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Prior Authorization : Services Requiring Prior Authorization

Topic #17397

Crinone®

PA requests for Crinone® may be approved for treatment of the following conditions:

  • Secondary amenorrhea.
  • Prevention of preterm birth in women with short cervical length.

Although Crinone® is also indicated for use in ART treatment, ForwardHealth does not cover infertility treatment, including ART.

PA requests for Crinone® must be submitted using Section VI (Clinical Information for Drugs with Specific Criteria Addressed in the Online Handbook) of the PA/DGA and the PA/RF. The gestational age (if applicable), in weeks and days, of the pregnancy must be indicated in Section VI of the PA/DGA.

PA requests for Crinone® may be submitted on the ForwardHealth Portal, by fax, or by mail. PA requests for Crinone® may not be submitted using the STAT-PA system.

Topic #17417

Clinical Criteria for Crinone®

Clinical Criteria for Crinone® for Members Who Have Secondary Amenorrhea

Secondary amenorrhea is the cessation of menses for six or more months in a woman who previously had normal menstrual cycles. Women who are pregnant, breastfeeding, or in menopause are not considered to have secondary amenorrhea.

Clinical criteria that must be documented for approval of a PA request for Crinone® for members who have secondary amenorrhea are all of the following:

  • The member has a diagnosis of secondary amenorrhea.
  • The member's last menstrual cycle occurred more than six months ago.
  • The member is not being treated for infertility.
  • The member is not pregnant or breastfeeding.
  • The member is not in menopause.
  • The member is currently receiving estrogen therapy.

Crinone® 4% will only be approved for every other day dosing up to a total of six doses.

In women who fail to respond to a trial of Crinone® 4%, Crinone® 8% will only be approved for every other day dosing up to a total of six doses.

Clinical Criteria for Crinone® for Women with Short Cervical Length

Short cervical length is associated with an increased risk of preterm birth.

Clinical criteria that must be documented for approval of a PA request for Crinone® for prevention of preterm birth in a woman with short cervical length are both of the following:

  • The member is pregnant with a singleton pregnancy.
  • The member has a short cervix, defined as cervical length of less than 25 mm at less than 28 weeks gestation. (Note: Short cervical length must be determined by transvaginal ultrasound. Neither digital examination nor transabdominal ultrasound is an acceptable means of determination of short cervical length.)

For women with short cervical length, documentation indicating the gestational age, in weeks and days, must be included with the PA request.

PA requests for Crinone® for women with short cervical length may be approved regardless of whether or not the woman has a history of spontaneous preterm birth.

Crinone® 8% for daily dosing will be approved through 36 weeks gestation.

Topic #1414

Drugs That Require Paper Prior Authorization

Paper PA request submission is required to determine medical necessity for the following drugs. Diagnosis and information regarding the medical requirements for these drug categories must be provided on the PA request for members enrolled in the BadgerCare Plus Standard Plan, Medicaid, and SeniorCare.

Drug Products That Require Paper PA Submission

Alitretinoin gel (when used to treat Kaposi's sarcoma lesions)

Brand medically necessary drugs

Diagnosis-restricted drugs that require PA outside approved diagnoses

Drugs without signed manufacturer rebate agreements*

Fertility enhancement drugs (when used to treat conditions other than infertility)

Impotence treatment drugs (when used for a condition other than impotence)

Unlisted or investigational drugs*

* SeniorCare does not cover prescription drugs, even with a PA request, that do not have a signed rebate agreement between the DHS and the manufacturer; however, these drug products may be covered for BadgerCare Plus or Wisconsin Medicaid members if a paper PA request is submitted.

Submitting Paper Prior Authorization Requests

Paper PA requests that are faxed to ForwardHealth will receive an adjudication response via telephone one business day after they are received. Providers who submit PA requests by mail should be aware that this option requires additional time for the PA request to reach ForwardHealth and for ForwardHealth to complete the adjudication process.

To avoid delayed adjudication, do not fax and mail duplicate copies of the same PA request forms.

Pharmacy providers may contact Provider Services to determine the status of any PA request that has been submitted.

Approved, Returned, and Denied Paper Requests

A paper PA request submitted to ForwardHealth may be approved, returned, or denied.

When a PA request is approved:

  • The "approved" box on the PA/RF is checked.
  • The grant and expiration dates are indicated.
  • A signature and a date signed are indicated.
  • A specific days' supply is indicated.

When a PA request is returned:

  • The "return" box on the PA/RF is checked.
  • An explanation for the return is indicated.

A PA request is returned because additional information is needed or because information on the request must be corrected. A returned PA request is not the same as a denied request. Providers should correct or add the missing information to the original PA request and resubmit it to BadgerCare Plus or SeniorCare.

When a PA request is denied:

  • The "denied" box on the PA/RF is checked and an explanation is given.
  • A signature and date signed are indicated.
Topic #13678

Fertility and Impotence Drugs

According to DHS 107.10(2)(f) and 107.10(2)(g), Wis. Admin. Code, the following drugs require PA:

  • Drugs identified by the DHS that are sometimes used to enhance the prospect of fertility in males or females, when proposed to be used for treatment of a condition not related to fertility.
  • Drugs identified by the DHS that are sometimes used to treat impotence, when proposed to be used for the treatment of a condition not related to impotence.

These types of drugs are not covered unless a paper PA request is submitted on the PA/DGA and the drug is being used to treat a condition unrelated to fertility or impotence.

Topic #17857

Hetlioz

PA requests for Hetlioz must be submitted using Section VI (Clinical Information for Drugs with Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA and the PA/RF.

PA requests for Hetlioz may be submitted on the Portal, by fax, or by mail. PA requests for Hetlioz may not be submitted using the STAT-PA system.

ForwardHealth has established clinical criteria for Hetlioz.

Clinical Criteria for Hetlioz

Clinical criteria that must be documented for approval of a PA request for Hetlioz are both of the following:

  • The member is totally blind.
  • The member has Non-24.

Clinical documentation and medical records must be submitted with the PA request to support the member's condition of total blindness and Non-24. Initial PA requests for Hetlioz may be approved for up to a maximum of 183 days.

Renewal PA requests may be approved for up to a maximum of 365 days. Medical records must be submitted demonstrating clinical improvement and must reflect patient compliance with medication use and safety precautions for Hetlioz.

Topic #13677

Kalydeco®

Kalydeco® (ivacaftor) requires PA and is only indicated for the treatment of a rare form of cystic fibrosis with a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R mutation in the CFTR gene. PA requests for Kalydeco® must be submitted using Section VI (Clinical Information for Drugs with Specific Criteria Addressed in the Online Handbook) of the PA/DGA and the PA/RF.

PA requests for Kalydeco® may be submitted on the ForwardHealth Portal, by fax, or by mail. PA requests for Kalydeco® may not be submitted using the STAT-PA system.

Topic #17437

Clinical Criteria for Kalydeco®

Clinical criteria that must be documented for approval of a PA request for Kalydeco® are all of the following:

  • The member has a diagnosis of cystic fibrosis.
  • The member is 6 years of age or older.
  • The prescriber has confirmed that the member has a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R mutation in the CFTR gene. (Note: A copy of the test results should be included with an initial PA request.)
  • The prescriber has confirmed that the member does not have a homozygous F508del mutation in the CFTR gene.
  • The prescriber has confirmed that liver function testing is being periodically monitored. (Note: A copy of the test results completed within the last 90 days should be included with initial and renewal PA requests.)

PA requests for Kalydeco® may be approved for up to a maximum of one year.

Topic #17877

Misoprostol

PA requests for misoprostol must be submitted using Section VI (Clinical Information for Drugs with Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA and the PA/RF.

PA requests for misoprostol may be submitted on the Portal, by fax, or by mail. PA requests for Hetlioz may not be submitted using the STAT-PA system.

ForwardHealth has established clinical criteria for misoprostol.

Clinical Criteria for Misoprostol

Clinical criteria that must be documented for approval of a PA request for misoprostol are all of the following:

  • The member is currently taking at least one NSAID.
  • The member is not pregnant.
  • Misoprostol is being prescribed to reduce the risk of an NSAID-induced gastrointestinal ulcer.

Misoprostol may be approved for up to a maximum of 365 days.

Note: ForwardHealth does not cover misoprostol when used in conjunction with gynecological procedures.

Topic #7877

Prior Authorization Requests and Amendments for Synagis

Synagis® requires PA. Prescribers or their designees, not pharmacy providers, are required to submit PA requests for Synagis®. Synagis® administered in a hospital does not require PA.

PA requests for Synagis® may be submitted beginning October 1 of each year.

When requesting PA for Synagis®, the prescribing provider must identify the name and NPI of the provider who intends to submit a claim for reimbursement for Synagis® (i.e., the billing provider).

If the prescribing provider intends to submit the claim, the prescribing provider must list his or her name and NPI on the PA request as the billing provider.

If the prescribing provider's clinic or group intends to submit the claim, the prescribing provider must list the clinic or group's name and NPI on the PA request as the billing provider.

If, instead, a pharmacy provider intends to submit the claim, the prescribing provider must list the pharmacy provider's name and NPI on the PA request as the billing provider. In this case, it is the prescribing provider's responsibility to acquire the pharmacy provider's name and NPI.

Prescribers or their designees are required to request PA for Synagis® using one of the following options:

A prescriber, or their designees, should have all PA information completed before calling the DAPO Center to obtain PA.

Prescribers are required to retain a copy of the PA form and any supporting documentation.

Prior Authorization Requests Submitted by Fax or Mail

If a prescriber or his or her designee chooses to submit a paper PA request for Synagis® by fax or mail, the following must be completed and submitted to ForwardHealth:

The Prior Authorization Fax Cover Sheet is available for providers submitting the forms and documentation by fax.

Prescribers are required to sign and date each PA request form when submitting the request on paper.

Prior Authorization Amendments

Prescribing providers and billing providers may amend approved PAs for Synagis® if a member's weight changes, resulting in an increase in Synagis® units during a treatment season. Providers have 30 days from the date of administering each dose change to amend an approved PA for Synagis®.

If the prescribing provider is not also the billing provider, the prescribing provider may only amend the PA by contacting the DAPO Center.

Billing providers may amend PA requests through the following:

  • DAPO Center.
  • Portal.
  • Mail or fax.

To amend a PA request for Synagis®, providers are required to provide the following information:

  • The member's most recent weight and the date it was measured.
  • The member's weight at the time the dose change occurred and the date it was measured.
  • The requested start date for the dose change.
  • The new Synagis® dose calculation.

Change in Billing Provider

If during the course of Synagis® treatment the billing provider changes, the prescribing provider (i.e., the provider who submitted the original PA request) is responsible for amending the PA. To amend the billing provider information, the prescribing provider must call the DAPO Center. The prescribing provider will be required to give the new billing provider's name and NPI.

Clinical Criteria

The following conditions will be considered for approval of a PA request:

  • CLD of prematurity.
  • CHD.
  • Heart transplant.
  • Pre-term infants.
  • Pulmonary Abnormalities and Neuromuscular Disease.
  • Immunocompromised.

Chronic Lung Disease of Prematurity

For children younger than 12 months of age at the start of the RSV season, PA requests must document that the child meets all of the following criteria:

  • Gestational age at delivery is younger than 32 weeks (i.e., zero days through 31 weeks, six days).
  • Required oxygen greater than 21 percent for at least the first 28 days after birth.

For children between 12 and 24 months of age at the start of the RSV season, PA requests must document that the child meets all of the following criteria:

  • Gestational age at delivery is younger than 32 weeks (i.e., zero days through 31 weeks, six days).
  • Required oxygen greater than 21 percent for at least the first 28 days after birth.
  • The child required medical support (corticosteroid, diuretic, or supplemental oxygen) during the six-month period before the start of the RSV season.

Congenital Heart Disease

PA requests must document that the child is younger than 12 months of age at the start of the RSV season and has hemodynamically significant CHD.

Heart Transplant

PA requests must document that the child is younger than 24 months of age at the start of the RSV season and will undergo cardiac transplantation during the RSV season.

Pre-term Infants

PA requests must document that the child was born before 29 weeks gestation (i.e., zero days through 28 weeks, six days) and is younger than 12 months of age at the start of the RSV season.

Pulmonary Abnormalities and Neuromuscular Disease

PA requests must document that the child meets all of the following criteria:

  • The child is younger than 12 months of age at the start of the RSV season.
  • The child has a neuromuscular disease or congenital anomaly that impairs the ability to clear secretions from the upper airway because of an ineffective cough.

Immunocompromised

PA requests must document that the child meets all of the following criteria:

  • The child is younger than 24 months of age at the start of the RSV season.
  • The child is profoundly immunocompromised. Immunodeficiency may be a result of, but not limited to, any of the following conditions:
    • AIDS.
    • Solid organ transplant.
    • Stem cell transplant.
    • Receiving chemotherapy.

Prior Authorization Approval

A maximum of five doses of Synagis® will be approved. For children born during the RSV season, fewer than five monthly doses will be needed. The following table includes the weight range, the rounded calculated Synagis® dose, and the number of 50 mg units of Synagis®. This information is used for the adjudication of PA requests to determine the allowed billing units per dose.

Weight Range (in kg) Synagis® Calculated Dose Number of Units*
Up to 3.6 kg 0 - 54 mg 1
3.7 to 6.9 kg 55 mg - 104 mg 2
7.0 to 10.2 kg 105 mg - 154 mg 3
10.3 to 13.6 kg 155 mg - 204 mg 4
13.7 to 16.9 kg 205 mg - 254 mg 5
17.0 to 20.3 kg 255 mg - 304 mg 6
* Units are a 50 mg dose.

PA requests for Synagis® may be submitted beginning October 1 of each year with an earliest possible PA grant date of November 1 and latest PA expiration date of the following April 30.

If any child receiving monthly Synagis® prophylaxis experiences a breakthrough RSV hospitalization, monthly prophylaxis will be discontinued.

Topic #7837

Prior Authorization for Anti-obesity Drugs

PA requests for the following anti-obesity drugs may be submitted on the Prior Authorization Drug Attachment for Anti-obesity Drugs:

  • Benzphetamine.
  • Contrave.
  • Diethylpropion.
  • Phentermine.
  • Phendimetrazine.
  • Belviq.
  • Qysmia.
  • Xenical®.

Anti-obesity drugs are covered for dual eligibles enrolled in a Medicare Part D PDP.

A 34-day supply is the maximum amount of any anti-obesity drug that may be dispensed each month.

Clinical Criteria for Anti-obesity Drugs

Clinical criteria for approval of a PA request for anti-obesity drugs require one of the following:

  • The member has a BMI greater than or equal to 30.
  • The member has a BMI greater than or equal to 27 but less than 30 and two or more of the following risk factors:
    • Coronary heart disease.
    • Dyslipidemia.
    • Hypertension.
    • Sleep apnea.
    • Type II diabetes mellitus.

In addition, all of the following must be true:

  • The member is 16 years of age or older. (Note: Members need only to be 12 years of age or older to take Xenical®.)
  • The member is not pregnant or nursing.
  • The member does not have a history of an eating disorder (e.g., anorexia, bulimia).
  • The member has not had bariatric surgery.
  • The prescriber has evaluated and determined that the member does not have any medical or medication contraindications to treatment with the anti-obesity drug being requested.
  • For controlled substance anti-obesity drugs, the member does not have a medical history of substance abuse or misuse.
  • The member has participated in a weight loss treatment plan (e.g., nutritional counseling, an exercise regimen, a calorie-restricted diet) in the past six months and will continue to follow the treatment plan while taking an anti-obesity drug.

PA requests for anti-obesity drugs will not be renewed if a member's BMI is below 24.

Note: ForwardHealth does not cover the following:

  • Brand name (i.e., innovator) anti-obesity drugs if an FDA-approved generic equivalent is available.
  • Any brand name innovator phentermine products.
  • OTC anti-obesity drugs.

ForwardHealth will return PA requests the above-listed drugs as noncovered services.

Clinical Criteria for Benzphetamine, Diethylpropion, Phendimetrazine, and Phentermine

If clinical criteria for anti-obesity drugs are met, initial PA requests for benzphetamine, diethylpropion, phendimetrazine, and phentermine will be approved for up to a maximum of three months. If the member meets a weight loss goal of at least 10 pounds of his or her weight from baseline during the initial three-month approval, PA may be requested for an additional three months of treatment. The maximum length of continuous drug therapy for benzphetamine, diethylpropion, phendimetrazine, and phentermine is six months.

If the member does not meet a weight loss goal of at least 10 pounds of his or her weight from baseline during the initial three-month approval, or if the member has completed six months of continuous benzphetamine, diethylpropion, phendimetrazine, or phentermine treatment, the member must wait six months before PA can be requested for any controlled substance anti-obesity drug.

ForwardHealth allows only two weight loss attempts with this group of drugs (benzphetamine, diethylpropion, phendimetrazine, and phentermine) during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the provider as noncovered services. Members do not have appeal rights for noncovered services.

Clinical Criteria for Belviq

If clinical criteria for anti-obesity drugs are met, initial PA requests for Belviq will be approved for up to a maximum of three months. If the member meets a weight loss goal of at least five percent of his or her weight from baseline during the first three months of treatment, PA may be requested for an additional six months of treatment. If the member's weight remains below baseline, subsequent PA renewal periods for Belviq are a maximum of six months. PA requests for Belviq may be approved for a maximum treatment period of 24 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least five percent of his or her weight from baseline during the initial three-month approval, or if the member's weight does not remain below baseline, or if the member has completed 24 months of continuous Belviq treatment, the member must wait six months before PA can be requested for any controlled substance anti-obesity drug.

ForwardHealth allows only two weight loss attempts with Belviq during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the provider as noncovered services. Members do not have appeal rights for noncovered services.

Clinical Criteria for Contrave

If clinical criteria for anti-obesity drugs are met, initial PA requests for Contrave will be approved for up to a maximum of three months. If the member meets a weight loss goal of at least five percent of his or her weight from baseline, PA may be requested for an additional six months of treatment. If the member's weight remains below baseline, a final PA renewal period of three months of Contrave may be approved. PA requests for Contrave may be approved for a maximum treatment period of 12 continuous months of drug therapy.

If any of the following occur, the member must wait six months before PA can be requested for Contrave:

  • The member does not meet a weight loss goal of at least five percent of his or her weight from baseline during the initial three-month approval.
  • The member's weight does not remain below baseline.
  • The member completes 12 months of continuous Contrave treatment.

ForwardHealth allows only two weight loss attempts with Contrave during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the provider as noncovered services. Members do not have appeal rights for noncovered services.

Clinical Criteria for Qysmia

If clinical criteria for anti-obesity drugs are met, initial PA requests for Qysmia will be approved for up to a maximum of six months. If the member meets a weight loss goal of at least five percent of his or her weight from baseline, PA may be requested for an additional six months of treatment. PA requests for Qysmia may be approved for a maximum treatment period of 12 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least five percent of his or her weight from baseline during the initial six-month approval, or if the member has completed 12 months of continuous Qysmia treatment, the member must wait six months before PA can be requested for any controlled substance anti-obesity drug.

ForwardHealth allows only two weight loss attempts with Qysmia during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the provider as noncovered services. Members do not have appeal rights for noncovered services.

Clinical Criteria for Xenical®

If clinical criteria for anti-obesity drugs are met, initial PA requests for Xenical® will be approved for up to a maximum of six months. If the member meets a weight loss goal of at least 10 pounds of his or her weight from baseline during the first six months of treatment, PA may be requested for an additional six months of treatment. If the member's weight remains below baseline, subsequent PA renewal periods for Xenical® are a maximum of six months. PA requests for Xenical® may be approved for a maximum treatment period of 24 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least 10 pounds during the initial six-month approval, or if the member's weight does not remain below baseline, or if the member has completed 24 months of continuous Xenical® treatment, the member must wait six months before PA can be requested for Xenical®.

ForwardHealth allows only two weight loss attempts with Xenical® during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the provider as noncovered services. Members do not have appeal rights for noncovered services.

Submitting Prior Authorization Requests for Anti-obesity Drugs

PA requests for anti-obesity drugs must be submitted using the Prior Authorization Drug Attachment for Anti-Obesity Drugs form and must be submitted by prescribers or their designees, not pharmacy providers.

Prior Authorization requests for anti-obesity drugs may be submitted through the following:

Note: PA requests for anti-obesity drugs submitted by mail or fax will not be processed as 24-hour drug PA requests If an immediate decision is needed for a PA request, providers should call the DAPO Center. during the noted business hours. If prescribers choose not to use the DAPO Center, the prescriber is required to submit a PA/RF along with the applicable PA drug attachment form with the additional medical documentation.

Prior authorization request submission procedures apply to members enrolled in the BadgerCare Plus Standard Plan, Medicaid, and SeniorCare.

Topic #16537

Prior Authorization for Antipsychotic Drugs for Children 7 Years of Age and Younger

All antipsychotic drugs prescribed for oral use for all children 7 years of age and younger require PA.

PA requests must meet the criteria for children 7 years of age and younger to maintain coverage of an antipsychotic drug.

PA requests for antipsychotic drugs for children 7 years of age and younger must be submitted on the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 7 Years of Age and Younger.

Claims submitted for an antipsychotic drug for children 7 years of age and younger without an approved Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 7 Years of Age and Younger on file will be denied.

Providers should refer to the Preferred Drug List Quick Reference for a list of covered antipsychotic drugs for members enrolled in the BadgerCare Plus Standard Plan or Medicaid. Prescribers are encouraged to write prescriptions for preferred antipsychotic drugs.

Background

In 2007, a consortium of state Medicaid medical directors for 16 states and the Rutgers Center for Education and research on Mental Health Therapeutics collaborated on an analysis of antipsychotic medication use among a combined enrollment of 12 million children and adolescents. This collaboration concluded the following:

  • Many children receive mental health care that is largely limited to medications without adequate evaluations and other therapy services.
  • The signs, symptoms, and diagnostic criteria for bipolar disorder in children are highly controversial and often lead to antipsychotic use in children and adolescents.
  • There are many concerns about the use of multiple psychoactive medications simultaneously (polypharmacy) within and between drug classes.
  • Off-label prescribing of antipsychotic medications in children occurs and some children are prescribed doses that may exceed maximum limits.
  • Antipsychotic prescribing occurs in young children with questionable diagnoses and without child psychiatric consultation.
  • There is limited knowledge about the long-term effects of antipsychotic medications.
  • Children in foster care appear to have significantly higher rates of antipsychotic medication use.
  • There are significant metabolic risks including weight gain and diabetes associated with the use of second generation antipsychotic medications.

The consortium surveyed 36 states regarding the possible approaches to monitoring antipsychotic use among children and adolescents. States have adopted many different approaches singularly or in combinations including PAs, PDLs, restrictions by provider types, step therapy protocols, guidelines, limited refills, second opinions, age restrictions, dose restrictions, polypharmacy restrictions, cost restrictions, and generic preferences. There is growing concern particularly regarding the use of antipsychotic medications in children placed in foster care and in very young (7 and under) preschool-age children.

The increased use of antipsychotic medications in young children over the past decade has been associated with the frequent use of the diagnosis of Bipolar Disorder, NOS (296.80) per the DSM-5 in many of these children. A discussion and review of the issues in differentiating Bipolar Disorder, NOS and DMDD can be found in the Journal of the American Academy of Child and Adolescent Psychiatry, Volume 52, Issue 5, May 5, 2013, pp.466-481 (Towbin, K. MD, Axelson, D. MD, Leibenluft, E. MD, Birmaher, B. MD. "Differentiating Bipolar Disorder-Not Otherwise Specified and Severe Mood Dysregulation."). There has been some progress in the research of these clinical issues in recent years. Specifically the DSM-5 addresses the inclusion of DMDD (296.99). This evolved out of the observation that many children with a diagnosis of bipolar disorder do not progress to having bipolar disorder, NOS as adults thus bringing into question the use of antipsychotic medications for these children. Many of the children with DMDD (or severe mood dysregulation as referenced in several research studies) respond to stimulants and/or SSRI antidepressants. Clinicians who prescribe antipsychotic medications to children with bipolar disorder, NOS diagnoses will need to become familiar with the details of the current research on differentiating DMDD from bipolar disorder, NOS.

Topic #16538

Prescriber Responsibilities for Antipsychotic Drugs for Children 7 Years of Age and Younger

If the child is 7 years of age or younger and requires an antipsychotic drug, the prescriber is required to complete the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 7 Years of Age and Younger form. PA request forms must be faxed, mailed, or sent with the member to the pharmacy provider.

The pharmacy provider will use the completed form to submit a PA request to ForwardHealth. Prescribers should not submit the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 7 Years of Age and Younger form directly to ForwardHealth. Prescribers are required to retain a completed and signed copy of the PA form.

PA requests for covered antipsychotic drugs for children 7 years of age and younger are approved at the active ingredient level. Therefore, an approved PA allows any covered NDC with the same active ingredient of the prior authorized drug to be covered with the same PA. For example, if a member has an approved PA for risperidone 1 mg tablets and the prescriber orders a new prescription for risperidone 2 mg tablets, an amended PA request or new PA request is not required.

Topic #16539

Required Documentation

The following factors will be considered for the approval of a PA request for antipsychotics for children 7 years of age and younger and should be documented on the PA request:

  • Diagnoses — There are appropriate indications for the use of antipsychotic medications in young children with certain diagnoses including autism spectrum disorders, psychotic disorders, and tic disorders. Antipsychotic medications may also be helpful for severe symptoms of irritability, aggression, anger, or defiance that may accompany severe mood disorders, developmental disorders, or attention-deficit/hyperactivity disorders.
  • BMI — Antipsychotic medications can have profoundly adverse effects on weight, glucose, and lipids. Because of these well-documented side effects, the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 7 Years of Age and Younger requires the submission of a BMI percentile measurement with each PA request. The BMI percentile measurement is required because it is the standard for stratifying individuals as obese or at-risk for obesity and therefore requiring closer monitoring and active intervention. Children who have a BMI percentile measurement greater than or equal to 85 percent are at risk for diabetes and the metabolic syndrome associated with many antipsychotic medications. If the child's BMI percentile is 85 percent or greater, the PA must include a fasting lipid panel and a fasting glucose drawn within the past six months for the PA to be approved. A BMI calculator is available and may be found on the CDC Web site.
  • Target symptoms — To appropriately prescribe and track the use of antipsychotic medications, the prescriber needs to carefully identify the primary target symptom (or target symptom cluster) so that the family, mental health clinicians, teachers, and all involved adults can help clarify and determine the efficacy of the medication.
  • Polypharmacy — The Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 7 Years of Age and Younger requires the notation of any psychoactive medications, concurrent medications, as well as previous medication trials in the preceding 12 months.
  • Specialty/Consultation information — Wisconsin Medicaid and BadgerCare Plus are interested in tracking the availability of sub-specialty consultations from Child Psychiatrists for children receiving antipsychotic medications as these medications are complicated and have many side effects, and the children often present with very complicated diagnostic considerations.
  • PDL — If the prescriber is requesting a non-preferred antipsychotic medication, clinical justification must be provided (e.g., failed trials of preferred medications including doses, length of treatment, clinical response, side effects, and/or target symptoms).
Topic #16540

Pharmacy Responsibilities for Antipsychotic Drugs for Children 7 Years of Age and Younger

Pharmacy providers should ensure that they have received the completed Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 7 Years of Age and Younger from the prescriber.

Pharmacy providers should determine the ForwardHealth benefit plan in which the member is enrolled. After the benefit plan is confirmed, pharmacy providers should review the program-specific covered drug or product list.

For Standard Plan and Medicaid members, pharmacy providers should review the Preferred Drug List Quick Reference for the most current list of preferred and non-preferred drugs.

If a Standard Plan or Medicaid member presents a prescription for a non-preferred antipsychotic drug, the pharmacy provider is encouraged to contact the prescriber to discuss preferred drug options. The prescriber may choose to change the prescription to a preferred antipsychotic drug, if medically appropriate for the member.

It is important that pharmacy providers work with prescribers to ensure that members are given appropriate assistance regarding coverage information and the PA request submission process for antipsychotic drugs. Pharmacy providers are responsible for the submission of the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 7 Years of Age and Younger to ForwardHealth. Pharmacy providers are required to retain a completed and signed copy of the PA form.

Brand name antipsychotic drugs prescribed to children 7 years of age and younger that are brand medically necessary require a PA Drug Attachment for Antipsychotic Drugs for Children 7 Years of Age and Younger to be submitted on the ForwardHealth Portal, by fax, or by mail with the PA/BMNA and the PA/RF.

Two unique PA numbers will be assigned for a brand medically necessary antipsychotic drug. One PA number will be assigned to the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 7 Years of Age and Younger and the other will be assigned to the PA/BMNA.

Prior Authorization Request Submission Methods

Pharmacy providers are encouraged to use the STAT-PA system to submit antipsychotic PA requests for members diagnosed with one of the following conditions:

  • ADHD (ICD-9-CM codes 314.0-314.9).
  • Autism Spectrum Disorder (ICD-9-CM codes 299.0-299.91).
  • Tic disorder (ICD-9-CM codes 307.20-307.23).

PA requests cannot be submitted using the STAT-PA system if at least one of the following is true:

  • The diagnosis code for the child is something other than ADHD, Autism Spectrum Disorder, or tic disorder.
  • The drug being requested is a non-preferred antipsychotic drug.
  • The member is 2 years of age or younger.
  • The PA is for a brand medically necessary antipsychotic drug.
  • The child's BMI percentile is greater than or equal to the 85th percentile for the age of the child.

If the PA is not approved through the STAT-PA system, pharmacy providers are required to submit the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 7 Years of Age and Younger form, and a PA/RF, and any supporting documentation from the prescriber via the FowardHealth Portal, by fax, or by mail.

Topic #16541

Approved Prior Authorization Requests for Antipsychotic Drugs for Children 7 Years of Age and Younger

Neither a new PA request nor a PA amendment is needed if the antipsychotic drug the child is taking has changed and the new drug contains the same active ingredient as the original drug approved or if the child is taking multiple strengths of the same drug.

PA decision notice letters for antipsychotic drugs for children 7 years of age and younger will include a message stating: "The prior authorization for this drug has been approved at the active ingredient level instead of the drug strength and dosage form level. Additional PAs are not needed for a different strength of this same drug."

Topic #12997

Prior Authorization for Drugs Outside ForwardHealth-Allowed Diagnoses

PA requests for drugs outside the ForwardHealth-allowed diagnoses must be submitted on paper using a PA/RF and a PA/DGA. The prescriber is required to complete the appropriate section(s) of the PA/DGA as it pertains to the drug being requested and submit peer-reviewed medical literature to support the proven efficacy of the requested use of the drug to the pharmacy where the prescription will be filled.

Topic #7817

Prior Authorization for Lipotropics, Omega-3 Acids

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Clinical PA is required for all omega-3 acids, including preferred omega-3 acids. PA requests for omega-3 acids must be submitted by prescribers or their designees, not pharmacy providers.

PA requests for Lovaza® and Vascepa® for BadgerCare Plus Standard Plan, Medicaid, and SeniorCare members should be submitted using the Prior Authorization Drug Attachment for Lipotropics, Omega-3 Acids.

PA requests for omega-3 acids may be submitted through the following:

Note: PA requests for omega-3 acids submitted by fax or mail will not be processed as 24-hour drug PA requests because providers may call the DAPO Center to obtain an immediate decision about a PA request.

Prior Authorization Requests Submitted by Fax or Mail

If a prescriber or his or her designee chooses to submit a PA request for an omega-3 acid by fax or mail, the following must be completed and submitted to ForwardHealth:

  • A PA/RF (which should be completed using the instructions for prescribers for drugs).
  • The Prior Authorization Drug Attachment for Lipotropics, Omega-3 Acids form.
  • Supporting documentation, as appropriate.

The Prior Authorization Fax Cover Sheet is available for providers submitting the forms and documentation by fax.

Clinical Criteria for Lovaza®

Clinical criteria for approval of a PA request for Lovaza® for members who are not currently taking Lovaza® are all of the following:

  • The member is 18 years of age or older.
  • The member does not have an allergy or sensitivity to fish.
  • One of following is true:
    • The member currently has a triglyceride level of 500 mg/dL or greater.
    • The member currently has a triglyceride level below 500 mg/dL and both of the following are true:
      • The member has had a triglyceride level of 500 mg/dL or greater in the past.
      • The member has a current triglyceride level between 200 and 499 mg/dL while taking a fibrate or niacin. (If a member's triglyceride level is below 200mg/dL, the PA request will be denied.)

Clinical criteria for approval of a PA request for Lovaza® for members who are currently taking Lovaza® are all of the following:

  • The member is 18 years of age or older.
  • The member does not have an allergy or sensitivity to fish.
  • The member's current triglyceride level has decreased by at least 20 percent from the baseline level.
  • The member has had a triglyceride level of 500 mg/dL or greater in the past.

Clinical Criteria for Non-Preferred Omega-3 Acids

Clinical criteria for approval of a PA request for a non-preferred omega-3 acid for members not currently taking a non-preferred omega-3 acid are all of the following:

  • The member is 18 years of age or older.
  • The member does not have an allergy or sensitivity to fish.
  • In the past year, the member has taken the maximum dose of Lovaza® for at least four consecutive months and one of the following is true:
    • The member failed to achieve at least a 30 percent decrease in triglyceride level from baseline.
    • The member's triglyceride level remained at 500 mg/dL or greater.
  • One of following is true:
    • The member currently has a triglyceride level of 500 mg/dL or greater.
    • The member currently has a triglyceride level below 500 mg/dL and both of the following are true:
      • The member has had a triglyceride level of 500 mg/dL or greater in the past.
      • The member has a current triglyceride level between 200 and 499 mg/dL while taking a fibrate, niacin, or Lovaza®. (If a member's triglyceride level is below 200mg/dL, the PA request will be denied.)

Clinical criteria for approval of a PA request for a non-preferred omega-3 acid for members currently taking a non-preferred omega-3 acid are all of the following:

  • The member is 18 years of age or older.
  • The member does not have an allergy or sensitivity to fish.
  • The member's current triglyceride level has decreased by at least 20 percent from the baseline level.
  • The member has had a triglyceride level of 500 mg/dL or greater in the past.

Approved Prior Authorization Requests for Omega-3 Acids

PA requests for omega-3 acids may be initially approved for four months. Renewal PA requests may be approved for up to a maximum of one year. For an initial renewal PA request to be approved, the member's triglyceride levels must decrease by at least 20 percent from the baseline triglyceride level. For subsequent renewal PA requests to be approved, the member must continue to maintain the improved triglyceride level.

Lipid panels, including triglyceride levels, within the previous three months are required for each yearly PA renewal request thereafter.

Topic #13017

Types of Drugs that Require Prior Authorization

The following are types of drugs that require PA:

  • Brand medically necessary drugs.
  • Diagnosis-restricted drugs.
  • Drugs outside approved diagnoses.
  • PDL drugs.
Topic #16437

Xyrem®

Xyrem® requires clinical PA.

Providers are required to submit PA requests for Xyrem® on the Prior Authorization/Drug Attachment for Xyrem®.

PA requests for Xyrem® may be submitted on the Portal, by fax, or by mail. PA requests for Xyrem® may not be submitted via the STAT-PA system.

Quantity limits will apply to Xyrem®. Members will be are limited to a maximum nightly dose of 18 ml (9g) of Xyrem®, which is equivalent to 540 ml (270g) of Xyrem® per month. Providers may refer to the Quantity Limit Drugs and Diabetic Supplies data table.

ForwardHealth has established clinical criteria for Xyrem®.

Clinical Criteria for Xyrem®

PA requests for Xyrem® will only be approved for use to treat the following identified clinical conditions:

  • Narcolepsy with cataplexy.
  • Narcolepsy without cataplexy.

Narcolepsy with Cataplexy

Clinical criteria for approval of a PA request for Xyrem® to treat narcolepsy with cataplexy are all of the following:

  • The member has narcolepsy with cataplexy.
  • The member is at least 16 years of age.
  • The member does not have a succinic semialdehyde dehydrogenase deficiency.
  • The member has a documented history of abstinence from alcohol for at least the past six months.
  • The member does not have a history of substance abuse, addiction, or diversion.
  • The member is not currently taking any sedative hypnotics.
  • The member is not currently taking CNS depressants (i.e., anxiolytics, barbiturates, opioids) that could significantly impact daytime sleepiness.
  • An overnight PSG sleep study and MSLT have been performed for the member using standard protocols, confirming the member has narcolepsy. (Note: Test results for the PSG and MSLT, along with provider interpretation, must be submitted with the PA request.)
  • At least one of the following is true:
    • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with a stimulant.
    • The member has a medical condition that prevents treatment with a stimulant.
    • There is a clinically significant drug interaction with another medication the member is taking and a stimulant.
  • At least one of the following is true:
    • The member has experienced an unsatisfactory therapeutic response that occurred after the medication has been titrated to a maximum recommended daily dose or experienced a clinically significant adverse drug reaction with modafinil or Nuvigil®.
    • The member has a medical condition that prevents treatment with modafinil or Nuvigil®.
    • There is a clinically significant drug interaction with another medication the member is taking and modafinil or Nuvigil®.
  • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction to at least one of the following:
    • TCA.
    • SSRI.
    • SNRI.

Initial PA requests for Xyrem® to treat narcolepsy with cataplexy may be approved for up to a maximum of 183 days.

In addition to documenting the clinical information listed above on the Prior Authorization Drug Attachment for Xyrem®, medical records must be submitted with the PA request to support the member's condition of narcolepsy with cataplexy.

Renewal PA requests may be approved for up to a maximum of 365 days. Medical records must be submitted demonstrating clinical improvement, including a decrease in cataplexy or a decrease in the member's EDS. A decrease in a member's EDS must be supported by an ESS, MWT, or MSLT. Medical records must also reflect patient compliance with medication use and safety precautions for Xyrem®.

Narcolepsy Without Cataplexy

Clinical criteria for approval of a PA request for Xyrem® to treat narcolepsy with cataplexy are all of the following:

  • The member has narcolepsy with cataplexy.
  • The member is at least 16 years of age.
  • The member does not have a succinic semialdehyde dehydrogenase deficiency.
  • The member has a documented history of abstinence from alcohol for at least the past six months.
  • The member does not have a history of substance abuse, addiction, or diversion.
  • The member is not currently taking any sedative hypnotics.
  • The member is not currently taking CNS depressants (i.e., anxiolytics, barbiturates, opioids) that could significantly impact daytime sleepiness.
  • An overnight PSG sleep study and MSLT have been performed for the member using standard protocols, confirming the member has narcolepsy. (Note: Test results for the PSG and MSLT, along with provider interpretation, must be submitted with the PA request.)
  • The member has EDS that interferes with normal activities on a daily basis.
  • An ESS questionnaire, MWT, or MSLT, has been performed for the member, confirming the member has EDS. (Note: Test results for the ESS, MWT, and/or MSLT must be submitted with the PA request.)
  • The prescriber ruled out or treated the member for other causes of EDS, including:
    • Other sleep disorders including sleep apnea.
    • Chronic pain or illness that disrupts normal sleep patterns.
    • Mood disorders such as depression.
    • Caffeine or nicotine use causing poor quality of nighttime sleep.
  • At least one of the following is true:
    • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with a stimulant.
    • The member has a medical condition that prevents treatment with a stimulant.
    • There is a clinically significant drug interaction with another medication the member is taking and a stimulant.
  • At least one of the following is true:
    • The member has experienced an unsatisfactory therapeutic response that occurred after the medication has been titrated to a maximum recommended daily dose or experienced a clinically significant adverse drug reaction with modafinil or Nuvigil®.
    • The member has a medical condition that prevents treatment with modafinil or Nuvigil®.
    • There is a clinically significant drug interaction with another medication the member is taking and modafinil or Nuvigil®.

Initial PA requests for Xyrem® to treat narcolepsy without cataplexy may be approved for up to a maximum of 183 days.

In addition to documenting the clinical information listed above on the Prior Authorization Drug Attachment for Xyrem®, medical records must be submitted with the PA request to support the member's condition of narcolepsy without cataplexy.

Renewal PA requests may be approved for up to a maximum of 365 days. Medical records must be submitted demonstrating clinical improvement, including a decrease in cataplexy or a decrease in the member's EDS. A decrease in a member's EDS must be supported by an ESS, MWT, or MSLT. Medical records must also reflect patient compliance with medication use and safety precautions for Xyrem®.



 
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