SENATE AMENDED
        PRIOR PRINTER'S NOS. 3519, 3817               PRINTER'S NO. 4193

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

No. 2443 Session of 2006


        INTRODUCED BY KILLION, BASTIAN, ADOLPH, BAKER, BARRAR, BUNT,
           CALTAGIRONE, CAPPELLI, CLYMER, CRAHALLA, CREIGHTON, DeWEESE,
           FREEMAN, GEIST, HARHAI, HENNESSEY, HERSHEY, KAUFFMAN,
           LaGROTTA, LEVDANSKY, MARKOSEK, MILLARD, MUSTIO, PERZEL,
           PICKETT, PYLE, ROBERTS, ROSS, SATHER, SAYLOR, E. Z. TAYLOR,
           TURZAI, WATSON, YOUNGBLOOD, BALDWIN, FLEAGLE, THOMAS, GANNON,
           WALKO, HARPER, SOLOBAY, SAINATO AND DALEY, FEBRUARY 8, 2006

        AS AMENDED ON THIRD CONSIDERATION, IN SENATE, JUNE 12, 2006

                                     AN ACT

     1  Amending the act of June 13, 1967 (P.L.31, No.21), entitled "An   <--
     2     act to consolidate, editorially revise, and codify the public
     3     welfare laws of the Commonwealth," providing for continuation
     4     of demonstration projects for cardiac care.
     5  AMENDING THE ACT OF JULY 19, 1979 (P.L.130, NO.48), ENTITLED "AN  <--
     6     ACT RELATING TO HEALTH CARE; PRESCRIBING THE POWERS AND
     7     DUTIES OF THE DEPARTMENT OF HEALTH; ESTABLISHING AND
     8     PROVIDING THE POWERS AND DUTIES OF THE STATE HEALTH
     9     COORDINATING COUNCIL, HEALTH SYSTEMS AGENCIES AND HEALTH CARE
    10     POLICY BOARD IN THE DEPARTMENT OF HEALTH, AND STATE HEALTH
    11     FACILITY HEARING BOARD IN THE DEPARTMENT OF JUSTICE;
    12     PROVIDING FOR CERTIFICATION OF NEED OF HEALTH CARE PROVIDERS
    13     AND PRESCRIBING PENALTIES," PROVIDING FOR CONTINUATION OF
    14     DEMONSTRATION PROJECTS FOR CARDIAC CARE.

    15     The General Assembly of the Commonwealth of Pennsylvania
    16  hereby enacts as follows:
    17     Section 1.  The act of June 13, 1967 (P.L.31, No.21), known    <--
    18  as the Public Welfare Code, is amended by adding a section to
    19  read:
    20     Section 1002.1.  Continuation of Demonstration Projects for
    21  Cardiac Care.--Any hospital that is subject to the provisions of

     1  this act, which also operates a demonstration project for
     2  percutaneous coronary intervention, shall, upon expiration of
     3  the demonstration project period initially approved by the
     4  Department of Health, receive permanent approval of the service
     5  operated under the demonstration project in accordance with the
     6  conditions as initially approved, unless otherwise agreed to in
     7  writing by the hospital. Nothing in this section shall prevent
     8  the Department of Health from promulgating regulations regarding
     9  percutaneous coronary intervention.
    10     Section 2.  This act shall take effect in 60 days.
    11     SECTION 1.  THE ACT OF JULY 19, 1979 (P.L.130, NO.48), KNOWN   <--
    12  AS THE HEALTH CARE FACILITIES ACT, IS AMENDED BY ADDING A
    13  SECTION TO READ:
    14     SECTION 822.  CONTINUATION OF DEMONSTRATION PROJECTS FOR       <--
    15  CARDIAC CARE.--ANY HOSPITAL THAT OPERATES A DEMONSTRATION
    16  PROJECT FOR PERCUTANEOUS CORONARY INTERVENTION SHALL, UPON
    17  EXPIRATION OF THE DEMONSTRATION PROJECT PERIOD INITIALLY
    18  APPROVED BY THE DEPARTMENT, RECEIVE APPROVAL TO CONTINUE IN THE
    19  DEMONSTRATION PROJECT IN ACCORDANCE WITH THE CONDITIONS AS
    20  INITIALLY APPROVED, UNLESS OTHERWISE AGREED TO IN WRITING BY THE
    21  HOSPITAL, EXCEPT THAT THE DEPARTMENT, AFTER CONSULTATION WITH
    22  THE PENNSYLVANIA CHAPTER OF THE AMERICAN COLLEGE OF CARDIOLOGY,
    23  MAY REQUIRE HOSPITALS PARTICIPATING IN THE DEMONSTRATION PROJECT
    24  TO PARTICIPATE IN A STUDY OF THE DEMONSTRATION PROJECT BY AN
    25  ACADEMIC INSTITUTION ACCEPTABLE TO THE HOSPITAL AND THE
    26  DEPARTMENT.
    27  SECTION 822.  CONTINUATION OF DEMONSTRATION PROJECTS FOR CARDIAC  <--
    28                 CARE.
    29     (A)  APPROVAL.--ANY HOSPITAL THAT OPERATES A DEMONSTRATION
    30  PROJECT FOR PERCUTANEOUS CORONARY INTERVENTION MUST, UPON
    20060H2443B4193                  - 2 -     

     1  EXPIRATION OF THE DEMONSTRATION PROJECT PERIOD INITIALLY
     2  APPROVED BY THE DEPARTMENT, RECEIVE APPROVAL TO CONTINUE IN THE
     3  DEMONSTRATION PROJECT IN ACCORDANCE WITH THE CONDITIONS AGREED
     4  TO BY THE DEPARTMENT, IF THE HOSPITAL PERFORMS 200 PROCEDURES OR
     5  MORE ANNUALLY OR IS DETERMINED BY THE DEPARTMENT TO BE WITHIN
     6  RANGE OF PERFORMING 200 PROCEDURES IN THE NEXT 12 MONTHS.
     7     (B)  LOWER VOLUME.--A HOSPITAL WHICH OPERATES A DEMONSTRATION
     8  PROJECT FOR PERCUTANEOUS CORONARY INTERVENTION THAT PERFORMS
     9  FEWER THAN 200 PROCEDURES ANNUALLY AND WHICH IS NOT DETERMINED
    10  BY THE DEPARTMENT TO BE WITHIN RANGE OF PERFORMING 200
    11  PROCEDURES IN THE NEXT 12 MONTHS MAY CONTINUE ITS ELECTIVE
    12  PERCUTANEOUS CORONARY INTERVENTION PROGRAM IN ACCORDANCE WITH
    13  ALL OF THE FOLLOWING REQUIREMENTS:
    14         (1)  THE HOSPITAL SHALL FOLLOW A PROSPECTIVE, RIGOROUS
    15     PROTOCOL FOR CASE SELECTION DEVELOPED BY A HOSPITAL WITH
    16     CARDIAC SURGERY CAPACITY.
    17         (2)  ALL PHYSICIANS PERFORMING PERCUTANEOUS CORONARY
    18     INTERVENTIONS AT THE HOSPITAL WITHOUT CARDIAC SURGICAL BACKUP
    19     SHALL RECEIVE OR HAVE RECEIVED FORMAL INTERVENTION TRAINING
    20     AT A HOSPITAL WITH OPEN-HEART SURGERY AND MAINTAIN PROCEDURAL
    21     VOLUMES COMPLIANT WITH THE AMERICAN COLLEGE OF CARDIOLOGY
    22     GUIDELINES. THE PHYSICIAN MUST PERFORM AT LEAST 75
    23     PERCUTANEOUS CORONARY INTERVENTIONS PER YEAR. THE
    24     PERCUTANEOUS CORONARY INTERVENTIONS CAN BE PERFORMED AT ANY
    25     COMBINATION OF FACILITIES.
    26         (3)  ALL PHYSICIANS PERFORMING PERCUTANEOUS CORONARY
    27     INTERVENTIONS AT THE HOSPITAL WITHOUT CARDIAC SURGICAL
    28     CAPACITY SHALL BE CREDENTIALED AND ROTATED THROUGH THE
    29     CATHETERIZATION LAB AT A HOSPITAL WITH CARDIAC SURGERY
    30     CAPACITY.
    20060H2443B4193                  - 3 -     

     1         (4)  THE HOSPITAL SHALL ENSURE THAT OVERSIGHT OF ITS
     2     PROGRAM IS PROVIDED BY INTERVENTIONALIST CARDIOLOGISTS WHO
     3     REGULARLY PRACTICE AT A HOSPITAL WITH CARDIAC SURGERY
     4     CAPACITY, WHO SHALL PROVIDE ASSISTANCE IN ACCORDANCE WITH ALL
     5     OF THE FOLLOWING:
     6             (I)  A REVIEW OF ALL POLICIES AND PROCEDURES FOR THE
     7         OPERATION OF THE CARDIAC CATHETERIZATION LABORATORY AND
     8         PERCUTANEOUS CORONARY INTERVENTION PROGRAM, WITH
     9         RECOMMENDATIONS FOR CHANGES, IF NECESSARY.
    10             (II)  AN OPERATIONS REVIEW OF THE CATHETERIZATION
    11         LABORATORY AND PERCUTANEOUS CORONARY INTERVENTION PROGRAM
    12         EVERY SIX MONTHS.
    13             (III)  PARTICIPATION IN QUARTERLY PEER REVIEW OF ALL
    14         ELECTIVE CASES AND SELECTED PRIMARY CASES.
    15             (IV)  TRAINING OF ALL NEW STAFF AT THE HOSPITAL
    16         WITHOUT CARDIAC SURGICAL BACKUP IN THE CATHETERIZATION
    17         LABORATORY, AND PERIODIC RETRAINING, AS NECESSARY.
    18         (5)  THE HOSPITAL SHALL HAVE IN PLACE A TRANSFER
    19     AGREEMENT WITH ONE OR MORE HOSPITALS WITH CARDIAC SURGERY
    20     CAPACITY FOR EMERGENCY TRANSFER OF PATIENTS FROM THE
    21     CATHETERIZATION LABORATORY, IF NECESSARY.
    22         (6)  THE HOSPITAL SHALL IMPLEMENT THE SAME PROTOCOLS FOR
    23     BOTH PREELECTIVE AND POSTELECTIVE PERCUTANEOUS CORONARY
    24     INTERVENTION CARE WHICH ARE UTILIZED BY THE HOSPITAL WITH
    25     CARDIAC SURGERY CAPACITY.
    26         (7)  A TESTED TRANSPORT PROTOCOL WHICH INCLUDES
    27     HELICOPTERS AND GROUND AMBULANCES WITH INTRA-AORTIC BALLOON
    28     PUMP CAPABILITY FOR HEMODYNAMIC SUPPORT SHALL BE ESTABLISHED.
    29         (8)  WHEN WEATHER CONDITIONS PREVENT THE USE OF THE
    30     TRANSPORT SYSTEM, ALL ELECTIVE PERCUTANEOUS CORONARY
    20060H2443B4193                  - 4 -     

     1     INTERVENTIONS SHALL BE CANCELED, UNLESS CANCELLATION WILL
     2     RESULT IN PATIENT HARM.
     3         (9)  THE HOSPITAL MUST TRACK THE OUTCOMES OF PATIENTS AT
     4     6 AND 12 MONTHS AFTER EACH PERCUTANEOUS CORONARY INTERVENTION
     5     AND YEARLY THEREAFTER, FOR TWO YEARS, TO ASSESS MAJOR ADVERSE
     6     CARDIOVASCULAR EVENTS.
     7         (10)  THE HOSPITAL MUST PARTICIPATE IN THE AMERICAN
     8     COLLEGE OF CARDIOLOGY NATIONAL CARDIOVASCULAR DISEASE
     9     REGISTRY. CARDIOLOGISTS FROM THE HOSPITAL WITH CARDIAC
    10     SURGERY CAPACITY WILL REVIEW A SAMPLE OF CASE REPORTS FROM
    11     THE PRIOR 12 MONTHS TO DETERMINE THE ACCURACY OF REPORTING.
    12     IN ADDITION TO THE REQUIREMENT OF THIS PARAGRAPH, THE
    13     HOSPITAL WITHOUT CARDIAC SURGICAL BACKUP MAY PARTICIPATE IN
    14     AN INDEPENDENT STUDY OF ELECTIVE PERCUTANEOUS CORONARY
    15     INTERVENTION CASES TO EVALUATE OUTCOMES FOR ELECTIVE
    16     PERCUTANEOUS CORONARY INTERVENTIONS AT DISCHARGE, AND AT 6
    17     AND 12 MONTHS.
    18     (C)  GENERAL REQUIREMENTS.--ALL HOSPITALS SUBJECT TO THIS
    19  SECTION SHALL COMPLY WITH ALL OF THE FOLLOWING:
    20         (1)  THE HOSPITAL SHALL USE A PATIENT CONSENT FORM FOR
    21     ALL ELECTIVE PERCUTANEOUS CORONARY INTERVENTIONS THAT
    22     INCLUDES THE FOLLOWING STATEMENT:
    23         "THE PENNSYLVANIA DEPARTMENT OF HEALTH AND THE AMERICAN
    24         COLLEGE OF CARDIOLOGY RECOMMEND THAT PATIENTS UNDERGO
    25         ELECTIVE ANGIOPLASTY PROCEDURES IN A HOSPITAL WITH ONSITE
    26         OPEN-HEART SURGERY SERVICES."
    27     A LIST OF HOSPITALS WHICH PROVIDE ONSITE OPEN-HEART SURGICAL
    28     SERVICES WITHIN A 50-MILE RADIUS OF THE HOSPITAL SHALL BE
    29     ATTACHED TO THE CONSENT FORM.
    30         (2)  THE HOSPITAL SHALL REPORT WITHIN 24 HOURS AND IN A
    20060H2443B4193                  - 5 -     

     1     MANNER PRESCRIBED BY THE DEPARTMENT, ANY TRANSFER MADE BY THE
     2     HOSPITAL TO ANY OTHER HOSPITAL AS A RESULT OF THE PERFORMANCE
     3     OF AN ELECTIVE PERCUTANEOUS CORONARY INTERVENTION.
     4         (3)  THE DEPARTMENT MAY TERMINATE A PERCUTANEOUS CORONARY
     5     INTERVENTION PROGRAM SUBJECT TO THIS SECTION IF THE
     6     DEPARTMENT DETERMINES THAT THE HOSPITAL HAS DEMONSTRATED
     7     NEGATIVE OUTCOMES THAT SERIOUSLY JEOPARDIZE PATIENT SAFETY,
     8     IN ACCORDANCE WITH THIS ACT.
     9         (4)  THE HOSPITAL SHALL NOTIFY ITS LIABILITY INSURANCE
    10     CARRIER THAT IT IS PROVIDING ELECTIVE PERCUTANEOUS CORONARY
    11     INTERVENTION SERVICES WITHOUT ONSITE AVAILABILITY OF OPEN-
    12     HEART SURGICAL SERVICE.
    13     (D)  PERMANENT APPROVAL.--THE DEPARTMENT MAY DETERMINE AT ANY
    14  TIME THAT CONTINUATION OF THE DEMONSTRATION PROJECT IS NO LONGER
    15  NECESSARY TO ALLOW FOR THE PROVISION OF PERCUTANEOUS CORONARY
    16  INTERVENTIONS IN HOSPITALS WITHOUT CARDIAC SURGICAL BACKUP AND
    17  MAY PERMANENTLY APPROVE SUCH SERVICES AT THAT TIME. THE
    18  DEPARTMENT SHALL ISSUE A DECISION REGARDING A DETERMINATION
    19  UNDER THIS SUBSECTION NO LATER THAN TWO YEARS FROM THE EFFECTIVE
    20  DATE OF THIS SECTION AND ANNUALLY THEREAFTER.
    21     SECTION 2.  THIS ACT SHALL TAKE EFFECT IMMEDIATELY.






    B1L67JS/20060H2443B4193          - 6 -
See other bills
under the
same topic