CHAPTER He-Hea 1600 MEGAVOLTAGE RADIATION THERAPY SERVICES
PART He-Hea 1601
DEFINITIONS
He-Hea
1601.01 Definitions.
(a) “Applicant” means “applicant” as defined in
RSA 151-C:2, II.
(b) “Application” means a proposal prepared by a
person and filed with the board for a certificate of need.
(c) “Board” means “board” as defined in RSA
151-C:2, IV.
(d) “Board certified” means the confirmation
given by a national or regional association to a professional 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) “Dosimetrist” means a person who generates
and calculates radiation dose distributions under the direction of a medical
physicist and a radiation oncologist.
(g) “Health care facility” means “health care
facility” as defined in RSA 151-C:2, XV-a.
(h) “Licensed facility” means an entity licensed
under RSA 151 to provide health or medical services.
(i) “Market share population” means the number
and/or percent of patients in a given service area utilizing a specific health
care facility.
(j) “Megavolt (MeV)” means one million electron
volts.
(k) “Megavoltage radiation therapy equipment”
means therapeutic equipment having a maximum power rating in excess of one MeV
which utilizes directed beams of ionizing radiation to kill cancerous
tissues. The term includes but is not
limited to Cobalt-60 and linear accelerator machines.
(l) “Procedure” means the setup and delivery,
through a single port or multiple ports, of a radiation treatment. It includes
the term “external beam procedure.”
(m) “Radiation oncologist” means a physician
certified by the American Board of Radiology in radiation oncology to manage
patients with cancer.
(n) “Radiation therapist” means a person who is
certified by the American Registry of Radiology Technology to provide patient
treatment with ionizing radiation under the supervision of a radiation
oncologist.
(o) “Service area” means a geographic area in
which a majority of a healthcare provider’s clientele reside.
(p) “Simulator therapist” means a radiation
therapist trained to mock-up or simulate a patient’s radiation treatment with
radiographic documentation of treatment portals under the supervision of a
radiation oncologist.
(q) “Uninsured” means a person who:
(1) Is not covered or eligible for health care
insurance;
(2) Is eligible but not enrolled in a health
insurance plan; or
(3) Is otherwise covered by a health insurance
plan that does not cover the medically needed radiation therapy service(s).
Source. #4574, eff 2-6-89; ss by #4987, eff 11-21-90;
ss by #5238, eff 9-27-91, EXPIRED: 9-27-97
New. #7236, eff 4-26-00; ss by #8774, eff
12-16-06, EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
PART
He-Hea 1602 STANDARDS FOR MEGAVOLTAGE RADIATION
THERAPY EQUIPMENT AND PROGRAMS
He-Hea
1602.01 Service Area.
(a) Each applicant for a certificate of need for
megavoltage radiation therapy equipment and program shall define the proposed
primary and secondary service areas for the new equipment.
(b) The primary service area shall include the
populations from those towns identified in Table
1003-1 of He-Hea 1003.01;
(c) The secondary service area shall include the
populations of any additional towns named by the applicant;
(d) In identifying the primary and secondary
service areas, the applicant shall include:
(1) A full description of the proposed service
area including the size, demographic and morbidity characteristics of the
service area; and
(2) Current radiation therapy referral patterns
from that service area.
Source.
#4574, eff 2-6-89; ss by #4987, eff 11-21-90; ss by #5238, eff 9-27-91,
EXPIRED: 9-27-97
New. #7236, eff 4-26-00; ss by #8774, eff
12-16-06, EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea
1602.02 Market Share Population.
(a) The applicant shall claim the following
market share of its defined primary and secondary service areas as follows:
(1) For the primary service area, 100% market
share; and
(2) For the secondary service area, 100% of those
towns located equally distant to, or less than half the distance to, to the
next available health care facility offering a megavoltage radiation therapy
program.
(b) Notwithstanding He-Hea 1602.02(a) above, for
any facility proposed to be located in the service area where a megavoltage
radiation therapy program already exists, the applicant shall claim a
fractional market share of the primary service area based on total existing and
proposed machines.
(c) In claiming its market share the applicant
shall include the following data, wherever possible:
(1) Out-of-state population and utilization data;
(2) Population data bases from bordering states;
and
(3) Admission patterns of bordering states.
Source. #4574, eff 2-6-89; ss by #4987, eff 11-21-90;
ss by #5238, eff 9-27-91, EXPIRED: 9-27-97
New. #7236, eff 4-26-00; ss by #8774, eff 12-16-06,
EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea
1602.03 Volume of Patients and
Procedures.
No new
megavoltage radiation therapy program shall be approved unless it can be
demonstrated that the proposed program can:
(a) Treat a minimum of 325 patients on an annual
basis by the end of the third year of operation; and
(b) Perform an average of 6,500 procedures per
machine on an annual basis by the end of the third year of operation.
Source. #4574, eff 2-6-89; ss by #4987, eff 11-21-90;
ss by #5238, eff 9-27-91, EXPIRED: 9-27-97
New. #7236, eff 4-26-00; ss by #8774, eff
12-16-06, EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea
1602.04 Megavoltage Radiation Therapy
Patient and Procedure Calculation.
(a) Applicants shall calculate projected patient
and procedure volume as specified in He-Hea 1602.03 in the following manner:
(1)
Identify the town names for all towns in the projected primary and
secondary service areas pursuant to He-Hea 1602.01;
(2)
Obtain population estimates for the expected third year of operation of
the program for each town in the projected primary and secondary service areas
by the following age groups:
a. Less than 15;
b. 15-24;
c. 25-34;
d. 35-39;
e. 40-44;
f. 45-49;
g. 50-54;
h. 55-59;
i. 60-64;
j. 65-69;
k. 70-74;
l. 75-79;
m. 80-84; and
n. 85 and older;
(3) Population estimates for (2) above shall be
obtained from either:
a. The
b. A nationally recognized demographic data
provider; or
c. A professional demographer experienced in
small-area population estimates.
(4) Apply the market share
developed by He-Hea 1602.02 to the population of each town named in (1) above;
(5) Multiply the service area’s
2007-2011 average estimated age-specific cancer rates as obtained from the N.
H. department of health and human services, bureau of public health statistics
and informatics, times the age-specific population estimates from (2) above;
(6) If
market area level age-specific cancer rates are not available then the applicant
shall use statewide age-specific cancer rates and multiply these rates times
the age-specific population estimates from (2) above;
(7) To determine the service area’s
total estimated cancer cases, sum the results for each age grouping from (5) above
for the projected operating year;
(8) To determine estimated cancer cases
requiring radiation therapy, multiply the result of (7) above times 0.6;
(9) To determine total estimated
radiation therapy procedures, multiply the result of (8) by 23.
(b) An applicant shall have successfully
demonstrated that the service area can support a new megavoltage radiation
therapy program when:
(1) The product of (8) above is greater than or
equal to 325; and
(2) The product of (9) above is greater than or
equal to 6,500.
Source. #4574, eff 2-6-89; ss by #4987, eff 11-21-90;
ss by #5238, eff 9-27-91, EXPIRED: 9-27-97
New. #7236, eff 4-26-00; ss by #8774, eff
12-16-06, EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea
1602.05 Impact on Existing Programs.
(a) A proposed megavoltage radiation therapy
program shall not have a detrimental impact on any existing megavoltage
radiation therapy program in the state.
(b) Applicants shall demonstrate that their
proposed megavoltage radiation therapy program will not cause the utilization
level at any existing megavoltage radiation therapy program in the state to
fall below an annual average of 6,500 procedures per machine by the end of the
third year of its proposed program.
(c) Demonstration shall be made in the form of an
analysis made by the applicant of the impact of the proposed program on any
existing program in the state performed in the following manner:
(1)
Obtain from the department of health and human services, health services
planning and review, the annual account of procedure and
patient volumes by town per MeV machine as submitted by MeV providers pursuant to
He-Hea 1602.10(b);
(2) To
determine the proposed percentage of market capture for the applicant, multiply
the result of market share by town determined in He-Hea 1602.04(a)(4) times the
number of patients by town as identified in the report from (1) above;
(3) Sum the results of (2) above;
(4) To determine the fractional loss per
machine, divide the sum of (3) above by total patients by MeV provider as
obtained in (1) above;
(5) For
each MeV provider, multiply the average number of treatments per machine from
(1) above by 1.13; and
(6) For
each current MeV provider, multiply the quotient of (4) above by the product in
(5) above and then subtract this result from the product of (5); and
(d) If the sum of (6) above is greater than or
equal to 6,500 then the applicant shall have successfully demonstrated support
for an additional MeV program that will not impact current utilization levels
of any existing program in the state.
Source. #4574, eff 2-6-89; ss by #4987, eff 11-21-90;
ss by #5238, eff 9-27-91, EXPIRED: 9-27-97
New. #7236, eff 4-26-00; ss by #8774, eff
12-16-06, EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea
1602.06 Equipment.
(a) Megavoltage radiation equipment shall only be
located at:
(1) Licensed facilities; or
(2) Facilities owned or operated,
directly or indirectly, by a:
a. Licensed facility; or
b. Licensed physician.
(b) Megavoltage radiation equipment shall be
registered or licensed in accordance with the rules for control of radiation,
He-P 4000.
(c) Owners of megavoltage equipment shall provide
a copy of the state radiation-producing machine registration certificate or
radioactive material license issued by the
(d) The document required by (c) above shall be
submitted with the annual data report as required by He-Hea 1602.10.
Source. #4574, eff 2-6-89; ss by #4987, eff 11-21-90;
ss by #5238, eff 9-27-91, EXPIRED: 9-27-97
New. #7236, eff 4-26-00; ss by #8774, eff
12-16-06, EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea
1602.07 Non-Hospital Site.
(a) Any applicant who proposes a non-hospital
site for support services to the new equipment shall submit, as part of the
application, protocols for the transportation of patients for the provision of
necessary support and emergency services.
(b) Demonstration shall be in the form of a
written agreement for the acceptance and transfer of patients needing such
emergency care, with:
(1) The nearest acute care hospital; or
(2) Any acute care hospital within
30 minutes travel time.
(c) The formal agreement submitted with the
application shall be:
(1) Signed by the applicant and
the hospital; and
(2) Dated within the past 12 months of submission
with the application.
(d) The applicant shall demonstrate that it has
entered a written agreement with an
(e) Demonstration of emergency transport shall be
in the form of a copy of the written agreement for emergency transportation
services.
Source. #4574, eff 2-6-89; ss by #4987, eff 11-21-90;
ss by #5238, eff 9-27-91, EXPIRED: 9-27-97
New. #7236, eff 4-26-00; ss by #8774, eff 12-16-06
(formerly He-Hea 1602.08), EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea
1602.08 Staffing and Support Services.
(a) The board shall not approve an application
for the acquisition of megavoltage radiation therapy equipment unless the
applicant includes as part of the application a staffing plan, including
curriculum vitae, which details and documents the availability of or plans for
obtaining the services of radiation therapy personnel.
(b) The staffing plan shall include the following
personnel:
(1) A radiation oncologist to serve as the
director of the radiation therapy program who shall be:
a. Licensed by the State of
b. Certified by the American Board
of Radiology in:
1.
Therapeutic radiology; or
2.
Radiation oncology;
(2) A total of 2 full-time equivalent (FTE)
radiation therapists per radiation therapy machine, one of whom shall
demonstrate additional training or experience as a simulator therapist.
(3) A dosimetrist;
(4) A physicist certified by:
a. The American Board of Radiology;
or
b. Another board recognized by the
American Board of Radiology; and
(5) An FTE registered nurse.
(c) The applicant shall include as part of the
application a detailed description of the availability of required support
services at the proposed site.
(d) The following support services shall be
available to the proposed radiation therapy program:
(1) Clinical oncology services, including
chemotherapy and surgical treatment of tumors and follow-up capabilities;
(2) Services of a tumor registry;
(3) Services of a simulation capability and dose
computation equipment;
(4) Services of a pathology laboratory;
(5) Services of a physics laboratory;
(6) Computerized tomography and/or magnetic
resonance imaging capability;
(7) Block fabrication;
(8) Services of an electronics shop for
maintenance of electronic equipment;
(9) Social work and counseling;
(10) In-house brachytherapy or a referral arrangement
for provision of the service;
(11) Nutrition and dietary consultation; and
(12) In-house capabilities encompassing the full
range of radiation therapy modalities, including megavoltage equipment and
superficial treatment equipment and systemic therapy or referral arrangements
for the provision of these services.
(e) If the support services described in He-Hea
1602.08(c) are not available on-site, the applicant shall provide a description
of the capital cost necessary to establish or upgrade these support services as
part of the total capital cost of the proposed megavoltage radiation therapy
service.
Source. #5238, eff 9-27-91, EXPIRED: 9-27-97
New. #7236, eff 4-26-00; ss by #8774, eff 12-16-06
(formerly He-Hea 1602.09), EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea
1602.09 Other Criteria. In addition to all other requirements in RSA
151-C:7 and He-Hea 303.02 through He-Hea 303.09, applicants shall meet the
following criteria for consideration of a CON for construction, expansion,
renovation or replacement of megavoltage radiation therapy equipment and
services:
(a) Applicants shall demonstrate that any anticipated
proposed cost per square foot shall be comparable in cost within a
10% margin to the 2014 edition of Marshall Valuation Service, section 15;
(b) Demonstration of project costs shall be made
in the form of a report included with the application which provides:
(1) A detail of the costs and space by department
or area affected by the proposed project;
(2) A comparison of these costs which shall be
within 10% of the 2014 edition of Marshall Valuation Service, section 15, for the
proposed class and type of construction; and
(3) An identification of the square footage for
each department or area before and after the project;
(c) Applicants shall include a report in the
application which provides:
(1) An analysis of the class and quality of
construction pursuant to section one of the 2014
(2) The allocation of costs within a multiple use
building;
(3) The allocations of site costs and land costs
where facilities are proposed to have multiple uses;
(4) The methodology used in calculating
construction costs for renovations;
(5) The methodology used in calculating
construction costs involving leasehold improvements; and
(6) The anticipated useful life of the building
for depreciation purposes;
(d) The following construction costs shall be
compared with the 2014
(1) Total costs associated with:
a. Labor;
b. Materials; and
c. Fixed equipment;
(2) Building permits;
(3) Architectural and engineering fees;
(4) Site preparation for the building;
(5) Utilities from structure to lot line;
(6) Insurance costs during construction; and
(7) Interest costs during construction;
(e) The applicant shall follow the outline of the
calculator method set forth in section 10 of the 2014
(f) The costs and factors to take into account
pursuant to (e) above shall include:
(1) The base cost found in the general hospital
table in section 15, page 24 of the 2014
(2) An adjustment to heating, ventilation and
air-conditioning costs for extreme climate;
(3) Sprinkler system costs;
(4) Story height multipliers;
(5) Perimeter multipliers; and
(6) Cost multipliers from section 99 of the 2014
(g) Applicants shall describe anticipated
operational cost savings that may occur as a result of the project due to:
(1) Consolidation of services;
(2) Improved heating and maintenance costs;
(3) Environmental design of the constructed or
renovated space;
(4) Space for future expansion; or
(5) Other
factors not listed above.
(h)
The expansion, renovation or replacement of the facility at which the
megavoltage radiation therapy equipment and services are provided shall be
financially feasible;
(i)
In order to assess the current and long-range financial feasibility of
the proposed project, applicants shall demonstrate that resources:
(1) Are available to fund the proposed capital
costs and operating costs;
(2) Will be available to maintain operations in
the event of interruptions to cash flow; and
(3) Will be available to ensure the continued
operation of the proposed project;
(j) Demonstration of financial feasibility shall
be made by providing with the application:
(1) Copies of the facility’s 3-year historical
and 3-year projected financial statements;
(2) A statement of the sources of funds to
finance the proposed project;
(3) Documentation from the applicant’s lender,
underwriter or other anticipated source of capital, which includes:
a. Financed amount;
b. Rate of interest; and
c. Term of debt;
(k) Applicants shall document the assumptions
used to determine the overall financial feasibility of the proposed projects to
expand, renovate or replace the megavoltage radiation therapy equipment and
service;
(l) Documentation of assumptions shall be made in
the form of a report including the following:
(1) The source of the documents used to determine
the population projections of the primary and secondary service areas, if
different than the office of energy and planning,
(2) The changes in market conditions which would
result in a change in market share;
(3) The causes of any anticipated changes in the
overall length of stay in the hospital;
(4) The assumptions used to prepare the projected
financial statements; and
(5) Other assumptions the applicant considers
pertinent to the project’s feasibility.
(m) Applicants shall identify the source of any
data or information provided pursuant paragraphs (c) through (l) above.
Source. #7236, eff 4-26-00
New. #8774, eff 12-16-06 (formerly He-Hea
1602.10), EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea
1602.10 Data Reporting.
(a) Owners of megavoltage radiation equipment
shall submit an annual account of volumes per machine on February 1 of each
year.
(b) The volume report shall include the following
information for the previous 12 months of volume, January through December:
(1) Name of hospital or facility where the
megavoltage equipment is in service:
(2) City or town where the hospital or facility
is located;
(3) Total number of megavoltage radiation therapy
machines in service;
(4) Total patients served within the past 12
consecutive months;
(5) Patient origin by city or town; and
(6) Total procedures performed within the past 12
consecutive months.
(c) The board shall make this data available in a
report to any interested persons on or before April 1 of each year.
Source. #7236, eff 4-26-00; ss by #8774, eff 12-16-06
(formerly He-Hea 1602.12),
EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea 1602.11
REPEALED
Source. #7236, eff 4-26-00; rpld by #8774, eff
12-16-06
PART He-Hea 1603
REQUEST FOR APPLICATIONS
He-Hea
1603.01 Request for Applications
(RFA).
(a) The board shall issue an RFA for megavoltage
radiation therapy services on May 1st of each year provided that:
(1) It has received a letter of intent that
contains the following information:
a. Name
of the requestor that intends to file an application, including the names of
all affiliates of such requestor;
b. An
outline of the proposed location of the new megavoltage radiation therapy
service;
c. An
outline, by zip code, of the proposed service area to be served by the program;
d. A
detailed description of the specific type of megavoltage radiation therapy
equipment to be purchased;
e. An
identification of any megavoltage radiation therapy providers in:
1. The
proposed service area; and
2. Next
closest service areas in all directions; and
(2) Each existing provider identified in He-Hea 1603.01(a)(1)e.
is performing an average of 7,000 treatments per machine during the most recent
12 months of operation, pursuant to the data collected in He-Hea 1602.10.
(b) Letters of intent shall be submitted to the
board no later than April 1st of each year.
Source. #4574, eff 2-6-89; ss by #4987, eff 11-21-90;
ss by #5238, eff 9-27-91, EXPIRED: 9-27-97
New. #7236, eff 4-26-00; ss by #7385, eff
10-25-00; ss by #8774, eff 12-16-06, EXPIRED: 12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea
1603.02 Submission of
Applications. Applications shall be:
(a) Prepared using the board’s application form
pursuant to He-Hea 304; and
(b) Submitted to the board within 90 days of the
issuance of the RFA.
Source. #7236, eff 4-26-00; ss by #8774, eff 12-16-06, EXPIRED:
12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
He-Hea
1603.03 Processing of Applications. Applications shall be processed in accordance
with the requirements of RSA 151-C:8.
Source. #8774, eff 12-16-06, EXPIRED:
12-16-14
New.
#10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
PART He-Hea 1604
GRANTING CERTIFICATES OF NEED
He-Hea
1604.01 Approval of Applications. The Board shall grant certificates of need in
accordance with RSA 151-C:9, II.
Source. #8774, eff 12-16-06, EXPIRED:
12-16-14
New. #10800, INTERIM, eff 3-21-15, EXPIRES:
9-17-15; ss by #10838, eff 5-27-15
APPENDIX I – STATE STATUTES IMPLEMENTED
Rule |
|
|
|
He-Hea 1601 |
RSA 151-C:2, RSA 151-C:11, I |
He-Hea 1602.01 – 1602.05 |
RSA 151-C:5,
II(d), RSA 151-C:11, I |
He-Hea 1602.06 |
RSA 151-C:5,
II(d), RSA 151-C:11, I |
He-Hea 1602.07 |
RSA 151-C:7, IV |
He-Hea 1602.08 |
RSA 151-C:7, II |
He-Hea 1602.09 |
RSA 151-C:7, I-V |
He-Hea 1602.10 |
RSA 151-C:7, I and II |
He-Hea 1603 |
RSA 151-C:8, RSA 151-C:11, I |
He-Hea 1604 |
RSA 151-C:9, RSA 151-C:11, I |
APPENDIX II – INCORPORATION BY REFERENCE INFORMATION
Rule |
Title |
Obtain at: |
He-Hea 1602.09(a) MVS,
2014, section 15. He-Hea1602.09(b)(2) MVS, 2014, section 15. He-Hea 1602.09(c)(1)
MVS, 2013, section 1. He-Hea 1602.09(d) MVS, 2014, section 15. He-Hea 1602.09(e) MVS,
2014, section 10. He-Hea 1602.09(f)(1)
MVS, 2014, section 15, page 24. He-Hea 1602.09 (f)(6)
MVS, 2014, section 99. |
Marshall Valuation
Service, 2014 edition |
Marshall &
Swift/Boeckh, LLC 34th Floor Telephone (800)
544-2678. Cost for the 2014
edition of the manual is $599.95. |