HOUSE AMENDED
PRIOR PRINTER'S NOS. 1004, 1327, 1617 PRINTER'S NO. 1833
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 818
Session of
2021
INTRODUCED BY J. WARD, MARTIN, PITTMAN, PHILLIPS-HILL, STEFANO,
MENSCH, BROWNE, BAKER, ARGALL, SCHWANK AND SCAVELLO,
JULY 26, 2021
AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES,
JUNE 28, 2022
AN ACT
1 Amending the act of July 19, 1979 (P.L.130, No.48), entitled "An
2 act relating to health care; prescribing the powers and
3 duties of the Department of Health; establishing and
4 providing the powers and duties of the State Health
5 Coordinating Council, health systems agencies and Health Care
6 Policy Board in the Department of Health, and State Health
7 Facility Hearing Board in the Department of Justice;
8 providing for certification of need of health care providers
9 and prescribing penalties," in licensing of health care
10 facilities, providing for ambulatory surgical facility
11 permitted surgical procedures; AND ABROGATING REGULATIONS. <--
12 The General Assembly of the Commonwealth of Pennsylvania
13 hereby enacts as follows:
14 Section 1. The act of July 19, 1979 (P.L.130, No.48), known <--
15 as the Health Care Facilities Act, is amended by adding a
16 section to read:
17 Section 822. Ambulatory surgical facility permitted surgical
18 procedures.
19 (a) Exception or waiver.--An ambulatory surgical facility
20 may seek an exception or waiver from the department for surgical
21 procedures not specified on the Centers for Medicare and
 1 Medicaid Services (CMS) Ambulatory Surgical Center Covered
2 Procedures List (ASC-CPL) on the effective date of this section
3 or otherwise provided by law or regulation.
4 (b) Permitted surgical procedures.--
5 An ambulatory surgical facility may perform surgical
6 procedures permitted under Federal or State law or regulation
7 and surgical procedures specified on the ASC-CPL on the
8 effective date of this section, if it does not conflict with
9 Federal or State law or regulation, without submitting a
10 request for an exception or waiver from the department for
11 approval.
12 (c) Publication of surgical procedures.--The department
13 shall transmit notice to the Legislative Reference Bureau for
14 publication in the Pennsylvania Bulletin of any updates to the
15 ASC-CPL made by the Centers for Medicare and Medicaid Services
16 (CMS). The updates shall be transmitted by the department
17 separately as notices to the Legislative Reference Bureau for
18 publication in the Pennsylvania Bulletin. The department shall
19 publish and maintain the complete ASC-CPL on the department's
20 publicly accessible Internet website.
21 Section 2. The provisions of 28 Pa. Code § 551.21(d)(1), (2)
22 and (3) are abrogated. The provisions of 28 Pa. Code Chs. 51 and
23 551-571 are abrogated to the extent that they are inconsistent
24 with section 822 of the act.
25 Section 3. This act shall take effect in 60 days.
26 SECTION 1. THE ACT OF JULY 19, 1979 (P.L.130, NO.48), KNOWN <--
27 AS THE HEALTH CARE FACILITIES ACT, IS AMENDED BY ADDING A
28 SECTION TO READ:
29 SECTION 822. AMBULATORY SURGICAL FACILITY PERMITTED SURGICAL
30 PROCEDURES.
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 1 (A) EXCEPTION OR WAIVER.--AN AMBULATORY SURGICAL FACILITY
2 MAY SEEK AN EXCEPTION OR WAIVER FROM THE DEPARTMENT FOR ANY OF
3 THE FOLLOWING SURGICAL PROCEDURES:
4 (1) A SURGICAL PROCEDURE NOT SPECIFIED IN ASC-CPL.
5 (2) A SURGICAL PROCEDURE NOT PUBLISHED IN A NOTICE UNDER <--
6 SUBSECTION (C)(1).
7 (3) (2) A SURGICAL PROCEDURE OTHERWISE PROHIBITED BY <--
8 STATE REGULATION.
9 (B) PERMITTED SURGICAL PROCEDURES.--AN AMBULATORY SURGICAL <--
10 FACILITY MAY PERFORM ANY OF THE FOLLOWING SURGICAL PROCEDURES
11 WITHOUT SEEKING A REQUEST FOR AN EXCEPTION OR WAIVER OR
12 RECEIVING AN APPROVAL OF AN EXCEPTION OR WAIVER FROM THE
13 DEPARTMENT UNDER SUBSECTION (A):
14 (1) A SURGICAL PROCEDURE PERMITTED TO BE PERFORMED BY AN
15 AMBULATORY SURGICAL FACILITY UNDER FEDERAL OR STATE LAW OR
16 REGULATION.
17 (2) A SURGICAL PROCEDURE SPECIFIED IN ASC-CPL THAT DOES
18 NOT CONFLICT WITH A STATE LAW OR REGULATION.
19 (3) A SURGICAL PROCEDURE PUBLISHED IN A NOTICE UNDER
20 SUBSECTION (C)(1).
21 (C) PUBLICATION OF SURGICAL PROCEDURES.--
22 (1) WITHIN 45 DAYS OF THE EFFECTIVE DATE OF AN UPDATE TO
23 ASC-CPL MADE BY CMS, THE DEPARTMENT SHALL TRANSMIT NOTICE TO
24 THE LEGISLATIVE REFERENCE BUREAU FOR PUBLICATION IN THE
25 PENNSYLVANIA BULLETIN. THE NOTICE SHALL LIST THE SURGICAL
26 PROCEDURES SPECIFIED IN ASC-CPL AND THE UPDATE TO ASC-CPL
27 MADE BY CMS, EXCEPT FOR A SURGICAL PROCEDURE THAT IS
28 DISAPPROVED UNDER PARAGRAPH (2).
29 (2) FOR AN UPDATE TO ASC-CPL MADE BY CMS, THE DEPARTMENT
30 MAY DISAPPROVE A SURGICAL PROCEDURE IF THE DEPARTMENT FINDS
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 1 THAT THE SURGICAL PROCEDURE WOULD CONFLICT WITH STATE LAW OR
2 REGULATION.
3 (3) IF THE DEPARTMENT DISAPPROVES A SURGICAL PROCEDURE
4 UNDER PARAGRAPH (2), THE DEPARTMENT SHALL SPECIFY THE STATE
5 LAW OR REGULATION AND THE REASONS FOR THE DISAPPROVAL IN EACH
6 NOTICE PUBLISHED UNDER PARAGRAPH (1) FOR THE DURATION WHEN
7 THE DEPARTMENT MAINTAINS THE DISAPPROVAL OF THE SURGICAL
8 PROCEDURE.
9 (4) UPON PUBLICATION OF THE NOTICE UNDER PARAGRAPH (1),
10 OR WITHIN 60 DAYS OF THE EFFECTIVE DATE OF AN UPDATE TO ASC-
11 CPL MADE BY CMS, WHICHEVER IS EARLIER, AN AMBULATORY SURGICAL
12 FACILITY MAY PERFORM A SURGICAL PROCEDURE THAT HAS NOT BEEN
13 DISAPPROVED BY THE DEPARTMENT UNDER PARAGRAPH (2).
14 (5) THE DEPARTMENT'S DISAPPROVAL OF A SURGICAL PROCEDURE
15 UNDER PARAGRAPH (2) SHALL NOT BE CONSTRUED AS PROHIBITING THE
16 DEPARTMENT'S APPROVAL OF AN EXCEPTION OR WAIVER UNDER
17 SUBSECTION (A).
18 (6) THE DEPARTMENT SHALL PUBLISH AND CONTINUALLY
19 MAINTAIN A COMPLETE LIST OF SURGICAL PROCEDURES FROM ASC-CPL
20 THAT MAY BE PERFORMED OR ARE PROHIBITED FROM BEING PERFORMED
21 BY AN AMBULATORY SURGICAL FACILITY ON THE DEPARTMENT'S
22 PUBLICLY ACCESSIBLE INTERNET WEBSITE.
23 (B) REVIEW PERIOD.-- <--
24 (1) UPON RECEIPT OF A REQUEST FOR AN EXCEPTION OR WAIVER
25 UNDER SUBSECTION (A), THE DEPARTMENT SHALL, WITHIN 60
26 CALENDAR DAYS, PROVIDE A WRITTEN RESPONSE TO THE AMBULATORY
27 SURGICAL FACILITY THAT APPROVES OR DENIES THE REQUEST OR
28 SHALL PROVIDE NOTICE THAT THE DEPARTMENT IS UNABLE TO ISSUE A
29 DETERMINATION BECAUSE A SUBSTANTIVE ELEMENT IS MISSING THAT
30 IS NECESSARY FOR THE DEPARTMENT TO APPROVE OR DENY THE
20210SB0818PN1833 - 4 -
 1 REQUEST.
2 (2) IF THE DEPARTMENT DENIES THE REQUEST, THE DEPARTMENT
3 SHALL INCLUDE THE BASIS FOR THE DENIAL, INCLUDING STATUTORY
4 OR REGULATORY CITATIONS THAT FORM THE BASIS OF THE DENIAL.
5 (3) IF THE DEPARTMENT DETERMINES THAT IT IS UNABLE TO
6 ISSUE A DETERMINATION, THE DEPARTMENT SHALL SPECIFY THE
7 SUBSTANTIVE ELEMENT THAT IS NEEDED FOR THE FACILITY TO
8 RESUBMIT ITS REQUEST. UPON RECEIPT OF THE FACILITY'S
9 RESUBMITTED APPLICATION, THE DEPARTMENT SHALL APPROVE OR DENY
10 THE RESUBMITTED APPLICATION WITHIN 60 CALENDAR DAYS OF
11 RECEIPT OF THE RESUBMITTED APPLICATION. THE DEPARTMENT SHALL
12 DENY AN INCOMPLETE RESUBMITTED APPLICATION.
13 (4) IF THE DEPARTMENT DOES NOT APPROVE, DENY OR PROVIDE
14 NOTICE THAT THE DEPARTMENT IS UNABLE TO ISSUE A DETERMINATION
15 ON AN INITIAL APPLICATION OR DOES NOT APPROVE OR DENY A
16 RESUBMITTED APPLICATION WITHIN 60 CALENDAR DAYS, THE REQUEST
17 SHALL BE DEEMED APPROVED AND THE AMBULATORY SURGICAL FACILITY
18 MAY PROCEED AS IF THE REQUEST HAS BEEN APPROVED BY THE
19 DEPARTMENT.
20 (C) PERMITTED SURGICAL PROCEDURES.--AN AMBULATORY SURGICAL
21 FACILITY MAY PERFORM SURGICAL PROCEDURES PERMITTED UNDER FEDERAL
22 OR STATE LAW OR REGULATION AND SURGICAL PROCEDURES SPECIFIED ON
23 THE ASC-CPL ON THE EFFECTIVE DATE OF THIS SECTION THAT DO NOT
24 OTHERWISE CONFLICT WITH STATE REGULATIONS RELATING TO LICENSE
25 CLASSIFICATION, CONSTRUCTION AND DESIGN STANDARDS, PERSONNEL,
26 EQUIPMENT, GOVERNANCE AND MANAGEMENT AND NOTIFICATION
27 REQUIREMENTS. THE DEPARTMENT MAY NOT REQUIRE AN AMBULATORY
28 SURGICAL FACILITY TO REQUEST AN EXCEPTION OR WAIVER OR RECEIVE
29 AN APPROVAL OF AN EXCEPTION OR WAIVER TO 28 PA. CODE § 551.21(D)
30 (RELATING TO CRITERIA FOR AMBULATORY SURGERY) FROM THE
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 1 DEPARTMENT FOR SURGICAL PROCEDURES SPECIFIED IN ASC-CPL.
2 (D) DEFINITIONS.--AS USED IN THIS SECTION, THE FOLLOWING
3 WORDS AND PHRASES SHALL HAVE THE MEANINGS GIVEN TO THEM IN THIS
4 SUBSECTION:
5 "ASC-CPL." THE CMS 2022 AMBULATORY SURGICAL CENTER COVERED
6 PROCEDURES LIST, EFFECTIVE JANUARY 1, 2022.
7 "CMS." THE CENTERS FOR MEDICARE AND MEDICAID SERVICES.
8 "SUBSTANTIVE ELEMENT." MATERIAL INFORMATION NECESSARY FOR <--
9 THE DEPARTMENT TO APPROVE OR DENY A REQUEST FOR AN EXCEPTION OR
10 WAIVER.
11 SECTION 2. THE PROVISIONS OF 28 PA. CODE §§ 51.22 AND <--
12 551.21(D)(1), (2) AND (3) § 51.22 ARE ABROGATED. THE PROVISIONS <--
13 OF 28 PA. CODE CHS. 51 AND 551-571 ARE ABROGATED TO THE EXTENT <--
14 THAT THEY ARE INCONSISTENT WITH THE ADDITION OF SECTION 822 OF
15 THE ACT. NOTHING IN THIS SECTION SHALL BE CONSTRUED TO ABROGATE
16 REGULATIONS RELATING TO ENVIRONMENTAL SERVICES, FIRE AND SAFETY
17 SERVICES, CONSTRUCTION STANDARDS, PATIENT AND PEDIATRIC
18 STANDARDS, BOARD-CERTIFIED STANDARDS FOR PHYSICIANS AND
19 ANESTHESIA SERVICES. 28 PA. CODE § 551.21 ARE ABROGATED INSOFAR <--
20 AS THEY ARE INCONSISTENT WITH THE ADDITION OF SECTION 822 OF THE
21 ACT.
22 SECTION 3. THIS ACT SHALL TAKE EFFECT IN 60 DAYS.
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Statutes/Laws affected:
Printer's No. 1004: P.L.130, No.48
Printer's No. 1327: P.L.130, No.48
Printer's No. 1617: P.L.130, No.48, P.L.130, NO.48
Printer's No. 1833: P.L.130, No.48, P.L.130, NO.48