Widespread Targeted Review Results- AL-FI- 1st Quarter Results of 100% Review of HCPCS J0885/Q0136 (Injection, epoetin alpha, (for Non-End Stage Renal Disease (ESRD) use, per 1, 000 units); Edit Reason Code 5112K

Educational Notification to Medicare Outpatient Hospital (Type of Bill 13X) of the results of the results of the 1st quarter widespread medical review of the billing of HCPCS J0885/Q0136.
 
Alabama Medical Review Part A has recently completed the 1st quarter widespread targeted prepay review of outpatient hospital billing of Healthcare Common Procedure Coding System (HCPCS) J0885/Q0136 (EPO) processed between January 1, 2007 and March 31, 2007.  Educational articles providing the results of previous reviews and guidelines for the appropriate utilization of EPO were posted on What’s New January 2006, August 2006 and October 2006 and February 2007.  These articles may be found at on the What New from Cahaba page.

The review results are as follows:

1st Quarter 2007:

Providers Reviewed:  29
Claims Reviewed:  703
Claims Approved:  353
Claims Denied:  350            
Charges Reviewed:  $2,414,713.27
Charges Approved: $1,549,244.15
Charges Denied:  $865,469.12

Error Rate:                     36%*
* error rate is based on the charges denied divided by the charges reviewed

The medical review decisions were based on Local Coverage Determination (LCD) L20432, which outlines indications and coverage guidelines for epoetin alpha (EPO) use in non-ESRD patients during this review timeframe. All providers administering EPO injections are strongly encouraged to review LCD- L20432 for full details of documentation and coverage criteria.  The LCD may be found on the Active LCD page.

The majority of denials were due to one of the following reasons:

  • Lack of key elements of documentation required to determine the medical necessity of the services provided (Denial Reason 55520):  In order to enable a medical review and to ensure coverage for EPO, the documentation submitted, at a minimum must include:
  • All labs pertinent to the indications for EPO administration
  • Patient’s weight in kilograms
  • Starting dose per kilograms
  • Diagnosis
  • Physician History and Physical
  • Physician orders
  • Medication administration documentation (e.g. treatment notes)
  • Any additional documentation pertinent to EPO orders/treatment
  • Lack of medical necessity to support EPO administration for non ESRD conditions (Denial Reason 54155):  This denial reason included the documentation of EPO administration without a covered diagnosis, and/or the documentation of EPO administration with normal hemoglobin/hematocrit levels without explanation of the necessity of EPO continuation.  For a complete listing of medical indications for the appropriate use of EPO in non-ESRD patients, please review LCD L20432.
  • Lack of documentation to support the HCPCS code billed (Denial Reason 53603):  This denial reason included claims submitted for HCPCS J0885 when the documentation indicated the patient was receiving dialysis.  Providers are reminded that J0885 is defined as EPO, per 1000 units for non-ESRD patients.  The appropriate HCPCS for ESRD patients on dialysis is J0886 (EPO, per 1000 units for ESRD on dialysis).   
  • Lack of correlation in the documentation between billed units and units administered (Denial Reason 53603):  Denials also occurred when the documentation reflected the number of units billed was greater than the number of units ordered by the physician and given to the patient.  Discussion with providers indicated this discrepancy was due to drug wastage.  According to the product information found in the latest addition of the United States Pharmacopoeia-Drug Information (USP-DI), EPO is available in 1mL single-dose vials in multiple strengths, including 2000 units/mL, 3000 units/mL, 4000 units/mL, 10,000 units/mL and 40,000 units/mL.  Multi-dose vials are also available in 10,000 units/mL - in 2 mL vials and 20,000 units/mL - in 1 mL vials.  The shelf life of the multi-dose vial is 21 days.  Because of the multiple dose options available for exact dose administration, the duration of stability of the multi-dose vial and the volume of patients receiving EPO, claims submitted should not include   billing for wastage of EPO. 

The Centers for Medicare and Medicaid Services (CMS) outlines coverage of drug wastage in The Medicare Claims Processing Manual, PUB 100-4, Chapter 17, §40, by encouraging the most efficient use of medications to avoid drug wastage.  In determining the appropriateness of billing for drug wastage, providers must consider the following:

  • Drug Packaging- Dose Options:
    • Are there multiple vial sizes and dose options or is the drug only packaged in an amount that exceeds the patient’s need?
    • What is shelf-life of the drug?
  • Patient Considerations:
    • What is the volume of patients receiving the medication?
    • What is the frequency of administration?
    • Is it practical to coordinate the schedules of patient’s receiving EPO to reduce the potential for drug wastage?

If after review of the above criteria, a provider determines they must discard the remainder of a vial or other package after administering the drug to a Medicare patient, coverage is available for the drug discarded along with the amount administered.  Documentation of drug wastage in the medical record is expected.   The coverage of discarded drugs applies only to single-dose vials.  Multi-dose vials are not subject to payment for discarded amounts of a drug.

  • Lack of timely submission of requested documentation (Denial Reason 56900):  Additionally, claims were denied due to a lack of record submission in a timely manner.  According to The Medicare Program Integrity Manual, PUB 100-8, Chapter 3, § 3.4.1.2, if a coverage or coding determination cannot be made based upon the information on the claim, the Fiscal Intermediary (FI) may solicit additional documentation from the provider by issuing an Additional Documentation Request (ADR) and must notify the provider of the 30 day time-period to respond.  The ADR requested information is not is received within 45 days after the date of the request, then the claim must be denied. 

           To eliminate 56900 denials, please review the following elements to ensure appropriate and
           timely record processing:

  • Beginning January 1, 2007, Cahaba will no longer send letters to inform providers of Additional Development Requests (ADRs). Instead, providers will need to access the Fiscal Intermediary Standard System (FISS) to identify claims selected for ADR. Claims selected for ADR can be identified by accessing FISS Inquiry Option 12, and will appear in status location S B6001. Pages 07 and 08 of the claim will contain the date your documentation is due, and the elements of documentation requested.
  • Print screen the ADR letter and attach the copy to the front of the requested medical documentation
  • Send requested information to the address on the ADR letter
  • Do NOT send certified mail or overnight mail
  • Include ALL requested documentation outlined in the ADR
  • Submit the above information via regular mail in a timeframe to ensure the FI receives the information by the 45th day after the date of the request.

As a result of this targeted review, Alabama Part A Medical Review will continue the 100% targeted pre-pay review of all outpatient hospitals  (Bill Type 13X) billing J0885 and/or Q0136, identified by edit reason code 5112K.  Also, providers identified through data analysis as driving this aberrancy may warrant provider-specific medical review.

Page last updated: May 2, 2007

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