Current through Register Vol. 54, No. 12, March 23, 2024
(a)
Status
and trends. Magnetic resonance (MR) is a category of service that uses
the magnetic spin property of certain atomic nuclei to visualize and analyze
tissue. Diagnostic techniques include both MR imaging and spectroscopy.
(1) MR imaging has proven to be a useful tool
in the diagnosis of the following:
(i) Brain,
brain stem, spinal cord disorders and demylenating diseases.
(ii) Diffuse or infiltrating diseases of the
liver and kidney.
(iii) Early
changes in ischemia and infarction of heart tissue.
(2) Ovarian and uterine tissue can be imaged
well through MR. Also, the process can be used to evaluate growth and
development of a fetus.
(3) MR
spectroscopy has potential application for in vivo analysis of biochemical
processes in healthy and diseased tissue. Potential applications include the
following:
(i) Determination of early chemical
changes in evolving cerebral or myocardial infarctions.
(ii) Determination of the chemical nature and
specific diagnosis of tumors throughout the body.
(iii) Analysis of chemical parameters and
changes in metabolic diseases of the liver and kidney.
(iv) In vivo analysis of early changes in
multiple sclerosis.
(v) In vivo
analysis of dementia-producing disorders such as Alzheimer's disease.
(4) The Federal Food and Drug
Administration (FDA) has approved MR imaging devices produced by certain
manufacturers.
(5) On July 1, 1985,
Blue Cross of Western Pennsylvania began coverage for all MR imaging scans
performed on FDA-approved equipment provided that a certificate of need has
been issued or a project has been deemed nonreviewable. Pennsylvania Blue
Shield followed suit in October 1985. In November 1985, The Health Care Finance
Administration announced that Medicare will provide reimbursement for MR
imaging procedures for a limited number of diagnoses. As of April 1987, third
party payers were not reimbursing facilities for spectroscopic services which
are regarded as experimental.
(6)
MR devices are available with one of three broad categories of magnets. Each
type of magnet can be obtained in a variety of field strengths up to 2.5 Telsa.
Higher field strength becomes important in MR spectroscopy. The three
categories of magnets are:
(i)
Resistive.
(ii)
Permanent.
(iii)
Superconductive.
(7) A
recent development is the mobile MR unit. Equipment manufacturers predict that
up to 40% of their market will be mobile units.
(8) A type of movable unit is the
transportable and relocatable system. These are larger than mobile units and
are not intended to be moved more than several times per year.
(9) Tables 1 and 2 show the estimated range
of purchase and installation costs, and annual operating costs, respectively,
as compiled by the American Hospital Association (AHA). Mobile systems will
have the following additional costs:
(i) For
the trailer-$500,000.
(ii) For the
tractor-$50,000 to $125,000.
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(10) Although MR imaging has distinct
advantages over the less expensive computerized axial tomography (CAT) scan,
there are important limitations. Seriously ill patients in monitored beds
cannot be imaged because the presence of strong magnetic fields will affect
electronic monitoring devices. Also, MR is contraindicated for patients with
intravenous (IV) needles and ferrous metal implants. The AHA projects that
across all disease categories, MR imaging will replace only about 34% of all
CAT scans.
(11) Table 4, set forth
in subsection (c), shows the present distribution of certificate of need
approved MR devices in this Commonwealth.
(b)
Policy. The following
criteria will be used in reviewing certificate of need proposals related to
magnetic resonance:
(1) The formula set forth
in subsection (c) will be used in certificate of need reviews for MR imaging
project proposals.
(2) To the
extent feasible, and consistent with other criteria, MR devices should be
dispersed throughout a region. Magnetic resonance imaging (MRI) services should
be located so that 90% of the population of the region is within 1 hour travel
time to a service.
(3) Applicants
shall establish and document a policy that MR services will be provided
regardless of a patient's ability to pay.
(4) Shared arrangements may be any of the
following:
(i) Reciprocal agreements among
hospitals with CAT and MRI capability.
(ii) Reciprocal agreements involving use of a
device located at a free-standing imaging center.
(iii) Reciprocal agreements involving use of
a mobile or a transportable/relocatable unit.
(5) The Department will deem the needs of the
population to be best served by hospitals proposing shared arrangements with
other health care facilities.
(6)
The Department will deem a shared arrangement to be economically more feasible
than a single facility use proposal. When comparing two or more shared
arrangement proposals, the Department will evaluate the following:
(i) The respective capabilities of the
project applicants and associated facilities of each.
(ii) The anticipated volume of care of
each.
(iii) The availability of
reasonable start-up capital of each.
(iv) Projected marginal revenues of
each.
(v) Projected marginal costs,
variable costs and fixed costs of each.
(7) An applicant facility shall establish and
document a policy that the hospitals in a region to be served by an MR unit
will have equal access to the unit. Equal access will be characterized by the
following:
(i) A scheduling priority based on
patient need. Documented urgent or emergent cases will be given priority
access.
(ii) A nondiscriminatory
charge schedule.
(iii)
Interhospital transport services with appropriate medical supervision
established either directly by the applicant or through a mutually agreed upon
arrangement with the referring facility.
(8) Charges for MRI services should be
reasonably related to service cost. Charges should not exceed the median charge
of Commonwealth providers of comparable MRI services by more than 20% without
reasonable justification.
(9)
Facilities providing MR services shall have a utilization review program that
includes MR examinations.
(10)
Hospitals offering MR shall be able to directly provide related diagnostic
modalities such as the following:
(i) CAT
full-body scanning.
(ii)
Ultrasound.
(iii) Radionuclide
scanning.
(iv) Conventional X-ray,
including, but not limited to, arteriography.
(11) A board-certified or board-qualified
physician trained in MRI shall be responsible for the operation of the MR
facility and interpretation of the MR data. This work shall be the full-time
activity of that physician or other physicians delegated by that physician if
they have been trained in MRI.
(12)
Medical physicist involvement is necessary for quality assurance, computer
maintenance and training of staff in magnetic field theory and related
issues.
(13) The MR program staff
shall include the specialty of radiology and subspecialists appropriate to the
applications intended, including experience in computed tomography or nuclear
medicine.
(14) Facilities proposing
to provide MR services shall also directly provide a variety of medical
subspecialty services which include, but are not limited to, oncology,
neurology, internal medicine, pathology and radiology.
(15) At least one staff person trained in
cardio-pulmonary resuscitation (CPR) shall be on duty in the unit at all
times.
(16) The facility shall have
a program on image quality control of MR services and a program to calibrate
and maintain its diagnostic equipment.
(17) The MR unit shall meet the standards
recommended by the FDA.
(18) The
area housing the MR unit shall be constructed in accordance with standards
established by the manufacturer and Federal or State standards, or both, as may
be developed.
(c)
MR need.
(1) Several
methodologies for projection of MRI utilization have been studied.
(i) The methodology used in New York State
assumes a ratio of one MR unit per three fully utilized CAT scanners. New York
considers 3,000 images per year as full utilization of an MR unit.
(ii) Massachusetts uses the AHA utilization
model, at least in part.
(iii)
Illinois will approve an MR unit at a hospital which does 4,500 CAT scans per
year or more.
(iv) The Health
Systems Agency of Southwestern Pennsylvania uses the methodology developed by
the AHA.
(v) The AHA methodology is
based on the opinions of an expert panel of physicians. The panel determined
the percent of patients within discrete ICD-9-CM categories who would require
MRI.
(2) The Department
adopts the AHA methodology, as set forth in the AHA Hospital Technology Series,
Vol. 11, No. 8, "NMR-Nuclear Magnetic Resonance Guideline Report" of 1983, to
predict the number of initial and followup scans. The Statewide results of this
methodology are given in Table 3.
Table 3
Statewide Revised Projections of MRI Procedures AHA
ICD-9-CM Projection Method
HSA REGION |
1990 PROJECTED MRI SCAN VOLUME |
1 |
83,372 |
2 |
22,294 |
3 |
17,747 |
4 |
34,336 |
5 |
17,246 |
6 |
62,775 |
7 |
17,352 |
8 |
2,516 |
9 |
11,024 |
Total |
268,662 |
(3)
Throughput is the number of patients imaged per year. The Health Systems Agency
of Southwestern Pennsylvania estimated that a unit is capable of 2,000
procedures per year. By the end of 1986, the 14 test sites in New York State
were achieving an average throughput of 2,500 patients per year. Full
utilization in New York State is 3,000. A radiological team headed by W. G.
Bradley reports in "MR Installation, 18 Months Clinical Experience" that
patient throughput at the MR operated by the 625-bed Huntington Medical
Research Institute averages more than 12 patients per day with as many as 18
patients per day often being examined. By reaching reasonable throughput, the
Huntington Institute has been able to keep average MR charges at about 25%
higher than CAT. Twelve patients per day yields a total annual throughput of
3,000 patients.
(4) The following
formula is used to predict the number of MRI devices needed in Pennsylvania.
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(5)
The Department of Health adopts 2,500 patients per year as a reasonable
throughput for a single unit. Therefore, using the formula in paragraph (4),
approximately 107 MR units will be adequate to meet the needs of patients in
this Commonwealth.
(6) Table 4
shows the projected need for MR units by health service area. Rounding of
fractional units next higher integer results in a total State need of 110
units.
Table 4
MR-Projected Need
HSA |
Approved* Units |
Projected Need |
(Shortage) Surplus |
MRI Applications Pending Review |
I |
26 |
34 |
(8) |
5 |
II |
4 |
9 |
(5) |
1 |
III |
4 |
7 |
(3) |
1 |
IV |
7 |
14 |
(7) |
1 |
V |
4 |
7 |
(3) |
1 |
VI |
20 |
26 |
(6) |
7** |
VII |
5 |
7 |
(2) |
1 |
VIII |
1 |
1 |
(0) |
0 |
IX |
3 |
5 |
(2) |
0 |
Total |
74 |
110 |
(36) |
17 |
*As of August 29, 1989
**One application is requesting 3 MRI
units.