In this chapter, the following terms have the meanings indicated. Terms Defined. “Admission” means the formal acceptance by a hospital of a patient who is to be provided with room, board, and medically necessary services in an area of the hospital where the patient stays at least overnight. “Ambulatory surgical center” means a distinct, Medicare-certified entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. “Annual gross income” means the total amount received per year from all sources before taxes are withheld. “Applicant” means an individual who has applied to be eligible to have certain health care costs associated with the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion paid for by the Department. “Biopsy” means the removal and microscopic examination of tissue from the living human body, performed to establish a precise diagnosis. “Breast reconstruction” means surgery performed after the removal of a breast as a result of breast cancer to reestablish symmetry between the two breasts. “Certified nurse anesthetist” means a registered nurse who: By reason of certification under COMAR 10.27.06, may practice in Maryland under the terms of those regulations; or Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. “Certified nurse midwife” means a registered nurse who: By reason of certification under COMAR 10.27.05, may practice in Maryland under the terms of those regulations; or Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. “Certified nurse practitioner” means a registered nurse who: By reason of certification under COMAR 10.27.07, may practice in Maryland under the terms of those regulations; or Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. “Cervical carcinoma in-situ” means cancer that involves only the intraepithelial layer of the cervix. “Clinical breast examination” is a physical examination of the breast performed by a qualified health professional for the purpose of detecting breast cancer. “Clinically significant mass” means the presence of a discrete, dominant, palpable lump that raises the level of concern by either a patient or a provider. “Controlled clinical trial” means a research study that: Is conducted with cancer patients to evaluate the safety and effectiveness of a new treatment; Is conducted after basic research in laboratory and animal studies have been well tested, and researchers have reason to believe that the new treatment will be as good as, or better than, current standard treatment; Is reviewed for medical ethics, patient safety, and scientific merit by a research institution; Includes an informed consent in which the patient is given information about the study and the potential benefits and risks; and Involves review of the protocol and progress of the study and provides for monitoring the data and the safety of the patient during and after the study by researchers at places other than the institution at which the study is conducted. “Department” means the Maryland Department of Health. “Diagnosis” means a histopathologic finding of breast cancer, cervical cancer, or a precancerous cervical lesion in a biopsy specimen. “Direct supervision” means that the physical therapist employer is physically present in the same area of the facility as the physical therapy assistant who provides service. “Disposable medical supplies” means consumable medical items with minimal or no potential for reuse. “Durable medical equipment” means equipment which satisfies all of the following requirements: Can withstand repeated use; Is used to serve a medical purpose; and Is appropriate for use in the home. “Eligible patient” means an applicant who has been determined to meet certain general, medical, health insurance, and financial criteria. “Excisional biopsy” means the removal of the entire tumor mass for cytologic examination. “Experimental drug” means a drug or biological not: Approved by the Food and Drug Administration for the treatment of breast cancer or cervical cancer; and Used under the protocol of a peer-reviewed, Phase-III controlled clinical trial approved by: The National Institutes of Health (NIH) or one of the NIH’s centers or cooperative groups; The Food and Drug Administration through an investigational new drug exemption; The Department of Veterans Affairs; or A qualified nongovernmental research entity as identified in guidelines issued by the NIH. “Experimental treatment” means a medical procedure or service for breast cancer, cervical cancer, or a precancerous cervical lesion that is not performed under the protocol of a peer-reviewed, Phase-III controlled clinical trial approved by: The National Institutes of Health (NIH) or one of the NIH's centers or cooperative groups; The Food and Drug Administration through an investigational new drug exemption; The Department of Veterans Affairs; or A qualified nongovernmental research entity as identified in guidelines issued by the NIH. “Explanation of benefits” means the statement sent to a patient or provider, or both, in a health plan that lists: The health care services provided; The amounts paid by the plan; and The total amount billed to the patient. “Family” means the unit comprised of the applicant or the applicant and one or more of the following: Spouse; A financially dependent child; or A financially dependent relative. “Freestanding ambulatory surgical center” means a unit capable of providing ambulatory surgical services which is not located in a hospital setting and which is: Certified by Medicare through the Health Care Finance Administration (HCFA) regional office to furnish ambulatory surgical services directly to patients; and Licensed by the State. “Homebound” means the status of a patient who is confined to the home due to a medical condition. “Home health services provider” means a public or private agency or organization, or part of any agency or organization, that: Meets one of the following licensure requirements: Is licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland; If the entity is part of a hospital or related institution located in Maryland, is licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland; If the entity is located outside of Maryland, is legally authorized to provide home health services in the jurisdiction in which the service is provided; or Is a registered nurse licensed pursuant to Health Occupations Article, §§8-101 and 8-301—8-315, Annotated Code of Maryland, with a contractual agreement with the Department to provide skilled nursing care; Provides nursing or physical therapy services in the home; and Meets the requirements for participation in Medicare. “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the jurisdiction in which the service is provided. “Initial physical therapy evaluation” means the determination of the condition of the patient by a physical therapist through the administration of appropriate tests and a written case history on the first visit. “Innovator multiple source drug” has the meaning set forth at 42 U.S.C. §1396r-8(k)(7), as amended, which is incorporated by reference. “Insurer” means a private carrier, nonprofit health service plan, or health maintenance organization that administers or provides reimbursement for health care benefits on an expense-incurred basis. “Intermittent basis” means a service which is furnished on or at medically predictable and recurring intervals. “Invasive cervical cancer” means cancer which has spread beyond the intraepithelial layer of the cervix or beyond to other body tissues and organs. “Invoice” means a: Form issued or approved by the Department for use by a provider in submitting bills for payment; or Bill issued by a manufacturer or wholesaler to the provider which indicates proof of purchase and the price paid by the provider. “Legend drug” means a substance used as a medicine which is prescribed by a licensed health care provider in accordance with federal or State law. “Local health department” means the Baltimore City or a county-wide organization providing health services operated by the local health officer and under the supervision of the Department. “Mammogram” means an X-ray of the breast that is performed to detect breast cancer. “Maryland Health Insurance Plan (MHIP)” means the nonprofit entity established under Insurance Article, §§14-501—14-509, Annotated Code of Maryland, to provide affordable, comprehensive health coverage for medically uninsurable Maryland residents. “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for eligible and medically needy low income individuals. “Medical case manager” means the participating physician or participating nurse practitioner who is responsible for making the medical decisions about the course of diagnosis and treatment for an eligible patient. “Medical laboratory” means a licensed or certified facility operated for the examination of material derived from the human body, by one or more scientific disciplines, for the purpose of obtaining information that may be used to aid in the diagnosis, treatment, and management of breast and cervical cancer. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Needle biopsy” means the removal of tissue from a solid mass with a needle. “Needle localization” means the application of radiologically guided needles to isolate breast lesions preoperatively. “Negative mammogram” means the X-ray revealed: Nothing of medical significance to comment on; A finding which is non-significant, but which may need to be described; or A finding which is probably non-significant, but which may need to be described and which suggests the need for short interval follow-up. “Occupational therapist” means an individual licensed by the Maryland Board of Occupational Therapy Practice or similarly licensed in the state in which the service is provided. “Oncologist” means a physician who specializes in the treatment of cancer. “Over-the-counter drug” means a substance used as a medicine that does not require a prescription under federal or State law. “Participating health care provider” means a local health department, hospital, or a participating: Certified nurse midwife; Freestanding ambulatory surgical center; Home health services provider; Hospital; Medical laboratory; Medical supply company; Nurse anesthetist; Nurse practitioner; Pharmacy; Physical therapist; Physician; Physician assistant; Occupational therapist; or Other appropriate health care providers. “Part-time basis” means services usually furnished during several visits per week, but not exceeding one visit per discipline per day, unless unusual circumstances are documented by the physician, which are reasonable and necessary to the treatment of breast and cervical cancer. “Patient contribution amount” means the amount of money required by an individual's health insurance policy to be paid by the individual for a given medical service received, excluding the deductible. “Pharmacist” means an individual licensed to practice pharmacy in Maryland. “Pharmacy” means an establishment or institution requiring a permit in accordance with Health Occupations Article, Title 12, Annotated Code of Maryland. “Phase-III controlled clinical trial” means a research study using an experimental drug or treatment which: Has been shown to be effective in the treatment of breast or cervical cancer; and May be compared with current standard treatment to evaluate which is more effective. “Physical therapist” means an individual licensed or registered by the Maryland Board of Physical Therapy Examiners or similarly licensed or registered in the state in which the service is provided. “Physical therapist assistant” means an individual licensed as a physical therapy assistant, working under the direct supervision of a physical therapist, and performing those physical therapy procedures that are assigned by a physical therapist within the scope of Health Occupations Article, Title 13, Annotated Code of Maryland. “Physical therapy aide” means a non-licensed individual in the employ of a physical therapist. “Physician” means an individual who is licensed to practice medicine in the jurisdiction in which the service is provided. “Physician assistant” means an individual who: Is licensed to practice medicine under the supervision of a physician under Health Occupations Article, Title 15, Annotated Code of Maryland; or Meets the licensure requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. “Prescriber” means a participating health care provider licensed to prescribe legend drugs in the state in which the service is provided. “Prescription” means a written order for medication, medical supplies, or equipment signed by the prescriber. “Program” means the Breast and Cervical Cancer Diagnosis and Treatment Program within the Department established to: Reimburse for breast and cervical cancer diagnostic and treatment services provided by participating health care providers to eligible patients; and Pay for MHIP coverage, if available, for eligible patients in lieu of providing direct reimbursement to participating health care providers. “Progress note” means a dated, written notation which summarizes facts about the patient care given and the patient response during a given period of time that: Specifically addresses the established goals of treatment; Is consistent with the patient plan of care; Is written immediately following each visit; and Is part of the permanent patient record. “Radiological examination of a breast surgical specimen” means an X-ray of the surgically removed tissue to ensure that the specimen contains the area of suspicion. “Release of patient information” means a Departmental consent form signed by the patient granting permission to certain individuals to allow the release of certain medical and demographic information for the purpose of follow-up, reimbursement, and medical case management. “Resident” means an individual who is currently living in, and intends to remain living within, Maryland. “Single source drug” means a drug that is: Available from only one producer or distributor; and Produced or distributed under an original new drug application approved by the Food and Drug Administration, including a drug marketed by a producer or distributor operating under the new drug application. “Stage I breast cancer” means a tumor 2 centimeters or less in greatest dimension without regional lymph node or distant metastasis. “Staging” means the categorization of a cancer according to tumor size, regional lymph node involvement, and metastasis to distant areas in the body. “Treatment” means the medical management and care of a patient for breast cancer, cervical cancer, or a precancerous cervical lesion. “Utilization control agent” means the organization responsible for reviewing the use of hospital services to determine medical necessity and lengths of stay according to applicable professional standards.