Ohio Health Care Service Rules Updated

Related Practices & Jurisdictions

Revisions to Ohio’s Health Care Services rules have been in the works since last September, as part of the required five-year review of Ohio Administrative Code Chapter 3701-84 by the Ohio Department of Health (ODH). Without much publicity, the finalized rules became effective on May 15, 2023.

“Health Care Services” include: (1) adult cardiac catheterization; (2) adult open heart surgery; (3) pediatric cardiac catheterization; (4) pediatric cardiovascular surgery; (5) pediatric intensive care; (6) a linear accelerator, cobalt radiation, or gamma knife service; (7) solid organ transplant services, and (8) blood and bone marrow transplant services. The revised Health Care Services rules make changes to nearly every regulation in Chapter 3701-84, many of a substantial nature.

Of particular interest to Ohio hospitals, changes to the adult cardiac catheterization services requirements include:

Applicable to All Adult Cardiac Catheterization Services – Level I, II, and III

Shortening the period for quality assessment review of major complications and emergency transfers from at least once every ninety days to at least once every sixty days
Changing the minimum for adult cardiac catheterization services from 22 to 18 years of age
Revising the procedure room and operating room requirements to align with current FGI standards and revising the control room requirements to remove square footage requirements and align with industry standards
Adding a new regulation (3701-84-30.4) with requirements for electrophysiology procedure rooms used by any adult cardiac catheterization service, as well as a new definition of “electrophysiology study”
Removing the service minimum procedure volume requirements and replacing this with the requirement that the service maintain volume “sufficient to ensure the safety and quality of procedures performed at the service and individual cardiologist proficiency”
Removing the medical director’s annual minimum procedure volume requirements and replacing this with the requirement that the medical director “actively” perform procedure in the service where they are the medical director

Level I Service Standards

Adding information required in the service’s annual report, changing the date of the annual report is due to March 1, and making this reporting part of hospital reporting (under hospital license rules) beginning in 2025.

Level II Service Standards

Removal of the requirement that a Level II service operate on a 24/7 basis, and changing this to require a Level II service operate “on an organized and regular basis”
- Changing the requirement that a Level II service participate in the National Cardiovascular Data Registry (NCDR) to require that the Level II service participate in a data registry to monitor operator and institutional volumes and outcomes, which may be a registry other than NCDR
Reducing the information required in the service’s annual report, changing the date of the annual report is due to March 1, and making this reporting part of hospital reporting (under hospital license rules) beginning in 2025.

Level III Service Standards

Changing the requirement that a Level III service participate in the National Cardiovascular Data Registry (NCDR) to require that the Level III service participate in a data registry to monitor operator and institutional volumes and outcomes, which may be a registry other than NCDR
Reducing the information required in the service’s annual report, changing the date of the annual report is due to March 1, and making this reporting part of hospital reporting (under hospital license rules) beginning in 2025.

Additional notable changes to other Health Care Services include:

Adult Open Heart Surgery

Removing the service annual procedure volume goals and replacing this with the requirement that the service maintain “a volume of open heart procedures per year sufficient to ensure the safety and quality of procedures performed at the service and individual surgeon proficiency”
Removing the recommend per-surgeon per-year procedure volume goals
Revising the procedure room and operating room requirements to align with current FGI standards

Pediatric Intensive Care

Reducing the practitioners and staff required to be available onsite within 60 minutes and allowing some services to be available via telephone or teleconference
Allowing certain services to be provided by agreement with other facilities available by emergency transport

Solid Organ Transplants

Replacing certain prior rules (personnel and staffing standards, facility standards, and safety standards) with the requirement to meet CMS hospital Conditions of Participation for solid organ transplant services
Replacing prior rules on patient selection criteria with criteria established by CMS and Organ Procurement and Transplantation Network