ODH Finalizes Revised Health Care Services Rules

Revisions to Ohio’s Health Care Services rules have been in the works since last September, as part of the required five-year of review 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 service. 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 age 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 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”
  • Permitting a Level II service to perform atrial fibrillation ablation, by removing it from the list of prohibited procedures at a Level II service
  • Changing the requirement that a Level II service participate in the National Cardiovascular Data Registry (NCDR) to requiring 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 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 requiring 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 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 phone or teleconference
• Allowing certain services to be provided by agreement with other facilities available by emergency transport

Solid Organ Transplant

• 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

For additional information about the issues discussed above, or if you have any other questions or concerns regarding Ohio’s Health Care Services rules, please contact the Epstein Becker Green attorney who regularly handles your legal matters, or the author of this blog post.

Webinar: Allen Killworth will present additional information in an upcoming webinar for the Ohio Hospital Association on June 6, 2023.