By Counterforce Health Team in Naglazyme (galsulfase) —

How to Get Naglazyme (Galsulfase) Covered by Blue Cross Blue Shield in Pennsylvania: Prior Authorization Forms, Appeal Process & Success Tips

Answer Box: Getting Naglazyme Covered in Pennsylvania

Eligibility: Patients with confirmed MPS VI (Maroteaux-Lamy syndrome) can get Naglazyme (galsulfase) covered by Blue Cross Blue Shield plans in Pennsylvania with proper documentation.

Fastest path: Submit prior authorization with enzyme assay results, genetic testing, and specialist documentation through your Blue Cross provider portal. If denied, Pennsylvania's external review program overturns about 50% of appeals.

First step today: Contact your prescribing physician to gather diagnostic documentation (ARSB enzyme activity results and genetic testing) and request they submit the Blue Cross prior authorization form for Naglazyme.

Table of Contents

  1. What This Guide Covers
  2. Before You Start
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timelines
  6. If You're Asked for More Information
  7. If Your Request Is Denied
  8. Pennsylvania External Review Process
  9. Renewal and Re-authorization
  10. Quick Reference Checklist
  11. FAQ

What This Guide Covers

This guide helps patients with MPS VI (Maroteaux-Lamy syndrome) and their healthcare teams navigate the prior authorization process for Naglazyme (galsulfase) with Blue Cross Blue Shield plans in Pennsylvania. We'll cover the specific requirements for both major Pennsylvania Blue Cross plans—Highmark Blue Shield (western PA) and Independence Blue Cross (Philadelphia region)—plus the state's powerful external review process that's helping patients overturn denials.

Who this helps: Patients diagnosed with MPS VI, their families, prescribing physicians, and patient advocates working to secure coverage for this life-saving enzyme replacement therapy.

Quick outcome preview: With proper documentation, most prior authorization requests for Naglazyme are approved. When denials occur, Pennsylvania's external review program has overturned more than 50% of appealed cases, making it one of the most patient-friendly appeal processes in the country.

Before You Start

Verify Your Plan Type

Not all Blue Cross Blue Shield plans are the same. Pennsylvania has two main Blue Cross insurers:

  • Highmark Blue Shield (western PA, including Pittsburgh)
  • Independence Blue Cross (Philadelphia and southeastern PA)

Check your insurance card to confirm which plan you have, as forms and submission processes differ slightly.

Confirm Naglazyme's Status

Naglazyme is typically placed on the specialty tier of Blue Cross formularies, requiring prior authorization. The medication is covered when medically necessary, but you'll need to prove your diagnosis and clinical need upfront.

Understand Your Benefits

Before starting, verify:

  • Your plan covers specialty medications
  • You're using in-network providers
  • Whether Naglazyme falls under your medical or pharmacy benefit (it's usually medical)
Tip: Call the customer service number on your insurance card to confirm these details before submitting paperwork.

Gather Required Documentation

Success depends on submitting complete documentation with your initial request. Here's what Blue Cross Blue Shield requires for Naglazyme coverage:

Essential Medical Documentation

Diagnostic Confirmation:

  • Enzyme assay results showing deficient arylsulfatase B (ARSB) activity in leukocytes or fibroblasts
  • Genetic testing confirming mutations in the ARSB gene
  • ICD-10 diagnosis code: E76.29 (Other mucopolysaccharidoses)

Clinical Documentation:

  • Specialist evaluation from a geneticist or metabolic disorder specialist
  • Documentation of MPS VI symptoms (joint stiffness, organomegaly, corneal clouding, etc.)
  • Baseline functional assessments (6-minute walk test, pulmonary function, etc.)
  • Treatment plan including dosing (1 mg/kg IV weekly) and infusion site

From Our Advocates

"We've seen the biggest difference in approval rates when families work with their specialist to submit a complete packet upfront rather than responding to requests for additional information later. One family's geneticist included photos showing disease progression alongside the lab results—their approval came through in just 8 days instead of the typical 2-3 weeks."

Required Forms

For Highmark Blue Shield: Use the current injectable prior authorization form from the Highmark Provider Resource Center.

For Independence Blue Cross: Submit through their provider portal or use specialty medication prior authorization forms available at IBX.com.

Submit Your Prior Authorization Request

Step-by-Step Submission Process

  1. Provider submits request through the Blue Cross provider portal or by fax
  2. Include all documentation in a single submission to avoid delays
  3. Use correct codes: Naglazyme HCPCS code J1458, NDC varies by manufacturer
  4. Specify infusion site: Hospital outpatient or certified infusion center
  5. Request expedited review if clinically urgent (severe symptoms or rapid progression)

Submission Tips

  • Submit Monday-Wednesday for faster processing
  • Include a cover letter summarizing medical necessity
  • Ensure all forms are signed and dated
  • Keep copies of everything submitted
Note: Both Highmark and Independence Blue Cross prefer electronic submissions through their provider portals, which typically process 1-2 days faster than fax submissions.

Follow-Up and Timelines

Standard Processing Times

  • Commercial plans: 15 business days for standard review
  • Expedited review: 72 hours when urgency is documented
  • Pennsylvania requirement: Plans must notify you within these timeframes

When to Follow Up

Call after 10 business days if you haven't received a decision. Use this script:

"I'm calling to check on the status of a prior authorization request for Naglazyme for [patient name], member ID [number], submitted on [date]. Can you provide an update and expected decision date?"

Document all calls with reference numbers, representative names, and follow-up dates.

If You're Asked for More Information

Blue Cross may request additional documentation, typically:

  • More detailed clinical notes from your specialist
  • Evidence of disease progression or severity
  • Confirmation of appropriate dosing calculations
  • Proof of infusion site certification

Response timeline: You typically have 14 days to provide additional information. Submit promptly to avoid automatic denial.

If Your Request Is Denied

Common Denial Reasons and Solutions

Denial Reason How to Address
"Lack of confirmed diagnosis" Submit complete enzyme assay and genetic test results
"Not medically necessary" Provide specialist letter detailing disease progression and functional impact
"Missing clinical documentation" Include comprehensive clinical notes and baseline assessments
"Incorrect site of care" Confirm infusion will occur at certified facility

First-Level Appeal Process

  1. File within 60 days of receiving denial letter
  2. Use official appeal forms from your Blue Cross plan
  3. Include peer-reviewed literature supporting Naglazyme's effectiveness
  4. Request peer-to-peer review between your doctor and Blue Cross medical director

Peer-to-Peer Review Script for Physicians

"This patient has confirmed MPS VI with documented enzyme deficiency and genetic confirmation. Naglazyme is the only FDA-approved therapy for this condition. Without treatment, patients face progressive multi-organ deterioration and shortened life expectancy. The clinical literature consistently shows benefit in walking capacity and quality of life measures."

Pennsylvania External Review Process

Pennsylvania offers one of the strongest patient protection programs in the country through its Independent External Review Program.

Key Statistics

  • Success rate: Over 50% of appeals are overturned
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Cost: Free to patients

How to Request External Review

  1. Complete internal appeals with your Blue Cross plan first
  2. Obtain Final Adverse Benefit Determination letter
  3. Submit request within 4 months via the Pennsylvania Insurance Department website
  4. Include all medical records and supporting documentation
  5. Independent physicians review your case based on medical evidence

Expedited External Review

For urgent cases where delay could seriously jeopardize your health, request expedited review with physician certification of urgency.

Renewal and Re-authorization

Naglazyme typically requires re-authorization every 6-12 months. Plan ahead by:

  • Scheduling renewal 60 days early to avoid treatment gaps
  • Documenting clinical benefit through functional assessments
  • Including specialist notes on continued medical necessity
  • Updating any changes in dosing or infusion protocols

Quick Reference Checklist

Before Submitting:

  • Enzyme assay results (ARSB deficiency)
  • Genetic testing confirmation
  • Specialist evaluation letter
  • ICD-10 code E76.29 documented
  • Dosing calculation (1 mg/kg weekly)
  • Infusion site verification
  • Blue Cross prior auth form completed

After Denial:

  • File appeal within 60 days
  • Request peer-to-peer review
  • Gather additional clinical literature
  • Consider external review if internal appeals fail

For Renewal:

  • Submit 60 days before expiration
  • Document ongoing clinical benefit
  • Update functional assessments
  • Confirm continued specialist oversight

FAQ

How long does Blue Cross prior authorization take in Pennsylvania? Standard review takes up to 15 business days, but expedited review is available within 72 hours for urgent cases.

What if Naglazyme isn't on my formulary? You can request a formulary exception by demonstrating medical necessity and lack of therapeutic alternatives for MPS VI.

Can I request an expedited appeal? Yes, if delay in treatment would seriously jeopardize your health or ability to regain maximum function, you can request expedited review at both internal and external appeal levels.

Does step therapy apply to Naglazyme? Generally no, since Naglazyme is the only FDA-approved therapy for MPS VI. However, some plans may require documentation that supportive therapies have been tried.

What if I'm on a Medicare Advantage Blue Cross plan? Medicare Advantage plans follow similar prior authorization processes but may have different appeal timelines and external review procedures.

How much does Naglazyme cost without insurance? The annual cost ranges from approximately $600,000 to $1.8 million depending on patient weight, making insurance coverage essential.

Can family members help with the appeal process? Yes, with proper authorization forms, family members can act as representatives in the appeal process.

What happens if I move between Blue Cross plans in Pennsylvania? You'll need to restart the prior authorization process with your new plan, even if moving between Highmark and Independence Blue Cross.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed responses. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements for medications like Naglazyme, providing the right clinical documentation and payer-specific appeal strategies that significantly improve approval rates.

For families facing Naglazyme denials, services like Counterforce Health can provide the specialized expertise needed to craft compelling appeals that speak directly to Blue Cross Blue Shield's specific coverage criteria and Pennsylvania's regulatory requirements.

Sources & Further Reading

Medical Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Always consult with your healthcare provider about treatment decisions and work with your medical team to determine the most appropriate care plan for your specific situation. Coverage policies and procedures may change; verify current requirements with your insurer and healthcare providers.

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