Transcript Controlling Off-Label Narcotics Usage

Controlling Off-Label Narcotics
Usage - Impact of New Arizona
Legislation
ARS § 23-1062.02
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23-1062.02. Off-label prescription of controlled substances; prescription of
schedule II controlled substances; reports; treatment plans; definition
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A. On written request of an interested party as defined in section 23-901, 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.
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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.
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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.
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Commonly prescribed narcotics that
constitute “Off-Label” use:
◦ Fentanyl based drugs –
 Actiq
 Duragesic
 Fentora
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“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. §23-1062.02, 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. §23-1062.02, it is requested that you provide the following information in your
next monthly report, as required by Industrial Commission Rule A.A.C. R20-5-113 (“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. §23-1062.02 and Industrial
Commission Rule A.A.C. R20-5-113, 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.
§23 - 1062.02. 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. §23- 1062.02, it is requested that you provide the following
information in your next monthly report, as required by the Industrial
Commission Rule A.A.C. R20 - 5 - 113 ("Physician's Duty to Provide
Signed Reports"):
Results after one year of 23-1062.02

1/1/2009 to 12/31/2009 – 28 claimants receiving
fentanyl drugs off label at an annual cost of $717K.
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Statute effective date September 2009
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1/1/2010 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 23-1062.01 –
potential 2011 legislative amendments
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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
Questions?