icd code for "off-label" use

Full Answer

What is the difference between off label and indication?

An off-label/unlabeled use of a drug is defined as a use for a non-FDA approved indication, that is, one that is not listed on the drug's official label/prescribing information. An indication is defined as a diagnosis, illness, injury, syndrome, condition, or other clinical parameter for which a drug may be given.

What is off-label use?

Off-label use is further defined as giving the drug in a way that deviates significantly from the labeled prescribing information for a particular indication. This includes but is not necessarily limited to, dosage, route of administration, duration and frequency of administration, and population to whom the drug would be administered.

What is off-label use of oncology drugs?

Off-label use of oncology drugs is common and has long been the focus of controversy. Payers are often confused by the broad use of a therapeutic agent across seemingly unrelated diagnoses. They look to the FDA label for guidance on the specific use of a drug, yet these indications are often narrow and outdated.

Are off-label indications covered by the compendia?

If an off-label indication is listed in any of the compendia as being supported at a given level of evidence—and is not defined by any one of the compendia as being useless—then that indication should be covered.

What is an off-label diagnosis?

Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is: Used for a disease or medical condition that it is not approved to treat, such as when a chemotherapy is approved to treat one type of cancer, but healthcare providers use it to treat a different type of cancer.

Does Medicare cover off labels?

Medicare Part D covers drugs prescribed for off-label use only if the drugs are identified as safe and effective for that use in one of three officially recognized drug compendia. "Compendia" are encyclopedias of drug chemicals, with information on dosage and usage.

Is off-label use covered by insurance?

The biggest problem is getting insurance plans to pay (reimburse) for off-label drug use. Many insurance companies will not pay for an expensive drug that's used in a way that's not listed in the approved drug label. They do this on the grounds that its use is “experimental” or “investigational.”

What is off labeling prescribing?

Off-label prescribing is when a physician gives you a drug that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different than your condition. This practice is legal and common. In fact, one in five prescriptions written today are for off-label use.

Does Medicare cover non FDA-approved drugs?

Q: Does Medicare forbid physicians to use drugs for indications not approved by the FDA? A: No, Medicare does not stand in the way of medical advancements. However, several issues present when a physician elects to use a drug in an unlabeled fashion.

Does insurance cover non FDA-approved drugs?

Policy: Coverage is subject to the terms, conditions, and limitations of the member's contract. Prescription drugs that are commercially available but not approved by the FDA are not considered a covered benefit.

What is an example of an off-label drug?

Examples of medications that are frequently prescribed off-label for children include drugs that treat gastrointestinal (GI) conditions, as well as antidepressants, antibiotics, and respiratory treatments.

Is off-label use an adverse event?

Off-label prescribing of drugs is common1,2 and has been identified as a potentially important contributor to preventable adverse drug events (ADEs).

What drugs are commonly used off-label?

Clinical indications associated with on-label and off-label uses for top 14 drugsRankDrug (brand name)Most common off-label use2Warfarin (Coumadin)Hypertensive heart disease3Escitalopram (Lexapro)Bipolar4Risperidone (Risperdal)Bipolar, maintenance5Montelukast (Singulair)COPD10 more rows•Nov 24, 2008

Is FDA approval required for off-label use?

Off-label drug use involves prescribing medications for an indication, or using a dosage or dosage form, that has not been approved by the FDA. Since the FDA does not regulate the practice of medicine, OLDU has become common.

Can doctors prescribe off-label medication?

The practice, called "off-label" prescribing, is entirely legal and very common. More than one in five outpatient prescriptions written in the U.S. are for off-label therapies. "Off-label" means the medication is being used in a manner not specified in the FDA's approved packaging label, or insert.

What is a non labeled indication?

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.

What are the recognized Medicare compendia?

Based on the process for revising the list of compendia established in 2008, CMS currently recognizes the following four compendia: American Hospital Formulary Service-Drug Information (AHFS-DI), Truven Health Analytics Micromedex DrugDEX (DrugDEX), National Comprehensive Cancer Network (NCCN) Drugs and Biologics ...

Does Medicare pay for Provigil?

Yes. 86% of Medicare prescription drug plans cover this drug.

Does Medicare cover ondansetron?

Yes. 100% of Medicare prescription drug plans cover this drug.

General Information

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Article Guidance

This First Coast Billing and Coding Article for Local Coverage Determination (LCD) L33915 Label and Off-label Coverage of Outpatient Drugs and Biologicals provides billing and coding guidance for frequency limitations as well as diagnosis limitations that support diagnosis to procedure code automated denials.

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Revenue Codes

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