Medicare Part B local coverage determination (LCD) comment summary

LCD Number

J0881

Contractor Name

First Coast Service Options, Inc.

Contractor Number

09102 – Florida
09202 – Puerto Rico
09302 – U.S. Virgin Islands

Contractor Type

MAC Part B

LCD Title

Erythropoiesis Stimulating Agents (ESAs)

AMA CPT Copyright Statement

CPT codes, descriptions, and other data only are copyright 2008 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.

Start Date of Comment Period:

02/20/2009

End Date of Comment Period:

04/06/2009

Comments Received:

Comment 1: A comment was received asking to clarify the ESA modifier rule for EA and EC. If the EA modifier is used, then no anemia ICD-9 CM code is required and if the EC modifier is used then an anemia diagnosis is required?

Contractor response: The EA modifier indicates that the patient is currently receiving chemotherapy or is in the 8 week post chemotherapy window for one of the covered cancer indications outlined in the national coverage decision for non-ESRD ESA use. The EC modifier indicates that the patient’s anemia is not related to chemotherapy or radiotherapy. FCSO has revised the coding rules for the cancer diagnosis codes outlined in the LCD that does not require the provider to submit a dual diagnosis when billing one of the malignancy ICD-9 codes listed as covered. Providers are required to append the EA modifier when billing for one of the malignancy ICD-9 CM codes. Appending any other modifier (EB or EC) to these ICD-9 codes is inappropriate and goes outside the coverage of the NCD. For the EC modifier, the list of covered diagnosis codes requires a dual only for those with an * beside it. The dual diagnosis rule for J0881 and J0885 are clearly outlined at the beginning of each diagnosis list. Because J0885 has additional covered indications, the list of diagnosis codes that requires the EC modifier has two dual diagnosis rules outlined. In addition, the list of non-covered conditions and their respective diagnosis codes are outlined in the coding guideline of the LCD.

Comment 2: Comments were received stating that they appreciate the new breakdown of ICD-9 CM codes to better show what modifiers are required for the ICD-9 CM codes and what ICD-9 CM codes require a dual diagnosis.

Contractor response: Thank you for these comments.

Comment #3: A comment was received asking FCSO to consider implementing this draft retroactively due to the coding issues encountered since last year.

Contractor response: FCSO does not retroactively implement draft LCDs. All LCDs are implemented by date of service. If for any reason the effective date for a revision needs to be implemented by any other date other than date of service, FCSO will outline this in the revision history and in the article published for that revision. An example for of this would be for a newly approved FDA indication of a drug. For this draft LCD there is no reason to retroactively implement the LCD.

Comment #4: Several comments were received surrounding language in the indications and limitations section of the LCD that deals with Hemoglobin and Hematocrit levels and symptoms to look for when ruling out iron deficiency asking that this language be revised and also whether or not language pertaining to patients who may refuse blood transfusion (i.e., Jehovah Witnesses) should be added to this LCD.

Contractor response: This language is not open for comment during this CAC cycle. The only language open for comment at this time are the revised coding for the ICD-9 CM codes listed under “ICD-9 codes that support medical necessity” and the second set of ICD-9 CM codes listed out in the coding guideline. FCSO will however note these comments and look at any revisions needed once this draft is final and make any revisions necessary at that time.

Comment #5: A comment was received stating that removing ICD-9 CM code V58.11 will be a very large change for those providers who are ordering oral chemotherapy drugs and monitoring the ESA levels as well as those patients receiving IV chemotherapy at a cancer center or physicians office where the month being billed is not the month the chemotherapy was administered. We are having a large number of appeals due to the absence of V58.11 coding combination.

Contractor response: ICD-9 CM code V58.11 has not been in the LCDs for ESAs since prior to April 7, 2008, when there were separate LCDs for Epo and Aranesp. This revised version of the ESA LCD is not impacting providers billing practices by eliminating the ability to bill V58.11. In addition, FCSO is not denying claims due to the absence of V58.11 on claims ESA when the anemia is due to chemotherapy. The coding requirements for this LCD do not prevent providers from appending additional diagnosis codes on a claim. FCSO took this into consideration when revising the coding rules as not all providers use the same coding system. The revised coding implemented in this LCD allows FCSO to stay in compliance with CPT and CMS rules issued through the national coverage language and instructions to contractors and still allows for providers to append additional diagnosis codes they feel are necessary.

Comment #6: A comment was received that states removal of the dual diagnosis combination for anemia due to chemotherapy with modifier EA is a move the commenter is hesitant toward as the ESA should only be given in the instance when the patient is anemic due to the chemotherapy. The claim is documented with the hemoglobin levels so that FCSO can deny if the level is above the threshold established by CMS. The only exception to the labs would be if the hemoglobin is greater than or equal to 10.0 in the first 4 weeks of chemo.

Contractor response: The removal of the dual diagnosis requirement does not prevent FCSO from monitoring claims to ensure that the appropriate modifier is appended to the appropriate diagnosis code. In addition, it is the onus if the provider to ensure they are billing and administering the ESAs per the guidelines issued by CMS and FCSO. FCSO has published through the LCD and numerous articles, the requirements for all ESAs regarding hemoglobin and hematocrit requirements, modifier use and diagnosis requirements. FCSO would also like to clarify the rules about reporting hemoglobin and hematocrit for chemotherapy induced anemia based on the following statement from the above comment: “The claim is documented with the hemoglobin levels so that FCSO can deny if the level is above the threshold established by CMS. The only exception to the labs would be if the hemoglobin is greater than or equal to 10.0 in the first 4 weeks of chemo.” CMS issued the National Coverage Determination (NCD) on July 30, 2007, and implemented all rules in this NCD on April 7, 2008. With this NCD, CMS instructed contractors through change request 5818, transmittals 80 and 1413, dated January 14, 2008. In this instruction to contractors, business requirement 5818.3 states that contractors are to deny non-ESRD services J0881 and J0885 reported with an EA modifier when the hemoglobin is 10.0 or greater or the hematocrit is 30.0% or greater. CMS did not give contractors any language on an exception to this rule. The NCD does not allow for an exception to the patients hemoglobin or hematocrit levels during the first 4 weeks of chemotherapy. Every claim for non-ESRD ESAs must report a hemoglobin or hematocrit level and an ESA modifier. FCSO cannot overturn national coverage rules as national language is binding all everyone.

Comment #7: A comment was received stating that the only thing missing from a coding stand point is the addition of diagnosis code E933.1, when the anemia due to chemotherapy rules are being applied.

Contractor response: Please see the contractor response for comment #5 above. This explanation applies to E933.1 as well.