Carotid Stenting Andrew Bloschichak, M.D. HGSAdministrators P.O. Box 890089 Camp Hill, PA 17089 Re: Proposed policy R-11 Myocardial SPECT Dear Doctor Bloschichak: On behalf of the Pennsylvania Chapter of the American College of Cardiology, thank you for allowing us to comment on the proposed policy R-11 Myocardial Spect. We feel that it is appropriate to have a separate policy regarding radionuclide perfusion imaging, specifically applied to the myocardial imaging application. On page two, the paragraph entitled “Indications and Limitations of Coverage and/or Medical Necessity” the language “SPECT is generally indicated when other studies are inconclusive or contradictory” sounds restrictive and suggests that another study should have been performed first. This is truly not the case, as an extensive body of literature has demonstrated that SPECT imaging adds substantial prognostic stratification beyond that of exercise stress testing alone. Hence, the conceptual restriction of this policy to the second level of testing is not appropriate in light of the available data. Certainly, SPECT is not cost effective in patients with a low pre-test probability of disease. In intermediate risk groups, stress testing alone may at times be preferable, but going directly to SPECT imaging is appropriate in most settings. In high pre-test groups, the initial choice is SPECT and not exercise testing. We would suggest addition of language such that “SPECT is generally indicated for evaluation of symptomatic patients who are at intermediate or high risk for having coronary artery disease. It is equally useful for the evaluation of asymptomatic patients at high risk for development or progression of coronary artery disease”. Language is also contained in the “Indications” paragraph stating that this technology is “indicated for patients with known or suspected cardiac disease who have received a preliminary workup including but not limited to an exercise treadmill test with or without thallium”. This statement is contradictory, since exercise stress testing with thallium is in fact an application of SPECT myocardial perfusion imaging. Under the Medical Necessity Indications, we agree with the five that are mentioned. In addition, we would propose addition of ”quantification and localization of ischemic myocardium” and “assessment of prognosis in patients with known or suspected coronary artery disease”. It should also be noted that SPECT myocardial perfusion imaging is required when performance of cardiovascular stress testing is by pharmacologic means (i.e., persantine, adenosine, or dobutamine). On page five, under the reasons for denial, the previously suggested indications for medical necessity should be added to the section under reasons for denial. Related to “he ICD-9 codes that support medical necessity”, the American Society of Nuclear Cardiology has suggested the addition of the following ICD-9 codes to the current policy: 426.0 Complete AV block 426.50-426.53 BBB unspecified 427.31 Atrial fibrillation 427.32 Atrial flutter 427.60 Premature beats, unspecific 427.61 Supraventriuclar premature beats 428.20-428.23 Systolic heart failure 428.30-428.33 Diastolic heart failure 428.40-428.43 Combined systolic and diastolic heart failure 440.0-440.9 Atherosclerosis of native arteries of the extremities 780.4 Dizziness 786.52 Painful respiration E942.0-E942.1 Agents affecting CV system V67.0 F/U exam following surgery V67.09 F/U exam following other surgery V67.51 High risk medicatioin V67.59 F/U other treatment V72.81 Pre-op cardiac exam On page five, under “Documentation Requirements”, the statement that “medical records must contain documentation of a preliminary cardiac workup and/or prior diagnostic studies that were inconclusive or contradictory” is not appropriate and should be deleted. On page six, under “Utilization Guidelines”, the statement regarding a reasonable and necessary frequency expectation is rather vague and should be either specifically defined or totally deleted. The current wording seems to allow application of an arbitrary frequency number which could hinder appropriate utilization of SPECT myocardial perfusion imaging by making it difficult to obtain authorization for necessary and appropriate studies. On page three, the “note” describing coverage of radiopharmaceuticals, it is a major issue regarding bundling of drug charges, particularly for patients studied in hospital based labs. Drug charges, both related to the radiopharmaceuticals used for imaging as well as the pharmacologic stress agent if these are required, should be paid separately. Bundling them merely serves to reduce reimbursement substantially with no justification. To reimburse hospital labs differently than out patient labs is not justified and makes no sense. Although not directly related to the proposed policy, it is our understanding that scheduled reimbursement for hospital based SPECT radionuclide myocardial perfusion imaging may be reduced by as much as 40%. This is entirely arbitrary and without justification, and we would strongly recommend that this planned reduction be reconsidered by CMS. Dr. Bloschichak, I hope these comments are of some help to you in “fine tuning” the current proposed policy. I understand that some of the issues that I have raised will be open to discussion, and I will be prepared to answer any questions you may have at the upcoming Carrier Advisory Committee meeting on December 12, 2002. Again, thank you for allowing us the opportunity to provide input into this proposed policy. Sincerely, James P. MacKrell, M.D. Cc: J. Cacchione, M.D. H. Hermann, M.D. D. Durbeck, M.D. M. Elias