Applicants should include a plan in their application to provide

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					                                         STATE OF TENNESSEE
                       DEPARTMENT OF FINANCE AND ADMINISTRATION
                                    DIVISION OF HEALTH PLANNING
                                             312 Rosa Parks Blvd
                                   Suite 2100 William R. Snodgrass Building
                                           Nashville, Tennessee 37243
                                 Phone (615) 532-3161       Fax (615) 532-8532

     M.D. GOETZ, JR.                                                                JEFF OCKERMAN
     COMMISSIONER                                                                      DIRECTOR

____________________________________________________________________________________________________________



       Questionnaire on Open Heart Surgery Services for the
       Revision of Certificate of Need Standards and Criteria
The Division of Health Planning (Division) has met with providers of open heart surgery
services throughout the State of Tennessee, ranging from rural community hospitals to
large urban hospital systems, to solicit background information and expert opinions on
the delivery of open heart services. As a follow-up to these meetings, the Division has
prepared this questionnaire that will help the Division draft specific standards and criteria
for public comment. Please return this questionnaire by email to Eric Harkness, planning
and research coordinator, by September 18, 2009 at eric.harkness@tn.gov. If you have
any questions, please email Mr. Harkness or call him at 615-532-3161.

Thank you in advance for your time and thoughtful response to this questionnaire.



Respondent Information

Name:
Organization:
Email:
Phone:




Division of Health Planning, 8/21/09                                                                      1
Questionnaire on Open Heart Surgery Services
Questions

    1. Please consider the current need formula for open heart surgery services
       contained in the Guidelines for Growth, 2000 Edition:

                The need for open heart surgery services is determined by applying the
                following formula. The formula serves to derive the number of open heart
                procedures which may be needed in a particular service area.

                N=UxP

                where: N = number of procedures in a service area;

                         U = latest available Tennessee use rate (number of procedures
                         performed per 1,000 population in the state); and

                         P = projection of population (in thousands) in the service area.

                The need for open heart surgery services shall be projected four years into
                the future from the current year.

        Please comment on the ability of the current need formula (above) to accurately
        estimate need in a service area. Please suggest any modifications to the formula
        that could more accurately define need. How could/should additional factors be
        incorporated into the formula? For example, should population-level risk factors
        such as heart disease and obesity rates factor into the need calculation for open
        heart surgery services? Also, could the use of a ratio of cardiac catheterizations to
        open heart surgeries, as some other states use, help inform the definition of need?


    2. Several states consider the current capacity of existing nearby open heart surgery
       programs through their need criteria. For example, one criterion of need under
       the State of Kentucky’s standards and criteria is that “every open heart surgery
       program within a fifty (50) mile radius of the proposed site performed at least four
       hundred (400) adult open-heart surgeries per year.” Please indicate why you
       agree or disagree with this approach, and, if you agree, please discuss how you
       would structure such a standard, including whether it should include hospitals
       outside of Tennessee.


    3. Several states require a hospital to operate a high-capacity cardiac catheterization
       program before it may be granted a CON for open heart surgery services. Please
       indicate why you agree or disagree with this approach, and, if you agree, discuss
       how you would structure such a standard.




Division of Health Planning, 8/21/09                                                        2
Questionnaire on Open Heart Surgery Services
    4. The Division is considering a standard that would require applicants to provide a
       plan for, and document the availability of, services in the continuum of care for
       open heart surgery patients (i.e., cardiac intensive care unit beds, cardiac step
       down beds, rehabilitation services, etc.) based on projected volume levels. Please
       comment on the reasonableness of such a standard and list what specific services,
       if any, should be included in this standard.


    5. The Division is considering whether to maintain the current institutional
       minimum volume standard at 200 operations per year for adult facilities and 100
       operations per year for pediatric facilities. An applicant should project that it will
       be able to perform this number of procedures three years from the initiation of its
       program. The Division is considering defining one operation as one visit to an
       operating room by one patient. Please indicate whether you think that volume
       should be a consideration to receive a CON for open heart surgery services, and,
       if so, whether you agree or disagree that the above minimum volume standards
       are sufficient. If you disagree with the above minimum volume standard, please
       suggest a preferred minimum volume standard with supporting rationale.


    6. The Division would like to expound upon the delivery of pediatric open heart
       surgery services in the revised standards. How should the standards define a
       pediatric patient? How should pediatric cases be counted at facilities that
       primarily treat adults? Should only pediatric facilities be permitted to treat
       pediatric patients?


    7. In addition to institutional volume, the Division is considering adding a minimum
       volume standard for individual surgeons. This standard would require applicants
       to project the total number of operations to be performed by each surgeon
       participating in the applicant’s open heart surgery program. Operations
       performed at other sites would count toward each surgeon’s total. Please indicate
       whether you think this approach is appropriate and, if so, in your opinion how
       many cases you think a physician should perform annually to retain and improve
       his or her skill. If possible, please cite peer reviewed literature to support your
       position. The State of Georgia, for example, requires a successful CON applicant
       to establish procedures to ensure that its open heart surgeons will perform at least
       100 operations annually across all practice locations.


    8. Several states, including Tennessee currently, consider the adverse impact of a
       new open heart surgery program on existing programs. The current Open Heart
       Surgery Services Allocation Guidelines contained in the Guidelines for Growth,
       2000 Edition state:




Division of Health Planning, 8/21/09                                                       3
Questionnaire on Open Heart Surgery Services
                No new adult open heart surgery programs may be established unless the
                number of open heart operations performed per year by each existing and
                approved program in the proposed service area of proposed facility
                exceeds 350. The pediatric standard is 130.

                No new open heart surgery programs shall be approved if the new
                program will cause the annual caseload of other programs within the
                service area to drop below 350 adult procedures or 130 pediatric
                procedures.

        Do you agree with the current (above) standards? Should the revised standards
        and criteria include a standard concerning adverse impact on existing programs?
        Given the limited data currently available through the Joint Annual Reports, how
        reliably can an applicant or an existing provider argue that an adverse impact is or
        is not likely to occur?


    9. The Division is considering adding a standard that would require applicants to
       document the availability of, or present a plan for recruiting, a qualified surgeon
       certified by the American Board of Thoracic Surgery with special qualifications
       in cardiac surgery. If this surgeon is to be the only open heart surgeon in the
       program, the standard under consideration is that he or she should have at least 5
       years of open heart operating experience. Please comment on the reasonableness
       of this possible standard and specify how you would structure it.


    10. The Division is considering a standard that would require applicants to document
        a plan for obtaining a sufficient number of professional and technical staff, e.g.,
        cardiac intensive care nurses, for the size of the open heart surgery program
        proposed and to document that the operating room team necessary for an open
        heart surgical procedure will be available. Please comment on the reasonableness
        of this possible standard and list what specific professionals and technicians, if
        any, should be included in this standard.


    11. The Division is considering a standard that would require applicants to document
        the capability to mobilize surgical and medical support teams rapidly for
        emergency cases 24 hours per day, seven days per week. Please comment on the
        reasonableness of this possible standard.


    12. The Division is considering a standard that would require applicants to document
        that the most recently published Guidelines for Coronary Artery Bypass Graft
        Surgery adopted by the American College of Cardiology and the American Heart
        Association will be followed. Please comment on the reasonableness of this
        possible standard.


Division of Health Planning, 8/21/09                                                      4
Questionnaire on Open Heart Surgery Services
    13. As is done in several other states, the Division is considering adding a standard
        requiring that open heart surgeries may only be performed in acute care hospitals
        that are licensed by the State of Tennessee. Please comment on the
        reasonableness of this possible standard.


    14. The Division is considering a standard requiring that applicants certify all medical
        staff performing open-heart surgery procedures will reside within forty-five (45)
        minutes normal driving time of the facility. Under this possible standard, the
        applicant should document that proposed open-heart surgery procedures will not
        be performed by traveling teams that reside beyond this distance and mainly
        practice at another facility. Please comment on the reasonableness of this
        possible standard.


    15. The Division is considering retaining the following standards pertaining to access
        that are included in the current Open Heart Surgery Services Allocation
        Guidelines contained in the Guidelines for Growth, 2000 Edition:

                The maximum travel time to hospitals providing open heart surgery
                services should be within a maximum one-way driving time of two hours
                for at least 90 percent of the population.

                Elective open heart surgery services should be available within two weeks
                from the date of the patient’s decision to undergo surgery.

        Do you agree or disagree with these possible standards?             Please provide
        supporting rationale for your position.


    16. The Division is considering how best to ensure that applicants monitor the quality
        of their open heart surgery programs, including, but not limited to, program
        outcomes and efficiency. One approach could be to ask applicants to document
        their intention to participate in the Society of Thoracic Surgeons (STS) National
        Database. Another approach could be to ask applicants to document a more
        generic plan. The State of Georgia, for instance, requires the following from
        applicants:

                Participation in a data reporting, quality improvement, outcome
                monitoring, and peer review system within the applicant hospital as well
                as a national, state or multi-hospital system which benchmarks outcomes
                based on national norms and which shall be named in the application and



Division of Health Planning, 8/21/09                                                      5
Questionnaire on Open Heart Surgery Services
                which provides for peer review between and among professionals
                practicing in facilities and programs other than the applicant hospital.

        Please discuss the costs and benefits of participation in the STS National Database
        as well as your preferred approach to ensure that facilities monitor and work to
        improve their outcome quality. Note that Policy Recommendation 2 for
        Improving the Provision of Cardiac Catheterization Services, offered by the
        Division in conjunction with the revised Standards and Criteria for Cardiac
        Catheterization Services, recommends that stakeholders should consider a robust
        system for measuring and improving the quality of cardiac care in Tennessee.
        This system could include a committee of experts and practitioners that would
        review quality data and make recommendations accordingly.


    17. Please offer any further comments, suggestions, or concerns for the Division to
        consider regarding the standards and criteria for the provision of open heart
        surgery services.




Division of Health Planning, 8/21/09                                                     6
Questionnaire on Open Heart Surgery Services

				
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