Md. Code Regs. 10.24.01.01

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.24.01.01 - Definitions

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.

Md. Code Regs. 10.24.01.01

Regulations .01 amended effective February 4, 1976 (3:3 Md. R. 151)
Regulations .01B amended as an emergency provision effective July 1, 1978 (5:17 Md. R. 1321); adopted permanently effective December 15, 1978 (5:25 Md. R. 1855)
Regulations .01B amended effective January 25, 1980 (7:2 Md. R. 115)
Regulation .01 amended as new Regulation .01 effective November 17, 1986 (13:23 Md. R. 2480)
Regulations .01B amended as an emergency provision effective August 1, 1985 (12:17 Md. R. 1694); emergency status extended at 12:26 Md. R. 2540; emergency status reapproved effective April 4, 1987 (13:9 Md. R. 1021); emergency status extended at 13:14 Md. R. 1629 and 13:20 Md. R. 2206 (Emergency provisions are temporary and not printed in COMAR)
Regulations .01B amended as an emergency provision and .03F adopted as an emergency provision effective February 28, 1986 (13:6 Md. R. 669) (Emergency provisions are temporary and not printed in COMAR)
Regulations .01B amended as an emergency provision effective March 15, 1986 (13:8 Md. R. 890) (Emergency provisions are temporary and not printed in COMAR)
Regulations .01 adopted effective November 6, 1995 (22:22 Md. R. 1658)
Regulation .01B amended as an emergency provision effective November 9, 1995 (22:24 Md. R. 1874); amended permanently effective March 11, 1996 (23:5 Md. R. 379)
Regulation .01B amended effective August 21, 2000 (27:16 Md. R. 1523); February 5, 2001 (28:2 Md. R. 100); November 24, 2003 (30:23 Md. R. 1652); April 11, 2005 (32:7 Md. R. 680); October 23, 2006 (33:21 Md. R. 1675); April 9, 2007 (34:7 Md. R. 699)
Regulation .01B amended as an emergency provision effective January 23, 2009 (36:4 Md. R. 345); amended permanently effective April 20, 2009 (36:8 Md. R. 595); adopted effective 50:22 Md. R. 975, eff. 12/1/2023