HomeMy WebLinkAbout2011-006ORDINANCE NO. 2011- ' oo6
AN ORDINANCE OF THE BOARD OF COUNTY COMMISSIONERS OF
INDIAN RIVER COUNTY, FLORIDA, AMENDING CHAPTER 315 OF THE
CODE OF INDIAN RIVER COUNTY ENTITLED "THE INDIAN RIVER
COUNTY PAIN MANAGEMENT CLINIC AND CONTROLLED SUBSTANCES
ORDINANCE"; REGULATING AND PROHIBITING CERTAIN ACTIVITIES
RELATING TO THE OPERATION OF CERTAIN PAIN MANAGEMENT
CLINICS AND PHARMACIES WHICH PRESCRIBE OR DISPENSE
CONTROLLED SUBSTANCES; AND PROVIDING. FOR SEVERABILTY, A
GENERAL REPEALER AND AN EFFECTIVE DATE. -
WHEREAS, on May 17, 2011, the Board of County Commissioners adopted
Ordinance No. 2011-004, creating chapter 315 of the Code of Indian River County entitled
"The Indian River County Pain Management Clinic and Controlled Substances Ordinance";
and
WHEREAS, on July 1, 2011, new state legislation became effective relating to pain
management clinics and pharmacies'which prescribe or dispense controlled substances; and
WHEREAS, it is necessary and appropriate to amend certain provisions of chapter
315 of the Code of Indian River County, in light of the new state legislation,
NOW, THEREFORE, BE IT ORDAINED BY THE -BOARD OF COUNTY
COMMISSIONERS OF INDIAN RIVER COUNTY, FLORIDA THAT:
Section 1. Enactment Authority.
Article VIII, section 1 of the Florida Constitution and chapter 125, Florida Statutes vest broad
home rule powers in counties to enact ordinances, not inconsistent with general or special
law, for the purpose of protecting the public health, safety and welfare of the residents of the
county. The Board specifically determines that the enactment of this ordinance is necessary
to protect the health, safety and welfare of the residents of Indian River County.
Section 2. Legislative Findings.
The Board finds that the "Whereas" clauses above are true and correct, and hereby
incorporates such clauses as the legislative findings of the Board.
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Section 3. Amendment of Chapter 315.
Chapter 315 of the Code of Indian River County, Florida is hereby amended to read as
follows (added language is underlined and set forth in italics, and deleted language is noted
by strikethrough):
CHAPTER 315. PAIN MANAGEMENT CLINICS AND CONTROLLED
SUBSTANCES
Section 315.01. Title.
This Ordinance shall be known as the Indian River County Pain Management Clinic
and Controlled Substances Ordinance.
Section. 315.02. Definitions.
For the purposes of this chapter, the following terms shall have the following
meanings:
(1) "Pain management clinic" shall mean any publicly or privately owned
facility that advertises in any medium for any type of pain management
services, or where in any month a majority of patients are prescribed
opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of
chonic nonmalignant pain, unless
a. The clinic is licensed as a facility pursuant to chapter 395, Florida Statutes;
b. The majority of physicians who provide services in the clinic primarily
provide surgical services;
c. The clinic is owned by a publicly held corporation whose shares are traded
on a national exchange or on the over-the-counter market and whose total
assets at the end of the corporation's most recent fiscal quarter exceeded
$50 million;
d. The clinic is affiliated with an accredited medical school at which training is
provided for medical students, residents or fellows;
e. The clinic does not prescribe or dispense controlled substances for the
treatment of pain; or
f. The clinic is owned by a corporate entity exempt from federal taxation
under 26 USC section 501(c)(3).
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Any clinic or facility meeting the definition above shall be considered a pain
management clinic, regardless of its use of any other descriptive name, such as
a center for "wellness," "detox," "detoxification," "urgent care," etc.
(2) "Applicable law" shall mean this Code, applicable Florida law, including,
without limitation, rules and regulations promulgated by the Florida
Department of Health, the Florida Board of Medicine, the Florida Board of
Osteopathic Medicine, the Florida Board of Pharmacy, and applicable
federal law.
(3) "Board" shall mean the Indian River County Board of County
Commissioners.
(4) "Controlled substance" shall mean a controlled substance listed in
Schedules II, Ill, or IV in section 893.03, Florida Statutes.
(5) "Chronic nonmalignant pain" shall mean pain unrelated to cancer or
rheumatoid arthritis which persists beyond the usual course of disease or
the injury that is the cause of the pain or more than 90 days after surgery.
(6) "Department" shall mean the Indian River County Community
Development Department.
(7) "Pharmacy" shall mean any pharmacy that is subject to licensure or
regulation by the Florida Department of Health under chapter 465, Florida
Statutes, and dispenses controlled substances in Indian River County.
(8) "Pain Clinic Responsible Party" shall mean any person or entity which
owns, in whole or in part, or operates a pain management clinic; any
person who manages or supervises the operations of a pain management
clinic; any person who has been designated as the responsible physician
or osteopathic physician for a pain management clinic, pursuant to
458.3265(1)(c) or 459.0137(1)(c), Florida Statutes; and any person who
participates, directly or indirectly, in any activity regulated or prohibited by
this chapter.
(9) "Pharmacy Responsible Party" shall mean any person or entity which owns,
in whole or in part, or operates a pharmacy engaged in activity regulated
or prohibited by this chapter; any person who manages or supervises any
activity regulated or prohibited by this chapter; and any person who
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participates, directly or indirectly, in any activity regulated or prohibited by
this chapter.
(10) "Qualified pain management clinic" shall mean
a. A pain management clinic which is wholly owned and operated by one or
more board-certified anesthesiologists, physiatrists, or neurologists; or
b. A pain management clinic which is wholly owned and operated by one or
more board-certified medical specialists who have also completed
fellowships in pain medicine approved by the Accreditation Council for
Graduate Medical Education or the American Osteopathic Association or
who are also board-certified in pain medicine by a board approved by the
American Board of Medical Specialties or the American Osteopathic
Association and perform interventional pain procedures of the type
routinely billed using surgical codes.
Except as otherwise provided, a qualified pain management clinic shall be
deemed to be a pain management clinic for all purposes set forth herein.
Section 315.03. Prohibited Activities.
Each of following activities shall be prohibited and shall constitute a violation of this
Code:
(1) Operation of a pain management clinic without a valid and current permit
issued pursuant to section 315.04;
(2) Operation of a pain management clinic without a valid and current
business tax receipt;
(3) Operation of a pain management clinic without a valid and current
registration pursuant to sections 458.3265(1) or 459.0137(1), Florida
Statutes, unless such clinic is exempt from registration under such
statutes;
(4) Submittal of a permit application, any sworn statement, or any other
information required by this chapter, which contains materially false
information;
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(5) Operation of a pain management clinic in violation of a sworn statement
submitted pursuant to sections 315.04 or 315.05;
(6) Operation of a pain management clinic or pharmacy in violation of
applicable law;
(7) Prescribing or dispensing of controlled substances in violation of
applicable law;
(8) Activity within a pain management clinic with respect to a controlled
substance which is in violation of the standards of practice set forth in
section 456.44(3), Florida Statutes;
(9) Operation of a pain management clinic in violation of the facility and
physical operations requirements, the infection control requirements, the
health and safety requirements, the quality assurance requirements or the
data collection and reporting requirements set forth in sections
458.3265(2)(f) -(j) and 459.0137(2)(f) -Q), Florida Statutes;
(10) Prescribing, administering or dispensing a controlled substance without a
valid and current controlled substance registration number issued by the
United States Department of Justice, Drug Enforcement Administration;
(11) Operation of a pain management clinic or pharmacy in a manner which
allows, permits or encourages persons to stand, sit (including inside
parked cars), gather or loiter in or about, the clinic's parking area, for a
period of time exceeding that which is reasonably required to arrive and
depart the parking area, and to walk to and from the parking area and the
clinic;
(12) Continued leasing or permitted use of a property or structure which is used
as a pain management clinic or pharmacy if (a) the landlord or property
owner knows, or; through the exercise of reasonable care should know,
that the clinic or pharmacy is being operated in violation of applicable law,
and (b) despite the passage of a reasonable period of time to do so, the
landlord or property owner has failed or refused to take reasonable
measures to stop or prevent the continued illegal activity on the premises;
or
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(13) Failure to advise the Department of any change in any information,
statements, facts or circumstances, as required by section 315.04(10).
Section 315.04. Permit Required for Operation of Pain Management Clinic.
(1) Permit Required. After the effective date of this ordinance, no pain
management clinic shall operate by any means in Indian River County
without a valid and current pain management clinic permit issued by the
Department; provided, however, that any pain management clinic in
existence as of the effective date of this ordinance shall have sixty (60)
days to obtain a valid and current pain management clinic permit.
(2) Application. Any pain management clinic requesting issuance of a pain
management clinic permit shall complete and submit to the Department a
sworn application, on a form provided by the Department, containing, at a
minimum, the following information:
a. The name and address of the pain management clinic;
b. The name and address of each owner of the pain management clinic
(including, if the owner is a business entity such as a corporation, limited
liability company, etc, the name and address of each officer, manager or
managing member, general partner or other comparable person
authorized by state law to manage the affairs of the business entity), each
person who will be managing or supervising the activities of the pain
management clinic, and each person who will be prescribing or
administering controlled substances at the pain management clinic;
c. The name and address of the person who has been designated as the
responsible physician or osteopathic physician for the pain management
clinic, pursuant to sections 458.3265(1)(c) or 459.0137(1)(c), Florida
Statutes;
d. The name and address of the person or entity which owns the real
property upon which the pain management clinic will be operated;
e. Proof that the applicant is currently registered as a pain management clinic
with the Florida Department of Health, pursuant to sections 458.3265 or
459.0137, Florida Statutes;
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f. Proof that any person who will be prescribing or administering controlled
substances at the pain management clinic has a valid and current
controlled substance registration number issued by the United States
Department of Justice, Drug Enforcement Administration, including the
controlled substance registration number for each such person;
g. A sworn statement certifying that within the ten (10) years prior to submittal
of the application, neither the pain management clinic, nor any person
identified pursuant to subsections b, c or d above, has been found by any
county or municipal board, commission or council, or by any state or
federal court, or by any state or federal regulatory body, to have acted with
respect to controlled substances in violation of applicable law; and
h. A sworn statement certifying that the pain management clinic, and every
other clinic owned or operated by any person identified pursuant to
subsections b, c or d above, will, during the term of the permit, be operated
in compliance with applicable law.
(3) Abbreviated Application for Qualified Pain Management Clinics. In lieu of
completing the application form described in subsection (2), a qualified
pain management clinic requesting issuance of a pain management clinic
permit may complete and submit to the Department a sworn application,
on a form provided by the Department, containing, at a minimum, the
following information:
a. The name and address of the pain management clinic;
b. The name and address of the owner of the pain management clinic;
c. The name and address of all physicians who will be prescribing controlled
substances at the pain management clinic;
d. Proof that the pain management clinic meets the definition of a "qualified
pain management clinic" which proof may consist of written verification or
confirmation from the State of Florida that the pain management clinic is
exempt from state registration pursuant to sections 458.3265(1)(a)2g or h
or 459.0137(1)(a)2g or h; and
e. A sworn statement certifying that the pain management clinic, and every
other clinic owned or operated by any person identified pursuant to
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subsections b or c above, will, during the term of the permit, be operated in
compliance with applicable law.
(4) Permit Application Fee. A permit application fee shall be paid by the
applicant at the time of submittal of the application, including renewal. The
amount of the fee shall be set by resolution of the Board. The amount shall be
sufficient to recover the County's approximate cost of reviewing and acting
upon the application.
(5) Denial of Application. The application for a pain management clinic
permit shall be denied if any of the following facts are found to exist and are not
cured within ten (10) days of written notice of such deficiency:
a. The applicant fails to pay the required permit application fee; or
b. The applicant fails to submit all information and statements required in
subsection (2) or (3) above, or the applicant has submitted such
information and statements but such information and statements are found
to contain materially false information.
(6) Issuance of Permit. The Department shall issue the permit within twenty
(20) days of submittal of a fully complete application, if the applicant has
submitted all information required in subsection (2) or (3) and none of the facts
set forth in subsection (5) is found to exist.
(7) Term of Permit. A pain management clinic permit shall remain in effect
for a term of two (2) years. Thereafter, a permit shall be subject to renewal in
the same manner that permits are issued initially as set forth in subsections (2)
through (6).
(8) Appeal. If an application for issuance or renewal of a pain management
clinic permit is denied, the applicant shall have the right of appeal as set forth in
section 100.06 of this Code. The denial shall be considered a decision of a
department head for the purpose of applying section 100.06. An appeal fee
shall be paid by the applicant at the time of filing an appeal to the Board. The
amount of the fee shall be set by resolution of the Board. The amount shall be
sufficient to recover the County's approximate cost of reviewing and acting
upon the appeal.
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(9) Revocation of Permit. A pain management clinic permit shall be subject
to revocation in proceedings before the Indian River County Code Enforcement
Board or any court of competent jurisdiction, in the event that:
a. The information or statements submitted to obtain issuance or renewal of
the permit contained materially false information;
b. The permit holder, or any Pain Clinic Responsible Party, has engaged in
activity prohibited by section 315.03;
c. The permit holder, or any Pain Clinic Responsible Party, has been found
by any county or municipal board, commission or council, or by any state
or federal court, or by any state or federal regulatory body, to have acted
with respect to controlled substances in violation of applicable law; or
d. The permit holder, although required to be registered, is no longer
registered with the Florida Department of Health, pursuant to sections
458.3265 or 459.0137, Florida Statutes, or no longer holds a current
business tax receipt for a pain management clinic, or the controlled
substance registration issued by the United States Department of Justice,
Drug Enforcement Administration to any person prescribing, administering
or dispensing controlled substances at the pain management clinic has
been suspended, revoked or denied renewal.
(10) Emergency Suspension of Permit. Upon clear and convincing proof that
one or more of the events set forth in subsection (9) have occurred, and
upon a finding that continued operation of the pain management clinic
presents an immediate danger to the health, safety and welfare of the
residents of Indian River County, the Department shall be authorized
immediately to suspend the pain management clinic's permit. In such
event, the permit holder shall have the right of appeal as set forth in
section 100.06 of this Code. The -suspension shall be considered a
decision of a department head for the purpose of applying section 100.06.
All aspects of the appeal shall be expedited. An appeal fee shall be paid
by the applicant at the time of filing an appeal to the Board. The amount of
the fee shall be set by resolution of the Board. The amount shall be
sufficient to recover the County's approximate cost of reviewing and acting
upon the appeal. Any emergency suspension pursuant to this subsection
shall continue for a period not to exceed six (6) months; provided,
however, that if revocation of the permit is sought, the Code Enforcement
Board or court of competent jurisdiction in which the revocation request is
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pending may extend the suspension beyond six (6) months until
completion of the revocation proceedings, if necessary to protect the
health, safety and welfare of the residents of Indian River County.
(11) Change in Information or Statements. The permit holder shall notify the
Department in writing of any change in any information or statements
submitted pursuant to subsections (2) a — h or (3) a — d above, or of any
change in any facts or circumstances such that any information or
statements submitted pursuant to subsections (2) a — h or (3) a — d are no
longer completely true and accurate. Such notification shall be provided
within thirty (30) days of the change.
Section 315.05. Business Tax Receipt for Pain Management Clinic.
No pain management clinic shall operate by any means in Indian River County without
having been issued a valid and current business tax receipt pursuant to this section
and chapter 207 of this Code. As a condition of issuance of a business tax receipt for a
pain management clinic, the owner or operator shall (a) provide proof that it holds a
valid and current permit issued pursuant to section 315.04, and (b) execute and deliver
to the Tax Collector a sworn statement containing substantially the same certifications
as the statements required by sections 315.04(2) g and h or 315.04(3)e. If, during the
term of the business tax receipt, the pain management clinic no longer holds a valid
and current permit issued pursuant to section 315.04, or operates contrary to the
sworn statement, or engages in any activity prohibited by section 315.03, the business
tax receipt shall be subject to revocation by the Tax Collector or by a court of
competent jurisdiction. V
Section 315.06. Onsite Dispensing of Controlled Substances at Pain
Management Clinic Prohibited.
The on-site dispensing of controlled substances at a pain management clinic is
prohibited, unless specifically authorized by applicable law.
Section 315.07. Dispensing of Controlled Substances by Pharmacy.
Any pharmacy which dispenses controlled substances shall be staffed and supervised
by one or more pharmacists duly licensed by the State of Florida, at least one of whom
shall be present during all hours that the pharmacy is open for dispensing controlled
substances.
Section 315.08. Inspections.
To the extent permitted by law, staff charged with the enforcement of this chapter shall
have the right to enter upon the premises of a pain management clinic or a pharmacy
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and conduct such inspections as are reasonably necessary to determine compliance
with the requirements of this chapter.
Section 315.09. Enforcement.
A pain management clinic, Pain Clinic Responsible Party, pharmacy, Pharmacy
Responsible Party, landlord or property owner found to be in violation of this chapter,
and any other person found to have actively participated in a violation of this chapter,
shall be subject to any one or more of the following penalties or remedies, in addition
to any other penalty or remedy available in law or in equity:
(1) Any penalty or remedy authorized under section 100.05 of this Code,
including, without limitation, a penalty up to $500 per day, with each day of
noncompliance constituting a separate violation, or imprisonment up to six
months, or both. A violation of this chapter shall be deemed a public
nuisance and may be abated as provided by this Code or by law; or
(2) Revocation or non -renewal of the pain management clinic permit or
business tax receipt; or
(3) Any order, injunction or other relief necessary to prevent the continued
operation of the pain management clinic or pharmacy in violation of this
chapter, including, without limitation, an order requiring the pain
management clinic or pharmacy to terminate all operations in Indian River
County; and
(4) Notwithstanding the above, no penalty imposed hereunder for any act
constituting a violation of state law shall exceed the penalty provided by
state law for such act.
Except as otherwise set forth herein, enforcement may occur through proceedings
before the Indian River County Code Enforcement Board or any court of competent
jurisdiction.
Section 315.10. Conformity to State and Federal Law.
Whenever in this chapter reference is made to a state or federal statute, rule or
regulation, or a definition is utilized that is based upon a state or federal statute, rule or
regulation, the intent of this ordinance is to refer to such statute, rule or regulation, or
utilize such definition, as amended from time to time.
Section 315.11. Geographic Application.
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This chapter shall apply throughout the incorporated and unincorporated areas of
Indian River County, except to the extent that a municipality has adopted or adopts an
ordinance in conflict with this ordinance.
Section 315.12. Implementation in Municipalities.
To the extent that this chapter applies within an incorporated municipality, the
municipality shall perform those actions, and shall be authorized to perform those
actions, which are required or authorized to be performed by the County hereunder.
Such actions may be performed by (a) the municipal board (including the municipal
council), department, official or employee whose purpose and function most closely
resemble that of the County board, department, official or employee required or
authorized to perform the action hereunder, or (b) by any other municipal board
(including the municipal council), department, official or employee designated by the
governing body of the municipality. All actions with respect to business tax receipts,
as set forth in section 315.05 or otherwise, shall be performed by the municipal official
or staff responsible for performing such actions with respect to business tax receipts
within the municipality; all references to Code provisions shall refer to the comparable
provisions of the municipal code or charter. Notwithstanding the above, the County
and the municipality shall have concurrent jurisdiction to enforce this chapter with
respect to violations occurring within the municipality.
Section 315.13. Cooperation Among Public Entities and Agencies
All public entities and agencies having jurisdiction with respect to the subject matter of
this ordinance, including, without limitation, the County, the municipalities and all law
enforcement agencies, are urged to cooperate and coordinate their efforts to
implement and enforce this chapter in an effective and consistent manner.
Section 4. Severability. If any part of this ordinance is held to be invalid or unconstitutional
by a court of competent jurisdiction, the remainder of this ordinance shall not be affected by
such holding and shall remain in full force and effect.
Section 5. Conflict. All ordinances or parts of ordinances in conflict herewith are hereby
repealed.
Section 6. Effective Date. This ordinance shall become effective upon adoption by the
Board of County Commissioners and filing with the Department of State.
This ordinance was advertised in the Vero Beach Press Journal on the 24th day of
June , 2011, for a public hearing to be held on the 12th day of July , 2011,
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at which time it was moved for adoption by Commissioner Davis ,
seconded by Commissioner Solari , and adopted by the following vote:
Chairman Bob Solari Aye
Vice -Chairman Gary C. Wheeler Aye
Commissioner Wesley S. Davis Aye
Commissioner Joseph E. Flescher Nay
Commissioner Peter D. O'Bryan Nay
The Chairman thereupon declared the ordinance duly passed and adopted this 12 day of
July , 2011.
ATTEST: Jeffrey K.
BOARD OF COUNTY COMMISSIONERS OF
INDIAN RIVER COUNTY, FLORIDA
By:
Bob Solari, Chairman
APPROVED AS TO FORM AND LEGAL
SUFFICIENCY
By:
Alan S. Polackwich, County Attorney
EFFECTIVE DATE: This Ordinance was filed with the Department of State on the is day
of ,T„ I V , 2011.
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