Massachusetts mulls clinic regulations

The Convenient Care Association is urging state health officials in Massachusetts to make amendments to its proposed retail health clinic regulations, which, according to the CCA, if adopted as proposed would create barriers to operating in-store health clinics within the state.

“Massachusetts should implement a regulatory framework that allows [convenient care clinics] to provide appropriate basic care to patients, reduce inappropriate emergency room usage and act as an overflow outlet for busy physician practices,” Steven Cooley, CCA board member, told health officials in testimony in early September. Cooley also serves as chief executive officer of SmartCare Family Medical Centers and is a founding member of the CCA.

In response to CVS’ application to open a MinuteClinic in one of its stores in Weymouth, Mass.—which would mark the first of its kind for the state—state health officials took a step back and decided it made more sense to draft retail clinic regulations. The move delayed the decision whether to allow CVS to open the first of the 20 to 30 planned clinics in the state.

In its application, CVS reportedly asked the Department of Public Health to waive some of the state’s requirements for licensing clinics. For example, because none of the conditions treated require blood tests, CVS reportedly is seeking approval to waive the requirement for blood collection equipment and facilities.

“After hearing from a number of stakeholders and interested parties, the department determined that the best way to address the risk and benefits was to develop new regulations governing the operation of the clinics,” stated Department of Public Health commissioner John Auerbach.

In August, the Department of Public Health unveiled the proposed regulations that call for, among other things, clinics to maintain rosters of primary care providers accepting new patients, clinics automatically sending patient records to their primary care physician and limits on the number of times a patient can visit a clinic each year.

Looking to receive feedback on the proposed rules, state officials held public hearings on Sept. 5 and 18. State officials will review all of the testimony before incorporating changes, if any. The Public Health Council then will vote on the regulations no earlier than November, said a spokeswoman for the Department of Public Health.

It was during the Sept. 5 hearing in Boston that Cooley urged officials to make the following amendments to the proposal:

Redraft to take into account the fact that half of all primary care physicians in the state are not currently accepting new patients and the fact that it can be tremendously difficult to find primary care physicians who are willing to accept new Medicaid patients. In its current form, the proposal states that each clinic must maintain a roster of primary care physicians, who currently are accepting new patients and are willing to accept a referral from the clinic, in the clinic’s geographic area.

Remove the requirement that clinics must limit the number of repeat encounters with individual patients. CCA said such a requirement is “an arbitrary and unnecessary restraint on patient freedom and CCC operations.”

Redraft to remove the requirement that all patient records be automatically submitted to a primary care physician following a patient’s visit, prior to receiving the patient’s informed consent. “While CCA members encourage all patients to share their health records with a primary care provider (if the patient has one), CCA members also believe that patients should have control over their own personal health records,” Cooley stated in the testimony.

Remove sections that pertain to advertising and naming of clinics. The proposed rules require that clinics submit all ad materials to the state for approval, and not use any ad materials, including Web sites, that have not first been approved. “Considering that CCA members’ clinics comply fully with all governing laws and regulations and do not engage in any deceptive advertising practices, this special regulation is overbroad and unduly burdensome to CCC operators,” Cooley stated.

State officials also proposed that clinics not be allowed to use any name that implies it provides a full range of medical services, and if a clinic is an affiliate or satellite of a licensed healthcare facility, the name of the in-store clinic must be sufficiently different from the parent facility. “Without the addition of more specific language, it is impossible to know whether all, some or none of the members of the CCA would be required to change their well-established, trademarked company names under this regulation,” Cooley stated. “If this regulation is adopted as proposed, this uncertainty will create a barrier to the establishment of CCCs in Massachusetts.”

In a statement issued at the Sept. 5 hearing, MinuteClinic chief executive officer Michael Howe said, “MinuteClinic looks forward to working with the Massachusetts Department of Public Health as it develops the regulations that will guide limited-service clinics in the state, as we are pleased to be part of the public dialogue today.”