Pre-Payment Provider-Specific Probe Results for Pembrolizumab (Keytruda) for September 2021 through March 2022

Published 05/04/2022

Palmetto GBA performed provider-specific pre-payment probe review on HCPCS Code J9271 — Pembrolizumab (Keytruda®). This edit was set in Alabama, Georgia and Tennessee. The results for the probe review, for claims processed September 1, 2021, through March 31, 2022, are presented here.

Cumulative Results 
A total of 1,271 claims from 34 providers were reviewed in Alabama, Georgia and Tennessee combined. Of the claims reviewed, 88 were either completely or partially denied. This resulted in an overall claim denial rate of seven percent. The total dollars reviewed were $12,459,802.18, of which $716,644.62 were denied, resulting in a charge denial rate of six percent. There were 102 auto-denied claims in the region for September 2021 through March 2022. The top denial reasons were identified, and the number of occurrences based on dollars denied are:

Percent of Total Denials

Denial Code

Denial Description

Number of Occurrences

98%

5D164/5H164

No Documentation of Medical Necessity

86

1%

5D199/5H199

Billing Error

1

1%

5D920/5H920

The Recommended Protocol Was Not Ordered and/or Followed

1

Alabama Results
A total of 308 claims were reviewed, with 13 of the claims either completely or partially denied. This resulted in a claim denial rate of four percent. The total dollars reviewed were $3,098,788.90, of which $122,601.67 were denied, resulting in a charge denial rate of four percent. The top denial reasons were identified, and the number of occurrences based on dollars denied are:

Percent of Total Denials

Denial Code

Denial Description

Number of Occurrences

92%

5D164/5H164

No Documentation of Medical Necessity

12

8%

5D199/5H199

Billing Error

1

Georgia Results
A total of 537 claims were reviewed, with 42 of the claims either completely or partially denied. This resulted in a claim denial rate of eight percent. The total dollars reviewed were $5,332,679.38, of which $348,232.60 were denied, resulting in a charge denial rate of seven percent. The top denial reasons were identified, and the number of occurrences based on dollars denied are:

Percent of Total Denials

Denial Code

Denial Description

Number of Occurrences

98%

5D164/ 5H164

No Documentation of Medical Necessity

41

2%

5D920/5H920

The Recommended Protocol Was Not Ordered and/or Followed

1

Tennessee Results
A total of 426 claims were reviewed, with 33 of the claims either completely or partially denied. This resulted in a claim denial rate of seven percent. The total dollars reviewed were $4,028,333.90, of which $245,810.35 were denied, resulting in a charge denial rate of six percent. The top denial reasons were identified, and the number of occurrences based on dollars denied are:

Percent of Total Denials

Denial Code

Denial Description

Number of Occurrences

100%

5D164/ 5H164

No Documentation of Medical Necessity

33

Denial Reasons and Prevention 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/NPP is managing the care of the covered indication or condition
    • Any medical history that supports a need for the service
    • Any diagnostic results or symptomology that supports a need for the service 
  • A legible physician or nonphysician provider (NPP) 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

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5D920/5H920 — The Recommended Protocol Was Not Ordered and/or Followed

Reason for Denial
Medicare cannot pay for this service because one or more requirements for coverage were not met.

How to Avoid This Denial
Documentation that may be helpful to avoid future denials for this reason may include, but are not limited to, the following:

For Drugs and Biologicals

  • Clear physician’s order with indication of need, dose, frequency, administration time, and route 
  •  Date and time of associated chemotherapy, as applicable
  •  Relevant medical history documented prior to the DOS and signed by the physician or appropriate nonphysician provider to include, but not limited to:
    • Clear indication of the diagnosis and need for the related service(s)
    • Clinical signs and symptoms
    • Prior treatment and response as applicable
    • Stage of treatment as applicable
    • Documentation of administration and signed by the person providing the service
  • Ensure the service was provided per the coverage guidelines for the service

For Outpatient Therapy 

  • Clear physician’s order with indication of specific skilled service, frequency and duration
  • Relevant medical history documented prior to the DOS and signed by the physician or appropriate nonphysician provider to include, but not limited to:
    • Clear indication of the diagnosis and need for the related therapy services 
    • Documentation related to the therapy services to include beneficiary's functional level, treatment plan, short- and long-term goals, beneficiary's response to therapy services, treatment and progress notes
    • Prior treatment and response as applicable
  • Ensure the service was provided per the coverage guidelines for the service

For IMRT

  • Clear physician/radiation oncologist orders for radiation treatment course, including specific anatomical target volumes, treatment technique, current dosage, type of radiation measuring and monitoring devices to be used and treatment fields.
  • Relevant medical history documented prior to the DOS and signed by the physician/radiation oncologist or appropriate nonphysician provider to include:
    • Clear indication of the diagnosis being treated and medical necessity of the services
    • Supporting reports such as dosimetry, physicist, simulation, oncology and radiology 
    • Documentation of design and construction of Multi-Leaf Collinator
    • Detailed itemized bill and supporting documentation of all billed services 
    • Documentation of treatment plan, including goals, treatment notes, specific dose constraints for the target and administration
  • Ensure the service was provided per the coverage guidelines for the service

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5D199/5H199 — Billing Error

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 that the service was rendered, and the dates of service billed

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56900 — Auto Deny — Requested Records Not Submitted Timely 

Reason for Denial
The services billed were not covered because the documentation was not received in response to the Additional Documentation Request (ADR) and therefore, we were unable to determine the medical necessity of the service billed. The provider has 45 days from the date the ADR was generated to respond with medical records. If less than 120 days after denial notification on the remittance advice, submit records to the contractor requesting records at the address listed on the original Additional Development Request (ADR) to request reopening. Do not resubmit the claim.

How to Avoid This Denial

  • Be aware of the Additional Development Request (ADR) date and the need to submit medical records within 45 days of the ADR date
  • Submit the medical records as soon as the Additional Development Request (ADR) is received
  • Monitor the status of your claims in Direct Data Entry (DDE) and begin gathering the medical records as soon as the claim goes to the location of SB6001
  • Return the medical records to the address on the Additional Development Request (ADR). Be sure to include the appropriate mail code or station number. This ensures that your responses are promptly routed to the medical review department. Fax and electronic data submissions are also accepted as indicated on the Additional Development Request (ADR).
  • Gather all of the information needed for the claim and submit it all at one time
  • Attach a copy of the Additional Development Request (ADR) request to each individual claim
  • If responding to multiple Additional Development Requests (ADRs), separate each response and attach a copy of the ADR to each individual set of medical records. Make sure each set of medical records is individually identifiable and bound securely to ensure that no documentation is detached or lost. Do not use paper clips. 
  •  Do not mail packages C.O.D.; we cannot accept them

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