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DHMH : Cosmetic Surgery Regulations

Request for Public Comment: Cosmetic Surgery

I       In 2012, three Maryland residents became seriously ill during an outbreak of Group A Streptococcus at a cosmetic surgical facility in Baltimore County.  One person died.  This episode brought to light gaps in current regulation of cosmetic surgical procedures in Maryland.With support from the Department of Health and Mental Hygiene (Department), the Maryland General Assembly passed legislation in 2013 providing for stricter oversight of cosmetic surgical procedures in Maryland.  This legislation authorizes the Secretary of the Department to adopt regulations for certain higher risk cosmetic surgical procedures.  The legislation is online at: http://mgaleg.maryland.gov/2013RS/chapters_noln/Ch_398_hb1009T.pdfThe Department faces two key tasks in developing these regulations.First, the Department must identify the circumstances under which cosmetic surgical procedures should be subject to regulatory oversight.  In doing so, the legislation requires that the Secretary shall consider available studies, reports, and other literature related to:

  • The safety or risks of the procedure;
  • The education and training of the health care practitioners administering anesthesia for the procedure;
  • The education and training of the health care practitioners performing the procedure; and
  • The setting in which the procedure is performed.

Second, the Department must determine what requirements to apply to covered procedures.  The legislation authorizes the Department to set licensing requirements for the facilities where the covered procedures will take place.  At a minimum, the Department must license facilities that are accredited by the American Association for Accreditation of Ambulatory Surgical Facilities, the Accreditation Association for Ambulatory Health, and The Joint Commission.

To assist in developing the regulations, the Department is seeking input on the following questions:

      1.   Which procedures should be regulated under the new law? How should these procedures be identified and defined?   In answering this question, please reference available studies, reports, and other literature related to:

  • The safety or risks of the procedure;
  • The education and training of the health care practitioners administering anesthesia for the procedure;
  • The education and training of the health care practitioners performing the procedure; and
  • The setting in which the procedure is performed.

2.    For covered procedures, should the Department develop an approach to licensing that relies exclusively on external accreditation of facilities, or also develop its own regulations?  Please explain your reasoning.

3.   Other than the American Association for Accreditation of Ambulatory Surgical Facilities, the Accreditation Association for Ambulatory Health, and The Joint Commission, are there other entities offering accreditation that  the Department should consider accepting as a sufficient for or supportive of licensure?

4.   If the Department should develop regulatory standards separate from those required for accreditation, what should these standards cover? 

5.   How, if at all, should the regulations differ from the regulations governing ambulatory surgical centers?

Please provide comments by July 8, 2013, to Michele Phinney, Director, Office of Regulation and Policy Coordination.  Please submit via email to dhmh.regs@maryland.gov or via postal mail to Michele Phinney, Department of Health and Mental Hygiene, 201 W. Preston St., Room 512, Baltimore, MD 21201.  For questions, call 410-767-6499, TTY: 800-735-2258.