Bill Text: CA AB3083 | 2019-2020 | Regular Session | Amended


Bill Title: Ambulatory surgical centers.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced) 2020-05-21 - Re-referred to Com. on APPR. [AB3083 Detail]

Download: California-2019-AB3083-Amended.html

Amended  IN  Assembly  May 20, 2020

CALIFORNIA LEGISLATURE— 2019–2020 REGULAR SESSION

Assembly Bill
No. 3083


Introduced by Assembly Member Arambula

February 21, 2020


An act to amend Section 1255 of, to add Section 1256.015 to, and to add Article 5 (commencing with Section 100923) to Chapter 4 of Part 1 of Division 101 of, the Health and Safety Code, relating to health facilities.


LEGISLATIVE COUNSEL'S DIGEST


AB 3083, as amended, Arambula. Ambulatory surgical centers.
(1) Existing law establishes the Elective Percutaneous Coronary Intervention (PCI) Program within the State Department of Public Health to allow the department to certify certain general acute care hospitals that are licensed to provide urgent and emergent cardiac catheterization laboratory service to perform scheduled, elective percutaneous transluminal coronary angioplasty and stent placement for eligible patients.
This bill would enact the California Outpatient Cardiology Patient Safety, Cost Reduction, and Quality Improvement Act. The bill would authorize the department, within the PCI Program, to certify an ambulatory surgical center to provide elective cardiac catheterization laboratory services that meet certain requirements to perform scheduled, elective percutaneous transluminal coronary angioplasty and stent placement for eligible patients. The bill would authorize the department to, among other things, charge a certified ambulatory surgical center a fee for the reasonable regulatory costs to the state incident to granting this certification and to retain experts or establish one or more committees to analyze reports and advise the department, as specified. The bill would require the Office of Statewide Health Planning and Development to annually report each certified ambulatory surgical center’s performance on mortality, stroke rate, and emergency coronary artery bypass graft rate.
(2) Existing law authorizes the State Department of Public Health to license a freestanding cardiac catheterization laboratory that meets certain requirements, including having been active in a completed pilot program as a freestanding cardiac catheterization laboratory.
This bill would authorize, beginning on January 1, 2021, an ambulatory surgical center certified to participate in the Medicare Program to perform cardiac catheterization laboratory services if certain requirements are met, including, among others, that the ambulatory surgical center complies with specified department regulations and only performs procedures on adults in an outpatient basis.
(3) This bill would also make legislative findings and declarations in support of its provisions.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 This act shall be known, and may be cited, as the California Outpatient Cardiology Patient Safety, Cost Reduction, and Quality Improvement Act.

SEC. 2.

 The Legislature finds and declares as follows:
(a) Medicare has approved for 2020 the addition of total knee replacement, diagnostic cardiology procedures, and several interventional therapeutic cardiology procedures, such as angioplasties and stents, to be performed in the ambulatory surgical center (ASC) setting. In its final rule, the Medicare Program stated these procedures do not pose a significant risk when performed in an ASC.
(b) In response to Medicare, the American College of Cardiology stated that allowing these cardiac catheterization and concomitant procedures to be performed in an ASC is consistent with the Centers for Medicare and Medicaid Services (CMS) goals to expand access to care and encourage the delivery of care in the lowest cost setting. Similarly, the national Society for Cardiovascular Angiography and Interventions (SCAI) stated that elective, nonemergent percutaneous coronary angioplasty and coronary stenting procedures have relatively low complication rates, are not expected to pose a significant risk to Medicare beneficiaries, and do not typically require inpatient-level care following the procedure.
(c) According to research published by the University of California at Berkeley, every procedure performed in an ASC saves the Medicare Program 40 percent in costs and saves Medicare beneficiaries 50 to 60 percent on their copayments.
(d) Independent national research also shows that for commercial health plans, ASCs result in more than $5,000,000,000 in cost reductions through lower deductibles and coinsurance payments for patients.
(e) Data and quality reporting show strong measures of patient safety and positive patient outcomes at ASCs. There are two ASC quality reporting programs that make their results publicly accessible online: Medicare’s Ambulatory Surgical Center Quality Reporting (ASCQR) Program, which is operated by CMS, and a program coordinated by the ASC Quality Collaboration (ASCQC) that includes ASC operators and centers and ASC associations, professional societies, and accrediting bodies that focus on health care quality and safety.
(f) California ASCs are regulated by several rigorous processes including Medicare certification, California state licensure, and national accreditation. All ASCs treating Medicare patients are overseen by the State Department of Public Health through their contract with CMS.
(g) Based on the Medicare Program authorizing diagnostic and interventional therapeutic cardiac catheterization procedures in certified ASCs under Title XVIII of the federal Social Security Act (42 U.S.C. Sec. 1395 et seq.), it is the intent of the Legislature that those Medicare-certified ASCs be deemed to provide diagnostic and interventional therapeutic cardiac catheterization procedures in nonhospital settings and that these ASCs maintain the quality of the diagnostic procedures while also reducing the cost of care.
(h) It is the intent of the Legislature in enacting this act to ensure that patients receive the safest, highest quality care in the lowest cost setting possible, and that expanding certain cardiac procedures in ASCs will reduce health care costs overall without compromising patient safety, while relieving limited hospital resources for the patients and procedures that need them.

SEC. 3.

 Section 1255 of the Health and Safety Code is amended to read:

1255.
 (a) In addition to the basic services offered under the license, a general acute care hospital may be approved in accordance with subdivision (c) of Section 1277 to offer special services, including, but not limited to, the following:
(1) Radiation therapy department.
(2) Burn center.
(3) Emergency center.
(4) Hemodialysis center (or unit).
(5) Psychiatric.
(6) Intensive care newborn nursery.
(7) Cardiac surgery.
(8) Cardiac catheterization laboratory.
(9) Renal transplant.
(10) Other special services as the department may prescribe by regulation.
(b) A general acute care hospital that exclusively provides acute medical rehabilitation center services may be approved in accordance with subdivision (b) of Section 1277 to offer special services not requiring surgical facilities.
(c) The department shall adopt standards for special services and other regulations as may be necessary to implement this section.
(d) (1) For cardiac catheterization laboratory service, the department shall, at a minimum, adopt standards and regulations that specify that only diagnostic services, and what diagnostic services, may be offered by a general acute care hospital or a multispecialty clinic as defined in subdivision (l) of Section 1206 that is approved to provide cardiac catheterization laboratory service but is not also approved to provide cardiac surgery service, together with the conditions under which the cardiac catheterization laboratory service may be offered.
(2) Except as provided in paragraph (3), a cardiac catheterization laboratory service shall be located in a general acute care hospital that is either licensed to perform cardiovascular procedures requiring extracorporeal coronary artery bypass that meets all of the applicable licensing requirements relating to staff, equipment, and space for service, or shall, at a minimum, have a licensed intensive care service and coronary care service and maintain a written agreement for the transfer of patients to a general acute care hospital that is licensed for cardiac surgery or shall be located in a multispecialty clinic as defined in subdivision (l) of Section 1206. The transfer agreement shall include protocols that will minimize the need for duplicative cardiac catheterizations at the hospital in which the cardiac surgery is to be performed.
(3) Commencing March 1, 2013, a general acute care hospital that has applied for program flexibility on or before July 1, 2012, to expand cardiac catheterization laboratory services may utilize cardiac catheterization space that is in conformance with applicable building code standards, including those promulgated by the Office of Statewide Health Planning and Development, provided that all of the following conditions are met:
(A) The expanded laboratory space is located in the building so that the space is connected to the general acute care hospital by an enclosed all-weather passageway that is accessible by staff and patients who are accompanied by staff.
(B) The service performs cardiac catheterization services on no more than 25 percent of the hospital’s inpatients who need cardiac catheterizations.
(C) The service complies with the same policies and procedures approved by hospital medical staff for cardiac catheterization laboratories that are located within the general acute care hospital, and the same standards and regulations prescribed by the department for cardiac catheterization laboratories located inside general acute care hospitals, including, but not limited to, appropriate nurse-to-patient ratios under Section 1276.4, and with all standards and regulations prescribed by the Office of Statewide Health Planning and Development. Emergency regulations allowing a general acute care hospital to operate a cardiac catheterization laboratory service shall be adopted by the department and by the Office of Statewide Health Planning and Development by February 28, 2013.
(D) Emergency regulations implementing this paragraph have been adopted by the department and by the Office of Statewide Health Planning and Development by February 28, 2013.
(E) This paragraph shall not apply to more than two general acute care hospitals.
(4) After March 1, 2014, an acute care hospital may only operate a cardiac catheterization laboratory service pursuant to paragraph (3) if the department and the Office of Statewide Health Planning and Development have adopted regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code that provide adequate protection to patient health and safety including, but not limited to, building standards contained in Part 2.5 (commencing with Section 18901) of Division 13.
(5) Notwithstanding Section 129885, cardiac catheterization laboratory services expanded in accordance with paragraph (3) shall be subject to all applicable building standards. The Office of Statewide Health Planning and Development shall review the services for compliance with the OSHPD 3 requirements of the most recent version of the California Building Standards Code.
(e) For purposes of this section, “multispecialty clinic,” as defined in subdivision (l) of Section 1206, includes an entity in which the multispecialty clinic holds at least a 50-percent general partner interest and maintains responsibility for the management of the service, if all of the following requirements are met:
(1) The multispecialty clinic existed as of March 1, 1983.
(2) Prior to March 1, 1985, the multispecialty clinic did not offer cardiac catheterization services, dynamic multiplane imaging, or other types of coronary or similar angiography.
(3) The multispecialty clinic creates only one entity that operates its service at one site.
(4) These entities shall have the equipment and procedures necessary for the stabilization of patients in emergency situations prior to transfer and patient transfer arrangements in emergency situations that shall be in accordance with the standards established by the Emergency Medical Services Authority, including the availability of comprehensive care and the qualifications of any general acute care hospital expected to provide emergency treatment.
(f) Except as provided in this section, Sections 100921 and 100922, and Article 5 (commencing with Section 100923) of Chapter 4 of Part 1 of Division 101, under no circumstances shall cardiac catheterizations be performed outside of a general acute care hospital or a multispecialty clinic, as defined in subdivision (l) of Section 1206, that qualifies for this definition as of March 1, 1983.

SEC. 4.

 Section 1256.015 is added to the Health and Safety Code, immediately following Section 1256.01, to read:

1256.015.
 (a) Within the Elective Percutaneous Coronary Intervention (PCI) Program established pursuant to Section 1256.01, the department may certify an ambulatory surgical center to provide elective cardiac catheterization laboratory services that meet the requirements of this section and to perform scheduled, elective percutaneous transluminal coronary angioplasty and stent placement for eligible patients.
(b) For purposes of this section, the following terms have the following meanings:
(1) “Certified ambulatory surgical center” means an eligible ambulatory surgical center that is certified by the department pursuant to this section.
(2) “Elective Percutaneous Coronary Intervention (elective PCI)” means scheduled percutaneous transluminal coronary angioplasty and stent placement service approved by the Medicare Program under Title XVIII of the federal Social Security Act (42 U.S.C. Sec. 1395 et seq.).
(3) “Eligible ambulatory surgical center” means an ambulatory surgical center certified to participate in the Medicare Program under Title XVIII of the federal Social Security Act (42 U.S.C. Sec. 1395 et seq.), that does not have onsite cardiac surgery, and is in substantial compliance with all applicable state and federal laws and regulations.
(4) “Interventionist” means a licensed cardiologist who meets all of the requirements for performing an elective PCI.
(c) The department shall certify an eligible ambulatory surgical clinic that meets all of the following requirements:
(1) Demonstrates that the ambulatory surgical center complies with the recommendations of the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology Foundation, and the American Heart Association for the performance of PCI without onsite cardiac surgery, as those recommendations may evolve over time.
(2) Provides evidence showing the full support from ambulatory surgical center administration in fulfilling the necessary institutional requirements, including, but not limited to, appropriate support services such as respiratory care and blood banking.
(3) Participates in, and provides timely submission of data to, the American College of Cardiology National Cardiovascular Data Registry.
(4) Confers rights to transfer the data submitted pursuant to paragraph (3) to the Office of Statewide Health Planning and Development.
(5) Is not located within 30 minutes travel distance of another facility certified to provide PCI without onsite surgery.

(5)

(6) Any additional requirements the department deems necessary to protect patient safety or ensure quality of care.
(d) (1) An eligible ambulatory surgical center shall submit an application to the department pursuant to Section 1265 to obtain certification to participate in the Elective PCI Program. The application shall include sufficient information, as determined by the department, to demonstrate compliance with the standards set forth in this section, and shall also include the effective date for initiating elective PCI service, the general service area, a description of the population to be served, a description of the services to be provided, a description of backup emergency services, the availability of comprehensive care, and the qualifications of the eligible ambulatory surgical center. The department may require that additional information be submitted with the application.
(2) Failure to submit any criteria or additional information required by this section or the department shall disqualify the applicant from the application process and from consideration for participation in the program. The department may deny an Elective PCI Program application pursuant to Article 2 (commencing with Section 1265).
(e) The Office of Statewide Health Planning and Development shall, using the data transferred pursuant to paragraph (4) of subdivision (c), annually develop and make available to the public a report regarding each certified ambulatory surgical center’s performance on mortality and stroke rate of ambulatory surgical centers certified pursuant to this section.
(f) The department may retain experts or establish one or more committees to analyze a report issued pursuant to this section and to advise the department on recommendations to improve the performance on mortality and stroke rate of ambulatory surgical centers certified pursuant to this section.
(g) If at any time a certified ambulatory surgical center fails to meet the criteria for being a certified ambulatory surgical center as set forth in this section or fails to safeguard patient safety, as determined by the department, the department may suspend or revoke, pursuant to Section 70309 of Title 22 of the California Code of Regulations, the certification issued to that ambulatory surgical center. An ambulatory surgical center whose certification is revoked pursuant to this subdivision may request an appeal with the department and is not precluded from reapplying for certification under this section.
(h) The department may charge a certified ambulatory surgical center a fee for the reasonable regulatory costs to the state incident to this section for issuing licenses and permits, performing investigations, inspections, and audits, and the administrative enforcement and adjudication thereof.
(i) The department may contract with a professional entity with medical program knowledge to meet the requirements of this section.

SEC. 5.

 Article 5 (commencing with Section 100923) is added to Chapter 4 of Part 1 of Division 101 of the Health and Safety Code, to read:
Article  5. Ambulatory Surgical Centers

100923.
 (a) An ambulatory surgical center certified to participate in the Medicare Program under Title XVIII of the federal Social Security Act (42 U.S.C. Sec. 1395 et seq.) may perform cardiac catheterization laboratory services pursuant to this article, only if all the following requirements are met:
(1) The ambulatory surgical center maintains a current written transfer agreement, as specified in Section 1255, which shall include all of the following:
(A) Provisions for emergency and routine transfer of patients.
(B) Provisions that specify cardiac surgery staff and facilities shall be immediately available to the patient upon notification of an emergency.
(C) Provisions that specify the cardiac catheterization staff shall have responsibility for arranging transportation to the receiving hospitals.
(2) The ambulatory surgical center complies with all of the following regulations as they existed on January 1, 2021: 2020:
(A) Subdivisions (a) and (b) of, paragraph (1) of subdivision (c) of, and subdivisions (e), (i), and (j) of, Section 70433 of Title 22 of the California Code of Regulations.
(B) Subdivision (a) of Section 70435 of Title 2 22 of the California Code of Regulations.
(C) Subdivision (a) of Section 70437 of Title 2 22 of the California Code of Regulations.
(3) The ambulatory surgical center has a system for the ongoing evaluation of its operations and the services it provides that includes a written plan for evaluating the efficiency and effectiveness of its health care services describing all of the following:
(A) The scope of services provided.
(B) Measurement indictors regarding the processes and outcomes of the services provided.
(C) The assignment of responsibility when the data from the measurement indicators demonstrates the need for action.
(D) A mechanism to ensure followup evaluation of the effectiveness of the actions taken.
(E) An annual evaluation of the plan.
(b) (1) An ambulatory surgical center, pursuant to this article, shall only perform its procedures on adults in an outpatient basis and shall define patient characteristics that are appropriate for the safe performance of procedures in the ambulatory surgical center, including evaluation of these criteria in its quality assurance process. In evaluating patient risk and lesion risk to determine patient eligibility, the interventionist shall apply the strategy set forth by the Society for Cardiovascular Angiography and Interventions (SCAI) as follows, or as it may otherwise evolve:
(i) A high-risk patient with a high-risk lesion shall not be eligible.
(ii) A high-risk patient with a not high-risk lesion may be eligible upon confirmation that a cardiac surgeon and an operating room are immediately available if necessary.
(iii) A not high-risk patient with a high-risk lesion may be eligible.
(iv) A not high-risk patient with a not high-risk lesion may be eligible.
(2) Only the following diagnostic procedures shall be performed in the ambulatory surgical center:
(A) Right heart catherization and angiography.
(B) Right and left heart catherization and angiography.
(C) Left heart catherization and angiography.
(D) Coronary angiography.
(E) Electrophysiology studies.
(F) Myocardial biopsy.
(c) Notwithstanding the requirements already set forth in this section, an ambulatory surgical center performing services pursuant to this article shall comply with all other applicable federal, state, and local laws.
(d) This section shall become operative on January 1, 2021, and does not require the department to adopt regulations.

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