Knowledge Base Article

When I was growing up, there were lots of television commercials about cigarettes (remember the Marlboro man?), but none about prescription drugs. Things change. Today television commercials featuring tobacco products are banned, but the airwaves are inundated with advertisements for prescription medications. I am not sure that is any wiser choice than the cigarette commercials, but that is the way it is. You may also notice that the generic name of a large number of the medicines advertised end with the letters “mab.” This means the drug is a monoclonal antibody. Even if there had been television advertisements for drugs when I was growing up, they would not have been MABs, because those drugs were not even developed back then. I am sure there are a lot of things that can be said about monoclonal antibodies, but two such statements could be - first, they offer new hope to many with certain conditions and second, “cha-ching!” meaning of course they are expensive drugs.

As a payor of healthcare services, specifically drugs in this case, Medicare wants to ensure the drugs they are paying for are appropriate (medically necessary), administered to the patient, and follow Medicare and evidence-based guidelines. Add this to the high costs of some of these drugs and it is not surprising that a number of Medicare Administrative Contractors (MACs) are auditing certain drugs under their Targeted Probe and Educate (TPE) audits. Specifically, Palmetto GBA (Jurisdictions J and M) and Novitas (Jurisdictions H and L) include the review of several drugs in their TPE Medical Reviews. As the name indicates, TPE reviews focus on individualized provider education. The MACs also offer educational resources that are available to all through their websites. Palmetto has recently added the following “checklists” for drugs to their website as well as an article about Prolia (Denosumab).

Neulasta Checklist

Prolia Checklist 

Rituxan Checklist 

Remicade Checklist 

Avastin Checklist 

These checklists include the basic requirements for the billing of any drug administered to outpatients –

• A signed and dated physician’s order that includes the dosage, frequency, and route of administration
• Documentation supporting the need for the drug and the patient’s diagnosis – this may require the hospital to obtain the physician’s office notes discussing the patient’s condition and treatment
• The units billed, the units ordered, and the units administered to the patient must all match
• A protocol was followed as specified in the package insert (FDA approved) or in accepted drug compendia for off-label uses
• Medicare and MAC-specific coverage requirements for the drug are met
• The medical record includes documentation of the administration of the drug with date, time, route, dose, and patient response

Some drugs require additional documentation such as the patient’s weight or body surface area to calculate dosage or other documentation based on coverage requirements. For example, the drug Prolia (denosumab) requires documentation the patient is taking calcium and vitamin D supplements or the reasons why not and documentation the patient has had an x-ray or DEXA scan.

The benefit of these checklists is that if you use them and make sure you submit all of the required documentation upon request for records for Medicare review, your chances of being paid by Medicare are much better than if you didn’t follow a checklist. Is this a Medicare contractor being nice to providers?!? Well, things change.