LCD Reference Article Response To Comments Article

Response to Comments: Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (DL39477)

A59306

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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Source Article ID
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Article ID
A59306
Original ICD-9 Article ID
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Article Title
Response to Comments: Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (DL39477)
Article Type
Response to Comments
Original Effective Date
02/12/2023
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (DL39477). Thank you for the comments.

Response To Comments

Number Comment Response
1

We received comment from the College of American Pathologists in support of our proposed policy for bringing additional local coverage to Medicare patients of all ages for allogenic stem cell for primary refractory or relapsed Hodgkin’s and non-Hodgkin’s lymphoma with B-cell or T-cell origin, for whom there are no other curative intent options. They expressed their sincere thanks.

WPS thanks you for your comment and support.

2

A physician with The University of Kansas Cancer Center commented in support of our policy for Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin.

WPS thanks you for your comment and support.

3

We received comments from the American Society of Hematology and the American Society for Transplantation and Cellular Therapy in appreciation and support of our policy Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin.

These societies noted in review of the policy concerns regarding the proposed language. They stated that want to ensure “donor matched” is inclusive of full/complete matches is addition to haploidentical matches and other donor matches. They state is not always possible to secure a full or complete match, especially for Blacks and African Americans.

They also stated concern that the language “refractory to standard of care treatment” could result in more restrictive coverage that what is allowed for under Palmetto’s LCD L39270 for allo-stem cell transplant for Medicare beneficiaries with lymphoma.

The societies request WPS mirror the language from Palmetto’s LCD L39270 that states “This policy describes additional locally covered indications for allo-HSCT for primary refractory or relapsed Hodgkin’s and non-Hodgkin’s lymphomas with B-cell or T-cell origin that are medically necessary in patients for whom there are no other curative intent options.”

WPS thanks you for your comments and agrees with the societies. Wording has been changed to mirror that of Palmetto’s LCD L39270 These changes can be seen under the section of the LCD Coverage Indications, Limitations, and/or Medical Necessity.

4

We received comments from the NCCN that the NCCN Guidelines for B-Cell Lymphomas and NCCN Guidelines for T-Cell Lymphomas recommend allogeneic HCT as an option for patients with relapsed/refractory disease who achieve a response to second-line therapy, NCCN Guidelines for B-Cell Lymphomas recommend consideration of allogeneic HCT in selected patients (those with stem mobilization failures and those with persistent disease in the bone marrow are not candidates for autologous HCT) who have achieved either a complete response (CR) or a partial response (PR) to second-line therapy and have chemo sensitive disease at the time of transplant. However, allogeneic HCT is not recommended for patients with primary refractory disease (i.e. patients with disease that has never achieved a CR from any therapy and also for patients who are not in PR at the time of the last evaluation prior to HCT). In general, the presence of refractory disease at the time of transplant is considered a poor prognostic factor and outcomes following allogeneic HCT are also very poor in patients with primary refractory disease. CAR T-cell therapy is the recommended treatment option for patients with primary refractory disease (i.e. primary refractory diffuse large B-cell lymphoma [DLBCL]) in the NCCN Guidelines for B-Cell Lymphomas.

WPS thanks you for your comments and we are making allogeneic transplant available per NCCN guidelines. We do not mention CAR-T therapy and are not restricting it’s use. We appreciate and thank you for your comments, but no new complete copy of literature was submitted for consideration of other items.

5

We received comment from a physician who is a stem cell transplanter with a focus on lymphoma in support of our proposed policy for Medicare patients. He encourages extending this benefit to Medicare patients, who have often been denied allogeneic transplants due to coverage.

WPS thanks you for your comment and support of our policy.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
NCDs
110.23 - Stem Cell Transplantation (Formerly 110.8.1)
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Updated On Effective Dates Status
12/22/2022 02/12/2023 - N/A Currently in Effect You are here

Keywords

  • allogeneic
  • stem cells
  • Hodgkin's lymphoma
  • non-Hodgkin's lymphoma
  • hematopoietic cell transplantation