|
Certificate of Need Related Statutes
ORS 442.015
ORS 442.025
ORS 442.315
ORS 442.325
ORS 442.342
ORS 442.344
ORS 442.347
442.015 Definitions. As used in ORS chapter 441 and this chapter, unless the context requires otherwise:
(1) "Acquire" or "acquisition" means obtaining equipment, supplies, components or facilities by any means, including purchase, capital or operating lease, rental or donation, with intention of using such equipment, supplies, components or facilities to provide health services in Oregon. When equipment or other materials are obtained outside of this state, acquisition is considered to occur when the equipment or other materials begin to be used in Oregon for the provision of health services or when such services are offered for use in Oregon.
(2) "Adjusted admission" means the sum of all inpatient admissions divided by the ratio of inpatient revenues to total patient revenues.
(3) "Affected persons" has the same meaning as given to "party" in ORS 183.310.
(4) "Ambulatory surgical center" means a facility that performs outpatient surgery not routinely or customarily performed in a physician's or dentist's office, and is able to meet health facility licensure requirements.
(5) "Audited actual experience" means data contained within financial statements examined by an independent, certified public accountant in accordance with generally accepted auditing standards.
(6) "Budget" means the projections by the hospital for a specified future time period of expenditures and revenues with supporting statistical indicators.
(7) "Case mix" means a calculated index for each hospital, based on financial accounting and case mix data collection as set forth in ORS 442.425, reflecting the relative costliness of that hospital's mix of cases compared to a state or national mix of cases.
(8) "Commission" means the Oregon Health Policy Commission.
(9) "Department" means the Department of Human Services of the State of Oregon.
(10) "Develop" means to undertake those activities that on their completion will result in the offer of a new institutional health service or the incurring of a financial obligation, as defined under applicable state law, in relation to the offering of such a health service.
(11) "Director" means the Director of Human Services.
(12) "Expenditure" or "capital expenditure" means the actual expenditure, an obligation to an expenditure, lease or similar arrangement in lieu of an expenditure, and the reasonable value of a donation or grant in lieu of an expenditure but not including any interest thereon.
(13) "Freestanding birthing center" means a facility licensed for the primary purpose of performing low risk deliveries.
(14) "Governmental unit" means the state, or any county, municipality or other political subdivision, or any related department, division, board or other agency.
(15) "Gross revenue" means the sum of daily hospital service charges, ambulatory service charges, ancillary service charges and other operating revenue. "Gross revenue" does not include contributions, donations, legacies or bequests made to a hospital without restriction by the donors.
(16)(a) "Health care facility" means a hospital, a long term care facility, an ambulatory surgical center, a freestanding birthing center or an outpatient renal dialysis facility.
(b) "Health care facility" does not mean:
(A) An establishment furnishing residential care or treatment not meeting federal intermediate care standards, not following a primarily medical model of treatment, prohibited from admitting persons requiring 24-hour nursing care and licensed or approved under the rules of the Department of Human Services or the Department of Corrections; or
(B) An establishment furnishing primarily domiciliary care.
(17) "Health maintenance organization" or "HMO" means a public organization or a private organization organized under the laws of any state that:
(a) Is a qualified HMO under section 1310 (d) of the U.S. Public Health Services Act; or
(b)(A) Provides or otherwise makes available to enrolled participants health care services, including at least the following basic health care services:
(i) Usual physician services;
(ii) Hospitalization;
(iii) Laboratory;
(iv) X-ray;
(v) Emergency and preventive services; and
(vi) Out-of-area coverage;
(B) Is compensated, except for copayments, for the provision of the basic health care services listed in subparagraph (A) of this paragraph to enrolled participants on a predetermined periodic rate basis; and
(C) Provides physicians' services primarily directly through physicians who are either employees or partners of such organization, or through arrangements with individual physicians or one or more groups of physicians organized on a group practice or individual practice basis.
(18) "Health services" means clinically related diagnostic, treatment or rehabilitative services, and includes alcohol, drug or controlled substance abuse and mental health services that may be provided either directly or indirectly on an inpatient or ambulatory patient basis.
(19) "Hospital" means a facility with an organized medical staff, with permanent facilities that include inpatient beds and with medical services, including physician services and continuous nursing services under the supervision of registered nurses, to provide diagnosis and medical or surgical treatment primarily for but not limited to acutely ill patients and accident victims, to provide treatment for the mentally ill or to provide treatment in special inpatient care facilities.
(20) "Institutional health services" means health services provided in or through health care facilities and includes the entities in or through which such services are provided.
(21) "Intermediate care facility" means a facility that provides, on a regular basis, health-related care and services to individuals who do not require the degree of care and treatment that a hospital or skilled nursing facility is designed to provide, but who because of their mental or physical condition require care and services above the level of room and board that can be made available to them only through institutional facilities.
(22) "Long term care facility" means a facility with permanent facilities that include inpatient beds, providing medical services, including nursing services but excluding surgical procedures except as may be permitted by the rules of the director, to provide treatment for two or more unrelated patients. "Long term care facility" includes skilled nursing facilities and intermediate care facilities but may not be construed to include facilities licensed and operated pursuant to ORS 443.400 to 443.455.
(23) "Major medical equipment" means medical equipment that is used to provide medical and other health services and that costs more than $1 million. "Major medical equipment" does not include medical equipment acquired by or on behalf of a clinical laboratory to provide clinical laboratory services, if the clinical laboratory is independent of a physician's office and a hospital and has been determined under Title XVIII of the Social Security Act to meet the requirements of paragraphs (10) and (11) of section 1861(s) of that Act.
(24) "Net revenue" means gross revenue minus deductions from revenue.
(25) "New hospital" means a facility that did not offer hospital services on a regular basis within its service area within the prior 12-month period and is initiating or proposing to initiate such services. "New hospital" also includes any replacement of an existing hospital that involves a substantial increase or change in the services offered.
(26) "New skilled nursing or intermediate care service or facility" means a service or facility that did not offer long term care services on a regular basis by or through the facility within the prior 12-month period and is initiating or proposing to initiate such services. "New skilled nursing or intermediate care service or facility" also includes the rebuilding of a long term care facility, the relocation of buildings that are a part of a long term care facility, the relocation of long term care beds from one facility to another or an increase in the number of beds of more than 10 or 10 percent of the bed capacity, whichever is the lesser, within a two-year period.
(27) "Offer" means that the health care facility holds itself out as capable of providing, or as having the means for the provision of, specified health services.
(28) "Operating expenses" means the sum of daily hospital service expenses, ambulatory service expenses, ancillary expenses and other operating expenses, excluding income taxes.
(29) "Outpatient renal dialysis facility" means a facility that provides renal dialysis services directly to outpatients.
(30) "Person" means an individual, a trust or estate, a partnership, a corporation (including associations, joint stock companies and insurance companies), a state, or a political subdivision or instrumentality, including a municipal corporation, of a state.
(31) "Skilled nursing facility" means a facility or a distinct part of a facility, that is primarily engaged in providing to inpatients skilled nursing care and related services for patients who require medical or nursing care, or an institution that provides rehabilitation services for the rehabilitation of injured, disabled or sick persons.
(32) "Special inpatient care facility" means a facility with permanent inpatient beds and other facilities designed and utilized for special health care purposes, including but not limited to a rehabilitation center, a college infirmary, a chiropractic facility, a facility for the treatment of alcoholism or drug abuse, an inpatient care facility meeting the requirements of ORS 441.065, and any other establishment falling within a classification established by the Department of Human Services, after determination of the need for such classification and the level and kind of health care appropriate for such classification.
(33) "Total deductions from gross revenue" or "deductions from revenue" means reductions from gross revenue resulting from inability to collect payment of charges. Such reductions include bad debts, contractual adjustments, uncompensated care, administrative, courtesy and policy discounts and adjustments and other such revenue deductions. The deduction shall be net of the offset of restricted donations and grants for indigent care. [1977 c.751 §1; 1979 c.697 §2; 1979 c.744 §31; 1981 c.693 §1; 1983 c.482 §1; 1985 c.747 §16; 1987 c.320 §233; 1987 c.660 §4; 1987 c.753 §2; 1989 c.708 §5; 1989 c.1034 §5; 1991 c.470 §9; 2001 c.100 §1; 2001 c.104 §181a; 2001 c.900 §179; 2003 c.75 §91; 2003 c.784 §11; 2005 c.22 §300]
442.025 Findings and policy. (1) The Legislative Assembly finds that the achievement of reasonable access to quality health care at a reasonable cost is a priority of the State of Oregon.
(2) Problems preventing the priority in subsection (1) of this section from being attained include:
(a) The inability of many citizens to pay for necessary health care, being covered neither by private insurance nor by publicly funded programs such as Medicare and Medicaid;
(b) Rising costs of medical care which exceed substantially the general rate of inflation;
(c) Insufficient price competition in the delivery of health care services that would provide a greater cost consciousness among providers, payers and consumers;
(d) Inadequate incentives for the use of less costly and more appropriate alternative levels of health care;
(e) Insufficient or inappropriate use of existing capacity, duplicated services and failure to use less costly alternatives in meeting significant health needs; and
(f) Insufficient primary and emergency medical care services in medically underserved areas of the state.
(3) As a result of rising health care costs and the concern expressed by health care providers, health care users, third-party payers and the general public, there is an urgent need to abate these rising costs so as to place the cost of health care within reach of all Oregonians without affecting the quality of care.
(4) To foster the cooperation of the separate industry forces, there is a need to compile and disseminate accurate and current data, including but not limited to price and utilization data, to meet the needs of the people of Oregon and improve the appropriate usage of health care services.
(5) It is the purpose of this chapter to establish area-wide and state planning for health services, staff and facilities in light of the findings of subsection (1) of this section and in furtherance of health planning policies of this state.
(6) It is further declared that hospital costs should be contained through improved competition between hospitals and improved competition between insurers and through financial incentives on behalf of providers, insurers and consumers to contain costs. As a safety net, it is the intent of the Legislative Assembly to monitor hospital performance. [1977 c.751 §2; 1981 c.693 §2; 1983 c.482 §2; 1985 c.747 §1; 1987 c.660 §3]
442.315 Certificate of need; rules; fees; enforcement; exceptions; letter of intent. (1) Any new hospital or new skilled nursing or intermediate care service or facility not excluded pursuant to ORS 441.065 shall obtain a certificate of need from the Department of Human Services prior to an offering or development.
(2) The department shall adopt rules specifying criteria and procedures for making decisions as to the need for the new services or facilities.
(3)(a) An applicant for a certificate of need shall apply to the department on forms provided for this purpose by department rule.
(b) An applicant shall pay a fee prescribed as provided in this section. Subject to the approval of the Oregon Department of Administrative Services, the Department of Human Services shall prescribe application fees, based on the complexity and scope of the proposed project.
(4) The Department of Human Services shall be the decision-making authority for the purpose of certificates of need.
(5)(a) An applicant or any affected person who is dissatisfied with the proposed decision of the department is entitled to an informal hearing in the course of review and before a final decision is rendered.
(b) Following a final decision being rendered by the department, an applicant or any affected person may request a reconsideration hearing pursuant to ORS chapter 183.
(c) In any proceeding brought by an affected person or an applicant challenging a department decision under this subsection, the department shall follow procedures consistent with the provisions of ORS chapter 183 relating to a contested case.
(6) Once a certificate of need has been issued, it may not be revoked or rescinded unless it was acquired by fraud or deceit. However, if the department finds that a person is offering or developing a project that is not within the scope of the certificate of need, the department may limit the project as specified in the issued certificate of need or reconsider the application. A certificate of need is not transferable.
(7) Nothing in this section applies to any hospital, skilled nursing or intermediate care service or facility that seeks to replace equipment with equipment of similar basic technological function or an upgrade that improves the quality or cost-effectiveness of the service provided. Any person acquiring such replacement or upgrade shall file a letter of intent for the project in accordance with the rules of the department if the price of the replacement equipment or upgrade exceeds $1 million.
(8) Except as required in subsection (1) of this section for a new hospital or new skilled nursing or intermediate care service or facility not operating as a Medicare swing bed program, nothing in this section requires a rural hospital as defined in ORS 442.470 (5)(a)(A) and (B) to obtain a certificate of need.
(9) Nothing in this section applies to basic health services, but basic health services do not include:
(a) Magnetic resonance imaging scanners;
(b) Positron emission tomography scanners;
(c) Cardiac catheterization equipment;
(d) Megavoltage radiation therapy equipment;
(e) Extracorporeal shock wave lithotriptors;
(f) Neonatal intensive care;
(g) Burn care;
(h) Trauma care;
(i) Inpatient psychiatric services;
(j) Inpatient chemical dependency services;
(k) Inpatient rehabilitation services;
(L) Open heart surgery; or
(m) Organ transplant services.
(10) In addition to any other remedy provided by law, whenever it appears that any person is engaged in, or is about to engage in, any acts that constitute a violation of this section, or any rule or order issued by the department under this section, the department may institute proceedings in the circuit courts to enforce obedience to such statute, rule or order by injunction or by other processes, mandatory or otherwise.
(11) As used in this section, "basic health services" means health services offered in or through a hospital licensed under ORS chapter 441, except skilled nursing or intermediate care nursing facilities or services and those services specified in subsection (9) of this section. [1989 c.1034 §2; 1993 c.722 §3; 1995 c.727 §39; 2001 c.875 §3; 2003 c.14 §258]
442.325 Certificate for health care facility of health maintenance organization; exempt activities; policy relating to health maintenance organizations. (1) A certificate of need shall be required for the development or establishment of a health care facility of any new health maintenance organization.
(2) Any activity of a health maintenance organization which does not involve the direct delivery of health services, as distinguished from arrangements for indirect delivery of health services through contracts with providers, shall be exempt from certificate of need review.
(3) Nothing in ORS 244.050, 431.250, 441.015 to 441.087, 442.015 to 442.420 and 442.450 applies to any decision of a health maintenance organization involving its organizational structure, its arrangements for financing health services, the terms of its contracts with enrolled beneficiaries or its scope of benefits.
(4) With the exception of certificate of need requirements, when applicable, the licensing and regulation of health maintenance organizations shall be controlled by ORS 750.005 to 750.095 and statutes incorporated by reference therein.
(5) It is the policy of ORS 244.050, 431.250, 441.015 to 441.087, 442.015 to 442.420 and 442.450 to encourage the growth of health maintenance organizations as an alternative delivery system and to provide the facilities for the provision of quality health care to the present and future members who may enroll within their defined service area.
(6)(a) It is also the policy of ORS 244.050, 431.250, 441.015 to 441.087, 442.015 to 442.420 and 442.450 to consider the special needs and circumstances of health maintenance organizations. Such needs and circumstances include the needs of and costs to members and projected members of the health maintenance organization in obtaining health services and the potential for a reduction in the use of inpatient care in the community through an extension of preventive health services and the provision of more systematic and comprehensive health services. The consideration of a new health service proposed by a health maintenance organization shall also address the availability and cost of obtaining the proposed new health service from the existing providers in the area that are not health maintenance organizations.
(b) The Department of Human Services shall issue a certificate of need for beds, services or equipment to meet the needs or reasonably anticipated needs of members of health maintenance organizations when beds, services or equipment are not available from nonplan providers. [1977 c.751 §56; 1981 c.693 §11; 1995 c.727 §40; 1999 c.581 §9]
442.342 Waiver of requirements; rules; penalties. (1) Notwithstanding any other provision of law, a hospital licensed under ORS 441.025, in accordance with rules adopted by the Department of Human Services, may apply for waiver from the provisions of ORS 442.325 and section 9, chapter 1034, Oregon Laws 1989, and the department shall grant such waiver if, for the most recently completed hospital fiscal year preceding the date of application for waiver and each succeeding fiscal year thereafter, the percentage of qualified inpatient revenue is not less than that described in subsection (2) of this section.
(2)(a) The percentage of qualified inpatient revenue for the first year in which a hospital is granted a waiver under subsection (1) of this section shall not be less than 60 percent.
(b) The percentage in paragraph (a) of this subsection shall be increased by five percentage points in each succeeding hospital fiscal year until the percentage of qualified inpatient revenue equals or exceeds 75 percent.
(3) As used in this section:
(a) "Qualified inpatient revenue" means revenue earned from public and private payers for inpatient hospital services approved by the department pursuant to rules, including:
(A) Revenue earned pursuant to Title XVIII, United States Social Security Act, when such revenue is based on diagnostic related group prices which include capital-related expenses or other risk-based payment programs as approved by the department;
(B) Revenue earned pursuant to Title XIX, United States Social Security Act, when such revenue is based on diagnostic related group prices which include capital-related expenses;
(C) Revenue earned under negotiated arrangements with public or private payers based on all-inclusive per diem rates for one or more hospital service categories;
(D) Revenue earned under negotiated arrangements with public or private payers based on all-inclusive per discharge or per admission rates related to diagnostic related groups or other service or intensity-related measures;
(E) Revenue earned under arrangements with one or more health maintenance organizations; or
(F) Other prospectively determined forms of inpatient hospital reimbursement approved in advance by the department in accordance with rules.
(b) "Percentage of qualified inpatient revenue" means qualified inpatient revenue divided by total gross inpatient revenue as defined by administrative rule of the department.
(4)(a) The department shall hold a hearing to determine the cause if any hospital granted a waiver pursuant to subsection (1) of this section fails to reach the applicable percentage of qualified inpatient revenue in any subsequent fiscal year of the hospital.
(b) If the department finds that the failure was without just cause and that the hospital has undertaken projects that, except for the provisions of this section would have been subject to ORS 442.325 or section 9, chapter 1034, Oregon Laws 1989, the department shall impose one of the penalties outlined in paragraph (c) of this subsection.
(c)(A) A one-time civil penalty of not less than $25,000 or more than $250,000; or
(B) An annual civil penalty equal to an amount not to exceed 110 percent of the net profit derived from such project or projects for a period not to exceed five years.
(5) Nothing in this section shall be construed to permit a hospital to develop a new inpatient hospital facility or provide new services authorized by facilities defined as "long term care facility" under ORS 442.015 under a waiver granted pursuant to subsection (1) of this section. [1985 c.747 §35; 1987 c.660 §9; 1991 c.470 §18; 1995 c.727 §41]
Note: 442.342 was enacted into law by the Legislative Assembly and added to or made a part of ORS chapter 442 by legislative action but not to any series therein. See Preface to Oregon Revised Statutes for further explanation.
442.344 Exemptions from requirements. In furtherance of the purpose and intent of the Legislative Assembly as expressed in ORS 442.025 to achieve reasonable access to quality health care at a reasonable cost, the requirements of ORS 442.325 shall not apply to ambulatory surgical centers performing only ophthalmic surgery. [1987 c.723 §1]
Note: 442.344 was enacted into law by the Legislative Assembly but was not added to or made a part of ORS chapter 442 or any series therein by legislative action. See Preface to Oregon Revised Statutes for further explanation.
442.347 Rural hospital required to report certain actions. A rural hospital exempted from the certificate of need requirement by ORS 442.315 (8) shall report any action taken by the hospital that would have required a certificate of need if the exemption did not exist. [1993 c.722 §4]
Note: 442.347 was enacted into law by the Legislative Assembly but was not added to or made a part of ORS chapter 442 or any series therein by legislative action. See Preface to Oregon Revised Statutes for further explanation.
|
