CHAPTER 3702: HOSPITAL CARE ASSURANCE PROGRAM; CERTIFICATES OF NEED

Effective Date: 09-29-1995

Effective Date: 07-26-1991

Effective Date: 09-29-1995

Effective Date: 07-26-191

The director of health shall adopt rules establishing safety standards and quality-of-care standards for each of the following:

(A) Solid organ and bone marrow transplantation;

(B) Stem cell harvesting and reinfusion;

(C) Cardiac catheterization;

(D) Open-heart surgery;

(E) Obstetric and newborn care;

(F) Pediatric intensive care;

(G) Operation of linear accelerators;

(H) Operation of cobalt radiation therapy units;

(I) Operation of gamma knives.

Effective Date: 04-20-1995; 11-13-2006

Initial rules for each activity specified in section 3702.11 of the Revised Code and for each facility listed in division (A)(4) of section 3702.30 of the Revised Code shall be adopted using the procedure prescribed by this section.

The director of health shall file proposed rules in accordance with section 119.03 of the Revised Code. If, prior to expiration of the time for legislative review and invalidation under division (I) of that section, the joint committee on agency rule review recommends the adoption of a concurrent resolution invalidating a proposed rule, the director shall withdraw the proposed rule, revise it, and refile it as if it were a newly proposed rule; the director shall not file the proposed rule in final form. A proposed rule that the director refiles following a recommendation for a concurrent resolution of invalidation shall be treated, for purposes of determining the time for legislative review and invalidation under section 119.03 of the Revised Code, as if it were a newly proposed rule. If, after filing the revised proposed rule, the joint committee again recommends the adoption of a concurrent resolution of invalidation, the director shall file the revised proposed rule in final form in accordance with section 111.15 of the Revised Code, and the rule shall take effect in accordance with that section.

If, prior to expiration of the time for legislative review and invalidation, the joint committee does not recommend the adoption of a concurrent resolution invalidating a proposed rule or revised proposed rule filed in accordance with section 119.03 of the Revised Code, the director shall file the rule in final form in accordance with section 119.04 of the Revised Code, and the rule shall take effect in accordance with that section.

Initial rules adopted for each activity specified in section 3702.11 of the Revised Code shall include rules pertaining to all of the matters required by section 3702.16 of the Revised Code.

Initial rules shall not be adopted as emergency rules.

Effective Date: 06-30-1995

After the adoption, in accordance with section 3702.12 of the Revised Code, of initial rules applicable to an activity specified in section 3702.11 of the Revised Code or a facility listed in division (A)(4) of section 3702.30 of the Revised Code, any amendments to the rules applicable to that activity or facility, including enactment of new rules or amendments or rescissions of existing rules, shall be adopted in accordance with Chapter 119. of the Revised Code.

Effective Date: 06-30-1995

No person or government entity shall fail to comply with any rule adopted under section 3702.11 of the Revised Code.

Effective Date: 04-20-1995

(A) As used in this section:

(1) ” Existing health care facility” means a health care facility that is licensed or otherwise approved to practice in this state, in accordance with applicable law, is staffed and equipped to provide health care services, and actively provides health services or has not been actively providing health services for less than twelve consecutive months.

(2) “Health care facility” and “health service” have the same meanings as in section 3702.51 of the Revised Code.

(B) Section 3702.14 of the Revised Code shall not be construed to require any existing health care facility that is conducting an activity specified in section 3702.11 of the Revised Code, which activity was initiated on or before March 20, 1997, to alter, upgrade, or otherwise improve the structure or fixtures of the facility in order to comply with any rule adopted under section 3702.11 of the Revised Code relating to that activity, unless one of the following applies:

(1) The facility initiates a construction, renovation, or reconstruction project that involves a capital expenditure of at least fifty thousand dollars, not including expenditures for equipment or staffing or operational costs, and that directly involves the area in which the existing service is conducted.

(2) The facility initiates another activity specified in section 3702.11 of the Revised Code.

(3) The facility initiates a service level designation change for obstetric and newborn care.

(4) The facility proposes to add a cardiac catheterization laboratory to an existing cardiac catheterization service.

(5) The facility proposes to add an open-heart operating room to an existing open-heart surgery service.

(6) The director of health determines, by clear and convincing evidence, that failure to comply with the rule would create an imminent risk to the health and welfare of any patient.

(C) If division (B)(4) or (5) of this section applies, any alteration, upgrade, or other improvement required shall apply only to the proposed addition to the existing service if the cost of the addition is less than the capital expenditure threshold set forth in division (B)(1) of this section.

(D) No person or government entity shall divide or otherwise segment a construction, renovation, or reconstruction project in order to evade application of the capital expenditure threshold set forth in division (B)(1) of this section.

Effective Date: 03-22-1999; 06-30-2005

The director of health shall monitor health care providers for compliance with the safety and quality-of-care standards established in the rules adopted under section 3702.11 of the Revised Code. The director may inspect any health care provider as the director determines adequate to monitor compliance. The rules may require health care providers regularly to issue reports and undergo independent audits.

Effective Date: 04-20-1995

The rules adopted under section 3702.11 of the Revised Code at a minimum shall specify the following:

(A) A procedure that the director of health shall follow to update and revise safety and quality-of-care standards to account for technological advances;

(B) The responsibilities of the department of health and of health care providers with respect to monitoring and enforcing compliance with the safety and quality-of-care standards established by the rules;

(C) A scale for determining the amount of penalties to be imposed under section 3702.20 of the Revised Code based on the severity of the violation.

Effective Date: 04-20-1995; 11-13-2006

Effective Date: 09-05-2001

The director of health and any employee or contractor of the department of health shall not make public any quality-of-care data reported to the department pursuant to rules adopted under section 3702.11 of the Revised Code, as that section existed immediately prior to the effective date of this amendment, or any record copied under section 3702.19 of the Revised Code, that identifies or would tend to identify specific patients.

The director and any employee or contractor of the department shall not make public any data reported to the department pursuant to rules adopted under section 3702.11 of the Revised Code, as that section existed immediately prior to the effective date of this amendment, that require reports on specific adverse events, bodily injuries, or complaints.

Effective Date: 03-13-1997; 11-13-2006

In investigating possible violations of section 3702.14 of the Revised Code, or in conducting hearings under section 3702.20 of the Revised Code, the director of health may administer oaths, order the taking of depositions, and issue subpoenas compelling attendance of witnesses or production of documents. The subpoenas shall be served in the same manner as subpoenas and subpoenas duces tecum issued for a trial of a civil action in a court of common pleas. If a person served a subpoena fails to attend a hearing or produce documents or refuses to be sworn or to answer any question, the director may apply to the court of common pleas of the county in which the person resides, or the county in which the hearing under section 3702.20 of the Revised Code is conducted, for a contempt order, as in the case of a failure of a person who is served a subpoena issued by the court to attend or produce documents or a refusal of such person to testify.

Effective Date: 04-20-1995

If the director of health determines that a person has violated section 3702.14 of the Revised Code, the director, after affording the person an opportunity for a hearing conducted in accordance with Chapter 119. of the Revised Code, shall impose a civil penalty of not less than one thousand dollars and not more than two hundred fifty thousand dollars on the person. In addition to the civil penalty, for a second or subsequent violation of section 3702.14 of the Revised Code, or for a first violation that the director determines has caused or poses an imminent threat of serious physical or life-threatening danger, the director, after affording the person an opportunity for a hearing conducted in accordance with Chapter 119. of the Revised Code, may issue an order that the person cease operating the health service. If a person issued such an order continues to operate the health service, the attorney general may apply to the court of common pleas of the county in which the person is located for an order enjoining the person from operating the service. The court shall grant the order on a showing that the person is operating the service.

Civil penalties collected under this section shall be deposited in the general operations fund created by section 3701.83 of the Revised Code and shall be used solely to administer and enforce the rules adopted under section 3702.11 of the Revised Code.

Effective Date: 04-20-1995

(A) As used in this section:

(1) “Ambulatory surgical facility” means a facility, whether or not part of the same organization as a hospital, that is located in a building distinct from another in which inpatient care is provided, and to which any of the following apply:

(a) Outpatient surgery is routinely performed in the facility, and the facility functions separately from a hospital’s inpatient surgical service and from the offices of private physicians, podiatrists, and dentists.

(b) Anesthesia is administered in the facility by an anesthesiologist or certified registered nurse anesthetist, and the facility functions separately from a hospital’s inpatient surgical service and from the offices of private physicians, podiatrists, and dentists.

(c) The facility applies to be certified by the United States centers for medicare and medicaid services as an ambulatory surgical center for purposes of reimbursement under Part B of the medicare program, Part B of Title XVIII of the “Social Security Act,” 79 Stat. 286 (1965), 42 U.S.C.A. 1395, as amended.

(d) The facility applies to be certified by a national accrediting body approved by the centers for medicare and medicaid services for purposes of deemed compliance with the conditions for participating in the medicare program as an ambulatory surgical center.

(e) The facility bills or receives from any third-party payer, governmental health care program, or other person or government entity any ambulatory surgical facility fee that is billed or paid in addition to any fee for professional services.

(f) The facility is held out to any person or government entity as an ambulatory surgical facility or similar facility by means of signage, advertising, or other promotional efforts.

“Ambulatory surgical facility” does not include a hospital emergency department.

(2) “Ambulatory surgical facility fee” means a fee for certain overhead costs associated with providing surgical services in an outpatient setting. A fee is an ambulatory surgical facility fee only if it directly or indirectly pays for costs associated with any of the following:

(a) Use of operating and recovery rooms, preparation areas, and waiting rooms and lounges for patients and relatives;

(b) Administrative functions, record keeping, housekeeping, utilities, and rent;

(c) Services provided by nurses, orderlies, technical personnel, and others involved in patient care related to providing surgery.

“Ambulatory surgical facility fee” does not include any additional payment in excess of a professional fee that is provided to encourage physicians, podiatrists, and dentists to perform certain surgical procedures in their office or their group practice’s office rather than a health care facility, if the purpose of the additional fee is to compensate for additional cost incurred in performing office-based surgery.

(3) “Governmental health care program” has the same meaning as in section 4731.65 of the Revised Code.

(4) “Health care facility” means any of the following:

(a) An ambulatory surgical facility;

(b) A freestanding dialysis center;

(c) A freestanding inpatient rehabilitation facility;

(d) A freestanding birthing center;

(e) A freestanding radiation therapy center;

(f) A freestanding or mobile diagnostic imaging center.

(5) “Third-party payer” has the same meaning as in section 3901.38 of the Revised Code.

(B) By rule adopted in accordance with sections 3702.12 and 3702.13 of the Revised Code, the director of health shall establish quality standards for health care facilities. The standards may incorporate accreditation standards or other quality standards established by any entity recognized by the director.

(C) Every ambulatory surgical facility shall require that each physician who practices at the facility comply with all relevant provisions in the Revised Code that relate to the obtaining of informed consent from a patient.

(D) The director shall issue a license to each health care facility that makes application for a license and demonstrates to the director that it meets the quality standards established by the rules adopted under division (B) of this section and satisfies the informed consent compliance requirements specified in division (C) of this section.

(E)(1) Except as provided in section 3702.301 of the Revised Code, no health care facility shall operate without a license issued under this section.

(2) If the department of health finds that a physician who practices at a health care facility is not complying with any provision of the Revised Code related to the obtaining of informed consent from a patient, the department shall report its finding to the state medical board, the physician, and the health care facility.

(3) This division does not create, and shall not be construed as creating, a new cause of action or substantive legal right against a health care facility and in favor of a patient who allegedly sustains harm as a result of the failure of the patient’s physician to obtain informed consent from the patient prior to performing a procedure on or otherwise caring for the patient in the health care facility.

(F) The rules adopted under division (B) of this section shall include all of the following:

(1) Provisions governing application for, renewal, suspension, and revocation of a license under this section;

(2) Provisions governing orders issued pursuant to section 3702.32 of the Revised Code for a health care facility to cease its operations or to prohibit certain types of services provided by a health care facility;

(3) Provisions governing the imposition under section 3702.32 of the Revised Code of civil penalties for violations of this section or the rules adopted under this section, including a scale for determining the amount of the penalties.

Effective Date: 09-17-2002; 08-17-2006

(A) Except as provided in division (C) of this section, a freestanding birthing center is not required to obtain a license under section 3702.30 of the Revised Code if all of the following are the case:

(1) A religious denomination, sect, or group owns and operates the center.

(2) Requiring that the center be licensed significantly abridges or infringes on the religious practices or beliefs of that religious denomination, sect, or group.

(3) The center provides care only during low-risk pregnancy, delivery, and the immediate postpartum period exclusively to women who are members of that religious denomination, sect, or group.

(4) The center monitors and evaluates the care provided to its patients in accordance with at least the minimum patient safety monitoring and evaluation requirements established in rules adopted under division (D) of this section.

(5) The center meets the quality assessment and improvement standards established in rules adopted under division (D) of this section.

(B) If the director determines that a freestanding birthing center is no longer exempt from the requirement to obtain a license under section 3702.30 of the Revised Code because the center ceases to comply with division (A)(4) or (5) of this section, the director may order the center to come into compliance. In the order, the director may do all of the following:

(1) Identify what the center is not in compliance with and what the center needs to do to come into compliance;

(2) Require that the center come into compliance within a period of time specified in the order;

(3) Require that the center provide the director a written notice within a period of time specified in the order that contains all of the following:

(a) Certification that the center has come into compliance;

(b) The signature of the center’s administrator or medical director and certification that the administrator or medical director, whichever signs the notice, is the center’s authorized representative;

(c) Certification that the information contained in the notice and in any accompanying documentation is true and accurate;

(d) Any other information or documentation that the director may require to verify that the center has come into compliance.

(C) If the director issues an order to a freestanding birthing center under division (B) of this section and the center fails to comply with the order within the time specified in the order, the director may issue a second order that requires the center to cease operations until the center obtains a license under section 3702.30 of the Revised Code.

(D) The director of health shall adopt rules in accordance with Chapter 119. of the Revised Code as necessary to implement this section. The rules shall establish all of the following:

(1) Minimum patient safety monitoring and evaluation requirements;

(2) Quality assessment and improvement standards;

(3) Procedures for determining whether freestanding birthing centers are in compliance with the rules.

Effective Date: 08-17-2006

(A) The quality monitoring and inspection fund is hereby created in the state treasury. The director of health shall use the fund to administer and enforce this section and sections 3702.11 to 3702.20, 3702.30, 3702.301, and 3702.32 of the Revised Code and rules adopted pursuant to those sections. The director shall deposit in the fund any moneys collected pursuant to this section or section 3702.32 of the Revised Code. All investment earnings of the fund shall be credited to the fund.

(B) The director of health shall adopt rules pursuant to Chapter 119. of the Revised Code establishing fees for both of the following:

(1) Initial and renewal license applications submitted under section 3702.30 of the Revised Code. The fees established under division (B)(1) of this section shall not exceed the actual and necessary costs of performing the activities described in division (A) of this section.

(2) Inspections conducted under section 3702.15 or 3702.30 of the Revised Code. The fees established under division (B)(2) of this section shall not exceed the actual and necessary costs incurred during an inspection, including any indirect costs incurred by the department for staff, salary, or other administrative costs. The director of health shall provide to each health care facility or provider inspected pursuant to section 3702.15 or 3702.30 of the Revised Code a written statement of the fee. The statement shall itemize and total the costs incurred. Within fifteen days after receiving a statement from the director, the facility or provider shall forward the total amount of the fee to the director.

(3) The fees described in divisions (B)(1) and (2) of this section shall meet both of the following requirements:

(a) For each service described in section 3702.11 of the Revised Code, the fee shall not exceed one thousand seven hundred fifty dollars annually, except that the total fees charged to a health care provider under this section shall not exceed five thousand dollars annually.

(b) The fee shall exclude any costs reimbursable by the United States centers for medicare and medicaid services as part of the certification process for the medicare program established under Title XVIII of the “Social Security Act,” 79 Stat. 286 (1935), 42 U.S.C.A. 1395, as amended, and the medicaid program established under Title XIX of the “Social Security Act,” 79 Stat. 286 (1965), 42 U.S.C. 1396.

(4) The director shall not establish a fee for any service for which a licensure or inspection fee is paid by the health care provider to a state agency for the same or similar licensure or inspection.

Effective Date: 06-26-2003; 08-17-2006

(A) If the director of health determines that a health care facility is operating without a license in violation of division (E)(1) of section 3702.30 of the Revised Code, the director shall do one or more of the following:

(1) Provide an opportunity for the health care facility to apply for a license within a specified time, not exceeding thirty days after the date of the facility’s receipt of the order;

(2) Issue an order that the health care facility cease its operations;

(3) Issue an order that prohibits the health care facility from performing certain types of services;

(4) Impose a civil penalty of not less than one thousand dollars and not more than two hundred fifty thousand dollars upon the health care facility for operating without a license;

(5) Impose an additional civil penalty of not less than one thousand dollars and not more than ten thousand dollars for each day that the health care facility operates without a license.

(B)(1) If a health care facility subject to an order issued under division (A)(1) of this section continues to operate, the director of health may file a petition in the court of common pleas of the county in which the health care facility is located for an injunction enjoining the facility from operating. The court shall grant an injunction upon a showing that the respondent named in the petition is operating without a license.

(2) If a health care facility subject to an order issued under division (A)(2) of this section continues to provide the types of services prohibited by the order, the director of health may file a petition in the court of common pleas of the county in which the health care facility is located for an injunction enjoining the facility from performing those types of services. The court shall grant an injunction upon a showing that the respondent named in the petition is providing the types of services prohibited by the director’s order.

(C) If, after making its reports as provided in division (E)(2) of section 3702.30 of the Revised Code, the department of health finds that a physician has continued to engage at the same health care facility in a pattern of repeating the same violation and that the health care facility has failed to take reasonable steps to ensure that the physician does not continue the same violation at the health care facility, the department may, after providing the health care facility an opportunity for a hearing pursuant to Chapter 119. of the Revised Code, impose a civil penalty on the health care facility. The penalty shall be not less than one thousand dollars and not more than fifty thousand dollars.

(D) If the director of health determines that a health care facility has violated any provision of section 3702.30 of the Revised Code, other than a violation of division (E)(1) or (2) of that section, any provision of Chapter 3701-83 of the Administrative Code, or any other rule adopted by the director of health under section 3702.30 of the Revised Code, the director may do any or all of the following:

(1) Provide an opportunity for the health care facility to correct the violation within a specified period of time;

(2) Revoke, suspend, or refuse to renew the health care facility’s license;

(3) Prior to or during the pendency of an administrative hearing under Chapter 119. of the Revised Code, issue an order that prohibits the health care facility from performing certain types of services;

(4) Provide an opportunity for the health care facility to correct the violation;

(5) Impose a civil penalty of not less than one thousand dollars and not more than two hundred fifty thousand dollars upon the health care facility for the violation;

(6) Impose an additional civil penalty of not less than five hundred dollars and not more than ten thousand dollars for each day that the health care facility fails to correct the violation.

(E) If a health care facility subject to an order issued under division (C)(2) of this section continues to provide the types of services prohibited by the order, the director of health may file a petition in the court of common pleas of the county in which the facility is located for an injunction enjoining the facility from performing those types of services. The court shall grant an injunction upon a showing that the respondent named in the petition is providing the types of services prohibited by the director’s order.

(F) The director shall deposit all moneys collected as civil penalties under this section into the quality monitoring and inspection fund created under section 3702.31 of the Revised Code for use in accordance with that section.

Effective Date: 09-17-2002

Any person who believes a health care facility is operating without a license in violation of division (E) of section 3702.30 of the Revised Code may petition the court of common pleas of the county in which the facility is located for an order enjoining the facility from continuing to operate without a license. The court shall grant the order on a showing that the facility named in the petition is violating division (E) of section 3702.30 of the Revised Code.

Effective Date: 04-05-2007

As used in sections 3702.51 to 3702.62 of the Revised Code:

(A) “Applicant” means any person that submits an application for a certificate of need and who is designated in the application as the applicant.

(B) “Person” means any individual, corporation, business trust, estate, firm, partnership, association, joint stock company, insurance company, government unit, or other entity.

(C) “Certificate of need” means a written approval granted by the director of health to an applicant to authorize conducting a reviewable activity.

(D) “Health service area” means a geographic region designated by the director of health under section 3702.58 of the Revised Code.

(E) “Health service” means a clinically related service, such as a diagnostic, treatment, rehabilitative, or preventive service.

(F) “Health service agency” means an agency designated to serve a health service area in accordance with section 3702.58 of the Revised Code.

(G) “Health care facility” means:

(1) A hospital registered under section 3701.07 of the Revised Code;

(2) A nursing home licensed under section 3721.02 of the Revised Code, or by a political subdivision certified under section 3721.09 of the Revised Code;

(3) A county home or a county nursing home as defined in section 5155.31 of the Revised Code that is certified under Title XVIII or XIX of the “Social Security Act,” 49 Stat. 620 (1935), 42 U.S.C.A. 301, as amended;

(4) A freestanding dialysis center;

(5) A freestanding inpatient rehabilitation facility;

(6) An ambulatory surgical facility;

(7) A freestanding cardiac catheterization facility;

(8) A freestanding birthing center;

(9) A freestanding or mobile diagnostic imaging center;

(10) A freestanding radiation therapy center.

A health care facility does not include the offices of private physicians and dentists whether for individual or group practice, residential facilities licensed under section 5123.19 of the Revised Code, or an institution for the sick that is operated exclusively for patients who use spiritual means for healing and for whom the acceptance of medical care is inconsistent with their religious beliefs, accredited by a national accrediting organization, exempt from federal income taxation under section 501 of the Internal Revenue Code of 1986, 100 Stat. 2085, 26 U.S.C.A. 1, as amended, and providing twenty-four hour nursing care pursuant to the exemption in division (E) of section 4723.32 of the Revised Code from the licensing requirements of Chapter 4723. of the Revised Code.

(H) “Medical equipment” means a single unit of medical equipment or a single system of components with related functions that is used to provide health services.

(I) “Third-party payer” means a health insuring corporation licensed under Chapter 1751. of the Revised Code, a health maintenance organization as defined in division (K) of this section, an insurance company that issues sickness and accident insurance in conformity with Chapter 3923. of the Revised Code, a state-financed health insurance program under Chapter 3701., 4123., or 5111. of the Revised Code, or any self-insurance plan.

(J) “Government unit” means the state and any county, municipal corporation, township, or other political subdivision of the state, or any department, division, board, or other agency of the state or a political subdivision.

(K) “Health maintenance organization” means a public or private organization organized under the law of any state that is qualified under section 1310(d) of Title XIII of the “Public Health Service Act,” 87 Stat. 931 (1973), 42 U.S.C. 300e-9.

(L) “Existing health care facility” means either of the following:

(1) A health care facility that is licensed or otherwise authorized to operate in this state in accordance with applicable law, is staffed and equipped to provide health care services, and is actively providing health services ;

(2) A health care facility that is licensed or has beds registered under section 3701.07 of the Revised Code as skilled nursing beds or long-term care beds and has provided services for at least three hundred sixty-five consecutive days within the twenty-four months immediately preceding the date a certificate of need application is filed with the director of health.

(M) “State” means the state of Ohio, including, but not limited to, the general assembly, the supreme court, the offices of all elected state officers, and all departments, boards, offices, commissions, agencies, institutions, and other instrumentalities of the state of Ohio. “State” does not include political subdivisions.

(N) “Political subdivision” means a municipal corporation, township, county, school district, and all other bodies corporate and politic responsible for governmental activities only in geographic areas smaller than that of the state to which the sovereign immunity of the state attaches.

(O) “Affected person” means:

(1) An applicant for a certificate of need, including an applicant whose application was reviewed comparatively with the application in question;

(2) The person that requested the reviewability ruling in question;

(3) Any person that resides or regularly uses health care facilities within the geographic area served or to be served by the health care services that would be provided under the certificate of need or reviewability ruling in question;

(4) Any health care facility that is located in the health service area where the health care services would be provided under the certificate of need or reviewability ruling in question;

(5) Third-party payers that reimburse health care facilities for services in the health service area where the health care services would be provided under the certificate of need or reviewability ruling in question;

(6) Any other person who testified at a public hearing held under division (B) of section 3702.52 of the Revised Code or submitted written comments in the course of review of the certificate of need application in question.

(P) “Osteopathic hospital” means a hospital registered under section 3701.07 of the Revised Code that advocates osteopathic principles and the practice and perpetuation of osteopathic medicine by doing any of the following:

(1) Maintaining a department or service of osteopathic medicine or a committee on the utilization of osteopathic principles and methods, under the supervision of an osteopathic physician;

(2) Maintaining an active medical staff, the majority of which is comprised of osteopathic physicians;

(3) Maintaining a medical staff executive committee that has osteopathic physicians as a majority of its members.

(Q) “Ambulatory surgical facility” has the same meaning as in section 3702.30 of the Revised Code.

(R) Except as otherwise provided in division (T) of this section, and until the termination date specified in section 3702.511 of the Revised Code, “reviewable activity” means any of the following:

(1) The addition by any person of any of the following health services, regardless of the amount of operating costs or capital expenditures:

(a) A heart, heart-lung, lung, liver, kidney, bowel, pancreas, or bone marrow transplantation service, a stem cell harvesting and reinfusion service, or a service for transplantation of any other organ unless transplantation of the organ is designated by public health council rule not to be a reviewable activity;

(b) A cardiac catheterization service;

(c) An open-heart surgery service;

(d) Any new, experimental medical technology that is designated by rule of the public health council.

(2) The acceptance of high-risk patients, as defined in rules adopted under section 3702.57 of the Revised Code, by any cardiac catheterization service that was initiated without a certificate of need pursuant to division (R)(3)(b) of the version of this section in effect immediately prior to April 20, 1995;

(3)(a) The establishment, development, or construction of a new health care facility other than a new long-term care facility or a new hospital;

(b) The establishment, development, or construction of a new hospital or the relocation of an existing hospital;

(c) The relocation of hospital beds, other than long-term care, perinatal, or pediatric intensive care beds, into or out of a rural area.

(4)(a) The replacement of an existing hospital;

(b) The replacement of an existing hospital obstetric or newborn care unit or freestanding birthing center.

(5)(a) The renovation of a hospital that involves a capital expenditure, obligated on or after June 30, 1995, of five million dollars or more, not including expenditures for equipment, staffing, or operational costs. For purposes of division (R)(5)(a) of this section, a capital expenditure is obligated:

(i) When a contract enforceable under Ohio law is entered into for the construction, acquisition, lease, or financing of a capital asset;

(ii) When the governing body of a hospital takes formal action to commit its own funds for a construction project undertaken by the hospital as its own contractor;

(iii) In the case of donated property, on the date the gift is completed under applicable Ohio law.

(b) The renovation of a hospital obstetric or newborn care unit or freestanding birthing center that involves a capital expenditure of five million dollars or more, not including expenditures for equipment, staffing, or operational costs.

(6) Any change in the health care services, bed capacity, or site, or any other failure to conduct the reviewable activity in substantial accordance with the approved application for which a certificate of need was granted, if the change is made prior to the date the activity for which the certificate was issued ceases to be a reviewable activity;

(7) Any of the following changes in perinatal bed capacity or pediatric intensive care bed capacity:

(a) An increase in bed capacity;

(b) A change in service or service-level designation of newborn care beds or obstetric beds in a hospital or freestanding birthing center, other than a change of service that is provided within the service-level designation of newborn care or obstetric beds as registered by the department of health;

(c) A relocation of perinatal or pediatric intensive care beds from one physical facility or site to another, excluding the relocation of beds within a hospital or freestanding birthing center or the relocation of beds among buildings of a hospital or freestanding birthing center at the same site.

(8) The expenditure of more than one hundred ten per cent of the maximum expenditure specified in a certificate of need;

(9) Any transfer of a certificate of need issued prior to April 20, 1995, from the person to whom it was issued to another person before the project that constitutes a reviewable activity is completed, any agreement that contemplates the transfer of a certificate of need issued prior to that date upon completion of the project, and any transfer of the controlling interest in an entity that holds a certificate of need issued prior to that date. However, the transfer of a certificate of need issued prior to that date or agreement to transfer such a certificate of need from the person to whom the certificate of need was issued to an affiliated or related person does not constitute a reviewable transfer of a certificate of need for the purposes of this division, unless the transfer results in a change in the person that holds the ultimate controlling interest in the certificate of need.

(10)(a) The acquisition by any person of any of the following medical equipment, regardless of the amount of operating costs or capital expenditure:

(i) A cobalt radiation therapy unit;

(ii) A linear accelerator;

(iii) A gamma knife unit.

(b) The acquisition by any person of medical equipment with a cost of two million dollars or more. The cost of acquiring medical equipment includes the sum of the following:

(i) The greater of its fair market value or the cost of its lease or purchase;

(ii) The cost of installation and any other activities essential to the acquisition of the equipment and its placement into service.

(11) The addition of another cardiac catheterization laboratory to an existing cardiac catheterization service.

(S) Except as provided in division (T) of this section, “reviewable activity” also means any of the following activities, none of which are subject to a termination date:

(1) The establishment, development, or construction of a new long-term care facility;

(2) The replacement of an existing long-term care facility;

(3) The renovation of a long-term care facility that involves a capital expenditure of two million dollars or more, not including expenditures for equipment, staffing, or operational costs;

(4) Any of the following changes in long-term care bed capacity:

(a) An increase in bed capacity;

(b) A relocation of beds from one physical facility or site to another, excluding the relocation of beds within a long-term care facility or among buildings of a long-term care facility at the same site;

(c) A recategorization of hospital beds registered under section 3701.07 of the Revised Code from another registration category to skilled nursing beds or long-term care beds.

(5) Any change in the health services, bed capacity, or site, or any other failure to conduct the reviewable activity in substantial accordance with the approved application for which a certificate of need concerning long-term care beds was granted, if the change is made within five years after the implementation of the reviewable activity for which the certificate was granted;

(6) The expenditure of more than one hundred ten per cent of the maximum expenditure specified in a certificate of need concerning long-term care beds;

(7) Any transfer of a certificate of need that concerns long-term care beds and was issued prior to April 20, 1995, from the person to whom it was issued to another person before the project that constitutes a reviewable activity is completed, any agreement that contemplates the transfer of such a certificate of need upon completion of the project, and any transfer of the controlling interest in an entity that holds such a certificate of need. However, the transfer of a certificate of need that concerns long-term care beds and was issued prior to April 20, 1995, or agreement to transfer such a certificate of need from the person to whom the certificate was issued to an affiliated or related person does not constitute a reviewable transfer of a certificate of need for purposes of this division, unless the transfer results in a change in the person that holds the ultimate controlling interest in the certificate of need.

(T) “Reviewable activity” does not include any of the following activities:

(1) Acquisition of computer hardware or software;

(2) Acquisition of a telephone system;

(3) Construction or acquisition of parking facilities;

(4) Correction of cited deficiencies that are in violation of federal, state, or local fire, building, or safety laws and rules and that constitute an imminent threat to public health or safety;

(5) Acquisition of an existing health care facility that does not involve a change in the number of the beds, by service, or in the number or type of health services;

(6) Correction of cited deficiencies identified by accreditation surveys of the joint commission on accreditation of healthcare organizations or of the American osteopathic association;

(7) Acquisition of medical equipment to replace the same or similar equipment for which a certificate of need has been issued if the replaced equipment is removed from service;

(8) Mergers, consolidations, or other corporate reorganizations of health care facilities that do not involve a change in the number of beds, by service, or in the number or type of health services;

(9) Construction, repair, or renovation of bathroom facilities;

(10) Construction of laundry facilities, waste disposal facilities, dietary department projects, heating and air conditioning projects, administrative offices, and portions of medical office buildings used exclusively for physician services;

(11) Acquisition of medical equipment to conduct research required by the United States food and drug administration or clinical trials sponsored by the national institute of health. Use of medical equipment that was acquired without a certificate of need under division (T)(11) of this section and for which premarket approval has been granted by the United States food and drug administration to provide services for which patients or reimbursement entities will be charged shall be a reviewable activity.

(12) Removal of asbestos from a health care facility.

Only that portion of a project that meets the requirements of division (T) of this section is not a reviewable activity.

(U) “Small rural hospital” means a hospital that is located within a rural area, has fewer than one hundred beds, and to which fewer than four thousand persons were admitted during the most recent calendar year.

(V) “Children’s hospital” means any of the following:

(1) A hospital registered under section 3701.07 of the Revised Code that provides general pediatric medical and surgical care, and in which at least seventy-five per cent of annual inpatient discharges for the preceding two calendar years were individuals less than eighteen years of age;

(2) A distinct portion of a hospital registered under section 3701.07 of the Revised Code that provides general pediatric medical and surgical care, has a total of at least one hundred fifty registered pediatric special care and pediatric acute care beds, and in which at least seventy-five per cent of annual inpatient discharges for the preceding two calendar years were individuals less than eighteen years of age;

(3) A distinct portion of a hospital, if the hospital is registered under section 3701.07 of the Revised Code as a children’s hospital and the children’s hospital meets all the requirements of division (V)(1) of this section.

(W) “Long-term care facility” means any of the following:

(1) A nursing home licensed under section 3721.02 of the Revised Code or by a political subdivision certified under section 3721.09 of the Revised Code;

(2) The portion of any facility, including a county home or county nursing home, that is certified as a skilled nursing facility or a nursing facility under Title XVIII or XIX of the “Social Security Act”;

(3) The portion of any hospital that contains beds registered under section 3701.07 of the Revised Code as skilled nursing beds or long-term care beds.

(X) “Long-term care bed” means a bed in a long-term care facility.

(Y) “Perinatal bed” means a bed in a hospital that is registered under section 3701.07 of the Revised Code as a newborn care bed or obstetric bed, or a bed in a freestanding birthing center.

(Z) “Freestanding birthing center” means any facility in which deliveries routinely occur, regardless of whether the facility is located on the campus of another health care facility, and which is not licensed under Chapter 3711. of the Revised Code as a level one, two, or three maternity unit or a limited maternity unit.

(AA)(1) “Reviewability ruling” means a ruling issued by the director of health under division (A) of section 3702.52 of the Revised Code as to whether a particular proposed project is or is not a reviewable activity.

(2) “Nonreviewability ruling” means a ruling issued under that division that a particular proposed project is not a reviewable activity.

(BB)(1) “Metropolitan statistical area” means an area of this state designated a metropolitan statistical area or primary metropolitan statistical area in United States office of management and budget bulletin No. 93-17, June 30, 1993, and its attachments.

(2) “Rural area” means any area of this state not located within a metropolitan statistical area.

Effective Date: 04-10-2001; 06-30-2005

Activities specified in division (R) of section 3702.51 of the Revised Code shall cease to be reviewable activities in accordance with this section.

(A) The activities specified in divisions (R)(1)(a) to (c), (2), (4)(b), (5)(b), (7), (10)(a), and (11) of section 3702.51 of the Revised Code cease to be reviewable activities as follows:

(1) Except as provided in division (A)(2) of this section, if initial rules adopted under section 3702.11 of the Revised Code take effect prior to May 1, 1997, for any service specified in that section, all activities related to that service cease to be reviewable activities one year after the effective date of the rules;

(2) If the director of health fails to file proposed initial rules in accordance with section 119.03 of the Revised Code prior to May 1, 1996, for any service specified in section 3702.11 of the Revised Code, all activities related to that service cease to be reviewable activities May 1, 1997;

(3) If initial rules for any service specified in section 3702.11 of the Revised Code do not take effect prior to May 1, 1997, all activities related to that service cease to be reviewable activities May 1, 1997.

(B) The activities specified in divisions (R)(1)(d), (3)(b), (3)(c), (4)(a), (5)(a), and (10)(b) of section 3702.51 of the Revised Code cease to be reviewable activities May 1, 1997.

(C) The activity specified in division (R)(3)(a) of section 3702.51 of the Revised Code ceases to be a reviewable activity March 31, 1996, if conducted within a metropolitan statistical area, and May 1, 1997, if conducted within a rural area.

(D) The activities specified in divisions (R)(6), (8), and (9) of section 3702.51 of the Revised Code pertain to implementation of reviewable activities for which a certificate of need has been granted. When an activity described in division (R)(1), (2), (3), (4), (5), (7), (10), or (11) of that section ceases to be a reviewable activity, divisions (R)(6), (8), and (9) cease to pertain to that activity.

Effective Date: 06-30-1995

Effective Date: 11-15-1991

The director of health shall administer a state certificate of need program in accordance with sections 3702.51 to 3702.62 of the Revised Code and rules adopted under those sections.

(A) The director shall issue rulings on whether a particular proposed project is a reviewable activity. The director shall issue a ruling not later than forty-five days after receiving a request for a ruling accompanied by the information needed to make the ruling. If the director does not issue a ruling in that time, the project shall be considered to have been ruled not a reviewable activity.

(B) The director shall review applications for certificates of need. Each application shall be submitted to the director on forms prescribed by the director, shall include all information required by rules adopted under division (B) of section 3702.57 of the Revised Code, and shall be accompanied by the application fee established in rules adopted under division (G) of that section.

Application fees received by the director under this division shall be deposited into the state treasury to the credit of the certificate of need fund, which is hereby created. The director shall use the fund only to pay the costs of administering sections 3702.11 to 3702.20, 3702.30, and 3702.51 to 3702.62 of the Revised Code and rules adopted under those sections.

The director shall mail to the applicant a written notice that the application meets the criteria for a complete application specified in rules adopted under section 3702.57 of the Revised Code, or a written request for additional information, not later than thirty days after receiving an application or a response to an earlier request for information. The director shall not make more than two requests for additional information.

The director may conduct a public informational hearing in the course of reviewing any application for a certificate of need, and shall conduct one if requested to do so by any affected person not later than fifteen days after the director mails the notice that the application is complete. The hearing shall be conducted in the community in which the activities authorized by the certificate of need would be carried out. Any affected person may testify at the hearing. The director may, with the health service agency’s consent, designate a health service agency to conduct the hearing.

Except during a public hearing or as necessary to comply with a subpoena issued under division (F) of this section, after a notice of completeness has been received, no person shall knowingly discuss in person or by telephone the merits of the application with the director. If one or more persons request a meeting in person or by telephone, the director shall make a reasonable effort to invite interested parties to the meeting or conference call.

(C) All of the following apply to the process of granting or denying a certificate of need:

(1) If the project proposed in a certificate of need application meets all of the applicable certificate of need criteria for approval under sections 3702.51 to 3702.62 of the Revised Code and the rules adopted under those sections, the director shall grant a certificate of need for the entire project that is the subject of the application immediately after both of the following conditions are met:

(a) The board of trustees of the health service agency of the health service area in which the reviewable activity is proposed to be conducted recommends, prior to the deadline specified in division (C)(4) of this section or any extension of it under division (C)(5) of this section, that the certificate of need be granted;

(b) The director does not receive any written objections to the application from any affected person by the thirtieth day after the director mails the notice of completeness.

(2) In the case of certificate of need applications under comparative review, if the projects proposed in the applications meet all of the applicable certificate of need criteria for approval under sections 3702.51 to 3702.62 of the Revised Code and the rules adopted under those sections, the director shall grant certificates of need for the entire projects that are the subject of the applications immediately after both of the following conditions are met:

(a) The board of trustees of the health service agency of each health service area in which the reviewable activities are proposed to be conducted recommends, prior to the deadline specified in division (C)(4) of this section or any extension of it under division (C)(5) of this section, that certificates of need be granted for each of the reviewable activities to be conducted in its health service area;

(b) The director does not receive any written objections to any of the applications from any affected person by the thirtieth day after the director mails the last notice of completeness.

The director’s grant of a certificate of need under division (C)(1) or (2) of this section does not affect, and sets no precedent for, the director’s decision to grant or deny other applications for similar reviewable activities proposed to be conducted in the same or different health service areas.

(3) If the director receives written objections to an application from any affected person by the thirtieth day after mailing the notice of completeness, regardless of the health service agency’s recommendation, the director shall notify the applicant and assign a hearing examiner to conduct an adjudication hearing concerning the application in accordance with Chapter 119. of the Revised Code. In the case of applications under comparative review, if the director receives written objections to any of the applications from any affected person by the thirtieth day after the director mails the last notice of completeness, regardless of the health service agencies’ recommendation, the director shall notify all of the applicants and appoint a hearing examiner to conduct a consolidated adjudication hearing concerning the applications in accordance with Chapter 119. of the Revised Code. The hearing examiner shall be employed by or under contract with the department of health.

The adjudication hearings may be conducted in the health service area in which the reviewable activity is proposed to be conducted. Consolidated adjudication hearings for applications in comparative review may be conducted in the geographic region in which all of the reviewable activities will be conducted. The applicant, the director, and the affected persons that filed objections to the application shall be parties to the hearing. If none of the affected persons that submitted written objections to the application appears or prosecutes the hearing, the hearing examiner shall dismiss the hearing and the director shall grant a certificate of need for the entire project that is the subject of the application if the proposed project meets all of the applicable certificate of need criteria for approval under sections 3702.51 to 3702.62 of the Revised Code and the rules adopted under those sections. The affected persons bear the burden of proving by a preponderance of evidence that the project is not needed or that granting the certificate would not be in accordance with sections 3702.51 to 3702.62 of the Revised Code or the rules adopted under those sections.

(4) Except as provided in divisions (C)(1) and (2) of this section, the director shall grant or deny certificate of need applications for which an adjudication hearing is not conducted under division (C)(3) of this section not later than sixty days after mailing the notice of completeness or, in the case of an application proposing addition of long-term care beds, not later than sixty days after such other time as is specified in rules adopted under section 3702.57 of the Revised Code. The director shall grant or deny certificate of need applications for which an adjudication hearing is conducted under division (C)(3) of this section not later than thirty days after the expiration of the time for filing objections to the report and recommendation of the hearing examiner under section 119.09 of the Revised Code. The director shall base decisions concerning applications for which an adjudication hearing is conducted under division (C)(3) of this section on the report and recommendations of the hearing examiner.

(5) Except as otherwise provided in division (C)(1), (2), or (6) of this section, the director or the applicant may extend the deadline prescribed in division (C)(4) of this section once, for no longer than thirty days, by written notice before the end of the original thirty-day period. An extension by the director under division (C)(5) of this section shall apply to all applications that are in comparative review.

(6) No applicant in a comparative review may extend the deadline specified in division (C)(4) of this section.

(7) Except as provided in divisions (C)(1) and (2) of this section, the director may grant a certificate of need for all or part of the project that is the subject of an application. If the director does not grant or deny the certificate by the applicable deadline specified in division (C)(4) of this section or any extension of it under division (C)(5) of this section, the certificate shall be considered to have been granted.

(8) In granting a certificate of need, the director shall specify as the maximum capital expenditure the certificate holder may obligate under the certificate a figure equal to one hundred ten per cent of the approved project cost.

(9) In granting a certificate of need, the director may grant the certificate with conditions that must be met by the holder of the certificate.

(D) The director shall monitor the activities of persons granted certificates of need concerning long-term care beds during the period beginning with the granting of the certificate of need and ending five years after implementation of the activity for which the certificate was granted.

In the case of any other certificate of need, the director shall monitor the activities of persons granted certificates of need during the period beginning with the granting of the certificate of need and ending when the activity for which the certificate was granted ceases to be a reviewable activity in accordance with section 3702.511 of the Revised Code.

(E) When reviewing applications for certificates of need or monitoring activities of persons granted certificates of need, the director may issue and enforce, in the manner provided in section 119.09 of the Revised Code, subpoenas duces tecum to compel the production of documents relevant to review of the application or monitoring of the activities. In addition, the director or the director’s designee, which may include a health service agency, may visit the sites where the activities are or will be conducted.

(F) The director may withdraw certificates of need.

(G) The director shall conduct, on a regular basis, health system data collection and analysis activities and prepare reports. The director shall make recommendations based upon these activities to the public health council concerning the adoption of appropriate rules under section 3702.57 of the Revised Code. All health care facilities and other health care providers shall submit to the director, upon request, any information that is necessary to conduct reviews of certificate of need applications and to develop recommendations for criteria for reviews, and that is prescribed by rules adopted under division (H) of section 3702.57 of the Revised Code.

(H) Any decision to grant or deny a certificate of need shall consider the special needs and circumstances resulting from moral and ethical values and the free exercise of religious rights of health care facilities administered by religious organizations, and the special needs and circumstances of children’s hospitals, inner city hospitals, and small rural hospitals.

Effective Date: 06-30-1999; 2007 HB119 09-29-2007

The director of health shall issue not later than twelve months after the effective date of this section, and annually thereafter shall review and if necessary revise, a state health resources plan. The plan shall include all of the following:

(A) A description of the optimal quantity and distribution of all health services, facilities, and other resources in this state;

(B) A description of existing deficiencies in the health resources of this state;

(C) A description of excess health resources in this state.

Effective Date: 04-20-1995

(A) Reviews of applications for certificates of need to recategorize hospital beds to skilled nursing beds shall be conducted in accordance with this division and rules adopted by the public health council.

(1) No hospital recategorizing beds shall apply for a certificate of need for more than twenty skilled nursing beds.

(2) No beds for which a certificate of need is requested under this division shall be reviewed under or counted in any formula developed under public health council rules for the purpose of determining the number of long-term care beds that may be needed within the state.

(3) No beds shall be approved under this division unless the hospital certifies and demonstrates in the application that the beds will be dedicated to patients with a length of stay of no more than thirty days.

(4) No beds shall be approved under this division unless the hospital can satisfactorily demonstrate in the application that it is routinely unable to place the patients planned for the beds in accessible skilled nursing facilities.

(5) In developing rules to implement this division, the public health council shall give special attention to the required documentation of the need for such beds, including the efforts made by the hospital to place patients in suitable skilled nursing facilities, and special attention to the appropriate size of units with such beds given the historical pattern of the applicant hospital’s documented difficulty in placing skilled nursing patients.

(B) To assist the director of health in monitoring the use of hospital beds recategorized as skilled nursing beds after August 5, 1989, the public health council shall adopt rules specifying appropriate quarterly procedures for reporting to the department of health.

(C) A patient may stay in a hospital bed that, after August 5, 1989, has been recategorized as a skilled nursing bed for more than thirty days if the hospital is able to demonstrate that it made a good faith effort to place the patient in an accessible skilled nursing facility acceptable to the patient within the thirty-day period, but was unable to do so.

(D) No hospital bed recategorized after August 5, 1989, as a skilled nursing bed shall be covered by a provider agreement under the medical assistance program established under Chapter 5111. of the Revised Code.

(E) Nothing in this section requires a hospital to place a patient in any nursing home if the patient does not wish to be placed in the nursing home. Nothing in this section limits the ability of a hospital to file a certificate of need application for the addition of long-term care beds that meet the definition of “home” in section 3721.01 of the Revised Code. Nothing in this section limits the ability of the director to grant certificates of need necessary for hospitals to engage in demonstration projects authorized by the federal government for the purpose of enhancing long-term quality of care and cost containment. Nothing in this section limits the ability of hospitals to develop swing bed programs in accordance with federal regulations.

No hospital that is granted a certificate of need after August 5, 1989, to recategorize hospital beds as skilled nursing beds is subject to sections 3721.01 to 3721.09 of the Revised Code. If the portion of the hospital in which the recategorized beds are located is certified as a skilled nursing facility under Title XVIII of the “Social Security Act,” 49 Stat. 620 (1935), 42 U.S.C.A. 301, as amended, that portion of the hospital is subject to sections 3721.10 to 3721.17 and sections 3721.21 to 3721.34 of the Revised Code. If the beds are registered pursuant to section 3701.07 of the Revised Code as long-term care beds, the beds are subject to sections 3721.50 to 3721.58 of the Revised Code.

(F) The public health council shall adopt rules authorizing the creation of one or more nursing home placement clearinghouses. Any public or private agency or facility may apply to the department of health to serve as a nursing home placement clearinghouse, and the rules shall provide the procedure for application and process for designation of clearinghouses.

The department may approve one or more clearinghouses, but in no event shall there be more than one nursing home placement clearinghouse in each county. Any nursing home may list with a nursing home placement clearinghouse the services it provides and the types of patients it is approved for and equipped to serve. The clearinghouse shall make reasonable efforts to update its information at least every six months.

If an appropriate clearinghouse has been designated, each hospital granted a certificate of need after August 5, 1989, to recategorize hospital beds as skilled nursing beds shall, and any other hospital may, utilize the nursing home placement clearinghouse prior to admitting a patient to a skilled nursing bed within the hospital and prior to keeping a patient in a skilled nursing bed within a hospital in excess of thirty days.

The department shall provide at least annually to all hospitals a list of the designated nursing home placement clearinghouses.

Effective Date: 04-20-1995

(A) Certificates of need authorizing the addition of a cardiac catheterization service, and certificates of need authorizing the acceptance of high-risk cardiac catheterization patients by a cardiac catheterization service that was initiated without a certificate of need pursuant to division (R)(3)(b) of the version of section 3702.51 of the Revised Code in effect immediately prior to April 20, 1995, shall be granted only to hospitals that operate open-heart surgery services in compliance with sections 3702.51 to 3702.62 of the Revised Code. This requirement is in addition to any other review requirements of sections 3702.51 to 3702.62 of the Revised Code and the rules adopted under section 3702.57 of the Revised Code that apply to cardiac catheterization. This division applies to certificate of need applications filed with the director of health on or after April 20, 1995.

(B) Certificates of need authorizing the addition of a cardiac catheterization laboratory to an existing cardiac catheterization service shall be granted only to hospitals that operate open-heart surgery services in accordance with sections 3702.51 to 3702.62 of the Revised Code. This requirement is in addition to any other review requirements of sections 3702.51 to 3702.62 of the Revised Code and the rules adopted under section 3702.57 of the Revised Code that apply to cardiac catheterization. This division applies to certificate of need applications filed with the director on and after the effective date of this amendment.

Effective Date: 06-30-1995

(A) Except as provided in division (B) or (C) of this section, a certificate of need granted on or after April 20, 1995, is not transferable prior to the completion of the reviewable activity for which it was granted. If any person holding a certificate of need issued on or after that date transfers the certificate of need to another person before the reviewable activity is completed, or enters into an agreement that contemplates the transfer of the certificate of need on the completion of the reviewable activity, the certificate of need is void. If the controlling interest in an entity that holds a certificate of need issued on or after that date is transferred prior to the completion of the reviewable activity, the certificate of need is void.

(B) Division (A) of this section does not prohibit the transfer of a certificate of need issued on or after April 20, 1995, between affiliated or related persons, as defined in rules adopted under section 3702.57 of the Revised Code, if the transfer does not result in a change in the person that holds the ultimate controlling interest, as defined in the rules, in the certificate of need.

The transfer of a health care facility after the completion of a reviewable activity for which a certificate of need was issued on or after April 20, 1995, is not a transfer of the certificate of need, unless the facility is transferred pursuant to an agreement entered into prior to the completion of the reviewable activity.

(C) Division (A) of this section does not apply to a transfer of a certificate of need that meets all of the following conditions:

(1) The certificate of need is transferred for no more than the amount of money the person transferring the certificate expended for reasonable and necessary expenses incurred in applying for and obtaining the certificate;

(2) The person holding the certificate of need is unable to complete the reviewable activity for which it was issued due to circumstances beyond the person’s control, including zoning restrictions, natural disasters, or comparable events;

(3) The director, after reviewing documentation supplied by the person transferring the certificate of need, certifies in writing prior to the transfer that the transfer meets the conditions specified in divisions (C)(1) and (2) of this section.

If the person that acquires a certificate of need under this division intends to implement the project other than in substantial compliance with the approved application for the certificate, that change is a reviewable activity for which the person must obtain another certificate of need.

Effective Date: 06-30-1995

(A) Not later than twenty-four months after the date the director of health mails the notice that the certificate of need has been granted or, if the grant or denial of the certificate of need is appealed under section 3702.60 of the Revised Code, not later than twenty-four months after issuance of an order granting the certificate that is not subject to further appeal, each person holding a certificate of need granted on or after April 20, 1995, shall:

(1) If the project for which the certificate of need was granted primarily involves construction and is to be financed primarily through external borrowing of funds, secure financial commitment for the stated purpose of developing the project and commence construction that continues uninterrupted except for interruptions or delays that are unavoidable due to reasons beyond the person’s control, including labor strikes, natural disasters, material shortages, or comparable events;

(2) If the project for which the certificate of need was granted primarily involves construction and is to be financed primarily internally, receive formal approval from the holder’s board of directors or trustees or other governing authority to commit specified funds for implementation of the project and commence construction that continues uninterrupted except for interruptions or delays that are unavoidable due to reasons beyond the person’s control, including labor strikes, natural disasters, material shortages, or comparable events;

(3) If the project for which the certificate of need was granted primarily involves acquisition of medical equipment, enter into a contract to purchase or lease the equipment and to accept the equipment at the site for which the certificate was granted;

(4) If the project for which the certificate of need was granted involves no capital expenditure or only minor renovations to existing structures, provide the health service or activity by the means specified in the approved application for the certificate;

(5) If the project for which the certificate of need was granted primarily involves leasing a building or space that requires only minor renovations to the existing space, execute a lease and provide the health service or activity by the means specified in the approved application for the certificate;

(6) If the project for which the certificate of need was granted primarily involves leasing a building or space that has not been constructed or requires substantial renovations to existing space, commence construction for the purpose of implementing the reviewable activity that continues uninterrupted except for interruptions or delays that are unavoidable due to reasons beyond the person’s control, including labor strikes, natural disasters, material shortages, or comparable events.

(B) The twenty-four-month period specified in division (A) of this section shall not be extended by any means, including the transfer of a certificate of need under division (C) of section 3702.524 of the Revised Code or granting of a subsequent or replacement certificate of need. Each person holding a certificate of need granted on or after April 20, 1995, shall provide the director of health documentation of compliance with that division not later than the earlier of thirty days after complying with that division or five days after the twenty-four-month period expires. Not later than the earlier of fifteen days after receiving the documentation or fifteen days after the twenty-four-month period expires, the director shall send by certified mail a notice to the holder of the certificate of need specifying whether the holder has complied with division (A) of this section.

(C) Notwithstanding division (B) of this section, the twenty-four-month period specified in division (A) of this section shall be extended for an additional twenty-four months for any certificate of need granted for the purchase and relocation of licensed nursing home beds on February 26, 1999.

(D) A certificate of need granted on or after April 20, 1995, expires, regardless of whether the director sends a notice under division (B) of this section, if the holder fails to comply with division (A) or (C) of this section or to provide information under division (B) of this section as necessary for the director to determine compliance.

Effective Date: 09-27-2000

Every six months after complying with section 3702.525 of the Revised Code, the holder of the certificate of need shall demonstrate to the director of health, in the form and manner required by rules adopted under section 3702.57 of the Revised Code, that reasonable progress is being made toward the completion of the reviewable activity. If the director determines, in accordance with standards specified in the rules, that reasonable progress is not being made, he shall withdraw the certificate of need.

Effective Date: 04-20-1995

A certificate of need is not required for any hospital to add beds that will be registered under section 3701.07 of the Revised Code as level I obstetric and newborn care beds or to establish a new obstetric and newborn care unit containing beds that will be registered under that section only as level I obstetric and newborn care beds.

Effective Date: 04-20-1995

(A) A certificate of need is not required for the relocation of existing beds or health services from a hospital located in a metropolitan statistical area to another hospital located in the same metropolitan statistical area, or from a hospital located in a rural area to another hospital located in the same county, that otherwise constitutes a reviewable activity as defined in division (R)(1), (2), (6), (7)(a) or (c), (8), (9), (10), or (11) of section 3702.51 of the Revised Code, if all of the following conditions are met:

(1) At least sixty days before the relocation occurs, each hospital requests from the director of health a reviewability ruling concerning the relocation;

(2) The director rules in accordance with division (B) of this section that the relocation is not a reviewable activity because access to health care for the patients historically served by the beds or services would not be adversely affected;

(3) If the relocation involves a health service that the receiving hospital does not operate at the time of the relocation, and for purposes of division (A)(3) of this section obstetric and newborn care services of differing service-level designations constitute different health services, the hospital operating the service at the time of the relocation ceases to provide it and removes from service all of the beds and medical equipment involved in providing it;

(4) If the relocation involves obstetric or newborn care, the relocation does not result in an increase in the service-level designation of the relocated beds;

(5) In addition to the beds removed from each hospital’s complement of registered beds because they have been relocated to the other hospital, the total number of registered beds in the hospitals participating in the relocation is reduced by the same number of beds as are involved in the relocation;

(6) Each hospital submits to the department of health, not later than thirty days after the relocation is completed, an accurate statement of the number of beds at the hospital and the health services added to or removed from the hospital.

(B) Each request for a reviewability ruling shall include information required in rules adopted under section 3702.57 of the Revised Code to enable the director to determine whether the relocation would adversely affect access to health care for patients historically served by the beds. If the director determines that a proposed relocation would adversely affect access to health care for those patients, the director shall rule the relocation a reviewable activity. If the director does not so determine, the director shall rule the activity not a reviewable activity. This division does not supersede the provision of division (A) of section 3702.52 of the Revised Code that an activity is considered to have been ruled not a reviewable activity if the director does not issue a ruling within forty-five days after receiving a request for a ruling.

(C) Division (A) of this section does not apply to relocations that involve a reviewable activity as defined in division (R)(3), (4), (5), or (7)(b) or division (S) of section 3702.51 of the Revised Code. Division (A) of this section does not apply to relocations between hospitals located in different primary metropolitan statistical areas that constitute a consolidated metropolitan statistical area, both as designated in United States office of management and budget bulletin No. 93-17, June 30, 1993, and its attachments.

Effective Date: 06-30-1995

(A) A person granted a nonreviewability ruling prior to April 20, 1995, may implement the activity for which the ruling was issued in accordance with the information provided to the director of health in the request for the ruling, notwithstanding the amendments to sections 3702.51 to 3702.62 of the Revised Code by Amended Substitute Senate Bill No. 50 and Amended Substitute Senate Bill No. 156, both of the 121st general assembly. A person granted a certificate of need or nonreviewability ruling prior to that date is not required to file a notice of intent under section 3702.581 of the Revised Code, as that section existed prior to the effective date of this amendment, with respect to the activity for which the certificate or ruling was issued.

(B) A certificate of need is not required for any person to add a cardiac catheterization laboratory to an existing cardiac catheterization service, as described in division (R)(11) of section 3702.51 of the Revised Code, if the person, prior to June 30, 1995, filed a notice of intent under section 3702.581 of the Revised Code, as that section existed prior to the effective date of this amendment, to do so. However, the exemption provided by this division expires six months after June 30, 1995, unless the person has taken action to implement the addition by taking the applicable action listed in divisions (A)(1) to (6) of section 3702.525 of the Revised Code and provides the director with written documentation that action has been taken.

(C) The director shall issue a reviewability ruling, in accordance with the version of section 3702.528 of the Revised Code in effect immediately prior to June 30, 1995, to any hospital that requested one prior to that date concerning a relocation of any of the following to another hospital in the same or a different metropolitan statistical area:

(1) Obstetric or newborn care beds registered under section 3701.07 of the Revised Code as level II or III beds;

(2) Pediatric intensive care beds;

(3) A health service specified in division (R)(1) of section 3702.51 of the Revised Code.

A certificate of need is not required to conduct such a relocation for which the director has issued a nonreviewability ruling. However, the exemption provided by this division expires six months after June 30, 1995, unless the hospital has taken action to implement the relocation by taking the applicable action listed in divisions (A)(1) to (6) of section 3702.525 of the Revised Code and provides the director with written documentation that action has been taken.

The director shall not issue a reviewability ruling requested under the previous version of section 3702.528 of the Revised Code concerning a relocation of long-term care beds.

(D) A certificate of need is not required to relocate existing health services from one hospital to another, as described in division (T) of the version of section 3702.51 of the Revised Code in effect immediately prior to June 30, 1995, if the hospitals filed the notice of intent required by division (T)(2) of that version prior to June 30, 1995, and comply with divisions (T)(1) and (T)(3) to (6) of that version.

Effective Date: 09-26-2003

The veterans’ home operated under Chapter 5907. of the Revised Code that is located in Sandusky is not required to obtain a certificate of need to increase bed capacity in its Secrest-Giffin nursing home by not more than twenty-five long-term care beds prior to June 30, 1997.

Effective Date: 03-14-2003

Notwithstanding any conflicting provision of sections 3702.51 to 3702.62 of the Revised Code, the veterans’ home operated under Chapter 5907. of the Revised Code that is located in Sandusky, including the Secrest nursing home and Giffin care facility, is not required to obtain a certificate of need for the addition of up to fifty-two additional nursing home beds to be licensed under Chapter 3721. of the Revised Code if the additional beds are placed in service prior to June 30, 1999.

Effective Date: 03-14-2003; 2007 HB119 09-29-2007

(A) This section applies to each long-term care facility that meets the following requirements:

(1) The facility has been in continuous operation for not less than one hundred twenty years prior to the effective date of this section;

(2) The facility is located in an inner city area;

(3) The facility is operating as a nonprofit entity organized under Chapter 1702. of the Revised Code or the nonprofit law of another state.

(B) Notwithstanding any conflicting provision of sections 3702.51 to 3702.62 of the Revised Code, the owner or operator of a long-term care facility described in division (A) of this section is not required to obtain a certificate of need for the addition of up to thirty long-term care beds to be licensed under Chapter 3721. of the Revised Code. The exemption shall apply only as long as the beds are owned and operated by the facility to which the exemption is granted.

Effective Date: 06-17-1998; 2007 HB119 09-29-2007

Notwithstanding any conflicting provision of sections 3702.51 to 3702.62 of the Revised Code, the veterans’ home operated under Chapter 5907. of the Revised Code that is located in Brown county is not required to obtain a certificate of need for the addition of up to one hundred sixty-eight additional nursing home beds to be licensed under Chapter 3721. of the Revised Code if the additional beds are placed in service prior to December 31, 2004.

Effective Date: 03-14-2003; 2007 HB119 09-29-2007

(A) No person shall carry out any reviewable activity unless a certificate of need for such activity has been granted under sections 3702.51 to 3702.62 of the Revised Code or the person is exempted by division (T) of section 3702.51 or section 3702.527, 3702.528, 3702.529, 3702.5210, or 3702.62 of the Revised Code from the requirement that a certificate of need be obtained. No person shall carry out any reviewable activity if a certificate of need authorizing that activity has been withdrawn by the director of health under section 3702.52 or 3702.526 of the Revised Code. No person shall carry out a reviewable activity if the certificate of need authorizing that activity is void pursuant to section 3702.524 of the Revised Code or has expired pursuant to section 3702.525 of the Revised Code.

(B) No person shall separate portions of any proposal for any reviewable activity to evade the requirements of sections 3702.51 to 3702.62 of the Revised Code.

(C) No person granted a certificate of need shall carry out the reviewable activity authorized by the certificate of need other than in substantial accordance with the approved application for the certificate of need.

Effective Date: 09-26-2003

The director of health shall evaluate and may investigate evidence that appears to demonstrate that any person has violated section 3702.53 of the Revised Code. If the director elects to conduct an investigation, he shall mail to the alleged violator by certified mail, return receipt requested, a notice that an investigation is underway.

When conducting an investigation under this section, the director may request any relevant information pertaining to the alleged violation, including the total operating cost of the activity in question during the period of the alleged violation and the total capital cost associated with implementation of the activity. A person shall provide information requested by the director not later than forty-five days after receiving the director’s request. The director also may issue and enforce, in the manner provided in Chapter 119. of the Revised Code, subpoenas duces tecum to compel the production of documents relevant to the alleged violation. The subpoenas may be served in any manner authorized by the rules of civil procedure.

The director or his designee, which may include a health service agency, may conduct a site visit to investigate an alleged violation of section 3702.53 of the Revised Code.

Each investigation under this section shall be conducted in a manner that protects patient confidentiality. Names or other identifying information about any patient shall not be made public without the written consent of the patient or his guardian, or, if the patient is a minor, his parent or guardian.

Effective Date: 04-20-1995

When the director of health determines that a person has violated section 3702.53 of the Revised Code, the director shall send a notice to the person by certified mail, return receipt requested, specifying the activity constituting the violation and the penalties imposed under section 3702.54, 3702.541, or 3702.542 of the Revised Code.

Effective Date: 09-26-2003

Effective Date: 04-20-1995

Except as provided in sections 3702.541 and 3702.542 and former section 3702.543 of the Revised Code, divisions (A) and (B) of this section apply when the director of health determines that a person has violated section 3702.53 of the Revised Code.

(A) The director shall impose a civil penalty on the person in an amount equal to the greatest of the following:

(1) Three thousand dollars;

(2) Five per cent of the operating cost of the activity that constitutes the violation during the period of time it was conducted in violation of section 3702.53 of the Revised Code;

(3) Two per cent of the total capital cost associated with implementation of the activity.

In no event, however, shall the penalty exceed two hundred fifty thousand dollars.

(B)(1) Notwithstanding section 3702.52 of the Revised Code, the director shall refuse to accept for review any application for a certificate of need filed by or on behalf of the person, or any successor to the person or entity related to the person, for a period of not less than one year and not more than three years after the director mails the notice of the director’s determination under section 3702.532 of the Revised Code or, if the determination is appealed under section 3702.60 of the Revised Code, the issuance of the order upholding the determination that is not subject to further appeal. In determining the length of time during which applications will not be accepted, the director may consider any of the following:

(a) The nature and magnitude of the violation;

(b) The ability of the person to have averted the violation;

(c) Whether the person disclosed the violation to the director before the director commenced his investigation;

(d) The person’s history of compliance with sections 3702.51 to 3702.62 and the rules adopted under section 3702.57 of the Revised Code;

(e) Any community hardship that may result from refusing to accept future applications from the person.

(2) Notwithstanding the one-year minimum imposed by division (B)(1) of this section, the director may establish a period of less than one year during which the director will refuse to accept certificate of need applications if, after reviewing all information available to the director, the director determines and expressly indicates in the notice mailed under section 3702.532 of the Revised Code that refusing to accept applications for a longer period would result in hardship to the community in which the person provides health services. The director’s finding of community hardship shall not affect the granting or denial of any future certificate of need application filed by the person.

Effective Date: 09-26-2003

When the director of health determines that a person has violated section 3702.53 of the Revised Code and the violation solely involves the expenditure of more than one hundred ten per cent of the maximum expenditure approved by the director when he granted a certificate of need, the director may impose a civil penalty in an amount not exceeding two hundred fifty thousand dollars. The director shall not apply division (B) of section 3702.54 of the Revised Code to the person. In determining whether to impose a civil penalty and the amount of the civil penalty, the director shall consider whether the violation resulted from a labor strike, natural disaster, material shortage, or comparable event.

Effective Date: 04-20-1995

When the director of health determines that a person has violated section 3702.53 of the Revised Code, the person shall pay the civil penalty imposed under division (A) of section 3702.54 of the Revised Code, but the director shall not apply division (B) of section 3702.54 of the Revised Code to the person if the person both:

(A) Not later than thirty days after the director mails the notice under section 3702.532 of the Revised Code, applies under section 3702.52 of the Revised Code for a certificate of need to conduct the activity that constitutes the violation;

(B) In accordance with a timetable established by the director, ceases conducting the activity or using the equipment or facility for which the certificate of need is sought until and unless the certificate of need is granted.

If the person fails to apply for a certificate of need within the thirty-day period or fails to cease conducting the activity or using the equipment or facility in accordance with the timetable established by the director, the director shall apply division (B) of that section.

Effective Date: 04-20-1995

Effective Date: 09-26-2003

Each person required by section 3702.54, 3702.541, or 3702.542, or former section 3702.543 of the Revised Code to pay a civil penalty shall do so not later than sixty days after receiving the notice mailed under section 3702.532 of the Revised Code or, if the person appeals under section 3702.60 of the Revised Code the director of health’s determination that a violation has occurred, not later than sixty days after the issuance of an order upholding the director’s determination that is not subject to further appeal. The civil penalties shall be paid to the director. The director shall deposit them into the certificate of need fund created by section 3702.52 of the Revised Code.

Effective Date: 09-26-2003

Except as provided in section 3702.542 of the Revised Code, a person that the director of health determines has violated section 3702.53 of the Revised Code shall cease conducting the activity that constitutes the violation or utilizing the equipment or facility resulting from the violation not later than thirty days after the person receives the notice mailed under section 3702.532 of the Revised Code or, if the person appeals the director’s determination under section 3702.60 of the Revised Code, thirty days after the person receives an order upholding the director’s determination that is not subject to further appeal. A person that applies for a certificate of need as described in section 3702.542 of the Revised Code shall cease conducting the activity or using the equipment or facility in accordance with the timetable established by the director of health under that section.

If any person determined to have violated section 3702.53 of the Revised Code fails to cease conducting an activity or using equipment or a facility as required by this section or a timetable established under section 3702.542 of the Revised Code, or if the person continues to seek payment or reimbursement for services rendered or costs incurred in conducting the activity as prohibited by section 3702.56 of the Revised Code, in addition to the penalties imposed under section 3702.54, 3702.541, or 3702.542 or former section 3702.543 of the Revised Code:

(A) The director of health may refuse to include any beds involved in the activity in the bed capacity of a hospital for purposes of registration under section 3701.07 of the Revised Code;

(B) The director of health may refuse to license, or may revoke a license or reduce bed capacity previously granted to, a maternity boardinghouse or lying-in hospital under section 3711.02 of the Revised Code; a hospice care program under section 3712.04 of the Revised Code; a nursing home, rest home, or home for the aging under section 3721.02 of the Revised Code; or any beds within any of those facilities that are involved in the activity;

(C) A political subdivision certified under section 3721.09 of the Revised Code may refuse to license, or may revoke a license or reduce bed capacity previously granted to, a nursing home, rest home, or home for the aging, or any beds within any of those facilities that are involved in the activity;

(D) The director of mental health may refuse to license under section 5119.20 of the Revised Code, or may revoke a license or reduce bed capacity previously granted to, a hospital receiving mentally ill persons or beds within such a hospital that are involved in the activity;

(E) The department of job and family services may refuse to enter into a provider agreement that includes a facility, beds, or services that result from the activity.

Effective Date: 09-26-2003

No third-party payer or other person or government entity is required to pay, and no person shall seek or accept payment or reimbursement for, any service rendered or costs incurred in conducting an activity during the period of time in which the activity was conducted in violation of section 3702.53 of the Revised Code. Each person that accepts any amount in violation of this division shall refund that amount on request of the person or government entity that paid it.

Effective Date: 04-20-1995

(A) The public health council shall adopt rules establishing procedures and criteria for reviews of applications for certificates of need and issuance, denial, or withdrawal of certificates.

(1) The rules shall require that, in addition to any other applicable review requirements of sections 3702.51 to 3702.62 of the Revised Code and rules adopted thereunder, any application for a certificate of need from an osteopathic hospital be reviewed on the basis of the need for and the availability in the community of services and hospitals for osteopathic physicians and their patients, and in terms of its impact on existing and proposed institutional training programs for doctors of osteopathy and doctors of medicine at the student, internship, and residency training levels.

(2) In adopting rules that establish criteria for reviews of applications of certificates of need, the council shall consider the availability of and need for long-term care beds to provide care and treatment to persons diagnosed as having traumatic brain injuries and shall prescribe criteria for reviewing applications that propose to add long-term care beds to provide care and treatment to persons diagnosed as having traumatic brain injuries.

(3) The criteria for reviews of applications for certificates of need shall relate to the need for the reviewable activity and shall pertain to all of the following matters:

(a) The impact of the reviewable activity on the cost and quality of health services in the relevant geographic area, including, but not limited, to the historical and projected utilization of the services to which the application pertains and the effect of the reviewable activity on utilization of other providers of similar services;

(b) The quality of the services to be provided as the result of the activity, as evidenced by the historical performance of the persons that will be involved in providing the services and by the provisions that are proposed in the application to ensure quality, including but not limited to adequate available personnel, available ancillary and support services, available equipment, size and configuration of physical plant, and relations with other providers;

(c) The impact of the reviewable activity on the availability and accessibility of the type of services proposed in the application to the population of the relevant geographic area, and the level of access to the services proposed in the application that will be provided to medically underserved individuals such as recipients of public assistance and individuals who have no health insurance or whose health insurance is insufficient;

(d) The activity’s short- and long-term financial feasibility and cost-effectiveness, the impact of the activity on the applicant’s costs and charges, and a comparison of the applicant’s costs and charges with those of providers of similar services in the applicant’s proposed service area;

(e) The advantages, disadvantages, and costs of alternatives to the reviewable activity;

(f) The impact of the activity on all other providers of similar services in the health service area or other relevant geographic area, including the impact on their utilization, market share, and financial status;

(g) The historical performance of the applicant and related or affiliated parties in complying with previously granted certificates of need and any applicable certification, accreditation, or licensure requirements;

(h) The relationship of the activity to the current edition of the state health resources plan issued under section 3702.521 of the Revised Code;

(i) The historical performance of the applicant and related or affiliated parties in providing cost-effective health care services;

(j) The special needs and circumstances of the applicant or population proposed to be served by the proposed project, including research activities, prevalence of particular diseases, unusual demographic characteristics, cost-effective contractual affiliations, and other special circumstances;

(k) The appropriateness of the zoning status of the proposed site of the activity;

(l) The participation by the applicant in research conducted by the United States food and drug administration or clinical trials sponsored by the national institutes of health.

(4) The criteria for reviews of applications may include formulas for determining need for beds and services.

(a) The criteria prescribing formulas shall not, either by themselves or in conjunction with any established occupancy guidelines, require, as a condition of being granted a certificate of need, that a hospital reduce its complement of registered beds or discontinue any service that is not related to the service or project for which the certificate of need is sought.

(b) With respect to applications to conduct reviewable activities that are affected directly by the inpatient occupancy of a health care facility, including addition, relocation, or recategorization of beds or renovation or other construction activities relating to inpatient services, the rules shall prescribe criteria for determining whether the scope of the proposed project is appropriate in light of the historical and reasonably projected occupancy rates for the beds related to the project.

(c) Any rules prescribing criteria that establish ratios of beds, services, or equipment to population shall specify the bases for establishing the ratios or mitigating factors or exceptions to the ratios.

(B) The council shall adopt rules specifying all of the following:

(1) Information that must be provided in applications for certificates of need, which shall include a plan for obligating the capital expenditure or implementing the proposed project on a timely basis in accordance with section 3702.525 of the Revised Code;

(2) Procedures for reviewing applications for completeness of information;

(3) Criteria for determining that the application is complete.

(C) The council shall adopt rules specifying requirements that holders of certificates of need must meet in order for the certificates to remain valid and establishing definitions and requirements for obligation of capital expenditures and implementation of projects authorized by certificates of need.

(D) The council shall adopt rules establishing criteria and procedures under which the director of health may withdraw a certificate of need if the holder fails to meet requirements for continued validity of the certificate.

(E) The council shall adopt rules establishing procedures under which the department of health shall monitor project implementation activities of holders of certificates of need. The rules adopted under this division also may establish procedures for monitoring implementation activities of persons that have received nonreviewability rulings.

(F) The council shall adopt rules establishing procedures under which the director of health shall review certificates of need whose holders exceed or appear likely to exceed an expenditure maximum specified in a certificate.

(G) The council shall adopt rules establishing certificate of need application fees sufficient to pay the costs incurred by the department for administering sections 3702.51 to 3702.62 of the Revised Code and to pay health service agencies for the functions they perform under division (D)(5) of section 3702.58 of the Revised Code. Unless rules are adopted under this division establishing different application fees, the application fee for a project not involving a capital expenditure shall be three thousand dollars and the application fee for a project involving a capital expenditure shall be nine-tenths of one per cent of the capital expenditure proposed subject to a minimum of three thousand dollars and a maximum of twenty thousand dollars.

(H) The council shall adopt rules specifying information that is necessary to conduct reviews of certificate of need applications and to develop recommendations for criteria for reviews that health care facilities and other health care providers are to submit to the director under division (G) of section 3702.52 of the Revised Code.

(I) The council shall adopt rules defining “affiliated person,” “related person,” and “ultimate controlling interest” for purposes of section 3702.524 of the Revised Code.

(J) The council shall adopt rules prescribing requirements for holders of certificates of need to demonstrate to the director under section 3702.526 of the Revised Code that reasonable progress is being made toward completion of the reviewable activity and establishing standards by which the director shall determine whether reasonable progress is being made.

(K) The council shall adopt rules defining high-risk cardiac catheterization patients. High-risk patients shall include patients with significant ischemic syndromes or unstable myocardial infarction, patients who need intervention such as angioplasty or bypass surgery, patients who may require difficult or complex catheterization procedures such as transeptal assessment of valvular dysfunction, patients with critical aortic stenosis or congestive heart failure, and other patients specified by the council.

(L) The public health council shall adopt all rules under divisions (A) to (K) of this section in accordance with Chapter 119. of the Revised Code. The council may adopt other rules as necessary to carry out the purposes of sections 3702.51 to 3702.62 of the Revised Code.

Effective Date: 06-30-1999; 2007 HB119 09-29-2007

(A) The director of health shall designate geographic regions of this state as health service areas and shall designate one health service agency for each health service area. All territory in this state shall be included in a health service area, but no territory shall be included in more than one health service area.

(B) The director shall designate as a health service area any health service area that was so designated in accordance with the former “National Health Planning and Resources Development Act of 1974,” 88 Stat. 2225, 42 U.S.C. 300k, as amended, as of November 13, 1986. The director shall designate as a health service agency any health systems agency designated under such former act that, on June 30, 1987, was performing the functions of a health systems agency as provided for in such former act.

(C) The director may designate health service areas and health service agencies in addition to those designated under division (B) of this section, may revise the boundaries of health service areas, and may revoke the designation of a health service agency and designate a new health service agency for a health service area.

Each health service agency designated under this division shall be a nonprofit private corporation that is incorporated in this state as a corporation that is exempt from federal income taxation under subsection 501(a) and described in subsection 501(c)(3) of the “Internal Revenue Act of 1986,” 100 Stat. 2085, 26 U.S.C.A. 1, as amended, that is not a subsidiary of, or otherwise controlled by, any other private or public corporation or other legal entity.

The board of trustees of each health service agency shall be nominated and elected by the agency’s membership in accordance with procedures specified in the agency’s by-laws. Each trustee shall be a resident of the health service area served by the agency, and any resident of the health service area age eighteen or older is eligible to be nominated. The board of trustees shall be broadly representative of the demographic characteristics of the health service area, including the geographic distribution and density of the population.

A majority of the trustees, but not more than seventy-five per cent, shall represent consumers and major purchasers of health care, including businesses and labor organizations, that are not health care providers. All other trustees shall represent health care providers and, to the extent practicable, shall be representative of the variety of health care disciplines and interests of the health service area. Only the trustees representing health care consumers and purchasers may vote on agency proceedings concerning a certificate of need application. However, no such trustees shall vote on proceedings concerning a certificate of need application if the trustee has a financial interest in the outcome of the proceedings.

A health service agency’s board of trustees may adopt policies governing the agency’s ability to sell health care information and resources to the public, to engage in activities on a fee-for-service basis, and to enter into contractual arrangements. No health service agency shall engage in any fee-for-service activity with a health care facility. Each board of trustees shall hire appropriate staff to perform duties required by the board.

(D) The functions of health service agencies shall include, but not be limited to:

(1) Performing functions related to the planning and implementation of health care facilities and health care services by:

(a) Identifying community health care needs and establishing community-based priorities and implementation strategies;

(b) Developing community-based plans to address identified needs and priorities;

(c) Providing technical assistance on community health care needs assessment and planning and implementation strategies to entities responsible for the delivery of health care services;

(d) Serving as the community resource to ensure that all concerned individuals and organizations of the community are represented and afforded an opportunity to participate in the planning and implementation of the health care systems and services that best meet the needs of the citizens of the health service area;

(e) Submitting to the director of health for inclusion in the state health resources plan issued under section 3702.521 of the Revised Code the local community-based health resources plan, which shall contain an analysis of the distribution of all health services, facilities, and other resources in the health service area, including existing deficiencies and excesses in local health resources;

(f) Submitting annually to the director a supplemental report recommending changes to the state health resources plan as it deems appropriate by the community health planning process.

(2) Performing functions related to monitoring of the health care system in the health service area, including:

(a) Compiling, analyzing, and disseminating technical information and data identifying statistical trends and gaps in health care services;

(b) Evaluating progress toward meeting local and state health care goals as established by their respective planning processes;

(c) Serving as the health service area community health information center by:

(i) Making available to the general public information about the quality, including performance and outcomes, and cost of, and access to, the health care delivery services and systems;

(ii) Maintaining copies of reports on utilization of, participation in, and performance of health care reform initiatives, including OhioCare, any health insurance access programs, and other health care cost, quality, and access reform program;

(iii) Maintaining copies of all reports required by state agencies that pertain to health care services, utilization, and cost.

(3) Conducting the following community activities:

(a) Informing and educating the public on health care issues, concerns, and proposed solutions, such as educating the public about the proper use of health care delivery reform initiatives;

(b) Providing forums for solving problems, resolving conflicts, and building consensus;

(c) Publishing and making available to the public reports on health care utilization, cost, and quality of services;

(d) Establishing and maintaining educational programs and other informational resources for promoting improvement in the health of the residents in the health service area.

(4) Promoting improvements in the health of the residents of the health service area by helping