N.J. Admin. Code § 8:33-3.11

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:33-3.11 - Demonstration and research projects

(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.

(d) The Commissioner shall accept certificate of need applications for bloodless surgery demonstration projects in accordance with the provisions of the expedited review process set forth at 8:33-5.1(a) following a call for applications.

1. The Commissioner shall approve, in writing, no more than two certificate of need applications for bloodless surgery demonstration projects in any consecutive 24-month period, beginning on August 16, 1999.

2. The Commissioner shall approve each bloodless surgical demonstration project for a period of no more than 30 months from the date of notice of the written approval, but the Commissioner, in his or her discretion, may extend the date of termination of a demonstration project upon written request made by the hospital approved for the bloodless surgical demonstration project, and the extent that the utilization, staffing, outcome, policy and procedure criteria of this rule have been achieved during the course of the demonstration period.

3. An applicant for a bloodless surgery demonstration project shall:

i. Be a general hospital meeting the requirements set forth at N.J.A.C. 8:33E and 8:43G; and

ii. Have an existing invasive cardiac diagnostic service that has been in compliance with the minimum annual utilization requirements at 8:33E-1.4(b)1 and the cardiac licensing requirements at N.J.A.C. 8:43G-7 for at least the three year period prior to the date of submission of the application for the bloodless surgery demonstration project.

4. A general hospital proposing to engage in a bloodless surgery demonstration project shall submit an application to the Department demonstrating the following:

i. That the applicant's bloodless surgery demonstration program shall serve a minimum of 100 patients per year in which each procedure, if performed conventionally, would result in a blood loss of greater than or equal to 1,000 cubic centimeters;

ii. That the applicant shall have qualified staff and staffing levels for the bloodless surgery demonstration project at all times that shall promote safety, including a bloodless surgery program coordinator who shall be a graduate of an accredited school of nursing and hold a current license to practice nursing care in New Jersey, and who shall be responsible for administration of:

(1) Patient care activities;

(2) Compilation of statistical information;

(3) Marketing activities designed to promote patient access;

(4) Physician referrals;

(5) Program staffing;

(6) Maintenance of policies and procedures; and

(7) Consultation services;

iii. That the applicant's physical plant and equipment standards for the bloodless surgery demonstration project shall result in the highest level of successful bloodless surgical outcomes;

iv. The service area for the provision of the bloodless surgery demonstration project;

v. That the applicant has developed and shall implement policies and procedures for the daily operation of the bloodless surgery demonstration project addressing, at a minimum:

(1) Hospital administration and governance;

(2) Patient services;

(3) Quality improvement;

(4) Patient health care needs;

(5) Safety and infection control;

(6) Comfort and pain management;

(7) Skin integrity;

(8) Psychosocial and spiritual health;

(9) Patient and family education;

(10) Discharge planning;

(11) Technical aspects of care; and

vi. That the applicant's bloodless surgery demonstration program will perform, at a minimum, 50 percent of its annual open heart surgery cases in accordance with the definition of "bloodless surgery" at N.J.A.C. 8:33-1.3.

5. A general hospital approved for a bloodless surgical demonstration project shall submit quarterly evaluation reports to the Department for the duration of the demonstration project, with a final evaluation report immediately following the completion of the demonstration project, unless the Commissioner determines and notifies the hospital in writing that the hospital shall report more or less frequently than quarterly.

i. Each evaluation report shall include documentation of the number of bloodless surgical procedures performed by type of surgery, and success rates in terms of both morbidity and mortality.

ii. Each report shall be accompanied by supporting data.

6. The standards and conditions set forth in the Commissioner's notice of approval of a bloodless surgical demonstration project shall be the applicable licensure standards for that demonstration project until the completion of the demonstration project, but shall be in addition to, not in lieu of, the general surgery licensure standards set forth at N.J.A.C. 8:43G-34, the cardiac surgery licensure standards set forth at N.J.A.C. 8:43G-7 and other licensing standards applicable for the type of surgery performed.

i. In the event that the Commissioner shall extend the period of the demonstration project by written notice, the same standards and conditions set forth in the initial notice of approval shall continue to apply during the duration of the extension of the demonstration project.

ii. All facilities seeking to initiate bloodless surgery demonstration projects described in this subchapter shall document compliance with all applicable requirements for cardiac surgery services and invasive therapeutic cardiac services as set forth at N.J.A.C. 8:33E, including facility and physician annual volume standards, personnel and staffing requirements. Compliance with the applicable requirements as set forth at 8:33E-2.1 through 2.14 shall be maintained throughout the period of the demonstration project and thereafter as required.

7. All facilities seeking to initiate bloodless surgery demonstration projects described in this subchapter shall be initially licensed in accordance with the provisions of N.J.A.C. 8:43G except as specifically set forth below.

i. Initial licenses granted to bloodless surgery demonstration projects shall be valid for a period not to exceed 30 months from the month in which the facility initiates its bloodless surgery demonstration project.

ii. Following the expiration of the initial license, licenses for bloodless surgery demonstration projects may be renewed only upon demonstration by the license holder to the satisfaction of the Commissioner of full compliance with all applicable standards and criteria of this chapter, N.J.A.C. 8:43G, 26:2H-1 et seq., any applicable Federal law, and any additional conditions imposed upon the license holder in the original certificate of need approval, and only in accordance with the following protocol:

(1) No earlier than the completion of the 24th month following the initiation of the bloodless surgery demonstration project under this program, and no later than the completion of the 26th month following the initiation of such services, all facilities seeking renewal of licenses issued pursuant to the demonstration program described in this subchapter shall submit to the Department, documentation of their full compliance with all standards and criteria referenced in (d)7ii above, specifically including, but not limited to, the independently audited and verified criteria specified in 8:33-3.11(d)4.

(A) Failure to submit all information/documentation required for consideration of renewal in the time and manner set forth in (d)7ii(1) above, shall, absent the express written consent of the Department, constitute a basis for denial of the request for license renewal.

(B) Following the completion of the 26th month after the initiation of services under the bloodless surgery demonstration project, documentation of compliance with the requirements of (d)7ii(1) above shall only be accepted for consideration at the express written request of the Department.

(2) Upon receipt of the documentation required for renewal as set forth in (d)7ii(1) above, the Department shall review and evaluate the documentation, shall communicate with the facility to clarify and/or supplement the documentation as it in its sole discretion deems appropriate, and shall, no later than the completion of the 30th month following the month in which the facility initiated services under the bloodless surgery demonstration project, communicate a decision to the facility as to whether the license to provide services approved under this bloodless surgery demonstration project will be renewed.

(3) Facilities not receiving an express written notification of the renewal of their license authorized under the bloodless surgery demonstration project described in this subchapter in accordance with (d)7ii(2) above, shall cease all such services that were initiated as a result of the bloodless demonstration project as of the completion of the 30th month following the month in which such services were initiated and make medically appropriate referrals for all patients.

8. Notwithstanding (d)6 and 7 above, within 180 days following the promulgation of rules by the Department, in accordance with the Administrative Procedure Act, 52:14B-1 et seq., specific to standards for bloodless surgical programs and procedures, any conditions and standards set forth in a notice of approval of a bloodless surgical demonstration project that is less stringent than, or otherwise in conflict with, the standards promulgated by the Department shall be superseded by the rules.

i. In order to maintain approval of a bloodless surgical demonstration project, each general hospital with a bloodless surgical demonstration project shall submit documentation no later than 180 days following the effective date of such rules demonstrating that its bloodless surgical demonstration project is in compliance with the new or additional standards set forth by the Department.

ii. A hospital that fails to submit documentation of its compliance with the new standards, or that otherwise fails to comply with the new or additional standards shall cease its bloodless surgical demonstration project within 30 days following the date of written notice from the Commissioner of the general hospital's failure to comply, except with respect to follow-up care and discharge planning for current patients participating in the bloodless surgical demonstration projects, and shall provide all necessary assistance to physicians and their patients in locating another hospital with an approved bloodless surgical program.

N.J. Admin. Code § 8:33-3.11

Amended by 47 N.J.R. 2063(a), effective 8/17/2015