OFFICE OF CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE. Types of Certificate of Need Applications: Demonstration and Research Projects

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1 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 Amendment: N.J.A.C. 8: Certificate of Need: Application and Review Process Types of Certificate of Need Applications: Demonstration and Research Projects Proposed: April 4, 2011 at 43 N.J.R. 801(a). Adopted:, 2011 by Mary E. O Dowd, M.P.H., Commissioner, Department of Health and Senior Services (with the approval of the Health Care Administration Board). Filed:, 2011 as R. 2011, d., without change. Authority: N.J.S.A. 26:2H-1 et seq., specifically 26:2H-5b. Effective Date:, Expiration Date: December 21, Summary of Public Comments and Agency Responses: The Department of Health and Senior Services (Department) received timely comments from the following commenters during the 60-day public comment period, which ended on June 3, 2011: 1. The following commenters submitted comments containing almost identical content: Rim Al-Bezem, MD, Penn Cardiac Care at Mercer Bucks Cardiology, Robbinsville, NJ

2 Aliya F. Browne, D.O. F.A.C.C., Central Jersey Heart Group, Ewing, NJ Prabodh M. Damani, MD, F.A.C.C., Capital Cardiology Associates, P.A., Trenton, NJ Rolando L. degoma, MD, F.A.C.C., F.N.L.A., NJ Preventive Cardiology and Cholesterol Clinic, PC, Trenton, NJ Trenton, NJ Trenton, NJ Steven M. Goldsmith, MD, F.A.C.C., Mercer Bucks Cardiology, Lawrenceville, NJ Krishan G. Kalra, MD, F.A.C.C., FACP, Capital Cardiology Associates, P.A., Craig McMackin, MD, Penn Cardiac Care at Mercer Bucks, Robbinsville, NJ Muhammad U. Mustafa, MD, F.A.C.C., Capital Cardiology Associates, P.A., Bipin Nagra, MD, F.A.C.C., Capital Cardiology Associates, P.A., Trenton, NJ Pirouz Parang, MD, Heart Care Specialists at Capital Health, Bordentown, NJ Neil Saxena, MD, F.A.C.C., Heart Care Specialists at Capital Health, Bordentown, NJ Jerome Thomas, MD, Penn Cardiac Care at Mercer Bucks, Robbinsville, NJ Andreas Wolf, MD, F.A.C.C., F.S.C.A.I., Penn Cardiac Care at Mercer Bucks, Robbinsville, NJ Keith Wolfson, MD, Cardiologist, Penn Cardiac Care at Mercer Bucks, Robbinsville, NJ Kristopher Young, DO, Heart Care Specialists at Capital Health, Bordentown, NJ 2. Lee M. Glickman, MD, F.A.C.C., Cardiologist, Clinical Cardiology, Pennington, NJ 2

3 3. Al Maghazehe, Ph.D., FACHE, President and CEO, Capital Health System, Trenton, NJ 4. The following commenters submitted comments containing almost identical content: Stephanie L. Bloom, FACHE, Executive Director, Community Medical Center, Saint Barnabas Health Care System Affiliate, Toms River, NJ MaryEllen Clyne, Executive Director, Clara Maass Medical Center, Saint Barnabas Health Care System, Belleville, NJ 5. The following commenters submitted comments containing almost identical content: Ray Fredericks, President and Chief Executive Officer, and William Oser, MD, Sr. VP and Chief Medical Officer, Solaris Health System, Edison, NJ Daniel A. Kane, President and Chief Executive Officer, Bayonne Medical Center, Bayonne, NJ Richard P. Miller, President and Chief Executive Officer, Virtua Health, Marlton, NJ Rakesh Sahni, MD, F.A.C.C., F.S.C.A.I., Director, Cardiac Catheterization Laboratory and Interventional Cardiology, Raritan Bay Medical Center, Perth Amboy, NJ 6. Randy Mintz, MD, Medical Director, Virtua Marlton Cardiac Catheterization Laboratory, Marlton, NJ 7. Catherine Yaxley, Vice President, Planning and Government Affairs, Holy Name Hospital, Teaneck, NJ 3

4 Neptune, NJ 8. Steven G. Littleson, President, Jersey Shore University Medical Center, 9. Gary S. Young, MPH, Executive Vice President, Cooper University Hospital, Camden, NJ, and Joseph E. Parillo, MD, Chief, Department of Medicine, Director, Cooper Heart Institute, Cooper University Hospital, Camden, NJ 10. The following commenters submitted comments containing almost identical content: Reginald J. Blaber, MD, F.A.C.C., Chief of Medicine, Our Lady of Lourdes Medical Center, Camden, NJ James C. Wallace, Community and Government Relations Officer, Deborah Heart and Lung Center, Browns Mills, NJ Trenton, NJ 11. David L. Knowlton, President and CEO, NJ Health Care Quality Institute, A summary of the comments and the Department s responses thereto follows. The numbers in parentheses following each comment below correspond to the commenters listed above. 1. COMMENT: Commenters oppose the proposed amendment, stating that it could potentially have a negative impact on patient outcomes. The commenters state, New Jersey is one of the few states that still require a certificate of need for these procedures. Primary PCI without surgical back up has been studied extensively throughout the country and there is ample evidence that elective PCI is safe at non-cardiac surgery hospitals. Patients who undergo diagnostic and emergent catheterization at non-cardiac surgery CN hospitals are then subject to 4

5 transfer to a cardiac surgery facility and possibly a second procedure which increases the risk of complications, delays intervention, is inefficient, and raises the cost of care without any proven benefits to safety or efficacy. (1 through 3) 2. COMMENT: A commenter asserts that the proposed amendment reflects the overregulation of cardiac care in New Jersey. (2) 3. COMMENT: A commenter asserts that the proposed amendment would create an unfair advantage to the participating hospitals and states, participation in C-Port should be extended to all hospitals with catheterization capability. Outcomes will be analyzed and studied and quality reported to the Department as currently done for diagnostic and primary procedures. (3) RESPONSE to Comments 1 through 3: The commenter s assertion, that elective PCI at facilities without on-site surgical backup is efficacious and safe, is a conclusion that neither the American College of Cardiology/American Heart Association (ACC/AHA) nor the Society of Cardiovascular Angiography and Interventions (SCAI) have yet reached. Rather, both the ACC/AHA and the SCAI have stated that more data is needed to assess whether elective angioplasty (that is, elective PCI) may be safely performed in hospitals without on-site cardiac surgery backup. The very purpose of the Atlantic C-PORT-E trial is to provide the rigorous research study and data that these prestigious national organizations have sought. The Atlantic C-PORT-E is the only multi-state randomized clinical research trial evaluating the issue of the comparative safety and efficacy of elective angioplasty at hospitals with and without cardiac surgery backup on-site. The Atlantic C-PORT-E research effort continues to collect enrolled 5

6 patient follow-up clinical data and is not expected to publish the results of the study until late As stated in the proposal Summary, the proposed amendment would extend the duration of elective angioplasty demonstration project participation in Atlantic C-PORT- E as it transitions from a trial to a registry 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. The Department disagrees with the commenter s recommendation that the Department extend authorization to participate in the Atlantic C-PORT-E trial or registry to all hospitals with catheterization capability. The robust Statewide cardiac database the Department maintains reveals that the vast majority of hospitals with cardiac catheterization capability that are not already participants in the Atlantic C-PORT-E trial or registry would be unable to document compliance with the eligibility criteria necessary to allow their participation in the trial or registry, particularly with respect to annual facility interventional and physician volumes. This is true with respect to many of the full-service cardiac catheterization providers in New Jersey and all of the low-risk cardiac catheterization providers in New Jersey. The Department declines to speculate as to the ultimate findings of the study in the manner the commenter suggests by assuming the commenter s assertions with respect to safety and efficacy are correct. Rather, the Department will await the published results of the rigorous Atlantic C-PORT-E trial, in the interest of patient safety, prior to any consideration of whether or not elective PCI is to be performed in hospitals that do not have backup cardiac surgery on site. 6

7 The Department disagrees with the assertion that the proposed amendment would have a negative impact on patient outcomes. Patient safety has been the primary concern of the Department whenever it has exercised its regulatory authority on the health care industry. This has been particularly true in the area of cardiovascular disease, where a succession of consultants, ad hoc and standing committees of experts and dedicated staff have combined to promulgate cardiac service certificate of need (CN) and licensing rules that have maintained consistency with clinical cardiac care despite unprecedented changes in clinical practice. For the past decade, the Department has required all of its licensed cardiac catheterization/intervention (PCI) and cardiac surgery programs to provide considerable performance data in the interest of patient safety. These reporting requirements have become highly sophisticated over the years to include a cardiac surgery report card and the introduction, in 2007, of a robust cardiac catheterization and PCI database patterned after the American College of Cardiology s National Cardiovascular Data Registry (NCDR). Pursuant to N.J.A.C. 8:43E and other laws, the Department is authorized to impose penalties and sanctions on facilities that fail to report required data. There have been few problems with reporting over the years despite the increased demands placed on facilities to provide patient-specific data for report card purposes. The Department considers its current patient safeguards to be appropriate for all patients in the State s cardiac facilities, regardless of whether patients elect to enroll in the Atlantic C-PORT-E trial. 7

8 As stated in the proposal Summary, Thomas Aversano, M.D., Johns Hopkins Medical Institutions, Principal Investigator of the Atlantic C-PORT-E trial, has informed the Department that patient recruitment will end in the first half of calendar year 2011, likely by mid-april. In fact, patient recruitment ended at midnight on March 31, 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 health agencies with jurisdiction over cardiac surgery in each of multiple states with hospital participants in the Atlantic C-PORT-E trial, recommended that New Jersey, Ohio, Pennsylvania, and Maryland authorize or require hospitals that are in good standing under the Atlantic C-PORT-E randomization trial to participate in a follow-on registry. Dr. Aversano stated that the purpose of the registry would be 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. Dr. Aversano stated that the sudden cessation of the availability of elective angioplasty at the demonstration project sites (which the existing rule at N.J.A.C. 8: (e) would have required once Atlantic C-PORT-E enrollment ended) could have a detrimental effect on quality. Dr. Aversano stated, there is a recognized relationship between institutional PCI volume and patient outcome. The relationship is reflected in the Department s facility and individual physician annual volume requirements, which are incorporated by reference in the Atlantic C-PORT-E Manual of Operations for both the randomized trial and the registry. 8

9 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. Dr. Aversano stated in his letter, the C-PORT E project does not conclude at the end of enrollment; 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. 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 would serve 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 (JHIRB) and the IRB at each participating demonstration project site, and a Data and Safety Monitoring Board (DSMB) will oversee participation. The proposed amendment would allow New Jersey hospitals participating in elective angioplasty demonstration projects that are in good standing under the Atlantic C-PORT-E randomization trial to participate in a follow-on registry. The Department 9

10 proposed this amendment in consideration of and in reliance upon the patient safety monitoring provisions contained in the Atlantic C-PORT-E Registry Manual of Operations. The Department therefore disagrees with the assertion that an extension of New Jersey hospital participation in the Atlantic C-PORT-E registry would have a negative impact on patient outcomes. For the foregoing reasons, the Department will make no change on adoption in response to the comments. 4. COMMENT: Commenters support the proposed amendment, stating that they consider the Johns Hopkins Atlantic C-PORT-E trial to be an important study to generate data needed to determine any difference in outcomes of elective percutaneous coronary intervention performed at hospitals that have cardiac surgery backup on site and those that have off-site surgical backup. The commenters support the proposed amendment to allow hospitals participating in elective angioplasty demonstration projects to continue performing elective PCI until the results of the study are published and the Department makes a final decision regarding certificate of need requirements for elective PCI services. The commenters state that the proposed amendment would ensure that participating hospitals will continue to submit data under the C-PORT-E Study protocols throughout the demonstration project to facilitate oversight and add supplemental data to be used for making a final policy determination. The commenters state that patient safety would be protected because the C-PORT-E Study protocols must continue to be observed under the proposed amendments. The commenters note that the Department s action to allow study participants to continue to participate in the study as 10

11 it transitions to a registry is consistent with the decisions of Ohio, Maryland, and Pennsylvania, the other state participants in the Atlantic C-PORT-E study, and consistent with the broader practice nationally as 28 states now permit elective PCI to be performed without surgical back-up on site. Most recently, Georgia, initially a participant in the C-PORT-E Study, deregulated the performance of elective angioplasty by exempting it from its Certificate of Need requirement. (4 and 5) 5. COMMENT: Commenters state that the Department s determination to authorize New Jersey hospitals to participate in the Atlantic C-PORT-E Study has been rewarded by approximately five years of successful operation of PCI programs in the participating hospitals. The commenters state, although the date on which the C-PORT-E study [ceases] enrolling has been reached, the published data on which the Department [would] rely for its re-evaluation of its cardiac regulations regarding elective PCI are not yet available. The commenters support the proposed amendment to permit the elective angioplasty demonstration projects to participate in the Atlantic C-PORT-E registry until the study results are published. The commenters state that the proposed amendment would safely serve the [Department s] goal of contributing to published data regarding the performance of elective angioplasty without surgery on site. The commenters state that the Practice Guidelines (Guidelines) issued by the ACC/AHA and co-sponsored by the SCAI support the Department s original decision to participate in the Atlantic C-PORT-E study. The commenters assert that the Guidelines for elective PCI without on-site cardiac surgery assign a rating of Class III with evidence level of C. The commenters quote the Guidelines as stating, it is recognized that the bases of these recommendations are 11

12 opinion and consensus of the writing group. In this setting, it is not unreasonable for clinical trials to be conducted to further investigate the validity of this consensus opinion. (Emphasis added by commenters.) The commenters state that the purpose of the proposed amendment would be consistent with the position statements of the ACC/AHA and the SCAI, which hold that more data is needed to assess whether elective PCI may be safely performed at hospitals without cardiac surgery on-site. The commenters state that the SCAI recently released best practices for coronary angioplasty programs in hospitals without cardiac surgery on-site. The commenters quote the SCAI s President, Gregory J. Dehmer, M.D., as stating, Despite the ACC/AHA recommendations, this horse is out of the barn and unlikely to be put back and that the safety issue will become clearer when the first large randomized trial comparing angioplasty rates at hospitals with and without surgical backup (that is, the C-PORT-E study) is completed. The commenters view the continuation of participation in the Atlantic C-PORT-E Registry by the elective angioplasty demonstration projects as furthering the universally accepted goal of collecting reliable data to allow an accurate assessment of whether to permit elective angioplasty without surgery on site. The commenters emphasize that existing N.J.A.C. 8: (e)3 requires all New Jersey hospitals participating in Atlantic C-PORT-E to cease performing elective PCI procedures at the conclusion of enrollment, thereby eliminating the eleven participating demonstration projects from providing the study s required nine-month follow-up period, during which enrolled patients may require additional angioplasty procedures. The commenters state that the proposed amendment would remedy the flaw in the existing 12

13 rule and would permit the inclusion of all of New Jersey s enrolled patients in the study s database. The commenters provide documentation regarding the safety and efficacy of the performance of elective PCI in hospitals without on-site cardiac surgery, and quote the 2007 statement of the Department that its [p]reliminary analysis indicates that there does not appear to be any significant differences in quality among the hospitals performing elective angioplasty with cardiac surgery off-site, citing 39 N.J.R. 5316(b). The commenters note that the Atlantic C-PORT-E study s independent DSMB has reviewed at regular intervals since 2005, and continues to review, the study data, and has approved the continuation of the study for the past six years. The commenters also cite to the 2009 study by Kutcher, M., et al., of data held by the National Cardiovascular Data Registry (NCDR), which concludes that off-site PCI centers had similar observed procedure success, morbidity, emergency cardiac surgery rates and mortality. Kutcher, M., et al., Percutaneous Coronary Interventions in Facilities without Cardiac Surgery on Site: A Report from the National Cardiovascular Data Registry, 54:1 Journal of the American College of Cardiology 16 (2009). The commenters assert that the Kutcher study confirms the safety of an off-site strategy at PCI centers where rigorous clinical, operator and institutional criteria are in place and where data are submitted and reviewed in a comprehensive multicenter registry such as the NCDR. The commenters state that operational and economic factors weigh in favor of the continuation of the elective angioplasty demonstration projects, and that because primary or emergency PCI programs are smaller programs, the inclusion of elective PCI services increases the volume of PCI cases seen by these hospitals PCI teams, which 13

14 corresponds directly to better quality of care to patients, and also contributes financial support for the hospital s overall PCI program. The commenters state that the discontinuation of elective angioplasty at the demonstration project hospitals would not only result in an economic loss to the hospital due to a reduction in PCI volume, but would also result in a significant loss of professional expertise and clinical knowledge. The commenters support the patient safety protections within the proposed amendment because compliance with the Atlantic C-PORT-E Registry Manual of Operations includes the adoption of the ACC/AHA/SCAI Guidelines that set forth the minimum interventional case volume requirements for all participating practitioners and institutions. The commenters note that the proposed amendments would require independent reviews of the Atlantic C-PORT-E Registry s protocols by the Johns Hopkins IRB and each individual hospital participant s IRB, and an independent Data Safety and Monitoring Board to evaluate patient safety issues. (5) 6. COMMENT: A commenter states that the proposed amendment would preserve the integrity of the C-PORT-E study data by permitting participating hospitals to make the transition to the C-PORT-E registry. The commenter states that this would be consistent with the Department s stated purpose in authorizing participation in the elective angioplasty demonstration project, that is, to safely obtain reliable data for it to consider when reviewing its elective PCI certificate of need and licensure requirements. The commenter asserts that the proposed amendment would permit the commenter to fulfill its contribution and commitment to this scientifically rigorous effort in the best scientific manner by adhering to the nine-month follow-up for patients enrolled in the study. 14

15 The commenter states that the C-PORT-E registry is important in its own right in that researchers will be able to use the data to research other theories by comparing various data points in the C-PORT-E registry. The commenter states that the proposed amendment would maintain the independent and continued oversight mandated by the Atlantic C-PORT-E study by further requiring participating hospitals to contribute elective PCI data to the C-PORT-E registry, and that participating hospitals would continue in a study overseen by their own IRBs, the JHIRB, the DSMB, and the Department. The commenter expresses high confidence in the quality of care provided to patients at the facility the commenter represents based on the oversight by the DSMB and the Department. The commenter states that the demonstration project has allowed patients to receive care closer to their important family support systems and remain under the care of their primary care physicians who may not travel to other regional cardiac centers. The commenter states that the C-PORT-E study activity has further supported the efforts of the facility the commenter represents to provide important timely emergency PCI care by maintaining a highly experienced catheterization lab and physician staff. (6) 7. COMMENT: A commenter expresses support of the proposed amendment and applauds the Commissioner and the Department for their continued support of evidence-based medicine, while ensuring safe clinical practice. The commenter views the Department s decision to be an active participant and contributor to the multi-state Atlantic C-Port E- study as demonstrating a 15

16 commitment to the practice of medicine based upon sound, scientifically collected and analyzed data and that the decision placed New Jersey in the forefront, rather than the sidelines, of medicine, actively shaping the determination of clinical practice standards. The commenter notes the emphasis placed on safe clinical practice that the Atlantic C-PORT-E Registry Manual of Operations reflects, including the continuation of DSMB oversight, strict patient selection criteria, and the requirements for informed patient consent. The commenter states, Safe practice is also ensured by the Department s own rigorous monitoring of data [and] enforced minimum volume requirements for both participating hospitals and physicians; and clinical back-up from supporting cardiac surgery centers. The commenter states, Given the DSMB s unwavering endorsement of the C-PORT-E study; the Department s own expression of preliminary findings in 2007 that no significant differences in quality were seen in the study (C-PORT-E hospitals) versus control (cardiac surgery providers) settings; and the Department s continued monitoring of outcomes; [the commenter is] confident that science, quality, safety and patient rights are all furthered through the proposed amendments. (7) RESPONSE to Comments 4 through 7: The Department acknowledges the commenters support of the proposed amendment. 8. COMMENT: A commenter states that it understands the need to continue elective angioplasty service under the C-PORT registry for a limited time to complete the data collection process, but objects to the open-ended timeframe implicit in the language of N.J.A.C. 8: (e)3 as proposed for amendment. The 16

17 commenter states, There is a presumption that there will be a publication and, assuming there is one, that such a publication will be forthcoming on a timely basis. Furthermore, and most important, is the presumption that the study results will indicate that elective angioplasty without on-site cardiac surgery is safe and that patient outcomes are favorable. While this may be the case, the adoption of this type of regulatory standard before supporting factual information is available sets a poor precedent for health care policy. The commenter urges the Department to specify a more definitive timeframe relative to the continuation of C-PORT. (8) RESPONSE: The proposed amendment does not reflect any assumption on the part of the Department as to the study findings. The proposed amendment establishes a reasonable timeframe based on the representations of Dr. Aversano with respect to the expected time needed to complete the Atlantic C-PORT-E trial and publish the trial results, and the time the Department thereafter would expect to require to evaluate the trial results and, as may be appropriate, develop rulemaking addressing the future provision and distribution of elective PCI services in New Jersey. This is consistent with the mandate at N.J.S.A. 26:2H, which obliges the Department to evaluate the impact of the trial results in developing New Jersey healthcare policy. Based on the foregoing, the Department will make no change on adoption in response to the comment. 9. COMMENT: A commenter states that the proposed amendment would put New Jersey patient safety at risk, as the [existing rule has] since the initiation of the C-Port-E trial. The American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions current recommendation is to NOT 17

18 perform angioplasty without on-site cardiac surgery. Despite considering this rule several times during the past five years, the guidelines committee has chosen not to change this recommendation due to concerns for patient safety. New Jersey has consistently ignored the recommendation of these expert clinical associations throughout the C-Port-E trial. The commenter urges the Commissioner to put patient safety first, and decline to implement the C-Port-E registry in New Jersey. The commenter states that the trial is the first prospectively designed study to evaluate the critical question of whether it is SAFE to perform angioplasty without on site cardiac surgery. The trial recently ended in May Until the data and results from this study are reported in the medical literature, it is inappropriate and unscientific to allow the performance of angioplasty without on site cardiac surgery at centers in New Jersey. Once the results are known and can be evaluated, and only then, should New Jersey consider a recommendation regarding continued conduct of angioplasty without on site surgery in New Jersey. The commenter states, there is no compelling reason for New Jersey to continue to put New Jersey patients at risk before a thorough investigation of the data from the C-Port-E Trial is completed. The commenter asserts that the Department should not permit existing participants in the trial to continue performing angioplasty without on-site surgery during the period of data analysis until the Department undertakes a site-by-site evaluation of patient safety including a review of the program volume. The commenter states, Only programs with patient volumes in excess of 400 cases annually should be permitted to continue performing elective PCI as participants in the registry. There is no benefit to the residents of New Jersey for the [Department] to promulgate regulations that would 18

19 result in low volume, low quality cardiac programs, in light of the wide availability and accessibility of elective angioplasty programs with on site cardiac surgery throughout the State. The commenter asserts that if the Department decides to allow elective angioplasty without on-site cardiac surgery, patients selected for these programs should have low risk clinical features and low risk coronary anatomy characteristics as defined by the [SCAI]. Only a small percentage of elective angioplasties should be performed without cardiac surgical backup available on site. (9) RESPONSE: The Department views this and some of the other comments summarized below as efforts to re-litigate issues of safety and efficacy and the appropriateness of the Department s determination to participate in the Atlantic C- PORT-E trial. The Department already addressed these matters in response to objections to the Department s original promulgation of rules allowing the Department to participate in the Atlantic C-PORT-E demonstration project. 39 N.J.R. 3462(a) (August 30, 2007), 39 N.J.R. 5316(b) (December 17, 2007), upheld by Cooper Univ. Hosp. v, Jacobs, N.J. Superior Court, App. Div. Docket No. A T2, 2009 N.J. Super. Unpub. LEXIS 2493 (September 10, 2009), and see related opinion at Cooper Univ. Hosp. v. Howard, N.J. Superior Court, Docket No. A T2, 2011 N.J. Super. Unpub. LEXIS 874 (April 11, 2011) (upholding award of certificate of need pursuant to demonstration project rules). The Department incorporates herein by reference its responses to those objections and the opinions of the New Jersey Superior Court, Appellate Division, with respect to these issues. 19

20 The proposal Summary and the Department s responses to previous comments, above, articulate the reasons and need for the Department to continue the State s participation in C-PORT-E as it transitions to a registry, and the consequences if the Departmen were to fail to continue its participation. The Manual of Operations establishes patient selection criteria. N.J.A.C. 8: as proposed for amendment would incorporate these criteria by reference as a condition of participation. While the SCAI criteria the commenter recommends may coincide or overlap to an extent with the manual of operations, it is critical to the integrity of the C-PORT-E study and data integrity that the Department establish licensure rules requiring demonstration project participants to adhere to the study design as articulated in the Manual of Operations. The commenter suggests that the Department should limit participation in the registry and continued authority to perform elective PCI to trial participants performing 400 or more cases per year, but provides no specify rationale that would warrant the Department enhancing existing minimum volume requirements as a condition of registry participation. N.J.A.C. 8:33E-2.3(d)1 and 2 require all facilities in the State performing elective PCI pursuant to a CN, regardless of whether they are trial participants, to maintain a volume of at least 200 cases per facility. This figure is identical to the volume standard of the Atlantic C-PORT-E Manual of Operations. The Manual of Operations and N.J.A.C. 8:33E-2.3(d)5 both require physicians performing PCI to maintain annual volumes of 75 cases per year. Notably, the Department uses this criterion in determining whether to authorize facilities to participate in the demonstration projects 20

21 but does not use this minimum volume standard in evaluating licensure compliance of cardiac surgery centers. Thus, trial participants already meet, and registry participants would meet, a more stringent standard with respect to physician minimum volumes than the standard facilities that have cardiac surgery backup meet. The Department disagrees with the assertion that it needs to perform a site-bysite evaluation of patient safety including a review of program volume. As part of its existing oversight of cardiac services Statewide, the Department annually evaluates all facilities in the State providing cardiac services, regardless of whether they are participants in the trial or registry, for conformance with licensure standards and performance measures. During this rigorous evaluation process, which is articulated in the rules of the Department at Title 8 of the New Jersey Administrative Code, the Department reviews facility and physician volumes and, as necessary, requires nonconforming facilities to submit plans of correction for violations and implements onsite program evaluation by independent reviewers in the event of continued noncompliance. Habitual licensure violations require a comprehensive review by the Society for Cardiovascular Angiography and Interventions (SCAI). The Department has taken and continues to take its responsibility to ensure patient safety very seriously. 10. COMMENT: Commenters inquire as to the date the Atlantic C-PORT-E trial reached its target of 18,360 enrollees. (10) RESPONSE: The Atlantic C-PORT-E trial ceased enrollment at midnight on March 31, COMMENT: Commenters note that in the December 17, 2007 issue of the New Jersey Register, the Department states that the licenses for Atlantic C-PORT-E 21

22 hospitals would terminate upon expiration of the trial. The commenters inquire whether the proposed amendment would allow hospitals to provide services to non-trial patients and, if so, how this would be consistent with 2007 comments, and whether this would reflect a change in Department policy. (10) RESPONSE: As the Department states in the proposal Summary, the trial s Principal Investigator, Dr. Thomas Aversano, notified the Department and other states participating in the trial of the need for participating hospitals to follow enrolled patients for nine months through the establishment of an ongoing Atlantic C-PORT-E Registry to minimize the impact of the end of recruitment on patient care and the quality and timeliness of data collection. This notification was the impetus for the Department s decision to propose the amendment. The proposed amendment would permit the continuation of elective angioplasty for those patients that meet the rigorous protocols set forth in the Atlantic C-PORT-E Registry s Manual of Operations, including patient and device selection criteria, informed patient consent and facility and physician performance criteria. Elective angioplasty services would be available to patients already enrolled in the Atlantic C-PORT-E trial for follow-up care, and to new patients, assuming participating facilities continued compliance with the patient selection and other protocols of the Atlantic C-PORT-E Registry Manual of Operations. 12. COMMENT: Commenters note that in the December 17, 2007 issue of the New Jersey Register, the Department responded to Comment 66 as follows: The elimination of the limitation on the maximum number of demonstration projects that would be permitted to participate in the Atlantic C-PORT-E trial, as recommended by the commenter, would pre-judge the outcome of the multi-state research project. The 22

23 commenters inquire as to how the Publication Period (the three-to-five month period following the termination of the Follow-on Registry Period) and the Unrelated Nine Month Period (the nine month period [that] follows the Publication Period), which goes beyond Dr. Aversano s requested extension, does not pre-judge the outcome of the multi-state research project. (10) RESPONSE: As stated more fully in response to a previous comment, the proposed amendment would establish a reasonable timeframe within which the Atlantic C-PORT-E trial and registry could be completed, Dr. Aversano could publish of trial results, and the Department could evaluate those results. The proposed amendments would exceed the time Dr. Aversano requested because Dr. Aversano s time demands encompass the time he needs to complete the trial and publish the results. Dr. Aversano is not involved in the added task of the Department evaluating the trial results in the context of developing New Jersey healthcare policy, for which additional time is necessary. 13. COMMENT: Commenters note that in the December 17, 2007 issue of the New Jersey Register, the Department responded to Comment 8 as follows: The principal investigator is responsible for evaluating data generated from the demonstration project with respect to safety and efficacy. The commenter quotes Dr. Aversano as stating, at the March 1, 2011 meeting of the Health Care Administration Board (HCAB), The [DSMB] have met approximately every six months over the years that the study has been going on. The summary reports and the statistical analysis are done independent of Hopkins. So what I can say is that I ve never gotten a letter saying, stop the project, it s not safe. So my assumption from that and nor have I 23

24 been asked to change the sample size on it, so I assume from that we re on target and that there is no indication of lack of safety. The commenter inquires, how the data evaluation moved from the the principal investigator is responsible to the summary reports and the statistical analysis are done independent of Hopkins. The commenter also inquires, how the reliance on assumptions does not pre-judge the outcome of the multi-state research project, and how this is consistent with Cardiac Services CN requirements. (10) RESPONSE: The Department has authority over New Jersey hospitals participating in the Atlantic C-PORT-E trial or registry because elective angioplasty is a service subject to Department licensure. As a result, the Department oversees elective angioplasty services at participating hospitals to the same extent that it oversees this service at non-participating hospitals because they are all licensed providers of elective angioplasty services. Participating and nonparticipating facilities remain subject to the CN review process and licensure standards. The commenter s characterization of the Department s oversight of its licensees in relation to their participation in the Atlantic C-PORT-E trial is an oversimplification. The representation that the study protocol establishes a safe means to collect data does not reflect a prejudgment of the study results. The safety threshold for the purpose of the study has been maintained through a combination of the JHIRB and DSMB study oversight activities, and the Department s continued application and enforcement of its cardiac facility licensure standards. The proposed amendment would not reflect a prejudgment of the results of the matter under study. Rather it would permit the completion of activities prerequisite to 24

25 the Department s eventual evaluation and judgment of the study findings in the context of New Jersey healthcare policy development. 14. COMMENT: A commenter states that the Department stated, in 2007, that the provision of performance data to the Department has improved the quality of care to residents of the State over the past 10 years. The commenter asserts that having actual data (as opposed to attestations) is critical to continue this trend. The commenter inquires as to who will be monitoring actual as opposed to attested compliance with these standards during the Publication Period and the Unrelated Nine Month Period and how this review will be undertaken. (10) 15. COMMENT: A commenter states that based on data appearing on the Department s website, five of the eleven hospitals do not meet the 200-procedure volume requirement to continue in the study. The commenter states that this is a serious violation of the study s protocol and would jeopardize meaningful study conclusions and publishable research. (11) RESPONSE to Comments 14 and 15: The Atlantic C-PORT-E trial is responsible for evaluating facilities adherence to study protocols and for the development of conclusions. The Department is responsible for evaluating each demonstration project s compliance with applicable licensure standards. Data the Department collects and makes available in report form on the Department s website does not necessarily line up with the data collected by the principal researcher. For example, the Department and the researcher may evaluate volume data over different periods. The Department uses four quarters of data relative to a facility s licensure date in evaluating compliance with applicable licensure standards. 25

26 16. COMMENT: Commenters note that the proposed amendment would authorize the Commissioner to accept applications for CNs for participation in the elective angioplasty demonstration project in accordance with the full review process. The commenters inquire whether a full review process will be held for CNs to be granted for the Follow-on Registry Period and then for the Publication Period and then for the Unrelated Nine Month Period, and, if not, why not. The commenters inquire as to the justification for allowing the demonstration project hospitals the ability to continue to provide elective angioplasty without having applied for and having been granted a CN. The commenters state that the Department has established no fail-safe end date during the nine months following the publication of trial results. The commenter inquires why the Department would not place a firm three-month limit on the publication period. The commenters state that the proposed amendment suggests that CNs issued for participation in the demonstration project may be extended indefinitely, as long as there is an Atlantic C-PORT-E registry. The commenters state that the proposal Summary indicates that the registry will continue to collect information for nine months following the termination of the trial. The commenters state that there is no definition of registry beyond that period into the publication period or the final nine-month period. The commenters inquire whether the JHIRB will be monitoring a registry for patients in the Publication Period and the Unrelated Nine Month Period, and if not, who will monitor the data. They inquire whether the Cardiovascular Health Advisory 26

27 Board (CHAP) will monitor and evaluate the data and make recommendations involving the Atlantic C-PORT-E registry during the Publication Period or the Unrelated Nine Month Period, and inquire as to what assurances the Department has as to the safety of patients pending a final decision by the Department on elective angioplasty without on-site cardiac back-up. (10) RESPONSE: The Department already granted CNs and licensure approval to existing participants in the demonstration project to provide elective PCI in accordance with the conditions placed on that CN approval. In fact, some of these demonstration projects have gone through the lengthy full review process twice due to previous litigation and court action. The proposed amendment would permit facilities participating in the demonstration project pursuant to CN licensure standards to continue to operate in accordance with those standards as the Atlantic C-PORT-E trial transitions into a registry. No further CN process is needed, although ongoing Department licensure oversight of these facilities, and all other facilities providing cardiac services, would continue. The proposed amendment would authorize participants in elective angioplasty demonstration projects to provide elective PCI services to those patients meeting the Atlantic C-PORT-E registry protocols. Dr. Aversano has indicated his willingness to continue the registry beyond the publication of the trial results. The Atlantic C-PORT-E registry s Data Safety Monitoring Board would continue to provide oversight services. The Department would continue to monitor facility and physician performance through its robust cardiac services data collection activities and its licensing processes. 27

28 Dr. Aversano has released a revision to the Manual of Operations to reflect the transition from a study to a registry. Patient selection, device exclusions, facility and physician standards would remain the same. The registry Manual of Operations would eliminate the requirement of patient randomization and economic information, as the registry does not require these data elements. Patients enrolled in the registry would not be subject to a nine-month follow up period, as a patient s discharge would terminate their enrollment in the registry. The Atlantic C-PORT-E trial is an independent multi-state randomized clinical trial. Atlantic C-PORT possesses a record of success at conducting such randomized clinical trials and producing timely research publications at the conclusion of those trials. The publication of trial results is dependent on many factors, making it extraordinarily difficult to predict. Major national cardiac organizations and numerous states throughout the nation are following this randomized trial and awaiting publication of its results. This undoubtedly provides the researchers sufficient incentive to publish their results in a timely manner. The commenter provides no rationale for limiting participants continuation in the registry to three months if the results are not published by then. The Department perceives no advantage to New Jersey in imposing this arbitrary limitation. The Department, in consultation with the CHAP, would evaluate the study results in developing State health policy. Based on the foregoing, the Department will make no change on adoption in response to the comment. 28

29 17. COMMENT: Commenters recommend that NJ emulate Maryland and require participating hospitals to apply through the CN process before they may continue into the Follow-on Registry Period. (10) RESPONSE: Each of the states that have authorized hospitals in their respective states to participate in the Atlantic C-PORT-E trial and registry are subject to unique statutory and regulatory schemes that preclude unified, identical courses of action by all the states. In joint discussions among all the states with Dr. Aversano regarding the impending conclusion to Atlantic C-PORT-E enrollment and the transition to the registry, it became clear that the uniqueness of each state s processes to authorize initial participation in the Atlantic C-PORT-E trial likewise would require independent action for each state to authorize participation in the Atlantic C-PORT-E registry. The commenter provides no rationale explaining whether and how adherence to Maryland s processes would comport with New Jersey law and/or provide an advantage to New Jersey in its implementation of the CN and licensure processes to authorize participation in the registry. Based on the foregoing, the Department will make no change on adoption in response to the comments. 18. COMMENT: Commenters note that in the December 17, 2007 issue of the New Jersey Register, the Department responded to Comment 52 as follows: To the extent the Department in the ordinary course generates reports using data it collects pursuant to proposed N.J.A.C. 8:33-11(e)vii, those reports are publicly accessible. The commenters inquire what reports the Department generates on quality and outcomes and how these reports may be obtained. 29

30 The commenters state that the proposed amendment would require hospitals that wish to continue to participate to maintain a quality and error management program, including a weekly interventional conference and monthly quality and error management survey. The commenters ask how the Department will monitor this compliance and whether the data will be subject to public access. The commenters state that the proposed amendment would require facilities to report elective PCI data to the Department. The commenters inquire as to the type of and the frequency with which data is to be reported, and whether that data is publicly accessible. (10) RESPONSE: Quality and error management programs are existing conditions of participation in Atlantic C-PORT-E and their existence at each site was a prerequisite to the Department granting approval for that site to participate in the Atlantic C-PORT-E trial. As these requirements have been and would be conditions of licensing, the Department would address compliance in the same ways that it responds to other licensing issues, as described above in response to previous comments. The PCI data the Department would collect from registry participants is identical to the data it currently collects from all elective PCI providers in the State, including cardiac surgery centers. Reports the Department generates with respect to cardiac services include periodic publications of cardiac surgery center performance reports, commonly referred to as report cards, and reports that track historical performance of certain types of cardiac catheterization facilities, that is, low-risk and full-service. The Department routinely prepares annual and quarterly cardiac services facility utilization reports. The 30