Ann: Ryoncil Pricing Set and Available This Quarter, page-451

Obligating Health Insurers to Cover an FDA-Approved Treatment Before Pricing Is Negotiated

The ability to force an insurer to cover a newly FDA-approved treatment before pricing is set depends on the type of insurance and applicable laws. Here’s a breakdown by insurance category:

1. Private Health Insurance (Employer-Sponsored & Marketplace Plans)

✅ Possible, but challenging

• Private insurers typically determine coverage through medical policies and formularies that assess clinical effectiveness and cost.
• Even if a treatment is FDA-approved, insurers may wait for pricing negotiations before deciding coverage.
• State laws may require quicker coverage for FDA-approved treatments, especially in cancer or rare disease cases.

Options for Patients & Providers

✔ Medical Exception or Appeal – A doctor can argue medical necessity to request early coverage.
✔ State-Level Insurance Commissioner Complaint – If state law mandates coverage, regulators can intervene.
✔ Employer Pressure – If an employer sponsors the plan, they may negotiate coverage directly.

2. Medicare (Traditional & Advantage Plans)

✅ Limited, but possible

• Medicare Part B (doctor-administered drugs) & Part D (prescription drugs) follow CMS reimbursement determinations, which take time after FDA approval.
• National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) influence whether Medicare pays early.

Options for Patients & Providers

✔ Compassionate Use / Expanded Access Programs – Some drugs may be available via patient assistance programs.
✔ Administrative Appeals – If a doctor proves medical necessity, Medicare may approve individual cases.
✔ Congressional or Legal Pressure – In high-profile cases, policymakers may push for faster Medicare coverage.

3. Medicaid (State-Run Programs)

✅ More likely due to federal mandates

• Medicaid must cover FDA-approved drugs that participate in the Medicaid Drug Rebate Program (MDRP).
• However, states can implement prior authorization requirements before formal pricing is set.

Options for Patients & Providers

✔ Medicaid Fair Hearing Request – Patients can challenge denials through a state appeals process.
✔ Legal Challenges – In cases where a state Medicaid program delays access, legal action may force coverage.

4. ACA Plans & Essential Health Benefits

✅ Depends on state mandates & plan policies

• ACA marketplace plans must cover essential health benefits, but they have discretion over which new treatments to include.
• Some states require insurers to cover new FDA-approved treatments faster than federal rules dictate.

Options for Patients & Providers

✔ State Insurance Commissioner Complaint – If state law supports coverage, regulators can intervene.
✔ Expedited Review Requests – Insurers may approve case-by-case exceptions.

Bottom Line

It is possible to push an insurer to cover an FDA-approved treatment before pricing is finalized, but it depends on the type of insurance, applicable laws, and medical necessity arguments.