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) “
(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
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
(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
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
He-Hea 2004.01 Requests
for Applications for
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
(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 |