CHAPTER He-Hea 600  MAGNETIC RESONANCE IMAGING SCANNERS

 

PART He-Hea 601  DEFINITIONS

 

          He-Hea 601.01  Definitions.

 

          (a)  “ACR” means American College of Radiology.

 

          (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)  Critical Access Hospital (CAH)” means a hospital which has been designated as such by the Federal Centers for Medicare and Medicaid Services.

 

          (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 MOBILE UNIT SERVICES

 

          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 American College of Radiology practice guideline for performing and interpreting magnetic resonance imaging (MRI), 2006.

 

          (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 American College of Radiology for the interpretation of MRI.

 

          (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 MOBILE SERVICES

 

          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 New Hampshire;

 

          (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 New Hampshire hospital to refer MRI service.

 

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 MOBILE UNIT SERVICES

 

          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 Mobile MRI Units.  The board shall issue a request for applications for mobile MRI units on April 1st of each year.

 

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 American College of Radiology practice guideline for performing and interpreting magnetic resonance imaging (MRI), 2006;

 

          (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 American College of Radiology for the interpretation of MRI; and

 

          (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 New Hampshire hospital to refer MRI service;

 

          (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