Pre-Payment Review Results for Privigen for Q4 2025

Published 03/17/2026

Pre-Payment Review Results for Privigen® (Immune Globulin) for Targeted Probe and Educate (TPE) for October through December 2025

The Centers for Medicare & Medicaid Services (CMS) implemented the TPE process for Healthcare Common Procedure Coding System (HCPCS) code J1459 for Privigen®. The reviews with edit effectiveness are presented here for Alabama, Georgia and Tennessee.

Cumulative Results

Table 1. Cumulative Results.

Number of Providers with Edit Effectiveness

Providers Compliant Completed/Removed After Probe

Providers Non-Compliant Progressing to Subsequent Probe

Providers Non-Compliant/Removed for Other Reason
16 15 1 0
Table 2. Cumulative Results.

Number of Claims with Edit Effectiveness

Number of Claims Denied

Overall Claim Denial Rate

Total Dollars Reviewed

Total Dollars Denied

Overall Charge Denial Rate
80 16 20% $1,885,555.90 $81,945.07 4%

Probe One Findings

Table 3. Probe One Findings.

State

Number of Providers with Edit Effectiveness

Providers Compliant Completed/Removed After Probe

Providers Non-Compliant Progressing to Subsequent Probe

Providers Non-Compliant/Removed for Other Reason
Ala. 4 4 0 0
Ga. 8 7 1 0
Tenn. 4 4 0 0
Table 4. Probe One Findings.

State

Number of Claims with Edit Effectiveness

Number of Claims Denied

Overall Claim Denial Rate

Total Dollars Reviewed

Total Dollars Denied

Overall Charge Denial Rate
Ala. 80 2 3% $365,266.44 $11,691.03 3%
Ga. 178 10 6% $861,550.44 $39,888.96 5%
Tenn. 85 4 5% $658,739.02 $30,365.08 5%

Risk Category

The categories for HCPCS code J1459 for Privigen® (Immune Globulin) are defined as:

Table 5. Risk Category.
Risk Category Error Rate
Minor 0–20%
Major 21–100%

Figure 1. Risk Category for Privigen HCPCS J1459.

Pie chart showing 6 percent major and 94 percent minor

Top Denial Reasons

Table 6. Top Denial Reasons.
Percent of Total Denials Denial Code Denial Description Number of Occurrences
38% 5D164, 5H164 No Documentation of Medical Necessity 3
25% 5D199, 5H199 Billing Error Associated with Inaccuracy or Billing Error Not Supportive of the Expected Length of Stay that is Less Than 2 Midnights 2
2% 5DMDP, 5HMDP Dependent Services Denied (Qualifying Service Denied Medically) 2
1% 5D151, 5H151 Units Billed More Than Ordered 1

Denial Reasons and Recommendations

5D164, 5H164 — No Documentation of Medical Necessity

Reason for Denial
This claim was denied because the documentation submitted does not support the medical necessity of the service reviewed. The records did not contain any covered condition/indication, symptomology or diagnostic results that would support the service was reasonable and necessary for the treatment of the beneficiary.

How to Avoid This Denial

  • Submit all documentation related to the services billed which support the medical necessity of the services. Documentation should support:
    • A covered indication or condition for the service billed
    • A physician or non-physician practitioner is managing the care of the covered indication or condition billed is documented in the record 
    • Any medical history that supports a need for the service
    • Any diagnostic results or symptomology that supports a need for the service
    • Legible documentation 
  • Submit all documentation to support ongoing skills of a qualified therapist were required to complete the treatment and that the initiation of therapy treatment services were medically necessary
  • Advance Beneficiary Notice (ABN) is valid, complete and submitted in the record if applicable
  • A legible physician or non-physician provider signature is required on all documentation necessary to support medical necessity
  • Use the most appropriate ICD-10-CM codes to identify the beneficiary’s medical diagnosis
  • Submit treatment note documentation that contains date of treatment, description of modality/procedure to support accurate billing, total treatment minutes/total timed code treatment minutes and signature of qualified professional
  • Documentation to include the therapy discharge note and summary
  • All documentation submitted is legible

References

5D199, 5H199 — Billing Error Associated with Inaccuracy or Billing Error Not Supportive of the Expected Length of Stay that is Less Than Two Midnights

Reason for Denial
The medical record documentation does not support the admitting physician/other qualified health care practitioner determination that the patient required inpatient care despite an expected length of stay that is less than two midnights.

How to Avoid This Denial

  • Documentation submitted should support the expected length of stay of less than two midnights
  • Documentation in response to the ADR corresponds with the expected length of stay of less than two midnights and the dates of service billed

References

5D199, 5H199 — Billing Error Associated with Inaccuracy

Reason for Denial
The services billed were not covered because the documentation provided did not support the claim as billed by the provider.

How to Avoid This Denial

  • Check all bills for accuracy prior to submitting to Medicare
  • Ensure that the documentation submitted in response to the ADR corresponds with the date the service was rendered and the dates of service billed

References

5DMDP, 5HMDP — Dependent Services Denied (Qualifying Service Denied Medically)

Reason for Denial
The dependent services will not be covered if the qualifying service has been denied. For example, the service was denied as documentation did not support medical necessity, and therefore all other charges associated with the service under review cannot be allowed and will be denied as dependent to the medical denial of the qualifying service.

How to Avoid This Denial

  • Ensure the documentation provided supports the services were reasonable and medically necessary for the treatment of the beneficiary
  • Ensure all records are properly and legibly signed
  • Ensure documentation supports the service(s) was rendered

References

5D151, 5H151 — Units Billed More Than Ordered

Reason for Denial
The medical record provided for the outpatient service did not support the number of units billed on the claim. Per the documentation, more units were billed than provided.

How to Avoid This Denial
Under the Outpatient Prospective Payment System (OPPS), when HCPCS code reporting is required, the number of times the service or procedure was performed, or the amount of the service used, must also be accurately reported in the service units.

  • For time-based general outpatient services, make sure the start and end time or total length of the service is documented clearly in the record
  • For other general outpatient services, make sure the amount of the service is documented clearly in the record
  • When reporting drugs or biologicals, make sure the amount of the drug given is clearly documented and properly converted into units when submitted for payment
  • For outpatient therapy services, make sure the timed treatment minutes/unit(s) for the timed services provided are documented clearly in the record

References

Education
Palmetto GBA offers providers selected for TPE an individualized educational session to discuss each claim denial. This is an opportunity to learn how to identify and correct claim errors. A variety of educational methods are offered such as webinar sessions, web-based presentations and teleconferences. Other educational methods may also be available. Providers do not have to be selected for TPE to request education. If education is desired, please complete the Education Request Form (PDF). 

Next Steps
Providers found to be non-compliant (major risk category/denial rate of 21–100 percent) at the completion of TPE Probe 1 will advance to Probe 2, and providers found to be non-compliant (major risk category/denial rate of 21–100 percent) at the completion of TPE Probe 2 will advance to Probe 3 of TPE after at least 45 days from completing the one-on-one post-probe education call date. 


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