CHAPTER He-Hea 2000  POSITRON EMISSION TOMOGRAPHY IMAGING SCANNERS

 

PART He-Hea 2001  DEFINITIONS

 

          He-Hea 2001.01  Definitions.

 

          (a)  “Applicant” means “applicant” as defined in RSA 151-C:2, II.

 

          (b)  “Application” means a proposal filed by a person for a certificate of need.

 

          (c)  “Board” means “board” as defined in RSA 151-C:3.

 

          (d)  “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.

 

          (e)  “Certificate of need (CON)” means “certificate of need” as defined in RSA 151-C:2, VIII.

 

          (f)  “Consortium” means an alliance of persons established for the purpose of participating in a joint business venture to offer PET services.

 

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

 

          (h)  "Diagnosis Related Groups code (DRG)” means the statistical symbol used to categorize major diagnosis and procedure of hospitalized patients for medical records and reimbursement purposes.

 

          (i)  “Fixed unit” means a positron emission tomography imaging scanner that is:

 

(1)  Given pre-market approval by the federal Food and Drug Administration for the provision of PET services; and

 

(2)  Permanently and physically located at and operated by a licensed facility.

 

          (j)  “Hospital” means a licensed facility that cares primarily for patients with diseases or injuries for a period of 30 days or less.

 

          (k)  “International Classification of Diseases code (ICD-9)” means the statistical symbol used to classify morbidity and mortality information for the indexing of hospital records by disease and operations.

 

          (l)  “Licensed facility” means an entity licensed under RSA 151 to provide health or medical services.

 

          (m)  “Mobile unit” means a positron emission tomography imaging scanner that is:

 

(1)  Given pre-market approval by the federal Food and Drug Administration for the provision of PET services; and

 

(2)  Physically located in a vehicle such as a self-contained van or tractor trailer capable of transporting the positron emission tomography imaging scanner.

 

          (n)  “Positron emission tomography imaging (PET)” means a nuclear medicine technique that uses a positron emitting isotope to image the function of an organ within the body.

 

          (o)  “Positron emission tomography imaging scanner” means an imaging device that is dedicated to the detection of positron emitters.

 

          (p)  “Positron emitting isotope” means a radioactive pharmaceutical that is introduced into a patient for the provision of PET scanning. It also includes the term “positron emitters”.

 

          (q)  “Person” means “person” as defined in RSA 151-C:2, XXVIII.

 

          (r)  “Procedure” means an anatomical radioactive scan of the body using a PET scanner.

 

          (s)  “Public notice” means any media advertisements, brochures, pamphlets, factsheets or other form of information conveyed to the public concerning an aspect of healthcare.

 

          (t)  “Small hospital service area” means the population from the cities and towns set forth for each designated CAH pursuant to Table 1003-2.

 

          (u)  “Vendor” means a person who owns and operates a positron emission tomography imaging scanner and contracts with licensed facilities for the purpose of providing such services.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

PART He-Hea 2002  STANDARDS FOR MOBILE PET UNIT SERVICES

 

          He-Hea 2002.01  Limitations and Permissible Use.  The following limitations and permissible uses shall be applicable to vendors of and licensed facilities receiving mobile unit services:

 

          (a)  The vendors of mobile PET services or the licensed facilities receiving mobile PET services shall be licensed by the bureau of radiological health, department of health and human services to manufacture, produce, prepare, compound, acquire, receive, possess use or transfer radioactive material for medical use in accordance with He-P 4030 and He-P 4032;

 

          (b)  Vendors shall not prevent any licensed facility from contracting with more than one vendor at any time;

 

          (c)  Vendors shall not require a licensed facility to sign an exclusive contract that requires the procurement of PET services only from their specific sources;

 

          (d)  Vendors may include the number of licensed facilities in a contract they deem necessary to render the project financially feasible;

 

          (e)  Licensed facilities 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; and

 

          (f)  Vendors shall provide mobile PET service in a small hospital service area only in a location owned or operated by the critical access hospital 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 2003.02(b)(4).

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

          He-Hea 2002.02  Limitations on Providers and Service Locations.  Mobile PET services shall only be provided by and operated on the site of a licensed facility.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

          He-Hea 2002.03  Staffing.

 

          (a)  Vendors of mobile PET unit services shall at a minimum provide or contract for the following personnel:

 

(1)  A driver/operator to operate the self-contained van or tractor-trailer; and

 

(2)  A coordinator who works with the licensed facility’s personnel to establish patient scheduling.

 

          (b)  Positron emitting isotopes shall be administered by:

 

(1)  The physician named on the radioactive materials license issued by the bureau of radiological health, department of health and human services; or

 

(2)  A technologist/radiographer acting under the supervision of the physician named on the license.

 

          (c)  PET services shall be supervised by a radiologist or nuclear medicine physician who is board certified by:

 

(1)  The American Board of Radiology;

 

(2)  The American Board of Nuclear Medicine; or

 

(3)  The American Society of Nuclear Cardiology.

 

          (d)  Technologists/radiographers operating the PET scanner and/or administering positron emitting isotopes shall be registered by:

 

(1)  The American Registry of Radiologic Technologists for nuclear medicine; or

 

(2)  The Society of Nuclear Medicine.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

          He-Hea 2002.04  Quality of Care.

 

          (a)  The patient’s clinical indications for PET shall be reviewed by a board certified radiologist or nuclear medicine physician per He-Hea 2002.03(c) for:

 

(1)  Clinical scanning safety; and

 

(2)  Clinical appropriateness of requested scanning.

 

          (b)  Clinical appropriateness shall be demonstrated by the submission of utilization review reports on patients scanned at the facility.

 

          (c)  Mobile PET providers shall not perform PET 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 PET service.

 

          (d)  A radiologist or board certified nuclear medicine physician per He-Hea 2002.03(c) shall be available on site or on call during the administration of positron emitting isotopes for PET scanning.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

PART He-Hea 2003  CRITERIA FOR EVALUATING MOBILE PET SERVICES

 

          He-Hea 2003.01  Criteria.

 

          (a)  In addition to the criteria in RSA 151-C:7 and He-Hea 303, the applicant shall meet all the criteria set forth in this section.

 

          (b)  Vendors shall demonstrate that their proposed projects will be financially feasible.

 

          (c)  Demonstration of financial feasibility 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.

 

          (d)  Vendors shall demonstrate that personnel resources will be available to operate the mobile unit at each licensed facility.

 

          (e)  Demonstration that personnel resources will be available 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 positron emission tomography imaging services.

 

          (f)  Vendors shall demonstrate that mobile unit services will meet quality assurance requirements.

 

          (g)  Demonstration of quality assurance shall be in the form of a report in the application indicating how the proposed project will meet the licensing and accreditation requirements of the bureau of radiological health, department of health and human services, as well as any other national or federal licensing and accreditation agencies.

 

          (h)  Vendors shall demonstrate that safety procedures will be available in case of emergency.

 

          (i)  Demonstration of available safety procedures 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 positron emitting isotopes are introduced into a patient.

 

          (j)  All vendors providing PET 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.

 

          (k)  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 PET scanning time per procedure;

 

(5)  Clinical indication for PET scanning by DRG or ICD-9 code;

 

(6)  Demographic/patient origin data;

 

(7)  Number of days of operation; and

 

(8)  Sources of payment for procedures and the total amounts charged during the most recent 12 months.

 

          (l)  The data collected pursuant to (k) above shall be prepared and sent to the N.H. department of health and human services, office of health services planning and review, on a yearly basis.  The yearly reports shall be submitted by January 31 of each year for the preceding 12 month period.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

          He-Hea 2003.02  Impact on Health Care Services.

 

          (a)  Applicants proposing to establish or extend mobile PET services to new sites shall demonstrate that the proposed service will 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 that quality of care, access, availability and cost effectiveness will be improved or maintained shall be made by submitting with the application:

 

(1)  A report identifying quality assurances pursuant to He-Hea 2003.01(g);

 

(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 intending to offer mobile PET 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 PET services will not have a detrimental impact on health services within the proposed service area.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

PART He-Hea 2004  APPLICATION PROCEDURES FOR MOBILE PET UNIT SERVICES

 

          He-Hea 2004.01  Requests for Applications for Mobile PET Units.  The board shall issue a request for applications for mobile PET units on June 1st of each year.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

          He-Hea 2004.02  Process.

 

          (a)  Applications for mobile PET units shall be processed in accordance with the requirements of RSA 151-C:8.

 

          (b)  A certificate of need shall be issued to the vendor if an application demonstrates that the proposed project will maintain or improve, for the proposed service area the:

 

(1)  Quality of care;

 

(2)  Access and availability of services; and

 

(3)  Cost effectiveness of services.

 

          (c)  Notice of the board’s action shall be given pursuant to RSA 151-C:9, I.

 

          (d)  Competitive impact, whether actual or prospective, upon the availability of PET services, existing vendors or other proposed vendors shall not be a basis for denying an application, except for an application to provide mobile PET service in a small hospital service area in a location that is not owned or operated by the critical access hospital located in the small hospital service area.  No application for a mobile vendor 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 CAH in the small hospital service area to meet the criteria set forth in He-Hea 2003.02(b)(4).

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

PART He-Hea 2005  STANDARDS FOR FIXED PET UNIT SERVICES

 

          He-Hea 2005.01  Mandatory Standards.  The board shall accept applications for fixed PET services only if the following standards are met:

 

          (a)  Fixed units shall only be located at:

 

(1)  Licensed facilities; or

 

(2)  Consortiums.

 

          (b)  Licensed facilities offering fixed unit PET services shall be licensed by the bureau of radiological health, department of health and human services to manufacture, produce, prepare, compound, acquire, receive, possess, use or transfer radioactive material for medical use in accordance with He-P 4030 and He-P 4032.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

          He-Hea 2005.02  Need for Fixed PET Units.

 

          (a)  No licensed facility or consortium shall apply for a certificate of need for a fixed unit until:

 

(1)  It is making 1200 referrals per year to a mobile PET 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 pursuant to He-Hea 2005.02(c).

 

          (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 1200 scans per annum on the first unit based on the previous 12 months of operation.

 

          (c)  At minimum, scanning totals in He-Hea 2005.02(a)(2) shall be based on scan volume for which Medicare and/or Medicaid reimbursement has been certified.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

          He-Hea 2005.03  Staffing.

 

          (a)  Positron emitting isotopes shall be administered by:

 

(1)  The physician named on the radioactive materials license issued by the bureau of radiological health, department of health and human services; or

 

(2)  A technologist/radiographer acting under the supervision of the physician named on the license.

 

          (b)  PET services shall be supervised by a radiologist or nuclear medicine physician who is board certified by:

 

(1)  The American Board of Radiology;

 

(2)  The American Board of Nuclear Medicine; or

 

(3)  The American Society of Nuclear Cardiology.

 

          (c)  Technologists/radiographers operating the PET scanner and/or administering positron emitting isotopes shall be registered by:

 

(1)  The American Registry of Radiologic Technologists for nuclear medicine; or

 

(2)  The Society of Nuclear Medicine.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

          He-Hea 2005.04  Quality of Care.

 

          (a)  The patient’s clinical indications for PET shall be reviewed by a board certified radiologist or nuclear medicine physician per He-Hea 2005.03 (b) for:

 

(1)  Clinical scanning safety; and

 

(2)  Clinical appropriateness of requested scanning.

 

          (b)  Clinical appropriateness shall be demonstrated by the submission of utilization review reports on patients scanned at the facility.

 

          (c)  Fixed PET providers shall not perform PET 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 PET service.

 

          (d)  A radiologist or board certified nuclear medicine physician per He-Hea 2005.03(b) shall be available on site or on call during the administration of positron emitting isotopes for PET scanning.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

PART He-Hea 2006  CRITERIA FOR EVALUATING FIXED PET UNIT SERVICES

 

          He-Hea 2006.01  Criteria.

 

          (a)  In addition to the criteria in RSA 151-C:7 and He-Hea 303, applicants shall meet the criteria set forth in this section.

 

          (b)  Applicants shall demonstrate that their proposed project will be financially feasible.

 

          (c)  Demonstration of financial feasibility 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 positron emission tomography 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 PET unit.

 

          (d)  Applicants shall demonstrate that personnel resources shall be available to operate the fixed unit.

 

          (e)  Demonstration of available personnel resources 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 positron emission tomography imaging services with a fixed unit.

 

          (f)  Applicants shall demonstrate that services shall meet quality assurance requirements.

 

          (g)  Demonstration of quality assurance shall be in the form of a report in the application indicating:

 

(1)  That the positron emission tomography imaging scanner has been given pre-market approval 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. bureau of radiological health, department of health and human services.

 

          (h)  Applicants shall demonstrate that safety procedures shall be available in case of emergency.

 

          (i)  Demonstration of available safety procedures 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)  During the application of positron emitting isotopes.

 

          (j)  Applicants shall demonstrate, in the form of a report in the application, the effect their application will have on the current PET delivery system specifically addressing the standards in He-Hea 303.02 through He-Hea 303.09.

 

          (k)  All vendors providing PET 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.

 

          (l)  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 PET scanning time per procedure;

 

(5)  Clinical indication for PET scanning by DRG or ICD-9 code;

 

(6)  Demographic/patient origin data;

 

(7)  Number of days of operation; and

 

(8)  Source of payment for procedures and the total amounts charged during the most recent 12 months.

 

          (m)  The data collected pursuant to (l) above shall be prepared and sent to the N.H. department of health and human services, office of health services planning and review, on a yearly basis.  The yearly reports shall be submitted by January 31of each year for the preceding 12 months.

 

          (n)  Applicants shall document the levels of anticipated construction costs associated with the renovations and alterations as a result of acquiring PET equipment.

 

          (o)  Documentation of anticipated construction costs shall be made 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.

 

          (p)  Applicants shall demonstrate that the needs of the underserved populations are or will be met.

 

          (q)  Demonstration that the needs of the underserved populations are or will be met shall be in the form of a report in the application indicating that PET services shall be made available and accessible to everyone; and

 

          (r)  Possible competitive impact upon the availability of PET 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 2003.02(b)(4).

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

          He-Hea 2006.02  Impact on Health Care Services.

 

          (a)  Applicants proposing to establish or expand fixed PET services shall demonstrate that the proposed service will 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 that quality of care, and access, availability and cost effectiveness will be improved or maintained shall be made by submitting with the application:

 

(1)  A report identifying quality assurances pursuant to He-Hea 2006.01(g);

 

(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 intending to offer fixed PET 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 PET services will not have a detrimental impact on health services within the proposed service area.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

PART He-Hea 2007  APPLICATION PROCEDURES FOR FIXED PET UNIT SERVICES

 

          He-Hea 2007.01  Process.  Applications shall be processed in accordance with the requirements of RSA 151-C:8.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

          He-Hea 2007.02  Consortia.  The board shall accept applications for a CON for fixed PET 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. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

PART He-Hea 2008  REQUESTS FOR APPLICATIONS FOR FIXED PET UNITS

 

          He-Hea 2008.01  Requests for Applications (RFA).  The board shall issue a request for CON applications for new fixed PET units if a need is determined pursuant to He-Hea 2005.02.

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 

          He-Hea 2008.02  Submission of Applications.  Applications shall be submitted to the board within 60 days of the RFA pursuant to RSA 151-C:8, I(b).

 

Source. #7386, eff 12-1-00, EXPIRED: 12-1-08

 

New.  #9432, eff 3-20-09

 


 

APPENDIX

 

RULE

STATUTE BEING IMPLEMENTED

 

 

He-Hea 2000

RSA 151-C:5, II(d) and RSA 151-C:11, I

He-Hea 2001

RSA 151-C:2

He-Hea 2001.01(a)

RSA 151-C:2, II

He-Hea 2001.01(c)

RSA 151-C:2, IV

He-Hea 2001.01(e)

RSA 151-C:2, VIII

He-Hea 2001.01(p)

RSA 151-C:2, XXVIII

He-Hea 2002.01

RSA 151-C:7, II, III

He-Hea 2002.02

RSA 151-C:5, II(d) and RSA 151-C:7, II, III

He-Hea 2002.03

RSA 151-C:7, II

He-Hea 2002.04

RSA 151-C:7, IV

He-Hea 2003.01

RSA 151-C:7, I-IV

He-Hea 2003.02

RSA 151-C:7, I-IV

He-Hea 2004

RSA 151-C:8

He-Hea 2005.01

RSA 151-C:7, I, II

He-Hea 2005.02

RSA 151-C:5, II(d) and RSA 151-C:7, I, II

He-Hea 2005.03

RSA 151-C:7, III

He-Hea 2005.04

RSA 151-C:7, IV

He-Hea 2006.01

RSA 151-C:7, I-IV

He-Hea 2006.02

RSA 151-C:7, I-IV

He-Hea 2007

RSA 151-C:8

He-Hea 2008

RSA 151-C:8