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The Certificate of Public Need Program in Virginia Code of Virginia and Regulation Review HB 2177 Task Force Erik Bodin, Director VDH Office of Licensure and Certification August 19, 2015

The Certificate of Public Need Program in Virginia Code of Virginia and Regulation Review HB 2177 Task Force Erik Bodin, Director VDH Office of Licensure

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The Certificate of Public Need Program in Virginia

Code of Virginia and Regulation Review

HB 2177 Task Force

Erik Bodin, DirectorVDH Office of Licensure and

CertificationAugust 19, 2015

The Certificate of Public Need Review Process is Established in:

• The Code of Virginia at §32.1-102.1 through §32.1-102.11

(The Code)

• Virginia Medical Care Facilities Certificate of Public Need Rules and Regulations 12VAC 5-220

(The Regulations)

• The State Medical Facilities Plan 12VAC 5-230 through 12VAC 5-360

(The SMFP)

Requirement for a COPN

§ 32.1-102.3. Certificate required; criteria for determining need.

A.No person shall commence any project without first obtaining a certificate issued by the Commissioner.

§ 32.1-102.1. Definitions."Project" means:1. Establishment of a medical care facility;

Medical Care Facility§ 32.1-102.1. Definitions."Medical care facility,”…, means any institution, place, building or

agency, whether or not licensed or required to be licensed by the Board or the Department of Behavioral Health and Developmental Services, whether operated for profit or nonprofit and whether privately owned or privately operated or owned or operated by a local governmental unit, (i) by or in which health services are furnished, conducted, operated or offered for the prevention, diagnosis or treatment of human disease, pain, injury, deformity or physical condition, whether medical or surgical, of two or more nonrelated persons who are injured or physically sick or have mental illness, or for the care of two or more nonrelated persons requiring or receiving medical, surgical or nursing attention or services as acute, chronic, convalescent, aged, physically disabled or crippled or (ii) which is the recipient of reimbursements from third-party health insurance programs or prepaid medical service plans.

Medical Care FacilityFacilities Subject to COPN Review

§ 32.1-102.1. Definitions."Medical care facility," …only the following medical care facilities shall be subject to

review:

1. General hospitals.

2. Sanitariums.

3. Nursing homes.

4. Intermediate care facilities…(ICF/IID)

5. Extended care facilities.

6. Mental hospitals.

7. Facilities for individuals with intellectual disability.

8. Psychiatric hospitals and intermediate care facilities established primarily for the medical, psychiatric or psychological treatment and rehabilitation of individuals with substance abuse.

Medical Care FacilityFacilities Subject to COPN Review continued

9. Specialized centers or clinics or that portion of a physician's office developed for the provision of:

• outpatient or ambulatory surgery,

• cardiac catheterization, • computed tomographic

(CT) scanning, • stereotactic

radiosurgery, • lithotripsy, • magnetic resonance

imaging (MRI), • magnetic source imaging

(MSI),

• positron emission tomographic (PET) scanning,

• radiation therapy, • stereotactic

radiotherapy, • proton beam therapy, • Non-cardiac nuclear

medicine imaging, • Or other specialty

services designated by the Board by regulation.

Medical Care FacilityFacilities Subject to COPN Review continued

10. Rehabilitation hospitals.11. Any facility licensed as a hospital.

The term "medical care facility" does not include any facility of:

(i) the Department of Behavioral Health and Developmental Services; (ii) any nonhospital substance abuse residential treatment program

operated by or contracted primarily for the use of a community services board under the Department of Behavioral Health and Developmental Services' Comprehensive State Plan;

(iii) an intermediate care facility for individuals with intellectual disability (ICF/MR) that has no more than 12 bed …;

(iv) a physician's office, except that portion of a physician's office described in subdivision 9 of the definition of "medical care facility";

(v) the Wilson Workforce and Rehabilitation Center of the Department for Aging and Rehabilitative Services;

(vi) the Department of Corrections; or (vii) the Department of Veterans Services.

"Medical care facility" shall also not include that portion of a physician's office dedicated to providing nuclear cardiac imaging.

Definition of COPN ProjectContinued

§ 32.1-102.1. Definitions.

"Project" means:1. Establishment of a medical care facility;

2. An increase in the total number of beds or operating rooms in an existing medical care facility;

Definition of ProjectContinued

3. Relocation of beds from one existing facility to another, provided that "project" does not include the relocation of up to 10 beds or 10 percent of the beds, whichever is less, …a hospital shall not be required to obtain a certificate for the use of 10 percent of its beds as nursing home beds as provided in § 32.1-132;

4. Introduction into an existing medical care facility of any new nursing home service, such as intermediate care facility services, extended care facility services, or skilled nursing facility services, regardless of the type of medical care facility in which those services are provided;

Definition of Project Continued

5. Introduction into an existing medical care facility of any new (which the facility has never provided or has not provided

in the previous 12 months;)

•cardiac catheterization, •computed tomographic (CT) scanning, •stereotactic radiosurgery, •lithotripsy, •magnetic resonance imaging (MRI), •magnetic source imaging (MSI), •medical rehabilitation, •neonatal special care, •obstetrical, •open heart surgery,

•positron emission tomographic (PET) scanning, •psychiatric, •organ or tissue transplant service, •radiation therapy, •stereotactic radiotherapy, •proton beam therapy, •nuclear medicine imaging, …•substance abuse treatment, •or such other specialty clinical services as may be designated by the Board…,

Definition of Project Continued 6. Conversion of beds in an existing medical care facility to medical rehabilitation beds or psychiatric beds;

•cardiac catheterization,•computed tomographic (CT) scanning,•stereotactic radiosurgery,•lithotripsy,•magnetic resonance imaging (MRI),•magnetic source imaging (MSI),•open heart surgery,

•positron emission tomographic (PET) scanning,•radiation therapy, •stereotactic radiotherapy,•proton beam therapy, or• other specialized service designated by the Board by regulation. •replacement of existing equipment shall not require a COPN

7. The addition by an existing medical care facility of any medical equipment for the provision of;

Definition of Project Continued

8. Any capital expenditure of $15 million or more, not defined as reviewable in subdivisions 1 through 7 of this definition, by or on behalf of a medical care facility other than a general hospital. Capital expenditures of $5 million or more by a general hospital and capital expenditures between $5 and $15 million by a medical care facility other than a general hospital shall be registered with the Commissioner pursuant to regulations developed by the Board. The amounts specified in this subdivision shall be revised effective July 1, 2008, and annually thereafter to reflect inflation using appropriate measures incorporating construction costs and medical inflation. Nothing in this subdivision shall be construed to modify or eliminate the reviewability of any project described in subdivisions 1 through 7 of this definition when undertaken by or on behalf of a general hospital; or

Definition of Project Continued

9. Conversion in an existing medical care facility of psychiatric inpatient beds approved pursuant to a Request for Applications (RFA) to nonpsychiatric inpatient beds.

Decision Criteria

§ 32.1-102.3. Certificate required; criteria for determining need.

A. ... If it is determined that a public need exists for only a portion of a project, a certificate may be issued for that portion and any appeal may be limited to the part of the decision with which the appellant disagrees without affecting the remainder of the decision...

B. In determining whether a public need for a project has been demonstrated, the Commissioner shall consider:

1. The extent to which the proposed service or facility will provide or increase access to needed services for residents of the area to be served, and the effects that the proposed service or facility will have on access to needed services in areas having distinct and unique geographic, socioeconomic, cultural, transportation, and other barriers to access to care;

Statutory ConsiderationsContinued

2. The extent to which the project will meet the needs of the residents of the area to be served, as demonstrated by each of the following: (i) the level of community support for the project…; (ii) the availability of reasonable alternatives to the

proposed service or facility …; (iii)any recommendation or report of the regional

health planning agency …; (iv)Any costs and benefits of the project; (v) the financial accessibility of the project ….; and (vi)at the discretion of the Commissioner, any other

factors as may be relevant to the determination of public need for a project;

Statutory ConsiderationsContinued

3. The extent to which the application is consistent with the State Medical Facilities Plan;

§ 32.1-102.3.A. Certificate required; criteria for determining need.…Any decision to issue or approve the issuance of a certificate shall be Consistent with the most recent applicable provisions of the State Medical Facilities Plan;…

§ 32.1-102.3.A. Certificate required; criteria for determining need.…Any decision to issue or approve the issuance of a certificate shall be Consistent with the most recent applicable provisions of the State Medical Facilities Plan;…

SMFP Regulatory Actions

• 1993 – Post deregulation SMFP

• 1999 – Emergency language for rural considerations

• 2003 – Permanent regulations for rural considerations

• 2009 – Comprehensive Revision

• 2014 – Capital expense dollar threshold

• 2015 – NOIRA Stage complete for cardiac catheterization and long term care

SMFP Set Aside

§ 32.1-102.3.A. Certificate required; criteria for determining need.

…if the Commissioner finds, upon presentation of appropriate evidence, that the provisions of such plan are not relevant to a rural locality's needs, inaccurate, outdated, inadequate or otherwise inapplicable, the Commissioner, consistent with such finding, may issue or approve the issuance of a certificate and shall initiate procedures to make appropriate amendments to such plan. In cases in which a provision of the State Medical Facilities Plan has been previously set aside by the Commissioner and relevant amendments to the Plan have not yet taken effect, the Commissioner's decision shall be consistent with the applicable portions of the State Medical Facilities Plan that have not been set aside and the remaining considerations in subsection B.

SMFP Task Force§ 32.1-102.2:1. State Medical Facilities Plan; task

force.The Board shall appoint and convene a task force of no

fewer than 15 individuals to meet at least once every two years. The task force shall consist of representatives from the Department and the Division of Certificate of Public Need, representatives of regional health planning agencies, representatives of the health care provider community, representatives of the academic medical community, experts in advanced medical technology, and health insurers. The task force shall complete a review of the State Medical Facilities Plan updating or validating existing criteria in the State Medical Facilities Plan at least every four years.

SMFP Task Force• First SMFP Task Force panel 2008

• Radiation Therapy• Acute Care Beds• Diagnostic Imaging (CT / MRI / PET)• Lithotripsy• Rehabilitation• “Emerging Technologies”

• Second SMFP Task Force Panel 2013• Radiation Therapy• Long Term Care • Cardiac Catheterization

• Third SMFP Task Force Panel 2015• Psychiatric Services• Intermediate Care Facilities for Substance Abuse

SMFP Guiding Principles12VAC5-230-30. Guiding Principles in the Development of

Project Review Criteria and Standards.1. The COPN program is based on the understanding that excess

capacity or underutilization of medical facilities are detrimental to both cost effectiveness and quality of medical services in Virginia.

2. The COPN program seeks the geographical distribution of medical facilities and to promote the availability and accessibility of proven technologies.

3. The COPN program seeks to promote the development and maintenance of services and access to those services by every person who needs them without respect to their ability to pay.

4. The COPN program seeks to encourage the conversion of facilities to new and efficient uses and the reallocation of resources to meet evolving community needs.

5. The COPN program discourages the proliferation of services that would undermine the ability of essential community providers to maintain their financial viability.

SMFP Review CriteriaService

Geographic Basis

Distance minutes

Measure for New

Measure to Expand

1st Year Volume

2nd Year Volume

Hospital Beds PD 30 805% 805% OccupancyFormula to determine number, by type, needed

Nursing Home Beds PD 30 93% 93% OccupancyBy RFA Only

Operating Rooms PD 30 1,600 hrs Formula to determine number of ORs neededOpen Heart Surgery PD 60 400 400 150 250 ProceduresCardiac Catheterization PD 60 1,200 1,200 200 500 ProceduresPediatric Cardiac Catheterization PD 60 100 200 ProceduresOrgan Transplant, Kidney Va 120 30 30 Transplants Pancreas or Kidney/Pancreas Va 120 12 12 Transplants Heart Va 120 17 17 Transplants Heart/Lung or Lung Va 120 12 12 Transplants Liver Va 120 21 21 Transplants Intestine Va 120 2 2 TransplantsObstetrical Services PD 30 Population and utilizationNeonatal Special Care - Intermediate from

general Ob30 85% Occupancy of lower level

Speciality & Sub-speciality from other Ob

90 85% Occupancy of lower level

Inpatient Rehabilitation PD 60 80% Rehab OccupancyEst new service when none in PD & population based formula

Inpatient Psychiatric PD 60 Est new service when none in PD & population based formulaIntermediate Care Facility for Individuals with Intellectual Disability

PD Max 20 beds, DMHDS plan

CT Scanner PD 30 7,400 7,400 ScansMRI Scanner PD 30 5,000 5,000 ScansPET PD 60 6,000 6,000 ScansNon-Cardiac Nuclear Imaging PD 30 650 1,000 ScansRadiation Therapy PD 60 8,000 5,000 Procedures

Formula to determine number of accelerators needed

Stereotactic Radiosurgery HPR 60 350 350 250 ProceduresRenal Lithotripsy HPR 30 750 750 ProceduresOrthopedic Lithotripsy HPR 30 500 500 Procedures

Statutory ConsiderationsContinued

4. The extent to which the proposed service or facility fosters institutional competition that benefits the area to be served while improving access to essential health care services for all persons in the area to be served;

5. The relationship of the project to the existing health care system of the area to be served, including the utilization and efficiency of existing services or facilities;

6. The feasibility of the project, including the financial benefits of the project to the applicant, the cost of construction, the availability of financial and human resources, and the cost of capital;

Statutory ConsiderationsContinued

7. The extent to which the project provides improvements or innovations in the financing and delivery of health services, as demonstrated by:

(i) the introduction of new technology that promotes quality, cost effectiveness, or both in the delivery of health care services;

(ii) the potential for provision of services on an outpatient basis;

(iii) any cooperative efforts to meet regional health care needs; and (iv) at the discretion of the Commissioner, any other factors as may be appropriate; and

Statutory ConsiderationsContinued

8. In the case of a project proposed by or affecting a teaching hospital associated with a public institution of higher education or a medical school in the area to be served,

(i) the unique research, training, and clinical mission of the teaching hospital or medical school, and

(ii) any contribution the teaching hospital or medical school may provide in the delivery, innovation, and improvement of health care for citizens of the Commonwealth, including indigent or underserved populations.

COPN Review ProcessLetter of Intent

12VAC5-220-180. Application Forms.A.Letter of intent. • by the later of

• 30 days prior to the submission of an application for a project included within a particular batch group or

• 10 days after the first letter of intent is filed for a project within a particular batch group for the same or similar services and facilities for the same area.

COPN Review ProcessApplication

12VAC5-220-180. Application Forms.

C. Filing application forms. Applications must be submitted at least 40 days prior to the first day of a scheduled review cycle to be considered for review in the same cycle.

COPN Review ProcessCompleteness Review

§ 32.1-102.6. Administrative procedures.

Within 10 calendar days of the date on which the document is received, the Department and the appropriate regional health planning agency, if a regional health planning agency has been designated, shall determine whether the application is complete or not and the Department shall notify the applicant, if the application is not complete, of the information needed to complete the application.

COPN Review ProcessRegional Health Planning Agency

Review§ 32.1-102.6. Administrative procedures.B. …the appropriate regional health planning agency shall (i) review each completed application for a certificate

within 60 calendar days of beginning of the batch review cycle and

(ii) hold one public hearing on each application in a location

in the county or city in which the project is proposed or a contiguous county or city.

The regional health planning agency shall submit its recommendations on each application and its reasons therefore to the Department within 10 calendar days after the completion of its 60-calendar-day review.

COPN Review ProcessStaff Review of the Application

§ 32.1-102.6. Administrative procedures.

D. The Department shall commence the review of each completed application upon the beginning of the batch review cycle.

A determination whether a public need exists for a project shall be made by the Commissioner within 190 calendar days of the day which begins the appropriate batch cycle.

E. Upon entry of each completed application or applications into the appropriate batch review cycle:

2. The Department shall review every application at or before the seventy-fifth calendar day within the 190-calendar-day review period to determine whether an informal fact-finding conference is necessary.

COPN Review ProcessInformal Fact-Finding Conference

§ 32.1-102.6. Administrative procedures.

E. Upon entry of each completed application or applications into the appropriate batch review cycle:

1. The Department shall establish a date between the 80th and 90th calendar days within the 190-calendar-day review period for holding an informal fact-finding conference (IFFC).

3. Any person seeking to be made a party to the case for good cause shall notify the Department of his request on or before the 80th calendar day following the beginning of the batch review cycle.

4. In any case in which an IFFC is held, a date shall be established for the closing of the record which shall not be more than 30 calendar days after the date of the IFFC.

5. In any case in which an IFFC is not held, the record shall close on the earlier of (i) the date established for holding the IFFC or (ii) the date that the Department determines an IFFC is not necessary.

COPN Review ProcessDecision

§ 32.1-102.6.E. Administrative procedures.A decision is required within 45 calendar days of the closing of the

record. If a decision is not made within 45 days of the closing of the record, the Commissioner shall, give notice to the applicant(s) and any persons seeking to show good cause, that the application(s) shall be deemed approved 25 calendar days after expiration of the 45-day period, unless a decision is made within that 25-day period.

In any case when a determination whether a public need exists for a project is not made by the Commissioner within 70 calendar days after the closing of the record, the application shall be deemed to be approved and the certificate shall be granted.

§ 32.1-102.3. Certificate required; criteria for determining need.If it is determined that a public need exists for only a portion of a

project, a certificate may be issued for that portion and any appeal may be limited to the part of the decision with which the appellant disagrees without affecting the remainder of the decision.

COPN Review ProcessDelays in the Review Schedule

§ 32.1-102.6. Administrative procedures.

I. The applicants, and only the applicants, shall have the authority to extend any of the time periods specified in this section. If all applicants consent to extending any time period in this section, the Commissioner, with the concurrence of the applicants, shall establish a new schedule for the remaining time periods.

Process for Nursing Home ProjectsRequest for Applications

§ 32.1-102.3:2. Certificates of public need; applications to be filed in response to Requests for Applications (RFAs).

A. Except for applications for continuing care retirement community nursing home bed projects the Commissioner shall only approve, authorize or accept applications for the issuance of any COPN only in response to Requests for Applications (RFAs) for any project which would result in an increase in the number of nursing facility beds in a planning district.

Process for Nursing Home ProjectsRequest for Applications

§ 32.1-102.3:2. Certificates of public need; applications to be filed in response to Requests for Applications (RFAs).

B. …The RFAs, which shall be published at least annually, shall be jointly developed by the Department and the Department of Medical Assistance Services. RFAs shall be based on analyses of the need, or lack thereof, for increases in the nursing home bed supply in each of the Commonwealth's planning districts.

Process for Nursing Home ProjectsRequest for Applications

12VAC5-230-610. Need for New Service.A. A health planning district should be considered to have a

need for additional nursing facility beds when: 1. The bed need forecast exceeds the current inventory of beds

for the health planning district; and 2. The average annual occupancy of all existing and authorized

Medicaid-certified nursing facility beds in the health planning district was at least 93%, excluding the bed inventory and utilization of the Virginia Veterans Care Centers.

B. No health planning district should be considered in need of additional beds if there are unconstructed beds designated as Medicaid-certified. This presumption of ‘no need' for additional beds extends for three years from the issuance date of the certificate.

Process for Nursing Home ProjectsException to the RFA

§ 32.1-102.3:7. Application for transfer of nursing facility beds.A. Notwithstanding the RFA process, the Commissioner may approve

applications for the transfer of nursing facility beds from one planning district to another when no RFA has been issued in cases in which the applicant can demonstrate (i) there is a shortage of nursing facility beds in the planning district to which beds are proposed to be transferred, (ii) the number of nursing facility beds in the planning district from which beds are proposed to be moved exceeds the need for such beds, (iii) the proposed transfer of nursing facility beds would not result in creation of a need for additional beds in the planning district from which the beds are proposed to be transferred, and (iv) the nursing facility beds proposed to be transferred will be made available to individuals in need of nursing facility services in the planning district to which they are proposed to be transferred without regard to the source of payment for such services.

Process for Nursing Home ProjectsContinuing Care Retirement

Communities§ 32.1-102.3:2. Certificates of public need; applications to

be filed in response to Requests for Applications (RFAs).

Applications for continuing care retirement community (CCRC) nursing home bed projects can only be accepted if:

• the facility is registered with the State Corporation Commission as a continuing care provider,

• the number of new nursing home beds does not exceed the lesser of 20% of the CCRC's total number of non-nursing home beds or 60 beds,

• the number of new nursing home beds requested in any subsequent application does not cause the CCRC's total number of nursing home beds to exceed 20 percent of its total number of non-nursing home beds, and

• the CCRC has established a qualified resident assistance policy.

Registration Under COPN§ 32.1-102.1:1

12VAC5-220-105. Requirements for Registration of the Replacement of Existing Medical Equipment &12VAC5-220-110. Requirements for Registration of Certain Capital Expenditures.

Within 30 days of any person contracting to make, or otherwise legally obligating to make, a capital expenditure for the replacement of medical equipment listed in the definition of "project" or a new capital expenditure by or on behalf of a medical care facility such expenditure shall be registered with the commissioner.

The replacement registration shall identify the specific unit of equipment to be replaced and the estimated capital cost of the replacement and shall include documentation that the equipment to be replaced has previously been authorized or exempted from COPN.

The format for registration shall include information concerning the purpose of such expenditure and projected impact that the expenditure will have upon the charges for services.

§ 32.1-102.5. Certificate not transferable.No certificate issued for a project shall be transferable.

§ 32.1-102.8. Enjoining project undertaken without certificate.

On petition of the Commissioner, the Board or the Attorney General, the circuit court of the county or city where a project is under construction or is intended to be constructed, located or undertaken shall have jurisdiction to enjoin any project which is constructed, undertaken or commenced without a certificate or to enjoin the admission of patients to the project or to enjoin the provision of services through the project.

§ 32.1-102.10. Commencing project without certificate grounds for refusing to issue license.

Commencing any project without a certificate required by this article shall constitute grounds for refusing to issue a license for such project. Persons commencing any project without a certificate as required by this article shall be subject to the penalties set forth in §§ 32.1-27 and 32.1-27.1.

COPN Monitoring§ 32.1-102.4. Conditions of certificates; monitoring; revocation of

certificates.A certificate shall be issued with a schedule for the completion of the

project and a maximum capital expenditure amount. The schedule may not be extended and the maximum capital expenditure may not be exceeded without the approval of the Commissioner in accordance with the regulations of the Board.

The Commissioner shall monitor each project for which a certificate is issued to determine its progress and compliance with the schedule and with the maximum capital expenditure. The Commissioner shall also monitor all continuing care retirement communities for which a certificate is issued authorizing the establishment of a nursing home facility. Any willful violation of a provision of § 32.1-102.3:2 or conditions of a certificate of public need granted under the provisions of § 32.1-102.3:2 shall be subject to a civil penalty of up to $100 per violation per day until the date the Commissioner determines that such facility is in compliance.

COPN Condition Enforcement§ 32.1-102.4. Conditions of certificates; monitoring;

revocation of certificates.The Commissioner may condition, pursuant to the regulations of the

Board, the approval of a certificate (i) upon the agreement of the applicant to provide a level of care at a reduced rate to indigents or accept patients requiring specialized care or (ii) upon the agreement of the applicant to facilitate the development and operation of primary medical care services in designated medically underserved areas of the applicant's service area.

The certificate holder shall provide documentation to the Department demonstrating that the certificate holder has satisfied the conditions of the certificate. The Department may approve alternative methods to satisfy the conditions pursuant to a plan of compliance. The plan of compliance shall identify a timeframe within which the certificate holder will satisfy the conditions of the certificate, and identify how the certificate holder will satisfy the conditions of the certificate, which may include

Failure to Meet Condition

§ 32.1-102.4. Conditions of certificates; monitoring; revocation of certificates.

Any person willfully refusing, failing, or neglecting to honor such agreement (COPN Condition) shall be subject to a civil penalty of up to $100 per violation per day until the date of compliance.

Authority for COPN Regulations§ 32.1-102.2. Regulations.A. The Board shall promulgate regulations which are consistent

with this article and:1. Shall establish concise procedures for the prompt review of

applications for certificates consistent with the provisions of this article which may include a structured batching process which incorporates, but is not limited to, authorization for the Commissioner to request proposals for certain projects.

2. May classify projects and may eliminate one or more or all of the procedures prescribed in § 32.1-102.6 for different classifications;

3. May provide for exempting from the requirement of a certificate projects determined by the Commissioner, upon application for exemption, to be subject to the economic forces of a competitive market or to have no discernible impact on the cost or quality of health services;

Authority for COPN RegulationsContinued

4. Shall establish specific criteria for determining need in rural areas, giving due consideration to distinct and unique geographic, socioeconomic, cultural, transportation, and other barriers to access to care in such areas and providing for weighted calculations of need based on the barriers to health care access in such rural areas in lieu of the determinations of need used for the particular proposed project within the relevant health systems area as a whole;

5. May establish a schedule of fees for applications for certificates to be applied to expenses for the administration and operation of the certificate of public need program. Such fees shall not be less than $1,000 nor exceed the lesser of one percent of the proposed expenditure for the project or $20,000.

Authority for COPN RegulationsContinued

6. Shall establish an expedited application and review process for any certificate for projects reviewable pursuant to subdivision 8 of the definition of "project" in § 32.1-102.1. Regulations establishing the expedited application and review procedure shall include provisions for notice and opportunity for public comment on the application for a certificate, and criteria pursuant to which an application that would normally undergo the review process would instead undergo the full certificate of public need review process set forth in § 32.1-102.6.

Authority for COPN RegulationsContinued

§ 32.1-102.2. Regulations.B. The Board shall promulgate regulations providing for

time limitations for schedules for completion and limitations on the exceeding of the maximum capital expenditure amount for all reviewable projects. The Commissioner shall not approve any such extension or excess unless it complies with the Board's regulations. However, the Commissioner may approve a significant change in cost for an approved project that exceeds the authorized capital expenditure by more than 20 percent, provided the applicant has demonstrated that the cost increases are reasonable and necessary under all the circumstances and do not result from any material expansion of the project as approved.

Authority for COPN RegulationsContinued

C. The Board shall also promulgate regulations authorizing the Commissioner to condition approval of a certificate on the agreement of the applicant to provide a level of care at a reduced rate to indigents or accept patients requiring specialized care. In addition, the Board's licensure regulations shall direct the Commissioner to condition the issuing or renewing of any license for any applicant whose certificate was approved upon such condition on whether such applicant has complied with any agreement to provide a level of care at a reduced rate to indigents or accept patients requiring specialized care.

Questions?