Session of 2022
No. 2022-87
 
SB 818
 
AN ACT
 
Amending the act of July 19, 1979 (P.L.130, No.48), entitled "An act relating to health
            care; prescribing the powers and duties of the Department of Health; establishing
            and providing the powers and duties of the State Health Coordinating Council, health
            systems agencies and Health Care Policy Board in the Department of Health, and State
            Health Facility Hearing Board in the Department of Justice; providing for certification
            of need of health care providers and prescribing penalties," in licensing of health
            care facilities, providing for ambulatory surgical facility permitted surgical procedures;
            and abrogating regulations.
         
 
The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows:
 
Section 1.  The act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act,
            is amended by adding a section to read:
         
Section 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.
         
Section 2.  The provisions of 28 Pa. Code  51.22 are abrogated. The provisions of 28 Pa. Code
             551.21 are abrogated insofar as they are inconsistent with the addition of section
            822 of the act.
         
Section 3.  This act shall take effect in 60 days.
 
APPROVED--The 11th day of July, A.D. 2022.
 
TOM WOLF