By Counterforce Health Team in Cerezyme (imiglucerase) —

How to Get Cerezyme (Imiglucerase) Covered by Aetna CVS Health in New York: Complete Guide to Prior Authorization and Appeals

Answer Box: Getting Cerezyme Covered by Aetna CVS Health in New York

Cerezyme (imiglucerase) requires prior authorization from Aetna CVS Health in New York. The fastest path to approval involves three key steps: 1) Your doctor must document confirmed Gaucher disease diagnosis via enzyme or genetic testing, 2) provide evidence you've tried and failed Elelyso (taliglucerase alfa) or have a contraindication, and 3) submit the Aetna Cerezyme precertification form with complete clinical documentation. If denied, you have strong appeal rights in New York including 72-hour expedited external review through the Department of Financial Services.

Start today: Contact your prescribing physician to begin the prior authorization process and gather documentation of your Gaucher disease diagnosis and prior treatment history.

Table of Contents

Why New York State Rules Matter

New York's insurance laws provide some of the strongest patient protections in the country for specialty medications like Cerezyme. Unlike many states, New York requires specific timelines for prior authorization decisions, mandates medical exceptions to step therapy protocols, and offers binding external appeals through an independent review process.

These state protections work alongside—and sometimes override—Aetna CVS Health's standard policies. For New York residents, this means faster decision timelines, clearer appeal rights, and additional consumer assistance programs that can significantly improve your chances of getting Cerezyme covered.

Note: These protections apply to most commercial insurance plans in New York, but self-funded employer plans may be governed by federal ERISA law instead. Check with your HR department if you're unsure about your plan type.

Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Cerezyme prescriptions Aetna provider portal or fax 1-888-267-3277 Aetna PA List
Diagnosis Confirmation Enzyme assay or genetic testing for Gaucher disease Medical records, lab reports Aetna Cerezyme Policy
Step Therapy Must try Elelyso first or document exception Provider notes, failure documentation Aetna Cerezyme Policy
Specialist Requirement Typically requires hematologist or geneticist Provider credentials verification Aetna medical policies

Step-by-Step: Fastest Path to Approval

  1. Confirm Your Diagnosis (Patient + Doctor)
    • Gather enzyme assay results showing beta-glucocerebrosidase deficiency OR genetic testing confirming Gaucher disease
    • Expected timeline: Same day if records are available
    • FDA Cerezyme Label
  2. Document Step Therapy History (Doctor)
    • Provide records of Elelyso trial and failure/intolerance, OR medical contraindication
    • Include specific adverse events, lack of efficacy, or clinical reasons why Elelyso isn't appropriate
    • Expected timeline: 1-2 days to compile records
  3. Complete Prior Authorization Form (Doctor's Office)
  4. Track Your Request (Patient)
    • Aetna must respond within 72 hours for standard requests in New York
    • For urgent cases, request expedited review (24-hour turnaround)
    • Follow up if you don't hear back within the timeline

Step Therapy Protections

New York Insurance Law Section 4903 provides strong protections against inappropriate step therapy requirements. Your doctor can request a medical exception if:

  • Contraindication exists: Elelyso would cause adverse reactions or harm
  • Expected ineffectiveness: Based on your medical history or condition
  • Prior failure: You've previously tried Elelyso (or similar drugs) without success
  • Current stability: You're doing well on Cerezyme and switching would be disruptive
  • Clinical barriers: Step therapy would create adherence problems or worsen other conditions

Documentation That Helps

When requesting a step therapy override, your physician should include:

  • Specific medical reasons why Elelyso isn't appropriate
  • Documentation of any prior enzyme replacement therapy trials
  • Current clinical status and treatment goals
  • Risk assessment of therapy interruption or change

Timeline: Aetna must decide step therapy override requests within 72 hours (24 hours for urgent cases) under New York law.

Appeals Process and Timelines

Internal Appeals with Aetna CVS Health

If your initial prior authorization is denied, you have the right to appeal:

Standard Appeals:

  • Must be filed within 180 days of denial
  • Aetna has 30 days to respond (non-urgent) or 72 hours (urgent)
  • Can be filed by phone, online, or mail

Expedited Appeals:

  • For urgent medical situations
  • Must be decided within 72 hours
  • Available when delay could seriously jeopardize your health

Required Information for Appeals

  • Original denial letter
  • Additional medical records supporting medical necessity
  • Provider letter explaining why Cerezyme is clinically appropriate
  • Documentation of Gaucher disease diagnosis
  • Evidence of step therapy compliance or exception criteria

External Review Rights

New York offers one of the strongest external appeal processes in the country through the Department of Financial Services (DFS).

When You Can File External Appeals

  • After receiving final denial from Aetna's internal appeal process
  • For denials based on "not medically necessary," "experimental," or similar grounds
  • Within 4 months of the final internal denial

External Appeal Timeline

  • Standard review: Decision within 30 days
  • Expedited review: Decision within 72 hours for urgent cases
  • Ultra-expedited: 24 hours for urgent drug denials that could cause serious harm

How to File

  1. Complete the DFS External Appeal Application
  2. Include all medical records and supporting documentation
  3. Pay $25 filing fee (waived for Medicaid and financial hardship cases)
  4. Submit online through DFS portal or by mail
Important: External appeal decisions are binding on Aetna. If you win, they must cover the treatment and refund your filing fee.

Continuity of Care Protections

If you're currently receiving Cerezyme and Aetna changes its formulary or your doctor leaves their network, New York law protects your access to continued treatment.

Your Rights

  • 90-day transition period at current cost-sharing levels
  • Protection applies to serious and complex conditions (including Gaucher disease)
  • Coverage continues while you transition to new provider or medication

How to Activate Protections

  1. Notify Aetna immediately when you learn of formulary changes or provider network changes
  2. Request continuity of care coverage citing New York state law
  3. Have your doctor document that changing treatment could cause serious harm
  4. Submit transition of care request form

For assistance, contact the New York Attorney General's Health Care Bureau.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Key Documents
"Not medically necessary" Provide FDA-approved indication evidence, specialist letter FDA label, clinical guidelines, provider attestation
"Step therapy not completed" Request medical exception under NY Law 4903 Prior trial documentation, contraindication evidence
"Experimental/investigational" Cite FDA approval and standard-of-care guidelines FDA approval letter, medical society guidelines
"Non-formulary drug" Request formulary exception with medical necessity Comparative effectiveness data, specialist recommendation

Sample Appeal Language

When appealing a Cerezyme denial, include language like:

"This appeal requests coverage for Cerezyme (imiglucerase) for the treatment of confirmed Type 1 Gaucher disease. Cerezyme is FDA-approved for this indication and represents standard-of-care enzyme replacement therapy. The patient has documented [enzyme deficiency/genetic confirmation] and has [tried and failed Elelyso/has contraindications to Elelyso]. Under New York Insurance Law Section 4903, step therapy requirements should be waived when [cite specific exception criteria]. Denial of this medically necessary treatment violates New York state coverage requirements."

When to Contact State Regulators

Contact New York regulators when:

  • Aetna violates state-mandated timelines (72 hours for step therapy, etc.)
  • Multiple appeals are denied without adequate medical review
  • You experience delays that could harm your health
  • Aetna refuses to honor external appeal decisions

Key Contacts

  • New York Department of Financial Services: File complaints about insurance practices
  • Community Health Advocates: Free assistance at (888) 614-5400
  • New York Attorney General: Health care insurance complaints and continuity of care issues

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Their platform helps patients and providers navigate complex prior authorization requirements and appeals processes more effectively.

From our advocates: "We've seen Gaucher disease patients succeed with appeals by focusing on three key elements: rock-solid diagnosis documentation, clear evidence of step therapy compliance or valid exceptions, and detailed specialist letters explaining why Cerezyme is clinically superior to alternatives for their specific case. The combination of strong medical evidence and knowledge of New York's patient protection laws significantly improves approval odds."

Resources and Next Steps

Immediate Action Items

  • Contact your prescribing physician to initiate prior authorization
  • Gather Gaucher disease diagnosis documentation (enzyme assay or genetic testing)
  • Document any prior enzyme replacement therapy trials
  • Review your Aetna plan documents for specific coverage policies

Financial Assistance

  • Sanofi Patient Support: Copay assistance and patient access programs
  • National Gaucher Foundation: Financial assistance and advocacy resources
  • New York State Medicaid: May provide coverage if eligible

Professional Support

For complex cases involving multiple denials or urgent medical needs, consider working with Counterforce Health, which specializes in transforming insurance denials into targeted appeals using plan-specific policies and evidence-based medical arguments.

Frequently Asked Questions

How long does Aetna prior authorization take in New York? Standard requests: up to 72 hours. Urgent requests: 24-72 hours depending on clinical circumstances.

What if Cerezyme isn't on Aetna's formulary? You can request a formulary exception with supporting medical documentation. New York law requires insurers to have exception processes for non-formulary medications.

Can I get expedited review for Cerezyme appeals? Yes, if your doctor certifies that delay could seriously jeopardize your health. Both Aetna internal appeals and New York external appeals offer expedited timelines.

Does step therapy apply if I tried Elelyso outside of New York? Yes, prior trials under any insurance plan count toward step therapy requirements. Provide documentation from your previous insurer and medical records.

What happens if I lose my external appeal? External appeal decisions are final and binding. However, you may have options through other regulatory channels or if new medical evidence becomes available.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations can change. Always consult with your healthcare provider and insurance plan for the most current requirements and your specific situation. For personalized assistance with insurance appeals, contact Community Health Advocates at (888) 614-5400 or visit the New York Department of Financial Services website.

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