Understanding insurance coverage
Navigating the insurance coverage process for healthcare expenses can be challenging and time consuming. The NPKUA is here to provide resources to make it easier for you and your family.
Your health insurance plan may change from year to year depending on who you get your health care coverage from. You need to know what is and is not covered under your current plan, and how to best understand your coverage.
Coverage for PKU-related medical foods varies from state to state. Some states have passed legislation to mandate insurance coverage for medical foods, while others provide medical formula and some low protein foods directly to PKU patients through newborn screening or state health department programs.
Insurance section of My PKU Binder
| Fully-Insured Employer Plan | Self-Funded Employer Plan |
|---|---|
Your insurance company (e.g., Aetna, BCBS, Cigna, Kaiser, etc) manage most of the financial risk for claims submitted by your company’s employees. |
Your insurance company (e.g., Aetna, BCBS, Cigna, Kaiser, etc) serves as an administrative coordinator. The insurance carrier will process employee claims. But the carrier does not assume financial risk for claims submitted. |
The health insurance company collects a monthly premium from each enrolled employee. Your employer pays this premium for coverage/network access. |
The insurance company is paid a fee to manage the administration of your employer’s self-funded plan. The insurance company’s role is to coordinate and process claims. |
If the claims submitted by the employees exceed the premium paid by the employer, the insurance company manages the excess costs. |
The employer is responsible for funding most of the financial claims submitted by employees. Your employer takes on most of the financial risk for all of the claims submitted by their employees. |
Providers, doctors, and hospitals are paid based on the negotiated rate set between the provider and your health insurance carrier. |
Providers, doctors, and hospitals are paid by your insurance company on behalf of your employer. The bills are paid from your company’s piggy bank. |
Fully insured plans are governed by most state laws. |
Self-insured plans are governed by ERISA, a federal law. Local governments are prohibited from applying state-level regulation on self-insured plans. |
Insurance Language
It’s important to understand insurance terminology. When dealing with your insurance carrier the language changes from simple questions to abbreviations and codes. It’s important for you to understand their terminology. Here are some examples:
Medical Foods, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.
Enteral Formula is a liquid food product that is specially formulated and designed to increase the amount of various food elements and nutrients that will maintain proper physiological function of the body (medical formula)
Durable Medical Equipment (DME)/Medical Supplies are equipment and supplies ordered by a health care provider for everyday or extended use.
HCPCS Codes/Service Code (Healthcare Common Procedure Coding System) is a uniform coding system consisting of descriptive terms and identifying codes that are used primarily to identify medical services and procedures.
Prior-Authorization/Pre-Certification is approval from a health plan that may be required before you get a service or fill a prescription in order for the service or prescription to be covered by your plan.
Exclusions are a provision within an insurance policy that eliminates coverage for certain acts, property, types of damage or locations.
Co-insurance is an insured individual’s share of the costs of a covered expense.
Deductible is a specified amount of money that the insured person must pay before an insurance company will pay a claim.
Out-of-Pocket expense is your expenses for medical care that aren’t reimbursed by insurance, including deductibles, coinsurance, and co-payments for covered services plus all costs for services that aren’t covered.
Annual Max is the annual limit of the total benefits an insurance company will pay in a year while an individual is enrolled in a particular health insurance plan.
Fully-Insured is a plan where your employer purchases insurance from an insurance company.
Self-funded is a plan where your employer provides health benefits directly to employees.
Patient Assistance Programs
Many companies offer guidance and sources of support for insurance coverage for their products and navigating PKU. See some resources below:
| Organization | Category | Reimbursement Contact |
|---|---|---|
| Abbott Pathway Plus | Medical Food Products | Website: www.pathwayreimbursement.com |
| BioMarin Rare Connections | Pharmaceutical | |
| CAMBROOKEcare | Medical Food Products | |
| Coram Healthcare | Self-Pay Pricing for uninsured & Financial Hardship Program for insured people that can’t afford their co-pay/co-ins. | 1-888 334-7978 (option #1 New Referral) |
| Cycle Vita | Copay Assistance Programs, Reimbursement Program, and more. | Website: https://javygtor.com/patient/cycle-vita/hub-support/ |
| Endo International (formerly PAR Pharmaceutical) Patient Assistance Resource | Patient Assistance program Copay Assistance | Patient Assistance: 1-833-727-4357, option 3 |
| KUVAN Patient Assistance Program (K-PAP) | Kuvan® access and insurance assistance | Website: www.kuvan.com |
| Mead Johnson Helping Hands | Medical Food Products | Website: www.enfamil.com |
| Medicaid – Medical Needy Programs | For people who are not eligible for Medicaid. Contact your local department of Human Services, for assistance with Medically Needy programs (spend-down). | www.medicaid.gov (Click on State Profiles, then the website above) |
| National Organization for Rare Disorders (NORD) | Patient Advocacy General and Appeal Assistance Co- Pay Assistance, Premium Assistance, Medical Assistance and Medical Food & Formulas | Website: https://rarediseases.org/patient-assistance/ (search PKU) Contact: 1-855-628-0646 This program does not offer assistance with medical foods. |
| Nutricia Metabolics | Medical Food Products | Website: https://www.nutriciametabolics.com/formula-coverage/ |
| Patient Advocacy Foundation | Patient Advocacy General and Appeal Assistance | Website: www.patientadvocate.org Call: 1-800-532-5274 |
| Vitaflo Fomula4Success | Medial Food Products | Website: www.vitaflo4success.com |
| Eton Pharmaceuticals | Medical Food Products / Pharmaceuticals | Website: https://www.pkugolike.com/support |
The NPKUA has sample letters to help you:
Letter of Medical Necessity
Letter of Medical Exclusion Removal