Current through Register Vol. 47, No. 6, September 18, 2024
(1)
Purpose
and scope.
a. These standards are
measures of some of those criteria in Iowa Code section
10A.714(1)
"a" through "q." Criteria that are measured
by a standard are cited in parentheses following each standard.
b. Certificate of need applications that are
to be evaluated against these standards include:
(1) Proposals to commence or expand the
capacity of positron emission tomography services.
(2) Proposals to replace a positron emission
tomography unit.
(3) Any other
applications that relate to positron emission tomography.
(2)
Definitions.
"Area" means the community or a metropolitan
statistical area (as defined by the U.S. Office of Management and Budget and
used by the U.S. Census Bureau).
"CT (computed tomography)" means an imaging
method in which a cross-sectional image of the structures in a body plane is
reconstructed by a computer program from the X-ray absorption of beams
projected through the body in the image plane.
"Cyclotron" means an apparatus for
accelerating protons or neutrons to high energies by means of a constant magnet
and an oscillating electric field.
"MRI (magnetic resonance imaging)" means a
diagnostic modality that employs a combination of magnetic and radio frequency
fields and computers to produce images of body organs and tissues.
"Radiopharmaceutical" means a radioactive
pharmaceutical used for diagnostic or therapeutic purposes.
"PET procedure" means an image-scanning
sequence derived from a single administration of PET, equated with a single
injection of the tracer.
"Positron emission tomography (PET)" means an
imaging method in which positron-emitting radionuclides, which are produced
either by a cyclotron or generator, and a nuclear camera are used to create
pictures of organ function rather than structure.
"SPECT (single photon emission computed
tomography)" means a camera-based imaging system using the
radionuclides in the routine practice of nuclear medicine.
(3)
Availability and need.
(Iowa Code section 10A.714(1)
"c," "d," "e," "g," "h")
a.
Applicants in areas with no other PET units.
(1) Applicants should demonstrate a
reasonable potential utilization of a PET unit based on diversified inpatient
and outpatient case mix thresholds including:
1. Intracranial cases.
* Primary brain tumors 50/year
* Metastasis 100/year
* Cerebral vascular disease 200/year
* Organic brain disease and dementia/psychiatric diagnoses
(including epilepsy-seizure disorders) 500/year
* Spinal 100/year
2. Cardiovascular cases.
* Ischemic heart disease (including acute and chronic
infarction) 1200/year
3.
Neoplasms (head, neck, thorax (excluding heart), abdomen, pelvic, prostate and
musculoskeletal 1300/year.
(2) Applicants should have other diagnostic
capabilities, on-site or through referral arrangements, with appropriate
volumes including:
|
Proposed Threshold
|
|
Nuclear medicine imaging services
|
5,600
|
|
Single photon emission computed tomography (including
brain, bone, liver, Gallium and Thallium stress)
|
1,600
|
|
CT
|
8,000
|
|
MRI
|
2,400
|
(3)
Applicants should demonstrate secondary and tertiary service capability,
on-site or through referral arrangements, including cardiac surgery,
cardiology, internal medicine, general surgery, hematology/oncology, neurology,
pathology, thoracic surgery and psychiatry.
b. Applicants in areas with one or more PET
units currently in operation or approved by the certificate of need program for
operation.
Existing PET units within the area (whether basic or enhanced)
should have been operating at a minimum of 1000 PET procedures during the most
recent annual period as reported to the certificate of need program according
to paragraph 203.13(6)"e."
(4)
Quality and continuity.
(Iowa Code section 10A.714(1)
"g," "h," "i," "k")
a. The
proposed PET unit should function as a component of a comprehensive inpatient
or outpatient diagnostic service. The proposed PET unit should have the
following modalities (and capabilities) on-site or through referral
arrangements:
(1) Computed
tomography.
(2) Magnetic resonance
imaging.
(3) Nuclear medicine -
(cardiac, SPECT).
(4) Conventional
radiography.
b. The
proposed PET unit should be located in a facility that has, either in-house or
through referral arrangement, the resources necessary to treat most of the
conditions diagnosed or confirmed by PET. The following medical specialties
should be available during PET service hours on-site or by referral
arrangements: cardiology, neurology, neurosurgery, oncology, and
psychiatry.
c. A proposal to
provide new or expanded PET must include satisfactory assurances that services
will be offered in a physical environment that conforms to federal standards,
manufacturer's specifications, and licensing agencies' requirements. The
following areas are to be addressed:
(1)
Quality control and assurance of radiopharmaceutical production of generator or
cyclotron-produced agents;
(2)
Quality control and assurance of PET tomograph and associated
instrumentation;
(3) Radiation
protection and shielding;
(4)
Radioactive emissions to the environment.
d. The applicant will provide evidence that
the proposed PET equipment has been certified for clinical use by the U.S. Food
and Drug Administration or will be operated under the approval and authority of
an institutional review board whose membership is consistent with U.S.
Department of Health and Human Services regulations.
e. Applicants for PET will document that the
necessary qualified staff are available to operate the proposed unit. The
applicants will document the PET training and experience of the staff. The
following minimum staff will be available to the PET unit:
(1) One or more nuclear medicine imaging
physician(s) available to the PET unit who have been licensed by the state for
the handling of medical radionuclides and whose primary responsibility for at
least a one-year period prior to submission of the certificate of need
application has been in acquisition and interpretation of tomographic images.
This individual shall have knowledge of PET through training, experience, or
documented postgraduate education. The individual shall also have training with
a functional PET facility.
(2)
Qualified PET radiochemist or radiopharmacist personnel, available to the
facility during PET service hours, with at least one year of training. The
individual(s) will demonstrate experience in the testing of chemical,
radiochemical, and radionuclidic purity of PET radiopharmaceutical
syntheses.
(3) Qualified
engineering and physics personnel, available to the facility during PET service
hours, with training and experience in the operation and maintenance of the PET
equipment.
(4) Qualified radiation
safety personnel, available to the facility at all times, with training and
experience in the handling of short-lived positron-emitting nuclides.
(5) Certified nuclear medicine technologists
with expertise in computed tomographic nuclear medicine imaging procedures, at
a staffing level consistent with the proposed center's expected PET service
volume.
(6) Other appropriate
personnel should be available during PET service hours, which may include
certified nuclear medicine technologists, computer programmers, nurses, and
radiochemistry technicians.
f. The applicant will demonstrate how
emergencies within the PET unit will be managed in conformity with accepted
medical practice.
(5)
Accessibility and acceptability. (Iowa Code section
10A.714(1)
"c," "d")
a. PET facilities
should have adequate scheduled hours to avoid an excessive backlog of
cases.
b. Selection of patients for
clinical PET studies will guarantee equal access to all persons regardless of
insurance coverage or ability to pay.
c. In addition to accepting patients from
participating institutions, facilities performing clinical PET procedures
should accept appropriate referrals from other local providers. These patients
will be accommodated to the extent possible by extending the hours of service
and by prioritizing patients according to standards of need and appropriateness
rather than source of referral.
(6)
Costs and financial
feasibility. (Iowa Code section
10A.714(1)
"e," "f," "i," "p")
a. The
applicant will identify capital and operating costs associated with the
proposed PET unit, identify sources of funding to cover those costs, and
demonstrate that the project is financially feasible.
b. The applicant will provide budgets for the
first three years of operation, including documentation and justification of
all assumptions used.
c. The
applicant will document its projected average cost per procedure and charge per
procedure for the first three years. Charges for PET should be reasonably
related to service cost and comparable to PET charges at other facilities in
the state.
d. The applicant should
verify whether the service is eligible for reimbursement by public and private
third-party payers.
e. The
applicant should demonstrate that alternatives were considered and the proposed
application is the most cost-effective and should accomplish the goals of the
project.
