Pembrolizumab - Service Specific Post-Payment Final Findings

CMS is required by the Social Security Act to ensure that payment is made only for those medical services that are reasonable and necessary. Noridian's priority is to minimize potential future losses to the Medicare Trust Fund by preventing inappropriate Medicare payments. This is accomplished through provider education, training, and the medical review of claims. A post-payment review has been initiated based on data analysis.

This is to update providers of the claim review findings and closure of the file of Healthcare Common Procedural Coding System (HCPCS) code J9271 for JE.

Summary of Findings

Since the initiation of the review, 150 claims were reviewed from May 3, 2021 through November 22, 2021 with an overall claim error rate of 25.3% and payment error rate of 20.6%. The breakdown of those findings are as follows:

  • 112 claims were accepted
  • 38 claims were denied in full for the following reasons:
    • Documentation did not support medical necessity of pembrolizumab/Keytruda.
    • Documentation did not support the medication was administered per FDA guidelines.
    • No documentation was received in response to ADR.

If you are a provider that had claims involved in the review sample and disagree with a claim determination, the normal appeal process may be followed as directed on the Noridian website under Appeals or as directed in your claim remittance advice.


Paragraph Name Paragraph Details
Keytruda® (Pembrolizumab) Per the Food and Drug Administration (FDA) label, Keytruda® is a programmed death receptor-1 (PD-L1)-blocking antibody with multiple approved indications. Careful review of the FDA label is warranted to ensure all prescribing requirements are supported in the documentation submitted for review. When submitting documentation for review of Keytruda® claims, ensure the documentation clearly supports the patient's diagnosis, pathology information, any prior or current treatments being completed, and review the FDA label for that indication to determine if any additional documentation is required.

Examples of required additional documentation to support include, but are not limited to:
  • Prior lines of anti-cancer drugs administered prior to starting Keytruda®
  • Keytruda® administered in combination with another medication
  • Tumor expressions and biomarker testing
Off-Label Use of Anti-Cancer Drugs For Medicare coverage of anti-cancer drugs, it is important to consider if the drug is being administered for an approved indication per the Food and Drug Administration (FDA) label and/or if the indication falls under one of the medically accepted indications per the CMS-approved drug compendia. 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 being administered for an off-label use and/or it's use does not meet a medically accepted drug compendia indication, the claim will be denied. If a claim is denied, the provider may appeal the claim with peer-reviewed authoritative medical literature to support the off-label use of the drug.

For additional information, reference, Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual (MBPM), Chapter 15, Section 50.4.5
Documentation to Support Medical Necessity The practitioner that orders a service must maintain documentation to support medical necessity for that service in the beneficiary's medical record. It is the responsibility of the provider submitting the claim to maintain documentation that is received and that it reflects the information received from the ordering practitioner. The submitting provider may request additional information from the ordering practitioner to support the service billed is reasonable and necessary as laid out in the Social Security Act 1862.

Upon receipt of the Additional Development Request (ADR), the billing provider must submit documentation of an order for the service, which includes information to identify and contact the ordering practitioner, to verify appropriate completion of the order and services billed.

For additional information on record keeping supporting medical necessity of billed claims, refer to 42 Code of Federal Registry (CFR) section 410.32.
Timely Submission of Documentation and 569PPs It is the responsibility of Medicare providers to submit all documentation requested on the additional documentation requests (ADR) within the allotted time frame. Noridian allows 45 calendar days for the medical records to be received per the ADR request for post-payment reviews. On day 46, if the medical records have not been received, the claim will be denied provider liable with reason code 569PP. If there is no documentation to complete the medical review (MR), services billed on the claim cannot be supported.

A redetermination request should be submitted to Noridian within 120 days from the date of the 569PP denial. Contractors shall reopen the claim for review as long as all conditions are met. The determination made on the reopening claim has the potential to reverse non-covered dollars.

For additional information, refer to Internet-only Manual Pub 100-08, Chapter 3, Section, 42 CFR 424.5(a)(6), and Social Security Act sections 1815(a), 1833(e) and 1862(a)(1)(A).



View references used in review. Further educational opportunities may be found under Education and Outreach. If you are in need of an individualized education training event, contact the POE Department at If you need coding assistance, please check your CPT®, HCPCS, ICD-10 books and your specific association.

Provider Action Required

File results and trending errors are being shared with all providers to assess compliance and billing practices if the service is provided within your facility. If your facility had claim documentation requested for this review, please refer to the individual result letter you received. You can also access individual determinations for claims that were requested from your facility by reviewing comments in either DDE or on the Noridian Medicare Portal (NMP).

Further provider action recommended includes:

  • Provide education regarding errors noted to applicable staff members.
  • Verify documentation supports medical necessity of HCPCS code J9271.


This service specific post-payment file is now closed for JE and Noridian will no longer request documentation for this review. Noridian will continue to monitor data analysis and perform medical review for medical necessity and appropriate coding practices.

If you have any other questions, contact the JE Provider Contact Center at 1-855-609-9960.


Last Updated Mon, 13 Dec 2021 15:14:02 +0000