Physicians pushing state lawmakers to regulate burgeoning retail clinics

With the number of store-based health clinics expanding quickly, physicians and lawmakers in at least seven states have explored legislation aimed at ensuring that these new sources of primary care do not worsen quality, patient safety and continuity of care. In some cases, doctors' legislative fights are against industry-supported measures that would loosen existing regulations that could be applied to retail clinics.

Industry watchers say these legislative and regulatory challenges are the next hurdles for retail clinics.

"A year ago, this industry was an interesting experiment, and a year later, it is a viable model. Now, regulators have a tremendous opportunity to either encourage or impede the advance of retail clinics," said Mary Kate Scott, a health care technology consultant. Scott prepared a July 2006 report on retail clinics for the California Healthcare Foundation, a nonprofit organization that aims to expand access for the underserved.

The country's leading pharmacy chains, retail outlets and health systems will have an estimated 1,500 convenient care clinic locations up and running by the end of next year, compared with about 400 today. There could be consumer demand for as many as 5,000, Scott said.

States regulate the extent to which nurse practitioners and physician assistants can operate independently of physicians, along with safety issues such as the proper handling of biohazards. Also, the AMA and national family physician, pediatric and internist organizations have set out standards for how retail clinics should interact with physicians to ensure quality, safety and continuity of care. Clinics say the recommendations reflect what they already are doing, and the Convenient Care Assn. adopted its own set of standards in March.

But no state regulation specifically addresses the unique circumstances of the store-based clinic -- a situation some medical society officials say needs to change.

Medical societies push for bills

The Illinois State Medical Society is among those societies becoming more vocal about the need for legislation.

An ISMS-backed Illinois House bill would force clinics to pay $2,500 per location for permits from the state health department. To secure the permit, retail clinics would have to notify patients' physicians about retail visits and outcomes, have one physician supervisor for every two NPs, and allow patients to fill their prescriptions at the pharmacy of their choosing.

The bill also would prohibit retail clinics from advertising their fees in comparison with physicians' fees, or misleading insured patients about the out-of-pocket costs of convenient care services.

"We have a lot of concern about retail health clinics, and about the oversight of these clinics," said Rodney C. Osborn, MD, ISMS president. The clinics have arisen in the breach, he said, straining the traditional regulatory understanding of how physician extenders' work ought to be supervised by doctors.

"Many nurse practitioners function in the physician's office, but there the nurse has the physician readily accessible," Dr. Osborn said. "In the storefront clinic, the physician is not on site, and he can be supervising or medically directing a large number of sites. The separation between patients and physicians is even greater at these clinics. We believe that the patient-physician relationship is key to good medical care."

While the Illinois bill may not reach the House floor for debate this session, ISMS wants to see the issue addressed nationally. The society has proposed two resolutions for consideration at the AMA House of Delegates' Annual Meeting this month. One calls for outright opposition to retail clinics, and another asks the AMA to lobby for tighter regulation.

Last year, Florida enacted a law -- not specific to retail clinics -- that prohibits primary care physicians from supervising more than four physician extender-staffed offices in addition to the doctor's primary practice location. Georgia enacted a law granting NPs prescribing authority, but only under close physician supervision. The Medical Assn. of Georgia supported the bill.

The Tennessee Medical Assn., meanwhile, is exploring what regulations exist and whether new measures will be needed to rein in retail clinics.

Doctors fight looser regulations

Often, physicians fought against proposals before state lawmakers that would make it easier for clinics to operate without physician supervision.

The Texas Medical Assn. strongly opposed a convenient care industry-supported bill that would have eliminated the on-site requirement for physicians so long as they reviewed 10% of NPs' and PAs' charts. The measure died after a parliamentary deadline but will come up again, a TMA spokesman said.

In Pennsylvania, the medical society opposes legislation proposed as part of Gov. Ed Rendell's "Prescription for Pennsylvania" health care plan, because it would eliminate the limit on how many NPs and PAs a single physician could supervise.

"It is not humanly possible for one person to be personally responsible for an unlimited number of individuals in a clinical setting and to keep patient care safe," said Mark A. Piasio, MD, president of the Pennsylvania Medical Society, in testimony before the state House.

In Massachusetts, doctors are concerned about the clinics' impact on primary care. The Massachusetts Medical Society believes that state laws on the licensing of clinics prohibit retail operations, but the state health department is considering a waiver of many of those requirements.

Convenient care clinics "could kill our fragile primary care system," MMS President Kenneth R. Peelle, MD, said in a statement responding to CVS' plans to open at least 20 new MinuteClinics in the Bay State. "Our primary care network is already in crisis. Allowing mini-clinics to skim the easy, less-complex patients might be the death knell of primary care. ... These clinics could replace what already exists -- with something worse."

Doctors will be fighting an uphill battle. Since the early 1990s, 23 states have moved to allow NPs to practice independently of physicians, and 12 allow them to prescribe without physician supervision or collaboration. The physician-led effort to regulate retail clinics is less about quality than it is about the economic threat retail clinics pose, say the leaders of nurse practitioner organizations.

The scrutiny of retail clinics is "an attempt to control resources and finances for physicians," said Kenneth Miller, RN, PhD, immediate past president of the American College of Nurse Practitioners. The business community, he said, is on the NPs' side because they view retail clinics as a cost-effective, convenient method of delivering a limited scope of simple, acute primary care services.