N.J. Admin. Code § 8:33-3.7

Current through Register Vol. 56, No. 24, December 18, 2024

Section 8:33-3.7 - Major moveable equipment

(a) Applications to initiate full service or low risk invasive adult cardiac diagnostic services will only be accepted by the Department in accordance with the eligibility and application review criteria set forth in N.J.A.C. 8:33E. All such applications will be subject to the expedited certificate of need review process set forth at N.J.A.C. 8:33-5.

(b) Addition of cardiac catheterization equipment by a general hospital licensed to provide full service invasive cardiac diagnostic services is exempt from the certificate of need requirement.

(c) Replacement of cardiac catheterization equipment is exempt from the certificate of need requirement.

(d) Health care equipment which involves new technology that is not identified in this chapter shall not be subject to certificate of need requirements, but shall meet the following requirements:

1. The new technology shall be directly related to an already licensed health care service for which the provider has obtained a certificate of need, if applicable, and is already licensed;

2. The provider shall provide the Commissioner with written notice of the intent to initiate the new technology at least 60 days prior to the date the provider will begin use of the technology;

3. The new technology shall have pre-market approval from the Federal Food and Drug Administration and meet all other applicable State and Federal legal and regulatory requirements, if any;

4. The provider shall use the new technology in accordance with guidelines approved by the Joint Commission on Accreditation of Health Care Organizations until such time as the Department may adopt licensing standards for the new technology. The provider shall comply with the Department's licensing standards for the new technology upon adoption of applicable standards; and

5. The provider shall agree to submit to the Department patient information and other data concerning use of new technology. The provider shall submit data, as specified by the Department until such time as the Department determines that further reporting is not required.

(e) Upon a finding by the Commissioner that the provider's use of new technology is not in compliance with the provisions set forth in (d)1 through 5 above, the Commissioner may suspend the use of same.

N.J. Admin. Code § 8:33-3.7

Amended by R.1993 d.442, effective 9/7/1993.
See: 25 New Jersey Register 2171(a), 25 New Jersey Register 4129(a).
Amended by R.1996 d.101, effective 2/20/1996.
See: 27 New Jersey Register 4179(a), 28 New Jersey Register 1228(a).
Amended by R.2002 d.243, effective 8/5/2002.
See: 34 New Jersey Register 458(a), 34 New Jersey Register 2814(a).
Rewrote the section.