N.J. Admin. Code § 8:33E-1.4

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:33E-1.4 - Utilization criteria for invasive cardiac diagnostic facilities

(a) Utilization criteria for all invasive cardiac diagnostic facilities are based on the number of patients upon whom invasive cardiac diagnostic procedures (cardiac catheterization) are performed.

(b) Except as specifically set forth with respect to low risk cardiac catheterization facility, at (c) below, all facilities licensed to provide full service invasive cardiac diagnostic services shall, as a condition of continued licensure, be required to maintain the following basic utilization criteria:

1. The minimum acceptable number of adult cardiac catheterization patients per full service cardiac laboratory is 400 per year. New full service providers (those previously operating as low risk cardiac catheterization laboratories) must provide documentation of full compliance with the minimum utilization level during their second year of operation or their most recent four quarters of operation, whichever is later and fully documented by the Department using audited data. Existing full service invasive cardiac diagnostic providers (with or without cardiac surgery on site) must achieve minimum utilization levels each year. Compliance with minimum annual facility volume requirements will be calculated on the basis of the last four quarters of operation prior to the facility's licensure anniversary date. Those new and existing full service laboratories unable to achieve the minimum level as set forth in this paragraph will be subject to the provisions of 8:33E-1.13.

2. Each physician must perform left heart catheterizations on a minimum of 50 patients per year. (This minimum caseload may be accomplished at more than one laboratory in or out of State). For the Director of the laboratory, the standard is left-heart catheterizations on 150 patients per year, at least 100 of which must be performed at the full service laboratory of which the physician is Director (the remaining 50 case requirement may be accomplished at more than one laboratory in or out of State).

i. Exceptions for cardiologists to the minimum director and physician volume requirements may be granted by the Commissioner upon application by a hospital for specific facility circumstances. Such circumstances as the temporary inability to perform cardiac catheterization, physician not a member of the staff for an entire year, or new program in operation less than one year require only timely written notification to the Department. Any other extraordinary circumstances shall require the submission by the hospital of a written waiver request in accordance with the hospital licensing waiver provisions as set forth at 8:43G-2.8.

ii. Compliance with the physician's minimum annual patient volume for cardiologists with laboratory privileges shall be based on the most recent calendar year's performance data available prior to the hospital's licensure anniversary date.

iii. Compliance with the Director's minimum annual patient volume, which includes the total number of catheterizations performed Statewide and the number of cases performed in the Director's laboratory, shall be based on the most recent four quarters of data available to the Department prior to the low risk laboratory's licensure anniversary date.

3. Those new and existing full-service laboratories unable to achieve the minimum volume levels set forth in this subsection shall be required to submit to the process that has been established at 8:33E-1.13.

(c) All facilities licensed to provide invasive cardiac diagnostic services pursuant to low risk catheterization facility standards described in this subchapter shall, as a condition of continued licensure, be required to maintain the following basic utilization criteria:

1. The minimum acceptable number of adult cardiac catheterization patients per year is 200. Those laboratories unable to achieve this minimum level by the end of the second year of operation as set forth at 8:33E-1.13, will be required to submit to the process that has been established at 8:33E-1.13(d).

2. Physicians practicing in hospitals operating a low risk catheterization facility shall meet minimum volume criteria. For the Director of the laboratory, the standard is left-heart catheterizations on 150 patients per year, at least 100 of which must be performed at the low-risk laboratory of which the physician is Director (the remaining 50 case requirement may be accomplished at more than one laboratory in or out of State). For other physicians with privileges in the low risk laboratory, the standard is left-heart catheterizations on 50 patients per year. (This minimum caseload may be accomplished at more than one laboratory in or out of State.)

i. Exceptions for cardiologists to the minimum director and physician volume requirements may be granted by the Commissioner upon application by a hospital for specific facility circumstances. Such circumstances as the temporary inability to perform cardiac catheterization, physician not a member of the staff for an entire year, or new program in operation less than two years, require only timely written notification to the Department. Any other extraordinary circumstances shall require the submission by the hospital of a written waiver request in accordance with the hospital licensing waiver provisions as set forth at 8:43G-2.8.

iii. Compliance with the Director's minimum annual patient volume, which includes the total number of catheterizations performed Statewide and the number of cases performed in the Director's laboratory, shall be based on the most recent four quarters of audited data available to the Department prior to the low-risk laboratory's licensure anniversary date.

3. Those low-risk laboratories unable to achieve the minimum volume levels as set forth in this subsection shall be required to submit to the process that has been established at 8:33E-1.13(d).

(d) Notwithstanding (a), (b), or (c) above, the minimum volume utilization requirements for invasive cardiac diagnostic facilities and physicians practicing at these facilities are suspended during the COVID-19 Public Health Emergency, as follows:

1. The minimum volume utilization requirements for invasive cardiac diagnostic facilities are waived if at least one quarter of the facility's reporting cycle occurred during the Public Health Emergency originally declared in Executive Order No. 103 (2020); and

2. The minimum volume utilization requirements for physicians are waived for any calendar year in which the Public Health Emergency originally declared in Executive Order No. 103 (2020) was in effect for 90 days or more.

N.J. Admin. Code § 8:33E-1.4

Amended by R.2001 d.210, effective 6/18/2001.
See: 33 New Jersey Register 616(b), 33 New Jersey Register 2105(a).
Rewrote section.
Amended by R.2004 d.37, effective January 20 2004.
See: 35 New Jersey Register 3773(a), 36 New Jersey Register 416(a).
Rewrote (b) and (c).

Modified by Executive Order No. 103 (2020) 53 N.J.R. 459(a), effective 3/4/2021