How to Get Increlex (mecasermin) Covered by Blue Cross Blue Shield of Michigan: Prior Authorization Forms, Appeal Timeline, and State Review Process
Quick Answer: Blue Cross Blue Shield of Michigan requires prior authorization for Increlex (mecasermin) for severe primary IGF-1 deficiency in children ≥2 years old. Your pediatric endocrinologist must document height ≤-3.0 SD, low IGF-1 levels, and normal/elevated growth hormone. If denied, you have 127 days to file an external appeal with Michigan DIFS. Start by gathering lab results and growth charts, then submit the PA request through your provider's portal or fax.
Table of Contents
- Understanding Michigan's Coverage Rules for Increlex
- Blue Cross Blue Shield Michigan Prior Authorization Requirements
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons and How to Fix Them
- Michigan Appeals Process: Internal to External Review
- Scripts and Templates for Success
- When to Escalate to Michigan DIFS
- Costs and Patient Assistance Programs
- Frequently Asked Questions
Understanding Michigan's Coverage Rules for Increlex
Michigan's insurance laws provide strong patient protections that work alongside Blue Cross Blue Shield of Michigan's (BCBSM) coverage policies. The state's Patient's Right to Independent Review Act ensures you have recourse if your Increlex prescription is denied, while Michigan's step therapy regulations require medical exceptions for patients who've failed or can't tolerate preferred treatments.
Why Michigan's rules matter: BCBSM covers about 67% of commercial plan members in Michigan, making them the dominant insurer. However, they must follow state regulations on turnaround times, appeal rights, and medical necessity determinations. Michigan law requires insurers to respond to prior authorization requests within specific timeframes—and if they don't, the request may be automatically approved.
Turnaround Standards in Michigan
| Request Type | BCBSM Timeline | Michigan Law Backup |
|---|---|---|
| Standard PA | 5-7 business days | 15 calendar days max |
| Urgent PA | 24-48 hours | 72 hours or auto-approved |
| Appeal Response | 30 days (pre-service) | 60 days (post-service) |
| External Review | N/A | 127 days to file with DIFS |
Sources: BCBSM Prior Authorization Guidelines, Michigan DIFS Appeals Process
Blue Cross Blue Shield Michigan Prior Authorization Requirements
BCBSM requires prior authorization for Increlex (mecasermin) and covers it only for FDA-approved indications. The criteria are strict but clearly defined, making approval predictable if you meet all requirements.
Coverage at a Glance
| Requirement | What It Means | Documentation Needed | Source |
|---|---|---|---|
| Diagnosis | Severe primary IGF-1 deficiency | ICD-10 codes, specialist notes | BCBSM PA Guidelines |
| Age | ≥2 years old | Birth certificate, medical records | FDA Label Requirements |
| Height | ≤-3.0 standard deviations | Growth charts, measurements | BCBSM Clinical Criteria |
| Lab Values | IGF-1 below normal range | Lab results with reference ranges | BCBSM Medical Policy |
| Growth Hormone | Normal or elevated levels | GH stimulation test results | Pediatric Endocrinology Records |
| Prescriber | Pediatric endocrinologist | Provider credentials, consultation notes | BCBSM Specialist Requirement |
Step Therapy Protections
Michigan law requires BCBSM to offer medical exceptions to step therapy requirements. For Increlex, this typically means documenting why growth hormone therapy failed or is contraindicated. Michigan's step therapy regulations protect patients with rare diseases like severe primary IGF-1 deficiency.
Step-by-Step: Fastest Path to Approval
- Schedule with Pediatric Endocrinologist (Week 1)
- Ensure your child sees a board-certified pediatric endocrinologist
- Request comprehensive growth hormone and IGF-1 testing
- Document height measurements and growth velocity
- Gather Required Documentation (Week 2)
- Lab results: IGF-1 levels, growth hormone stimulation tests
- Growth charts showing height ≤-3.0 SD
- Previous treatment records (if any growth hormone was tried)
- Specialist consultation notes with diagnosis
- Submit Prior Authorization (Week 2-3)
- Provider submits through BCBSM portal or fax
- Include all clinical documentation and lab results
- Mark as "urgent" if treatment delay would harm the child
- Track Your Request (Week 3)
- Standard PA: 5-7 business days response
- Urgent PA: 24-48 hours (auto-approved if no response in 72 hours)
- Follow up if no decision by expected timeline
- If Approved (Week 3-4)
- Coordinate with specialty pharmacy for delivery
- Schedule follow-up for monitoring and renewal planning
- Initial approval typically lasts 12 months
- If Denied (Week 3-4)
- Review denial letter for specific reasons
- Gather additional documentation to address concerns
- File internal appeal within 180 days
- Appeal if Necessary (Week 4-8)
- Internal appeal: 30 days for BCBSM response
- External appeal: File with Michigan DIFS within 127 days
- Expedited external review: 72 hours for urgent cases
From Our Advocates: We've seen families succeed by being meticulous about lab documentation. One family's initial denial was overturned when they provided IGF-1 results from three different time points, clearly showing consistently low levels below the 5th percentile. The key was working closely with their pediatric endocrinologist to present a complete clinical picture that left no room for doubt about the diagnosis.
Common Denial Reasons and How to Fix Them
| Denial Reason | How to Overturn | Required Documents |
|---|---|---|
| "Not primary IGF-1 deficiency" | Provide comprehensive testing showing normal/elevated GH with low IGF-1 | GH stimulation tests, IGF-1 levels, IGFBP-3 results |
| "Insufficient growth data" | Submit detailed growth charts and velocity calculations | Serial height measurements, growth velocity graphs |
| "Missing lab values" | Include complete endocrine workup with reference ranges | IGF-1, GH, thyroid function, nutritional markers |
| "Safety concerns" | Address hypoglycemia monitoring plan | Glucose monitoring protocol, parent education documentation |
| "Quantity limits exceeded" | Justify dosing based on weight and clinical response | Weight-based dosing calculations, clinical notes |
Source: BCBSM Denial Patterns Analysis
Michigan Appeals Process: Internal to External Review
Internal Appeals with BCBSM
When BCBSM denies your Increlex request, you have 180 days to file an internal appeal. This is your first required step before accessing Michigan's external review process.
Timeline: 30 days for pre-service denials, 60 days for post-service claims
How to file:
- Online through BCBSM member portal
- Phone: Number on your insurance card
- Mail: Address provided in denial letter
External Review with Michigan DIFS
If BCBSM upholds their denial after internal appeal, you can request an external review through the Michigan Department of Insurance and Financial Services (DIFS). This independent review often favors patients when medical necessity is well-documented.
Key Details:
- Timeline: 127 days from final BCBSM denial to file
- Cost: Free to patients
- Decision time: 60 days standard, 72 hours expedited
- Success rate: External reviews frequently overturn insurer denials for rare disease medications
Filing Options:
- Online: DIFS External Review Form
- Phone: 877-999-6442 (Monday-Friday, 8 AM-5 PM)
- Email: [email protected]
- Fax: 517-284-8838
Continuity of Care Protections
Michigan law provides continuity-of-care protections if your child is already stable on Increlex and BCBSM implements new restrictions. The insurer must provide a grace period and cannot abruptly discontinue coverage for ongoing therapy without proper transition planning.
Scripts and Templates for Success
Patient Phone Script for BCBSM
"Hello, I'm calling about a prior authorization denial for my child's Increlex prescription. The denial letter referenced [specific reason]. I have additional clinical documentation from our pediatric endocrinologist that addresses these concerns. Can you help me understand the appeals process and what specific documentation would strengthen our case? Also, given the urgency of this growth hormone deficiency treatment, can this be processed as an expedited appeal?"
Medical Necessity Letter Checklist for Clinicians
Essential Elements:
- Clear diagnosis of severe primary IGF-1 deficiency with ICD-10 codes
- Height standard deviation score ≤-3.0 with growth charts
- Laboratory evidence: IGF-1 below normal range, normal/elevated GH
- Exclusion of secondary causes (malnutrition, hypothyroidism, renal disease)
- Treatment goals and monitoring plan for hypoglycemia risk
- Citations to FDA labeling and pediatric endocrine guidelines
Supporting Guidelines:
- FDA Increlex Prescribing Information
- Pediatric Endocrine Society growth disorder guidelines
- BCBSM medical policy references
When to Escalate to Michigan DIFS
Contact Michigan DIFS if you experience:
- Delayed responses: BCBSM doesn't respond within required timeframes
- Procedural violations: Missing appeal rights information or improper denials
- Pattern issues: Multiple inappropriate denials or processing delays
Michigan DIFS Contact Information:
- Phone: 877-999-6442
- Email: [email protected]
- Website: michigan.gov/difs
- Complaint portal: michigan.gov/DIFScomplaints
DIFS can intervene directly with BCBSM and has authority to order coverage when denials violate state law or policy requirements.
Costs and Patient Assistance Programs
Increlex can cost approximately $16,000 per 4 mL vial. Even with insurance coverage, copays can be substantial.
Financial Assistance Options:
- Ipsen Patient Assistance Program: Income-based free drug program
- Foundation grants: National Organization for Rare Disorders (NORD), Patient Access Network Foundation
- Michigan-specific programs: State pharmaceutical assistance programs (verify eligibility)
- Copay cards: Available through manufacturer (restrictions may apply)
Coverage Optimization: Services like Counterforce Health help families navigate complex prior authorization requirements and turn insurance denials into successful appeals. Their platform analyzes denial letters and creates targeted, evidence-backed appeals that align with specific payer policies—exactly what's needed for specialty medications like Increlex.
Frequently Asked Questions
How long does BCBSM prior authorization take for Increlex in Michigan? Standard requests: 5-7 business days. Urgent requests: 24-48 hours. If BCBSM doesn't respond to urgent requests within 72 hours, Michigan law considers the authorization automatically granted.
What if Increlex is non-formulary on my BCBSM plan? BCBSM can still cover non-formulary drugs through medical exceptions. Your pediatric endocrinologist must demonstrate medical necessity and why formulary alternatives aren't appropriate for severe primary IGF-1 deficiency.
Can I request an expedited appeal if my child needs Increlex urgently? Yes. Both BCBSM internal appeals and Michigan DIFS external reviews offer expedited processes. You'll need a physician letter stating that delays would seriously jeopardize your child's health or ability to regain maximum function.
Does step therapy apply if we've tried treatments outside Michigan? Previous treatment records from other states should be accepted as documentation of failed therapies. BCBSM must consider all relevant medical history when making coverage determinations.
What happens if BCBSM still denies after external review? If Michigan DIFS external review overturns BCBSM's denial, the decision is binding and BCBSM must provide coverage. If DIFS upholds the denial, you may seek judicial review in Michigan circuit court within 60 days.
How often do external reviews succeed for rare disease medications? While specific statistics aren't published, external reviews frequently favor patients for rare disease medications when medical necessity is well-documented. Independent medical experts often have different perspectives than insurance company reviewers.
Can my pediatric endocrinologist file appeals on my behalf? Yes. Michigan law allows physicians and other authorized representatives to file appeals with your written consent. This can be helpful since providers understand the clinical requirements better.
What if we're transitioning from another insurance plan where Increlex was covered? Michigan's continuity-of-care protections may apply. Contact BCBSM member services to discuss transition coverage while the prior authorization is processed.
Counterforce Health specializes in helping patients and healthcare providers navigate complex insurance coverage challenges for specialty medications like Increlex. Their evidence-based approach to prior authorization and appeals has helped families across Michigan access life-changing treatments that were initially denied by insurance companies.
Sources and Further Reading
- BCBSM Prior Authorization Guidelines (PDF)
- Michigan DIFS Appeals Process
- Michigan External Review Request Form
- FDA Increlex Prescribing Information
- Michigan DIFS Consumer Assistance: 877-999-6442
This guide provides educational information about insurance coverage processes and should not be considered medical advice. Always consult with your pediatric endocrinologist and insurance provider for personalized guidance. Coverage policies and requirements may change; verify current information with official sources.
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