CHAPTER
He-Hea 600 MAGNETIC RESONANCE IMAGING
SCANNERS
PART
He-Hea 601 DEFINITIONS
He-Hea 601.01 Definitions.
(a)
“ACR” means
(b)
“Applicant” means “applicant” as defined in RSA 151-C:2, II.
(c)
“Application” means a proposal filed by a person for a certificate of
need.
(d)
“Board” means “board” as defined in RSA 151-C:3.
(e)
“Board certified” means the confirmation given by a national or regional
association to a physician as having passed special examinations for his/her
medical specialty.
(f)
“
(g)
“Certificate of need (CON)” means “certificate of need” as defined in
RSA 151-C:2, VIII.
(h)
“Consortium” means an alliance of persons established for the purpose of
participating in a joint business venture to offer MRI services.
(i)
“Fixed unit” means a magnetic resonance imaging scanner that is approved
by the federal Food and Drug Administration for the provision of diagnostic MRI
services and:
(1) Physically located in or operated by a
licensed facility; or
(2) A free standing location which is affiliated
with a licensed facility or owned by licensed physicians and whose purpose is operating
for the provision of MRI services.
(j)
“Hospital” means an acute hospital which cares primarily for patients
with diseases or injuries for a period of 30 days or less.
(k)
“Licensed facility” means an entity licensed under RSA 151 to provide
health or medical services.
(l)
“Magnetic resonance imaging scanner” means a diagnostic tool using a
combination of magnetic fields and radio frequency waves to create
cross-sectional images of the body.
(m)
“Mobile unit” means a magnetic resonance imaging scanner that is
approved by the federal Food and Drug Administration for the provision of
diagnostic MRI services and which is physically located in a vehicle such as a
self-contained van or tractor trailer for the purpose of transporting the magnetic
resonance imaging scanner from one site to another.
(n)
“Magnetic resonance imaging” or “MRI” means a non-invasive diagnostic
procedure used to:
(1) Create cross-sectional images of the body by
the use of magnetic fields and radio frequency fields; and
(2) Show certain biochemical activity.
(o)
“Person” means “person” as defined in RSA 151-C:2, XXVIII.
(p)
“Procedure” means an anatomical diagnostic scan of the body using an MRI
scanner.
(q)
“Provider owned entities” means a facility owned by licensed physicians
to provide health or medical services.
(r)
“Public notice” means any media advertisements, brochures, pamphlets,
fact sheets or other form of information conveyed to the public concerning an
aspect of healthcare.
(s)
“Small hospital service area” means the population from the cities and
towns set forth for each designated CAH pursuant to Table 1003-2.
(t)
“Vendor” means a person who owns and operates a magnetic resonance
imaging scanner and contracts with licensed facilities for the purpose of
providing diagnostic services.
Source. #4057, eff 5-28-86; ss by #5350, eff 3-10-92;
ss by #5453, eff 8-28-92; ss by #5754, eff 12-14-93; ss by #6676, eff 1-29-98;
ss by #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260, eff 9-13-08
PART
He-Hea 602 STANDARDS FOR
He-Hea 602.01 Limitations and Permissible Use. The following limitations and permissible
uses shall be applicable to vendors of mobile unit services:
(a)
Vendors shall not prevent any licensed facility or provider owned entity
from contracting with more than one vendor at any time;
(b)
Vendors shall not require a licensed facility or provider owned entity
to sign an exclusive contract that requires the procurement of diagnostic MRI
services only from their specific sources;
(c)
Vendors may include the number of licensed facilities or provider owned
entities in a contract they deem necessary to render the project financially
feasible;
(d)
Licensed facilities or provider owned entities under contract with a
vendor shall not prohibit that vendor or any other vendor from contracting with
or providing mobile unit services to other licensed facilities or provider
owned entities; and
(e)
Vendors shall provide mobile MRI service in a small hospital service
area only in a location owned or operated by the CAH located in the small
hospital service area, unless the board finds that the proposal shall not
adversely affect the continued ability of the CAH in the small hospital service
area to meet the criteria set forth in He-Hea 604.02(b)(4).
Source. #4057, eff 5-28-86; ss by #5350, eff 3-10-92;
ss by #5453, eff 8-28-92; ss by #5754, eff 12-14-93; ss by #7156, INTERIM, eff
12-15-99, EXPIRED: 4-13-00
New. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260, eff 9-13-08
He-Hea 602.02 Limitations on Providers and Service
Locations. Mobile MRI services shall
only be provided by and operated on the site of a licensed facility or its
affiliate, or operated at a free standing location which is affiliated with a
licensed facility or owned by licensed physicians and whose purpose is
operating for the provision of MRI services.
Source. #4057, eff 5-28-86; ss by #5350, eff 3-10-92;
ss by #5453, eff 8-28-92; ss by #5754, eff 12-14-93; ss by #6676, eff 1-29-98;
ss by #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260, eff 9-13-08
He-Hea 602.03 Staffing.
(a)
MRI equipment, personnel, accessories and/or attachments shall conform
to the
(b)
Vendors of mobile unit services shall at a minimum provide or contract
for the following personnel:
(1) A driver/operator of the self-contained van
or tractor-trailer; and
(2) A coordinator who works with the licensed
facility’s personnel to establish patient scheduling.
(c)
Licensed facilities or provider owned entities receiving mobile MRI
services shall have a technologist/radiographer available on site when the
equipment is in operation who is registered by the American Registry of
Radiologic Technologists for MRI.
(d)
Each licensed facility or provider owned entity shall have the following
personnel accessible either on site or by telephone when the equipment is in operation:
(1) A medical physicist who is certified by the
American Board of Radiology; and
(2) A radiologist who is certified by the
licensed facility as meeting the standards of the
(e) A board certified radiologist or board
certified emergency physician shall be on site at the facility for any
application of contrast media or any form of anesthesia to any patient
receiving MRI.
Source. #4057, eff 5-28-86; ss by #5350, eff 3-10-92;
ss by #5453, eff 8-28-92; ss by #5754, eff 12-14-93; ss by #6676, eff 1-29-98;
ss by #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260, eff 9-13-08
PART
He-Hea 603 CRITERIA FOR EVALUATING
He-Hea 603.01 Criteria. In addition to the criteria in RSA 151-C:7
and He-Hea 303, the applicant shall meet all of the following criteria:
(a)
Vendors shall demonstrate that their proposed projects will be
financially feasible;
(b)
Demonstration shall be in the form of a report in the application
indicating:
(1) Financial resources are available to meet the
long-term capital costs of procuring the vehicle and equipment; and
(2) The start-up costs and the operating costs of
the mobile unit;
(c)
Vendors shall demonstrate that personnel resources will be available to
operate the mobile unit;
(d)
Demonstration shall be in the form of a report in the application that
includes a staffing plan of all managerial and support personnel needed to operate
the mobile unit and provide diagnostic magnetic resonance imaging services;
(e)
Vendors shall demonstrate that mobile unit services will meet quality
assurance requirements;
(f)
Demonstration shall be in the form of a report in the application indicating
how the proposed project will meet the requirements of any applicable licensing
and accreditation agency of the state of
(g)
Vendors shall demonstrate that safety procedures will be available in
case of emergency;
(h)
Demonstration shall be in the form of a report in the application
indicating how personnel will be trained in the use of the equipment and the
safety procedures:
(1) In the event of an emergency; and
(2) When contrast media or any form of anesthesia
is applied;
(i)
All vendors providing MRI services shall collect utilization data to be
submitted to the N.H. department of health and human services, office of health
services planning and review;
(j)
At minimum, the following utilization data elements shall be included:
(1) Total number of procedures performed;
(2) Number of inpatient procedures;
(3) Number of outpatient procedures;
(4) Average MRI scanning time per procedure;
(5) Number of days of operation; and
(6) Sources of payment for procedures and the
total amounts charged during the most recent 12 months;
(k)
The data collected pursuant to (j) above shall be prepared and sent to
the board on a yearly basis. The yearly
reports shall be submitted on January 31 of each year for the preceding
12-month period;
(l)
Prior to the MRI scan being performed, the patient’s clinical
indications for MRI shall be reviewed by a board certified radiologist for:
(1) Clinical scanning safety; and
(2) Clinical appropriateness of requested
scanning;
(m)
Demonstration of clinical appropriateness shall be demonstrated by the
submission of utilization review reports on patients scanned at the facility;
and
(n)
Mobile MRI providers shall not perform MRI scans without a referral made
by:
(1) A licensed physician; or
(2) Other licensed health care practitioner who
is credentialed by a
Source. #4057, eff 5-28-86; ss and moved by #5350,
eff 3-10-92 (see He-Hea 605); 5453, eff 8-28-92; ss by #5754, eff 12-14-93; ss
by #7156, INTERIM, eff 12-15-99, EXPIRED: 4-13-00
New. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260, eff 9-13-08
PART
He-Hea 604 APPLICATION PROCEDURES FOR
He-Hea 604.01 Process.
(a)
Applications for mobile MRI units shall be processed in accordance with
the requirements of RSA 151-C:8.
(b)
If an application demonstrates that the proposed project shall maintain
or improve, for the proposed service area, quality of care, access and
availability and cost effectiveness of services, a certificate of need shall be
issued to the vendor. Notice of the
board’s action shall be given pursuant to RSA 151-C:9, I.
(c)
Possible competitive impact upon the availability of MRI services,
existing vendors or other proposed vendors shall not be a basis for denying an
application, except for that as outlined in He-Hea 602.01(e).
Source. #4057, eff 5-28-86; ss by #5350, eff 3-10-92;
ss by #5453, eff 8-28-92; ss by #5754, eff 12-14-93; ss by #7156, INTERIM, eff
12-15-99, EXPIRED: 4-13-00
New. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260, eff 9-13-08
He-Hea 604.02 Impact on Health Care Services.
(a)
Notwithstanding He-Hea 604.01(c), applicants proposing to establish or
extend mobile MRI services to new sites shall demonstrate that the proposed
service shall maintain or improve, for the proposed service area, the:
(1) Quality of care;
(2) Access and availability to health care
services; and
(3) Cost effectiveness of health care services
provided.
(b)
Demonstration shall be made by submitting with the application:
(1) A report identifying quality assurances per
He-Hea 603.01(f);
(2)
A report addressing physicians’ ability
to access resources which allow them to perform health care services or obtain
admitting privileges at existing licensed facilities including correspondence
from physicians intending to refer patients to the licensed facility or
provider owned entity intending to offer mobile MRI services;
(3) To the extent data is available, a statistical report in the application
which shows how the proposed project is projected to affect health care
services in the proposed service area in terms of:
a. Utilization;
b. Patient charges;
c. Market share;
d. Physician referral patterns; and
e. Personnel resources;
(4) Correspondence, if any, from other facilities in the service area regarding the impact of the proposed project
on their existing health care services including their continued ability to:
a. Maintain quality health care services;
b. Provide essential community services;
c. Provide emergency services; and
d. Provide charity care; and
(5) A report in the application addressing how
the establishment of mobile MRI services will not have a detrimental impact on
health services within the proposed service area.
Source. #4057, eff 5-28-86; ss by #5350, eff 3-10-92;
ss by #5453, eff 8-28-92; ss by #5754, eff 12-14-93; ss by #7156, INTERIM, eff
12-15-99, EXPIRED: 4-13-00
New. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260, eff 9-13-08
He-Hea 604.03 Requests for Applications for
Source. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260, eff 9-13-08
PART
He-Hea 605 STANDARDS FOR FIXED UNIT
SERVICES
He-Hea 605.01 Mandatory Standards.
(a)
No licensed facility or provider owned entity or consortium shall apply
for a certificate of need for a fixed unit until:
(1) It is making 1500 referrals per year to a
vendor based on the previous 12 months of operation; or
(2) A report can be made to the board
demonstrating projected volume of, at minimum, 1000 scans per year.
(b)
No applicant shall add an additional fixed unit under the provisions of
RSA 151-C:5, II(d) until it is performing a total of 1500 scans per annum on
the first unit based on the previous 12 months of operation.
Source. #4057, eff 5-28-86; ss and moved by #5350,
eff 3-10-92 (from He-Hea 603); ss by #5453, eff 8-28-92; ss by #5754, eff
12-14-93; ss by #7156, INTERIM, eff 12-15-99, EXPIRED: 4-13-00
New. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260, eff 9-13-08
He-Hea 605.02 Minimum Staffing Levels. Applicants filing a certificate of need application
to acquire and operate a fixed magnetic resonance imaging scanner shall meet
the following requirements:
(a)
MRI equipment, personnel, accessories and/or attachments shall conform
to the
(b)
Licensed facilities or provider owned entities providing fixed MRI
services shall have a technologist/radiographer available on site when the
equipment is in operation who is registered by the American Registry of
Radiologic Technologists;
(c)
Each licensed facility or provider owned entity shall have the following
personnel accessible either on site or by telephone when the equipment is in
operation:
(1) A medical physicist who is certified by the
American Board of Radiology; and
(2) A radiologist who is certified by the
licensed facility as meeting the standards of the
(d)
A board certified radiologist or board certified emergency physician
shall be on site at the facility for any application of contrast media or any
form of anesthesia to any patient receiving MRI.
Source. #4057, eff 5-28-86; ss and moved by #5350, eff
3-10-92 (from He-Hea 603); ss by #5453, eff 8-28-92; ss by and moved by #5754,
eff 12-14-93 (from He-Hea 605.03); ss by #7156, INTERIM, eff 12-15-99, EXPIRED:
4-13-00
New. #7268,
eff 5-10-00, EXPIRED: 5-10-08
New. #9260,
eff 9-13-08
PART
He-Hea 606 CRITERIA FOR EVALUATING FIXED
UNIT SERVICES
He-Hea 606.01 Criteria. In addition to the criteria in RSA 151-C:7
and He-Hea 303, applicants shall meet the following criteria:
(a)
Applicants shall demonstrate that their proposed project shall be financially
feasible;
(b)
Demonstration shall be in the form of a report in the application
indicating:
(1) Financial resources are available to meet the
long-term capital costs of procuring the magnetic resonance imaging equipment
as well as any inherent building renovations and alterations to accommodate the
new equipment; and
(2) The amount of start-up and operating costs
associated with the proposed fixed MRI unit;
(c)
Applicants shall demonstrate that personnel resources shall be available
to operate the fixed unit;
(d)
Demonstration shall be in the form of a report in the application that
includes a staffing plan of all professional, technical and support personnel
needed to provide diagnostic magnetic resonance imaging services with a fixed
unit;
(e)
Applicants shall demonstrate that services shall meet quality assurance
requirements;
(f)
Demonstration shall be in the form of a report in the application
indicating:
(1) That the magnetic resonance imaging scanner
is approved by the federal Food and Drug Administration; and
(2) How the proposed project will meet the
requirements of licensing and accrediting by the N. H. department of health and
human services;
(g)
Applicants shall demonstrate that safety procedures shall be available
in case of emergency;
(h)
Demonstration shall be in the form of a report in the application
indicating how personnel will be trained in the use of the equipment and the
safety procedures:
(1) In the event of an emergency; and
(2) When contrast media or any form of anesthesia
is applied;
(i)
Applicants shall demonstrate, in the form of a report in the
application, the effect their application will have on the current MRI delivery
system specifically addressing the standards in He-Hea 303.02 through He-Hea
303.09;
(j)
Pursuant to RSA 126:25, all licensed facilities providing MRI services shall collect
utilization data to be submitted to the N.H. department of health and human
services, office of health services planning and review, and shall include at a
minimum the following data elements:
(1) Total number of procedures performed;
(2) Number of inpatient procedures;
(3) Number of outpatient procedures;
(4) Average MRI scanning time per procedure;
(5) Number of days of operation; and
(6) Source of payment for procedures and the
total amounts charged during the most recent 12 months;
(k)
The data collected pursuant to (j) above shall be prepared and sent to
the board on a yearly basis. The yearly
reports shall be submitted on or by January 31 of each year for the preceding
12 month period;
(l)
Prior to the scan being performed, the patient’s clinical indications
for MRI shall be reviewed by a board certified radiologist for:
(1) Clinical scanning safety; and
(2) Clinical appropriateness of requested
scanning;
(m)
Demonstration of clinical appropriateness shall be demonstrated by the
submission of utilization review reports on patients scanned at the facility;
(n)
All fixed MRI providers shall not perform MRI scans without a referral
made by:
(1) A licensed physician; or
(2) Other licensed health care practitioner who
is credentialed by a
(o)
Applicants shall document the levels of anticipated construction costs
associated with the renovations and alterations as a result of acquiring MRI
equipment;
(p)
Documentation shall be in the form of a report in the application that
includes a detail of the overall costs of the project on a per square foot
basis;
(q)
Applicants shall demonstrate that the needs of the underserved
populations are or shall be met;
(r)
Demonstration shall be in the form of a report in the application
indicating that MRI services shall be made available and accessible to
everyone; and
(s)
Possible competitive impact upon the availability of MRI services,
existing vendors or other proposed vendors shall not be a basis for denying an
application except for an application to install a fixed unit at a location in
a small hospital service area that is not owned or operated by the hospital
located in the small hospital service area. No application for a fixed unit in
a small hospital service area shall be granted unless the Board finds that the
proposal shall not adversely affect the continued ability of the hospital in
the small hospital service area to meet the criteria set forth in He-Hea
606.02(b)(4).
Source. #5350, eff 3-10-92; ss by #5453, eff 8-28-92;
ss by #5754, eff 12-14-93; ss by #7156, INTERIM, eff 12-15-99, EXPIRED: 4-13-00
New. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260,
eff 9-13-08
He-Hea 606.02 Impact on Health Care Services.
(a)
Notwithstanding He-Hea 606.01(s), applicants proposing to establish or
expand fixed MRI services shall demonstrate that the proposed service shall
maintain or improve, for the proposed service area, the:
(1) Quality of care;
(2) Access and availability to health care
services; and
(3) Cost effectiveness of health care services
provided.
(b)
Demonstration shall be made by submitting with the application:
(1) A report identifying quality assurances per
He-Hea 606.01(f);
(2) A report addressing physicians’ ability to
access resources which allow them to perform health care services or obtain
admitting privileges at existing licensed facilities including correspondence
from physicians intending to refer patients to the licensed facility or
provider owned entity intending to offer fixed MRI services;
(3) To the extent data is available, a statistical report in the application
which shows how the proposed project is projected to affect health care
services in the proposed service area in terms of:
a. Utilization;
b. Patient charges;
c. Market share;
d. Physician referral patterns; and
e. Personnel resources;
(4) Correspondence, if any, from other facilities in the service area regarding the impact of the proposed
project on their existing health care services including their continued
ability to:
a. Maintain quality health care services;
b. Provide essential community services;
c. Provide emergency services; and
d. Provide charity care; and
(5) A report in the application addressing how
the establishment or expansion of fixed MRI services will not have a
detrimental impact on health services within the proposed service area.
Source. #5453, eff 8-28-92; ss by #5754, eff
12-14-93; ss by #7156, INTERIM, eff 12-15-99, EXPIRED: 4-13-00
New. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260,
eff 9-13-08
PART
He-Hea 607 APPLICATION PROCEDURES FOR
FIXED UNIT SERVICES
He-Hea 607.01 Process. Applications shall be processed in accordance
with the requirements of RSA 151-C:8.
Source. #5350, eff 3-10-92; ss by #5453, eff 8-28-92;
ss by #5754, eff 12-14-93; ss by #7156, INTERIM, eff 12-15-99, EXPIRED: 4-13-00
New. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260,
eff 9-13-08
He-Hea 607.02 Consortia. The board shall accept applications for a CON
for fixed MRI services from a consortium provided that:
(a)
The application is filed as one applicant for a CON; and
(b)
The application meets the requirements in this chapter.
Source. #5350, eff 3-10-92; ss by #5453, eff 8-28-92;
ss by #5754, eff 12-14-93; ss by #7156, INTERIM, eff 12-15-99, EXPIRED: 4-13-00
New. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260,
eff 9-13-08
PART
He-Hea 608 REQUESTS FOR APPLICATIONS FOR
FIXED MRI UNITS
He-Hea 608.01 Requests for Applications (RFA). The board shall issue a request for CON
applications for new fixed MRI units if a need is determined pursuant to He-Hea
605.01.
Source. #5754, eff 12-14-93; ss by #7156, INTERIM,
eff 12-15-99, EXPIRED: 4-13-00
New. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260,
eff 9-13-08
He-Hea 608.02 Submissions of Applications. Applications shall be submitted to the board
within 60 days of the RFA pursuant to RSA 151-C:8, I(b).
Source. #5754, eff 12-14-93; ss by #7156, INTERIM,
eff 12-15-99, EXPIRED: 4-13-00
New. #7268, eff 5-10-00, EXPIRED: 5-10-08
New. #9260,
eff 9-13-08
RULE |
STATUTE
IMPLEMENTED |
|
|
He-Hea 601 |
RSA 151-C:2 |
He-Hea 602.01 |
RSA 151-C:5, II(d) |
He-Hea 602.02 |
RSA 151-C:5, II(d) |
He-Hea 602.03 |
RSA 151-C:5, II(d) and RSA 151-C:7, II |
He-Hea 603 |
RSA 151-C:7, I-V |
He-Hea 604 |
RSA 151-C:8 |
He-Hea 605 |
RSA 151-C:5, II(d) |
He-Hea 606.01 |
RSA 151-C:7, I-IV |
He-Hea 606.02 |
RSA 151-C:8 |
He-Hea 607 |
RSA 151-C:8 |
He-Hea 608 |
RSA 151-C:8 |