On April 28, the Massachusetts Public Health Council (“PHC”) approved final proposed amendments to the clinic licensure regulations.  The initial revisions presented by the Department of Public Health (the “Department”) in 2016 focused on making the regulations more readable, updating definitions as necessary, and aligning the clinics’ reporting requirements with other state and federal requirements.  Following the initial public comment period, the Department collaborated with MassHealth, the Department of Mental Health (“DMH”), and the Bureau of Substance Addiction Services (“BSAS”) to better integrate mental health services and treatment of substance use disorder in clinic settings.  Additional revisions reflecting the collaboration with MassHealth, DMH, and BSAS were presented to the PHC in January 2020.  Following that presentation, the Department held a second public comment period and made additional revisions to the regulations.  Below, we summarize some of the key changes and takeaways from the amended regulations. 

Reporting of Serious Reportable Events and Serious Adverse Drug Events

The requirements for reporting serious complaints and incidents have been updated to align with other state and federal reporting requirements.  The Department has also added reporting requirements for serious adverse drugs events in compliance with existing statutory language.  The reporting requirements for healthcare-acquired infections were also updated to align with federal requirements. 

Amendments Related to Mobile Sites

New provisions related to mobile services add long-term care facilities, assisted living facilities, corporate or business locations, community centers, social services agencies and churches as host sites for mobile services.  The amendments are aimed at allowing greater flexibility for clinics seeking to reach rural and underserved communities.  The amendments also clarify that clinics may not store medications at any host site or store medications overnight in a mobile or portable unit. 

Amendments Related to Mental Health and Substance Use Disorder Services

The amendments related to clinics providing mental health services are largely aimed at increased flexibility for providers.  In furtherance of this goal, the Department has removed the cap on mental health outreach visits as well as limits on the number of outreach clients that a clinic may serve.  Additionally, in collaboration with BSAS and DMH, the amendments include changes related to screening for substance use disorder at intake, allowing mental health treatment to begin prior to completion of the initial evaluation.  The Department has also added new definitions of “mental health” and “substance use disorder” that refer to the current version of the Diagnostic and Statistical Manual of Mental Disorders.  The amendments also clarify that a pre-recorded message does not fulfill the requirement that mental health services provide clinic coverage 24 hours per day, 7 days per week; however, 24/7 coverage, including evaluation, diagnosis and disposition services, must only be available for an existing patient’s presenting crisis.  

Amendments Related to Birth Centers

The amendments related to birth centers incorporate provisions that are currently set forth under 105 CMR 142.000, which the Department has proposed to rescind.  In making these changes, the Department has stated that it intends to eliminate any duplication between the clinic regulations and birth center regulations and reduce any confusion caused by the two sets of regulations.  The amended regulations include protocols for health and safety policies, staffing requirements, necessary equipment, and specific requirements for medical records, off-hour coverage, and a referral system for transfer of patients to hospitals. 

Other Updates

• The amended regulations clarify that every entity that fits into the definition of a “clinic” under M.G.L. c. 111 § must obtain a license from the Department “covering all locations at which the clinic provides services,” including satellites.  The amendments further provide that a clinic may not provide services at a satellite unless the satellite independently meets all of the requirements imposed on clinics by the applicable regulations. 

• The Department has updated the definition of Surgical Service to clarity that any endoscopic procedure, regardless of the type of anesthesia used, is considered to be a Surgical Service. 

• The definition of Transfer of Ownership now includes language (consistent with the Determination of Need Regulations and Hospital Licensure Regulations) providing that Transfer of Ownership also means any change in the ownership interest or structure of the clinic or the clinic’s organization or parent organization(s) that the Commissioner determines to effect a change in control of the operation of the clinic.  Conversely, the Commissioner may, in his or her discretion, determine that a proposed transaction does not rise to the level of a Transfer of Ownership.   In addition, the amended regulations clarify that requirements related to disclosure of stockholders holding 5% or more of any class of outstanding stock apply only to privately held for-profit corporations. 

• The amendments update the requirements for having space accessible to people with disabilities, and clarify that these rules apply to all clinic space.  The regulations also include a carve-out for small clinics with no more than two examination rooms, allowing such clinics to operate without a clean supply storage room and a soiled workroom or holding room. 

• Requirements related to patient records now provide that each clinic must maintain centralized records for all clinic patients but remove the requirement that the records be stored on the clinic’s premises.  This also applies to mobile medical services and mental health outreach programs, which must maintain patient records as records of the clinic and not of the host locations or outreach locations. 

• The amended regulations for the first time define “Urgent Care” and clarify that urgent care is not a separate service but rather a health care delivery model.  The amendments also include specific requirements for the provision of medical records to patients receiving care at an Urgent Care clinic.

• Clinics are no longer required to have a written agreement with a nearby hospital for transfer of patients in an emergency but must instead have a policy addressing the procedures for calling 911 for patients who need emergency treatment. 

• The amendments provide that clinic administrators and professional services directors must be physically present in the clinic as necessary to oversee the professional services provided by the clinic.  In the absence of the clinic administrator or professional services director, an appropriately qualified staff person must be designated to act in their place. 

• The time frame for clinic licensure renewal applications has been reduced from 90 days prior to expiration of the license to 60 days, consistent with requirements for BSAS.

The amendments are expected to take effect upon publication in the May 14, 2021 Massachusetts Register.