MinuteClinic Waiver Request Prompts Proposed Regulation Revisions

The Massachusetts Department of Public Health conducted its second public hearing on Sept. 18 regarding a revised set of regulations (39-page Word file; About Downloading) that would cover the operation of limited-scope medical clinics, such as retail health clinics.

The revisions were prompted by an application CVS Caremark Corp. submitted earlier this year to open Massachusetts' first retail health clinic -- a CVS MinuteClinic -- in Weymouth.

If the regulations are approved, clinics licensed to provide limited services in Massachusetts would operate under less stringent restrictions than full-service clinics and physician offices. For instance, a retail health clinic operating in a retail store would not be required to provide facilities and services such as

A decision on the new regulations is expected in late fall.

MinuteClinic, which has received ambulatory care accreditation from The Joint Commission, maintains that public health regulations covering full-service clinics and physician offices don't apply to its clinics because they provide a limited scope of treatment and services.

According to a MinuteClinic spokesperson, the company currently operates 266 clinics in 22 states and is opening as many as 20 new clinics each week.

Patricia Sereno, M.D., of Stoneham, Mass., president of the Massachusetts AFP was among those who testified at the first hearing on this issue on Sept. 5. She said in a recent interview that the concept of patients walking through a retail store stock room to use a restroom -- or of a nurse practitioner lacking access to soap and water between strep tests -- was hard to imagine. She said physician offices "wouldn't be granted these waivers, and the department of public health would laugh at us if we requested these waivers."

Representatives from the Massachusetts AFP attended a series of meetings with representatives from the Massachusetts Medical Society, the Massachusetts Chapter of the American Academy of Pediatrics, the Massachusetts Hospital Association and the Massachusetts League of Community Health Centers when CVS first presented its waiver request to the state. Those waivers were denied, but, according to Sereno, all of the language contained in the original waivers was incorporated into the proposed regulations now being debated.

The AAFP has said repeatedly it does not support retail health clinics; however, the Academy has worked to help shape the business model for such clinics, and, as a part of that effort, it published a list of desired attributes for retail health clinics in 2006. Some retail health clinics, including MinuteClinic, have agreed in writing to adhere to those attributes.

In addition, the AAFP worked with MinuteClinic CEO Michael Howe recently to clarify statements contained in documents MinuteClinic submitted to the Massachusetts Department of Public Health as part of its initial clinic application process.

In a Sept. 4 letter to Massachusetts Public Health Commissioner John Auerbach, the Academy corrected misconceptions regarding AAFP's relationship with MinuteClinic, reiterating that the AAFP does not endorse MinuteClinic. Furthermore, "The AAFP has never commented on MinuteClinic's site layout or building specifications nor expressed support," as MinuteClinic had claimed, says the letter.

The letter, which was signed by AAFP President Rick Kellerman, M.D., of Wichita, Kan., and Howe, closed by saying that the two organizations were "engaged in a productive dialogue concerning the role of retail clinics in U.S. health care and the importance of everyone having a personal medical home through (his or her) private physician."

Massachusetts physicians, such as Sereno, are concerned about the safety and quality of health care delivered in clinics that would operate under the revised regulations.

Howe stressed MinuteClinic's commitment to continuity of care and the medical home concept in a statement submitted by MinuteClinic to the Sept. 5 public hearing. He said patients without a primary care physician would be referred to one. "As hundreds of thousands of Massachusetts residents enter the health care system, we believe MinuteClinic can help these patients find a medical home," said Howe.

Sereno told AAFP News Now that although patients would have quick access to the clinics, the clinics would do little to improve patient access to primary care. "They're improving access to a 'quick fix' that doesn't provide patients any preventive services. They're providing a piece of primary care, which is acute-visit care," she said.