Senior services and health systems branch health facilities evaluation and licensing division office of certificate of need and healthcare facility licensure

Authorized By: Poonam Alaigh, MD, MSHCPM, FACP, Commissioner, Department of Health and Senior Services (with the approval of the Health Care Administration Board).

Authority: N.J.S.A. 26:2H-1 et seq., specifically N.J.S.A. 26:2H-5.

Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2011-

Submit written comments by , 2011 to:

Office of Legal and Regulatory Compliance

NJ Department of Health and Senior Services

PO Box 360

Trenton, NJ 08625-0360

The agency proposal follows:

The proposed amendments would allow qualified elective angioplasty demonstration projects to continue to provide elective PCI as participants in the Atlantic C-PORT-E registry, which will commence once the Atlantic C-PORT-E trial has reached its patient enrollment target of 18,360. The Department has been informed by Thomas Aversano, M.D., Johns Hopkins Medical Institutions, Principal Investigator of the Atlantic C-PORT-E trial, that patient recruitment will end in the first half of calendar year 2011, likely by mid-April. Under the Atlantic C-PORT-E trial protocols, patient follow-up will continue for nine months and an additional three to five months will be needed for data editing and analysis. Dr. Aversano, in a letter dated February 16, 2011 to the multiple states with hospital participants in the Atlantic C-PORT-E trial, has recommended that the Departments of Health in New Jersey, Ohio, Pennsylvania and Maryland allow or require hospitals that are in good standing under the Atlantic C-PORT-E randomization trial to participate in a follow-on registry. The purpose of such a registry is to ensure that hospital participants in the Atlantic C-PORT-E trial continue to perform elective PCI on patients already enrolled in the randomized trial who are in their nine-month follow-up period. The sudden cessation of the availability of elective angioplasty at the demonstration project sites, which would be required under current rules once Atlantic C-PORT-E enrollment ends, could have a detrimental effect on quality. As Dr. Aversano states, “there is a recognized relationship between institutional PCI volume and patient outcome.” The relationship is reflected in both the Department’s facility and individual physician annual volume requirements which are also included in the Atlantic C-PORT-E Manual of Operations for both the randomized trial and the registry.

A second benefit of allowing the elective PCI demonstration projects to continue in an Atlantic C-PORT-E registry is to provide assurance that the quality, accuracy and timeliness of follow-up data collection, which is so necessary for the completion of the trial is maintained over the nine months from the end of trial enrollment until the end of the follow-up period. It is important to emphasize that the Atlantic C-PORT-E trial does not conclude at the end of enrollment. As Dr. Aversano states:

“…the collection of data in the follow-up period is absolutely essential to the study’s completion. Indeed, C-PORT-E is not completed until all data are entered into the database. This, in fact, extends beyond the nine-month follow-up period since outcomes that occur late in the follow-up period may take weeks or even months to document in the database. Some delay in data collection is inevitable because it takes time and effort to obtain the necessary documentation, enter the data into the database, and then have the clinical coordinating center staff review and edit the information in conjunction with local site study staff.”

In order to minimize the potential impact of the end of recruitment into the randomized Atlantic C-PORT-E trial on the quality of patient care and the quality and timeliness of data collection, an Atlantic C-PORT-E elective PCI registry is proposed as a temporary follow-on to the Atlantic C-PORT-E randomized trial. Just as in the Atlantic C-PORT-E trial, the Atlantic C-PORT-E registry would require approval by the Johns Hopkins Institutional Review Board (IRB), the IRB at each participating demonstration project site, and will be overseen by a Data and Safety Monitoring Board.

Given the documented patient safety monitoring provisions that are set forth in the Atlantic C-PORT-E registry Manual of Operations, the Department is proposing amendments that will allow New Jersey elective angioplasty demonstration project hospitals that are in good standing under the Atlantic C-PORT-E randomization trial to participate in a follow-on registry.

A summary of the proposed amendments follows:

Proposed amendments at N.J.A.C. 8:33-3.11(e)3 and N.J.A.C. 8:33-3.11(e)5iii would indicate that the Department would allow hospitals previously granted certificates of need and which are in good standing to participate as elective angioplasty demonstration projects in the Atlantic C-PORT-E trial to continue participation in the Atlantic C-PORT-E registry until nine months following publication of the results of the Atlantic C-PORT-E trial.

The Department is proposing an amendment at N.J.A.C. 8:33-3.11(e)3iii.(1)-(8) that requires each demonstration project to provide the Department with written attestation of its agreement with: Atlantic C-PORT-E registry physician, patient and device selection criteria; approval of the registry protocols by the demonstration project’s institutional review board; Atlantic C-PORT-E registry minimum annual facility and physician PCI volume requirements and Department volume and licensing requirements; limitation of performance of elective PCI only via the Atlantic C-PORT-E registry protocol and only while cases are being entered in the registry; the timely collection and transmission of registry data; the maintenance of a quality and error management program; willingness to report elective PCI data to the Department separate from the Atlantic C-PORT-E data reporting; and to obtain necessary informed consent for patient participation in the demonstration.

The Department also proposes amendments throughout N.J.A.C. 8:33-3.11(e)3 and N.J.A.C. 8:33-3.11(e)5iii that replace references to the term “Atlantic C-PORT-E trial” with the term “Atlantic C-PORT-E registry.”

As the Department has provided a 60-day comment period for this notice of proposal, pursuant to N.J.A.C. 1:30-3.3(a)5, this notice is exempt from the rulemaking calendar requirement, as set forth at N.J.A.C. 1:30-3.1 and 3.2.

Social Impact

N.J.S.A. 26:2H-1 et seq., as amended, recognizes as the "public policy of the State that hospitals and related health care services of the highest quality, of demonstrated need, efficiently provided and properly utilized at a reasonable cost are of vital concern to the public health."

The proposed amendments would continue to authorize general hospitals to establish demonstration projects to participate in the Atlantic C-PORT-E registry, through the scientifically rigorous collection and analysis of data that would contribute to the evidence base nationally on the issue of the comparative safety and efficacy of elective angioplasty in hospitals without on-site coronary artery bypass graft (CABG) surgery. Clinical advances in coronary intervention techniques over the years have continued to greatly reduced the rate of PCI complications requiring emergency surgery. More recently, with improvements in catheter and device design, the advent of coronary stents and improved techniques, and the monitoring of antiplatelet and anticoagulation regimens, PCI has become increasingly safe and effective, with emergency CABG rates ranging from two percent to less than 0.4 percent (Smith, et al., American College of Cardiology/American Heart Association Task Force on Practice Guidelines, "2005 Guideline Update for Percutaneous Coronary Intervention").

When New Jersey hospitals began enrolling elective PCI patients in the Atlantic C-PORT-E trial, 21 states allowed elective PCI without on-site cardiac surgery backup. The proposed amendments would ensure that New Jersey hospitals that participate in the elective angioplasty demonstration projects comply with Department and Atlantic C-PORT-E trial and registry facility and physician volume requirements and Atlantic C-PORT-E trial and registry informed consent, patient selection, device selection criteria, and data reporting standards. Strict compliance with these requirements would continue to provide the scientific performance data that is necessary to evaluate and compare the safety and efficacy of elective angioplasty and PCI at hospitals with and without on-site cardiac surgery backup.

The proposed amendments would continue to establish criteria and standards to ensure patient safety. The Atlantic C-PORT-E registry’s Manual of Operations will continue to require participants to obtain institutional review board approval, the need for informed consent for every PCI patient entered in the Atlantic C-PORT-E registry, as well as adherence to strict Atlantic C-PORT-E trial and registry patient selection criteria and facility and interventional cardiologist inclusion criteria. Most importantly, the proposed amendments would continue to require hospitals participating in the elective angioplasty demonstration project to comply with stricter performance standards and oversight than other providers of elective PCI services in New Jersey (that is, cardiac surgery centers).

The proposed amendments would ensure that those hospitals that participate in the elective angioplasty demonstration project going forward would continue to adhere to the performance standards of the Department and the Atlantic C-PORT-E registry.

The proposed amendments would continue to allow the successful applicants, who may have incurred costs associated with renovating or constructing physical space to provide PCI services, and employing additional staff to provide the services and implement administrative activities associated with the Atlantic C-PORT-E registry. These costs would continue to depend on facility-specific variations in existing physical and staff resources and corresponding needs to augment those resources to comply with Department and Atlantic C-PORT-E standards. The Department anticipates that it is more likely that facilities would conduct reporting and other administrative requirements associated with participation in the Atlantic C-PORT-E registry using existing staff resources.

Those successful applicants who have obtained certificates of need to provide elective angioplasty demonstration projects may continue to realize increased patient censuses and reimbursement levels from the addition of elective PCI. Hospitals with cardiac surgery facilities may have realized a corresponding decrease in patient censuses and reimbursement levels.

Federal Standards Statement

The Department is not proposing the proposed amendments under the authority of or to implement, comply with, or participate in any program established under Federal law or under a State statute that incorporates or refers to Federal law, standards, or requirements. Therefore, a Federal standards analysis is not required.

As discussed in the Economic Impact above, facilities that participate in the Atlantic C-PORT-E registry may need to continue to supplement existing staff depending on their existing resources as necessary to comply with reporting and other administrative requirements associated with the registry, but the Department anticipates that is it more likely that facilities would fulfill these requirements using existing staff resources.

As discussed in the Economic Impact above, hospitals with cardiac surgery facilities may continue to realize a decrease in patient census and reimbursement levels which would have already resulted in some job losses related to providing this procedure in a reduced capacity.

Subject to the discussion above, the Department does not anticipate that the proposed amendments would result in the creation or loss of any jobs.

The proposed amendments would have no impact upon the agriculture industry in New Jersey.

The proposed amendments would continue to impose reporting, recordkeeping and compliance requirements only on New Jersey licensed general hospitals, none of which is a "small business" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., as each employs more than 100 people full-time. Therefore, a regulatory flexibility analysis is unnecessary.

The proposed amendments would have no impact upon the achievement of smart growth and implementation of the State Development and Redevelopment Plan.

8:33-3.11 Demonstration and research projects

(a)-(d) (No change.)

(e) The Commissioner shall accept certificate of need applications from general hospitals for participation in the elective angioplasty demonstration project, in accordance with the full review process at N.J.A.C. 8:33-4.1 following a call for applications.

1. - 2. (No change in text.)

3. Notwithstanding the duration of demonstration projects set forth at (f)4 below, the Commissioner shall issue certificates of need to participate in the elective angioplasty demonstration project for a period [of no more than three years] that extends for nine months following the publication of the trial results in a peer-reviewed journal, [not counting any intervening lapse in enrollment associated with the pendency of litigation described at Cooper University Hospital v. Jacobs, 191 N.J. 125 (2007),] which certificates of need are annually renewable during the [three-year] period, and provided that such certificates of need shall be valid only during the period that cases are being [enrolled] entered in the Atlantic C-PORT-E [trial] registry.

i. The Department may extend the certificates of need to participate in the elective angioplasty demonstration project on an annual basis only if the Medical Director of the Atlantic C-PORT-E [trial] registry submits written notice to the Commissioner that the Atlantic C-PORT-E [trial] registry is authorized to continue patient [enrollment] entry in the registry.

ii. Absent a valid certificate of need, participating hospitals in the Atlantic C-PORT-E [trial] registry shall discontinue patient enrollment and cease performance of elective angioplasty or PCI. Certificate holders are allowed to comply with final reporting and other administrative requirements associated with participation in the Atlantic C-PORT-E [trial] registry.

4. (No change in text.)

5. The Department's issuance of a certificate of need to a participating hospital pursuant to this subsection is conditioned upon the following:

i. A participating hospital shall provide elective angioplasty or PCI only on patients enrolled or entered in the Atlantic C-PORT-E trial or registry.

ii. A participating hospital that discontinues its participation in the Atlantic C-PORT-E trial or registry, whether voluntarily or involuntarily, shall immediately cease performing elective angioplasty or PCI, shall notify the Department of the termination of its participation in the Atlantic C-PORT-E trial or registry and shall return the certificate of need authorizing it to participate in the elective angioplasty demonstration project to the Department within 30 days of the date that its participation ceases, and the Department shall issue the hospital an amended certificate of need deleting its authorization to participate in the elective angioplasty demonstration project.

iii. When the Atlantic C-PORT-E trial [provides notice that it is ceasing to enroll new patients] publishes the trial results in a peer-reviewed journal, all hospitals participating in the elective angioplasty demonstration project shall cease performing elective angioplasty or PCI, and shall return the certificates of need authorizing them to participate in the elective angioplasty demonstration project to the Department within [30 days] nine months of the date of publication of the trial results [that enrollment ceases], and the Department shall issue amended certificates of need and licenses to the participating hospitals deleting their authorization to participate in the elective angioplasty demonstration project.

iv. (No change in text.)

v. All participating hospitals shall continue to provide required documentation as required in the protocol Atlantic C-PORT-E trial and registry.

6. - 7. (No change in text.)

(f) (No change in text.)