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<chapter num="03" heading="Breast Cancer Treatment Methods" title_num="10" subtitle_num="14">
  <regulation prefix="Regulation" num=".01" heading="Definitions.">
    <paragraph num="A.">
      <text>The following terms have the meanings indicated.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Terms Defined.</text>
      <paragraph num="(1)">
        <text>“Department” means the Maryland Department of Health.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Diagnosis” means a histopathologic finding of breast cancer in a biopsy specimen.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>“Treating physician” means an individual authorized under the Medical Practice Act to practice medicine in Maryland who, in Maryland, treats a patient for breast cancer.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Requirements for the Maryland Department of Health.">
    <paragraph num="A.">
      <text>The Department shall provide a standardized written summary in layman's language that:</text>
      <paragraph num="(1)">
        <text>Lists effective methods of treating breast cancer that may be medically practicable including all types of surgical treatment and radiological, hormonal, and chemotherapeutic treatment and combinations of these treatments; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Describes the advantages, disadvantages, risks, and procedures associated with each method of treatment.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The Department shall update the standardized written summary annually.</text>
    </paragraph>
    <paragraph num="C.">
      <text>The Department shall provide a statement indicating acknowledgement of receipt of the standardized written summary to be signed by the patient.</text>
    </paragraph>
    <paragraph num="D.">
      <text>The Department shall distribute copies of the standardized written summary and the acknowledgement of receipt statement to all hospitals, clinics, other facilities, and physicians' offices where treatment of breast cancer is performed.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Requirements of Treating Physicians.">
    <paragraph num="A.">
      <text>At any time before, but not more than 5 days after, a treating physician informs a patient of a diagnosis of breast cancer, and before treatment, the treating physician shall give the patient:</text>
      <paragraph num="(1)">
        <text>The standardized written summary provided by the Department; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>An equivalent summary including the requirements under Regulation .02A written in language that the patient understands.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>A treating physician may not undertake any of the treatments described in Regulation .02A(1) until a breast cancer patient has been given the written summary described in §A(1) and (2) of this regulation.</text>
    </paragraph>
    <paragraph num="C.">
      <text>A treating physician who provides a patient with the written summary required under these regulations shall have the patient sign a statement provided by the Department acknowledging receipt of the summary and shall have a copy of this signed acknowledgement placed in the patient's medical record which is used by the treating physician.</text>
    </paragraph>
    <paragraph num="D.">
      <text>The requirements under this regulation do not apply if the:</text>
      <paragraph num="(1)">
        <text>Treating physician certifies in writing in the patient's medical record that one of the treatments for breast cancer described in Regulation .02A(1) occurred within 5 days of the physician informing the patient of the diagnosis; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Treatment within this period of time was necessary to save the life of the patient.</text>
      </paragraph>
    </paragraph>
    <paragraph num="E.">
      <text>These regulations should not be interpreted to require a waiting period between diagnosis and treatment.</text>
    </paragraph>
    <paragraph num="F.">
      <text>This regulation is supplemental and additional to any other requirements established by other laws upon a treating physician and may not be regarded as in derogation or substitution of any requirements now existing upon a treating physician, such as the need to obtain informed consent for treatment.</text>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Health-General Article, §20-113, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: November 14, 1988 (15:23 Md. R. 2658)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 20, 1992 (19:1 Md. R. 31)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 20, 1992 (19:1 Md. R. 31)</annotation>
    <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 10.06.05 to COMAR 10.14.03 in July, 1993</annotation>
  </annotations>
</chapter>