Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.16 - Positron Emission Tomography (PET) services; interim criteria for Certificate of Need (CON) review-statement of policy

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Acquisition of a PET scanner is subject
				  to review under section 701 of the act (35 P. S. §
											448.701).
(b) Certificate of Need review for proposed
				  PET scanners will be conducted using the need methodology in subsection (c),
				  and the review criteria in subsection (h).
(c) The Department will use the following
				  methodology to determine the need for PET scanners in this Commonwealth:
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(d)
				  The incidence rate for open heart surgery is derived from the formula found at
				  Chapter 26 of the SHP as amended July 16, 1991.
(e) Incidence rates for percutaneous
				  transluminal coronary angioplasty (PTCA), epilepsy, brain tumor and dementia
				  are derived from a methodology developed by the American Hospital Association.
				  This methodology determined which ICD-9 diagnostic codes involve conditions
				  which might require a PET scan, the percentage of patients with the condition
				  who would receive a scan and the average number of scans each patient would be
				  likely to receive. Incidence data are based on 1989 hospital discharge data
				  reported to the National Center for Health Statistics.
(f) The optimal use rate, expressed as number
				  of scans per unit, is taken from a number of studies as well as from literature
				  supplied to the Department by manufacturers of PET scan devices. This material
				  supports a rate range of six to ten scans per device per day. A midpoint of
				  eight scans per device per day is adopted, and results in a total annual use
				  rate of 2,000 scans per device per year.
(g) Application of the formula in subsection
				  (c) projects the following need by health planning area through the year 1995.
Health Planning Area
Projected Need
I
5
II
1
III
1
IV
2
V
1
VI
4
VII
1
VIII
0
IX
1
Total
16
(h)
				  The Department will use the following review criteria in addition to the need
				  projections in subsection (g) to determine the need for a PET service:
(1) A site where PET services are proposed to
				  be offered shall be a site where the following clinical services also are
				  currently offered:
(i) An open heart surgery
				  program that is approved by the Department and where an average of at least 700
				  open heart cases per year during the most recent 3-year period were performed.
				  In the interest of geographic distribution of PET services, the Department may
				  waive this requirement in its consideration of an application from a hospital
				  where at least 450 open heart cases per year were performed during the most
				  recent 3-year period, if no other hospital in the same health planning area met
				  the 700 case standard. The Department may also waive this requirement in its
				  consideration of an application from a medical college.
(ii) A therapeutic cardiac catheterization
				  service that is approved by the Department and that includes a PTCA
				  program.
(iii) A full range of
				  full-time, onsite related diagnostic modalities including conventional x-ray,
				  full-body computed tomography, ultrasound, magnetic resonance imaging and other
				  radio-nuclide scanning.