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					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

Certificate of Need: Application and Review Process

General Provisions: Definitions

Types of Certificate of Need Applications: Demonstration and Research

          Projects

Certificate of Need: Cardiac Diagnostic Facilities and Cardiac Surgery

          Centers

Cardiac Diagnostic Facilities: General Criteria for Invasive Cardiac

          Diagnostic Facilities

Regional Cardiac Surgery Centers: Utilization of Cardiac Surgical Centers

Hospital Licensing Standards

Cardiac: Percutaneous Transluminal Coronary Angioplasty Policies and

          Procedures

Adopted Amendments: N.J.A.C. 8:33-1.3 and 3.11; N.J.A.C. 8:33E-1.3

          and 2.3; and N.J.A.C. 8:43G-7.28

Proposed: August 20, 2007 at 39 N.J.R. 3462(a).

Adopted:                                , 2007, by                                                     Fred

          M. Jacobs, M.D., J.D., Commissioner, Department of Health and




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.
          Senior Services (with the approval of the Health Care

          Administration Board).

Filed:                                  , 2007, as R. 2007 d.                    , with a technical

          change not requiring additional public notice and comment (see

          N.J.A.C. 1:30-6.3.

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

Effective Date: December 17, 2007.

Expiration Date: N.J.A.C. 8:33-1.3 and 3.11, December 30, 2007;

                              N.J.A.C. 8:33E-1.3 and 2.3, June 19, 2011;

                              N.J.A.C. 8:43G-7.28; July 22, 2010.

Summary of Public Comments and Agency Responses:

          The Department of Health and Senior Services (Department)

received comments from the following:

          1.        Henry Altszuler, M.D., Medical Director, Interventional

Cardiology, Muhlenberg Regional Medical Center, Solaris Health System,

Edison, NJ;

          2.        Susan Bonfield, Esq., Vice President, Legal and Regulatory

Affairs, Deborah Heart and Lung Center, Browns Mills, NJ;

          3.        Eric Burkett, M.D., Vice President, Medical Affairs,

Monmouth Medical Center;

          4.        Mr. James F. Carlino, Moorestown NJ;

          5.        Chao-Tarng Cheng, M.D., FACC, Richard Leeds, M.D.,

FACC, Patrick Saulino, M.D., FACC, Sharan Mahal, M.D., FACC, Kenneth
                                                       2
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document and the official version of the proposal or adoption, the official version will govern.
Sternberg, DO, FACC, Jason Hall, M.D. FACC, Steven Georgeson, M.D.,

FACC, FACP, Rachana Kulkarni, M.D., FACC, Glenn Freidman, M.D.,

FACC, Ashok Patel, M.D., FACC, and Parag Patel, M.D., FACC, of

Medicor Cardiology, PA, (practicing at Somerset Medical Center),

Bridgewater and Hillsborough, NJ;

          6.        James P. Dwyer, D.O., MBA, Executive Vice President and

Chief Medical Officer, Virtua Health, Marlton, NJ;

          7.        Judith C. Flynn, M.A., R.N., C.N.A.A., Director, Non-Invasive

Cardio-Pulmonary-Neuro Services, Bayonne Medical Center, Bayonne,

NJ;

          8.        Mr. Leonard E. Gray, Jr., Galloway, NJ;

          9.        Wanda Forys, President, Woodbridge, Perth Amboy Rotary,

Rotary International District 7510, Woodbridge, NJ;

          10.       Steven Georgeson, M.D., FACC, FACP, Chief of Cardiology,

Somerset Medical Center, of Medicor Cardiology, PA, Bridgewater and

Somerset, NJ;

          11.       Fred Hipp, Jr., Vice President, Government Relations, Virtua

Health, Marlton, NJ;

          12.       Gary S. Horan, FACHE, President and CEO, and Nancy M.

DiLiegro, Ph.D., FACHE, Director, Clinical Services, Trinitas Hospital,

Elizabeth, NJ;

          13.       Mary P. Hugues, Esq., Virtua Health, Marlton, NJ;

          14.       Elizabeth Jackson, MSN, RN, CCRN, CNAA, BC, Director of
                                                       3
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document and the official version of the proposal or adoption, the official version will govern.
Critical Care and Cardiovascular Services, Somerset Medical Center,

Somerville, NJ;

          15.       Leon Jarvis, RN, Nurse Manager, Cardiac Catheterization

Laboratory, Somerset Medical Center, Somerville, NJ;

          16.       E. Stephen Kirby, Acting President and CEO, Jersey City

Medical Center, Jersey City, NJ;

          17.       David L. Knowlton, President and CEO, New Jersey Health

Care Quality Institute, Trenton, NJ;

          18.       Mark Lebenthal, M.D., FACC, Stephen Ochen, M.D., FACC,

Chandreshwar Shahi, M.D., FACC, Jeff Taylor, M.D., FACC, FSCAI,

Alexander Ivanov, M.D., FACC, Shivang Trivedi, M.D., FACC, facp, fasnc

Robert Beningo, M.D., FACC, and Ranjita Sengupta, M.D., Cardiology

Associates of Somerset County, Bridgewater, NJ;

          19.       Joseph I. Morris, Vice President for Business Development

and Government Relations, Mountainside Hospital, Montclair, NJ;

          20.       Mrs. Roslyn Pollack, Mount Laurel, NJ;

          21.       Kenneth Sternberg, D.O., FACC, Medical Director Cardiac

Catheterization Laboratory, Somerset Medical Center, Medicor

Cardiology, PA, Bridgewater, Hillsborough, and Warren, NJ;

          22.       Mark Van Kooy, M.D., Virtua Health, Marlton, NJ;

          23.       James C. Wallace, SVP for Advocacy and Institutional

Advancement, Lourdes Health System, Camden, NJ;

          24.       Jan R. Weber, M.D., Camden, NJ;
                                                       4
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document and the official version of the proposal or adoption, the official version will govern.
          25.       Catherine Yaxley, Vice President, Planning and Government

Affairs, Holy Name Hospital, Teaneck, NJ;

          26.       Gary S. Young, Executive Vice President, Cooper University

Hospital, Camden, NJ;

          27.       The following commenters, who appear to be staff and

patients Raritan Bay Medical Center and their supporters, each signed a

letter containing identical content:

                    Lillian Abate, Rahway, NJ (angioplasty patient);

                    Solomon Ali (angioplasty patient);

                    (Illegible), RN

                    Micki Patrick, RN, post angioplasty unit

                    Lydia (illegible), RN

                    Elizabeth (illegible)

                    Ian Hunter, RN, RBMC

                    Kristin Frank, RN

                    K. (illegible), RN, RBMC

                    Ma. Angeli (illegible) RBMC

                    Emee Esfoesfu, RN

                    Donna C. Schmidt, RN, RBMC

                    Claudia (illegible), RBMC

                    (Illegible), RBMC

                    Ebuen, Mariabena, RBMC

                    Louis Trinidad, RBMC
                                                       5
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document and the official version of the proposal or adoption, the official version will govern.
                    (Illegible), RBMC

                    Michelle M. Genelien, RN, RBMC

                    Manual O. Sadaya, RN, RBMC

                    (Illegible), RBMC

                    (Illegible), RBMC

                    Christie A. Ciaccio, RN, RBMC

                    (Illegible)

                    Mark (illegible), M.D.

                    Rakesn Pasn, M.D.

                    (Illegible), M.D.

                    Rosemarie Ventura, RN,

                    (Illegible), RN

                    (Illegible), ICU staff

                    Gloria Garcie

                    (Illegible)

                    (Illegible), RN

                    (Illegible), RN

                    Nadine Martin, RN

                    Joshua Moke

                    Jennifer C. Frialda, RBAC

                    (Illegible)

                    B Krouo (illegible), RN

                    Danielle (illegible)
                                                       6
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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.
                    (Illegible)

                    Debbie Petruzzo, RNC

                    Analis Fernandez, RN

                    (Illegible)

                    Lucy Davis

                    Sharon Morgan

                    Ida M. (illegible)

                    (Illegible), RN

                    Sandra Nagy, RN, RBMC

                    (Illegible) Chambers, RBMC

                    June Mandays, RN

                    Anthony Chiaramida, M.D., FACC

                    Grace (illegible), RN

                    Cynthia (illegible)

                    Joseph Kristoff, RN

                    Edyte (illegible)

                    (Illegible), MSN

                    Remed (illegible)

                    Joseph Marson, RN

                    Marie Perrino, RN

                    (Illegible)

                    (Illegible), R.T

                    (Illegible)
                                                       7
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document and the official version of the proposal or adoption, the official version will govern.
                    (Illegible)

                    Rakesh Sahni, M.D.

                    Puneet Sahgal, M.D.

                    Maria (illegible), RN

                    (Illegible)

                    Susan Bednar, RN

                    (Illegible), RN

                    Josephine Perez, RN

                    Estephanie Sarroca, RN

                    Nancy (illegible), RN

                    Rita (illegible), RN

                    Elsie Martinez, RN

                    (Illegible)

                    Linda (Illegible)

                    (Illegible)

                    Cheryl Crawford

                    Betty M. (illegible)

                    Debra (Illegible), RN

                    Maria Kho, RN

                    Kathleen (Illegible) (RN)

                    Nancy Godeski, RN

                    (Illegible)

                    Maria Mila Balo, RN
                                                       8
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document and the official version of the proposal or adoption, the official version will govern.
                    Lisa Obermann

                    (Illegible)

                    (Illegible)

                    Diane (illegible)

                    Rosario Bumarlong

                    Pharlya (illegible)

                    Mary Tardiff, RN

                    (Illegible)

                    Kathleen DeJohn, RN

                    Theresa B. (Illegible), RN

                    Priscila B.Santos, LPN

                    Joselle Simon, RN

                    John Boston, RN

                    Kim MacAvoy-Sorochen, RN

                    Joan A. Friedman, RN

                    Carole Watkins, RN

                    Messie Icamara, RN

                    Sharon Drahos, RN

                    Arianne Zagniti, RN

                    Nancy (illegible)

                    (Illegible), RN, RBMC

                    Ruthanne Rodiewicz, LPN

                    Maureen Y. (illegible), RN
                                                       9
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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.
                    Jan Sager, LPN

                    Susan Shelton, RN

                    Beverly (illegible)

                    (Illegible)

                    (Illegible)

                    Ada Delgado

                    (Illegible)

                    Marion Ruber, RN, RBMC

                    Debra Kerr, RN, RBMC

                    Gaton J Callilla

                    Samuel Delose

                    Maureen Baradet

                    Michael R. Baradet

                    Noberto Rosado

                    John O. (illegible);

                    Mark Moshiyakhov, M.D.;

                    Gloria Arrajo (angioplasty patient);

                    Pete Russell (angioplasty patient);

                    Ann J. Zsinga, RN;

                    Runinden (illegible), M.D.;

          28.       The following commenters, who appear to be staff and

patients of Trinitas Hospital and their supporters, each signed a letter

containing identical content:
                                                      10
The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
                    Amparo Aquirre, Outreach Coordinator, Cancer Program;

                    Karen Celano, Cancer Registry

                    Leslie Queen, Cancer Registry;

                    Leonora Panagopoulos, Cancer Program Coordinator;

                    (Illegible)

                    Sr. Maria Scranton;

                    Alan Bernstein;

                    Sr. Mary Corrigan;

                    Rudolph Gibbs;

                    Sr. Maria Kratz;

                    Rabbi, Dr. Milton Kroopnick, Chaplain;

                    Rev. West Hopson;

                    Wayne (Illegible);

                    Diane T. Frezzi, RN;

                    Mary Ann L. Purcell, RN;

                    Alice Forster, RN;

                    (Illegible);

                    (Illegible), M.D.;

                    (Illegible), M.D.;

                    (Illegible), M.D.;

                    (Illegible);

                    (Illegible);

                    Michael Z (illegible), M.D.;
                                                      11
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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.
                    Javier Dieguez, M.D.;

                    (Illegible);

                    (Illegible);

                    (Illegible)

                    P. (Illegible);

                    (Illegible);

                    (Illegible) Joshi;

                    (Illegible);

                    (Illegible);

                    (Illegible);

                    (Illegible);

                    (Illegible), M.D;

                    (Illegible);

                    (Illegible);

                    illegible;

                    Prudentia (Illegible);

                    Sr. Marie C. Tansey;

                    Rev. Brendan H. (Illegible);

                    Rev. John A. Quill;

                    Rev. West Hopson;

                    Elizabeth Ocamps-T. (Illegible);

                    (Illegible);

                    (Illegible) Hope;
                                                      12
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document and the official version of the proposal or adoption, the official version will govern.
                    Dorothy J. Herman;

                    Ann Marie (Illegible);

                    Maria I. Figue (Illegible);

                    Cath (Illegible) Bell;

                    Wayne Greenwood;

                    (Illegible);

                    (Illegible) Barnes Wilson;

                    (Illegible);

                    Marie Galem;

                    (Illegible) Joseph;

                    Rose (Illegible);

                    Rayendra N. Dishi;

                    Gwen Norman;

                    Pankaj T. Shah;

                    (Illegible);

                    (Illegible), M.D.;

                    Evelina Torres;

                    Janice (Illegible);

                    (Illegible);

                    (Illegible);

                    Amelia Corrigan;

                    Jose Rivera, CME Coordinator;

                    (Illegible);
                                                      13
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.
                    (Illegible);

                    Donna Bryant;

                    Joanne (Illegible);

                    (Illegible);

                    Carol (Illegible);

                    Nicole G. (iillegible;)

                    Lily Duran;

                    Me (Illegible);

                    Emil Alvarez, HT;

                    (Illegible);

                    P. Mc Neill, RN;

                    (Illegible);

                    Sandra Powell;

                    Pamela P. (Illegible);

                    Lyna M. Stark;

                    Henry Ur (illegible);

                    Janet Whitt (illegible);

                    John R. P. (Illegible)

                    John Perina;

                    (Illegible);

                    (Illegible);

                    Rosa M. (Illegible);

                    Patricia Monaco;
                                                      14
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document and the official version of the proposal or adoption, the official version will govern.
                    (Illegible);

                    Teresita Dimondi;

                    Vivan R. T. (Illegible);

                    SouSam (Illegible) Samuel;

                    Erla S. Lynn;

                    Sharon Rial;

                    Carole Lang;

                    Jennifer Davila;

                    Sherline Budhram;

                    (Illegible);

                    Kim Dargen;

                    K. Pater;

                    Prabha Shah;

                    Joceline Rev. (Illegible);

                    (Illegible);

                    (Illegible);

                    Mary Catarini;

                    Mary J. Carpinullo;

                    Sawuda F. Lajuda;

                    (Illegible);

                    (Illegible) Piln;

                    Rosita Daug;

                    Lisa Wetzel;
                                                      15
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.
                    (Illegible);

                    (Illegible);

                    (Illegible);

                    Christian Mentor, RRT;

                    Naomi Rodriguez;

                    (Illegible); and

                    Parviz-Babalavi, M.D., Linden, NJ.

          29.       The following commenters, who appear to be staff and

patients Muhlenberg Regional Medical Center and their supporters, each

signed a letter containing identical content:

                    Edwin Blumberg, M.D.;

                    Joseph A. Catapano, M.D., FACC;

                    Mohammed T. Javed, M.D.;

                    Robert Lauer, M.D.;

                    Thomas Leopold, M.D.;

                    S (illegible), M.D.

          30.       The following commenters submitted comments through the

Deborah Foundation:

                    JoAnn Harding;

                    Joan Mills

                    Linda S. Shupp

                    Fran Houghtling

                    Louise Barton
                                                      16
The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
                    Mrs. Samuel Bell

                    John G. Mari, Jr.

                    Doris Merizio

                    Bernadette Peluso, R.N

                    Adolph Pratola, Jr.

                    Jeanne (illegible)

                    Donna Fijalkowski

                    William L. Emmons

                    Doreen Cesaretti

                    Marian N. Nelson

                    Charlotte Anker

                    Angela Davis

                    Virginia Fuller

                    Jean Meehan

                    R. (illegible)

                    Donna McArdle

                    Barbara A. Simpkins

                    Wanda Stokolski

                    Grace (illegible)

                    Rosemary M. Frank

                    Ronald J. Petrosky

                    Loretta Hall

                    Antonina Emmons
                                                      17
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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.
                    Arthur F. Hood

                    Robert Huber

                    Joseph Gillies

                    Corneilus Chirichella

                    Donna Wood

                    Maureen O’Neill

                    Ronald Chirichella

                    Maria Torres

                    Jiawen Yu

                    M. Catherine Donatelli

                    Boguslawa Huang

                    Frances Pelliccia

                    Mary A. Elsayed

                    Alice Chirichilla

                    Joseph Chirichella

                    Jeannette Wainaina

                    Ephraim Wainaina

                    Sella Troiano

                    Joseph Ferrara

                    Carol Ann Criipino

                    Sue Thurairatnam

                    Thomas O’Neill, Sr.

                    Robert G. Sacks
                                                      18
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document and the official version of the proposal or adoption, the official version will govern.
                    Alina Myronova

                    Stephanie C. Kakolewski

                    Joanne Sanchez

                    Ray Storck

                    Charles Morra

                    Joan P. Anderson

                    Edwin P. Poling

                    Evelyn C. Taylor

                    Ed and Dori O’Connor

                    Gloria C. Largi

                    Margaret O’Brien

                    Mary Woods

                    John King

                    Angelina and Daniel DeLuca

                    George Blanar

                    Mrs. Lorraine Michener Hanna

                    John H. Ferguson

                    William J. Dutton, Sr.

                    Patricia Grieshaber

                    Lois Vallimont

                    John N. Noel

                    Edward Robert Erbe

                    Kathleen Garske
                                                      19
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document and the official version of the proposal or adoption, the official version will govern.
                    Karen Young

                    Jean Thomas

                    Joy S. Hadley

                    Wayne Singer

                    Arthur Astorino

                    Judith Cartlidge

                    Charles M. Gagliardi

                    Donald R. Ackermann

                    Samuel Brethwaite

                    Harold Cox, Jr.

                    Leon Crespy

                    Charles R. Weber

                    Elisabeth Hofmann

                    Marcy J. DiBlasio

                    Wilfred S. Sharp

                    Rita B. Flood

                    Jacqueline F. Emery

                    George Mollin

                    Elizabeth Goodman

                    Richard and Estelle Weintraub

                    Kenneth E. Wilson

                    Charles E. Dill

                    Annette E. McAnany, RN
                                                      20
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document and the official version of the proposal or adoption, the official version will govern.
                    Arlene G. Sulley

                    Marie Wagner

                    Catherine Dorman

                    Mrs. John Egan

                    Grace Barone

                    Marie F. Cooper

                    A. Farr

                    Bessie and Anthony Zoppina

                    Brian Verga

                    David C. Evans

                    Mr and Mrs Kenneth Pressey

                    Horace E. Crane, Jr

                    Almira Yates Campagna

                    Teresa and James Ment (illegible)

                    Edward V. Soderland

                    Richard and Louise Howarth

                    Ruth S. Rypkema

                    J. Arthur Steitz, M.D.

                    Rachel G. Garfoll

                    Joyce Mahn

                    Dorothy Baar

                    George Costello

                    Charles H. Coles
                                                      21
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document and the official version of the proposal or adoption, the official version will govern.
                    Howard F. Clark

                    Michael Sinibaldi

                    Helen McChesney

                    Marie M. Dunman

                    Marie R. Brown

                    Denise A. Brasher, LPN

                    Robert E. Ritter

                    Rev. Dr. Michael E. Harris

                    Walter C. Robertson

                    Josephine Bongiorno

                    Flora E. Bair

                    Virginia Moll

                    Patricia Emmons

                    Lois M. Scheetz

                    Larry Smedley

                    Sharon L. Moore

                    (Illegible)

                    Donna M. Ervin

                    Phyllis Schneiderman

                    Jewell Wade

                    Gerard A. Viglin

                    Roger A. Milley, Sr.

                    Samuel (illegible)
                                                      22
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document and the official version of the proposal or adoption, the official version will govern.
                    Alice Harrison

                    Alice Harrison

                    Thomas J. Keating

                    Patricia Gaber

                    Thomas O’Drain

                    illegible

                    Josephine Switzer

                    L(illegible) Golia

                    Marjorie M. Eiver

                    Herbert A. Gordon

                    Walter H. Lind

                    Charles Arrison

                    Ronald N. Chamberlain

                    Joseph Lipari

                    Annie Bowker

                    Irene Papaycik

                    Frank Ingrassia

                    Mr. and Mrs.George J. Robertazzi

                    Lily B. McBeth

                    Sondra Horton

                    Regina Lamarra

                    Abbas and Diana Bahri and Nunziante

                    John Zelinski
                                                      23
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document and the official version of the proposal or adoption, the official version will govern.
                    Susan Davison

                    Louise Cizmarik

                    Stanley and Nancy Gauss

                    Joseph Leso

                    Wanda Gillen

                    Richard LaBarbera

                    Walter Stansh

                    Jo Wismar

                    Edna Leonelli

                    Marten and Ruth Hansen

                    Sheila A. Batts

                    Walter J. Fersberg

                    Thomas J. Boivin

                    Warl (illegible)

                    Mrs. Zwang

                    Leon Tallick

                    Dorothy Mulvihill

                    Katherine Rivera

                    Dennis Rivera, RN

                    Carl Howard

                    Jean Spohn

                    Laura S. Brazenski

                    Oreste Avallone
                                                      24
The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
                    Jo Ann Comfort

                    Donald J. Miller

                    Andrew C. Prusienski

                    Fred and Theresa Carbone

                    Donna Walter

                    James Tarantino

                    Jon J. Malpass

                    Doris Dorsey

                    Dino J. D’Androa

                    Charles F. Ellis



          The numbers in parentheses following each comment below

corresponds to the commenters above.



          1. COMMENT:                   A commenter provides supportive information

regarding the charge by those opposed to the proposal that there is no

unmet need for elective angioplasty in New Jersey. The commenter

indicates that the Department had identified and explained a need at the

time that a certificate of need (CN) call was issued on November 1, 2004.

The commenter cites the factual basis for the CN call, which indicated that

statewide utilization trends for cardiac surgery and percutaneous coronary

interventions (PCI) had been moving in opposite directions (that is, 15

percent decline in cardiac surgery; 26 percent increase in PCI) from 2000
                                                      25
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document and the official version of the proposal or adoption, the official version will govern.
to 2004, and that these trends were expected to continue. The

commenter also notes that cardiac surgery utilization declines may lead to

fewer cardiac surgery centers through licensing action, thereby providing

further justification of the Department’s exploration of “decoupling the

requirement that elective angioplasty only be performed in a cardiac

surgery center.” Furthermore, the commenter emphasizes that both the

American College of Cardiology/American Heart Association (ACC/AHA)

and the Society for Cardiovascular Angiography and Interventions (SCAI)

have stated that more data is needed to assess whether elective

angioplasty (that is, PCI) may be safely performed in hospitals without on-

site cardiac surgery back-up.

          The commenter also provides information in response to opponent

claims that the rule proposal does not consider the impact that the

hospitals participating in the demonstration project will have on current

cardiac surgery programs. The commenter indicates that the rule

proposal contemplates the use of the full review CN process which

includes a consideration of the availability of facilities or services which

may serve as alternatives or substitutes in order to comply with this

statutory (N.J.S.A. 26:2H-8) and rule requirement (N.J.A.C. 8:33-4.9(a)).

          The commenter also provides information in response to opponents

of the proposal that claim that the Atlantic C-PORT-E demonstration

project defined in the rule proposal is more aptly described as a “research

project” because it involves data collection and analysis. The commenter
                                                      26
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.
indicates that the criteria set forth in the definition of a “research project” in

the chapter is applicable to services that are not competing with and do

not negatively impact upon licensed providers of health care services in

the state. Thus, the commenter argues, the Atlantic C-PORT-E trial does

not meet the chapter’s definition of a “research project” but does meet the

chapter’s definition of a “demonstration project.” The commenter states

that therefore, it “supports the Department’s decision to authorize New

Jersey hospitals participation in the Atlantic C-PORT-E trial as a

demonstration project.”

          The commenter seeks to respond to opponents of the proposed

amendments that question the Department’s ability to monitor patient

care, outcomes, deaths, and complications of New Jersey residents

enrolled in the Atlantic C-PORT-E trial. The commenter points out that the

proposed amendments would require each Atlantic C-PORT-E

demonstration project hospital to report elective PCI data to the

Department that is separate from data submitted as part of the Atlantic C-

PORT-E trial protocol. The commenter indicates that the proposal

requires Atlantic C-PORT-E trial hospital participants to be subject to the

identical Department data reporting requirements as cardiac surgery

centers for elective PCIs performed in their respective facilities.

          The commenter also seeks to provide information regarding claims

by opponents of the proposed amendments that patient safety issues are

not fully and properly addressed. The commenter cites several articles in
                                                      27
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 cardiac literature as illustrative of the patient safety factors that have

been incorporated in the Atlantic C-PORT-E trial design. The commenter

states that the proposed amendments require compliance with minimum

annual procedure volumes, which is a key factor in assuring patient safety

for PCI patients. The commenter provides a comparison of the Atlantic C-

PORT-E demonstration project participation requirements contained in the

Department’s proposal with that of the state of Maryland in an effort to

refute opposition comments, made at the July 19, 2007 meeting of the

Health Care Administration Board, that New Jersey’s requirements were

less stringent than that of Maryland with respect to patient safety. The

commenter states that “New Jersey’s and Maryland’s regulations

governing each state’s participation in the Atlantic C-PORT-E trial are

substantially similar and are designed to protect patient safety” and

concludes that it is “Maryland’s application process that is less stringent

than New Jersey’s.”

          Finally, the commenter responds to comments made by opponents

of the proposal that the rules are not specific enough to meet the Supreme

Court’s requirements and that the Department has substantially adopted

the contents of the original CN Call as its new regulations. The

commenter argues that the proposal is even more detailed than the

demonstration projects authorized under N.J.A.C. 8:33-3.11(c) and (d)

dealing, respectively, with inner city cardiac satellite demonstration

projects and bloodless surgery demonstration projects, since the
                                                      28
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.
Department’s rule proposal incorporates by reference the Atlantic C-

PORT-E trial requirements. Those requirements include patient eligibility,

inclusion criteria for participating hospitals and physicians performing the

elective PCI procedures, device inclusion and exclusion criteria, and

extensive patient-specific data reporting.

          The commenter states that it strongly supports the Department’s

proposed regulatory amendments as well as the Atlantic C-PORT-E trial’s

multiple levels of monitoring and review to protect patient safety. The

commenter indicates its appreciation and respect of Atlantic C-PORT-E

protocols that place clear limits on the public discussion of demonstration

project data and outcomes designed to protect the integrity of the benefits

to be derived by patients associated with Atlantic C-PORT-E

demonstration project participation, including earlier and effective

treatment that is able to involve the patient’s primary care physician and

cardiologist, as well as family members and supportive friends. The

commenter notes that several reports have surfaced in the media that

reference the occurrence of four to seven patient deaths statewide related

to the trial. The commenter also indicates that he is aware of one case

involving the commenter of which the media has made reference. The

commenter further states that it welcomes the opportunity to speak with

the family about any concerns they have regarding the care provided by

the commenter, just as it does with any patient and his or her family. The

commenter notes that the Federal Health Insurance Portability and
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document and the official version of the proposal or adoption, the official version will govern.
Accountability Act (HIPAA) and Atlantic C-PORT-E restrictions prohibit

hospitals from specifically commenting on the cases unless the patient or

other responsible party grants permission. The commenter indicates that

it is distressed and concerned from an ethical perspective that a

competitor hospital has taken a specific Atlantic C-PORT-E patient matter

to the media. (13)

          RESPONSE: The Department thanks the commenter for its support

of the proposed amendments.

          With respect to the specific case of a patient enrolled in the Atlantic

C-PORT-E trial, the Department cannot comment with respect to alleged

matters that may be the subject of a Department investigation.

          The proposed amendments would authorize facilities to participate

in the Atlantic C-PORT-E trial as a “demonstration project,” and not as a

“research project” as N.J.A.C. 8:33-1.3 defines those terms.

          2. COMMENT:                   A commenter expressed its position that “the

demonstration project unnecessarily endangers New Jersey patients.”

The commenter states that the proposed amendments “should require

more rigorous reporting of patient outcomes and volume data by

[demonstration] site hospitals, and more frequent monitoring and oversight

of this data by the Department, than is required in connection with cardiac

surgery facilities. If this effort is indeed a ‘demonstration project,’ [then]

data collection and careful monitoring [are] essential to evaluating its

success.” The commenter states that the proposed amendments “merely
                                                      30
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.
require applicants to demonstrate a ‘willingness to report elective PCI data

to the Department,’ and [do] not set forth specific reporting requirements

or impose sanctions for failure to report. The proposal also does not

describe whether or when data collected by the C-PORT-E demonstration

project team will be reviewed by the Department to ensure patient safety.

Given the fact that the purpose of the demonstration project is to

determine whether elective angioplasty can be safely performed in the

[demonstration] site hospitals, the Department has a responsibility to

monitor patient safety at these (potentially less safe) sites more rigorously

than it monitors patient safety at non-[demonstration]-site facilities.” (17)

          RESPONSE: The Department disagrees with the commenter’s

general assertion that the demonstration project unnecessarily endangers

New Jersey patients. The Department will respond to this general

assertion by responding to the commenter’s specific assertions, in the

series of comments and responses that follow.

          The commenter is incorrect in its assertion that the proposed

amendments fail to “articulate specific reporting requirements or impose

sanctions for failure to report.” Proposed N.J.A.C. 8:33(e)6vii would

require facilities participating in the demonstration project to report data

“pursuant to N.J.A.C. 8:33E-1.9 and 2.10,” which set forth specific

reporting requirements and consequences of failure to report. In addition,

failure of a demonstration project to adhere to the proposed amendments


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document and the official version of the proposal or adoption, the official version will govern.
would give rise to the consequence of there being grounds for action

against that facility’s license.

          The commenter provides no support for its assertion that the

Department must require more rigorous reporting of patient outcomes and

volume data and provide greater attention to patient safety at

demonstration project sites than it does at all licensed facilities generally

and all facilities that provide cardiac care specifically.

          Nonetheless, patient safety is and has been a primary concern of

the Department in all its efforts to exercise regulatory authority over

licensed health care facilities under its jurisdiction. This has been

particularly true in the area of cardiovascular disease. Consultants, ad

hoc and standing committees of experts, and dedicated staff have

combined to promulgate cardiac service licensure standards that maintain

consistency and quality among clinical cardiac care facilities, despite

unprecedented changes in clinical practice.

          For the past decade, the Department has required all licensed

cardiac catheterization, intervention, and cardiac surgery programs to

provide 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.


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document and the official version of the proposal or adoption, the official version will govern.
          The Department has the authority, as set forth at N.J.A.C. 8:43E, to

impose penalties and sanctions on facilities that fail to report required data

and 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 existing patient

safeguards in place for all patients in the State’s cardiac facilities,

regardless of whether they elect to enroll in the Atlantic C-PORT-E trial, to

be appropriate.

          3. COMMENT:                   The commenter states, the “license of any

[demonstration] site facility that fails to meet specified volume, reporting,

or quality standards should be immediately revoked” and asserts that the

proposed amendments do “not contain clear standards describing the

consequences for failure to meet minimum standards. This is essential to

maintain patient safety.” (17)

          RESPONSE: The Department disagrees with the commenter’s

assertion that the proposed amendments do not contain consequences for

failure to meet minimum standards. All eligible demonstration project

hospitals are licensed by the Department and are subject to N.J.A.C.

8:33E and N.J.A.C. 8:43G-7, N.J.A.C. 8:33E-2.3(d)2iii, and N.J.A.C.

8:43E, which establish cardiac facility licensure requirements, procedures

for licensure enforcement actions, and sanctions, which can include

monetary penalties and facility license revocation. Actions against the

license of a facility are subject to hearing rights in accordance with the
                                                      33
The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
Administrative Procedure Act (N.J.S.A. 52:14B-1 et seq.). The existence

of these standards and procedures of general applicability to all licensed

facilities generally and to cardiac care facilities specifically negates the

commenter’s assertion that the proposed amendments fail to address a

facility’s obligations to meet minimum standards.

          4. COMMENT:                   The commenter inquires as to “how the

Department will ensure that each [demonstration] site complies with the C-

PORT-E trial criteria and protocol” and whether the Department “is

delegating this function to C-PORT-E” and if “so, whether the Department

has verified the manner in which C-PORT-E evaluates individual

demonstration sites for compliance, and the frequency of its evaluation of

each of the New Jersey [demonstration] sites.” (17)

          RESPONSE: The Department is satisfied with the quality of the

demonstration project, and on the principal investigator’s compliance with

the Johns Hopkins IRB process and that IRB’s approval of the Manual of

Operations. A facility participating in the demonstration project agrees to

adhere to the trial’s Manual of Operations. The Manual of Operations

identifies the many programs and oversight committees designed to

ensure the integrity and safety of the demonstration project and to identify

and remediate potential errors as quickly as possible. For example, an

Events Committee reviews adverse outcomes potentially related to the

procedure rather than other factors, including death or emergency

coronary artery bypass graft, within 24 hours of a procedure and
                                                      34
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.
adjudicates within 72 hours whether the outcome was either definitely,

probably, or possibly related to a patient’s participation in the trial or the

procedure itself. Within 72 hours of the Event Committee determination, a

Data and Safety Monitoring Board reviews the Event Committee’s

determination and recommends responsive actions as appropriate,

including suspension of the trial. The Manual of Operations recognizes

that “continued inclusion of a participating hospital in the C-PORT study

requires adherence to the spirit and letter of state health-care regulation[.

R]egular reporting of the course of the Atlantic C-PORT-E trial, including

adherence to the terms and conditions of the granted waiver, will be made

to the Department of Health of each state in which there are participating

sites.” If the Department were to receive of information from the principal

investigator that a facility’s continued participation in the demonstration

project would be violative of the licensure requirements or otherwise

inappropriate, the Department would take appropriate administrative

measures in accordance with applicable licensure standards.

          At the same time, the Department monitors volume and other

indicia relating to the quality of all cardiac care patients through the

cardiac data reporting and through measures applicable to all licensed

healthcare facilities to ensure patient safety.

          Thus, once the Department is satisfied as to the general

appropriateness of the procedure as a demonstration project in New

Jersey and in the selection of appropriate demonstration project sites, the
                                                      35
The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
quality of data collected relevant to the demonstration project is the

responsibility of the principal investigator. At the same time, the

Department continues to maintain its commitment and obligation to

enforce licensure standards and to ensure patient safety through existing

reporting and oversight measures applicable to licensed healthcare

facilities generally and to cardiac care facilities specifically.

          5. COMMENT:                   The commenter inquires “when the maximum

three-year period for [demonstration] site Certificates of Need … begin”

and inquires whether the Department would “count the time during which

the existing [demonstration] sites, all of which have been operating

pursuant to previously issued CNs, have held CNs and have been

licensed in calculating the three-year maximum.” (17)

          RESPONSE: Proposed N.J.A.C. 8:33-3.11(e)3 would establish that

the period of licensure for certificates of need the Department issues to

facilities to participate in the demonstration project would be three years,

not counting any period of lapse associated with the litigation described at

Cooper University Hospital v. Jacobs, 191 N.J. 125 (2007). Proposed

N.J.A.C. 8:33-3.11(e)3i would authorize the Department to extend the

license if the Medical Director of the Atlantic C-PORT-E trial is authorized

to continue patient enrollment.

          6. COMMENT:                   The commenter asserts that the proposed

amendments “do not further the policies of the controlling law,” and quotes

from N.J.S.A. 26:2H-1 et seq., which “declares it to be ‘the public policy of
                                                      36
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 State that hospital 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] describe the purpose of the State’s participation in the C-

PORT-E [demonstration project] as being to ‘facilitate scientifically

rigorous collection and analysis of data that will contribute significantly to

the evidence base nationally on the issue of the comparative safety and

efficacy of elective angioplasty or PCI with and without on-site CABG

surgical back-up.’” The commenter inquires, how “will participation in the

study improve the quality of cardiac services in New Jersey? Is there any

possibility that the study will show that elective PCI is more safe when

performed at sites without CABG surgical back-up? Is the study designed

to make this determination?” (17)

          RESPONSE: The demonstration project is designed to evaluate the

comparative safety and efficacy of elective angioplasty or PCI with and

without on-site coronary artery bypass graft (CABG) surgical back-up.

While the demonstration project may ultimately result in data that shows

that “elective PCI is more safe when performed at sites without CABG

surgical back-up,” a purpose of the demonstration project is to ascertain

whether elective PCI is as safe when performed at sites without CABG

surgical back-up as it is at sites with CABG surgical back-up. The

demonstration project is also intended to provide efficacy data.


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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
          7. COMMENT:                   The commenter inquires, “What need has been

demonstrated within New Jersey for additional elective angioplasty

services, whether at sites with or without on-site CABG back-up.” (17)

          RESPONSE: The proposal Social Impact at (39 N.J.R. 3462)

describes the need for scientific performance data “to evaluate and

compare the safety and efficacy of elective angioplasty and PCI at

hospitals with and without on-site cardiac surgery backup.” In addition, in

its presentation at the public hearing on July 19, 2007, before the Health

Care Administration Board, the Department described the trends

indicating an increase in demand for angioplasty and a decrease in

demand for cardiac surgical intervention. These trends, combined with

data suggesting the increasing safety and efficacy of angioplasty without

resort to CABG, indicate a need for the Department to investigate by

means of a scientifically rigorous demonstration project the

appropriateness of increasing public access to facilities that provide

elective angioplasty with and without cardiac backup.

          8. COMMENT:                   The commenter inquires, “How will the

Department ensure that the [demonstration] sites’ services are efficiently

provided and properly utilized?” (17)

          RESPONSE: The process for certificate of need and N.J.A.C. 8:33

and the criteria for review address the orderly development of adequate

and effective health care. Facilities participating in the demonstration

project are obliged to adhere to the Manual of Operations and to adhere to
                                                      38
The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
applicable licensure standards. As described in response to a previous

comment, the principal investigator is responsible to monitor the quality of

data collected. The Department is responsible to enforce applicable

licensure and patient safety standards and to collect cardiac data. The

principal investigator is responsible for evaluating data generated from the

demonstration project with respect to safety and efficacy. The Department

is responsible for evaluating the demonstration project results in

determining appropriate State policy with respect to whether or not to

authorize licensure of elective angioplasty without cardiac surgery backup

as a regular licensed service in the ordinary course.

          9. COMMENT:                   The commenter inquires, “What are the

anticipated costs associated with the participation of 12 New Jersey

hospitals in the C-PORT-E project? What have the start-up costs at each

of the [nine] existing [demonstration] site hospitals been to date? Has the

Department made a determination that these costs are reasonable? Has

the Department evaluated the costs associated with duplication of

services such as increased competition among area cardiac providers for

specialized staffing and duplication of equipment and supplies)?” (17)

          RESPONSE: Costs that a facility electing to participate in the

demonstration project will incur will depend on factors specific to that

facility. Upon conclusion of the demonstration project, the Department

may determine to collect, as necessary, and to analyze, as appropriate,

startup and redundancy costs in determining appropriate State policy with
                                                      39
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.
respect to whether or not to authorize licensure of elective angioplasty

without cardiac surgery backup as a regular licensed service in the

ordinary course.

          10. COMMENT:                  The commenter inquires, “Has the Department

evaluated the experience of the C-PORT-E study in New Jersey and in

other states in terms of demonstration site ability to meet projected volume

requirements, the number of patients refusing to participate in the study,

study retention rates, and adverse events? If not, why not?” (17)

          RESPONSE: As stated in response to a previous comment,

N.J.A.C. 8:33E-1.9 and 2.10 require facilities participating in the

demonstration project to report elective PCI data to the Department on a

quarterly basis in addition to the extensive data reporting required of

Atlantic C-PORT-E participants. The Department uses this data reported

to the cardiac services database to monitor and conduct licensure review

of all licensed cardiac providers.

          The Department routinely processes and analyzes crude mortality

and in-hospital complication data submitted by all hospitals in New Jersey

providing cardiac catheterization and primary and elective PCI services.

For the first time, that analysis includes elective PCI cases performed at

the nine facilities participating in the demonstration project.

          The Department receives reports relating to adverse events in

accordance with the general cardiac licensure reporting standards and in

connection with the Patient Safety Act, P.L. 2004, c.9, N.J.S.A. 26:2H-
                                                      40
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.
12.23. (A pending proposal to establish rules implementing the Patient

Safety Act appears at 39 N.J.R. 315(a) (February 5, 2007).)

          The Department does not collect data relating to patient refusal to

participate in the demonstration project or “study retention rates” but the

Manual of Operations requires the reporting of this data to the principal

investigator, inasmuch as it may relate to the quality of demonstration

project data collected.

          11. COMMENT:                  The commenter inquires, “Has the Department

determined whether the number of elective angioplasties [Statewide] have

increased over the past [six to] 12 months? If elective angioplasty

utilization levels off or drops on a statewide or regional basis, will the

Department revoke the licenses of currently operating [demonstration]

sites? If the number of diagnostic catheterizations at an applicant or

licensed [demonstration] site facility decreases, or if the number of elective

angioplasty enrollees at a given site is lower than projected (when

projected based on diagnostic cath volume at that facility), will the

Department revoke a facility’s [demonstration] site license? At what point

will discrepancies between projected volume and actual volume be

evaluated by the Department and how frequently?” (17)

          RESPONSE: The Department annually evaluates all licensed

cardiac service providers for compliance with existing licensing

requirements for cardiac services at N.J.A.C. 8:33E and N.J.A.C. 8:43G-7.

In addition, the Department responds to complaints of its licensed cardiac
                                                      41
The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
services just as it does for all other licensed health care. Consistent with

these licensing rules, the Department includes facility and physician

performance criteria in its annual cardiac licensure reviews, which it

conducts concurrently with the review of the hospital prior to its licensure

anniversary date. N.J.A.C. 8:33E-1.13 and 2.13 establish procedures to

which the Department adheres in addressing non-compliant cardiac

services. These rules require, among other measures, external review by

an independent external organization the Department approves to assess

the overall performance of the facility and its staff, a detailed plan of

correction to ensure that a non-compliant facility implements corrective

action to achieve compliance, and the articulation of a date by which a

noncompliant facility will reach compliance with applicable licensure

standards.

          With respect to hospitals providing PCI services without cardiac

surgery back-up services on site, N.J.A.C. 8:33E-2.16(b)6 requires

participating facilities to achieve annual physician volume requirements for

primary PCI, in accordance with existing CN licensure conditions, and

elective PCI, in accordance with the demonstration project criteria at

proposed N.J.A.C. 8:33-3.11(e)6ii(1). Pursuant to N.J.A.C. 8:33E-

2.3(d)4iii, the Department does not consider the minimum annual

physician PCI volume standard of 75 cases in the evaluation of cardiac

surgery center licensure compliance.


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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.
          Beginning January 1, 2007, the Department initiated a significant

upgrading of its Statewide cardiac catheterization and PCI quarterly data

collection process. This process collects 245 individual data elements and

considerably more procedure categories, interventional devices, and

patient complications. Collection of this data will provide greater insight of

facility and physician performance. All providers of cardiac catheterization

and PCI services in New Jersey, including the current nine elective PCI

demonstration project participants, must report to this robust cardiac

database.

          This extensive cardiac surgery data reporting is in addition to the

substantial research data that facilities participating in the demonstration

project must report to the Atlantic C-PORT-E study. The demonstration

project’s independent Data Safety Monitoring Board meets regularly to

analyze study data as it is gathered.

          The nine existing Atlantic C-PORT-E demonstration project

participants began their enrollment of patients between April 19, 2006 and

June 27, 2006. The proposed amendments require them, as a condition

of CN approval, to provide elective PCI data to the Department on a

quarterly basis in addition to the extensive data reporting required of

Atlantic C-PORT-E participants. The Department collects cardiac service

data on a quarterly basis from all licensed cardiac providers, verifies it

using appropriate methods of scientific data review, and uses it in the

licensure review process. Within the past year, that quarterly data
                                                      43
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document and the official version of the proposal or adoption, the official version will govern.
reporting has included the elective PCI data generated by the nine existing

participants in the demonstration project.

          The Department anticipates conducting a first-year review of

elective PCI data generated during the first four quarters (that is, for the

period from July 1, 2006 through June 30, 2007) in which all nine New

Jersey demonstration project sites were enrolling patients in the Atlantic

C-PORT-E trial. The Department routinely processes and analyzes crude

mortality and in-hospital complication data submitted by all hospitals in

New Jersey providing cardiac catheterization and primary and elective PCI

services. For the first time, that analysis will include elective PCI cases

that the nine Atlantic C-PORT-E demonstration sites are performing.

Preliminary analysis indicates that there do not appear to be any

significant differences in quality among the hospitals performing PCI.

However, any conclusive statement with respect to quality differences for

those hospitals participating in the Atlantic C-PORT-E trial can only be

made upon completion of the demonstration project and conclusion of a

careful analysis of the extensive data collected.

          12. COMMENT:                  A commenter states that it strongly supports

the Atlantic C-PORT-E demonstration project and accompanying

proposed regulatory amendments.” The commenter stated that it viewed

the Atlantic C-PORT-E trial as timely and addressed nationwide trends in

cardiac care. The commenter noted that 28 states allow PCI at hospitals

without on-site surgery and that more than 10,000 PCIs were performed in
                                                      44
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document and the official version of the proposal or adoption, the official version will govern.
hospitals without on-site surgery in 2005. The commenter noted that

internationally there are 35 nations that allow PCI without on-site cardiac

surgery.

          The commenter recommends the Department change proposed

N.J.A.C. 8:33-3.11(e)6i(3) upon adoption to refer to the most recent

version of the Manual of Operations. (21, 25)

          RESPONSE: The Department thanks the commenter for its

support of the proposed amendments.

          The Department agrees with the commenter’s suggestion and will

change N.J.A.C. 8:33-3.11(e)6i(3) upon adoption to refer to the most

recent version of the Manual of Operations.

          13. COMMENT:                  Several commenters submitted comments in

support of the proposed amendments. One noted the importance of the

continuation of elective PCI at the hospital to area residents. (15)

          One emphasized the importance of patient safety that is required of

participants in the Atlantic C-PORT-E trial, noting that each site must meet

a stringent set of safety and clinical requirements to ensure positive

patient outcomes. (14)

          Several commenters submitted similar letters of support for the

proposed amendments, indicating that the proposed amendments “allow

for the involvement of a network of medical professionals, including the

patient’s primary physician and cardiologist, as well as the support of

family members and friends. The commenters indicated that the
                                                      45
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.
continuation of the Atlantic C-PORT-E demonstration project was a priority

and that they strongly support its continuation. (18)

          A commenter expressed his support for the proposed amendments

and the continuation of Atlantic C-PORT-E demonstration project, noting

the clinical advances in coronary intervention that have made PCI

increasingly safe, with emergency surgery rates of only 0.4 percent. (10)

          A commenter expressed support of the proposed amendments and

emphasizes the fact that Johns Hopkins University Medical Center, one of

the most respected medical institutions in the nation, is conducting the

demonstration project and that all facilities involved have met a stringent

set of safety and clinical requirements. (21)

          Several commenters were signatories to a letter of support for the

proposed amendments, noting that the availability of elective PCI at

facilities participating in the demonstration project allows for the

involvement of the patient’s primary care physician and cardiologist. (5)

          A commenter expresses her strong support for the proposed

amendments, noting that in her professional role at a facility participating

in the demonstration project, she shares the responsibility for data

collection and reporting for the facility’s cardiology department and is a

participant in meetings to assure absolute compliance with safety and

clinical standards for the Atlantic C-PORT-E trial without exception. (7)

          Several commenters submitted a letter expressing support of for

the proposed amendments to enable New Jersey to continue its
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
participation in the demonstration project. The commenters indicate that

there are benefits to be derived by patients associated with Atlantic C-

PORT-E demonstration project participation, including earlier and effective

treatment that is able to involve the patient’s primary care physician and

cardiologist, as well as family members and supportive friends.

          Approximately 256 persons submitted identical letters expressing

support of the proposed amendments. (12), (6)

          A commenter expresses support for the proposed amendments and

states that it is reasonable and appropriate to explore the possibility of

providing elective PCI at hospitals without cardiac surgery on-site. (11)

          RESPONSE: The Department thanks the commenters for their

support of the proposed amendments.

          14. COMMENT:                  A commenter states, “[A]lthough clinical

evidence has shown that angioplasty without on-site cardiac surgery back-

up is safe and effective in facilities that perform more than 50 cases per

year, more study is appropriate.” The commenter disagrees with

opponents of the proposed amendments who rely on the 2004 study by

David E. Wennberg, M.D., from the Journal of the American Medical

Association, “Outcomes of Percutaneous Coronary Interventions

Performed at Centers Without and With Onsite Coronary Artery Bypass

Graft Surgery,” David E. Wennberg, M.D., MPH, et al. JAMA. 2004;

292:1961-1968, as evidence that angioplasty is more dangerous at

centers without on-site cardiac surgery. The commenter asserts that while
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
the Wennberg study indicated a 38 percent higher mortality in patients

receiving non-emergency PCI in hospitals without on-site cardiac surgery,

these results applied only to hospitals that performed fewer than 50 PCIs

per year. The commenter states that hospitals performing between 50

and 100 PCIs had statistically equivalent outcomes as compared to

cardiac surgery centers. The commenter concludes that the Wennberg

study supports the adoption of the proposed amendments because it

shows a relationship between procedure volume and outcomes, whereas

the effect of procedure venue is unknown and “is precisely what the

Atlantic C-PORT-E trial is designed to investigate.”

          The commenter responds to issues others have raised in

opposition to the proposed amendments and reviews the experience of a

particular facility participating in the demonstration project. (1)

          RESPONSE: The Department thanks the commenters for their

support of the proposed amendments.

          15. COMMENT:                  A commenter states that allowing the State to

continue to participate in the demonstration project would “ensure our

local residents have access to the most advanced cardiac life support and

treatment closer to home.” (9)

          RESPONSE: The Department thanks the commenter for its

support of the proposed amendments.

          16. COMMENT:                  A commenter states, “Though emergent

cardiac surgery is not commonly needed after an elective diagnostic
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document and the official version of the proposal or adoption, the official version will govern.
procedure or elective angioplasty, preparation and resources available for

transport cannot be done expeditiously enough to maximize the patient’s

outcome. When emergent surgery is required, patients need to be moved

quickly or to an [operating room] setting, [that is,] less than 10 to 15

minutes. Waiting for ambulance transport and mechanically moving the

patient out of the hospital to another facility raises the risk of further

complications and poor patient outcome….

          Planned elective angioplasty is always at risk for complexity. This

is not always known until the patient has the diagnostic study. It is not

uncommon for patients to have dissections and (probably less common)

perforations. Both situations require skilled practitioners, nurses and

techs to manage these cases in the moment. These patients cannot

tolerate transfer to another facility since intervention must be immediate.

Unless these complex situations are managed on an ongoing basis staff

cannot remain competent in the care of these patients. These types of

patients are often seen at high[-]level centers that see a moderate to high

volume of patients and the staff is well versed and comfortable in their

care. Low-level labs may not see these patients very often and are often

not prepared for these emergencies. New Jersey demographics are such

that a patient need only travel a short distance in order to reach a full

service hospital, thus, having their procedure performed at a full service

hospital (one with surgical back-up) would require a very short additional


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document and the official version of the proposal or adoption, the official version will govern.
transportation time. This is in line with the recent calls for regionalizing

cardiac care services in the State of New Jersey….

          Supplies for interventional labs are very expensive. For example,

the supply of very expensive stents required for each lab is extensive, thus

increasing the cost of procedures. Moreover these stents are subject to

expiration. The high inventory cost for low volume labs makes this model

of practice inefficient and costly….

          Qualified technicians who perform angioplasty are often difficult to

recruit and retain due to the high salaries implicit in the role. Experienced

Cath lab nurses are also difficult to recruit (even more so) because of the

nursing shortage. Low-level labs have a fair share of non-productive time,

which every lab does encounter. However, the department must have

available staff at all times including on call staff to properly service the lab.

The cost of running the department may once again outweigh the revenue

associated with the procedures being performed. Physicians are required

to perform a minimum number of interventions overall, and a minimum

number of interventions per hospital. These requirements would obviously

be more challenging to meet if New Jersey did not regionalize cardiac

care services….

          State regulations require that [electrophysiology] service be

performed only in hospitals that have a full range of cardiac services. If a

patient requires further [electrophysiology] studies or ICD intervention then

the patient must be transferred to another facility….
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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          Patients are entitled to go to hospitals [that] are capable and

competent in providing specialized services. They may not realize that

small community hospitals without cardiac surgical capability essentially

put them at risk, no matter how slight that risk may seem. EMS services

are coordinated, and with mobile intensive care units, paramedic support

and ACLS availability, the few extra minutes needed to transport to a full

service cardiac institution is well worth every minute needed for transport.

(16)

          RESPONSE: These assertions generally appear to address the

appropriateness of decisions that are within the province of individual

facilities in making the business decision to apply to participate in the

demonstration project, and within the discretion of patients in their

exercise of informed consent. The commenter’s assertions do not provide

a basis for the Department to decline to adopt the proposed amendments,

and the Department will make no change on adoption in response to the

comments.

          The Department agrees with the assertion that PCI services are

sophisticated and require skilled professionals performing a considerable

number of cases to deliver a quality service. The Department disagrees

with the commenter’s assertion that community hospitals, particularly the

sizeable community hospitals in New Jersey, are not capable of providing

well-trained professionals to perform PCI around the clock in the volume

the demonstration project requires. The proposed amendments would
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
enable the Department to authorize New Jersey hospitals to participate in

a study that would elicit data that would enable the Department to

determine that issue.

          The Department’s responses to previous comments address

patient safety and quality measures that are part of the demonstration

project, as reflected in the Manual of Operations, and that are part of the

Department’s existing licensure standards. A patient need not elect to

participate in the demonstration project if the patient has concerns of the

nature the commenter raises.

          The Department agrees with the commenter’s general assertions

relating to the quality of State EMS services and their ability to provide

prompt transports.

          17. COMMENT:                  A commenter opposes the proposed

amendments, asserting that they are “unnecessary and exposing patients

to more risk [than] is necessary. Given the current number and location of

open-heart surgical programs in the state, there is no reason why a

rational person would [forego] receiving angioplasty at a hospital that has

on-site surgical backup, unless they are misinformed or uninformed by

providers or hospitals that have other priorities—such as convenience or

profits! Approving hospitals without surgical backup will add costs to the

healthcare system, resulting in even higher insurance premiums,

unnecessary medical complications and death. For our regulators and

legislators to support such a scheme is simply unconscionable!” (4)
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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          RESPONSE: The Department disagrees with the commenter’s

assertions. Many other states currently authorize the procedure as a

regular licensed service. Nine other states currently participate in the

demonstration project. The commenter’s assertion would require the

conclusion that all of these regulators and legislators are uninformed or

else willfully engaged in a scheme to harm patients and/or raise insurance

premiums; that the principal investigator, the John’s Hopkins IRB, and the

Department are willfully hiding information necessary to securing patients’

informed consent; and that none of the many patients who have received

the procedure in New Jersey and in other states are of sound mind. This

conclusion is unsupported and untenable and the Department will make

no change on adoption in response to the comment.

          In fact, prestigious national organizations such as the American

College of Cardiology/American Heart Association (ACC/AHA) and the

Society for Cardiovascular Angiography and Interventions (SCAI)

recognize that PCI without cardiac surgery backup is a dynamic area and

that national guidelines may be subject to revision as clinical data and

experience increase. The Atlantic C-PORT-E trial represents a

scientifically rigorous effort to provide an evidence base of clinical data

and experience that these prestigious groups acknowledge as necessary

to identify the precise circumstances under which PCI without on-site

backup cardiac surgery is safe and effective.


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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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document and the official version of the proposal or adoption, the official version will govern.
          18. COMMENT:                  “Why is it necessary to permit hospitals without

on-site surgical backup to provide angioplasty when existing hospitals

have a track record of successful outcomes, trained staff, facilities and

equipment, and surplus capacity?” (4)

          RESPONSE: The demonstration project will generate data that will

assist the Department to determine the efficacy and safety of the

procedure. The Department’s response to previous comments addresses

the “need” for the proposed amendments.

          19. COMMENT:                  “What is the advantage of the proposed

regulations to the citizens of New Jersey?” (4)

          RESPONSE: As stated at proposed N.J.A.C. 8:33-3.11(e)1, the

proposed amendments would “facilitate scientifically rigorous collection

and analysis of data that will contribute significantly to the evidence base

nationally on the issue of the comparative safety and efficacy of elective

angioplasty or PCI with and without on-site CABG surgical back-up.”

          20. COMMENT:                  “Will approving hospitals to do elective

angioplasty add cost to the New Jersey healthcare system and/or increase

costs in terms of higher taxes or higher healthcare premiums for the

citizens of New Jersey?” (4)

          RESPONSE: The Department anticipates that the demonstration

project would generate data that would enable the Department to evaluate

the efficacy of the procedure in making public policy determinations as 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.
whether to authorize the procedure as a regular licensed procedure in the

ordinary course.

          21. COMMENT:                  “Please provide evidence of the financial

impact analysis of this regulation on: … the taxpayers of New Jersey; …

the hospitals in New Jersey that have angioplasty programs with on-site

surgical programs now;… [and] the nine … hospitals in New Jersey that

have already been approved to perform angioplasty without on-site

surgical backup.” (4)

          RESPONSE: See the Department’s response to previous

comments addressing this topic, and the proposal Economic Impact at 39

N.J.R. 3463(a) (August 20, 2007). The Department anticipates that the

demonstration project will generate data that would enable the

Department to evaluate the efficacy of the procedure in making public

policy determinations as to whether to authorize the procedure as a

regular licensed procedure in the ordinary course.

          22. COMMENT:                  “What will be the cost, in terms of staff layoff

and unemployment benefits, underutilized technology and viability of the

hospitals in New Jersey, of adding angioplasty programs that do not have

on-site surgical backup?” (4)

          RESPONSE: See the Department’s response to previous comment

addressing this topic, and the proposal Economic Impact at 39 N.J.R.

3463(a) (August 20, 2007). The Department anticipates that the

demonstration project would generate data that would enable 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.
Department to evaluate the efficacy of the procedure in making public

policy determinations as to whether to authorize the procedure as a

regular licensed procedure in the ordinary course.

          The Department anticipates that there would be little capital startup

cost involved, because all eligible hospitals already provide cardiac

catheterization and primary PCI and have qualified staff to provide the

services.

          23. COMMENT:                  “How does the Department reconcile the

increased non-invasive methods for diagnosis and treatment of heart

disease, resulting in a trend of decreased need for diagnostic and

interventional catheterizations, with the need to add more providers of

angioplasty as proposed in this regulation?” (4)

          RESPONSE: The State’s participation in the demonstration project

is to assist the Department in determining whether New Jersey should

authorize the procedure as a regular licensed service in the ordinary

course, and to explore whether the wider availability of the procedure can

enhance patient outcomes, and result in benefits to be derived by patients

associated with earlier and effective treatment that can involve the

patient’s primary care physician and cardiologist, as well as family

members and supportive friends.

          24. COMMENT:                  “Why is New Jersey supporting this elective

angioplasty research study when so many other states have opted not to

do so?” (4)
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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          RESPONSE: The Department states the purpose of its participation

in the demonstration project in the proposal Summary, at proposed

N.J.A.C. 8:33-3.11(e), in comments before the HCAB, and in its responses

to other comments on this issue throughout this notice of adoption. The

Department can make no representation as to the decision-making

processes of other states, however, the Department provides its

understanding as to some of the bases of those states’ decisions to

decline to participate in the demonstration project elsewhere in this notice.

          25. COMMENT:                  “Please share the facts and supporting data

that explain the Department’s recommendation to participate in this

research experiment and allow approval for hospitals to perform elective

angioplasty without on-site surgical backup.” (4)

          RESPONSE: The Department states its rationale for participating in

the demonstration project in the proposal Summary, at proposed N.J.A.C.

8:33-3.11(e), in comments before the HCAB, and in its responses to

comments preceding and subsequent to this comment throughout this

notice of adoption.

          26. COMMENT:                  “What is the morbidity and mortality (in terms of

actual raw numbers and as a percent of total patients treated) of the nine

… hospitals that have already been granted the right to do elective

angioplasty without on-site surgical backup? Please provide the data by

hospital, and by physician operator. If this specific data is not being

collected by the Department, why isn’t it?” (4)
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          RESPONSE: The demonstration project results will provide risk-

adjusted conclusions as to the safety and efficacy of the procedure. As

stated more fully below in response to a comment relating to data release,

data may be release pursuant to the Open Public Records Act or the

Department’s Institutional Review Board.

          27. COMMENT:                  “What is the Department’s plan with respect to

monitoring the results of this study, on a hospital-by-hospital and

physician-by-physician basis?” (4)

          RESPONSE: The Department responds to this issue in response to

previous comments.

          28. COMMENT:                  “What is the department’s threshold for

acceptable angioplasty mortality and morbidity at hospitals performing

elective angioplasty without on-site surgical backup?” (4)

          RESPONSE: The premise of the comment suggests that the

Department maintains a threshold of acceptable morbidity and mortality.

There is no such threshold. The Department requires a facility

participating in the demonstration project to adhere to the Manual of

Operations and to comply with the Department’s licensing standards and

patient safety requirements.

          29. COMMENT:                  “How does the Department of Health audit this

research study to be sure that its citizens are being properly informed of

the experimental nature of this exercise? If they are not now monitoring

this, why not?” (4)
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The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in
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          RESPONSE: The Department requires facilities participating in the

demonstration project to adhere to the Manual of Operations and to

comply with the Department’s licensing standards and patient safety

requirements. The Manual of Operations addresses patient informed

consent requirements.

          30. COMMENT:                  “What specific criterion is the Department of

Health using to determine if this experiment is successful, or if it should be

immediately terminated (Number of deaths? Complications? Cost?)?”

(4)

          RESPONSE: See the Department’s response to previous

comments addressing this topic, and the proposal Economic Impact at 39

N.J.R. 3463(a) (August 20, 2007). The Department anticipates that the

demonstration project would generate data that would enable the

Department to evaluate the safety and efficacy of the procedure in making

public policy determinations as to whether to authorize the procedure as a

regular licensed procedure in the ordinary course.

          31. COMMENT:                  “How does the Department anticipate that

quality of services will be affected by reducing the volume of angioplasty

at individual hospitals throughout the state as more programs are

approved? Please share the data that supports this conclusion.” (4)

          RESPONSE: See the Department’s response to previous

comments addressing this topic, and the proposal Economic Impact at 39

N.J.R. 3463(a) (August 20, 2007). The Department anticipates that the
                                                      59
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.
demonstration project would generate data that would enable the

Department to evaluate the safety and efficacy of the procedure in making

public policy determinations as to whether to authorize the procedure as a

regular licensed procedure in the ordinary course.

          32. COMMENT:                  “What assurance will there be that the

Department will withdraw approval from hospitals who do not achieve

appropriate mortality or morbidity ratings?” (4)

          RESPONSE: The Department addresses the measures in place to

ensure quality and patient safety that are part of the demonstration project

and that are part of the Department’s licensure standards in response to

previous comments.

          33. COMMENT:                  “What assurances will there be that the

Department will withdraw approval from hospitals who do not achieve

defined volume, when other existing programs throughout the state have

routinely fallen below stated volume minimums and have not been

closed?” (4)

          RESPONSE: The Department routinely takes appropriate licensure

actions in accordance with its legislative and regulatory mandate.

          34. COMMENT:                  “If approval is withdrawn from a hospital or

hospitals that are granted approval to do elective angioplasty without on-

site surgical backup, what does the Department feel will happen to the

staff hired to provide this service, and the equipment purchased to do so,

and how can the costs associated with these failures be kept from
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document and the official version of the proposal or adoption, the official version will govern.
creeping back into the cost of healthcare and health insurance premiums

for New Jersey citizens?” (4)

          RESPONSE: The comment requires the Department to speculate

and offer opinion on matters relating to individual facilities’ and employees’

decision-making processes. The Department declines inasmuch as this

exceeds its obligations in the rulemaking process.

          35. COMMENT:                  “I understand that Virtua Health – Marlton

Division, intends to transfer their patients who suffer harm during elective

angioplasty to Atlantic City Medical Center. Further, I understand that

Atlantic City Medical Center’s cardiothoracic surgeon is flown by helicopter

from New York City when there is a patient problem. Is this true? If not,

please clarify. If so, how can that possibly be safe?” (4)

          RESPONSE: Specific allegations about a particular facility’s plan

of compliance with the proposed amendments are not relevant to the

Department’s evaluation of the decision to proceed to adoption of the

proposed amendments. The Department would evaluate the

appropriateness of each CN applicant’s plan of compliance with the

proposed amendments, once adopted, during the CN review process.

          36. COMMENT:                  “Are patients informed where they will be

transported to, how the transport will occur, and the likely timeframe for

surgery to occur, in the event of a complication at one of these hospitals

performing angioplasty without on-site surgical backup? If no, why?” (4)


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document and the official version of the proposal or adoption, the official version will govern.
          RESPONSE: The comment goes to the adequacy of the consent

procedures the Johns-Hopkins IRB has approved and that individual

facilities provide in consultation with their counsel. The Department

declines to second-guess the IRB, or to interfere in the relationship

between patients and their providers, just as the Department does not

evaluate the quality of informed consent other licensed cardiac facilities

provide to their patients.

          37. COMMENT:                  “Why are the New Jersey regulators putting its

citizens at higher risk than is necessary, simply to support a research

study of someone in another state?” (4)

          RESPONSE: The Department disagrees with the premise of the

comment that the State’s participation in the demonstration project puts

the people of New Jersey at higher risk. The Department describes its

reasons for authorizing the State’s participation in the demonstration

project in response to previous comments.

          38. COMMENT:                  “Would the Commissioner personally

recommend a loved one receive elective angioplasty at a hospital without

on-site surgical backup? If so, on what basis would he choose such a

facility over another that has surgical backup, assuming the same

physician performed both procedures?” (4)

          RESPONSE: Response to the comment is irrelevant to the

appropriateness of the proposed amendments and beyond the scope of

the rulemaking. Nonetheless, the Commissioner’s decision would likely
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document and the official version of the proposal or adoption, the official version will govern.
entail a fact-sensitive evaluation of the recommendations of the particular

family member’s treating physician and the family member’s preference to

use a particular local facility rather than one that is more remotely located

from the family member’s home.

          39. COMMENT:                  “I understand that this experiment is being

opposed by the American Heart Association, the American College of

Cardiology and the Society for Cardiovascular Angiography and

Interventions. Why, then does the Commissioner of Health and Senior

Services support such an experiment?” (4)

          RESPONSE: The Department is unaware of the opposition of these

entities to the demonstration project. The Department states its reasons

for authorizing participation in the demonstration project in response to

previous comments.

          40. COMMENT:                  “What are the advantages for the citizens of

New Jersey, in regulation approving any programs to provide elective

angioplasty at a hospital without on-site cardiac surgical backup?” (4)

          RESPONSE: The Department responds to this issue in response to

previous comments.

          41. COMMENT:                  “What are the advantages for the citizens of

New Jersey in receiving angioplasty at a hospital without on-site cardiac

surgical backup, over a hospital with on-site cardiac surgical backup?” (4)

          RESPONSE: The Department responds to this issue in response to

previous comments.
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document and the official version of the proposal or adoption, the official version will govern.
          42. COMMENT:                  “Are there any counties or regions in New

Jersey that do not have at least one hospital with an angioplasty program

supported by on-site cardiac surgical backup?” (4)

          RESPONSE: There are ten counties in New Jersey that do not

have at least one hospital with an angioplasty program supported by on-

site cardiac surgery backup. Those counties are Cape May, Cumberland,

Gloucester, Hunterdon, Ocean, Salem, Somerset, Sussex, Union and

Warren Counties.

          43. COMMENT:                  “What was the specific criterion used to

determine which hospitals would be approved for elective angioplasty

without on-site surgical backup? How was this criterion arrived at?” (4)

          RESPONSE: See the call for applications for certificates of need at

36 N.J.R. 4996(b) (November 1, 2004). The criteria reflect the eligibility

requirements of the demonstration project and Department licensure

standards.

          44. COMMENT:                  “Specifically, which counties or regions does

the Department feel do not have appropriate access to a hospital with

angioplasty and on-site surgical backup?” (4)

          RESPONSE: The comment incorrectly assumes that the

promulgation of the proposed amendments requires the Department to

make such a finding. Such a finding may be appropriate upon the

Department’s review of the demonstration project results in making policy

determinations for the State.
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document and the official version of the proposal or adoption, the official version will govern.
          45. COMMENT:                  “What does the Department feel is appropriate

access to angiography in terms of number of miles; or distance by

Ambulance or car? Is this definition different for ‘emergency’ vs. ‘non-

emergency’ procedures? If so, please provide both. If the Department

does not have a criterion for appropriate ‘access,’ why not?” (4)

          RESPONSE: The comment incorrectly assumes that the

promulgation of the proposed amendments requires the Department to

make such findings. Such findings may be appropriate upon the

Department’s review of the demonstration project results in making policy

determinations for the State.

          46. COMMENT:                  “The Governor has stated that consolidation of

parts of the healthcare system needs to occur. Why, then, is the

Commissioner approving the expansion of angioplasty?” (4)

          RESPONSE: The comment provides no citation to the alleged

statement of the Governor and the Department will not guess at the

Governor’s meaning in an alleged statement that the commenter provides

without context. The Department provides its rationale for authorizing

participation in the demonstration project in response to previous

comments.

          47. COMMENT:                  “What is the plan to evaluate the need for,

over-abundance, or reallocation of, all healthcare services in the State?”

(4)


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document and the official version of the proposal or adoption, the official version will govern.
          RESPONSE: The comment exceeds the scope of the proposal.

However, the final report and recommendations of the Commission on

Rationalizing New Jersey’ Health Care Resources that Governor Corzine

established by issuing Executive Order No. 39 (Governor Corzine,

October 12, 2006), 38 N.J.R. 4529(a) (November 6, 2006), available at

http://www.state.nj.us/infobank/circular/eojsc39.htm; see also

http://nj.gov/health/rhc/index.shtml (Commission website) may provide

guidance to the commenter. The Department expects that the final report

will be posted on the Commission’s website.

          48. COMMENT:                  “If the approval of elective angioplasty

programs to hospitals without on-site surgical backup is not a component

of a larger, broad-based healthcare delivery plan, why isn’t the

Commissioner spearheading such an important initiative? In the absence

of a broad-based statewide assessment of need, how can the Department

rationalize the support of expanding the number of angioplasty

programs?” (4)

          RESPONSE: The comment exceeds the scope of the proposal.

The Department provides its rationale for authorizing participation in the

demonstration project in response to previous comments.

          The Department indicated during its original CN review process that

while cardiac surgery had declined 15 percent from 2000 to 2004, cardiac

interventional procedures had increased 26 percent during that same five-

year period. These trends continued through calendar year 2006 with
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some indication that these increases may have leveled off during the first

six months of this year (2007)

          49. COMMENT:                  A commenter objects to the proposed

amendments, asserting that the proposed amendments “do not ‘reflect

detail that is necessary to provide for patient care in conducting elective

angioplasty,’” citing Cooper University Hospital v. Jacobs, 191 N.J. 125,

146 (2007). The commenter asserts that the proposed amendments are

lacking in the two areas relating to patient safety protection: minimum

facility eligibility standards and Department oversight; and in other

respects. The series of comments and responses below will address

these issues.

          With respect to minimum facility eligibility standards, the

commenter asserts that the proposed amendments are improper in

allowing facilities that have no track record in primary (that is, on an

emergent basis) PCI to compete to participate in the pilot project for

elective (that is, on a non-emergent basis) PCI. The commenter suggests

that the Department prohibit facilities from competing in the pilot project

unless they have been licensed for six months to provide primary PCI, as

a means to track volume. The commenter asserts that this requirement

would be consistent with a general CN requirement to which primary PCI

applicants must adhere. (2)

          RESPONSE: As stated in the proposal Social Impact, 39 N.J.R.

3462(a) (August 20, 2007), the goal of the demonstration project is to
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contribute to the evidence base nationally with respect to the safety and

efficacy of elective PCI without cardiac surgery backup. The

demonstration project’s contribution to regional volume measures, which

is relevant to Department decision-making for Statewide CN awards in the

ordinary course, is not determinative as to the issue of which facilities are

appropriate to contribute data to the demonstration project, although they

may ultimately prove relevant if the Department were to determine to

authorize elective PCI without cardiac surgery backup as a regular CN

service.

          Proposed N.J.A.C. 8:33E-3.11(e)4 establishes that a condition of

eligibility to apply to participate in the demonstration project is that a

facility either be already licensed to provide primary PCI or have an

approved but not yet implemented certificate of need to provide primary

PCI. The issuance of a CN for primary PCI requires documentation that

appropriate qualified staff will be retained, appropriate policies and

procedures for PCI care will be developed and that an appropriate

emergency transport system will be in place prior to licensure.

          50. COMMENT:                  Also with respect to minimum facility eligibility

standards, the commenter inquires whether N.J.A.C. 8:33E-2.16(d)

applies to cardiac surgery centers that agree to provide emergency

cardiac surgery services for patients of facilities applying to participate in

the pilot program. The commenter inquires as to the responsibilities of

cardiac surgery centers that do not agree to participate in the trial with
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respect to data reporting. The commenter inquires as to whether a

cardiac surgery center’s participation in the trial requires amendment of

“the transport agreement.” (2)

          RESPONSE: Should cardiac surgery centers that do not agree to

participate in the Atlantic C-PORT-E trial generate data because of an

emergent transfer, the Department would assist the principal investigator

as necessary to facilitate the centers’ assistance and cooperation to

retrieve and report the data if the principal investigator believes it would be

relevant to the trial.

          51. COMMENT:                  With respect to Department oversight, the

commenter notes that facilities participating in the Atlantic C-PORT-E trial

are to report data relating to patients in the demonstration project to the

principal investigator rather than to the Department. The commenter

inquires whether facilities participating in the demonstration project are

subject to any licensure requirements to ensure patient safety. The

commenter also inquires whether the Department would require facilities

to report to the Department information a facility may collect in compliance

with proposed N.J.A.C. 8:33-3.11(e)6i(6), and if that data is reported,

whether that information is considered a record subject to public access

and disclosure. (2)

          RESPONSE: Facilities participating in the trial are subject to the

licensure standards of general applicability to all Department-licensed

health care facilities at N.J.A.C. 8:43E, and to the hospital licensure
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standards at N.J.A.C. 8:43G. Those rules address the safety of patients

who may happen to be participants of the demonstration project as they

do for patients of all licensed health care facilities. Existing mechanisms

for patient safety and complaint investigation remain in place and

applicable. N.J.A.C. 8:33-3.11(e)6i(6) ensures that facilities participating

in the demonstration project address patient safety in the manner the

principal investigator requires; whereas N.J.A.C. 8:43E and 8:43G, and

the Patient Safety Act, address patient safety in the manner the

Department requires. Existing Department mechanisms to monitor

licensed facilities will continue to ensure the general safety of patients

participating in the demonstration project to the same degree that they

protect all patients at all licensed facilities. Moreover, facilities

participating in the trial are subject to the demonstration project protocol

“stopping rules” to ensure that adverse events relating specifically to the

PCI procedure without cardiac surgery backup trigger an appropriate

response.

          Records a facility may generate to comply with N.J.A.C. 8:33-

3.11(e)6i(6) are not transmitted to the Department as such, and therefore

the Department is unable to state whether such records would be

accessible to the public.

          52. COMMENT:                  The commenter inquires as to the procedure

by which the public may obtain de-identified data from the Department to

weigh and ensure the safety of the programs at New Jersey facilities
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participating in the demonstration project pending the principal

investigator’s issuance of a final report. The commenter suggests that the

Department publish a quarterly “report card” on the demonstration sites.

The commenter suggests that the Department should monitor patient

safety and disclose outcomes at demonstration project sites more

rigorously than it does with respect to licensed health care facilities

generally and other cardiac services particularly. The commenter

inquires, with respect to data the Department may hold relating to study

outcomes such as morbidity and mortality, whether that data is a record

subject to public access and disclosure. (2)

          RESPONSE: The Department collects separate licensing data

generated by facilities participating in the demonstration project pursuant

to N.J.A.C. 8:33E-1.9 and 2.10. The Department is obliged in its activities

relating to human research, including data release relating to an

authorized research protocol, to comply with Federal and State laws and

international codes and treaties, such as the Nuremberg Code and the

Belmont Report, governing the protection of the rights and welfare of

human subjects enrolled in research. A list of these laws appears at the

website of the Department’s Human Research Ethics Program at

http://www.state.nj.us/health/hrep/index.shtml, specifically at

http://www.state.nj.us/health/hrep/ethics.shtml. These laws are grounded

in the ethical principles of respect for persons, beneficence, justice, and

stewardship, and promotion of the responsible conduct of research.
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          The nature of a specific request will inform the Department as to

whether a person can obtain data the Department holds in accordance

with N.J.S.A. 47:1A-1 et seq., An Act concerning public access to

government records, or upon application to the Department’s Human

Research Ethics Program and, as applicable in accordance with

procedures of that Program, to the Department’s Institutional Review

Board, for approval of the request as a research project.

          N.J.S.A. 47:1A-1 et seq., An Act concerning public access to

government records (Act), particularly N.J.S.A. 47:1A-9 Other laws

regulations, privileges unaffected, establishes that the Act does not

supersede the Department’s obligation to comply with other laws limiting

or prohibiting the release of records the Department holds.

          With respect to the commenter’s request that the Department issue

a quarterly “report card” on the progress of the demonstration project in

New Jersey, for the reasons stated above and in response to previous

comments, the Department perceives no reason related to patient safety

and quality of care to warrant the expenditure of its resources to engage in

a “shadow” research project of the principal investigator’s efforts. To the

extent the Department in the ordinary course generates reports using the

data it collects pursuant to proposed N.J.A.C. 8:33-11(e)6vii, those reports

are publicly accessible. However, N.J.S.A. 47:1A-1 et seq. does not

require the Department to perform research or to create documents to

respond to a request made pursuant thereto. MAG Entertainment, LLC v.
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Division of Alcoholic Beverage Control, 375 N.J. Super. 534 (App. Div.

2005).

          Over 20 states across the nation currently permit elective PCI

without cardiac surgery backup. Nine additional states are enrolled in the

demonstration project. Patients can inquire of their physicians as part of

the informed consent process. Ultimately, patients who are uncomfortable

with participating in a research study without first reviewing data of

procedures performed on others in New Jersey are under no obligation to

have the elective PCI procedure performed at a facility that does not have

cardiac surgery backup.

          53. COMMENT:                  The commenter inquires as to the

Department’s role in monitoring facility compliance with the demonstration

project protocol and inquires whether a facility’s failure to adhere to

aspects of the protocol are grounds for action against the facility’s CN to

participate in the demonstration project. The commenter encourages the

Department to promulgate a rule, similar to one Maryland enacted relating

to the demonstration project, requiring facilities participating in the

demonstration project to report events relating to: a facility’s adherence to

the patient selection criteria in the protocol; the expiration, relinquishment

or withdrawal of a CN; a patient death or need for cardiac surgery; a

facility’s ability to meet protocol volume requirements; and a facility’s

continued eligibility to participate in the demonstration project (Maryland

rule). (2)
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          RESPONSE: The Department monitors the activities of facilities

participating in the demonstration project to the same extent it monitors

the activities of all licensees, in accordance with the standards for

licensure described above in response to a previous comment. A facility’s

deviation from the protocol would be a violation of its agreement to

participate in the demonstration project, which is a condition of the CN.

Were a violation of this nature to become known to the Department, the

Department would take appropriate action against the facility’s license, in

accordance with the standards for licensure described above in response

to a previous comment, regardless of whether the principal investigator

determines to terminate the facility’s participation in the demonstration

project.

          The extent of a facility’s faithful adherence to the protocol is, in part,

a function of the quality of the licensed professionals the facility employs.

These professionals are subject to the minimum competency standards

and the ethical and licensure requirements of their respective licensing

boards. No government agency can guarantee against error,

malfeasance, and/or unethical conduct by licensed professionals, but

sanctions attendant to such activities, as well as market factors, exist as

safeguards to provide incentives against such conduct. Thus, in addition

to the Department enforcing its existing regulatory standards to ensure

patient safety and quality of care, the Department, and the public

generally, can and must rely on these safeguards every time they enter a
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licensed healthcare facility. Nonetheless, proposed N.J.A.C. 8:33-

3.11(e)6ii would specifically address the responsibilities of the facility’s

participating interventional cardiologist to comply with the demonstration

project protocol.

          A hospital that performs a procedure that exceeds the scope of its

license or performs a licensed procedure on an expired license is in

violation of the law. Proposed N.J.A.C. 8:33-3.11(e)3ii, and 5 specifically

address these matters. A facility that fails to maintain the conditions for

licensure or that fails to meet volume requirements is in violation of its CN

under existing laws and regulations. Requiring facilities to report illegal

conduct after the fact does little to protect the patient that was the subject

of the activity, and does little to serve the commenter’s asserted interest in

ensuring patient safety in connection with the demonstration project.

Generally, the demonstration project serves to assist the Department and

researchers in the compilation of data to develop trends for industry best

practices over the long term.

          The Department considers its existing licensing rules, as set forth at

N.J.A.C. 8:43E, 8:33E, 8:43G, and the Patient Safety Act, to require

reporting of essentially the same information sought by the commenter.

          54. COMMENT:                  The commenter inquires as to the procedure

by which a participating facility can enroll in an elective PCI development

program, referenced in N.J.A.C. 8:33-3.11(e)6i(2). (2)

          RESPONSE: N.J.A.C. 8:33-3.11(e)6i requires facilities applying to
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participate in the demonstration project to document that they will meet the

requirements of the principal investigator’s study protocol, one of which is

participation in an “elective PCI development program.” The procedure to

participate in an elective PCI development program, as a requirement of

the principal investigator, is available from the principal investigator.

          55. COMMENT:                  The commenter objects to N.J.A.C. 8:33-

3.11(e)6ii, which would require each participating hospital to document its

interventional cardiologists’ compliance with the Atlantic C-PORT-E

interventional cardiologist inclusion criteria. The commenter recommends

that the rule require a minimum annual PCI volume specific to elective PCI

instead of the requirement at N.J.A.C. 8:33-3.11(e)6ii(1), which woud

require adherence to the annual physician volume requirement for primary

PCI. (2)

          RESPONSE: The minimum annual PCI volume requirement for

interventional cardiologists at proposed N.J.A.C. 8:33-3.11(e)6ii(1), which

applies to both primary and elective PCI, is consistent with the

recommendations of both the American College of Cardiology/American

Heart Association and the Society for Cardiovascular Angiography and

Interventions. In addition, both the Department and the Atlantic C-PORT-

E minimum annual volume requirements for physicians and the facility

include the performance of primary and elective PCI cases in this annual

total. Therefore, the Department disagrees with the commenter’s

suggestion and will make no change on adoption in response to the
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comment.

          56. COMMENT:                  The commenter inquires whether every

interventional cardiologist with privileges at a demonstration project

hospital would be required to submit statements to satisfy N.J.A.C. 8:33-

3.11(e)6ii, and, if not, how the Department would monitor compliance.

The commenter suggests that the Department post a list of “approved”

cardiologists on its, with their volumes and outcomes, on a quarterly real-

time basis and in a fashion similar to that issued by the cardiac surgery

report card. (2)

          RESPONSE: Proposed N.J.A.C. 8:33-3.11(e)6ii would not require

individual physicians to submit statements. Proposed N.J.A.C. 8:33-

3.11(e)6ii would require each CN applicant to document in its application

that its physicians would comply with the Atlantic C-PORT-E interventional

cardiologist inclusion criteria. The Atlantic C-PORT-E trial monitors

compliance with the Atlantic C-PORT-E interventional cardiologist

inclusion criteria. The Department’s licensure requirements for cardiac

services require quarterly reporting that includes physician volume. The

Department reviews this data as part of the annual hospital relicensure

process. The Department initiated robust quarterly data reporting for

cardiac catheterization and therapeutic cardiac interventions on January 1,

2007. The Department expects this data to form the basis for the

evaluation of facility and physician performance in the future. It will take

several years of data collection and analysis by the Department, with the
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assistance of the Cardiovascular Health Advisory Panel, to establish a

report card similar to the cardiac surgery report card. The latter was

established only after a decade of cardiac surgery data collection and

analysis.

          57. COMMENT:                  The commenter objects to the sufficiency of

proposed N.J.A.C. 8:33-3.11(e)6ii(3), and asserts that it would not ensure

that patients at facilities participating in the demonstration project have

“adequate information or an opportunity to review the study risks.” The

commenter urges the Department to require patient consent forms to

contain certain additional information relating to the risks and costs of the

procedure and specific transfer plans in the event of an emergency. The

commenter suggests that the Department require that facilities

participating in the demonstration project provide patients with the form at

least 24 hours prior to the scheduled procedure and with a list of facilities

that provide elective PCI with cardiac surgery backup. The commenter

suggests that the Department establish rules imposing liability and

punitive damages on participating hospitals for providing false and/or

misleading statements in their consent forms as a “severe threat” to

ensure that facilities participating in the demonstration project care about

the content of statements they make to patients. The commenter

suggests that the Department require facilities to post their consent forms

on their websites, establish a “hotline” for questions, and require all


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facilities participating in the demonstration project to use the same

consent form. (2)

          RESPONSE: The demonstration project protocol prescribes the

minimum content of the patient consent form. The Institutional Review

Board of the principal investigator’s sponsoring facility, the Johns Hopkins

University Medical Center, reviewed and approved the form for

consistency with the Federal and international laws relating to protection

of human research subjects described above in response to a previous

comment.

          The content of the consent form is also part of the relationship

between the patient and the patient’s physician and provider facility, in

consultation with counsel. The Department declines to second-guess the

expertise of the professional bioethicists and other professionals of that

board, or to interfere with the relationship between patients and their

providers. The Department likewise does not interfere in the content of

consent forms used by licensed facilities generally, including cardiac

surgery facilities. For the foregoing reasons, the Department will make no

change on adoption in response to the comment.

          58. COMMENT:                  The commenter inquires as to the role of the

Department’s Institutional Review Board in connection with oversight and

approval of the demonstration project. (2)

          RESPONSE: The Department’s Human Research Ethics Program

and its Institutional Review Board have no role in the oversight and
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approval of the demonstration project. The demonstration project is

subject to the oversight and approval of the Institutional Review Board

(IRB) of the sponsoring facility of the principal investigator, the Johns

Hopkins University Medical Center, as well as the IRB of each facility

participating in the demonstration project.

          59. COMMENT:                  The commenter inquires as to the

Department’s commitment to patient safety with respect to the dates on

which it reviews volume data and the procedure by which it calculates a

volume year, and suggests that the lack of contemporaneous

quantification of volume data indicates the Department’s lack of

commitment to patient safety. The commenter inquires as to the volume

results achieved by facilities already participating in the demonstration

project. (2)

          RESPONSE: The Department issues reports of facility volume (that

is, the number of elective PCI procedures a facility performs) using data it

collects in accordance with the cardiac data reporting requirements.

Turnaround time for the issuance of volume data reports relating to

elective PCI performed at facilities participating in the demonstration

project generally corresponds to turnaround time for volume data reports

relating to other types of PCI procedures and cardiac surgery generally.

Technical problems relating to data transmission and staff resource

allocation can affect the issuance dates of volume data reports for all

procedures. The commenter’s suggestion that report issuance dates
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should give rise to a negative inference with respect to the Department’s

commitment to patient safety is unwarranted. There is no correlation.

          The start date of a facility’s participation in the demonstration

project for purposes of calculating facility volume depends on the

particular facility’s licensure date.

          60. COMMENT:                  The commenter objects to N.J.A.C. 8:33-

3.11(e)7i, which requires applicants to demonstrate their “ability to offer a

high quality program,” as vague and undefined. (2)

          RESPONSE: The Department disagrees. Health care quality is in

part a term of art among health care professionals and providers

encompassing best practices, in part a general principal incorporating the

specific requirements and goals of the demonstration project protocol, and

in part an evaluation of an applicant’s demonstration of how well it has

satisfied the application content requirements listed at N.J.A.C. 8:33-

3.11(e)6, standing alone, and in comparison to other applicants and

existing programs. The Commissioner performs this evaluation based on

his or her knowledge and experience, and in consultation with the

professionals on the Health Care Administration Board who bring their

own areas of expertise and experience to bear on the decision-making

process. The Department will make no change on adoption in response to

the comment.

          61. COMMENT:                  The commenter notes that proposed N.J.A.C.

8:33-3.11(e)7 states that the Department would consider applications
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upon consideration of, among other factors, the criteria at N.J.S.A. 26:2H-

8, and at proposed N.J.A.C. 8:33-3.11(e)7ii and iii. The commenter

objects to the Department granting a CN to participate in the

demonstration project absent an applicant showing that medically

underserved persons have a complete absence of access to elective PCI

in the region in which the applicant is located. The commenter suggests

the Department amend N.J.A.C. 8:33-3.11(e) to establish provisions that

would restate criteria at N.J.S.A. 26:2H-8. The commenter inquires

whether cardiac surgery facilities that serve as backup to facilities

participating in the demonstration project have to provide documentation

supporting the criteria at N.J.A.C. 8:33-3.11(e)7.

          RESPONSE: The statutory criteria for the CN review process are

stated at N.J.A.C. 8:33. Therefore, the Department will make no change

on adoption in response to the comment.

          62. COMMENT:                  The commenter requests the Department to

“identify data” to which it made reference during a Health Care

Administration Board hearing, indicating an increase in the number of

PCIs statewide. The commenter disagrees with this representation. (2)

          RESPONSE: Statewide PCI volume has steadily increased over

the past two decades. The Department reports this data periodically and

makes it available on the Department’s website. A preliminary review of

cardiac service data for the first two quarters of 2007 indicates that fewer

PCI cases were performed in that period than in the first two quarters of
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the previous year. This may result in a decline in Statewide PCI volume

for the 2007 calendar year. There have been years during these two

decades that have exhibited a decline, and that have been followed by

continued growth. It would be inappropriate and premature to project

long-term trends based on the first two quarters of 2007.

          63. COMMENT:                  With respect to proposed N.J.A.C. 8:33-

3.11(e)7ii, the commenter requests that the Department to articulate a

standard that tells applicants how to identify the communities they plan to

target for their services as urban, suburban, and rural. The commenter

inquires as to the relevance of the inquiry proposed N.J.A.C. 8:33-

3.11(e)7ii would require, “in light of the fact that the service is elective and

patients are able to travel for this service.” (2)

          RESPONSE: The Department has no experience that would

suggest that applicants for CN approval generally have ever had any

difficulty in understanding the concepts of “urban,” “suburban,” and “rural”

and providing demographic information such as statistics, anecdotal

evidence, and matters of which the commissioner can take as given in a

manner akin to a court taking “judicial notice.” For example, it is unlikely

that anyone in New Jersey would take issue with the contention that

Plainfield is generally an “urban” community. Therefore, the Department

will make no change on adoption in response to the comment.

          The issue of the community that a particular provider serves is

relevant to access to healthcare. While people seeking access to elective
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angioplasty certainly are free to travel to different facilities for this service,

access takes into consideration patients’ ability to travel and not just their

individual volition to use a particular facility. Thus, analysis of the

availability of a service to a community can include consideration of

whether a particular facility is on a regular route of public transportation

such as bus or rail service.

          64. COMMENT:                  The commenter inquires whether the proposed

amendments would authorize facilities to participate in the demonstration

project using freestanding facilities or facilities not located on hospital

premises. (2)

          RESPONSE: Proposed N.J.A.C. 8:33-3.11(e)4 states that only

licensed general hospitals are eligible to participate in the demonstration

project. Thus, applicants can perform procedures only on the premises of

licensed general hospitals. In accordance with N.J.A.C. 8:33E-1.3(b), all

cardiac catheterization procedures (including PCI), “regardless of the

category, shall be performed in a hospital-based facility where inpatient

services are available on site.”

          65. COMMENT:                  The commenter inquires why the State is

“participating in a program geared toward decentralizing cardiac care” and

how the proposed amendments “fit within the current climate of cost

reduction” when other states are adopting models geared toward

centralization of health care into high-volume “centers of excellence.” (2)

          RESPONSE: The proposed amendments accomplish the purpose
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of establishing rulemaking to authorize the State’s participation in a

demonstration project “to facilitate scientifically rigorous collection and

analysis of data that will contribute significantly to the evidence base

nationally on the issue of the comparative safety and efficacy of elective

angioplasty or PCI with and without on-site coronary artery bypass graft

surgical back-up.” N.J.A.C. 8:33-3.11(e)1. The purpose of the State’s

participation in the project is not to decentralize healthcare but to evaluate

the safety and efficacy of the procedure by means of the scientific method.

Moreover, as stated in response to a previous comment, consideration of

the “models” adopted by “other states” includes consideration of the fact

that 21 other states authorize this procedure as a regular licensed service,

and another nine states are participating in the demonstration project.

Whether in the long term the Department determines to adhere to the

“centers of excellence” model for this procedure and other procedures will

depend on the results of the demonstration project and may also depend

upon the final report and recommendations of the Commission on

Rationalizing New Jersey’ Health Care Resources that Governor Corzine

established by issuing Executive Order No. 39 (Governor Corzine,

October 12, 2006), 38 N.J.R. 4529(a) (November 6, 2006), available at

http://www.state.nj.us/infobank/circular/eojsc39.htm; see also

http://nj.gov/health/rhc/index.shtml (Commission website).

          66. COMMENT:                  A commenter offers comments “intended to

clarify and strengthen the rules and assist the Commissioner to render
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informed decisions for the expansion of cardiac services.” The

commenter states that participation of New Jersey hospitals in the Atlantic

C-PORT-E trial would contribute “significantly to the study to determine

the safety of elective PCI in non-surgical centers.” The commenter

questions the wisdom of limiting the number of centers with elective PCI

since it will only result in delays for patients to receive a PCI if required.

The commenter argues that more centers need to be approved than the

12 demonstration projects that are permitted at N.J.A.C. 8:33-3.11(e)2 and

(e)7 in order to assure that elective PCI is accessible to the population.

Furthermore, the commenter states that the New Jersey healthcare

system is “decidedly under-funded” and additional investment is needed or

more community hospitals will fail. The commenter suggests that in order

for community hospitals to be financially viable, full service cardiac

catheterization laboratories must be able to perform elective PCI. The

commenter emphasizes the availability of an expanded cardiac data

collection effort as of January 1, 2007, which will enable the Department to

improve outcome measurement rather than rely on the use of volume as a

proxy quality measure. The commenter suggests that the Commissioner

should be allowed discretion in the number of certificate of need approvals

that are permitted under these rules based on the available evidence at

the time applications are reviewed. “Further, the Commissioner should

have the discretion to make conditional approvals pending receipt of C-

PORT E research results.” (19)
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          RESPONSE: The Department thanks the commenter for its

support of the proposed amendments. The Department disagrees with

the commenter’s suggestion that the Commissioner should have

discretion to grant certificate of need approval to an indeterminate number

of elective PCI demonstration projects. As the Department indicated in

the proposal Summary, the purpose of the proposed amendments is to

permit New Jersey hospitals to participate in the demonstration project

that would contribute to the evidence base nationally on the issue of the

comparative safety and efficacy of elective angioplasty in hospitals with

and without on-site CABG surgery. 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 changes that the commenter suggests are also sufficiently

substantive in nature to require additional public notice and comment

before the Department could adopt them. The Department considers the

maximum of up to twelve demonstration sites proposed to be permitted at

N.J.A.C. 8:33-3.11(e)2 and (e)7 to be appropriate and the Department will

make no change on adoption in response to the comment.

          67. COMMENT:                  Two commenters state, “The level of risk

increases by performing elective angioplasty at hospitals without cardiac

surgery on-site…. A frequently cited study … reports that the mortality

(risk of death rate) for elective angioplasty at … hospitals [without on-site
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cardiac surgery backup facilities] is 38 percent higher than when [on-site

cardiac surgery backup] is available. Elective angioplasty is not an

emergent procedure; it is an elective procedure that is scheduled in

advance of patients’ treatment. But there always is a risk of complications

and damage to critically important blood vessels feeding the heart. When

this occurs, cardiac surgery is necessary. Thus far, we understand that

there have been at least four deaths related to the [demonstration project],

though neither the Department… nor the Principal Investigator … has

been willing to publicly report such data….” (23, 26)

          “Why has there has not been any report issued by the Department

… evaluating the results of the Demonstration project after the first year of

operation, in terms of risk-adjusted mortality rates or number of adverse

events and whether quality of care has been compromised at any of the

demonstration sites? [Has] the Department’s own Internal Review Board

… reviewed the deaths reported or studied the adverse events in the

study[? Will] the Department … make public its report?” (26)

          “What are the actual and expected deaths for the volume of

procedures that have been performed thus far?” (23)

          RESPONSE: The Department does not maintain an “internal review

board,” and therefore no such board has conducted a review of the first

year of the demonstration project. The Department maintains an

institutional review board that plays a role in research the Department

sponsors, but which has no role in the demonstration project, as that
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project is administered under the auspices of the Johns Hopkins

University Institutional Review Board. The Department is without authority

to comment on individual patient outcomes. Department licensure staff

routinely examine issues relating to quality and patient safety as they may

arise, regardless of whether they may occur in the context of a

demonstration project or otherwise. The Department is aware of no issue

concerning patient safety or quality of care relating to the demonstration

project that would warrant discontinuation of the State’s participation in the

demonstration project. The Department maintains no projection of

“expected deaths for the volume of procedures that have been performed

thus far.”

          68. COMMENT:                  “There are three ‘gold standard cardiac

organizations in the US: 1. American Heart Association (AHA)[;] 2.

American College of Cardiology (ACC)[; and] 3. Society for Cardiovascular

Angiography and Intervention (SCAI). These organizations recommend

that elective angioplasty not be performed at hospitals without on-site

cardiac surgery. These standards are, in part the basis for NJ’s regulatory

requirement for on-site cardiac surgery for the performance of elective

angioplasty. In August 2005, these organizations reaffirmed their

opposition to the unnecessary, increased risk. And their recent Practice

Guideline amendments, which amended other guidelines, made no

changes to these particular guidelines, thereby once again reaffirming

their opposition to the unnecessary, increased risk.” (23, 26)
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          RESPONSE: The commenters overstate the position of the three

listed entities. The ACC/AHA/SCAI 2005 Guideline Update for

Percutaneous Coronary Intervention: A Report of the American College of

Cardiology/American Heart Association Task Force on Practice Guidelines

(ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for

Percutaneous Coronary Intervention) at 35-36 (American College of

Cardiology Foundation and the American Heart Association, Inc., 2005)

available at

http://www.americanheart.org/downloadable/heart/1131740149971PCI_Fi

nal%20Final%20Clean%20Revision_AHA.pdf provides as follows:

“Elective PCI should not be performed at institutions that do not provide

onsite cardiac surgery…. Several centers have reported satisfactory

results based on careful case selection with well-defined arrangements for

immediate transfer to a surgical program…. A small, but real fraction of

patients undergoing elective PCI will experience a life-threatening

complication that could be managed with the immediate onsite availability

of cardiac surgical support but cannot be managed effectively by urgent

transfer. Wennberg, et al., found higher mortality in the Medicare

database for patients undergoing elective PCI in institutions without onsite

cardiac surgery …. This recommendation may be subject to revision as

clinical data and experience increase” (citations omitted).

          Thus, the entities the commenters rely upon as the “gold standard”

agree with the need for additional clinical data and experience.
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          This statement is consistent with the commentary of W. Douglas

Weaver, M.D., that the findings of Wennberg et al., “are provocative and

demonstrate the need for more data. By design, data from an

administrative registry such as used in this study have the potential of

being inadequate to adjust for important patient differences that could

affect the findings. One possible hint that this may be present in this

analysis was that patients who were admitted to hospitals without onsite

surgery and who received the procedure were more likely to have acute

[myocardial infarction] (51 [percent] vs 29 [percent]) than those admitted to

hospitals with onsite surgical hospitals. Higher mortality would be

expected in this subset of patients receiving elective PCI procedures and

hence possibly could explain the worse results…. For now, the available

data are not sufficient to require halting the performance of [percutaneous

coronary interventions] in centers without surgical onsite backup.”

Weaver, “Is Onsite Surgery Backup Necessary for Percutaneous Coronary

Interventions?” JAMA. 2004; 292:2014-2016.

          69. COMMENT:                  “The standardized patient consent form used in

the study does not inform patients that the project involves performing the

procedure in a way that is in violation of accepted clinical standards….

(23, 26)

          The “disclosure form does not disclose to the patient the additional

risk associated with participating in the [demonstration project] separately

from the risk of having an angioplasty procedure performed at a facility
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with cardiac surgical back-up. They are confounded and confused with

each other in one paragraph on the form. One of the leading scholars in

bioethics in the U.S., and director of the Center for Bioethics at the

University of Pennsylvania, Dr. Arthur Caplan, is publicly on record as

describing the [demonstration project’s] lack of adequate patient

disclosure as unambiguously ‘unethical.’” (26)

          “I am pleased that the proposed [amendments] require the

disclosure of the identity of the study partner in this trial. I’d make two

recommendations for additional disclosure: 1. Include the national clinical

standard so the ‘Informed Patient Consent Form’ truly informs the patient

how this trial differs from the national clinical standard; [and] 2. Include the

identity of any emergency treatment site(s) if it/they differ from the study

partner and disclose whether the emergency site is a willing participant in

the Atlantic C-PORT-E trial. Our Lady of Lourdes Medical Center is not a

willing participant in the Atlantic C-PORT-E trial. But let me be absolutely

clear—Our Lady of Lourdes Medical Center has and will continue to

accept and provide the highest level of care to all cardiac emergencies,

irrespective of their origin. When the emergency treatment site is not a

willing participant in the Atlantic C-PORT-E trial, this means that he clinical

trial has not gone through its Institutional Review Board[,] which further

means the treatment data is not transmitted and included in the … study.

If this were to happen, what, then, would have been the point of subjecting

the patient to this avoidable and unnecessary risk in the first place? Are
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there [Department] expectations concerning an emergency back-up

hospital’s reporting responsibilities with respect to [the demonstration

project]? Since [the Department] requires an executed transport

agreement for primary angioplasty, would it not follow that [the

Department (?)] would require an executed transport agreement for

participation in the Atlantic C-PORT-E trial?” (21)

          RESPONSE: In accordance with the Department’s response to the

previous comment, the Department disagrees with the commenters’

premise that the demonstration project “is in violation of accepted clinical

standards.” 21 states authorize the performance of elective angioplasty

without cardiac surgery backup as a matter of routine, and nine states

participate in the demonstration project.

          The Johns Hopkins Institutional Review Board approved the

minimum content of disclosures required for informed consent. Esteemed

bioethicists are part of that Board, and reasonable bioethicists presumably

may disagree as to minimum content of a consent form. As with respect

to all procedures performed at licensed health care facilities, additional

disclosures are matters between the patient, the patient’s physician, and

the facility.

          As stated in response to a previous comment, a condition of a

facility’s eligibility to apply to participate in the demonstration project is that

the facility has an agreement in place with a cardiac surgery facility willing

to participate in the trial.
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          As stated in response to a previous comment, should a non-

participating facility generate data because of an emergent transfer, the

Department would assist the principal investigator as necessary to

facilitate the non-participating facility’s assistance and cooperation to

retrieve and report the data if the principal investigator believes it would be

relevant to the trial.

          70. COMMENT:                  A commenter “acknowledge[s] and express[es]

appreciation to Assemblyman Conaway for introducing A-2949 and

Senator Madden for introducing S-2194 which are companion bills that

would require the Commissioner of [the Department] to adopt a uniform

informed consent form for clinical research (‘demonstration’) projects

approved by [the Department].” (23)

          RESPONSE: The comment is noted.

          71. COMMENT:                  “The study … is severely compromised by its

inherent bias and conflict of interest among the participating institution and

physicians. The clinicians and hospitals participating in the study have a

financial interest in the study, and the study is not designed to reduce bias

related to financial interest. The physician advising patients about the

best options for their care has a financial interest in performing angioplasty

in a facility without onsite cardiac surgical backup. In true scientific

research studies, namely research projects, New Jersey regulations do

not allow patients to be charged fees. This is unequivocally a human

subject research project.
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          The study has been severely criticized as violating ethical and legal

principles requiring equipoise in research objectives and research design,

as articulated by the National Bioethics Advisory Commission. As stated

by one analyst of the protocol, ‘the stated goal of the … study is to

demonstrate its lack of clinical benefit. Its aims are to demonstrate that

the incidence of death, myocardial infarction or other complications are not

greater, and clinical success rates are not lower, for elective PCI at

hospitals without [on-site cardiac surgical backup] versus elective PCI

performed at a hospital with [on-site cardiac surgical backup]. In other

words, the best outcome of the study is a showing that patients in the

study group are not clinically harmed by their participation in the study.’

(comments submitted by St Joseph Medical Center, MedStar Health, and

LifeBridge Health on January 12, 2007). ‘Research equipoise means that

there is a genuine uncertainty on the part of the medical community about

which intervention—experimental or control—is better. An experimental

intervention may pose greater risk to participant than accepted practice as

long as it also offers the prospect of greater direct benefit to the

participant….’ ‘Ethical and Policy Issues in Research Involving Human

Participants’ (National Bioethics Advisory Comm’n, Bethesda, MD) Aug.

2001, Vol. 1 at 78, Exh. 4.1.” (26)

          “The only purpose of the project is to see if the same number of

people might die in catheterization labs without onsite cardiac surgery

back up as they do in catheterization labs with onsite cardiac surgery back
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up. There is no focus on how to improve outcomes in angioplasty, nor is

there any provision to study the quality of the outcomes in terms of

relapse, restenosis, or subsequent failure of the procedure after

discharge. Why subject NJ patients to unnecessary and avoidable risk in

return for so little of clinical value in improving the quality of patient care?”

(23, 26)

          RESPONSE: The Manual of Operations requires participating

facilities to provide to patients considering participation in the

demonstration project a statement of conflict of interest related to the

institution and the practitioner regarding the financial benefit to be derived

from a participant’s enrollment in the trial.

          The Department disagrees with the commenter’s assertion that the

demonstration project is inherently unethical and illegal with respect to the

concept of equipoise. The Johns Hopkins University Medical Center

Institutional Review Board has conducted the appropriate bioethical and

legal review and ascertained that the demonstration project is ethical and

legal.

          72. COMMENT:                  The demonstration project “does not permit

interventional cardiologist to use the standard set of tools they normally

use in fully licensed cath labs with cardiac surgical centers onsite. [The]

Manual of Operations [identifies] certain ‘excluded devices’ regularly used

in connection with PCI [that] may not be used in connection with [the

demonstration project,]” that “carry with them a variable degree of
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additional risk of procedure-related complications[, and that] may only be

used at hospitals that have surgery on site … because … they … increase

the likelihood that emergent open heart surgery will be needed to deal with

such complications.” The commenter asserts that the exclusion of these

devices in treating patients enrolled in the demonstration project

“increases the probability that there will be fewer morbidities and

mortalities” thereby “inevitably skewing … the results in favor of a [study]

conclusion that … the performance of elective PCI at hospitals without

cardiac surgery on site is safer than is the case. Thus, the [study] does

not provide for an adequate comparison of the two types of labs. The

study design is also flawed because it does not control for selection bias.

Physicians performing the procedure … are the ones selecting the

patients for inclusion [in the demonstration project and] can affect the

study by lessening the acuity of the patient they select…, artificially

influencing the outcome of the study.” (26), accord (23), (24)

          RESPONSE: The Department disagrees. Atlantic C-PORT-E is a

randomized trial. Patients in the demonstration project randomly allocated

to hospitals with and without on-site cardiac surgery will be as comparable

as possible and should be essentially identical. The patient selection

criteria require the exclusion of a patient from consideration for the

demonstration project prior to randomization if the patient’s condition is

such that he or she may require use of one of the excluded high-risk


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devices. The demonstration project results will reflect this pre-

randomization selection criterion.

          73. COMMENT:                  A commenter provides data indicating,

“patients treated at a community hospital without on-site cardiac surgery

incurred, on average, $3,024 more in estimated total costs… when

compared to a tertiary hospital with on-site cardiac surgery. [Why] would

the [State] move in a direction that would increase, rather than contain

healthcare costs?” (23), accord (26)

          RESPONSE: The purpose of the demonstration project is to

evaluate the comparative safety and efficacy of elective angioplasty or PCI

with and without on-site CABG surgical back-up. The Department

anticipates that cost efficiency would be part of the efficacy analysis.

          74. COMMENT:                  A commenter asserts that some facilities

participating in the study are not meeting minimum volume requirements

and inquires why these facilities licenses to participate in the study have

not been revoked?” (23), accord (26)

          RESPONSE: The Department’s licensure staff review volume

reports as they are finalized to ensure compliance with licensure

standards relating to volume. The Department is taking appropriate action

to examine the compliance of facilities participating in the demonstration

project with volume standards and will take appropriate licensure action

with respect to noncompliant facilities.


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          75. COMMENT:                  Two commenters assert that there is no unmet

need in New Jersey for angioplasty services, that all New Jersey patients

are within 30 minutes of a full service cardiac catheterization laboratory

with on-site cardiac surgical backup, and that there is excess capacity to

provide PCI services in southern New Jersey. The commenters assert

that the demand for angioplasty is decreasing in New Jersey and the

United States. (23, 26)

          A commenter asserts that one of the justifications for New Jersey’s

participation in the demonstration project was the increasing demand for

angioplasty, and questions this justification based on the asserted surplus

capacity and the reduced demand. (26)

          RESPONSE: All existing cardiac surgery centers in New Jersey are

performing angioplasty at five to 10 times the minimum annual facility

volume of 200 cases required as a surrogate quality measure. Each

potential demonstration project site will also be required to perform a

minimum of 200 cases by the second year of operation. This represents a

more stringent requirement than that required of new angioplasty

programs at facilities with cardiac surgery backup on site, which are given

three years to achieve the minimum of 200 annual angioplasty cases,

pursuant to N.J.A.C. 8:33E-2.3(d)1. The same annual facility volume

standard is required of all demonstration project sites and the Department

projects that participants will achieve this volume by the end of the second

year of participation in the demonstration project.
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          The Department recognizes the importance of achieving

appropriate volume levels in the delivery of cardiac services. The

Department indicated during the original CN review process for the

demonstration project that while cardiac surgery had declined 15 percent

from 2000 to 2004, cardiac interventional procedures have increased 26

percent during that same five-year period. These trends continued

through calendar year 2006 with some indication that these increases may

have leveled off during the first six months of 2007. It is unclear whether

calendar year 2007 will yield an increased, decreased, or equalized

Statewide PCI volume for calendar year 2007 as compared to 2006.

          76. COMMENT:                  A commenter asserts that Virtua Health

System should not have received a CN because there is no demonstration

of unmet need for elective angioplasty in southern New Jersey, and that

Virtua’s license “has had and will continue to have deleterious effects on

the ability of Cooper University Hospital and Our Lady of Lourdes Medical

Center to serve minorities and underserved indigents in inner city by

reducing volume and siphoning insured patients from those programs.”

          The commenter objects to Virtua’s selection as not increasing

minority access. The commenter objects to Virtua’s study partner, Virtua’s

emergency surgery back-up, its informed consent, and its volume to date.

(26)

          RESPONSE: The commenter’s objections to the Commissioner’s

selection of a particular facility to participate in the demonstration project
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are irrelevant to the propriety and validity of the proposed amendments

and the Department’s comment thereon in this context would be

inappropriate. Even assuming these allegations to be true, they would

have no bearing on the appropriateness of the decision to adopt the

proposed amendments.

          77. COMMENT:                  A commenter describes a particular case at a

facility participating in the demonstration project. The commenter asserts

that the facility solicited the patient to participate in the demonstration

project and that the facility instead should have excluded the patient as

being incapable of informed consent because English was not the

patient’s first language. (20)

          RESPONSE: A particular facility’s alleged actions are irrelevant to

the propriety and validity of the proposed amendments and the

Department’s comment thereon in this context would be inappropriate.

The Department is prohibited from addressing patient-specific information

in this context. Generally, if the Department receives a complaint with

respect to a particular licensee, the Department investigates those

allegations in the ordinary course and takes action as appropriate against

that facility’s license. Even assuming these allegations to be true, they

would have no bearing on the appropriateness of the decision to adopt the

proposed amendments.

          78. COMMENT:                  A commenter asserts that it is unethical and

unconscionable for the Department to not address Atlantic C-PORT-E
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trial’s track record of morbidity and mortality and to respond to it before

further actions taken on the proposed amendments. (24)

          RESPONSE: The commenter is incorrect in asserting the

Department’s failure to consider morbidity and mortality in authorizing the

State’s participation in the demonstration project. At the July 19, 2007,

meeting of the Health Care Administration Board, the principal investigator

addressed Atlantic C-PORT-E morbidity and mortality data. The principal

investigator stated that entities established within the trial to ensure patient

safety review such data and take action on it as appropriate within the

context of the Manual of Operations, including, as appropriate, the

demonstration project “stopping rules.”

          79. COMMENT:                  A commenter provides several published

articles relating to a decreasing demand for angioplasty. (24)

          RESPONSE: As stated in response to previous comments, the

purpose of the demonstration project is to evaluate the comparative safety

and efficacy of elective angioplasty or PCI with and without on-site CABG

surgical back-up. The results of that study, viewed in the context of

Statewide need for angioplasty services, will inform future Department

policymaking with respect to whether or not to authorize elective

angioplasty with and without onsite cardiac surgery backup as a licensed

service in the ordinary course.

          80. COMMENT:                  A commenter asserts that a 2007 report of the

Office of the Inspector General finds that the Food and Drug
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Administration “lacks a comprehensive data base for tracking its

inspections of clinical trials and that ‘data limitations hinder the FDA’s

ability to insure that participants are protected from unreasonable risks.”

The commenter inquires as to whether the quantity and quality of FDA

oversight of the Atlantic C-PORT-E trial study is of concern to the

Department. (24)

          RESPONSE: The quantity and quality of FDA oversight of the

Atlantic C-PORT-E trial study is not of concern to the Department because

the trial is not under FDA oversight. It is the Department’s understanding

that the FDA monitors studies related to biologics and devices, and that

the Atlantic C-PORT-E trial is being conducted under National Institutes of

Health oversight.

          81. COMMENT:                  A number of commenters submitted as

comments on the proposal some or all of a list of 20 “talking points,”

through the auspices of the Deborah Foundation. The Department will

respond to these comments in the series of comments and responses that

follow.

          “[How] much time [does it take] to transfer a patient from a hospital

that does not have on-site surgical backup to one that does? How does

this compare to the time it takes to have a patient wheeled to surgery in a

hospital? Is there any damage that occurs to the heart as a result of the

delay? I have heard that … for the Virtua system the transfer is to Atlantic


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City Medical Center … over an hour away. What if there is a traffic jam?

[Will] the [State] track how long these transfers take?” (30)

          RESPONSE: The time to transfer a patient to another facility varies

depending on whether the transfer is made by automobile or by helicopter,

and in some cases occur more quickly than the wait to be moved to a

cardiac surgical facility in the same hospital. Ambulances and helicopters

licensed by the Department maintain data on transfer times pursuant to

applicable licensure standards. A heart can experience damage if there is

delay in treatment.

          82. COMMENT:                  “If the [State] is promoting this experiment, can

I sue the [State] if I am hurt as a result of delay in the transfer to a cardiac

surgery center if I enroll in it?” (30)

          RESPONSE: The Department is not “promoting” the State’s

participation in the demonstration project; it is authorizing it. The

proposed amendments would have no impact on the commenter’s ability

to commence legal action against any person or entity. The Department

makes no representation as to the merits any such action against the

State would have. Patients are free to decline to participate in the

demonstration project should they be concerned by its safety.

          83. COMMENT:                  “How many patients require surgery as a result

of complication that occurs during elective angioplasty?” (30)

          RESPONSE: Generally, the need for surgery after complications

that occur during elective angioplasty depends on factors such as the
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severity of the case and the devices used during the procedure. As stated

in response to previous comments, the trial’s selection criteria exclude

patients who are likely to require surgical intervention or the use of

angioplasty devices that tend to result in the need for surgical intervention.

The demonstration project results would reflect these pre-selection

criteria.

          84. COMMENT:                  “Why do we need to participate in this study?

Why don’t we wait to see the outcome from other states’ data?” (30)

          RESPONSE: As stated in response to previous comments, New

Jersey hospital participation in the Atlantic C-PORT-E trial is intended to

facilitate scientifically rigorous collection and analysis of data that will

contribute significantly to the evidence base nationally on the issue of

comparative safety and efficacy of elective PCI in hospitals with and

without on-site coronary artery bypass graft surgical back-up.

          85. COMMENT:                  “What is [the Department’s] understanding of

the reason some states declined to adopt elective angioplasty without

onsite surgical backup.” (30)

          RESPONSE: The Department was aware that several states,

including New York, Massachusetts and Maryland had chosen not to

participate in the Atlantic C-PORT-E trial and that those individual state’s

decisions were based on numerous factors. The Department understands

that the Commonwealth of Massachusetts based its decision to decline to

participate in the trial in part on the fact that the Commonwealth is itself
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conducting a similar randomized trial, the MASS COMM trial. Similarly,

the Department understands that New York State based its decision in

part on the fact that it is permitting five of its hospitals to participate in a

"pilot program” relating to elective angioplasty without cardiac surgery

backup. The Department understands that the State of Maryland

originally declined to participate in Atlantic C-PORT-E, and that upon

reconsideration, it decided to participate in Atlantic C-PORT-E.



          86. COMMENT:                  “[How] and when [are] patients [enrolled in the]

study … informed of the fact that this study is an experiment and that they

have the option to have their procedure done at a hospital that [has] on-

site surgical backup? How does the [Department] monitor whether

patients truly understand what is going on? Does anybody at a hospital

monitor this process? I understand this study has been going on for a

year now at [nine] hospitals. How many patients have died as a result of

not having on-site surgical backup? How can consumers find out if

patients have died? Isn’t this information we should all have access to so

we can make an informed choice? How are patients informed that they

have the option to have the same elective procedure at one of the 18 New

Jersey hospitals with emergency, on-site, life-saving surgical backup?

How will the state audit this? Why doesn’t the consent form tell the patient

which hospital they will be sent to for emergency surgical backup? Why

doesn’t it also tell them how transportation will occur? Or how long it will
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take to get into the emergency operating room of that other hospital?

[Why wouldn’t a patient] need to know those facts before he [or] she could

give informed consent [?] How are patients informed, during the consent

process, of all the alternatives to elective angioplasty at a hospital with no

on-site surgical backup, including alternatives the physician may not agree

with, like having the procedure at a hospital with surgical backup? If a

reasonable patient would want to know of the option of having the elective

procedure at a hospital with life saving on-site surgical backup, why

wouldn’t that patient elect to have the procedure at a safer location? (30)

          RESPONSE: The demonstration project requires patient consent to

be obtained prior to the patient’s enrollment in the demonstration project.

Substantial patient safety protections are in place, including patient and

device exclusion criteria established by study protocol. The trial provides

oversight by an Events Committee and a Data Safety and Monitoring

Board that periodically recommend either the continuation or suspension

of the trial. The Department does not “monitor” the procedure and manner

by which any health care facilities licensed in the State obtain patient

consent, as this is part of the relationship between patients, their

physicians, and their provider facilities. Hospitals generally have patient

advocates and risk managers in place to ensure patients fully realize and

exercise their rights. Patients can make the inquiries the commenter

suggests to their physicians in deciding whether to consent to participate

in the demonstration project. Some patients prefer to have procedures
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performed at hospitals closer to their homes, at which they have received

other procedures in the past, or at which their physicians have privileges.

These are some reasons why reasonable patients may elect to receive

elective angioplasty at facilities without onsite surgical backup.

          87. COMMENT:                   “I have read … that it is better to have your

heart care done at places that do more procedures. How does this fit in

with those findings? If the number of hospitals able to perform elective

angioplasties in NJ increases won’t that dilute the number of cases that

each doctor performs, and diminish their skills overall? [How will this]

affect the doctors currently performing elective angioplasties in our state at

facilities that do have on-site surgical backup[?] Will allowing this at other

hospitals hurt the existing hospitals? Why would we approve new

services that will hurt already ailing hospitals?” (30)

          RESPONSE: As stated in response to previous comments, the

proposed amendments and the demonstration project protocol establish

minimum procedure volume standards to ensure quality. Individual

physicians’ volumes would decline if the Statewide volume is decreasing.

The proposed amendments were predicated in part on data indicating that

Statewide volume was increasing.

          The proposed amendments may have an economic impact on

existing facilities that provide elective angioplasty with cardiac surgery

backup. See the proposal Economic Impact. The Department provides its


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rationale in authorizing the State’s participation in the demonstration

project in the proposal and in response to previous comments.

          88. COMMENT:                  “How do the proposed [amendments] comply

with the clinical guidelines of the American Heart Association, the

American College of Cardiology, and the Society for Cardiovascular

Angiography and Interventions regarding elective angioplasty and on-site

surgical backup? Haven’t they come out against this? Why would we do

it then? If the American Heart Association does not recommend this

procedure, is it ethical to do this type of experiment?” (30)

          RESPONSE: As stated more fully in response to previous

comments, the entities to which the commenter refers agree that

additional clinical data and experience are necessary, and the proposed

amendments authorizing the State’s participation in the demonstration

project would facilitate scientifically rigorous collection and analysis of

data, with the intention that this will contribute significantly to the evidence

base nationally on the issue of comparative safety and efficacy of elective

PCI in hospitals with and without on-site coronary artery bypass graft

surgical back-up. The Johns Hopkins University Institutional Review

Board has reviewed the demonstration project protocol and determined

that it is ethical.

          89. COMMENT:                  “What is the furthest distance that a patient

wishing to have elective angioplasty has to travel now to be cared for at


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one of the 18 hospitals in our [State] that offers on-site surgical backup?”

(30)

          RESPONSE: Some commenters have asserted that all New Jersey

patients are within “30 minutes” of a full-service cardiac catheterization

laboratory with on-site cardiac surgical backup. The Department makes

no representation as to the accuracy of this statement.

          The commenter implicitly suggests that with respect to the issue of

access, distance alone is the sole relevant criterion. It is not. Other

relevant issues the Department considers relating to the issue of access

include whether or not the facility is accessible by public transportation,

the timeliness within which existing providers of angioplasty services can

provide elective angioplasty services, and whether authorizing a particular

facility to provide elective angioplasty can reduce transfers and

readmissions.

          90. COMMENT:                  “[Why is it] medically beneficial for a patient to

have … elective angioplasty performed at a hospital without on-site

surgical backup rather than at a hospital with surgical backup[?]” (30)

          RESPONSE: As stated in response to previous comments,

depending on the patient and the devices used, the demonstration project

may result in data suggesting that having the procedure at a facility that

does not have cardiac surgery backup could reduce the risk of the

procedure and the likelihood of complications requiring surgical

intervention. Emergency cardiac surgery is sometimes required because
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of a procedure-related complication, although this occurs rarely, that is, in

approximately one or two of every 1,000 cases. However, a response to

the commenter’s question likely would be available upon conclusion of the

demonstration project.

          91. COMMENT:                  “Will doing this procedure increase the cost to

consumers of the procedure? Have you done a study on this? If not, why

not?” (30)

          RESPONSE: See responses to previous comments on the

economic impact of the proposed amendments. See the proposal

Economic Impact. The Department anticipates that the demonstration

project will yield data bearing on efficacy of the procedure that the

Department would take into consideration in developing future Statewide

policy on whether to authorize the procedure as a regular licensed service.

          92. COMMENT:                  “[Hospitals] advertise all over and I have read

that the Governor has a task force looking at elimination of some

hospitals. If true, which areas of the [State] do not currently have access

to elective angioplasty?” (30)

          RESPONSE: The commenter is correct that some hospitals

advertise. The Department is unaware of the existence of a task force of

the Governor “looking at elimination of some hospitals.” As stated in

response to previous comments, other commenters have asserted that all

New Jersey patients are within “30 minutes” of a full-service cardiac

catheterization laboratory with on-site cardiac surgical backup.” The issue
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of access in the context of selection of facilities to which the Department

should grant certificates of need does not turn solely on the absence of

access but also on whether selection of the particular facility can improve

existing access.

          93. COMMENT:                  “What is elective angioplasty? What is

percutaneous coronary intervention?” (30)

          RESPONSE: N.J.A.C. 8:33E-2.2 defines “percutaneous coronary

intervention” or PCI to mean “the passage of a balloon-tipped catheter

(thin tube) to the site of narrowing in an artery and the inflation of the

balloon to reduce the obstruction.… PCI also includes other invasive

procedures to dilate coronary obstruction such as atherectomy of various

kinds (for example, excisional, laser) and arterial stenting procedures.”

Elective angioplasty refers to PCI that is non-emergent or scheduled as

opposed to an emergency or “primary” procedure.”

          94. COMMENT:                  A commenter describes his personal medical

history with respect to receiving cardiac procedures. The commenter

states, “Permitting hospitals to perform cardiac catheterization only when

the facility has cardiac operating suites makes a lot of sense. Although

the cardiac catheterization procedure has been simplified and improved

upon, it is hardly a minimal or minor procedure. People can, and do die

from the procedure and its aftermath. The patient needs to be monitored

for many hours after a procedure and, if something goes horribly wrong,

the patient has no chance if the procedure was conducted at a non-
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cardiac-based hospital. Losing even one patient in order to permit other

hospitals to perform this procedure cannot be considered ‘collateral.’ We

are talking about unnecessarily ending a life that has spouses, offspring

siblings, parents, grandparents and may relatives. Additionally, the

economy would lose an earner and a spender. Many lives would be

destroyed in addition to the life that was lost due to this experiment. I

believe that this ‘experiment’ should stop immediately. In fact, I believe

that all cardiac-related tests that stress the heart muscle should be

conducted at a facility that includes both cardiac catheterization labs and

cardiac operating suites.” The commenter describes a personal medical

experience. “So, while we are at it, lets also move all cardiac-stressing

tests and pacemaker implants to hospitals that can help if a patient gets in

trouble.” The commenter then provides a list of questions that the

Department addresses in the series of comments and responses that

follow. (8)

          RESPONSE: The Department thanks the commenter for providing

his personal experiences and opinions. The proposed amendments would

permit the Department to participate in the demonstration project to

determine the safety and efficacy of the procedure. The commenter’s

suggestions with respect to stress tests and pacemakers exceed the

scope of the proposal.

          95. COMMENT:                  “How may people have to die before the

‘experiment’ will cease? Is even one ‘experiment’ death permissible?” (8)
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          RESPONSE: No “people have to die” for the demonstration project

to cease. The Manual of Operations establishes the demonstration

project stopping rules.

          96. COMMENT:                  “How will you compensate the families who

lose loved ones in this ‘experiment’? How will you explain this to a child?”

(8)

          RESPONSE: The commenter’s questions raise issues that exceed

the scope of the proposal.

          97. COMMENT:                  “Will you expand the mortality measuring

period to one month after the procedure rather than a mere day or two?”

(8)

          RESPONSE: Analysis of raw data collected from the demonstration

project is the responsibility of the principal investigator in accordance with

the demonstration project protocol, the Manual of Operations, and the

direction of the Johns Hopkins Institutional Review Board.

          98. COMMENT:                  “How much money in campaign contributions

have the hospitals without on-site cardiac surgical backup given to

lobbyists, our elected officials their campaigns and PACs in 2005, 2006

and 2007. This question is a serious question and it is not meant as a

rhetorical question. The State … has a bad track record when it comes to

ethical choices by our voting legislators. The people paying taxes will

have little to say about this issue and definitely less to say than the

businesses that will benefit from this new legislation.” (8)
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          RESPONSE: The comment exceeds the scope of the proposal.

However, in an effort to be responsive, the Department notes that

information on campaign contributions to candidates for State elective

office is available from the New Jersey Election Law Enforcement

Commission, the website of which is http://www.elec.state.nj.us. Upon

information and belief, only natural persons, not entities such as hospitals,

can make campaign contributions. The State does not track

compensation arrangements between private entities and their lobbyists.

The expenditures of public entities may be available through a request for

access to government records.

          99. COMMENT:                  A commenter asserts that the demonstration

project “is simply another concept designed to provide the poor and

uneducated with lower quality health services. Obviously, anyone with

even cursory medical health knowledge would ‘Elect’ to have a major

procedure such as angioplasty done in a facility that is the most

experienced and skilled, as well as fully staffed and equipped to

immediately deal with any unforeseen emergencies. Therefore it appears

to me that only the poor and uneducated would end up in the lesser

capable non-surgical facilities. Either I’m confused on the term ‘elective’

or simply confused in general. Please set me straight.” (20)

          RESPONSE: As stated more fully in response to previous

comments, patients must execute written informed consent prior to

enrollment in the demonstration project.
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          The demonstration project is randomized. Therefore, it neither

targets nor excludes specific population groups, such as the poor.

          100. COMMENT:                 One commenter asked what would happen if a

patient refuses to sign the consent form. One commenter asked whether

a facility would notify the patient’s family would be notified prior to an

emergency transport. One commenter asked if the patient would have a

choice in emergency transport. (30)

          RESPONSE: A patient who declines to consent to participate in

the demonstration project will not participate in the demonstration project.

Facilities will observe their ordinary protocols with respect to facility

notifications. The demonstration project will have no bearing on the

procedures for transport. The Manual of Operations requires facilities to

have a plan in place for emergency transfer.

          101. COMMENT:                 Some commenters asked whether there are

facilities without on-site surgical backup owned by doctors and whether

this constitutes a conflict of interest. One commenter asked whether

cardiologists can perform this procedure in their office. (30)

          RESPONSE: With few exceptions, New Jersey hospitals, including

all those currently participating in the Atlantic C-PORT-E trial, are non-

profit. The state’s cardiac rules prohibit physician performance of PCI in

private office settings. In accordance with N.J.A.C. 8:33E-1.3(b), New

Jersey requires cardiac catheterization and PCI to be performed in a

hospital-based facility where inpatient services are available on site.
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          102. COMMENT:                 Commenters requested information on the life

saving equipment available on-site at the Atlantic C-PORT-E

demonstration sites. (30)

          One commenter requested statistics on the age range of study

participants. (30)

          RESPONSE: The life-sustaining equipment that is available at

facilities participating in the demonstration project is the same equipment

available at all hospitals in New Jersey. The demonstration project is a

randomized trial. The Manual of Operations articulates patient selection

and eligibility criteria. Persons ultimately selected to participate in the

demonstration project as patients and their respective demographics

would be collected by the principal investigator and would be available

upon conclusion of the demonstration project.



                                 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.

          Full text of the adoption follows (additions to proposal indicated in

boldface with asterisks *thus*; deletions from proposal indicated in

brackets with asterisks *[thus]*):
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8:33-3.11 Demonstration and research projects

          (a)—(d) (No change from proposal.)

          (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.—5. (No change from proposal.)

                    6. Applicants shall submit documentation addressing the

          following:

                              i. How the applicant will satisfy the study site inclusion

                    criteria specified in the protocol for Atlantic C-PORT-E trial

                    including:

                                        (1)—(2) (No change from proposal.)

                                        (3) Agreement to abide by physician, patient

                              and device selection criteria defined in "The Atlantic

                              C-PORT Trial, Elective Angioplasty Study, Manual of

                              Operations," Version *[2.5 (March 22, 2005)]* *3.0

                              (March 24, 2006)*, (Manual of Operations), as

                              amended and supplemented;

                                        (4)—(6) (No change from proposal.)




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Description: Proposal Notice of Adoption document sample