HEALTH AND SENIOR SERVICES
SENIOR SERVICES AND HEALTH SYSTEMS BRANCH
HEALTH FACILITIES EVALUATION AND LICENSING DIVISION
OFFICE OF CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE
Proposed Amendments: N.J.A.C. 8:33-3.11(e)3 and (e)5
Certificate of Need: Application and Review Process
Types of Certificate of Need Applications: Demonstration and Research
Projects
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 2011Submit written comments by
, 2011 to:
Devon L. Graf, Director
Office of Legal and Regulatory Compliance
NJ Department of Health and Senior Services
PO Box 360
Trenton, NJ 08625-0360
The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.
The agency proposal follows:
Summary
The Department of Health and Senior Services (Department) proposes
amendments to establish criteria for the continued participation of New Jersey
licensed general hospitals, through a demonstration project, in the Atlantic
Cardiovascular Patient Outcomes Research Team (Atlantic C-PORT-E) trial as it
transitions to a registry. The Atlantic C-PORT-E trial is a multi-state randomized
clinical trial of elective angioplasty or percutaneous coronary intervention (PCI) in
hospital settings with and without on-site cardiac surgery.
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
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.
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
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.
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
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.
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. 8:333.11(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 CPORT-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. 8:333.11(e)3 and N.J.A.C. 8:33-3.11(e)5iii that replace references to the term “Atlantic CPORT-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.
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.
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
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.
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.
Economic Impact
7
The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.
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 CPORT-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.
Jobs Impact
8
The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.
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.
Agriculture Industry Impact
The proposed amendments would have no impact upon the agriculture
industry in New Jersey.
Regulatory Flexibility Statement
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.
Smart Growth Impact
9
The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.
The proposed amendments would have no impact upon the achievement of
smart growth and implementation of the State Development and Redevelopment
Plan.
Full text of the proposal follows (additions indicated in boldface thus; deletions
indicated in brackets [thus]):
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 peerreviewed 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
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.
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 CPORT-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.
iii. Prior to licensure by the Department to continue elective PCI in the
Atlantic C-PORT-E registry, all elective angioplasty demonstration project
hospitals shall provide written attestation to the Department that it will
comply with all protocols and standards set forth in the Atlantic C-PORT-E
registry Manual of Operations and Department PCI licensing standards,
including but not limited to:
(1) Agreement to abide by physician, patient and device selection
criteria;
(2) Approval of the registry protocol by the demonstration project’s
Institutional Review Board;
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.
(3) Agreement to comply with Atlantic C-PORT-E minimum annual
facility and physician PCI volume requirements and Department annual PCI
volume and licensing requirements set forth at N.J.A.C. 8:33E and N.J.A.C.
8:43G-7;
(4) Agreement to perform elective PCI only via the Atlantic C-PORT-E
registry protocol and only while cases are being entered in the registry;
(5) Agreement to collect and transmit Atlantic C-PORT-E trial nine
month follow-up data and Atlantic C-PORT-E registry data in a timely
fashion;
(6) Agreement to maintain a quality and error management program,
including a weekly interventional conference and monthly quality and error
management review;
(7) Agreement that the demonstration project hospital is willing to
report elective PCI data to the Department separate from data collected as
part of the registry protocol, to support the Department’s ongoing
monitoring of licensed cardiac services pursuant to N.J.A.C. 8:33E-1.9 and
2.10; and
(8) Agreement to obtain necessary informed consent for patient
participation in the demonstration.
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:
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
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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 CPORT-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.)
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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.)
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version
will govern.