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October 16, 2013

Rituximab (HCPCS code J9310): Probe Medical Review for Bill Type 13x in Kentucky – Probe Review Results

The J15 Part A Medical Review department performed a service-specific prepay probe review on claims for the drug Rituximab (HCPCS code J9310) in Kentucky. Based on the results, this service-specific prepay probe edit will be advanced to complex in Kentucky.

Probe Medical Review of the Drug Rituximab (HCPCS code J9310)—Kentucky
  Charges Claims
Reviewed $2,058,906.19 91
Denied $1,111,751.82 41
Charge Denial Rate 54.0%  

The top denial reasons associated with this edit are:

5D161/5H161 - No Physician’s Order

  • Reason for denial:
    • For services to be covered by the Medicare program, all diagnostic tests and services must be ordered by the physician who is treating the beneficiary’s specific medical problems. Diagnostic tests or services that are not ordered by the physician are not reasonable and necessary.
  • How to prevent denials:
    • Submit all documentation relevant to the medical necessity for and administration of rituximab, including but not limited to:
      • A physician’s order or Standard Operating Procedures (SOP) for all services billed.  Information should be sufficient to enable CGS to identify and contact the ordering physician or non-physician practitioner (NPP) if necessary.
      • Order(s) must be dated prior to or on the date(s) of service.
      • A physician’s progress note indicating what services the physician ordered
      • A history and physical that indicates what services the physician ordered
      • Ensure that each page of the beneficiary’s medical records include the beneficiary’s name, date of service, and treating physician or NPP’s name and credentials. 
      • Ensure that copies of the medical records are clear and legible.  Copy both sides if necessary. 

5D164/5H164 - No Documentation of Medical Necessity

  • Reason for denial:
    • Medicare coverage and payment are allowed for only those services that are considered reasonable and necessary. Tests that are reasonable and necessary are those tests used in the diagnosis and management of illness or injury or to improve the function of a malformed body part.
    • Health care providers are responsible for submitting complete documentation, upon request, to substantiate that the services were medically necessary.
  • How to prevent denials:
    • Submit all documentation relevant to the medical necessity for and administration of rituximab, including but not limited to:
      • Supporting documentation to substantiate all diagnoses and diagnosis codes in the medical records for the patient, in order to demonstrate that services meet the “reasonable and medically necessary” standard 
      • Documentation of the signs and symptoms that prompted the services/tests billed
      • Documentation to justify the frequency of services above the accepted standard, such as any pertinent information regarding medication changes, recent exacerbations of disease process, etc.

56900 - Requested Records Not Submitted

  • Reason for denial:
    • The medical records were not received in response to an Additional Development Request (ADR) in the required timeframe; therefore, we were unable to determine medical necessity.
  • How to prevent denials:
    • Monitor your claim status on Direct Data Entry (DDE). If the claim is in status/location SB6001, the claim has been selected for review and records must be submitted. Please note: CGS may request records through our Medical Review or Claims departments, and other contractors such as the Zone Program Integrity Contractor (ZPIC) may also request records.  Ensure the records are submitted to the appropriate entity.
    • Alert your mail room staff to be aware of any mail you receive from CGS.
    • Be aware of the need to submit medical records within 30 days of the date on the ADR in the upper left corner.
    • Gather all information and submit at one time.
    • Submit medical records as soon as the ADR is received.
    • Attach a copy of the ADR to each individual claim.
    • If you are responding to multiple ADRs, separate each response and attach a copy of the ADR to each individual set of medical records. Ensure each set of medical records is bound securely so the submitted documentation is not detached or lost.
    • Do not mail packages COD; we cannot accept them.
    • Return the medical records to the address indicated in the ADR. Be sure to include the appropriate mail code.

If you receive a request for medical records, please submit the following information within 30 days to the address on the ADR: 

  • Physician’s orders for the admission and all services billed
  • Itemized list of charges
  • Hospital Admission Assessment and hospital discharge summary
  • Hospital History and Physical
  • Physician progress notes
  • Consultation reports
  • Plan of care
  • Diagnostic test results/reports, including imaging reports
  • Clinical/therapy notes
  • Please submit all documentation to support the medical necessity of services billed and the DRG code billed
  • A signature log or an attestation statement, if you question the legibility of your signature. Medicare requires that medical records entries for services provided/ordered be authenticated by the author. The signature may be hand-written or electronic; stamp signatures are not acceptable. Patient identification, date of service, and provider of the service should be clearly identified on the submitted documentation. 
    • If the signature requirements are not met, we will conduct the review without considering the documentation with the missing or illegible signature. This may lead us to determine that the medical necessity for the service billed has not been substantiated.
    • For more information regarding signature requirements for Medicare purposes, refer to the CMS Medicare Program Integrity Manual (Pub. 100-08), chapter 3, section 3.3.2.4 and CMS MLN Matters article MM6698, “Signature Requirements for Medical Review Purposes.”

Options for Submitting Records

  • You may submit medical records compact disks (CDs) or digital video disks (DVDs) to CGS.  You must use the correct file format of tagged image file format (tiff), which may be saved to your CD/DVD. 
  • You may also submit records via fax to: 803.462.2596.  Use the ADR letter as a cover sheet.
  • If you choose to respond by mail, send the requested records to the address indicated in the ADR letter.

Completed review results will be posted on the CGS website.  Individual providers with significant denials will be contacted for one-on-one education.

If you have questions regarding this review, please call the Medical Review department at 803.763.4999.


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