Prior authorization is required

Formulary agents listed as requiring prior authorization must be submitted for PA review. Dexcom G6 standalone CGM requests require prior authorization and, when criteria are met, are approved for 12 months with specified quantity limits (meter 1 per 12 months; transmitter 1 per 90 days; sensors 3 per 30 days).

• Submit PA per Med Impact process; each request reviewed individually.
• If criteria met, authorize Dexcom G6 components for 12 months with the listed quantity limits.

Authorization requirement for excluded test strips

Prior authorization is required for excluded (non-preferred) blood glucose test strips; providers should confirm the patient has tried one of the preferred Abbott FreeStyle or Precision meters/strips, or document an approved exception (visual/cognitive impairment or companion pump use). Requests for excluded strips due to need for data management software will not be approved.

• If preferred Abbott FreeStyle or Precision products tried, approve open-ended and override restrictions (enter 'Y' for OVR_RES).
• Do not approve requests justified solely by need for data management software; direct prescriber to Abbott.

Excluded formulary drug exception — prior authorization requirements

Requests for excluded formulary drug exceptions require meeting the guideline criteria, including FDA-approved or medically accepted indication and documentation of required prior trials or valid contraindications/intolerances before approval is granted (typically for 12 months).

• Provide trial history of alternatives or documented medical rationale if alternatives cannot be used.
• Combination products require prior trial of individual components and prescriber rationale.

Fentanyl lozenge prior authorization

Generic fentanyl citrate lozenge (transmucosal) requires prior authorization; if approved, authorize for 6 months by GPID or GPI-14 with a quantity limit of 120 lozenges per month for the requested strength.

• Documentation must show cancer-related pain, maintenance controlled‑release opioid use, and prior trial of an immediate‑release oral opioid (unless contraindicated) and generic fentanyl lozenge (unless contraindicated).

Golimumab (Simponi) prior authorization

Golimumab (Simponi) initial requests require prior authorization entered by GPID or GPI-14 and are issued as two authorizations totaling 6 months (first approval: 1 month with quantity limit 3 mL per 28 days; second approval: 5 months with quantity limit 1 mL per 28 days).

• Initial approval requires diagnosis of moderate to severe ulcerative colitis, age ≥18, gastroenterology involvement, and prior trial/contraindication to a conventional agent and to the preferred immunomodulator Humira.

Interferons — product-specific prior authorization entries

Prior authorizations for interferon products (Plegridy, Rebif, Avonex, Betaseron) must be entered using GPID or GPI-14 with product-specific quantity limits and durations per the guideline (examples: Plegridy starter pack then 12 months; Rebif titration pack then maintenance).

• Follow product-specific entry and quantity limits as listed in the guideline when submitting PA.

Miltefosine prior authorization

Miltefosine (Impavido) requires prior authorization; when criteria are met, approve for 12 months by HICL with a quantity limit of 84 capsules per 28 days.

• Ensure patient is ≥12 years and >30 kg and provide species identification testing per CDC‑recommended methods.

PA requirement for Impavido (miltefosine)

Prior authorization is required for Impavido (miltefosine) for FDA‑approved leishmaniasis indications in patients >12 years and >30 kg; documentation must include species identification when available and dosing for 28 consecutive days per labeling.

• Provide CDC‑recommended diagnostic test results (stained slides, culture, PCR, or serologic rK39) to support approval.

Zorbtive prior authorization rule

Zorbtive prior authorization must be entered by GPID or GPID‑14; when criteria are met, approve for up to 4 weeks for one vial per day (maximum dose not to exceed 8 mg/day).

• Initial approval requires short bowel syndrome, specialized nutritional support, gastroenterologist involvement, and not for athletic/anti‑aging use.

Serostim prior authorization rule

Serostim (somatropin) prior authorization approvals are entered by GPID or GPI‑14; approve Serostim for 12 weeks when initial or renewal criteria are met (different branches for hypogonadal vs non‑hypogonadal patients).

• Document specialist involvement, ART use, prior therapy failures, and weight/BCM/BMI thresholds as required.

Serostim prior authorization

Approve Serostim for 12 weeks by GPID or GPI‑14 for patients with HIV wasting/cachexia who meet renewal criteria, are on antiretroviral therapy, and demonstrate required clinical benefit.

• Provide current and baseline weight measurements with dates to document ≥10% increase in weight or BCM from baseline for renewal.

Zorbtive prior authorization

For Zorbtive renewals, approve for the remainder of therapy up to a maximum cumulative 4 weeks (subtract any previous fills); do not approve if the patient has already been on medication for 4 weeks (only one 4‑week lifetime fill allowed).

• Ensure previous fills are subtracted and total cumulative therapy does not exceed 4 weeks.

Renewal authorization rule

Renewal approvals require meeting the diagnosis‑specific renewal criteria listed in the guideline; for diagnoses meeting criteria (e.g., Prader‑Willi syndrome) Norditropin FlexPro may be approved for 12 months by GPID or GPI‑14.

• Submit required renewal documentation (e.g., growth velocity, radiograph for open epiphyses) as specified for the diagnosis.

Prior authorization and approval durations

Most prior authorizations are issued for 12 months by GPID or GPI codes when criteria are met; some agents or indications have different durations (e.g., fentanyl lozenge 6 months; Zorbtive maximum 4 weeks lifetime; Serostim 12 weeks authorization periods).

• Check product‑specific duration and quantity limits in the guideline when submitting PA.

Authorization requirements (initial)

Initial prior authorization requires documentation that the patient meets diagnosis‑specific criteria, including required trials of lower‑cost agents where specified, age/weight limits, compendia support for certain indications, and specified laboratory or prior‑therapy evidence.

• Provide prior trial history, lab results, specialist consultation notes, and any compendia support required for the indication.

Renewal authorization overview

Renewal approvals are granted only when the member meets one of the specified diagnoses and any subgroup‑specific renewal requirements; for gender dysphoria, only compendia‑supported agents are approvable for 12 months and certain indications may be approved for lifetime.

• Submit documentation demonstrating clinical improvement, lab normalization, or other renewal metrics as required for the diagnosis.

Non-formulary trial requirement

Non‑formulary or excluded product coverage requires trial and failure of appropriate formulary or related agents unless the prescriber documents a contraindication or clinical unsuitability.

• Document prior trials and reasons for failure, intolerance, or contraindication when requesting non‑formulary coverage.

Preferred-first requirement

Providers should confirm the patient has tried preferred Abbott FreeStyle or Precision meters/strips before seeking approval of excluded alternatives; if preferred products were tried, approve open‑ended and enter override per instructions.

• If preferred product tried, override restrictions by entering 'Y' for OVR_RES when approving.

Prior trials / step requirements

Prior authorization for excluded or higher‑cost agents commonly requires documentation of prior trials: at least three clinically appropriate covered alternatives with the same active ingredient and route when available, or three different active‑ingredient agents with same route (one in same class), unless contraindicated.

• Provide dates and agents for prior trials and specific reasons for therapeutic failure, intolerance, or contraindication.

Fentanyl trial requirement (immediate-release opioid)

For fentanyl transmucosal agents, the patient must have tried an immediate‑release oral opioid unless contraindicated or unable to swallow, and must have tried generic fentanyl citrate lozenge unless contraindicated prior to approval.

• Document maintenance controlled‑release opioid use and reasons why immediate‑release opioid or generic fentanyl lozenge could not be used if applicable.

Golimumab prior trial requirement

For golimumab (Simponi) initial requests, document a prior trial of one conventional agent (corticosteroid, azathioprine, mercaptopurine, methotrexate, or mesalamine) and prior trial of the formulary preferred immunomodulator (Humira) unless contraindicated.

• Pharmaceutical samples do not count as prior therapy; document actual prior prescriptions or medical rationale for exemption.

Rebif titration/step requirement

New starts of Rebif require entry of a titration pack prior authorization for 1 month, followed by standard Rebif approval to complete a 12‑month total authorization.

• Submit PA for the Rebif titration pack first, then follow with the maintenance PA per the guideline.

Therapeutic context / expert consultation

When alternative therapies, availability issues, or complex infectious disease decisions are involved (e.g., leishmaniasis), expert consultation—preferably with CDC—is recommended to determine the appropriate course prior to or as part of the PA submission.

• Obtain and include expert consultation notes or CDC testing/consultation when submitting PA for complex infections like leishmaniasis.

Serostim step therapy requirements

For Serostim, documentation must show inadequate response to prior non‑pharmacologic therapies and to prior pharmacologic agents (cyproheptadine, dronabinol/Marinol, or megestrol acetate) before approval is granted.

• Include dates and outcomes of prior non‑pharmacologic and pharmacologic treatments in the PA submission.

Specialist consultation requirement

For pediatric growth hormone deficiency and related pediatric indications, therapy must be prescribed by or in consultation with an endocrinologist as part of renewal and continuation requirements.

• Include endocrinology consult notes or co‑signature when submitting initial or renewal PA for pediatric GHD/short stature.

Step therapy — not specified in these chunks

Step therapy sequencing is not further specified in the excerpt for some product groups; follow the guideline's specific step requirements for each drug when provided.

• Refer to product‑specific sections for applicable step requirements.

Step therapy / trials required (testosterone products)

Mandatory prior trials are required for many testosterone/branded patch/buccal products: some branded agents (Androderm, Fortesta, Striant) require trial of a generic lower‑cost agent; Android/Methitest/Testred require trial of TWO lower‑cost agents unless contraindicated.

• Document prior trials or reasons for contraindication to lower‑cost agents when requesting branded testosterone/patch/buccal products.

Step therapy / trials required (branded/patch/buccal products)

For certain branded/patch/buccal testosterone products (Androderm, Fortesta, Striant), a trial of a generic lower‑cost agent (e.g., AndroGel 1%/1.62%, Axiron, Testim, Vogelxo, Depo‑Testosterone, IM enanthate) is required unless contraindicated.

• Provide documentation of the generic agent trial and outcome or a medical reason why it cannot be used.

Compendia requirement for gender dysphoria

For gender dysphoria requests, only agents supported by compendia (e.g., DrugDex Class I/IIa/IIb) are approvable; compendia support is required rather than step‑therapy sequencing specified in these chunks.

• Include compendia citations (DrugDex classification) supporting the requested agent for gender dysphoria in the PA submission.

How to obtain coverage / documentation to submit

To obtain coverage, fax a completed Medication Request Form to Med Impact at (858) 790‑7100 or contact Med Impact at (800) 788‑2949 and provide the requested information; Med Impact will provide an authorization number for approved requests and the prescriber must provide information to support appeals.

• Include all supporting clinical documentation with the PA submission to expedite review.

Approval override/documentation for preferred meters/strips

When approving preferred meters/strips or approved exceptions, override restrictions by entering 'Y' for OVR_RES and use GPID/GPI‑14 and NDC identifiers as provided in the guideline product tables.

• Enter the appropriate GPID/GPI‑14 and NDC values and set OVR_RES = 'Y' when authorizing preferred products or exceptions.

Required clinical documentation (general)

Provide documented reasons for therapeutic failure, intolerance, or contraindication to alternative agents; for combination products, document prior trial of individual components and prescriber rationale that combination is safer or more efficacious.

• Include dates, doses, and clinical outcomes for prior therapies in the PA submission.

Golimumab documentation specifics

For golimumab initial authorization, include documentation showing diagnosis of moderate to severe ulcerative colitis, age ≥18, gastroenterology involvement, prior trial or contraindication to one conventional agent, and prior trial or contraindication to Humira.

• Note that pharmaceutical samples do not count as prior therapy.

Fentanyl transmucosal documentation specifics

For fentanyl transmucosal agent requests, document cancer‑related pain, current use of a maintenance controlled‑release opioid, prior trial or contraindication to an immediate‑release oral opioid (or inability to swallow), and prior trial or contraindication to generic fentanyl citrate lozenge where applicable.

• If immediate‑release opioid or generic fentanyl lozenge were not tried, document medical contraindication or inability to swallow.

Golimumab documentation (renewal)

For golimumab renewals, the provider must supply patient‑specific information demonstrating continued diagnosis of moderate to severe ulcerative colitis and any other requested renewal criteria; renewal approvals are for 12 months with maintenance quantity limits.

• Include clinical status and any objective measures used to document ongoing disease activity.

Miltefosine documentation (species ID methods)

For miltefosine (Impavido), provide documentation of Leishmania species identification by one of the CDC‑recommended methods (stained slides, culture, PCR, or serologic testing such as rK39) to support approval.

• If local testing is unavailable, note that CDC can assist with testing and may provide gratis diagnostic services.

Interferons documentation

For interferon products, document diagnosis of a relapsing form of multiple sclerosis (clinically isolated syndrome, relapsing‑remitting, or active secondary progressive disease) and that the patient is 18 years or older.

• Include relevant neurologist documentation or clinic notes confirming relapsing MS diagnosis.

Diagnostic evidence (parasite testing / CDC assistance)

Diagnosis for leishmaniasis should be supported by clinical signs plus parasitological or serological tests; providers may use CDC testing assistance and should include such diagnostic evidence with the PA submission.

• Attach pathology, culture, PCR, or serology results used to establish diagnosis and species identification.

Required documentation (diagnoses and baseline measures)

When requesting Serostim, Zorbtive, Norditropin or similar agents, include documentation of the diagnosis, specialist prescribing or consultation, prior therapies and inadequate responses, and laboratory or weight/BCM/BMI measurements where required.

• For Serostim renewal: include current and baseline weight with dates to demonstrate clinical benefit.

Serostim documentation — weight and baseline measures

For Serostim, include current and baseline weights with dates to document ≥10% increase in weight or BCM from baseline for renewal; weight/BCM/BMI criteria must be met and documented.

• Document dates, measurement methods, and supporting specialist notes for weight/BCM assessments.

Growth/epiphyseal documentation requirement

For pediatric growth hormone and short stature renewals, include a radiograph of the wrist and hand confirming that epiphyses are NOT closed (bone age) or documentation that the patient has not completed prepubertal growth.

• Attach the radiograph report and growth velocity calculations comparing current to prior year.

Required documentation for renewal (radiograph and growth velocity)

Required documentation for pediatric renewal includes a wrist/hand radiograph confirming open epiphyses (bone age) and documentation of growth velocity compared to the prior year and/or predicted adult height percentiles; include endocrinologist consultation.

• Provide growth charts, radiograph images/reports, and endocrinology notes with renewal requests.

Required diagnostic documentation for hypogonadism

For male hypogonadism initial or renewal PA, include documentation of diagnosis and either prior authorization/claims history of testosterone therapy or laboratory confirmation of low testosterone (at least two morning total serum testosterone <300 ng/dL on separate occasions while fasting or free serum testosterone <5 pg/mL).

• If relying on labs, include two morning fasting total testosterone results or a free testosterone measurement with reference ranges.

Prior authorization history / attestation requirement for male hypogonadism

For male hypogonadism PA, provide either prior PA/attestation or claims history showing prior testosterone therapy, or laboratory confirmation of low testosterone as specified; for renewals, include documentation of symptom improvement, tolerance, and normalized labs.

• Include attestation/claims history or lab reports and notes documenting symptom improvement and hematocrit normalization for renewal.

Required documentation for male hypogonadism renewal

For male hypogonadism renewals, documentation must show symptom improvement, treatment tolerance, and normalized serum testosterone and hematocrit compared to baseline to support a 12‑month renewal.

• Attach symptom assessments, lab results, and any endocrinology follow‑up notes demonstrating response to therapy.

Criteria triggers for denial (Dexcom G6 and diabetes)

Requests will be denied if the patient does not meet the specified diagnosis/age/insulin‑treatment or clinical‑need criteria for Dexcom G6 (e.g., not type 1/2/gestational diabetes, age <2 years) or if coverage should be provided under the medical benefit or manufacturer assistance programs per POS message.

• If claim rejects with POS message indicating coverage through medical benefit or manufacturer program, the PA guideline does not apply.

Denial condition: data management software

Requests for excluded diabetic test strips that are justified by a need for data management software will be denied; providers should contact Abbott for available data management software and connection cables for formulary products.

• Do not submit PA for excluded strips based solely on data management software needs.

Failure to document required prior trials

Requests will be denied when documentation does not show required prior trials of identified alternatives or when combination‑product criteria (prior trial of components and prescriber rationale) are not documented.

• Ensure prior trial records and prescriber rationale are included to avoid denial for missing trial documentation.

Fentanyl denial triggers

Requests for fentanyl transmucosal agents will be denied if the patient does not have cancer‑related pain, is not on a maintenance controlled‑release opioid, has not tried an immediate‑release oral opioid (unless contraindicated/unable to swallow), or has not tried generic fentanyl lozenge when indicated.

• Provide documentation of cancer pain diagnosis, maintenance opioid regimen, and prior trials or contraindications to immediate‑release opioids and generic fentanyl lozenge.

Golimumab denial triggers

Golimumab requests will be denied if the patient does not have moderate to severe ulcerative colitis, is under 18 years of age, therapy is not prescribed or consulted by a gastroenterologist, or required prior trials (conventional agent and Humira) or valid contraindications are not documented.

• Document age, gastroenterologist involvement, and prior trials or contraindications to avoid denial.

Golimumab renewal denial triggers

Renewal requests for golimumab (Simponi SQ 100 mg) will be denied if documentation does not show the patient continues to have moderate to severe ulcerative colitis or if required renewal information is not provided.

• Include clinical evidence of ongoing moderate to severe UC when requesting renewal.

Interferons denial triggers

Interferon product requests will be denied if the patient does not have a relapsing form of multiple sclerosis or is under 18 years of age.

• Confirm relapsing MS diagnosis and patient age ≥18 in the submission to avoid denial.

Miltefosine denial triggers

Miltefosine (Impavido) requests will be denied if the patient is under 12 years of age, does not have one of the FDA‑approved leishmaniasis infection types, or if species identification via an accepted CDC‑recommended test is not documented.

• Attach species identification (stained slide, culture, PCR, or rK39 serology) to support approval and prevent denial.

Indication and patient eligibility (Leishmania/miltefosine)

Coverage for miltefosine is restricted to the FDA‑approved indications and specified Leishmania species; mismatch of species or failure to meet the age/weight criteria (>12 years, >30 kg) may trigger denial.

• Verify indication, age, and weight eligibility and include species testing results in the PA.

Serostim denial trigger

If a patient does not meet the Serostim diagnosis and all listed criteria (specialist involvement, ART use, prior therapy failures, alternative causes ruled out, weight/BCM/BMI thresholds), the request will be denied.

• Include specialist consultation notes, ART documentation, prior therapy history, exclusion of alternative causes, and weight/BCM/BMI data.

Zorbtive denial trigger

Zorbtive requests will be denied if the patient does not meet criteria for short bowel syndrome, is prescribed the agent for athletic enhancement/anti‑aging, is not on specialized nutritional support, or lacks gastroenterologist involvement.

• Document short bowel syndrome diagnosis, nutritional support regimen, and gastroenterology consultation when submitting PA.

Norditropin excluded indications

Norditropin FlexPro requests for athletic enhancement, anti‑aging, or idiopathic short stature are not approved; approval for listed indications requires fulfillment of diagnostic and specialist criteria.

• Do not submit PA for excluded indications; include endocrinology documentation and required diagnostic tests for approved indications.

Serostim renewal denial triggers

Serostim renewal requests will be denied if the patient has received more than 24 weeks of therapy within the plan year, is prescribed the agent for athletic enhancement/anti‑aging, or has not shown ≥10% increase in weight or BCM from baseline, or is not on HIV antiretroviral therapy.

• Include cumulative therapy duration within the plan year and documented clinical benefit to support renewal.

Zorbtive renewal denial triggers

Zorbtive renewal will be denied if the patient has already been on the medication for 4 weeks (patient should only be approved for one 4‑week lifetime fill); otherwise approve remaining therapy up to the 4‑week maximum by subtracting previous fills.

• Verify prior Zorbtive exposure and subtract fills to ensure cumulative therapy does not exceed 4 weeks.

Norditropin excluded indications

Requests for Norditropin FlexPro for athletic enhancement, anti‑aging, or idiopathic short stature are explicitly not approved and will be denied.

• Ensure indication does not meet excluded categories before submitting PA.

Insufficient documentation triggers denial

Requests will be denied when supporting documentation does not demonstrate the patient meets the specified renewal criteria; denial text will instruct the provider to supply the missing information or consider alternative therapy.

• Include all required renewal documentation (labs, growth velocity, specialist notes) to avoid denial for insufficient documentation.

Denial triggers (general)

Products or requests that do not meet the listed indication criteria (lack of required diagnosis, lab confirmation, trials of lower‑cost agents, or age criteria) will not be approved; denial text references required missing information.

• Review indication‑specific criteria and supply any missing labs, trials, or specialist documentation with the PA.

Denial when supporting documentation missing

If supporting documentation does not show required criteria—such as prior therapy, laboratory values, age thresholds, or compendia support—the request will be denied; providers should submit the missing documentation to request reconsideration.

• Attach lab values, prior therapy records, compendia citations, and specialist notes as applicable.

Renewal denial triggers

Renewal requests that do not meet the diagnosis and subgroup‑specific renewal criteria (A–E) will be denied; template denial text is provided indicating the missing information required to demonstrate criteria.

• Provide the specific renewal elements requested (e.g., symptom improvement, labs, radiograph, growth velocity) to support renewal.