35 Pa. Stat. § 448.822

Current through Pa Acts 2024-53, 2024-56 through 2024-111
Section 448.822 - Ambulatory surgical facility permitted surgical procedures.
(a) Exception or waiver.--An ambulatory surgical facility may seek an exception or waiver from the department for any of the following surgical procedures:
(1) A surgical procedure not specified in ASC-CPL.

(2) A surgical procedure otherwise prohibited by State regulation.

(b) Review period.--
(1) Upon receipt of a request for an exception or waiver under subsection (a), the department shall, within 60 calendar days, provide a written response to the ambulatory surgical facility that approves or denies the request or shall provide notice that the department is unable to issue a determination because a substantive element is missing that is necessary for the department to approve or deny the request.
(2) If the department denies the request, the department shall include the basis for the denial, including statutory or regulatory citations that form the basis of the denial.
(3) If the department determines that it is unable to issue a determination, the department shall specify the substantive element that is needed for the facility to resubmit its request. Upon receipt of the facility's resubmitted application, the department shall approve or deny the resubmitted application within 60 calendar days of receipt of the resubmitted application. The department shall deny an incomplete resubmitted application.
(4) If the department does not approve, deny or provide notice that the department is unable to issue a determination on an initial application or does not approve or deny a resubmitted application within 60 calendar days, the request shall be deemed approved and the ambulatory surgical facility may proceed as if the request has been approved by the department.
(c)Permitted surgical procedures.--An ambulatory surgical facility may perform surgical procedures permitted under Federal or State law or regulation and surgical procedures specified on the ASC-CPL on the effective date of this section that do not otherwise conflict with State regulations relating to license classification, construction and design standards, personnel, equipment, governance and management and notification requirements. The department may not require an ambulatory surgical facility to request an exception or waiver or receive an approval of an exception or waiver to 28 Pa. Code § 551.21(d) (relating to criteria for ambulatory surgery) from the department for surgical procedures specified in ASC-CPL.
(d)Definitions.--As used in this section, the following words and phrases shall have the meanings given to them in this subsection:

"ASC-CPL." The CMS 2022 ambulatory surgical center covered procedures list, effective January 1, 2022.

"CMS." The Centers for Medicare and Medicaid Services.

"Substantive element." Material information necessary for the department to approve or deny a request for an exception or waiver.

35 P.S. § 448.822

Added by P.L. TBD 2022 No. 87, § 1, eff. 9/9/2022.