Comment from Fete, Charles, FLDDS

FL DDS Response to DDSAL No. 761 NPRM – Evaluating Malignant Neoplastic Diseases Docket No. SSA-2007-0066 Adult Malignant Neoplastic Listings ?Changes/revisions to the introductory text-We appreciate the efforts to incorporate into the BS 13 listings information relating to the advances in medical knowledge, new medications and treatment, as well as, methods for evaluation of malignant neoplastic diseases. We are pleased that the definition of “inoperable” will be expanded further to discuss neoadjuvant therapy. This helps clarify the intent of listing level severity, along with the discussion of “adjuvant therapy” in the discussion of “unresectable” and the definition of “metastases” as opposed to direct extension of a tumor to other tissue or organs. Revising the listing introductory text to reflect current medical terminology will be very helpful for adjudicators when reviewing the medical records for similar listing criteria, i.e., the use of “indolent” lymphoma instead of “low grade or indolent,” and clarifying “visceral metastases” to mean “metastasis to internal organs” (listing 13.24B). We would also suggest adding the term “multimodal” or phrase “multimodal therapy” to the list of terms defined in 13.00I and 113.00I. Additionally, reorganizing the terms in alphabetical order for easier reference will also be of assistance. ?Adjudicators and medical consultants will improve their evaluation of recurrent leukemia and lymphoma with the expanded acceptable methods of documentation, i.e., testicular biopsy for recurrent leukemia, “clinically apparent” by imaging studies or clinical examination to be of equivalent severity for melanoma (13.02B2). Adding clarification that a brain tumor is considered malignant if classified grade II or higher under WHO classification of the central nervous system (CNS) will aid in evaluation of CNS. We are especially pleased to see the addition of the WHO classification of the CNS, since this has been a very complex body system with little formal guidance. ?We are also pleased to note the proposed revisions to the criteria in the adult listing criteria will incorporate information from many of the Policy Net Questions and Answers for further clarification of the intent of listing criteria: 13.02C- clarification of recurrent disease in the “false” vocal cords, rather than in the “true” vocal cords; 13.03B2-adding additional criteria that melanoma with metastases to “clinically apparent” lymph nodes or a finding of metastasis to four or more lymph nodes that are not clinically apparent are both equivalent in severity to palpable nodal metastases. 13.05A2-examples of aggressive and indolent lymphomas. 13.09C- new proposed listing for medullary carcinoma of the thyroid gland with metastases beyond the regional lymph nodes. Although this cancer is relatively rare, this new listing category provides additional guidance for listing level severity. 13.10B-addition of criteria for metastasis to the supraclavicular nodes and metastasis to the infraclavicular nodes or to 10 or more axillary nodes to be of listing-level severity. These additional listing criteria will be very helpful for case evaluation/adjudication purposes. 13.11 and 13.13A1-editorial changes. 13.14C-expanding the criteria in current listing 13.14 for carcinoma of the lungs. Childhood Malignant Neoplastic Diseases The proposed revisions to 113.00 Childhood listings appear to correspond to proposed changes to the 13.00 Adult listings. We appreciate the guidance to evaluate medullary carcinoma of the thyroid for children under the criteria in the 13.09C adult listing. General Comments The FL DDS would like to submit the following recommendations and issues for consideration: 1.RECOMMENDATION: We suggest that SSA add the AJCC Cancer Staging Manual, 6th edition, to the STAT! Ref library in the SSA Digital Library in order to make it available to all DDSs. This resource has been found to be extremely helpful to FLDDS staff in evaluating criteria under the Malignant Neoplastic Disease listings. 2.RECOMMENDATION: Our policy and Quality Assurance staff frequently receives questions regarding duration issues, head and neck tumors, and recurrent lymphoma. Please consider emphasizing these issues in the introductory text, particularly regarding: •Evidence needed to show the effectiveness of treatment and residuals to consider after treatment (Tracking #05-129 and Tracking #05-053); •clarification of multi-modal treatment (tracking #07-216), •evaluation of tumors under listing 13.02A (Tracking #05-085); and •recurrence three years or more after remission (Tracking #05-079). •Additional discussion in the introductory text regarding common side effects would be useful, e.g. lymphedema following a mastectomy. 3.Listing 13.03A Skin requires “to or beyond the regional lymph nodes.” Tumor staging of either N1 or M1 criteria would be required to meet this listing level severity requirement. (Stage III with any T, N1, M0 and Stage IV with any T, Any N, M1). However, we find that extension of the skin cancer to the bone is not considered “to or beyond the regional lymph node.” This scenario is generally responsive/amenable to surgery. Please provide formal guidance on an example involving T4, including RFC considerations. In the AJCC Cancer Staging Manual, T4 staging indicates that the tumor invades deep extradermal structures (e.g., cartilage, skeletal muscle, or bone). 4.Listing 13.10A-Consider adding to the listings the criteria for metastatic breast cancer to the axillary lymph node(s) involving perforation of the capsule of the lymph node (with or without matting of the lymph nodes). 5.Please consider providing clarification in the introductory text or in the National Q&As regarding the use of Gleason Grading. If the medical evidence of record shows Gleason grade 5, can we use this to equate with listing level severity in 13.24? 6.Please provide general guidance on how to evaluate 13.02A for bilateral neuroblastoma – is this considered extension beyond the midline? If you have any questions or need further clarification of these comments, please contact Patricia Sanders, Health Program Analyst, Florida DDS at Patricia.Sanders@ssa.gov or 850/487-1491, ext 253. Submitted on behalf of: C. Louis Feté Acting Director, FLDDS