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<regulation prefix="Regulation" num=".02" citation="COMAR 10.14.01.02" title_num="10" subtitle_num="14" chapter_num="01" heading="Definitions.">
  <paragraph num="A.">
    <text>In this chapter, the following terms have the meanings indicated.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Terms Defined.</text>
    <paragraph num="(1)">
      <text>“Assisted living program” has the meaning stated in COMAR 10.07.14.02B.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>“Cancer registry” means a computerized system to register all cases of reportable human cancer or reportable human central nervous system (CNS) tumors of Maryland residents and nonresidents diagnosed or treated in Maryland.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>“Cancer report” means a one-time abstract from one or more of the following documents maintained by a reporting facility, nursing facility, assisted living program, or general hospice care program of each new case of reportable human cancer or CNS tumor diagnosed or treated, and any other case of reportable human cancer or CNS tumor initially diagnosed or treated for time periods as designated by the Secretary:</text>
      <paragraph num="(a)">
        <text>Medical record;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Pathology report; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Radiological report.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Case of a Reportable Human CNS Tumor.</text>
      <paragraph num="(a)">
        <text>“Case of a reportable human CNS tumor” means an identified human tumor, irrespective of histologic type or behavior, occurring as a primary tumor in any of the following sites or subsites with International Classification of Diseases for Oncology, Third Edition (ICD-O-3) topography codes C70.0 — C72.9 and C75.1 — C75.3:</text>
        <paragraph num="(i)">
          <text>The brain;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The meninges;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>The spinal cord;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>The cauda equina;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>A cranial nerve;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>The pituitary gland;</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>The pineal gland; or</text>
        </paragraph>
        <paragraph num="(viii)">
          <text>The craniopharyngeal duct.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>“Case of a reportable human CNS tumor” includes all benign and uncertain behavior tumors of the CNS (ICD-10-CM Codes D18.02, D32.0 — D33.9, D35.2 — D35.4, D42.0 — D43.9, D44.3 — D44.5, Q85.00 — Q85.09 and D49.6, and all tumors of the CNS of benign and uncertain behavior with ICD-O-3 codes of “0” or “1”), which includes codes from:</text>
        <paragraph num="(i)">
          <text>The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM); and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The International Classification of Diseases for Oncology, Third Edition (ICD-O-3).</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>“Case of reportable human cancer” means the identification of a human cancer from the following list, which includes codes from the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) and the International Classification of Diseases for Oncology, Third Edition (ICD-O-3):</text>
      <paragraph num="(a)">
        <text>All malignant neoplasms with ICD-10-CM Codes C00 — C43.9, C44.00, C44.09, C44.10_, C44.19_, C44.20_, C44.29_, C44.30_, C44.39_, C44.40, C44.49, C44.50_, C44.59_, C44.60_, C44.69_, C44.70_, C44.79_, C44.80, C44.89, C44.90, C44.99, C45._ — C96._, or with ICD-O-3 behavior code of “3”, including genital skin cancer of the vagina, clitoris, vulva, prepuce, penis, and scrotum and excluding other sites of skin cancer with ICD-O-3 topography codes C44.0 — C44.9 with one of the following ICD-O-3 histologies:</text>
        <paragraph num="(i)">
          <text>M-8000 — 8005 Neoplasms, malignant, not otherwise specified of skin;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>M-8010 — 8046 Epithelial carcinomas of skin;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>M-8050 — 8084 Papillary and squamous cell carcinomas of skin (C44.02, C44.12_, C44.22_, C44.32_, C44.42, C44.52_, C44.62_, C44.72_, C44.82, C44.92); or</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>M-8090 — 8110 Basal cell carcinomas (C44.01, C44.11_, C44.21_, C44.31_, C44.41, C44.51_, C44.61_, C44.71_, C44.81, C44.91);</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>All malignant neoplasms with the following ICD-10-CM codes where ICD-O-3 behavior is “3” and ICD-O-3 histologies are reported except as follows:</text>
        <paragraph num="(i)">
          <text>If there is evidence of multiple foci, lymph node involvement, or metastasis, C37 — Thymoma (M-8580);</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>C7A.020 — Malignant carcinoid tumor of the appendix (M-8240);</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>C54.1 — Endometrial stroma, low grade (M-8931);</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>If there is evidence of multiple foci, lymph node involvement, or metastasis, D48.1 — Stromal Tumor of the digestive system (GIST 8639);</text>
        </paragraph>
        <paragraph num="(v)">
          <text>D48.60 — Phylloides tumor (M-9020);</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>D45 — Polycythema (M-9950);</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>D47.Z9 — Plasmacytoma (M-9731, M-9734);</text>
        </paragraph>
        <paragraph num="(viii)">
          <text>D47.3 — Essential thrombocythemia (M-9962), D46.0, D46.1, D46.20, D46.21, D46A, D46B — Low grade myelodysplastic syndrome lesions (M-9980), D46.22 — High grade myelodysplastic syndrome lesions (M-9983), D46.C — Myelodysplastic syndrome with 5q deletion (M-9986), D469 — Myelodysplastic syndrome, unspecified (M-9975), D47.1 — Myelofibrosis with myeloid metaplasia (primary myelofibrosis) (M-9961), D47.Z1 — post-transplant lymphoproliferative disorder (M-9989), C94.40, C94.41, C94.42, D47.9, D47.Z9 — lympho and myeloproliferative disease (M-9960, M-9970);</text>
        </paragraph>
        <paragraph num="(ix)">
          <text>C88.2 — Alpha and gamma heavy chain disease (M-9762) or Franklin disease (M-9763);</text>
        </paragraph>
        <paragraph num="(x)">
          <text>C88.0 — Waldenstrom macroglobulinemia (M-9761);</text>
        </paragraph>
        <paragraph num="(xi)">
          <text>D46.4 — Refractory anemia (M-9980); or</text>
        </paragraph>
        <paragraph num="(xii)">
          <text>D46.1 — Refractory anemia with ringed sideroblasts (M-9982), refractory anemia with excess blasts (M-9983), or refractory anemia with excess blasts in transformation (M-9984);</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>All cases of carcinoma in situ with ICD-10-CM Codes D00._ — D09.9, D47.Z2, D49.511 — D49.519, D49.59, D78.31 — D78.34, and D89.40 — D89.49, or with ICD-O-3 behavior code of “2”, including genital skin cancers of the vagina, clitoris, vulva, prepuce, penis, and scrotum and excluding other skin cancers with ICD-O-3 topography codes C44.0_ — C44.9_ with one of the following ICD-O-3 histologies:</text>
        <paragraph num="(i)">
          <text>M-8000 — 8005 Neoplasms, malignant, not otherwise specified of skin;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>M-8010 — 8046 Epithelial carcinomas of skin;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>M-8050 — 8084 Papillary and squamous cell carcinomas of skin; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>M-8090 — 8110 Basal cell carcinomas; or</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>All cases of intraepithelial neoplasia with ICD-O-3 histology code of M-8077/2:</text>
        <paragraph num="(i)">
          <text>Including squamous intraepithelial neoplasia of the larynx (LIN), vagina (VAIN), vulva (VIN), and anus (AIN) (ICD-10-CM codes D02.0, D07.2, D07.1, and D01.3; and ICD-O-3 topography codes C52, C51, and C21._); and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Excluding squamous intraepithelial neoplasia of the cervix (CIN III) and glandular intraepithelial neoplasia of the prostate (PIN) (ICD-10-CM codes D06._ and D07.5; and ICD-O-3 topography codes C53 and C61.9).</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>“Computerized file” means an electronic data file using software approved for use by the Secretary, containing complete cancer report information transferable to a master electronic database system maintained by the Department.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>“Department” means the Maryland Department of Health or a designee.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>“Freestanding ambulatory care facility” has the meaning stated in Health-General Article, §19-3B-01, Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(9)">
      <text>“Freestanding laboratory” means a facility, place, establishment, or institution which performs a laboratory examination for a person, authorized by law to request the examination, in connection with the diagnosis of a reportable human cancer or CNS tumor, and is licensed by the State pursuant to COMAR 10.10.03, and:</text>
      <paragraph num="(a)">
        <text>Not under the administrative control of a hospital; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Under the administrative control of a hospital for a diagnosis of reportable human cancer or CNS tumor of a nonhospitalized patient.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(10)">
      <text>“General hospice care program” has the meaning stated in COMAR 10.07.21.02.</text>
    </paragraph>
    <paragraph num="(11)">
      <text>“Hospital” means a facility which is licensed by the State pursuant to COMAR 10.07.01.</text>
    </paragraph>
    <paragraph num="(11-1)">
      <text>“Maryland Cancer Registry Data Use Manual and Procedures” means the document that describes the Maryland cancer registry procedures for release of cancer data and that outlines the procedures to obtain both non-confidential aggregate data and confidential individual-level data.</text>
    </paragraph>
    <paragraph num="(12)">
      <text>“Nursing facility” has the meaning stated in COMAR 10.07.02.01B.</text>
    </paragraph>
    <paragraph num="(13)">
      <text>“Physician” means an individual who:</text>
      <paragraph num="(a)">
        <text>Practices medicine, as defined in Health Occupations Article, §14-101, Annotated Code of Maryland; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Diagnoses or treats a case of reportable human cancer or a reportable human CNS tumor at a practice located in Maryland.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(14)">
      <text>“Reporting facility” means any of the following:</text>
      <paragraph num="(a)">
        <text>A hospital, freestanding laboratory, freestanding ambulatory care facility, or therapeutic radiological center; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A physician who has care of or has diagnosed a case of reportable human cancer or reportable human CNS tumor for a nonhospitalized patient not otherwise reported.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(15)">
      <text>“Secretary” means the Secretary of Health or a designee of the Secretary.</text>
    </paragraph>
    <paragraph num="(16)">
      <text>“Therapeutic radiological center” means a facility or institution:</text>
      <paragraph num="(a)">
        <text>Performing radiological treatment for a person authorized by law to request the treatment in connection with a reportable human cancer or a reportable human CNS tumor; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Licensed or registered by the State pursuant to COMAR 10.05.03 and not under the administrative control of a hospital.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>