Massachusetts sets new rules for health clinics in retail stores

Massachusetts has developed a set of guidelines for in-store clinics, becoming what is believed to be the first state to issue specific regulations for the fast-growing market.

The Massachusetts Public Health Council approved the regulations on Jan. 9, with eight members voting for them and five abstaining. The council, which develops regulations for the state's Dept. of Public Health, began its work last year when CVS Corp.-owned MinuteClinic applied for a license to open in-store clinics but asked for several waivers to the state's regulations for traditional medical clinics.

The new regulations cover sanitary conditions in the store-based clinics, as well as requiring that a clinic located in a retail store that sells tobacco products must post a sign saying it does not endorse the use of tobacco.

Many of the regulations, reflecting the concerns of council members, center around who is staffing the clinics, and how the clinic handles emergency and referral situations.

The health department's Division of Health Care Quality must review every application and will look at site plans, and also the applicant's own policies and procedures. The department will also review staff credentials.

The regulations include a requirement that retail clinics must develop policies and procedures for referring patients whose needs exceed the scope of the clinic's services. That includes keeping a roster of primary care physicians accepting new patients so an in-store clinic patient without one may be referred to one. A clinic must have a written plan for how it will deal with repeat patients without a primary doctor.

Also, each clinic must have a written agreement with a nearby hospital that has emergency services where patients can be transferred.

The Massachusetts Medical Society was among those who testified and made several suggestions before the Public Health Council. When MinuteClinic applied for a clinic license in May 2007 -- an application that included 18 pages of waiver request forms -- the society said the company should follow the same standards as other practices.

But the society, in a prepared statement, said the new regulations "addressed to a significant degree" its public safety concerns.

"I think one of the advantages to having a set of regulations that is standardized is you have a better opportunity to ensure quality and safety and you also have a process to which anyone can apply," said Bruce Auerbach, MD, president-elect of the Massachusetts Medical Society.

Dr. Auerbach, chief of emergency and ambulatory services at Sturdy Memorial Hospital in Attleboro, Mass., said suggestions made by the society included sanitation and infection control, accessibility and the oversight of employees. He said a significant addition to the regulations was the requirement that clinic employees and operations be overseen by the state's Dept. of Public Health.

MinuteClinic, which put off building out its clinics until the state passed the new rules, said it plans to open its facilities under the regulations with no objections, according to a statement e-mailed to AMNews from MinuteClinic CEO Michael Howe. The company plans to open approximately 30 clinics in Massachusetts by late summer or early fall this year, Howe said. MinuteClinic will be the first retail clinic chain to open in Massachusetts.

Dr. Auerbach said while the new regulations help alleviate some concerns over the clinics, it's too soon to tell what impact they will have on health care delivery in the state.

"Allegedly it will allow patients the opportunity to be seen in a convenient location without a long wait for minor illnesses. Whether that will have any favorable impact on the health care delivery system is still a big question mark," he said.

In a statement released Jan. 10, one day after the public health department's decision, Boston Mayor Thomas N. Menino said the clinics were "ill-equipped to monitor community health needs" and "may hinder the city's ability to quickly respond to public health emergencies."

Menino called on the board of the Boston Public Health Commission to take a closer look at the clinics. According to published reports, the commission met later that night to discuss ways it could block the clinics from opening in Boston but has not yet taken any official action.