The WV Health Care Authority has filed a second draft of the proposed Certificate of Need (CON) Standards with the Secretary of State for the provision of Computed Tomography (CT) scanner services. These standards are a next step in the process since the passage of a legislative rule last Legislative Session which modified the requirements for healthcare providers offering diagnostic services. The proposed standards are out for public comment until October 12. The WVSMA is encouraging our members who are interested in this issue to read the current draft and respond to this email with feedback. Additionally, we are encouraging our members to comment directly to the Health Care Authority (address is listed at the bottom of this message).
Proposed CT Standards
Background:
The West Virginia Health Care Authority (HCA) has a set of rules (approved by the Legislature) that regulate certain diagnostic services including some used by physicians in their private practice office. Generally, these rules contain two sets of criteria to determine whether or not a physician must first obtain a CON from the HCA before purchasing and placing into service a particular piece of diagnostic equipment. The first set states that if the piece of equipment costs over $2 million, a CON is required. The second set contains a specific list of diagnostic equipment that, regardless of cost, a CON is required. Prior to last year, CT Scanners were not on the specific named list that required a CON regardless of cost. Thus, physicians could purchase a CT Scanner so long as it fell under the $2 million cost threshold. In recent years, high end CT Scanners (64-slice CTs) became available for less than $2 million and several were purchased by physicians in West Virginia. The Health Care Authority was urged this past year by the WV Hospital Association to tighten up the regulations in order to limit physicians from purchasing this diagnostic equipment. The rule which passed in March 2007 put the purchase of all CT Scanners under the purview of the Authority's CON process.
Shortly after the passage of the rule, the Authority convened a task force of all interested parties to advise them on drafting the Standards. The "standards" are the document which specifically articulates the regulations and steps a provider must go through to prove need for the purchase of a CT Scanner. The WVSMA was invited to participate in this workgroup and was represented at each of the meetings over the past few months.
Current Draft of Proposed CT Standards:
This current version of the CT standards is written with a different in approach from the previous version which the WVSMA sent out to our members in July. The standards are structured into three parts:
1. Limited requirements for Low Dose CT scanners. (Mini-Cts typically used for head and neck scans).
2. Specific requirements for a 64-slice CT scanner to be used only for Cardiac Computed Tomography Angiography (CCTA) scans.
3. Specific requirements for all multiple use CT scanners.
The following is an outline of the current draft CT Standards:
Low Dose CT CON Requirements:
- Must give 30 days notice to Health Care Authority before implementation
- Document that expenditure less than $2 Million.
- Cannot upgrade through replacement to a multi-use or CCTA without meeting additional CON standards.
Multi Use and CCTA:
- Need methodology
- Must delineate the proposed service area
- Document expected utilization for the service to be provided
- CCTA
- Existing provider with multi use that proposes to provide CCTA is not required to undergo further CON review for a new service.
- For new CCTA service applicants-
- Project 700 scans annually by the end of the third year of operation.
- Non-hospital must address Series 17 criteria.
- CCTA applicant may not expand use of the CT. scanner other than CCTA without CON for multi use.
- If applying for CCTA and multi use, must meet need methodology for multi use CT.
- Multi use CT
- Identify patient base.
- Multiply patient base by use rate per 1,000 population
- Project the number of users the applicant would be expected to serve.
- Project 3,500 scans annually by the end of the third year of operation
- Replacement CT Services
- Replacement/Upgrade of an existing CT unit not subject to CON if capital expenditure is less than $2 Million. If over $2 Million must demonstrate financial feasibility.
- Replaced/Upgraded equipment must be removed from service.
- Replacing/Upgrading a Low Dose or CCTA unit to a multi use CT requires CON review
- Additional CT Services
- Adding an additional CT unit by an existing provider shall not be subject to the Standards so long as capital expenditure is less than $2 Million.
- May not add a different type of CT without meeting the Standards.
- Quality
- Applicants shall demonstrate compliance with the following:
- Hospitals be accredited by JCAHO.
- Non-hospitals obtain CT accreditation by the third year of operation from either ACR or ICACTL.
- Non-hospital for multi use or low dose CT scanner must meet the training requirements of their specialty society
- Applicants for CCTA-
- Cardiologists meet American College of Cardiology requirements for CCTA.
- Radiologists meet American College of Radiology requirements for CCTA.
- Services offered in compliant environment.
- Unit must have received pre-market FDA approval.
- Documentation of personnel training and availability of safety equipment.
- Physician on site or immediately available when patients are undergoing CT scans.
- Safety manual must be provided.
- Unit operated by trained physicians and/or radiologic technologists with proper licensure.
- Employ or contract with a radiation physicist to review quality and safety of CT.
- Not deny CT scanner services to any individual based on the ability to pay or source of payment.
- Maintain and report annually;
- Gross revenue by payor.
- Total cost.
- Volume by payor and non-paying sources.
- Charity care and bad debt.
- Volume of in-patient and outpatient procedures.
- Report charity care and bad debt reported separately.
- Accessible to the disabled.
- Demonstrate how the project enhances geographic access to the services.
- Financial Feasibility
- Demonstrate sufficient capital to finance the project.
- Present a three year projection of revenues and expenses.
The West Virginia Health Care Authority has scheduled a public comment period to receive comments on the proposed Certificate of Need Standards through October 12. All comments received, including emails, are considered part of the public comment and are posted on the Health Care Authority's web site at www.hcawv.org
Written comments may be submitted in care of Dayle D. Stepp, Director of Certificate of Need, at the West Virginia Health Care Authority, 100 Dee Drive, Charleston, WV. 25311, and must be received no later than October 12, 2007.
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