Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 24 - MARYLAND HEALTH CARE COMMISSION
Chapter 10.24.01 - Procedural Regulations for Health Care Facilities and Services
Section 10.24.01.01 - Definitions
Universal Citation: MD Code Reg 10.24.01.01
Current through Register Vol. 51, No. 19, September 20, 2024
A. In this chapter, the following terms have the meanings indicated.
B. Terms Defined.
(1) "Acquisition" means:
(a) Any transfer of stock or assets that
results in a change of the person or persons who control a health care
facility; or
(b) The transfer of
any stock or ownership interest in excess of 25 percent.
(2) "Adversely affected", for purposes of
determining interested party status in a Certificate of Need review, as defined
in §B(35) of this regulation, means that a person:
(a) Is authorized to provide the same service
as the applicant, in the same planning region, or contiguous planning region if
the proposed new facility or service could reasonably provide services to
residents in the contiguous area, and can demonstrate that the approval of the
application:
(i) Would materially affect the
quality of care at a health care facility that the person operates, such as by
causing a reduction in the volume of services when volume is linked to
maintaining quality of care; or
(ii) Would result in a substantial depletion
of essential personnel or other resources at a health care facility that the
person operates; or
(b)
Can demonstrate to the reviewer that a health care facility operated by the
person could suffer a potentially detrimental impact from the approval of a
project before the Commission, in an issue area over which the Commission has
jurisdiction, such that the reviewer, in the reviewer's sole discretion,
determines that the person should be qualified as an interested party in the
review.
(3) "Aggrieved
party" means:
(a) An applicant or interested
party who has submitted written exceptions to a proposed decision to the
Commission and would be adversely affected by the final decision of the
Commission; or
(b) The
Secretary.
(4)
Ambulatory Surgery Center.
(a) "Ambulatory
surgery center" or "ASC" means any center, service, office, facility, or office
of one or more health care practitioners, a group practice, or a
non-rate-regulated center owned by a hospital that:
(i) Has no more than two operating
rooms;
(ii) Operates primarily for
the purpose of providing surgical services to patients who do not require
overnight hospitalization; and
(iii) Seeks reimbursement from payors for the
provision of ambulatory surgical services.
(b) "Ambulatory surgery center" or "ASC"
includes the following subcategories:
(i) An
ASC-P, which has only procedure rooms;
(ii) An ASC-1, which has one operating room;
and
(iii) An ASC-2, which has two
operating rooms.
(5) "Ambulatory surgical facility" means any
center, service, office, facility, or office of one or more health care
practitioners or a group practice that:
(a)
Has three or more operating rooms;
(b) Operates primarily for the purpose of
providing surgical services to patients who do not require overnight
hospitalization; and
(c) Seeks
reimbursement from a third-party payor as an ambulatory surgical
facility.
(6) "Approved
bed" means a bed approved by the Commission in a Certificate of Need, but not
yet licensed.
(7) "Bed capacity" or
"physical bed capacity" means the total number of beds that a health care
facility can set up and staff in space designed for and licensable for use by
patients requiring an overnight stay at the facility.
(8) "By or on behalf of" includes a capital
expenditure that affects the physical plant, service volume, or service
capacity of a health care facility or health maintenance organization
regardless of the source of the funds.
(9) "Capital expenditure" means:
(a) An expenditure, including predevelopment
costs, which:
(i) Is made as part of an
acquisition, improvement, expansion, or physical plant replacement;
(ii) Results in a change or relocation that
would require a CON under Regulation .02A(2)-(4) of this chapter; and
(iii) Is made by or on behalf of a health
care facility that under generally accepted accounting principles is not
properly chargeable as an expense of operation and maintenance or is made to
obtain any physical plant for a facility by lease or comparable
arrangement;
(b) A
donation of a physical plant to a health care facility, if a Certificate of
Need would be required for an expenditure by the health care facility to
acquire the physical plant directly; or
(c) A transfer of a physical plant to a
facility for less than fair market value, if the transfer of the physical plant
at fair market value would be a capital expenditure.
(10) "Center for Health Care Facilities
Planning and Development" means that center in the Commission that acts as the
entry and information point for applications for Certificate of Need, requests
for an exemption from Certificate of Need review, or other health care
facility-related matters requiring action by the Commission, or its staff, as
provided in this chapter.
(11)
"Certificate of Conformance" means an approval issued by the Commission under
Health-General Article, §19-120.1, Annotated Code of Maryland, that allows
an acute general hospital to establish emergency percutaneous coronary
intervention (PCI) services or elective PCI services without a Certificate of
Need.
(12) "Certificate of Need" or
"CON" means a certification of public need issued by the Commission under
Health-General Article, Title 19, Subtitle 1, Annotated Code of
Maryland.
(13) "Certificate of
Ongoing Performance" means an approval issued by the Commission that the
cardiac surgery services, emergency PCI services, or elective PCI services
provided by an acute general hospital meet standards evidencing continued
quality under Health-General Article, §19-120.1, Annotated Code of
Maryland.
(14) "Commission" means
the Maryland Health Care Commission.
(15) "Comparable" when used to determine
whether two or more CON applications are subject to comparative review means
that the proposed projects are in the same health planning region and involve
the addition or expansion of at least one of the same medical
services.
(16) "Comparative review"
means a review in which two or more comparable CON applications are reviewed
together and ranked based on each application's satisfaction of the CON review
criteria because the most recently published need projections do not support
the implementation of all comparable projects.
(17) "CON-approved service" means any health
care service for which a CON was obtained, including:
(a) Medical services;
(b) Cardiac surgery services;
(c) Organ transplant services;
(d) Burn treatment services; and
(e) Neonatal intensive care
services.
(18)
"Consolidation" means the reconfiguration of two or more health care facilities
within a merged asset system such that:
(a)
The health care facilities in the merged asset system are combined and the
total number of health care facilities of the merged asset system is reduced;
or
(b) The medical services or bed
capacity are reallocated among two or more health care facilities of the merged
asset system.
(19)
"Contested review" means a review in which a person has been recognized as an
interested party.
(20) "Department"
means the Maryland Department of Health.
(21) "Determination of coverage" means the
written determination in accordance with Regulation .14A of this chapter
whether CON or other Commission review is required for a project.
(22) "Executive Director" means the person
appointed chief administrative officer of the Commission in accordance with
Health-General Article, §19-106, Annotated Code of Maryland.
(23) "Existing health care facility" means a
health care facility that is licensed by the Department.
(24) "Freestanding medical facility" has the
meaning stated in Health-General Article, §19-3A-01, Annotated Code of
Maryland.
(25) "General hospice
care program" has the meaning stated in Health-General Article, §19-901,
Annotated Code of Maryland.
(26)
Health Care Facility.
(a) "Health care
facility" means:
(i) A hospital, as defined
in Health-General Article, §19-301, Annotated Code of Maryland;
(ii) A limited service hospital, as defined
in Health-General Article, §19-301, Annotated Code of Maryland;
(iii) A related institution, as defined in
Health-General Article, §19-301, Annotated Code of Maryland;
(iv) An ambulatory surgical
facility;
(v) An inpatient facility
that is organized primarily to help in the rehabilitation of disabled
individuals, through an integrated program of medical and other services
provided under competent professional supervision;
(vi) A home health agency, as defined in
Health-General Article, §19-401, Annotated Code of Maryland;
(vii) A hospice, as defined in Health-General
Article, §19-901, Annotated Code of Maryland;
(viii) A freestanding medical facility, as
defined in Health-General Article, §19-3A-01, Annotated Code of
Maryland;
(ix) A comprehensive care
facility, except as provided by Regulation .03 of this chapter and
Health-General Article, §19-114(d)(2), Annotated Code of Maryland;
and
(x) Other health institutions,
services, or programs that may be specified as requiring a CON under State
law.
(b) "Health care
facility" does not mean:
(i) A hospital or
related institution operated, or listed and certified, by the First Church of
Christ Scientist, Boston, Massachusetts;
(ii) A kidney disease treatment facility, or
the kidney disease treatment stations and services provided by or on behalf of
a hospital, if the facility or the services do not include kidney transplant
services or programs; or
(iii) The
office of one or more individuals licensed to practice dentistry under Health
Occupations Article, Title 4, Annotated Code of Maryland, for the purposes of
practicing dentistry.
(27) "Health care project" means a health
care project requiring a Certificate of Need as set forth in Regulation .02 of
this chapter.
(28) "Health care
services" means clinically-related patient services, including medical
services.
(29) "Health maintenance
organization" or "HMO" means a health maintenance organization under
Health-General Article, §19-701, Annotated Code of Maryland.
(30) "Health planning region" means the area
used for regulation of a particular service as provided in the State Health
Plan.
(31) "Holder" means the
applicant or applicants to whom the Commission awarded a Certificate of Need,
an exemption from Certificate of Need, or other Commission approval for a
project that has not received first use approval or, if necessary, a license
from the Department for that project.
(32) Home Health Agency.
(a) "Home health agency" has the meaning
stated in Health-General Article, §19-401(b), Annotated Code of
Maryland.
(b) "Home health agency"
includes a parent home health agency, as defined by the Centers for Medicare
and Medicaid Services under 42 CFR § 484.2.
(33) "Hospital capital threshold"
has the meaning stated in Health-General Article, §19-120(a)(4), Annotated
Code of Maryland.
(34) "Initiation
of construction" means:
(a) For a new health
care facility or expansion of an existing health care facility, that an
approved project has:
(i) Obtained all permits
and approvals considered necessary by applicable federal, State, and local
authorities to initiate construction;
(ii) Completed all necessary preconstruction
site work; and
(iii) Started the
installation of the foundation system with placement of permanent components
such as reinforcing steel, concrete, and piles; and
(b) For the renovation of an existing health
care facility, that an approved project has:
(i) Obtained all permits and approvals
considered necessary by applicable federal, State, and local authorities to
initiate renovation; and
(ii)
Started the demolition or relocation of affected services necessary to
undertake the renovation project.
(35) "Interested party" means a person
recognized by a reviewer as an interested party, including:
(a) Any applicant who has submitted a
competing application in a comparative review;
(b) The staff of the Commission;
(c) A local health department in the
jurisdiction or, in the case of regional services, in the planning region, in
which the proposed facility or service is to be offered;
(d) In the review of a replacement acute
general hospital project proposed by or on behalf of a regional health system
that serves multiple contiguous jurisdictions, a jurisdiction within the region
served by the regional health system that does not contain the proposed
replacement acute general hospital project; and
(e) A person who has demonstrated to the
reviewer that it meets the definition of adversely affected by the approval of
a proposed project.
(36)
"Intermediate care" means:
(a) A planned
regimen of 24-hour professional directed evaluation, observation, medical
monitoring, and addiction treatment in an inpatient setting for individuals
with substance abuse disorder, including American Society of Addiction Medicine
(ASAM) Level 3.7 medically monitored intensive inpatient services;
and
(b) Residential care,
treatment, or custody of individuals with intellectual disability or persons
with related conditions.
(37) "Jurisdiction" means the 23 counties of
Maryland and Baltimore City.
(38)
Licensed Bed Capacity.
(a) "Licensed bed
capacity" means the number of health care facility beds in any of the medical
service categories or subcategories, as they appear in the Commission's
inventories of licensed service capacity.
(b) "Licensed bed capacity" for acute general
hospitals:
(i) Means the capacity authorized
by the Secretary under Health-General Article, §19-307.2, Annotated Code
of Maryland;
(ii) Does not mean the
number of holding beds to support hospital emergency services, bassinets, beds
dedicated to observation of patients, an outpatient service, or recovery beds
to support ambulatory surgical services.
(39) "Limited service hospital" means a
health care facility that:
(a) Is licensed as
a hospital;
(b) Changes the type or
scope of health care services offered by eliminating the facility's capability
to admit or retain patients for overnight hospitalization;
(c) Retains an emergency or urgent care
center; and
(d) Complies with the
regulations adopted by the Secretary under Health-General Article,
§19-307.1, Annotated Code of Maryland.
(40) "Local health department" means the
health department in a jurisdiction or a body designated by that jurisdiction
to perform health planning functions.
(41) "Long-term significant relationship"
means a relationship characterized by mutual economic dependence, demonstrated
by evidence such as a joint lease or mortgage or power of attorney, and
evidence of common legal residence shown by driver's licenses, voter
registration, or other identification.
(42) "Maryland Health Care Commission" means
the agency established by Health-General Article, Title 19, Subtitle 1,
Annotated Code of Maryland.
(43)
"Medical service" means:
(a) Any of the
following categories of health care services as they appear in the Commission's
inventories of service capacity:
(i)
Medical/surgical/gynecological/addictions;
(ii) Obstetrics;
(iii) Pediatrics;
(iv) Psychiatry;
(v) Rehabilitation;
(vi) Chronic care;
(vii) Comprehensive care;
(viii) Extended care;
(ix) Intermediate care; or
(x) Residential treatment center care;
or
(b) A subcategory of
the rehabilitation, psychiatry, comprehensive care, or intermediate care
categories of medical services for which the State Health Plan provides a need
projection methodology or specific standards.
(44) "Merged asset system" means an
organization comprised of one or more regulated health care facilities under
common ownership or control.
(45)
"Merger" means the union of two or more health care facilities by the transfer
of all the property of one or more of them to one of them, which continues in
existence, the others being merged therein.
(46) "Multiphased plan of construction" means
a plan of construction for an addition, replacement, modernization, relocation,
or conversion of an existing health care facility that involves distinct
elements of construction, demolition, or renovation that require sequential
implementation such that one element can be initiated before subsequent
elements of the overall project can be initiated.
(47) "Operating room" means a sterile room in
a surgical suite that meets the requirements of a restricted area and is
designated and equipped for performing surgical operations or other invasive
procedures that require an aseptic field.
(48) "Other Commission approval" means
approval of a Certificate of Conformance, Certificate of Ongoing Performance,
or an exemption from CON review.
(49) "Partial closing" or "partial closure"
means the closure or decommission of one or more but not all CON-approved
services offered by a health care facility.
(50) "Participating entity" means a person
recognized by the Executive Director as a participating entity and may include:
(a) A third-party payor including:
(i) An insurer or nonprofit health service
plan that holds a certificate of authority and provides health insurance
policies or contracts in Maryland;
(ii) A health maintenance organization that
holds a certificate of authority in Maryland;
(iii) A union that is providing a health plan
to union members on behalf of an employer in a jurisdiction in which the
proposed project will be located or from which an existing health care facility
seeks to relocate;
(iv) A pharmacy
benefit manager; and
(v) A
self-insured employer offering health benefits through the Employer Retirement
Insurance Security Act of 1974;
(b) A municipality where the proposed project
will be located or from which an existing health care facility seeks to
relocate; or
(c) In the case of a
hospital project, a local health department in a jurisdiction that borders a
jurisdiction in which a proposed facility or service will be located.
(51) "Person" includes an
individual, receiver, trustee, guardian, executor, administrator, fiduciary, or
representative of any kind and any partnership, firm, association, limited
liability company, limited liability partnership, public or private
corporation, or other entity.
(52)
Personal Physician.
(a) "Personal physician"
means a physician licensed to practice medicine who:
(i) Was chosen by an individual;
(ii) Has an established physician-patient
relationship with the individual; and
(iii) Has provided health care services to
the individual.
(b)
"Personal physician" does not mean an owner of, an employee of, a person under
contract with, or a person who has a material financial interest in a
continuing care retirement community, its management company, or related
entity.
(53)
Predevelopment Costs.
(a) "Predevelopment
costs" means all costs related to the preliminary development of a project,
which include, but are not limited to, the costs of preliminary plans, studies,
surveys, architectural designs, plans, reports, application fees, legal fees,
financing fees, consulting fees, working drawings, or specifications undertaken
in preparation for the development or offering of a health care
project.
(b) "Predevelopment costs"
does not include activities routinely undertaken by a health care facility as a
part of its internal management or long-range planning process.
(54) "Primary service area" means:
(a) The Maryland postal ZIP code areas from
which the first 60 percent of a hospital's patient discharges originate during
the most recent 12-month period, where:
(i)
The discharges from each ZIP code area are ordered from largest to smallest
number of discharges; and
(ii) Two
or more ZIP code areas having the same numbers of discharges are ordered from
the largest to smallest based on the percentage of the hospital's discharges
originating from the ZIP code area in the most recent 12-month
period;
(b) Point ZIP
codes physically within any of the ZIP code areas designated in §B(54) of
this regulation;
(c) Maryland ZIP
code areas physically contiguous to any of the ZIP codes designated in
§B(54) of this regulation that provided 50 percent or more of their
discharges to the hospital in the most recent 12-month period; and
(d) For a merged asset system, the ZIP code
areas that are tabulated separately for each hospital, and all ZIP code areas
identified for each hospital which are included in the primary service area of
the merged asset system.
(55) Public Obligation.
(a) "Public obligation" means a bond, note,
evidence of indebtedness, or other obligation to repay borrowed money issued
by:
(i) The Maryland Health and Higher
Educational Facilities Authority;
(ii) The State, or any agency,
instrumentality, or public corporation of the State;
(iii) A governmental entity described in
Local Government Article, §19-205(a),
Annotated Code of Maryland;
(iv)
The Mayor and City Council of Baltimore; or
(v) A municipal corporation.
(b) "Public obligation" does not
include an obligation, or portion of an obligation, if:
(i) The principal of and interest on the
obligation or the portion of the obligation is insured by an effective
municipal bond insurance policy and issued on behalf of a hospital that
voluntarily closed in accordance with Health-General Article, §19-120(l);
and
(ii) The proceeds of the
obligation or the portion of the obligation are used to finance wholly or
partly a facility or part of a facility that is used primarily to provide
outpatient services at a location other than the hospital or that is used
primarily by physicians who are not employees of the hospital to provide
services to nonhospital patients.
(56) "Regional health system" means a
hospital whose primary or secondary service area cover multiple
jurisdictions.
(57) "Rehabilitation
facility" means an inpatient facility that:
(a) Is organized for the primary purpose of
assisting in the rehabilitation of persons with disabilities through an
integrated program of medical and other services, which are provided under
competent professional supervision;
(b) Is licensed as a special rehabilitation
hospital; and
(c) Complies with the
regulations adopted by the Secretary under Health-General Article, Title 19,
Subtitle 3, Annotated Code of Maryland.
(58) "Religious order" means an incorporated,
not-for-profit organization:
(a) That is owned
or is wholly operated by an entity founded and operating for the sole purpose
of carrying out religious precepts; and
(b) Whose members have taken the vows
required by the order and have devoted their lives to religious service, to the
exclusion of lay life and activities.
(59) "Residential treatment center" has the
meaning stated in Health-General Article, §19-301(p), Annotated Code of
Maryland.
(60) "Reviewer" means one
Commissioner, appointed by the Executive Director of the Commission, who:
(a) Evaluates a Certificate of Need
application;
(b) Prepares a
proposed decision for the consideration of the full Commission; and
(c) Serves as presiding officer at an
evidentiary hearing on an application or applications, if any.
(61) "Secretary" means the
Secretary of Health.
(62) "Service
area" means the geographic area from which a health care facility or provider
draws its patients. Unless otherwise specified in a relevant State Health Plan
chapter, service area means the zip code areas from which the greatest number
of patients reside, which, when ordered from largest to smallest, comprise the
top 85 percent of patients who receive a specific service at a health care
facility for the most recent 12-month period of data available.
(63) "State Health Plan" means the State
Health Plan for Facilities and Services and its modifications or additions,
adopted by the Commission pursuant to Health-General Article, §19-118,
Annotated Code of Maryland.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
