Current through Register Vol. 54, No. 12, March 23, 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.
(2) The Department will consider applications
for shared PET services. The standards in paragraph (1) shall be met by each
hospital participating in the shared PET service.
(3) Hospitals in a region served by one or
more PET scanners will have equal access to at least one of the units. Equal
access will be characterized by the following:
(i) A scheduling priority based on patient
need.
(ii) Services provided to
patients from referring hospitals will be charged for the PET services at the
same rate as patients in the hospital housing the PET scanner.
(iii) Transportation services with
appropriate supervision established either directly through the sponsor or
through a mutually agreed upon arrangement with the referral
facilities.
(4) The
equipment shall be certified for clinical use by the Federal Food and Drug
Administration (FDA). The facility shall also present evidence of approval by
the FDA of its New Drug Application (NDA) for the production of
radiopharmaceuticals as part of the CON application.
(5) A PET service shall be under the medical
direction of a physician who is board certified in nuclear medicine or nuclear
radiology, or trained and licensed in nuclear cardiology and has additional
documented experience and training in PET technology, including radiochemistry.
The physician shall be licensed by the Nuclear Regulatory Commission to possess
radiopharmaceuticals and perform diagnostic procedures employing
radiopharmaceuticals in human beings.
(6) Additional staff for a PET service shall
include at a minimum the following staff as appropriate:
(i) A radiochemist trained at the master's or
Ph.D. level in radiochemistry or radiopharmacy who also has a background in PET
physics or radiochemistry and experience in radiopharmaceutical
production.
(ii) A nuclear medicine
technologist with training onsite or offsite in cyclotron operation and
radiopharmaceutical production, and who will work under direction and
supervision of the medical director.
(iii) Two radiological technologists with
documented training in radiology, nuclear medicine or MRI/CT scanning and who
are able to provide support in the areas of PET imaging systems operation,
patient preparation for PET studies and image analysis and
processing.
(7) The PET
service should be available for operation at least 8 hours per day, 5 days per
week. Evening and weekend hours are encouraged as an aid to
accessibility.
(8) It is the policy
of the Department to encourage efficient use of expensive technology through
sharing of cyclotron facilities.
(9) Proposals to convert an existing research
scanner to clinical use will be subject to CON review.
(10) Additional scanners in a health planning
area beyond the need projected in subsection (g) will not be approved until
previously approved PET scanners in the health planning area are operating at
an average of 2,000 scans per year.
(i) This section shall serve as an interim
policy until replaced with standards and criteria in the State Health Services
Plan.