Controlling Off-Label Narcotics Usage - Impact of New Arizona Legislation ARS §

Off-label prescription of controlled substances; prescription of schedule II controlled substances; reports; treatment plans; definition A. On written request of an interested party as defined in section , a physician shall include in the report required under commission rule information pertaining to the off-label use of a narcotic, opium based controlled substance or schedule II controlled substance by a claimant, which may include the justification for use of the controlled substance, and a treatment plan that includes a description of measures that the physician will implement to monitor and prevent the development of abuse, dependence, addiction or diversion by the employee. The interested party may also request that the treatment plan include a medication contract, a plan for subsequent follow-up visits and drug testing and documentation that the medication regime is providing relief that is demonstrated by improved function. B. If the physician does not comply with this section, the interested party is not responsible for payment for the physician's services until the physician complies with subsection A of this section. C. For the purposes of this section, "off-label use" means use of a prescription medication by a physician to treat a condition other than the use for which the drug was approved by the United States food and drug administration.

Commonly prescribed narcotics that constitute “Off-Label” use: ◦ Fentanyl based drugs –  Actiq  Duragesic  Fentora “ACTIQ is an opioid analgesic indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients must remain on around-the-clock opioids when taking ACTIQ.” ◦ Label approved by FDA on 11/09/09

Initial letter to physicians: Dear Dr. _________: As part of SCF’s efforts to implement the provisions of A.R.S. § , a review of this claim reveals that you have been prescribing the following drugs to the above-referenced injured worker:____________________ As you know, these drugs are narcotic, opium based controlled substance or schedule II controlled substances, and our medical review indicates that the drug(s) are being prescribed in a manner inconsistent with the indications and usage as approved by the United States Food and Drug Administration. Pursuant to A.R.S. § , it is requested that you provide the following information in your next monthly report, as required by Industrial Commission Rule A.A.C. R (“Physician’s Duty to Provide Signed Reports”): Your justification for use of the controlled substance. A treatment plan that includes a description of measures that you will implement to monitor and prevent the development of abuse, dependence, addiction or diversion by the injured worker. We request that you require the injured worker to sign a medication contract (the same or similar to the enclosed sample) and that you assure compliance with the contract. Your plan for subsequent follow-up visits and drug testing (at SCF Arizona’s expense). Documentation that the medication regime is providing relief that is demonstrated by improved function, either through an ability to return to work, or if unable to work, an improved ability to perform normal daily activities. We appreciate your attention to this request. Should you have any questions, please do not hesitate to contact me.

Follow-up letter to non-compliant physicians Dear Dr. ________________: On ____date___, you were sent a letter requesting information regarding the continued prescription of drugs to the above-referenced injured workers (copy enclosed). Pursuant to A.R.S. § and Industrial Commission Rule A.A.C. R , you are required to provide this information in your monthly signed report. To date, I have not received your report. Please be advised that if I do not receive the requested information within 10 business days, I will be forced to deny further payment for your services, as permitted pursuant to the statute. Thank you for your prompt attention to this matter.

High doses as “off-label” use We have reviewed the prescription history of the above-referenced injured worker as a part of SCF's efforts to implement the provisions of A.R.S. § It appears that this injured worker has a daily opioid intake exceeding 120 mg MED (morphine equivalent dose). In some cases, such high-dose therapy is not needed to treat moderate to severe pain, and can even be counterproductive. Recent medical literature suggests that patients with a daily intake in excess of 120 mg MED should be more closely evaluated, and the chronic use of opioids has actually been linked to heightened pain sensitivity. For these reasons, prescribing this patient medications in such high doses may be inconsistent with the indications and usage as approved by the United States Food and Drug Administration. Therefore, in accordance with A.R.S. § , it is requested that you provide the following information in your next monthly report, as required by the Industrial Commission Rule A.A.C. R ("Physician's Duty to Provide Signed Reports"):

Results after one year of /1/2009 to 12/31/2009 – 28 claimants receiving fentanyl drugs off label at an annual cost of $717K. Statute effective date September /1/2010 thru 8/30/2010 – Total drug cost $30K As of 8/30/2010 – 2 claimants on fentanyl drugs at cost of $7K

Increasing the scope of – potential 2011 legislative amendments Broaden application to all Class II narcotics or controlled substances (medical marijuana?) Set dosage threshold for physician mandatory reporting: 120 MED (morphine equivalent dose) Create presumption of unprofessional conduct by physician for medical board disciplinary action for failure to comply with statute Create right of carrier to request change of physicians for physician noncompliance Immunity against bad faith if carrier acts consistently with statute Exception to res judicata to allow review of prior awards

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