Guidance on the New Adult Cardiac Catheterization Service Rules
On April 30, 2016 new adult cardiac catheterization service rules (OAC 3701-84-30 through 3701-84-34.2) become effective. While several minor changes were made, the most significant is that Ohio has shifted from a two level of service model (low risk/diagnostic and high risk/interventional) to a three level model. The new three level model consists of:
Level I – low risk/diagnostic service;
Level II – Some high risk and interventional procedures without on-site open heart surgical back-up; and
Level III – All risk/all procedures with on-site open heart surgical back-up.
In essence, Level I is the current low risk service and Level III is the current high risk service. Level II is a new development, expanding the possibility of interventional services (PCI) to facilities without an on-site open heart surgery service.
After much consideration, the Ohio Department of Health has decided to request that all existing services submit a new Health Care Service Notification Survey and a new Attestation of Compliance. Doing this serves the dual purpose of updating our information on the service and documenting any changes in the service. Specific guidance is as follows:
Existing Low Risk/Diagnostic Service: If the service is to remain the same, submit the Notification Survey and an Attestation indicating a “Level 1” service. If the service wishes to become a Level II or Level III service, mark the documentation accordingly. Hospitals with a C-PORT waiver are technically still a low risk service and need to request designation as a Level II service. The existing waivers will be terminated regardless, as the need for them will no longer exist after April 30, 2016.
Existing High Risk/Interventional Service: If the service is not seeking a change in service level, submit the Notification Survey and an Attestation indicating a “Level III” service. If the service wishes to convert to a Level II service, the Notification Survey and an Attestation should indicate “Level II.” In addition, a separate letter notifying ODH of the termination of the adult open heart surgery service must be sent.
New Service: A Notice of Intent to initiate a service must be sent to ODH at least thirty days prior to commencing the service (see OAC 3701-84-04) as well as a Notification Survey and an Attestation. Please note that a Level II service must have operated for at least one year as a Level I service.
As a final note, both Level II and Level III services are required to participate in NCDR’s CATH-PCI registry.