CVS and is the leader in the retail clinic industry. (18) With the swipe of a credit card, a consumer at the supermarket can get a strep test administered by a trained medical professional at the first sign of a sore throat and walk out of the supermarket with the appropriate prescription drugs if necessary. From three locations in the Twin Cities to national chains such as MinuteClinic, the retail clinic model has emerged specifically to provide low-cost preventive and early diagnostic care to a broad range of patients.
The retail clinic model is fairly straightforward. A small staff of one or two advanced-practice nurses ("APN") holds open office hours to treat certain specifically listed medical issues. (19) The clinic is normally situated towards the back of the store, near the pharmacy. (20) Many clinic chains use computerized sign-in systems for check-in. (21) Customers enter their name and the reason for their visit into a touch-screen display and then are placed on a waiting list. Some locations provide clinic customers with electronic pagers, which allow these customers to shop in the retail store while waiting to be examined. (22) Most retail clinics consist of one or two small examination rooms with limited medical equipment, a stripped down version of a physician's examination table, and a computer terminal. Clinic staff must follow rigid protocols that specifically address how each medical issue on the clinic's menu should be diagnosed and treated. (23) The patient's information is entered digitally and may be shared between clinics of the same chain and even forwarded to the particular customer's physician. (24) Indeed, retail clinics' use of technology and low-cost space makes retail clinics cost...