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Nc dma: a7, off label antipsychotic safey monitoring in recipients 18 and older

Division of Medical Assistance
General Clinical Policy No. A7
Off Label Antipsychotic
Original Effective Date: March 20, 2012
Safety Monitoring
Revised Date:
in Recipients 18 and Older
Table of Contents
Eligible Recipients . 1 2.1.1  General Provisions . 1 2.1.2  EPSDT Special Provision: Exception to Policy Limitations for Recipients under Prior Authorization . 2 2.2.1  Exemptions . 2  Monitoring Portal for Prescriber Registry . 3  Information Sources to Develop Monitoring Parameters . 3  Indications and Maximum Dose Parameters . 4  Adverse Effects and Clinical Assessment Monitoring . 6  Policy Implementation/Revision Information . 6  Division of Medical Assistance
General Clinical Policy No. A7
Off Label Antipsychotic
Original Effective Date: March 20, 2012
Safety Monitoring
Revised Date:
in Recipients 18 and Older
Policy Statement
This policy applies to safety monitoring for recipients age 18 and older who are prescribed antipsychotic agents. Safety monitoring with documentation shall result when an antipsychotic medication is used without indications and dosage levels approved by the federal Food and Drug Administration. Safety monitoring will target metabolic and neurologic side effects. Policy Guidelines
Eligible Recipients
2.1.1 General Provisions
Medicaid recipients may have service restrictions due to their eligibility category,
which would make them ineligible for this service.
Note: Outpatient pharmacy services are available to all eligible Medicaid
recipients.
2.1.2 EPSDT Special Provision: Exception to Policy Limitations for
Recipients under 21 Years of Age
42 U.S.C. § 1396d(r) [1905(r) of the Social Security Act]
Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) is a federal
Medicaid requirement that requires the state Medicaid agency to cover services,
products, or procedures for Medicaid recipients under 21 years of age if the
service is medically necessary health care to correct or ameliorate a defect,
physical or mental illness, or a condition [health problem] identified through a
screening examination** (includes any evaluation by a physician or other
licensed clinician). This means EPSDT covers most of the medical or remedial
care a child needs to improve or maintain his/her health in the best condition
possible, compensate for a health problem, prevent it from worsening, or prevent
the development of additional health problems. Medically necessary services will
be provided in the most economic mode, as long as the treatment made available
is similarly efficacious to the service requested by the recipient’s physician,
therapist, or other licensed practitioner; the determination process does not delay
the delivery of the needed service; and the determination does not limit the
recipient’s right to a free choice of providers.
EPSDT does not require the state Medicaid agency to provide any service, product, or procedure Division of Medical Assistance
Clinical Coverage Policy No.: A7
Off Label Antipsychotic Safety
Original Effective Date: March 20, 2012
Monitoring in Recipients 18 and older
Revised Date:
that is unsafe, ineffective, or experimental/investigational. that is not medical in nature or not generally recognized as an accepted method of medical practice or treatment. Service limitations on scope, amount, duration, frequency, location of service, and/or other specific criteria described in clinical coverage policies may be exceeded or may not apply as long as the provider’s documentation shows that the requested service is medically necessary “to correct or ameliorate a defect, physical or mental illness, or a condition” [health problem]; that is, provider documentation shows how the service, product, or procedure will correct or improve or maintain the recipient’s health in the best condition possible, compensate for a health problem, prevent it from worsening, or prevent the development of additional health problems. **EPSDT and Prior Approval Requirements
a. If the service, product, or procedure requires prior approval, the fact that the recipient is under 21 years of age does NOT eliminate the requirement for
prior approval.
b. IMPORTANT ADDITIONAL INFORMATION about EPSDT and prior
approval is found in the Basic Medicaid Billing Guide, sections 2 and 6, and on the EPSDT provider page. The Web addresses are specified below. Basic Medicaid Billing Guide: http://www.ncdhhs.gov/dma/basicmed/
EPSDT provider page: http://www.ncdhhs.gov/dma/epsdt/
Prior Authorization
The Department of Health and Human Services, Division of Medical Assistance, may initiate a registration and/or prior authorization process for the off label prescribing of an antipsychotic for a recipient age 18 and older to ensure safety monitoring documentation by the prescriber if: The antipsychotic is prescribed for an indication that is not approved by the federal Food and Drug Administration. The antipsychotic is prescribed at a different dosage than approved for an indication by the federal Food and Drug Administration. The prescribed antipsychotic will result in the concomitant use of two or more antipsychotics. 2.2.1 Exemptions
Recipients with any of the following diagnoses are exempt from the
requirements of the policy.

a. Schizophrenia
b. Schizophreniform

disorder
c. Schizoaffective
disorder
d. Delusional
disorder
e. Brief psychotic disorder
f. Shared psychotic disorder
g. Psychotic disorder NOS
h. Bipolar disorder
i. Major depressive disorder with psychotic features
j. Treatment resistant depression (antipsychotic use for TRD is

adjunctive only)
Division of Medical Assistance
Clinical Coverage Policy No.: A7
Off Label Antipsychotic Safety
Original Effective Date: March 20, 2012
Monitoring in Recipients 18 and older
Revised Date:
k. Tourette
syndrome
l. Other psychoses
The pharmacist may override the prior authorization edit at point of sale if the
prescriber writes on the face of the prescription in his/her own handwriting:
“Meets PA Criteria”. This information may also be entered in the comment
block on e-prescriptions.
Monitoring Portal for Prescriber Registry
Prescribers shall input information for each recipient age 18 and older for whom an
antipsychotic is prescribed that meet any of the criteria listed in Subsection 2.2. The data
elements collected are used to support a generally accepted clinical analysis of the safety
and efficacy of the prescribed pharmacotherapy.
Safety Monitoring Documentation
A request for an antipsychotic medication meeting any of the descriptions as outlined below will require safety monitoring documentation by the prescriber in order for the claim to successfully complete point of sale processing. An antipsychotic prescribed without a clinical diagnosis corresponding to an FDA approved indication. An antipsychotic prescribed in an amount differing from the FDA approved dosage for that indication for a recipient 18 years of age and older. An antipsychotic prescribed that meets the definition of intraclass
polypharmacy*.
Note: *Intraclass polypharmacy is defined as combination therapy with two or more
agents outside of a 60 day window allowing for cross titration when converting agents.
Information Sources to Develop Monitoring Parameters
Safety monitoring parameters in the registry shall be based upon standards established by the American Psychiatric Association and currently accepted practice standards for the efficacious and safe use of antipsychotics. Provider Education
Providers shall be offered training and regular follow-up with a review of recent prescribing data. The initial education shall focus on clinical issues related to the use of antipsychotics including levels of evidence for use, safety and outcomes assessments, use of psychosocial supports, and interventions to consider if adverse effects present during antipsychotic therapy. Subsequent education shall focus on clinical issues identified either statewide or at the specific practice level. Consultative support by psychiatry specialists shall be available as needed. Access Assured
If FDA approved guidelines for use are met for a specific recipient, further safety documentation will not be required by the provider for a period of up to one year. The ability to bypass the documentation shall be granted on a recipient specific basis. Systems will be built to assure recipients will be able to obtain the appropriate medications as prescribed by the physician. Division of Medical Assistance
Clinical Coverage Policy No.: A7
Off Label Antipsychotic Safety
Original Effective Date: March 20, 2012
Monitoring in Recipients 18 and older
Revised Date:
Indications and Maximum Dose Parameters
Selected antipsychotic agents have age dependent FDA approved indications and recommended dosages. Drug specific parameters by diagnosis shall be in accordance with the FDA guidelines. (Refer to table 1) Division of Medical Assistance
Clinical Coverage Policy No.: A7
Off Label Antipsychotic Safety
Original Effective Date: March 20, 2012
Monitoring in Recipients 18 and older
Revised Date:
Division of Medical Assistance
Clinical Coverage Policy No.: A7
Off Label Antipsychotic Safety
Original Effective Date: March 20, 2012
Monitoring in Recipients 18 and older
Revised Date:
Adverse Effects and Clinical Assessment Monitoring
Specific monitoring parameters recommended by the American Psychiatric Association and other evidence based sources at baseline and predetermined therapy intervals may include BMI percentile, blood pressure, glucose, lipid, CBC and EKG. Parameters should be monitored at baseline and then at recommended frequencies. Policy Implementation/Revision Information
Original Effective Date: March 20, 2012
Revision Information:

Date Section
Additional diagnoses h. – l. were added to the list of exemptions; procedures for point-of-sale override were added Division of Medical Assistance
Clinical Coverage Policy No.: A7
Off Label Antipsychotic Safety
Original Effective Date: March 20, 2012
Monitoring in Recipients 18 and older
Revised Date:
Attachment A: References
1. Buchanan RW, Kreyenbuhl J, Kelly DL, et al. The 2009 PORT psychopharmacological treatment recommendations and summary statements. Schizophrenia Bulletin 2009; (36) 1, 71-93. 2. Consensus Development Conference on Antipychotic Drugs and Obesity and Diabetes. American Diabetes Association-American Psychiatric Association. Diabetes Care 2004. 27(2). 596-601. 3. Dixon L, Perkins D, Calmes C. Guideline Watch (September 2009): Practice guideline for the treatment of patients with schizophrenia. American Psychiatric Association. Available at http://www.psychiatryonline.com/pracGuide/PracticePDFs/Schizophrenia_Guideline%20Watch.pdf Accessed 8/25/2010. 4. Kreyenbuhl J, Buchanan RW, Dickerson FB, et al. The schizophrenia patient outcomes research team (PORT): updated treatment recommendations. Schizophrenia Bulletin 2009; (36) 1, 94-103. 5. Marder SR, Essock SM, Miller AL. The Mount Sinai conference on the pharmacotherapy of schizophrenia. Schizophrenia Bulletin 2002. 28(1): 5-16. 6. Parks J, Svendsen D, Singer P, et al. eds. Morbidity and Mortality in People with Serious Mental Illness. National Association of State Mental Health Program Directors. October 2006. www.nasmhpd.org. Accessed 8/24/2010. 7. Rosenheck RA, Leslie DL, Busch SB, et al. Rethinking antipsychotic formulary policy. Schizophrenia Bulletin 2008; (34) 2, 375-380. 8. Rosenheck RA. Outcomes, costs, and policy caution. A commentary on the Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1). Arch Gen Psychiatry 2006. 63: 1074-1076. 9. Sicouri S, Antzelevitch C. Sudden cardiac death secondary to antidepressant and antipsychotic drugs. Expert Opinion on Drug Safety 2008. 7(2):181-194.

Source: http://www.documentforsafety.org/pub/forms/A7.pdf

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