64B-7.002: Disciplinary Guidelines
PURPOSE AND EFFECT: The department determined the need to adopt a rule setting forth disciplinary guidelines for registered pain-management clinics.
SUMMARY: This rule comprehensively describes all facets of how discipline shall be imposed including the consideration of mitigating and aggravating factors and the effect of settlements. This rule also lists the penalties for 39 possible offenses, which generally includes the range that may be used for a first and a subsequent offense.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: The Agency has determined that this rule will have an impact on small business. A SERC has been prepared by the agency.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 456.079, 458.3265, 459.0137 FS.
LAW IMPLEMENTED: 456.072(1)(2), 458.3265(1)(5), 458.327, 458.331, 459.0137(1)(5), 459.013, 459.015 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Larry McPherson, Executive Director, 4052 Bald Cypress Way, Bin #C03, Tallahassee, Florida 32399-3253
THE FULL TEXT OF THE PROPOSED RULE IS:
64B-7.002 Disciplinary Guidelines.
(1) In imposing discipline on a pain-management clinic, the department shall act in accordance with these disciplinary guidelines and shall impose a penalty within the range corresponding to the severity and repetition of the violations unless the department finds it necessary to deviate from the guidelines in accordance with this rule. Any and all offenses listed are sufficient grounds for the initial refusal of registration to an applicant. The department shall recover the costs of the investigation and prosecution of the case as well as imposing the appropriate penalty. In addition to any other penalty, if the violation includes proof of intentional fraud or fraudulent misrepresentation, the department shall impose a penalty of $10,000 per count or offense. When the penalty is suspension, the period of suspension for the registration of the clinic shall not exceed one year.
(2) Violations and Range of Penalties:
(a) Failing to comply with any requirement of Chapter 499, the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Drug Abuse Prevention and Control Act; or Chapter 893, the Florida Comprehensive Drug Abuse Prevention and Control Act. (Sections 458.3265(5)(a), 459.0137(5)(a), F.S.). First offense- a fine of up to $5,000 per violation and six months probation to one year suspension or revocation. For a subsequent offense, a fine of up to $5,000 per violation and a minimum of one year suspension to revocation.
(b) Knowingly and intentionally misrepresenting actions taken to correct a violation. (Sections 458.3265(5)(c), 459.0137(5)(c), F.S.). First offense a fine of up to $5,000 and/or revocation. For a subsequent offense, a fine of $5,000 and revocation.
(c) Concurrently operating an unregistered pain-management clinic. (Sections 458.3265(5)(d), 459.0137(5)(d), F.S.). First offense a fine of $5,000 per day. For a subsequent offense, a fine of $5,000 per day and revocation.
(d) Failing to apply to register a clinic that requires registration upon change of ownership and operating the clinic under new ownership. (Sections 458.3265(5)(d), 459.0137(5)(d), F.S.). First offense a fine of up to $5,000. For a subsequent offense, a fine of $5,000 and one year suspension or revocation.
(e) Aiding, assisting, procuring, employing, or advising any unlicensed person or entity to practice contrary to Chapter 458, 459, or the rules of the department or the appropriate board. (Section 456.072(1)(j), F.S.). First offense a fine of $5,000 and/or up to one year suspension or revocation. For a subsequent offense, a fine of $5,000 per violation and revocation.
(f) Knowingly prescribing or dispensing, or causing to be prescribed or dispensed, controlled substances in a nonregistered pain-management clinic that is required to be registered with the department. (Sections 458.327(2)(f), 459.013(2)(d), F.S.). First offense a fine of up to $5,000 per day. For a subsequent offense, a fine of up to $5,000 per day and up to one year suspension or revocation.
(g) Registering a pain-management clinic through misrepresentation, fraud, or by making a false or fraudulent representation. (Section 456.072(2)(d), F.S.). A fine of $10,000 per count or offense and up to one year suspension or revocation.
(h) Being convicted of or pled guilty or nolo contendere to, regardless of adjudication, an offense that constitutes a felony for receipt of illicit and diverted drugs, including a controlled substance listed in Schedule I, II, III, IV, or V of s. 893.03, in this state, any other state, or the United States. (Sections 458.3265(1)(e), 459.0137(1)(e), F.S). Revocation unless more than ten years have passed since the conviction and the owner has received recognition from the Governor for providing extraordinary service to the state.
(i) Being convicted or found guilty of, regardless of adjudication to, a felony or any other crime involving moral turpitude, fraud, dishonest, or deceit in any jurisdiction of the courts of the state, of any other state, or of the United States. (Sections 458.331(1)(oo)4., 459.015(1)(qq)4., F.S.). First offense, a fine of up to $5,000 and up to one year suspension to revocation. For a subsequent offense, a fine of $5,000 and one year of suspension or revocation.
(j) Being convicted of, or disciplined by a regulatory agency of the Federal Government or a regulatory agency of another state for any offense that would constitute a violation of Chapter 458 or Chapter 459, F.S. (Sections 458.331(1)(oo)5., 459.015(1)(qq)5., F.S.). First offense, a fine of up to $5,000 and one year probation to revocation. For a subsequent offense, a fine of $5,000 and from three months to one year suspension or revocation.
(k) Being convicted of, or entering a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction of the courts of this state, of any other state, or of the United States which relates to the practice of, or the ability to practice, a licensed health care profession. (Sections 456.072(1)(c), 458.331(1)(oo)6., 459.015(1)(qq)6., F.S.). First offense, a fine of up to $5,000 and up to one year suspension or revocation. For a subsequent offense, a fine of $5,000 and revocation.
(l) Being convicted of, or entering a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction of the courts of this state, of any other state, or of the United States which relates to health care fraud. (Sections 456.072(1)(ll), 458.331(1)(oo)7., 459.015(1)(qq)7., F.S.). First offense, a fine of up to $5,000 and up to one year suspension or revocation. For a subsequent offense, a fine of $5,000 and revocation.
(m) Being convicted of, or entering a plea of guilty or nolo contendere to, any misdemeanor or felony, regardless of adjudication, under 18 U.S.C. s. 669, ss. 285-287, s. 371, s. 1001, s. 1035, s. 1341, s. 1343, s. 1347, s. 1349, or s. 1518, or 42 U.S.C. ss. 1320a-7b, relating to the Medicaid program. (Section 456.072(1)(ii), F.S.). First offense, a fine of up to $5,000 and one year suspension to revocation. For a subsequent offense, a fine of $5,000 and revocation.
(n) Dispensing any medicinal drug based upon a communication that purports to be a prescription as defined in Section 465.003(14) or Section 893.02, F.S., if the owner or holder of the registration knows or has reason to believe that the purported prescription is not based on a valid practitioner-patient relationship. (Sections 458.331(1)(oo)8., 459.015(1)(qq)8., F.S.). First offense, a fine of up to $5,000 and from up to one year suspension or revocation. For a subsequent offense, a fine of $5,000 and revocation.
(o) Failing to timely notify the department of the date that the dispensing practitioner has terminated from a pain-management clinic as required by Section 458.3265(2) or 459.0137(2), F.S. (Sections 458.331(1)(oo)9., 459.015(1)(qq)9., F.S.). First offense, a fine of up to $3,500 and from a reprimand to six months suspension. For a subsequent offense, a fine of up to $5,000 and up to one year suspension or revocation.
(p) Failing to timely notify the department of the theft of prescription blanks from a pain-management clinic or a breach of other methods for prescribing within 24 hours as required by Section 458.3265(2) or 459.0137(2), F.S. (Sections 458.331(1)(pp), 459.015(1)(rr), F.S.). First offense, a fine of up to $5,000 and from one year of probation to one year suspension or revocation. For a subsequent offense, a fine of up to $5,000 and one year suspension or revocation.
(q) Promoting or advertising through any communication media the use, sale, or dispensing of any controlled substance appearing on any schedule in Chapter 893, F.S. (Sections 458.331(1)(qq), 459.015(1)(ss), F.S.). First offense, a fine of up to $5,000 and a reprimand and six months to one year suspension. For a subsequent offense, a fine of up to $5,000 and up to one year suspension or revocation.
(r) Making misleading, deceptive, or fraudulent representations in or related to the practice. (Section 456.072(1)(a), F.S.) First offense, a fine of $10,000 and from a reprimand to one year suspension. For a subsequent offense, a fine of $10,000 and one year suspension or revocation.
(s) Intentionally violating any rule adopted by the board or the department as appropriate. (Section 456.072(1)(b), F.S.) First offense, a fine of up to $5,000 and from one year probation up to one year suspension or revocation. For a subsequent offense, a fine of $5,000 and up to one year suspension or revocation.
(t) Having a license or the authority to practice any regulated profession revoked, suspended, or otherwise acted against, including denial, by the licensing authority of any jurisdiction for what would be a violation under Florida law. (Section 456.072(1)(f), F.S.) First offense, a fine of up to $5,000 and up to one year suspension or revocation considering what the penalty would have been had the offense occurred in Florida. For a subsequent offense, a fine of up to $5,000 and up to one year suspension or revocation considering what the penalty would have been had the subsequent offense occurred in Florida.
(u) Attempting to obtain or obtaining the registration by bribery, by fraudulent misrepresentation, or through an error of the department or a board. (Section 456.072(1)(h), F.S.) First offense, a fine of up to $5,000 and up to one year suspension or revocation. For a subsequent offense, a fine of up to $5,000 and one year suspension or revocation.
(v) Failing to report to the department any person known to be in violation of Chapter 456, 458 or 459, or the rules of the department or board. (Section 456.072(1)(i), F.S.) First offense, a fine of up to $3,000 and up to one year suspension. For a subsequent offense, a fine of up to $5,000 and one year suspension or revocation.
(w) Failing to perform any statutory or legal obligation (Section 456.072(1)(k), F.S.). First offense, from a fine of up to $5,000 and/or from a three month to one year suspension. For a subsequent offense, a fine of up to $5,000 and from one year probation to one year suspension or revocation.
(x) Filing a false report (Section 456.072(1)(l), F.S.). First offense, a fine of up to $5,000 and up to one year suspension. For a subsequent offense, a fine of $5,000 and up to one year suspension or revocation.
(y) Making deceptive, untrue, or fraudulent representations or employing a trick or scheme related to the operation of the business (Section 456.072(1)(m), F.S.). First offense, a fine of up to $5,000 and/or probation to one year suspension or revocation. For a subsequent offense, a fine of $5,000 and revocation.
(z) Exercising influence on a patient or client for the purpose of financial gain of the clinic licensee or a third party. (Section 456.072(1)(n), F.S.). First offense, a fine of up to $5,000 and from one year probation to one year suspension or revocation. For a subsequent offense, a fine of up to $5,000 and one year suspension or revocation.
(aa) Practicing or offering to practice beyond the scope permitted by law or accepting and performing professional responsibilities that the owner or designated physician know that the clinic employee is not competent to perform. (Section 456.072(1)(o), F.S.). First offense, a fine of up to $5,000 and up to one year suspension or revocation. For a subsequent offense, a fine of up to $5,000 and revocation.
(bb) Delegating or contracting for the performance of professional responsibilities by a person when the owner or designated physician delegating or contracting for performance of the responsibilities knows, or has reason to know, the person is not qualified by training, experience, and authorization when required to perform them. (Section 456.072(1)(p), F.S.). First offense, a fine of up to $5,000 and from one year probation to up to one year suspension or revocation. For a subsequent offense, a fine of up to $5,000 and one year suspension or revocation.
(cc) Violating an order of the department or the appropriate board, or failing to comply with subpoena of the department (Section 456.072(1)(q), F.S.). First offense, a fine of up to $5,000 and from a reprimand to up to one year suspension. For a subsequent offense, a fine of $5,000 and one year suspension or revocation.
(dd) Improperly interfering with an investigation, inspection, or disciplinary proceeding (Section 456.072(1)(r), F.S.). First offense, a fine of up to $5,000 and up to one year suspension or revocation. For a subsequent offense, a fine of $5,000 and revocation.
(ee) Failing to identify through written notice, which may include the wearing of a name tag, or orally to a patient the type of license under which the practitioner is practicing at the clinic (Section 456.072(1)(t), F.S.). First offense, a fine of up to $2,500 and/or up to a three month suspension. For a subsequent offense, a fine of up to $5,000 and up to one year of suspension of registration.
(ff) Failing to comply with Sections 381.026 and 381.0261, F.S., requirements to provide patients with information about patient rights and how to file a patient complaint (Section 456.072(1)(u), F.S.). First offense, a fine of up to $3,500 and a reprimand up to a six month suspension. For a second offense, a fine of up to $5,000 and from one year probation to up to one year suspension. For a subsequent offense, a fine of $5,000 and one year suspension or revocation.
(gg) Failing to report to the department in writing within 30 days after having been convicted or found guilty of, or entered a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction. (Section 456.072(1)(x), F.S.). First offense, a fine of up to $2,500 and up to a six month suspension. For a subsequent offense, a fine of $5,000 and one year suspension or revocation.
(hh) Violating any applicable provision of Chapter 456, Chapter 458 or Chapter 459, F.S., or the rules of these chapters (Section 456.072(1)(dd), F.S.). First offense, from a fine of up to $5,000 and from six months probation to one year suspension. For a subsequent offense, a fine of up to $5,000 and up to a one year suspension or revocation.
(ii) With respect to a personal injury protection claim as required by Section 627.736, F.S., intentionally submitting a claim, statement, or bill that has been upcoded as defined in Section 627.732, F.S., (Section 456.072(1)(ee), F.S.). First offense, a fine of up to $5,000 and from a reprimand up to one year suspension. For a subsequent offense, a fine of up to $5,000 and up to one year suspension or revocation.
(jj) With respect to a personal injury protection claim as required by Section 627.736, F.S., intentionally submitting a claim, statement, or bill for payment of services that were not rendered. (Section 456.072(1)(ff), F.S.). First offense, a fine of up to $5,000 and from one year of probation to revocation. For a subsequent offense, a fine of up to $5,000 and one year suspension or revocation.
(kk) Engaging in a pattern of practice when prescribing drugs or controlled substances which demonstrates a lack of reasonable skill and safety to patients or a violation of Chapter 456, 458 or 459, or any applicable rules. (Section 456.072(1)(gg), F.S.). First offense, a fine of up to $5,000 and up to one year suspension or revocation. For a subsequent offense, a fine of up to $5,000 and one year suspension or revocation.
(ll) Failing to remit the sum owed to the state for an overpayment from the Medicaid program pursuant to a final order, judgment, or stipulation or settlement (Section 456.072(1)(jj), F.S.). First offense, from a minimum fine equal to the lesser of the amount owed to the state for an overpayment or up to $5,000 and from 6 months probation to one year suspension or revocation. For a subsequent offense, a fine of up to $5,000 and up to a one year suspension or revocation.
(mm) Being terminated from the state Medicaid program, any other state Medicaid program, or the federal Medicare program, unless eligibility has been restored. (Section 456.072(1)(kk), F.S.). First offense, from a fine of up to $5,000 and from one year suspension to revocation. For a subsequent offense, a fine of $5,000 and revocation.
(3) The range of disciplinary penalties which the department is authorized to impose includes those set forth in Section 456.072, 458.3265(5), or 459.0137(5), F.S. In determining the appropriate disciplinary action to be imposed in each case, the department shall take into consideration the mitigating and aggravating factors described in Section 458.3265(5) or 459.0137(5), F.S. The final order shall explain the mitigating or aggravating circumstances used to justify any deviation from the specified guidelines.
(4) Stipulation or Settlements. The provisions of this rule are not intended and shall not be construed to limit the ability of the department to dispose informally of disciplinary actions by stipulation, agreed settlement, or consent order pursuant to Section 120.57(4), F.S.
(5) Other Action. The provisions of this rule are not intended to and shall not be construed to limit the ability of the department to pursue collateral civil or criminal actions when appropriate.
Rulemaking Authority 456.079, 458.3265, 459.0137 FS. Law Implemented 456.072(1)(2), 458.3265(1)(5), 458.327, 458.331, 459.0137(1)(5), 459.013, 459.015 FS. HistoryNew________.
