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May 20, 2021

Amendments to Clinic Licensure Regulations

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After several years of revisions, hearings, and public comments, the Public Health Council (PHC) adopted proposed amendments to 105 CMR 140.000, Licensure of Clinics (the “Regulations”), presented for approval by the Department of Public Health (DPH) at the PHC’s April 28, 2021 meeting. 3

DPH first proposed revisions to the Regulations in 2016, soliciting public comment and then hosting the first public hearing on the proposal in 2017. Following the first round of comment and hearing, On January 15, 2020, DPH presented revisions to the proposed amendments and a memorandum highlighting additional revisions to the Regulations to the PHC. These amendments took into consideration public comments and collaborative efforts between DPH, MassHealth and the Department of Mental Health. Notably, revisions recommended significant integration of mental health and substance use disorder services. Additional public comment was solicited and, on March 9, 2020, a second public hearing was held. On April 28, 2021, nearly five years after the initial proposed amendments, the PHC approved the most recent version of the proposed amendments, became effective on May 14, 2021. We highlight below some of the substantive changes to the regulations.

Staffing
• Surgery and Anesthesia Directors must be board-certified. See e.g., 105 CMR 140.603. Depending on the type of clinic, certain professionals previously required to be board-certified may now be board-eligible. See e.g., 105 CMR 140.530.
• Clinic Administrators and Professional Services Directors must be physically present onsite when necessary to perform and oversee clinic services; however, they may designate an individual with appropriate skills and training to be onsite when they are otherwise unable. See 105 CMR 140.310 and 140.311.
Mental Health Clinics
• Mental health services clinics must provide services for co-occurring substance use disorder and employ clinic staff capable of screening for such services. 105 CMR 140.510; 140.520.
• Lessened restrictions for commencing treatment for mental health services even if patient evaluation is incomplete. 105 CMR 140.520(B)(2).
• Modifications to definitions and requirements for staffing, evaluation, diagnosis, and treatment, and emergency access to services, among other requirements. See 105 CMR 140.500 through 140.560.
Urgent Care
• Regulations now define “Urgent Care” as a type of care delivery provided in a clinic, not a separate license designation.
Emergency Transfer Agreements
• The Regulations no longer require that clinics enter into a written emergency transfer agreement with a nearby hospital. 105 CMR 140.020; 140.305.

For more information on the April 28th adoption of the revisions to 105 CMR 140.000, please visit the proposed amendments, accompanying memorandum, and presentation before the PHC.

About the Authors

Crystal Bloom

Crystal Bloom is a partner and Chair of the firm's healthcare regulatory practice. She provides state and federal regulatory guidance and corporate legal services to healthcare providers. You can find her on LinkedIn.

Sydney Sachs

Sydney Sachs is an associate with Summit Health Law Partners’ Health Law practice. Sydney assists healthcare providers, including hospitals, physicians and physician groups, skilled care facilities, ambulatory surgery centers, and more. You can find her on LinkedIn.

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