Drugs and Biological Services Targeted Probe and Educate Review Results

The Jurisdiction F, Part A Medical Review Department is conducting a Targeted Probe and Educate (TPE) review on a variety of drug and biological service codes. The findings of the claims reviewed from January 1, 2025 through March 31, 2025 are as follows:

Review Results

  • 515 claims were reviewed with 3.29% error rate

Top Trending Errors

  • Medical necessity for specific drug or biological on review
  • Documentation requirements
  • Proper modifier use

Educational Resources

Education

Anti-Cancer Drug Documentation Requirements

When submitting documentation for review of anti-cancer drug claims, ensure the documentation clearly supports the patient’s diagnosis, pathology information, any prior or current treatments being completed, and review the FDA label indication(s) and/or drug compendia to determine if any additional documentation is required.

Examples of additional documentation could include, but are not limited to:

  • Prior lines of anti-cancer drugs administered
  • Other drugs being administered in combination with the anti-cancer drug
  • Tumor expressions and biomarker testing
  • Peer-reviewed literature, if applicable

Off-Label Use of Anti-Cancer Drugs

For Medicare coverage of anti-cancer drugs, it is important to consider if the drug being administered is for an approved indication per the Food and Drug Administration (FDA) label. If there is not FDA labeled indication, consider if the indication falls under an off-label, medically accepted indication considering the CMS-approved drug compendia or authoritative medical literature.

There are five drug compendia approved by CMS that are considered authoritative sources for anti-cancer drugs. The use of the drug would need to be listed in the approved compendia and cannot be listed as unsupported, not indicated, or not recommended in the compendia. For example, if a drug is being administered for a particular indication and per the National Comprehensive Cancer Network (NCCN) Drugs and Biologicals Compendia, this falls into a 1 or 2A category, the use of the drug would be covered.

During medical review of anti-cancer drugs, if the documentation supports the drug is not administered per a FDA labeled indication or its use does not meet an off-label, medically accepted indication, the claim will be denied.

For additional information, reference, Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual (MBPM), Chapter 15, Section 50.4.5.

Approved Use of a Drug

Per Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual (MPBM), Chapter 15, Section 50.4.1, "drugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective for purposes of this requirement when used for indications specified on the labeling."

For Medicare coverage, FDA approved drugs or biologicals must: be given on or after the FDA’s approval date; be supported in the submitted documentation to be reasonable and necessary; and other pertinent coverage requirements must be met.

Reasonable and Necessary

Per the Internet Only Manual (IOM), Publication 100-08, Medicare Program Integrity Manual (MPIM), Chapter 3, Section 3.6.2.2 for services with no National Coverage Determination (NCD) or Local Coverage Determination (LCD), Medicare contractors must determine whether services are reasonable and necessary. To determine if a service is reasonable and necessary contractors consider the following information:

  • Safe and effective;
  • It is not experimental or investigational; and
  • Appropriate for patient:
  • Provided within the accepted standards of medical practice for that patient’s diagnosis or treatment;
  • Provided in the appropriate setting;
  • Ordered and provided by the qualified personnel; and
  • Meets the patient’s medical needs

JZ Modifier: Drugs in Single-Dose Containers or Single-Use Packages

The JZ modifier must be appended on all claims that bill for drugs separately payable under Medicare Part B when there are no discarded amounts from single-dose containers or single-use packages. This is effective July 1, 2023, for applicable claims. Appending the JZ modifier attests there were no discarded amounts of the drug administered from a single-dose container.

For additional information on the JZ modifier, reference the:

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