S2427

An Act concerning hospital licensure to perform certain cardiac procedures, amending P.L.1992, c.160, and supplementing Title 26 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. (New section) As used in this act:

“Angioplasty” or “percutaneous coronary intervention” means the mechanical reopening of an occluded vessel in the heart or corona using a balloon-tipped catheter.

“Applicant hospital” means a general hospital that has entered into a collaboration agreement with a cardiac surgery center licensed in New Jersey.

“C-PORT-E study” means the Atlantic Cardiovascular Patient Outcomes Research Team Elective Angioplasty Study clinical trial.

“Collaboration agreement” means an agreement between a licensed cardiac surgery center and a general hospital that includes:

(1) written protocols for enrolled patients who require transfer to, and receipt at, a cardiac surgery center’s operating room within one hour of the determination of the need for such transfer, including the emergency transfer of patients who require an intra-aortic balloon pump;

(2) regular consultation between the two hospitals on individual cases, including use of technology to share case information in a rapid manner; and

(3) evidence of adequate cardiac surgery on-call backup.

“Commissioner” means the Commissioner of Health.

“Department” means the Department of Health.

“Elective angioplasty” means an angioplasty or percutaneous coronary intervention performed on a non-emergent basis.

“Primary angioplasty” means an angioplasty or percutaneous coronary intervention performed on an acute or emergent basis.

2. (New section) a. An applicant hospital may apply to the commissioner for a license to provide full service diagnostic cardiac catheterization services. The commissioner shall issue a license pursuant to such application to any hospital that:

(1) is not licensed as a cardiac surgery center;

(2) is licensed by the department to provide low-risk catheterization services;

(3) demonstrates the ability to provide full service diagnostic catheterization services consistent with national standards of care and current best practices;

(4) commencing in the second year of licensure pursuant to this subsection, and in each year thereafter, performs at least 250 catheterizations per year, with each interventional cardiologist performing at least 50 catheterizations per year; and

(5) meets such other requirements as the commissioner may establish by regulation.

b. An applicant hospital may apply to the commissioner for a license to provide primary angioplasty services. The commissioner shall issue a license pursuant to such application to any hospital that:

(1) is not licensed as a cardiac surgery center;

(2) has been licensed for at least six months pursuant to subsection a. of this section to provide full service diagnostic catheterization services;

(3) demonstrates the ability to provide primary angioplasty services consistent with national standards of care and current best practices; and

(4) meets such other requirements as the commissioner may establish by regulation.

c. An applicant hospital may apply to the commissioner for a license to provide elective angioplasty services. The commissioner shall issue a license pursuant to such application to any hospital that:

(1) is not licensed as a cardiac surgery center;

(2) holds licensure to participate in the C-PORT-E study or the Elective Angioplasty Demonstration Project, or is an applicant hospital licensed by the department to provide primary angioplasty services pursuant to subsection b. of this section;

(3) demonstrates the ability to provide elective angioplasty services consistent with national standards of care and current best practices;

(4) commencing in the second year of licensure pursuant to this subsection, and in each year thereafter, performs a minimum of 200 elective angioplasty procedures per year, with each interventional cardiologist performing at least 75 elective angioplasty procedures per year; and

(5) meets such other requirements as the commissioner may establish by regulation.

d. The commissioner may waive any requirement for licensure established pursuant to this section based on the applicant hospital’s special need or the applicant hospital’s special experience with cardiac and endovascular catheterizations.

3. (New section) Prior to performing any procedure authorized under a license issued pursuant to section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill), the applicant hospital shall furnish the following information to the patient and afford the patient the opportunity to review and consider such information before being asked to consent in writing to the procedure:

a. notice that the procedure is not being performed at a licensed cardiac surgery center, and in the event that the patient requires emergency cardiac surgery, the patient will be transferred to a licensed cardiac surgery center; and

b. details concerning the applicant hospital’s plan and protocols for transferring patients who require emergency cardiac surgery, including the name and location of the cardiac surgery center with which the applicant hospital has entered into a collaboration agreement.

The applicant hospital shall, upon request, furnish the patient with a written copy of the hospital’s transfer protocols and a summary of the collaboration agreement.

4. Section 19 of P.L.1992, c.160 (C.26:2H-7a) is amended to read as follows:

19. Notwithstanding the provisions of section 7 of P.L.1971, c.136 (C.26:2H-7) to the contrary, the following are exempt from the certificate of need requirement:

Community-based primary care centers;

Outpatient drug and alcohol services;

Hospital-based medical detoxification for drugs and alcohol;

Ambulance and invalid coach services;

Mental health services which are non-bed related outpatient services;

Full service diagnostic catheterization services, primary angioplasty services, and elective angioplasty services in accordance with a license issued under section 2 of P.L. , c. (C.) (pending before the Legislature as this bill);

Residential health care facility services;

Dementia care homes;

Capital improvements and renovations to health care facilities;

Additions of medical/surgical, adult intensive care and adult critical care beds in hospitals;

Inpatient special psychiatric beds used solely for services for patients with co-occurring mental health and substance use disorders;

Replacement of existing major moveable equipment;

Inpatient operating rooms;

Alternate family care programs;

Hospital-based subacute care;

Ambulatory care facilities;

Comprehensive outpatient rehabilitation services;

Special child health clinics;

New technology in accordance with the provisions of section 18 of P.L.1998, c.43 (C.26:2H-7d);

Transfer of ownership interest except in the case of an acute care hospital;

Change of site for approved certificate of need within the same county;

Additions to vehicles or hours of operation of a mobile intensive care unit;

Relocation or replacement of a health care facility within the same county, except for an acute care hospital;

Continuing care retirement communities authorized pursuant to P.L.1986, c.103 (C.52:27D-330 et seq.);

Magnetic resonance imaging;

Adult day health care facilities;

Pediatric day health care facilities;

Chronic or acute renal dialysis facilities; and

Transfer of ownership of a hospital to an authority in accordance with P.L.2006, c.46 (C.30:9-23.15 et al.).

(cf: P.L.2017, c.94, s.1)

5. The Commissioner of Health may, pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), adopt such rules and regulations as shall be necessary to implement the provisions of this act.

6. This act shall take effect immediately.

STATEMENT

This bill requires the Department of Health (DOH) to license certain hospitals to provide full service diagnostic cardiac catheterization, primary angioplasty, and elective angioplasty services.

Specifically, the bill provides that a hospital that is not a licensed cardiac surgery center may apply to the Commissioner of Health:

· For a license to provide full service diagnostic cardiac catheterization services, provided the hospital is licensed by DOH to provide low-risk catheterization services and, commencing in the second year of licensure, and in each year thereafter, performs at least 250 catheterizations per year, with each interventional cardiologist performing at least 50 catheterizations per year;

· For a license to provide primary angioplasty services, which are angioplasty procedures performed on an acute or emergency basis, provided the hospital has been licensed to provide full service diagnostic catheterization services under the bill for at least six months; and

· For a license to provide elective angioplasty services, provided the hospital is licensed to provide primary angioplasty services under the bill or was licensed to participate in the Atlantic Cardiovascular Patient Outcomes Research Team Elective Angioplasty Study (C-PORT-E) clinical trial or the State Elective Angioplasty Demonstration Project, and, commencing in the second year of licensure, and in each year thereafter, performs a minimum of 200 elective angioplasty procedures per year, with each interventional cardiologist performing at least 75 elective angioplasty procedures per year.

A hospital applying for licensure under the bill will be required to enter into a collaboration agreement with a licensed cardiac surgery center; the agreement is to include written protocols for transferring patients requiring emergency cardiac surgery to the licensed cardiac surgery center, regular consultation between the hospitals on individual cases, and evidence of adequate cardiac surgery on-call backup. Applicant hospitals will further be required to demonstrate the ability to provide services consistent with national standards of care and current best practices and to meet any other requirements established by the commissioner by regulation. The commissioner will be permitted to waive any requirement for licensure based on the applicant hospital’s special need or the applicant hospital’s special experience with cardiac and endovascular catheterizations.

Before providing services authorized pursuant to a license issued under the bill or requesting written consent for the procedures, a hospital will be required to ensure that patients receive, and have an opportunity to review, written notice providing that the procedure is not being performed at a licensed cardiac surgery center, the patient will be transferred to a licensed cardiac surgery center in the event of an emergency, and the name and location of the cardiac surgery center with which the applicant hospital has entered into a collaboration agreement. The hospital is to additionally provide patients, upon request, with a written copy of the hospital’s transfer protocols and a summary of the collaboration agreement. The bill provides an exception from the certificate of need requirement for diagnostic catheterization and angioplasty services authorized by a license issued under the bill.

Angioplasty, which is also known as percutaneous coronary intervention (PCI), is a procedure used to widen clogged arteries and help remove blockages, restoring blood flow and potentially reducing the risk of an adverse cardiac event. In 2012, the C-PORT-E study found that there is no increased risk of death or complications from an elective angioplasty procedure performed at a facility that does not have cardiac surgery capabilities, as compared with a licensed cardiac surgery center.

It is the sponsor’s belief that expanding the number of facilities that are authorized to perform certain cardiac interventions, consistent with studies suggesting that these procedures can safely and routinely be performed outside of licensed cardiac surgery centers, will improve access to high quality cardiovascular care for patients throughout New Jersey.