- (a) “Malpractice” includes any professional misconduct, unreasonable lack of skill or fidelity in professional duties, evil practice, or illegal conduct in the practice of medicine and surgery.
(b) It shall include, among other things, but not be limited to:
- (1) Violation of laws, rules, and procedures governing payment to physicians for medical services for eligible public assistance recipients and/or other third-party payment programs;
- (2) Participation in any plan, agreement, or arrangement which compromises the quality or extent of professional medical services or facilities at the expense of the public health, safety, and welfare;
- (3) Practicing fraud, deceit, or misrepresentation in the practice of medicine;
(4)
- (A) The prescribing of excessive amounts of controlled substances to a patient including the writing of an excessive number of prescriptions for an addicting or potentially harmful drug to a patient.
- (B)
(i) “Excessive” means the writing of any prescription in any amount without a detailed medical justification for the prescription documented in the patient record.
- (ii) Chronic pain. If there is documented medical justification, “excessive” means, pursuant to the Centers for Disease Control and Prevention guideline for prescribing opioids for chronic pain, as prescribing opioids at a level that exceeds greater than or equal to fifty morphine milligram equivalents (≥50 MME) per day, unless the physician/physician assistant documents each of the following:
- (a) (a) Objective findings, which include, but are not limited to, imaging studies, lab testing and results, nerve conduction testing, biopsy, and any other test that would establish pain generating pathology;
(b) (b) Specific reasons for the need to prescribe greater than or equal to fifty morphine milligram equivalents (≥ 50 MME) per day;
(c) (c) Documented alternative treatment plans as well as alternative therapies trialed and failed prior to considering chronic opioid therapy;
- (d) (d) Documented risk factor assessment detailing that the patient was informed of the risk and the addictive nature of the prescribed drug;
- (e) (e) Documented assessment of the potential for abuse and/or diversion of the prescribed drug;
- (f) (f) That the Prescription Drug Monitoring Program had been checked prior to issuing the prescription;
- (g) (g) A detailed clinical rationale for the prescribing and the patient must be seen in an in-person examination every three (3) months or every ninety (90) days;
(h) (h) The definition of “excessive” as contained in this section shall not apply to prescriptions written for a patient in hospice care, in active cancer treatment, palliative care, end-of-life care, nursing home, assisted living, or a patient while in an inpatient setting or in an emergency situation;
- (i)
- (1) (i)(1) Regular urine drug screens should be performed on patients to ensure the patient is taking prescribed medications and is not participating or suspected in participating in diversion or abuse of nonprescribed medications.
- (2) (2) The treatment of chronic pain shall be consistent with the Centers for Disease Control and Prevention guidelines as they relate to baseline drug testing and at least annual follow up testing as warranted for treatment; and
(j)
- (1) (j)(1) A pain treatment agreement must be signed and reviewed by the patient when initiating chronic opioid therapy.
(2) (2) This agreement should discuss the following:
- (A) (A) Informed risk and addictive nature of prescribed medications;
- (B) (B) Outline of the specific expectations between patient and physician; and
(C) (C) Informed consent for periodic urine drug screenings and random pill counts with urine screening as well as the provisions for termination of opioid therapy.
- (iii) Acute pain.
- (a) (a) For treatment of acute pain, “excessive” means, further, an initial prescription written for more than seven (7) days, without detailed, documented medical justification in the medical record.
(b) (b) If the patient requires further prescriptions, they must be evaluated in regular increments with documented medical justification for continued treatment in medical record.
- (iv)
- (a) (a) When opioids are started, clinicians should prescribe the lowest effective dosage.
(b) (b) Clinicians should:
- (1) (1) Use caution when prescribing opioids at any dosage;
- (2) (2) Carefully reassess evidence of individual benefits and risks when considering increasing dosage to greater than fifty morphine milligram equivalents per day (> 50 MME/day); and
- (3) (3) Avoid increasing dosage to greater than ninety morphine milligram equivalents per day (> 90 MME/day) or carefully justify a decision to titrate dosage to greater than ninety morphine milligram equivalents per day (> 90 MME/day);
- (5) The prescribing of Schedule II controlled substances by a physician/physician assistant for his or her own use or for the use of his or her immediate family;
(6)
(A)
- (i) The treatment of pain with dangerous drugs and controlled substances is a legitimate medical purpose when done in the usual course of medical practice.
- (ii) If the provisions as set out below in this section are met, and if all drug treatment is properly documented, the Arkansas State Medical Board will consider such practices as prescribing in a therapeutic manner and prescribing and practicing medicine in a manner consistent with public health and welfare.
(B) However, a physician/physician assistant who prescribes narcotic agents Schedule II (except 2.6(e)), III, IV, and V, and to include the schedule drugs Talwin, Stadol, and Nubain, for a patient with pain not associated with malignant or terminal illness will be considered exhibiting gross negligence or ignorant malpractice unless he or she has complied with the following:
- (i) The physician/physician assistant will keep accurate records to include:
- (a) (a) The medical history;
(b) (b) Physical examination;
(c) (c) Other evaluations and consultations;
- (d) (d) Treatment plan objective;
- (e) (e) Informed consent noted in the patient record;
- (f) (f) Treatment;
- (g) (g) Medications given;
(h) (h) Agreements with the patient; and
(i) (i) Periodic reviews;
- (ii)
- (a) (a) The physician/physician assistant will periodically review the course of scheduled drug treatment of the patient and any new information about etiology of the pain.
(b) (b) If the patient has not improved, the physician/physician assistant should assess the appropriateness of continued prescribing of scheduled medications or dangerous drugs or trial of other modalities;
- (iii) The physician/physician assistant will obtain written informed consent from those patients he or she is concerned may abuse controlled substances and discuss the risks and benefits of the use of controlled substances with:
- (a) (a) The patient;
(b) (b) His or her guardian; or
(c) (c) Authorized representatives; and
- (iv) The physician/physician assistant will be licensed appropriately in Arkansas and have a valid controlled substance registration and comply with the federal and state rules for the issuing of controlled substances and prescriptions, more especially the regulations as set forth in 21 C.F.R. § 1300 et seq.
(C) Treatment of chronic nonmalignant pain.
- (i)
(a) (a) “Chronic nonmalignant pain” means pain requiring more than three (3) consecutive months of prescriptions for:
- (1) (1) An opioid that is written for more than the equivalent of ninety (90) tablets, each containing five milligrams (5mg) of hydrocodone;
- (2) (2) A morphine equivalent dose of more than fifteen milligrams (15mg) per day; or
- (3) (3) In the specific case of tramadol, a dose of fifty milligrams (50mg) per tablet with a quantity of one hundred twenty (120) tablets.
(b) (b) “Opioid” means a drug or medication that relieves pain, including without limitation:
- (1) (1) Hydrocodone;
- (2) (2) Oxycodone;
- (3) (3) Morphine;
- (4) (4) Codeine;
- (5) (5) Heroin; and
(6) (6) Fentanyl.
(c) (c) “Prescriber” means a practitioner or other authorized person who prescribes a Schedule II, III, IV, or V controlled substance.
- (ii) Patient evaluation. A patient who is being treated with controlled substances for chronic nonmalignant pain shall be evaluated at least one (1) time every six (6) months by a physician/physician assistant who is licensed by the board.
- (iii) Prescriber requirements:
(a) (a) For a patient with chronic nonmalignant pain, a prescriber, at a minimum and in addition to any additional requirements of the board, shall:
- (1) (1) Check the prescriptive history of the patient on the Prescription Drug Monitoring Program pursuant to 17 CAR § 140-3501; and
- (2) (2) Follow the specific requirements of 17 CAR § 140-1301 et seq., and any and all other rules of the board pertaining to prescribing; and
(b)
- (1) (b)(1) For prescribers licensed after December 31, 2015, within the first two (2) years of being granted a license in the state, a prescriber shall obtain a minimum of three (3) hours of prescribing education approved by the board.
(2) (2) The education approved by the board under this section shall include:
- (A) (A) Options for online and in-person programs;
- (B) (B) Information on prescribing rules and laws that apply to individuals who are licensed in the state; and
- (C) (C) Information and instructions on prescribing controlled substances, recordkeeping, and maintaining safe and professional boundaries;
(7)
- (A) A licensed physician/physician assistant engaging in sexual contact, sexual relations, or a romantic relationship with a patient concurrent with the physician/physician assistant-patient relationship, or a licensed physician/physician assistant engaging in the same conduct with a former patient, if the physician/physician assistant uses or exploits trust, knowledge, emotions, or influence derived from the previous professional relationship, shows a lack of fidelity of professional duties, thus exhibiting gross negligence and ignorant malpractice.
- (B) A patient's consent to, initiation of, or participation in a sexual relationship or conduct with a physician/physician assistant does not change the nature of the conduct nor the prohibition; and
(8)
(A) Requiring minimum standards for establishing patient/provider relationships.
- (i) “Provider” means a person licensed by the Arkansas State Medical Board.
- (ii) A provider exhibits gross negligence if he or she provides and/or recommends any form of treatment, including prescribing legend drugs, without first establishing a proper patient/provider relationship.
(B) For purposes of this subpart, a proper patient/provider relationship, at a minimum, requires that:
- (i) The provider performs a history and an in-person physical examination of the patient adequate to establish a diagnosis and identify underlying conditions and/or contraindications to the treatment recommended/provided;
- (ii)
- (a) (a) The provider has access to a patient’s personal health record, defined by the Telemedicine Act, Arkansas Code § 17-80-401 et seq., as relevant clinical information required to treat a patient, that is maintained by a provider and uses any technology deemed appropriate by the provider, including the telephone, with a patient located in Arkansas to diagnose, treat, and if clinically appropriate, prescribe a noncontrolled drug to the patient.
(b) (b) A proper professional relationship does not include one established only by:
- (1) (1) Internet questionnaire;
- (2) (2) Email message;
- (3) (3) Patient-generated medical history;
- (4) (4) Text message;
- (5) (5) Facsimile; or
(6) (6) Any combination of these means; or
- (iii)
- (a) (a) The provider personally knows the patient and the patient’s general health status through an ongoing personal or professional relationship.
(b) (b) Appropriate follow-up shall be provided or arranged, when necessary, at medically necessary intervals.
(c) (c) A health record may be created with the use of telemedicine and consists of relevant clinical information required to treat a patient, and is reviewed by the healthcare professional who meets the same standard of care for a telemedicine visit as an in-person visit.
(C) For the purposes of this subpart, a proper patient/provider relationship is deemed to exist in the following situations:
- (i) When treatment is provided in consultation with, or upon referral by, another provider who has an ongoing relationship with the patient, and who has agreed to supervise the patient’s treatment, including follow-up care and the use of any prescribed medications; and
- (ii) On-call or cross-coverage situations is arranged by the patient’s treating provider.