New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33 - CERTIFICATE OF NEED: APPLICATION AND REVIEW PROCESS › Subchapter 3 - TYPES OF CERTIFICATE OF NEED APPLICATIONS › Section 8:33-3.11 - Demonstration and research projects

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Projects which
				satisfy the definition of a research project, as specified at
				8:33-1.3, shall be exempt from
				certificate of need requirements as long as they are conducted exclusively for the
				purposes of investigational studies and scientific research.
(b) At the conclusion of the research project, the
				health care services and equipment provided in the course of the research shall no
				longer have certificate of need exemption status. At that time, if the services and
				equipment used are to be continued such that they shall be provided to the general
				population or where billings for such services or equipment shall occur or
				reimbursement received, a certificate of need where applicable shall be obtained in
				accordance with the provisions of this chapter and all other applicable health
				planning rules.
(c) The Commissioner
				shall accept certificate of need applications for the State demonstration project
				from eligible hospitals, which are those facilities holding Department licensure to
				participate in the Atlantic C-PORT-E registry as of August 17, 2015.
1. An eligible hospital that elects to participate
				in the State demonstration project shall submit to the Department a completed
				certificate of need application , in accordance with the expedited review process at
				8:33-5.2, and a non-refundable
				application fee of $ 7,500, by September 16, 2015.
2. At the time of submission of a certificate of
				need application, an applicant hospital shall also provide the Department
				documentation that supports adherence within the past year to the protocol set forth
				in the Atlantic C-PORT-E Manual of Operations, listed below:
i. Performance of a minimum of 200 PCI cases at
				the participating hospital;
ii.
				Performance of at least 75 PCI cases per interventionalist; iii. Patient selection
				protocols; and iv. Device limitations.
3. If the Department denies an application for a
				certificate of need pursuant to
				8:33-5.2 to participate in the State
				demonstration project, the applicant hospital shall cease performing elective PCI
				within 30 days of receipt of the letter of denial.
i. An applicant hospital that receives a letter of
				denial pursuant to (c)3 above has the right to appeal the Department's decision in
				accordance with 8:33-4.15.
4. If the Department approves an application for a
				certificate of need pursuant to
				8:33-5.2 for participation in the State
				demonstration project, an applicant hospital that obtains licensure to perform
				elective PCI within the State demonstration project shall:
i. Perform a minimum of 200 PCI cases per year at
				the participating hospital, in accordance with
				8:33E-2.3(d),
				calculated based on the last four quarters of operation prior to the facility's
				licensure anniversary date;
ii. Ensure
				that each of its interventionalists perform at least 75 PCI cases per year per
				interventionalist, in accordance with
				8:33E-2.3(d),
				calculated on a calendar-year basis;
iii. Designate for the cardiac catheterization
				laboratory a medical director who is licensed in New Jersey as a physician,
				board-certified in Interventional Cardiology by the Cardiovascular Subspecialty
				Board of the American Board of Internal Medicine, and responsible for maintaining
				compliance with, and assuring the overall integrity of, the hospital's participation
				in the State demonstration project;
iv.
				Provide support staff to assist with elective PCI in accordance with
				8:33E-2.4(e)  and
				8:43G-7.29 and 7.30;
v. Provide registered professional nurses licensed
				in New Jersey who possess demonstrated competencies in hemodynamic monitoring and
				intra-aortic balloon pump (IABP) management;
vi. Provide cardiac catheterization laboratory
				technical staff who have been trained at an interventional laboratory in a cardiac
				surgery center, in accordance with
				8:33E-2.16(b)7;
vii. Provide cardiac catheterization laboratory
				equipment required at
				8:33E-2.16(b)8  and
				8:43G-7.19;
viii. Provide primary PCI in accordance with
				8:33E-2.16 and 8:43G-7, as
				applicable;
ix. Obtain from each
				enrolled patient written informed consent for participation in the State
				demonstration project as set forth at (c)5 below;
x. Comply with patient selection protocols at (c)9
				and 10 below;
xi. Comply with
				exclusionary criteria for patients with high procedural risk at (c)11
				below;
xii. Comply with device
				limitations at (c)12 below;
xiii. Obtain
				written approval from the participant hospital's Institutional Review Board (IRB) of
				the State demonstration project protocols prior to licensure for elective
				PCI;
xiv. Report to the Data Monitor all
				available patient data and any additional information as requested by the Department
				and/or the Data Monitor to assess the safety and efficacy outcomes of the State
				demonstration project;
xv. Maintain, as
				part of the participating hospital's quality assessment program, an ongoing program
				of outcomes analysis and periodic case review;
xvi. Maintain the equivalent of one full-time
				employee (FTE) responsible for the timely and accurate collection and submission of
				data on each elective PCI case , who shall initiate submission of data to the Data
				Monitor within 24 hours of procedure completion and complete such submission as
				promptly as possible in accordance with
				8:33E-1.9 and 2.10;
xvii. Report to the Data Monitor, within 72 hours
				thereof, the occurrence of a death from any cause, a need for emergency cardiac
				surgery, and other events as the Data Monitor may identify, and, within seven days
				thereof, the occurrence of other adverse events such as recurrent myocardial
				infarction, stroke, bleeding, a need for vascular surgery or repair, unplanned
				cardiac catheterization, a subsequent PCI and/or CABG for any reason, or renal
				failure; and
xviii. Compensate the Data
				Monitor for costs associated with reviewing the participating hospital's performance
				in the State demonstration project as set forth at N.J.A.C. 8:33-1.3.
5. Participating hospitals shall ensure
				that each enrolled patient provides written informed consent pursuant to (c)6 below
				to participate in the State demonstration project :
i. Before the commencement of diagnostic cardiac
				catheterization;
ii. After a patient has
				received primary PCI at a participating hospital and before the patient undergoes
				elective PCI at that hospital; or
iii.
				After a patient has received diagnostic cardiac catheterization at a
				non-participating hospital and before the patient undergoes elective PCI at a
				participating hospital;
6.
				Participating hospitals shall ensure that patients receive* the following
				information and an opportunity to review and consider such information before being
				asked to consent in writing to participate in the State demonstration project:
i. Elective PCI without surgery on site is not
				permitted in New Jersey except as part of the State demonstration project;
ii. Elective PCI is performed in hospitals with
				surgery on site because emergency cardiac surgery may be required for
				procedure-related complications;
iii. If
				an enrolled patient requires emergency cardiac surgery, the participating hospital
				has a plan in place for emergency transfer;
iv. An enrolled patient may not be eligible for
				elective PCI at a participating hospital if the enrolled patient needs cardiac
				surgery, meets the exclusionary criteria for patients with high procedural risk for
				elective PCI at (c)12 below, or requires treatment that is not available at the
				participating hospital;
v. For
				ineligibility based on the reasons cited in (c)6iv above, a participating hospital
				would transfer an enrolled patient to a licensed cardiac surgery center for
				appropriate care; and
vi. A
				participating hospital is required to share an enrolled patient's medical
				information with the Data Monitor and the Department, who shall treat such
				information confidentially.
7. The participating hospital's IRB shall approve
				the individual that the hospital designates to provide information to, and obtain
				written informed consent from, enrolled patients.
8. Each participating hospital shall have a
				collaboration agreement with a New Jersey cardiac surgery center located, in the
				following order of preference:
i. In the same
				municipality as that in which the applicant is located;
ii. In the same county as that in which the
				applicant is located; or
iii. In a
				county that is contiguous to the county in which the applicant is located.
9. The documented collaboration
				agreement required pursuant to (c)8 above shall include the following:
i. 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 transport of patients who require an IABP;
ii. Regular consultation between the two hospitals
				on individual cases, including use of technology to share case information in a
				rapid manner; and
iii. Evidence of
				adequate cardiac surgery on-call backup.
10. Participating hospitals shall limit enrollment
				in the State demonstration project to those inpatients and outpatients undergoing
				diagnostic cardiac catheterization for suspected coronary artery disease who do not
				exhibit any of the following exclusionary criteria:
i. Inability to give informed consent;
ii. ST-segment elevation myocardial
				infarction;
iii. Pregnancy; or
iv. Refusal to participate in the State
				demonstration project.
11.
				Following diagnostic cardiac catheterization and prior to performing PCI services,
				participating hospitals shall not perform PCI on enrolled patients who demonstrate
				the following:
i. No need for PCI;
ii. Need for coronary artery bypass
				surgery;
iii. High procedural risk as
				defined at (c)12 below; or
iv. High
				likelihood of requiring a device that is not available at the participating hospital
				as defined at (c)13 below.
12. Participating hospitals shall not perform
				elective PCI on enrolled patients who, upon completion of a diagnostic cardiac
				catheterization, exhibit any of the following criteria for high procedural risk:
i. Unprotected left main coronary
				artery;
ii. Left circulation lesion in
				the presence of greater than 70 percent unprotected left main coronary artery
				lesion; or
iii. Poor left ventricular
				function with an ejection fraction of 20 percent or less, and need for PCI in a
				vessel supplying to significant myocardium.
13. Participating hospitals shall not use the
				following devices in PCI services:
i. Any
				atherectomy device; or
ii. Cutting
				balloons, except within stents for in-stent restenosis.
14. Participating hospitals licensed to provide
				elective PCI under the State demonstration project shall comply with
				8:33E-2.3(d), as
				applicable, this chapter, and any conditions imposed in its certificate of need as a
				condition of licensure.
15.
				Participating hospitals that discontinue participation in the State demonstration
				project, whether voluntarily or involuntarily, shall immediately cease performing
				elective PCI and, within 30 days of discontinuation, shall return to the Department
				the license authorizing participation in the State demonstration project.
16. Upon termination of the State demonstration
				project, all participating hospitals shall immediately cease performing elective PCI
				and shall return the demonstration project license to the Department.
17. Notwithstanding (d)4 below, and the
				Department's intention that the State demonstration project will last no more than
				18 months, the State demonstration project shall be in effect until the Department
				promulgates new rules at N.J.A.C. 8:33E for elective angioplasty without cardiac
				surgery backup and issues licenses under those rules, and establishes the following:
i. Minimum standards by which hospitals may
				perform elective PCI without cardiac surgery backup.
ii. A Statewide certificate of need call for a
				limited number of hospitals to provide elective PCI without cardiac surgery on-site
				under the full review process.