ARTICLE
10 April 2002

New Con Standards for Cardiac Surgery

RM
Robinson & McElwee
Contributor
Robinson & McElwee
United States Food, Drugs, Healthcare, Life Sciences
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On December 6, 2001, the West Virginia Health Care Authority ("HCA") issued new proposed certificate of need rules which will have a dramatic impact upon the expansion of cardiac surgery services throughout the State of West Virginia. These rules are currently undergoing a comment period of thirty (30) days. After the end of the comment period, the HCA will then present the rules together with any revisions to Governor Wise for approval. Given the fragile financial condition of many hospitals in West Virginia, these proposed rules will likely have a significant impact upon the continued financial viability and ability to fund specialized services for many West Virginia hospitals.

Currently, there are open heart surgery programs at CAMC Memorial Division in Charleston, St. Mary’s Hospital in Huntington, Wheeling Hospital in Wheeling, and WVU Hospitals and Monongalia General Hospital in Morgantown. Of these programs, only WVU Hospitals and Monongalia General Hospital conduct a joint cardiac surgery program. Other hospitals that have recently sought approval for open heart surgery programs include: Raleigh General Hospital in Beckley, Princeton Community Hospital in Princeton, Bluefield Regional Medical Center in Bluefield, Camden-Clark Memorial Hospital and St. Joseph’s Hospital in Parkersburg, and Weirton Medical Center in Weirton. Hospitals with established cardiac surgery programs have asserted that the approval of additional cardiac surgery programs in West Virginia will diminish surgical volumes at these centers, and as a result, these hospitals will not be able to subsidize other less profitable specialized services, and as a result consumers will have less access and layoffs will likely result. Hospitals like CAMC, who is reported to have annual net revenue of $26,000,000 from open heart surgeries, assert that profit from open heart surgeries are used to fund programs that are less profitable such as pediatric intensive care, trauma and other specialized services. CAMC has asserted that the loss of open heart surgery procedures will result in a decrease in the level of services and possibly layoffs. In addition, there is an ongoing debate as to the minimum number of procedures that should be performed in a cardiac surgery program in order to assure sufficient quality of care.

The major changes in the proposed certificate of need standards for cardiac surgery are:

1. Hospitals must establish that they could perform at least 1,000 diagnostic cardiac catheterization procedures annually. This number can now be met by combining the numbers for joint applicants;

2. Applicants must demonstrate that they will provide at least 250 cardiac surgeries by the third year of the project. This number was reduced from 350;

3. Initial applicants under the new standards will be limited to two areas of the State of West Virginia: a) Raleigh, Summers, Monroe, Wyoming, Mercer, and McDowell Counties in Southern West Virginia, and b) Wood, Wirt, Jackson, Calhoun, Ritchie, Pleasants and Tyler Counties in the Mid-Ohio Valley. After 2002, all applications state-wide under the new standards will be considered;

4. Applicants must demonstrate that the impact of the project will not reduce the number of surgical procedures in established open heart programs below 500 cardiac surgeries annually;

5. Failure to meet the 250 minimum annual procedures by the third year may result in withdrawal of the certificate of need.

In addition to the foregoing, the HCA has also proposed a demonstration pilot project for therapeutic cardiac catheterization services at facilities that do not have on-site cardiac surgery capabilities. As a result of this proposed pilot project, facilities must be within 30 minutes air travel time of a tertiary care facility and must possess the ability to transfer patients by air. This proposed demonstration pilot project is intended to provide accessibility to therapeutic cardiac catheterization services at hospitals that currently do not provide open heart surgery procedures on a demonstration basis.

The foregoing changes will likely impact West Virginia hospitals over the next ten years. The HCA in issuing these standards has placed special emphasis on the needs of the Mid-Ohio Valley and Southern West Virginia based in part upon previous applications for these regions which have been submitted to the HCA. Sonia Chambers, Chair of the West Virginia Health Care Authority stated, "the West Virginia Health Care Authority wanted to increase access to cardiac surgery services for West Virginia by allowing more community hospitals to offer these services, especially in the Southern West Virginia and Mid-Ohio Valley regions." At the same time, the West Virginia Health Care Authority has made changes to minimize the

impact of any new programs upon existing facilities. Sonia Chambers underscored that, "West Virginians should have better access to cardiac surgeries without providing unnecessary duplication of services."

Copies of the proposed certificate of need standards can be obtained from Dayle

Stepp, Director of the Certificate of Need Program, by contacting him at (304) 558-7000.

Anyone wishing to make comments regarding these proposed standards should submit the comments to the attention of Sonia D. Chambers, Chair, West Virginia Health Care Authority, 100 Dee Drive, Suite 201, Charleston, West Virginia 25311-1692.

Charles M. Johnson, Esquire is a Member of Robinson & McElwee, PLLC, where he coordinates the Health Care Practice Group. He is a graduate of Harvard College (1981), and West Virginia University College of Law (1986). The primary focus of Mr. Johnson’s practice is health care matters involving hospitals, long-term care, assisted living facilities, physicians, behavioral health care providers, and other health care providers and health care related businesses. Mr. Johnson currently serves the Program Chair of the American Law Firm Association’s Health Care Practice Group. He regularly speaks and publishes on health care law issues, including HIPAA compliance.

The content of this article does not constitute legal advice and should not be relied on in that way. Specific advice should be sought about your specific circumstances.

ARTICLE
10 April 2002

New Con Standards for Cardiac Surgery

United States Food, Drugs, Healthcare, Life Sciences
Contributor
Robinson & McElwee
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