Md. Code Regs. 10.14.02.02 - Definitions
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.
Notes
Regulations .02 adopted effective December 5, 1994 (21:24 Md. R. 1988)
Regulation .02B amended as an emergency provision effective August 1, 2006 (33:21 Md. R. 1672); emergency status extended at 34:4 Md. R. 396; emergency status expired May 1, 2007; amended permanently effective May 7, 2007 (34:9 Md. R. 825)
Regulation .02B amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521)
Regulations .02 amended effective 42:7 Md. R. 569, eff.
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No prior version found.