(1) Endocrinologists do not have the training and do not possess the skills to perform specimen adequacy assessment.

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1 February 20, 2014 Kathleen Todd, MT (ASCP) Medical Technologist Division of Laboratory Services Survey and Certification Group Centers for Medicare & Medicaid Services 7500 Security Blvd. (Mailstop: C ) Baltimore, Maryland Dear Ms. Todd, Thank you for arranging and participating in a teleconference with your colleagues at CMS and representatives of the American Association of Clinical Endocrinologists (AACE), American Thyroid Association (ATA), and The Endocrine Society (ES) on January 30 th. We greatly appreciate the opportunity to discuss the Clinical Laboratory Improvement Amendments (CLIA) edit made by Centers for Medicare & Medicaid Services (CMS) effective January 1, 2013 for the following two Current Procedural Terminology (CPT) codes: (cytopathology, evaluation of FNA; immediate cytohistologic study to determine adequacy for diagnosis, first evaluation episode, each site) (cytopathology, evaluation of FNA; immediate cytohistologic study to determine adequacy for diagnosis, each separate additional evaluations episode, same site (list separately in addition to code for primary procedure). Use when repeat immediate evaluation is required on subsequent cytologic material from the same site following determination that the prior sample was not adequate.). We appreciate the helpful information clarifying that these codes were taken out of CLIA entirely in 2011 based on information provided by CLIA surveyors. We understand that categorizing these codes as provider performed microscopy procedures (PPMPs) would require collaboration with the Centers for Disease Control (CDC) and may not be an optimal solution. As we stated during our discussion, the preference of AACE, ATA and ES is that CMS reverse the 2013 policy change mandating that these codes be subject to high-complexity CLIA subspecialty codes 610 and 630 and again remove them from CLIA. We are interested in learning more from CMS about how these codes might be handled, if not taken entirely out of CLIA, to ensure that the Medicare program provides access to costeffective, high quality care for patients with thyroid disease and disorders. Given that the recent CLIA edit in 2013 was based solely on information CMS received from a laboratory professional society, we would like to again respond to what we believe to be inaccurate claims made by the society in an article that they may have used in proposing this policy change to CMS. These claims are refuted below: (1) Endocrinologists do not have the training and do not possess the skills to perform specimen adequacy assessment. Microscope training is part of every medical school curriculum. In addition, the Accreditation Council on Graduate Medical Education requires that all endocrinology fellows be trained in performance of thyroid FNA, and many institutions provide instruction in assessment of specimen adequacy as an integral part of this training. Furthermore, basic cytology slide preparation and adequacy assessment is taught as part of thyroid

2 nodule ultrasound fine needle aspiration (US-FNA) courses through AACE, ATA and ES. Confirming there are adequate groups of follicular cells in a sample is a straight-forward task that falls within the scope of the FNA clinician. Cytopathologists often relegate adequacy assessment to trainees or paraprofessionals who have far less training than the average endocrinologist. As one cytopathologist has noted (ref 7), "We interpret almost all FNAs performed in our hospital on site, but not those performed at an outside endocrinology clinic, and know that the outside clinic has, in the end, a higher rate of adequacy for their thyroid FNAs than our hospital radiology service. This same cytopathologist has commented that our fellows and residents perform most of our on-site and rapid assessments.... (2) Immediate assessment is more than counting cells for adequacy assessment; it is rendering a preliminary diagnosis and collecting triage material or culture and flow cytometric analysis as well as molecular studies. The descriptors for CPT code and do not describe the work of providing an examination and diagnosis, preliminary or definitive. Our societies believe that this service a separate procedure, performed at a later time by a pathologist as described by CPT code We would refer you to the procedure vignette for provided in the Relative Value Scale Update Committee (RUC) database states the following: A fine needle aspiration is being performed for evaluation of a 1.0 cm lung nodule in a 56-year-old male with chronic obstructive pulmonary disease (COPD). The physician is asked to immediately evaluate the smears to determine if the specimen is adequate to make a definitive diagnosis. Not only do we believe that codes 88172/88177 do not constitute diagnostic tests, since no diagnosis is reached as a consequence of the procedure, but our societies also contend that a physician office which performs only assessment of specimen adequacy tests (88172/88177) is not a laboratory as defined by CLIA. Specifically, assessment of specimen adequacy is not used for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings, (42 USC 263a(a)). Consequently, performance of and does not fall under the jurisdiction of CLIA. We would appreciate your sending us any documentation that relates to the interpretation of this provision and we would appreciate the opportunity to discuss this matter further with you and your legal counsel. (3) There is an increase interest by biotechnology companies in obtaining tissue samples for molecular studies and they are able to persuade clinicians to submit tissue samples for their ventures. Pathologists are less persuaded by these requests and can serve as gatekeepers to prevent tissue samples from being allocated based on criteria that may not be in the best interest of the patient. Simply stated, there is absolutely no data to support this baseless this claim. For any professional group not directly involved in patient care to suggest that endocrinologists do not provide care that is in the best interest of their patients is surprising and troubling. Furthermore, it is disconcerting to think that Federal Medicare policy could be governed by such unsubstantiated claims. (4) To be CLIA certified, a laboratory must have a quality assessment program. The specimens that use the CPT code are part of a much larger CLIA-mandated quality assessment program that has significant positive effect on patient care quality. Our focus is on improved patient care with attention to quality control. Quality assessment programs are an important component of the FNA procedure. Even without performing adequacy, slides have to be carefully prepared, labeled and shipped to the lab. The simple steps of adequacy assessment do not increase the chance of specimen handling error. Furthermore, endocrinologists frequently have close, loyal relationships with their pathologists, which readily allow for feedback on specimen quality and assessment of adequacy. It is clearly in the best interest of the cytopathologist to receive high-quality specimens. Performing on-site immediate adequacy assessment while the patient is in the clinic, allowing for additional FNA passes if

3 indicated, helps to ensure that a well-prepared specimen reaches the pathology lab for interpretation. This allows for greater efficiency and satisfaction for the patient, pathologist and clinician. According to the Bethesda System for reporting thyroid cytopathology, a common cause of an atypical FNA result is sample preparation artifacts. These include air-drying which can create nuclear atypia, clot-artifact mimicking cellular crowding, sparse cellularity (borderline or inadequate samples) and obscuring blood (1). The incidence of atypical category ranges from 3-20% (2). Some of these are considered inadequate when interpreted by another pathologist and over 1/3 are re-classified as benign (3). A large series of expert second review of thyroid FNA samples conducted at Johns Hopkins found that 32% of the time classification is changed, often due to low specimen cellularity and quality (4). On-site confirmation of high-quality smears with adequate cellularity reduces this clinical problem that could potentially lead to unnecessary diagnostic surgery, The statute criteria acknowledges this fact by explicitly stating that the specimen is labile and delay in performing the test could compromise the accuracy of the test result (see subsection (b)(4)). Our societies believe the benefits to patient care of providing on-site adequacy assessment are numerous: 1. Significant decrease in the number of repeat FNA procedures for inadequate specimens (5). 2. Decreased patient anxiety since it will be known that an adequate has been obtained at the time of the procedure, reducing or eliminating the need for repeat FNA. 3. Less time off work or away from other duties. 4. Less delay in initiating treatment for thyroid cancer. 5. Potential cost savings with a decrease in the need for repeat FNA procedures (6). Moreover, it is important to emphasize that the procedures identified by CPT codes and are to be used at the time of the patient visit while the patient remains available for immediate repeat FNA, if indicated. These are not codes that can be used by a facility or a provider that is not an immediate part of the patient interaction. Therefore, the FNA clinician (endocrinologist) is the most appropriate provider to utilize these codes. We all practice in resource constrained environments and need to assure access to safe and cost-effective patient care. Limiting access to adequacy determinations will not enhance safety but will surely limit access to cost-effective care. Lastly, we want to bring to your attention the attached correspondence from UnitedHealthcare responding to a request from AACE that states UHC Oxford health plan will allow separate reimbursement for CPT code and for office-based microscopic evaluation of thyroid nodule specimens obtained by fine needle aspiration. We hope you will reconsider the current CMS policy and continue to work with our societies to ensure patient access to cost-effective, high quality care. We look forward to continuing the dialogue on this issue and hearing your recommendations about how these codes may be handled moving forward. In the meantime, if you have questions please contact Sara Milo, AACE Director of Legislation & Governmental Affairs, at smilo@aace.com or ext 148. Thank you for meeting with us via teleconference and for your willingness to continue to work with our societies on this issue. Sincerely, Jeffrey I. Mechanick, MD, FACP, FACE, FACN, ECNU President, AACE R. Mack Harrell, MD, FACP, FACE, ECNU President Elect, AACE

4 Hossein Gharib, MD, MACP, MACE President, ATA Teresa K. Woodruff, PhD President, ES Attachment 1. Krane J et al Atypia of Undetermined Significance/Follicular Lesion of Undetermined Significance in The Bethesda System for Reporting Thyroid Cytopathology (Ali S and Cibas E, Editors). Springer Bongiovanni M, et al. Acta Cytologica 2012, 56(4); The Bethesda System for Reporting Thyroid Cytopathology: A Meta-Analysis. 3. Haugen BR, et al. [Abstract LB-03], International Thyroid Congress, Paris, FR Olson, M et al. JCEM 2013 Apr; 98 (4); A Tertiary Center s Experience with Second Review of 3885 Cytopathology Specimens. 5. Witt BL, Schmidt RL. Thyroid Apr;23(4): Rapid onsite evaluation improves the adequacy of fine-needle aspiration for thyroid lesions: a systematic review and meta-analysis. 6. Poller DN, Kandaswamy P. J Clin Pathol Jul;66(7): A simplified economic approach to thyroid FNA cytology and surgical intervention in thyroid nodules. 7. Stelow EB Who should perform rapid or on-site assessment of thyroid fine-needle aspirations? Am J Clin Path 2012; 138:8-9

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