section .0300 - exemptions

 

10A NCAC 14c .0301       RESEARCH ACTIVITY

(a)  Under G.S. 131E‑179 a health care facility may

apply to the agency for an exemption from obtaining a certificate of need for

any of the following if they are to be used solely for research:

(1)           acquisition of major medical equipment;

(2)           the offering of institutional health

services; or

(3)           the incurring of the obligation of a

capital expenditure.

If any of the foregoing is used to provide patient care on

an occasional and irregular basis and not as a part of the research program,

the agency will not deny any request for an exemption solely on that basis.

(b)  The exemption shall be granted if notice is filed in

accordance with this Rule and if the notice shows that the proposed new institutional

health service will not:

(1)           affect the charges of the health care

facility for the provision of medical or other patient care services other than

the services which are included in research;

(2)           substantially change the bed capacity of

the facility; or

(3)           substantially change the medical or other

patient care services of the facility.

(c)  The notice required by G.S. 131E‑179 shall be

given on a form "Notice of Proposed Research Activity."  This form

may be obtained by contacting the agency at the address and telephone number

stated in 10A NCAC 14C .0102.

(d)  The notice must be completed and delivered to the

agency before the new institutional health service is offered or developed. 

The notice is not filed in accordance with this Rule until the notice is deemed

complete.

(e)  The agency shall promptly acknowledge in writing

receipt of the notice.  The notice shall be deemed complete unless the agency,

within seven days after receipt, mails a letter to the person submitting the

notice which states that the notice was incomplete and specifies what

information is necessary to make it complete.  As soon as the requested

information is delivered to the agency, the notice shall be deemed complete and

filed in accordance with this Rule.

(f)  Within 30 days after receipt of a completed notice, the

agency shall notify the health care facility submitting the notice whether the

agency has granted the exemption.  If the exemption has been granted, the

health care facility may proceed to offer and develop the new institutional

health service.  If a certificate of need is required, the notice and review

under this Rule shall be deemed to be in compliance with 10A NCAC 14C .0201.

(g)  Any affected person, as defined in G.S. 131E‑188(c),

may obtain a contested case hearing on a decision of the agency under this Rule

by following procedures set forth in G.S. 150B and G.S. 131E-188.

 

History Note:        Authority G.S. 131E‑177; 131E‑179;

Eff. January 1, 1982;

Amended Eff. February 1, 2000; January 1, 1990; November 1, 1989; February 1, 1986.