LCD Reference Article Response To Comments Article

Response to Comments: Erythropoiesis Stimulating Agents (ESAs) (L34633)

A57844

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Article ID
A57844
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Article Title
Response to Comments: Erythropoiesis Stimulating Agents (ESAs) (L34633)
Article Type
Response to Comments
Original Effective Date
02/09/2020
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As an important part of Medicare Local Coverage Determination (LCD) development, Wisconsin Physician Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the LCD and Billing and Coding Article for Erythropoiesis Stimulating Agents (ESAs). The official notice period for the final LCD begins on December 26, 2019 and the final determination will become effective for services rendered on or after February 09, 2020.

Response To Comments

Number Comment Response
1

We are pleased to see that the recommendation of our member was accepted and is in the last phase for approval. Our member practice that initially proposed this change has contacted us to inquire with WPS as to whether this will apply to all ESAs such as Retacrit Q5106? The group 11 paragraph only reads J0881 and J0885. If this does not include Retacrit, Q5106, what do we need to do to have that included as well.
Michelle Weiss CHONC Senior Reimbursement Consultant Michigan Society of Hematology Oncology

Thank you for your request and we appreciate the overall support of the draft and the request to include Q5106, epoetin alfa-epbx, biosimilar (retacrit) (for non-ESRD use). Research determined that Q5106 will be included in Group 11 Paragraph Myelofibrosis. Per the Food & Drug Administration: Biosimilarity of Retacrit has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.

2

Please include coverage for Retacrit Q5106 and Procrit J0885 for Myelofibrosis D75.81
Debbie Gonzalez – Business Team Leader SSM Health Medical Group Cancer Care – Infusion Access

Thank you for your comment and request to include Q5106, epoetin alfa-epbx, biosimilar (retacrit) (for non-ESRD use). For clarification J0885, epoetin alfa, Procrit (for Non-ESRD use), was included in the proposed draft LCD & Billing and Coding Article. Please refer to Response 1 to include Q5106.

3

This comment is to discuss the proposed accepted diagnosis codes relating to the addition of myelofibrosis indication to LCD DL34633 Erythopoiesis Stimulating Agents. Limiting the allowed diagnosis code to D75.81 would eliminate other clinically accurate diagnosis codes for myelofibrosis as listed in the ICD10 Manual.
At Washington University School of Medicine, Division of Oncology and Hematology, we have a fairly high population of patients with Myelofibrosis. Our physicians utilize Erythropoietin agents for anemia due to myelofibrosis. We would like to encourage inclusion of all of the ICD10 diagnosis codes listed in the NCCN Compendium for this indication rather than only the proposed D75.81 myelofibrosis.
The Index of the ICD10 Manual lists several diagnosis codes under the heading “myelofibrosis”. All of these diagnosis codes are listed in the NCCN Compendium. We are extremely concerned that only allowing D75.81 is problematic because the ICD10 Manual specifically lists an “Excludes 1” note that directs primary myelofibrosis to be assigned the diagnosis code of D47.1. In any EHR system, if a provider chooses myelofibrosis, their system will direct them to D75.81. But if they choose primary myelofibrosis, it will direct them to D47.1. It would be prudent to include the same codes as the NCCN Compendium, which are all listed under Myelofibrosis which you will see in the Snip it’s below from Optum 360 Encoder Pro.
We are pleased with the opportunity to bring this to your attention. The additional of this indication to the LCD has been needed and will be helpful to Medicare Beneficiaries.
Barbara K Murphy, CPC Compliance Review/Claims Analyst Division of Oncology Washington University

Thank you for your comments and request to include all of the ICD-10 diagnosis codes listed in the NCCN Compendium for Group 11 Paragraph: Myelofibrosis. Research determined that ICD-10 diagnosis codes C94.40-C94.42, D47.1 and D47.4 will be included in Group 11 Codes and removed from ICD-10 Codes that do not support medical necessity.

4

On behalf of our eight oncologists, I respectfully request that the biosimilar Retacrit Q5106, be added to this covered indication of Myelofibrosis. Our pharmacy department is also supportive of this as the FDA has already approved Retacrit’s use as an erythropoiesis stimulating agent.

Christine Meek, CPC, CMOM Oncology Service Line Business Manager Cowell Family Cancer Center
Munson Healthcare Traverse City, MI

Thank you for your comment and request to include Q5106, epoetin alfa-epbx, biosimilar (retacrit) (for non-ESRD use). Please refer to Response 1 to include Q5106.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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