Pain Policy and Regulation: Louisiana
Summary
Louisiana has one of the most unusual rules pertaining to pain management in the country. The state adopted the rule to respond to the number of "pill mill" facilities fueling drug abuse and diversion in Louisiana. All Louisiana physicians should read all Board materials very carefully, and make sure they understand the pain management clinic rule before operating a pain medication management clinic in the state.
Uniform Controlled Substances Act
In 2009, the State of Louisiana revised and reorganized the state's list of controlled substances such that the state list is now the same as the federal list. Currently, whatever drugs are controlled on the federal list are also listed as controlled on the state list. There are no drugs on the state list that do not appear on the federal list.
Forthcoming New Rules on Controlled Substances
In late 2009, the State of Louisiana will issue new rules relative to all conduct relating to the administering, dispensing, and prescribing of controlled substances.
Registrant Responsibilities
A registrant is personally responsible for knowledge of and compliance with the provisions, requirements, and procedures and with knowledge of and compliance with all other federal, state, and local laws and regulations applicable to the purchase, acquisition, possession, storage, maintenance, and dispensation of and record keeping and reporting for medication.
Pain Management Clinic Rule
The Louisiana rule defines a pain management clinic "as a publicly or privately owned facility which primarily engages in the treatment of pain by prescribing narcotic medications." The rule defines "primarily engages" as the issuance of a narcotic prescription for the treatment of chronic nonmalignant pain to 51% or more of the patients seen on any day the clinic is in operation.
Subject to certain very specific exceptions, the Louisiana rule requires that each clinic be 100% owned and operated by a physician certified in the subspecialty of pain management by a member board of the American Boards of Medical Specialties. Pain management clinics are subject to a number of other requirements as set forth in the rules. The Louisiana Board will deem it unprofessional conduct for a physician to practice in a clinic that is not in conformity with its rules.
Key Definitions Relating to the Pain Clinic Rule
This section contains only key definitions relating to the pain clinic rule. Physicians should read the rule for all definitions under this section.
Addiction Facility. An addiction facility is one that is licensed for the treatment of addiction to or abuse of illicit drugs or alcohol or both.
Chronic Pain. Chronic pain is pain that persists beyond the usual course of a disease, beyond the expected time for healing from bodily trauma, or pain associated with a long-term incurable or intractable medical illness or disease.
Deficient Practice. Deficient practice is a finding of noncompliance with a licensing regulation.
Department. Department refers to the Department of Health and Hospitals, Health Standards Section, which is the section within the Department of Health and Hospitals with responsibility for licensing pain management clinics.
Intractable Pain. Intractable pain is a chronic pain state in which the cause of the pain cannot be eliminated or successfully treated without the use of controlled substance therapy, and which in the generally accepted course of medical practice, no cure of the cause of pain is possible or no cure has been achieved after reasonable efforts have been attempted and documented in the patient's medical record.
Noncancer-related Pain. Noncancer-related pain is pain that is not directly related to symptomatic cancer.
Nonmalignant Pain. Nonmalignant pain is synonymous with noncancer-related pain.
Operated By. Operated by indicates a person who is actively engaged in the care of patients at a clinic.
Pain Management Clinic or Clinic. A pain management clinic is a publicly or privately owned facility that primarily engages in the treatment of pain by prescribing narcotic medications.
Pain Specialist. A pain specialist is a physician, licensed in Louisiana, with a certification in the subspecialty of pain management by a member board of the American Boards of Medical Specialties.
Primarily Engaged. Primarily engaged indicates a facility where the majority of patients, 51% or more of the patients seen on any day the clinic is in operation, are issued a narcotic prescription for the treatment of chronic nonmalignant pain. A physician who in the course of his or her practice treats patients with chronic pain should not be considered primarily engaged in the treatment of chronic nonmalignant pain by prescribing narcotic medications provided that the physician: (1) treats patients within their areas of specialty and uses other treatment modalities in conjunction with narcotic medications; (2) is certified by a member board of the American Board of Medical Specialties, or is eligible for certification based upon completion of an Accreditation Council for Graduate Medical Education-certified residency training program; and (3) currently holds medical staff privileges that are in good standing at a hospital in this state.
Urgent Care Facility. An urgent care facility is a medical clinic that offers primary and acute health services to the public during stated hours of operation and which must accommodate walk-in patients seeking health services for acute conditions. For purposes of this definition, the treatment of patients with chronic pain is not considered an acute health service.
Interventional Pain Management Position Statement
It is the opinion of the Louisiana Board of Medical Examiners that the injection of local anesthetics, steroids and analgesics, peripheral nerve blocks, epidural injections, and spinal facet joint injections, when used for purposes of interventional pain management, constitute the practice of medicine,are not delegable by a physician to a nonphysician by prescription, direction, or supervision and may only be performed in this state by a Louisiana-licensed physician. Read the entire position statement on the Board's Web site at:http://www.lsbme.louisiana.gov/statements%20of%20position/interventional%20pain%20management.pdf.
State Prescription Drug Monitoring Program
Louisiana has a Prescription Drug Monitoring Program, which is funded through the collection of an annual fee as part of a prescriber's Controlled Dangerous Substance license. The program requires the reporting of all controlled substances and other drugs of concern. The Board of Pharmacy will house the database. The information will be available to prescribers and dispensers for their own patients. Regulatory agencies will also have access to the information. Law enforcement agencies will have access to the information provided they have acquired the appropriate administrative warrants or other judicial documents.
Reporting of Unexplained Loss or Theft
Any theft or unexplained loss of controlled substances in the possession of a registrant must be reported by the registrant to the Board, in writing, within 10 days of the date of the registrant's discovery of such theft or loss, but in no event later than 10 days following the completion of the next quarterly physical inventory following such theft or loss. The written report must state the date or estimated date of such theft or loss, the generic chemical or trade name of the substance, the amount or quantity, and the dosage form and strength of any medications stolen or lost as well as a detailed description of the circumstances surrounding the theft or loss.
Medications Used in the Treatment of Noncancer-Related Chronic or Intractable Pain
Louisiana also has an older rule on the use of medications in the treatment of noncancer-related chronic or intractable pain. This rule can be found at: http://doa.louisiana.gov/osr/lac/46v45/46v45.pdfpage 148. The following key definitions relate to this rule and may or may not be the same as those relating to the pain clinic rule:
Chronic Pain. Chronic pain is pain that persists beyond the usual course of a disease, beyond the expected time for healing from bodily trauma, or pain associated with a long term-incurable or intractable medical illness or disease.
Diversion. Diversion is the conveyance of a controlled substance to a person other than the person to whom the physician prescribed or dispensed the drug.
Intractable Pain. Intractable pain is a chronic pain state in which the cause of the pain cannot be eliminated or successfully treated without the use of controlled substance therapy, and for which in the generally accepted course of medical practice no cure for the cause of pain is possible or no cure has been achieved after reasonable efforts have been attempted and documented in the patient's medical record.
Noncancer-Related Pain. Noncancer-related pain is defined as pain that is not directly related to symptomatic cancer.
Physical Dependence. Physical dependence is the physiologic state of neuroadaptation to controlled substance use that is characterized by the emergence of a withdrawal syndrome if the controlled substance is stopped or decreased abruptly, or if an antagonist is administered. Withdrawal may be relieved by readministration of the controlled substance.
Protracted Basis. Use of a controlled substance on a protracted basis is defined as the use of any controlled substance for the treatment of noncancer-related chronic or intractable pain for a period in excess of 12 weeks during any 12-month period.
Substance Abuse. Substance abuse is a compulsive disorder in which an individual becomes preoccupied with obtaining and using a substance, despite adverse social, psychological, and/or physical consequences, and the continued use of which results in a decreased quality of life. Substance abuse is also called addiction. The development of controlled substance tolerance or physical dependence does not equate with substance abuse or addiction.
Tolerance. Tolerance refers to the physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect or a reduced effect is observed with a constant dose. Controlled substance tolerance refers to the need to increase the dose of the drug to achieve the same level of analgesia. Controlled substance tolerance may or may not be evident during controlled substance treatment.
General Conditions and Prohibitions Under the Rule
The treatment of noncancer-related chronic or intractable pain with controlled substances constitutes legitimate medical therapy when provided in the course of professional medical practice and when fully documented in the patient's medical record. A Louisiana-licensed physician must not, however, prescribe, dispense, administer, supply, sell, give, or otherwise use for the purpose of treating such pain, any controlled substance unless done in strict compliance with applicable state and federal laws and rules.
Limitations and Requisite Prior Conditions
When using any controlled substance for the treatment of noncancer-related chronic or intractable pain on a protracted basis, a physician must comply with the following rules:
Evaluation of the Patient. The physician's initial evaluation of the patient must include relevant medical, pain, and alcohol and substance abuse histories; an assessment of the impact of pain on the patient's physical and psychological functions; a review of previous diagnostic studies and previously used therapies; an assessment of coexisting illnesses, diseases, or conditions; and an appropriate physical examination.
Medical Diagnosis. The physician must establish a medical diagnosis and fully document it in the patient's medical record. The medical diagnosis must indicate not only the presence of noncancer-related chronic or intractable pain, but also the nature of the underlying disease and pain mechanism, if such are determinable.
Treatment Plan. The physician must formulate and document in the medical record an individualized treatment plan that includes medical justification for controlled substance therapy. The physician's treatment plan must include documentation that other medically reasonable alternative treatments for relief of the patient's noncancer-related chronic or intractable pain have been considered or attempted without adequate or reasonable success. The physician's treatment plan must specify the intended role of controlled substance therapy within the overall plan and must tailor the therapy to the individual medical needs of each patient.
Informed Consent. The physician must inform the patient and/or his or her guardian of the benefits and risks of controlled substance therapy. The physician should note the discussions of risks and benefits in some format in the patient's record.
When the Treatment Plan Involves Controlled Substance Therapy
Upon completion and satisfaction of the conditions stated above, and upon the physician's judgment that controlled medications should be used for a patient, the physician must then comply with the following rules:
Assessment of Treatment Efficacy and Monitoring. The physician must see all patients treated under this rule at appropriate intervals, not to exceed every 12 weeks, and during these interval visits must assess the efficacy of treatment, must assure that controlled substance therapy remains indicated, and must evaluate the patient's progress toward treatment objectives and any adverse drug effects. If there are exceptions to this interval, the physician must adequately document the same in the patient's record. During each visit, the physician must pay attention to the possibility of decreased function or quality of life because of controlled substance treatment. The physician should also evaluate indications of substance abuse or diversion. At each visit, the physician should seek evidence of undertreatment of pain.
Drug Screen. If the physician reasonably believes that the patient has substance abuse problems or is diverting controlled substances, the physician must obtain a drug screen on the patient. It is within the physician's discretion to decide the nature of the screen and which type of drug(s) to be screened for.
Responsibility for Treatment. A single physician should take primary responsibility for the controlled substance therapy of a patient's noncancer-related chronic or intractable pain.
Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment to achieve treatment objectives. The physician should pay special attention to those patients with pain who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation, and consultation with or referral to an expert in the management of such patients.
Medications Employed. A physician must document in the patient's medical record the medical necessity for the use of more than one type or schedule of controlled substance for the management of a patient's noncancer-related chronic or intractable pain.
Treatment Records. A physician must document and maintain in the patient's medical record accurate and complete records of history, physical and other examinations and evaluations, consultations, laboratory and diagnostic reports, treatment plans and objectives, controlled substance and other medication therapy, informed consents, periodic assessments, and reviews and the results of all other attempts at analgesia that the physician has used as an alternative to controlled substance therapy.
Documentation of Controlled Substance Therapy. At a minimum, the physician must document in the patient's medical record the date, quantity, dosage, route, frequency of administration, number of controlled substance refills authorized, and frequency of physician visits required to obtain refills.
Medscape Neurology & Neurosurgery. 2009; ©2009 Medscape
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