Oncology & Hematology Coding Alert

Repeating a single mistake can lead to more than $100,000 in overpayments.

Herceptin units are under nationwide scrutiny by the Office of Inspector General (OIG). Here’s a look at the mistakes practices are making and the steps you can take to avoid those traps.

Focus on Units Actually Administered

Herceptin’s indications include treating breast cancer and metastatic gastric cancer, and that means you need to keep your oncology coding team on top of Herceptin reporting rules. Be sure to share this key lesson from the OIG’s recent reports on Herceptin payments: You should report units of Herceptin based on the amount administered. You should not report wasted amounts from the 440 mg multi-use vial, according to Medicare rules.

The examples below reveal how reporting incorrect units can lead to costly refund issues.

Example 1: Suppose staff administers 100 mg of Herceptin to a patient from a 440 mg multi-use vial. The appropriate code for Herceptin is J9355 (Injection, trastuzumab, 10 mg). How many units should you report?

Right: For 100 mg, you should report 10 units of J9355. Each unit of J9355 represents 10 mg. If you divide the 100 mg administered by the 10 mg in the definition, the solution is 10 units.

Wrong: You should not report 44 units to represent the complete 440 mg multi-use vial. One provider made this error 23 times for a single patient, resulting in a $44,102 overpayment, states the OIG’s report on J10 MAC Cahaba claims (https://oig.hhs.gov/oas/reports/region4/41203070.pdf).

Example 2: If a patient receives 85 mg of Herceptin from a 440 mg multi-use vial, how many units should you report?

Right: The correct number of units is 9. Divide the 85 mg administered by the 10 mg in the HCPCS definition to get 8.5. You should round up 8.5 and report 9 units.

Wrong: Reporting 44 units to claim all 440 mg when only 85 mg are administered would be incorrect. The OIG presented an example of a provider who claimed 44 units, instead of 9 units, 69 different times for a single patient, resulting in WPS sending an extra $119,493 (https://oig.hhs.gov/oas/reports/region5/51100114.pdf).

Example 3: How many units should you report when staff administers 130 mg of Herceptin from a 440 mg multi-use vial?

Right: You should report 13 units of J9355 to claim 130 mg administered.

Wrong: You should not report 44 units when only 130 mg are administered. The OIG audit of J1 claims, now under Palmetto, revealed one provider made this mistake 98 times for one patient (https://oig.hhs.gov/oas/reports/region9/91202069.pdf). As a result, the provider received $218,486 instead of the correct amount of $64,552. That’s an overpayment of $153,934 that needs to be returned.

Understand Why You Can’t Report Waste

If you know the reason why you should report the amount administered, rather than the complete vial, you’re more likely to remember to apply the rule to your claims.

The rule: “Multi-use vials are not subject to payment for discarded amounts of drug or biological,” according to Medicare Claims Processing Manual, Chapter 17, Section 40 (www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf).

Application: Herceptin comes in 440 mg multi-use vials. Because discarded amounts of multi-use vials aren’t subject to Medicare payment, you should report only the amounts actually administered to patients.

The confusion probably stems from the fact that Medicare will pay for discarded amounts of single-use vials. The Manual states: “When a physician, hospital or other provider or supplier must discard the remainder of a single use vial or other single use package after administering a dose/quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label.”

So for proper reporting of any drug or biological, you need to distinguish multi-use vials (for which waste IS NOT reportable to Medicare) from single-use vials (for which waste IS reportable to Medicare; note that the payer may require use of modifier JW [Drug amount discarded/not administered to any patient]).

If you’re unsure, the packaging for the administered agent should clarify whether it is intended as a single-use or multi-use vial. For instance, the package insert for Herceptin refers to it as a multi-dose solution (www.accessdata.fda.gov/drugsatfda_docs/label/2000/trasgen020900lb.htm).

Prevent Denials by Applying OIG Ideas

To help increase your chances of submitting pristine Herceptin claims, adapt the OIG’s recommendations to payers into strategies that work for your practice.

Unit edits: The OIG recommended that payers create “system edits that identify for review multiuse-vial drugs that are billed with units of service equivalent to the dosage of an entire vial(s),” stated the reports addressed to Cahaba, WPS legacy payers, and Palmetto (links above), as well as to National Government Services in a pilot study (https://oig.hhs.gov/oas/reports/region5/51000091.asp).

For Herceptin, that means identifying for review units of service that are multiples of 44 to detect when providers report a complete vial. Cahaba, for example, commented that it would “put into place an edit to identify dosage units of 44, 88, 132, and 176.”

Consider creating your own system to catch when you enter 44, 88, 132, or 176 units of Herceptin so you can double check that the units are correct. If your payer has similar edits, the alert can also remind you to prepare an appeal with proof of medical necessity and an infusion log showing the units are correct.

Education: The OIG also recommended to all the payers that the audit results be used in provider education.

In your practice, take the time to educate all those connected to documenting and reporting Herceptin use on the rules for calculating units and the rules for reporting drugs from multi-use vials and single-dose vials.

You also should include infusion schedule considerations as part of your team’s multi-use vial education. When Herceptin is reconstituted as directed and stored properly, it should be stable for 28 days. That means a practice has almost an entire month to schedule multiple patients who require Herceptin.

“Multiple patients can receive their correct dose from one multi-use vial,” said CMS contractor NHIC Corp. in the article “Submitting Claims Correctly for Multi-Use Vial Medications.” “Providers careful to schedule patients who will be receiving these multi-use vial packaged medications within the effective shelf life of a given vial of medication will keep wastage at an absolute minimum” (www.medicarenhic.com/providers/articles/J14mutliusvials.pdf).