Certificate of Need (CON) Overview

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Like many other states, West Virginia has an extensive CON process in place for healthcare services and facilities. Winning approval for a CON application is often a time consuming and difficult undertaking. Working with RPC provides clients with a team of consultants with experience working with CON projects.

When working on a CON project, RPC can prepare the entire CON application or sections of the application as the client prefers. When the client is defining the project and deciding whether to apply, RPC can help assess the market and regulatory situation to determine the relative likelihood of success for a project. RPC not only completes a thorough review of the competitive environment, market need and financial analysis, but also works seamlessly with the client’s staff, architects, engineers, and other outside consultants to create a solid CON application.

RPC is led by Ron Luke, JD, PhD, who has prepared CON applications and presented testimony in CON hearings since 1981 in over 20 states.  RPC’s work on CON projects includes the opening of new acute care hospitals, hospices, physical rehabilitation and psychiatric specialty hospitals, ambulatory surgery centers and nursing homes, the relocation and addition of beds, and acquiring major medical equipment. Working with RPC during the CON process gives the applicant the advantage of a skilled, experienced team that can provide expert advice and produce an effective CON application.

State Agencies

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West Virginia Healthcare Authority
Generally referred to on CON materials as “the authority,” this group administers the CON program.  The authority reviews and rules on applications.

Certificate of Need Staff
The staff consists of a director and two analysts.

Certificate of Need Program
West Virginia Health Care Authority
100 Dee Drive
Charleston, West Virginia 25311-1692
(304) 558-7000

Services that Require CON

West Virginia issues a Certificate of Need (CON) to indicate a health service’s compliance with W. Va. Code §16-2D-1 et seq., and to fulfill a need in the community.  The program intends to provide protection for small, rural hospitals, discourage duplicative services, control costs, make services available to all residents of the state, and improve quality and efficiency in the health care system.  In West Virginia, all healthcare providers, unless otherwise exempt, must obtain a CON before:

  • Developing or acquiring new health care facilities
  • Exceeding the capital expenditure threshold of $5,803,788
  • Obtaining major medical equipment valued at $5,803,788 or more
  • Adding or expanding health care services, including:
    • Hospitals
    • Acute care bed expansion
    • Birthing centers
    • Surgical services / Operating rooms
    • Rehabilitation facilities
    • Radiation therapy
    • Cardiac catheterization
    • Skilled nursing facilities
    • Kidney disease treatment centers
    • Freestanding hemodialysis units
    • Transplant programs
    • Intermediate care facilities
    • Ambulatory health care facilities
    • Ambulatory surgical facilities
    • Home health agencies
    • Hospice agencies
    • Personal care services
    • Diagnostic imaging
    • Magnetic resonance imaging (MRI)
    • Computed tomography
    • Positron emission tomography (PET)

Moratoriums

The following services are currently ineligible to receive a certificate of need:

  • Addition of intermediate care or skilled nursing beds at an existing facility
  • New or replacement skilled nursing facilities
  • Intermediate care beds for individuals with intellectual disabilities
  • Opioid treatment programs

CON-Exempt Services

The following services may be developed without obtaining a certificate of need or receiving approval from the authority:

  • Private offices for one or more health professionals
  • Dispensaries and employee health services solely for the use of employees
  • Spiritual care services
  • Telehealth
  • Laboratory or diagnostic imaging facilities owned by health professionals where at least 75 percent of the services are provided to patients of the practice
  • Sale of a financially distressed hospital
  • Acquisition by a qualified hospital of another hospital within twenty (20) miles of the main campus facility
  • Hospital acquisition of a physician practice that owns an ambulatory surgery center

In addition, specific services may apply for a certificate of need exemption by submitting a statement describing which exemption criteria apply and the circumstances that justify an exemption.

Certain projects qualify for expedited review if they create a minimal impact upon the scope, quality or cost of health services to be provided by the facility. The projects may include, but are not limited to:

  • changes required in order to comply with codes, laws, rules and standards
  • capital expenditures not involving the renovation/replacement of beds, a substantial change to bed capacity, or a substantial change to services provided
  • replacement of equipment
  • acquisition of health care facilities
  • substantial change to a new institutional health service for which a CON is in effect
  • applications for non-health related projects
  • any other application within the discretion of the authority when there are no letters of intent on file for projects that may be potentially unnecessarily duplicative

Certificate of Need Process Milestones

The Standard Application review cycle occurs in batches four times per year.  Expedited and Non-Health Projects have specialized review cycles.  To obtain a standard CON, the client will follow the process described below.

  1. File Letter of Intent (LOI)
    The applicant files the LOI ten days before submitting a CON application.  The LOI provides project description, applicant information, estimated project cost, proposed location, and time frame.
  2. File Application
    The certificate of need application must be submitted ten days after the LOI is filed. Applicants must file by the prescribed batch cycle application deadline.  Fees are submitted at the time of application. Applicants must submit two copies of the application, with the original copy in a three-hole binder with alphabetized section dividers. One unbound and unstapled copy must also be submitted.
  3. Review for Completeness
    The Certificate of Need staff reviews applications for completeness.  Within ten days, the application will either be declared complete or a request for additional information will be issued.  Staff has ten additional days to review completeness after receiving additional information.
  4. Publication
    The West Virginia Health Care Authority publishes notice within five days of receiving the LOI. The notice is posted on the authority’s website and in a newspaper with general circulation within the service area for the proposed project.
  5. Public Hearing
    Any affected person may submit a written request for a public hearing within 30 calendar days from the date the application is batched.  Any party may be represented by counsel and may present oral or written arguments and evidence relevant to the project.
  6. Review
    The file closes on the 75th day of the review cycle.  The authority measures the application against standard review criteria and considers information from the public hearing.
  7. Decision
    The authority makes a decision on the application by the 90th day of the review cycle and mails the decision and written findings to the applicant. Additional copies are available to other parties upon request.
  8. Reconsideration
    Within 30 days of the decision, any person may request reconsideration of a decision rendered by the authority by demonstrating good cause (e.g., presenting relevant information not previously considered, changes in circumstances, material failure to follow procedures by the authority, etc).  In the following 30 days, the authority may hold hearings for the reconsideration request.  After hearings conclude, the authority has up to 45 days to deliver a final decision.
  9. Appeal Process
    The appeal deadline is 30 days from the date of the authority’s initial decision (if reconsideration is not sought), the date the authority denies reconsideration, or the date it renders reconsideration.  The Office of Judges, Bureau of Employment Programs reviews the authority’s decision in conformance with the West Virginia Rules of Civil Procedure and the local rules for the civil courts of Kanawha County.
  10. Judicial Review
    The Office of Judges’ decision may be appealed to the circuit court of Kanawha County for review in accordance with the judicial review process.
  11. Progress Reports
    A certificate of need is valid for one year from the date of issuance. The applicant files progress reports according to its application timetable.  A report must be filed at least 45 days prior to the expiration of the certificate of need or exemption.  Progress reports include a description of the project’s current status, projected completion date, cause(s) of delays, changes in the project, and projected total cost.

What Criteria are Used to Review a CON?

The authority considers many service-specific criteria, but generally it considers:

  • Need

Need is determined by type-specific CON standards for 22 services.  Need methodology uses population-based quantifiable data; an applicant’s proposal must not exceed the need amount predetermined by the methodology.

  • Superiority to alternatives

The authority considers whether other options (existing or possible) may be less costly or more efficient.  The applicant must demonstrate that its project is superior to all alternatives.

  • Accessibility

Is the project accessible to the medically underserved?  Would patients have problems obtaining care without the proposed service?  The proposal cannot adversely affect the viability of an existing facility that serves a population of more than 10,000 who do not have 30-minute access to another hospital.

  • Financial feasibility and resources

The authority considers the total fiscal liability to the state for the proposed project. Staffing resources and funding for capital or operational needs must match the facility’s plans.  The authority evaluates the immediate and long-range development/financing plans and probable impact on charges for services.

  • Relationships

The project must be consistent with the State Health Plan.  The authority also assesses the proposal’s relationship to the existing healthcare system in the area and ancillary/support services.

  • Quality

The applicant demonstrates compliance with applicable licensing and certification requirements.

  • Continuum of care

The applicant must demonstrate that it has effective utilization review, quality assurance, peer review, and discharge planning processes.

  • Special needs and circumstances

For example, a medical school would have certain needs and unique circumstances.

Certificate of Need Application Filing Fees

Application fees are based on the project’s total capital expenditure. Project costing up to $1,500,000 must pay a $1,500 fee. Projects between $1,500,001 and $5,000,000 must pay a $5,000 fee. Projects between $5,000,001 and $25,000,000 must pay a $25,000 fee. Projects costing more than $25,000,000 must pay a fee of $35,000. A determination of reviewability costs $100. Exemptions require filing an exemption application, along with a nonrefundable $1,000 fee.

Additional Sources

(links good as of January 2022)

West Virginia Health Care Authority, Certificate of Need
https://hca.wv.gov/certificateofneed/Pages/default.aspx

CON Statute
http://www.wvlegislature.gov/WVCODE/Code.cfm?chap=16&art=2D#02D

CON Application Forms
https://hca.wv.gov/certificateofneed/Pages/Applications.aspx

Review Cycle Schedules
https://hca.wv.gov/certificateofneed/Documents/Review%20Cycle%202022.pdf

Contact RPC Consulting
Should you or your client need an expert team to help you with the West Virginia Certificate of Need Process (CON) please contact Dr. Ron Luke at 512-371-8166.

Disclaimer: The information on this page has been compiled by RPC in June 2010 and was updated in January 2022 based on sources believed to be reliable. Where possible we have had the material reviewed by state CON officials or others knowledgeable of the state’s CON program. The information is not offered as legal advice. A state may change its rules, forms and procedures at any time and RPC offers no assurance that the information will be correct on the date it is viewed. Therefore the reader is urged to use this information only as a starting point for any CON application and to speak with state officials or seek legal or consulting advice early in the process.