Drug and Biological Services Targeted Probe and Educate Review Results

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

Review Results

  • 242 claims were reviewed with 7.64% error rate

Top Trending Errors

  • Medical necessity of the specific drug or biological on review
  • Documentation Requirements
  • Proper Modifier Use

Educational Resources

Education

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

Immune Globulin Intravenous (IVIg)

IVIg is covered by Medicare if Local Coverage Determination (LCD) L34314 (JE) requirements are met. Careful review of the LCD is needed to ensure all appropriate documentation is submitted for review. Each covered indication has documentation required in order to support payment. Some examples include:

  • Neurology consult, as applicable
  • Physician notes
  • Prior therapies trialed and failed
  • Diagnostic and/or laboratory evidence

If a patient is receiving IVIg for an off-label indication not listed in the LCD, an appeal of a denied claim should be submitted for individual patient consideration by the contractor medical director.

For additional information, reference Immune Globulin Intravenous (IVIg) LCD L34314 (JE).

Leqvio® (inclisiran)

As referenced in the Food and Drug Administration (FDA) prescribing information, Leqvio® is a small interfering subtilisin kexin type 9 (PCSK 9) mRNA indicated as an adjunct to diet and exercise to treat hypercholesterolemia including heterozygous familial hypercholesterolemia (HeFH). It is used to reduce low-density lipoprotein cholesterol (LDL-C) in adults.

Documentation must support diet and exercise are being addressed for patient’s receiving Leqvio®. To support this FDA label requirement, some examples of documentation that may be submitted include:

  • Practitioner notes with statement addressing diet and exercise
  • Referral to dietician
  • Dietician notes

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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