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MICHIGAN DEPARTMENT OF COMMUNITY HEALTH CERTIFICATE OF NEED REVIEW STANDARDS
FOR MAGNETIC RESONANCE IMAGING SERVICES
(By authority conferred on the Certificate of Need Commission by Section 22215 of Act No. 368 of the Public Acts of 1978, as amended, and sections 7 and 8 of Act No. 306 of the Public Acts of 1969, as amended, being sections 333.22215, 24.207, and 24.208 of the Michigan Compiled Laws.)
Section 1. Applicability
Sec. 1. (1) These standards are requirements for the approval of the initiation, expansion, replacement, relocation, or acquisition of MRI services and the delivery of services for all projects approved and certificates of need issued under Part 222 of the Code which involve magnetic resonance imaging services.
(2) A magnetic resonance imaging service is a covered clinical service for purposes of Part 222 of the Code. An MRI unit approved pursuant to Section 9(1) seeking approval to operate pursuant to sections 3, 4, 5, 6, 7, or 8 shall be considered as a person requesting certificate of need approval to initiate, expand, replace, relocate, or acquire a covered clinical service, as applicable.
(3) The Department shall use sections 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, and 14, as applicable, in applying Section 22225(1) of the Code, being Section 333.22225(1) of the Michigan Compiled Laws.
(4) The Department shall use Section 10, as applicable, in applying Section 22225(2) (c) of the Code, being Section 333.22225(2) (c) of the Michigan Compiled Laws.
Section 2. Definitions
Sec. 2. (1) For purposes of these standards:
(a) "Acquisition of an MRI service or unit" means obtaining control or possession of an existing fixed or mobile MRI service or unit by contract, ownership, lease, or other comparable arrangement.
(b) "Actual MRI adjusted procedures," for purposes of sections 13 and 14, means the number of MRI procedures, adjusted in accordance with the applicable provisions of Section 11, performed on an existing MRI unit, or if an MRI service has two or more MRI units at the same site, the average number of MRI adjusted procedures performed on each unit, for the 12-month period reported on the most recently published "Available MRI Adjusted Procedures List," as of the date an application is deemed complete by the Department.
(c) "Available MRI adjusted procedures," for purposes of Section 13, means the number of MRI adjusted procedures performed by an existing MRI service in excess of 8,000 per fixed MRI unit and 7,000 per mobile MRI unit. For either a fixed or mobile MRI service, the number of MRI units used to compute available MRI adjusted procedures shall include both existing and approved but not operational MRI units. In determining the number of available MRI adjusted procedures, the Department shall use data for the 12-month period reported on the most recently published list of available MRI adjusted procedures as of the date an application is deemed complete by the Department.
In the case of an MRI service that operates, or has a valid certificate of need to operate, more than one fixed MRI unit at the same site, the term means the number of MRI adjusted procedures in excess of 8,000 multiplied by the number of fixed MRI units at the same site. For example, if an MRI service operates, or has a valid certificate of need to operate, two fixed MRI units at the same site, the available number of MRI adjusted procedures is the number that is in excess of 16,000 (8,000 x 2).
In the case of a mobile MRI unit, the term means the sum of all MRI adjusted procedures performed by the same mobile MRI unit at all of the host sites combined that is in excess of 7,000. For example, if a mobile MRI unit serves five host sites, the term means the sum of MRI adjusted procedures for all five host sites combined that is in excess of 7,000.
(d) "Central service coordinator" means the organizational unit which has operational responsibility for a mobile MRI unit. It shall be a legal entity authorized to do business in the State of Michigan.
(e) "Certificate of Need Commission" means the Commission created pursuant to Section 22211 of the Code, being Section 333.22211 of the Michigan Compiled Laws.
(f) "Code" means Act No. 368 of the Public Acts of 1978, as amended, being Section 333.1101 et seq. of the Michigan Compiled Laws.
(g) "Contrast MRI procedure" means an MRI procedure involving either of the following: (i) a procedure following use of a contrast agent or (ii) procedures performed both before and after the use of a contrast agent.
(h) "Department" means the state agency known as the Michigan Department of Community Health.
(i) "Doctor," for purposes of these standards, means an individual licensed under Article 15 of the Code to engage in the practice of medicine, osteopathic medicine and surgery, chiropractic, dentistry, or podiatry.
(j) "Existing magnetic resonance imaging service" or "existing MRI service" means either the utilization of an MRI unit(s) at one site in the case of a fixed MRI service and in the case of a mobile MRI service, the utilization of a mobile MRI unit(s) at each host site, on the date an application is submitted to the Department.
(k) "Expand a fixed MRI service" means an increase in the number of fixed MRI units to be operated by an applicant at the same site.
(l) "Expand a mobile MRI service" means the addition of a mobile MRI unit that will be operated by a central service coordinator that is approved to operate one or more mobile MRI units as of the date an application is submitted to the Department.
(m) "Group practice," for purposes of Section 13(3) (b), means a group practice as defined pursuant to the provisions of 42 U.S.C. 1395nn (h) (4), commonly known as Stark II, and the Code of Federal Regulations, 42 CFR, Part 411, published in the Federal Register on August 14, 1995.
(n) “Health service area” or “HSA” means the geographic areas set forth in Section 16.
(o) "Host site" means the site at which a mobile MRI unit is authorized by certificate of need to provide MRI services.
(p) "Initiate a fixed MRI service" means begin operation of a fixed MRI unit at a site that does not provide fixed MRI services as of the date an application is submitted to the Department. The term does not include the relocation of an existing MRI service meeting the requirements of Section 7 or the renewal of a lease.
(q) “Initiate a mobile MRI host site” means the provision of MRI services at a host site that has not received any MRI services within 12 months from the date an application is submitted to the Department.
The term does not include the renewal of a lease.
(r) "Initiate a mobile MRI service" means begin operation of a mobile MRI unit that serves two or more host sites.
The term does not include the renewal of a lease.
(s) "Inpatient," for purposes of Section 11 of these standards, means an MRI visit involving an individual who has been admitted to the licensed hospital at the site of the MRI unit or in the case of an MRI unit that is not
located at that licensed hospital site, an admitted patient transported from a licensed hospital site by ambulance to the MRI service.
(t) "IRB" or "institutional review board" means an institutional review board as defined by Public Law 93-348 which is regulated by Title 45 CFR 46.
(u) "Licensed hospital site" means a health facility licensed under Part 215 of the Code. In the case of a single site hospital, it is either (i) the location of the facility authorized by license and listed on that licensee's certificate of licensure or (ii) in the case of a hospital with multiple sites, the location of each separate and distinct inpatient unit of the health facility as authorized by the licensee’s certificate of licensure.
(v) "Magnetic resonance" or "MR" means the analysis of the interaction which occurs between radio frequency energy, atomic nuclei, and strong magnetic fields to produce cross sectional images similar to those displayed by computed tomography (CT) but without the use of ionizing radiation.
(w) "Magnetic resonance imaging adjusted procedure" or "MRI adjusted procedure" means an MRI visit at an existing MRI service that has been adjusted in accordance with the applicable provisions of Section 11.
(x) "Magnetic resonance imaging database" or "MRI database" means the database, maintained by the Department pursuant to Section 10 of these standards, that collects information about each MRI visit at MRI units located in Michigan.
(y) "Magnetic resonance imaging procedure" or "MRI procedure" means a procedure conducted by an MRI unit approved pursuant to sections 3, 4, 5, 6, 7, or 8 of these standards which is either a single, billable diagnostic magnetic resonance procedure or a procedure conducted by an MRI unit at a site participating with an approved diagnostic radiology residency program, under a research protocol approved by an institutional review board. The capital and operating costs relating to the research use are charged to a specific research account and not charged to or collected from third-party payors or patients. The term does not include a procedure conducted by an MRI unit approved pursuant to Section 9(1).
(z) "Magnetic resonance imaging services" or "MRI services" means either the utilization of an MRI unit(s) at one site in the case of a fixed MRI service or in the case of a mobile MRI service, the utilization of a mobile MRI unit at each host site.
(aa) "Magnetic resonance imaging unit" or "MRI unit" means the magnetic resonance system consisting of an integrated set of machines and related equipment necessary to produce the images and/or spectroscopic quantitative data from scans.
(bb) "Magnetic resonance imaging visit" or "MRI visit" means a single patient visit to an MRI unit which may involve one or more MRI procedures.
(cc) "Mobile MRI unit" means an MRI unit operating at two or more host sites and that has a central service coordinator. The mobile MRI unit shall operate under a contractual agreement for the provision of MRI services at each host site on a regularly scheduled basis.
(dd) "Ownership interest, direct or indirect," for purposes of these standards, means a direct ownership relationship between a doctor and an applicant entity or an ownership relationship between a doctor and an entity that has an ownership relationship with an applicant entity.
(ee) "Pediatric patient," for purposes of these standards, means a patient who is 12 years of age or less. (ff) "Planning area," for purposes of these standards, means
(i) in the case of a proposed fixed MRI service or unit, the geographic area within a 20-mile radius from the proposed site if the proposed site is not in a rural county and a 50-mile radius from the proposed site if the proposed site is in a rural county.
For purposes of Section 7(8) of these standards, the planning area shall be measured from the original site at which the MRI service was first initiated.
(ii) in the case of a proposed mobile MRI service or unit, except as provided in subsection (iii), the geographic area within a 20-mile radius from each proposed host site if the proposed site is not in a rural county and within a 50-mile radius from each proposed host site if the proposed site is in a rural county.
(iii) in the case of a proposed mobile MRI service or unit meeting the requirement of Section 11(2)(d), the health service area in which all the proposed mobile host sites will be located.
(gg) "Referring doctor," for purposes of these standards, means the doctor of record who ordered the MRI procedure(s) and either to whom the primary report of the results of an MRI procedure(s) is sent or in the case of a teaching facility, the attending doctor who is responsible for the house officer or resident that requested the MRI procedure.
(hh) "Relocate an existing MRI service or unit" means a change in the location of an existing MRI service or unit from the existing site to a different site within the relocation zone.
(ii) "Relocation zone," for purposes of these standards, means the geographic area that is within a 5-mile radius of the existing site of the MRI service or unit to be relocated if the existing MRI service or unit is not located in a rural county and a 10-mile radius if the existing MRI service or unit is located in a rural county.
(jj) "Renewal of a lease" means extending the effective period of a lease for an existing MRI unit that does not involve either replacement of the MRI unit, as defined in Section 2(1) (kk) (i), or (ii) a change in the parties to the lease.
(kk) "Replace an MRI service or unit" means (i) any equipment change involving a change in, or replacement of, the magnet resulting in an applicant operating the same number and type (fixed or mobile) of MRI units before and after project completion or (ii) an equipment change other than a change in the magnet that involves a capital expenditure of $500,000 or more in any consecutive 24-month period or (iii) the renewal of a lease. The term does not include an upgrade of an existing MRI service or unit, and it does not include a host site that proposes to receive mobile MRI services from a different central service coordinator if the requirements of Section 3(5) (a) -(d), as applicable, have been met.
(ll) "Rural county" means a county not located in a metropolitan area as that term is defined pursuant to the "revised standards for defining metropolitan areas in the 1990's" by the statistical policy office of the office of information and regulatory affairs of the United States office of management and budget, 55 F.R. p. 12154 (March 30, 1990).
(mm) "Sedated patient" means a patient that meets all of the following:
(i) whose level of consciousness is either conscious-sedation or a higher level of sedation, as defined by the American Association of Anesthesiologists, the American Academy of Pediatrics, the Joint Commission on the Accreditation of Health Care Organizations, or an equivalent definition.
(ii) who is monitored by mechanical devices while in the magnet.
(iii) who requires observation while in the magnet by personnel, other than employees routinely assigned to the MRI unit, who are trained in cardiopulmonary resuscitation (CPR).
(nn) "Site," for purposes of these standards, means
(i) in the case of a licensed hospital site, a location that is part of the licensed hospital site or a location that is contiguous to the licensed hospital site or
(ii) in the case of a location that is not a licensed hospital site, a location at the same address or a location that is contiguous to that address.
(oo) “Teaching facility," for purposes of these standards, means a licensed hospital site, or other location, that provides either fixed or mobile MRI services and at which residents or fellows of a training program in diagnostic radiology, that is approved by the Accreditation Council on Graduate Medical Education or American Osteopathic Association, are assigned.
(pp) "Unadjusted MRI scan" means an MRI procedure performed on a single anatomical site as defined by the MRI database and that is not adjusted pursuant to the applicable provisions of Section 11.
(qq) "Upgrade an existing MRI unit" means any equipment change that
(i) does not involve a change in, or replacement of, the magnet; does not result in an increase in the number of MRI units; or does not result in a change in the type of MRI unit (e.g., changing a mobile MRI unit to a fixed MRI unit); and
(ii) involves a capital expenditure of less than $500,000 in any consecutive 24-month period.
(2) Terms defined in the Code have the same meanings when used in these standards.
Section 3. Requirements for approval of applicants proposing to initiate an MRI service or mobile MRI host site
Sec. 3. (1) An applicant proposing to initiate a fixed MRI service shall demonstrate that 4,500 MRI adjusted procedures per proposed unit result from application of the methodology in Section 13 of these standards.
(2) (a) An applicant proposing to initiate a mobile MRI service that involves beginning operation of a mobile MRI unit shall demonstrate that a minimum of 4,000 MRI adjusted procedures per proposed unit result from application of the methodology in Section 13 of these standards.
(b) The applicant, whether the central service coordinator or the host site, must demonstrate that a minimum of 600 MRI adjusted procedures result from the application of the methodology in Section 13 of these standards, for each proposed host site that
(i) is not located in a rural county and
(ii) has not received any mobile MRI service within the most recent 12-month period as of the date an application is submitted to the Department.
(c) The applicant, whether the central service coordinator or the host site, must demonstrate that a minimum of 400 MRI adjusted procedures result from the application of the methodology in Section 13 of these standards for each proposed host site that
(i) is located in a rural county and
(ii) has not received any mobile MRI service within the most recent 12-month period as of the date an application is submitted to the Department.
(3) (a) An applicant, whether the central service coordinator or a proposed host site, proposing to initiate a mobile MRI host site not in a rural county, that is to be part of an existing mobile MRI service, must demonstrate that at least 600 MRI adjusted procedures result from the application of the methodology in Section 13 of these standards for that host site.
(b) An applicant, whether the central service coordinator or a proposed host site, proposing to initiate a mobile MRI host site in a rural county, that is to be part of an existing mobile MRI service, must demonstrate that at least 400 MRI adjusted procedures result from the application of the methodology in Section 13 of these standards for that host site.
(4) An applicant that meets all of the following requirements shall not be required to be in compliance with subsection (1):
(a) The applicant is proposing to initiate a fixed MRI service.
(b) The applicant is currently a host site being served by one or more mobile MRI units.
(c) The applicant has received, in aggregate, at least 6,000 MRI adjusted procedures within the most recent 12- month period for which data, verifiable by the Department, are available.
(d) All of the MRI adjusted procedures provided at the applicant's approved site in the most recent 12-month period, referenced in (c) above, by each mobile MRI service/units from which any of the MRI adjusted procedures are being utilized to meet the minimum 6,000 MRI adjusted procedures shall be utilized to meet the
requirements of (c). [For example: If mobile network 19 provided 4,000 adjusted procedures, network 21 provided 2,100, and network 18 provided 1,000, all of the adjusted procedures from network 19 and 21 must be used (i.e., 6,100) but the 1,000 adjusted procedures from network 18 do not need to be used to meet the 6,000 minimum.]
(e) The applicant shall install the fixed MRI unit within the same relocation zone as the applicant's current, approved host site.
(5) Initiation of a mobile MRI host site does not include the provision of mobile MRI services at a host site if the applicant, whether the host site or the central service coordinator, demonstrates or provides each of the following, as applicable:
(a) The host site has received mobile MRI services from an existing mobile MRI unit within the most recent 12- month period as of the date an application is submitted to the Department.
(b) The addition of a host site to a mobile MRI unit will not increase the number of MRI units operated by the central service coordinator or by any other person.
(c) Notification to the Department of the addition of a host site prior to the provision of MRI services by that mobile MRI unit in accordance with (d).
(d) A signed certification, on a form provided by the Department, whereby each host site for each mobile MRI unit has agreed and assured that it will provide MRI services in accordance with the terms for approval set forth in Section 10 of these standards, as applicable. The central service coordinator also shall identify all current host sites, on this form, that are served by the mobile route as of the date of the signed certification or are committed in writing to be served by the mobile route.
(e) The central service coordinator requires, as a condition of any contract with a host site, compliance with the requirements of these standards by that host site, and the central service coordinator assures compliance, by that host site, as a condition of the certificate of need issued to the central service coordinator.
Section 4. Requirements for approval of an application proposing to expand an existing MRI service Sec. 4. (1) An applicant proposing to expand a fixed MRI service shall demonstrate that 4,500 MRI adjusted procedures per proposed additional unit result from application of the methodology in Section 13 of these standards.
(2) An applicant proposing to expand a mobile MRI service shall demonstrate that 4,000 MRI adjusted procedures per proposed additional unit result from application of the methodology in Section 13 of these standards.
(3) An applicant proposing to expand a mobile MRI service must provide a copy of the existing or revised contracts between the central service coordinator and each host site(s) that includes the same stipulations as specified in Section 6(2).
Section 5. Requirements for approval of an applicant proposing to replace an existing MRI unit
Sec. 5. An applicant proposing to replace an existing MRI unit shall demonstrate that the proposed project meets each of the following requirements:
(1) Within the most recent 12-month period for which data, verifiable by the Department, are available, at least the applicable minimum number of MRI adjusted procedures set forth in subdivision (a) or (b) have been performed. In meeting this requirement, an applicant shall not include any procedures conducted by an MRI unit approved pursuant to Section 9(1).
(a) Each mobile MRI unit to be replaced has performed in excess of an average of 3,500 MRI adjusted procedures per MRI unit.
(b) Each fixed MRI unit to be replaced has performed in excess of an average of 4,000 MRI adjusted procedures per MRI unit.
(2) An applicant proposing to replace an MRI unit that does not involve a renewal of a lease shall demonstrate that the MRI unit to be replaced is fully depreciated according to generally accepted accounting principles; the existing equipment clearly poses a threat to the safety of the public; or the proposed replacement equipment offers a significant technological improvement which enhances quality of care, increases efficiency, and/or reduces operating costs.
(3) Equipment that is replaced shall be removed from service prior to the replacement equipment becoming operational.
(4) An applicant proposing to replace a mobile MRI unit must provide a copy of the existing or revised contracts between the central service coordinator and each host site(s) that includes the same stipulations as specified in Section 6(2).
Section 6. Additional requirements for approval of an applicant proposing to initiate a mobile MRI service
Sec. 6. (1) An applicant proposing to initiate a mobile MRI service that involves beginning operation of a mobile MRI unit shall identify the proposed regular route schedule and the procedures for handling emergency situations.
(2) An applicant proposing a mobile MRI unit shall submit copies of all proposed contracts related to the mobile MRI unit in the certificate of need application submitted by the central service coordinator. The contract shall include the following:
(a) A signed certification, on a form provided by the Department, whereby each host site has agreed and assured that it will provide MRI services for each mobile MRI unit in accordance with the terms of approval set forth in Section 10 of these standards, as applicable. The central services coordinator also shall identify all current host sites, on this form, as of the date of the signed certification.
(b) A statement that requires compliance with the requirements of these standards by that host site and assures compliance, by that host site, as a condition of the certificate of need issued to the central service coordinator.
(c) A signed agreement between the central service coordinator and the host site(s) that states that for any host site applying, at any time in the future, for a fixed MRI unit under Section 3(4), that the mobile services at the host site will not cease until the fixed unit is in operation or upon the request of the host site. Further, the applicant applying for the fixed MRI unit must stipulate in the application at the time it is submitted to the Department that it has notified all affected host sites as well as the central service coordinator at least six months prior to beginning operation of the fixed MRI unit.
Section 7. Requirements for approval of an application proposing to relocate an existing MRI service or unit
Sec 7. An applicant proposing to relocate an existing MRI service or unit shall demonstrate that the proposed project meets all of the following:
(1) The unit to be relocated is a fixed MRI unit.
(2) The MRI unit to be relocated has been in operation for at least 36 months as of the date an application is submitted to the Department.
(3) The proposed new site of the existing MRI service or unit to be relocated is in the relocation zone.
(4) The proposed project will not result in the replacement of the MRI unit to be relocated unless the applicant demonstrates that the requirements of Section 5, as applicable, also have been met.
(5) The proposed project will not result in an increase of the number of MRI units operated by the MRI service.
(6) The MRI unit to be relocated performed at least the applicable minimum number of MRI adjusted procedures set forth in Section 10(1)(d)(i) of these standards based on the most recent 12-month period for which the Department has verifiable data.
(7) The applicant agrees to operate the MRI service or unit in accordance with all applicable project delivery requirements set forth in Section 10 of these standards.
(8) An applicant that meets all of the following requirements shall be exempt from subsection (3):
(a) The licensed hospital site to which the MRI service is to be relocated and the MRI service at the site from which the MRI service is to be relocated are owned by the same person as defined in Section 1106 of this public act or the same governmental entity.
(b) The licensed hospital site to which the MRI service is to be relocated is located within the planning area.
(c) As evidenced in the governing body resolution required in (e), the MRI service to be relocated shall cease at its current location within 24 months after the date the application receives a final decision of approval from the Department or upon the date the service becomes operational at the relocation site, whichever occurs first.
(d) The MRI service shall be relocated and shall be operational within 24 months after the date the application receives a final decision of approval from the Department or the certificate of need to relocate the MRI service shall expire.
(e) The certificate of need application includes a resolution of the applicant’s governing body that commits to the provisions of (c) and (d).
(f) The relocation of the MRI service shall not result in the licensed hospital site having more than one fixed MRI unit.
Section 8. Requirements for approval of an application proposing to acquire an existing MRI service or unit
Sec 8. An applicant proposing to acquire an existing fixed or mobile MRI service or unit shall demonstrate that the proposed project meets all of the following:
(1) The project will not change the number of MRI units at the site of the MRI service being acquired unless the applicant demonstrates that the project is in compliance with the requirements of sections 3 or 4, as applicable.
(2) The project will not result in the replacement of an MRI unit at the MRI service to be acquired unless the applicant demonstrates that the requirements of Section 5 also have been met.
(3) The applicant agrees to operate the MRI service or unit in accordance with all applicable project delivery requirements set forth in Section 10 of these standards.
(4) For the first application proposing to acquire an existing fixed or mobile MRI service on or after July 1, 1997, the existing MRI service or unit to be acquired shall not be required to be in compliance with the volume requirements applicable to a seller/lessor on the date the acquisition occurs. The MRI service shall be operating at the applicable volume requirements set forth in Section 10(1) (d) (i) of these standards in the second 12 months after the effective date of the acquisition, and annually thereafter.
(5) For any application proposing to acquire an existing fixed or mobile MRI service or unit, except the first application approved pursuant to subsection (4), an applicant shall be required to document that the MRI service or unit to be acquired is operating in compliance with the volume requirements set forth in Section 10(1)
(d) (i) of these standards applicable to an existing MRI service on the date the application is submitted to the Department.
Section 9. Requirements for approval of an application proposing an MRI unit to be used exclusively for research
Sec. 9. (1) An applicant proposing an MRI unit to be used exclusively for research shall demonstrate each of the following:
(a) The applicant operates a diagnostic radiology residency program approved by the Accreditation Council for Graduate Medical Education, the American Osteopathic Association, or an equivalent organization.
(b) The MRI unit shall operate under a protocol approved by the applicant's institutional review board.
(c) The applicant agrees to operate the unit in accordance with the terms of approval in Section 10(2).
(2) An applicant meeting the requirements of subsection (1) shall be exempt from meeting the requirements and terms of sections 3, 4, 5, 6, 7, 8, 10 [with the exception of 10(1) (d) (iii)], and 13 of these standards.
Section 10. Project delivery requirements--terms of approval
Sec. 10. (1) An applicant shall agree that, if approved, the services provided by the MRI unit, whether fixed or mobile, shall be delivered and maintained in compliance with the following terms of certificate of need approval:
(a) Compliance with these standards.
(b) Compliance with applicable safety and operating standards for the specific MRI unit approved.
(c) Compliance with the following quality assurance standards:
(i) An applicant shall develop and maintain policies and procedures that establish protocols for the following system performance measures. The protocols shall establish the required benchmarks; identify the testing interval, which shall be at least quarterly; and identify the MRI staff person responsible for testing the system performance measures.
(A) Signal-to-noise ratio.
(B) Spatial resolution.
(C) Slice thickness, location, and separation.
(D) Spatial linearity.
(E) Field homogeneity and drift.
(F) System calibration and stability.
(G) Cryogen level and boiloff rate.
(H) Radio frequency power monitor.
(I) Hard copy image quality.
In addition to the designated staff person, the system performance measures in subdivisions (A) through (F) and
(H) also shall be evaluated by an appropriately trained MRI physicist or engineer. The physicist/engineer shall conduct tests of these system performance measures when the MRI unit begins to operate, and annually thereafter. The purpose of the physicist/engineer test shall be to certify to the Department that the MRI unit meets or exceeds all of the system performance specifications of the manufacturer of the MRI unit in effect for that MRI unit at the time of installation or most recent upgrade. The physicist/engineer shall make available for review the periodic system performance measures test data established in this subsection.
(ii) An applicant shall develop and maintain policies, procedures, and protocols for assuring the functionality of each of the following MRI accessories. The protocols shall establish the required benchmarks, identify the testing interval for each accessory, and identify the staff person responsible for testing the system performance measures.
(A) All surface coils.
(B) Positioning devices.
(C) Physiologic triggering/monitoring equipment.
(D) Patient communication devices.
(E) Scan table position indicator and drives.
(F) Data network including storage and retrieval.
(G) Emergency rundown/shutdown units.
(H) Hard copy devices.
(iii) An applicant shall develop and maintain policies and procedures that establish protocols for assuring the effectiveness of operation and the safety of the general public, patients, and staff in the MRI service. Each of the following must be included and the staff person responsible for development and enforcement of these policies shall be indicated.
(A) Access to the MRI service.
(B) Access to the MRI scan room.
(C) Patient safety clearance before imaging and safety during imaging.
(D) Adverse bioeffects, including
(1) acoustic hazard.
(2) radio frequency burn hazard.
(3) specific absorption rates.
(4) peripheral nerve stimulation.
(5) pregnancy.
(6) magnet quench hazard.
(E) Sedation.
(F) Contrast administration.
(G) Treatment of adverse reactions to contrast.
(H) Patient monitoring for sedation, anesthesia, and unstable patients.
(I) Patient resuscitation, management of emergencies, maintenance of cardiopulmonary resuscitation equipment, and certification requirements for personnel for either basic or advanced cardiopulmonary resuscitation.
(J) Screening for metallic implants, pacemakers, and metallic foreign bodies, as well as a list of contraindications.
(K) Mechanism for consultation regarding difficult cases.
(L) Pulse sequence protocols for specific indications.
(M) Institutional review board policies relating to non-FDA approved pulse sequences or investigational procedures.
(N) Staff inservice regarding subdivisions (A) through (M).
(iv) An applicant shall establish a schedule for preventive maintenance for the MRI unit.
(v) An applicant shall maintain records of the results of the periodic test data required by subdivisions (i) and (ii), including the results of the tests performed by the MRI physicist/engineer required in subdivision (i). An applicant, upon request, shall submit annually to the Department a report of the test data results and evidence of compliance with the applicable project delivery requirements.
(vi) An applicant shall provide documentation identifying the specific individuals that form the MRI team. At a minimum, the MRI team shall consist of the following professionals:
(A) An MRI team leader who shall be responsible for
(1) developing criteria for procedure performance.
(2) developing protocols for procedure performance.
(3) developing a clinical data base for utilization review and quality assurance purposes.
(4) transmitting requested data to the Department.
(5) screening of patients to assure appropriate utilization of the MRI service.
(6) taking and interpretation of scans.
(7) coordinating MRI activity at MRI host sites for a mobile MRI unit.
(8) identifying and correcting MRI image quality deficiencies.
(B) Physicians who shall be responsible for screening of patients to assure appropriate utilization of the MRI service and taking and interpretation of scans. At least one of these physicians shall be a board-certified radiologist.
(C) An appropriately trained MRI technician who shall be responsible for taking an MRI scan.
(D) An MRI physicist/engineer available as a team member on a full-time, part-time, or contractual basis. An MRI physicist/engineer shall be responsible for at least the following:
(1) Providing technical specifications for new equipment and assistance in equipment procurement.
(2) Performing or validating technical performance for system acceptance.
(3) Establishing preventive maintenance schedules and quality assurance test procedures and recording and reviewing preventive maintenance and quality assurance data.
(4) Facilitating the repair of acute system malfunctions.
(5) Training personnel in the MRI service with respect to the technical aspects of MRI scanning and patient and staff safety.
(6) Assisting in designing and optimizing clinical imaging procedures.
(E) System maintenance personnel who shall be responsible for calibrating the MRI system and preventive maintenance at regularly scheduled intervals and who shall compile and submit quality control data to the MRI team leader.
(vii) An applicant shall document that the MRI team members have the following qualifications:
(A) The MRI team leader is a board-certified or board-eligible radiologist, or other physician trained in MRI, who spends greater than 75 percent of his or her professional time in multiple anatomic site medical imaging. The MRI team leader also shall demonstrate that he or she meets the requirements set forth in subsection (B) for a physician who interprets MRI images.
(B) Each physician credentialed to interpret MRI scans meets the requirements of each of the following:
(1) The physician is licensed to practice medicine in the State of Michigan.
(2) The physician has had at least 60 hours of training in MRI physics, MRI safety, and MRI instrumentation in a program that is part of an imaging program accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association, and the physician meets the requirements of subdivision (i), (ii), or (iii):
(i) Board certification by the American Board of Radiology, the American Osteopathic Board of Radiology, or the Royal College of Physicians and Surgeons of Canada. If the diagnostic radiology program completed by a physician in order to become board certified did not include at least two months of MRI training, that physician shall document that he or she has had the equivalent of two months of postgraduate training in clinical MRI imaging at an institution which has a radiology program accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association.
(ii) Formal training by an imaging program(s), accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association, that included two years of training in cross-sectional imaging and six months training in organ-specific imaging areas.
(iii) A practice in which at least one-third of total professional time, based on a full-time clinical practice during the most recent 5-year period, has been the primary interpretation of MR imaging.
(3) The physician has completed and will complete a minimum of 40 hours every two years of Category in Continuing Medical Education credits in topics directly involving MR imaging.
(4) The physician interprets, as the primary interpreting physician, at least 250 unadjusted MRI scans annually.
(C) An MRI technologist who is registered by the American Registry of Radiologic Technicians and has, or will have within 36 months of the effective date of these standards or the date a technologist is employed by an MRI service, whichever is later, special certification in MRI. If a technologist does not have special certification in
MRI within either of the 3-year periods of time, all continuing education requirements shall be in the area of MRI services.
(D) An applicant shall document that an MRI physicist/ engineer is appropriately qualified. For purposes of evaluating this subdivision, the Department shall consider it prima facie evidence as to the qualifications of the physicist/engineer if the physicist/engineer is certified as a medical physicist by the American Board of Radiology, the American Board of Medical Physics, or the American Board of Science in Nuclear Medicine. However, the applicant may submit and the Department may accept other evidence that an MRI physicist/engineer is qualified appropriately.
(E) An applicant shall document that system maintenance personnel are qualified on the basis of training and experience to perform the calibration, preventive maintenance, and quality control functions on the specific MRI unit approved.
(viii) The applicant shall have, within the MRI unit/service, equipment and supplies to handle clinical emergencies that might occur in the unit. MRI service staff will be trained in CPR and other appropriate emergency interventions. A physician shall be on-site, in, or immediately available to the MRI unit at all times when patients are undergoing scans.
(ix) In addition to all other applicable terms of approval, each mobile MRI unit shall have an operations committee with members representing each host site, the central service coordinator, and the medical director. This committee shall oversee the effective and efficient use of the MRI unit, establish the normal route schedule, identify the process by which changes shall be made to the schedule, develop procedures for handling emergency situations, and review the ongoing operations of the mobile MRI unit on at least a quarterly basis.
(d) Compliance with the following terms of approval, as applicable:
(i) MRI units shall be operating at a minimum average annual level of utilization during the second 12 months of operation, and annually thereafter, of 4,500 MRI adjusted procedures per unit for fixed MRI services and 4,000 MRI adjusted procedures per unit for mobile MRI services. Each mobile host site in a rural county shall have provided at least a total of 400 adjusted procedures during its second 12 months of operation, and annually thereafter, from all mobile units providing services to the site. Each mobile host site not in a rural county shall have provided at least a total of 600 adjusted procedures during its second 12 months of operation and annually thereafter, from all mobile units providing services to the site. In meeting these requirements, an applicant shall not include any MRI adjusted procedures performed on an MRI unit used exclusively for research and approved pursuant to Section 9(1).
(ii) The applicant, to assure that the MRI unit will be utilized by all segments of the Michigan population, shall
(A) provide magnetic resonance services to all individuals based on the clinical indications of need for the service and not on ability to pay or source of payment.
(B) maintain information by source of payment to indicate the volume of care from each source provided annually.
Compliance with selective contracting requirements shall not be construed as a violation of this term.
(iii) The applicant shall participate in a data collection network established and administered by the Department. The data may include, but is not limited to annual budget and cost information, operating schedules, throughout schedules, demographic and diagnostic information, and the volume of care provided to patients from all payor sources, as well as other data requested by the Department and approved by the Commission. The applicant shall provide the required data in a format established by the Department and in a mutually agreed upon media no later than 30 days following the last day of the quarter for which data are being reported to the Department. An applicant shall be considered in violation of this term of approval if the required data are not submitted to the Department within 30 days following the last day of the quarter for which data are being reported. However, the Department shall allow an applicant up to an additional 60 days to submit the required data if reasonable efforts
are made by an applicant to provide the required data. The Department may elect to verify the data through on-site review of appropriate records. Data for an MRI unit approved pursuant to Section 9(1) shall be reported separately.
(iv) The operation of and referral of patients to the MRI unit shall be in conformance with 1978 PA 368, Sec. 16221, as amended by 1986 PA 319; MCL 333.16221; MSA 14.15 (16221).
(e) (i) The applicant shall provide the Department with a notice stating the first date on which the MRI unit became operational, and such notice shall be submitted to the Department within 10 days after the MRI unit is placed into operation.
(ii) An applicant who is a central service coordinator shall notify the Department of any additions, deletions, or changes in the host sites of each approved mobile MRI unit within 10 days after the change(s) in host sites is made.
(2) An applicant for an MRI unit under Section 9(1) shall agree that the services provided by the MRI unit approved pursuant to Section 9(1) shall be delivered in compliance with the following terms of certificate of need approval:
(a) The capital and operating costs relating to the research use of the MRI unit approved pursuant to Section 9(1) shall be charged only to a specific research account(s) and not to any patient or third-party payor.
(b) The MRI unit approved pursuant to Section 9(1) shall not be used for any purposes other than as approved by the institutional review board unless the applicant has obtained certificate of need approval for the MRI unit pursuant to Part 222 and these standards, other than Section 9.
(3) The agreements and assurances required by this section shall be in the form of a certification authorized by the owner or governing body of the applicant.
(4) An applicant approved to initiate a fixed MRI service pursuant to Section 3(4) of these standards shall cease operation of the mobile MRI host site converted to a fixed service and shall not initiate mobile MRI services at that host site for a period of 12 months from the date the fixed service/unit becomes operational.
Section 11. MRI procedure adjustments
Sec. 11. (1) The Department shall apply the following formula, as applicable, to determine the number of MRI adjusted procedures that are performed by an existing MRI service or unit:
(a) The base value for each MRI procedure is 1.0.
(b) For each MRI visit performed on a pediatric patient, 0.25 shall be added to the base value.
(c) For each MRI visit performed on an inpatient, 0.50 shall be added to the base value.
(d) For each MRI procedure performed on a sedated patient, 0.75 shall be added to the base value.
(e) For each contrast MRI procedure performed after use of a contrast agent, and not involving a procedure before use of a contrast agent, 0.35 shall be added to the base value.
(f) For each contrast MRI procedure involving a procedure before and after use of a contrast agent, 1.0 shall be added to the base value.
(g) For each MRI procedure performed at a teaching facility, 0.15 shall be added to the base value.
(h) The results of subsections (a) through (g) shall be summed, and that sum shall represent an MRI adjusted procedure.
(2) The Department shall apply not more than one of the adjustment factors set forth in this subsection, as applicable, to the number of MRI procedures adjusted in accordance with the applicable provisions of subsection (1) that are performed by an existing MRI service or unit.
(a) For a site located in a rural county, the number of MRI adjusted procedures shall be multiplied by a factor of 1.4.
(b) For a mobile MRI unit that serves hospitals and other host sites located in rural and nonrural counties, the number of MRI adjusted procedures for a site located in a rural county shall be multiplied by a factor of 1.4 and for a site located in a nonrural county, the number of MRI adjusted procedures shall be multiplied by a factor of 1.0.
(c) For a mobile MRI unit that serves only sites located in rural counties, the number of MRI adjusted procedures shall be multiplied by a factor of 2.0.
(d) For a mobile MRI unit that serves only sites located in a health service area with one or fewer fixed MRI units and one or fewer mobile MRI units, the number of MRI adjusted procedures shall be multiplied by a factor of 3.5.
(e) Subsection (2) shall not apply to an application proposing a subsequent fixed MRI unit (second, third, etc.) at the same site.
(3) The num ber of MRI adjusted procedur es perform ed by an exis t ing MRI service is th e sum of th e results of subse ct ions (1) an d (2).
Section 12. Documentation of actual utilization
Sec. 12. Documentation of the number of MRI procedures performed by an MRI unit shall be substantiated by the Department utilizing data submitted by the applicant on the form used for reporting MRI procedure data (form PD9 or any subsequent form used for that purpose). The number of MRI procedures actually performed shall be documented by procedure records and not by application of the methodology required in Section 13. The Department may elect to verify the data through on-site review of appropriate records.
Section 13. Methodology for computing the number of available MRI adjusted procedures and requirements for submission and consideration of data commitments from referring doctors
Sec. 13. (1) An applicant shall apply the methodology set forth in this section for computing the number of available MRI adjusted procedures required pursuant to section 3 or 4 of these standards, as applicable. In applying the methodology, the following steps shall be taken in sequence, and data for the 12-month period reported on the most recently published Available MRI Adjusted Procedures List, as of the date an application is deemed complete by the Department, shall be used:
(a) Determine the number of actual MRI adjusted procedures performed by each existing MRI service within the planning area.
(b) Determine the number of available MRI adjusted procedures, if any, for each existing MRI service within the planning area from which a referring doctor has submitted a signed data commitment, on a form provided by the Department, to commit his or her available MRI adjusted procedures to a proposed MRI service or unit.
(c) Determine the number of available MRI adjusted procedures that each referring doctor may commit to an application in accordance with the following:
(i) Divide the number of available MRI adjusted procedures determined in subsection (b) by the number of actual MRI adjusted procedures determined in subsection (a) for each existing MRI service within the planning area. The result is the proportion of available MRI adjusted procedures for each existing MRI service.
(ii) Multiply the number of actual MRI adjusted procedures that each referring doctor made to each existing MRI service within the planning area, for which a signed data commitment form has been submitted, by the applicable proportion obtained in subdivision (i). The sum of each of these calculations is the number of available MRI adjusted procedures that each referring doctor may commit to a proposed MRI service or unit that will be located within the planning area.
(iii) For purposes of computing available MRI adjusted procedures pursuant to this section, if one or more host sites on a mobile MRI service are located within the planning area of the proposed site, the available MRI adjusted procedures for the entire mobile MRI service will be considered.
(iv) For purposes of computing MRI adjusted procedures pursuant to this section, MRI adjusted procedures performed on MRI units used exclusively for research and approved pursuant to Section 9(1) shall not be included.
(v) For purposes of computing MRI adjusted procedures pursuant to this section, all of the MRI adjusted procedures utilized to meet the requirements of Section 3(4) (d) shall be excluded for three years from the date the fixed MRI unit becomes operational.
(2) An applicant shall submit a signed data commitment, on a form provided by the Department, for each referring doctor committing available MRI adjusted procedures to the same application for a new or additional MRI unit. An applicant also shall submit a computer file that lists, for each MRI service from which data are being committed to the same application, the name and license number of each referring doctor for whom a signed data commitment form is submitted. The computer file shall be provided to the Department on mutually agreed upon media and in a format prescribed by the Department.
(3) The Department shall consider a data commitment, on a form provided by the Department, submitted by an applicant in support of an application, that meets the requirements of each of the following, as applicable:
(a) A referring doctor certifies that 100% of available MRI adjusted procedures for each specified MRI service, calculated pursuant to subsection (1), is being committed and specifies the certificate of need application number, for a new or additional MRI unit proposed to be located within the planning area, to which the data commitment is made. A referring doctor shall not be required to commit available MRI adjusted procedures from all MRI services to which his or her patients are referred for MRI services but only from those MRI services specified by the referring doctor in the data commitment form provided by the Department and submitted by an applicant in support of an application.
(b) A referring doctor certifies that he or she does not have an ownership interest, either direct or indirect, in the applicant entity, except that this requirement shall not apply if the applicant entity is a group practice of which the referring doctor is a member.
(c) A referring doctor certifies that he or she has not been provided, or received a promise of being provided, a financial incentive to commit any of his or her available MRI adjusted procedures to an application.
(4) (a) The Department shall not consider a data commitment from a referring doctor for available MRI adjusted procedures from a specific MRI service if the available MRI adjusted procedures from that specific MRI service were used to support approval of an application for a new or additional MRI unit for which a final decision to approve has been issued by the Director of the Department until either of the following occurs:
(i) The approved certificate of need is withdrawn or expires.
(ii) The MRI service or unit to which the data was committed has been in operation for at least 36 continuous months.
(b) The Department shall not consider a data commitment from a referring doctor for available MRI adjusted procedures from a specific MRI service if the available MRI adjusted procedures from that specific MRI service were used to support an application for a new or additional MRI unit for which a final decision to disapprove was issued by the Director of the Department until either of the following occurs:
(i) A final decision to disapprove an application is issued by the Director and the applicant does not appeal that disapproval or
(ii) If an appeal was made, either that appeal is withdrawn by the applicant or the referring doctor withdraws his or her data commitment pursuant to the requirements of subsection (8).
(5) The Department shall not consider a data commitment from a referring doctor for available MRI adjusted procedures from the same MRI service if that referring doctor has submitted a signed data commitment, on a form provided by Department, for more than one (1) application for which a final decision has not been issued by the Department. If the Department determines that a referring doctor has submitted a signed data commitment for the same available MRI adjusted procedures from the same MRI service to more than one certificate of need application for a new or additional MRI unit pending a final decision, the Department shall
(a) if the applications were filed on the same designated application date, notify all applicants, simultaneously and in writing, that one or more referring doctors have submitted data commitments for available MRI adjusted procedures from the same MRI service and that the referring doctors' data from the same MRI service shall not be considered in the review of any of the pending applications filed on the same designated application date until the referring doctor notifies the Department, in writing, of the one (1) application for which the data commitment shall be considered.
(b) if the applications were filed on different designated application dates, consider the data commitment submitted in the application filed on the earliest designated application date and shall notify, simultaneously in writing, all applicants of applications filed on designated application dates subsequent to the earliest date that one or more referring doctors have submitted data commitments for available MRI adjusted procedures from the same MRI service and that the referring doctors' data shall not be considered in the review of the application(s) filed on the subsequent designated application date(s).
(6) The Department shall not consider any data commitment submitted by an applicant after the date an application is deemed complete unless an applicant is notified by the Department, pursuant to subsection (5), that one or more referring doctors submitted data commitments for available MRI adjusted procedures from the same MRI service. If an applicant is notified that one or more referring doctors' data commitments will not be considered by the Department, the Department shall consider data commitments submitted after the date an application is deemed complete only to the extent necessary to replace the data commitments not being considered pursuant to subsection (5).
(7) In accordance with either of the following, the Department shall not consider a withdrawal of a referring doctor's signed data commitment
(a) during the 120-day period following the date on which the Department's review of an application commences.
(b) after a proposed decision to approve an application has been issued by the Department.
(8) The Department shall consider a withdrawal of a signed data commitment if a referring doctor submits a written notice to the Department, which specifies the certificate of need application number and the specific MRI services for which a data commitment is being withdrawn, and if an applicant demonstrates that the requirements of subsection (7) also have been met.
Section 14. Lists of MRI adjusted procedures published by the Department
Sec. 14. (1) On or before January 1 and July 1 of each year, the Department shall publish the following lists:
(a) A list, known as the "MRI Service Utilization List," of all MRI services in Michigan that includes at least the following for each MRI service:
(i) The number of actual MRI adjusted procedures;
(ii) The number of available MRI adjusted procedures, if any; and
(iii) The number of MRI units, including whether each unit is a clinical unit or an MRI unit used exclusively for research.
(b) A list, known as the "Available MRI Adjusted Procedures List," that identifies each MRI service that has available MRI adjusted procedures and includes at least the following:
(i) The number of available MRI adjusted procedures;
(ii) The name, address, and license number of each referring doctor whose patients received MRI services at that MRI service; and
(iii) The number of available MRI adjusted procedures performed on patients referred by each referring doctor and if any are committed to an MRI service. This number shall be calculated in accordance with the requirements of Section 13 (1). A referring doctor may have fractional portions of available MRI adjusted procedures.
(c) For the lists published pursuant to subsections (a) or (b), the July 1 list will report 12 months of data from the previous calendar year, and the January 1 list will report 12 months of data from the first six months of the previous calendar year and the second six months of the calendar year prior to the previous calendar year. Copies of both lists shall be available upon request.
(d) The Department shall not be required to publish a list that sorts MRI database information by referring doctor, only by MRI service.
(2) When an MRI service begins to operate at a site at which MRI services previously were not provided, the Department shall include in the MRI database, data beginning with the second full quarter of operation of the new MRI service. Data from the start-up date to the start of the first full quarter will not be collected to allow a new MRI service sufficient time to develop its data reporting capability. Data from the first full quarter of operation will be submitted as test data but will not be reported in the lists published pursuant to this section.
(3) In publishing the lists pursuant to subsections (a) and (b), if an MRI service has not reported data in compliance with the requirements of Section 10(1) (d) (iii), the Department shall indicate on both lists that the MRI service is in violation of the requirements set forth in Section 10(1)(d)(iii), and no data will be shown for that service on either list.
(4) In the case of an MRI service at which MRI services previously were not provided, the Department may use annualized data from at least a consecutive 6-month period in publishing the lists pursuant to subsections (a) and (b).
Section 15. Comparative reviews
Sec. 15. (1) These certificate of need review standards supersede and replace the Certificate of Need Review Standards for Magnetic Resonance Imaging Services approved by the Certificate of Need Commission on March 14, 2000 and effective April 28, 2000.
(2) Projects reviewed under these standards shall not be subject to comparative review.
SECTION 16. HEALTH SERVICE AREAS
SEC. 16. COUNTIES ASSIGNED TO EACH OF THE HEALTH SERVICE AREAS ARE AS FOLLOWS: HSA COUNTIES
1
LIVINGSTON MACOMB WAYNE
MONROE OAKLAND
ST. CLAIR WASHTENAW
2
CLINTON EATON
HILLSDALE INGHAM
JACKSON LENAWEE
3
BARRY BERRIEN BRANCH
CALHOUN CASS KALAMAZOO
ST. JOSEPH VAN BUREN
4
ALLEGAN IONIA KENT LAKE
MASON MECOSTA MONTCALM MUSKEGON
NEWAYGO OCEANA OSCEOLA OTTAWA
5
GENESEE
LAPEER
SHIAWASSEE
6
ARENAC BAY CLARE GLADWIN GRATIOT
HURON IOSCO ISABELLA MIDLAND
ROSCOMMON SAGINAW SANILAC TUSCOLA OGEMAW
7
ALCONA ALPENA ANTRIM BENZIE CHARLEVOIX CHEBOYGAN
CRAWFORD EMMET
GD TRAVERSE KALKASKA LEELANAU MANISTEE
MISSAUKEE MONTMORENCY OSCODA OTSEGO PRESQUE ISLE WEXFORD
8
ALGER BARAGA CHIPPEWA DELTA DICKINSON
GOGEBIC HOUGHTON IRON KEWEENAW LUCE
MACKINAC MARQUETTE MENOMINEE ONTONAGON SCHOOLCRAFT
