The Ohio Health Services rule reviews have been underway since last September as part of a five-year review of Ohio Administrative Code Chapter 3701-84 by the Ohio Department of Health (ODH). Without much publicity, the finalized rules went into effect on May 15, 2023.
“Health Care Services” include: (1) adult cardiac catheterization; (2) open heart surgery for adults; (3) pediatric cardiac catheterization; (4) pediatric cardiovascular surgery; (5) pediatric intensive care; (6) a linear acceleration service, cobalt radiation or gamma knife; (7) solid organ transplant services and (8) blood and bone marrow transplant service. The revised Health Services Rules make changes to nearly all Chapter 3701-84 regulations, many of which are substantive in nature.
Of particular concern to Ohio hospitals, changes to adult cardiac catheterization services requirements include:
Applicable to all adult cardiac catheterization services – Levels I, II and III
- Reduction of the period for the quality assessment review of major complications and emergency transfers from at least once every ninety days to at least once every sixty days
- Change in minimum for cardiac catheterization services for adults 22 to 18 years of age
- Review of operating room and procedure room requirements to align with current FGI standards and review of control room requirements to remove square footage requirements and align with industry standards
- Added 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 office”
- Removing the service’s minimum procedure volume requirements and replacing it with a requirement that the service maintain a volume “sufficient to ensure the safety and quality of procedures performed at the service and the expertise of the individual cardiologist”
- Removed the Medical Director’s annual minimum procedure volume requirements and replaced this with a requirement that the Medical Director “actively” perform the procedure in the service where they are the Medical Director
Tier I Service Standards
- Added required information in Annual Service Report, changed Annual Report due date to March 1, and included this report in Hospital Report (according to hospital license rules) effective 2025.
Level II service standard
- Removed the requirement that a Tier II service operate on a 24/7 basis and changed this to require a Tier II service to operate “on an organized and regular basis”
- Allow a Level II service to perform atrial fibrillation ablation by removing it from the Prohibited Procedures list at a Level II service
- Changed the requirement that a Tier II service participate in the National Cardiovascular Data Registry (NCDR) to require that the Tier II service participate in a data registry to monitor provider and institution volumes and outcomes, which it can be a different register than the NCDR
- Reducing the information required in the annual service report, changing the date the annual report is due to March 1, and making this report part of the hospital report (under hospital licensing rules) starting in 2025.
Level III service standards
- Changed the requirement that a Tier III service participate in the National Cardiovascular Data Registry (NCDR) to require that the Tier III service participate in a data registry to track provider and institution volumes and outcomes, which it can be a different register than the NCDR
- Reducing the information required in the annual service report, changing the date the annual report is due to March 1, and making this report part of the hospital report (under hospital licensing rules) starting in 2025.
Additional notable changes to other health care services include:
Open heart surgery for adults
- Removing the service’s annual procedure volume targets and replacing it with a 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 the expertise of the individual surgeon “
- Removal of best practice volume targets per surgeon per year
- Review of OR and operating room requirements to align with current FGI standards
Pediatric intensive care
- Reducing professionals and staff who need to be on site within 60 minutes and allowing some services to be available by telephone or conference call
- Permit the provision of certain services in conjunction with other facilities available for emergency transport
Solid organ transplant
- Replacement of some previous rules (personnel and personnel standards, facility standards and safety standards) with the obligation to meet the conditions of participation of the CMS hospital for solid organ transplant services
- Replacement of the previous rules on patient selection criteria with criteria established by the CMS and the organ harvesting and transplantation network
For more information on the issues discussed above, or if you have other questions or concerns about Ohio health services rules, please contact Epstein Becker Green’s attorney who regularly handles your legal matters or the author of this blog post.
Web seminar: Allen Killworth will present more information in an upcoming webinar for the Ohio Hospital Association on June 6, 2023.
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