Massachusetts § 51N - Licensing of office-based surgical centers

§ 51N. Licensing of office-based surgical centers

Section 51N. (a) As used in this section, the following words shall have the following meanings unless the context clearly requires otherwise:

''Deep sedation'', a drug-induced depression of consciousness during which: (i) the patient cannot be easily awakened but responds purposefully following repeated painful stimulation; (ii) the patient's ability to maintain independent ventilatory function may be impaired; (iii) the patient may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate; and (iv) the patient's cardiovascular function is usually maintained without assistance.

''General anesthesia'', a drug-induced depression of consciousness during which: (i) the patient is not able to be awakened, even by painful stimulation; (ii) the patient's ability to maintain independent ventilatory function is often impaired; (iii) the patient, in many cases, often requires assistance in maintaining a patent airway and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function; and (iv) the patient's cardiovascular function may be impaired.

''Minimal sedation'', a drug-induced state during which: (i) patients respond normally to verbal commands; (ii) cognitive function and coordination may be impaired; and (iii) ventilatory and cardiovascular functions are unaffected.

''Minor procedures'', (i) procedures that can be performed safely with a minimum of discomfort where the likelihood of complications requiring hospitalization is minimal; (ii) procedures performed with local or topical anesthesia; or (iii) liposuction with removal of less than 500cc of fat under un-supplemented local anesthesia.

''Moderate sedation'', a drug-induced depression of consciousness during which: (i) the patient responds purposefully to verbal commands, either alone or accompanied by light tactile stimulation; (ii) no interventions are required to maintain a patent airway; (iii) spontaneous ventilation is adequate; and (iv) the patient's cardiovascular function is usually maintained without assistance.

''Office-based surgical center'', an office, group of offices, a facility or any portion thereof owned, leased or operated by 1 or more practitioners engaged in a solo or group practice, however organized, whether conducted for profit or not for profit, which is advertised, announced, established or maintained for the purpose of providing office-based surgical services; provided, however, that ''office-based surgical center'' shall not include: (i) a hospital licensed under section 51 or by the federal government; (ii) an ambulatory surgical center as defined pursuant to section 25B and licensed under said section 51; or (iii) a surgical center performing services in accordance with section 12M of chapter 112.

''Office-based surgical services'', an ambulatory surgical or other invasive procedure requiring: (i) general anesthesia; (ii) moderate sedation; or (iii) deep sedation and any liposuction procedure, excluding minor procedures and procedures requiring minimal sedation, where such surgical or other invasive procedure or liposuction is performed by a practitioner at an office-based surgical center.

(b) The department shall establish rules, regulations and practice standards for the licensing of office-based surgical centers. In determining rules, regulations and practice standards necessary for licensure as an office-based surgical center, the department may, at its discretion, determine which regulations applicable to an ambulatory surgical center, as defined in section 25B, shall apply to an office-based surgical center. The department shall consult with the board of registration in medicine prior to promulgating regulations or establishing rules or practice standards pursuant to this section.

(c) The department shall issue for a term of 2 years and renew for a like term, a license to maintain an office-based surgical center to an entity or organization that demonstrates to the department that it is responsible and suitable to maintain such a center. An office-based surgical center license shall list the specific locations on the premises where surgical services are provided. In the case of the transfer of ownership of an office-based surgical center, the application of the new owner for a license, when filed with the department on the date of transfer of ownership, shall have the effect of a license for a period of 3 months.

(d) An office-based surgical center license shall be subject to suspension, revocation or refusal to issue or to renew for cause if, in its reasonable discretion, the department determines that the issuance of such license would be inconsistent with the best interests of the public health, welfare or safety. Nothing in this subsection shall limit the authority of the department to require a fee, impose a fine, conduct surveys and investigations or to suspend, revoke or refuse to renew a license issued pursuant to subsection (c).

(e) Initial application and renewal fees for the license shall be established pursuant to section 3B of chapter 7.

(f) The department may impose a fine of up to $10,000 on a person or entity that advertises, announces, establishes or maintains an office-based surgical center without a license granted by the department. The department may impose a fine of not more than $10,000 on a licensed office-based surgical center for violations of this section or any rule or regulation promulgated pursuant to this section. Each day during which a violation continues shall constitute a separate offense. The department may conduct surveys and investigations to enforce compliance with this section.

(g) Notwithstanding any general or special law or rule to the contrary, the department may issue a 1–time provisional license to an applicant for an office-based surgical center licensed pursuant to this section if such office-based surgical center holds: (i) a current accreditation from the Accreditation Association for Ambulatory Health Care, American Association for Accreditation of Ambulatory Surgery Facilities, Inc., or the Joint Commission, or (ii) a current certification for participation in either Medicare or Medicaid. The department may approve such a provisional application upon a finding of responsibility and suitability and that the office-based surgical center meets all other licensure requirements as determined by the department. Such provisional license issued to an office-based surgical center shall not be extended or renewed.