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Store-based clinics face rocky regulatory landscape

By John Pulley
Published on April 28, 2008

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The growth of limited-service clinics — found in pharmacies, shopping malls and big-box stores — could hinge on an inconsistent and shifting regulatory landscape, according to a panel of health care experts who met last week at a public workshop sponsored by the Federal Trade Commission.

In overseeing the new health services market, FTC favors policies that balance consumer protection and business competition, William Kovacic, the agency’s chairman, said at the Innovations in Health Care Delivery conference.

But achieving that balance has been elusive, especially at the state level, industry insiders say. Rhode Island and Illinois, for example, have proposed “onerous bills … that would prevent clinics from flourishing,” said Sara Ratner, senior legal counsel at MinuteClinic, a division of CVS Caremark that operates more than 500 retail clinics in 25 states.

Lawmakers have proposed banning retail clinics from operating in stores that sell tobacco, dictating the proximity of restrooms and water fountains, and requiring strict physician oversight requirements. Texas law already requires limited-service clinics to have a physician on the premises during 20 percent of its operating hours — even if a physician is available for remote consultation.

“They have to take time to go to a clinic and sit there,” said Web Golinkin, president of the Convenient Care Association. “None of these regulations are based, to my knowledge, on any research.”

States’ requirements for physician oversight — the ratio of doctors to nurse practitioners, for example — also vary widely, Ratner said, making it “extremely difficult to create a business model that complies with every state.”

However, some states are making it easier to operate retail clinics. Earlier this year, the Massachusetts Health Department issued regulations that exempt retail clinics from some federal, state, and local public health and safety requirements. Health care providers in Massachusetts, which last year passed a law requiring all residents to have health coverage, have struggled to keep up with spikes in demand for services.

The retail clinic sector is booming. Analysts say the industry, which barely existed a year ago, could have 6,000 sites in operation by the end of 2012. Clinics are operated by retailers such as Walgreens, CVS and Wal-Mart, which plans to open 400 sites by the end of 2009; independent operators such as RediClinic; and hospital-owned operators.

Retail clinics leverage technology — electronic medical records, telemedicine, evidence-based diagnosis — to advance a business model predicated on a limited menu of services, convenience, consumer satisfaction, value and price transparency.

“Innovation is critical,” said William Sage, vice provost of health affairs at the University of Texas School of Law. “At the end of the day, the genie is out of the bottle, and it’s not going back.”














 
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