Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 14 - CANCER CONTROL › Chapter 10.14.02 - Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment › Section 10.14.02.02 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following terms have the meanings indicated.
B. Terms Defined.
(1) "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.
(2) "Ambulatory
				  surgical center" means a distinct, Medicare-certified entity that operates
				  exclusively for the purpose of providing surgical services to patients not
				  requiring hospitalization.
(3)
				  "Annual gross income" means the total amount received per year from all sources
				  before taxes are withheld.
(4)
				  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.
(5) "Biopsy" means the
				  removal and microscopic examination of tissue from the living human body,
				  performed to establish a precise diagnosis.
(6) "Breast reconstruction" means surgery
				  performed after the removal of a breast as a result of breast cancer to
				  reestablish symmetry between the two breasts.
(7) "Certified nurse anesthetist" means a
				  registered nurse who:
(a) By reason of
				  certification under COMAR 10.27.06, may practice in Maryland under the terms of
				  those regulations; or
(b) Meets the
				  certification requirements in the jurisdiction in which the service is
				  provided, if the service is provided out-of-State.
(8) Certified nurse midwife means a
				  registered nurse who:
(a) By reason of
				  certification under COMAR 10.27.05, may practice in Maryland under the terms of
				  those regulations; or
(b) Meets the
				  certification requirements in the jurisdiction in which the service is
				  provided, if the service is provided out-of-State.
(9) "Certified nurse practitioner" means a
				  registered nurse who:
(a) By reason of
				  certification under COMAR 10.27.07, may practice in Maryland under the terms of
				  those regulations; or
(b) Meets the
				  certification requirements in the jurisdiction in which the service is
				  provided, if the service is provided out-of-State.
(10) "Cervical carcinoma in-situ" means
				  cancer that involves only the intraepithelial layer of the cervix.
(11) "Clinical breast examination" is a
				  physical examination of the breast performed by a qualified health professional
				  for the purpose of detecting breast cancer.
(12) "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.
(13) "Controlled clinical trial" means a
				  research study that:
(a) Is conducted with
				  cancer patients to evaluate the safety and effectiveness of a new
				  treatment;
(b) 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;
(c) Is reviewed for medical ethics, patient
				  safety, and scientific merit by a research institution;
(d) Includes an informed consent in which the
				  patient is given information about the study and the potential benefits and
				  risks; and
(e) 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.
(14) "Department" means the
				  Maryland Department of Health and Mental Hygiene.
(15) "Diagnosis" means a histopathologic
				  finding of breast cancer, cervical cancer, or a precancerous cervical lesion in
				  a biopsy specimen.
(16) "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.
(17) "Disposable medical
				  supplies" means consumable medical items with minimal or no potential for
				  reuse.
(18) "Durable medical
				  equipment" means equipment which satisfies all of the following requirements:
(a) Can withstand repeated use;
(b) Is used to serve a medical purpose;
				  and
(c) Is appropriate for use in
				  the home.
(19) "Eligible
				  patient" means an applicant who has been determined to meet certain general,
				  medical, health insurance, and financial criteria.
(20) "Excisional biopsy" means the removal of
				  the entire tumor mass for cytologic examination.
(21) "Experimental drug" means a drug or
				  biological not:
(a) Approved by the Food and
				  Drug Administration for the treatment of breast cancer or cervical cancer; and
(b) Used under the protocol of a
				  peer-reviewed, Phase-III controlled clinical trial approved by:
(i) The National Institutes of Health (NIH)
				  or one of the NIH's centers or cooperative groups;
(ii) The Food and Drug Administration through
				  an investigational new drug exemption;
(iii) The Department of Veterans Affairs;
				  or
(iv) A qualified nongovernmental
				  research entity as identified in guidelines issued by the NIH.
(22) "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:
(a) The National Institutes of Health (NIH)
				  or one of the NIH's centers or cooperative groups;
(b) The Food and Drug Administration through
				  an investigational new drug exemption;
(c) The Department of Veterans Affairs;
				  or
(d) A qualified nongovernmental
				  research entity as identified in guidelines issued by the NIH.
(22-1) "Explanation of benefits"
				  means the statement sent to a patient or provider, or both, in a health plan
				  that lists:
(a) The health care services
				  provided;
(b) The amounts paid by
				  the plan; and
(c) The total amount
				  billed to the patient.
(23) "Family" means the unit comprised of the
				  applicant or the applicant and one or more of the following:
(a) Spouse ;
(b) A financially dependent child; or
(c) A financially dependent
				  relative.
(24)
				  "Freestanding ambulatory surgical center" means a unit capable of providing
				  ambulatory surgical services which is not located in a hospital setting and
				  which is:
(a) Certified by Medicare through
				  the Health Care Finance Administration (HCFA) regional office to furnish
				  ambulatory surgical services directly to patients; and
(b) Licensed by the State.
(25) "Homebound" means the status
				  of a patient who is confined to the home due to a medical condition.
(26) "Home health services provider" means a
				  public or private agency or organization, or part of any agency or
				  organization, that:
(a) Meets one of the
				  following licensure requirements:
(i) Is
				  licensed pursuant to Health-General Article, §§19-401 -19-408,
				  Annotated Code of Maryland;
(ii) 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;
(iii)
				  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
(iv) 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;
(b) Provides nursing or physical therapy
				  services in the home; and
(c) Meets
				  the requirements for participation in Medicare.
(27) "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.
(28) "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.
(29) "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.
(30) "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.
(31)
				  "Intermittent basis" means a service which is furnished on or at medically
				  predictable and recurring intervals.
(32) "Invasive cervical cancer" means cancer
				  which has spread beyond the intraepithelial layer of the cervix or beyond to
				  other body tissues and organs.
(33)
				  "Invoice" means a:
(a) Form issued or
				  approved by the Department for use by a provider in submitting bills for
				  payment; or
(b) Bill issued by a
				  manufacturer or wholesaler to the provider which indicates proof of purchase
				  and the price paid by the provider.
(34) "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.
(35)
				  "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.
(36) "Mammogram" means an X-ray of the breast
				  that is performed to detect breast cancer.
(37) "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.
(38) 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.
(39) "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.
(40)
				  "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.
(41) "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.
(42) "Needle biopsy" means the removal of
				  tissue from a solid mass with a needle.
(43) "Needle localization" means the
				  application of radiologically guided needles to isolate breast lesions
				  preoperatively.
(44) "Negative
				  mammogram" means the X-ray revealed:
(a)
				  Nothing of medical significance to comment on;
(b) A finding which is nonsignificant, but
				  which may need to be described; or
(c) A finding which is probably
				  non-significant, but which may need to be described and which suggests the need
				  for short interval follow-up.
(45) "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.
(46) "Oncologist" means a physician who
				  specializes in the treatment of cancer.
(47) "Over-the-counter drug" means a
				  substance used as a medicine that does not require a prescription under federal
				  or State law.
(48) Participating
				  health care provider means a local health department, hospital, or a
				  participating:
(a) Certified nurse midwife;
(b) Freestanding ambulatory
				  surgical center;
(c) Home health
				  services provider;
(d)
				  Hospital;
(e) Medical
				  laboratory;
(f) Medical supply
				  company;
(g) Nurse
				  anesthetist;
(h) Nurse
				  practitioner;
(i)
				  Pharmacy;
(j) Physical
				  therapist;
(k) Physician;
(l) Physician assistant;
(m) Occupational therapist; or
(n) Other appropriate health care providers.
(49) "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.
(50) "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.
(51) "Pharmacist" means
				  an individual licensed to practice pharmacy in Maryland.
(52) "Pharmacy" means an establishment or
				  institution requiring a permit in accordance with Health Occupations Article,
				  Title 12, Annotated Code of Maryland.
(53) "Phase-III controlled clinical trial"
				  means a research study using an experimental drug or treatment which:
(a) Has been shown to be effective in the
				  treatment of breast or cervical cancer; and
(b) May be compared with current standard
				  treatment to evaluate which is more effective.
(54) "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.
(55) "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.
(56) "Physical therapy
				  aide" means a non-licensed individual in the employ of a physical therapist.
(57) "Physician" means an
				  individual who is licensed to practice medicine in the jurisdiction in which
				  the service is provided.
(58)
				  Physician assistant means an individual who:
(a) Is licensed to practice medicine under
				  the supervision of a physician under Health Occupations Article, Title 15,
				  Annotated Code of Maryland; or
(b)
				  Meets the licensure requirements in the jurisdiction in which the service is
				  provided, if the service is provided out-of-State.
(59) Prescriber means a participating health
				  care provider licensed to prescribe legend drugs in the state in which the
				  service is provided.
(60)
				  "Prescription" means a written order for medication, medical supplies, or
				  equipment signed by the prescriber.
(61) Program means the Breast and Cervical Cancer
				  Diagnosis and Treatment Program within the Department established to:
(a) Reimburse for breast and cervical cancer
				  diagnostic and treatment services provided by participating health care
				  providers to eligible patients; and
(b) Pay for MHIP coverage, if available, for
				  eligible patients in lieu of providing direct reimbursement to participating
				  health care providers.
(62) "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:
(a) Specifically addresses the established
				  goals of treatment;
(b) Is
				  consistent with the patient plan of care;
(c) Is written immediately following each
				  visit; and
(d) Is part of the
				  permanent patient record.
(63) "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.
(64) "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.
(65) "Resident" means
				  an individual who is currently living in, and intends to remain living within,
				  Maryland.
(66) "Single source drug"
				  means a drug that is:
(a) Available from only
				  one producer or distributor; and
(b) 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.
(67) "Stage
				  I breast cancer" means a tumor 2 centimeters or less in greatest dimension
				  without regional lymph node or distant metastasis.
(68) "Staging" means the categorization of a
				  cancer according to tumor size, regional lymph node involvement, and metastasis
				  to distant areas in the body.
(69)
				  "Treatment" means the medical management and care of a patient for breast
				  cancer, cervical cancer, or a precancerous cervical lesion.
(70) "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.