Prior Authorization Required for Brand Medically Necessary Drugs

Effective for dates of service (DOS) on and after September 1, 2004, Wisconsin Medicaid, BadgerCare, and SeniorCare require prior authorization (PA) for brand medically necessary prescription drugs on the Maximum Allowable Cost (MAC) list. This policy applies to new and refill prescriptions. Although PA is required for these drugs, prescribers are still required to continue writing "Brand Medically Necessary" on these prescriptions. Providers who submit claims are also still required to indicate the appropriate one-digit National Council for Prescription Drug Programs Dispense As Written code on each claim for a brand medically necessary drug.

Brand medically necessary PA requests must be submitted using the paper PA process. Refer to Attachment 1 of this Wisconsin Medicaid and BadgerCare Update for a list of brand medically necessary drugs that require PA whenever the prescriber writes "Brand Medically Necessary" on the prescription to prohibit the substitution of any Food and Drug Administration (FDA)-approved generic equivalent. Attachment 1 is based on the MAC list for generic drugs. The list may be expanded to include additional brand medically necessary drugs. Providers will be informed as changes occur.

MedWatch Reporting Form

An FDA-approved MedWatch Reporting form (PDF, 53 KB) must accompany each brand medically necessary drug prescription. The MedWatch form must be completed by the prescriber (i.e., physician, physician assistant, nurse practitioner) and must include the prescriber’s name, address, and telephone number.

For new and refill prescriptions, the prescriber may mail, fax, or e-mail a completed copy of the form to the pharmacy, or he or she may send a completed copy with the recipient to the pharmacy. MedWatch forms must accompany all brand medically necessary PA requests. Wisconsin Medicaid submits completed MedWatch forms to the FDA.

In addition to the completed MedWatch form, pharmacy providers are required to attach specific prescription information (i.e., a photocopy of the prescription) to each PA request. Refer to Attachment 2 for brand medically necessary PA request documentation requirements. Attachment 3 (PDF, 53 KB) is a copy of the MedWatch Reporting form (PDF, 53 KB).

If a MedWatch form does not accompany a prescription for a brand medically necessary drug, the pharmacy may contact the prescriber to obtain a completed copy of the form. Prescribers may also change the prescription to the FDA-approved generic equivalent if medically appropriate for the recipient.

Prescribers are responsible for providing pharmacies with the required brand medically necessary documentation to assist pharmacies in obtaining PA. Pharmacies are responsible for submitting this documentation with the PA request to Wisconsin Medicaid. Prescribers received a separate Update describing their responsibilities for obtaining PA for brand medically necessary drugs.

Brand Medically Necessary Prior Authorization Approval Criteria for Brand Name Drugs Except Clozaril^®

Clinical criteria for prescribing brand medically necessary drugs must be documented by the prescriber on the MedWatch form (PDF, 53 KB). Criteria for approval of a PA request for a brand name drug include the following:

• An adverse reaction to the generic drug(s).
• An allergic reaction to the generic drug(s).
• Actual therapeutic failure of the generic drug(s).

Documentation on the MedWatch form must indicate how the brand medically necessary drug will prevent recurrence of an adverse or allergic reaction or therapeutic failure of the generic drug.

Providers are encouraged to retain copies of approved Prior Authorization Request Forms (PA/RFs) or approved PA/RFs and MedWatch forms with modifications in the recipient’s medical record.

If a PA request is denied by Wisconsin Medicaid and the pharmacy informs the recipient prior to filling the prescription that Wisconsin Medicaid will not cover the brand name drug, the recipient is responsible for payment of the cost of the brand name drug.

Prior Authorization for Brand Name Clozaril^®

Effective for DOS from September 1, 2004, to September 30, 2004, pharmacies may obtain PA for brand name Clozaril^® by using Wisconsin Medicaid’s Specialized Transmission Approval Technology-Prior Authorization (STAT-PA) system. Refer to Attachment 13 for a copy of the Obsolete 1/1/05: STAT-PA Drug Worksheet for Brand Name Clozaril^®, HCF 11072, (08/04) — Use Prior Authorization / Brand Medically Necessary Attachment (PA/BMNA) (fillable PDF, 225 KB)  | Instructions (PDF, 71 KB)

Effective for DOS on and after October 1, 2004, PA for brand name Clozaril^® may only be obtained using the brand medically necessary PA policies located in the "Prior Authorization Required for Brand Medically Necessary Drugs" section of this Update. Prior authorization for brand name Clozaril^® may not be obtained using the STAT-PA system for DOS after September 30, 2004.

Prior authorization is required for claims for brand name Clozaril^® that are submitted to Wisconsin Medicaid for DOS on and after September 1, 2004. A pharmacy provider should contact the prescribing provider when a recipient receives a refill of brand name Clozaril^® to determine if the prescription should be changed to generic clozapine or if it is clinically appropriate for the recipient to remain on the brand name drug. If the prescribing provider determines that it is medically necessary that the recipient remain on brand name Clozaril^®, the pharmacy provider may submit a STAT-PA request for up to a 30 days’ supply. If the pharmacy provider is unable to reach the prescriber, the STAT-PA system may still be used to obtain PA for up to a 30 days’ supply. However, pharmacy providers are required to contact the prescriber to determine if the recipient should switch to generic clozapine or remain on brand name Clozaril^® before the STAT-PA expiration date.

For brand name Clozaril^® prescriptions, the prescriber is required to fax, mail, or e-mail a copy of the MedWatch form (PDF, 53 KB) to the pharmacy within two weeks of the STAT-PA request. This allows the pharmacy provider time to complete the paper PA process prior to the recipient’s next refill.

For medication monitoring purposes, if a prescribing provider changes a recipient’s medication to the generic form, pharmacy providers must register the recipient with the generic manufacturer. Pharmacy providers can refer to the generic drug manufacturer’s Web site for more information.

As a reminder to pharmacy providers, if the recipient is switched from brand name Clozaril^® to the generic form, a claim may be submitted to Wisconsin Medicaid for Pharmaceutical Care reimbursement.

In some cases, a 72-hour emergency medication supply may be dispensed (e.g., if the STAT-PA system is unavailable).

Brand Medically Necessary Prior Authorization Approval Criteria for Brand Name Clozaril^® Only

Clinical criteria for prescribing brand medically necessary drugs must be documented by the prescriber on the MedWatch form (PDF, 53 KB). Criteria for approval of a PA request for a brand name drug include the following:

• An adverse reaction to the generic drug(s).
• An allergic reaction to the generic drug(s).
• Actual or anticipated therapeutic failure of the generic drug(s).

Documentation on the MedWatch form must indicate how the brand medically necessary drug will prevent recurrence of an adverse or allergic reaction or therapeutic failure of the generic drug.

Providers are encouraged to retain copies of approved PA/RFs or approved PA/RFs and MedWatch forms (PDF, 53 KB) with modifications in the recipient’s medical record.

If a PA request is denied by Wisconsin Medicaid and the pharmacy informs the recipient prior to filling the prescription that Wisconsin Medicaid will not cover the brand name drug, the recipient is responsible for payment of the cost of the brand name drug.

Prior Authorization Request Form Amendments

Pharmacy providers are required to amend a PA request if a different strength of a brand medically necessary drug is prescribed in place of a brand medically necessary drug that has an approved PA. (Providers cannot amend a denied or returned PA request.) To amend the original PA request, use the following instructions:

• Photocopy the original, approved brand medically necessary PA/RF.
• Indicate the new National Drug Code (NDC), drug description, and other information on the photocopy of the PA/RF.
• Indicate "Brand Medically Necessary Amendment" on the top of the photocopy of the original PA/RF.
• Attach a photocopy of the new prescription to the PA/RF.
• Mail or fax the completed PA amendment and the photocopy of the prescription to the address or fax number listed at the end of the "Submitting Prior Authorization Requests" section of this Update.

Note: Prescribers are required to complete a new MedWatch form (PDF, 53 KB) for each new brand medically necessary drug. Drug strength and dose changes for a brand medically necessary drug that has an approved PA request does not require a new MedWatch form.

Submitting Prior Authorization Requests

Prior authorization requests, including PA/RFs, PA attachment(s), MedWatch form(s), and photocopies of prescriptions, may be submitted by fax to Wisconsin Medicaid at (608) 221-8616. If faxed PA requests are received by Wisconsin Medicaid by 1 p.m. on business days, providers will receive an adjudication response after three business days. If a faxed PA request is received by Wisconsin Medicaid after 1 p.m., allow an additional business day for Wisconsin Medicaid to return the adjudicated PA.

Prior authorization requests submitted by mail may be sent to:

Wisconsin Medicaid
Prior Authorization
Ste 88
6406 Bridge Rd
Madison WI 53784-0088

Providers who submit PA requests by mail should be aware that this requires additional time for the PA request to reach Wisconsin Medicaid and for Medicaid to complete the adjudication process.

Pharmacies may contact Provider Services at (800) 947-9627 or (608) 221-9883 to determine the status of any PA request that has been submitted.

Reimbursement for Brand Name and Generic Drugs

Wisconsin Medicaid reimburses providers for innovator drugs (i.e., the patented brand name product of the generic drug on the MAC list) at an amount greater than the Medicaid maximum allowable cost only if the provider indicates "Brand Medically Necessary" on the prescription and obtains PA for the innovator drug. If PA is not obtained for a brand medically necessary drug, and the drug is dispensed without a "Brand Medically Necessary" indication on the prescription, Wisconsin Medicaid will reimburse providers at the generic rate; however, Wisconsin SeniorCare will deny a claim for a brand medically necessary drug unless the prescriber obtains PA and indicates "Brand Medically Necessary" on the prescription.

Emergency Situations

As a reminder for drugs that require PA, in an emergency situation (i.e., a situation where services necessary to prevent the death or serious impairment of the health of the individual are required), PA is never required to provide medically necessary services. A 72-hour medication supply may be dispensed in emergency situations; however, providers cannot bill the recipient or participant for a 72-hour emergency medication supply.

When drugs are dispensed in an emergency situation, providers may submit a Noncompound Drug Claim form, HCF 13072 (fillable PDF, 82 KB) (Rev. 06/03), with a Pharmacy Special Handling Request form, HCF 13074 (fillable PDF, 26KB) (Rev. 06/03), indicating the nature of the emergency. Prior authorization must be obtained for any nonemergency refills.

Send completed Noncompound Drug Claim forms and special handling requests to the address listed in the following section of this Update.

Overview of Wisconsin Medicaid Drug Coverage

Prior authorization for all drugs may be submitted on paper. Prior authorization requests for certain drugs may be submitted through the STAT-PA system.

Refer to the Medicaid Web site at dhs.wisconsin.gov/medicaid/ and the attachments of this Update for more information on the STAT-PA system, paper PA, and drugs.

Refer to the following attachments for more specific information about Wisconsin Medicaid drug coverage and limitations:

• Attachment 1 — Brand medically necessary drugs that require PA.
• Attachment 2 — Brand medically necessary PA documentation.
• Attachment 3 — MedWatch Reporting form (for photocopying) (PDF, 53 KB).
• Attachment 4 — STAT-PA drug products.
• Attachment 5 — Drug products requiring paper PA.
• Attachment 6 — Diagnosis-restricted drugs (organized by generic drug name).
• Attachment 7 — Diagnosis-restricted drugs (organized by diagnosis code description).
• Attachment 8 — Covered over-the-counter drugs.
• Attachment 9 — Noncovered drugs.
• Attachment 10 — Age- and gender-restricted drugs.
• Attachment 11 — Covered over-the-counter drugs for HealthCheck "Other Services."
• Attachment 12 — Comparison of Wisconsin SeniorCare and Wisconsin Medicaid policies.
• Obsolete 1/1/05: Attachment 13 — STAT-PA Drug Worksheet for Brand Name Clozaril^® — Use Prior Authorization / Brand Medically Necessary Attachment (PA/BMNA) (fillable PDF, 225 KB)  | Instructions (PDF, 71 KB).

Claims for drugs that are submitted outside Wisconsin Medicaid’s requirements listed in this Update may be submitted on the Noncompound Drug Claim form, HCF 13072 (fillable PDF, 82 KB), (Rev. 06/03), with the Pharmacy Special Handling Request form, HCF 13074 (fillable PDF, 26 KB) (Rev. 06/03). For example, providers may submit claims for age- or gender-restricted drugs that are outside the requirements listed in Attachment 10 using the Noncompound Drug Claim form and a Pharmacy Special Handling Request form.

Providers can refer to the August 2003 Update (2003-84), titled "Changes to claims and prior authorization for retail pharmacies dispensing drugs and biologics as a result of HIPAA (PDF, 303 KB)," or to the Medicaid Web site at dhs.wisconsin.gov/medicaid/ for a copy of the Noncompound Drug Claim form and the Pharmacy Special Handling Request form (PDF, 26 KB). Refer to the Claims Submission section of the Pharmacy Handbook for more information on special handling requests.

Send completed Pharmacy Special Handling Requests attached to Noncompound Drug Claim forms to:

Wisconsin Medicaid
Pharmacy Special Handling
Ste 20
6406 Bridge Rd
Madison WI 53784-0020

Information Regarding Medicaid HMOs

This Update contains Medicaid fee-for-service policy and applies to providers of services to recipients on fee-for-service Medicaid only. For Medicaid HMO or managed care policy, contact the appropriate managed care organization. Wisconsin Medicaid HMOs are required to provide at least the same benefits as those provided under fee-for-service arrangements.

Attachment 1: Brand Medically Necessary Drugs That Require Prior Authorization
Attachment 2: Brand Medically Necessary Prior Authorization Documentation
Attachment 3: MedWatch Reporting Form (FDA Web site) (PDF, 53 KB)
Attachment 4: Specialized Transmission Approval Technology-Prior Authorization (STAT-PA) Drugs
Attachment 5: Drug Products Requiring Paper Prior Authorization
Attachment 6: Diagnosis-Restricted Drugs (Organized by Generic Drug Name)
Attachment 7: Diagnosis-Restricted Drugs (Organized by Diagnosis Code Description)
Attachment 8: Covered Over-the-Counter Drugs
Attachment 9: Noncovered Drugs
Attachment 10: Age- and Gender-Restricted Drugs
Attachment 11: Covered Over-the-Counter Drugs for HealthCheck "Other Services"
Attachment 12: Comparison of Wisconsin Medicaid and Wisconsin SeniorCare Policies
Attachment 13: Obsolete 1/1/05: STAT-PA Drug Worksheet for Brand Name Clozaril^® (fillable PDF, 236 KB) — Use Prior Authorization / Brand Medically Necessary Attachment (PA/BMNA) (fillable PDF, 225 KB)  | Instructions (PDF, 71 KB)