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Coding: Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions.
Regular Session, 2010
SENATE BILL NO. 355
BY SENATOR MOUNT
HEALTH CARE. Provides for a facility need process for proton radiotherapy facilities.
(gov sig)
AN ACT1
To enact Part XV of Chapter 11 of Title 40 of the Louisiana Revised Statutes of 1950, to be2
comprised of R.S. 40:2200.11 through 2200.14, relative to proton beam3
radiotherapy; to provide for a facility need review process for proton beam4
radiotherapy facilities; to provide for definitions; to provide for rules and regulations5
and penalties; and to provide for related matters.6
Be it enacted by the Legislature of Louisiana:7
Section 1. Part XV of Chapter 11 of Title 40 of the Louisiana Revised Statutes,8
comprised of R.S. 40:2200.11 through 2200.14, is hereby enacted to read as follows:9
PART XV. FACILITY NEED REVIEW OF PROTON BEAM RADIOTHERAPY10
FACILITIES11
§2200.11. Definitions12
As used in this Part, the following terms shall have the following13
meanings, except when the context clearly indicates otherwise:14
(1) "Department" means the Department of Health and Hospitals.15
(2) "Proton beam radiotherapy facility" means any facility which16
provides proton beam radiotherapy treatments.17 SB NO. 355
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Coding: Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions.
§2200.12. Facility need review1
A. The Department of Health and Hospitals, in accordance with the2
Administrative Procedure Act, shall establish a facility need review process for3
proton beam radiotherapy facilities.4
B. The department shall promulgate rules and regulations in accordance5
with the Administrative Procedure Act to provide for facility need review. The6
rules and regulations shall include but not be limited to the following:7
(1) Criteria for review of a proton beam radiotherapy facility to8
determine if there is a need for additional facilities to provide proton beam9
radiotherapy services and treatments.10
(2) Specific duties of the department to review proposals for new11
facilities and determine the need therefor.12
(3) Appropriate methodology for the collection of data necessary for the13
administration of the program.14
(4) Procedures to grant and revoke approvals.15
(5) Procedures for review of applications by the department.16
(6) Procedures to request a fair hearing from a determination made by17
the department.18
(7) Provisions for judicial review from the decision rendered after a fair19
hearing.20
§2200.13. Facility need review procedure21
A. Each application for approval under the facility need review process22
for a proton beam radiotherapy facility shall be made to the department on23
forms prescribed by the department and shall contain such information as the24
department may require. Additional information required by the department25
shall be provided by the applicant as requested.26
B. Following receipt of the application, the department shall perform a27
facility need review analysis and if the department finds a new facility is28
warranted under the facility need review process an approval shall be issued.29 SB NO. 355
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words in boldface type and underscored are additions.
§2200.14. Operation without facility need review approval; penalty1
A. No public or private proton beam radiotherapy facility shall operate2
without approval from the department under the facility need review process3
pursuant to this Part. Any such facility or provider operating without such4
approval shall be guilty of a misdemeanor and upon conviction shall be fined5
no less than two hundred fifty dollars nor more than one thousand dollars. It6
shall be the responsibility of the department to inform the appropriate district7
attorney of the alleged violation to assure enforcement.8
B. If a public or private proton beam radiotherapy facility is operating9
without an approval issued by the department, the department shall have the10
authority to issue an immediate cease and desist order to that facility. Any such11
facility or provider receiving such a cease and desist order from the department12
shall immediately cease operations until such time as that provider is issued an13
approval by the department.14
C. The department shall seek an injunction in the Nineteenth Judicial15
District Court against any facility or provider who receives a cease and desist16
order from the department under Subsection B of this Section and who does not17
cease operations immediately. Any such facility or provider against whom an18
injunction is granted shall be liable to the department for attorney fees, costs,19
and damages.20
Section 2. The Department of Health and Hospitals shall promulgate all rules and21
regulations necessary to carry out the provisions of this Act by October 1, 2010; however,22
failure by the department to promulgate rules and regulations by that date shall not affect the23
validity of any rules and regulations promulgated pursuant to this Act.24
Section 3. This Act shall become effective upon signature by the governor or, if not25
signed by the governor, upon expiration of the time for bills to become law without signature26
by the governor, as provided by Article III, Section 18 of the Constitution of Louisiana. If27
vetoed by the governor and subsequently approved by the legislature, this Act shall become28
effective on the day following such approval.29 SB NO. 355
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Coding: Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions.
The original instrument and the following digest, which constitutes no part
of the legislative instrument, were prepared by Greg Waddell.
DIGEST
Proposed law provides that DHH, in accordance with the APA, shall establish a facility need
review process for proton beam radiotherapy facilities .
Proposed law provides that DHH shall promulgate rules and regulations relative to a facility
need review process which shall include but not be limited to the following:
(1) Criteria for review of a proton beam radiotherapy facility to determine if there is a
need for additional facilities to provide proton beam radiotherapy services and
treatments.
(2) Specific duties of the department to review proposals for new facilities and
determine the need therefor.
(3) Appropriate methodology for the collection of data necessary for the administration
of the program.
(4) Procedures to grant and revoke approvals.
(5) Procedures for review of applications by the department.
(6) Procedures to request a fair hearing from a determination made by the department.
(7) Provisions for judicial review from the decision rendered after a fair hearing.
Proposed law provides that each application for a facility need review for a proton beam
radiotherapy facility shall be made to DHH on forms prescribed by DHH and shall contain
such information as may be required.
Proposed law provides that following receipt of the application, DHH shall perform a facility
need review analysis and if DHH finds a new facility is warranted under the facility need
review process an approval shall be issued.
Proposed law provides that no public or private proton beam radiotherapy facility shall
operate without an approval issued by DHH.
Proposed law provides that any such facility or provider operating without an approval shall
be guilty of a misdemeanor and upon conviction shall be fined no less than $250 nor more
than $1000.
Proposed law provides that if a public or private proton beam radiotherapy facility is
operating without an approval, DHH has the authority to issue an immediate cease and desist
order to that facility. Proposed law further provides that any such facility or provider
receiving such a cease and desist order from DHH shall immediately cease operations until
such time as that provider is issued an approval by DHH pursuant to the facility need review
process. SB NO. 355
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Coding: Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions.
Proposed law provides that DHH shall promulgate all rules and regulations necessary to
carry out the provisions of proposed law by October 1, 2010; however, failure by the
department to promulgate rules and regulations by this date shall not affect the validity of
any rules and regulations promulgated pursuant to proposed law.
Effective upon signature of the governor or lapse of time for gubernatorial action.
(Adds R.S. 40:2200.11 - 2200.14)