In previous blog posts, we addressed the Massachusetts Department of Public Health’s (DPH) proposed regulations that affect hospitals, dialysis clinics and medical marijuana programs. In this final post on DPH’s recent regulatory review and overhaul, we address the proposed amendments to the clinic licensure regulations. DPH’s presentation to the Public Health Council is available here. As with the proposed amendments to the hospital and dialysis clinic regulations, many of the changes to the clinic licensure regulations are technical in nature and aimed at reducing the regulatory burden on clinics, aligning reporting obligations with other state and federal Massachusetts requirements and updating regulatory language. DPH did, however, propose some a number of substantive amendments to the clinic licensure regulations, including the following:
Recognizing that access to care is still a challenge in some locations and communities, the proposed amendments include a new definition of mobile/portable unit that contemplates an exclusively portable unit (a vehicle that only transports equipment, supplies and/or personnel to a host site location at which the clinic will provide licensed services). The portable unit may be an extension/addition of services provided by a clinic with a licensed physical site, an addition/extension of services provided by a mobile unit, or a clinic that is exclusively portable, with no licensed physical site or mobile unit in which services are provided, but the portable unit is not a satellite location. The host site for the mobile/portable unit could be a long term care facility, assisted living facility, a corporate or business location, community center, social service agency or a church, but may not be commercial office space rented by the licensed clinic. If such space is rented or otherwise under the control of the clinic, it must be licensed as a satellite. Mobile/portable services may not store medications at any host site or overnight in the mobile/portable unit.
Urgent Care providers have been filling an important need in the continuum of care for Massachusetts patients. For the first time, DPH defines Urgent Care and uses the definition to drive home its focus on the importance of primary care. The proposed rule defines Urgent Care as“[A] model of episodic care delivery that is primarily the immediate diagnosis, treatment, management or monitoring of acute and chronic disease, generally provided on a walk-in basis, and not intended as the patient’s primary care provider.” In language similar to the limited services clinic requirements, DPH proposes to require Urgent Care clinics to provide (with patient consent) a copy of the record of the patient’s visit to the patient’s primary care provider and a copy to the patient at the end of the visit, or as soon as available, at no cost to the patient.
Currently, free-standing birth centers are required to obtain clinic licensure under the clinic regulations and must also comply with the rules set out in a separate set of regulations that govern free-standing birth centers. In an effort to eliminate this redundancy, the proposed regulations incorporate the requirements that are currently included in the free standing birth center regulations (105 CMR 142.000) which DPH is recommending be rescinded.
Transfer of Ownership
The current transfer of ownership regulations provide a degree of certainty to providers seeking to sell or otherwise make changes to its ownership structure. The proposed amendment would give the Commissioner broad discretion to define a transfer of ownership by allowing the Commissioner to determine that a change in ownership interest or structure of the clinic or the clinic’s organization or parent organization effects a change in control of the operation of the clinic. At the same time, the proposed amendments make clear that the Commissioner has the discretion to determine that a proposed transaction does not rise to the level of a transfer of ownership.
Grounds for Denial or Refusal to Renew a License
While the current regulations give DPH fairly broad authority to deny or refuse to renew a clinic license DPH, the proposed regulations zero in on both the application process as well as the operation of the clinic. Under the proposed regulations, DPH can deny, revoke or refuse to renew a license if the applicant or provider willfully misrepresents information or data submitted to DPH or any other agency of the Commonwealth. The proposed regulation removes as a basis for licensure action the failure to give proper care but adds the provision of services for which the clinic is not licensed.
While many of the proposed regulations, such as the elimination of the written transfer agreement, are aimed easing the Clinic’s administrative burdens, others such providing each patient with the Notice of Patient’s Rights in the major languages spoken by the clinic’s patients, will definitely add to the clinic’s administrative responsibilities.
Comment Period is Open
The proposed amendments cover a broad range of issues and should be reviewed carefully by providers and other stakeholders. The public hearing for proposed amendments to the clinic licensure regulations is scheduled for October 25, at 9:30 a.m., Room 417, 239 Causeway Street, Boston, MA 02114 The proposed amendments to the dialysis unit regulations will be addressed at the same public hearing. The written public comment period for the proposed amendments to the clinic licensure regulations, as well as the dialysis unit regulations and the hospital licensure regulations closes at 5:00 p.m. on October 28, 2016.