Prior authorization medical necessity guidelines — Part 1 (drug product list excerpt)
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Portion of the payer's prior authorization and medical necessity guidelines listing Part D drugs, associated indications/requirements, prescriber restrictions, and coverage duration for Tufts Health One Care (HMO D-SNP) and related products; affects providers prescribing the listed specialty and Part D drugs.
No material clinical or coverage changes in this revision.
Drug-specific Coverage Criteria (Selected Excerpts)
Biologic/advanced therapy — rheumatology and SSc-ILD
Covered when ALL of the following are met:
ALL of the following
- Diagnosis: The member has a documented diagnosis consistent with the labeled rheumatologic indication (e.g., rheumatoid arthritis [RA], psoriatic arthritis [PsA], ankylosing spondylitis, polyarticular juvenile idiopathic arthritis [PJIA], systemic juvenile idiopathic arthritis [SJIA], giant cell arteritis [GCA]) as specified for the requested biologic/advanced therapy.
- Prior therapy: The member has had an adequate trial and failure, contraindication, or intolerance to the required number of conventional or prior biologic therapies where specified by the product-specific criteria (for RA and similar indications this generally means trial and failure, contraindication, or intolerance to ONE or TWO conventional DMARDs such as methotrexate, leflunomide, or sulfasalazine as noted in product sections).
- Prescriber: The medication is prescribed by or in consultation with an appropriate specialist (e.g., rheumatologist for RA, PsA, SjIA; dermatologist for psoriasis; gastroenterologist for IBD-related biologics) when specified in the product-specific criteria.
- Baseline evaluation: Relevant baseline assessments (e.g., TB screening, hepatitis B/C testing, baseline CBC and liver function tests, pregnancy status when applicable) have been documented when required by the product labeling or clinical guidance.
- Dosing and intent: The requested agent, dose, and frequency are consistent with FDA- labeled dosing for the requested indication and the request is for initiation or continuation consistent with established coverage duration (typically up to 1–2 years subject to reauthorization criteria).
- Use limitations: The agent will not be used in combination with another biologic agent or targeted immunomodulator unless specifically allowed by the product labeling or other product-specific criteria.
Systemic sclerosis-associated interstitial lung disease (SSc-ILD) - product-specific
- Diagnosis: The member has a documented diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD) confirmed by exclusion of other known causes of interstitial lung disease and supportive imaging and/or biopsy consistent with SSc-ILD (for example, HRCT showing fibrotic NSIP, UIP, or centrilobular fibrosis patterns or lung biopsy consistent with SSc-ILD).
- Prescriber: The request is prescribed by or in consultation with a pulmonologist or rheumatologist experienced in management of SSc-ILD.
- Disease severity / progression: Documentation of physiologic impairment or disease progression attributable to SSc-ILD (for example, decline in forced vital capacity [FVC] or worsening symptoms, radiographic progression, or other objective evidence) or other clinical rationale for therapy initiation per product labeling.
- Prior therapy: Documentation of prior supportive or standard therapy trials when appropriate (e.g., immunosuppressive therapy such as mycophenolate mofetil or alternatives) OR documentation that such therapies are contraindicated or not tolerated, when aligned with product-specific labeling or guideline recommendations.
- Monitoring and follow-up: Baseline pulmonary function tests (PFTs) including FVC and diffusing capacity for carbon monoxide (DLCO) when available, and plan for periodic monitoring of clinical response and adverse effects consistent with product labeling.
- Reauthorization: For continuation, documentation of positive clinical response or stabilization (e.g., improvement or no meaningful decline in PFTs, symptom improvement, or radiographic stability) is required at renewal.
Operational notes
- Coverage duration: Approvals are generally granted for up to 1 year for SSc-ILD and up to 1–2 years for other rheumatologic indications; reauthorization requires evidence of continued benefit as described above.
- Concomitant therapies: When clinically indicated and allowed by labeling, concomitant use of low-dose corticosteroids or conventional DMARDs may be permitted; concurrent use of two biologic or targeted immunomodulators is not permitted unless specified by product labeling.
- Documentation: Prior authorization must include relevant medical records supporting diagnosis, prior therapy trials (dates, doses, responses), baseline testing, and plan for monitoring; incomplete documentation may result in denial or delay.
Voquezna (vonoprazan-containing regimens) — H. pylori / erosive esophagitis / NERD
Covered when ALL of the following are met:
ALL of the following
- Helicobacter pylori infection: The member has a documented diagnosis of H. pylori infection confirmed by an appropriate diagnostic test (e.g., urea breath test, stool antigen, or biopsy-based testing).
- Regimen selection: The requested vonoprazan-containing regimen (e.g., vonoprazan/amoxicillin/clarithromycin; vonoprazan/amoxicillin/metronidazole; Voquezna Dual/Triple Pak where applicable) is consistent with an FDA-approved regimen or evidence-based guideline for H. pylori eradication.
- Prior therapy requirement: The member has had a trial and failure, contraindication, or intolerance to bismuth quadruple therapy (e.g., bismuth + metronidazole + tetracycline + a PPI) OR clinician documents why bismuth quadruple therapy is inappropriate, when Voquezna is being requested as salvage therapy per criteria.
- Combination agents: When Voquezna Dual or Triple Pak is requested, the combination components are being used as specified (Dual Pak = vonoprazan + amoxicillin; Triple Pak = vonoprazan + amoxicillin + clarithromycin) and accompanied by appropriate duration of therapy per labeling.
- Prescriber: The medication is prescribed by or in consultation with a gastroenterologist, infectious disease specialist, or other clinician experienced in management of H. pylori infection when requested for salvage therapy or complicated cases.
- Duration: Therapy duration requested is consistent with the indication (typical H. pylori eradication courses per product labeling; see coverage duration below).
Erosive esophagitis and NERD
- Erosive esophagitis (healing and maintenance): The member has a documented diagnosis of erosive esophagitis and one of the following: a) For initial healing (HRH): trial and inadequate response, contraindication, or intolerance to TWO generic proton pump inhibitors (omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, dexlansoprazole), OR b) For maintenance (MHRH): trial and inadequate response, contraindication, or intolerance to TWO generic PPIs and documentation of prior healing response when applicable.
- Non-erosive reflux disease (NERD) - relief of heartburn: The member has a history of heartburn for at least 6 months with current symptoms present on at least 4 days in any consecutive 7-day period AND trial and inadequate response, contraindication, or intolerance to TWO generic PPIs.
- Prescriber and monitoring: Prescribed by an appropriate clinician; plan for assessment of symptom response and safety monitoring is documented.
Duration and coverage limits
- H. pylori regimens (Voquezna Dual/Triple Pak): Typical course duration as per product labeling; coverage duration for H. pylori indication is 1 month (Voquezna Dual/Triple Pak).
- Healing and relief of heartburn associated with erosive esophagitis (HRH): Coverage duration = 2 months for healing courses; Maintenance of healing (MHRH): Coverage duration = up to 6 months per authorization when criteria met.
- Relief of heartburn associated with NERD: Coverage duration = 1 month when criteria are met.
Exclusions
- Voquezna will not be approved when criteria are not met, including use without prior trials of required generic PPIs for erosive esophagitis/NERD indications or without documented failure/intolerance to bismuth quadruple therapy when required for H. pylori salvage use.
Actions, Documentation, and Denial Risks for Prescribers
Prior Authorization Required
Prior Authorization Required: Many specialty and Part D drugs listed below require prior authorization. Submit complete clinical documentation to avoid delays or denials.
- Prior authorization is required for the specific products listed in the "Products Affected" entries.
- PA duration notes vary by product (examples below).
- When applicable, a prerequisite Part D drug or step-therapy trial must be documented.
Prior Authorization — detailed clinical documentation expected
Some products require detailed prior authorization clinical criteria to be met (diagnosis, mutation status, prior response to platinum therapy, prior endocrine or chemotherapy trials, prescriber specialty, etc.). Review the individual product entry under "Products Affected" for required diagnostic tests and prior therapy history.
- Examples: Rubraca requires documented deleterious BRCA mutation (germline or somatic) and prior response to platinum therapy for maintenance; Lynparza requires oncologist prescriber and may require prior endocrine/chemotherapy history.
- Many biologic and advanced therapies require prescriber specialty (e.g., oncologist, rheumatologist, dermatologist) and step-therapy documentation.
Prior authorization and duration (example: everolimus)
Prior authorization approvals may be limited in duration and tied to specific prior-therapy windows. For example, everolimus approvals reference required prior therapies (e.g., progression after letrozole/anastrozole for HR+ breast cancer) and a coverage duration (commonly 2 years).
- Everolimus: coverage duration = 2 years; required documentation includes failure of listed prior endocrine or targeted therapies as applicable.
- Check each product entry for coverage duration and prior-therapy specifics.
GLP‑1 / Type 2 diabetes agent PA requirements
GLP‑1 agents and other diabetes agents may require documentation of prior antidiabetic therapy or trials. Document either prescriber confirmation of diagnosis or a trial history with oral antidiabetic agents as specified.
- Type 2 diabetes confirmation may be met by prescriber documentation or a record of a 90‑day trial of a metformin-containing agent or other listed classes.
- Ensure documentation shows trials of listed drug classes or rationale for intolerance/contraindication.
Prior authorization and duration (general)
PA approvals frequently reference a standard coverage duration (often 2 years) and reauthorization requirements (e.g., clinical response). Document response at reauthorizations.
- Many products list Coverage Duration = 2 years; some specify 1 year or plan-year for conditions like ATTR-CM.
- Reauthorization typically requires evidence of clinical benefit (per product entry).
PA required per product — check each product entry
Prior authorization may be required on a per-product basis and frequently includes prescriber specialty, required diagnostic evidence, and prior therapy steps. Review the product-specific "Products Affected" entry for details.
- Products listed in the policy each include Required Medical Information, Prescriber Restrictions, Coverage Duration, and whether a prerequisite Part D drug is required.
Prescriber restriction example — Lynparza
Some oncology agents (e.g., Lynparza) are restricted to specialists. Ensure the prescriber is an oncologist or that consultation documentation is provided.
- Lynparza: Prescribing physician must be an oncologist; required documentation includes mutation and prior chemotherapy/endocrine therapy history.
Prior authorization and prerequisite / step therapy
Prior authorization often requires documentation of prior therapy trials or step therapy. For immunomodulators and targeted agents, the policy commonly requires failure, contraindication, or intolerance to specified conventional or biologic therapies before approval.
- Document trials and outcomes (failure, intolerance, contraindication) for required prior agents (e.g., methotrexate, leflunomide, sulfasalazine; prior TNF inhibitors for some agents).
- Examples: Cosentyx, Enbrel, Wyost, and other biologics require specified prior trials or failure of listed agents.
Rinvoq prior auth — required prior therapy documentation
For some products (e.g., Rinvoq), prior authorization requires documentation of prior failed therapies and specific step-therapy pathways. Provide dates and durations of prior trials and clinical rationale for switching.
- Rinvoq: document failed trials of conventional or specified biologic therapies as detailed in the product entry.
- Provide duration and reasons for discontinuation (failure, intolerance, contraindication).
TIRF (transmucosal fentanyl) prior authorization requirements
Transmucosal Immediate‑Release Fentanyl (TIRF) products are restricted to management of cancer-related breakthrough pain in opioid‑tolerant cancer patients and require prescriber specialty documentation. They are not covered for non-cancer pain.
- TIRF will not be covered for any non-cancer pain indication.
- Coverage limited to adult cancer patients already tolerant to around‑the‑clock opioid therapy; pediatric approval for fentanyl lozenges may be approvable for patients ≥16 years in some cases.
- Prescribing physician must be an oncologist or pain management specialist; document opioid‑tolerant baseline regimen and continuing around‑the‑clock opioids.
Biologic / advanced therapy PA and step requirements
Biologics and advanced therapies have step-therapy, prerequisite Part D drug requirements, and prescriber‑specialty expectations. Provide documentation of prior biologic or conventional therapy trials and specialty consultation when required.
- Examples: Many TNF and interleukin inhibitors require trial/failure of conventional therapies like methotrexate or prior TNF inhibitors.
- Prescriber specialty (dermatologist, rheumatologist, gastroenterologist, oncologist, etc.) is commonly required or requested.
ATTR‑CM — PA and prescriber restriction
ATTR‑CM therapies require cardiologist prescribing and specific diagnostic confirmation; provide mutation or biopsy/scintigraphy/MRI evidence and NYHA class.
- ATTR‑CM initial: provide diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy by either: documented TTR mutation, cardiac or noncardiac tissue biopsy confirming TTR amyloid deposits, or cardiac imaging (MRI or scintigraphy) suggestive of amyloidosis with exclusion of light‑chain amyloidosis.
- Document NYHA Functional Class I–III heart failure and note prescriber is a cardiologist.
- Coverage and reauth duration notes: often plan‑year or specified in product entry.
Wyost — PA and prescriber restriction
Wyost and similar immunomodulators require prescriber specialty and specific prior‑therapy documentation. Provide evidence of TNF inhibitor failure/intolerance and conventional therapy trials as applicable.
- Wyost: Prescribed by or in consultation with a gastroenterologist or rheumatologist; document inadequate response or intolerance to one or more TNF inhibitors and required conventional therapy trials.
- Include dates and reasons for prior therapy discontinuation.
Products Affected — confirm product is listed
Products Affected: The policy lists numerous specific NDC / product entries (see "Products Affected" blocks). Providers must confirm whether the prescribed product appears on the list and follow the product‑specific requirements.
- Examples include Abilify Mycite kits, Arikayce (Cayston listed separately), many branded biologics (Humira/adalimumab variants, Enbrel, Cosentyx), specialty oncology and rare disease agents (Lynparza, Rubraca, Trikafta, Truqap, Lytgobi, Turalio, Vyndamax, etc.).
- When a product is on the list, follow the Required Medical Information and Prerequisite Therapy guidance in its entry.
Missing diagnosis or prescriber specialty — denial risk
Missing diagnosis or prescriber specialty documentation is a common cause of denial. Ensure the submitted chart notes explicitly state the diagnosis, relevant mutation or lab results, prior therapy trials (with dates and outcomes), and the specialty of the prescriber or consultant.
- For oncology agents, include mutation testing results (BRCA, EGFR, ALK, FGFR2, PIK3CA/AKT1/PTEN), prior platinum response, and lines of therapy.
- For specialty conditions, document subspecialty consultation or that prescriber is within the required specialty (e.g., cardiologist for ATTR‑CM, pulmonologist for pulmonary fibrosis agents, neurologist for certain seizure/disorder drugs).
ATTR‑CM — required documentation
ATTR‑CM documentation: include genetic testing or biopsy/imaging evidence, NYHA class, and cardiology prescriber information to support coverage. Lack of these items may result in denial.
- Provide one of: documented TTR mutation, histologic confirmation of TTR amyloid deposits, or cardiac imaging (MRI/scintigraphy) suggestive of amyloidosis plus exclusion of light‑chain amyloidosis.
- Document NYHA Functional Class I–III and that a cardiologist prescribed or co‑managed therapy.
Submission of use and setting information (Part B vs Part D)
Whether a drug is covered under Medicare Part B or Part D may depend on the drug's use and setting. Submit information describing the drug use (indication, administration route, infusion vs outpatient prescription) and setting to enable correct Part B vs Part D determination.
- Include details on administration (e.g., physician office infusion, facility-administered vs pharmacy-dispensed self‑administered), the clinical indication, and any billing codes if available.
- Failure to submit use/setting information may delay determination of whether the drug is covered under Part B or Part D.
Examples — required documentation for select products
Product-specific documentation examples: include device/dev kit information, prior oral therapy documentation, specialty prescriber notes, and infectious disease or pulmonary testing as applicable.
- Abilify Mycite: include documentation of diagnosis (bipolar I disorder, major depressive disorder, or schizophrenia), evidence of worsening symptoms on oral aripiprazole, and that the prescriber is a psychiatrist.
- Arikayce / Cayston: for MAC lung disease, include diagnosis of MAC lung disease, documentation of use as part of combination regimen, and prior sputum culture results showing failure to achieve at least two negative cultures after ≥6 months of multidrug background therapy; prescriber should be infectious disease specialist or pulmonologist.
- Everolimus: include diagnosis specifics (e.g., Advanced HR+ breast cancer with prior aromatase inhibitor failure, ARCC with progression after sorafenib/sunitinib) and prescriber specialty (neurologist/oncologist as applicable).
- Icatibant: include documented HAE diagnosis with at least one severe attack in past 6 months and confirmatory labs for Types 1 & 2 (low C4, reduced C1 esterase inhibitor level or function); prescriber should be allergist/hematologist/immunologist.
- Jynarque (tolvaptan for ADPKD): include baseline liver tests and monitoring plan (ALT, AST, bilirubin measured pre-initiation, at 2 and 4 weeks, then monthly for first 18 months; if >18 months on therapy, labs at least every 3 months).
- Lytgobi: include diagnosis of unresectable/metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions; prescriber = oncologist.
- Rubraca: include documented deleterious BRCA mutation and platinum‑sensitive response history for maintenance therapy; prescriber = oncologist.
- Stivarga: include diagnosis (GIST, HCC, metastatic colorectal cancer) and documentation of prior failures (imatinib, sunitinib, sorafenib, and relevant chemotherapies); prescriber = oncologist.
- Turalio: include documented diagnosis of symptomatic TGCT not amenable to surgery and supporting clinical details.
- Vyndamax / Vyndaqel (ATTR agents): include transthyretin mutation or biopsy/imaging evidence and cardiology prescriber documentation.
Step therapy / prerequisite Part D drug — provider actions
Step therapy / prerequisite Part D drug notes: when Criteria indicates "Criteria DOES require use of a prerequisite Part D drug", attach pharmacy records or prescriber attestation documenting prior Part D drug trials or provide rationale for why a trial is clinically inadvisable.
- Kineret (RA): document trial and failure/intolerance/contraindication to conventional therapies as specified for RA.
- Lipid‑lowering (Nexletol/Nexlizet): document maximally tolerated statin therapy or statin intolerance and LDL‑C level and qualifying diagnosis (HeFH, ASCVD, high CVD risk).
- Otezla: for certain dermatologic indications, document trial and failure of required topical therapies.
- Stelara, Voquezna, select immunomodulators: document required prior generic or branded therapy trials per product entry.
Initial Therapy / Conventional Therapy Requirements
Reauthorization and Continuation of Therapy
Step Therapy / Required Prior Trials
| Drug / Context | Required prior agent(s) |
|---|---|
| Adalimumab family — Rheumatoid arthritis (RA) | |
| Trial and failure, contraindication, or intolerance to ONE conventional therapy: methotrexate, leflunomide, or sulfasalazine | |
| Adalimumab family — Polyarticular juvenile idiopathic arthritis (PJIA) | |
| Trial and failure, contraindication, or intolerance to ONE conventional therapy: methotrexate, leflunomide, or sulfasalazine | |
| Adalimumab family — Plaque psoriasis | |
| Failed or unable to tolerate at least one topical agent (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, or coal tar) |
| Situation | Documented trial(s) required |
|---|---|
| Plaque psoriasis (biologics like Cosentyx, Skyrizi) | |
| Failure or intolerance to at least one topical class (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar) | |
| Non-radiographic axial spondyloarthritis / Enthesitis-related arthritis | |
| Minimum one-month trial and failure, contraindication, or intolerance to TWO NSAIDs at maximally indicated doses | |
| Migraine (Ubrelvy) — acute treatment | |
| Inadequate response, intolerance, or contraindication to at least one triptan medication |
| Product / Area | Prerequisite Part D drug required? |
|---|---|
| Everolimus (multiple indications) — e.g., Advanced HR+ BC, ARCC, NET | |
| Criteria DOES require use of a prerequisite Part D drug (specified per indication) | |
| Gomekli (neurofibromatosis type 1) — plexiform neurofibromas | |
| Criteria DOES NOT require use of a prerequisite Part D drug | |
| Type 2 Diabetes GLP-1 agents (initial) | |
| Criteria DOES require use of a prerequisite Part D drug (minimum 90-day trial of listed comparator agents or documentation) | |
| Jaypirca (GVHD, myelofibrosis, PV) — hematology indications | |
| Criteria DOES require use of a prerequisite Part D drug |
| Scenario | Required documentation / alternative |
|---|---|
| Kineret — Rheumatoid arthritis initial | |
| Trial and failure, contraindication, or intolerance to TWO of the listed agents (etanercept, a formulary adalimumab, abatacept, upadacitinib, tofacitinib) OR attestation that trials are inappropriate OR continuation of prior therapy | |
| Kineret — NOMID initial | |
| Confirmatory NLRP3 mutation OR two characteristic clinical symptoms plus elevated acute phase reactants (attest if mutation testing not available) |
| Agent / Indication | Required prior chemotherapy regimens (document) |
|---|---|
| Krazati (adagrasib) — NSCLC | |
| Document prior systemic therapy: patient has received at least one prior systemic therapy (eg, chemotherapy, immunotherapy) | |
| Krazati — Colorectal cancer | |
| Document prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy | |
| Fotivda — relapsed/refractory RCC | |
| Document prior two or more systemic therapies for advanced RCC |
| Therapy area / product | Trial and failure requirement |
|---|---|
| Nerlynx (extended adjuvant HER2+ breast cancer) | |
| Prior adjuvant Herceptin-based therapy required; for advanced/metastatic use, prior two or more anti-HER2 regimens | |
| Nexletol / Nexlizet (lipid-lowering) | |
| Elevated LDL-C while on maximally tolerated statin therapy OR statin contraindication/intolerance |
| Drug (example) | Prior therapy failure required |
|---|---|
| Rinvoq — Rheumatoid arthritis and other indications | |
| Requires trial and inadequate response or intolerance to TNF inhibitors for multiple indications; for RA includes trial/failure of a conventional therapy plus TNF inhibitor failure (documentation required) |
| Product / Indication | Topical trial required |
|---|---|
| Otezla — Plaque psoriasis | |
| Failure or intolerance to at least one listed topical therapy (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar) required before approval |
| Product | Prior trial(s) required before approval |
|---|---|
| Skyrizi — Plaque psoriasis | |
| Failed or intolerant to at least one topical class (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar) or other listed therapies prior to biologic approval | |
| Skyrizi — Crohn's disease | |
| Document diagnosis of moderate-to-severe Crohn's disease with prescriber consultation as specified (prior therapy per indication) |
| Voquezna use case | Required prior therapies |
|---|---|
| H. pylori (Voquezna Dual/Triple Pak or Voquezna) | |
| Trial and failure, contraindication, or intolerance to bismuth quadruple therapy required before Voquezna regimens | |
| HRH / MHRH / NERD indications | |
| Inadequate response, intolerance, or contraindication to TWO generic PPIs required for erosive esophagitis healing/maintenance or NERD criteria as specified |
| Acute migraine treatment | Required prior agent |
|---|---|
| Ubrelvy — migraine acute treatment | |
| Inadequate response, intolerance, or contraindication to at least one triptan medication required prior to approval |
| Agent / Example | Required prior therapies before authorization |
|---|---|
| Xeljanz / other JAK inhibitors — Rheumatoid arthritis | |
| Trial and failure, contraindication, or intolerance to ONE conventional therapy (methotrexate, leflunomide, or sulfasalazine) AND inadequate response or intolerance to one or more TNF inhibitors required before authorization | |
| Stelara / similar biologics | |
| Trial, intolerance, or contraindication to Yesintek or Steqeyma prior to coverage (per indication) |
Site of Care and Billing Determination Notes
Site‑of‑care: no explicit site‑of‑care rules stated
No explicit site‑of‑care rules are stated in these chunks; the policy does not mandate infusion center restrictions here.
Provide use and setting to determine Part B vs Part D coverage
Coverage determination (Part B vs Part D) depends on the clinical use and setting; include information about route, administration setting, and intended use to enable correct billing/coverage determination.
Coverage Exclusions and Coding-related Notes
Denial risk: missing diagnosis or prescriber specialty
Requests lacking required documentation of diagnosis or prescriber specialty for drugs that list those requirements may be denied; always include the diagnosis and specialty documented in the product entry.
Denial risk: Dupixent exclusion for acute bronchospasm/status asthmaticus
Dupixent will not be approved for relief of acute bronchospasm or status asthmaticus; do not submit PA requests for those indications.
Denial risk: Icatibant exclusion for acquired angioedema or ACE inhibitor use
Icatibant will not be approved for members with acquired angioedema or for those concurrently taking an ACE inhibitor.
Denial risk: Iclusig exclusion for newly diagnosed chronic phase CML
Iclusig will not be approved for members with newly diagnosed chronic phase CML; verify that the indication and disease phase match the product criteria.
Denial risk: insufficient diagnostic or prior therapy documentation
Requests lacking documentation of required diagnosis or prior therapy (e.g., high fracture risk or prior osteoporosis therapy trials for denosumab entries) may be denied—include the necessary diagnostic and prior therapy evidence.
Denial risk: Mekinist prior therapy exclusion
Mekinist will not be approved as a single agent for members who have received prior BRAF‑inhibitor therapy; ensure prior therapy history matches the product exclusion.
Denial risk: explicit coverage exclusion — quinine for leg cramps
Quinine sulfate will not be approved for treatment or prevention of nocturnal leg cramps; do not submit for this indication.
Denial risk: Rubraca concurrent therapy exclusion
Rubraca will not be approved for concurrent use with other chemotherapy agents; ensure requests document non‑concurrent use when seeking maintenance coverage.
Denial risk: Rydapt treatment setting exclusion (no single‑agent induction)
Rydapt will not be approved as single‑agent induction therapy for AML; authorization applies when used as first‑line in combination with standard induction and consolidation regimens per the product criteria.
Denial risk: TIRF exclusion for non‑cancer pain
TIRF products are not covered for any non‑cancer pain indication; PA requests for non‑cancer pain will be denied.
Denial risk: TIRF non‑cancer indication denied
TIRF coverage is limited to opioid‑tolerant cancer patients; do not submit for non‑cancer pain as these requests will be denied.
Denial risk: Voquezna prerequisite therapy not met
Voquezna indications require prior trial/failure/intolerance/contraindication to bismuth quadruple therapy for H. pylori and inadequate response to two generic PPIs for HRH/MHRH/NERD—include those prior therapy records to avoid denial.
Denial risk: missing ATTR‑CM documentation
Missing documentation for ATTR‑CM (confirmatory testing or NYHA class) may trigger denial; include required confirmatory items and NYHA documentation.
Billing risk: missing use/setting information affects Part B vs Part D determination
Failure to submit the use and setting of the drug can prevent determination of Medicare Part B versus Part D coverage; include setting and intended use information with the PA.
Key Definitions and Terms Used
Background and Scope
Background: This excerpt is a formulary prior authorization guideline that enumerates specific Part D and specialty drugs, the clinical conditions for which coverage is considered medically necessary, and the documentation and prescriber requirements needed for prior authorization. The document routinely requires a documented diagnosis that matches the drug-specific criteria, specialist prescribers for many oncology and immunology agents, and commonly specifies an initial authorization period (frequently 2 years) or other durations where indicated. It also lists explicit exclusions and not medically necessary uses that will result in denial if requested without appropriate supporting documentation.
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