Medical Necessity Determination
Medical necessity determination criteria are created by Horizon NJ Health’s committee of doctors and pharmacists. The Committee uses guidance from the U.S. Food and Drug Administration (FDA) and other approved medical information to create the criteria. Certain drugs may be subject to a review based on medical need. The review makes sure that the drugs ordered by your doctor to treat your health condition are medically needed and correct.
Drugs may be reviewed because of the high risk of misuse or abuse, safety concerns, or high-cost. The medical necessity determination process is made up of Drug Quantity Limits, Drug Utilization (Use) Review (DUR), and Prior Authorization/Approval (PA)/Medical Necessity Determination (MND).
- Drug Limits. Certain prescription and non-prescription drugs (over-the-counter) may have set quantity, duration, age, sex and dose limits. These limits make sure drugs are used safely and effectively. If the ordered drug goes over the set limits, your doctor may request an exception if he or she feels that the drug is medically needed to treat your condition.
- Drug Utilization (Use) Review (DUR). Members may see many doctors and use many pharmacies. The DUR process helps to spot drug safety issues such as drug interactions, drug duplications, and incorrect doses. A computer created safety flag is sent to your pharmacist if a safety issue is found. Before giving you the ordered drug, your pharmacist may contact your doctor to talk about the possible safety concern.
- Prior Authorization/Approval (PA)/Medical Necessity Determination (MND). Certain prescription and non-prescription (over-the-counter) drugs may require your doctor to ask for a prior authorization/approval (PA)/Medical Necessity Determination (MND) before your drug is covered. The following may be reasons why your doctor may need to ask for a PA/MND on your behalf:
- Generic Substitution. The FDA approves generic drugs that are safe and work in the same way as the brand-name drugs. You will have to use generic drugs if available before the brand-name drugs are considered for approval. Your doctor may request an exception if he or she orders a brand-name drug for which a generic is available. Your doctor will need to show that the brand-name drug is medically needed to treat your condition.
- Non-Formulary (non-preferred) Drugs. The prescription drug list contains formulary (preferred) drugs. Formulary (preferred) drugs in many cases do not require that your doctor call and ask for special permission to get the ordered drug. Non-formulary (non-preferred) drugs are not included in the prescription drug list. You may have to try certain formulary (preferred) drugs before coverage is considered for non-formulary (non-preferred) drugs. Your doctor will need to give clinical information if he or she orders a non-formulary (non-preferred) drug. The information will need to show that the ordered drug is medically needed to treat your condition.
- Step Therapy. Step therapy requires you to use a “first-line” drug before using a “second-line” drug to treat the same health condition. If your doctor orders a “second-line” drug he or she will need to give clinical information to show that the drug is medically needed to treat your condition.