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 July 1, 2025 through September 30, 2025 are as follows:

Review Results

  • 764 claims were reviewed with 5.0% error rate

Top Trending Errors

  • Medical necessity of 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

Indications and Usage of Prolia® (denosumab)

As referenced in the Food and Drug Administration (FDA) prescribing information, Prolia® is a RANK ligand (RANKL) inhibitor indicated for treating:

  • Postmenopausal women with osteoporosis at high risk for fracture
  • Men with osteoporosis at high risk for fracture
  • Glucocorticoid induced osteoporosis in men and women at high risk for fracture
  • Men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • Women receiving adjuvant aromatase inhibitor therapy for breast cancer at high risk for fracture

Documentation must include appropriate imaging commonly supported by dual-energy x-ray absorptiometry (DEXA) to support the indication for Prolia®. Per the World Health Organization, osteoporosis is supported with a bone density score that is 2.5 standard deviations or more below the young adult mean or a T score of < -2.5. If imaging has improved with the use denosumab, but continued use is warranted, documentation must support a previous finding supporting an approved indication.

Prolia® may also be appropriate for patients at high risk for fractures. Examples of patients with a high risk for fracture include but are not limited to:

  • Patients with osteopenia and a bone density between 1-2.5 standard deviations below the young adult mean or a T score of -1 to -2.5 and a history of a fragility fracture
  • Patients with a high fracture risk assessment (FRAX) score defined as a 10-year probability of a major osteoporosis related fracture of > 20% or hip fracture of > 3%.

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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