STATE OF TENNESSEE                       DEPARTMENT OF FINANCE AND ADMINISTRATION                                    DIVIS...
Questions    1. Please consider the current need formula for open heart surgery services       contained in the Guidelines...
4. The Division is considering a standard that would require applicants to provide a       plan for, and document the avai...
No new adult open heart surgery programs may be established unless the                number of open heart operations perf...
13. As is done in several other states, the Division is considering adding a standard        requiring that open heart sur...
which provides for peer review between and among professionals                practicing in facilities and programs other ...
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Nashville, Tennessee 37243

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Transcript of "Nashville, Tennessee 37243"

  1. 1. 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 CriteriaThe Division of Health Planning (Division) has met with providers of open heart surgeryservices throughout the State of Tennessee, ranging from rural community hospitals tolarge urban hospital systems, to solicit background information and expert opinions onthe delivery of open heart services. As a follow-up to these meetings, the Division hasprepared this questionnaire that will help the Division draft specific standards and criteriafor public comment. Please return this questionnaire by email to Eric Harkness, planningand research coordinator, by September 18, 2009 at eric.harkness@tn.gov. If you haveany 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 InformationName:Organization:Email:Phone:Division of Health Planning, 8/21/09 1Questionnaire on Open Heart Surgery Services
  2. 2. 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 2Questionnaire on Open Heart Surgery Services
  3. 3. 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 3Questionnaire on Open Heart Surgery Services
  4. 4. 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 4Questionnaire on Open Heart Surgery Services
  5. 5. 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 andDivision of Health Planning, 8/21/09 5Questionnaire on Open Heart Surgery Services
  6. 6. 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 6Questionnaire on Open Heart Surgery Services

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