How to Get Strensiq (asfotase alfa) Covered by Humana in Texas: Complete Prior Authorization and Appeal Guide
Answer Box: Getting Strensiq (asfotase alfa) Covered by Humana in Texas
Strensiq (asfotase alfa) is covered by Humana Medicare Advantage in Texas, but requires prior authorization with strict clinical criteria. Fastest path to approval: Ensure your prescriber submits genetic confirmation (ALPL mutation), low alkaline phosphatase levels for your age, and radiographic evidence of hypophosphatasia. First step today: Contact your prescriber to gather these three key documents and submit through Humana's provider portal. If denied, Texas law guarantees external review rights within 180 days. Appeals success rates exceed 80% with complete documentation.
Table of Contents
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- Medical vs. Pharmacy Benefit Coding
- ICD-10 and Documentation Requirements
- Product Coding: HCPCS, J-Codes, and NDC
- Common Denial Reasons and Solutions
- Appeals Process in Texas
- Cost Assistance Programs
- Frequently Asked Questions
- Sources and Further Reading
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required for all Strensiq prescriptions | Humana provider portal | Humana PA Requirements |
| Formulary Tier | Specialty tier with high copays | Plan formulary documents | Humana Drug Lists |
| Age Restriction | Pediatric/juvenile-onset HPP only | FDA labeling and plan policy | FDA Access Data |
| Genetic Testing | ALPL mutation confirmation required | Laboratory genetic report | Humana Coverage Criteria |
| Specialty Pharmacy | Must use network specialty pharmacy | CenterWell or approved network | Humana Specialty Network |
| Appeal Deadline | 65 days from denial (Medicare) | Plan denial letter | CMS Appeals Process |
Step-by-Step: Fastest Path to Approval
1. Confirm Your Diagnosis Meets Criteria
Who: Your specialist (endocrinologist, geneticist, or metabolic specialist) Document needed: Diagnosis of perinatal, infantile, or juvenile-onset hypophosphatasia Timeline: Before prescription is written Key point: Adult-onset HPP is typically not covered
2. Gather Required Laboratory Evidence
Who: Your prescriber's office Documents needed:
- Serum alkaline phosphatase levels (must be low for age/gender)
- Pyridoxal 5'-phosphate (PLP) levels (typically elevated)
- Urinary phosphoethanolamine (if available) Timeline: Within 6 months of request Source: Laboratory Requirements
3. Obtain Genetic Confirmation
Who: Genetic counselor or ordering physician Document needed: ALPL gene mutation analysis from certified laboratory Timeline: Can be historical if previously performed Note: This is often the most critical missing piece in denials
4. Document Radiographic Evidence
Who: Radiologist and prescriber Documents needed: X-rays showing rickets, fractures, or bone mineralization defects Timeline: Recent imaging preferred (within 12 months) Key point: Reports must specifically describe HPP-related findings
5. Submit Prior Authorization
Who: Prescriber or their staff How: Through Humana provider portal or fax Timeline: Allow 72 hours for standard decision, 24 hours if expedited Required: All documentation from steps 1-4
6. Choose Network Specialty Pharmacy
Who: Patient with prescriber guidance Options: CenterWell Specialty Pharmacy or other Humana-approved network pharmacy Timeline: After PA approval Cost consideration: Verify copay assistance eligibility
7. Monitor and Prepare for Renewal
Who: Patient and prescriber Timeline: Approvals typically last 12 months Required for renewal: Updated clinical assessment showing continued benefit
Tip: Request expedited review if any delay could worsen symptoms or bone health. Document this urgency in your PA submission.
Medical vs. Pharmacy Benefit Coding
Strensiq is primarily covered under the pharmacy benefit for most Humana plans, not the medical benefit. This affects how it's billed and where you obtain the medication.
Pharmacy Benefit Coverage:
- Dispensed through specialty pharmacy
- Home administration allowed
- Uses NDC codes for billing
- Subject to pharmacy copays and deductibles
- Requires specialty pharmacy network compliance
HCPCS J-Code: Currently billed using J3590 (unclassified biologics) as Strensiq doesn't have a permanent drug-specific J-code.
ICD-10 and Documentation Requirements
Primary Diagnosis Code
ICD-10 E83.39 (Other disorders of phosphorus metabolism) is the correct code for all forms of hypophosphatasia, including pediatric, juvenile, perinatal, and infantile cases.
Required Clinical Documentation
Your medical record must include:
- Age at symptom onset (must be pediatric for coverage)
- Growth patterns and failure to thrive documentation
- Skeletal symptoms: bone pain, fractures, dental issues
- Functional impact: mobility limitations, quality of life effects
- Prior treatments attempted and their outcomes
Laboratory Documentation Words That Support Coding
Include these specific terms in medical records:
- "Persistently low alkaline phosphatase for age"
- "Elevated pyridoxal 5'-phosphate (PLP)"
- "Confirmed ALPL gene mutation"
- "Radiographic evidence of rickets/osteomalacia"
- "Failed conventional therapy"
Product Coding: HCPCS, J-Codes, and NDC
Dosing and Units Calculation
Standard dosing: 6 mg/kg/week for juvenile-onset HPP, up to 9 mg/kg/week for perinatal/infantile-onset
Example calculation:
- 15 kg patient at 6 mg/kg/week = 90 mg total weekly dose
- Typically divided as 2 mg/kg three times weekly (30 mg per injection)
- Each 40 mg vial provides one 30 mg dose with minimal waste
NDC and Billing Units
- NDC codes: Must match the specific vial strength dispensed
- Single-use vials: Each vial is billed as dispensed, regardless of dose drawn
- Units: Bill by actual vials dispensed, not mg administered
Common Coding Pitfalls
- Mismatched codes: Using wrong HCPCS code for payer requirements
- Unit conversion errors: Billing mg instead of vials
- Missing start dates: PA approval date must align with first fill date
Common Denial Reasons and Solutions
| Denial Reason | How to Overturn | Required Documents |
|---|---|---|
| Insufficient genetic testing | Submit certified ALPL mutation report | Laboratory genetic analysis |
| Missing ALP levels | Provide age-specific reference ranges | Comprehensive metabolic panel |
| Lack of radiographic evidence | Include imaging reports with HPP findings | X-rays with radiologist interpretation |
| Adult-onset HPP | Document pediatric symptom onset | Childhood medical records |
| Dosing above label | Justify with specialist assessment | Endocrinologist letter explaining need |
Appeal Success Strategy: Address each denial reason point-by-point with specific documentation. Counterforce Health helps patients and clinicians turn denials into targeted, evidence-backed appeals by identifying the exact denial basis and crafting responses aligned to the plan's own rules.
Appeals Process in Texas
Internal Appeal (First Level)
Timeline: Must file within 65 days of denial for Medicare plans Decision deadline: 7 days for standard, 72 hours for expedited How to file: Online through Humana member portal, phone, or mail Required: Original denial letter, supporting medical records, prescriber letter
External Review (Independent Review)
When available: After internal appeal denial, or concurrently if urgent Timeline: Request within 4 months of final internal denial Decision deadline: 20 days standard, 5 days for urgent cases Authority: Independent Review Organization contracted through Texas Department of Insurance Cost: Free to patient (insurer pays IRO fees)
Texas-Specific Rights
- Expedited reviews available for urgent medical needs
- Binding decisions: IRO rulings must be followed by Humana
- Consumer assistance: Texas Department of Insurance helpline at 1-800-252-3439
Note: ERISA self-funded employer plans follow federal appeals rules, not Texas state requirements.
Getting Help in Texas
- Texas Department of Insurance: www.tdi.texas.gov or 1-800-252-3439
- Office of Public Insurance Counsel: 1-877-611-6742 for consumer guidance
- Disability Rights Texas: Assists families with Medicaid fair hearings and MCO appeals
Cost Assistance Programs
Manufacturer Support
Alexion Access Navigator: Provides coverage support, prior authorization assistance, and financial aid programs. Contact through alexionaccessnavigator.com.
Copay Assistance
- Commercial insurance: Manufacturer copay cards may reduce out-of-pocket costs
- Medicare patients: Limited assistance due to federal anti-kickback rules
- Income-based programs: Available through manufacturer patient assistance programs
Foundation Grants
Several rare disease foundations offer emergency financial assistance for Strensiq. Eligibility typically requires income verification and medical necessity documentation.
From our advocates: "We've seen families successfully reduce seven-figure annual costs to manageable monthly payments through a combination of manufacturer programs, foundation grants, and state assistance. The key is applying to multiple programs simultaneously and maintaining all documentation current."
Frequently Asked Questions
How long does Humana prior authorization take for Strensiq in Texas? Standard decisions within 72 hours, expedited within 24 hours. Complex cases requiring medical director review may take up to 7 days.
What if Strensiq is non-formulary on my Humana plan? You can request a formulary exception with prescriber support. Humana must approve if no formulary alternatives are medically appropriate for your condition.
Can I request an expedited appeal if Humana denies coverage? Yes, if delaying treatment could jeopardize your health. Document the urgency and submit both expedited internal appeal and external review requests simultaneously.
Does step therapy apply to Strensiq? No, Strensiq is the only FDA-approved treatment for hypophosphatasia. Step therapy typically doesn't apply when no therapeutic alternatives exist.
What happens if I move from another state to Texas? Humana must provide a transition supply (up to 31 days) while processing your new authorization. Texas appeal rights apply to all Humana plans regulated by the state.
How often do I need to renew prior authorization? Typically annually, but some approvals are shorter. Your prescriber must document continued medical necessity and treatment response for renewal.
Can my doctor request a peer-to-peer review? Yes, prescribers can request to speak directly with Humana's medical director to discuss complex cases and provide additional clinical context.
What if I can't afford the copay even with insurance? Contact the Alexion Access Navigator program and investigate patient assistance foundations. Counterforce Health can also help identify all available financial assistance options while managing your coverage appeals.
Sources and Further Reading
- FDA Strensiq Label and Prescribing Information
- Humana Prior Authorization Resources
- Humana Medicare Drug Formularies
- CMS Medicare Part D Appeals Process
- Texas Department of Insurance Consumer Guide
- Alexion Access Navigator Program
- Texas Office of Public Insurance Counsel
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances, plan terms, and medical necessity determinations. Always consult with your healthcare provider and insurance plan directly for guidance specific to your situation. Coverage policies and appeal procedures may change; verify current requirements with official sources before taking action.
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