Local Coverage Article Response to Comments

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


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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
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Response to Comments
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This article is the response to comments received by Noridian Healthcare Solutions regarding the proposed Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin’s and Non-Hodgkin’s Lymphoma with B-Cell or T-Cell Origin. The comment period began on 08/04/2022 and was presented at the 08/25/2022 Open Public Meeting. The Comment period ended on 09/17/2022. The notice period begins on 01/19/2023 and ends on 03/04/2023. The LCD becomes final on 03/05/2023. All comments were reviewed, and the responses are provided in this document. 

Response To Comments


Request to mirror the language used in Palmetto’s LCD L39270 (see underlined). “It is the intention of this Local Coverage Determination to formally notify Medicare enrolled providers of Noridian Medicare’s coverage and allowance for reimbursement of services related to Allogeneic Stem Cell Transplantation in compliance with NCD 110.23. Covered indications for allogeneic stem cell transplant of hemopoietic cells extracted from healthy donor matched peripheral blood and/or bone marrow for infusion as treatment of primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphoma, B-cell or T-cell origin, is limited to Medicare beneficiaries for whom the primary disease is refractory to standard-of-care treatment or for those whose disease has relapsed and are without alternative potentially curative options.”

We appreciate the input from the American Society of Hematology. The article was revised from the original Palmetto draft to address what was felt to be some issues with the language proper but not coverage. Noridian does not intend to constrain coverage delineated in the policy. The main goal of the LCD was to provide guidance for coverage and allow reasonable assurance of payment for clinically indicated procedures addressed in the policy which heretofore had been unclear to some facilities. Should any issues arise stemming from this policy we will welcome feedback at that time.


A comment was received in support of the LCD.

Noridian appreciates the College of American Pathologists review and feedback. Such feedback is always welcomed to help assure the best policy based on current accepted medical practice therein optimizing care of the Medicare beneficiaries.


The following comment was received, “This LCD expands coverage under NCD 110.23 ‘Stem Cell Transplantation’. The NCD restricts payment to patients enrolled in a prospective clinical study and because NCDs supersede LCDs I believe the LCD cannot circumvent this coverage criteria. Is that correct? In other words, in order to receive coverage under Noridian’s LCD does it need to comport with the clinical study requirement?”

The purpose of the LCD is for clarification of coverage in place by Noridian for the entities addressed. It’s design neither supersedes nor circumvents provisions of National Coverage Determination (NCD 110.23) for Stem Cell Transplantation (Formerly 110.8.1). Rather than expansion of the NCD, it purports to alleviate provider concern for coverage and reimbursement of entities presently included for coverage and reimbursement by this Medicare Administrative Contractor.

The Local Coverage Determination relates to Section D. Other of NCD 110.23: All other indications for stem cell transplantation not otherwise noted above as covered or non-covered remain at local Medicare Administrative Contractor discretion.

Section B. lists Nationally Covered Indications for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) with 3 initially controversial entities (5/24/1996) which have now become less so. Multiple Clinical trials have opened and closed with available outcomes published. Similar studies are available in peer-reviewed publications for the entities considered in this LCD.

The coverage criteria for the original entities do not apply to the disease entities listed in this Local Coverage Determination; however, accurate and timely documentation of patient data, therapeutic procedure and outcome continue to be required for Medicare coverage and reimbursement, made available to the Medicare Contractor and CMS on request. The Contractor will monitor the utilization of the LCD for frequency and adherence to listed provisions for coverage and reimbursement.

Associated Documents

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